TitleYear PublishedCitation
Update on Cardiovascular Implantable Electronic Device Infections and Their Management: A Scientific Statement from the American Heart Association 2010

Baddour LM, Epstein AE, Erickson CC, Knight BP, Levison ME, Lockhart PB, Masoudi FA, Okum EJ, Wilson WR, Beerman LB, Bolger AF, Estes NA 3rd, Gewitz M, Newburger JW, Schron EB, Taubert KA; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; Council on Cardiovascular Disease in Young; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Nursing; Council on Clinical Cardiology; Interdisciplinary Council on Quality of Care; American Heart Association.
Circulation. 2010;121:458-77

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Abstract
Despite improvements in cardiovascular implantable electronic device (CIED) design, application of timely infection control practices, and administration of antibiotic prophylaxis at the time of device placement, CIED infections continue to occur and can be life-threatening. This has prompted the study of all aspects of CIED infections. Recognizing the recent advances in our understanding of the epidemiology, risk factors, microbiology, management, and prevention of CIED infections, the American Heart Association commissioned this scientific statement to educate clinicians about CIED infections, provide explicit recommendations for the care of patients with suspected or established CIED infections, and highlight areas of needed research.

Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management: This document was endorsed by the American Heart Association (AHA) 2009

Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH 3rd, Epstein LM, Friedman RA, Kennergren CE, Mitkowski P, Schaerf RH, Wazni OM; Heart Rhythm Society; American Heart Association.
Heart Rhythm. 2009;6:1085-104.

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Multicenter Experience with Extraction of the Riata/Riata ST ICD Lead2014

Maytin M, Wilkoff BL, Brunner M, Cronin E, Love C, Grazia Bongiorni M, Segreti L, Carrillo RG, Garisto JD, Kutalek S, Subzposh F, Fischer A, Coffey JO, Gangireddy SR, Saba S, Mittal S, Arshad A, O'Keefe RM, Henrikson CA, Belott P, John RM, Epstein LM.
Heart Rhythm. 2014;11:1613-8.

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Abstract
Background: In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial.

Objective: Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited.

Methods: We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers.

Results: Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P < .0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs. 17.7% failure; P = .23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P = .01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%).

Conclusion: Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.

Lead Extraction in the Contemporary Setting: The LExICon Study: An Observational Retrospective Study of Consecutive Laser Lead Extractions2010

Wazni O, Epstein LM, Carrillo RG, Love C, Adler SW, Riggio DW, Karim SS, Bashir J, Greenspon AJ, DiMarco JP, Cooper JM, Onufer JR, Ellenbogen KA, Kutalek SP, Dentry-Mabry S, Ervin CM, Wilkoff BL.
J Am Coll Cardiol. 2010;55:579-86.

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Abstract
Objectives: This study sought to examine the safety and efficacy of laser-assisted lead extraction and the indications, outcomes, and risk factors in a large series of consecutive patients.

Background: The need for lead extraction has been increasing in direct relationship to the increased numbers of cardiovascular implantable electronic devices.

Methods: Consecutive patients undergoing transvenous laser-assisted lead extraction at 13 centers were included.

Results: Between January 2004 and December 2007, 1,449 consecutive patients underwent laser-assisted lead extraction of 2,405 leads (20 to 270 procedures/site). Median implantation duration was 82.1 months (0.4 to 356.8 months). Leads were completely removed 96.5% of the time, with a 97.7% clinical success rate whereby clinical goals associated with the indication for lead removal were achieved. Failure to achieve clinical success was associated with body mass index <25 kg/m(2) and low extraction volume centers. Procedural failure was higher in leads implanted for >10 years and when performed in low volume centers. Major adverse events in 20 patients were directly related to the procedure (1.4%) including 4 deaths (0.28%). Major adverse effects were associated with patients with a body mass index <25 kg/m(2). Overall all-cause in-hospital mortality was 1.86%; 4.3% when associated with endocarditis, 7.9% when associated with endocarditis and diabetes, and 12.4% when associated with endocarditis and creatinine > or =2.0. Indicators of all-cause in-hospital mortality were pocket infections, device-related endocarditis, diabetes, and creatinine > or =2.0.

Conclusions: Lead extraction employing laser sheaths is highly successful with a low procedural complication rate. Total mortality is substantially increased with pocket infections or device-related endocarditis, particularly in the setting of diabetes, renal insufficiency, or body mass index <25 kg/m(2). Centers with smaller case volumes tended to have a lower rate of successful extraction.

Pacemaker Lead Extraction with the Laser Sheath: Results of the Pacing Lead Extraction with the Excimer Sheath (PLEXES) Trial1999

Wilkoff BL, Byrd CL, Love CJ, Hayes DL, Sellers TD, Schaerf R, Parsonnet V, Epstein LM, Sorrentino RA, Reiser C.
J Am Coll Cardiol. 1999;33:1671-6.

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Abstract
Objectives:
The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction.

Background: Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser light dissolves instead of tearing the tissue attachments.

Methods: A randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications.

Results: Complete lead removal rate was 94% in the laser group and 64% in the nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lead extraction was significantly reduced for patients randomized to the laser tools, 10.1 +/- 11.5 min compared with 12.9 +/- 19.2 min for patients randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS).

Conclusions: Laser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks.

Safety and Outcomes of Magnetic Resonance Imaging in Patients with Abandoned Pacemaker and Defibrillator Leads 2014

Higgins JV, Gard JJ, Sheldon SH, Espinosa RE, Wood CP, Felmlee JP, Cha YM, Asirvatham SJ, Dalzell C, Acker N, Watson RE Jr, Friedman PA.
Pacing Clin Electrophysiol. 2014;37:1284-90.

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Abstract
Introduction: Abandoned cardiovascular implantable electronic device (CIED) leads remain a contraindication to magnetic resonance imaging (MRI) studies, largely due to in vitro data showing endocardial heating secondary to the radiofrequency field. We tested the hypothesis that abandoned CIED leads do not pose an increased risk of clinical harm for patients undergoing MRI.

Methods: This single-center retrospective study examined the outcomes of patients who had device generators removed before MRI, rendering the device leads abandoned. Information was gathered through chart review. Data collected included lead model, pacing threshold before MRI, anatomic region examined, threshold data after generator reimplantation, and clinical patient outcome.

Results: Patients (n = 19, 11 men and eight women) ranged in age from 19 to 85 at the time of MRI. There was a mean of 1.63 abandoned leads at the time of imaging; none of the leads were MRI conditional. Of the three implantable cardioverter defibrillator (ICD) leads, two of three were dual coil. Most (31/35) of the scans performed were of the central nervous system, including head and spinal imaging. There were no adverse events associated with MRI in any of these patients with abandoned leads within 7 days of the scan. No lead malfunctions or clinically significant change in pacing thresholds were noted with generator reimplantation.

Conclusion: The use of MRI in patients with abandoned cardiac device leads appears feasible when performed under careful monitoring, with no adverse events, although the experience is small. MRI did not affect the function of leads that were subsequently reconnected to a cardiac device.

A Simple Infection-Control Protocol to Reduce Serious Cardiac Device Infections2014

Ahsan SY, Saberwal B, Lambiase PD, Koo CY, Lee S, Gopalamurugan AB, Rogers DP, Lowe MD, Chow AW.
Europace. 2014;16:1482-9.

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Abstract
Aim: Device infection is a serious complication and is considered procedure-related if occurring within 12 months of an intervention. We analysed the effectiveness of a simple infection-control protocol (ICP) at reducing cardiac device infections (CDIs) in a tertiary referral centre.

Methods and Results: Prior to the introduction of a new ICP, we retrospectively analysed all simple and complex device implants, related procedures, and infections over a 3-year period. A new protocol was implemented from November 2007, including antibiotic prophylaxis determined by risk stratification, improved glycaemic control, specific skin preparation, and closure techniques, as well as different diathermy settings. Follow-up data for all patients were collected. Risk factors for infection were compared between pre- and post-intervention groups to ensure that the populations were comparable. A cost analysis of CDI and a review of the commonly identified micro-organisms were also undertaken. One thousand seven hundred and ninety-eight procedures were performed between November 2004 and November 2007 and 981 procedures between November 2007 and May 2009. There were no significant differences in the risk factors for infection between the two groups. Following the introduction of the ICP, there was a 54% reduction in the incidence of CDI from 1.3 to 0.6% (P < 0.03; CI 0.25, 1.36). Most patients with CDI had negative blood cultures or grew Staphylococcus sp. The average cost was £30 958.40 per infection incident and the cost of the new ICP was minimal.

Conclusions: A significant reduction in CDI can be achieved with the introduction of a simple ICP with substantial cost savings.

In-Hospital Complications Associated with Reoperations of Implantable Cardioverter Defibrillators2014

Steckman DA, Varosy PD, Parzynski CS, Masoudi FA, Curtis JP, Sauer WH, Nguyen DT.
Am J Cardiol. 2014;114:419-26.

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Abstract
Repeat implantable cardioverter defibrillator (ICD) procedures are increasing and may be associated with higher risks for complications. To provide more information for clinical decision making, especially in light of recent defibrillator advisories, we examined a large national cohort to characterize repeat ICD procedural outcomes. Using data from the National Cardiovascular Data Registry (ICD Registry), we compared patient characteristics, reasons for ICD implantation, and associated in-hospital adverse events among 92,751 patients receiving their first device and 81,748 patients who underwent repeat procedures with (n = 31,057) and without (n = 50,691) lead involvement. Hierarchical multivariable logistic regression was used to determine the predictors of in-hospital complications. Complication rates were higher in those who underwent repeat ICD procedures with lead involvement (lead implantation or revision), compared with patients who underwent initial implants (3.2% vs 2.6%, p <0.001) or versus those with pocket-only (e.g., generator change only) procedures (3.2% vs 0.6%, p <0.001). There were significantly more in-hospital deaths, lead dislodgements, and infections requiring antibiotics in the lead involvement cohort. Compared with those who had a pocket-only procedure, the multivariable adjusted odds ratio of any complication were increased at 4.20 (95% confidence interval: 3.66 to 4.82, p <0.001) in patients who underwent repeat procedures with lead involvement excluding lead extraction or 7.11 (95% confidence interval: 5.96 to 8.48, p <0.001) in procedures involving lead extractions. In conclusion, repeat ICD procedures, when involving the addition or revision of a lead with or without concurrent lead extraction, are associated with higher complication rates compared with initial implants and with those who underwent pocket-only procedures.

Predicting the Difficulty of a Lead Extraction Procedure: The LED Index 2014

Bontempi L, Vassanelli F, Cerini M, D'Aloia A, Vizzardi E, Gargaro A, Chiusso F, Mamedouv R, Lipari A, Curnis A.
J Cardiovasc Med (Hagerstown). 2014;15:668-73.

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Abstract
Background: According to recent surveys, many sites performing permanent lead extractions do not meet the minimum prerequisites concerning personnel training, procedures' volume, or facility requirements. The current Heart Rhythm Society consensus on lead extractions suggests that patients should be referred to more experienced sites when a better outcome could be achieved. The purpose of this study was to develop a score aimed at predicting the difficulty of a lead extraction procedure through the analysis of a high-volume center database. This score could help to discriminate patients who should be sent to a referral site.

Methods: A total of 889 permanent leads were extracted from 469 patients. All procedures were performed from January 2009 to May 2012 by two expert electrophysiologists, at the University Hospital of Brescia. Factors influencing the difficulty of a procedure were assessed using a univariate and a multivariate logistic regression model. The fluoroscopy time of the procedure was taken as an index of difficulty. A Lead Extraction Difficulty (LED) score was defined, considering the strongest predictors.

Results: Overall, 873 of 889 (98.2%) leads were completely removed. Major complications were reported in one patient (0.2%) who manifested cardiac tamponade. Minor complications occurred in six (1.3%) patients. No deaths occurred. Median fluoroscopic time was 8.7 min (3.3-17.3). A procedure was classified as difficult when fluoroscopy time was more than 31.2 min [90th percentile (PCTL)].At a univariate analysis, the number of extracted leads and years from implant were significantly associated with an increased risk of fluoroscopy time above 90th PCTL [odds ratio (OR) 1.51, 95% confidence interval (CI) 1.08-2.11, P = 0.01; and OR 1.19, 95% CI 1.12-1.25, P < 0.001, respectively). After adjusting for patient age and sex, and combining with other covariates potentially influencing the extraction procedure, a multivariate analysis confirmed a 71% increased risk of fluoroscopy time above 90th PCTL for each additional lead extracted (OR 1.71, 95% CI 1.06-2.77, P = 0.028) and a 23% increased risk for each year of lead age (OR 1.23, 95% CI 1.15-1.31, P < 0.001). Further nonindependent factors increasing the risk were the presence of active fixation leads and dual-coil implantable cardiac defibrillator leads. Conversely, vegetations significantly favored lead extraction. The LED score was defined as: number of extracted leads within a procedure + lead age (years from implant) + 1 if dual-coil - 1 if vegetation. The LED score independently predicted complex procedure (with fluoroscopic time >90th PCTL) both at univariate and multivariate analysis. A receiver-operating characteristic analysis showed an area under the curve of 0.81. A LED score greater than 10 could predict fluoroscopy time above 90th PCTL with a sensitivity of 78.3% and a specificity of 76.7%.

Conclusion: The LED score is easy to compute and potentially predicts fluoroscopy time above 90th PCTL with a relatively high accuracy.

Heart Rhythm Society Members' Views on Pacemaker and Implantable Cardioverter-Defibrillator Reuse2014

Hughey AB, Desai N, Baman TS, Gakenheimer L, Hagan L, Kirkpatrick JN, Oral H, Eagle KA, Crawford TC.
Pacing Clin Electrophysiol. 2014;37:969-77.

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Abstract
Background: Reuse of cardiac implantable electronic devices (CIEDs) may help address the unmet need among patients in low- and middle-income countries (LMICs).

Methods: To examine Heart Rhythm Society (HRS) physicians' opinions regarding CIED reuse, an online survey eliciting attitudes toward CIED reuse was sent to all 3,380 HRS physician members.

Results: There were 429 responses (response rate 13%). A large majority of respondents agreed or strongly agreed that resterilization of devices for reimplantation in patients who cannot afford new devices may be safe (370, 87%) and, if proven to be safe, would be ethical (375, 88%). A total of 340 (81%) respondents would be comfortable asking their patients to consider donating their device, and 353 (84%) would be willing to reimplant a resterilized device if it were legal. The most commonly cited concerns about device reuse were infection (270, 64%) and device malfunction (125, 29%). Respondents from the United States and Canada had more favorable impressions of device reuse than respondents from other high-income countries (P < 0.05 for three of five positive statements regarding reuse), and were less likely to cite ethical concerns (P < 0.001). However, when responses from all high-income countries were compared with lower- and upper-middle income countries, there were no significant differences in the rates of approval.

Conclusions: HRS survey respondents support the concept of CIED reuse for patients in LMICs who cannot afford new devices. Studies are needed to demonstrate the clinical efficacy and safety of this practice and to identify potential barriers to adoption among physicians.

Perforated Tricuspid Valve Leaflet Resulting from Defibrillator Leads: A Review of the Literature 2014

Wilner BR, Coffey JO, Mitrani R, Carrillo RG.
J Cardiac Surgery. 2014;29:470-2.

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Abstract
Tricuspid valve (TV) perforation is a rare complication after implantable cardioverter defibrillator (ICD) and permanent pacemaker implantation. In reported cases of lead-related TV perforations, patients' present with symptoms months to years postimplantation. We describe a case where a patient presented with signs of severe TV regurgitation secondary to traumatic perforation of the septal leaflet two weeks after ICD implantation and review of the literature associated with this complication.

Clinical Significance of Collateral Superficial Vein across Clavicle in Patients with Cardiovascular Implantable Electronic Device2014

Hosoda J, Ishikawa T, Matsushita K, Matsumoto K, Sugano T, Ishigami T, Kimura K, Umemura S.
Circ J. 2014;78:1846-50.

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Abstract
Background: Obstruction of the access vein is a well-known complication after cardiovascular implantable electronic device (CIED) implantation. In that case, well-developed collateral superficial veins are frequently observed on the skin surface around the CIED. The aim of this study was to clarify the relationship between venous obstruction and development of a superficial vein across the clavicle.

Methods and Results: A total of 107 patients scheduled for generator replacement, device upgrade, or lead extraction were enrolled. The skin surface around the device was photographed. A 20-ml bolus of contrast medium was injected into a peripheral arm vein on the side of CIED implantation, and contrast venography was performed. Venous obstruction was defined as luminal diameter narrowing >75%. Venography showed venous obstruction in 27 patients (25.2%). There were no statistically significant differences in patient characteristics between the venous obstruction and no venous obstruction group. Of 107 patients, 44 (41.1%) had a superficial vein across the clavicle on the side of CIED implantation. The sensitivity of the presence of a superficial vein across the clavicle in the diagnosis of venous obstruction was 96.3% and specificity was 77.5% (P<0.001).

Conclusions: The presence of a superficial vein across the clavicle is useful for the prediction of venous obstruction in patients with CIED.

Influence of Vegetation Size on the Clinical Presentation and Outcome of Lead-Associated Endocarditis: Results from the MEDIC Registry2014

Greenspon AJ, Le KY, Prutkin JM, Sohail MR, Vikram HR, Baddour LM, Danik SB, Peacock J, Falces C, Miro JM, Naber C, Carrillo RG, Tseng CH, Uslan DZ.
JACC Cardiovasc Imaging. 2014;7:541-9.

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Abstract
Objectives: The purpose of this study was to determine whether the clinical presentation of lead-associated endocarditis (LAE) is related to the size of lead vegetations and how size is related to bacteriology and clinical outcomes.

Background: Cardiac implantable electronic device (CIED) infection may present as either local pocket infection or bloodstream infection with or without LAE. LAE is associated with significant morbidity and mortality.

Methods: The clinical presentation and course of LAE were evaluated by the MEDIC (Multicenter Electrophysiologic Device Cohort) registry, an international registry enrolling patients with CIED infection. Consecutive LAE patients enrolled in the MEDIC registry between January 1, 2009 and December 31, 2012 were analyzed. The clinical features and outcomes of 2 groups of patients were compared based on the size of the lead vegetation detected by echocardiography (> or <1 cm in diameter).

Results: There were 129 patients with LAE enrolled into the MEDIC registry. Of these, 61 patients had a vegetation <1 cm in diameter (Group I) whereas 68 patients had a vegetation ≥1 cm in diameter (Group II). Patients in Group I more often presented with signs of local pocket infection, whereas Group II patients presented with clinical evidence of systemic infection. Staphylococcus aureus was the organism most often responsible for LAE, whereas infection with coagulase-negative staphylococci was associated with larger vegetations. Outcomes were improved among those who underwent complete device removal. However, major complications were associated with an open surgical approach for device removal.

Conclusions: The clinical presentation of LAE is influenced by the size of the lead vegetation. Prompt recognition and management of LAE depends on obtaining blood cultures and echocardiography, including transesophageal echocardiography, in CIED patients who present with either signs of local pocket or systemic infection.

Coronary sinus lead extraction in CRT patients with CIED-related infection: risks, implications and outcomes2014

Lisy M, Schmid E, Kalender G, Stock UA, Doernberger V, Khalil M, Kornberger A.
Minerva Cardioangiol. 2014 Jun 19. [Epub ahead of print]

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Abstract
Aims: To examine risks, implications and outcomes of coronary sinus (CS) lead extraction in patients with infections of cardiac resynchronization therapy (CRT) systems.

Methods: 40 (65.5±11.1 years; 80% male) transvenous CS lead extraction procedures were performed between 2000--2011. Nine (22.5%) patients suffered from infection and included one sepsis (11.1%), two (22.2%) of lead and valve endocarditis, and four (44.4%) cases of pocket infection. CS lead extraction in the infection subgroup was performed between 14 days and more than five years after the last CIED--related surgical procedure.

Results: 42 CS and 35 non--CS leads were extracted. Leads extracted in the infection subgroup were significantly longer in situ (49.7±30.7 months) compared to the non--infection subgroup (19.2±28.6 months). Extraction in infected patients required more aggressive methods and longer exposure to radiation than non--infected. Procedural success without major complications was achieved in all patients. Minor post--procedural complications occurred in four (44.4%) of the infected and one (3.2%) of the non--infected patients and were surgical--related in three cases. Overall hospitalization times were significantly longer for the infection than for the non--infection subgroup (21.4±15.0 versus 9.6±6.9 days).

Conclusions: Our results support the concept of complete CIED--system removal in CIED-associated infection, regardless of whether or not infection appears to be limited to the generator pocket site, despite risk of heart failure, patient frailty and a high level of comorbidity. An interdisciplinary approach encompassing appropriate diagnostic, procedural and safety standards allows CS lead extraction in this high--risk subpopulation to be performed with excellent outcomes and low complication rates.

Cardiac Implantable Electronic Device Lead Extraction in Patients with Underlying Infection Using Open Thoracotomy or Percutaneous Techniques2014

Patel D, Khan F, Shah H, Bhattacharya S, Adelstein E, Saba S.
Cardiol J. 2014 May 20. [Epub ahead of print]

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Abstract
Background: Explanting infected cardiac implantable electronic devices (CIEDs) and extracting their associated leads can be performed percutaneously (EP) or via open-thoracotomy (OR) approach. In this study, we examined the characteristics and outcomes of infected CIED patients undergoing EP versus OR extraction procedures.

Methods: All patients (EP n=329 and OR n=24) who received lead extraction in the presence of an infected CIED from 2005 to 2010 at the University of Pittsburgh Medical Center were included in this study. Demographic and clinical characteristics were obtained from the electronic medical records. The Charlson comorbidity index (CCI) was used to adjust for severity of co-morbid conditions.

Results: Compared to the EP group, OR patients were more likely to have positive blood cultures, larger vegetations, and worse CCI scores. They also had higher total mortality rates at 1 (p=0.036), 6 (p=0.020), and 12 months (p=0.012) after the procedure. One-year survival after lead extractions was significantly better for the EP compared to the OR group (p=0.002) even after adjusting for other comorbid illnesses (HR=2.6, p=0.010) in a Cox regression model.

Conclusions: infected CIED patients undergoing open-chest lead extraction are sicker and have higher mortality rates compared to those undergoing percutaneous extraction. Randomized, prospective data are needed to determine whether the procedural strategy for lead extraction accounts in part for the difference in outcome.

Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision (Make It Clean): A Prospective Randomized Study2015

Lakkireddy D, Pillarisetti J, Atkins D, Biria M, Reddy M, Murray C, Bommana S, Shanberg D, Adabala N, Pimentel R, Dendi R, Emert M, Vacek J, Dawn B, Berenbom L.
Heart Rhythm. 2015 Jan 24. [Epub ahead of print]

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Abstract
Background: 
The fibrous capsule around cardiac implantable device generators is known to promote bacterial colonization and latent infection. Removal of the capsule during device replacement procedures may reduce infection rates but may increase hemorrhagic complications.

Objectives: The purpose of the study is to evaluate the effect of pocket capsule decortication procedure on infection and bleeding rates in patients undergoing device replacement procedures METHODS: In a prospective randomized single blind control study, patients undergoing device replacement, upgrade or lead extraction were randomized to Group A "with pocket revision" (n=131) and group B "without pocket revision" (n=127). Deep and superficial infection rates, bleeding and prolonged serous drainage were assessed during 12 months of follow up. Data were analyzed according to intention to treat principle.

Results: A total of 258 patients were enrolled in the study. Rates of generator change, upgrade and lead extraction/replacement were similar between both groups. There was no incidence of deep infection in either group at 12 months of follow up. There was no significant difference in the incidence of superficial infection between groups (1.5% vs. 4.7%, p = 0.13) during 12 months of follow up. There was a significant increase in acute hematoma formation in group A compared to group B (6.1% vs. 0.8%, p value 0.03). Two patients had to undergo hematoma evacuation in group A.

Conclusion: There was increased incidence of hematoma formation in group A with no effect on infection rates. Our study suggests that there is no benefit to performing empiric pocket revision.

Insulation Failure and Externalized Conductor of a Single-Coil Kentrox Lead: An Ongoing Story?2015

Bogossian H, Mijic D, Frommeyer G, Winter J.
J Cardiovasc Electrophysiol. 2015;26:226-7.

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Abstract
Conductor externalization is a frequent complication with the St. Jude Medical Riata lead. Single case reports also reported externalization of conductors for dual-coil Biotronik leads. Up to now, conductor externalization has not yet been reported for any single coil leads. We report for the first time an externalization of conductors in a Biotronik Kentrox single-coil implantable cardioverter defibrillator (ICD) lead. 

Multicenter Study of the Safety and Effects of Magnetic Resonance Imaging in Patients with Coronary Sinus Left Ventricular Pacing Leads2015

Sheldon SH, Bunch TJ, Cogert GA, Acker NG, Dalzell CM, Higgins JV, Espinosa RE, Asirvatham SJ, Cha YM, Felmlee JP, Watson RE Jr, Anderson JL, Brooks MH, Osborn JS, Friedman PA.
Heart Rhythm. 2015;12:345-9.

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Abstract
Background: 
Magnetic resonance imaging (MRI) in patients with left ventricular (LV) leads may cause tissue or lead heating, dislodgment, venous damage, or lead dysfunction.

Objective: The purpose of this study was to determine the safety of MRI in patients with LV pacing leads.

Methods: Prospective data on patients with coronary sinus LV leads undergoing clinically indicated MRI at 3 institutions were collected. Patients were not pacemaker-dependent. Scans were performed under pacing nurse, technician, radiologist, and physicist supervision using continuous vital sign, pulse oximetry, and ECG monitoring and a 1.5-T scanner with specific absorption rate <1.5 W/kg. Devices were interrogated pre- and post-MRI, programmed to asynchronous or inhibition mode with tachyarrhythmia therapies off (if present), and reprogrammed to their original settings post-MRI.

Results: MRI scans (n = 42) were performed in 40 patients with non-MRI conditional LV leads between 2005 and 2013 (mean age 67 ± 9 years, n = 16 [40%] women, median lead implant duration 740 days with interquartile range 125-1173 days). MRIs were performed on the head/neck/spine (n = 35 [83%]), lower extremities (n = 4 [10%]), chest (n = 2 [5%]), and abdomen (n = 1 [2%]). There were no overall differences in pre- and post-MRI interrogation LV lead sensing (12.4 ± 6.2 mV vs 12.9 ± 6.7 mV, P = .38), impedance (724 ± 294 Ω vs 718 ± 312 Ω, P = .67), or threshold (1.4 ± 1.1 V vs 1.4 ± 1.0 V, P = .91). No individual LV lead changes required intervention.

Conclusion: MRI scanning was performed safely in non-pacemaker-dependent patients with coronary sinus LV leads who were carefully monitored during imaging without clinically significant adverse effect on LV lead function.

Optimal Management of Riata Leads with No Known Electrical Abnormalities or Externalization: A Decision Analysis 2015

Pokorney SD, Piccini JP, Pokorney SD, Zhou K, Matchar DB, Love S, Zeitler EP, Lewis R, Piccini JP.
J Cardiovasc Electrophysiol. 2015;26:184-91.

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Abstract
Introduction: 
Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA) can develop conductor cable externalization and/or electrical failure. Optimal management of these leads remains unknown.

Methods and Results: A Markov model compared 4 lead management strategies: (1) routine device interrogation for electrical failure, (2) systematic yearly fluoroscopic screening and routine device interrogation, (3) implantation of new ICD lead with capping of the in situ lead, and (4) implantation of new ICD lead with extraction of the in situ lead. The base case was a 64-year-old primary prevention ICD patient. Modeling demonstrated average life expectancies as follows: capping with new lead implanted at 134.5 months, extraction with new lead implanted at 134.0 months, fluoroscopy with routine interrogation at 133.9 months, and routine interrogation at 133.5 months. One-way sensitivity analyses identified capping as the preferred strategy with only one parameter having a threshold value: when risk of nonarrhythmic death associated with lead abandonment is greater than 0.05% per year, lead extraction is preferred over capping. A second-order Monte Carlo simulation (n = 10,000), as a probabilistic sensitivity analysis, found that lead revision was favored with 100% certainty (extraction 76% and capping 24%).

Conclusions: Overall there were minimal differences in survival with monitoring versus active lead management approaches. There is no evidence to support fluoroscopic screening for externalization of Riata or Riata ST leads.

Surgical Management of Major Intrathoracic Hemorrhage Resulting from High-Risk Transvenous Pacemaker/Defibrillator Lead Extraction 2015

Caniglia-Miller JM, Bussey WD, Kamtz NM, Tsai SF, Erickson CC, Anderson DR, Moulton MJ.
J Card Surg. 2015;30:149-53.

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Abstract
A method, based on well-established trauma principles, is described for surgical management of serious intrathoracic bleeding complications that can occur during the extraction of pacemaker or defibrillator leads. Using this method, four patients who experienced rapid hemodynamic deterioration due to traumatic injury of the superior vena cava and its tributaries during defibrillator lead extraction underwent successful surgical repair. Perioperative preparation for high-risk lead extractions, management of major bleeding complications, and surgical repair techniques are discussed. Major bleeding complications can be managed effectively with this strategy leading to excellent overall success rates for extractions without mortality.

Tricuspid Regurgitation and Implantable Devices2015

Al-Bawardy R, Krishnaswamy A, Rajeswaran J, Bhargava M, Wazni O, Wilkoff B, Tuzcu EM, Martin D, Thomas J, Blackstone E, Kapadia S.
Pacing Clin Electrophysiol. 2015;38:259-66.

