Good morning, guys. We're going to get started. So I would like to welcome everyone to the global session. It is my pleasure to welcome you to San Diego and Heart Rhythm 2025. It's the 46th annual meeting of the Heart Rhythm Society. If you have not already done so, please download the HRS 2025 mobile app from your preferred app store. This is how to participate in the live Q&A sessions. Scan the QR code on the screen. Well, you get the idea. And assess the Q&A sessions. Note that the visual presentation reproduction of HRS 2025 is not allowed either by video or still photography and it is actually strictly prohibited. It's my pleasure to begin this session. So I'd like to introduce our first speaker, prolific electrophysiologist, Dr. Felix Shogady. He is the director of the Georgia Arrhythmia Institute and the incoming president of the Africa HRA. He will be presenting a talk on CRT in Africa, understanding the landscape of implantation. Thank you. All right. Thank you. Good morning, ladies and gentlemen. And those are my disclosures. Today, I'm going to talk about the landscape of CRT implantation in Africa with some special focus on the country of Nigeria. That's where I'm originally from. And basically, we'll go over just as a background the indication of CRT and understanding the landscape of implantation and some of the issues that surrounds the access to CRT therapy in Africa and some data with our ongoing survey through. And then what else can we do after that? As we know, cardiophysiologic pacing encompasses cardiac resynchronization therapy as well as conduction system pacing. And this has emerged as a therapeutic strategy that may mitigate or prevent the development of heart failure in patients who have known with ventricular dyssynchrony or pacing-induced cardiomyopathy. The class one indication for CRT remains heart failure with reduced ejection fraction less than 35 percent or people with left bundle branch block or those with QRS duration more than 150 milliseconds and heart failure with NYHA 2 to 4 symptoms despite medical therapy. In Africa, there is a paucity of population-based studies evaluating the prevalence of and incidence of heart failure because before we start discussing about CRT and some of the therapeutics, we need to really understand what is the population-based denominator that we are dealing with. There are no centralized registries to inform data on utilization and outcomes. Many of the published reports in the literature are based on surveys and as you know, these have their own attendant limitations. There is kind of a reporting bias already when you rely solely on surveys. And in this paper by Karat and group, it shows that even in Africa, there is a big regional variations on practice patterns where there is a big difference whether you are in North Africa, East Africa, West Africa, or Southern Africa. There is a lot of regional variation and some of that I will highlight that when you look at in North Africa, the major source of cardiomyopathy is ischemic in etiology and the population is a bit older, generally in the 60s to 70s age group. And when you come back to Sub-Saharan Africa and maybe with the focus on Nigeria, the age group is much younger, average of about 50 years, and there is almost an equal distribution between men and women. In Northern Africa, almost 75-80% of the patients reported in their survey are men. So in Sub-Saharan Africa, they are younger and there is a more balanced distribution between the sexes. In this work published in 2022 by Sherif and group, it shows that in many low to middle income countries, implantation is very low and most of these countries are in Asia and Africa, whereby the rate of implantation is less than 1 per 100,000 people. And the rates may be a bit slightly higher in North Africa, but when you compare to rates in the Western world, which is about 200 to 1,000 people, you can see there is a big disparity in terms of the rate of implantation of devices in these parts of the world. And in this work that was published by Kevergag and we collaborated with her in the African Heart Association, that when you look at the landscape of arrhythmias in general, there is a very, we know in lower to middle income countries, people tend to die at disproportionately higher rates from arrhythmia-related conditions due to many factors. Some of this may be in the basic ability to make a diagnosis, availability of things as basic as an EKG machine, then we'll talk to Holter monitoring, the therapeutics that are available. And so she highlighted some of this in this article. And I think some of these slides are seen during this meeting, that when you look at the area of bradyarrhythmia and sudden cardiac death, there is a lot of limitations that has been highlighted as well, where the rates of pacemaker implantation is significantly lower because of lack of implanters, lack of devices, and sometimes even the facility where you have to do these devices. And also in terms of sudden cardiac death, there is limited categorization of how do people die. There is just no systematic way of reporting that, and when you don't have a systematic way of analyzing the data, it is very difficult to develop therapeutic approaches. And as we know, even in people who have survived sudden death, even the rate of implantation remains very low in these patients. Then what do we do with all this data? It shows that, you know, we need to have solutions to eliminate these disparities and basically to have a global collaboration in terms of device utilization and training, and also starting up some of these programs. What we looked at in the work in Nigeria, we had this survey, and most of the assets of CRT in this reporting, which is many of the people that responded are implanters, and it's available in over 90. Most of the implanters are electrophysiologists, but when you look at in Africa, electrophysiologists and interventional cardiologists tend to wear the same hat, where there is not as clear a distinction as we have in