All right, well, good morning, everyone. I'm Kevin Heist. I'm going to chair this session on leadless pacing. For those of you using headphones, it's the purple color. And for those of you who can hear in person, you don't have to have headphones on. We'll ask all of the speakers to speak into the microphone so those with headphones can hear. These will be 10-minute presentations, two minutes for questions. There's not an online question. You have to raise your hand and ask. So our first speaker coming to us from Japan is Naruya Ishize, talking about a novel risk score for predicting difficulty in leadless pacemaker implantation. Thank you, Chairman. I'm honored to be here. So I'm Naruya Ishize from Kitasato University in Japan. So I would like to talk about a novel risk score for predicting difficulty in leadless pacemaker implantation. So leadless pacemaker, MICRA, is one of the established pacing tools. The leadless pacemaker was associated with a lower rate of reintervention and a lower rate of chronic complication compared to with a transvenous pacemaker. In contrast, complications associated with a leadless pacemaker procedure, including pericardial effusion and myocardial injury, were sometimes life-threatening. Higher rates of in-hospital mortality and acute phase complications have been reported following a leadless pacemaker implantation compared to a transvenous pacemaker. So sometimes we experience a challenging case for like this. It is important for safety and effectiveness while minimizing the risk of complication for leadless pacemaker implantation. However, procedural assessment in predicting a procedure difficulty remains unclear. Therefore, this study aimed to identify factors contributing to difficulty of MICRA implantation, focusing on anatomical features on the pre-procedural CT imaging data. This study focused on the difficulty for the MICRA implantation. So this study, difficulty for MICRA implantation defined as a procedure time over the 45 minutes and more than three times deployment attempts. This study design was a single-center retrospective analysis, including patients who underwent the MICRA implantation between the 2018 to 2024. We excluded the patient without procedural CT imaging data. The patients were divided into two groups, in the difficult group and the easy group. So we evaluated the distance and angle between the anatomical points, which were related to passing through the MICRA delivery catheter like this. This slide shows a measurement made in the CT imaging data. RV septum angle were measured at the level of the coronary sinus ostium like this. Right atrium and the right ventricular sides were measured at the level of the 4 chamber view. Tricuspid annulus angle and tricuspid IVC angle were measured at the level of RAO. And IVC to tricuspid valve distance were measured at the level of the lateral view like this. We compare the baseline characteristics. Let me show the result. In demographic data and underlying disease, there are no differences in the two groups. Severe TR was frequently seen in the difficult group. In CT imaging data, RV septum angle did not differ between the two groups. But tricuspid valve to IVC distance was shorter in difficult group. And tricuspid annulus angle was wider in difficult group. Additionally, tricuspid valve to IVC angle was narrower in difficult group. In terms of complication, there are no differences between the two groups. So RV septum angle did not differ between the two groups. But the RV septum angle exhibited a distinctive characteristic. In easy group, RV septum angle are more tightly clustered around the mid-range. In contrast, in difficult group showed a broader and more variable distribution with a possible bimodal pattern. This suggests that more acute or obtuse RV septum angle may be associated with greater procedure difficulty. We performed a multi-logistic regression analysis based on these results. Right atrial enlargement and acute or obtuse RV septum angle and a narrower IVC to tricuspid valve angle and a shorter IVC to tricuspid distance, these factors were associated with the difficulty of the microimplantation. We evaluated the difficulty scoring of the microimplantation. The factor with a significantly higher rate in multivalent rate analysis was set at one point. If these factors present, one point was added for each. Difficulty score was calculated from the total number of the points. As you can see, as the score increases, the probability of a difficulty procedure rate significantly. Specifically, a score of 3 or higher is associated with a sharp increase in procedure difficulty. ROC curve illustrated the predictive accuracy of the difficulty scores. Cut-off value was set at a three-point AUC with AUC of 0.91. Previous study reported the operator experience and septum marginal trabeculation in right ventricle and right heart dilatation in echogram. These factors are associated with the procedure time. However, as well as known, there are few reports on the multi-phase evaluation such present study. How this study can benefit both patients and operators? Perioperative recidivification to assess procedure difficulty can help instruction of the optimal device and optimal approach site. It may be possible to extract suitable cases for the less experienced operators. This study has several limitations. The study population was small. We didn't evaluate the operator bias. There were no criteria clearly defined criteria for device selection. The device selection was made selection bias. We couldn't validate the scoring results in prospective study. Further study are needed to evaluate the impact the scoring results can have. In conclusion, right atrial enlargement and acute or obtuse IV septum angle, acute IVC entrance angle, and narrow IVC to tricuspid valve distance and severe