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Abstract
Background: 
There are limited and conflicting data regarding the prevalence of tricuspid regurgitation (TR) after cardiac device implantation (implantable cardioverter defibrillator [ICD]; permanent pacemaker [PPM]).

Objective: The goal of this study was to assess the prevalence of TR after cardiac device implantation and determine its clinical significance.

Methods: A total of 1,596 patients, who had cardiac devices implanted between 2005 and 2011 at the Cleveland Clinic and had at least one preimplantation echocardiogram and at least one postimplantation echocardiogram were included in this study. A total of 3,566 postimplantation echocardiograms were available for the 1,596 patients (median follow-up 10 months). The primary end point was postimplantation TR and the secondary end point was all-cause mortality after implantation. We have used a cumulative logistic nonlinear mixed-effects model to assess the temporal trend of TR prevalence and a parametric multiphase hazard model to assess survival.

Results: Of the 1,596 patients (mean age: 60 ± 10 years, 61% of patients were men), 985 (62%) had ICDs (including 334 patients with cardiac resynchronization therapy defibrillator) and 611 (38%) had PPMs. The prevalence of grade 3 or 4+ TR increased from 27% to 31% by 1 month and to 35% at 4 years. Accordingly, prevalence of grade 0/1+ TR decreased from 46% preimplantation to 37% at 1 month and to 32% at 4 years. Device type (ICD vs PPM) and the number of leads placed did not have an effect on postimplantation TR (P > 0.2). Right ventricular systolic pressure (RVSP) did not change over time (36 mm Hg baseline, 37.5 mm Hg by 3 months, and 37 mm Hg by 1 year). One-year and 5-year survival were 93% and 73%, respectively. Postimplantation TR was an independent risk factor for late death (P < 0.05).

Conclusion: Cardiac device implantation was associated with a small but significant increase in the prevalence of moderate and severe TR, both acutely and chronically after implantation. The increase in TR was similar with both ICD and PPM placement, which was not related to the number of leads implanted and not associated with a significant increase in RVSP. Postimplantation TR was associated with a higher risk of mortality.

Very Late Follow-Up of a Passive Defibrillator Lead under Recall: Do Failure Rates Increase during Long-Term Observation2015

Frey SM, Sticherling C, Kraus R, Ammann P, Kühne M, Osswald S, Schaer B.
Pacing Clin Electrophysiol. 2015 Jan 20. [Epub ahead of print]

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Abstract
Background: 
The Medtronic Sprint Fidelis lead (SFL; Medtronic Inc., Minneapolis, MN, USA) has a significantly impaired long-term survival, and active fixation leads fare worse than passive leads. The goal of this study was to present data of a series of passive SFL only with very long mean follow-up of more than 6 years.

Methods: Patients in whom a passive SFL was implanted in two large Swiss centers were followed. We excluded eight (5.5%) patients with a follow-up of <6 months. Patients who died or were lost during follow-up were censored at death or last device check, all others on January 31, 2014. We employed two different definitions of failure: strict = fracture with inappropriate discharge; sudden increase in impedance >1,500 or high-voltage impedance >100 Ohm; >300 nonphysiological short interventricular-intervals. Lenient = any of the above plus a linear increase in impedance >1,500 Ohm or a linear decrease in sensing to a level that treating cardiologists considered inappropriate.

Results: We included 137 patients. Age was 60 ± 12 years. Mean and median follow-up were 6.2 ± 2.1 and 6.8 (interquartile range 4.8-7.8) years. Applying the strict definition, 12 leads (8.8%) were replaced after 4.9 ± 2.4 years (range 1.2-8.1). Applying the lenient definition, 14 leads (10.2%) failed. Cumulative lead survival was 98.5% at 3, 96.9% at 4, 94.2% at 5, and 93.1% at 6 years. Leads "at risk" were: n = 122 (89%), 115 (84%), 101 (74%), and 88 (64%).

Conclusions: In this population with passive SFLs, 5-year lead survival is impaired with 94.2% based on 74% of leads "at risk" at this time point.

Endocardial Lead Extraction in the Polish Registry - Clinical Practice versus Current Heart Rhythm Society Consensus2014

Chudzik M, Kutarski A, Mitkowski P, Przybylski A, Lewek J, Małecka B, Smukowski T, Maciąg A, Smigielski J.
Arch Med Sci. 2014;10:258-65.

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Abstract
Introduction: 
Over the last 10 years, there has been an increasing number of patients with pacemaker (PM) and cardioverter-defibrillator (ICD). This study is a retrospective analysis of indications for endocardial pacemaker and ICD lead extractions between 2003 and 2009 based on the experience of three Polish Referral Lead Extraction Centers.

Material and Methods: Since 2003, the authors have consecutively retrospectively collected all cases and entered the information in the database. All patients which had indication for lead extraction according to Heart Rhythm Society Guidelines were included to final analyze. Between 2003 and 2005, the data were analyzed together. Since 2006, data have been collected and analyzed annually.

Results: In each year, a significant increase in lead extraction was observed. The main indications for LE were infections in 52.4% of patients. Nonfunctioning lead extraction constituted the second group of indications for LE in 29.7% of patients. During the registry period, the percentage of class I indications decreased from 80% in 2006 to only 47% in 2009. On the other hand, increasingly more leads were removed because of class 2, especially class 2b. In 2009, 40% of leads were extracted due to class 2b.

Conclusions: Polish Registry of Endocardial Lead Extraction 2003-2009, shows an increasing frequency of lead extraction. The main indication for LE is infection: systemic and pocket. An increase in class 2, especially 2b, LE indication in every center during the study period was found.

Mechanical and Electrical Dysfunction of Riata Implantable Cardioverter-Defibrillator Leads2014

Demirel F, Adiyaman A, Delnoy PP, Smit JJ, Ramdat Misier AR, Elvan A.
Europace. 2014;16:1787-94.

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Abstract
Aim:
 Riata implantable cardioverter-defibrillator leads are prone to failure by conductor externalization and/or electrical dysfunction. The objectives of this study were to determine the predictors of the Riata lead failure, to assess the association of conductor externalization and electrical lead failure, and to analyse the rates of lead failure over time.

Methods and Results: Of 273 implanted Riata leads in our centre, 197 were investigated according to the Riata recall protocol, including electrical measurements by device interrogation and annually fluoroscopy. During a mean follow-up period of 5.6 ± 1.4 years, Riata lead failure was 18.8% (37 of 197) for externalization and 17.3% (34 of 197) for electrical lead failure. Electrical lead failure was correlated with time after implant. Externalization and electrical dysfunction co-existed in only 6 of 197 (3%) patients and were not related (Phi's coefficient -0.013, P = 0.85). During the second annual screening, 145 (73.6%) patients underwent fluoroscopy and 9 patients had novel externalizations resulting in an incidence of 6.72%/patient/year which was higher than expected based on cross-sectional analysis. Besides, there was a significant increase in the extent of externalization (17.65 ± 11.14 mm vs. 21.77 ± 11.95 mm, P = 0.001). In multivariate Cox regression analysis, non-ischaemic cardiomyopathy and impaired LVEF were independent predictors of externalization, and 7 Fr lead was a predictor of electrical lead failure.

Conclusion: Riata leads show progressive and high externalization rates without correlation between externalization and electrical lead failure. Non-ischaemic cardiomyopathy and impaired LVEF are independent predictors of structural lead failure in cross-sectional analysis, whereas 7 Fr lead is a predictor of electrical lead failure.

Optimizing Lead Body Control During Lead Extractions: The "Felix Helix" Lead Compression Method2014

Yang F.
Heart Rhythm. 2014;11:1666-7.

Link to PubMed

Abstract
A crucial factor in the success of a lead extraction is maintaining control of the lead body. Control of the lead can be obtained by using multiple tools. A lead locking stylet is usually placed down the pace-sense conductor of the lead to be extracted and secured. Spectranetics (Colorado Springs, CO) offers a line of lead locking devices, and Cook Medical (Bloomington, IN) offers the Liberator Beacon Tip Locking Stylet. When the lead locking device or stylet is retracted more forcibly relative to the outer components of the lead, there is an increased chance that the inner components will unravel and control of the lead may be lost.

MRI and Cardiac Implantable Electronic Devices; Current Status and Required Safety Conditions 2014

van der Graaf AW, Bhagirath P, Götte MJ.
Neth Heart J. 2014;22:269-76.

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Abstract
Magnetic resonance imaging (MRI) has evolved into an essential diagnostic modality for the evaluation of all patient categories. This gain in popularity coincided with an increase in the number of implanted cardiac implantable electronic devices (CIEDs). Therefore, questions arose with regard to the MRI compatibility of these devices. Various investigators have reported the harmless performance of MRI in patients with conventional (non-MRI conditional) devices. The recently published European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronisation therapy (CRT) indicate that MRI can be safely performed in patients with an implanted pacemaker or ICD (MRI conditional or not), as long as strict safety conditions are met. This is a major modification of the former general opinion that patients with a pacemaker or ICD were not eligible to undergo MRI. This review paper attempts to elucidate the current situation for practising cardiologists by providing a clear overview of the potential life-threatening interactions and discuss safety measures to be taken prior to and during scanning. An overview of all available MRI conditional devices and their individual restrictions is given. In addition, an up-to-date safety protocol is provided that can be used to ensure patient safety before, during and after the scan. Key points • Historically, MRI examination of patients with a CIED has been considered hazardous. • Ongoing advances in technology and increasing usage of MRI in clinical practice have led to the introduction of MRI conditional CIEDs and to more lenient regulations on the examination of patients with non-conditional CIEDs. • MRI investigations can be performed safely in selected patients when adhering to a standardised up-to-date safety protocol.

Risk Factors for 1-Year Mortality among Patients with Cardiac Implantable Electronic Device Infection Undergoing Transvenous Lead Extraction: The Impact of the Infection Type and the Presence of Vegetation on Survival 2014

Tarakji KG, Wazni OM, Harb S, Hsu A, Saliba W, Wilkoff BL.
Europace. 2014;16:1490-5.

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Abstract
Aims:
 Infections of cardiac implantable electronic devices (CIEDs) are infrequent but carry significant morbidity and mortality. We aimed to assess risk factors for 1-year mortality among patients with CIED infection and to evaluate if the type of infection and the presence of vegetation affect survival.

Methods and Results: We reviewed records of all patients with infected CIEDs who underwent transvenous lead extraction at our tertiary care centre between 2002 and 2008. Patients who presented with infection involving the device pocket were classified as 'pocket infection', and those who presented with bacteraemia with or without vegetation and a pocket that looked benign were classified as 'endovascular infection' (EVI). One-year mortality was examined using the social security death index. Five hundred and two patients were identified (68.5 ± 15 years); 289 (58%) had pocket infection and 213 (42%) had EVI. One-year mortality rate was 20%. Using multivariable Cox regression model, EVI was associated with significantly higher 1-year mortality (hazard ratio 2.1, P-value 0.0008). Among patients with EVI, 100 patients had vegetation on transoesophageal echo; however, there was no difference in 1-year mortality between patients with EVI and vegetation compared with patients with EVI and no vegetation (27, 27 vs. 40, 35%; P-value 0.188). Risk factors for 1-year mortality among patients with EVI included renal failure, worse functional class, and bleeding requiring transfusion. The presence of vegetation was not associated with increased 1-year mortality.

Conclusion: One-year mortality is higher among patients with EVI compared with patients with pocket infection; this increased mortality does not seem to be related to the presence of vegetations.

Cardiac Implanted Electronic Device-Related Infective Endocarditis: Clinical Features, Management, and Outcomes of 80 Consecutive Patients2014

Kim DH, Tate J, Dresen WF, Papa FC Jr, Bloch KC, Kalams SA, Ellis CR, Baker MT, Lenihan DJ, Mendes LA.
Pacing Clin Electrophysiol. 2014;37:978-85.

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Abstract
Background:
 The use of cardiac implantable electronic devices (CIEDs) has expanded dramatically over the past decade, but net clinical benefit has been curtailed by increasing infectious complications. In particular, CIED-related infectious endocarditis (IE) is a serious condition with significant morbidity and mortality.

Methods: We performed a single-center, retrospective study between July 2006 and February 2011 with CIED-related IE, defined by either lead vegetations detected on echocardiography or by fulfilling Duke criteria for definite endocarditis. Clinical parameters and outcomes were detailed by electronic medical record review and vital status was confirmed by the Social Security Death Index.

Results: Eighty patients (median age 67, interquartile range 56-75, 58 M/22 F) were diagnosed with CIED-related IE. Overall mortality was 36% with a median time to death of 95 days from presentation. Over half (52%) of the deaths were infection related with a median time to death of 29 days. Multivariate analysis showed methicillin-resistant Staphylococcus aureus (MRSA) infection (odds ratio [OR] 0.158; 95% confidence interval [CI], 0.047-0.534; P = .003) and concomitant valve endocarditis (OR 0.141, CI 0.041-0.491, P = .002) independently predicted mortality.

Conclusion: In this contemporary series, all-cause mortality in patients with CIED-related IE was high with a short time to death from onset of infection. MRSA and concomitant valve infection were the most powerful independent predictors of mortality.

Fluoroscopic and Electrical Assessment of Implantable Cardioverter Defibrillator Leads: A Prospective Observational Study2014

McKeag NA, Hodkinson EC, Noad RL, Kodoth VN, Ashfield K, Wilson CM, McEneaney DJ, Roberts MJ.
Pacing Clin Electrophysiol. 2014;37:1538-43.

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Abstract
Background:
 Insulation defects resulting in conductor externalization (CE) have been reported in the Riata family of implantable cardioverter defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA). The aim of this study was to identify, prospectively, the rate of CE and outcomes following this, within a group of patients with a Riata ICD lead.

Methods: Patients with a Riata ICD lead attended for fluoroscopic screening and electrical assessment of the lead at yearly intervals between 2010 and 2012.

Results: One hundred and forty patients had no or borderline evidence of CE on initial assessment in 2010. These patients were prospectively followed for 3 years (304.6 patient-years). During this time, 11 patients developed definite CE, equating to an event rate of 3.6 (95% confidence intervals: 1.8-6.5) per 100 patient-years of follow-up. Of those patients developing definite CE, one patient had the ICD lead explanted (for reasons unrelated to CE) and no patients died. CE was not associated with any electrical abnormalities of the ICD lead.

Conclusions: CE was observed at a rate of 3.6 per 100 patient-years of follow-up, in 140 individuals with a Riata ICD lead and no definite evidence of CE at baseline.

Prospective Nationwide Fluoroscopic and Electrical Longitudinal Follow-up of Recalled Riata Defibrillator Leads in Denmark 2014

Larsen JM, Nielsen JC, Johansen JB, Haarbo J, Petersen HH, Thøgersen AM, Hjortshøj SP.
Heart Rhythm. 2014;11:2141-7.

Link to Abstract on PubMed

Abstract
Background:
 Recalled St. Jude Medical Riata defibrillator leads are prone to insulation failures with externalized conductors (ECs). Longitudinal studies are needed to guide lead management.

Objective: The purpose of this study was to describe the dynamic nature of EC and the association with electrical abnormalities and lead extraction outcomes.

Methods: A nationwide cohort established in 2012 of 295 patients with recalled Riata leads with dwell time 5.1 ± 1.1 years, 34 ECs, and 19 electrical abnormalities were followed until death, lead discontinuation with fluoroscopy, or a new 2013 screening with fluoroscopy and device interrogation.

Results: Fluoroscopic follow-up of 239 patients with normal baseline fluoroscopy revealed incident overt EC in 8 leads and borderline EC in 2 leads after 1.1 ± 0.2 years, with an incidence rate of 3.7 per 100 person-years (95% confidence interval 2.0-6.9). Fluoroscopic follow-up in 27 patients with baseline EC showed an increase in EC length of 4 ± 1 mm (P <.001) after 1.1 ± 0.3 years. Electrical follow-up in 276 patients with normal baseline electrical function demonstrated 20 incident electrical abnormalities after 1.0 ± 0.3 years, with an incidence rate of 7.1 per 100 person-years (95% confidence interval 4.6-11.0). This rate was significantly higher in leads with baseline EC, with an adjusted incidence rate ratio of 4.4 (95% confidence interval 1.7-11.5, P = .002). In 15 extractions, all leads were removed, with 2 major complications.

Conclusion: The development of EC is a dynamic process despite long lead dwell time. ECs are associated with a higher risk of electrical abnormalities. Therefore, lead replacement should be considered, especially in patients with a long life expectancy.

Safety of Transvenous Lead Extraction According to Center Volume: A Systematic Review and Meta-Analysis 2014

Di Monaco A, Pelargonio G, Narducci ML, Manzoli L, Boccia S, Flacco ME, Capasso L, Barone L, Perna F, Bencardino G, Rio T, Leo M, Di Biase L, Santangeli P, Natale A, Rebuzzi AG, Crea F.
Europace. 2014;16:1496-507.

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Abstract
Background: 
Transvenous lead extraction (TLE) is a complex invasive procedure and the experience of the operator and the team is a major determinant of procedural outcomes.

Aim: Because of very limited data available on minimum procedural volumes to enable training and ongoing competency for TLEs, we performed a meta-analysis aimed at assessing the outcomes of TLE in the centres with low, medium, and high volume of procedures.

Methods: Of the 280 papers initially retrieved until February 2013, 66 observational studies met inclusion criteria and were included in at least one stratified meta-analysis: 17 were prospective studies; 47 had a retrospective design; and 2 were defined 'experience studies'. We included only articles published after the introduction of laser technique (year 1999). We divided the studies in low, medium, and high volume centres utilizing either the European Heart Rhythm Association (EHRA) or Lexicon classification criteria.

Results: When meta-analyses were carried out separately for the studies with larger and smaller sample sizes, either using EHRA or Lexicon classification criteria, no clear differences emerged in the combined rate of major complications or intraoperative deaths. In contrast, both minor complications and mortality at 30 days decreased as centre volume increased.

Conclusions: In our meta-analysis of observational studies, patients who have been treated in higher volume centres have a lower probability of minor complications and death at 30 days regardless of the infection rate, length of lead duration, type of device, and type of extraction.

Prevalence of Venous Occlusion in Patients Referred for Lead Extraction: Implications for Tool Selection2014

Li X, Ze F, Wang L, Li D, Duan J, Guo F, Yuan C, Li Y, Guo J.
Europace. 2014;16:1795-9.

Link to Abstract on PubMed

Abstract
Aims:
 Data concerning the incidence of venous obstruction in patients referred for lead extraction is limited. Thus, we aimed to assess the incidence of venous obstruction in patients referred for lead extraction and the implications for tool selection.

Methods and Results: Contrast venography of the access vein was obtained in 202 patients (147 men; mean age, 62.4 ± 14.5 years) scheduled for lead extraction. The indication for lead extraction included infection (n = 145, 72%) and other causes (n = 57, 28%). Two patients with device infection had superior vena caval occlusion. Access vein occlusion occurred in 6 (11%) patients without infection vs. 46 (32%) patients with infection [P = 0.002; odds ratio (OR) 3.94; 95% confidence interval (CI) 1.58-9.87]. No significant differences between occluded and non-occluded patients were seen for age, sex, device type, number of leads, time from implant of the initial lead, or anticoagulation therapy (all P>0.05). Procedural duration and fluoroscopy exposure time were significantly lower in the open group than in the occluded group (P < 0.05). Patients with venous occlusion required more advanced tools for lead extraction, such as dilator sheaths, evolution sheaths, and needle's eye snares (P = 0.019).

Conclusion: Both systemic and local infections are associated with increased risk of access vein occlusion. We found no support for the hypothesis that venous occlusion increases with the number of leads present. Lead extraction was more difficult in patients with venous occlusion, requiring advanced tools and more time.

Generator Replacement Is Associated with an Increased Rate of ICD Lead Alerts2014

Lovelock JD, Cruz C, Hoskins MH, Jones P, El-Chami MF, Lloyd MS, Leon A, DeLurgio DB, Langberg JJ.
Heart Rhythm. 2014;11:1785-9.

Link to Abstract on PubMed

Abstract
Background: 
Lead malfunction is an important cause of morbidity and mortality in patients with an implantable cardioverter-defibrillator (ICD). We have shown that the failure of recalled high-voltage leads significantly increases after ICD generator replacement. However, generator replacement has not been recognized as a predictor of lead failure in general.

Objective: The purpose of this study is to assess the effect of ICD generator exchange on the rate of ICD lead alerts.

Methods: A time-dependent Cox proportional hazards model was used to analyze a database of remotely monitored ICDs. The model assessed the impact of generator exchange on the rate of lead alerts after ICD generator replacement.

Results: The analysis included 60,219 patients followed for 37 ± 19 months. The 5-year lead survival was 99.3% (95% confidence interval 99.2%-99.4%). Of 60,219 patients, 7458 patients (12.9%) underwent ICD generator exchange without lead replacement. After generator replacement, the rate of lead alerts was more than 5-fold higher than in controls with leads of the same age without generator replacement (hazard ratio 5.19; 95% confidence interval 3.45-7.84). A large number of lead alerted within 3 months of generator replacement. Lead alerts were more common in patients with single- vs dual-chamber ICDs and in younger patients. Sex was not associated with lead alerts.

Conclusion: Routine generator replacement is associated with a 5-fold higher risk of lead alert compared to age-matched leads without generator replacement. This suggests the need for intense surveillance after generator replacement and the development of techniques to minimize the risk of lead damage during generator replacement.

Prospective Long-term Evaluation of Optim-insulated (Riata ST Optim and Durata) Implantable Cardioverter-Defibrillator Leads2014

Cairns JA, Epstein AE, Rickard J, Connolly SJ, Buller C, Wilkoff BL, Pogue J, Themeles E, Healey JS.
Heart Rhythm. 2014;11:2156-62.

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Abstract
Background: 
St Jude Medical Optim-insulated implantable cardioverter-defibrillator leads were designed to impart lubricity, strength, and abrasion resistance while maintaining flexibility and biostability. No long-term prospective follow-up data have been published.

Objective: The objective of this study was to determine the rates of all-cause mechanical failure and its subtypes (conductor fracture, insulation abrasion, externalized conductors, and other mechanical failures) in a prospective cohort of Optim-insulated implantable cardioverter-defibrillator leads.

Methods: St Jude Medical established 3 prospective registries and enrolled 11,016 leads implanted in 10,835 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reports (verified by expert staff using detailed algorithms), and documentation of lead revisions or inactivation, study withdrawal, and death. The Population Health Research Institute (McMaster University) was engaged to review database functions, adjudicate all potential mechanical lead failures, and conduct independent analyses of the data.

Results: During a median follow-up of 3.2 years, there were 51 mechanical failures (0.46%), with 99.0% survival free of this outcome by 5 years of follow-up. Freedom from conductor fracture was identified in 99.4% and from all-cause abrasion in 99.8% of the leads, and there were no reports of externalized conductors. There were no significant differences in survival among Durata DF4, Durata DF1, and Riata ST Optim leads.

Conclusion: Over a mean follow-up of 3.2 years, Optim-insulated leads have low rates of all-cause mechanical failure and no observed externalized conductors. Independent analyses of these registries are designed to provide reliable long-term follow-up information and are ongoing.

Major Predictors of Fibrous Adherences in Transvenous Implantable Cardioverter-Defibrillator Lead Extraction2014

Segreti L, Di Cori A, Soldati E, Zucchelli G, Viani S, Paperini L, De Lucia R, Coluccia G, Valsecchi S, Bongiorni MG.
Heart Rhythm. 2014;11:2196-201.

Link to Abstract on PubMed

Abstract
Background: 
Percutaneous removal of implantable cardioverter-defibrillator (ICD) leads is a difficult procedure because of the consequence of massive fibrous tissue growth along the lead.

Objective: The purpose of this study was to describe the occurrence and location of fibrous adherences in ICD lead extraction and to identify potential predictors among patient and lead characteristics.

Methods: We studied 637 consecutive patients who underwent transvenous extraction of 678 ICD leads from 1997 to 2013.

Results: Procedural success rate was 99%, without major complications. Areas of adherence were found in the subclavian vein (78%), innominate vein (65%), superior vena cava (66%), and heart (73%). Dwell-time, passive fixation, and dual-coil lead design were independently associated with adherences. Dual-coil lead design was associated with adherences in the innominate vein and superior vena cava, whereas coil treatment (eg, expandable polytetrafluoroethylene-coated or medical adhesive back-filled strategies) prevented adherences. Passive fixation mechanism was associated with adherences in the heart.

Conclusion: ICD leads, after long dwell-time, are affected by fibrous adherences uniformly distributed along the lead course. Lead features represent major predictors of the phenomenon. Careful lead selection is recommended at the time of implantation to prevent adherences. In addition, lead-related risk stratification is mandatory before a transvenous extraction procedure.

Management of Malfunctioning and Recalled Pacemaker and Defibrillator Leads: Results of the European Heart Rhythm Association Survey2014

Grazia Bongiorni M, Dagres N, Estner H, Pison L, Todd D, Blomstrom-Lundqvist C, Scientific Initiative Committee, European Heart Rhythm Association.
Europace. 2014;16:1674-8.

Link to Abstract on PubMed

Abstract
The aim of this survey was to describe the different strategies regarding the management of malfunctioning and recalled pacemaker and defibrillator leads across Europe. A questionnaire has been designed to assess the current practice and physician's approach to the management of leads which are faulty, unnecessary, and/or recalled. Responses to the questionnaire were received from 34 hospitals-members of the European Heart Rhythm Association (EHRA) electrophysiology (EP) research network. The survey involved both very high and low volume implanting centres, with 85% of the responding centres performing lead extraction. The survey provides a panoramic view of operator's decision making in the field of malfunctioning, recalled, and redundant leads and outlines a common point of view on lead abandonment and factors influencing the decision about lead extraction. The main factors strongly influencing the decision making were patient's age (59%), the presence of the damaged leads (44%), and the lead dwelling time (44%). Regarding the lead abandonment, the main concern (61%) was the potential greater difficulty associated with lead extraction in the future. High volume extracting centres showed a greater propensity to removing the malfunctioning or recalled leads compared with low volume or non-extracting centres. This EP Wire survey gives a snapshot of the operators' approaches and options regarding redundant, malfunctioning, and recalled lead management and may form the basis for future prospective research on this topic.

Radiographic Predictors of Lead Conductor Fracture 2014

Krahn AD, Morissette J, Lahm R, Haddad T, Baxter WW, McVenes R, Crystal E, Ayala-Paredes F, Cameron D, Verma A, Simpson CS, Exner DV, Birnie DH.
Circ Arrhythm Electrophysiol. 2014;7:1070-7.

Link to Abstract on PubMed

Abstract
Background: 
Lead fracture is a limiting factor in high voltage lead durability. Fractures noted with the Medtronic Fidelis leads provide an opportunity to examine factors captured on implant chest x-ray that correlate with risk for lead conductor fracture. We evaluated contributory factors in a large population of fractures.

Methods and Results: We conducted a retrospective case-control study at 8 Canadian centers that routinely capture anterior posterior and lateral chest x-rays within 2 weeks of implant. Cases were patients that experienced confirmed Medtronic Fidelis 6949 lead fracture based on standard definitions, matched one-to-one to controls for date of implant, sex, and age with normally functioning Fidelis leads from the same center. Select chart data and x-rays were collected for all patients. Radiographic measurements by ≥2 individuals per case/control were blinded to patient status. The data were analyzed using a time to failure multivariable Cox proportional hazards model with stratification for each matched pair. X-ray pairs from 111 fracture patients were compared with 111 controls (age 61.5±12.8 years, 75% male, 221 model 6949 leads). Six parameters included in the statistical analysis were significantly associated with risk of fracture, including slack/tortuosity measures, pulse generator and superior vena cava coil location, and angle of lead exit from the pocket.

Conclusions: Pocket, intravascular and intracardiac lead characteristics on x-ray correlate with risk of lead conductor fracture. These observations may be useful to direct implant technique to optimize lead durability. Validation in larger populations and other lead models may inform the application of these results.

Radiographic and Electrocardiography-Gated Noncontrast Cardiac CT Assessment of Lead Perforation: Modality Comparison and Interobserver Agreement 2014

Balabanoff C, Gaffney CE, Ghersin E, Okamoto Y, Carrillo R, Fishman JE.
J Cardiovasc Comput Tomogr. 2014;8:384-90.

Link to Abstract on PubMed

Abstract
Background: 
Pacemaker or implantable cardioverter-defibrillator lead extraction may be required because of infection, malfunction, or breakage. The preprocedural identification of lead tip position may help ensure safe performance of the procedure.

Objective: To analyze the ability of chest radiography and CT imaging to characterize lead tip position and identify perforation in a population of patients who underwent lead extraction.

Methods: Among patients who underwent lead extraction between November 2008 and April 2011, a nonrandom subset of 50 patients with 116 leads was selected for retrospective analysis. All patients had undergone chest radiography and thin-section electrocardiography-gated noncontrast cardiac CT. Two radiologists independently evaluated the imaging studies, using oblique multiplanar image reconstruction techniques for the CT examinations. Beam hardening artifacts were graded (0-3). Likelihood of perforation on each imaging study was graded on a 5-point scale.

Results: Among 116 leads, 17 were identified as perforated on CT, 12 leads were equivocal, and 87 were not perforated. Interobserver agreement for CT perforation vs nonperforation was good (κ = 0.71); weighted kappa for the entire 5-point scale was moderate (κ = 0.54). Beam hardening artifacts were common, with a mean value of 2.1. The 2 observers identified perforation on chest radiography with an average sensitivity of 15% compared with CT. The 2 observers did not agree on any cases of chest radiographic perforation (κ = -0.1).

