Okay, so I'm using as a case study PFA, Pulse Field Ablation, which is the hot new thing. This is the golden age of EP and so I'm using this as a case study from how do you get new tech, what your hospital administrator needs in order to get the latest and the greatest. So really quickly, how did we get PFA to the HCA Mountain Division? So I am a clinical electrophysiologist at St. Mark's Hospital and I have one third protected time to do administrative where I'm head of cardiovascular for the Mountain Division of HCA. So I have all the hospitals from Utah up to Anchorage, Alaska. So we knew PFA was coming. We knew it was big and our EPs wanted it. Because of the decentralized nature of HCA, I had to convince six hospital CEOs to get PFA right from time zero for our EPs. So we have six EP hospitals in our division, six CEO decision makers. We have six HCA employee EPs, six private practice EPs and our center of our tertiary care center for the Mountain Division at St. Mark's Hospital in Salt Lake City, Utah, which is where I am from. We do half of the ablations for the division. So we started with St. Mark's and if we could get St. Mark's, then the goal was to get the other CEOs to all fall in line. So St. Mark's Hospital, we have two EP labs, two EPs, we're both HCA employed. You can see Dr. Nana Panini and then myself. We have zero private practice EPs, but yet we do 51% of the ablations in our division. So what does a CEO need or a hospital administrator, whatever you may? In the HCA system, it's the hospital CEO. In different healthcare organizations, it may be a different decision maker. So what are the five needs? And we had to do this six times and as a representative for my physicians, we had to fight, I helped fight the battle for six CEOs for them. Number one, financial impact. What are the costs? What is the capital? If you can avoid, capital is a dirty word to an administrator. It's part of a budgetary cycle and it will kill many projects. You have to be thinking several years in advance. So if there's no capital, it's a lot easier. What are the savings, if any, for the hospital and what is the revenue? Second thing a hospital administrator wants to know, patient outcomes. Is this going to improve quality, safety, and patient scores? Is this going to help their Google ratings or their Yelp ratings of their hospital? Number three, which is a headache for administrators, regulatory compliance. Is this something that's going to help them with CMS or JACO, which is now Joint Commission? Operational efficiency. Is this going to help workflow, decrease length of stay, complications? And then, is there a strategic advantage? Is this a hospital differentiator or are you out of the game if you don't get this technology and will it help to bring in new patients in the door? Fortunately, in the case of PFA, it really hits on four out of these five. And so that right there is one aspect that was working in our favor. So what about for a physician? As a physician, and in my case I represented our EP physicians at six hospitals, what are the steps? And each hospital may vary, but in general, you can see me here looking down thinking how are we going to make our AFib ablations easier by getting this technology. Number one, clinical evidence. You've got to speak in the terms of your hospital administrators. You can't do physician speak. And so clinical evidence. Why are the patients going to do better with this? Next, what is the business case for it? What are the costs? Capital, savings, revenue. In this case, in the case of PFA, costs definitely, a big step up in costs. Capital, fortunately, with bulk purchases, we could avoid it. Some of our hospitals are high volume, some are lower volume. We did it through our division office so that the higher volume hospitals could carry the lower volume hospitals in our division to get the best rebates, absolute lowest cost for all of the hospitals in our division. So working together as a system got us much better pricing. Savings, this was something working with the physicians. Do you absolutely have to have that second ablation catheter? And by allowing our physicians to know what was involved made it easier to swallow. And then from a revenue standpoint, what was it going to take to bring in revenue to offset all of the new costs? And in our case, we have good reimbursement in the Mountain Division. For us and my partnered site, we have a dyad, I'm partnered with an MBA with accounting training. He's the one that put together all the spreadsheets and that for our CEOs. The bottom line is we had to grow our volumes 20% for our division to break even. So 20% was our number. You need to have a physician champion. If you don't have a physician champion, good luck navigating through these hospital administrators. You got to have somebody who can speak their language. Number four, the new tech needs to align with the hospital goals. In our case, we wanted to be the premier cardiac center in each of our markets. And so PFA aligned nicely. Fifth, and this is a backup, if you can't get it through as a physician, this is your backup. If you can't tell your administrators aren't with you, then the fallback position is, can we just do a pilot or a trial? Let us do 10 cases and then we'll report back our findings. Fortunately, I did not have to go to number five for any of our six hospitals. We were able to present it to them. And in our case, for our division, 20% growth in ablations is what we had to make it work. So what happened at our six EP hospitals, all six hospital CEOs approved it. And these are our numbers for 2024. Many of our hospitals didn't get PFA till the second half of the year. You can see in our division, we were able to grow ablation volumes in 2024 versus 2023 by 52.4%, which is three times what HCA Healthcare nationally was able to do. So how did we blow out these numbers? Well, it came down to, we did not have any new net EP, so it wasn't by hiring. We did replace one EP in our Idaho Falls Hospital. Our low volume hospitals with PFA were able to go from one