Okay, I think I'm going to get started here. My name is Gordon Ho, I'm at UC San Diego, and I want to welcome everybody to San Diego. Hopefully the sun will come out later. This is usually what happens, so don't worry. So we have exciting five talks today, all talking about different lead management issues in this age of transcatheter, tricuspid valve interventions, and other new technologies that we have available. And I guess before we start off, can you just nod if you can hear me with your headset? Okay, very good. We're the red color. You'll see a little red light if it doesn't work, and you can come grab me or one of the specialists if you have any problems. So we're going to start at 10 o'clock. Our first talk is by Dr. Graham Pei, and he's from Northwestern, talking about outcomes of entrapped right ventricular pacing or defibrillator leads following transcatheter tricuspid valve replacement with the EVOKE system. Dr. Pei. Thank you so much for the introduction. Thanks for having me. And a big thank you to the entire Northwestern EP lab for showing up today. My name is Graham Pei, and on behalf of my co-authors at Northwestern, it's my pleasure to present our data on the outcomes of entrapped leads after transcatheter tricuspid valve replacement. So the EVOKE transcatheter tricuspid valve is a commercially available percutaneous treatment for severe or greater tricuspid regurgitation. This valve entails a self-expanding nitinol frame with nine anchors, and for those of you not familiar with the valve, this is what it looks like. On the right side here, you see the valve deployed, and the manufacturer provides this video showing the self-expanding nature of it. After obtaining femoral venous access, the sheath is put across the tricuspid valve, and then with the assistance of real-time TEE, the valve self-deploys, and those nine anchors adhere to the valve annulus. Importantly, in the TRISEN trials, the pivotal trials for the EVOKE system, EVOKE was shown to improve tricuspid regurgitation severity and quality of life compared to medical therapy. Importantly as well, in the pivotal trial TRISEN 2, 39% of patients had a pre-existing right ventricular pacing or defibrillator lead. However, those patients with integrated bipolar leads, those patients who were pacemaker-dependent without an alternative pacing option, or those who had had a secondary prevention ICD with prior therapy were excluded. In patients with pre-existing right ventricular pacing or defibrillator leads, deployment of the EVOKE transcatheter tricuspid valve results in lead entrapment. In a representative chest x-ray as shown here, prior to EVOKE deployment on the right, you see a right-sided dual-chamber pacemaker, and then following EVOKE deployment on the left, you see the EVOKE frame and the right ventricular lead that's entrapped with decreased slack. The clinical valvular and lead-related outcomes after an endocardial right ventricular pacing or defibrillator lead are entrapped by the EVOKE transcatheter tricuspid valve replacement system are currently unknown. Therefore, the objective of this study was to describe the clinical outcomes following RV pacing or defibrillator lead entrapment by EVOKE. Secondary objectives of this study included, one, an assessment of short and long-term lead parameters after entrapment, and two, the etiologies of tricuspid regurgitation in these patients with pre-existing RV leads. So to do this, we looked at all patients with pre-existing RV leads who underwent EVOKE evaluation at three medical centers from 2020 to 2024. All of these patients were evaluated by a local heart team pre-procedure, and that local heart team, of course, did include an electrophysiologist. Patients who had a preoperative RV lead extraction were excluded, therefore the study cohort consisted of all patients with entrapped right ventricular pacing or defibrillator leads. We looked at clinical, valvular, and specific device-related follow-up. The clinical follow-up was done per study protocol if a patient was in one of the studies, and then according to local practice. We did device interrogations immediately prior to EVOKE, immediately after the EVOKE procedure was done, and then in follow-up per the patient's local device clinics. And transesophageal echoes were done prior to EVOKE for planning, obviously during the procedure itself, and surface echoes were routinely done 30 days following the procedure. The primary endpoint was incidence and clinical outcomes of severe lead-related complications through the duration of clinical follow-up, and a severe complication for the purposes of this study was defined as any lead-related event resulting in a repeat hospitalization, any sort of additional procedure, or mortality. Secondary endpoints included changes in entrapped right ventricular lead sensing, pacing impedance, or capture threshold, and then a categorization of tricuspid regurgitation etiologies in those undergoing EVOKE with a preexisting right ventricular lead. In total, 146 patients at three medical centers underwent evaluation for EVOKE. 90 patients didn't have a lead, and 56 patients did have a lead during their initial evaluation. Four patients underwent prospective RV lead extraction. There were no extraction-related complications. And our study cohort, therefore, consisted of 52 patients with an entrapped right ventricular lead. General demographics of our cohort of 52 patients are shown here. I'm going to highlight a few things. The median age of our patients in our cohort was 81 years. The majority of patients were female, 63.5% were female, 48, 92% of patients had atrial fibrillation, and 40% of these cases were done on a commercial basis. 40% of patients were not in a trial. The device characteristics are shown on this slide. The most frequent indication for device implant was high-degree AV block. 21.2% of patients had a defibrillator lead entrapped. The median age of entrapped RV lead was just under nine years, and the median pacing burden was 76%. 