Dr. Alexandra Wick and Dr. Rizwan Sohail take us through the three main points that are covered in this recorded webinar addressing there being a major gap in guideline driven care. First, greater than 8 in 10 CIED infection patients are not treated according to Class 1 guidelines. Second, early lead extraction is associated with a 42.9% lower risk of mortality. Third, there is seven times decrease in 30-day mortality with extraction vs antibiotics alone. A multi-disciplinary approach to decrease knowledge gaps and improve provider comfort levels in the diagnosis and management of CIED infections. Both Hospitalist and Infection Disease Physicians can lead this charge to help drive better guideline driven care within their hospital facility and communities.
DO62699-00
So the topic for today's webinar is no infected lead left behind uh gaps in the care of patients with C ID infection. And we're looking forward to an interactive and interesting discussion uh with my uh colleague, uh Dr Alexandra Wick. Uh Here are disclosures and the learning objectives are that after attending this webinar, the participants should be able to understand the seriousness of cardiac device infections and know that there are gaps between what's recommended and what is actually being done to treat these patients, choose the appropriate diagnostic testing uh when patients present with especially bloodstream infection and happen to have a cardiac device and understand that the timing impacts the outcome, especially mortality in patients with bloodstream infection and then how to manage these complicated cases with the multidisciplinary approach. So me and Alex will be taking turns uh and uh uh we'll start with some background epidemiology and how these infections present and how to diagnose those. Great. So, um C ID infections are unfortunately common, more than 400,000 pacemakers and IC DS are implanted in the US every year. An infection is a serious complication of these. Um after C ID implantation affecting 5 to 20% of patients. The annual rate of C ID infection is increasing and the mortality rate can be up to 35% at one year. Unfortunately, the diagnosis, the diagnosis can be challenging because the presentation can vary. There are two different types of C ID infection. So pocket infection is due to device contamination. And as a result, these patients, these infections will present earlier about weeks to months, post implantation. And the second type of C ID infection that can occur is a systemic or endovascular infection. These are caused by hematogenous seeding of the C ID leads and these infections can present at a later time point about um greater than six months post implantation. And in one study, when they looked at the breakdown of the different types of infections for patients who had C ID infection. Um a greater majority of 59% presented with a pocket infection and 41% presented with an endovascular infection in this study and specifically for the study of the endovascular infection. Patients who had that, they did not have any evidence of inflammation at the pocket site. So it was truly only the leads that were infected. And so to discuss diagnosis of the pocket infection, um to diagnose this, the um it really is based on what the pocket looks like. So the pocket will appear abnormal on exam. Um it may be swollen, erythemas warm. Um the patient may complain of pain at their pocket site. Sometimes they might have purulent discharge or sinus formation. Um The pocket, the skin around it may be deformed. The skin may be adhering to the generator and um you could have threatened erosion or even the generator or the leaves are completely exposed um and out exposed, out of the skin. These are some examples of images of pocket infection and so it can vary, but in all cases, the pocket appears abnormal on exam. Um On the bottom here, we have some more obvious signs um or more obvious pictures of infection. Um bottom left, for example, is very erythematous. Um It's swollen, I can imagine it's warm. Um That clearly looks like it's a cellulitis and um infection right at the pocket site. Um You can have as you can see purulent discharge or um the device is actually just eroding out of the skin and importantly, the skin around, it looks normal, but because the device is now exposed to the elements um that's infected on the top here, you know, it can be a little bit less obvious too. Um So maybe just a mild ery fema, perhaps the patient's complaining of pain and there's a little bit of dimpling of the skin um or the skin is kind of just adhered to the generator and you can see it. Um and see there's a difference compared to um possibly prior exams. So, one of the situations that we frequently get into and get consulted. You know, is that uh while if there's erosion of peril and drainage, it's quite obvious that the device is infected. Uh Well, sometimes, you know, as you show in the picture at the bottom left, uh there's this red swollen pocket a day or two after implantation. Uh And uh the question that you have asked, like, should we aspirate this pocket? Like should we put a needle in? Uh what do you recommend if such situations arise? Yeah, they don't recommend aspirating it or um trying to get a