at a professor of medicine at Yale. And I also want to introduce my colleague, Dr. Bharat Kanthariya at Mount Sinai in New York, really one of the world's experts on this very issue. And again, so that you're all oriented in the right spot, this is on device use in the developing world. And witness recent developments in the United States and unstable times, as it might appear to people in the developing world, if not in the United States. This seems to be a session that's quite appropriate to the times. And I do want to reassure you all in the audience that things will work out. They do have a way of working out how, I don't know. But that's what I tell my patients when they come to me with concerns. This is like that Jeopardy game show. The answer is, everything will work out. The question is, what's it going to take to get us there? And so far, it seems like a lot. In any case, what I am going to ask you is to welcome you to San Diego and Heart Rhythm 2025, the 46th annual meeting of the Heart Rhythm Society. And if you've not already done so, please download the HRS 2025 mobile app from your preferred app store, whatever that may be. This is how you can participate in live Q&A during sessions. You can scan the QR code over there on the screen to access this session's Q&A. When using the mobile app, log in with your HRS credentials. And please note that visual reproduction of Heart Rhythm 2025, either by video or still photography, is strictly prohibited. There will be time to ask questions, depending on how things go, probably at the end. And therefore, without further ado, I think we'll start with our first speaker, Dr. Thomas Crawford from the University of Michigan, who will speak on Restorization and Reuse of Cadet Pacemaker Lessons Learned, Next Steps. I'm already on the timer. Good afternoon. Actually, good morning still. Let's see if this will load up. So my disclosures are that I have no conflicts of interest, but I will be discussing off-label use of permanent pacemakers. Very briefly, I just want to put this introductory slide here so that we can recognize that the vast majority of the world is where most of the cardiovascular disease occurs, and that's where people die. And unfortunately, there are many disparities in access to health care, and one of them is a disparity in terms of access to pacemaker. I've shown this slide before, but I think it's very powerful because it shows you the level of magnitude in terms of per capita implantation of devices in various countries. And so it is a very dramatic difference between, let's say, the Western world and Kenya and Nigeria, as shown here. So briefly, what are the reasons behind poor access to pacemakers in low- and middle-income countries? Well, the cost of the pacemaker itself provides one of the barriers. Then the providers, there may not be providers who know how to implant devices, and they don't have support staff. And then the entire health care environment and infrastructure may be lacking, like lack of fluoroscopy or scarcity of OR time. In many countries where we work, patients pay out-of-pocket for most of their health care. So the patient is expected to purchase the pacemaker, and if they can't do that, then they don't get it. So what are some solutions that we can use to gain access, bridge the gap in access? So the donations from manufacturers are grossly inadequate and unsustainable. I know that there will be a session, or one of the speakers today will talk about low-cost pacemaker, which is very interesting. What we at the University of Michigan have done is, for the past 15 years, we've been studying systematically post-mortem reuse of pacemakers. And then another component to this is capacity building. So sort of My Heart, Your Heart, which is the project that we have at the University of Michigan, takes care of the pacemaker costs. But we really need to work with other folks who do capacity building in order to be able to actually sustain implantation centers. So in 2010, we established a formal research project at the University of Michigan called My Heart, Your Heart. We partnered with companies and charities that were helpful in establishing, bringing the pacemakers from the funeral industry through implant recycling. World of Medical Relief is another Detroit-based charity that, for 70 years, has been sending shipments of medical equipment around the world. And this is where we are today. And this is where we physically housed. And Any Scientific is a company that is in the business of reprocessing catheters for the US market. And they have, for all these years, they've been doing service to us for free by providing the cleaning and sterilization component of this work. So let me briefly describe this process. So there are four phases in this process. And the devices travel between World Medical Relief in Detroit and Any Scientific in Connecticut, and then back to World Medical Relief, and then back to Any Scientific because of the complexity of what we're doing. So first of all, we get the devices. We make sure that they have enough battery life longevity. And we remove screw caps and set screws so that the header can be cleaned in its entirety. Then Any Scientific does further decontamination and device cleaning and sends us devices which are clean but not sterile. Then our folks, our project manager, Eric Pural, and device nurses will actually do a detailed electrical testing after the set screw is reinstalled. And then finally, the pacemaker is shipped back to Connecticut where the device packaging and sterilization occur. Here are some pictures that show the process, how we remove the seal plugs and set screws, how we clean and decontaminate the devices. And one of the features of this process is that if we actually can visually see a residue on the device, we reject it. So at gross examination, there should be really no problems with the device. There should be no dents on the device either. So we have published cleaning and sterilization validation that essentially showed that we meet industry standards for implantable devices. And that's what really the slide shows here. We spent about six to seven minutes where Eric and a device nurse from our university volunteers and basically examines every pacemaker in terms of its functionality. So the pacemaker is at the pace. The motherboard is where the pacemaker is plugged into the lead. And then through that, we have access to the simulator, the oscilloscope. Oscilloscope is a device that measures outputs from an electrical device. So you can actually measure. You can program a certain output, so