So the first presentation is from Dr. Charles Henrickson from Portland, Oregon. Thanks. All right, thanks for this opportunity to come present a case that's not in the guidelines. There we go. I guess we just saw the disclosures. So the case is a 79-year-old man with an ischemic cardiomyopathy and substantial COPD who has paroxysmal atrial fibrillation on warfarin, had a prior left-sided primary prevention by the ICD five years ago with an excellent response with heart failure improved from class three to class two, an injection fraction in the low 20s went to the high 30s. In the interim, he had progressed to persistent atrial fibrillation and had a AV node ablation. All of these were done outside. Unfortunately, he came in with an erosion of his generator where it was exposed, so had to have everything taken out. And that was uneventful. So now we have a pacer dependent on the basis of his AV node ablation, now on what we call an externalized permanent pacemaker through his neck awaiting re-implant. His EF's 35 to 40%. He did have a prior appropriate shock for sustained VT shortly after the original device was placed. First question, or first thing to contemplate is what is the appropriate device to go back in? So that's everyone's nightmare. Buy the ICD and patient's doing reasonably well, and then they get an infection. Nightmare scenario. And so now you have to take everything out and pretty much start all over, which the only good thing about that is it sort of gives you a chance to figure out what the patient absolutely needs and what they don't need because they really have limited options. So in this patient, one thing I would wanna know is, and that would be useful for making a decision about what to do with the patient, is what type of VT did he have? Did he have very rapid VT like V-flutter, V-fib, or did he have sort of slow monomorphic sustained VT? He had rapid, rapid unstable. So if he has rapid VT, he needs to be protected, and I think you have a couple of options in a patient like this. One option is to put sort of a minimal pacing device in the patient. Potentially a conduction system device to keep things simple. One of the problems with this scenario is that I'd say at least 40% of the times, maybe 50% of the time, when you, 95% of the time when you remove a CS lead, that branch of the CS is gone forever. That's an excellent foreshadowing. And so you may only have a suitable vein, suitable physiologically or even anatomically in maybe 25, 30% of patients. We also know from studies that were done at the Cleveland Clinic, patients who get a Bi-VICD removed and don't get CRT back do very poorly, have a high prognosis. So I don't know whether you want me to tell you exactly what I do or you want to give me more depressing information. We can go on to the depressing information. So they were taken back to the lab. The plan was to put in a new Bi-VICD for the reasons discussed. However, as you said, the prior CS tributary that had had the coronary sinus lead was thrombosed, presumably secondary to the extraction. There were really no other targets that could be cannulated. So it ended up after this with a single chamber ICD and obviously a Bi-VICD generator in anticipation of doing something more. And so in terms of what's next, oh, we have four options that I can put up there for us to contemplate. Go ahead. So the four, yeah, so those are sort of the main options. So one option is RV apical pacing only and that's a pretty horrible option for the patient. The second option is a surgical LV epicardial lead. That certainly, I think, is not an unreasonable option but for us it would be sort of the last option primarily because you said the patient had COPD and you're putting the patient through a procedure. Now, some of that will depend upon the individual institution you're at. So some institutions have very talented surgeons who can do this thoroscopically and patients who do very well. But it still would tend to be absolutely for us sort of the last option. I think the two options are endocardial LV lead which is to put an endocardial LV lead in transvenously which involves sort of a bunch of makeshift tools and grabbing stuff from the femoral vein. Don't have any experience. Another way to put an endocardial LV lead in would be to do the investigational EBR lead which involves putting a pulse generator in the abdomen and an ultrasound transducer apically. That would be something we would do and that would be an ideal patient for LV endocardial pacing and the LV stimulus is triggered off the RV pacing. But I think what we almost certainly would do is pace the conduction system for a variety of reasons. First of all, because it's relatively easy to do, particularly if you pace the distal conduction system. Second of all, you're leaving the patient with a QRS duration of 120 milliseconds as opposed to 150, 160. The hemodynamics are better and with his bundle pacing, you know, the follow-up looks pretty good in 85, 90% of patients and this patient's gonna do a lot better if he has physiologic pacing. You could even make an argument this patient has very rapid VT and it's with the least amount of things transvenously and we would have probably, the more times you open up the pocket, the worse off you are and I think probably the thing to do is if you couldn't get an LV lead in would be to put a conduction system pacing lead in at that time and maybe put a sub-Q defibrillator in the patient who has very rapid VT and we all know that we've had enough experience with people who have concomitant pacemakers and sub-Q ICDs and over-sensing of the pacing spike doesn't seem to be a clinical problem for the most part. And so does the, obviously with the prior extraction, this is going in on the right, how's your experience with right-sided? I think they're more difficult. They're certainly more difficult but again, you're there, you're gonna try that while you're there before you send him to the surgeon. Okay, so our approach, you know, we obviously, as you said, MRV apical pacing was not a great long-term