sample um from that. I mean, I think if there is, you know, there's purulent drainage, I think it's a little bit controversial but whether you swab that or not, um but it's, if it is infection, it's most likely gonna be skin um flora. And so um they don't recommend aspirating it. What they do recommend is blood cultures. And so if you're looking at it and you're not sure if it's hematoma or if it's an infection, probably a good idea just, just to get blood cultures and then decide to cover it empirically if um if need be while waiting for the cultures. So this is really critical and I want our listeners to remember this, that, you know, if you suspect this could be hematoma or just a seroma like a sterile fluid collection, uh do not put a needle in these pockets because you could actually introduce in the infection, even if it's not previously infected. Uh So if the thing is not very clear than observation and blood cultures and if everything is negative, sometimes a trial of antibiotics to see how things go. Uh But uh uh invasive interventions can be problematic at this stage. Yeah. And I think also taking pictures of it. So if like the patients being seen in clinic, like taking a picture of putting that in the chart and then having them come back and then having that picture can also be helpful to see how it's evolving, right? And that can be really helpful because, you know, especially in a group practice, we have different providers rotating in the clinic in and out. Some are inpatient, some are outpatient and we encourage our patients to take like if, if you know something like this happens, like take daily pictures or every other day, just send them to us through Mychart, which comes to us through epic uh to keep a track of how things are going because uh sometimes uh just seeing the actual picture uh is the most helpful thing in uh diagnosing your pocket infection. Yeah. Um And so here we've in, I've included um the uh clinical Diagnostic criteria for C ID infection. This was put out, this is the 2019 International C ID Infection Criteria that was put up by the European Heart Rhythm Association. And so this is something I use when I'm um concerned specifically for systemic infection. Um I think I already talked about the pocket infection. They have a definition um at the top here, which is really all just looking at the pocket. What does it look like? Um What are some exam findings that would um make you concerned for infection? Um for systemic or endovascular infection. It's a little bit more difficult to diagnose. And so we have um or what they've included here is a major and minor criteria that you can use um to diagnose it. And so major criteria include uh microbiologic findings. So, positive blood cultures for organisms that um commonly cause infective endocarditis or C ID infection and then um imaging criteria. So, echocardiography um showing evidence of a bleed vegetation or other evidence of infective endocarditis and then pet CT as well. And then the minor criteria is pretty similar to infective endocarditis. Um minor criteria. So, predisposing factors, predisposing heart conditions, injection, drug use, um fever vascular phenomenon, et cetera. And I'll go more into the um into how to diagnose systemic infection on the next slide. And so um patients who have systemic or endovascular infection, um their presentation can be pretty non-specific. Um They may have symptoms like fevers, chills, night sweats, fatigue, malaise that um can have a broad differential. Um and they may, and a lot of times they have a normal appearing pocket and you know, knowing the timing of these infections, they may have had their pacemaker placed months or years prior. And so that they may not even be thinking about the pocket. The clinician who's evaluating the patient may not even be thinking about. Um you know, the fact that they have a pacemaker because the pocket appears completely normal. Um um sometimes they can present with some mebolic phenomena, vertebral osteomyelitis or gitis that's not otherwise explained. And so knowing that they have AC ID in place can help um help lead the clinician if they gave out ac ID systemic infection. Um And then bacteremia, these patients paper that with um it could be that they have a source identified or they don't have a source identified and they're having um kind of unexplained recurrent bacteremia. Um That can be one of the presentations for Civ infection to uh diagnose this. You wanna get at least two sets of blood cultures um and then imaging uh studies. So a lot of times we'll start with a transthoracic echo for these patients. Um look to see if there's any vegetation present on the lead or um on any of the valves of the heart. Um oftentimes we do have to follow this up with a transesophageal echo um which is um definitely superior to TT E when we're able to get that. Um And then pet CT is also um an option for us to uh determine if the um leaves are infected and then it's a clinical diagnosis and So, um on the previous side, we talked about that 2019 infe uh diagnostic criteria for infection for C I DS. And then you can also use the um the newly updated 2023 Duke infective endocarditis criteria, which includes specific um criteria for