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Pocket Infection-Lessons learned from PADIT (Prese ...
Pocket Infection-Lessons learned from PADIT (Presenter: Andrew D. Krahn, MD, FHRS)
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What I'm going to talk about basically is just the overarching prevention of infection with a focus on the pocket, and some of this is going to be a little bit of recent clinical trial evidence and then how to interpret that and apply it in your practice, including some data from a light breaker earlier today, just to give you a sense of the very latest thing. So one of the things that I wanted to emphasize to start with is we've had a recent focus, I think, on how to intervene with antibiotics to prevent infection, and that's an incredibly important focus, but the reality is infection prevention is a multi-component enterprise that involves things like if you have poor surgical technique and a lot of retained thrombotic material and incomplete incision closure and poor sterile technique for prep, all the antibiotics in the world are not going to save you or the patient. So I like to divide this into four different areas. There's things that are done kind of remote from the procedure that I call pre-pre-op, skin prep, nasal decongestant, antithrombotic planning, and these things are important if you're running a device program. And then immediately pre-op are things like the actual skin prep, and the intravenous antibiotics are typically given beforehand. Intra-op, we have saline irrigation or other kind of antibacterial irrigation, and then of course the ability to leave antibiotic impregnated materials in the wound, and then post-op the use of different dressings, wound care, antithrombotic management, and antibiotics. And so the important thing is that for every given patient or within your device program that you're thinking of all of the elements of this, and then the discretionary question, for example, of which antibiotics to give or what strategy or who to use an envelope in as part of that decision process, but I'm hoping you have SOPs around all of this to try to reduce infection. So I was asked to talk about PADET and a little reminder about PADET, which was presented here last year as a late breaker. So PADET asked the question on a large-scale population basis about adding antibiotics to the entire process of implant, and seeing what measures it would have on the impact of infection. And so we'll walk through just enough of that detail to do some comparisons. So first of all, guidelines tell you to do this, give a dose of cefazolin, and then conduct the procedure. And that's the single recommendation in our existing guidelines, and incremental things to do are typically tailored or personalized, but are without really comparative evidence. So what PADET did is it took half of the people who were randomized in the trial, which is about almost 20,000 patients, and they were treated like this, and then the additional people also got vancomycin pre-op, and then during the procedure they had their pocket washed with a bacitracin wash, and then they got two days of oral cephalosporin afterwards. So this was the sort of multi-component, incremental, systemic antibiotics, both pre-op and then a small intra-procedure measure with a surgical wash, and lastly with a bit of retained antibiotic for the next two to three days. And what PADET taught us was that there were a few pretty profound observations. So it was primarily focused in high-risk patients, who were patients having repeat procedures or CRTs. These patients historically had infection rates in the order of two to three percent, and there were a couple of profound observations. One is all of these antibiotics reduced infection rate by about 20 percent across the board, and that little detail I'm going to explain to you, that was not significant. The other compelling thing is the infection rate was half of what we expected. We were looking for two, two and a half percent, the trial was powered around two percent, and the infection rate was one percent. This is pretty profound, low infection rates, and what the good news is, this is reproducible. So second thing I want to draw your attention to is, if we take the conventional arm on the left here, look at the kinds of infections there are, right? So there were 83 pocket infections and 40, if you might call them systemic or intravascular infections. And if you look at the effects, if you look over here on the right-hand side, what you see is, although it wasn't significant, in general, if anything, there was a trend to being a little better about intravascular infection and not very good about pocket infection. And the reason is, it's a systemic drug that's not particularly concentrated in the pocket. So there's some very good logic to this, and we'll compare that to RAPID, which in a way has the opposite findings. And if you look at the classic forest plot, to look for the subgroups who should benefit, who does it actually work in, and that kind of thing, there's really nothing there. And so an argument is that if everybody gets about a 20% reduction rate, there's two interpretations. One is, you can't pick somebody who needs this approach. The second thing is, the effect is real, but it's very modest, it's so modest it doesn't achieve significance. And if you look, for instance, at, say, well, what about pacemakers or ICDs or CRTs? So this is the summary figure from the JAC paper. And what this shows is, there's a couple important points. You notice that there's, again, the gray, which is the incremental antibiotics, has a little bit lower rate than the standard. But you notice the driving force is actually how big or how complex your device is. So you move up that scale, and you get much more infection. So then we come to the RAPID trial, which was presented at ACC and ERA, and then published simultaneously in New England Journal. Kudos to the RAPID team, led by our fearless co-chair. And what they did in this situation, that most are familiar with, is they used a pocket intervention with a Tyrex pouch and compared that to conventional antibiotics, which didn't involve a local pocket intervention, and made a profound dent on pocket infection. And in fact, we just said, if you looked at the conventional arm and pat it in 10,000 patients, what drives infection risk is pocket infection. And that's no less serious from the standpoint of the need to still do a system extraction and re-implant and so on. But it makes sense that if the driver is pocket infection, a pocket-directed intervention is going to be