There are many aspects of a worrisome CIED site that factor into the steps toward treatment. Drs. Callahan and Wilkoff take us through the steps of diagnosis and treatment, and how technology can assist in early diagnosis.
Join a discussion on use of technology to manage pocket sites
Podcast: Episode 5 – Management of the Worrisome Site Transcript
Callahan, M.D., Thomas
Welcome to the Lead Connection podcast where we talk about all things related to lead management. I’m Tom Callahan.
Wilkoff, M.D., Bruce
And I’m Bruce Wilkoff. We’re both from the Cleveland Clinic and from leadconnection.org. We’re really excited about our new topic for today.
Callahan, M.D., Thomas
So, I thought what we could talk about today would be management of the worrisome site. So somebody has an CIED and their site, either the incision or the surrounding area looks a little bit worrisome. I thought that would be a great topic for conversation and I thought we might start with the early presentation. So just for an example, let’s talk about a patient that comes in maybe four weeks post implant with a little bit of redness, a little bit of itching and pain around that incision site and what sort of things we are thinking about, how do we manage that?
Wilkoff, M.D., Bruce
Tom, I think it starts even earlier, in that I don’t know that patients know how to look at their sites and I think early detection of problems starts with making patients a little bit more aware of what’s going on and how to look at it. Many people see their patients back a few days later, some people a week later, a couple of weeks later. We have a less intense way of going about that. But we have a very aggressive stance when a patient has a question – they come in right away whenever it is. And so I think it’s important to tell the patients what to expect, and I think they are part of the early warning system and we need to look at that and in fact just looking at the pocket is sometimes a lost art.
It seems to me that there are way too many patients that go in and out of our offices and our device clinics without us ever opening up the gown and or the shirt or whatever was like that and taking a look. Sometimes these things are subtle and sometimes normal healing looks funny to a patient or to somebody, and sometimes what people thought was normal healing is really something more or more dangerous. So I think it starts with when you implant, and you start talking to the patient, what makes them want to come back and raise it to a question and we’ll probably talk about this more. But one of the new tools that we have and that I want to promote is the use of these wonderful cameras that we have in our telephones and our patients, everybody’s got one.
And they do two things. One is they document better than any description we could make in our charts. What it looks like now and then what changes occur over time (if you do additional pictures) and getting that into the chart. Because, you may not be the individual that looks at the incision the next time. It may be one of your partners. You may not be available at the time, and so the ability to have an objective metric of what’s going on is important. There are other objective metrics but a picture is so valuable. I don’t know, what are your thoughts about that?
Callahan, M.D., Thomas
Oh I totally agree. I’d like to focus on that one a little bit longer because you know you bring up the power of the camera phone and technology in helping us assess these issues. And I think just at first blush it helps in two very important ways.
As you pointed out, we’re very aggressive about getting patients into clinic. So we can put eyes on that device site if they have any problems or questions whatsoever. And I think that’s an important part of management, but it’s not always practical for the patient. They can’t always get in in a timely fashion. So using something like a smartphone camera can give you the next best thing – can give you a way to look at that site and see what they’re seeing without actually having to bring the patient in.
And then the second point, which you made well, is I think it’s so important to try and not just look at that image but capture that image so that you have that as a reference for next time or if you’re unavailable, your partners have that so they can see what the evolution might look like. So I couldn’t agree with you more on the power of smartphones and cameras to help in assessing these.
Wilkoff, M.D., Bruce
Right. And the other point here is I recognize that a lot of our patients are probably not the most tech savvy, some are, some aren’t, but there is usually a family member that is enough. I mean, it doesn’t take a lot to be tech savvy, but a little to be able to take a picture, learn how to either e-mail it or text it or whatever else to working with. And it takes a little bit effort on your part to know your electronic medical system to know how to get it into the system because you don’t want this basically on their personal phone or whatever else like that. I mean what you want here is to get it into the hospital chart and, but leverage the daughter or son-in-law or the husband or whoever it is that has a little bit more comfort with this. We’re doing a lot more telemedicine. This is part of telemedicine. And I think we need to learn how to leverage this and I find it one of the most valuable tools.
But you asked the question about the person about a month out and for some reason the patients uncomfortable or you know brings it up to you and I think the first thing that you have to do is lay eyes on it because a description, sometimes it’s just a hyperemic area and sometimes incisions stay red forever it seems. And sometimes it disappears. But the ones that are visible are often normal, but I think the most common thing is that there’s a little bit of the suture; the subcutaneous suture that’s either poking through or there’s a little redness and there’s a little what we fondly call stitch abscesses. I don’t know if they’re really stitch abscesses just a little bit inflammation or what they are. I mean, they usually go away without anything, but if there’s actually a knot that’s coming through, it can be right to actually cut it out. And just clean it up and using local techniques, if it you know you’re looking for evidence of being deep. But of course, in some of our patients, deep is….