C I Ds Cie Ds as well. Um And then when looking at the patients who have bacteremia, not all organisms will cause the ID infection. And so there's certain organisms that are more likely to cause um the device to be infected. And so, in this study, we looked at um multiple different C ID infections in which organisms are uh were implicated. And so most commonly patients are gonna have um gram positive bacteria in their bloodstream that's gonna cause C ID infection about 70 to 90%. Um And among those staph aureus is gonna be the most common but other organisms to really be aware of are coagulase negative staph and trox. I. And then the other ones mentioned here, Strep Kani bacterium pab. And then while gram positive bacteria are much more likely to cause C ID infection, gram negative bacteria are also um uh important to think about and specifically um pseudomonas seria and the hai organisms. Yeah. So, you know, I would like to take this opportunity to also pitch in the American Heart Association work that we are doing. Uh so just like the European heart rhythm association and is CV ID, the American heart association has been working in the last year on uh its own guidelines as well. Uh And they're soon to be published hopefully next month. And so some of the things that we took in a little different approach uh in uh diagnostic strategy is that uh we sort of divided it into two big uh categories as you had previously mentioned. So for pocket infections, uh simply we suggest that if it looks infected, it is infected. So and not a, not a whole lot of work up is needed. Uh And uh even for echo in those patients, uh uh many of the electrophysiologist will do intraoperative te in those patients when they are there to extract the lead. Uh So preoperative tee may not even be needed uh for lead infect uh uh for pocket infections because you're gonna get a tee anyways. Uh But for bacteria, patients with normal looking pocket, definitely tee remains uh the test of choice. Uh And uh also we kind of uh discuss the pep CT that while it is great for uh pocket infections and it has excellent negative uh predictive values. Fa pocket infection is the concern. And if pet CT is negative, you can, in most cases for all practical purposes, rule out a pocket infection. Uh but pet CT is not the best for lead infections. So while it picks up 70 75% of the lead infections, a negative pe T scan in a patient with high grade bloodstream infection, especially with grand positives bacteria, uh may not rule out a lead infection. So you still may need to do the extraction even with the negative pet CT. If there's no alternative source of the bacteria, persistent or bacterin is recurrent. Uh so we kind of move towards more a clinical definition in the eh a document rather than this major minor criteria because we feel like while those are great for research studies to make sure that all patients have very uh consistent, similar inclusion exclusion criteria. But for day to day clinical management, I think, you know, uh uh sometimes those minor major criteria become overly overly complicated, uh what diagnosis is right in front of your eyes. Uh So uh thank you Alex for the background. Uh And I think uh next couple of slides kind of highlight uh what you have already kind of went over the major minor criteria. Uh And uh even in the 2023 duke is CV ID uh infection uh guidelines. Uh What's new is that they have removed uh uh that there needs to be the blood culture needs to be 12 hours apart. So a anytime you can get two or three blood cultures before starting antibiotics, uh and then uh uh nucleic acid testing, especially PC RS and even next generation sequencing are now considered a major criteria. Uh And as you mentioned, pet CT is included there as well. Mhm So some of the challenges in diagnosis, systemic infection uh that Alex has mentioned that the pocket may look just fine. Uh but the symptoms otherwise can be non-specific. So they are very similar to any patient presenting with a bloodstream infection. Uh Therefore, the clinicians need to be very cognizant uh and aware that in and anybody who's living with the pacemaker, I CDC it device, they need to think that the device could be infected in patients presenting with bacteria. Uh So they need to do a good physical exam to look at the pocket, look at other sites of hematogenous seeing. Uh So as it was mentioned that they could present with liver apy. So apses deis osteomyelitis. So a patient with bladder stream infection and hematogenous seeing elsewhere should make you think about a uh a possibility of a lead infection in these patients. Uh Sometimes if the availability of echo or pet scan is difficult. Uh and uh patient is at a smaller referral medical center, then it's better to refer them quickly to uh a, a higher level of care uh center which where they can do the uh TE or PC T if it's needed and plan the extraction because as we'll see, especially for staph, for spectrum. Yeah, a delay in diagnosis and extraction can be really a life threatening for the patients. So I'll go over some of the cases, highlighting uh challenges and specific factors uh based on the organism uh uh in these patients presenting with uh bloodstream infection. So, case one is a 