Wilkoff BL, Kudenchuk PJ, Buxton AE, Sharma A, Cook JR, Bhandari AK, Biehl M, Tomassoni G, Leonen A, Klevan LR, Hallstrom AP; DAVID II Investigators. The DAVID (Dual Chamber and VVI Implantable Defibrillator) II trial. J Am Coll Cardiol. 2009 Mar 10;53(10):872-80. doi: 10.1016/j.jacc.2008.10.057. PMID: 19264245.
The DAVID (Dual Chamber and VVI Implantable Defibrillator) II trial
Abstract
Objectives: The purpose of this study was to determine whether atrial pacing is a safe alternative to minimal (backup-only) ventricular pacing in defibrillator recipients with impaired ventricular function.
Background: The DAVID (Dual Chamber and VVI Implantable Defibrillator) trial demonstrated that dual chamber rate responsive pacing as compared with ventricular backup-only pacing worsens the combined end point of mortality and heart failure hospitalization. Although altered ventricular activation from right ventricular pacing was presumed to be the likely cause for these maladaptive effects, this supposition is unproven.
Methods: In all, 600 patients with impaired ventricular function from 29 North American sites, who required an implanted defibrillator for primary or secondary prevention, with no clinical indication for pacing, were randomly assigned to atrial pacing (at 70 beats/min) versus minimal ventricular pacing (at 40 beats/min) and followed up for a mean of 2.7 years.
Results: There were no significant differences between pacing arms in patients’ baseline characteristics, use of heart failure medications, and combined primary end point of time to death or heart failure hospitalization during follow-up, with an overall incidence of 11.1%, 16.9%, and 24.6% at 1, 2, and 3 years, respectively. Similarly, the incidence of atrial fibrillation, syncope, appropriate or inappropriate shocks, and quality of life measures did not significantly differ between treatment groups.
Conclusions: The effect of atrial pacing on event-free survival and quality of life was not substantially worse than, and was likely equivalent to, backup-only ventricular pacing. Atrial pacing may be considered a “safe alternative” when pacing is desired in defibrillator recipients, but affords no clear advantage or disadvantage over a ventricular pacing mode that minimizes pacing altogether. (Dual Chamber and VVI Implantable Defibrillator [DAVID] Trial II; NCT00187187).