TR are significant predictors of challenge microimplantation. The proposed difficulty score could help to identify the right device. Scores could help to identify patients at high risk of procedure difficulty, thereby more than effective planning and better outcomes. Thank you very much for your attention. So open for questions and we'll repeat each question into the microphone. So feel free to raise your hand. I may just start you off with one question, which is what was the definition of an easy or difficult implantation? Was that objective? Were there certain criteria for what you call difficult or easy? So most important factor is the IV septum angle. Because odds ratio is the highest. Let me restate the question. What made an implant difficult or easy? Not what predicted it, but was it time of implant? Was it the operator saying, boy, that was really hard? You know, what defined what you call the difficult implant? So a longer procedure time and more than the three time attempts. So just to repeat the question, was height and weight a variable? And then by position on the table, what do you mean? OK, and so did height and weight of the patient matter? And position, like arm position of the patient, things like that. Arm position is a 40 degrees. And so we usually optimal angle. So for this, based on the CT, replaces our CT imaging data. It's correct. Yes? I think the question is, at some points, did tissue get on the end of the micro that made the implant more difficult? Yeah, so maybe so. So more frequent attempts is difficult for the implantation factors. Right, OK. Was it ever the case that the device was brought out to see if there was tissue on the end of it? So we checked the tissue. So more frequently attempt cases, we checked the tissue and flashed the catheter. And I think we're at time, but we'll ask, if possible, the speakers to stay around to perhaps answer questions in person. So thank you very much. Thank you very much. And then next, we have Lydia Messelet talking on outcomes of leadless pacemaker implantation. I'm going to have to get the rest of your title here. In the United States, based on race, ethnicity. So, and you're off. Thank you so much, Dr. Heiss. It's more important to know what sort of person has a disease than to know what sort of disease a person has. My name is Lydia Afkaru Messelet. I'm a first-year cardiology fellow at University of California, Davis, and today, I'll be presenting to you our findings on outcomes of leadless pacemaker in the United States based on race and ethnicity. And before I go, I have to remind you to scan this for polling and questions for participation. Thank you. We have come such a long way. From the first pacemaker implantation on October 8, 1958, and a 43-year-old man who was having syncopal episodes and was later found to have complete heart block, whose medical management at that time included caffeine, digoxin, and whiskey, to 1960, when we had a fully implantable pacemaker powered by five mercury batteries came along, and to 2010, when rate-adaptive sensing, remote monitoring, and interrogation were developed. And 2016, the latest advancement, leadless pacemakers were FDA-approved. For our study, we looked at which groups in the United States were receiving these pacemakers and what their outcomes were. For that, we accessed the National Inpatient Sample Database, which is a publicly available database of all hospitalizations in the United States, including discharges, excluding the VA, from 2016 to 2020, and there were 29,000 leadless pacemaker implantations. We stratified patients into previously studied racial and ethnic subgroups of Black individuals, Hispanic individuals, white individuals, and individuals from other races. And we looked at baseline characteristics and assessed outcomes. In addition to the 29 Alex Hauser comorbidities, we adjusted for age, sex, Chagvas score, and median income. By using multivariate logistic regression, we calculated the odds ratio for mortality, major complications, length of stay, and cost. Our first finding, 74% of the leadless pacemaker implantations occurred in white individuals, 10% in Black individuals, 7% in Hispanic individuals, and 9% in individuals from other races. For audience participation, which of the following do you believe to be true to account for the difference we just saw? There is a biologic or genetic factor that accounts for lower incidence of conditions that would warrant pacemaker implantation, such as atrial fibrillation in non-white patients. Differences are due to disparities in diagnosis and management, or this is an accurate reflection of the United States demographics, A and B, or you will defer review of such topic to a different time. Thank you for your attention. We will discuss them later. Continuing with our results, for inpatient mortality, compared to white individuals who are used as a reference, all the subgroups had higher odds ratio of inpatient mortality, around 25%. Major complications, which were pericardial effusions requiring interventions, and vascular complications, were almost twice as much and higher odds in black individuals compared to white individuals, 35% higher odds in Hispanic individuals, and 21% in individuals from other races. Length of stay greater than six days was also higher in the subgroups, 68% in black individuals, 17% in Hispanic individuals, and 27% in individuals from other races. Median cost, which is a reflection of the factors we looked at, was also high in all the subgroups, 39% in black individuals, 34% in Hispanic individuals, and 53% in individuals from other races. According to the United States 2020 Census, white individuals make up 57% of the United States population, Hispanic and Latino individuals make up 20%, black and Asian individuals each make up 12%, 4% is composed of two