many volts at so many milliseconds. And you can confirm in an oscilloscope that that's actually what the device does. The waveform generator is providing inputs to the device so that we can observe the pacemaker behavior. And finally, we have the programmer which we use that are company specific. And these are the tests that we perform on every single device. And that's why it takes seven minutes for two human beings to do that right now. You have a picture here on the left showing how Eric is reinserting the set screws and the seal plugs and uses silicone with a little nice dispenser to be able to do this in some amount of volume. And then here are examples of pictures of what the packaging looks like. So we use double Tyvek pouches. And the devices are placed in a hard box with foam. So it is protected from injury. For the last several years, we've been conducting a randomized multi-center single blind study that was showing non-feriority study of new versus reconditioned pacemakers. The primary endpoint was freedom from procedure related infections at 12 months. And secondary was freedom from pacemaker malfunction. The study was conducted in six different countries. We enrolled 298 patients. Half and half were receiving a brand new device versus a reconditioned device. And at AHA last fall, we presented this abstract showing the 90 day results. And it basically shows that there is no statistical difference between the rate of infection of new versus reconditioned devices. Likewise, the secondary endpoint is shown here. There were no deaths or malfunctions related to the generator itself. Well, there was some lead dislodgements, obviously. Over the years, we have systematically addressed the ethical, legal, and regulatory issues that are involved. And so here's some of the papers that we have written that basically address this issue, like is it OK to send devices that are not acceptable for US patients to patients in other countries. And so if you ever need some talking points about people who put some thought into the appropriateness of doing this, this is where they can be found. So this is what we have accomplished so far. We have created a collaborative among academic medical centers, the funeral industry. We have standardized the protocol for reprocessing. We've gotten foreign government approvals. We received US FDA export permit for the pacemakers. And we performed a randomized study of safety and efficacy. And we're still continuing to collect data. And we will present the findings at probably ESC if we get our stuff together, which of course we will. OK, so what's our vision for the future? We will continue to fundraise. And we'll offer devices free of charge, as we have. We grow relationship with funeral industry, US physicians, and US hospitals. We need to expand operations to other countries. All patients who receive our devices are entered in our registry. We offer pacemakers to injured and patients and the implanters traveling on missions under compassionate use principle. We grow relationship with Four Hearts and other philanthropic partners, seek FDA export permit to reprocess ICDs, and scale up device reprocessing, as well as collaborate with CRM and EP capacity building organizations. These are the organizations that are currently aligned with what we do. So in addition to the five organizations I've already mentioned before, we've created a relationship with Four Hearts, the Cardiovascular Education Foundation, and Dennis and Jane Rees Foundation. Here's some acknowledgments. A lot of people have contributed to this work. And here's how you can contact either me or our project. Thank you, Thomas. Really remarkable work. We're going to save questions for a little bit later. I should know that Kim Eagle, who was the top on your list, was a former fellow under me. And it's nice to see you still employed. Having said that, I'd be remiss if I didn't mention, at least at this juncture, an organization that goes back decades, Heartbeat International, which actually was under the auspices of Henry McIntosh, who I'd met decades ago when I was chairing a session with him. And essentially, this was to provide new devices through industry and also to provide people out there. And we can address that later. But I think he coined the expression to the point of peacemaking through pacemaking. And it's quite appropriate to these times. If I may briefly mention that. So Heartbeat International is now called 4Hearts. And that's the organization that I mentioned in the presentation. But it does have 40 years of history behind it. It's also nice to see that from University of Michigan, the first, not the first, probably one of the first series that came out was a research letter, not even a full clinical paper, but research letter in JAC. And there were more authors than the number of patients. And I think in the end, no, partly because there are more physicians interested and more individuals interested in this field than the number of patients that we could find in the US. That is the whole point that I'm driving. And in the end, Tom has taken this in his stride with Kim Eagle's tutelage. And I'm very happy that this has gone to this level. I have some scientific questions, which I'll ask later. Thank you. This is for you, just a little bit. Why don't you introduce yourself? So that's not, that's his own. This is your chair. Sorry. Yeah. My bad. OK, so our next speaker is Dr. Nwowo, a case for the development of a cheaper pacemaker. Dr. Nwowo is from the Mid-Atlantic Permanente Group. Good afternoon. My name is Dr. Nwowo. I'm here to talk about how we can get more pacemakers to more people globally. Let me get this slide to move forward. There's a mouse. I was using the mouse. Yeah. Use the mouse. To the right. OK. OK, no disclosures. So I think this is the way to look at this problem is that we have a lot of global inequities in electrophysiology as a whole. So we're looking at inequities in management of certain diseases like atrial fibrillation, sudden cardiac death. Yesterday, we had a session on sudden cardiac death from a global impact. And also, we have to think about bradyarrhythmias and pacemakers because sometimes it's easier to address certain situations than others. So what are we looking at? The global burden of what we're talking about is cardiovascular disease is still the leading cause of mortality and morbidity. In spite of the fact that we talk about infectious diseases like malaria, TB, HIV, and AIDS, cardiovascular disease still has double the mortality of those illnesses. And also, it results in a