Conclusion: Electrocardiography-gated noncontrast cardiac CT imaging with oblique multiplanar analysis can identify potential lead perforation with a moderate-to-good level of interobserver agreement. Chest radiography demonstrates poor sensitivity and interobserver agreement compared with CT

Compression Coil Provides Increased Lead Control in Extraction Procedures2014

Starck CT, Stepuk A, Holubec T, Steffel J, Stark JW, Falk V.
Europace. 2014 Oct 26. [Epub ahead of print]

Link to Abstract on PubMed

Abstract
​Aims: 
We investigated a new lead extraction tool (Compression Coil; One-Tie, Cook Medical) in an experimental traction force study.

Methods and Results: On 13 pacemaker leads (Setrox JS53, Biotronik) traction force testing was performed under different configurations. The leads were assigned to three groups: (i) traction force testing without central locking stylet support (n = 5), (ii) traction force testing with the use of a locking stylet (Liberator, Cook Medical) and a proximal ligation suture (n = 4), (iii) traction force testing with the use of a locking stylet and a compression coil (n = 4). The following parameters were obtained for all groups: stress-strain curves, maximal forces, elastic modulus, post-testing lead length and lead elongation. In Groups 2 and 3 retraction of the locking stylet within the lead was measured [lead tip-locking stylet distance (LTLSD)]. Maximal forces for the three groups were: (i) 28.3 ± 0.3 N; (ii) 30.6 ± 3.0 N; (iii) 31.6 ± 2.9 N (1 vs. 2, P = 0.13; 1 vs. 3, P = 0.04; 2 vs. 3, P = 0.65). Elastic modulus was (i) 22.8 ± 0.1 MPa; (ii) 2830.8 ± 351.1 MPa; (iii) 2447.0 ± 510.5 MPa (1 vs. 2, P < 0.01; 1 vs. 3, P < 0.01; 2 vs. 3, P = 0.26). Mean LTLSD in Group 2 was 19.8 ± 3.2 cm and was 13.8 ± 1.7 cm in Group 3 (P = 0.02). The ratio of LTLSD/post-testing lead length was 0.37 ± 0.03 for Group 2 and 0.24 ± 0.03 for Group 3 (P < 0.01).

Conclusion: The application of a compression coil leads to an increased lead control expressed by less retraction of the locking stylet within the lead. This enables improved central support of extraction sheaths in the case of challenging extraction procedures.

Longitudinal Follow-up of Riata Leads Reveals High Annual Incidence of New Conductor Externalization and Electrical Failure2014

Steinberg C, Sarrazin JF, Philippon F, Champagne J, Bouchard MA, Molin F, Nault I, Blier L, O'Hara G.
J Interv Card Electrophysiol. 2014;41:217-22.

Link to Abstract on PubMed

Abstract
Background and Purpose: 
Riata(TM) defibrillation leads are susceptible to conductor externalization. The point prevalence of insulation defect in Riata(TM) leads is up to 33 %, but prospective data concerning incidence of new lead abnormalities are lacking. The purpose of our study was to determine the annual incidence of new conductor externalizations and electrical lead failure.

Methods: A prospective observational study was conducted at a single tertiary center. One hundred forty-one patients were followed over 12 months. A posterior-anterior (PA)/lateral chest x-ray (CXR) with zooming was performed at baseline and at 12 months to screen for conductor externalization. Electrical abnormalities and clinical outcome were also assessed.

Results: The overall incidence of new insulation defects was 8.5 % at 12 months. High-risk leads for new conductor externalization were lead models 1580, 1582, and 1590 with an annual rate of 11.9, 11.1, and 10 %, respectively. New conductor externalizations were three times more common in 8 Fr leads compared to 7 Fr leads. The overall incidence of new electrical dysfunction was 6.4 % at 12 months. Electrical dysfunction was significantly higher in abnormal leads (25 % [3/12], 4.7 % [6/129]; p = 0.03) and mostly driven by high ventricular pacing thresholds. There was no difference in inappropriate shock or failure of high-voltage therapy.

Conclusion: The annual incidence of new insulation defects in Riata(TM) leads is much higher than previously reported. Lead models 1580, 1582, and 1590 are at highest risk for new conductor externalization. Electrical dysfunction in Riata(TM) leads is also much higher than reported and is associated with conductor externalization.

Virtual Reality Lead Extraction as a Method for Training New Physicians: A Pilot Study2014

Maytin M, Daily TP, Carillo RG.
Pacing Clin Electrophysiol. 2014 Dec 12. [Epub ahead of print]

Link to Abstract on PubMed

Abstract
Background: 
It is estimated that the demand for transvenous lead extraction (TLE) has reached an annual extraction rate of nearly 24,000 patients worldwide. Despite technologic advances, TLE still has the potential for significant morbidity and mortality. Complication rates with TLE directly parallel operator experience. However, obtaining adequate training during and postfellowship can be difficult. Given the potential for catastrophic complications and the steep learning curve (up to 300 cases) associated with this procedure, we sought to validate a virtual reality (VR) lead extraction simulator as an innovative training and evaluation tool for physicians new to TLE.

Methods: We randomized eight electrophysiology fellows to VR simulator versus conventional training. We compared procedural skill competency between the groups using simulator competency, tactile measurements, markers of proficiency and attitudes, and cognitive abilities battery.

Results: Practical skills and simulator complications differed significantly between the VR simulator and conventional training groups. The VR simulator group executed patient preparation and procedure performance better than the conventional group (P < 0.01). All four fellows randomized to conventional training experienced a simulator complication (two superior vena cava [SVC] tears, three right ventricle [RV] avulsions) versus one fellow in the VR simulator group (one SVC tear) (P = 0.02). Tactile measurements revealed a trend toward excess pushing versus pulling forces among the conventionally trained group. The time for lead removal was also significantly higher in the conventional training group (12.46 minutes vs 5.54 minutes, P = 0.02). There was no significant difference in baseline or posttraining cognitive ability.

Conclusions: We contend that the implementation of alternative training tools such as a VR simulation model will improve physician training and allow for an innovative pathway to assess the achievement of competency.

Rates of and Factors Associated with Infection in 200,909 Medicare Implantable Cardioverter-Defibrillator Implants: Results from the National Cardiovascular Data Registry2014

Prutkin JM, Reynolds MR, Bao H, Curtis JP, Al-Khatib SM, Aggarwal S, Uslan DZ.
Circulation. 2014;130:1037-43.

Further Observations on a New Wound Closure Technique for Cardiac Implantable Electronic Devices: Single Center Experience2015

Zak PW, Welch M, Kanjwal K, Grubb BP.
The Journal of Innovations in Cardiac Rhythm Management. 2015. [epub ahead of print]

Troubleshooting during a challenging high-risk pacemaker lead extraction: A case report and review of the literature2015

Rizkallah J, Kent W, Kuriachan V, Burgess J, Exner D5.
BMC Res Notes. 2015;8:94

Link to Abstract on PubMed

Abstract
Background:
The use of cardiac implantable electrical devices continues to increase with the validation of new beneficial indications. While the risks of device implantation decreased significantly over time, significant risk remains associated with their extraction when indicated. A high-risk pacemaker lead extraction case is described, wherein a chronically implanted lead that had perforated the right atrium was successfully removed without the need for cardiopulmonary bypass. In this report we share our approach to this challenging extraction case and describe an infrequently utilized off-pump hybrid technique that we term the "lead-inverting stitch".

Case Presentation: A 74 year-old Caucasian woman with complete heart block and remote pacemaker implantation presents with a swollen and erythematous infected pacemaker pocket necessitating device extraction. Chest computerized tomographic imaging revealed a chronically perforating right atrial lead tip approximately 2 cm within the pericardial space. A successful hybrid transvenous and open surgical extraction approach was undertaken without the need for cardiopulmonary bypass; this was made possible due to a successfully positioned "lead-inverting stitch".

Conclusion: Implantable cardiac electrical device infections are amongst the most dreaded post implant complications. Risks of device extraction are further complicated in cases of chronic lead perforations. Extraction strategies that avoid cardiopulmonary bypass initiation are preferred.

Increased late complex device infections are determined by cardiac resynchronization therapy-defibrillator infection 2015

Unsworth JD, Zaidi A, Hargreaves MR.
Europace. 2015 Apr 16. [Epub ahead of print]

Link to Abstract on PubMed

Abstract
Aims:
The incidence of cardiac device infection (CDI) more than 12 months following complex device implant (late infection) has not been extensively reported. Our objective was to compare both early (within 12 months) and late infection rates following complex device implantation.

Methods and Results: Patients who received either a cardiac resynchronization therapy (CRT) device with or without a defibrillator (CRT-D or CRT-P), or a defibrillator alone [implantable cardioverter-defibrillator (ICD)], between March 2005 and December 2011 were studied retrospectively. The study endpoint was device removal due to CDI. A total of 496 patients underwent complex device implantation. There were 1883 patient years of follow-up. Mean age was 73 ± 8 years. Seventy per cent were male. Overall, 24 infections (4.8%) were identified; 6 infections were within 12 months (1.2%) and 18 (3.7%) infections at least 12 months following implant (P < 0.025). The mean intervals between implant and infection were 6 months (±3.7) and 30 months (±14.4) in the early and late groups, respectively. Early infection rates (%) for ICD, CRT-P, and CRT-D devices were 1.5, 1.6, and 0.6, respectively. Corresponding late infection rates were 2.2, 2.1, and 6.4. The increased late infection rate was driven by increased CRT-D infection (P < 0.01; compared with early CRT-D infection).

Conclusion: Early CDI rates are consistent with published data. Compared with early infection late CDI rates are significantly increased and are due to CRT-D infection. These findings are consistent with emerging reports. Late CRT-D infection threatens to undermine the long-term costs and overall health gain from these devices.

Preoperative skin antiseptics for prevention of cardiac implantable electronic device infections: A historical-controlled interventional trial comparing aqueous against alcoholic povidone-iodine solutions2015

Da Costa A, Tulane C, Dauphinot V, Terreaux J, Romeyer-Bouchard C, Gate-Martinet A,
Levallois M, Isaaz K.
Europace. 2015 Apr 26. [Epub ahead of print]

Link to Abstract on PubMed

Abstract
Aims:
Local skin antiseptic prevention against cardiac implantable electronic device (CIED) infections is not yet fully understood. This monocentre historical-controlled study sought to (i) conduct a prospective observational analysis comparing two antiseptic skin preparations over two similar consecutive periods of time, one conducted over a 1-year period using an aqueous povidone-iodine solution (Group I) and the other over the following with an alcoholic povidone-iodine solution (Group II); (ii) determine the predictive factors of CIED infection.

Methods and Results: Cardiac implantable electronic device implantation was performed in 1326 patients (pts). A total of 32 pts (2.4%) developed a CIED infection. Long-term follow-up (26 ± 3 months) revealed no significant difference between the groups: infections were observed in 14 of the 648 pts (2.2%) in Group I vs. 18 of the 678 pts (2.7%) in Group II (P = 0.9). Single- and multiple-variable logistic regression analyses were performed to identify risk factors; adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. The occurrence of infection was positively correlated with re-intervention (aOR, 7.16; 95% CI, 2.56-19.99; P < 0.0001), number of generator replacements, mean (aOR, 3.47; 95% CI, 2.22-5.44; P < 0.001), and haematoma (aOR, 48.4; 95% CI, 13.45-174.25; P < 0.0001).

Conclusion: This study found that aqueous and alcoholic povidone-iodine solutions displayed similar antiseptic effects regarding CIED infection prevention. Independent predictive factors of CIED infection were re-intervention, haematoma, and number of generator replacements.

Factors predicting Sprint Fidelis lead fracture: Results at 5 years from a French multicentre registry 2015

Piot O, Deballon R, Nitu D, Marquié C, da Costa A, Leclercq C, Defaye P, Sadoul N.
Arch Cardiovasc Dis. 2015;108:220-6. 

Link to Abstract on PubMed

Abstract
Background:
The small diameter Sprint Fidelis defibrillation lead has not been implanted in patients since 2007 due to its unusually high rate of fracture. Predictors of lead fracture risk were identified in several studies, mainly in North American studies.

Aim: We established a multicentre registry to determine the lead fracture rate and predictors of fracture in a large cohort of French patients.

Methods: Nine hundred and eighty-six patients implanted with a Sprint Fidelis lead at six centres between December 2004 and November 2007 were included in this registry.

Results: Over a mean follow-up of 51.4±20months, the mean fracture rate was 11.2%, and increased over time: 1.2% at 1year, 3.8% at 2years, 7.4% at 3years, 13.9% at 4years, and 20.7% at 5years. In multivariable analysis, younger age (<40years) was associated with a higher risk of fracture compared to patients<40years, patients aged between 40-60years had a relative risk of 0.53 (95% confidence interval [CI] 0.29-0.98) and patients>60years had a relative risk of 0.45 (95% CI 0.24-0.84) and subpectoral implantation (at 3years) with a relative risk of 2.35 (95% CI 1.29-4.28). Lead model 6930 (single-coil, passive-fixation) had a relative risk of 3.47 (95% CI 1.13-10.7) compared with the 6949 model (double coil, active-fixation). No other predictor of fracture was identified.

Conclusions: In a large multicentre cohort of French patients implanted with a Sprint Fidelis electrode, the fracture rate remains high, especially in young patients with submuscular implant and the 6930 electrode model.

Superior vena cava echocardiography as a screening tool to predict cardiovascular implantable electronic device lead fibrosis2015

Yakish SJ, Narula A, Foley R, Kohut A, Kutalek S.
J Cardiovasc Ultrasound. 2015;23:27-31

Link to Abstract on PubMed

Abstract
Background:
Currently there is no noninvasive imaging modality used to risk stratify patients requiring lead extractions. We report the novel use of superior vena cava (SVC) echocardiography to identify lead fibrosis and complex cardiac implantable electronic device (CIED) lead extraction. With an aging population and expanding indications for cardiac device implantation, the ability to deal with the complications associated with chronically implanted device has also increased.

Methods: This was a retrospective analysis of Doppler echocardiography recorded in our outpatient Electrophysiology/Device Clinic office over 6 months. Images from 109 consecutive patients were reviewed.

Results: 62% (68/109) did not have a CIED and 38% (41/109) had a CIED. In patients without a CIED, 6% (4/68) displayed turbulent color flow by Doppler in the SVC, while 22% (9/41) of patients with a CIED displayed turbulent flow. Fisher's exact test found a statistically significant difference between the two groups (p value < 0.05). The CIED group was subdivided into 2 groups based on device implant duration (< 2 years vs. ≥ 2 years). Of the CIED implanted for ≥ 2 years, 27% (9/33) had turbulent flow in the SVC by Doppler, while no patients (0/8) with implant durations < 2 years demonstrated turbulent flow. Nine patients underwent subsequent lead extraction. A turbulent color pattern successfully identified all 3 patients that had significant fibrosis in the SVC found during extraction.

Conclusion: Our data suggests that assessing turbulent flow using color Doppler in the SVC may be a valuable noninvasive screening tool prior to lead extraction in predicting complex procedures.

Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry2015

Burke MC, Gold MR, Knight BP, Barr CS, Theuns DA, Boersma LV, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD.
J Am Coll Cardiol. 2015;65:1605-15. 

Link to Abstract on PubMed

Abstract
Background:
The entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) is the first implantable defibrillator that avoids placing electrodes in or around the heart. Two large prospective studies (IDE [S-ICD System IDE Clinical Investigation] and EFFORTLESS [Boston Scientific Post Market S-ICD Registry]) have reported 6-month to 1-year data on the S-ICD.

Objectives: The objective of this study was to evaluate the safety and efficacy of the S-ICD in a large diverse population.

Methods: Data from the IDE and EFFORTLESS studies were pooled. Shocks were independently adjudicated, and complications were measured with a standardized classification scheme. Enrollment date quartiles were used to assess event rates over time.

Results: Eight hundred eighty-two patients who underwent implantation were followed for 651 ± 345 days. Spontaneous ventricular tachyarrhythmia (VT)/ventricular fibrillation (VF) events (n = 111) were treated in 59 patients; 100 (90.1%) events were terminated with 1 shock, and 109 events (98.2%) were terminated within the 5 available shocks. The estimated 3-year inappropriate shock rate was 13.1%. Estimated 3-year, all-cause mortality was 4.7% (95% confidence interval: 0.9% to 8.5%), with 26 deaths (2.9%). Device-related complications occurred in 11.1% of patients at 3 years. There were no electrode failures, and no S-ICD-related endocarditis or bacteremia occurred. Three devices (0.3%) were replaced for right ventricular pacing. The 6-month complication rate decreased by quartile of enrollment (Q1: 8.9%; Q4: 5.5%), and there was a trend toward a reduction in inappropriate shocks (Q1: 6.9% Q4: 4.5%).

Conclusions: The S-ICD demonstrated high efficacy for VT/VF. Complications and inappropriate shock rates were reduced consistently with strategic programming and as operator experience increased. These data provide further evidence for the safety and efficacy of the S-ICD.

Managing patients with advisory defibrillator leads: what can we learn from published data?2015

Bracke FA, Van Gelder BM. Managing patients with advisory defibrillator leads: what can we learn from published data? Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation. 2015;23(4):199-204. doi:10.1007/s12471-015-0669-6.

Defibrillator lead advisories stir a lot of emo- tions, both with patients and physicians, and this may in- fluence lead management. We reviewed the literature for a more evidence-based approach to this issue.

From the complications of two of the current advisory leads, the Medtronic Sprint Fidelis and St. Jude Riata leads, and the consequences of possible interventions, we can conclude that a restrained approach to premature replacement is appropriate. It may be opportune to replace the leads during a scheduled generator replacement in case of a higher electrical failure rate, in order to prevent future premature interventions.

We found no support to extract non-functional advisory leads. In contrast, extraction is often more demanding than anticipated, and the risk substantially exceeds that of simply abandoning the leads. 

 

Outcomes and Complications of Lead Removal: Can We Establish a Risk Stratification Schema for a Collaborative and Effective Approach?2015

Fu H, Huang XM, Zhong L, Osborn MJ, Asirvatham SJ, Espinosa RE, Brady PA, Lee HC, Greason KL, Baddour LM, Sohail RM, Aker NG, Hodge DO, Friedman PA, Cha YM.

Pacing Clin Electrophysiol. 2015;Aug 21. [Epub ahead of print]

Link to Abstract on PubMed

Abstract

Background: Removal of an entire cardiovascular implantable electronic device (CIED) is associated with morbidity and mortality. We sought to establish a risk classification scheme according to the outcomes of transvenous lead removal in a single center, with the goal of using that scheme to guide electrophysiology lab vs. operating room extraction.

Methods: Consecutive patients undergoing transvenous lead removal from 1/1 through 10/ 2012 at Mayo Clinic were retrospectively reviewed.

Results: A total of 1,378 leads were removed from 652 (age 64±17 years, M 68%) patients undergoing 702 procedures. Mean (SD) lead age was 57.6 (58.8) months. Forty-four percent of leads required laser-assisted extraction. Lead duration (P<0.001) and an implantable cardioverter defibrillator (ICD) lead (P<0.001) were associated with the need for laser extraction, and procedure failure (P<.0001 and P = .02). The major complication rate was 1.9% and was significantly associated with longer lead duration (OR, 1.2; 95% CI, 1.1-1.3; P<0.001). High risk patients (with a >10-year-old pacing or an >5-year-old ICD lead) had significantly higher major events than moderate (with pacing lead 1-10-year-old or ICD lead 1-5 year-old) and low (any lead ≤ 1-year-old) risk patients (5.3%, 1.2% and 0%, respectively; P<0.001).

Conclusions: Transvenous lead removal is highly successful, with few serious procedural complications. We propose a risk stratification scheme that may categorize patients as low-, moderate- and high-risk for lead extraction. Such a strategy may guide which extractions are best performed in the operating room.

Predictors of Long-Term Survival Following Transvenous Extraction of Defibrillator Leads.2015

Merchant FM, Levy MR, Kelli HM, Hoskins MH, Lloyd MS, Delurgio DB, Langberg JJ, Leon AR, El-Chami MF.

Pacing Clin Electrophysiol. 2015;Aug 10. [Epub ahead of print]

Link to Abstract on PubMed

Abstract

Background: Little data exist on long-term outcomes following extraction of implantable cardioverter defibrillator (ICD) leads, particularly for noninfectious indications. We sought to identify predictors of long-term survival after ICD lead extraction.

Methods: We retrospectively reviewed ICD lead extractions at our institution (n = 508). Procedural outcomes and long-term survival were ascertained by medical records review.

Results: Indication for lead extraction was infection in 32.5% and lead failure in 61.8%. Mean dwell time of the oldest extracted lead was 5.1 ± 5.9 years. Complete procedural success was achieved in 96.5% of cases. Major procedure-related complications occurred in 1.6% with six periprocedural deaths. During a mean follow-up of 866 ± 798 days, survival was significantly worse among patients with infection as the indication for extraction. At 1 year after extraction, survival among those with infection was 88.2%, compared to 95.0% in the lead failure cohort (P < 0.001). Procedural failure was a significant predictor of long-term mortality, even after excluding periprocedural deaths. In multivariate models, the presence of chronic kidney disease, increased number of leads requiring extraction, lower ejection fraction, and procedural failure were predictors of mortality.

Conclusion: Despite high rates of procedural success, infectious indication for ICD lead extraction is associated with increased long-term mortality. In contrast, among patients undergoing extraction for lead failure, long-term survival was excellent. The presence of procedural failure was a significant predictor of long-term mortality. Further studies will be necessary to better understand the mechanisms by which procedural failure may adversely impact long-term outcomes.

Sudden and Fatal Malfunction of a Durata Defibrillator Lead due to External Insulation Failure.2015

Shah AD, Hirsh DS, Langberg JJ.

Pacing Clin Electrophysiol. 2015;Aug 21. [Epub ahead of print]

Link to Abstract on Pub Med

Abstract

Defibrillator lead malfunction can be a disastrous complication, leading to loss of protection from sudden cardiac death in a high-risk patient population. Recognition of lead-specific risk for failure can assist in development of focused screening or surveillance, as in the case of the Riata lead (St. Jude Medical, St. Paul, MN, USA) or the Sprint Fidelis lead (Medtronic Inc., Minneapolis, MN, USA). A case of defibrillation failure secondary to a Durata lead insulation failure is presented. A brief review of the literature and current St. Jude Medical implantable cardiac defibrillator lead design is presented. Identification of arcing is identified as a potential sign of catastrophic insulation failure.

Pulse generator exchange does not accelerate the rate of electrical failure in a recalled small caliber ICD lead.2015

Lovelock JD, Premkumar A, Levy MR, Mengistu A, Hoskins MH, El-Chami MF, Lloyd MS, Leon AR, Langberg JJ, DeLurgio DB.

Pacing Clin Electrophysiol. 2015;Aug 19. [Epub ahead of print]

Link to Abstract on PubMed

Abstract

Introduction: St. Jude Riata/Riata ST defibrillator leads were recalled by the FDA in 2011 for an increased rate of failure. More than 227,000 leads were implanted and at least 79,000 patients still have active Riata leads. Studies have examined clinical predictors of lead failure in Riata leads, but none have addressed the effect of ICD generator exchange on lead failure. The purpose of this study is to assess the effect of ICD generator exchange on the rate of electrical failure in the Riata lead at 1 year.

Methods: A retrospective chart review was conducted in patients who underwent implantation of a Riata/Riata ST lead at one center. Patients with a functioning Riata lead (with/with externalized conductor) at the time of ICD exchange were compared to controls with Riata leads implanted for a comparable amount of time who did not undergo generator replacement.

Results: Riata leads were implanted in 1,042 patients prior to the recall and153 of these patients underwent generator exchange without lead replacement. Conductor externalization was noted in 21.5% of Riata leads in the ICD exchange cohort, which was not different from the control group, 19.2% (p = 0.32). Two leads failed in the first year after generator replacement (1.5%) which did not significantly differ from the control group (2.0%), (p = 0.57). At change-out 54% received a commanded shock (18.6 ± 0.9 J) that did not result in any change in the high voltage lead impedance (46.1 ± 1.1 ohms).

Conclusions: Conductor externalization was seen frequently in our cohort of patients. ICD generator exchange did not accelerate the rate of Riata lead failure at 1 year. Although, both the control and the change-out cohorts failed at a rate much greater than nonrecalled leads, generator exchange did not appear to add to the problem.

Predictive factors of lead failure in patients implanted with cardiac devices.2015

Aizawa Y, Negishi M, Kashimura S, Nakajima K, Kunitomi A, Katsumata Y, Nishiyama T, Kimura T, Nishiyama N, Fukumoto K,Tanimoto Y, Kohsaka S, Takatsuki S, Fukuda K.

Int J Cardiol. 2015;199:277-81.

Link to Abstract on PubMed

Abstract

Introduction: implantable electronic devices. LFs often cause serious secondary complications such as inappropriate ICD shocks or asystole. This study aimed to identify the clinical factors associated with the occurrence of LFs.

Methods: A total of 735 consecutive device implantations (mean age 67±15years, males 64%) performed at a single university hospital setting from 1997 to 2014 were included. The implanted devices consisted of 421 pacemakers, 250 implantable cardioverter defibrillators (ICD), 9 cardiac resynchronization therapy pacemakers (CRT-P), and 55 CRT defibrillators (CRT-D). The primary endpoint was the development of an LF.

Results: During a mean duration of 5.8±4.3years, 38 LFs developed in 31 patients (mean age 56±14years). LFs included 32 ICD (7 Sprint Fidelis, 2 Riata), and 6 pacing leads. Nine patients received inappropriate ICD shocks and 1 had syncope due to an LF. All patients underwent lead reinsertions with device replacements. Eight patients required opposite site implantations due to venous occlusions. The predictive factors of LFs were the age, male sex, taller body length, ICD vs. pacemaker, lesser lead number, extra-thoracic puncture of the axillary vein vs. a cut-down of the cephalic vein, use of recalled leads and patients with idiopathic ventricular fibrillation (IVF) and Brugada syndrome (BrS).

Conclusion: LFs occurred mainly with ICD leads. A lesser age, the puncture method, lead model, and diagnosis of IVF/BrS were associated with the development of LFs.

Successful stent implantation for superior vena cava injury during transvenous lead extraction.2015

Xiaoying L, Brunner MP, Wilkoff BL, Martin DO, Clair DG, Soltesz EG.

Heart Rhythm Case Reports. 2015;In press.

Value of a Joint Cardiac Surgery-Cardiac Electrophysiology Approach.2015

Bernardes de Souza B, Benharash P, Esmailian F, Bradfield J, Boyle NG.

J Card Surg. 2015;Oct 2. [Epub ahead of print]

Abstract

We report three cases of vascular injury during laser lead extractions, requiring urgent surgical correction. Immediate sternotomy and cardiopulmonary bypass were possible because of an institutional collaboration where cardiac surgeon and cardiac electrophysiologist jointly perform these cases, and all patients survived. We propose this joint approach is ultimately the best option for patients undergoing lead extraction.

Link to abstract on PubMed

Extracting versus abandoning sterile pacemaker and defibrillator leads.2015

Rijal S, Shah RU, Saba S.

Am J Cardiol. 2015;115:1107-10.

Abstract

Nonfunctional or recalled cardiac implantable electronic device leads can be revised with either lead extraction (LE) or lead capping (LC). Factors that influence this decision and comparative outcomes of these strategies are unclear. We reviewed data from our institution to identify patients who received LE (n = 296) or LC (n = 192) from 2006 to 2012. Patients with infectious indications for lead removal were excluded. We compared unanticipated device-related procedures, defined as cardiac implantable electronic device procedures not for device upgrade or battery depletion, using a proportional hazards model adjusted for differences in baseline characteristics. Secondary outcomes were procedural complications, hospitalizations, and all-cause mortality. Patients who received LE were younger and more likely to have an operator with extraction experience (76% vs 26%, p <0.001). Leads removed by experienced extractors versus nonextractors had longer dwell times (4.2 ± 3.6 vs 0.9 ± 1.1 years, p <0.001). Over a median follow-up of 3.0 (interquartile range = 3.2) years, the adjusted risk of unanticipated device-related procedures was similar for LE versus LC (hazard ratio 1.04, 95% confidence interval 0.62 to 1.75). Complications, hospitalization rates, and mortality rates were also similar between the 2 groups. In conclusion, lead revision strategy is influenced by operator extraction experience and dwell time of leads. In our analysis, we found no difference in outcomes between the 2 strategies.

Link to abstract on PubMed

Infection and mortality after implantation of a subcutaneous ICD after transvenous ICD extraction.2015

Boersma L, Burke MC, Neuzil P, Lambiase P, Friehling T, Theuns DA, Garcia F, Carter N, Stivland T, Weiss R; EFFORTLESS and IDE Study Investigators.

Heart Rhythm. 2015;Sep 1. [Epub ahead of print]

Abstract

Background:

The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited.

Objective:

This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation.

Methods:

Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747).

Results:

Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection.

Conclusion:

The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection.

Link to abstract on PubMed

Malfunction of cardiac devices after radiotherapy without direct exposure to ionizing radiation: mechanisms and experimental data.2015

Zecchin M, Morea G, Severgnini M, Sergi E, Baratto Roldan A, Bianco E, Magnani S, De Luca A, Zorzin Fantasia A, Salvatore L, Milan V, Giannini G, Sinagra G.