31% of patients had an RV pacing burden of greater than 95%, and 17% of patients had a pre-procedure RV pacing burden of under 5%. The tricuspid regurgitation characteristics are shown here. I'm going to highlight a few things for this audience. One is that only 11.5% of patients had pure secondary TR that was ventricular only. 32.7% of patients had tricuspid regurgitation that was exclusively related to the RV lead. Getting to the meat of the matter here, our primary results are as follows. In 48 out of 52 cases, there were no lead-related complications. The four lead-related complications are as follows. One was immediate lead dislodgement after evoke deployment. This occurred in the second early feasibility study case at the respective institution. The lead that dislodged was a nine-year-old 5076 lead. This was managed with emergent implantation of a coronary sinus pacing lead, which has been functioning normally for the past four years. The second complication was RV lead fracture eight weeks post-evoke, leading to inappropriate shocks. The lead that was fractured was a 16-year-old 7120 lead. All anti-tachycardia therapies were disabled, and the patient underwent implantation of a leadless pacemaker for underlying complete heart block. The leadless pacemaker has been functioning normally for over a year. The third complication was RV lead fracture six weeks post-evoke. That was detected on routine monitoring. This was a six-year-old S65 lead. The transvenous ICD was deactivated, and a subcutaneous ICD was implanted. And finally, there was one patient with MSSA endocarditis one month post-evoke with a confirmed vegetation on the entrapped lead, an inability to extract that entrapped lead. The patient ultimately suffered antibiotic-induced renal injury and unfortunately passed. So there were 48 patients without lead-related complications in our cohort, and we had 46 patients who were alive on post-op day 30. All 46 of those patients had clinical follow-up greater than 30 days post-evoke, and there were no additional clinical lead-related complications through a median of 356 days of clinical follow-up. There were 33 patients of the 48 patients with no lead-related complications who had RV lead data 30 days post-evoke. And the lead parameter, the serial lead parameter data are shown here. The median duration of final follow-up is 424 days. So through that median duration of 424 days, there was no change in sensed R waves. There was a significant decrease in entrapped RV lead pacing impedance through final follow-up, and there was a significant increase in entrapped RV lead capture threshold through final follow-up. Importantly, that increase in capture threshold is not necessarily clinically significant, as no additional patients required a lead revision due to those elevated thresholds. Finally, there were four patients with new complete heart block or pacing dependency following this evoked procedure. So in summary, this is the first study to report the lead-related and associated clinical outcomes following right ventricular pacing or defibrillator lead entrapment by an evoked transcatheter tricuspid valve replacement. Fortunately, the majority of patients with entrapped leads following evoke, sorry, had baseline TR related to the device lead. And the majority of patients, this is fortunately, remained free of lead-related complications. There were four out of 52 lead-related complications, including one immediate lead dislodgement, two lead fractures, and one case of endocarditis with the inability to extract the entrapped lead. And despite a statistically significant increase in RV capture threshold and decrease in pacing impedance through one year of follow-up, there's been no further evidence of lead failure necessitating lead revision. And what we really hope is that these data start to inform future heart team discussions regarding lead management prior to transcatheter tricuspid valve therapies. Thank you all for your time and your attention, and I'm happy to take any questions. Thank you. That was a really informative talk. So we have two minutes for questions. The way to ask questions is to go into your app, go into the session, and there's a Q&A there. Actually, let me look at, I mean, I guess I'll first start off with a question. So out of the four patients, I mean, I was actually a little bit surprised that only four patients had a lead extraction prior to the implant. Do you know the circumstances, like how you chose which patients, or how the four patients were chosen to have a lead extraction while the majority weren't? Yeah, absolutely. Thanks for the question. I think that's a very timely question. What I will say is a significant pivot point for our institution has been actually putting a lead management electrophysiologist on the heart team. For a number of these cases, it was the patient's primary electrophysiologist who consulted with the structural cardiology team, the cardiac surgeons, and the imagers. But since, in the past few months, we've actually changed our practice, have put a lead management electrophysiologist on the heart team, and the rate of lead extraction has subsequently increased. Great. Okay. Thank you. I don't think we have time for any questions unless anybody in the audience would like to come up. Okay. Thank you. Great. Thank you. Great job. Our next presenter is Dr. Christian Bichard. He's going to talk about CIED fragment prevalence and sequelae following heart transplant. Welcome. Hi everyone, thank you for having me. My name is Cristian Bichard and I'm thrilled to present to you the results of our study CID fragment prevalence and sequelae following heart transplant which was done at our institution Temple University Hospital. So nowadays more and more patients are listed for heart transplant with pacemaker leads, ICD leads and CRT systems but it turns out that after heart transplants lead fragments are left behind which was quite surprising to me and it's a known fact from the literature. So the scope of our study was to assess prevalence, location, association with dwell time as well as sequelae. So just as a general recap the way a heart transplant works is that the surgeon will cut open the SVC and they will expose the leads as well as the PA catheter. They then cut the leads creating two portions, a proximal portion in the veins and a distal portion in the native heart. The native heart is then removed together with the distal portion of the leads and then the new heart is placed in the pericardial well and the surgeon then cuts open the generator pocket and they will attempt to remove the device by simple manual traction but then at times the whole thing comes out, at times it breaks, at times they are unable to pull it so they cut the lead proximally and they will retract into the venous system and at times actually we don't know because no one cares about these leads anymore so they may break, they may leave insulation fragments behind. So we designed a retrospective core study and we enrolled all consecutive patients undergoing heart transplant at our institution from 2017 to 2024 and we excluded all patients that did not have transvenous system in place and we then collected baseline demographic, clinical and lead variables. The presence of fragments was determined by post-op chest x-ray and by post-op CT chest whenever this was available. We looked for the location of fragments and we look for possible factors associated with fragment presence such as demographic like age, gender, BMI, comorbidities like diabetes and chronic kidneys and dwell time of the oldest lead. We then, in terms of sequelae, we then looked for bacteremia prevalence, which pathogens recurrence of bacteremia over time as well as deferral of clinically indicated MRI because of fragment prevalence and then we looked for DVT and fragment embolism. So this is