ablation a day to two, predictable times. Our higher volume EPs were able to go from three a day up to four or five a day in a single lab. Really also that played a role, because we were the first in every one of our markets, and this was something we focused on right from time zero, many private EPs switched where they wanted to do their cases to HCA hospitals due to access to PFA, the technology that they couldn't get at their other hospitals. And this fortunately has continued into 2025. The other hospitals, basically we forced a change in all of our markets, because in order to compete, they needed to adopt this, and this loyalty is now persisting, as they could see that we were a champion for the physician, a champion for quality, a champion for new technology, and it's continued to help us into 2025. Thank you. Thank you very much, John, for this very interesting advice to discuss with your medical administration, and I think that next time I have to discuss with my administration in France, and we'll invite you definitely. You have to start ahead of time. So now we will move to the next topic, and Richard will give the topic about the large healthcare system goals. So you have no slides, so you can stay. I have no slides, and I'll speak from right here. So just by background, I'm the chief clinical officer. So I am electrophysiologist, but I'm also the chief clinical officer for a large system in the U.S. with well over 100 hospitals in 20 different states. So I agree. So I am the hospital administrator. You're the bad guy. Well, I'm the guy that's going to... But we're good friends. Yeah, we were. So I'm the guy that's going to make sure that you're making a good case. So we can talk specifically about PFA, but I'd like to speak a little bit more broadly. You know, the very first thing that you need to think about, and even though, you know, I think hospital administrators sometimes get a bad rap, or health system administrators get a bad rap, but at the core, the business is healthcare. So you need to start with, why is this better? Why is this safer? Why does this create better outcomes? And what is the evidentiary base for that? Now, you don't need to, you know, volume does not necessarily make an evidentiary base. You also don't need multiple, randomized, double-blind, placebo-controlled trials. You need to be able to make a good case because if you bring in a new technology, I'm going to say, I'm just going to ask the question, why is this better than the old technology? Is it safer? Can you... Is it more efficient? Is it less costly? By the way, it's usually never less costly, but that's just the reality. So that's the first question. You know, I've always believed you put the patient, and I think maybe afterwards we can talk about patient goals and what's important to patients, but I think you need to put the patient at the center of all the decision-making, and I've also believed that good medicine is good business. The second thing is, it would be very, very, very naive to believe that there's not economics involved. And Dr. Day is exactly right. There are two expenses you have to understand. One is called CAPEX, capital expense, the other is called OPEX, operational expense. If you're going to buy a big PFA system or a big system for everything else, you're going to be asking to spend money from the balance sheet, money from capital. There are a lot of demands. There are... You know, I would say every week I'm being asked for three to four capital projects. So not only does Dr. Day want his PFA, but somebody else wants their newest and greatest technology, and also I've got a fleet of 1,500 ventilators, of which I've got to replace 200 of them at $100,000 per ventilator, so there's a prioritization. So you've got to make your case. You've got to show me where it fits in the priority. That's the capital side of things. You also have to look at the operational side of things. We would call that OPEX. How is the operational expense compared? Is there new operational expense? Are you cannibalizing old procedures? Are you taking old contact force sensing catheters and now replacing them? You really do need to work with a DIAT partner or be able to present a very compelling case financially. We would say, what's the return on investment? And Dr. Day, he didn't use that phrase, return on investment, but he did say that they needed to break even, and the break even, I think you said, was a 20% growth. 20% growth in volume. Right. So my question is going to be... So your markets could support 20% growth. My question is going to be, to anybody who comes to me across a broad system, how are you going to grow 20%? Are you saturated? What are your marketing plans? What are your growth plans? There's an old saying, first to market, first to bank. If you're the first in a geography, if you're first in a city, you may very well just get that because it's the newest technology. A lot of times people bring me technologies because it's new and cool, but I have to then say, what's the priority and will it really bring new volume? Generally revenue positive. So income minus expense, you want something that's revenue positive, that's the ideal. Things that you can grow are going to be supported. The other thing that I think is really, really important is to be very transparent and come in and know what you don't know and not try to present something that you don't know. I've seen too often docs come in to talk to me and they really don't understand the financials or they bring me the financials that were produced from industry. I'm like, that's great, but industry doesn't know our reimbursement. They don't know our contracts. They may know Medicare, but they don't know our contracts. They may say they do, but those contracts are pretty confidential. Just be honest about what you know, be honest what you don't know, work in partnership. The last pearl I'll say is it's really important to be transparent and candid. If you have a relationship, and I don't have any on my disclosures, I have no relationships, but