Europace. 2015;Sep 1. [Epub ahead of print]

Abstract

Aims: Malfunctions of cardiac implantable electronical devices (CIED) have been described after high-energy radiation therapy even in the absence of direct exposure to ionizing radiation, due to diffusion of neutrons (n) causing soft errors in inner circuits. The purpose of the study was to analyse the effect of scattered radiation on different types and models of CIED and the possible sources of malfunctions.

Methods and Results: Fifty-nine explanted CIED were placed on an anthropomorphous phantom of tissue-equivalent material, and a high-energy photon (15 MV) radiotherapy course (total dose = 70 Gy) for prostate treatment was performed. All devices were interrogated before and after radiation. Radiation dose, the electromagnetic field, and neutron fluence at the CIED site were measured. Thirty-four pacemakers (PM) and 25 implantable cardioverter-defibrillators (ICD) were analysed. No malfunctions were detected before radiation. After radiation a software malfunction was evident in 13 (52%) ICD and 6 (18%) PM; no significant electromagnetic field or photon radiations were detected in the thoracic region. Neutron capture was demonstrated by the presence of the 198Au(197Au + n) or 192Ir(191Ir + n) isotope activation; it was significantly greater in ICD than in PM and non-significantly greater in damaged devices. A greater effect in St Jude PM (2/2 damaged), Boston (9/11), and St Jude ICD (3/6) and in older ICD models was observed; the year of production was not relevant in PM.

Conclusion: High-energy radiation can cause different malfunctions on CIED, particularly ICD, even without direct exposure to ionizing radiation due to scattered radiation of neutrons produced by the linear accelerator.

Link to abstract on PubMed

Initial experience with the TightRail rotating mechanical dilator sheath for transvenous lead extraction.2016

Aytemir K, Yorgun H, Canpolat U, Sahiner ML, Kaya EB, Evranos B, Ozer N.

Europace. 2016;18:1043-8

Abstract

Aims: In parallel with increasing implantation rates and patients' longer life expectancy, the need for transvenous lead extraction (TLE) as a specialized procedure has shown a significant growth over years. Herein, we aimed to present our initial experience in TLE by using a novelTightRail™ Rotating Mechanical Dilator Sheath.

Methods and Results: Between October 2014 and March 2015, a total of 42 leads in 23 patients were removed at our tertiary referral centre. All of the extracted leads were >12 months old and indications for extraction were based on the recommendations of the Heart Rhythm Society. The leads were removed by using the TightRail™ Mechanical Dilator Sheath (Spectranetics Corporation) with the rotational cutting force only. Indications for lead removal included cardiac device infection in 12 (52.2%) cases, lead malfunction in the 10 (43.5%) cases, and upgrade to cardiac resynchronization therapy-defibrillator (CRT-D) in the remaining 1 case (4.3%). The extracted devices were pacemaker in 10 (43.4%) cases, implantable cardioverter-defibrillator (ICD) in 7 (30.4%) cases, and CRT in the remaining 6 (26.0%) subjects. Among 42 leads, 10 (23.8%) were right ventricular, 14 (33.3%) were atrial, 13 (31.0%) were defibrilator, and 5 (11.9%) were coronary sinus electrodes. The median time from implantation was 72 (18-216) months. Complete procedural success with TightRail™ system alone was achieved in 22 (95.7%) patients (41/42 leads) and overall clinical success was 100%. One right ventricular lead was completely removed with the help of femoral snare. All the patients were discharged uneventfully without any complication.

Conclusion: Our preliminary data with small sample size show that TightRail™ Mechanical Dilator Sheath is a new useful tool for chronically implanted pacemaker (PM)/ICD leads. Continued investigation including large patient cohort is required to evaluate success and complication rates in comparison to other tools and techniques.

Link to Abstract on PubMed

Clinical performance of a new bidirectional rotational mechanical lead extraction sheath.2015

Starck CT, Steffel J, Caliskan E, Holubec T, Schoenrath F, Maisano F, Falk V.

Europace. 2015;May 19. [Epub ahead of print]

Abstract

Aims: We investigated the safety and efficacy of a new bidirectional rotational mechanical extraction sheath (Evolution RL, Cook Medical, USA).

Methods and Results: From April 2013 until September 2014, we performed lead extraction procedures in 71 patients with 112 leads scheduled for extraction. During this time period, we used the new Evolution RL rotational sheath in 40 patients on 52 leads (24 pacemaker leads and 28 implantable cardioverter-defibrillator leads) scheduled for extraction. The mean lead implant duration in these patients was 100.2 (22-271) months. Forty leads were right ventricular leads, 10 right atrial leads, and 2 coronary sinus leads. Clinical success among the leads approached with the Evolution RL device was 98.1%. Operative mortality was zero. Major complications did not occur. Four minor complications were encountered (all pocket haematomas). No device-related complications were noted. In cases with multiple leads in situ, no wrapping of companion leads was seen. The average number of extraction tools used per lead was 2.4 (2-4) in the Evolution RL cohort.

Conclusion: Based on the presented results of our initial experience with the new bidirectional rotational mechanical extraction device, its use is safe and efficient with high success rates in long implanted leads.

Link to abstract on PubMed

Nomogram for predicting 30-day all-cause mortality after transvenous pacemaker and defibrillator lead extraction.2015

Brunner MP, Yu C, Hussein AA, Tarakji KG, Wazni OM, Kattan MW, Wilkoff BL.

Heart Rhythm. 2015;Jul 17. [Epub ahead of print]

Abstract

Background: For each clinical circumstance, the benefits of transvenous lead extraction (TLE) need to be weighed against the risks. Clinical decision-making tools for predicting mortality after TLE are lacking.

Objective: To create a preoperative risk score for prediction of 30-day all-cause mortality after TLE of pacemaker and defibrillator leads.

Methods: Consecutive patients undergoing TLE at the Cleveland Clinic between August 1996 and August 2011 were included in the analysis. A risk nomogram for predicting 30-day all-cause mortality was developed using baseline clinical variables and multivariable logistic regression modeling. Discrimination and calibration were assessed by using bootstrapping for internal validation. Continuous data are presented as median (25th, 75th percentile); categorical data are presented as number (percentage).

Results: A total of 5521 (4137 [74.9%] pacemaker and 1384 [25.1%] defibrillator) leads were extracted during 2999 TLE procedures (patient age 67.2 [55.2, 76.2] years, 30.2% female). Lead implant duration was 4.7 (2.4, 8.3) years and 2.0 (1.0, 2.0) leads were extracted per procedure. Sixty-seven patients (2.2%) had died by 30 days after TLE. Variables with the highest predictive value for 30-day all-cause mortality included age, body mass index, hemoglobin, end-stage renal disease, left ventricular ejection fraction, New York Heart Association functional class, extraction for infection, number of prior lead extractions performed by the operator, and extraction of a dual-coil defibrillator lead. These variables were used to create a nomogram with a bootstrap-corrected concordance index value of 0.867.

Conclusions: Thirty-day all-cause mortality after TLE can be assessed with good discriminative power using readily available clinical information.

Link to abstract on PubMed

Incidence of and risk factors for infectious complications in patients with cardiac device implantation.2015

Ann HW, Ahn JY, Jeon YD, Jung IY, Jeong SJ, Joung B, Lee M, Ku NS, Han SH, Kim JM, Choi JY.

Int J Infect Dis. 2015;36:9-14. 

Abstract

Objectives: The use of cardiac implantable electronic device (CIED; pacemakers, implantable cardioverter-defibrillators [ICD], cardiac re-synchronized therapy [CRT]) implantation, one essential treatment for cardiac arrhythmias, is increasing. Infectious complications related to implants are the main reason for device removal and patient morbidity. We sought to identify the incidence of infectious complications among patients with cardiac device implantation and analyze the risk factors for infectious complications.

Methods: A retrospective analysis was conducted of 1307 patients (61.5±14.2 years-old, 49.6% male) with cardiac device implantation from January 1990 to April 2013. We analyzed the incidence of infectious complications during the follow-up period. To investigate risk factors associated with infectious complications, we conducted a 1:2 matched case-control study of patients with infectious complications and controls without infectious complications who had the same implantation period and physician.

Results: Among 1307 patients, 12 had a confirmed device-related infection: 7 with a pocket infection and 5 with infective endocarditis. Over a total of 9091.9 device-years, the incidence of infectious complications was 1.3/1000 device-years, based on the 12 patients with an infection. ICD (5.1/1000 device-year) had a higher incidence of infectious complications than other cardiac devices, and no infectious complications were observed among patients with CRT implantation. Mean duration from the time of implantation to infection was 2.02±1.65 years. In a multivariate analysis, the number of prior procedures including wound revision or scar revision was an independent risk factor for infectious complications (OR=10.88, 95% CI 1.11->999, p=0.040).

Conclusions: Infection was a rare complication of cardiac device implantation, but repeated procedures were associated with infectious complications.

Link to abstract on PubMed

Impact of Pacemaker Lead Characteristics on Pacemaker Related Infection and Heart Perforation: A Nationwide Population-Based Cohort Study.2015

Lin YS, Chen TH, Hung SP, Chen DY, Mao CT, Tsai ML, Chang ST, Wang CC, Wen MS, Chen MC.

PLoS One. 2015;10:e0128320.

Abstract

Background: Several risk factors for pacemaker (PM) related complications have been reported. However, no study has investigated the impact of lead characteristics on pacemaker-related complications.

Methods and Results: Patients who received a new pacemaker implant from January 1997 to December 2011 were selected from the Taiwan National Health Insurance Database. This population was grouped according to the pacemaker lead characteristics in terms of fixation and insulation. The impact of the characteristics of leads on early heart perforation was analyzed by multivariable logistic regression analysis, while the impact of the lead characteristics on early and late infection and late heart perforation over a three-year period were analyzed using Cox regression. This study included 36,104 patients with a mean age of 73.4±12.5 years. In terms of both early and late heart perforations, there were no significant differences between groups across the different types of fixation and insulations. In the multivariable Cox regression analysis, the pacemaker-related infection rate was significantly lower in the active fixation only group compared to either the both fixation (OR, 0.23; 95% CI, 0.07-0.80; P = 0.020) or the passive fixation group (OR, 0.26; 95% CI, 0.08-0.83; P = 0.023).

Conclusions: There was no difference in heart perforation between active and passive fixation leads. Active fixation leads were associated with reduced risk of pacemaker-related infection.

Link to abstract on PubMed

Outcomes of Sprint Fidelis and Riata lead extraction: Data from 2 high-volume centers.2015

El-Chami MF, Merchant FM, Levy M, Alam MB, Rattan R, Hoskins MH, Langberg JJ, Delurgio D, Lloyd MS, Leon AR, Saba S.

Heart Rhythm. 2015;12:1216-20.

Abstract

Background: The Sprint Fidelis (SF) and the Riata (RT) implantable cardioverter-defibrillator leads have been recalled for premature failure.

Objective: Data on SF and RT extractions are limited; therefore, we performed a pooled analysis to compare the safety and efficacy of lead extraction for the SF and RT lead families.

Methods: We retrospectively reviewed consecutive patients undergoing transvenous extraction of SF and RT leads at Emory University and the University of Pittsburgh Medical Center from January 2007 to October 2013. Patients were placed into 2 groups based on the presence of an SF or RT lead. The primary endpoint was a major procedural complication, defined as death, need for urgent cardiac surgery, and hemopericardium or hemothorax that required an intervention.

Results: A total of 462 patients underwent extraction of recalled leads (SF, n = 360; RT, n = 102). The mean number of leads extracted in the RT group was higher than in the SF group (1.8 ± 0.9 vs 1.3 ± 0.7, P < .001), and there was a longer implantation time in the RT group (5.5 ± 2.5 vs 4.3 ± 2.0 years, P < .001). Complete procedural success was higher in the SF group (99.4% vs 96.1%, P =.024). Clinical success was similar (SF 99.4% vs RT 97.1%, P = .075). There were 6 major procedural complications in the entire cohort (1.3%). The rate of major complications was not different between the SF and RT groups (SF 1.1% vs RT 2.0%, P = .618). Total mortality was 0.65%, with no difference between the groups

Conclusion: Our data from 2 high-volume centers suggest that extraction of SF and RT leads is associated with excellent clinical success and a similar rate of major procedural complications.

Link to abstract on PubMed

User-reported abrasion-related lead failure is more common with Durata compared to other implantable cardiac defibrillator leads.2015

Shah AD, Hirsh DS, Langberg JJ.

Heart Rhythm. 2015;Jul 9. [Epub ahead of print]

Abstract

Background: Following increased rates of inside-out abrasion with the St Jude Medical Riata lead, the Durata implantable cardiac defibrillator (ICD) lead was introduced with modifications intended to increase abrasion resistance. Recent case reports have described insulation failures of the Durata.

Objective: To determine if increased rates of abrasion-related failure are present with the Durata lead.

Methods: The Food and Drug Administration Manufacturer and User Facility Device Experience database was queried for reports of insulation failure of the Durata lead from 2014. Comparison was made to other ICD leads. Incidence was estimated and case characteristics were compared.

Results: The estimated incidence of abrasion was significantly higher for the Durata lead than for the Boston Scientific Endotak or the Medtronic Quattro leads. The mode of abrasion was most often lead-to-can, as compared to "inside-out" abrasion with the Riata lead. Full-thickness abrasion was associated with failure to defibrillate or inappropriate therapy. Four patients had failure of therapy or death.

Conclusions: The findings indicate higher rates of insulation failures of the Durata lead, despite design modifications. External abrasion from the pulse generator to the adjacent lead within the device pocket was the most common etiology. Shocks unmasked previously undetected abrasion, resulting in failure to defibrillate. Data are presented indicating a possible time dependency to abrasion risk. This limited query suggests need for ongoing scrutiny of Durata lead performance. Careful inspection of Durata leads at the time of ICD replacement is warranted, as are vigorous attempts to gather information about terminal events in patients with Durata leads.

Link to abstract on PubMed

Transvenous implantable cardioverter-defibrillator lead reliability: implications for postmarket surveillance.2015

Kramer DB, Hatfield LA, McGriff D, Ellis CR, Gura MT, Samuel M, Retel LK, Hauser RG.

J Am Heart Assoc. 2015;4:e001672.

Abstract

Background: As implantable cardioverter-defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter-defibrillator systems. In addition, real-world reliability data could inform postmarket surveillance strategies directed by regulators and manufacturers.

Methods and Results: We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow-up.

Conclusions: Currently marketed implantable cardioverter-defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter-defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.

Link to abstract on PubMed

Latin American Registry On Implantable Cardiac Device Infection2015

Aguinaga L, Dubner S, Albornoz H, Lombide I, Fenelon G, Baranc A.

http://www.jafib.com

Background: Implantable cardiac device infection is a well-recognized complication. No prior efforts were made to systematically evaluate this problem in Latin American Centers. The aim of this study was to determine the prevalence of implantable cardiac device infection and its management in Latin American centers.

Gender And Age Related Differences In Implantable Defibrillator Recipients: Results From The Pacemaker And Implantable Defibrillator Leads Survival Study (“PAIDLESS”)2015

Feldman A, Kersten D, Chung J, Asheld W, Germano J, Islam S, Cohen T.

http://www.jafib.com

Introduction: This study investigated the influences of gender and age on defibrillator lead failure and mortality.

Mechanisms Of Lead Failure In The Pacemaker And Defibrillator Lead Survival Study (“Paidless”)2015

Feldman A, Asheld W, Kersten D, Chung J, Brahmbhatt K, Germano J, Islam S, Cohen T.

http://www.jafib.com/

Introduction: This study examined the mechanisms of lead failure among three manufacturers (Boston Scientific (BSC), Medtronic (MDT), St Jude Medical (SJM).

Outcomes Of Defibrillator Lead Implants Performed By High Volume Versus Low Volume Operators: Results From The Pacemaker And Implantable Defibrillator Leads Survival Study (“Paidless”)2015

Feldman A, Chung J, Kersten D, Islam S, Asheld W, Germano J, Cohen T.

http://www.jafib.com/

Introduction: This study investigated the effects of operator volume on implantable defibrillator lead failure.

The Impact Of Receiving Two Recalled Defibrillator Leads On Lead Failure And Survival: Results From The Pacemaker And Implantable Defibrillator Leads Survival Study (“PAIDLESS”)2015

Kersten D, Feldman A, Chung J, Islam S, Brahmbhatt K, Asheld W, Germano J, Cohen T.

http://www.jafib.com/

Introduction: This study analyzed lead failure and mortality in patients with respect to the number of recalled leads implanted.

Infection control in implantation of cardiac implantable electronic devices: current evidence, controversial points, and unresolved issues2015

Korantzopoulos P, Sideris S, Dilaveris P, Gatzoulis K, Goudevenos JA.

Europace Advance Access published October 29, 2015.

Usefulness Of Spect-Ct With Radioisotope Labeled Leucocytes For Diagnosis Of Lead-Dependent Infective Endocarditis2015

Malecka B, Zabek A, Szot W, Boczar K, Debski M, Lelakowski J, Kostkiewicz M.

http://www.jafib.com/

Introduction: Our aim was to evaluate the diagnostic accuracy of SPECT-CT with radioisotope labeled leucocytes (SCY) in patients with suspected LDIE.

Differences In Risk Factors Of Pm/Icd Pocket Infection And Lead Dependent Infective Endocarditis In Patients Qualified For Transvenous Lead Extraction2015

Małecka B, Wysokiński A.

http://www.jafib.com/

Introduction: Evaluation of risk factors of isolated pocket infection (PI) and isolated lead dependent infective endocarditis (LDIE) in patients referred for transvenous lead extraction (TLE).

Feasibility, Efficacy And Safety Of Percutaneous Retrieval Of A Leadless Cardiac Pacemaker2015

Sperzel J, Khairkahan A, Ligon D.

http://www.jafib.com/

Introduction & Purpose: Leadless pacemaker technology is an emerging method to deliver pacing therapy to the right ventricle with several potential advantages. In this study, we examine the feasibility, safety and effectiveness of retrieval of a leadless cardiac pacemaker (LCP) in an in vivo ovine model.

Lead extractions: the Zwolle experience with the Evolution mechanical sheath.2015
Europace. 2015;Oct 14. [Epub ahead of print]
 
Delnoy PP, Witte OA, Adiyaman A, Ghani A, Smit JJ, Ramdat Misier AR, Elvan A.
 

Abstract

Aims: The Evolution sheath (Cook, USA) is a power sheath with a cutting screw tip operated by mechanical rotation. It has been reported to be an effective tool for chronic lead extraction. We evaluated the safety and efficacy of this system.

Methods and Results: From 2009 to 2014, all lead extractions requiring the use of an Evolution sheath were prospectively examined. In 77 patients, 111 leads were extracted. The first 57 leads were extracted with the original unidirectional sheath, and since 2013, 54 leads were extracted with the bidirectional R/L type. According to the current guidelines, complete procedural success was defined as the removal of all targeted leadmaterial. Clinical success was the retention of a small portion of the lead, and failure was the inability to achieve either complete procedural or clinical success or the development of any permanently disabling complication. The Evolution sheath was used to extract 111 leads in 77 patients. The median age of the lead at time of extraction was 8.0 years (median 6.9, interquartile range 6.4, minimum: 0.6 and maximum: 34.4), with a clinical success rate of 98% and a complete procedural success of 88%. Complete procedural success was higher for the R/L type Evolution sheath(96 vs. 80%, P = 0.006). There were 21 (19%) implantable cardioverter defibrillator leads, 22 (20%) right ventricular pacing leads, 60 (54%) right atrial leads, and 8 (7%) left ventricular leads. There were no major complications and six (8%) minor complications. There was no need for the usage of a femoral tool or snares.

Conclusion: Use of Evolution for lead extractions seems to be safe and effective, with a high clinical success rate.

Link to abstract on PubMed

Trends in Use and Adverse Outcomes Associated with Transvenous Lead Removal in the United States.2015

Circulation. 2015;132:2363-71.

Deshmukh A, Patel N, Noseworthy PA, Patel AA, Patel N, Arora S, Badheka A, Kapa S, Mulpuru S, Noheria A, Fischer A, Coffey JO, Cha YM,Friedman P, Asirvatham S, Viles-Gonzalez JF.

Abstract

Background: Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy and safety. However, limited data exist regarding trends in utilization and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine utilization patterns, frequency of adverse events and influence of hospital volume on complications.

Methods and Results: Using the Nationwide Inpatient Sample (NIS), we identified 91,890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases (9th Edition) Clinical Modification (ICD-9-CM) diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female gender and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period.

Conclusions: The overall complication rate in patients undergoing TLR was higher than previously reported. Female gender and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.

Link to abstract on PubMed

When You Have Nowhere to Look, You Look Where You Can.2015

Circulation. 2015;Nov 3. [Epub ahead of print]

Maytin M, Epstein LM.

Abstract

While many physicians implant cardiac implantable electronic devices (CIED), only a small fraction performs transvenous lead extraction (TLE). This has led to inconsistent and, at times, inappropriate patient management. Despite clear Class I recommendations for lead extraction for infected devices, patients all too often receive multiple debridements and rounds of antibiotics for device-related infection. In addition, in cases of device system upgrade and lead malfunction, lead after lead is often added, sometimes involving tunneling and frequently resulting in the elimination of vascular access. Why are more of these patients not offered or referred for, lead extraction? In many cases, we believe it is driven by unfounded fear of the procedure as well as a knowledge gap. In a survey performed by Spectranetics (Colorado Springs, CO), cardiologists perceived the major complication rate associated with the extraction procedure itself to be greater than 5% and the mortality rate to be nearly 1.5%. Henrikson and colleagues performed a similar survey among 252 electrophysiologists (63% of whom identified themselves as performing TLE) with similar observations. More than 75% of respondents perceived the morbidity risk associated with TLE to be ≥2% and close to 30% of respondents estimated the risk to be ≥5%. Among the group surveyed, the mortality risk with TLE was similarly perceived to be excessive despite the surprising preponderance of "extractionists" among the group. It is not surprising that more patients are not referred if this is the impression. In a global survey of 820 clinicians addressing the understanding of CIED infection and lead management, 50% or less of all respondents failed to correctly identify and implement Class I recommendations for device-related infection despite >60% of respondents identifying themselves as performing TLE. Clearly what is needed are data and education, both of which are lacking. In this issue of Circulation, Deshmukh and colleagues rightfully recognize that "limited data exist regarding trends in utilization and adverse outcomes outside the centers of considerable experience" and attempt to extend the available data with observations from a retrospective, descriptive study utilizing a national, large, administrative database.

Link to abstract on PubMed

Transvenous Implantable Cardioverter-Defibrillator (ICD) Lead Performance: A Meta-Analysis of Observational Studies.2015

J Am Heart Assoc. 2015;4:e002418.

Providência R, Kramer DB, Pimenta D, Babu GG, Hatfield LA, Ioannou A, Novak J, Hauser RG, Lambiase PD.

Abstract

Background: Despite the widespread use of implantable cardioverter-defibrillators (ICDs) in clinical practice, concerns exist regarding ICD leaddurability. The performance of specific lead designs and factors determining this in large populations need clarification.

Methods and Results: The Medline, Embase, and Cochrane Collaboration databases were searched for studies including ≥2 of the most commonly implanted leads. The Mantel-Haenszel random-effects model was used. Seventeen studies were selected, including a total of 49 871 patients-5538 implanted with Durata (St. Jude Medical Inc), 10 605 with Endotak Reliance (Boston Scientific), 16 119 with Sprint Quattro (Medtronic Corp), 11 709 with Sprint Fidelis (Medtronic Corp), and 5900 with Riata (St. Jude Medical Inc)-with follow-up of 136 509 lead-years. Although the Durata lead presented a numerically higher rate, no statistically significant differences in the mean incidence of lead failure (0.29%-0.45% per year) were observed in comparison of the 3 nonrecalled leads. A higher event rate was documented with the Riata (1.0% per-year increase) and Sprint Fidelis (>2.0% per-year increase) leads compared with nonrecalled leads. An indication of increased incidence of Durata lead failure versus Sprint Quattro and Endotak Reliance leads was observed in 1 of 3 included studies, allowing for comparison of purely electrical lead failure, but this requires further evaluation.

Conclusions: Endotak Reliance (8F), Sprint Quattro (8F), and Durata (7F) leads displayed low annual incidence of failure; however, long-term follow-up data are still scarce. More data are needed to clarify the performance and safety of the Durata lead.

Link to abstract on PubMed

Differences of Mortality Rates between Pocket and Nonpocket Cardiovascular Implantable Electronic Device Infections.2015

Pacing Clin Electrophysiol. 2015;Sep 9. [Epub ahead of print]

Lee DH, Gracely EJ, Aleem SY, Kutalek SP, Vielemeyer O.

Abstract

Background: A steady rise in the use of cardiovascular implantable electronic devices (CIEDs), particularly in the elderly, has led to an increase in device-related infections. Although often studied and reported as a single entity, these complications in fact comprise a heterogeneous group. Specific subgroups may be associated with distinct mortality risks.

Methods: Medical records of all patients who underwent device extraction for CIED-related infection at a single tertiary referral center between 1991 and 2007 were reviewed. Infections were divided into four subgroups: primary pocket site infection (PPSI), pocket site infection with bacteremia, primary/isolated bacteremia (PIB), and device-related infective endocarditis (DRIE). Clinical presentation, laboratory data, and mortality rates were obtained by chart review and by querying the Social Security Death Index.

Results: A total of 387 cases were analyzed. The overall in-hospital and 1-year all-cause mortality rates were 7.2% and 25.3%, respectively. Patients with PIB or DRIE had significantly higher mortality rates (hazard ratio [HR] 2.3; 95% confidence interval [CI] 1.2-4.6 and HR 2.5; 95% CI 1.6-4.1, respectively) when compared with patients in the PPSI group. Patients who did not receive a new device during the initial admission also had a higher 1-year mortality rate compared to those who did (HR 2.7; 95% CI 1.8-4.1).

Conclusions: Our patients with CIED-related infections requiring extraction/hospitalization had a significant mortality risk. Presence of pocketsite infection carried a more favorable prognosis, regardless of the presence of bacteremia. Early detection and prevention of CIED-related infectionswith PIB (i.e., no pocket site involvement), especially for high-risk populations, is needed.

Link to abstract on PubMed

Clinical Outcomes of Patients with HIV Undergoing Lead Extraction for Infectious and Non-Infectious Indications.2015

Pacing Clin Electrophysiol. 2015;Oct 30. [Epub ahead of print]

Cohen JA, Govea A, Carrillo RG.

Abstract

Background: With the increasing prevalence of HIV+ patients in the United States, and the association between HIV and cardiovascular morbidity and mortality, the use of Cardiac Implantable Electronic Devices (CIEDs) in patients with HIV has become more common. With the increasing incidence of device-related complications, lead extraction is becoming a topic of importance in this population. As the use of implantable devices increases in the HIV+ population, complications are to be expected; therefore, lead extraction in the HIV population must be addressed.

Methods: From January 2004 to May 2013, 1018 patients requiring lead extraction were referred to a single, high-volume tertiary cardiovascular center. Within this group of patients, 10 were HIV+. We retrospectively reviewed the charts of this cohort and reported clinical variables of interest.

Results: Infection was the most common indication for lead extraction and device removal. Four patients were in advanced heart failure, and the overall average ejection fraction of the sample population was 32.7±16.3%. In addition, the majority of patients had one or more medical comorbidities. Devices removed, in order of frequency, were implantable cardioverter defibrillators, permanent pacemakers, and cardiac resynchronization therapy devices. On average, 35.6± 41.6 months elapsed from implantation of the oldest lead to the date of extraction. There were no major or minor complications and all procedures were clinically successful.

Conclusions: Laser lead extraction is both safe and effective in patients with HIV. This study sets a level of clinical precedent regarding the management of CIED infection or malfunction in patients with HIV.

Link to abstract on PubMed

The novel active fixation coronary sinus lead: efficacy and safety of transvenous extraction procedure.2015

Europace. 2015;Oct 14. [Epub ahead of print]

Bontempi L, Vassanelli F, Ashofair N, Inama L, Mariggiò D, Cerini M, Curnis A.

Abstract

Aims: Benefits of cardiac resynchronization therapy (CRT) are well known for heart failure; however, some patients might experience complications related to the coronary sinus (CS) lead (high pacing threshold, phrenic nerve stimulation, and dislodgment) with unfavourable impact on quality of life, costs, and management. Lead stability is one of the most common unmet needs for CRT procedures.

Methods and Results: Recently, new model Medtronic 20066 Attain Stability® (Maastricht, The Netherlands) active fixation LV lead has been released, to overcome this issue. The lead has a small side helix of 0.20 mm (0.008 in.) that allows for secure placement of the lead within the vein at the desired location. We report our first experience with the extraction of this novel active fixation left ventricular lead.

Conclusion: In our case, to our knowledge the first reported in humans, the extraction of this new model of active fixation lead was proved to be a safe and effective procedure at 8 months after implantation. Indeed, under angiographic and fluoroscopic check, there was no documented dissection or damage to the CS during and after removal of the lead. The rotation manoeuvre was effective when combined with moderate traction of the lead itself.

Link to abstract on PubMed

Management of a previously unreported implantable cardioverter-defibrillator lead complication.2015

Europace. 2015;Oct 20. [Epub ahead of print]

Mendenhall GS, Saba S, Voigt A.