our court, we enrolled 116 patients in our studies and at least in 24 of them, so 21%, fragments were left behind and I said at least and I'm going to tell you why in the next slide. But this is just the demographic table. A few things that I want to point out, the age did not differ across groups. Younger patients are tougher to extract but older leads, older patients may have had leads for a longer period of time. Chronic kidney disease, it was interestingly more frequent in patients without fragments but did not reach statistical significance and oldest lead dwell time was significantly higher in patients with fragments compared to without fragments. And just as a quick recap from the literature, there have been a few very small studies which looked for factors associated with lead fragments and the only factor associated was dwell time, so this comes to no surprise. And usually seeing fragments is pretty easy on chest x-ray, there are radiopaque bodies in the venous systems. But what about the hidden fragments? So here you can see a chest x-ray and I want you to focus on the yellow circle and as you can see, there is nothing. But then this patient got a CT chest and interestingly you can see a fragment here which is an insulation fragment and that occurred in 5 out of the 24 patients with fragments. And even more interestingly, a CT chest is not done routinely after heart transplant and in fact of the 92 patients without fragments, one third of them had no CT chest done. So we actually do not know the exact prevalence of fragments, it's probably underreported the prevalence. And literature has not studied fragment prevalence with CT chest, just with chest x-ray and CT chest is the most sensitive test for detection of fragments. In terms of medium fragment dwell time, it was 10 years but very interestingly the youngest fragment was just three and a half years old. And for every five years of lead dwell time, the risk of leaving a fragment behind doubled. We also looked for other factors but none of them was significantly associated with lead fragment prevalence such as age, gender, chronic kidney disease, diabetes, BMI and age was not associated even after we corrected for lead dwell time. On the right, I want to show instead the distribution of the fragments. So the most common site was the innominate vein site, 75% of them. Half of them were in the superior vena cava and 40% in the subclavian. Here just to show you the infectious sequelae, so of the patients with fragments, bacteremia occurred in one third of them, so eight patients out of 24. And six patients had gram positive yeast infection and five patients had gram negative infection. And of the gram positive, two of them was staph aureus. Shown differently, what I want to point out is that bacteremia was as common, if not more common, in patients with fragments compared to patients without fragments. This did not reach statistical significance but again we don't know the exact prevalence of fragments, so we actually don't know if in patients without fragments, if they actually did not have a fragment in place, had they got a CT chest. So it may actually be that patients in this group without fragments had bacteremia and they had fragment underlying. And what I also want to point out is that gram negative bacteremia was significantly more frequent in patients with fragments compared to patients without fragments. Now I know I'm talking to a room full of ET people, so deferring an MRI for presence of lead fragments makes no sense, but that happened. And it happened in five out of 24 patients who actually needed that MRI, but that was deferred. And there was no DVT, no fragment embolism in our study. So to conclude, 21, at least 21 percent of post-heart transplant patients had fragments and usually in the innominate vein. However, the prevalence is possibly underestimated because not all of them had a CT chest done and we show that certain fragments are visible on CT chest only, not on chest x-ray. Longer lead dwell time is associated with increased risk of fragment retention, but again we had a fragment which was just three years old, so pretty young. And to conclude, our protocol for periop lead management. We suggest that EP remains involved perioperatively. EP will actually comment whether it's a better idea to try and open the generator pocket and attempt to pull, but to stop in case there's any resistance, or just to leave the pocket closed, leave the leads there, and then decide later on whether to leave the leads indefinitely or to do a planned extraction later. But what's important is to never ever ever cut the leads in the pocket because then what if this patient becomes bacteremic, and we know the treatment of bacteremia is device removal in its entirety, but we cannot remove those leads once they are cut, and the only way would be to do an open heart, a reduced serenotopy, and that is not feasible in a big, in majority of cases. Thank you very much. I'm happy to take any questions. Wow, 21 percent patients with infection, and so this is a big problem. This is a great study. So the first question is, were there any patients with fragments who had recurrent bacteremia thought secondary to the retained fragments? Yes, thank you for the question. Yes, there were. I did not show the results here, but actually, first of all, fragment presence increases also the risk of recurrent bacteremia. So bacteremia to be treated requires source control, and if we're not, majority of cases these fragments are not, we are not able to extract them, so we're not able to achieve good source control, and also literature has shown that a lot of this pathogen creates biofilm, and the only way to eliminate that is by removing the fragment itself. So yeah, it was presence of fragments significantly predisposed to recurrent bacteremia, and it's a big issue because these patients are immunosuppressed because of their heart transplant, so it's very tough to manage at that point. Yeah, these are all very good, important points. So based on your findings, would you change the protocol, the multidisciplinary protocol ahead of a transplant in any way? Yeah, great question. So I think the big reasoning behind this is that we know that lead-12 time, for instance, predisposes to lead fragment. Another thing that predisposes, we didn't show it here, is, for instance, presence of dual-coil ICDs because they tend to break, particularly the proximal coil. So if we know that a lead is prone to break, we may not suggest even attempting the removal by manual traction with a surgeon. What we may suggest instead is cut the leads at the SVC site, remove the native heart, and then patients can, for instance, come back later for a planned extraction later with EP technique to remove the lead in its entirety, reducing the risk of lead breakage at that point. Okay, great. Yeah, at UC San Diego, we actually have our surgeons do a laser lead extraction