72 year old male uh who's diabetic has his heart failure uh has the C RT in place. Uh Patient is hospitalized with right lower extremity peril and cellulitis. And as we know, majority of the cases of peril and cellulitis are due to staph aureus, unlike non peril, which are usually due to streptococcal cellulitis. So that was obviously a concern in this patient. Uh The patient has a cardiac Rey therapy defibrillator uh for the last three years. And as uh we were worried, the admission blood cultures did turn positive for four years on exam. The generator pocket looked just fine and there's no stigma off endocarditis or hematogenous seating elsewhere. The back exam is fine, abdominal imaging was fine. So what do you do in those cases? Uh And how do you go about it? So, there are a number of studies uh some done in the nineties and early two thousands. But the most recent that was published uh uh April of last year uh was from your clinic. Uh They looked at uh 110 patients with CIE Ds with Staph spectrum and a normal looking pocket. Uh 83% and tee and based on the European heart rhythm uh uh criteria, uh 51% had evidence of definite C ad infection and almost 30% of possible C ad infection. So, this is a big number that you know, up to 80% of the patient, the staph is bacteria and a device possibly have a lead infection. Uh Therefore, in uh every patient who presents with Staph or Specter and the presence of the cardi device, the admitting clinic or consulting service should definitely think about underlying a infection. And what was also very significant as you see in the last bullet that uh in patient uh who had definite C ad infection, which was 50% of those patients uh in early extraction, which was defined as within seven days of admission was associated with 83% reduction in the risk of oneyear mortality. So this is really huge and and trying to manage a patient with staph spectre and infected lead conservatively can really be a fatal choice. Uh Therefore, uh I think if there's one thing that people can remember from this uh webinar is that if you choy specter and device think about underlying lead infection, do the imaging and refer them early for extraction because this can you could really save your patient's life that way. How about other organisms? So we there we move to case two. I'm just gonna take a pause and drink water. So case two is a 55 year old male uh with anti renal disease on uh hemodialysis who presents to the hospital because he missed a dialysis session and feels a little short of breath and he coughing uh but had no fever, no systemic signs of infection, normal white cell count. Uh But the uncle did get the blood cultures done in this patient. Uh And uh now they are growing uh quite less negative cepal oxide CCRP is normal. Exam is normal. So what do you do in these situations? Uh When do you have a patient with become positive bacteria other than step four years. Um So, before we get to this slide, uh just kind of closing the loop on the previous patient. So that patient uh did have colic imaging uh which was negative for endocarditis and the admitting team uh consulted ID before starting antibiotics. Uh And the ID recommended repeat blood cultures as negative. Uh So we thought that the uh single positive blood culture with coag negative stylo coccus on admission was a contaminant. Uh and patient had to repeat blood cultures and was observed and did just fine. So, you know, again, highlighting that common skin organisms can be a contaminant, but they can also be a true cause of infection. And one needs to put the clinical context with the blood cultures to figure out uh what's the right approach in that patient. So, as we see in this uh study published in heart rhythm General uh in March of this year. Uh also from your clinic, there are 100 and 60 patients with card devices and nonstop or is composited bacteria. And uh when they looked at the risk of the infection. The odds of hematogenous seeding with bacteria uh was 19 fold with negative cepal oxide, fourteenfold with anoxia and 15 fold higher than very dense group of streptococci compared to other organisms. So therefore, uh every time you have ground positive bacteria, even if it's nonstop for uh device infection is a big concern and patients should be evaluated for it. When they looked at the uh short term and long term mortality. Uh for non Staal compositor bacteria, there was not really significant association. Uh So, while non t four years positives bacteremia would not immediately put your patient's life at risk. Uh But there are several studies published on risk of relapse. So these patients will continue to relapse until you remove the device. Therefore, extraction is necessary. Uh It's just it's non emergent for non step four years and it's emergent for step four years. But in either case, uh removal is necessary to achieve the cure. Otherwise, these patients will relapse even if they survive the hospitalization. Uh Moving on to case number three, which is a totally different scenario. So the 67 year old female with diabetes, coronary artery disease, uh uh chronic kidney disease who's hospitalized with fever chill arthritis and flank pain. Ah everything pointing towards maybe possible pyelonephritis. Uh patient had ad chamber pacemaker implanted two years ago on exam patient appear has febrile toxic appearing has plant tenderness, the pacemaker pocket looks fine. Uh blood and urine cultures are a pain and both heavy growth of clep yellow. So what should be done in these patients uh who present with gram negative bacteria and presence of a device. Uh So in this study, published an open forum infectious disease uh in August of last year. Uh This is also from the clinic. They looked at all the patients hospitalized there for over nine years. 