or more mixed races, and the rest of the United States is made of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander. Summarizing and reframing our study, there are groups of individuals with one group having fewer people going to the hospital to undergo the same procedure but having higher rates of complications. Possible reasons include hospital allocation, hospital type and the support involved, post-procedure monitoring, biases that can be implicit or explicit, including racism, that can be structural as well, that in turn affect symptom recognition. Differences across arrhythmia care based on race actually has been recognized. According to analysis of landmark trials and registry studies, there was a difference between white individuals and minorities, specifically studied black individuals, in this case shown in gray. There was a difference in enrollment for clinical trials in white individuals compared to black individuals for rhythm control, for direct or anticoagulant usage, left HL appendage occlusion devices, and highlighted in yellow are actually registry trials showing lower number of black patients undergoing these procedures as you see here. Medical mistrust plays a huge role. According to the 2019 Survivors and End-of-Life Survey, out of 2000 Californians who were surveyed, which were composed of Hispanic, black, and white individuals, 73% black patients had higher odds of saying they had mistrust, and Hispanic individuals had 50% higher odds of medical mistrust compared to white individuals. So where is our role? As we know, the social determinants of health, which include health care access, education, environment, all have direct impacts on our patients, and we as health care providers are effects modifiers. For example, the use of patient navigators was shown to increase procedure utilizations in minorities, specifically in this case colonoscopy. In this very small study of 21 patients, we found that the use of patient navigators was shown to increase procedure utilizations in minorities, specifically in this case, colonoscopy. In this very small study of 21 patients, 80% below the poverty line, 70% Hispanic patients who were randomized to having patient navigators, which were culturally aware workers providing resources, shown in blue, patients who were navigated completed the procedure, more than 50% of them, compared to yellow who were not navigated, 60% of the patients who did not have patient navigators refused the procedure, compared to around 20% who had patient navigators, twice as much patients in the patient navigator group had proper rescheduling, and none of the patients who had patient navigators had an unplanned no-show. Even though this is done in a small study, that's the non-invasive screening test, the message is translatable. Participation, I apologize, the poll isn't working. So there have been publications showing differences, for example, smaller left atrial size in black individuals by around 2 millimeters, and a genotype difference conferring higher risk of atrial fibrillation in white individuals, though these differences seem to be out of proportion to the underutilization, so there's likely an underlying disparity in diagnosis and management. Our study does have limitations. This is from a single hospital stay, and not all the mortality and complications may not be due to leadless pacemaker implantation, and data is not equipped to explain the reasons behind these findings, and as we know, the sample does not identify all the ethnic and racial groups in the United States. In conclusion, we have a long way to go. Despite major advances in the field of pacemakers, there's a gap in the delivery of care. Only 26% of leadless pacemakers occurred in non-white individuals, and even with that, complication rates were higher in these minority groups. Our study is not designed to address the difference in outcomes, but we believe disparity plays a role, and as individuals in healthcare, we all are effect modifiers. And with that, I thank you sincerely. Thank you. Wonderful talk, open for questions and again repeat any question into the microphone. I can repeat the question and our participant, thank you, from France is saying he does implant these needless pacemakers and the biggest question we should look at is if money plays a role in these differences and I do agree. So as you know this is just from all the hospitals in the United States just like a kind of a mixed bag and you're right, addressing this part, one of those five social determinants of health is that. So that would be a very good future direction, thank you. Other questions? I may ask one more. Have you looked at the age breakdown by race or ethnicity? Are they similar age profiles or are there races or ethnicities younger or older than the sort of index white population that might explain some of the differences? I don't have to repeat the question. I think everyone heard, yeah, thank you, no, that's a good question. Everyone we looked at was above age 18, so we have not looked at the breakdown, but that may explain, you know, what other underlying things that we did not adjust, that did not pass the adjustment by the 29 Alex Hauser and the ones we looked for. So that's also something to be looked at. Thank you. Thank you so much for a great presentation, again, if you could stay around to answer others. All right, let me click out of here. And then is Christopher Gerwag here? Yes, all right. So our next speaker is Christopher Gerwag, speaking on a leadless ventricular pacemaker providing AV synchronous pacing in real-world setting, updated results from the micro-AV post-approval registry. Take it away. Good morning, dear chairman, dear ladies and gentlemen, dear colleagues. I'm Christopher Gerwag from the University Hospital of Leuven in Belgium, and I'm pleased