Thanks to the organizers and Edwards and Herms, of course, for involving me in this. So, what I'd like to do is talk about how we can always do better, and particularly with regard to pacemaker implantation, how can we optimize peripheral bailout strategies in those patients that need it, and then how can we help patients leave the hospital earlier. There is, of course, a number of things that make patients have a pacemaker after TAVR, most of which we can't control, although implantation depth is one of the things that we can. So, this was a paper we published a few years ago. We looked at about 1,000 patients we treated with the S3 valve between 2015, when that valve started, and 2018, initially, of course, deploying it as we were taught with the balloon marker right at the annulus in the first 600 patients. In the next 400, we adopted this higher deployment strategy, basically going to the REO caudal in order to isolate the non-coronary sinus, and then placing this line of lucency at about the level of the annulus, because that's where the valve will foreshorten to. No difference in baseline conduction changes between these two groups. No difference in the major clinical outcomes afterward with AR, embolization, and so forth. And as intended, the high deployment group was, in fact, deployed higher. Now, arranging this valve is not really rocket science. You don't have to measure, you know, membranous septum lengths, et cetera. You just bring the valve into the annulus, and then you put the CRM into an REO caudal at a point where the valve essentially squares off. And that's all it is. That's all the planning. There's no CT, nothing. So here's how the valve started. Here's where it finishes. And with that high deployment technique, we substantially reduced the pacemaker rate, as you see there, from 13 to 5.5%, also a reduction in new onset left bundle. Now, in the more contemporary era, we've been even more aggressive with how we implant the valve in terms of the height. So we're essentially putting most of our valves in like this, where the bottom of the valve is pretty much in line with the nadir of the non-coronary sinus. And with sort of slow and controlled deployment, some use of the fine adjust knob, you can essentially keep the valve exactly where you want it to stay. And with that, you end up with a valve that's essentially at around 100-0, a minimal sort of pacemaker risk. And importantly, we can see that a future TAV and TAV is still feasible. And so with this, what we have found is over the last 5 years, we've done about 3,200 TAVRs, and our new pacemaker rate is about 2.9% at 30 days. I see Keith is there shaking his head. I don't know what that means, Keith. I mean, this is like objective data. Anyhow, I know Keith is also always upset when I give this talk because then he says, well, you're not going to be able to do TAV and TAV. So not to worry, Keith, we do think about future TAV and TAV, and it's important. So here's a patient, size is well for a 29S3. There's adequate room in the sinus, but you can see that a 22.5 mm 29S3 frame is going to sequester the sinuses if you place it at 0 because STJ only measures about 29-30 mm. So when you bring the patient to the lab, you just look in the LAO. You can place the valve so that you know the frame is not going to reach the STJ, not cover the left main. Go back to the REO. You can still see here the line of lucency, probably give you about an 85-15-90-10 kind of a valve once it pore shortens. And so here is that valve in position, still a relatively high implantation, low pacemaker risk, and of course, Keith, future TAV and TAV is feasible. What do we do once the valve is in? We're not terribly good at saying who does or doesn't require a pacemaker in many cases. We know 50% of patients are no longer dependent on the pacemaker 30 days out. So this was an analysis we did with Azeem Lateeb when he was still in Milan, about 300 patients, and what we did was withdraw the right ventricular temp wire to the RA and then pace starting at 70 beats a minute at 10-beat intervals until about 120. You can see in some of the patients, as in the example ECG there, they start to develop wanky back and then drop a heartbeat. So what does all of that mean? Well, when you can pace and you don't develop wanky back, you have an adequate stress of the HV interval up to about 120 beats a minute, and you imagine there's some degree of healthiness there. If you get wanky back with pacing, you don't have a very good understanding of what the HV conduction is really all about, but what it does mean is that if you don't have wanky back, you have a 99% negative predictive value for a pacemaker at 30 days. In fact, the two patients who got a pacemaker that didn't get wanky back were both patients with LV dysfunction that got planned CRT devices. So it's actually quite encouraging, especially for those patients that come into it with the right bundle or other kind of conduction deficits where you worry, should we give this person a pacemaker because what's going to happen in three days after they get discharged? Moving on then to the access point, we shifted a few years ago to putting everything in one side. So this is how we do it logistically. So there's the microneedle for where we want the delivery sheath to be. We take our angio, place a perclose, and then put in an 8-french sheath to bookmark that spot. We then place another sheath about 2-3 centimeters inferior to that for the angiographic sheath, whether that's in the SFA, CFA, doesn't really matter, honestly. So