the U.S. And the primary credential of these physicians are mostly interventional cardiologists that do most of the work, and then some designated electrophysiologists. The limitation relates to cost for a lot of people, and the basic devices are paid by out-of-pocket and donated devices from mission teams. Medicaid funding is very limited, as well as insurance coverage. Medtronic remains the main supplier, and like we said, these are the big three that dominate the device landscape in our survey. And for a lot of people, even I must say in the United States, a lot of people are not aware of the cost of what does the devices really cost. If you ask people in their room, what does a device implantation cost in your institution, I can tell you many people don't know. And but in Africa, those who the response varies from 3,500 to 12,000. The situation in Nigeria is also a little bit kind of unique, that it's a very highly populated country, and which is what is classified as lower-middle-income country, with almost 227 million people, a short life expectancy of 54 years. And in some of the data from the post-mortem pacemakers were used in the past from the data published in 2023, that it's been shown that from a period of over 10 years in these autos experience, they were found to be safe, and they had a very low malfunction rate, and they do not pose any additional risk to the patient. And the number of functioning cardiac device implantation centers in Nigeria from this survey at that time was 12, but Nigeria still had the lowest rate for ICD and seroity implantation per million population on a global scale, just because of the sheer size of the country. The lowest rate of implantation is in Nigeria globally, and as well as pacemaker implantation, which stands at 0.14 implants per million population. And the problems relates to need of the population, which is a large population, limited access to facilities and implanters, and it's very difficult to come up with cash to pay for this type of therapy. And though the workforce is young and energetic, but they tend to leave the region as well. In addition, when we do some of these cases, I know a lot of us have traveled on mission trips, and this is a gentleman that I think was originally implanted, he said, in India, came back to Nigeria, went back, then he started applying some local therapy, local heat with a lantern. Of course, the pocket eroded, and he was walking around like this for almost three years. And his physicians called me when they heard I was coming, so I took some. Of course, I called around to the only country that has laser extraction device in Africa is in South Africa, and he said he doesn't have funds, so I took the old cook extraction. So the highlight of this is that when you look at this kind of cases, we have to also be prepared to manage the downside of doing these therapies, whereby, in addition to implantation, we have to think of a holistic manner of having lead management issues, and these are some of the highlights. Highlights is always a fulfilling experience when you're able to help people when you travel on these trips, but we have to also remember that beyond the need for philanthropy, we have to address the underlying reasons why philanthropy is needed in the first place. My call to members in this room is that we all should need to work collaboratively. The heart failure is a common problem in Africa. Rate of CRT implantation by heart failure diagnosis is still very low, and there is still a tremendous opportunity to boost CRT implantation efforts in Africa. As we know, the projected number of people living with heart failure will continue to rise, and I call on friends and colleagues in the global EP world to join AFRA, which is Africa Heart Freedom Association, in our efforts to address these challenges. Thank you. Thank you very much, Dr. Sogade. So for purposes of time, we might move on to our next speaker, and we'll give the questions to the end. I'm pleased to welcome Dr. Brian Bezzi to the stage, who's based in South Africa, who's a national and international leader in CSP, and is running a large registry, and he has an interesting, innovative case to share with us today. Thank you very much. While she's preparing my talk, Felix, what's the proportion of patients in Nigeria who feel they have money for the device, but cannot go to maybe UK or India, where if you get someone to come, we can do that for them. Yeah, like I said, there is just no standardized manner. We just know that Nigeria spends $2 billion in medical tourism for people traveling out. And I have seen that. We always said, if the cost is under $10,000, we did a survey about probably about 15 years ago that people through family and church and everything, they can raise $10,000. And the estimate, probably about 20% of the population may be able to do that. But it takes to raise $10,000, that was when the country was financially even more buoyant. In today's time, with much more economic realities, my estimate will be less than 1%. OK, that we'll talk about later. Thank you very much for the invite. I'm Brian from South Africa. We're going to look at the few case studies that we did as part of AFRA. We have this registry that we developed a couple of years ago. It's largely based in South Africa and in Kenya, but we're trying to expand, hopefully include Nigeria in these registries in the forthcoming times. So how do I proceed with my slide changer? Actually, you said through the computer. Oh, OK. All right. So we started, we were early takers of conduction system pacing in Africa. And like everyone else, we started with his bundle pacing, but short of 100 patients, we realized the problems that the rest of the world was realizing, and then we stopped. But I'm going to show a case that make me think of revisiting that issue. We then went into left bundle branch block and our pacing. One of the major things that we realized, about a third of all patients presented quite late with a very wide QRS complex. And probably we