at the time of the transplant. We're very fortunate that our surgeons are part of our extraction team, and they're comfortable using our tools. And so, you know, that's just something that future work needs to see if that would improve outcomes with disinfection. But thank you. All right, so we're right on schedule. Our next talk is Dr. Susunis, and he's talking about safety of abandoned leads in patients implanted with the subcuICD following transvenous ICD extraction. Insights from the French SICD nationwide cohort called Honest. So, thank you for the introduction, and thank you for having me here. I would like to say that this is a great honor to present on behalf of all the investigators of the Honest cohort our results on patients implanted with subcutaneous ICD who had the previous transvenous ICD system and abandoned leads. I have nothing to disclose. We all know that the weakest part of a transvenous ICD system is the ICD lead itself, which predisposes patients to complicate a series of complications such as infections, lead fracture, dislodgement, and various vascular complications. The subcutaneous ICD has received a 2A indication both in the American and the European guidelines and should be considered in order to avoid the complications related to transvenous ICDs when antibradycardia pacing, resynchronization, or anti-tachycardia pacing is not needed nor anticipated. As such, the subcutaneous ICD could be a viable alternative for patients with transvenous ICDs who present with device-related complications, an indication which we refer to as rescue subcutaneous ICD implantation. However, this group of patients is a very heterogeneous group as transvenous leads are often abandoned in up to 40% of these patients, and while there are some concerns about abandoned leads and long-term adverse events, so far there are no data on the clinical impact for abandoned leads in patients implanted with a subcutaneous ICD. So, our objective was to evaluate the clinical outcomes of rescue subcutaneous ICD implantation in patients with abandoned and extracted leads using data from the Honest French Nationwide Subcutaneous ICD Cohort. The Honest Cohort enrolled all patients who were implanted with a subcutaneous ICD from October 2012 to December 2019 across 150 centers in France. Patient characteristics and procedural data were systematically captured at the time of subcutaneous ICD implantation, and follow-up data were retrospectively collected during the period from 2020 to 2022, when a yearly prospective follow-up was initiated. What we did was in that cohort to retrospectively identify all patients with transvenous ICD who underwent subcutaneous ICD implantation due to revised related complications. Outcomes were then compared between patients with abandoned and extracted leads, and included complications which were categorized as local complications, lead-related complications, and inappropriate shocks. Re-interventions defined as all interventional procedures that were performed to address the above complications, and mortality. Here we have an overview of the patients enrolled in the Honest Cohort. In total, 4,924 patients received a subcutaneous ICD in the 115 planting centers in France. 651 patients had the previous transvenous ICD systems and were implanted due to device-related complications, and out of them, 244 patients had abandoned leads at the time of subcutaneous ICD implantation, which is about 37 to 38 percent of their SQS ICD patients, and 407 patients had undergone complete lead extraction at the time of subcutaneous ICD implantation. These patients were followed up for a median of five and a half years. This slide shows patient characteristics at the time of subcutaneous ICD implantation, and we can readily tell that the two groups had significant differences. Patients with extracted leads were older, they were less likely to be females, they had a higher BMI, a higher incidence of diabetes, a lower left ventricular ejection fraction, a higher incidence of structural heart disease, and as expected, they were more likely to have been implanted with subcutaneous ICD due to an infective complication, and lead yield time was much shorter compared to patients with abundant leads. Moving to complications, we found no difference in the rate of complications between the two groups. With the patients having complications being 21.7% in patients with extracted leads and 24.3% in patients with abundant leads, this difference was not statistically significant. Nor did we find any difference in the prevalence of local complications, lead-related complications, and inappropriate shocks. As expected, the same was true for re-interventions. There was no difference in the total number of re-interventions between patients with extracted and patients with abundant leads, nor was there a difference in re-interventions performed for local complications, lead-related complications, and inappropriate shocks. However, when we looked to mortality, we found that patients with extracted leads had a higher mortality, which was 21.9%, compared to mortality rate of 8.6% in patients with abundant leads. And this was also true for both cardiovascular and non-cardiovascular deaths. Here we have the Kaplan-Meier estimated mortality at eight years in patients with extracted and abundant leads, and we can see that the mortality was, the predicted mortality was 29.6% for patients with extracted leads, and 11, just 11.1% in patients with abundant leads. Next, we performed multivariate analysis to adjust for potential confounders and center effects, and the valuables included in the multivariate models were AIDS, sex, BMI, diabetes, left mutatorial ejection fraction, the presence of structural heart disease, the indication for NICD, and several procedural factors, as well as the use of the smart passive filter when we were looking for inappropriate shocks and overall complications. Here we have the results of the multivariate analysis, and we can see that when adjusted for the above factors, lead management was not independently associated with mortality, nor with any other outcome. So to conclude, rescue subcuticid patients with abundant extracted leads had similar rates of complications and reinterventions in the honest cohorts. Rescue subcuticid patients with extracted leads had a higher unadjusted mortality, which was largely attributed to a higher burden of comorbidities, as in multivariate analysis, lead management was not independently associated with mortality. And taken together, our data indicate that lead abandonment in rescue subcuticid patients in the absence of an effective medication is safe, and may be a reasonable strategy to mitigate the risks associated with lead extraction procedures. I would like to take this opportunity to thank all the investigators in the Honest network for enrolling their patients in the cohort, and for providing high quality data. Our results have