A 68-year-old male with a right pectoral implantable cardioverter-defibrillator (ICD) in situ underwent a technically challenging extraction/replacement of a Sprint Fidelis lead at the time of elective replacement of the generator. During implantation of the new model 6935M 55 cm defibrillator lead, the suture sleeve...

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Coronary Sinus Lead Extraction2015

Cronin EM, Wilkoff BL.

Card Electrophysiol Clin. 2015;7:661-71.

Abstract

Expanded indications for cardiac resynchronization therapy and the increasing incidence of cardiac implantable electronic device infection have led to an increased need for coronary sinus (CS) lead extraction. The CS presents unique anatomical obstacles to successful lead extraction. Training and facility requirements for CS lead extraction should mirror those for other leads. Here we review the indications, technique, and results of CS lead extraction. Published success rates and complications are similar to those reported for other leads, although multiple techniques may be required. Re-implantation options may be limited, which should be incorporated into pre-procedural decision making.

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Single-coil and dual-coil defibrillator leads and association with clinical outcomes in a complete Danish nationwide ICD cohort2015

Larsen JM, Hjortshøj SP, Nielsen JC, Johansen JB, Petersen HH, Haarbo J, Johansen MB, Margrethe Thøgersen A.

Heart Rhythm. 2015;Nov 21. [Epub ahead of print]

Abstract

Background: The best choice of defibrillator lead in patients with routine implantable cardioverter-defibrillator (ICD) is not settled. Traditionally, most physicians prefer dual-coil leads but the use of single-coil leads is increasing.

Objective: The purpose of this study was to compare clinical outcomes in patients with single- and dual-coil leads.

Methods: All 4769 Danish patients 18 years or older with first-time ICD implants from 2007 to 2011 were included from the Danish Pacemaker and ICD Register. Defibrillator leads were 38.9% single-coil leads and 61.1% dual-coil leads. The primary end point was all-cause mortality. Secondary end points were lowest successful energy at implant defibrillation testing, first shock failure in spontaneous arrhythmias, structural lead failure, and lead extraction outcomes.

Results: Single-coil leads were associated with lower all-cause mortality with an adjusted hazard ratio of 0.85 (95% confidence interval 0.73-0.99; P = .04). This finding was robust in a supplementary propensity score-matched analysis. However, dual-coil leads were used in patients with slightly higher preimplant morbidity, making residual confounding by indication the most likely explanation for the observed association between lead type and mortality. The lowest successful defibrillation energy was higher using single-coil leads (23.2 ± 4.3 J vs 22.1 ± 3.9 J; P < .001). No significant differences were observed for other secondary end points showing high shock efficacies and low rates of lead failures and extraction complications.

Conclusion: Shock efficacy is high for modern ICD systems. The choice between single-coil and dual-coil defibrillator leads is unlikely to have a clinically significant impact on patient outcomes in routine ICD implants.

Link to abstract on PubMed

Transvenous Lead Extraction of Cardiac Implantable Electronic Devices: Who, When, How and Where?2015

Hussein AA, Wilkoff BL.

Rev Esp Cardiol (Engl Ed). 2016;69:3-6.

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Surgical management of infected cardiac implantable electronic devices2016

Chaudhry UA, Harling L, Ashrafian H, Athanasiou C, Tsipas P, Kokotsakis J, Athanasiou T.

Int J Cardiol. 2016;203:714-21.

Abstract

The growing use of cardiac implantable electronic devices (CIED) has led to infections requiring intervention. These are traditionally managed using a percutaneous transvenous approach to fully extract the culpable leads. Indications for such strategies are well-established and range from simple traction to the use of powered extraction tools including laser sheaths. Where such attempts fail, or if there are further complications, then there may be need for a cardiothoracic surgical approach. Limited evidence is currently available on the merits of individual strategies, and these are mainly drawn from case reports or series. Most utilise cardiopulmonary bypass, cardioplegic arrest and entry within the right atrium to allow direct visualisation of any vegetation and safely explant all CIED components whilst avoiding perforation, valvular and paravalvular damage. In this review, we describe a number of these and the unique challenges faced by surgeons when attempting to extract CIED. It is clear that future work should concentrate on creating clear consensus and guidelines on indications, risks and measures of efficacy outcomes for various surgical techniques.

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Predictive factors of lead failure in patients implanted with cardiac devices.2015

Aizawa Y, Negishi M, Kashimura S, Nakajima K, Kunitomi A, Katsumata Y, Nishiyama T, Kimura T, Nishiyama N, Fukumoto K, Tanimoto Y, Kohsaka S, Takatsuki S, Fukuda K.

Int J Cardiol. 2015;199:277-81.

Abstract

Introduction: Lead failures (LFs) are one of the most common complications in patients implanted with cardiovascular implantable electronicdevices. LFs often cause serious secondary complications such as inappropriate ICD shocks or asystole. This study aimed to identify the clinicalfactors associated with the occurrence of LFs.

Methods: A total of 735 consecutive device implantations (mean age 67±15years, males 64%) performed at a single university hospital setting from 1997 to 2014 were included. The implanted devices consisted of 421 pacemakers, 250 implantable cardioverter defibrillators (ICD), 9 cardiacresynchronization therapy pacemakers (CRT-P), and 55 CRT defibrillators (CRT-D). The primary endpoint was the development of an LF.

Results: During a mean duration of 5.8±4.3years, 38 LFs developed in 31 patients (mean age 56±14years). LFs included 32 ICD (7 Sprint Fidelis, 2 Riata), and 6 pacing leads. Nine patients received inappropriate ICD shocks and 1 had syncope due to an LF. All patients underwent leadreinsertions with device replacements. Eight patients required opposite site implantations due to venous occlusions. The predictive factors of LFs were the age, male sex, taller body length, ICD vs. pacemaker, lesser lead number, extra-thoracic puncture of the axillary vein vs. a cut-down of the cephalic vein, use of recalled leads and patients with idiopathic ventricular fibrillation (IVF) and Brugada syndrome (BrS).

Conclusion: LFs occurred mainly with ICD leads. A lesser age, the puncture method, lead model, and diagnosis of IVF/BrS were associated with the development of LFs.

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Device Pocket Scar Predicts Transvenous Lead Extraction Difficulty2015

Maytin M, John RM, Epstein LM.

J Innov Card Rhythm Man. 2015;6:2173-7.

Abstract: The challenges and risks of transvenous lead extraction (TLE) of cardiovascular implantable electronic devices (CIEDs) are principally related to the body’s foreign body response to endovascular leads. Despite this understanding, predictors of severe endovascular scar formation have not been clearly identified. The aim was to evaluate if the severity of the pocket scar may help predict endovascular scar and TLE difficulty. We performed a prospective analysis of consecutive patients undergoing TLE. Patient and procedural characteristics, classification of pocket scar severity, operator assessment of TLE difficulty, extraction time, and number of extraction sheaths (ESs) used are reported. Logistic and linear regression analyses were utilized to test the adjusted association between pocket scar and the combined endpoint and subjective difficulty assessed by the operator, respectively. Between November 2010 and February 2012, 144 patients underwent TLE with assessment of pocket scar. The cohort was 63% male with mean age 62±16 years. Average implant duration was 84±53 months. Indications for TLE included infection 35%, malfunction 30%, upgrade 8%, and other 27%. Each incremental increase in pocket scar severity was associated with a twofold increase in TLE difficulty (OR 2.03; 95% CI 1.005–4.110). TLE difficulty endpoint correlated significantly with the operator’s assessment of procedural difficulty (r=0.74, p<0.001). Operator scoring of TLE difficulty (1–10) was highly correlated with severity of CIED pocket scar (p=0.001). The severity of the scar in the device pocket correlates with multiple ES use and long extraction times and operator quantification of extraction difficulty. CIED pocket scar may help predict TLE difficulty.

Link to article on The Journal of Innovations in Cardiac Rhythm Management website

Lead Integrity Alert Is Useful for Assessment of Performance of Biotronik Linox Leads2015

Steinberg C Padfield GJ, Hahn E, Flavelle S, McILROY C, VAN Bremen O, Yeung-Lai-Wah JA, Kerr CR, Deyell MW, Tung SK, Andrade JG, Bennett MT, Bashir JG, Krahn AD, Chakrabarti S.

J Cardiovasc Electrophysiol. 2015;26:1340-5.

Abstract

Introduction: Medtronic's Lead Integrity Alert (LIA) software algorithm is useful for detecting abnormal parameters across various ICD-lead families. However, its utility in the assessment of the Biotronik Linox™ family of high-voltage (HV) leads is unknown.

Methods: We conducted a retrospective cohort study to assess the performance of the LIA algorithm to detect abnormalities and lead failure in Linox ICD-leads. All LIA-enabled Medtronic devices connected to an active Linox lead were included. The alerts were adjudicated by 2 blinded electrophysiologists and correlated with clinical data.

Results: Between 2008 and 2012, data from 208 patients with 564 patient-years of follow-up were available for analysis. The median follow-up duration was 32 (IQR 21-41 months). Twenty-one LIA triggers were noted in 20 different patients. The median delay until a positive LIA was 32 months (IQR 21-41 months) postimplant with a 5-year lead survival free from LIA of 76%. Ninety-five percent (19/20) LIA alerts were true lead failures. The most common LIA triggers were short V-V intervals (85%) and nonsustained ventricular tachycardia (85%). Abrupt changes of the ICD-lead impedance occurred in 5/20 triggers. Inappropriate ICD-shocks were strongly associated with a positive LIA (30% vs. 7.4%; P = 0.006). Of the explanted Linox leads 53% had visible abnormalities. The sensitivity, specificity, and positive predictive value for lead failure in the presence of a LIA trigger were 87%, 99.5%, and 95.2%, respectively.

Conclusions: A positive LIA trigger in Biotronik Linox ICD-leads is highly predictive of lead failure. LIA is useful in ongoing surveillance of lead performance.

Link to abstract on PubMed

The analysis of indications and early results of transvenous lead extraction in patients with a pacemaker, ICD and CRT - single-center experience2015

Zabek A, Malecka B, Haberka K, Boczar K, Pfitzner R, Debski M, Lelakowski J.

Acta Cardiol. 2015;70:685-92.

Abstract

Introduction: Transvenous lead extraction (TLE) is a recognized method of treatment in the case of permanent stimulation complication.

Objectives: The objective of this study was to analyse the indications and presentation of the early experience of TLE procedures in a group of patients with old pacing systems.

Patients and Methods: Patients with a relevant history of stimulation (at least 12 months in case of a pacemaker) qualified for the research. Indications, effectiveness and complications of TLE procedures were analysed.

Results: Two hundred patients at the age of 66.4 (19.1-86.2 years) were enrolled and 278 leads with dwell time 76.2 months (2.1-327.4) were removed. The indications for TLE were: lead-dependent infective endocarditis in 13 cases (6.5%), pocket infection in 29 cases (14.5%), lead damage in 120 cases (60.0%), and upgrade of device system in 38 cases (19.0%). Manual traction was used to remove 66 active fixation leads (23.7%). A femoral approach was required to extract 4 leads (1.4%). Two hundred and eight leads (74.8%) were extracted using the mechanical (Cook) system and subclavian approach. Laser technique, and an electrosurgical sheath were not used. Complete procedural success was achieved in 96% of cases and overall clinical success was 98.5%. Complication rate was 5.5% (11 patients): minor and major complication rate was 3.0% (6 patients) and 2.5% (5 cases), respectively. Low body mass index (BMI) was associated with a higher rate of complications.

Conclusions: The dominant indication to TLE procedures was lead dysfunction. Transvenous lead extraction has a high success rate and a low complication rate. Low BMI increased the complication rate.

Link to the abstract on PubMed

One-Year Follow-Up of Patients Undergoing Transvenous Extraction of Pacemaker and Defibrillator Leads2015

Kempa M, Budrejko S, Piepiorka-Broniecka M, Rogowski J, Kozlowski D, Raczak G.

PLoS One. 2015;10:e0144915.

Abstract

Introduction: The number of pacemaker and ICD implantations has increased substantially in the recent years. Therefore, complications are also observed in a greater number. In many cases, transvenous extraction of the previously implanted device (pacemaker or ICD) is the only solution. One may find in the literature information about the efficacy and safety of that procedure, but data concerning the results of long-term follow up are still limited.

Aim: The aim of the study was to assess the one-year mortality in the cohort of patients undergoing transvenous lead extraction procedures in our centre.

Methods: Records of the patients undergoing transvenous lead removal in the Department of Cardiology and Electrotherapy of the Medical University of Gdańsk were analyzed. We collected detailed information about 192 patients that had undergone the procedure from January 2003 until June 2012. Data were collected from medical and surgical records. We analyzed concomitant diseases, indications, and possible complications. Long-term follow-up data were gathered in the follow-upambulatory records and over-the-phone interviews with patients or families. In several cases, we consulted the database of the Polish National Health Fund.

Results: During the early post-operative period 5 patients died, although none of those deaths was associated with the procedure itself. No other major complications were observed. During one-year follow-up other 5 patients died, which gave the overall one-year survival rate of 92.7%. Heart failure, renal failure and an infective indication showed significant association with increased mortality.

Conclusion: Results of transvenous lead extraction, a relatively safe procedure, should be assessed over time extending beyond the sole perioperative period. Some complications may be delayed in their nature, and may be observed only during the long-term follow up.

Link to abstract on PubMed

Cardiovascular implantable electronic device lead extraction: evidence, techniques, results, and future directions2016

Sadek MM, Goldstein W, Epstein AE, Schaller RD.

Curr Opin Cardiol. 2016;31:23-8.

Abstract

Purpose of Review: Cardiovascular implantable electronic devices are widely used to treat symptomatic arrhythmias, prevent sudden cardiac death, and improve symptoms and cardiac function. Continued population growth and expanding indications have resulted in a progressive increase in the number of cardiovascular implantable electronic device implantations. Mirroring this growth, an increasing number of leads require removal because of a variety of indications. Transvenous lead extraction continues to evolve with better techniques and risk-management strategies. This review highlights the indications, techniques, procedural outcomes, and future directions of arrhythmia device management and extraction.

Recent Findings: Indications for extractions are reviewed in light of newly published data. Same day contralateral reimplantation has been shown to be safe in patients with localized pocket infection. Alternative extraction techniques, utilizing the femoral and internal jugular veins, provide additional routes for device removal as stand-alone procedures or in cases of difficult extraction via the subclavian vein. Preprocedural imaging to identify adherence sites and cardiac perforation can help to reduce complications. Routine capsulectomy at generator change does not seem to reduce the risk of device infection, and multiple trials are underway to assess other methods of reducing infections as part of a lead management strategy.

Summary: Improvement in technology, alternative routes of extraction and preprocedural imaging continue to add to procedural efficacy and reduce complication rates of lead extraction.

Link to abstract on PubMed

Reimplantation surgery in patients with implantable cardioverter defibrillators: A qualitative study2016

Jakub KE, Sandelowski M.

Heart Lung. 2016;45:48-55.

Abstract

Objective: The purpose of this study was to examine the experience of recurrent surgery for patients with implantablecardioverter defibrillators (ICD).

Background: Device replacement is typically required every 4-7 years due to battery depletion. Furthermore, recurrentsurgery may be related to lead malfunction or pocket infection.

Methods: Ethnographic methods were used for data collection with 23 ICD reimplanted recipients, 12 men and 11 women, 26-85 years of age. Data were analyzed using a with-in case and cross-case method.

Results: Three major themes were identified: Anticipation regarding implantation with three sub-themes of logistics and social considerations, decisions regarding replacement, and financial considerations. Relinquishing control and somatic changes frame perceptions related to the operative and postoperative periods.

Conclusions: The frequency of ICD reimplantation differentiates it from other surgical interventions. Perceptions varied according to past experiences and present day social, financial, and somatic differences. Recipients are resolved to life-longsurgery aided by their trust in health care professionals.

Link to abstract on PubMed

Considerations for cardiac device lead extraction2016

Wazni O, Wilkoff BL.

Nat Rev Cardiol. 2016 Jan 29. [Epub ahead of print]

Abstract

Extraction of cardiovascular implantable electronic device leads is the removal of a lead that has been implanted for >1 year or that requires more than a standard stylet. The number of these procedures has greatly increased over the past few decades owing to the growing demand for primary and secondary implantations in ageing populations, and an accompanying rise in revisions for complications, infections, and lead advisory safety alerts. In this Review, we present the most common indications and techniques used for extraction. Particular consideration is given to the extraction of leads with large vegetations, recalled leads, stented leads, and those placed in the coronary sinus. We also summarize the most relevant and contemporary data on safety, efficacy, and outcomes of lead extraction.

Link to abstract on PubMed

Long-Term Outcomes Following Transvenous Lead Extraction2016

Gomes S, Cranney G, Bennett M, Giles R.

Pacing Clin Electrophysiol. 2016 Jan 14. [Epub ahead of print]

Abstract

Background: Complications related to a cardiac implantable electronic device (CIED) sometimes require transvenous lead extraction (TLE). We report long term follow up of patients undergoing TLE particularly mortality, recurrent device infection and need for repeat procedures.

Methods and Results: Consecutive patients undergoing TLE at a high volume centre were assessed for characteristics, indications, and outcomes. 1006 leads were extracted from 510 patients. Clinical success rate was 98.2% and complete procedural success was 92.2%, with one intra-procedural death. The mean follow up was 5.5+/-4.9 years (range 0.2 - 18 years). Cumulative mortality was 3.3% at 30 days, 7.7% at 6 months, 10.0% at 1 year and 33.0% at 10 years. Factors associated with increased long term mortality included cardiac device infection (CDI) [33% vs 17% for non-CDI; χ² 13.8, P = 0.0003], procedural complications (43% vs 27% for no complications; χ² 4.2, P = 0.04), age (75.0 +/- 10.9 years in patients who died vs 62.7 +/- 17.2 years, P < 0.0001) and impaired renal function (Creatinine 142.5 +/- 106.4 umol/L in patients who died vs 106.3 +/- 90.7 umol/L, P = 0.001). The rate of CDI after TLE was 3.9% (mean 11.6 months post extraction, range 0.3 to 84 months) and is higher in patients with retained lead fragments (13.5% vs 3.0% % with complete removal; χ² 10.7 P = 0.001).

Conclusion: Long term mortality following TLE is high particularly in those with systemic infection, procedural complications, advanced age and renal impairment. Retained fragments are a risk factor for CDI post extraction.

Link to abstract on PubMed

Extraction of Chronically Implanted Coronary Sinus Leads Active Fixation vs. Passive Fixation Leads2016

Crossley GH, Sorrentino RA, Exner DV, Merliss AD, Tobias SM, Martin DO, Augostini R, Piccini JP, Schaerf R, Li S, Miller CT, Adler SW.

Heart Rhythm. 2016 Jan 29. [Epub ahead of print]

Abstract

Background: The Medtronic model 4195 (StarfixTM) left ventricular (LV) lead is an active fixation lead that provides additional support within the coronary sinus (CS) via deployable lobes. While this lead has been shown to have excellent stability within the CS, concerns regarding its' extractability have been raised.

Objective: To prospectively compare the safety and efficacy of extraction of the 4195 lead versus other Medtronic CS leadsin a prospective cohort study.

Methods: Patients undergoing extraction of this and other CS leads for standard indications were prospectively enrolled and studied. The primary outcomes of interest were the removal success rates and associated complication rates. Patients were followed for a month post procedure.

Results: The overall LV lead extraction success rate was 97.6%(n=205). Among 40 patients with chronic 4195 leads, there were 37 successful extractions (92.5%) as compared to 98.8% for the 165 non-4195 leads. However, in 2 of the three StarFix lead extraction failures, standard extraction techniques were not employed. All 10 of the 4195 leads that had been implantedfor less than 6 months were extracted without incident.

Conclusions: In the largest study of CS lead extraction study to date, the overall success rate for extraction of chronicallyimplanted CS leads is high and the complication rate is similar among these lead models. The extraction of the 4195 lead is clearly more challenging, but it can be accomplished in high volume extraction centers with experienced operators. It is recommended that the Starfix Lead be extracted by experienced operators.

Link to abstract on PubMed

Characteristics of cardiac device infections in the Isala Hospital; a large volume tertiary care cardiology centre2016

Steenmeijer R, Adiyaman A, Demirel F, Schram HC, Smit JJ, Delnoy PP, Ramdat Misier AR, Elvan A.

Neth Heart J. 2016;24:199-203.

Abstract

Aims: To determine the frequency, characteristics, and risk factors of cardiac device infections in the Isala Hospital.

Methods: We retrospectively studied all patients who underwent cardiac device procedures performed in the cardiac catheterization lab and the operating room from 2010 to 2012. All patients who developed a cardiac device infection were reviewed for its characteristics.

Results: 31/2026 patients developed a cardiac device infection (1.5%). One (3.2%) patient died within 30 days of hospitalisation. Device infection rates for procedures in the catheterisation lab and operating room were similar (p = 0.60). Positive cultures were present in 27/31 (87%) cases. These consisted predominantly of micro-organisms that are part of the skin flora (84%). The mean time between device procedure and infection was 14 ± 21 months (range 0-79). Cardiac device infection was significantly associated with device revision, (65% were revisions in patients with device infection vs. 30% revisions in patients without device infection, p = 0.011) and placement of a left ventricular lead in pacemaker implantations (59% of patients with vs. 51% of patients without device infection, p < 0.001).

Conclusion: The frequency of cardiac device infection was 1.5% with a mortality of 3.2% within 30 days, which is lower compared with other registries. Cardiac device infections were associated with device revisions and placement of left ventricular leads in pacemaker implantations.

Link to abstract on PubMed

Long-Term Performance of the Riata/ST Implantable Cardioverter-Defibrillator Lead.2016

Ströker E, de Asmundis C, Vanduynhoven P, De Vadder K, De Vusser P, Mullens W, Chierchia GB, Brugada P, Czapla J, La Meir M, Wellens F, Van Herendael H, Rivero-Ayerza M.

Am J Cardiol. 2016;117:807-12.

Abstract
Riata and Riata ST implantable cardioverter-defibrillator leads are prone to structural and electrical failure (EF). Our objective was to evaluate Riata/ST lead performance over a long-term follow-up. Of 184 patients having undergone Riata/ST and Riata ST Optim lead implantation from September 2003 to June 2008, 154 patients were evaluated for EF and radiographic conductor externalization (CE). Survival analysis for EF was performed for Riata/ST leads, both for failure-free lead survival and cumulative hazard. Subanalysis on 7Fr leads was performed to evaluate EF and CE rates both for different Riata ST lead management (monitoring vs proactive) and between Riata ST and Riata ST Optim leads. During a mean follow-up of 7 years, Riata/ST lead EF rate was 13% overall. Similar failure-free survival rate was noted for 7Fr as for 8Fr leads (log-rank, p = 0.63). Of all failed leads, 64% failed only after 5 years of follow-up. Compared with the absolute failure rate of 1.84% per device year, cumulative hazard analysis for leads surviving past 5 years revealed an estimated failure rate of 7% per year. No clinical or procedural predictors for EF were found. The subanalysis on 7Fr leads showed an excellent outcome both for a proactive lead management approach as for Optim leads. In conclusion, long-term survival of the Riata/ST lead is impaired with an accelerating EF risk over time. An initial exponential trend was followed by a linear lead failure pattern for leads surviving past 5 years, corresponding to an estimated 7% annual EF rate. These findings may have repercussions on the lead management strategy in patients currently surviving with a Riata/ST lead to prevent significant clinical events like inappropriate shocks or failed device interventions.

Link to abstract on PubMed

Incidence and predictors of clinically relevant cardiac perforation associated with systematic implantation of active-fixation pacing and defibrillation leads: a single-centre experience with over 3800 implanted leads.2016

Cano Ó, Andrés A, Alonso P, Osca J, Sancho-Tello MJ, Olagüe J, Martínez-Dolz L.

Europace. 2016 Feb 3. [Epub ahead of print]

Abstract

Aims: Active-fixation leads have been associated with higher incidence of cardiac perforation. Large series specifically evaluating this complication are lacking. We sought to evaluate the incidence and predictors of clinically relevant cardiac perforation in a consecutive series of patients implanted with active-fixation pacing and defibrillation leads.

Methods and Results: We conducted a retrospective observational study including all consecutive patients implanted with an active-fixation pacing/defibrillation lead at our institution from July 2008 to July 2015. The incidence of clinically relevant cardiac perforation and cardiac tamponade was evaluated. Univariate and multivariate analyses were used to identify predictors of cardiac perforation. Acute and long-term management of these patients was also investigated. A total of 3822 active-fixation pacing (n = 3035) and defibrillation (n = 787) leads were implanted in 2200 patients. Seventeen patients (0.8%) had clinically relevant cardiac perforation (13 acute and 4 subacute perforations), and 13 (0.5%) had cardiac tamponade resolved with pericardiocentesis. None of the patients with cardiac perforation required surgical treatment. In multivariate analysis, an age >80 years (OR 3.84, 95% CI 1.14-12.87, P = 0.029), female sex (OR 3.14, 95% CI 1.07-9.22, P = 0.037), and an apical position of the right ventricular lead (OR 3.37, 95% CI 1.17-9.67, P = 0.024) were independent predictors of cardiac perforation.

Conclusions: Implantation of active-fixation leads is associated with a low incidence of clinically relevant cardiac perforation. Older and female patients have a higher risk of perforation as well as those patients receiving the ventricular lead in an apical position.

Link to abstract on PubMed

Contribution of PET Imaging to the Diagnosis of Septic Embolism in Patients with Pacing Lead Endocarditis.2016

Amraoui S, Tlili G, Sohal M, Berte B, Hindié E, Ritter P, Ploux S, Denis A, Derval N, Rinaldi CA, Cazanave C, Jais P, Haissaguerre M, Bordenave L, Bordachar P.

JACC Cardiovasc Imaging. 2016;9:283-90.

Abstract

Objectives: The aim of this study was to investigate the role of 18-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) scanning in identifying septic embolism in patients with lead endocarditis.

Background: Lead endocarditis may be associated with septic embolism, in which case the administration mode, type, and duration of antibiotic therapy must be adapted. However, diagnosis can be challenging: magnetic resonance imaging (MRI) cannot be performed in the vast majority of patients with cardiac implantable electronic devices (CIEDs). FDG PET/CT scanning has been proposed as a diagnostic tool for suspected CIED infection.

Methods: Thirty-five consecutive patients with lead endocarditis were prospectively studied. FDG PET/CT scanning was performed and analyzed blindly by experienced nuclear medicine physicians to assess for the presence of septic embolism 2 days before lead extraction.

Results: FDG PET/CT scanning identified septic emboli in 10 patients (29%): 7 with spondylodiscitis, 2 with septic pulmonary emboli, and 1 with an infected vascular prosthesis. Among the 7 patients with occult spondylodiscitis, 4 were asymptomatic, and 3 had back pain with negative CT imaging, MRI being contraindicated due to non MRI-compatible CIEDs. Antimicrobial therapy was adapted (double antibiotic therapy with good bone penetration) and prolonged. Among other important ancillary findings, 3 patients presented focal FDG uptake in the colon (1 adenocarcinoma, and 2 resected polyps) and 2 in the esophagus (both cases confirmed as neoplasia).

Conclusions: This study emphasizes the potential utility of FDG PET/CT scanning as a diagnostic tool for septic emboli in patients with pacing lead endocarditis. This promising diagnostic tool may be integrated in the diagnostic algorithm of patients with lead endocarditis because diagnosis of septic embolisms has a direct and significant impact on the therapeutic care pathway.

Link to abstract on PubMed

 

Combined leadless pacemaker and subcutaneous implantable defibrillator therapy: feasibility, safety, and performance.2016

Europace. 2016 Mar 3. [Epub ahead of print]

Tjong FV, Brouwer TF, Smeding L, Kooiman KM, de Groot JR, Ligon D, Sanghera R, Schalij MJ, Wilde AA, Knops RE.

Abstract

Aims: The subcutaneous implantable cardioverter-defibrillator (S-ICD) and leadless pacemaker (LP) are evolving technologies that do not require intracardiac leads. However, interactions between these two devices are unexplored. We investigated the feasibility, safety, and performance of combined LP and S-ICD therapy, considering (i) simultaneous device-programmer communication, (ii) S-ICD rhythm discrimination during LP communication and pacing, and (iii) post-shock LP performance.

Methods and Results: The study consists of two parts. Animal experiments: Two sheep were implanted with both an S-ICD and LP (Nanostim, SJM), and the objectives above were tested. Human experience: Follow-up of one S-ICD patient with bilateral subclavian occlusion who received an LP and two LP (all Nanostim, SJM) patients (without S-ICD) who received electrical cardioversion (ECV) are presented. Animal experiments : Simultaneous device-programmer communication was successful, but LP-programmer communication telemetry was temporarily lost (2 ± 2 s) during ventricular fibrillation (VF) induction and 4/54 shocks. Leadless pacemaker communication and pacing did not interfere with S-ICD rhythm discrimination. Additionally, all VF episodes (n = 12/12), including during simultaneous LP pacing, were detected and treated by the S-ICD. Post-shock LP performance was unaltered, and no post-shock device resets or dislodgements were observed (24 S-ICD and 30 external shocks). Human experience : The S-ICD/LP patient showed adequate S-ICD sensing during intrinsic rhythm, nominal, and high-output LP pacing. Two LP patients (without S-ICD) received ECV during follow-up. No impact on performance or LP dislodgements were observed.