didn't expect this, so we decided that we're going to have a look at that. Hence the case I'm going to present today. But what was interesting is that these patients were just as easy to reduce the QRS duration like other patients and the fluoroscopy time between the very wide and not so wide was not that different. And the follow up in terms of pacing threshold was also the same. This is the case that makes me want to rethink going back to conduction system pacing using the HIS bundle, in the sense that this is a patient that had sick sinus syndrome. Like if you look at this fluoroscopy LO view after I've put in the solar lead, which is about 11.8 millimeters, here's a septogram. This lead is quite deep in. And this looks like, to me, at least I'm open to discussion, looks like it's a patient who has just received left bundle pacing. But this was the ECG. This is native. This is what it looked like to me. And this RSR pattern, of course, is like an incomplete right bundle branch block. But it's not typical of what we usually see in left bundle branch pacing. And what was important was clear. I could see A and very fractionated H, which you don't expect to see in patients who are undergoing a typical location of the left bundle branch pacing. So through the transition, as we do threshold testing, you can see with the local electrogram, as well as the ECG, that the way it changes. So this is what I'm assuming. I'm not sure if I'm correct. But this is what I'm assuming. This is a transition from non-selective his bundle pacing to selective left bundle pacing. So this is a case of maybe, maybe there is a way of doing his bundle pacing, not the original way that we were accustomed to. I don't know exactly what is this. And I'm open to discussion. Is this his bundle pacing? Is it some sort of fusion between his bundle pacing and left bundle pacing? I don't know. I don't have the answer. But if you look at the ECG, it's not typical of the left bundle pacing. Let's come back to our case. So this is a patient, 62-year-old, who had lots of cardiac issues, had undergone CABG, arterial valve replacement, and a very wide QRS of almost 200, and with an optimal medical therapy, ejection friction of 21%. So we proceeded to implant what we didn't plan, but it's just like an impromptu. Can you try something different? Because a German group had described a two-lead ECG, first in human, and another group had described a similar thing. But they put the ICD in the left bundle, but then put it back into the RV, just a proof of concept. So we proceeded to do this. At implant, putting a jurata lead in the left bundle area, there was some sort of transition. As you can see, that QRS and that QRS are not the same. So I'm thinking some sort of transition. But the local electrogram remained identical. So I'm not sure what is this transition. Is it a transition from non-selective left bundle area pacing to left ventricular septal pacing? Why this, I'm not sure. But if you look at the ECG, OK, this is when we were pacing. We call this a split. This is native, 198 millisecond compared to about 148. We've got the RS pattern there, which is quite good. Interpeak is more than 33. It's not more than 44, but it's quite good. Stim to peak QRS or R-wave is 88. I mean, most of the time when the heart is enlarged, I think 85 is acceptable. But you see other people have recorded that or reported that under 91 is still acceptable. And this is how it looked like at the end of the day. Of course, we are always worried about the coil, which is 5 centimeters, that it could come back into the RA. I couldn't do the ventriculogram because the Jurata lead and the selection 3D that I used was a bit tight. So I wasn't sure. But just looking at the anatomy of the aortic valve, I'm assuming the heat is here and the septal deflate is somewhere there. So maybe a bit of it could be in the RA. So as recommended, we did the DFT testing, which was successful. The echocardiogram didn't show any issues. And these were the settings. I'm not sure it's going to play. This was a patient, remember, this is a patient with right pulmonary branch block. I'm not an expert in echocardiography. It doesn't look like there's a mechanical desynchrony. But on the follow-up, you'll see that that's an initial one. The LVDD had appeared to be reduced in size, and there was an increase in ejection fraction. This was the ECG 12 weeks later, which I think is pretty decent for left pulmonary error pacing, particularly using a lead that I'm not accustomed to. These are the two together. This was the original ECG. Sorry for poor quality there. Where are we? So there's always an issue about putting leads into unconventional position. And one of the major issues and the recommendation of doing a DFT testing and be successful is that you want the patient to be safe. As far as we know, this is probably the first case report showing that the clinical VET had been treated with this ICD lead in this current position, which is quite comforting, even though this patient had undergone the DFT testing that was successful. And what also is important, if you look at the EGMs, there was no far-field atrial pacing sensing. And even though I'm not sure, or it doesn't show on this slide, there was an attempt to do ventricular overdrive that was not successful. But what was successful is the fact that the first cardiovascular defibrillation was successful. So what could you take out of these patients? One is that the two-lead ICD, or in the future, the one-lead ICD with atrial sensing, may be quite effective. And we probably also reduce cost and time in terms of implant. And with all these stable parameters, and maybe ejection friction may be improved. I've got about three minutes left. I'm going to quickly go through the other similar cases that we did. So we decided that we're going to now try using only a stylet because we have also had people who use just a stylet. So I shipped the stylet similar to Selecta3D65. And we proceeded to do two cases. As you can see, this is a