been accepted for publication in ZAKIP, and a pre-proof should be online by now, for those of you who are interested in more data, as well as in a comparison between rescue subcuticid and de novo subcuticid patients, and a comparison between rescue subcuticid patients with effective and non-effective indications. Thank you very much for your attention. Thank you. We have two minutes for questions. I'll start off with one of them. In the patients that got infected, it seemed like there was a trend for infections, surprisingly, in the extracted group. Do you happen to know where the infections were? Did they involve the SICD or was it somewhere outside of the heart? No, these were all local infections that were... I guess I'll have one more question is do you know what were the factors that would that the patient underwent extraction before this at the time of SICD what what would make someone extracted versus the other ones not that's that's a very very very good question thank you very much actually this was not captured in detail and in the cohort so I cannot tell you for sure what were the reasons definitely it was it was physicians preference and just make it clear we talked about patients who did not the majority of them did not present with infective indication so they will have the non-infective indication and it was it was on the operators discretion whether the previous ICD would be extracted or not So moving right along to our next presentation is with Dr. Malchev, he's going to talk about adjunctive mechanical aspiration and debulking of large vegetations during cardiac implantable electronic device extraction. All right, yes, good morning. First of all, thank you to all the organizers, thank you to all the doctors from various different centers who helped to make this happen. So yeah, and first of all, so on behalf of all the co-authors, I'd like to present our study on the adjunctive mechanical aspiration and debulking of the large vegetations during the cardiac implantable electronic device extraction. This is our disclosure. It was an investigator-initiated and funded study and was approved by the ethics committee. So first of all, as all of you know, infections of the devices is probably one of the worst things that can happen to an electrophysiologist, but unfortunately, infections of these devices are increasing disproportionately to the number of implanted devices. So for approximately 12% increase in implants, there is a 57% increase in the infections. And as all of us know, the mortality is pretty high. So if left untreated, the mortality is up to 66%. If treated with antibiotics alone, mortality is as high as 40%. And antibiotics plus extraction, mortality is still very high at almost 20%. And knowing all of that, what's pretty striking is that in people age 65 or older, the rate of extractions is only 18.6%, which kind of probably tells you that people are just afraid of this thing and probably wanna just put it away until maybe some kind of miracle happens to avoid complications with extraction. Amongst these patients with infection, there's a subgroup of patients with large lead-related vegetations. Who are even at a higher risk compared to the people with infection, but without vegetations. So these vegetations on the leads can cause embolization. So it can cause pulmonary embolization, strokes, both pre and post extraction, especially in the presence of PFO. And the vegetation doesn't have to be large to cause a stroke if there's a PFO. And this picture kind of like a quick summary of what can happen with the vegetation during the extraction. And then another problem is that you can cause a bacterial seeding during the extraction when the lead is kind of, when you pull the lead through the vessel and the vegetation just flies out and pretty much you're causing the bacterial seeding in these patients. And again, as I mentioned, so the mortality of these patients is even higher. So kind of historically, the method of extraction that was recommended was a surgical extraction. But this is associated with a very high mortality in part because it's an open heart surgery and also the patient population is gonna be sick who go for these procedures. So as we all know, the percutaneous extraction has been gaining more and more popularity in these situations, but the mortality is still pretty high at the 10, like an average 10% in the more modern studies. And sometimes regular percutaneous extraction with the vegetation can cause a pretty dramatic outcome. So this is an example of just one patient who went for an extraction, had vegetation on the leads and this was the WBC count just pre-extraction. And then the first WBC after the extraction showed a dramatic increase from 9.9 to 94 in WBC. And eventually this patient passed away from bacterial seeding. So probably this is why people have been looking for other options of how to manage these patients. And recently vegetation debulking with various devices has been gaining popularity. And in one study, it showed that the mortality can be as low as 3%. So compared to all the previous data, this is a pretty, pretty big achievement. So this has been reported with a device that's called an AngelVac device, and it requires an extracorporeal system and circulation, but this system has just its own drawbacks. So first of all, you need an extracorporeal circulation system, you need a perfusionist to be with you, you need two large axes, de-aired system, there's a lot of logistical challenges, even with a regular extraction, there are logistical challenges, but if you put another layer of, like a perfusionist team, that's another layer of, you know, how to arrange for these procedures. For this system, you need high doses of heparin, and in the study that reported that 3% mortality, the mean ACT was 379, almost 380. So as you can imagine, in a patient who's gonna go for an extraction, as soon as the debulking is done, that can be an issue. So there is a similar device, which doesn't require, doesn't need a perfusionist, and all of the things. So it's a mechanical aspiration device, without the extracorporeal circulation. So the procedure can be done just with a single operator, just a single thermal axis. The device, so the curvature of the device can go from zero to 180 degrees as needed, and then each pull of the, so each pull of the handle can aspirate 10 cc or up to 30 cc of fluid or whatever material. And the funnel will open to 30 frames size. So it's a pretty large funnel, so which can entrap and suck out whatever material is there. And this is how it would look. So the, I guess, yeah. So this is just a pre-op imaging, so with obviously vegetation, and then this is the intra-op ice imaging, so you can see the lead, you can see the vegetation, kind of on the lead, and almost blocking the valve. On the floor image, you'll see this particular case was done with ice guidance and the TE guidance, and this is how