if you have a relationship, you need to disclose that to me so I can view the context in that framework. Because if I find out that there's a relationship and you're a consultant for that company and you're receiving significant dollars and you haven't told me about that up front, it's going to cause me to question some things. So I would say most hospital administrators, most health system administrators, despite what you may think, we do care about the patients, we do want to lead with quality. Quality is our product. And honestly, the best way for me to grow my business is to have the best quality in town and then patients want to come because we're doing the right thing. Thanks. Thanks so much for that great perspective from physician and from a healthcare systems leader. So I think that gives us a really nice segue to invite Dr. Ken Stein, cardiac electrophysiologist and the current global chief medical officer for Boston Scientific, to talk a little bit about what industry can do and what industry's interests are. Thanks, Ken. Yeah, thanks. And maybe for Rich, I'll begin with my disclosures. So I am an employee and shareholder of Boston Scientific. I think two other important disclosures. Up until the beginning of this talk, at least, I'm friends with everyone on this panel. We'll see at the end. And also, I am an AF patient and I have had an ablation. And I think I just want to begin with that. AF is epidemic in this country. There is much more AF than we have previously recognized. Estimates are U.S. adults over the age of 40 have somewhere between a one in four and a one in three chance of developing atrial fibrillation at some point in our lifetimes. And there is an absolute need for a system that is capable of treating those patients safely, that is capable of treating those patients effectively, and that is capable of getting those patients access to those technologies that treat them safely and effectively. And access is a function of a lot of different things. It's a function of cost. It's a function of price, which is not always the same thing as cost. It's a function of capacity and it's a function of training. But I think, I hope we are all agreed here that the goal that every one of us has and success for every one of us on this panel is getting patients access to those therapeutic strategies that safely and effectively work for them. So how do we do that as industry? Well, again, it begins by considering every one of those three things early on as we start developing any type of innovative new therapy. So we think very hard from the very get-go, you know, not just is this a shiny new toy, but why are we developing this toy? What is the major unmet medical need that it serves? And again, to Rich's point and John's, you know, how is it better, all right? Because I've got no interest in making things that aren't better. And I can be a lot more successful if I do make things that are better. And again, better is safer. Better can be more effective. Better can be more efficient. But better has to be sustainable. There was an economist named Herbert Stein, no relative of mine, but an award-winning economist who won his award in large part for promulgating what became known as Stein's Law. And Stein's Law states that things that cannot go on forever will stop, all right? And again, non-sustainability is a god-awful business model for all of us, all right? So we do focus from the beginning, and again, to take PFA as an example, all right, our initial investments in the company that became Farrapulse, that then became this PFA revolution that we're using as the case study, began over a decade ago, all right? And the reason that we invested in that company back then was this promise of a technology that, because it could be relatively myocardial selective, held the promise of being safer. Because of that promise of being safer, held the promise of also being more effective because you can deliver lesions in places where you're just prohibited when you're using thermal energy, and had the promise of greater predictability. And I think that that has borne out with the clinical evidence. And another thing where, you know, honestly, I am in violent agreement with everything that you've heard previously, right, is, you know, we don't expect you to trust me when I say it's safer, it's better, it's more efficient, all right? You have to be able to back that up with clinical evidence. And so, for example, again, just to use Farrapulse as the poster child here, and it's not the only poster child, I could have used other examples. We have now, in the year, slightly year plus since approval in the United States, seen over 200,000 patients treated worldwide with the Farrapulse system. There is published clinical data, and a thank you to some of the folks I see around here who are part of those publications, but published clinical data on approximately 20,000 of those patients. So, in other words, one in 10 patients who've been treated with this system to date actually have results that are published, and that includes, right, both large-scale randomized clinical trials, but also prospective registries, real-world evidence, data collection, right? And that's why I can be as confident as I am in stating the advantages of using this system, and I do believe it's absolutely been foundational, right, to that kind of growth that John was talking about. The other important thing about technology innovation, right, is one of the unique things, I think particularly about our field, is technology innovation isn't one and done, right? And there is also a constant need, right, not just to be the first to innovate, but also to continually innovate. And so I think one of the good examples of that, again, that I'll take from TheraPulse, right, is, you know, it would have been very easy to launch that TheraWave catheter and talk to John, and John's got it in every single hospital he can get his hands on and say, hey, this is great, but we didn't stop there, right? We've already got a second-generation TheraPulse catheter