Callahan, M.D., Thomas
Very deep.
Wilkoff, M.D., Bruce
It’s very deep, but on other patients there is no deep – it’s everything. Superficially it goes both ways. So you have to be a little bit more concerned, but I think we’ll talk about timing later on, but I think that you should be sure there’s a problem before you consider any sort of intervention. So observation is a key tool here and evolution of this with small measures in the meantime is in is important. This is where again the camera comes back into play.
Callahan, M.D., Thomas
Right. I totally agree. I think it’s so important to lay eyes on the incision and the device site whether in person or with the camera. And then of course the history is so important as well, right. Trying to get a sense from the patient, did it look like this all along? Did it get better, and then it got worse. Do you have systemic symptoms that might be suggestive of infection? So all of those things are important in trying to manage these early sites.
What about lab work for these patients? How aggressive are you if there’s sort of, you’re in that gray zone, how aggressive are you in terms of getting some laboratory work and what sort of things do you typically reach for?
Wilkoff, M.D., Bruce
Well, I think lab tests are important, but unfortunately it’s usually unrevealing, but I think if we get maybe that far, there’s another major category of incisional pocket issues, and it’s the overlap to hematomas and hematomas are important too. And you know they are separate topic by themselves but well, if there is swelling in the pocket, it could be blood. It could be a seroma, or, it could be infection. You don’t know, and erythema doesn’t necessarily help you and heat may not help you. Discoloration may not help you. These are all things that are kind of infection related. What helps you a lot is also time of onset, and medications like anticoagulation antiplatelets. What’s going on here? Hematomas are not rare. They’re much more common. But hematomas are good from the standpoint, if it’s not an infection; but hematomas are bad because the risk of infection are much higher in this group. So I’d say that early pocket decision comes down to is it an incisional stitch abscess or Is it a hematoma deeper in the pocket?
Callahan, M.D., Thomas
Right.
Wilkoff, M.D., Bruce
Or is it really a pocket infection? And I think that the purpose of the lab test that you were just asking about is trying to help us to, you know, get a handle on the on the thing. And of course, there could be overlap. You can have a red incision, you can have the hematoma and you can have an infection on all at the same time. And so you have to work with that. I usually get a sed rate on these patients, but it’s very nonspecific. A CRP is somewhat useful sometimes elevated again very nonspecific type of findings.
Callahan, M.D., Thomas
So I know what you are going to say here, but I’m going to ask it anyway. Just so we have it on record. What do you think about putting a needle in it? If you if you see some fluctuance, what do you think?
Wilkoff, M.D., Bruce
So there is some discussion about this point. A good friend and person who I greatly respect Chuck Love always tells me that it may not be as bad as most people make it out to be, but I don’t think it’s useful, quite frankly. And there are several reasons I don’t think it’s useful. One is that I can make a decision whether it’s infected or not without sticking a needle in it. When sticking a needle in it, it always brings the question, did you actually seed something from that? And of course, if you were to do this, using the utmost sterile technique to make sure that does not happen. But remember the bacteria that caused this come from the skin and then that’s where they are. 80% approximately are staph aureus or non-staph aureus staphylococcal organisms and they are Public Enemy number one, so to speak. And so if it’s a clot – you stick a needle in it and guess what? You don’t get anything out because it’s clotted and and so that doesn’t help you much either.
So I don’t find it that useful. If you are going to open up a pocket anyway and you’re looking for capturing a bacteria and to get them on antibiotics because you’re worried about the systemic nature that they have systemic symptoms and we didn’t talk about that, but looking for systemic symptoms is obviously an important part of this. Then, I think there may be value in doing this in order to get the person on the antibiotic that you want to get them on. But if you’re going to do so, you have to have a big enough needle because it’s often viscous and a thin needle is going to get nothing – absolutely nothing out of the situation. So I would only do it if I already knew that I was pulling this out. One of the keys here, though, is the problems with starting antibiotics early when you don’t have a diagnosis.
I mean, even without antibiotics, we often with an infection, a clear infection, we get negative cultures. And so getting all your cultures first is really pretty important. So if there’s any signs, blood cultures, certainly we’re talking about and then we’ll go on to imaging.
But if we just have a suspicious little incision, it’s just a little red or there’s a little bit of drainage at the Edge and such like that, and it looks to be very superficial I think you are not going to go to any of these things. You’re not thinking TEE or not thinking scans or anything else like that. There are no systemic signs, most of this is handled without any lab work, I would say.
Callahan, M.D., Thomas
So before we move on to some of the other maybe even more challenging cases, what is your threshold for antibiotics in this sort of more acute setting? So a few weeks after implant, maybe you have that scenario of sort of something that looks like a little suture reaction or stitch abscess, that kind of thing?