the device will look. Hopefully you can see it. So the funnel will open, and then you will maneuver the funnel to your vegetation. On ice, this is how it will look. So your funnel is pretty much in close proximity to the vegetation. And this is obviously not in the human body, but this is how it would look. So you will pull the handle, and each aspiration will, each pull on the handle will aspirate 10 or 30 cc of this material, which will then be just collected in the bag, and that's about it. And so after this is done, then you move on to the actual extraction. So just a quick summary before we go into actual results. So the infections of the devices have very high mortality. Large lead-associated vegetations can cause PE, stroke, bacterial seeding, and elevated mortality. And then the ultimate method of which method of extraction to use in these cases is not certain. So therefore, our objective in this study was to study the outcomes of percutaneous mechanical debulking of lead-associated vegetations using a manual vacuum aspiration device during the extraction. So in this study, we looked at 13 patients who underwent debulking in three different centers, and compared them to a historical cohort of patients who underwent the extraction with the vegetation, but without the debulking. And then we analyzed and compared all the device-related information, microbiology, procedure details, outcomes, including complications, including the levels of hemoglobin and the WBC count, length of stay, and mortality. Baseline characteristics were, for the most part, pretty similar between the two groups. So the two most prevalent comorbidities were hypertension and heart failure. And the most prevalent comorbidities were heart failure and heart failure. It's not surprising that most of the devices have been various types of defibrillators. Mean age of the oldest component of the device was around 5 to 6 years, but it was not different between the groups. The interesting thing was that in the group that underwent the debulking, the pre-procedure mean WBC count was significantly higher than compared to the control group. And then there was no significant difference in terms of vegetation size. So on average, the vegetations were close to 2 centimeters. And again, there was no statistically significant difference, but there was a trend towards vegetations of larger size in the debulking group. In terms of the procedures, so the laser sheath was used more often in the debulking group. Successful debulking was performed in pretty much all the patients who underwent debulking, and the diagnosis to extraction time was pretty similar between groups. And this is how the successful debulking would look. So this is the just IC image just pre-debulking, then with the one kind of like pull on the handle and one aspiration, the vegetation was gone. And then this is the kind of stuff that we would see in that little bag that, you know, that will collect all the aspirated material. So in terms of the outcomes, there were no procedure-related complications in both groups. There was no significant difference between the change in the hemoglobin and the need for the blood transfusion after the procedure. The interesting thing is that there was a significant difference between the change in the WBC count. So in the debulking group, the WBC count on average decreased by almost 8.5%. In the no debulking group, which is regular extraction, the WBC count actually increased by 21%. And then there was a trend towards faster discharge from the time of the extraction to discharge from the hospital. And there was also a trend towards different mortality. So no patients died in the debulking group, but four patients died in the control group. And just to summarize the results, so this is just a graph of the white cell count change from day to day after the procedure. And as you can see, after the debulking procedure and extraction, the W cell count pretty much just kept decreasing and decreasing and decreasing just day by day. And compared to the historical control group, so the WBC count pretty much started increasing after the procedure and kept going and plateauing maybe after a couple days, which probably means that there was like a bacterial seeding happening at the time of the extractions. There are a few limitations to the study, so this is a non, it was not randomized study, but the groups as you saw, they were relatively well balanced. The difference in the pre-procedure WBC count, if anything, it should bias against the debulking. There were no procedure-related complications, so the extraction itself shouldn't really play a role. And then it is going to be difficult to perform a truly randomized trial in this kind of patients because of the acuity and not that frequent presentation. As I said, so the laser sheath was used more frequently, but based on all the previous studies, it shouldn't really affect the mortality. We didn't have a pre- or post-procedure imaging, but there were no clinical signs of embolization, and then it's still possible, but clinically we didn't see any signs of embolization. And we didn't have a long-term follow-up, so further studies are needed for this. So in conclusion, transvenous extraction of leads with large lead-related vegetation is associated with vegetation embolization, bacterial seeding, and high mortality, and concomitant percutaneous mechanical debulking can improve outcomes in these patients. Thank you. That's a neat device. Can you steer it? Yeah. Okay. We have a couple of questions. The first one is, what is the cutoff regarding the size of the vegetation that you would rather just extract and not aspirate versus aspirate? Yeah, so I think it will change. So in our study, we used vegetation that were larger than one centimeter in diameter, but as you saw, there are studies that show even smaller vegetations, especially in the presence of PFO, they can cause a stroke and some more complications. So I would definitely say one centimeter and above for sure. Less than one centimeter probably dependent on maybe some other factors. And what was the introducer French size for the device? So the introducer, I think it's 26 French, 26 French size. And then some of the questions, I'll combine them. How does this compare to AlphaVac versus a Inari cath for PEs? So yeah, all of these procedures were performed with the AlphaVac device. So can't really say how this compares because we didn't really look at that. In general, I would say comparing AlphaVac to the AngioVac, again, this study did not compare them, but in general, with this procedure, it's a single operator. In terms of logistical issues, pretty much it's all dependent on a single operator. I would say there was maybe concern because with AngioVac, when you have a full circulation, so you're not losing any blood, so there was a concern maybe with AlphaVac because you're like aspirating blood all the time, so maybe