on behalf of the co-investigator of the post-approval registry to give an update on the results of the registry. So as we all know, first generation of leadless pacemaker, in particular, micro-VR, is able to reduce and to eliminate the risk of complication related to the presence of a subcutaneous generator onto a transvenous lead. The only problem is that the first generation of micro-VR was only able to deliver a synchronous ventricular pacing. Second generation of device called micro-EV were built to promote atrial ventricular synchrony thanks to atrial mechanical sensing of the atrial mechanical activity. Up to now, we have no data on the long-term performance of micro-EV in the real-world setting. The micro-EV post-approval registry was a study to assess the efficacy and safety of the device in a real-world setting following the clinical approval in 2020. It's a prospective multisensory single-arm real-world registry. All patients who were implanted with micro-EV could be implanted in the registry. In this interim analysis, we will characterize the major complication and system revision rate at three years. We will compare these both rates with a group of patients who were implanted with a conventional dual-chamber pacemaker, and finally, we will summarize the device performance. Note that the full follow-up of the study was maximum at three years. The study of the registry included 801 patients in 97 sites worldwide, meaning that more than 150 physicians implanted at least two micro-EV, and we have now a mean follow-up of 26 months. As you see on the slide, the implant success rate of micro-EV is still very high, as 99.4% of the device was successfully implanted. Let's have a look to the patient demographic. It's interesting to note that patients with micro-EV were quite older than the patient with the conventional dual-pacing system. Nevertheless, there were less atrial fibrillation and less coronary artery disease. It's also interesting to note that patients with micro-EV had a higher risk for device infection, as patients with micro-EV had more diabetes and more renal dysfunction. Finally, a third of the patients who were implanted with micro-EV were considered to be precluded for the implant procedure of a conventional device. What about the pacing indication? As expected, majority of the patients, 55% of the patients, had any disturbance of the EV conduction. It's nevertheless interesting to note that 13% of the patients had sinus node dysfunction, and almost 40% were implanted with a pacing indication as body arrhythmia with atrial fibrillation, meaning that 26% of the patients who were implanted with micro-EV were not considered to be as a primary indication for implantation of a VDD pacing system. Let's have a look to the major complication. The major complication at one month post-implant procedure was 3.1%. It rise a little bit up to 4.9% at three years follow-up, meaning that we have the majority of the major complication that occurred within the first months. It's interesting to note that the majority of complication that arose within the longer term follow-up were associated to pacing issue, the occurrence of ventricular arrhythmia, and eight patients developed pacemaker syndrome. When compared with the population who was implanted with a conventional dual chamber pacing system, it means that we have a risk reduction of 52% for major complication at three years follow-up. Let's have a look to the system revision. The rate of system revision in micro-EV population was low at 4.4%, so clearly lower than in population with a conventional system, 54% risk reduction. The reduction in system revision was largely due to the absence of acute revision of lead dislodgements. It's also important to note that in this extra registry on micro-EV, we have still no report of micro-infections. Let's have a look into more details, the system revision. A total of 31 patients had a system revision. In the majority of the case, 24%, the micro was turned off and was let in place. Nevertheless, it's feasible to retrieve micro if the physician decide to do. Seven micro were successfully implanted from the first day following the implant procedure to a maximal follow-up of two years. No major complication were associated with extraction of the device. Also important to note, when you look to the reason of system revision, we have only 1% of the total population with a system revision due to the occurrence of pacemaker syndrome. Let's have a look to the performance of the micro-EV. It's important to note that this slide is only based on 380 patients with at least a device interrogation at six months follow-up. Of these 380 patients, 82%, meaning 240 patients, were programmed in a VDD mode. It's interesting to note that 10% of the population had never been programmed to a VDD mode, and then during the follow-up, about 8% of the population had a mode switch from VDD to VVI. The registry doesn't give the reason for the mode switch. On the slide, you can see that thanks to the presence of the AV conduction mode, we have high AV synchrony in patients with, for example, paroxysmal AV block who do not need a high ventricular passing rate, and so we can avoid the unneeded ventricular passing. In patients with high degree of V block, meaning patients with more than 90% ventricular passing, the median AV synchrony index was 77%. It's about the same that the data that we had in DAX cell EV without any improvement of the programming. To conclude, the micro-EVDD-less pacemaker was implanted with a high rate of success and is still associated with a low rate of major complication at three-year follow-up with a 52% risk reduction of major complication. The system revision is slow at three-year follow-up and specifically 54% less revision than in patients who should be implanted with a dual