reduction in people's quality of life and people's productivity overall. So the greatest impact that we see is in Africa, Eastern Europe, Central Asia, and Middle East. And we are still dealing with a situation that is markedly underreported. So what we know is that millions of people in the world need pacemakers, and most can't afford one. And overall incidence of complete heart block is estimated at about 0.04%. And about 1 to 2 million pacemakers are implanted annually. However, over 70% of patients in low and middle income countries never get a pacemaker implanted. So there may be people out there, 2.5 million people, who need pacers and don't get it due to lack of access and due to lack of places that implant pacemakers in some of these countries. So looking at this and looking at the rate of implant in the US, and I think there's going to be slides that show this over and over, about 62 pacemakers per 100,000 persons in the US, and about 103 per 100,000 persons in Western Europe. And we'll have less than 1 patient per 100,000 in some of these countries. Africa PACE program reported a few years back that about 50% of patients die while waiting for a pacemaker implantation. And we do know that in Africa, about 18% of the countries don't even have a pacemaker implant in sight. So the current state is that we have international mission trips that happen every few months in some of these countries. Sometimes patients have a median waiting between diagnosis and intervention of about a year and a half waiting for a pacemaker. And again, the information we have, there's a lot of limited data, the limited implant locations, and marked limits in access to devices, and also monitoring of the devices that are implanted. This is similar to what Dr. Crawford implanted, but this is a slide that shows overall implanting centers in some of the developed world, and a huge reduction in the number of sites that you can get pacemakers in some of the countries that we're talking about. So how about current pacemaker costs? Even when we have implanted sites. The cost of the price of survival. So we have data that shows in the US what usually people pay for pacemakers. The cost of pacemakers, the actual device itself, the surgery itself, hospitalization and professional fees sometimes can be up to 20,000. And other certain parts of the world, in India, you do have costs that vary based on the type of pacemaker, whether it's a single chamber versus dual versus bi-view devices or leadless devices. But again, we have a cost that for most of these countries, this is way beyond what patients who are suffering from this need for pacemaker would end in their whole lifetime. So it's something that really is completely inaccessible. Malaysia, we have about 7,500, depending again on the kind of pacemakers that we're talking about. South Korea, it's about 21,500. They do have an advanced healthcare infrastructure and they do represent a high associated cost. United Arab Emirates, Turkey and the UK. So looking at the prices that we see and for the countries that we're talking about, these are prices that are not affordable by patients in these countries. So several years ago, the first initial study, Mexican doctors published a study that showed that you can actually reuse pacemakers. They had 33 patients that had great indication for devices. Sinus node dysfunction and advanced AV block. 25 of them were new, eight were gen changes and they used pacemakers that had about six years minimum battery life. So this was, and they had a process that washed, they washed the devices, sterilized it at an autoclave and they reported no complications at six months. Then of course, we come all the way to the future and we have the presentation that we just had from Dr. Crawford where they presented it last year at AHA. Again, a much more robust study with almost 300 patients one-to-one as he presented and they used devices that were four-year longevity and as he presented, a very complex reconditioning process. And the countries that were enrolled in this study includes Venezuela, Nigeria, Paraguay, Kenya, Mozambique and Mexico. Half of this, about 80% of the patients had complete heart blocks. So it really was a very strong indication. And as he presented, they presented a 90-year preliminary result which he presented. So again, it did talk to the fact that reconditioned devices does fill a critical gap. However, we know that when these patients don't have access to pacemakers, we're looking at patients that have a high rate of symptoms, higher mortality, recurrent hospital visits because of syncope and loss of income due to poor health. We have patients who, I remember doing my first implant in Nigeria on a young woman in her 40s with three children, she was in complete heart block with a junctional rhythm and she was struggling to raise her kids until she got her pacemaker almost about a year and a half after her initial diagnosis of complete heart block. So we know that pacemakers have evolved. We do have the technology to do better with these pacemakers. There's advances in microelectronics and battery design and focusing on core functions of these devices. It is true that the pacemakers we have have a lot of functions. We've gone from simple Sigma devices to highly advanced MRI conditional devices that many of the companies have. But also we know that we do have a potential for doing something that does not have all the functions that we have on the most advanced pacemaker. So we've gone from pacemakers that were much bulkier all the way to the dual chamber device, the bivy device, now the leadless device. And perhaps in the future we're gonna have a pacemaker that really is self-propelling because the heartbeat perhaps will be the battery that it needs to make it function. So we have a market opportunity that is a huge unmet demand for pacemakers. And with these pacemakers, the low and middle income countries have millions of patients who don't have any access to the actual device. And even as we build up personnel to implant these devices or we increase the number of paces that these pacers can be implanted, we still need to have devices that are so much cheaper than what we have in the current environment. So this is a big impact on health equity and global impact. So again, being innovative so that we can get pacemakers can help us reduce the healthcare burden in developing countries. And hopefully we can intervene earlier so that patients are not waiting a year and a half to get pacemakers. And perhaps we can also empower local manufacturing and training so that this