out, TheraWave Nav, and one of the very deliberate reasons to do that, right, is because with that Nav-enabled catheter, if you're doing a mapped AF ablation, you no longer need to pay for a separate mapping catheter, right? That is a catheter that is a technology innovation that very literally does lead to a cheaper procedure cost than the prior generation. And, you know, I think maybe just the close on that, then, is, you know, we have to have a focus, right, not just on bringing out shiny new toys, but, again, on proving to your satisfaction that they're better, but also doing that kind of innovation in a way that's economically sustainable that, again, gets you back to the how do we get access to our patients? Because the major problem today in AF care for our patients is not that we don't have therapies that work. It's that patients don't get access to those therapies. And that's true in the United States. It's even more true internationally. Just the one last thing I want to say, again, up until the latest political upheaval, I also had a lot of friends in Canada. The great thing about EP research in Canada, right, is Jason Andrade, Jeff Healy, a number of fantastic electrophysiologists there who proved the absolute importance of early intervention in atrial fibrillation. Waiting lists in Canada to get an atrial fibrillation are 9 to 12 months, right? They are as long as has been proven detrimental to patient outcomes as was proven in Canada. And so maybe my plea to all of you, right, is that we've got to get a way to get more access to patients who need AFib care, whether it's ablation, whether it's Watchman, whether it's lifestyle intervention, but whatever it is, we've got a capacity and access problem that needs to be solved urgently. Thank you very much, Ken, and very interesting. We will ask you some questions after the two next talks. The next will be the perspective from a practicing physician, it's Michael Lloyd, who will give us his perspective, and you have no slide as well, right? Well, like the speakers before me, I don't have slides, it's five minutes, what the practicing physician needs with new technology. And I will continue this theme of PulseField, just to keep it coherent, and I think a lot of us don't care about a lot of the things that maybe are very important to administrators and important to industry, and it's much easier for us because it's really patient focused. And the first thing, the first thing is safety of a new technology. And if, you know, in my medium length career so far, I've never seen such a revolutionary shift such as PulseField, but that has led to some maybe unintended consequences, some blind adoption, and we've seen some signals that there may be issues, thromboembolic. Two minutes ago, there was a release from Embargo that will talk about long-term coronary. So I think above all else, for the physician, a new technology has to have safety as number one, and I worry a little bit about PulseField, I drank the Kool-Aid, I'm a complete adapter of the technology, but we just don't have long-term data yet. So continued vigilance on the part of industry, but more importantly, continued outspokenness on the part of physicians, which we are terrible at. Take the leadless pacer example. Industry will report what they know of, but if they don't know, it's not going to be reported. We have a poor track record of submitting our bad outcomes because we want to forget them. And we, you know, there is a database out there that is underutilized, so I think we could do a better job. That's what we need to do. The second thing, and this is just exactly what Ken said, the second thing is efficacy. For PulseField specifically, and as with any ablation technology, the holy grail is knowing when you've made an effective lesion. And I still believe that we don't have, we haven't reached that point. We haven't reached that point yet. Malleability, maneuverability, obviously, is critical. One thing I would need from our administrators is a much easier way of trialing validated products in our clinical use, trialing them before we come pleading to you to make a financial case, to see if it's in our hands an important tool or something that we think would help with our patients. And finally, and I hope Dr. Stein doesn't get mad at me about this, but finally, especially with PulseField, we need versatility and compatibility. What do I mean by that? The pacemaker leads early on were not IS1 or DF1. They were all separate. And then finally, someone said, whoa, whoa, this is too big. Everybody needs to play nicely in the sandbox. Everybody needs to plug in to, you know, X, Y, or Z's impulse generator. And I think the same should be true for PulseField, that one catheter of the six that I've heard at this very session has to be able to plug and play with a variety of mapping systems, which is maybe not financially the best for the specific company, but would be the best for specific hospitals who only have a certain mapping system. That's access. Only have a certain mapping system. Or only have a good set of mappers. So I'll end there. Can I just, I want to, because I, no, I want to hug you. I don't, I don't hate you at all. So we, in fact, if you look on this exhibit floor, there are some of our competitors who are out there bragging about how well they can track our catheter on their system. We have made a very deliberate decision to do exactly what you asked for, which is not to lock down Farrapulse and require that it be used in our system. We hope that you would. But again, I absolutely agree with you. Anyone who has to force you into their ecosystem doesn't have the right ecosystem. Again, I don't hate you at all. No, good. Well, I mean. At least not about that. And that speaks to access, and it speaks to safety, I guess. So I'll shut up. Thank you. Thanks, Mike. A nice physician perspective, and I'm going to invite next Jose Osorio, who has some slides, another physician perspective as well. Thanks. I'm sorry. I'm breaking away from the tradition here. I'm going to use some slides and