chamber pacemaker. This interim data suggests that micro-EVDD is a safe and effective single lead-less device solution for patients with any kind of AV conduction without any need for atrial passing. I thank you for your attention. We're open to questions, and again, if you could repeat the questions that are asked. I may start you with one, then. Along the way, the company revised the AV synchrony algorithm and frankly improved it. Does your registry include people before and after those modifications, and any analysis then of one versus the other? It's a very important question. Indeed, this registry is based on the first generation of micro-EVDD, meaning that we have no data in real-world setting on micro-EVDD2 with any improved setting for AV synchrony. Very good. Other questions? All right. Well, thank you so much, and again, to the extent you're able, hang around for questions from the audience. Thank you for your attention. Thank you. And next, we have James Ip, speaking on chronic retrieval outcomes for an atrial lead-less pacemaker. You can just hit start. Yeah, sure. Thank you, Dr. Heist, and thank you, all of you, for joining me this morning. OK, great. On behalf of my co-authors, it is my honor to share with you the results of our chronic retrieval outcomes of an atrial lead-less pacemaker. My name is James Ip from Weill Cornell Medicine. I am a consultant on the steering committee and have speaking fees from Abbott, who is the sponsor for the AVIR-DR trial. The advantages of lead-less pacemakers is clear. There is no risk of fracture. There is reduced infection risk. No vascular problems. No mobility restrictions or pocket issues. And there are low rates of acute and long-term complications with lead-less pacemakers, despite the higher comorbidities in this population receiving them. As Dr. Garwick showed, the incidence of pacing-induced cardiomyopathy is quite low. The majority of pacemakers implanted are for sinus node dysfunction. And through multiple studies in the last 30 years, we can see that the rate of progression to AV plaque in patients who have received pacemakers for sinus node dysfunction is quite low. The transition from AAI pacing to DDD pacing ranges from 0 to 1.7% per year. Of course, this may vary according to the age of patients studied and the years of follow-up, but you can see that it is quite low. So perhaps it may be interesting going forward that the number of atrial-only lead-less pacers will increase. The Helix fixation lead-less pacemaker has been designed to be retrieved acutely as well as long-term with a dedicated retrieval catheter, as you can see here. It has a triple-loop snare that is used to grab the back end of the device. And it was evaluated, this as well as the first-generation retrieval catheter, was evaluated through the first-generation Helix fixation pacemaker, the NanoStim device. This was recently published in JAK, the experience of 234 attempts. There was a success rate of 87.6%, and this was regardless of the implant duration or the operator experience. You can see operators that had no prior experience were just as successful as those who had retrieved more than one. Methods for Helix fixation lead-less pacemaker retrieval have been published previously, including the conventional reverse-orientation free-floating and using a superior approach through the right IJ vein. Occasionally, an assist snare can be helpful in retrieving these devices. And since we, although we have experience with ventricular lead-less pacemaker retrieval over up to nine years at this point, the question is whether or not atrial lead-less pacemakers, which have become more popular, how can they be retrieved long-term? We wanted to look at the 480 patients that were implanted with an atrial lead-less pacemaker in the AVIR-DR study. Only chronic retrieval attempts that took place after 365 days were included. We evaluated the chronic revision data that occurred after study participation concluded and submitted by the investigators upon request, and all of these days were included in this case series. In total, 10 patients were included that had chronic more than one year of atrial lead-less pacemaker dwell time across eight operators at eight sites in the United States, Canada, and Europe, average age being 70, ranging from 44 to 89 years old, and most of these patients being male with sinus node dysfunction. The indications for retrieval are shown on this slide. Out of the 10 patients, six of them were retrieved because of low battery. Four patients had a medical condition change, two of which developed worsening development of heart failure or pacing-induced cardiomyopathy. To put that in perspective, that is two out of 480 patients, so it's 0.4%. And so the rate of pacing-induced cardiomyopathy was quite low. One patient had thrombus lodged on the atrial LP, resistant to anticoagulation therapy, so an investigator retrieved a device for that, and one patient developed tricuspid regurgitation. Four patients were pacemaker-dependent. There are various degrees of AV block and sinus node dysfunction in this cohort. And here are the—of the six patients who had retrievals for low battery are included on this slide. Compared to the medium settings across the DR population of 302 patients, these patients that had a low battery were set at quite high values. You can see that the pacing amplitude on average is 1.25 in the study. These were almost three times that, the pulse width being more than twice that, and with a high burden of atrial pacing leading to the early battery depletion. The retrieval results are shown in this slide. Out of the 10 patients that were retrieved, the medium dwell time was 24 months, ranging from 13 to 31 months. There was 100% retrieval success, all of them using the retrieval catheter. Retrieval time took about 