can reduce the global impact of what we have right now. So how do we get there? We have to design essential functionality. Do we need everything that we currently have in a pacemaker? Could we make pacemakers that are a little bit simpler? Maybe we just have a pacemaker with rate response and it will cost us perhaps 75% cheaper to make those kind of pacemakers. So that is something that we need to look at, collaborate with global partners, with NGOs, with places like My Heart, Your Heart, academic labs, to find a way to pilot for low cost prototypes that would allow us to have a better impact to reduce the burden of need for pacemakers globally. Thank you. Thank you, Dr. Ng-Wu. We'll have questions afterwards. So now it's my distinct pleasure to invite my former fellow, Ijeoma Ikeru from University of Texas. And she's going to talk about, you have set up a new device program, now what? Ijeoma. Thank you so much, Dr. Kantaria. So again, my name is Ijeoma Ikeru. I'm actually out of Houston, presently working. I used to be part of the University of Texas now at the Arrhythmia Care Center. But in my spare time, I also do a lot of work with the Cardiovascular Education Foundation and it will be under those auspices that I'll be presenting today. First of all, I would like to thank HRS for continuing to support this session. I think it really provides a lot of information that we need moving forward. And so I'm just going to start off with a case. I don't really have any relevant disclosures. So we had a patient who came into the hospital. He had returned from Italy and he had a device put in and he was being seen in Nigeria. And apparently his device was shocking him and he decided to come to a hospital after he had been shocked about 30 times. So this was the EKG that was initially obtained and there was a lot of drama, right? So the first thing, he went to hospital number one. They said, you don't have a device, you go home. They checked him, you don't have the device. So he says, okay, obviously I have something because I'm getting shocked. He goes to hospital number two where they say the same thing. He says, no, they did this in Italy. So he got a chest X-ray and as a lot of you can probably guess, he had an SICD. So they said, well, you do have a device. We don't know anything about this device. So why don't you, nothing is happening now. Why don't you still go home after they got the EKG? And he was a little bit concerned. So he went to a third hospital and this was the WhatsApp. Anybody who's used WhatsApp, this is how everybody communicates. That was the discussion. They had talked to a Boston rep and luckily we had actually given him or given this third hospital analyzer for an SICD and so I had to tell him directions on how to get it checked and basically we got an interrogation that basically showed that he had been shocked about 40 times. So this brings to the forefront the problem, which is you have a place where you're placing devices. What happens after that? What is all the infrastructure that's needed after you have opened the doors to placement of devices? And you also have to remember that even outside of the devices that are being placed in country, we still have an international society where people are traveling, they get stuff done and then they come back. So just because you have a defibrillator or a pacemaker, you don't stay in wherever you have it placed. You also have to come back to your home country and this is where we now have to start thinking about building this infrastructure that can actually support these devices. So I'm going to use a case in point of the Cardiovascular Education Foundation that started about 12 years ago and has been going strong in Nigeria. This is a brief timeline of events, but basically started off in 2013, over time did a few mission trips. We had COVID and then through great partnerships, we were able to increase the amount of devices that were able to be placed. And so, we've had some success in two different sites. This is an example of the physicians that are there and the devices that have been placed. And this is in addition to doctors who have also left the United States, maybe gone to live in Nigeria, also placed devices as well. So there is somewhat of a more robust device implantation program there. But, initial implantation is just the beginning. You still have to have a complete ecosystem. You also have to look at the unique challenges that these environments have. There are financial constraints, there is knowledge gaps that we sometimes don't appreciate when you live in an ecosystem such as ours, where you can always get the information that you need. And so, this is what we have envisioned, where if you are to have a complete device implant program, you have to set up a device clinic, you have to talk to your referrals. Because not only do you want them to be able to identify patients, you also want those patients who go back to those referrals for the physicians to know how to take care of those patients because you are not always there. There has to be local buy-in from the CMOs, from the hospital executives, from the government and the politicians. You also have to be able to educate the patients enough so that they're able to know what devices they have. For example, in our patient, he was a little bit confused as to did I get a device, did I not get a device? Somebody's chasing me away from the hospital because they say I don't have a device, but I know I have something because I'm getting shocked. There should be no thought process as to, okay, what did I get? So, patient education is key. There is also engagement with industry and I'll talk a little bit about that. So, when we talk about building your team, who does your team include? Physicians, yes, but also physiologists, technicians, basically what we call device representatives here, the people who are going to check the device. In Nigeria, they actually have physiologists, they graduate with a degree in physiology and those are who we have empowered, teaching them about device function. Those are the ones that check the device and we basically said, hey, these are the people who are supposed to be responsible for building up your device program. They check the devices, they're the ones who talk to the patients as well. And then you want to have continuing education for not just the physiologists, but also for your implantation staff, your nurses, your techs, so that they understand exactly what goes on during an implant and they're able to sustain the program even after we've left. For your device