patient with a sarcoid heart. It's always an issue with the sarcoid heart and the fidelity of the lead in this area. But this is last year. It's only about seven months follow-up. We haven't seen any issues. I'm not sure what's going to happen. But I think it's important to note that even with this kind of patient with a lot of scarring, all the parameters are pretty much acceptable for left boundary area pacing using the ICD lead. This was original ECG. I'm not sure whether that's a right boundary branch block or epsilon wave. And as you know, sarcoid heart and ARVC can have very similar ECG features. But anyway, if it is indeed an epsilon wave, epsilon wave is supposed to be at the end of the QRS, which looks like it. But anyway, this is an ECG afterwards, which I thought was okay. The last patient with dilated cardiomyopathy so I had difficulty in getting the coil in this position all the way in and ended up with quite a distal pacing site. I don't know exactly where I am, but the ECG says I'm okay. So I couldn't get the R prime, as you can see, but the QRS, it's pretty decent. But I was just worried about the negative in lead one, which could potentially mean that you're too anterior, you're too lateral, or even perforated. But the following day, if you look at the ECG at baseline and the ECG after a bipolar pacing, you can only use bipolar pacing in ICD in this position, I think it was pretty decent. So using these cases, it just illustrates that connection system pacing. One, maybe we should revisit, maybe I should revisit his spinal pacing in a different position than the conventional position that we are accustomed to. And coming to fewer lead CRTDs, it may be safe and feasible. And more importantly, it can deliver the ICD shocks appropriately. Thank you very much. Thank you. All right, we would like to introduce Dr. Fatih Siddiqui, cardiac electrophysiologist from Pakistan, who will be presenting on the cultural aspects and considerations of device implant in Pakistan. Good morning, everybody, and thank you so very much for having me here. It is going to be a – it is a pleasure to present Pakistani version of device implantation, and I will take you on to the journey of different cultural and economical hindrances that we face while we implant a procedure. I'm Fareeha Sadiq-Ali. I'm one of the cardiac electrophysiologists from Karachi, Pakistan. Karachi – Pakistan is a country in Southeast Asia, and I'm not sure what a lot of people know about it. It's the fifth most populous country of the world with 241 million population. Karachi is the largest city. It's not the capital, but the population exceeding 20 million people, and the average income per capita GDP for an average Pakistani person is about $1,600 a year, and about 21 percent of population below the poverty line. The average life expectancy is around 67, and very unfortunately, the literacy rate stands between 62 to 68 percent. The healthcare system in Pakistan is very, very complex. It's not homogenous, and there is both public, private, and non-profit organizations. The key challenges always remain the lack of funding, no health access to the rural areas, brain drains, shortage of treating physicians and staff, yet we have globally recognized hospitals and institutions who are doing great job for our people. There are public sector hospitals, which are actually run by the provincial and the government and the federal government. We have private sector hospitals, and they're NGO trust-based hospital where free or low-cost care is given. Taba Heart Institute is one of those free, low-cost care, which is a combination of private and NGO-run hospital. And then we have a unique hospital with a public-private partnership, Indus Hospital of Health Network. Taba Heart Institute was established in 2005. It's 150 to 170 hospitals, about 14 to 16 cardiologists work there. I'm the only electrophysiologist sharing the practice with other 14 general cardiologists. So my journey as an arrhythmia specialist, I embarked on to become an electrophysiologist in 2013, the first woman cardiologist from Pakistan to go to Canada and get trained. I joined Kingston General Hospital in 2013 and returned to Pakistan in 2016 through Taba Heart Institute. Returning to Pakistan was itself a difficult transition. I was driving a Ferrari or a Rolls-Royce metamorphically for the technology in electrophysiology, and coming to Pakistan was like driving a tuk-tuk. It took eight years to be where I am today, but perseverance paid off. We are the only private hospital in the country which have a dedicated EP and device lab, and this is my A-team, all female nurses, technicians, manager, and myself as the director of the arrhythmia services. I'm the only female electrophysiologist who holds this title in the country. And at Taba Heart, we, as a primary operator, I probably see around 3,000-plus outpatient electrophysiology patients, and we do 300 to 350 procedures, device implantations only in a year. Twenty percent of these devices are actually high-voltage devices. In low-voltage, we have a mix of device companies. Medtronic is leading, but with Abbott just right at the back, and we do have Biotronic, Boston Scientific, and Sorin sharing small volumes. The high-voltage is primarily taken by Medtronic, but other companies are following through. The cultural barrier that, as a physician, I have to face is mainly two extremes of age. One is at the younger age, where I see a lot of congenital heart blocks and cardiomyopathies and requiring pacemaker. There's a confusion, there's a myth that pacemaker implantation is a taboo, especially for girls who have AV blocks and they don't go for it because it's a taboo for marriage. There is hindrances to their marital life, to their jobs, and to their relationships with their family. This is actually very difficult to come over. The other extreme is the old age, where people at extreme age requiring bradycardia pacing, they're already accepted that this is God's will. To fight the confusion between