there's the 8-french sheath that's going to become the E sheath. There's a 5-french for the pigtail and the root, and then there's the pacing sheath. Once we're done with the valve and we close the perclose, you can see this patient has a pinch at the delivery sheath access. You'll never occlude the delivery sheath site because you've always got the inferior sheath going beyond it. So you just put a balloon in from the inferior side, dilate, and you're done. I mean all this takes 3-4 minutes. There's no worry about occluding a CFA, and it's certainly easier and faster than crossing over. More importantly in the patient where you could have significant CFA compromise, this is a patient with a BMI of 52, you can see here significant bleeding once we took out the E sheath. You can imagine having someone hold on that groin while someone's coming across from the other side would be a total nightmare, but with an inferior sheath, a minute later, there's a Viobon, pull it back to the arteriotomy site, and you're done. The vessel is closed. So we looked at our data, about 300 patients between bilateral versus unilateral access. Ultimately, there was no harm here, no safety concern about putting all these sheaths in on one side, and so essentially that's our default strategy. In the last, looking at length of stay, I think there's a lot of potential benefits to patients leaving soon. Early mobilization, return to comfortable surroundings, less time and risk for delirium, especially among the elderly like the nonagenarians that Kim was just telling us about, less chance for nosocomial infections, and while we hate to talk about it, we have to talk about system impact and cost implications, and so this is important for hospital throughput as well. So what I'd like to do in the next couple of minutes is just review our same-day discharge pathway, demonstrate the safety of this approach, and if anyone's interested in looking further, we published this in Jack about a year ago. So we took patients who had a transfemoral approach TAVR under conscious sedation as an outpatient. More than 90% of these patients were treated with a balloon expandable valve, so to be aware. The TAVR was finished with enough time that they could have a six-hour post-TAVR bed rest, no major complications or need for further observation. They were stable with regard to hemodynamics and rhythm. They were comfortable ambulating on the floor once their bed rest was over, and they had support to take them home and watch them overnight. Importantly, we made no restrictions to this based on the patient age, STS score, comorbid conditions, chronic kidney disease, what have you. After that six-hour observation, the primary operator and the bedside team reviewed regarding the same-day discharge. If the patient was in agreement, all these patients left after 7 p.m. They were seen on the next day or the day after by one of our APPs along with an ECG. So that outpatient infrastructure is also important, again, to the safety of this kind of a program. We started the program in March of 2020, the early part of the COVID pandemic. So for this analysis, we took the 2019 patients who were discharged on the next day as sort of a control group, and then the 2020 group were either same-day or next-day discharge that we compared. It's a busy slide. Ultimately, there are no differences in any of these groups. If you just highlight the 2020 group between same and next-day discharge, no real difference is there and a bit easier to see graphically represented here. At 30 days, no difference in death, pacemaker, cardiovascular readmission, or stroke. If we look at a little bit more granular detail for those patients in the same-day discharge group that came back within a week, one patient came back the next day with rapid AFib. One patient came back with a fever that was probably atelectasis. One patient came back a week later with a hypertensive emergency and needed treatment. Pacemaker, this is, of course, everybody's concern in sending patients, whether it's the same day, the next day, the day after. One patient came back at day 25 with intermittent heart block that was symptomatic. There were no ECG changes after the TAVR or on the next day ECG in the clinic, so no one that we would even consider spending more time in the hospital, frankly. So it was back in 2020. In that series, about 22% of our patients were discharged on the same day. As of 2022, we're discharging about 35% to 40% of our patients on the same day now. So to conclude, I think the opportunities that I discussed are pretty easily reproduced by most programs. High deployment significantly reduces pacemaker risk, and deployment height can be iteratively more aortic over time as you get comfortable with the technique. A brief RA pacing study after valve placement can help risk stratify the need for post-TAVR pacemaker implantation. Same-side arterial access facilitates peripheral intervention. Honestly, we have a lower threshold to touch up some of the delivery access sites that you might see, whether it's a little bit of an ooze that might become a pseudo later, what's the little pinch that might give them claudication, tend to just dilate them. And certainly in a case where you've got significant extravasation, this is a lot quicker. And same-day discharge is helpful for patients to return to familiar surroundings and can improve hospital-based resource utilization. Thanks very much.

pacemaker implantation

early discharge

TAVR

deployment strategies

pacemaker rates

aortic

TAVI