follow-up infrastructure, you don't have to only think about the clinical structure, you also have to talk about what happens with follow-up of your devices. So for instance, in Nigeria as a case study, we have patients who are coming from very far away. We don't have a remote monitoring system. So those patients who are coming from very far, telling them to come to a clinic that is probably six to eight, even 10 hours away every three months is not feasible, not just with time, but also with regards to money. So you have to think about what are we going to do to be able to alleviate that burden on the patients while still giving good, adequate care? And what is an alternative to the standard three to six month schedule? The other thing that you also have to think about is whether we can also talk about remote monitoring considerations. Presently, there are certain countries where you can have remote monitoring, but there are others that you cannot. So we have to talk to industry to figure out what we can do. There are complications that can happen as a result of placing devices in patients, such as ICD shocks, device dislodgements, lead dislodgements, pocket hematomas, and also device infections. What do we do about that? And then looking at resource specific challenges. So just because somebody has money to get a device placed, if something happens with the device and you have to take the device out, then what happens? Who pays for the device to come out? If you have to reimplant, who's going to pay for that? Those are things we also have to think about. And of course, prevention is better than cure, but we cannot prevent everything. For the patient support systems, teaching them education and addressing your cost constraints would be the most helpful. Looking at your referrals, educating the referrals. We've had a virtual symposium for the past more than 10 years talking about the different procedures that we do and talking to them about who and which patients are appropriate for these procedures and also what you do with those patients afterwards. We've also talked about referral efficiency, where we have a standardized referral form. If you hit the QR code, you'd be able to see that. Taking just kind of a step away, just for everybody to understand the scope of the problem. Nigeria is a country that's maybe as big as four states. The land mass in the United States is about 11 times that of Nigeria, but yet you have about two thirds of the population of the United States in that small area. And in that area, these are the implant centers that are there, and those are the places that we have device clinics. What I would love to see is probably even if we could have one in the major cities, which would be much more than that, and then maybe in every state, we should have a device clinic so that even though you're not implanting, at least you know how to interrogate these devices. Somebody has an easy area or physician that they can talk to and create a referral network so that they can also get in touch with us. Now, looking at government collaboration, we've talked about this a lot. We have to build a case for support. Data collection is key. Getting a little bit more research. Inviting officials to kind of see the impact that this has on their communities, very helpful. And then finally, talking to industry partners where we can talk about equipment access challenges. PSAs are very important. Still haven't been able to get those, and I keep on talking about that all the time, so if anybody has friends, please let them know. And then also, basically having advocacy strategies to talk to those industry partners. So key is quality over quantity. We have to basically have good equipment access solutions and sustainable growth. Start small, but build robust systems so that we can expand as the ecosystem matures. And remember that implantation is just the beginning. Success requires an entire ecosystem, and patient outcomes really depend on the follow-up system quality. So with that, I would like to thank all the folks that are involved here. If you would like to be involved, please scan the QR code, and that will lead you to our volunteer access form. And I want to leave you with this. If you think you are too small to make a difference, you haven't spent a night with a mosquito. Thank you. if you don't mind. Thank you, Dr. Akaruo. And our last speaker before questions is Dr. Sri Sundaram from South Denver Cardiology Associates. His talk is from intention to impact exploring the effect of skill sharing missions in the global south. All right. Thank you, everyone. I appreciate the invitation. Here, my disclosure is nothing relevant to this. So first, why do we need to do this? Well, we need to do this because the need is there. The patients are there. Remember, in the U.S. and developed world, most of our pacemakers are for SA nodal disease, right? But in the rest of the world, most of the pacemakers are for AV nodal disease. Remember, and hist, Purkinje disease. There's a mortality benefit to this. It's not patients feeling bad. There's actual mortality. And compared to ablation, learning how to do a pacemaker is actually significantly easier to do. So that's where I think our highest impact actually is. Now, we're part of a mission that goes to Cambodia, Vietnam, and also now starting to Tanzania. But I wanted to concentrate in Cambodia because it's where we've been going the longest. So the population of about 10 million, when we first started going in 2013, there are zero EP doctors there, and there were less than 10 pacemakers performed a year. Asia Pacific Heart Rhythm Society lists this thing called a white book. And if you're not familiar with it, what it is is it literally publishes every pacemaker, every ablation, every ICD, everything ever done in those countries. This is 2013. You'll notice there is no listing for Cambodia or for Vietnam. They are just not there. It doesn't exist at that time. So we started going there, and one of the first cases that got me interested in this was this case. And here's his EKG, and I still have it from 2013. Eleven-year-old boy, so not SA nodal disease, but you can see that EKG clearly needs a pacemaker. He was not able to walk in three years. Every time he stands up, he has syncope, and he couldn't afford it. Even if he could afford it, there's really no one there to implant it. And this is with permission. This is actually the 11-year-old boy, and this is his dad. His dad gave us the permission. His dad's on the right. And that's me when I had a lot of hair and Jared Bunch when he looked