Conclusion: Combined LP and S-ICD therapy appears feasible in all animal experiments (n = 2) and in one human subject. No interference in sensing and pacing during intrinsic and paced rhythm was noted in both animal and human subjects. However, induced arrhythmia testing was not performed in the patient. Defibrillation therapy did not seem to affect LP function. More data on safety and performance are needed.

Link to abstract on PubMed

Creation of the sole regional laser lead extraction program serving Atlantic Canada: initial experience2016

Williams KJ, O'Keefe S, Légaré JF.

Can J Surg. 2016 Apr 1;59:11115. [Epub ahead of print]

Abstract

Background: An increasing need for laser lead extraction has grown in parallel with the increase of implantation of pacing and defibrillating devices. We reviewed the initial experience of a regional laser-assisted lead extraction program serving Atlantic Canada.

Methods: We retrospectively reviewed the cases of all consecutive patients who underwent laser lead extraction at the Maritime Heart Centre in Halifax, NS, between 2006 and 2015. We conducted univariate and Kaplan-Meier survivorship analyses.

Results: During the 9-year study period, 108 consecutive patients underwent laser lead extractions (218 leads extracted). The most common indication for extraction was infection (84.3%). Most patients were older than 60 years (73.1%) and had leads chronically implanted; the explanted leads were an average of 7.5 ± 6.8 years old. Procedural and clinical success (resolution of preoperative symptoms) rates and mortality were 96.8%, 97.2%, and 0.9%, respectively. Sternotomy procedures were performed in 3 instances: once for vascular repair due to perforation and twice to ensure that all infected lead material was removed. No minor complications required surgical intervention. Survival after discharge was 98.4% at 30 days and 94% at 12 months.

Conclusion: Atlantic Canada's sole surgical extraction centre achieved high extraction success with a low complication rate. Lead extraction in an operative setting provides for immediate surgical intervention and is essential for the survival of patients with complicated cases. Surgeons must weigh the risks versus benefits in patients older than 60 years who have chronically implanted leads (> 1 yr) and infection.

Link to abstract on PubMed

Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study2016

Essebag V, Verma A, Healey JS, Krahn AD, Kalfon E, Coutu B, Ayala-Paredes F, Tang AS, Sapp J, Sturmer M, Keren A, Wells GA, Birnie DH; BRUISE CONTROL Investigators.

J Am Coll Cardiol. 2016 Mar 22;67:1300-8.

Abstract

Background: The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma.

Objectives: The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection.

Methods: The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection.

Results: The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk.

Conclusions: CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137).

Link to abstract on PubMed

Presence of 'ghosts' and mortality after transvenous lead extraction2016

Narducci ML, Di Monaco A, Pelargonio G, Leoncini E, Boccia S, Mollo R, Perna F, Bencardino G, Pennestrì F, Scoppettuolo G, Rebuzzi AG, Santangeli P, Di Biase L, Natale A, Crea F.

Europace. 2016 Mar 29. [Epub ahead of print]

Abstract

Aims: The number of cardiovascular implantable electronic devices has increased progressively, leading to an increased need for transvenous lead extraction (TLE) due to device infections. Previous studies described 'ghost' as a post-removal, new, tubular, mobile mass detected by echocardiography following the lead's intracardiac route in the right-sided heart chambers, associated with diagnosis of cardiac device-related infective endocarditis. We aimed to analyse the association between 'ghosts' assessed by transesophageal echocardiography (TEE) and intracardiac echocardiography (ICE) and mortality in patients undergoing TLE.

Methods and Results: We prospectively enrolled 217 patients (70 ± 13 years; 164 males) undergoing TLE for systemic infection (139), local device infection (67), and lead malfunction (11). All patients underwent TEE before and 48 h after TLE and ICE during TLE. Patients were allocated to two groups: either with (Group 1) or without (Group 2) post-procedural 'ghost'. Mid-term clinical follow-up was obtained in all patients (11 months, IQR 1-34 months). We identified 30 (14%) patients with 'ghost', after TLE. The significant predictors of 'ghost' were Charlson co-morbidity index (HR = 1.24, 95% CI 1.04-1.48, P = 0.03) and diagnosis of endocarditis assessed by ICE (HR = 1.82, 95% CI 1.01-3.29, P = 0.04). Mortality was higher in Group 1 than in Group 2 (28 vs. 5%; log-rank P < 0.001). Independent predictors of mid-term mortality were the presence of 'ghost' and systemic infection as the clinical presentation of device infection (HR = 3.47, 95% CI 1.18-10.18, P = 0.002; HR = 3.39, 95% CI 1.15-9.95, P = 0.001, respectively).

Conclusion: The presence of 'ghost' could be an independent predictor of mortality after TLE, thus identifying a subgroup of patients who need closer clinical surveillance to promptly detect any complications.

Link to abstract on PubMed

Implantable Cardiac Defibrillator Lead Failure and Management2016

Swerdlow CD, Kalahasty G, Ellenbogen KA.

J Am Coll Cardiol. 2016;67:1358-68.

Abstract

The implantable-cardioverter defibrillator (ICD) lead is the most vulnerable component of the ICD system. Despite advanced engineering design, sophisticated manufacturing techniques, and extensive bench, pre-clinical, and clinical testing, lead failure (LF) remains the Achilles' heel of the ICD system. ICD LF has a broad range of adverse outcomes, ranging from intermittent inappropriate pacing to proarrhythmia leading to patient mortality. ICD LF is often considered in the context of design or construction defects, but is more appropriately considered in the context of the finite service life of a mechanical component placed in chemically stressful environment and subjected to continuous mechanical stresses. This clinical review summarizes LF mechanisms, assessment, and differential diagnosis of LF, including lead diagnostics, recent prominent lead recalls, and management of LF and functioning, but recalled leads. Despite recent advances in lead technology, physicians will likely continue to need to understand how to manage patients with transvenous ICD leads.

Link to abstract on PubMed

Transvenous extraction of pacemaker and implantable cardioverter defibrillator leads using Evolution® mechanical dilator sheath: a single center confirmatory experience2016

Kocabaş U, Duygu H, Eren NK, Akyıldız Zİ, Özyıldırım S, Tülüce SY, Kırış T, Nazlı C.

Springerplus. 2016;5:356. 

Abstract

Objective: In recent years there has been an increase in clinical situations requiring lead extraction procedures of implanted cardiac devices. In our clinic, extraction procedures are performed with Evolution® mechanical lead extraction system. In this manuscript we aimed to evaluate our lead extraction procedures.

Methods: We retrospectively evaluated lead extraction procedures carried out on 41 patients [30 male, 11 female patient; mean age 61.5 ± 18.5 median 67 (23-85)] between 2008 and 2015 using Evolution® system. Procedural success, major and minor complications are determined according to previously published guidelines.

Results: Mean duration of the lead implantation was 88.4 ± 62.5 months (6-240). Implanted device was a pacemaker in 27 (65.8 %) and ICD in 14 (34.2 %) of patients. Total 67 leads were extracted from the patients, 22 (32.8 %) were atrial, 30 (44.2 %) were ventricular, 14 (21.5 %) were dual coil defibrillator and 1 (1.5 %) was coronary sinus lead. Indications for lead removal were pacemaker decubitis and infection in 29 (70.8 %), lead dysfunction in 11 (26.8 %) and subclavian vein thrombosis in 1 (2.4 %) patient. Success rate with Evolution® system without using snare was 85.3 %. Clinical success rate was 97.5 % procedural success rate was 95.1 % and failure occurred in one patient. Major complications occurred in 2 (4.8 %) patients, 1 (2.4 %) was procedure related mortality. Minor complications were seen in 5 (12.2 %) of patients.

Conclusions: In our single center study it is shown that extraction of pacemaker and defibrillator leads of relatively long implantation duration and in an older age patient group may be successfully carried out using the Evolution® system. However due to potentially serious complications it is advised to be done by experienced operators in centers with cardiovascular surgery backup.

Link to abstract on PubMed

Coronary Sinus Lead Removal: A Comparison between Active and Passive Fixation Leads2016

Pecha S, Kennergren C, Yildirim Y, Gosau N, Aydin A, Willems S, Treede H, Reichenspurner H, Hakmi S.

PLoS One. 2016;11:e0153651. 

Abstract

Background: Implantation of coronary sinus (CS) leads may be a difficult procedure due to different vein anatomies and a possible lead dislodgement. The mode of CS lead fixation has changed and developed in recent years.

Objectives: We compared the removal procedures of active and passive fixation leads.

Methods: Between January 2009 and January 2014, 22 patients at our centre underwent CS lead removal, 6 active and 16 passive fixation leads were attempted using simple traction or lead locking devices with or without laser extraction sheaths. Data on procedural variables and success rates were collected and retrospectively analyzed.

Results: The mean patient age was 67.2 ± 9.8 years, and 90.9% were male. The indication for lead removal was infection in all cases. All active fixation leads were Medtronic® Attain StarFix™ Model 4195 (Medtronic Inc., Minneapolis, MN, USA). The mean time from implantation for the active and passive fixation leads was 9.9 ± 11.7 months (range 1.0-30.1) and 48.7 ± 33.6 months (range 5.7-106.4), respectively (p = 0.012). Only 3 of 6 StarFix leads were successfully removed (50%) compared to 16 of 16 (100%) of the passive fixation CS leads (p = 0.013). No death or complications occurred during the 30-day follow-up.

Conclusion: According to our experience, removal of the Starfix active fixation CS leads had a higher procedural failure rate compared to passive.

Link to abstract on PubMed

High recurrence of device-related adverse events following transvenous lead extraction procedure in patients with cardiac resynchronization devices2016

Regoli F, Bongiorni MG, Rordorf R, Santamaria M, Klersy C, Segreti L, De Regibus V, Moccetti T, Conte G, Caputo ML, Auricchio A.

Eur J Heart Fail. 2016;May 12. [Epub ahead of print]

Abstract

Introduction: Little is known about the clinical outcome and recurring system-related adverse events (SAE) in cardiac resynchronization therapy (CRT) patients after transvenous lead extraction (TLE).

Methods and Results: From January 2009 to June 2014, 256 consecutive CRT patients (mean age 68.3 ± 11.6 years, 216 male, 88% in New York Heart Association class II-IV, ejection fraction 35.1 ± 10.8%) were treated at four European institutions with TLE. Indications for TLE included systemic (18%) or local (45%) infection, system malfunction (34%), or other (3%). Demographic, clinical, TLE procedural, and follow-up data were collected retrospectively. Adverse events (AE) were considered as death from any cause, cardiovascular hospitalization, and SAE (SAE included pocket and/or systemic infection, lead malfunction, or pocket haematoma requiring revision). Complete removal was achieved for 607 out of 614 leads (98.9%) by using either manual traction (29%), mechanical (43%) or laser (28%) sheaths. Over a median follow-up of 21 (interquartile range 12-29) months, cumulative incidences of any AE and SAE were 39.8% and 21.5%, respectively. Recurring system malfunction occurred in 23 patients (9.0%), infection in 17 patients (6.6%), and pocket haematoma requiring revision in 15 patients (5.9%). Oral anticoagulation therapy was an independent predictor of both any AE [hazard ratio (HR) 2.09, 95% confidence interval (CI) 1.35-3.22, P < 0.001] and SAE (HR 2.38, 95% CI 1.21-4.68, P = 0.012) after TLE.

Conclusions: Even though TLE is safe and effective to treat CRT patients, a high burden of recurring SAE after TLE was observed at mid-term follow-up. Careful evaluation of both patient characteristics as well as implantation strategy is suggested when indicating TLE in a CRT patient, particularly in patients receiving oral anticoagulation therapy.

Link to abstract on PubMed

Extraction of a CardioFix neurostimulator with concomitant laser-assisted lead and intracardiac cardiac defibrillator extraction due to Staphylococcus aureus pocket infection2016

Hebsur S, Pollema T, Birgersdotter-Green U, Pretorius V.

HeartRhythm Case Reports. 2016;2:208-10.

Abstract

Introduction: This is a case report of the first reported laser lead extraction of a CardioFit vagal nerve stimulator owing to automatic implantable cardioverter-defibrillator (AICD) pocket infection.

Case report: A 61-year-old man with a history of ischemic cardiomyopathy status post dual-chamber Medtronic Evera XT AICD implanted in the left infraclavicular fossa area in 2007 was subsequently enrolled in the Innervate HF trial in 2013 and had a CardioFix (BioControl Medical LTD, Yehud, Isreal) neurotransmitter implanted.

Conclusion: Laser lead extraction procedures will increase in technical complexity as the heart failure population grows and there is a higher utilization of implantable intracardiac devices for pressure monitoring and autonomic regulation. Therefore, a multidisciplinary approach with electrophysiology and cardiac surgery is required for such complex cases.

Link to abstract on HeartRhythm Case Reports

Magnetic resonance imaging in patients with cardiac implanted electronic devices: focus on contraindications to magnetic resonance imaging protocols2016

Horwood L, Attili A, Luba F, Ibrahim EH, Parmar H, Stojanovska J, Gadoth-Goodman S, Fette C, Oral H, Bogun F.

Europace. 2016;Jun 2. [Epub ahead of print]

Abstract

Aims: Magnetic resonance imaging (MRI) has been reported to be safe in patients with cardiac implantable electronic devices (CIED) provided a specific protocol is followed. The objective of this study was to assess whether this is also true for patients excluded from published protocols.

Methods and Results: A total of 160 MRIs were obtained in 142 consecutive patients with CIEDs [106 patients had an implantable cardioverter defibrillator (ICD) and 36 had a pacemaker implanted] using an adapted, pre-specified protocol. A cardiac MRI was performed in 95 patients, and a spinal/brain MRI was performed in 47 patients. Forty-six patients (32%) had either abandoned leads (n = 10), and/or were pacemaker dependent with an implanted ICD (n = 19), had recently implanted CIEDs (n = 1), and/or had a CIED device with battery depletion (n = 2), and/or a component of the CIED was recalled or on advisory (n = 32). No major complications occurred. Some device parameters changed slightly, but significantly, right after or at 1-week post-MRI without requiring any reprogramming. In one patient with an ICD on advisory, the pacing rate changed inexplicably during one of his two MRIs from 90 to 50 b.p.m.

Conclusion: Using a pre-specified protocol, cardiac and non-cardiac MRIs were performed in CIED patients with pacemaker dependency, abandoned leads, or depleted batteries without occurrence of major adverse events. Patients with devices on advisory need to be monitored carefully during MRI, especially if they are pacemaker dependent.

Link to abstract on PuMed

Provision of magnetic resonance imaging for patients with 'MR-conditional' cardiac implantable electronic devices: an unmet clinical need2016

Sabzevari K, Oldman J, Herrey AS, Moon JC, Kydd AC, Manisty C.

Europace. 2016;Jun 2. [Epub ahead of print]

Abstract

Aims: Increasing need for magnetic resonance imaging (MRI) has driven the development of MR-conditional cardiac implantable electronic devices (CIEDs; pacemakers and defibrillators); however, patients still report difficulties obtaining scans. We sought to establish current provision for MRI scanning of patients with CIEDs in England.

Methods: A survey was distributed to all hospitals in England with MRI, to assess current practice. Information requested included whether hospitals currently offer MRI to this patient group, the number and type of scans acquired, local safety considerations, complications experienced and perceived obstacles to service provision in those departments not currently offering it.

Results: Responses were received from 195 of 227 (86%) of hospitals surveyed. Although 98% of departments were aware of MR-conditional devices, only 46% (n = 89) currently offer MRI scans to patients with CIED's; of these, 85% of departments perform ≤10 scans per year. No major complications were reported from MRI scanning in patients with MR-conditional devices. Current barriers to service expansion include perceived concerns regarding potential risk, lack of training, logistical difficulties, and lack of cardiology support.

Conclusion: Provision of MRI for patients with CIEDs is currently poor, despite increasing numbers of patients with MR-conditional devices and extremely low reported complication rates.

Link to abstract on PuMed

Venous thromboembolism in patients with implantable cardioverter-defibrillators2016

Pedersen SB, Hjortshøj SP, Bøtker HE, Farkas DK, Schmidt M5, Sørensen HT, Nielsen JC.

Europace. 2016;Jun 2. [Epub ahead of print]

Abstract

Aims: To examine the incidence of venous thromboembolism (VTE) and its risk factors among patients with implantable cardioverter-defibrillators (ICDs).

Methods and Results: All first-time ICD recipients in Denmark during 2000-12 were identified from medical databases. Incident VTEs were ascertained, overall and according to gender, age, Charlson Comorbidity Index score (no, moderate, or severe comorbidity), prior pacemaker or cardiac resynchronization therapy (CRT-D) implantation, and ICD type (single-chamber, dual-chamber, or CRT-D). We computed the risk of VTE within 3 months and 5 years of implantation, taking death into account as a competing risk. We used Cox proportional hazards regression to compute hazard ratios as estimates of incidence rate ratios (IRRs). Among 8132 ICD recipients, 136 VTEs were diagnosed during up to 13 years of follow-up (median = 3.0 years). The VTE incidence rate was thus 4.5 per 1000 person-years [95% confidence interval (CI): 3.7-5.2]. Venous thromboembolism risk was 0.3% (95% CIs ranging from 0.1 to 0.7%) within 3 months following ICD implantation regardless of comorbidity level. Within 5 years following implantation it was 1.4% (95% CI: 0.8-2.3%), 1.3% (1.0-1.8%), and 3.2% (95% CI: 2.4-4.1%) for patients with no, moderate, and severe comorbidity, respectively. Overall, severe comorbidity conferred a 2.7-fold higher incidence rate ratio than no comorbidity (95% CI: 1.6-4.6). Incidence rate ratios did not differ by gender, age, or ICD type.

Conclusion: Three-month risk of VTE following ICD implantation was 0.3% regardless of comorbidity level. Five-year risk of VTE following ICD implantation was 1.9% and more than twice as high for patients with severe comorbidity as for patients without comorbidity.

Link to abstract on PuMed

Intra- and Extra-pericardial Lengths of the Superior Vena Cava in Vivo: Implication for the Positioning of Central Venous Catheters2005

Kwon TD, Kim KH, Ryu HG, Jung CW, Goo JM, Bahk JH.

Anaesth Intensive Care. 2005;33:384-7.

Click the links below for the article and additional slides.

Managing patients with advisory defibrillator leads: what can we learn from published data?2015

Defibrillator lead advisories stir a lot of emotions, both with patients and physicians, and this may influence lead management. We reviewed the literature for a more evidence-based approach to this issue.

From the complications of two of the current advisory leads, the Medtronic Sprint Fidelis and St. Jude Riata leads, and the consequences of possible interventions, we can conclude that a restrained approach to premature replacement is appropriate. It may be opportune to replace the leads during a scheduled generator replacement in case of a higher electrical failure rate, in order to prevent future premature interventions.

We found no support to extract non-functional advisory leads. In contrast, extraction is often more demanding than anticipated, and the risk substantially exceeds that of simply abandoning the leads. 

Outcomes 1 Year After Implantable Cardioverter-Defibrillator Lead Abandonment Versus Explantation for Unused or Malfunctioning Leads: A Report from the National Cardiovascular Data Registry2016
Zeitler EP, Wang Y, Dharmarajan K, Anstrom KJ, Peterson ED, Daubert JP, Curtis JP, Al-Khatib SM. Circ Arrhythm Electrophysiol. 2016;9:e003953.
 

Abstract

Introduction: Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA) can develop conductor cable externalization and/or electrical failure. Optimal management of these leads remains unknown.

Methods and Results: A Markov model compared 4 lead management strategies: (1) routine device interrogation for electrical failure, (2) systematic yearly fluoroscopic screening and routine device interrogation, (3) implantation of new ICD lead with capping of the in situ lead, and (4) implantation of new ICD lead with extraction of the in situ lead. The base case was a 64-year-old primary prevention ICD patient. Modeling demonstrated average life expectancies as follows: capping with new lead implanted at 134.5 months, extraction with new lead implanted at 134.0 months, fluoroscopy with routine interrogation at 133.9 months, and routine interrogation at 133.5 months. One-way sensitivity analyses identified capping as the preferred strategy with only one parameter having a threshold value: when risk of nonarrhythmic death associated with lead abandonment is greater than 0.05% per year, lead extraction is preferred over capping. A second-order Monte Carlo simulation (n = 10,000), as a probabilistic sensitivity analysis, found that lead revision was favored with 100% certainty (extraction 76% and capping 24%).

Conclusions: Overall there were minimal differences in survival with monitoring versus active lead management approaches. There is no evidence to support fluoroscopic screening for externalization of Riata or Riata ST leads.

Link to abstract on PubMed.

Impact of generator replacement on the risk of Fidelis lead fracture2016

Krahn AD, Bashir J, Birnie DH, Brown J, Spencer JH, Leander C, Estes NA. Heart Rhythm. 2016;13:1618-23.
 

Abstract

Background: A dilemma arises about the merits of conservative management vs lead replacement and/or extraction when patients with a Medtronic Sprint Fidelis lead undergo generator replacement. Conflicting reports suggest that the fracture rate may increase after generator change.

Objective: The purpose of this study was to investigate the effect of generator replacement on Fidelis lead performance.

Methods: The Carelink PLUS cohort is composed of 21,500 Fidelis leads (model 6949) implanted in 1,006 centers. The survival rate for leads that remained active after the first generator replacement was compared with that for a control group with matched lead implant duration, patient age, patient sex, and generator type using the Kaplan-Meier method. The control group's starting point was adjusted to match the implant duration of each lead in the replacement group to allow for the comparison of similarly aged leads.

Results: Of the 2,988 implanted leads in each group, there was no statistical difference in the number of lead fractures between cases and controls (replacement, n = 227; no replacement, n = 257; Fisher exact, P = .169). Lead survival analysis demonstrated that lead performance since the first replacement procedure did not differ from that of the matched control group.

Conclusion: The Fidelis lead survival rate after generator replacement does not differ from that of the Fidelis leads that have not had replacement. In the event of generator replacement with no manifestation of lead fracture, the lead model, patient age and life expectancy, ejection fraction, comorbidities, ease of extraction, local extraction expertise, and patient preference should be considered to determine the best course of action.

Link to abstract on PubMed.

Less with More: Hospitalization Cost and Event Rates with Quadripolar versus Bipolar CRT-D System2016

Corbisiero R, Kazemian P, Bharmi R, Shah R, Muller D.  Pacing Clin Electrophysiol. 2016;39:1038-45.

Abstract

Background: This is a comparative effectiveness study for cardiac resynchronization therapy defibrillator (CRT-D) therapy enabled by quadripolar (QUAD) versus bipolar (BIP) left ventricular (LV) leads.  Heart failure (HF) hospitalization (HFH) rates, associated costs, and 30-day readmissions after index HFH were compared.

Methods: Patients with de novo LV leads implanted as part of a CRT-D system between January 2011 and August 2013 with ≥1-year follow-up were included. Medical history, dates, and locations of HFH were collected thereafter. Patients were divided based on LV lead model: QUAD or BIP. Universal billing records (UB-04) for each HFH and ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) diagnoses/procedure codes were used to classify hospitalizations as HF or non-HF and calculate concurrent U.S. national-average medicare reimbursement. Rates, associated payer costs, and 30-day readmissions were then compared using nonparametric bootstrapping.

Results: Baseline characteristics (N = 69 QUAD and N = 56 BIP) were similar. The inpatient HFH for the QUAD group (0.20/patient-year) was lower than the BIP group (0.31/patient-year, incidence rate ratio [IRR] = 0.62, P = 0.036). The overall HFH rate for the inpatient or outpatient setting for QUAD (0.29/patient-year) was lower than the BIP group (0.42/patient-year, IRR = 0.69, P = 0.055). Average cost of HFH in QUAD ($4,428/patient-year) was lower than BIP ($7,354/patient-year), a 39.8% cost reduction (P = 0.026). The 30-day readmission rate was also lower in QUAD compared to BIP (19% vs 28%, IRR = 0.68, P = 0.18).

Conclusion: This U.S. economic comparative study demonstrated that QUAD exhibited lower postimplant inpatient HFH rates and reduced healthcare utilization compared to BIP systems.

Link to abstract on PubMed.

Cardiac Implantable Electronic Device Infections: Added Complexity and Suboptimal Outcomes With Previously Abandoned Leads2017

Hussein AA, Tarakji KG, Martin DO, Gadre A, Fraser T, Kim A, Brunner MP, Barakat AF, Saliba WI, Kanj M, Baranowski B, Cantillon D, Niebauer M, Callahan T, Dresing T, Lindsay BD, Gordon S, Wilkoff BL, Wazni OM. 

JACC Clin Electrophysiol. 2017;3:1-9.

Abstract

Objectives:  The study sought to assess the impact of previously abandoned leads on the clinical management of cardiac device infections, notably transvenous lead extraction and subsequent clinical course.

Background:  The population of patients with cardiac implantable electronic devices continues to grow with a disproportionate increase in device infections, which are invariably life threatening. A potentially complicating issue is the widely practiced strategy of device lead abandonment at the time of system revision, change, or upgrade, which is affecting an increasing number of patients.

Methods:  The study assessed the impact of previously abandoned leads in a prospectively maintained registry of consecutive patients undergoing percutaneous extraction of infected cardiac devices at the Cleveland Clinic between August 1996 and September 2012. The primary clinical endpoint was complete procedural and clinical success defined as the successful removal of the device and all lead material from the vascular space, in the absence of a major complication.

Results:  Of 1,386 patients with infected cardiac devices, 323 (23.3%) had previously abandoned leads. Failure to achieve the primary endpoint occurred more frequently in patients with abandoned leads (13.0% vs. 3.7%; p < 0.0001). This was primarily due to retention of lead material (11.5% vs. 2.9%; p < 0.0001), which was associated with poor clinical outcomes including higher rates of 1-month mortality (7.4% vs. 3.5% in those without lead remnants). Lead extraction procedures in patients with previously abandoned leads were longer (p < 0.0001), with longer fluoroscopy times (p < 0.0001), and more likely to require specialized extraction tools (94.4% vs. 81.8%; p < 0.0001) or adjunctive rescue femoral workstations (14.9% vs. 2.9%; p < 0.0001). Procedural complications occurred more frequently in patients with previously abandoned leads (11.5% vs. 5.6%; p = 0.0003), which was true for both major (3.7% vs. 1.4%; p = 0.009) and minor complications (7.7% vs. 4.4%; p = 0.02).

Conclusions:  Previously abandoned leads complicate the management of cardiac device infections, leading to worse clinical outcomes.

Link to article on JACC: Clinical Electrophysiology

Lead Extraction for Treatment of Cardiac Device Infection: A 20-Year Single Centre Experience2016

Gomes S, Cranney G, Bennett M, Giles R.  Heart Lung Circ. 2016;Aug 12. [Epub ahead of print]

Abstract

Background: Infection is one of the most feared complications of cardiac implantable electronic devices. We report microbiology, antimicrobial therapy and infection recurrence in patients with cardiac device infection (CDI) treated with transvenous lead extraction (TLE) at a single centre over a 20-year period.

Methods: We identified a cohort of consecutive patients undergoing TLE for CDI by a single operator at a single high volume centre. Retrospective analysis of patient characteristics, microbiology, outcomes and infection recurrence was performed.

Results: Between May 1992 to March 2012, 348 patients underwent extraction due to localised or systemic infection. Seven hundred and twenty leads were extracted from these patients. The mean follow-up was 5.5+/-4.9 years. Staphylococcal species accounted for 81% of CDI. A difference is seen in infection onset for device revision compared with initial implants [median 10 months vs 24 months, P=0.0001]. Duration of antibiotics therapy depended on the nature of the CDI (21 days post TLE for systemic vs. 10 days for localised infection, P < 0.0001). There was comparable mortality in the 37 (11.2%) patients who did not have a replacement device compared with a replacement (30% vs 29%, P=0.9). Retained lead fragments are a risk factor for CDI recurrence (20.8% recurrence in retained fragments vs 4.3% in complete removal, P=0.006).

Conclusion: Cardiac device infection can be successfully treated with a combination of TLE and antibiotic therapy. Device therapy can be safely withdrawn in some patients. Retained lead fragments are a risk factor for recurrent CDI following extraction.

Link to abstract on PubMed.

A Novel Video-Assisted Approach to Excimer Laser-Guided Cardiac Implantable Electronic Devices Lead Extraction2016

Zardo P, Busk H, Hadem J, Baraki H, Kensah G, Kutschka I.
Innovations (Phila). 2016;11:210-3.

Abstract

Objective: Even though roughly 90% of all implanted cardiac implantable electronic devices leads can be removed through conventional techniques, presence of large vegetations or thrombi, fractured leads, previous failed extraction, or long duration from implantation often impede classical transvenous extraction. In these cases, laser-assisted procedures represent a highly successful alternative and have a low procedural complication rate with major adverse events in less than 2% of cases. Unfortunately, most encountered complications are potentially fatal, which prompted us to develop a novel approach that adds additional safety measures by allowing for real-time intrathoracic visualization and intervention.

Methods: Five consecutive patients classified as high-risk patients received concomitant laser sheet extraction and right-sided uniportal video-assisted thoracic surgery for real-time intrathoracic visualization.

Results: Complete extraction was achieved in all cases without observing major intraoperative events, and on-table extubation was feasible in all cases. No chest tube-associated or incision-related complications were encountered.

Conclusions: Concomitant laser sheet extraction and video-assisted thoracoscopy are feasible and may offer benefits in high-risk patients. Further studies to document the actual safety and clinical value of our procedure are warranted.

Link to abstract on PubMed.