medicine and faith is an extreme challenge. They often refuse treatment because they think this is a mutation to your body and this is an interference and this should not be done and this is unnatural. This myth and confusion is not just of the patient understanding the culture, it is of the immediate family members and then there are extended family members which become part of the discussion and part of decision making. So we have to deal with the confusion of at least 10 to 12 people when we are implanting one pacemaker. And this is not enough. The economical clash. You've already mentioned that the average economy or average pay is about $1,600 and this is the average cost of a device. For brady devices it's around less than $2,000 US and for ICDs and CRTs it's going up to high as $10,000 to $11,000 US. Impacting the exchange rate over the last five years have changed humongously. So it was 180 Pakistani rupees five years ago and it is 280 Pakistani rupees today. So this also impacts. At TAPA we are only implanting about 30 to 40, maybe 50 devices, high voltage and heart failure devices. 30% of these devices, of all these devices are actually supported by the charity at the hospital and remaining 60%, 70% comes out of the patient pocket. This is very unfortunate. However, we do have some unique opportunities of support. The first pacemaker bank was formed by the APCNA Rotary and Heartbeat International in 2007 and it continued until 2016 till when the drug regulatory stopped the shipment of the devices because they were less than six months of use by date. They supported around 200 plus devices of both high voltage and low voltage and they were a huge support. Following that, we still have a pacemaker bank by support of Association of Pakistani Descent Cardiologists of North America and they gave us devices in agreement by Medtronic with a subsidized rate. And I'm very thankful to Dr. Wajid Beg and Dr. Maria Waqar, who are the chairpersons of this pacemaker project. They not only support my institute but also other institutes in the country. And then we had a unique support from Syrian American Medical Society Foundation, which is a global medical relief organization which works on the front lines of crisis relief in Syria. Their first ever mission to out of refugee area was in October 23 to Indus Hospital and Health Network in Karachi, Pakistan. They had a team of electrophysiologists and intervention cardiologists and they partnered with the Pakistani team. They supported our EP cases, pacemakers, and ICDs. And I was very fortunate to be leading the Pakistan team for this mission. They implanted urgent pacemakers, left bundle devices, and so this was something very, very unique to us. Before I end my talk, I have a few cases to share with you that how we work around the guidelines. Managing advanced heart failure and atrial fibrillation is a huge debate and ablation is a class one indication. Understanding that ablation cost about $10,000 to $12,000 US dollars per procedure and in patients with end stage heart disease in this economy, they may not be the first choice and we have to tailor the guidelines accordingly. And so we have been using upfront CRT and AVJ ablation which comes to be around $4,000 US dollars but in long term, it has a huge impact. So my first case is a 72-year-old ischemic cardiomyopathy with sinus node dysfunction just like a regular Pakistani patient. They've been sitting on it, medical noncompliance, coming in and out of the hospital many a times, not responding to treatment. Finally he comes in with shock, tachybrady, refractory to medical treatment and finally he agreed to undergo an AVJ ablation and CRTP in December 2023. This was the initial ECG with the neuro QRS atrial tachycardia. The LA size was 96 mils per meter square, huge, gigantic. EF was 15% with both RV and LV dysfunction and moderate to severe TRs. I was able to do a CRT and AVJ ablation. This is the post-CRT ECG and after a year of follow up, there was significant improvement in the quality of life, hemodynamics and EF improved to 47% with improvement in heart failure. My second case is a 65 lady, hep C positive, dilated cardiomyopathy, persistent AT, difficult heart rate control, progressive decline in EF, similar situation, difficult patient. I offered her AVJ ablation as my up front strategy. This was her initial ECG, LA size was 55, EF was 20%, post-CRT, this was her ECG with AVJ. One year down the line, she's been very stable, EF improved to 50% with significant improvement. We've also been using left bundle for last two years as an alternative for CRT and heart failure. My case of a left bundle, 30% non ischemic, LA size 34, failed CRT, so I put a left bundle lead with a still a driven solia. This was the post-CRT ECG, her improvement in symptoms and EF within six months. Necessity is the mother of invention, we all hear about it. This is a case of a right sided lead implantation where the extraction and venoplasty was not possible. This is a lady who had, 90 lady, 2018, she had an AV block, recurrent heart failure symptoms, occluded venous system on the left side, I implanted a right sided LV lead and without proper tunneling tools, makeshift tools, I tunneled it onto the left sided pocket and hooked up to the CRT device with the existing old RA and RV leads. This was the ECG post-CRT. And just the last case, following up with Dr. Vezi's cases, this was a lady with dilated cardiomyopathy, large scar on CMR, she had heart failure in AV block, and we planned for a CRT-D, unfortunately failed, and so we had to do a dual chamber ICD contemplating if this just a dual chamber ICD will work or not, she has heart failure, and so I had a dual chamber ICD with a DF1 configuration in my inventory, and so I did a left bundle lead with a CRT-D and Medtronic DF1 dual chamber ICD, and this was the ECG post-procedure. She's been fairly stable with heart failure, and no therapies have been required. So thank you so very much. Thank you so much, Dr. Fahri, a really inspiring journey, and