a lot younger going with us. So we actually implanted the pacemaker. We did this ourselves. This was us doing everything on our own. And so we would come, we'd do it, we'd leave, we felt great, but we're not really making that much of a difference. We need to be sustainable. So the business side of this when you're doing these missions is the products, they come from donations. They come from grants. It's expired equipment. It's a lot of times we're mixing and matching. There's this lead with that header and this pacemaker and this cable. The problems is when you do that and you bring things in, you're really interfering with the local supply chain. You really, what you'd rather do is you want to buy it from the local distributors so they're still invested in the process too. So what we started doing was now, particularly Medtronic's been very useful for us. I'm going to give them a shout out for this, is we buy it from the companies themselves. We get donations, buy it from the companies, and then we buy it from the distributor, from their locales. And then Medtronic gives us this huge discount for it. And then we started emphasizing the need for follow-up and device clinics. So in order to do this and really grow this, you've got to start. This is a lot more hard work than you coming in for one or two weeks and doing it. You have to identify medical students, residents, cardiology federals that are interested. You have to show them what the fun of EP is. I mean, these are fun procedures. We all got into EP because we like it, right? And we have to spend a lot of time teaching ECG analysis, indications for pacemakers. You have to train with the implants. So here's where we started. We started teaching at medical school. This is Dr. Jonathan Lipton, who's actually sitting in the back of the audience now. He's from Tasmania. And he was actually teaching indications for pacemakers. And then the students in the rest of the world are absolutely wonderful in that here they are. They're staying more than an hour after the lecture is done to gain more knowledge. We started going to the residents. This is Dr. Mel Scheinman, who's actually taught the residents. We did EKG workshops every day. And then we go to morning report with the cardiology fellows. So again, we spend a lot more time teaching, educating. With the advanced fellows, we did a little more education. Here we are in the EP lab. Mel's on the left and Jared Bunch is on the right. We actually started our own education conference. At one point, this is pre-COVID, we had up to 533 attendees one year. It's free for everyone. Eight hours of American CME credit, didactic lectures. So you really educate. You spend a lot of time on the education. That's a much harder infrastructure to build than just coming in and doing it. Along the way, we started getting the government to work with us. Or we started working with the government. This is Mr. Han Manet. He was actually a keynote speaker at one of our education conferences one year. And now he's the president of Cambodia. And the following year, we had the U.S. ambassador to Cambodia actually come as a speaker. So this is now, I showed you the 2013 white book. This is now the 2023 white book. The 24 one hasn't been published yet. But if you look, Cambodia and Vietnam are actually made the list now. So the countries that we go to are actually on the list. And these are the numbers for the 2022. So if you look, remember I said we had zero implants without us. Now if you look at a half a year in 2023 at 113, and more importantly, you see there's now six implanting centers and nine implanting physicians. So this is what skills training in the global south can actually do. If you spend a lot of time, you'll go from zero and literally 10 years later, you now have a self-perpetuating process where the doctors there are trained and they're teaching each other how to do it next. Along the way, we did some highlights. We did the first bivy done in Southeast Asia, the first leadless pacemaker, the first left bundle area pacemaker. So we were teaching not just basic bread and butter, how to do a dual chamber, but how to do the more cutting edge stuff. So in summary, build a sustained program. You can't be going there and just doing it on your own. You have to help build it there. This is a decade long process for us. This is not something we can do. Invest in education and start with the medical students. Get them interested in electrophysiology. And then local customs, understand the business aspects of EP. Understand if you're coming in and bringing a donated device, there's some local distributor there that is not gonna be happy that you're undercutting his business. And then start working with the government. And finally, if anyone's interested, this is the organization we go with, the Mel Scheinman Foundation, Dr. David Singh, who's the president or CEO of the organization is right here in the front desk. So thank you everyone. I appreciate everyone's time and attention. Thank you. Thank you, Dr. Sundaram. We invite questions, but if you have questions, please come to the speaker. And while you're thinking about your questions, number one, I would say that if I was a medical student, had the ability to spend an hour with Mel Scheinman and Jared Bunch, who I've known for years, I would do it anyway. I also wanted to address certain issues that I'm gonna mention and not in any order, which you guys might want to address, the speakers might want to address in terms of rechargeable units have been around for years. I have two patients whose devices lasted 30 years because they were able to use programmers, which I still have, where you spend an hour a week recharging units, you can get a lot of longevity out of those devices and therefore fewer battery changes. The older types of pacemakers, I have two patients, one was a Delta TRS that lasted 33 years and a Spectrax SXT that lasted 32 years. Sometimes all you need is a pacer that paces. And so I think we have to address those types of issues. I think the issue of remote monitoring has also already been started to be addressed. I was part of the original CareLink studies. And we were one of 10 centers and one of them most notably was Steve Comptons in Fairbanks, Alaska, who drew upon a radius of 400 miles. So he was very enthusiastic about using remote monitoring wherever possible because it cut down on the problems with direct clinic visits. I also wanted to mention that in certain areas, I lectured in Southeast Asia, in particular in Japan, where the electrophysiologists years ago were chomping