you will lose more blood compared to the system where you kind of just will recirculate all the blood back into the patient. But in our patients, we didn't see any changes compared to just regular extraction. So I would assume there won't be any changes compared to the AngioVac. All right, thank you. That was great. Okay, we have one more presentation. This is Dr. Kogan. He's going to talk about comparative outcomes for tricuspid valve repair or replacement with concurrent or subsequent pacemaker implantation. Okay, I'm not sure what happened to the presentation version, but we'll just zoom around instead here. So thank you everyone for coming. So what we'll talk about is a project off of the National Readmissions Database of the NRDE examining the outcomes of concurrent or subsequent pacemaker implementation. And just as a bit of a description, the NRDE, so high-grade AV block and complete heart block are certainly very common after various valve repairs including tricuspid valve repair just at the proximity of the conduction tree itself. So basically using the National Readmission Database, I'll talk about essentially how that database is actually structured and works. We looked at 90-day, we looked at both what we call early mortality, so that's index and readmission mortality over a 90-day period for patients who initially had tricuspid valve replacement or tricuspid valve repair that we grouped together. You'll see the subsets in a second here. That either had pacemakers put in at the time of their original valve procedure or subsequently during the index admission. And so just to go into the methods, so the National Readmission Database is a nationwide readmission database. It's really not a true national database. It's essentially an aggregation of state databases. There are 24 state databases in the last iteration. But essentially it combines these state databases and tracks outcomes including readmissions for the calendar year. Now the reason I bring this up in part is that it meant that when we track, this is an anonymized database, so we can't track a patient across the calendar year itself. So whatever readmission outcomes we have for the calendar year, that is what we are limited to. So to get around this issue, I told you we were looking at 90-day readmissions. So we actually excluded patients who had tricuspid valve procedures in the last three months of the year to avoid the issue of having incomplete follow-up with these patients. The way we actually derived our patient cohort is we looked at, so this database is based on ICD codes, ICD-10 codes and associated PCS codes for the procedures. So we filtered about 15,000 patients over this time span who had tricuspid valve replacement and repair procedures and those who, we filtered them by those that had ICD, that had PCS codes corresponding to those procedures and subsequently PCS codes to the pacemaker procedures themselves. Now the way we can figure out whether these are concurrent or subsequent is that unlike the ICD-10 codes, for instance, that don't have date stamps, every procedure that a patient had on their index hospitalization has some associated day relative to the date of admission. And so that's how we're able to tell the time frame of concurrent versus subsequent pacemaker devices. We also looked into some of the, so we looked at the procedural outcomes as well which included cardiac perforation, pneumothorax, cardiac arrest, endocarditis, valve deployment complications. Again, those would be under, those would be couched under ICD-10 codes which we do have, which we also have in this database. However, there aren't as distinct of time stamps, but again, we're doing it for the index admission. And again, as I mentioned, we wanted three months of follow-up data based on some of the previous literature. Looking at other follow-up timetables vary between 60 or 90 days for some of the percutaneous literature. And so we mirrored, and some of the other surgical literature mirrors 90 days, so we picked a 90 day, three months of follow-up for 90 days. And again, we excluded valve procedures that did not have the full span of the follow-up data. So to go over how we got to the analysis originally, so again, our primary endpoints were the procedural complications as I mentioned, early, or what we call early mortality, which is either admission on the index procedure or any of the 90 day readmissions, and acute to compensator heart failure readmission. Now the way we could tell that readmissions were primarily for heart failure is again based on those ICD-10 codes. There are limitations to how you can do this in this kind of database, however, the methodology we chose is that if the, it had to be that they had the primary ICD-10 code associated with their readmission had to be for heart failure specifically. So if it was in the second or third or some subsequent spot, we excluded those patients, again, just to keep it as clean as possible essentially. And then we secondarily also looked at early mortality by itself, instead of combined with heart failure readmission. This was all performed in SAS, and again, these are all, all the figures are in fact weighted figures, so again, the way the NRD works is in order, in part for the anonymization and to make a nationally representative sample, technically all the encounters are essentially weighted numbers here. And then otherwise we use logistical regression to look at predictors for covariates for mortality specifically, as I'll talk about. So just go over to the table. So to start, so here we have the concurrent pacemaker readmission, so again, of the 15,000 or so patients that underwent tricuspid valve repair or replacement, there are about 124 that had concurrent pacemakers, and 289 that had subsequent pacemakers, which the first comment I'll make on this is that there's, is isolated tricuspid valve procedures are comparatively rare. I can tell you that from looking at similar data in the mitral valve or in the SAVR or mitral valve replacement cohorts as well, there are much more expansive numbers about an order of magnitude greater. But again, in the interest of keeping this as pure as possible, we excluded other valve procedures done concurrently with these tricuspids, so these are truly isolated tricuspid valve replacements and repairs with subsequent pacemakers. And so you can see there's a split here between the replacement and the repairs, so about two-thirds had replacements, about one-third had repairs, again in the absence of other valvular procedures, in terms of what actual valves they received, so about 10% in both groups, not significantly different, had mechanical valves, the rest were bioprosthetic for the, of the replacements. In the subsequent pacemaker group, the mean time to pacemaker implant was 6.6 days. And then in terms of the leads that were used, so as you might imagine, these are, these are replacement, these are open cases, so