12 minutes on average. The ventricular device was left in place in six out of patients. Three of them were retrieved, and one patient was left in situ. There were no adverse events. Importantly, no pericardial fusions or dislodgements during the retrieval procedure. Out of the four patients that were revised because of a medical condition change, two of them received a transvenous device, two received a CRT device. And of the six patients that had a replacement atrial LP, two of them were replaced in the same position along the right atrial base— base of the right atrial appendage. Four of them were placed in a different location. Of the ones that were placed in the same location, both of the thresholds with the new device in the same location were quite good at 1 volt at 0.4 and 0.8 milliseconds respectively. And the ones that were placed in a different location also had acceptable thresholds. You can see on this chart that prior to retrieval, the capture thresholds were high, which is why the programmed outputs were high. But with the new device, the electrical parameters were quite good at 0.7 volts. And with similar sensing and impedance values. Here is a video of an atrial leadless pacemaker that was extracted in this series. This was a case that was also published previously. But you can see using the retrieval catheter, the back end of the device is snared with this triple loop snare. Following snaring of the device, I recommend that if your operators are extracting these devices, that you do a short tether mode to get closer to the device, but not fully dock the device, because there has been a case report published of tissue inadvertently being snared. So I recommend advancing the protective sleeve over that mating point prior to fully docking the pacemaker into the docking cap of the retrieval catheter as shown here. Once the protective sleeve is over, the device preventing inadvertent catch snaring or trapping of tissue, the device is fully docked within the retrieval catheter. The device is then unscrewed through the myocardium at least three full revolutions and the retrieval procedure is complete. So once you see the retrieval process is quite quick. This was a patient who was retrieved after twenty months. I had the privilege of observing a post-mortem examination of a patient I implanted in the DRID study who had passed away fifteen months after the initial implant. As you can see there's very little tissue encapsulation over the device. Say less than ten percent in the A, less than thirty percent in the B. Based on the composition of the device and the parylene coating, the encapsulation is not that high especially after fifteen months, enabling the successful retrieval if needed. So in conclusion, sinus node dysfunction is a common indication for pacemaker implantation. The utilization of atrial leadless pacemakers will increase with time and this particular case series wanted to evaluate the greater than one year post-implant retrieval, demonstrating one hundred percent success without any procedural complications. And the implantation of a replacement device in the same location or a different location is quite feasible with adequate electrical performance and was actually better in this case series. Thank you very much for your attention. Great talk James. We'll open this up for questions. Maybe I'll start you with one. For someone who doesn't extract leadless pacemakers or frankly doesn't extract anything else and doesn't have a colleague to help them, how do you recommend starting if someone wants to start down this path and start extracting these devices? Yeah, I would say as part of the Abbott has derived a simulator and it's definitely before your first retrieval, get used to the knobs and practice on the simulator. It's quite portable and so personnel can help train that and then perhaps talking to other physicians who have experience. I've published a few papers out there describing retrieval techniques with videos as well. I think those are important to think about. But once the first one is done, I think that the next one becomes much easier. Other questions from the audience? And if you could just repeat the question. These are all done in the same procedure, so they're retrieved and then replaced in the same spot. As I said, two locations with identical locations. That's often a question, well can I implant the device in the same location? Is there too much scar or capsule or tissue there? But clearly it was fine in these two cases. Four operators decided to plant somewhere else and that was also fine. For replacements, this is going to come up in the future and I think this helps, although it's small numbers, it helps give us an idea that it's going to be practical for these patients that need generator changes. You may have to be loud. So the question is, am I doing these extractions in the lab or in the hybrid OR with CT surgery? I actually think it's much safer. I do them in the EP lab because I'm not worried about SBC tears with the transvenous lead. All I'm worried about is perhaps with long dwell times, if there's a capsule formation. Some people, operators, that choose ice, use ice. I like to not use ice because it's more cost effective that way. But I do, I think that if the device is moving and swinging well, that's a good sign that it's freely floating. If the back end is not moving well, then there might be some issues there and you have to think about ways. But as long as you can get to that back button, I don't worry about it too much. And then I have seen, at least with ventricular leadless, and this is the atrial, but ventricular leadless, sometimes the cast around the device may break and then it'll be left behind. Other times, actually many times I've seen it, it just comes with the device and you might see it partially