Leadless Cardiac Devices-Pacemakers and Implantable Cardioverter-Defibrillators2016

Rutzen-Lopez H, Silva J, Helm RH.  Curr Treat Options Cardiovasc Med. 2016;18:49.

Abstract

Opinion Statement: Since the initial introduction of pacemakers and defibrillators, the rapid growth in microcircuit and battery technology has increased the longevity demands and exposed the vulnerabilities of transvenous leads. Over a half of century later, leadless pacemaker and defibrillation systems are just reaching the clinical arena. Despite the remarkable advantages of leadless pacing systems, the data are still quite limited and broad implementation of these technologies need to occur in a cautious and deliberate fashion as the peri-procedural risks remains high. Two of the three systems, Nanostim(TM) (St. Jude Medical) and Micra Transcatheter Pacing System (Medtronic Inc.), have shown the greatest applicability, although they are currently only limited to single chamber pacing and procedural risks are modest. The WiCS(TM)-LV system (EBR Systems, Inc.) is anatomically limited and benefits a small subset of patients. Leadless implantable cardioverter-defibrillator (ICD) therapy, the subcutaneous ICD (S-ICD, Cameron Health/Boston Scientific), has demonstrated encouraging short-term safety and efficacy data supporting its use. Since its introduction, modifications to the implant procedure, pre-screening of patients, and programming of the devices have reduced procedural-related complications and inappropriate shocks. The S-ICD is a promising technology, but it is premature to conclude that it will supplant conventional ICDs. At this current time, the S-ICD may benefit select patients, such as those with recurrent bacteremia, vascular access limitations, and who may be prone to transvenous lead failure.

Link to abstract on PubMed.

Management of bacteremia in patients living with cardiovascular implantable electronic devices2016

DeSimone DC, Sohail MR.  Heart Rhythm. 2016 Aug 19. [Epub ahead of print]

Abstract

Cardiovascular implantable electronic devices (CIEDs) have become a critical component in management of patientswith cardiac rhythm disturbances, heart failure, and prevention of sudden cardiac death. However, infection remains a major complication of CIED implantation and is associated with significant morbidity and mortality for device recipients. Early-onset CIED infections frequently originate from the generator pocket, secondary to device or pocket contamination at the time of implantation, and may progress to involve device leads or cardiac valves. However, hematogenous seeding of the device leads from a remote source of bacteremia is not infrequent in patients with late-onset CIED infections. Whereas CIED pocket infection can be diagnosed in the majority of cases based on physical findings at the pulse generator site, device lead infection may only manifest with fever and positive blood cultures. However, not every patient with a CIED and positive blood cultures has underlying CIED lead infection. Consequently, management of bacteremia in a CIED recipient without local signs of infection presents a significant challenge. The risk of underlying CIED lead infection in patients presenting with bacteremia depends on several factors, including the type of microorganism isolated in blood cultures, duration and source of bacteremia, type of CIED, and number of device-related procedures. These risk factors must be considered when making decisions regarding the need for further diagnostic imaging and whether to retain or remove the device. In this article, we review the published data regarding risk of CIED infection in patients presenting with bacteremia and propose an algorithm for appropriate evaluation and management.

Link to abstract on PubMed.

The utility of a CHA2DS2-VASc score in predicting the presence of significant stenosis and occlusion of veins with indwelling endocardial leads2016

Boczar K, Ząbek A, Dębski M, Haberka K, Rydlewska A, Lelakowski J, Małecka B.  Int J Cardiol. 2016;218:164-9.

Abstract

Background: Currently, there are no studies in which a CHA2DS2-VASc score has been used to predict the risk of venous stenosis and occlusion (VSO) in patients after the implantation of a cardiac implantable electronic device (CIED).

Methods: The material consists of the records of 223 consecutive patients qualified for transvenous lead extraction, generator change and system revisions or upgrades in whom we assessed the utility of a CHA2DS2-VASc score in the prediction of VSO. The CHA2DS2-VASc score was calculated retrospectively based on the clinical data. The whole study population was divided into two groups, based on the presence (group I) or absence (group II) of VSO. Using the receiver operating characteristic (ROC) curve, we identified the optimal cut-off point for the CHA2DS2-VASc score that allowed the prediction of the absence of VSO.

Results: The venography was performed in 223 consecutive patients aged on average 68.2years (25.7-95.3), 77 females (34.5%). The presence of VSO was detected in 79 (35.4%) patients aged 68.3±14.1years, 30 female (40%) patients-group I. The level of the cut-off point for the CHA2DS2-VASc score that allowed the prediction of the absence of VSO was 3.0.

Conclusion: In the whole population the incidence of VSO amounted to 35.4%. The result of the CHA2DS2-VASc score was a destimulant of VSO occurrence and was characterized by moderate sensitivity (73.4%) and specificity (42.4%) in predicting the absence of VSO. The most significant factor, which prevented VSO development was diabetes.

Link to abstract on PubMed.

Comparative study of the failure rates among 3 implantable defibrillator leads2016

van Malderen SC, Szili-Torok T, Yap SC, Hoeks SE, Zijlstra F, Theuns DA.  Heart Rhythm. 2016;Aug 2. [Epub ahead of print]

Abstract

Background: After the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed.

Objective: The purpose of this article was to assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads.

Methods: We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n = 408), Durata (St. Jude Medical, model 7122) (n = 340), and Endotak Reliance (Boston Scientific, models 0155, 0138, and 0158) (n = 343) leads. Lead failure was defined by low- or high-voltage impedance, failure to capture, sense or defibrillate, or the presence of nonphysiological signals not due to external interference.

Results: During a median follow-up of 5.1 years, 24 Linox (5.9%), 5 Endotak (1.5%), and 5 Durata (1.5%) leads failed. At 5-year follow-up, the cumulative failure rate of Linox leads (6.4%) was higher than that of Endotak (0.4%; P < .0001) and Durata (2.0%; P = .003) leads. The incidence rate was higher in Linox leads (1.3 per 100 patient-years) than in Endotak and Durata leads (0.2 and 0.3 per 100 patient-years, respectively; P < .001). A log-log analysis of the cumulative hazard for Linox leads functioning at 3-year follow-up revealed a stable failure rate of 3% per year. The majority of failures consisted of noise (62.5%) and abnormal impedance (33.3%).

Conclusion: This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure.

Link to abstract on PubMed.

Prevalence and predictor factors of severe venous obstruction after cardiovascular electronic device implantation2016

Santini M, Di Fusco SA, Santini A, Magris B, Pignalberi C, Aquilani S, Colivicchi F, Gargaro A, Ricci RP.  Europace. 2016 Aug;18:1220-6.

Abstract

Aims: Despite not being uncommon, limited evidence exists about predisposing factors for venous obstruction in patients with implantable electronic devices. We aimed to assess the prevalence of severe venous obstruction in patients with intravenous devices and identify predictor factors.

Methods and Results: A total of 184 patients underwent venography to detect venous obstruction associated with the inserted lead. Vessel obstruction was graded as venous occlusion (complete flow interruption), severe obstruction (narrowing >90%), or mild-moderate obstruction (narrowing 50-90%). Severe venous obstruction/occlusion prevalence was 11.4% (n = 21) and was always asymptomatic. Collateral circulation was found in 80.9% of patients with severe obstruction/occlusion. Twelve patients (6.5%) had 3 leads. The rates of patients with secondary prevention of sudden cardiac death as indication for implantable devices and of those of patients with 3 leads were significantly greater in the group with severe obstruction/occlusion than in the non-severe obstruction/occlusion group (respectively, P = 0.004 and P = 0.03). Logistic analysis adjusted for venous thromboembolic risk factors confirmed that secondary prevention of sudden cardiac death as indication for implantable devices [odds ratio (OR), 7.1; 95% confidence interval (CI): 1.4-35.3; P = 0.017] and the presence of 3 leads (OR, 8.5; 95% CI: 1.75-41.35; P = 0.008) were predictors of severe obstruction/occlusion.

Conclusion: In patients with implantable devices, severe venous obstruction prevalence is not negligible and the lack of symptoms does not exclude it. The presence of three leads and sudden cardiac death as indication for implantable devices seem to be associated with the presence of severe venous obstruction/occlusion.

Link to abstract in PubMed.

Classification and Surgical Repair of Injuries Sustained During Transvenous Lead Extraction2016

Bashir J, Fedoruk LM, Ofiesh J, Karim SS, Tyers GF.
Circ Arrhythm Electrophysiol. 2016;9:e003741.

Abstract

Background: Injuries to cardiac and venous structures during pacemaker and defibrillator lead extraction are serious complications that have been studied poorly. The incidence of these injuries is unknown but likely underestimated. No systematic multicenter review of these injuries or their management has been undertaken.

Methods and Results: We interrogated our mandatory administrative database for all excimer laser extractions that sustained a cardiac or venous injury in the province of British Columbia. Injuries were classified according to presentation and compared with respect to nature of injury, type of repair, utilization of cardiopulmonary bypass, and outcome. Of 1082 excimer laser extractions over 19 years, 33 sustained an injury (3.0%). The majority of injuriesoccurred in women (21/33; 63.6%), and median age of oldest lead extracted was 10.8 (7.5, 12.2) years. A type 1 presentation, defined as circulatory collapse, was found in 12/33 patients (36.4%). A type 2 presentation, defined as progressive hypotension responsive to treatment, was found in 20/33 patients (60.6%). Over half the patients had a moderate or large injury, and cardiopulmonary bypass was required in 13 patients with extensive injury. Despite the presence of devastating injuries, the immediate availability of aggressive salvage measures resulted in a survival of 87.9% of patients at 30 days.

Conclusions: The immediate availability of a cardiovascular surgeon, perfusionist, and cardiopulmonary bypass pump facilitates lifesaving repair of injuries sustained during laser lead extraction. The size and complexity of injury correlates closely with the presentation, blood loss, and need for cardiopulmonary bypass to facilitate repair.

Link to abstract on PubMed.

Laser lead extraction allows for safe and effective removal of single- and dual-coil implantable cardioverter defibrillator leads: A single-centre experience over 12 years2016

Pecha S, Yildirim Y, Gosau N, Aydin MA, Willems S, Treede H, Reichenspurner H, Hakmi S.
Interact Cardiovasc Thorac Surg. 2016;Sep 13. [Epub ahead of print]

Abstract

Objectives: Lead extraction in patients with multiple or old leads of an implantable cardioverter defibrillator (ICD) is challenging. As adhesions are common at the side of the shock coils, we investigated success and procedural complication rates of laser lead extraction procedures in single- and dual-coil leads.

Methods: Between January 2001 and June 2013, 41 single- and 145 dual-coil ICD leads were extracted from 171 patients using laser sheaths. Procedural data, success rates and complications were collected into a database and retrospectively analysed.

Results: The mean patient age was 58.2 ± 16.1 years. The mean time from initial lead implantation to extraction was 50.3 ± 18.4 and 45.8 ± 14.5 months in the single- and dual-coil group, respectively (P = 0.1). In the single-coil group, complete procedural success was achieved in 36 of 37 (97.3%) cases, and clinical success in all cases (100.0%). In the dual-coil group, complete procedural success was seen in 131 out of 134 (97.8%) patients, and clinical success in 132 of 134 cases (98.5%). The transvenous extraction failed in 2 cases (1.5%). The overall complication rate was 2.7% in the single-coil group and 3.7% in the dual-coil group, respectively (P = 1.0). No deaths occurred during the 30-day follow-up. The mean laser treatment time was 1.8 ± 1.5 min for the single-coil group and 2.5 ± 1.2 min for dual-coil group (P = 0.002).

Conclusions: Laser lead extraction allows for safe and effective removal of ICD leads. Compared with single-coil leads, the extraction of dual-coil leads is associated with longer laser treatment times but without statistically significant differences in complications and procedural success rates.

Link to abstract on PubMed.

Percutaneous occlusion balloon as a bridge to surgery in a swine model of superior vena cava perforation2016

Clancy JF, Carrillo RG, Sotak R, Ram R, Ryu RK, Kennergren C.
Heart Rhythm. 2016;Jun 23. [Epub ahead of print]

Abstract

Background: Superior vena cava (SVC) perforation is a rare but potentially fatal complication of transvenous lead removal.

Objective: The aim of this study was to evaluate the feasibility of hemodynamic stabilization using an occlusion balloon during SVC tear in a porcine model.

Methods: A surgically induced SVC perforation was created in Yorkshire cross swine (n = 7). Three animals were used to develop and test surgical repair methods. Four animals were used to evaluate hemodynamic, behavioral, and neurological effects up to 5 days after SVC tear and repair. An occlusion balloon (Bridge Occlusion Balloon, Spectranetics Corporation, Colorado Springs, CO) was percutaneously delivered through the femoral vein to the location of the injury and inflated. Once hemodynamic control was achieved, the perforation was surgically repaired.

Results: After SVC perforation and clamp release, the rate of blood loss was 7.0 ± 0.8 mL/s. Mean time from SVC tear to occlusion balloon deployment was 55 ± 12 seconds, during which mean arterial pressure decreased from 56 ± 2 to 25 ± 3 mm Hg and heart rate decreased from 76 ± 7 to 62 ± 7 beats/min. After the deployment of the occlusion balloon, the rate of blood loss decreased by 90%, to 0.7 ± 0.2 mL/s. The mean time of balloon occlusion of the SVC was 16 ± 4 minutes and hemodynamic measures returned to baseline levels during this time. Study animals experienced no major complications, demonstrated stable recovery, and exhibited normal neurological function at each postoperative assessment.

Conclusion: Endovascular temporary balloon occlusion may be a feasible option to reduce blood loss, maintain hemodynamic control, and provide a bridge to surgery after SVC injury.

Link to abstract on PubMed.

Predictors of intraoperative electrosurgery-induced implantable cardioverter defibrillator (ICD) detection2016

Friedman H, Higgins JV, Ryan JD, Konecny T, Asirvatham SJ, Cha YM.
J Interv Card Electrophysiol. 2016 Sep 24. [Epub ahead of print]

Abstract

Background: In the USA, the number of people needing implantable cardioverter defibrillators (ICDs) has grown dramatically. Many ICD recipients will need to undergo a surgical procedure at some point following ICD implantation. Most surgeries involve the use of electrocautery. Currently, the effects of electrocautery-induced electromagnetic interference (EI-EMI) on ICDs are poorly understood. The aim of this study was to study EI-EMI using prospectively collected clinical data.

Methods: We analyzed prospectively collected ICD data from patients undergoing a surgical procedure at Mayo Clinic between 2011 and 2012. Information on clinical, device history, device interrogation pre- and post-surgery, and surgical information were collected for all patients. ICDs were programmed with detections on and therapies off. The patients were then categorized into two groups: those with EI-EMI inappropriate arrhythmia detection and those without detection. The stored electrograms were reviewed. Clinical and device parameters were analyzed to identify predictors of EI-EMI.

Results: Of 103 patients studied, bipolar cautery did not induce EI-EMI (0/11 cases), whereas monopolar cautery resulted in noise detection in 11/92 procedures. Among 11 inappropriate episodes of detection, 10 had surgery at chest, neck, and upper extremity sites with cautery current across the ICD lead tip; 1 had abdominal surgery; and none had back or low extremity surgery. On average, the near-field electrogram amplitude values were greater than the far-field amplitude values.

Conclusions: EI-EMI does not occur when bipolar cautery or monopolar cautery is used below the hips with the dispersive ground pad applied to the lower extremities. In contrast to external EMI, EI-EMI may be larger on near-field than far-field electrograms.

Link to abstract on PubMed.

Pacing Without Wires: Leadless Cardiac Pacing2016

Bernard ML.  Ochsner J. 2016;16:238-42.

Abstract

Background: Worldwide, more than 700,000 pacemakers are implanted annually with more than 250,000 implanted in the United States. Since the first fully transvenous pacemaker implantations in the early 1960s, great technologic advances have been made in pacing systems. However, the combination of subcutaneous pulse generators and transvenous pacing leads has remained constant for more than 50 years. Leadless pacing systems offer an alternative to traditional pacing systems by eliminating the need for permanent transvenous leads while providing therapy for patients with bradyarrhythmias.

Methods: We discuss the 2 leadless cardiac pacemakers (LCPs), the Nanostim Leadless Pacemaker and Micra Transcatheter Pacing System, and the 1 ultrasound-powered device, the WiCS-LV, that have been studied in humans. Currently LCPs are restricted to single-chamber pacing, specifically, ventricular pacing. Dual-chamber pacing and multichamber pacing with leadless systems have yet to be studied.

Results: LCPs represent the greatest advancement in bradycardia therapy since the first transvenous pacemaker implantation more than 50 years ago.

Conclusion: Initial studies of both the Nanostim and Micra LCPs show favorable efficacy and safety results compared to transvenous pacemakers. Pending US Food and Drug Administration approval, these devices will transform our ability to provide pacing for patients with bradyarrhythmias. Future developments may allow for completely leadless single-chamber and multichamber pacing, ushering in an era of pacing without wires.

Link to abstract on PubMed.

Leadless Cardiac Pacemaker Implantation After Lead Extraction in Patients With Severe Device Infection2016

Kypta A, Blessberger H, Kammler J, Lambert T, Lichtenauer M, Brandstaetter W, Gabriel M, Steinwender C.
J Cardiovasc Electrophysiol. 2016;27:1067-71.

Abstract

Background: Conventional pacemaker therapy is limited by short- and long-term complications, most notably device infection. Transcatheter pacing systems (TPS) may be beneficial in this kind of patients as they eliminate the need for a device pocket and leads and thus may reduce the risk of re-infection.

Methods: We assessed a novel procedure in 6 patients with severe device infection who were pacemaker dependent. After lead extraction a single chamber TPS was implanted into the right ventricle.

Results: Of the 6 patients who underwent lead extraction due to severe device infection at our institution, 3 were diagnosed with a pocket infection only, whereas the other 3 showed symptoms of both pocket and lead infection. Successful lead extraction and TPS implantation was accomplished in all patients. Four patients were bridged with a temporary pacemaker between 2 hours and 2 days after lead extraction, whereas 2 patients had the TPS implanted during the same procedure just before traditional pacemaker system removal. All patients stayed free of infection during the follow-up period of 12 weeks. An additional positron emission tomography scan was performed in each patient and indicated no signs of an infection around the TPS.

Conclusion: Transcather pacemaker implantation was safe and feasible in 6 patients and did not result in re-infection even if implanted before removal of the infected pacemaker system within the same procedure. Therefore, implantation of a TPS may be an option for patients with severe device infection, especially in those with blocked venous access or who are pacemaker dependent.

Link to abstract on PubMed.

Clinical Outcomes of Patients Who Received the Subcutaneous Implantable Cardioverter Defibrillator2016

Estes NA 3rd.  JAMA Cardiol. 2016;Sep 7. [Epub ahead of print]

Link to abstract on JAMA Cardiology.

 

Right ventricular lead placement and ventricular dyssynchrony in a pacemaker population: An acute analysis from the evaluation of apical and non-apical position (right pace) study2016

Muto C, Calvi V, Botto GL, Pecora D, Zuccaro LM, Costa A, Ciaramitaro G, Airò Farulla R, Nigro G, Tuccillo B, Racheli M, Lilli A, Reggiani A, Malacrida M, Valsecchi S, Maglia G.

Int J Cardiol. 2016;225:296-9.

Link to abstract on International Journal Cardiology.

A novel use of EP catheter in extraction of trapped intracardiac devices: Two case reports2015

Kumar D, Banerjee S, Naik J, Gupta K, Roy RR, Kumar A.
Indian Heart J. 2015;67:Suppl 3:S92-6.

Abstract

The decision to retrieve chronically implanted abandoned leads and trapped intracardiac devices percutaneously has been difficult and highly controversial. We present two case reports in which electrophysiological ablation catheter was used to retrieve infected abandoned pacemaker lead and trapped permacatheter (permacath) in right ventricle. We could avert major cardiovascular surgeries in both the patients by simply modifying the traditionally used techniques for extraction of intracardiac devices.

Link to abstract on PubMed.

Safety of CMR in patients with cardiac implanted electronic devices2016

Ibrahim E-SH, Horwood L, Stojanovska J, Attili A, Frank L, Oral H,  Bogun F.

J Cardiovasc Magn Reson. 2016;18(Suppl 1):O123.

Abstract

Background: CMR has been reported to be safe in patients with cardiac implantable electronic device (CIED), provided a specific protocol is followed. The goal of this study is to examine whether this is true for patients excluded from published protocols, e.g. CIED patients with abandoned leads or pacemaker dependency.

Methods: The protocol followed at our institution for MR imaging of CIED patients is as follows: 1) Necessity and absence of an alternative imaging modality; 2) Device-related relative contraindications, including the presence of abandoned leads, pacemaker dependency, and time to lead implant < 6 weeks, with the possibility of the ordering physician to overrule these exclusions. 3) A provider with CIED management expertise assesses the baseline device information, where the device was programmed according to the patient's needs with tachyarrhythmia detection and therapy disabled during the scan. 4) Device reinterrogation and reprogramming after completion of the scan, as well as at 1 week and 3 months after imaging.

Results: A total of 162 MR scans were obtained in 142 consecutive patients with CIED's (106 patients had defibrillators and 36 had pacemakers, as shown in Figure 1). 29 patients were pacemaker dependent and 11 patients had abandoned leads. Cardiac MR scans were performed in 94 patients (late gadolinium enhancement (LGE) was used to determine myocardial scar prior to ablation) and spinal/brain scans were performed in 47 patients. In the cardiac scans, the images were non-diagnostic only in 4 patients due to extensive artifact from the implanted cardiac defibrillator (ICD). In 65 patients, LGE was detected without artifact. No LGE was identified in 25 scans. Only one patient developed ventricular tachycardia (VT) during a spine scan and was removed from the scanner for device reactivation, which terminated VT without consequences. No other adverse events were noted. The device parameters essentially remained the same immediately, 1 week, and 3 months after the scans.

Conclusions: In the analyzed cohort of 142 patients, only in one pacemaker dependent patient, the heart rate dropped from 90 to 50 bpm during spinal imaging using a fast spin echo sequence (specific absorption rate (SAR) = 1.89 W/Kg) due to elevated noise rate of the ICD. In this patient, a prior cardiac scan was performed a week earlier where no problem was observed, as the cardiac LGE sequences have low SAR of 0.11 W/Kg. Therefore, with the protocol described in this study, CMR imaging can be safely performed in CIED patients without exposing the patients to risk, despite pacemaker dependency, presence of abandoned leads, and other CIED contraindications. This study recommends that CMR imaging be available to more CIED patients who can benefit from it.

Is dual-chamber pacemaker implantation feasible through a cephalic vein with a supraclavicular course?2016

Dilaveris P, Sotiropoulos E, Georgiopoulos G, Gatzoulis K, Kallikazaros I, Tousoulis D.
Int J Cardiol. 2016;212:297-8.

Abstract
Cephalic vein cutdown is commonly used as a first choice for venous access during cardiac implantable electronic device (CIED) implantation because of lower risk of complications. However, anatomic abnormalities of the vein are possible, such as the absence or supraclavicular course. Supraclavicular course of the cephalic vein significantly affects both first-time and later revision CIED procedures. In older studies, when mostly unipolar leads were used, there was a recommendation to abandon the cephalic vein with a supraclavicular course because of the risk of lead fracture or skin erosion over the clavicle.

Link to abstract on International Journal of Cardiology.

Outcomes of Transvenous Lead Extraction for Cardiovascular Implantable Electronic Device Infections in Patients With Prosthetic Heart Valves2016

Huang XM, Fu HX, Zhong L, Cao J, Asirvatham SJ, Baddour LM, Sohail MR, Nkomo VT, Nishimura RA, Greason KL, Suri RM, Friedman PA, Cha YM. 
Circ Arrhythm Electrophysiol. 2016;9:e004188.

Abstract

Background: Lead-related or valve-related endocarditis can complicate cardiovascular implantable electronic device (CIED) infection in patients with both CIED and prosthetic valves. The objective of this study was to determine the outcomes of transvenous lead extraction for CIED infection in patients with prosthetic valves.

Methods and Results: We retrospectively screened 794 transvenous lead extraction procedures, between September 1, 2001 and August 31, 2012, at Mayo Clinic to identify patients with prosthetic valves who underwent lead extraction for infection. Demographic, clinical, and follow-up characteristics were analyzed. In total, 51 patients (6%) met the study inclusion criteria, of whom 20 had pocket infection and 31 had lead-related or valve-related, or both, endocarditis or bloodstream infection (mean age, 67 [18] years). Staphylococcal species were the most common pathogens, including Staphylococcus aureus in 20 cases (39%) and coagulase-negative staphylococci in 19 cases (37%). Overall, 127 transvenous leads (median lead age, 52 months) were extracted. Of these leads, 123 (97%) were removed completely. The in-hospital mortality rate was 9.8%; no deaths were attributable to the extraction procedure. Ninety-five percent of patients who survived had no evidence of recurrent device-related or valve-related infection.

Conclusions: Transvenous lead extraction seems safe and curative in patients with CIED infection and prosthetic valves. Cure of infection can be achieved in the majority of patients with complete CIED removal and antimicrobial therapy and without valve surgery.

Link to abstract on PubMed.

Cardiac Implantable Electronic Device Infections: Added Complexity and Suboptimal Outcomes With Previously Abandoned Leads2017

Hussein AA, Tarakji KG, Martin DO, Gadre A, Fraser T, Kim A, Brunner MP, Barakat AF, Saliba WI, Kanj M, Baranowski B, Cantillon D, Niebauer M, Callahan T, Dresing T, Lindsay BD, Gordon S, Wilkoff BL, Wazni OM.

JACC Clin Electrophysiol. 2017;3:1-9

Abstract

Objectives: The study sought to assess the impact of previously abandoned leads on the clinical management of cardiac device infections, notably transvenous lead extraction and subsequent clinical course.

Background: The population of patients with cardiac implantable electronic devices continues to grow with a disproportionate increase in device infections, which are invariably life threatening. A potentially complicating issue is the widely practiced strategy of device lead abandonment at the time of system revision, change, or upgrade, which is affecting an increasing number of patients.

Methods: The study assessed the impact of previously abandoned leads in a prospectively maintained registry of consecutive patients undergoing percutaneous extraction of infected cardiac devices at the Cleveland Clinic between August 1996 and September 2012. The primary clinical endpoint was complete procedural and clinical success defined as the successful removal of the device and all lead material from the vascular space, in the absence of a major complication.

Results: Of 1,386 patients with infected cardiac devices, 323 (23.3%) had previously abandoned leads. Failure to achieve the primary endpoint occurred more frequently in patients with abandoned leads (13.0% vs. 3.7%; p < 0.0001). This was primarily due to retention of lead material (11.5% vs. 2.9%; p < 0.0001), which was associated with poor clinical outcomes including higher rates of 1-month mortality (7.4% vs. 3.5% in those without lead remnants). Lead extraction procedures in patients with previously abandoned leads were longer (p < 0.0001), with longer fluoroscopy times (p < 0.0001), and more likely to require specialized extraction tools (94.4% vs. 81.8%; p < 0.0001) or adjunctive rescue femoral workstations (14.9% vs. 2.9%; p < 0.0001). Procedural complications occurred more frequently in patients with previously abandoned leads (11.5% vs. 5.6%; p = 0.0003), which was true for both major (3.7% vs. 1.4%; p = 0.009) and minor complications (7.7% vs. 4.4%; p = 0.02).

Conclusions: Previously abandoned leads complicate the management of cardiac device infections, leading to worse clinical outcomes.

Link to article on JACC: Clinical Electrophysiology.

Outcomes 1 Year after Implantable Cardioverter-Defibrillator Lead Abandonment versus Explantation for Unused or Malfunctioning Leads: A Report from the National Cardiovascular Data Registry2016

Zeitler EP, Wang Y, Dharmarajan K, Anstrom KJ, Peterson ED, Daubert JP, Curtis JP, Al-Khatib SM.

Circ Arrhythm Electrophysiol. 2016;9:e003953.

Abstract

Background: Patients with an unused or malfunctioning implantable cardioverter-defibrillator (ICD) lead may have the lead either abandoned or explanted; yet there are limited data on the comparative acute and longer-term safety of these 2 approaches.

Methods and Results: We examined in-hospital events among 24 908 subject encounters using propensity score 1:1 matching for ICD lead abandonment or explantation in the National Cardiovascular Data Registry (NCDR) ICD Registry (April 2010 to June 2014). Relative to patients undergoing lead abandonment, patients undergoing lead explantation had more in-hospital procedure-related complications: 2.19% (n=273) versus 3.77% (n=469; P<0.001), respectively. Similarly, patients undergoing lead explantation had slightly higher rates of in-hospital death: 0.21% (n=26) versus 0.64% (n=80; P<0.001), respectively. At 1 year in a Medicare subset for survival, there was a trend of increased mortality in the explantation group (11% versus 8%; P=0.06). In the Medicare subset analyzed for postprocedure complications, there was no difference with respect to 6-month bleeding (4.80% in both the groups), tamponade (0.38% versus 0.58%), infection (1.34% versus 3.07%), upper extremity thrombosis (0.77% versus 0.96%), pulmonary embolism (0.38% versus 0.96%), or urgent surgery (1.15% for both the groups; P>0.05 for all).

Conclusions: After matching, patients undergoing removal of an unused or malfunctioning ICD lead had slightly higher in-hospital complications and deaths than those with a lead abandonment strategy. Although the 1-year mortality risk was slightly higher in the lead explantation group, this difference was not statistically significant and may be explained by chance.