profoundly effective, and it was. And so we see that here. So if I click here on the bottom, what you see is pocket infection, 14 versus 36 infections. I mean, that is a dramatic reduction in risk of pocket infection. If you look under bacteremia or endocarditis, that part's awash. There's a possible paranoid argument to say maybe, in fact, it sort of slightly enabled a little bit more systemic infection, because there are a few more. But that's nowhere near significant. But the bottom line is its big and profound and trial-positive effect was in pocket infection. So if you want to dent infection, in retrospect, as I think about planning PAT-IT from seven to 10 years ago, looking at the kinds of infections there are, we should have been more aggressive in targeting the pocket, because that's where the trouble usually starts. So this is the late-breaker from earlier today. And what we did in those 20,000 patients is we looked at what parameters predicted the risk of infection, because one of the things that's helpful is to understand if you can predict the risk, then you can then potentially tailor that to what interventions you choose to do. And so, for example, there are five risk factors that came out of this. You see them from top to bottom. One is age. Believe it or not, younger people are more likely to get infection. Second is the type of procedure. And you can compare pacemakers, for instance, like you saw in the PAT-IT reference group. If you go to ICDs, you get more risk. You go to CRTs, you get even more risk. Second thing is things like renal insufficiency, being immunocompromised, and the number of previous procedures. Those are the five major parameters that drove infection risk. And the highest-risk group of people are people who are having revisions and upgrades. That's the top of the scale, if you like. And if you look on the right, each of those, if you're a statistician, we can talk about the mechanism by which how this is derived. But the bottom line is you get a number of points for that risk factor. If you have those things, and then you get this escalating scale of risk. And this scale, theoretically, if you had everything imaginable, you'd have a score as high as 14, but 90% of the population has a score from 1 to 7. And you can then argue you have a low-risk group of people, score 0 to 4, like a new pacemaker implant, like a simple generator change, to high-risk people who are things like CRTs, upgrades, revisions with renal impairment, who are young, or who are immunocompromised, for example. More procedures, more complex procedures, are patients who are much more prone to infection. And you can use this, for example, to say to the patient, or in your procedure planning, or for example, in your choice of things like giving incremental antibiotics or the use of the Tyrex pouch, we will have to socialize the question that what threshold do we think we should throw the book at them, in terms of doing everything we can, including the use of the pouch in our current climate of choices that we have. So to conclude then, we'll go back to the reminder of the basics, which is ensure that your program has a process that looks at all the elements of device care, including procedure planning, prep, intra-procedure, and post-procedure care, to try to minimize the reduce of infection. Technology and drugs and the prospects are outstanding for us to have an improved, if you like, suite of things to help to prevent infection. And it is entirely possible, what's really great is that a 1% infection rate is a very achievable goal. The same infection rate was seen in RAPID. This includes in complex patients or high-risk patients. So if you were going through audits and quality processes in your own institution, you can look at this and say the benchmark we should aspire to. RAPID was 227 centers? RAPID was 171 centers. And 900 operators or something like that. 776 operators. Yeah. So I'm a little inflated, but the bottom line is on a very large global scale, a 1% infection rate is an achievable goal. That is wonderful news for patients. I think there's an argument that more antibiotics has a little bit of an effect, which if anything is probably around systemic infection, and the most potent intervention is to use the use of an antibiotic pouch, because that dramatically reduces pocket infection. And I think the risk score and other things that are looking at risk will be insightful for us to predict risk and then scale interventions to that risk. And I think I finished early, which is good news, at 6 o'clock, when you probably need a beer. Thank you. We can have one or two questions. I have one question, and I attended the labor conference. Congratulations again. And we desperately need, we needed knowledge about what is the standard? Because we were in your shoes sitting five years ago, what is the rate of infection? And these are smart people sitting in one room. It was really hard. I don't think this is hard anymore with both PADDED and RAPID. And people talk about hopper effect. If both trials didn't achieve anything, but to get this hopper effect and make it the standard of care, I think we've achieved something for the people. One question I have, and these scores, they're great, and I can't wait until we test the score with the RAPID population. Did you test, in PADDED population, if you set the threshold of six, would there be any benefit from the additional antibiotics? So there was no interaction between this risk score and the treatment effect. So it's not like the treatment was uniquely effective in patients who were particularly high risk, which is utterly disappointing, of course, because once again, you're sort of looking for that population where the extra work or extra antibiotics are worth it. And that's not the case. I think in retrospect, if I think about design, you know, the driver of pocket infection is a compelling story here, and it's part of, it's very aligned with what RAPID showed. And I wish that was the case. I'll now turn it back to you and say what I'm interested in is applying this score to the RAPID population and see whether the envelope was particularly effective in a high or low risk group or it was equivalent across those sectors. At the back. Hi. I have a couple questions. One is with the use of the envelope, when you come back later to do a gen change, is the envelope grown into the tissue, and what do you do about that? My second question is, have you found that who closes it impacts infection as far as like the provider versus the cath lab tech? And then my third question is, what do you guys use to dress