hopefully inspires others to come back to their countries and set up services. So it's an absolute pleasure to introduce Dr. Fania Mela. Dr. Mela is an attending in Mass General Hospital and heads the device extraction program. She's a former mentor of mine and a current mentor of mine, and I'm happy to say a friend as well. So she's going to be talking about setting up lead extraction programs. Good morning, everybody, and thank you for the invitation. As a disclosure, I do not have a vast experience in practicing in areas of the world that the means are not available, but we did share actually with Dr. Sharif two weeks of practicing in Nigeria and Ethiopia in planting devices and always wondering what happens if and when these devices need to be explanted, and it seems that the system is not there. So I will talk a little bit about what the standard of care needs to be and maybe some thoughts for setting up programs. So some epidemiological data that we all know, millions of CRM devices in the U.S. exist and even many more, 7.7 million CRM devices worldwide with 450,000 new devices annually implanted in the U.S. and 1.5 million new devices implanted annually worldwide. And of course, the number of leads is an increment of that with 2.6 million new leads implanted annually and 14 million leads existing worldwide. While with everything that we do, we keep the patients alive longer, so these devices only get older and the leads older. The usual indications for lead extraction include malfunction of the lead, as you can see in the first picture with the externalization of the conductors, the most common and urgent infection, and we will talk more about that, a great number of redundant leads as we saw in the previous case from Pakistan, new technologies, so a patient with an old system needs to be upgraded to, let's say, CRT. Making a system MRI conditional is another reason to require extraction. And finally, venous occlusion that sometimes can be bilateral, so there's no access for a new device. And speaking a little more in infection, which in my opinion is the most urgent need for extraction, it is a class one indication for a device to be extracted if there is system infection, even more so when it is associated with endocarditis and bacteremia, and the guidelines call for the presence of an experienced extractor to consult with the patient when that case arises. But as a result of that, and as a result of the lack of the experienced extractors, six out of ten patients are undertreated, even in the United States, with 2.7% infection rate when a replacement or an upgrade happens. And these are some known to most examples of pocket infection with or without bacteremia and subsequent necrosis and externalization of the device, as we can see here. To really emphasize the importance of lead extraction and infection management for devices, these statistics, when we only use antibiotics, the reported mortality for a device system infection is up to 47%, while if there is an extraction involved, the mortality is still significant, but much less, 16.7% when there is bacteremia present. If there is endocarditis present, then the mortality rate just with antibiotic use is up to 66%. And even if we decide to give a course of antibiotics and see how the patient does and wait on the extraction, the recurrence, the relapse rate for systems that have not been extracted can be up to 50% to 100%. and every time that endocarditis recurs the need, the mortality rate goes up, whereas in comparison, if an extraction happens, that can be a safe procedure with a mortality risk less than 1 percent, really less than half percent in experienced hands. And this is the problem, why leads do not move out easily over the years, fibrosis and adhesions and calcification happens. And this is what was happening in the early days, and I don't know, maybe in some parts of the world it may still be happening if a system is really infected and there is no access to extraction. So what it was happening, they were tying the leads with rubber bands and put some weight on the head of the patient and waited for days, as one of the gurus of pacing, Dr. Hathorne, has told me from his early days, and were waiting for the lead to slowly come out as it was working against the heart beating. I don't know that we have any data about the mortality rate of this procedure. And this is what we have today, really a pliad of tools, starting from locking stylettes to be able to pull the lead from its inner end, telescopic sheaths for fibrous adhesions, laser sheaths for fibrous adhesions, more calcified lesions can use the mechanical cutting tool or electrosurgical dissection sheaths, and various snares with which you can grab the lead and pull it from the groin or from the jugular veins. And this is what has happened over the years in terms of the evolution of pacing and ICD since the first pacemaker in the 50s, as the devices were becoming more widespread and advanced, similar, the need for lead extraction happened, and gradually various tools were developed over the years, really between 1990 and 2010, with large registries telling us that actually, like the Lexicon registry, the Electra registry, really telling us that device extraction is safe when it's happening in experienced hands. And these are the guidelines for 2017, who should be doing extractions. So these organizations suggest that competency is reached after a physician has performed 40 lead extractions as a primary operator, supervised by a competent operator, with maintenance of the skill that requires 20 lead extractions annually at the very minimum. Simulator training has been studied and has been proven to be very helpful. So this is some thought maybe for new programs that are built in underserved areas where experienced mentors and proctors may not be available. But one very significant point is cardiothoracic surgery should be available really in the same institution where the extractions happen. These are some additional guidelines when it comes to more