covering the device after you grab it and take it out. I might have missed it, but were there any complications with any of those kind of extractions? No. Yes, yes. Anything else? Now that I'm on this tour, I'm particularly concerned with the one that we did for two and a half years. Yeah, so the question is, were there any complications with any of these extractions and procedures? And the answer is no. A hundred percent success, zero complications, no. That's the concern. Will you have a pericardial fusion when you take these things out? In this series, there were none. But certainly, it's important to be aware of that. I think that whether or not tissue, the second question is whether or not something came off on the device. And these, we didn't specifically ask the highest dwell time. This series was 31 months. I don't, not all operators used ice, so you can't necessarily see the cast. But if you use the ice, you could see if there's something left behind. My particular, my particular patients in this one, there was no, there was nothing on the device. Yeah, so in this particular series, you can see that some of them were implanted in the, in the appendage initially. And I'm showing it here. Yeah, so basically appendage, you can see that there are one, two, three, four. And then this one had one on the septum, one on the posterior wall. I think, I guess the nice thing, it is a heterogeneous group. And we had success no matter where the device was implanted. Yeah, personally, when I implant, a question is, what percentage are my devices implanted in which parts of the heart? And typically, when I implant an atrial leadless pacemaker, I'm often aiming for the base of the right atrial appendage. The tissue tends to be a little thicker there, maybe a little more lateral to avoid far-field over-sensing. If the tissue is not good, either whether the pacing thresholds are too high or the sensing is not good, then I may come out of the appendage or go within the appendage, different spots. And then I come outside the appendage, go high lateral wall, come down the lateral wall, and then find a spot there. Thank you very much. Okay, yeah, thank you. Wonderful talk. He may be able to stay around because it seems like there are lots of questions. And then our last speaker, Yuya Komai, speaking on efficacy and safety of same-day procedure involving transvenous lead extraction and leadless pacemaker implantation for CIED-related infections. Thank you. Thank you, Chaplain. Good morning, everyone. For the start, I am Yuya Komai from Chiba University, Japan. My topic of presentation today is the same-day procedure, lead extraction, leadless pacemaker implantation. The result is a few words. Transvenous lead extraction is recommended as a causal indication for CIED-related infections. The selection of leadless pacemaker as a re-implantation device after infection is also recommended as a causal indication for CIED-related infections. However, there is no clear evidence regarding the optimal timing for re-implantation. In Japan, when temporary pacemaker is used as a bridge after TLE, a prolonged hospital stay of at least three weeks is generally required. However, with same-day TLE and LPM implantation, bridging is not necessary, and if infection is controllable, an earlier transition to outpatient follow-up can be considered. So, the purpose of this study was to evaluate the efficacy and safety of simultaneous TLE and LPM implantation for CIED-related infections. We retrospectively analyzed consecutive patients who underwent TLE, optional transvenous PM, and LPM re-implantations for CIED-related infections at the hospital from January 2020 to August 2024. Their primary endpoints are as defined as major complications, and major complications were defined as follows. 16 patients underwent TLE for CIED-related infections from January 2020 to August 2024, 35 patients implanted ICD or CLTD were excluded, and 12 patients who were re-implanted PM on the other day were excluded. We analyzed 22 patients firstly. The average age was 8 years, indicating an elderly population, and 5 patients were female. So, patients with patient dependence was observed in 11 patients. Infection was localized only in 20 patients and systemic in 2 patients. No patients involved both local and systemic infection, and all preoperative blood cultures were negative. The most common causative organism was staphylococcus aureus, followed by staphylococcus epidermidis, and pseudomonas aeruginosa. The mean ROVF was preserved at 56%. The median duration since device implantation was 8 years. Further CCs were used in 13 patients, and clinical success was achieved in 21 patients. The average procedure time was approximately 2 hours. This is a case slide. The median observation period was 720 days. Major complications occurred in 2 patients, and were observed during the acute to subacute phase within 180 days. One acute phase complication involved re-implantation due to elevation in patient threshold. This was related to the fact that in same-day procedures, LPM implantation was performed in a hybrid operating room using a single-plane fluoroscopic system. Infection recurrence was observed as a mid-term complication, and we would like to present the case here. This is a case of a man in his 70s with a history of local infection. He got a total of 3 leads, one in the left side for 34 years, and two on the right side for 21 and 28 years respectively, associated with local infection. Initially, the patient had negative blood cultures and only localized infection at surgical site. The two leads on the right side were successfully removed with TLA, but removal of the transected residual lead was difficult in the left side. Implantation of the available LPM was also performed to the same day. However, postoperative blood cultures, later