apologize for being late. I was coming from another session. So I'm going to take this, throw a curveball here, and get this discussion. I'm not John Day. I'm going to get this conversation. I'll talk a little bit about my journey with outcomes data collection, building large databases, and what that did in terms of collaboration, both amongst physicians and also collaboration with industry, and how that actually impacts physician well-being and burnout, believe it or not. So we have seen breakneck speed of innovation over the past five years. You all know that. It took 30 years of RF to get to where we started with PFA. But the journey is far from over. There are new PFA-related complications. There are potential signals about stroke. So there's a lot of work that needs to be done. Really, when I started doing AFib ablations, I felt uncomfortable with the idea of doing an AFib ablation and not knowing what my own outcome was. If I'm doing an ablation on you, you are my patient, what is the success rate? Is it 80% or is it 40%? I don't know. It obviously changes with your skill set. So reading on a clinical trial and quoting to a patient, I was uncomfortable with that. So I started collecting outcomes a long time ago. Every patient, we standardized how we see patients. We followed them for one year, do monitors, echoes, and what started with a retrospective chart review, access database, then created a software for it. And what that gave me is really this ability to track all of the outcomes, all procedures I did for over a decade. And you can see how many insights you can have with each new technology that was released. I see that it doesn't progress well, but you see procedure times decreasing as we started using contact force. Procedure times increasing significantly when I shift to a different hospital or when I hire the new physicians. Decreasing again when I started using high frequency, low tidal volume. And look at the RF time per procedure decreasing from mid-20s to about 10 minutes, highlighting how much more efficacious we're effective with our lesions. So this became a way for even to introduce new technology. We had, for example, an example of a catheter that was $400 more expensive. We were using for niche and immediately realized that patients were going home and not coming back because of heart failure, volume overload. So this is very important. Collecting outcomes, you see that. So the first lesson learned for me, this is not my idea, was if you don't measure, you cannot do quality improvement. This is important for hospitals. This is important for physicians. This is important for industry. And this is something that I think, unfortunately, through our training, we look at quality improvement as someone with a board telling you what to do. I think quality improvement is not research. It's part of clinical care, and we all should do. But the more important thing that I learned is when I started doing these large registries and collaborating with a lot of physicians. One thing is you're doing quality improvement in your own silo, your own institution. When you are now collaborating with 30, 40, 50, 200 physicians, I think the possibilities are just absolutely, you know, limitless what you can do. And believe it or not, one of the areas of research that we went to, unexpected, and really after I talked to Sam Sears, who's here at HRS a few years ago, he said the model of registry you're doing, the model of data collection addresses burnout. So it is really interesting to see that. The best paper about burnout, which I think highlights how healthcare systems are addressing burnout the wrong way, is that burnout is about motivation. Intrinsic motivation is deriving the reward as the task itself. You have to consider the human factor, and the pillars for you to improve intrinsic motivation are autonomy, competency, and relatedness. Physicians typically practice in a silo or in a hospital don't talk to another physician, particularly if you're not in a large academic institution with seven, eight, ten electrophysiologists. A lot of us are in of one or two. So the ability to talk to other physicians, the ability of a private practice electrophysiologist to collaborate with an academic cardiologist, this is very important, and these models don't exist. Going beyond that, doing that supported by industry in a completely different model, I think it's very unique, because then we're all part of the stakeholders that are supporting better care. So if you consider now this, supporting better care, I think it's for us, physicians, hospitals, and industry, and we can do that by prioritizing quality improvement and collaboration. You have to be stakeholder-centered, the hospital, the physicians, and industry. That's how it needs to be not only designed, but also implemented, and I think we fail at that if you're not being stakeholder-centric. And finally, innovation has to be physician-led or with collaboration from a physician. We need to either drive or collaborate with industry, both with how technology is designed and then adopted. Once a catheter is released, that's really not even half the work. Understanding the best workflows, understanding how to avoid complications, I think it's imperative for us, and we can do it as a team, hospitals, physicians, and industry. As an example, we've launched this Disrupt AF Registry, which is sponsored by Boston Scientific. We've collected over 2,000 patients with monitored data sets. We have data on safety, efficacy, sub-studies that are being done. This is bringing physicians to the creation of where this therapy is going to be going. Thank you. Can I ask my fellow panelists a question, just to be provocative? If you look at the title, it's VBC, value-based care, a large health system perspective. And we've been talking about PFA. But from a large health system, let me pull back a second. I can completely agree with Dr. Stein that access is critically important. But my question is access to what? So is it better for me to spend a million bucks and buy a PFA system, or