Wilkoff, M.D., Bruce
At this very early stage where I know there was a surgery and such like that, I have no trouble with a week of an anti-staphylococcal type of antibiotic. I even go to older things like Dicloxacillin and similar medications.
But the point being is that a week of antibiotics to reduce the inflammation, most likely just there on the skin. But realize you do not change the course of this if it’s deep.
Callahan, M.D., Thomas
That’s right.
Wilkoff, M.D., Bruce
But I’m not talking of you’re not curing something. You’re just managing something on the surface there. And so I think that’s OK.
Callahan, M.D., Thomas
Right, right.
Wilkoff, M.D., Bruce
If there’s nothing to really do look at, it’s just red and it looks angry and you’re not sure you whether it’s just healing or whatever like that, I don’t use antibiotics in that situation, and I let it play out because you’re not going to change it. You just sort of delay things as to what’s goes on. How do you handle it?
Callahan, M.D., Thomas
Well, I think similar to you I think it varies from patient to patient. I certainly do use antibiotics occasionally if I have something that I think is superficial maybe it’s a suture reaction, but maybe it’s some sort of very superficial infection then I might be prone to use five days, seven days of anti -staphylococcal antibiotic. If it’s something deeper. I agree with you. I actually want to let it play out because I don’t believe antibiotics are going change the course. We’re just going to delay.
So maybe now we move on to the scenario of a later presentation. If somebody comes in with a worrisome site and maybe now they’re six months, a year or longer out from any sort of intervention or surgery on that site and they come in and they say, OK, it’s been itching, maybe there’s a little bit of redness plus minus some sort of seat belt trauma. These come up occasionally as well.
Wilkoff, M.D., Bruce
Yeah. So, so first of all, it’s important to understand the time course in which infections actually do present. And one of the I think more important parts of the data from the WRAP-IT trial, there was a manuscript, first authored by Rizwan Sohail (J Am Coll Cardiol EP 2021;7:50–61) that described the bacteriology, and also talked about the time course of presentation of these infections. It’s really hard when people just come to you because they’re referred in. You really don’t know when it was first observed, but in the WRAP-IT trial we had a prospective cohort of patients that we were following for infection and we kind of knew when their infections became manifest and the pocket infections and systemic infections.
First of all, they had two time courses. It was about 180 days, maybe a little bit less than that for the pocket infections. Almost a year for the systemic infections for the median time. The range they tend to be earlier for pocket infections than the systemic infections, some of them happen very early, first week or so, but much of them occurred much later. Much, much later. This thought that it can’t be an infection later on is just completely wrong.
On the other hand, other things happen later. People on anticoagulation, some after trauma, they can have hematomas too from trauma, turning over in bed and twisting their pockets and stuff like that. Hematomas can happen late too, so but most likely if you have a pocket problem that is six months to a year out or longer and the other thing the WRAP-IT showed us is that people continue to have infections as long as we followed them, which was three years. I’m sure it happened at a decreased rate, but continue to have them at three years. I’m sure it would happen at four years. I’ve seen people as many as nine years out with infections with the same type bacteria from something that’s being seen before. So this tells me that many of these infections are more indolent, but then for some reason become the manifest later. So you tell me that there’s a change in the pocket six months to a year out. I’m thinking infection and.
Callahan, M.D., Thomas
I agree. I’m so much more worried in that scenario.
Wilkoff, M.D., Bruce
Yeah, and. And they don’t have to be red, they can be just swollen, but usually what happens is it’s an evolving pocket and this is where pocket pictures are ideal and lacking systemic symptoms and such like that – bringing them back in two weeks to take another picture. If all you have is a change in the pocket, seeing it because patients are not close enough observers. Sometimes doctors are not close enough observers. But patients? I’ve had people who wear the generators out of the skin and I asked them when did this start? They said, well, just this morning and so they either don’t look at themselves. They don’t. They’re not aware of the changes in their own body. It’s like that, other patients, of course, are obsessive, and we’ll talk to you about the ingrown hair that they have got in their chest wall and such like that. But that’s why you need this objective information and bringing them back at close intervals 2 to 4 weeks later. But this is when you also have to be suspicious of the overlap between pocket presentations and systemic infections.
Callahan, M.D., Thomas
Right. Sure, sure.
Wilkoff, M.D., Bruce
Because pockets tend to be the first sign of what happens with endocarditis.
Callahan, M.D., Thomas
Right. And. And so let’s say you have one of these again, I think both of us are much more worried, much more suspicious for infection. If you have this later presentation, some change in the pocket, either redness or swelling. But do you see PET scan or other imaging playing a role, obviously TEE and so forth. If you’re not worried about systemic symptoms, but if you’re just concerned about this worrisome pocket, do you see something like a PET scan changing your practice?
