Hi, I'm Sunit Mittal, Director of Electrophysiology at Valley Hospital in Paramus, New Jersey. I'm joined by my good friend, former electrophysiologist, currently General Manager and Vice President of the Pacing Business at Medtronic, Rob Kowal. Hey, Rob. Good to be here. Thanks. I was going to say, even the President is called President when we're former. I was like, I'm former status now? That's right. That's right. We're at HRX 2024 in Atlanta, and the meeting is all about innovation, and today we're here to talk about innovation in cardiac pacing. Now, I'm going to start, Rob, just saying that a few years ago, it would have been impossible to even use the word innovation and pacing together. We've certainly come a long way. It's been incredible. I was actually presenting about pacing at the Medtronic board about two years ago, and I said that this mature technology is a rambunctious toddler again, because it's just the whole world is flipped in pacing, and it's interesting once more. Absolutely. Now, I want to really get your thoughts, because you're now thinking about this on a daily basis, that there's innovation in two distinct ways. Of course, there's innovation that's occurring in the traditional reasons we implant pacemakers for treatment of symptomatic bradycardia, but there's also incredible innovations that are occurring for new indications in pacing, so I'm going to, in our talk today, cover both of these areas, but let's start with what's known to most people, which is we typically implant pacemakers for symptomatic bradycardia, and even there, with the advent of leadless pacing, conduction system pacing, it's a totally different ballgame now. Oh, totally, and I think what we've done in those areas is said, let's take a look at the biggest things that limit pacing, pocket lead infections, lead problems, even generator issues, and we've combated that with leadless, and we've collected a data set to show we've made progress. We can cut those complications dramatically, and on the other side, the other big complication was that if you pace too much, you risk a cardiomyopathy, so you're really, for the last 40 years, we've had to meter out where we can use pacing because you were limited by pace-induced cardiomyopathy, and I think conduction system pacing has made a big inroad there. We still have more data to collect, but there's a lot of emerging evidence that all corroborates with that same notion, that like leadless, we've been able to drive down these different complications, and as a result, I think what we're seeing is the threshold to use pacing, even for traditional indications like heart block, or more importantly, sick sinus syndrome, have lowered. Yeah. Rob, obviously, we don't have, to the best of my knowledge, a randomized trial currently planned comparing conduction system pacing to leadless pacing, but in terms of the evidence generation, what do we have at this point? We've got to now look at large data sets, and so the kind of information we have now is methodology using Medicare claims to look at centers that do transvenous versus leadless. We can collect every single patient and then compare the different characteristics of the patients and the outcomes, and it's really fascinating. What we see is that even though the leadless patient population is much sicker, the pacer-related complications are much lower in these. Now again, it's not randomized. In the end, I think there's a lot of evidence that leadless consistently lowers the risk of pacemaker-related complications, and interestingly, there's some data that outcomes such as hospitalization are lower when you normalize or try to control for the patient comorbidities. We're not sure we understand that part of it yet, so there's more to do. Yeah. Another area ripe for innovation, of course, is battery technology. Whether you buy a cell phone or an electric car, obviously there's massive improvements in battery technology with leadless, of course, lots of people stand to benefit if the batteries are more reliable, last longer. What can you share with us about innovations in battery technology? So first off, the current generation micro, we made a big stride, and I think what's important for everyone to know is there's a couple things. One is the battery chemistry itself, and the other is how the circuitry works. So we do everything we can to make sure the circuitry is doing as little as possible, and that uses less energy. So we attack it from two approaches, and that is going to continue. And then there's ways to look at how to think about different energy sources with an idea of kind of what we call micro for life, and then that's measuring, okay, what's the life expectancy of, let's say, 80% of 90% of micropatients, and can we meet their needs? Currently, our data suggests that about 80% of micropatients need only one device. Well, that's great. Now let's shift gears a little bit about using pacing in populations that we don't never really think about. Now one population is a patient who already has a pacemaker implanted, and we can think about what additional value can that pacemaker provide to that patient. And of course, hypertension is one thing that's common in our patients, and I think you're thinking a lot about that. And the other, of course, is this population with heart failure with preserved ejection fraction where there's some data that, you know, pacing these patients may be beneficial. So maybe you can comment a little bit about those. Yeah, and in fact, to me, this is one of the most exciting things, right? You take a 65-year-old technology that hasn't had a substantive new indication in 40 years and suddenly think about how can we use it differently? And I think the idea here, the paradigm shift, is if you can really knock down the complications that limited pacing, how do you redeploy it in ways beyond bradycardia? And to your point, the two we're focused on right now, one is hypertension, and we're working with a colleague, a partner, Orchestra Biomedical, who came up with an algorithm to dynamically change AV delays to change left ventricular filling and lower blood pressure. And that's in trials now, and that's very interesting since so many patients have uncontrolled hypertension or don't want to take all their medications. And that's something that's designed for patients who already need a pacemaker. So again, if positive, that's something we could potentially back-fit into current pacemakers. But the other one that's super interesting is this population of HFPEF patients who really don't have great therapies. And this comes from the work of Marcus Meyer and Dan Lustgarten, where they basically have flipped the concepts on their head where we always thought we should slow patients with diastolic filling problems, and their idea was maybe we should gently speed them up and arrest that last bit of LV filling that drives pressure up. And their initial studies looked very promising, and we're about to launch a big study to really test that hypothesis, not just in pacer-indicated patients, but in those who don't have a current pacer indication. So it would be a just completely de novo indication. Well, Rob, I think in conclusion it'd be fair for me to say that a few years ago if you told me that pacing is going to be fun again, I would have thought you're crazy. But it is very clear that pacing is fun again because there's just an incredible amount of innovation that's happening. You've shared some great examples. I'm sure it makes your job a lot more fun to see this happening, and I look forward to seeing over the next couple of years what unshapes in this industry. Pacing is now the physiology of electrophysiology, so it's a lot of fun. Well, thanks for joining me today. Oh, thanks for having me.

cardiac pacing

leadless pacing

conduction system pacing

pacemaker innovations

battery technology