revealed pseudomonas aeruginosa bacteremia, and antibiotic therapy was initiated. Despite this, infection recurred 27 days after discharge. A PET-CT scan was performed to evaluate the infectivity of the residual leads. Increased FD2A uptake was observed around the residual X lead and at myocardial attachment site of the time. Therefore, open heart surgical removal of the residual lead and LPM was performed, followed by the administration of the antibiotics. However, the infection recurred again 5 days after discharge, and lifelong oral administration of level processing was ultimately required. We also conducted a comparison with the 12 patients shown in the table who underwent TLA and LPM implantation on separate days. In the same-day procedure group, patients tend to be relatively old, thinner, and more likely to have localized infections. Although the procedure time was longer, this is likely related to the fact that many patients had long-standing device implantations. The length of hospital stay was significantly shorter. In addition, no significant difference was observed in the incidence or major complications within 108 days between the same-day and separate-day procedure group. Summary of results. In 90.9% of same-day procedure groups, no major complications were observed. Recurrent infection was observed in a patient of pseudomonas aeruginosa bacteremia and with an infected residual lead. No significant difference in major complications between the separate-day and same-day procedure groups. Finally, the same-day procedure group had a significantly shorter length of hospital stay. Now, I'll move on to the discussion phase. The first point of discussion, which cases should be avoided by same-day procedures. In a previous retrospective study of 86 cases received same-day TLA and LPM implantation, poor prognosis was observed when the cause of the organics was MRSA or cangida. Additionally, some cases with MRSA bacteremia or cangida fungemia remained persistently bacteremia even after TLA. Based on the previous discussion, same-day procedure should be avoided as follows. The infected lead cannot be removed completely. Infection control is a challenge, especially in the causative pathogen of pseudomonas aeruginosa, MRSA, or cangida. The cases in which discouraged LPM implantation, for example, younger, high reactivity or organic heart diseases, are having patients. Next, I'll discuss another point. The advantages of same-day procedure include a shorter hospital stay and, most notably, a reduced risk of complications associated with prolonged use of temporary pacemaker, as listed below. Disadvantages include a longer procedure time, limitations due to single-plane imaging, and the inability to claim procedure fee for LPM implantation in Japan. In clinical perspective, in elderly patients with dementia at risk of prolonged TPM placement and extended hospitalization, the same-day procedure may be considered. However, in patients for whom infected lead cannot be extracted or infection cannot be controllable, careful consideration is required. This study has some limitations. Small number, single-center, and retrospective study, and long-term outcomes are unknown. Differences based on the type of extracted seeds or LPMs were not examined. In conclusion, the same-day procedure with delay and LPM implantation was considered effective and safe for seed-related infections, while careful decision-making was required. That's all. Thank you for your attention. So, happy to open up for questions, and we'll repeat the questions. I may start with one. How did the results of this change the way you practice in this regard of deciding whether or not to re-implant on the same day? What have you learned from this study? Thank you for the question. So, actually, I changed the strategy in this study, after this study. So, in patients who have active blood cultures and who are discouraged by LPM implantation, we should not, so, we should not re-implant on the same day. So, same-day procedure, but the patient whose infection was localized only, we should perform the same-day procedure actively. And maybe an extension of that, but something that's coming up at our hospital often, if an infected transvenous system is coming out and comes out fully, given the very, very low or perhaps nearly zero risk of infection of a leadless pacemaker, can a leadless pacemaker go in in that same setting? You pull out an infected transvenous system, can you put a leadless right in without a period of waiting on antibiotics? Sorry, one more again, please. One more again, your question, please. If you pull out an infected transvenous pacemaker, all comes out, because the infection rate of leadless is so very low, can you put a leadless in right in that same procedure? Actually, so, yeah, so, I'm not experienced in that case, so, I'm not experienced in that case, so, Sorry, so, I don't know. Yeah, sorry, your question is, this case is so, sorry, sorry, one more again, please. Sorry, one more again, your question. Oh, the question is just, on the same day, can you remove an infected transvenous and put a leadless in? Implant leadless. Implant leadless? Yes. Same day that infected transvenous comes out. Same day? Yeah, so, same day comes out. Same day comes out. I don't know. Sorry, Sorry, we have no experience. Okay, fair enough, fair enough. Other questions from the audience? All right, well, we will wrap up this session. Thank you all for your attention. Great audience, great presenters, great presentations, and at least some of the speakers may be able to stay around to answer questions. So, thank you very much. Yeah, thank you.

leadless pacemaker

MICRA

risk score

racial disparities

micro-AV

ventricular pacing

atrial leadless pacemaker

chronic retrieval

CIED-related infections

healthcare equity