solution for him. We talked to the surgeons about an epicardial LV lead and while I think if pushed they would have done it, they were unhappy about his potential morbidity given his COPD and age. And for his bundle pacing, we are relatively new to his bundle pacing and coming from the right was more than we were ready to take on. So we ended up doing an endocardial LV lead. The LV endocardial leads have several challenges. You know, partly it's a new procedure. There are no specialized tools to help make it easier that are available. There are various competing techniques on how to do this. They certainly require lifelong anticoagulation and still with probably a slightly higher risk of stroke than we'd like. And there's always questions about mitral regurgitation. So the procedure, we do them either in the EP lab or in the hybrid room where we do the extractions. For some of them, we've had a TEE in place. It's theoretically, you could put the lead anywhere on the endocardial LV lead, endocardial LV surface so you could use the echo to find the area of latest activation and target the lead that way. So the sequence that we go through that we'll work through in a series of slides is you open the pocket and get access from above. It is an opportunity to try for the coronary sinus again. Especially if they're referred from outside. And get groin access and have the usual transeptal approach. You snare the transeptal sheath from above using the deflectible lead delivery sheath from above. Then use the, typically the deflectible medtronic sheath and use the transeptal sheath to carry the superior sheath across, then place the lead via the superior sheath. And so I've got a few pictures of this. On this, you can see you've got the sheath from above. Yep, there we go. You've got the sheath from above. That's the delivery sheath, the end of the delivery sheath. And you've got a snare around the transeptal. And the transeptal is here. This is at the stage where you've got a wire across. And you're trying to start to push this across. And then here, you can either push across with your transeptal needle, or here I've changed to a deflectible EP catheter to help nudge things across. There, it's, and there are rare times that it won't go across from above. And so doing a balloon across the septum to make enough space to get your delivery sheath across is occasionally needed. But once you get that superior sheath across, then you detach the loop snare from the groin sheath. And then, and you've got your sheath up to there. So then you have a way to deliver the lead. Which we have coming across here very slowly and deliberately. And then you can manipulate from there and get the lead to where you want it to be. Manipulating the lead tends to be a very high stakes game. Because if you lose your transeptal access with your lead, you have to start all over again. And so through my trial and error on our handful of cases, I go in feeling that it's gonna fall out once. And if it doesn't, it's a celebration. And so what you end up with is a lead in a good spot here. And the lead is typically, can be either the Medtronic 5076 or any extendable retractable lead or the Hisp Bundle Pacing Lead. 3830, yeah. And so, I don't know if you wanna comment at all. At this point, or? Well, I think, well, you did what the patient needs. I needed some sort of, something other than RV apical pacing. And epicardial probably would have been the bail out, as you pointed out. Surgeons probably would have done it if push comes to shove. But the best things were clearly LV endocardial or conduction system pacing. The sort of, the bad thing, the weak link about LV endocardial pacing is the patient is committed to lifelong anticoagulation. Now, they have persistent day fib, so they're committed to lifelong anticoagulation. But if you look at the European trials of the LV endocardial leads, some of these patients had strokes when their INRs were not therapeutic. So, I guess, you know, NOACs are the way to go. And particularly now that they have an LV endocardial lead, you have to be particularly careful about stopping anticoagulation, even for brief periods. You know, we all see the junk on leads when we do transesoptial echoes. And we get the calls from the TE lab saying, hey, did you know your patient has junk or debris on their leads? And you're like, so what, who cares? It'll go to the lungs. But I think the first chink in that armor was the data, I forgot, I think it may have been published in JAMA, but from the Mayo Clinic, showing that patients who had pacemakers and PFOs had a slightly higher risk of stroke. So, all that junk that forms on leads, which we call debris and we have no idea what it is, platelet clumps, whatever, that stuff's now in the LV. Potentially can go to the brain, so. Right, now go through a little bit of the data from the European trial, if we have a chance. The ALSYNC trial. The ALSYNC. But, you know, for this patient and for the patients who we've done, make sure that they're already on warfarin, that it's well tolerated, and that they can tolerate a higher INR target in the two and a half to three and a half. You know, and everything we do is a risk benefit. So, this is there because, in theory, placing these leads isn't that bad, but in practice, it can be painful. As I said, if they fall out, it's a real high-stakes game to get them back there. And as I said, for endocardial leads, for me, for sure, they should already be on warfarin with a lifelong indication and well tolerated. Unable to place a CS lead. Unable to place a HISS or a left bundle lead. Clear indication for CRT, you know, and a poor surgical candidate. So, this isn't gonna eliminate a public health problem. For epicardial leads, I think what I found on doing some of these, certainly at our institution, that it's not always a easy thing for the surgeon to do. And I've had a patient or two come back where it's been a failed epicardial lead placement. Which, from the cardiologist's point of view, like, how could you fail? The heart's there, you open