is it better for me to spend a million bucks and go to a very underserved, vulnerable population, get their hypertension treated, get them access to primary care, get them access to statins, and maybe access to GLP-1s, which are coming down in price? Am I going to affect the population more globally if I spend that million dollars treating, I don't know, 100,000 patients with better access, or a couple hundred patients with a PFA system? I don't have an answer, maybe the way I'm asking it is, but I'm trying to be a little bit provocative here. Because certainly I do believe that PFA and AFib ablation technologies have a role, but I also think that if you look at American health care, we spend a lot to treat sick people. We don't spend a lot to keep people from getting sick. I think it's a really difficult question to answer. In some ways I think it's a bit of a false dichotomy in that I don't think any of us on this panel are in a position to make that tradeoff. Well, I am. So that's the decision point for me. Rich, I don't know that you really are. Again, I think you can choose to invest in aspects of all of that, right? But the issue, particularly of preventative care and improving social determinants of health, goes way beyond any of our individual capabilities and is fundamentally a political problem, all right? And how you allocate spending for social welfare, right, really is something that, for better or for worse, gets solved via elections. Because we can all do what we can do individually. And I think it's also a bit of a false dichotomy in the sense that, you know, why not do both? And I think this gets something that almost all of us were talking about, and you were talking about it too, right, you know, instead of choosing between spending your money on ablation versus a Zempak, right, let's talk about not spending our money on things that we know don't work, and yet we spend money on it anyway, all right? We waste a heck of a lot of money on health care in this country and across the world, on things that we know not to be effective, all right? And we spend an awful lot of money on things that aren't proven yet whether or not they're effective. So I think if we've gotta cut something first, right, let's cut the things that we know based on the evidence that don't work, let's stop giving out antibiotics for the common cold, for God's sake, right? You know, let's look really closely at some of the ways we manage people with chronic back pain, right? So, yeah. Ken, I think, you know, I'll just sort of add to that a little bit. I don't think you can sort of say pick one or the other. I will 100% agree with that, only because you're talking about AFib as a continuitum of care for the patient's lifetime, right? You have to treat the patients who currently have AFib, who are suffering from their symptoms or having heart failure or will develop heart failure, for instance, but you also have to prevent the AFib that is going to happen, which is longitudinal. If you invest in that now, you're gonna see the effects of that 10 years or more later, right? So that's my personal opinion. And if I can, and maybe the one other thing, and that's why I was just gonna say, if there's one talk that people come away from this remembering, again, do apologies to everyone else here, including myself, it's remember Jose's talk, right? It's, you know, the best way to deal with this is to keep gathering data and continue to analyze outcomes. And, you know, let's learn from every patient who gets exposed to any one of our technologies. And I just think, I think what you're doing, you know, just needs to be continually applauded, because I think it is the best path forward as we try to solve some of these dilemmas. I fully agree with you, and the talk by Jose was excellent, and I like your sentence to consider patient as he was in a clinical trial, because I think it's very important. If I ask all of you, what is the number of complication you have per year, if you don't have a registry, you don't know. And everybody want to be optimistic. I'm sure that the number you will give me will not be the right one. You will forget some complications. So I fully agree, especially for innovation. I think it's very important now, when we discuss with the hospital, when we discuss with the regulatory affair of the healthcare administration, because in Europe and in France, we face the same issue. I think it's very important to show that we follow very carefully the patients. We will know exactly the rate of complication, the length of stay, the switch from complete hospitalization to ambulatory as well. So I fully agree with you, that is something we should do all together. From the perspective from the hospital, it's possible we have the resources, but we need money for that. And I think that, and I'm very keen to know that Boston give you some grants to have this registry, and also we have to have the administration also. For example, in France, for each study, you have to fill a registry with a follow-up of at least one year, which is not so high. But if you don't do that, you lose authorization of study. And I think that is something for the future to implement. Another comment, I think that somebody is missing in this panel, it's a patient. Yeah, that's exactly right. I was, when I read the program, I say, oh, perhaps one of the two practicing physician is perhaps a patient. But I think that the patient should express what they want. Because when you discuss with your patient, the perspective of the outcome is totally different. Just about AFib, there was a huge registry between patient, a questionnaire between patient and physician. Do you know what is the worst complication for physician? It's bleeding, because you give anticoagulants and you feel responsible for that. But when you ask the patient, the worst complication is stroke, because they know that probably they will not recover from the stroke. So I think that now, in all our discussion, in guidelines, probably for the industry, the development of innovation, patient