complex patients with congenital heart disease, where the extractor not only needs to be experienced in terms of the extractions, but also understanding the physiology of the congenital heart disease. So some guidelines in that regard that parallel the guidelines that we use for general population lead extraction. What we have in my institution is a center for extraction that has been running for over 25 years. We perform the lead extractions in a designated hybrid operating room with a multidisciplinary team that involves a cardiothoracic surgeon as a standby and, of course, cardiac anesthesia. All these cases are done under general anesthesia. But other teams of doctors are frequently involved, like interventional radiologists that help us with snaring leads or vascular surgery or vascular medicine team that help us put stents in stenotic superior vena cava regions, as well as very close collaboration with an infectious disease team that usually advises about the course of antibiotics and the type of antibiotics that the patient needs. And then some additional tools that are ancillary to the main work, but very recently we realized the merit of lithotripsy. And actually we use it for difficult cases that leads have been there for over, this is a case for over 26 years, that after we performed lithotripsy, as you can see with the balloon here, the leads were able to be extracted much easier. Same with aspiration thrombectomy with the angiovax system for large vegetations. And the role of imaging, of course, presence of CT scan that helps us understand the anatomy and the calcification as well, transesophageal and sometimes intracardiac echocardiography. So what are the challenges of starting a lead extraction program? I would say everywhere on the globe, trained EP operators with flexible availability is required, support by CT surgeons and anesthesiologists, collaboration with infectious disease, vascular surgery or medicine, and interventional radiology. And of course the hospital support in terms of obtaining the required tools and equipment as well as allocating a space where the EP person as well as a surgeon could work effectively in case of an emergency. And of course trained supportive personnel that can help with the extraction case. It is important in terms of the maintenance of the accreditation of the program to have a steady volume of cases, at least 20 patients per year, high quality of pre-op, intra-op, and post-op care, and continue to make the case for the hospital that this procedure, especially in case of a private hospital, can be cost effective and continue to maintain and upgrade equipment as well as continuing education for the operators. So take home points, really treating infection in CIDs is critical and it's life saving. So at the very least that indication should be treated the best possible way even with the existing means. That lead extraction in the hands of experienced operators can be a safe procedure and setting up a new program does pose a lot of challenges, but optimal use of teamwork and technology can help address those barriers. Thank you very much. Okay, thanks very much to our speakers. We've got obviously time for some questions, we'll open up the floor if anyone wants to. I might start actually a question for Dr. Segade actually. Very good talk. Obviously data collection registries are so important in terms of identifying the scope of the problem, but in terms of follow-up for these devices after they're put in, obviously that presents many challenges as well. Is there any data in terms of the follow-up or any advice in terms of getting over the challenges of device follow-up? Some of my experience has been quite a very interesting scenario because a lot of the implanters may lack the necessary background in training and knowledge of device operation. Many are surgeons, many are interventional cardiologists. So there's usually a reliance on representative device, company representatives, and in the United States we really call them to come and check the device in some clinics or the hospital, but in several countries in Africa you actually have to pay the rep to travel to come and interrogate the device. So follow-up has been very challenging and so a lot of our focus has been to when you start in the program, a lot of time has to be devoted into training the implanters on how to interrogate and troubleshoot the devices. And the downside also is that with a lot of the donated devices, there are a plethora of them, it may be easier to maybe focus on certain areas or regions that just have one device, have access to programmers because a lack of access to programmers is an issue, and those are some of the challenges that I have seen that has been there. There is really very limited opportunities for remote monitoring of these devices because they are usually local devices and the infrastructure is not there yet. Just as a follow-up to that, it's quite strange that even within Africa things are very different. So at home, everyone gets a home monitor as part of the package price for that, there's no additional package. When I go to Nairobi and so what we've decided is that everyone will be monitored by us, which makes things easier for them, but part of it is training local guys. But we realized that in Nairobi, patients had to pay extra for a home monitor, so we had to challenge that, challenge the hospital that if the patient is paid for the device, that should go with a home monitor. So that has changed only in the last couple of weeks. So what we do for every implant that we do, everyone comes to our South African virtual clinic, but we also rotate the guys from Nairobi to come to South Africa to spend some time with us for follow-up. I have a question for Dr. Mella. So as far as the lead extraction programs, is there a facility or anything, programs you know of that can have live case overview of a local explanter or an extractionist? So if they come in with unexpected snags, is there a program or facility that they can be in