at the bits to put implants in. But some of the patients were opposed to having implants on the basis of cultural and ethical concerns. So that even though the need may be perceived, convincing the patients that they may need it is a separate issue. And then finally, the only other question that I wanted to ask, and again, whoever wants to, is that should we be putting in devices if we can't follow them? Okay. First question, or anybody else who wants to answer what I said. I think we have a question there, but why don't we start with that question, so important, and then go in that order. Sorry. So the question is, is should we be implanting devices we can't follow? We've been doing it, and we have done it. And the reason is we know that patients need it. And quite honestly, we all know that most of the time, if you put in a pacemaker, thresholds are pretty good. They're gonna stay probably pretty good. And our problems can occur down the road, and we obviously prefer to follow it and check it. And that's one of the things we've done now is we've implanted essentially a pacemaker clinic that we check at least once a year now. But this is a matter of necessity. If someone needs it to survive, I'm more than happy to put in a pacemaker. Let me point, it happens even in the US. I don't think we should kind of focus only on certain countries. I spent a year in practice in South Carolina, and a patient came after so many years of pacemaker, not followed, with the same exact symptoms, syncope. And that time, the battery was dead. So I think the follow-up is a different issue. Implanting devices for lifesaving therapy, that's a different issue. And I agree with Sai that I think yes, if there's an indication, you implant. Subsequently, we can take care of the other stuff afterwards. My question to you, Sai, is that you started out with saying that the indication in Cambodia is usually AV block. Now that your numbers have gone up, have you expanded, or is mainly still common heart block and high-grade AV block as your? You know, we all have limited resources. And if I have a limited number of pacemakers, I would prefer to do it in the patients that have high-grade AV block. But if we have an unlimited number, or we don't have enough patients, or we have more than enough pacemakers afterwards, we'll do it for SA nodal disease, too. So it's a matter of kind of picking and choosing who needs the pacemaker more critically. Anyone else on the panel want to speak before I allow? I think also the idea of symptomatic bradycardia probably exists, but I would say that the referring physicians focus more on the patients who have complete heart block. It's not that they're not there, but they're just like, by priority, they're being brought to the top. Right in shoes. Yeah. Hi, thanks for the chance to ask a question. My name is Jim Fralick. I'm from the University of Michigan, and I have the incredible pleasure and honor of watching Thomas do this great work. So congratulations, Thomas. And actually, congratulations to everyone. This has been a very informative session, and I've learned a lot, and that's where my question comes from. But I can't help but answer that first question. I think your point is well taken. It's not just outside the United States about the question of follow-up. I would take it back even more. Forget about device. You're getting hung up on a device if you're thinking, does the device need follow-up? Patients need follow-up. And if you take out someone's appendix in a third world country, and they're not gonna get the type of follow-up we would want them to have. If you stent someone with a STEMI, are they gonna get the follow-up? That's a separate question from whether or not you stent them for a STEMI, in my opinion. So I think congratulations to everyone for the efforts you've made. And that leads to my question. I was gonna start by asking it of Thomas, but you all have expertise in different areas. You've identified all kinds of challenges, and you each have tried to take them on in different ways. Infrastructure, education, hardware, follow-up, et cetera. So Thomas first, but anybody else who wanted to enter or answer, where are the biggest choke points right now? If you could address one, whether you're addressing it now or not, what would you put, if you could wave a magic wand, what's the biggest choke point right now to getting devices to underserved populations? Thank you. I think that's probably the diagnosis of the underlying conduction system disease that is most lacking. In this country, we have patients who have monitors. They wear them twice a year. In most of the countries that I've traveled and done some work, there really is an ambulatory monitoring. So you're lucky if you get a 12-lead ECG. And so I think that is, I think the referral's not happening to the cardiologists. There are not enough cardiologists. So I think it's, I mean, there's a lot of bottlenecks for us for the longest time. I mean, we've been around for 15 years. The longest time, it was the government letters because as a University of Michigan organization, like we had lawyers who told us you can't do it without government approval. So, I mean, we spend an inordinate amount of time just trying to convince somebody to sign a letter saying that we were not breaking the law. And then that, interestingly, what would happen is that, so the FDA approval for export permit was contingent on the government. But the government was willing to write a letter if the FDA already approved it. So it's almost like catch-22, like somebody has to go first. And so I think what I'm really hoping is that the momentum will build. And if the products are available in many countries, more people will join. And so I'm hoping that there is this kind of magnifying effect and that patients will be able to get those devices when they need them. The other bottleneck, thank you, Thomas, for everything that you've done. The other bottleneck that I would say that we definitely have to appreciate and becomes more apparent once you have the availability of devices, right? And you have the patients, is the fact that this costs money, right? And so for the patients who, in a lot of the countries where we work, they are in a cash pay system where you have to pay some amount of money and the government doesn't really, they cover little to nothing. And so when you have that sort of situation, then of course, if I have to pay for everything, I don't go to the doctor, period. And I don't go to a doctor to get referred to a cardiologist who then refers me to a specialized center