Outcomes-1-Year

Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience2016

Reddy VY, Miller MA, Knops RE, Neuzil P, Defaye P, Jung W, Doshi R, Castellani M, Strickberger A, Mead RH, Doppalapudi H, Lakkireddy D, Bennett M, Sperzel J.

Circ Arrhythm Electrophysiol. 2016;9:e004626.

Abstract

Background: Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans.

Methods and Results: This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for <6 weeks (acute retrieval cohort), complete retrieval was achieved in 100% (n=5/5); for those implanted for ≥ 6 weeks (chronic retrieval cohort), retrieval was achieved in 91% (n=10/11) of patients. The mean duration of time from implant to retrieval attempt was 346 days (range, 88-1188 days) in the chronic retrieval cohort, and nearly two thirds (n=7; 63%) had been implanted for >6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure.

Conclusions: This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker.

Link to abstract on Circulation: Arrhythmia and Electrophysiology

Endovascular Occlusion of the Superior Vena Cava in a Patient with Stenosis and Chronic Intracardiac Leads2016

Boyle TA, Healy CA, Irizarry F, Carrillo RG.

J Innov Cardiac Rhythm Mgmt. 2016;7:2473-5.

Abstract

The aim was to increase the safety of a high-risk lead extraction with pre-emptive positioning of an endovascular occlusion balloon in the superior vena cava (SVC). A patient with lead failure was evaluated prior to lead extraction with chest computed tomography, which revealed central venous stenosis and epicardial scarring around an old device. A Bridget Occlusion Balloon (Spectranetics, Colorado Springs, CO) was positioned in the superior vena cava prior to extraction. The balloon occluded the SVC despite chronic indwelling leads and stenosis. The malfunctioning lead was safely removed and replaced. Endovascular occlusion is possible even with numerous intravascular obstacles. This case can help inform protocols for the use of occlusion balloons in lead extractions.

Endovascular-Occlusion

Canadian Registry of Implantable Electronic Device Outcomes: Surveillance of the Riata Lead Under Advisory2016

Parkash R, Thibault B, Mangat I, Coutu B, Bennett M, Healey J, Verma A, Philippon F, Sandhu R, Cameron D, Ayala-Paredes F, Sterns L, Essebag V, Kus T, Nery P, Stephenson E, Yee R, Exner D, Toal S, Birnie D, Wells G, Krahn A.

Circ Arrhythm Electrophysiol. 2016;9:e004282.

Abstract

Background: The Riata lead under advisory has posed a unique clinical scenario where inside-out abrasion results in externalization of conductor cables, with a higher risk of electrical failure. We developed a comprehensive registry to assist with clinical management of this lead.

Methods and Results: This Canadian registry reports the findings of 3763 (74.2% of all Riata leads in Canada) Riata leads under advisory, with a mean follow-up time of 8.9±1.5 years. The overall electrical failure rate was 5.2% at 8 years, with no difference between 7-French and 8-French lead models. Cable externalization was found to be more common in the 8-French model (12.3% versus 5.2%, P<0.0001) and was associated with a higher risk of electrical failure. Predictors of electrical lead failure included cable externalization, higher left ventricular ejection fraction, younger age, higher body mass index, and a passive fixation lead. One patient died due to electrical failure, a further 2 patients survived an event where the device failed to deliver high-voltage therapy. Major complications because of lead extraction were higher when compared with lead abandonment, no difference among lead model observed. Two deaths occurred as a consequence of lead extraction, in the context of an underlying infection.

Conculsions: The Riata lead under advisory has a steady electrical failure rate over time. There are identifiable predictors of lead failure that can assist with clinical decisions as to whether lead revision should be performed prophylactically.

Link to abstract on PubMed

Contemporary Rates and Outcomes of Single- vs. Dual-Coil Implantable Cardioverter Defibrillator Lead Implantation: Data from the Israeli ICD Registry2016

Leshem E, Suleiman M, Laish-Farkash A, Konstantino Y, Glikson M, Barsheshet A, Goldenberg I, Michowitz Y; Israeli Working Group of Pacing and Electrophysiology.

Europace. 2016 Oct 4. [Epub ahead of print]

Abstract

Aims: Dual-coil leads were traditionally considered standard of care due to lower defibrillation thresholds (DFT). Higher complication rates during extraction with parallel progression in implantable cardioverter defibrillator (ICD) technology raised questions on dual coil necessity. Prior substudies found no significant outcome difference between dual and single coils, although using higher rates of DFT testing then currently practiced. We evaluated the temporal trends in implantation rates of single- vs. dual-coil leads and determined the associated adverse clinical outcomes, using a contemporary nation-wide ICD registry.

Methods and Results: Between July 2010 and March 2015, 6343 consecutive ICD (n = 3998) or CRT-D (n = 2345) implantation patients were prospectively enrolled in the Israeli ICD Registry. A follow-up of at least 1 year of 2285 patients was available for outcome analysis. The primary endpoint was all-cause mortality. Single-coil leads were implanted in 32% of our cohort, 36% among ICD recipients, and 26% among CRT-D recipients. Secondary prevention indication was associated with an increased rate of dual-coil implantation. A significant decline in dual-coil leads with reciprocal incline of single coils was observed, despite low rates of DFT testing (11.6%) during implantation, which also declined from 31 to 2%. In the multivariate Cox model analysis, dual- vs. single-coil lead implantation was not associated with an increased risk of mortality [hazard ratio (HR) = 1.23; P= 0.33], heart failure hospitalization (HR = 1.34; P=0.13), appropriate (HR = 1.25; P= 0.33), or inappropriate ICD therapy (HR = 2.07; P= 0.12).

Conclusion: Real-life rates of single-coil lead implantation are rising while adding no additional risk. These results of single-coil safety are reassuring and obtained, despite low and contemporary rates of DFT testing.

Link to abstract on PubMed

Management of Bacteremia in Patients Living with Cardiovascular Implantable Electronic Devices2016

DeSimone DC, Sohail MR.

Heart Rhythm. 2016;13:2247-52.

Abstract

Cardiovascular implantable electronic devices (CIEDs) have become a critical component in management of patients with cardiac rhythm disturbances, heart failure, and prevention of sudden cardiac death. However, infection remains a major complication of CIED implantation and is associated with significant morbidity and mortality for device recipients. Early-onset CIED infections frequently originate from the generator pocket, secondary to device or pocket contamination at the time of implantation, and may progress to involve device leads or cardiac valves. However, hematogenous seeding of the device leads from a remote source of bacteremia is not infrequent in patients with late-onset CIED infections. Whereas CIED pocket infection can be diagnosed in the majority of cases based on physical findings at the pulse generator site, device lead infection may only manifest with fever and positive blood cultures. However, not every patient with a CIED and positive blood cultures has underlying CIED lead infection. Consequently, management of bacteremia in a CIED recipient without local signs of infection presents a significant challenge. The risk of underlying CIED lead infection in patients presenting with bacteremia depends on several factors, including the type of microorganism isolated in blood cultures, duration and source of bacteremia, type of CIED, and number of device-related procedures. These risk factors must be considered when making decisions regarding the need for further diagnostic imaging and whether to retain or remove the device. In this article, we review the published data regarding risk of CIED infection in patients presenting with bacteremia and propose an algorithm for appropriate evaluation and management.

Link to abstract on PubMed

Current Management of Cardiac Implantable Electronic Device Infections by Infectious Disease Specialists2016

Liang SY, Beekmann SE, Polgreen PM, Warren DK.

Clin Infect Dis. 2016;63:1072-5.

Abstract

Management guidelines for cardiac implantable electronic device infections exist, but practice patterns of infectious disease (ID) specialists are not well known. We found that while many ID specialist practices mirror existing guidelines, a combination of complete device removal and prolonged antimicrobial therapy is favored when Staphylococcus aureus is involved.

Link to abstract on PubMed

Coronary Sinus Lead Extraction2017

Cronin EM, Wilkoff BL.

Heart Fail Clin. 2017;13:105-115.

Abstract

Expanded indications for cardiac resynchronization therapy and the increasing incidence of cardiac implantable electronic device infection have led to an increased need for coronary sinus (CS) lead extraction. The CS presents unique anatomical obstacles to successful lead extraction. Training and facility requirements for CS lead extraction should mirror those for other leads. Here we review the indications, technique, and results of CS lead extraction. Published success rates and complications are similar to those reported for other leads, although multiple techniques may be required. Re-implantation options may be limited, which should be incorporated into pre-procedural decision making.

Link to abstract on PubMed

Severe Tricuspid Valve Injury During Right Ventricular Lead Extraction2016

Hai T, Lerner AB, Khamooshian A.

J Cardiothorac Vasc Anesth. 2016 Aug 20. [Epub ahead of print]

Case Report
A 67-year-old male (height 183 cm, weight 100 kg) with a history of anterior myocardial infarction and cardiomyopathy (estimated ejection fraction of 20%-25%) presented for implantable cardioverter-defibrillator (ICD) lead extraction and single-chamber ICD reimplantation. At the time of presentation, his device was a single-chamber Medtronic Virtuoso ICD (Medtronic, Dublin, Ireland), which was implanted in 2007 for inducible ventricular tachycardia. The extraction was planned because the existing right ventricular (RV) Fidelis lead (Medtronic) had been placed on Food and Drug Administration advisory and the device battery was nearing elective replacement indications. His preoperative transthoracic echocardiogram showed severe regional left ventricular (LV) systolic dysfunction, with akinesis of the septum and severe hypokinesis of the mid-anterior wall and all distal LV segments. An apical LV aneurysm also was demonstrated on transthoracic echocardiography. The RV free wall displayed mild-to-moderate global hypokinesis. The valvular structure and function were normal. The patient was scheduled for an elective lead extraction under general anesthesia with cardiopulmonary bypass as standby.

Link to article on Science Direct

Tricuspid Regurgitation following Lead Extraction: Risk Factors and Clinical Course2016

Givon A, Vedernikova N, Luria D, Vatury O, Kuperstein R, Feinberg MS, Eldar M, Glikson M, Nof E.

Isr Med Assoc J. 2016;18:18-22.

Abstract

Background: Transvenous lead extraction can lead to tricuspid valve damage.

Objectives: To assess the incidence, risk factors and clinical outcome of tricuspid regurgitation (TR) following lead extraction.

Methods: We prospectively collected data on patients who underwent lead extraction at the Sheba Medical Center prior to laser use (i.e., before 2012). Echocardiography results before and following the procedure were used to confirm TR worsening, defined as an echocardiographic increase of at least one TR grade. Various clinical and echocardiographic parameters were analyzed as risk factors for TR. Clinical and echocardiographic follow-up was conducted to assess the clinical significance outcome of extraction-induced TR.

Results: Of 152 patients who underwent lead extraction without laser before 2012, 86 (56%) (192 electrodes) had echocardiography results before and within one week following the procedure. New or worsening TR was discovered in 13 patients (15%). Use of mechanical tools and younger age at extraction were found on multivariate analysis to be factors for TR development (P = 0.04 and P = 0.03 respectively). Average follow-up was 22.25 ± 21.34 months (range 8-93). There were no significant differences in the incidence of right-sided heart failure (50% vs. 23%, P = 0.192) or hospitalizations due to heart failure exacerbations (37.5% vs. 11%, P = 0.110). No patient required tricuspid valve repair or replacement. Death rates were similar in the TR and non-TR groups (20% vs. 33%).

Conclusions: TR following lead extraction is not uncommon but does not seem to affect survival or outcomes such as need for valve surgery. Its long-term effects remain to be determined.

Link to abstract on PubMed

Severe Tricuspid Valve Regurgitation Requiring Surgical Intervention as a Result of Pacemaker Lead Extraction: A Case Series2014

Patel B, Daraghmeh A, Machado C.

J Innov Cardiac Rhythm Manage. 2014;5:1525-9.

Abstract
Tricuspid regurgitation (TR) due to pacemaker and implantable cardioverter defibrillator (ICD) leads is a well-known condition. As these leads remain implanted, they tend to stimulate an inflammatory response leading to fibrosis and adhesions between valve tissues and the metallic component of the leads. With growing numbers of lead implantations, lead extraction procedures are also rising. The extraction of a chronic lead poses a challenge for the operators because of fibrosis and adhesions. TR after pacemaker lead extractions requiring surgical intervention is an uncommon presentation. We report two cases of severe TR after pacemaker lead extractions requiring tricuspid valve replacement.

Link to article on the Journal of Innovations in Cardiac Rhythm Management

The Impact of Transvenous Lead Extraction on Tricuspid Valve Function2014

Coffey JO, Sager SJ, Gangireddy S, Levine A, Viles-Gonzalez JF, Fischer A.

Pacing Clin Electrophysiol. 2014;37:19-24.

Abstract

Background: Few data exist regarding the effect of transvenous lead extraction (TLE) on tricuspid valve function. The objective of this study was to examine the effect of TLE on the development of postprocedure tricuspid regurgitation (TR).

Objective: To assess the impact of TLE on tricuspid valve function.

Methods: A single center retrospective analysis of consecutive patients referred for TLE between June 2006 and November 2011. Patients were included only if they underwent transthoracic echocardiography (TTE) before and after lead extraction (N = 124). Patients were assigned a preprocedure and postprocedure TR score on a continuous scale from 0 to 6 (0 = none, 1 = trace, 2 = mild, 3 = mild/moderate, 4 = moderate, 5 = moderate/severe, and 6 = severe). A clinically significant increase in TR was defined as both (1) an increase in TR score of at least two points, and (2) a postprocedure TR score ≥4 (moderate).

Results: A total of 124 patients referred for TLE underwent a TTE both before (9 ±16 months) and after lead extraction (4 ± 8 months). A total of 200 leads (1.6 ± 0.8 per patient) were extracted. The mean change in TR score after lead extraction was +0.18 (95% confidence interval [CI] -0.03 to 0.39, P = 0.11). A clinically significant increase in TR occurred in 7/124 (5.6% [CI 2.3-11.3%]) patients. Age ≥75 (+0.45, [CI 0.07-0.84, P = 0.02]), removal of ≥2 leads (+0.40 [CI 0-0.81, P = 0.05]), and powered sheath-assisted extraction (+0.34 [CI 0.05-0.62, P = 0.02]) were significantly associated with an increase in TR score.

Conclusion: TLE is rarely associated with the development of clinically significant TR. In our cohort, patient age ≥75 years, pacemaker as opposed to ICD, and removal of ≥2 leads predicted worsening TR.

Link to abstract on PubMed

Tricuspid Insufficiency after Laser Lead Extraction2013

Rodriguez Y, Mesa J, Arguelles E, Carrillo RG.

Pacing Clin Electrophysiol. 2013;36:939-44.

Abstract

Background: The use of laser lead extraction (LLE) to remove pacemaker and implantable cardiac defibrillator leads has become more prevalent in the past decade. Though the procedure is associated with a low rate of complications, LLE still poses some risks to patients. Some reports have suggested an increase in tricuspid insufficiency (TI) associated with LLE. We present a series of patients who underwent both LLE and complete evaluation for TI with echocardiographic techniques.

Methods: From August 2008 to January 2010, 173 prospective, consecutive patients underwent LLE in a single center. All patients had transesophageal echocardiograms (TEE) during the extraction. Fifty-three patients had tricuspid valve function evaluated a day before the procedure with a transthoracic echocardiogram (TTE), during the procedure with a TEE and 2 days postoperatively with a TTE.

Results: All 173 patients experienced no change in tricuspid valve function during the procedure with TEE. Of the 53 patients who underwent a complete TI evaluation, 38 were males (72%) and 15 females (38%), with a mean age of 69.45 ± 14.08. Mean ejection fraction was 35.82 ± 14.72. Three (6%) patients experienced TI after the procedure (two mild and one severe, all with tricuspid valve endocarditis); 16 (30%) patients were found to have TI before LLE that returned to normal valve function during or after the procedure. Thirty-four (64%) patients did not experience any significant change of the tricuspid valve performance after LLE.

Conclusion: LLE was not associated with increased TI.

Link to abstract on PubMed

Tricuspid Valve Repair for Torrential Tricuspid Regurgitation after Permanent Pacemaker Lead Extraction2011

Mehrotra D, Kejriwal NK.

Tex Heart Inst J. 2011;38:305-7.

Abstract
Tricuspid regurgitation secondary to percutaneous lead extraction is uncommon, and it rarely requires surgical intervention. Most tricuspid regurgitation occurs during the implantation of tined leads, which can be entrapped in the tricuspid valve apparatus and may require immediate withdrawal. Severe tricuspid regurgitation as a sequela of extracting chronically implanted leads has rarely been reported. Herein, we report a case of torrential tricuspid regurgitation in a 67-year-old woman after the extraction of a permanent pacemaker lead. The regurgitation was confirmed on transesophageal echocardiography during lead extraction, and the tricuspid valve was successfully repaired with suture bicuspidization of the valve and the support of ring annuloplasty. A short review of the relevant literature follows the case report.

Link to abstract on PubMed

Prevalence of tricuspid regurgitation and pericardial effusions following pacemaker and defibrillator lead extraction2010

Glover BM, Watkins S, Mariani JA, Yap S, Asta J, Cusimano RJ, Ralph-Edwards AC, Cameron DA.

Int J Cardiol. 2010;145:593-4.

Incidence, Risk Factors, and Outcome of Traumatic Tricuspid Regurgitation After Percutaneous Ventricular Lead Removal2009

Franceschi F, Thuny F, Giorgi R, Sanaa I, Peyrouse E, Assouan X, Prévôt S, Bastard E, Habib G, Deharo JC.

J Am Coll Cardiol. 2009;53:2168-74.

Abstract

Objectives: This study sought to evaluate the incidence, risk factors, and outcome of traumatic tricuspid regurgitation (TTR) induced by percutaneous removal of chronically implanted transvenous leads.

Background: Although lead removal using modern tools has been shown to be highly effective and safe, TTR has not been systematically evaluated.

Methods: All patients undergoing ventricular lead removal at our center were studied. Lead removal was performed by simple traction, laser sheath, and/or lasso technique. Presence of a new TTR after removal was assessed by transthoracic echocardiography. Pre-defined clinical and technical parameters were studied for their association with TTR. Patients were followed up by outpatient visits.

Results: We removed 237 ventricular leads in 208 patients. Median time from lead implantation was 46.4 months (range 0.7 to 260.5 months). A TTR occurred in 19 patients (9.1%), severe in 14. Three independent risk factors of TTR were found: use of laser sheath (p = 0.004), use of both laser sheath and lasso (p = 0.02), and female sex (p = 0.02). After a follow-up of 4,130 person-months (median 17.9 months), 5 TTR patients were medically treated for new right-sided heart failure symptoms, 2 had undergone surgical repair of the tricuspid valve, and 6 had died (2 from heart failure and 4 from noncardiac causes). Right-sided heart failure occurred only in patients with severe TTR.

Conclusions: This study found that TTR is not uncommon after percutaneous lead removal. It is strongly associated with the use of additional tools beyond simple traction and also with female sex. In the long term, right-sided heart failure is frequent in patients with severe TTR.

Link to abstract on PubMed

Transesophageal Echocardiographic Evaluation of Tricuspid Valve Regurgitation During Pacemaker and Implantable Cardioverter Defibrillator Lead Extraction2002

Roeffel S, Bracke F, Meijer A, Van Gelder B, Van Dantzig JM, Botman CJ, Peels K.

Pacing Clin Electrophysiol. 2002;25:1583-6.

Abstract
Chronically implanted ventricular pacing and defibrillator (ICD) leads can adhere to the tricuspid valve. This study examined the effect of lead extraction, and laser sheath extraction in particular, on tricuspid valve regurgitation. Lead extraction was first tried with traction using limited force followed by a laser sheath if not successful. Tricuspid valve regurgitation before and after extraction was evaluated with transesophageal echocardiography and graded from 0 (none) to 4 (severe). A change in regurgitation was considered clinically relevant if it increased with two grades or more and resulted in at least grade 3 regurgitation. Fifty ventricular leads were extracted in 43 consecutive patients, including 14 ICD leads. In 20 patients (group I) leads were removed without a (laser) sheath crossing the tricuspid valve, in 23 patients (group II) leads were extracted with lasing across the valve. The mean time from implant was 43 +/- 43 months and 99 +/- 78 months, respectively, (P = 0.007). Tricuspid regurgitation increased in five (12%) patients. In group I only in one patient the laser failed proximal of the valve and forceful traction was subsequently used, and in group II this occurred in four (17%) patients. This difference did not reach statistical significance even excluding the patient from group I (P = 0.111). The increase of tricuspid regurgitation cautions against indiscriminate extraction of superfluous leads. There is a trend that when tools like a laser sheath are necessary the chance of tricuspid valve damage increases.

Link to abstract on PubMed

Partial Rupture of the Tricuspid Valve after Extraction of Permanent Pacemaker Leads: Detection by Transesophageal Echocardiography1999

Assayag P, Thuaire C, Benamer H, Sebbah J, Leport C, Brochet E.

Pacing Clin Electrophysiol. 1999;22:971-4.

Abstract
Traumatic lesions of the tricuspid valve complicating pacemaker lead extractions appear to be rare. We report two cases of partial rupture of the tricuspid valve, following apparently uneventful extraction of permanent ventricular leads, resulting in severe regurgitation and, in one case, chronic heart failure. TEE was useful to identify the traumatic mechanism of tricuspid regurgitation (TR) and the extent of valvular lesions in these patients. Such etiology should be suspected, and TEE performed, in patients developing TR or heart failure late after lead extraction.

Link to abstract on PubMed

Use of Preprocedural MDCT for Cardiac Implantable Electric Device Lead Extraction: Frequency of Findings That Change Management2017

Ehieli WL, Boll DT, Marin D, Lewis R, Piccini JP, Hurwitz LM.

AJR Am J Roentgenol. 2017 Jan 11. [Epub ahead of print]

Abstract

Objective: Five percent of cardiac implantable electric devices (CIEDs) are removed each year. Percutaneous extraction is preferred but can be complicated if the leads adhere to the vasculature or perforate. The goal of this study is to assess the frequency of findings on dedicated MDCT that alter preprocedural planning for percutaneous CIED extraction.

Materials and Methods: One hundred patients with CIEDs who underwent MDCT before percutaneous lead extraction were analyzed. Major findings that could preclude percutaneous removal, including lead course and termination, were distinguished from moderately significant findings that could alter but not preclude percutaneous removal, including endofibrosis of leads to the vasculature, lead termination abnormalities, central vein stenosis, or thrombus. Incidental findings were characterized separately. Findings were correlated with preprocedural decisions, the extraction procedure performed, and procedural outcomes.

Results: Twenty-six women and 74 men with 125 right ventricular leads, 84 right atrial leads, and 26 coronary venous leads were evaluated. Major findings were present in 7% of patients, including six patients with lead perforation and one with a lead coursing outside a tricuspid annuloplasty ring. Moderately significant findings of endothelial fibrosis were found in 78% of patients. The central veins were narrowed or occluded in 42% of patients, and thrombus was present in 2% of patients. Thirty-six percent of patients had incidental findings, and 4% of patients had unexpected findings requiring immediate inpatient attention.

Conclusion: MDCT performed before CIED lead extraction is able to identify major and moderately significant findings that can alter either percutaneous extraction or preprocedural planning. The use of dedicated preprocedural MDCT can help to stratify patient risk, guide decision making by the proceduralist, and identify non-catheter-related findings that affect patient management.

Link to abstract on PuMed

The Challenge of Aggressive Adhesions: Tool Combination for Successful Lead Extraction2017

Linder M, Pecha S, Castro L, Zipfel S, Gosau N, Willems S, Reichenspurner H, Hakmi S.

Thorac Cardiovasc Surg. 2017;65(S01):S1-S110.

Abstract

Objectives: Extraction of old pacemaker (PM) and implantable cardioverter defibrillator (ICD) leads with aggressive adhesions can be very challenging. Furthermore, the presence of abandoned lead fragments adds to the complexity of an extraction procedure. The aim of this study was to present our experience with combination of different extraction tools, to enhance procedural success rate in those challenging cases.

Methods: A total of 161 consecutive PM and ICD lead extraction procedures has been performed between 01/2012 and 08/2016. We here present a series of 12 cases where one extraction tool was not sufficient to achieve complete procedural success and combination of two or more extraction tools was necessary. All extraction procedures were performed in a hybrid operating room, having patients under general anesthesia with continuous invasive arterial blood pressure and 3D TEE monitoring.

Results: Patients were 63 ± 14 years of age, 41.7% were female. A total of 35 leads (22 PM leads, 7 single-coil lCD leads and 6 dual-coil ICD leads) with a mean implantation duration of 127.2 ± 77.8 months had to be extracted. In 6 cases laser sheaths and mechanical extraction tools were combined. Combination of laser sheaths and femoral snares was used in 3 cases, while simultaneous use of mechanical extraction sheaths and femoral snares was necessary in 3 cases. With combination of these different extraction tools, a clinical as well as procedural success rate of 100% was achieved in all cases. No peri-procedural death was observed and no major or minor complications occurred during lead extraction procedures.

Conclusion: In cases of severe calcified adhesions or abandoned lead fragments, one extraction tool often is not enough to achieve complete procedural success. In those procedures, the combination of different extraction tools using a hybrid operating room, allows for safe extraction with success rates up to 100%.

Link to abstract on The Thoracic and Cardiovascular Surgeon

Hybrid Minimally Invasive Approach for Transvenous Lead Extraction: A Feasible Technique in High-Risk Patients2017

Bontempi L, Vassanelli F, Cerini M, Bisleri G, Repossini A, Giroletti L, Inama L, Salghetti F, Liberto D, Giacopelli D, Raweh A, Muneretto C, Curnis A.

J Cardiovasc Electrophysiol. 2017 Jan 7. [Epub ahead of print]

Abstract

Introduction: Despite the overall safety, transvenous lead extraction (TLE) remains a challenging procedure with inherent risks, where surgery can still be required in elective cases. In this study, we report our experience with a minimally invasive "hybrid" approach, defined as a procedure performed by an electrophysiologist with the support of a cardiac surgeon in the same operative session.

Methods and Results: We reported 12 cases of planned hybrid lead extraction; minithoracotomy and thoracoscopy were performed on 10 (83%) and 2 (17%) patients, respectively. A total of 25 leads out of 27 (median lead age 19 years) were successfully extracted with laser, mechanical or combined transvenous sheath. In 3 patients, the direct monitoring of vascular and myocardial integrity allowed for prompt treatment of potential vascular injury during the lead extraction maneuvers. Mean in-hospital stay was 4 ± 2 days. There were no major intraoperative complications and no deaths occurred after 30 days' follow-up.

Conclusion: The hybrid approach, with minithoracotomy or thoracoscopy, is feasible and it might increase the safety in the most challenging TLE procedures: the minimally invasive surgical intervention allows for continuous monitoring of the critical cardiac structures and prompt treatment of potential complications.

Link to abstract on PubMed

Percutaneous Retrieval of Implanted Leadless Pacemakers: Feasibility at 2.5 Years Post-Implantation in an In Vivo Ovine Model2015

Koruth JS, Rippy MK, Khairkhahan A, Ligon DA, Hubbard CA, Miller MA, Dukkipati S, Neuzil P, Reddy VY.

JACC Clin Electrophysiol. 2015;1:563-70.

Abstract

Objectives: This in vivo ovine study describes the feasibility and safety of retrieving implanted leadless pacemakers (LPs).

Background: Although LPs have been shown to be removable soon after implantation, there are no data on the feasibility of removing chronically implanted LPs.

Methods: This study was performed in 2 phases. In the mid-term cohort, 10 chronically (5.3 months) implanted animals underwent retrieval, followed by: 1) immediate necropsy in 5; and 2) in the remaining 5, reimplantation of a new LP followed by necropsy at 6 weeks. In the long-term cohort, 8 additional sheep underwent retrieval at 2.3 ± 0.1 years followed by necropsy. Retrieval was performed using either a single or triple loop snare. All 18 LPs (100%) were successfully retrieved. The time from retrieval catheter insertion to retrieval was 2:35 ± 01:11 and 3:04 ± 01:13 minutes in the mid-term and long-term study groups, respectively.

Results: There were no significant differences in retrieval times using either snare. Intracardiac echocardiography was used pre- and post-retrieval to confirm the absence of pericardial effusion in all 8 sheep. On necropsy, there was no evidence of pericardial bleeding or perforation. Only minor tissue disruption and hemorrhage was noted at the implant site after retrieval. Histology demonstrated fibrous connective tissue at the contact sites of endocardium and LP can and at the helix. There was no evidence of pulmonary thromboembolism.

Conclusions: We demonstrate the feasibility and safety of percutaneous, catheter-based retrieval in chronic LP implants of a maximum duration of approximately 2.5 years.

Link to article on JACC: Clinical Electrophysiology

2017 HRS expert consensus statement on magnetic resonance imaging and radiation exposure in patients with cardiovascular implantable electronic devices2017
Indik JH, Gimbel JR, Abe H, Alkmim-Teixeira R, Birgersdotter-Green U, Clarke GD, Dickfeld TL, Froelich JW, Grant J, Hayes DL, Heidbuchel H, Idriss SF, Kanal E, Lampert R, Machado CE, Mandrola JM, Nazarian S, Patton KK, Rozner MA, Russo RJ, Shen WK, Shinbane JS, Teo WS, Uribe W, Verma A, Wilkoff WL, Woodard PK.

Heart Rhythm. 2017;14:e97-e153.

Link to press release on Heart Rhythm Society website

Link to article