touch with if they're in a resource-poor position? Not that I know of, but I think this is a great idea, and I think this could apply in many challenging cases, like even implants or even more so ablations, especially of SVT, implementing SVT ablations. And that is probably the easiest to be set up. From our experience with the facility that we were implanting devices with Zane, definitely the ability to do an implant in a safe way is there. So the room is there, but I think what was lacking is the backup of the additional services that you may need, especially a cardiothoracic surgeon. And I can tell you this is not only a problem in Africa or Asia. My fellow who has become an attending in Hawaii has been trying to set up a lead extraction program for the last three years, afraid that he's going to lose his skill, and he has not persuaded the hospital yet. So it is a challenging issue for many areas. It's a problem in Ireland as well, but I might open the floor for another question. Hi, everyone. Thank you so much. This has been an excellent presentation by everyone. I wanted to kind of ask a question about remote monitoring, because Dr. Vasey said, you know, in South Africa, they have remote monitoring, and they're able to extend it to Kenya, but a lot of us that have practiced in West Africa or even in Pakistan, that has not been a possibility. And I guess my question is, does anybody know the reason why? Because the internet is available, cell service is available. What is the reason that it's not able to be done? I've heard different things from different companies, but I don't know if anybody has any thoughts. I think the one, the obvious one in Kenya was that there's no regulation, and the fact that they were charging patients extra for home monitoring system. So that was the biggest thing, and it took some time for the hospital. Fortunately, I go to one or two hospitals, so it's easy, as they see volume increase, and they make money out of me going there to do the implants, that the original value for what the patient paid for should be inclusive of the home monitoring system. So that, like I said, only changed a couple of weeks ago. I've been going there for like 12 years. So I'm not sure about the other regions of the country why it hasn't happened yet. For Pakistan, I can say that the only answer that we get, it's not regulated. The internet is not allowed by the XY authority. The device for remote monitoring does not come as parcel and package of the device itself. None of the device companies are offering remote monitoring, except for a few elite models of Abbott with app-based monitoring are available, which will be launched in the country soon. But this comes with additional cost, and we are also struggling with the cost of a simple pacemaker. So I don't think this is the answer, additional cost for remote monitoring. We need to look into other areas of how to do remote monitoring without devices, like a kiosk placed at one center and able to monitor a region with a kiosk-based monitoring. So is it a question for the companies? Because even my patients, I live in Washington, D.C., they travel all over the world, and they're always like, we can't monitor you when you're outside the country, which doesn't make any sense. So I'm wondering if it's something that's based on, you know, I'm planting an American device, but once they travel to Ghana, I'm told, oh, no, no, we can't monitor it, even when they're in Canada, you know. So I'm wondering if it's something that the companies are just doing. We have found that remote monitoring is much easier globally with the biotronic devices, and when I have patients traveling from outside the United States, I tend to use that more selectively. But the main concern, I think, when you look at, like, in Nigeria, over 50 percent of the devices are from donated sources, and these donated devices do not come with remote monitoring capability. So to have access to clinics, people have to travel long distances. I have had people call, they have to travel long distances to get to a clinic with a programmer. And I think that may be something, maybe the MyHeart, YourHeart program can look at, maybe regionalized centers, where instead of remote monitoring, which will add another cost to the devices that are already being donated, maybe standing regionalized centers may be a more practical way. And we have patients we monitor from practice in Georgia, in Nigeria, in the Middle East, but for those patients that are local and are relying on donated devices, I think it's a challenge, realistically, yeah. Very good. Maybe one more question for Dr. Fahry as well. Obviously, the population of Pakistan, Karachi, massive, huge device needs, and you've talked about some innovative ways that device affordability can come into play. Reprocessed device in Pakistan? Well, we have been using reprocessed devices in Pakistan, but under the radar. It is still not regulated by the authority, and so we cannot disclose it. Once we are prepared with our legal and ethical policies, we might put this up to the drug regulatory authority in a year or two. But as for now, we use it. Our personal data shows that they have less than 1% of infection, no malfunctions. These are reprocessed devices, re-sterilized, and I use the processing that was published in a New England Journal from Montreal. No problems with that, but it's still under the radar. We cannot disclose it. But with the My Heart, Your Heart program, maybe we will be able to convince the drug regulatory authorities, which is a challenge right now. We're still working, taking baby steps. Hopefully in a year or two, we will be there. I would like to thank everybody for coming. We are over a lot of time, but if there are other discussions, we can have it offline. Thank you so much. Thank you.

Heart Rhythm 2025

cardiac device implantation

Africa

Pakistan

cardiac resynchronization therapy

socio-economic factors

electrophysiology practice

cultural barriers

remote monitoring

lead extraction programs