should be also present. And if you do the same session next year, I think you should invite a patient for that. So our most recent guidelines, I think it emphasizes quite well that you should be treating the continuum, right? And you should focus on lifestyle. And the risk factors. But it is extremely frustrating as an electrophysiologist, knowing that you're the fourth physician that saw that patient, that the blood pressure is still 160. And that I have two nurse practitioners that maybe 70% of their time is doing a hypertension clinic. Because that's the way to get patient good outcomes. But I think we have to focus on both at the same time. Yeah, and I didn't mean to imply that it's a dichotomous choice. But I think that too many times people get seduced by the bright and shiny object, the cool technology, the thing that's neat. And they glom onto it. And yes, we've made it about PFA, but there are hundreds of requests that come to me every year. And really just prioritizing what is going to have the maximal input to improve the global health. Yes, I think of course we should have effective atrial fibrillation ablation systems. And there are people that no matter what they do with their blood pressure control. But I also know that there are patients that we've all seen, they come for 5V pacing. And they're not on an ARNI. They're on 3.125 twice a day of Carbidolol. And you're thinking, they were referred to me for the 5V ICD, but they're not even close to guideline directed medical therapy. So the patient who comes whose diabetes is not controlled, whose hypertension is not well controlled, who's had two five minute episodes of atrial fibrillation to take it for their smartwatch, I hope we're not ablating them. But I'm gonna tell you, somebody's ablating them. And that's on us. Because we gotta make sure that it's the right people. And just because, to a man with a hammer, everything is a nail. I just don't want PFA to be the hammer. I think that's a fair statement. I think when you talk about the longitudinal, big population care that's gonna prevent AFib down the line that requires a large investment from governmental systems and reimbursement systems to make that a priority. And I think in the US it's difficult because I know prevention doesn't get as much reimbursement as it is currently. But I also think it's fair to believe that it's not only the government that's doing that. My system gets two billion in community benefit. So, that's a lot of people. I should say healthcare system change. Maybe that's a better way to phrase it, right? So, and one of the things I do see is inordinate access issues. If you were gonna ask me what the biggest problem in healthcare right now, it's global access. People just aren't getting seen. They're not getting their primary care docs. And I know it's not only in our system. It's everywhere I am. They can't find a primary care doc. So, I don't wanna go down that tangent. I'm just saying that PFA is a very, seems to be safer, seems to be more efficacious, seems to be faster. It's just, it has to be part of a continuum and we can't always chase the bright, shiny object. Well, I think that also we have a responsibility as academic physician to teach to the students. Because now, when you look at the new generation, and I don't want to criticize the new generation, but they are very excited by innovation. PFA, it's fantastic. You go fast. You do ablation, ablation, ablation. And sometimes I call for my young fellow ablationists. They are not more hippy. They just want to do ablation, ablation, ablation, ablation. And they're very happy because they did five or six K in a day. But I agree with you, when you look at the record of the patients, hypertension is not controlled. Diabetes is very bad. And I think that is something that we have to take into consideration for the future, that innovation should be included in the global care of the patient. Because we know, for example, we increase the success of FE ablation if you lose weight. This was shown by many people. So I think that we should have a more global view. For the prevention, I'm not from the US, I'm from Europe and France, and I can tell you it's exactly the same. The prevention is not a priority for politicians because I can have no problem with the politics here. And in France, it's a very short view. When they invest money, they want to have a return of investment in one or two years. But prevention takes 10 to 15 years. And this is, for me, the big issue for that. And I think that we should advocate for global care of the patient. Innovation is very useful, it's fantastic, but I think we have to keep the basic of our care as well. So I think it's important. Now, I was on the board of an ACO when I was in Alabama, and now in Florida, I have to deal with managed care. I did an executive training on value-based care at Delmed. So I was fascinated about the model of the patient-centric care. And I think part of the problem we have today is that we are living this transition from the physician-centric care models that exist to now patient-centric. And it's not nefarious from the physician standpoint. Changing to a patient-centric model, it's difficult. It requires a reorganization of how care teams are created and how care is delivered. And physicians cannot do that by themselves. So the hospital systems have to step in to make that happen. You know, I think I started out, what I said is, I have two principles. Put the patient at the center of all the care, and good medicine is good business. So that's kind of just words I've lived with for 30 years. So that's what I'd ask you all to do. Put the patient at the center of everything and take really good care. And if you take really good care of people, some people are gonna need atrial fibrillation ablations, and that's the appropriate person. Some people are gonna need bio-VICDs. If you have hypertension, you should be on an antihypertensive. Or in Ken's case, get a renal denervation. I wasn't gonna go there. To be studied in clinical trials. That's, again, which