the site? We have a lot of issues with skin issues after implant. So after the wonderment of being introduced to the Parson's pouch at the beginning of my career, I'm very pleased to say that this sucker dissolves in six weeks, so there's nothing left when you come to generate a replacement. So it's all gone, which is great. And it's that, think of it like an absorbable suture where that six-week dissolving period means it's essentially sustained release antibiotic. So there's answer to one. So second thing is, there's no good comparative evidence about the details of the operators and the closure processes and so on. What I can say is that several data sets, including ours, have looked at some of the operator components, including surgeon versus EP, trainee, present, present, not present. And for the most part, there's no compelling signal coming from those kinds of sub-analyses. They're not head-to-head, they're not randomized really, they're descriptive, but there's no obvious thing that says that when an EP closes, the risk is, for instance, there's legitimate concern the risk is higher because we don't have the same rigor of surgical training. But the reality is what you need is committed people in the device space, not a heritage of one area or the other. In Canada, which is where most of the padded work was done, as well as the Netherlands, we don't have non-physicians doing closure. So it's always the surgeon or the junior surgeon who's the person who's most likely to do the closure. Dressing-wise, there's some heterogeneity, but no standard set. And I know there are some devices in the works that are, again, antibiotic-impregnated sutures and dressings and so on to try to achieve the same thing. And so at our place, for example, anyone on antithrombotic therapy or anyone with active concern during the procedure gets a pressure dressing. There's pretty compelling evidence it's useless, but we still do it empirically. And other than that, we just put a simple occlusive dressing on. Seth? I saw a patient recently, it was like eight weeks or so after they had the device put in and they had the Tyvek pouch. And then when we opened the incision to put the LV lead in, they couldn't get in. It was just all soupy. There was no healing whatsoever. And I'm wondering, we weren't sure whether it was related to the pouch or whether it was infection or what was going on. Is there any less healing as a result of the pouch? I mean, because it was just a soupy mess when we got in there. I mean, it's dapamycin and rifampin that's impregnated in the materials, and it does liquefy over time. As far as I... We'll ask Khaldun what his experience is. As far as I understand, there's very few pockets that have been opened in that one to two-month window. I've seen a couple photos from them, and there is some dissolving materials with a bit of liquid, but I wouldn't describe it as a boggy or fluid collection pocket. I don't know. Khaldun? Yeah, no. Again, what was the timeframe? I'm sorry, after the procedure that you're talking about? Two months? It was a complicated case in that whoever did the case outside had put the dapamycin on one side, got infected, put something on the other side and perforated, and then they reopened it, and then they put it back in, and then they put a Tyvek in there. Right, because it does take nine weeks for the envelope to dissolve completely. There was no envelope in there. Right, right. But again... Does it impede healing, I guess, is my question. Yeah. No, it's a great question. I mean, I don't... My personal feeling is that the answer is no, but who knows? We never opened those pockets again in that short period of time. There's nothing... What we did look into, the second safe end point for RAPID was safety, and we looked at things like hematomas and pain and allergic reactions, and there was non-inferiority analysis. There was no increase in any of the complications using the envelope. I can tell you that part for 7,000 patients. As a matter of fact, it looked in. It's not suggesting the envelope is protected from complications, it was actually lower in the envelope group. So the healing and things like this, not the direct answer to your question, I don't know what's going on inside, but at least something that would manifest as a clinical complication. There were very thorough list of complications. There was no increase in complications using the envelope. I can tell you that part with confidence. It was probably infected, I guess, is the bottom line, or she's allergic to the can. We weren't really sure what's going on with her. And honestly, when we see our own pocket, when they come early on, not the device changed after many years, they don't look good. And then it becomes difficult to say what's this old blood or thrombus that was left there. I'm not sure what your definition of a quick healing within that week's period after the last intervention, between some old blood that's remained there or maybe it's infected. I'm not sure how you define a good healing of a pocket that early after an intervention. I'm not sure how early that was. Great. Well, thank you everybody. Thanks for your attention. Good evening.
Video Summary
In this video, the speaker discusses the prevention of infection in implantable device procedures, focusing on the importance of a multi-component approach. They emphasize the need to address factors both before and after the procedure, including preoperative preparations, intraoperative precautions, and postoperative care. The speaker mentions two clinical trials, PADET and RAPID, which both investigated different strategies to prevent infection. PADET found that a combination of antibiotics given before and during the procedure, as well as retained antibiotic material in the wound, reduced infection rates by 20%. RAPID, on the other hand, showed the effectiveness of a pocket-directed intervention using a Tyrex pouch to significantly reduce pocket infections. The speaker also discusses a risk score developed from the PADET trial, which can help predict the risk of infection and guide intervention choices. Overall, the speaker emphasizes the importance of a comprehensive approach to infection prevention and the potential for achieving a 1% infection rate.
Meta Tag
Lecture ID
6508
Location
Room 155
Presenter
Andrew D. Krahn, MD, FHRS
Role
Invited Speaker
Session Date and Time
May 10, 2019 4:30 PM - 6:00 PM
Session Number
S-088
Keywords
infection prevention
implantable device procedures
multi-component approach
clinical trials
pocket-directed intervention
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