there were a significant fraction of these, of these groups that had epicardial leads as their lead type. Again, these are data you can get from the NRD based on the procedure codes specifically, so about 66% of patients in the concurrent pacemaker group had epicardial leads and 80, 88% in the subsequent pacemaker implant had leads, and there was some relatively greater proportion in the subsequent pacemaker leads. And then similarly, there was a small fraction with leadless pacemakers, there were about 6% that had coronary sinus leads, so as you might imagine, one of the ways to get around the problem of putting leads durably through a tricuspid valve, a tricuspid valve replacement, would be to go into the CS. And interestingly, this was actually compared, this was comparatively rare in both of these groups, whether it was on the day of the procedure or, or subsequently on the admission, and then there were more open lead classifications. Another caveat about the NRD that I will make in general is that there are certain catch-all codes that are, that are sort of not otherwise specified, which we did specifically, did not for any category of device or ICD diagnosis, we specifically excluded all of those, again, to keep, keep things as clean as possible. And then for the other patient characteristics, you can see that, that by and large the baseline characteristics are similar across these populations. The only relevant difference is there were slightly more women in the subsequent pacemaker implants, 64% versus 50% of the subsequent implants. And then the other interesting point, so we did look at, we did allow concurrent CABG procedures, which were relatively small proportions, about nine to seven percent, and interestingly, so you might posit that there may be some difference in these groups by their underlying conduction disease, pre, prior to these tricuspid valve replacements, and there's no difference between any, any variety of block. We didn't include complete heart block, because presumably if they had had complete heart block, they already would have had a device, as opposed to getting one implanted post-operatively. So to go over the figures themselves, so first, just looking at the trends in, in implantation and complications, so here from 2016 to 2020, we have two lines, so one is the rate of permanent pacemaker implantation, which is fair, which is in general fairly similar across the, across this, this time span, and again, we exclude the last three months, which is why you don't see any December 1st dates here in the time axis, but no, but no significant change in the rate of permanent pacemaker implantation. Reassuringly, there's no change in mortality over this time span either, whether it's index or readmission mortality, that's combined outcome here. And so to get the main result here, so for the next figure, so we're looking at the concurrent pacemaker versus subsequent pacemaker complication rate, so there's no difference in the procedural complications between these two cohorts, there's no difference in the total in either all-cause readmissions for these patients at 90 days, or they were actually zero heart, primarily acute heart failure readmissions. There was, however, difference in early mortality, so the, and this is primarily driven by index procedure mortality, so this is about 7.1 percent in the concurrent group versus about 0.9 percent in the subsequent pacemaker group. Let me see, and then we also charted the overall time to permanent pacemaker implantation, we'll zoom in a little bit more here, so what you can see in the, in the red are the concurrent devices, and in orange the subsequent devices, but the broad strokes are that you have relative, or you have relatively the same time frame to implantation for the subsequent devices, I'm sorry, so the orange are for the tricuspid valve repairs, the red are for the tricuspid valve replacement, these are all subsequent pacemaker implantations, and the time frame is relatively the same between these two, there's no significant difference, it's about six days, it's 4.6 days for the replacements, and about two days or so for the, for the repairs, that actually is the difference here, and about half of the devices overall for both were implanted after about five days, and so we looked at predictors of early mortality in this case as well, or combined early mortality and heart failure, which is really just mortality, and we see that not surprisingly, at least with these other results that we have, so concurrent pacemaker implantation is a higher risk, portends a higher risk of early mortality, again driven by index mortality, epicardioleads seem to be negatively associated with this actually here, and then preceding renal disease or CABG, the interesting thing about the CABG association is mechanistically, other than adhesions and other issues, the conduction relevance of needing a pacemaker I would think might be, perhaps could be related to their underlying conduction disease, but again we, as I showed you in the baseline characteristic, there's no difference in underlying conduction disease between these two cohorts, so in summary, so we found that there were higher rates of permanent pacemaker in tricuspid valve repair versus replacement, so about 21% versus 6%, there were similar rates of concurrent pacemaker, these are subsequent pacemakers, so similar rates of concurrent pacemaker use, there is a significant difference between the time to implantation, so it's about five days versus two days for the repairs versus the replacement, and then we do see this difference in mortality in the concurrent pacemaker procedures as opposed to the subsequent ones, again about 7% to 0.9%, and with that I'm happy to take any questions. Great, thank you, that was a good study, I'll just have one question, we're running out of time, so did you see anybody with a transvenous lead through the tricuspid valve repair or replacement? Right, so I didn't highlight that explicitly in this table, but what you do see is that although the bulk of these are in fact epicardial leads, so we specifically, there should be about 20 or so percent and about 10% in the concurrent pacemaker implantation, about 10% for the subsequent pacemaker implantation, essentially I'm just adding up the pre-specified leadless devices, epicardial devices, and coronary sinus, and certainly the coronary sinus leads would also be transvenous devices, so relatively less common with respect to epicardial leads, perhaps unsurprisingly, but we do actually see it in this cohort as well. Great, thank you, all right, well that wraps it up, thanks everybody, enjoy the rest of your time in San Diego.

cardiac device management

tricuspid valve interventions

lead management

cardiac implantable electronic devices

right ventricular pacing

lead entrapment

retained lead fragments

subcutaneous ICD

pacemaker implantation

device extraction techniques