comes back to the evidence. I absolutely agree with you. And I think some of this also, and maybe, Josie, this is where I thought you were going, and then you didn't quite get there, is empowering patients to take care of themselves better and to be their own advocates. And some of that is technology solutions, some of that is education. Some of that is just a change in culture, right? I mean, the patients who do the best are the patients who are most engaged in their own care. And then the last, just to reiterate, but to say it the opposite way, bad care is the most expensive care that there is, all right? Bad patient outcomes cost money. Doing procedures that don't make a difference cost money. And you have to believe, again, that doing the right thing for patients in the long run is the best thing to do in the long run. And eliminating, to the extent that we can, the things that don't benefit patients is what you need to do to keep the system sustainable. Yeah. Can I be a little bit provocative with the question? Each time we have an innovation, each time, we have an issue, especially in France, because the price of the innovation, I don't discuss the price, but the price of the innovation is very, very high. For example, a VVI pacemaker in France is a little bit less than 2,000 euro, and a leadless pacemaker is about 7,000 euro. And so when I want to implant leadless pacemaker, I have to convince my administration, but also the social security, that it's the right device for this patient, because each time, I say, but it's got very, the cost is very high, so why don't you put a conventional VVI pacemaker? And this is something that we have to face, and I think that it's very important to have registry, because we can show that at long term, in fact, with a new device, we avoid complication, and so we avoid specific cost. But this is an issue each time we have an innovation, and I don't discuss the price of the innovation, because you have a lot of research and so on behind. But for us, sometimes it's a limitation for the innovation. Oh, understood, and I think it is a fair, we do have a leadless pacemaker that we hope to have approved before the end of this year. I think it is a very fair question to ask, to the extent that there are improved outcomes with a leadless pacemaker, are those improved outcomes worth the extra cost? And there are well-established methodologies. And in whom? Yeah. Right, I mean, I think it can't be for everyone, but maybe there's a subset. Yeah, how do you select? And there are well-established methodologies, I think, for doing that. There is a little bit of a dilemma from an industry standpoint, in terms of how do you prove out cost-effectiveness of some of these therapies? And the fundamental problem is the duration of time it takes to conduct these studies laid up against the iterative nature of medical technology and pharmacology development. I'll come back to Watchman. I think it's another very good example of this phenomenon. Right, when Watchman was in its first ever pivotal clinical trials, it was studied against warfarin, because that was all that was available at the time those trials were launched. By the time the trials were done, right, all of a sudden there were the NOACs. And so, I would say, well, okay, that's great, but how did they do against the NOACs, right? And it's only this year and this time next year that we've got good randomized data now out against the NOACs. By the time that data's out, they're gonna be factor XI inhibitors hitting the market. And if you just sort of say, you want to do a clinical trial, it takes a year to enroll, you want to do two years of follow-up, and then you want to get the data published, all right, that's, I don't know, who's counting? Is that five or four? Who's doing the math? Always takes longer than you think it will. That's five years from the onset, right? And by the time we're at the end of those five years, we're already onto a next generation device. And all I've got from that trial is an understanding of what went on over those two or three years. And I think the upshot of all that, right, is we also have to do just a lot of estimation and a lot of guessing to sort of project out, okay, but over a patient lifetime, here's what we think we're gonna show in terms of cost effectiveness of a given therapy. Again, it just, I want to come back, it also gets back to the importance of work like Jose's of just continuing to always accumulate data. And the more we can get real world evidence and the more we can learn from every single patient who gets exposed to a therapy, the better we can understand the comparative effectiveness and cost effectiveness of our therapies. Because the conventional, you run a pivotal trial and you roll patients for two years and you publish the data, and then for the next 10 years, you're still using decade-old data. It just doesn't work anymore. I'm sorry, but time is running now and I think we have to close this session. I hope that you enjoyed this session as I enjoyed it. And I thank all the panelists for their talk and their discussion. And I think also that innovation is why we are very happy in our business day as well. And I think that the collaboration, I don't remember who mentioned that, but the collaboration between physician and industry is a key point. And I think that we should collaborate. I know that sometimes the health authority are a little bit worked on because they always want to have any conflict of interest. But I think that we have to be transparent with our relationship with industry. But if we want to keep on working on innovation, we have to work close together. So I wish you a next very nice session and also next good time in San Diego. We were lucky to attend this session because outside it's raining. So you didn't miss any external activity. So thank you very much and enjoy the Congress. Bye-bye.

Pulse Field Ablation

health technologies

patient safety

innovation

healthcare systems

regulatory challenges

outcome data

physician collaboration

preventive care