where I can get the implant done. And so if we can fix that problem, which that's where the advocacy in front of government to basically say, hey, can we have a basic system where the patients can at least get the diagnosis, then that will do a lot in fixing the problem. I'll let you in a minute. I think to what Tom say about breaking the law, not breaking the law, you are lucky to have University of Michigan behind you. When I started doing this, I was on my own. And in a way you are breaking law, the OSHA, one time use FDA, and you still kind of collect the pacemaker. All the things that you showed that your staff is now doing is what we do individually, cleaning, removing the data of the previous person, taking it to the leading countries and whatnot. So I think it is not as simple as it sounds. And my question for you particularly is that, have you extended your good work from pacemaker to defibrillators? We have now patients who are on the third or probably fourth defibrillators refurbished who would have been kind of not alive in a situation like that. So have you started doing something like that? Yes, so originally we were actually intending to use defibrillators as pacemakers as well. And since we went through the motions and the whole process with the FDA, they said, you should first show us safety and efficacy of pacemakers, and then we can talk about the high voltage devices. And so we are actually currently in the process of submitting the ICD workup, but it requires the ability to discharge and to recognize the signals of both sensing, which is very different than a pacemaker. So it's, I mean, it takes people with computer background engineering who are helping us with this. And then there's also the issue is like, once you implement a defibrillator, it's much more problematic if there's a problem, right? So if the patient gets multiple shocks, will they be able to present somewhere where those shocks will stop if they're inappropriate? Yeah, in terms of safety, there's plenty of data now. And you showed very nicely the protein contents, much, much, much below than the expected level. So with that amount of protein level, you are not going to expect the infection rate to be higher or some of the immune reaction to be higher than the de novo pacemakers or de novo devices. Your questions. So I have two questions. One, I know years ago Medtronic Foundation had a couple year grant where they were sending a physician and either a nurse or a tech to learn how to do pacemakers. They go six months to the University of Cape Town and with the goal of having one implant or in every African country. So the question with that is what do you guys think as far as the pros and cons of such a model? That was, so that's one question. And the other is talking about diagnosis being a limiting factor. Getting a six lead EKG would probably be enough for most rhythm issues. What, or do you think there is a technology that would be helpful in more, let's say, remote clinics? Because I've spent a good bit of time in Africa and the cell phone service is great. And you can send, I've looked into it, you can send for one penny an EKG to a center and so forth. But is there a technology that you guys are aware of that would be more amenable to that than another? So one about the Medtronic Foundation model and the other is diagnostic. So I'm not sure about the current state of the Medtronic model, but I know that they do support what we do by donating devices. I would say that the structure, because we're trying to do skill transfer to the folks in Nigeria, we don't have an EP fellowship. And so we have physicians who are trained, sometimes they spend time in India to train as interventional cardiologists. So those are the people that we transfer the skills to. I mean, ablation is a different ballgame, but we're trying to get the low-hanging fruit. So we do try to get the interventional cardiologists who have done some training in India to be the implanters. And that has been very successful with respect to skill transfer. Because when somebody has complete heart block, they can't wait for the next mission. And the second question was about using any other kind of devices but 12-lead. I know that some parts of the country are using the cardiac device, because really you don't need a 12-lead. If you see the P waves matching without the QRS, you have your diagnosis there. So more and more we're encouraging physicians to use whatever is available to them without having, because a 12-lead machine is not available in every big hospital. You'll be kind of amazed. So by that means of documenting rhythm, like smart watches, smart devices, and the cardiac devices, we do use those. And we often get WhatsApp messages from physicians out of the country saying this is what we have, and we're able to tell this is what is going on. And with regards to the training of physicians, I think that if they were still doing that, I think that that would be a great model, because a lot of physicians would love to spend time in a high-volume center. The limitation of that is, and that's basically where we come in, is when they've gone out and trained for a little bit, then they have to have somewhere where they can actually cement their skills. And that's where support of programs like ours, where we do missions ever so often at a center of excellence, is very helpful to that physician, so that they will have somebody watching them over a period of time. They'll have a steady supply of devices for them to implant patients, and they're able to cement those skills that they learned over a six-month period. So the learning part, we actually have a few physicians who have gone outside the country, like Dr. Ngo said, have gone out of the country and learned, but then they come back to Nigeria, and then there's a dearth of cases, and then they lose their skills in a year or two. So I think support of, you know, both with personnel, as well as with folks volunteering to go, is actually more helpful than you think. All right, well, thank you all for your attention. This has been a remarkable session. I wanna congratulate the speakers and all the work that they've done. And this is a problem that's not gonna go away. We're gonna hear only more and more about it, and hopefully there are solutions on the horizon. Thank you for all your attention.

Heart Rhythm 2025

cardiovascular diseases

pacemakers

developing countries

device sterilization

healthcare disparities

My Heart Your Heart project

affordable pacemaker alternatives

skill transfer missions

remote monitoring technologies