126 patients were identified who had cardiac devices and gram negative bacteria. And only four of them had evidence of definite C ID infection. And amongst those four serra resistance was the most common organism. Uh not big numbers to draw much statistical associations. Uh But two things that we can take home from this study. First of all, device seeding with gram negative bacteria is rare. So if you have a patient with gram negative bacteria and a non alternative source, whether it's intraabdominal or lung or skin or catheter treat the primary source and you do not need to do additional imaging and testing routinely to look for lead infection. Uh But if there is no alternative source or if it's A or SAS, then you should uh look for underlying lead infection. So for gram negative, the suspicion is low unless you have no alternative explanation. In which case, uh it could definitely be lead infection. And as I mentioned, uh uh when I was talking about nonstop is no positives bacteria that regardless whether it's just cocky infection or combination of pocket infection and bloodstream infection or just lead infection with a ne negative pocket. No matter which study, you look at the risk of relapse ranges from 50% to 100% compared to device removal. The risk is 1% or less. So, in no medical decision making in any other syndrome, if your chances of success or cure were uh 100% versus 1% you will choose the 1% option. And yet, unfortunately, we continue to see uh that uh these patients with cardi devices are not treated appropriately. Uh In the most recent Medicare analysis of uh uh profound by Duke, uh looking at uh uh uh Medicare patients who had delayed onset lead infection uh only 20% underwent uh device removal even when a case of uh infection was diagnosed. So this is really problematic. Uh And uh especially knowing that uh extraction can save lives and delayed extraction leads to hide mortality. Uh And I think this is where uh we and a lot of other centers struggle uh is about how to expedite the care of these patients, how to make sure they get the treatment that they need. Uh which is extraction, how to remove uh misperceptions in both patients and non ep providers who think that extraction is such a high risk that it's kind of like a death sentence. And they don't want to send the patient for extraction because they're worried uh that uh extraction is high risk. Even though there are several trials and studies showing that extraction done by a, a person who has expertise in it is the risks are like, you know, less than 1% or so for most cases, uh while as we saw the risk of relapse and Deb can vary from 20% to even 80% in these patients who do not undergo extraction. So I would like to kind of uh throw this question to you, Alex that uh what are the barriers and struggles you face uh at your institution? Uh When you're dealing with these patients with bacteremia and possibility of lead infection and how do you kind of uh address those then? Yeah, I think um barriers to, I guess timely diagnosis um is really trying to get if we need to a transesophageal echo um cause that can take many days to arrange. And so if we're trying to get these devices extracted as soon as possible, um what I need to do is talk to my infectious disease colleagues as soon as possible. Electrophysiology, make sure that we have somebody who's capable of doing device extraction at the institution that I'm at um and get them involved as soon as possible because scheduling um device extraction can take many days and that can lead to a delay. And so I think really scheduling of like transit toptal echo and device extraction are kind of the biggest um barriers and then in making sure that the patients cause I, I work at several different hospitals and so only one of them uh can do device extraction. And so if I have to transfer the patient, then I have to get that process started kind of as soon as possible too. So I think those are all um all various that unfortunately because of just how um how busy hospitals are and um just capacity issues that can take a while sometimes to get the patients to the place where they need to be, to get the care they need to get right. And, and, and we kind of struggle with the same issues, you know, depending on when patients get admitted and how to arrange the imaging. And one of the things that we found really helpful is that uh it is best to have uh pre identified individuals that you work with and kind of had the conversation with them. Uh So having kind of an understanding that everybody is on the same page. Uh So if one doesn't have to reinvented the wheel every time the patient comes in, so you have your trusted