it up. But where they put the lead in several places and have poor numbers, and then bleeding where they're taking it out, and they bail out and say, I'm sure the patient will get by without it. And so, there's always that danger of calling on colleagues for a procedure they don't do very often and often aren't that comfortable with. Well, I think part of the problem is, when we forget the right ventricle's anterior, the left ventricle's actually posterior. So, I always think of right and left, but it's actually anterior and posterior. And we want them to put the LV lead laterally, or posterolaterally. And that's not so easy for them to get to. You're right, they open the chest. But what's there is the anterior RV. So, that's even worse than RV endocardial pacing. And I think that's why, you know, when early on, and everyone who implants devices, getting a 12 lead electrocardiogram to look at what a QRS morphology looks like with pacing is really critical. They have a hard time getting laterally, and they certainly have a hard time getting posterolaterally. So, they really have to work at that. And for all the reasons you said, they often abandon it way too early. All right. So, we promised to go quickly through all sync, which is by far the best trial of endocardial LV pacing. This was a trial that was done in 18 centers in Europe and Canada, taking patients for whom there was unable to place the CS lead, or had a CS lead, and weren't responding, you know, presumably because of suboptimal anatomic placement. This was using a investigational sheath and a Bayless RF needle from above. So, they go in through the pocket and do a transeptal from above. And these guys, they had a target INR of three with an acceptable range of two to four. 12 month minimum follow-up, but not eligible at very high risk for a stroke. This is the figure from their paper. You can see here in panel A, you've got this fancy sheath from above with the wire. And on echo, you can see the septum tenting from above. Here's the wires across and the wires further across. And then you can deliver the lead and then peel out the sheath. This, I think, was one of the things that they showed in the trial was it was possible to do it this way. But this is not a system that's available anywhere that I'm aware of. Not commercially, the system is not commercially available. It has not been made so because I think it's somewhat fallen out of favor for whatever reason. Or they've chosen not to develop it. The other thing is the Bayless needle is different from the Bayless needle everyone's familiar with for doing a transeptal from the leg. So, don't assume you have the correct equipment to do this at home. It is a special needle. Yeah. And the, do you have more about this? Because I think people need to realize that the people in this study were patients who either, were patients who were non-responders. Correct. Or had no other options, CS options. Right. And you're gonna talk about that. Yeah, just a little briefly. There were 138 patients in the trial. There was a 89% success rate in terms of placing the lead. Most of them, most of the failures were because they couldn't get transeptal from above. Follow-up was about 17 months. The response rate was in the 50% range. They broke, there was rough, the population was divided roughly in half between patients who, previous procedures, they couldn't place a CS lead. And half of whom, there had a CS lead but had a poor response. And in both of those, the response rate with the new system was in the high 50% range. And there were substantial, there's no comparison group for AllSync, but the risk of CNS events were substantial with stroke at 2.6 per 100 patient years and TIA of seven per 100 patient years. And so, but for the CNS events where an INR was measured at the same time, a lot of those were on the low side. So it's, that's a touch of data without a ton to go on. Yeah, so I think I'm out of time. This is probably adequate. I had another paper to go through which was a meta-analysis which is really AllSync plus a bunch of short reports. Yeah, we have a few minutes and do you have any comments or should we open it up? Yeah, let's open it up. But I think it's a great case, fascinating. You know, this is something that, you know, probably you need to have in your back pocket if you can't do conduction system pacing because the response rate is really pretty striking. Clearly, the take-home message is narrower is better when it comes to pacing and endocardial is always better than epicardial. Hi, Raul Matrani, Miami. Very nice case, thank you. Pacing the LV endocardium scares the daylights out of me for the reasons you mentioned. And I would do everything possible to avoid it. So let me ask you, are there any new technologies where you actually cross from the C gas into the epicardial space? Where you can place a lead? There are no new technologies except people have done that by mistake and gotten away with it and patients have done just fine. You actually, that angioplasty wire goes through a very distal branch and, you know, you keep on moving that LV lead out and it's going in some weird place. You did a venogram and you're not sure how the heck it got there and thresholds are okay and people have left it in there and they're probably epicardial. I've seen a couple people have presented, I've been at a couple of meetings where people presented a case and I'm like, wait a second, there's no vein branch there and yeah, it was epicardial. They have some pericarditis for a couple days and then they did fine. So, but none where people set out to do that on purpose. You get away with it because veins are low pressure. You know, you poke a hole through the CS, patient will bleed like stink in tamponade but you'll poke a hole through a distal branch of the CS and then you jam a small lead through it, it's essentially preventing it from bleeding a lot. So you can get away with it, not on purpose.

endocardial LV lead

cardiac resynchronization therapy

ICD

patient selection

response rate

generator erosion