Wilkoff, M.D., Bruce
Sure. Yeah. We should talk about echo imaging, but I think this is an evolving thing. It’s becoming popular. I don’t think there is a huge amount of data. I’m aware of a document that’s going to be coming out from the American Society of Nuclear Cardiology, looking at both white cells scans and PET scanning of this. And there is some sensitivity to this. How specific it is, I don’t know.
Wilkoff, M.D., Bruce
And, I think it can be useful when you’re on the fence, but I think you could make the clinical diagnosis without those things most of the time. It’s in those questionable situations, particularly in those patients that have a lot of comorbidities, a lot of other things going on.
Callahan, M.D., Thomas
Right, right.
Wilkoff, M.D., Bruce
Usually the patients you least want to operate on. That you that you want to nail the diagnosis the most because you’re going to be doing some dramatic things with them within extraction. I do think they can be useful. Sometimes you’ll see the inflammation around the can, along the leads. Sometimes it will even light up inside the heart when you didn’t know that there was an endocarditis situation. But the ASNC the American Society of Nuclear Cardiology is pulling together an interdisciplinary group that will come up with some care paths here and I think it’s going to encourage the use. Part of the problem though is getting codes to bill for these things and getting them ordered. So I think this is going to be a process and working out how you can get this. And of course they’re not cheap and make sure that the insurance pays for these things. It’s one thing to say you want it. It’s another thing to be able to, to actually get these scans. So you have to be careful about that. But I think they have an evolving role and I think it’s becoming recognized that this is something that you might want to consider.
Callahan, M.D., Thomas
Right. And you want to talk about specifically about TEE in this scenario as well?
Wilkoff, M.D., Bruce
Yeah. So if a patient presents without a fever. They have a pocket that you’re suspicious. You’re almost certain is – let’s say you’re sure this pocket is infected. It’s red. It’s hot. Whatever. It’s like that. You know that you’re going do an extraction, I still do a TEE on these patients 100%. And there are several things that you can get from this.
One is that you are 1/3 to half of the time you are going to find something on the leads. Is it connected? Is it infected? You can’t be sure, but you’re going to treat it that way. If that’s the case. There are other things that that TEE is useful for. Was is there PFO and this is very important. Are you worried about paradoxical embolization? What’s the status of the tricuspid valve? There are other things that TEE is useful for.
But in this case, if there’s an infection, we do a TEE up front, we like to do TEE monitoring during our extraction, so we can compare it. It’s interesting sometimes what was there beforehand has disappeared already by the time the surgery gets done and shows that time is of the essence here. But surface echos are important for understanding longitudinally about tricuspid valve function and getting other information, but I think a TEE is actually pretty important. And what we didn’t say, but is we get blood cultures on anybody that I’m suspicious of there being a pocket infection for sure.
Callahan, M.D., Thomas
Right. I agree with your comments about the TEE. It really is a not that uncommon to have some findings, things that you didn’t expect,. You didn’t expect systemic infection and yet a TEE there it is. So I couldn’t agree more on the TEE.
One other topic I would hope to touch on here was that we have data that supports doing an extraction soon after diagnosis and that can make a big impact in terms of hard outcomes like mortality.
And yet on the other side of that coin we talked about, especially in these early cases, you know, conservative management giving these some time to play out and see what happens without antibiotics. How do you think you balance that?
That the decision between conservative management and knowing that time can matter in terms of extraction.
Wilkoff, M.D., Bruce
So I think the data that suggests importance of early intervention comes from people that have been admitted to the hospital and usually there’s a long lead time before they get into the hospital. But even modest delays once they get into the hospital can make a mortality difference. We are still working on getting it published, but at ACC in 2022, Sean Pokorney and John Piccini and the people at Duke and a group of us looked at the national inpatient sample and even waiting, though those that waited seven days or more, to get their extraction had a mortality cost. But these are sicker patients. They’re in the hospital. We don’t have a lot of data on that.
That’s part of the reason why staging a pocket versus systemic infection are important, the mortality rate on systemic infection is you know, an order of magnitude higher than what we’re talking about here.
So I think we have some time to look at this. As long as we have negative blood cultures, we don’t have vegetations going on here. There are no fevers. Whatever else like that, I think we have to be sure. If it’s just incisional, the pocket, whatever we have to be sure there’s infection that we’re going to take them to surgery. Once you make that decision, go for it. But be sure before you do because I don’t want to operate on people that we don’t need to be operating on. And I’m not sure that that mortality data applies to just this pocket presentation that we’ve excluded the systemic part of the equation.
Callahan, M.D., Thomas
Right. Yeah, I think it’s difficult to translate that data from the inpatient side into this more outpatient assessment.
Callahan, M.D., Thomas
This was a great conversation, really helpful and I look forward to our next conversation.
Wilkoff, M.D., Bruce
I agree Tom, and these are fun and I want to encourage people to not only listen but suggest topics for us to talk about, start discussions on lead connection where you’re this is your community. Please join in.