partners within the institutions, whether it's the eco person or the nuclear radiologist or electrophysiologist. And so kind of having an existing understanding where you know, whom to reach out to and whom to call. And if things get stalled, like, you know how to expedite it, so having a team approach really is helpful in these complicated cases rather than trying to kind of uh get things done on a case by case basis, which is obviously necessary as well. Another thing that some of the institutions have found it helpful uh uh is to build uh electronic health alerts uh in their electronic medical records. Uh Does your institution have that or have you guys considered it or? Yeah, I think one of the hospitals I work at does have um like kind of a best practice advisory. So if a patient has a fever or leukocytosis um and a device in place, it will pop up and say, oh, you know, think about whether this patient has AC ID infection, it doesn't get routed anywhere else though. Um Besides the initial um clinician who's looking at the chart. Um So I do know that some institutions will actually have like some something that goes um it routes to like in basket for an infectious disease um specialist or the electrophysiologist um who can um extract the device. Um I think you just have to be careful with these alerts that there's alert, fatigue and in basket um in baskets will just kind of blow up with lots of alerts that come out. And so um that is one possibility that some institutions can do and maybe it's helpful for them. Um But I think it's helpful to have like a team like a multidisciplinary, like team that's gets activated in some way with an algorithm. Like once you're concerned about a device infection, something could, could go out whether it's through the EMR or some other, um some other way to let the people know the right people um know to kind of get this process started. Right. And I, I think that, you know, we kind of struggle with the same thing as you mentioned, there's alert fatigue, you don't want to build too many pop ups. Uh And uh what we have kind of discussed and uh reach that conclusion that uh probably the best way and obviously it varies based on the institution is to have some sort of coordinator, uh who's to whom this in basket, uh uh alert gets routed. Uh because uh there's so many providers involved in the care uh because these patients are complicated. So there may be a G I person and ID and cardiology and ep and, you know, endocrine and nephrology are all seeing the same patient. Uh And so who gets the alert and who gets to dismiss it and who's interested and is not interested can really be a dependent on what their perspective. And while in the patient, uh so having a coordinator uh designated and obviously that requires resources as well is probably the best way to uh execute uh this plan. Uh But it's really dependent on the uh uh uh institution and these conversations are sometimes needed. Uh with the other specialties of the hospital administrator and management uh and making the case that, you know, uh these infections can be deadly, extraction can be life saving and within the given resources of institution. What's the best way to get this implemented? What works at bay? I mean, hard work at Duke or other institutions uh alike. Mhm. So uh some of the uh uh take home points uh that uh I think you would like the audience with. First of all, uh uh device infections are becoming more common uh because we're implanting these devices in uh elderly patients with multiple comorbid conditions, uh some patients get early infections which mostly in all the pocket and that's where the physical exam uh and direct evaluation of those patients uh is essential to monitor those patients. Uh If there is period drainage or erosion, that's definitely infected and these patients should be referred for extraction while you can buy time with using antibiotics. But these infections do not go away with just antibiotics alone. Uh On the other end of the spectrum, some patients present with just fever and positive blood culture. So, in these patients, if they have a gram positive bacteria such as coleus negative staph or SCLE aureus or enterococcal, uh these are high risk for underlying lead infection and these patients require further imaging. Uh And if there is uh no alternative source or if the imaging is suspicious for a lead infection early referral for extraction is critical because delayed extraction can be life-threatening for these patients. And finally, uh uh working together between hospitalist uh uh groups, uh infectious disease, uh electrophysiology, cardiology, imaging pharmacy altogether. Uh is uh the only way to make sure that these complicated patients get the best care that they need. Uh And it's important for both uh like, you know, providers as well uh to feel satisfied that they provided the best care and obviously for the patients as well. Uh Because uh they really need our help to navigate uh these uh difficult situations. Uh So, with that, uh we would uh like to thank our audience for uh uh listening to this webinar and uh uh be on the lookout for the new American Heart Association guidelines, which are coming out very soon. Uh And thank you very much.
