And thank you everyone for joining us. We're going to talk about Leads and how to avoid the lemon. I don't think I need to talk about whether all leads are the same I think we all know they aren't So we'll move on to the second line. So first off. What is a lemon lead? Obviously this comes from Cars the Edsel and such and I want to start out by saying as there's probably some engineers I hope there's some engineers in the audience. I Highly respect everything you folks do and with innovation The only way innovation continues is if you take chances and if you take chances There's going to be an occasional one that you're going to have to walk back And I think what distinguishes industry Is how to respond to those? And how to be honest and transparent when they arise and what do you do afterwards to mitigate what has happened? And that's where we see where we see people distinguish themselves. So this is not a bashing Talk, but we will go into some some areas that are that are, you know uncomfortable I think in terms of an investment thought when we're talking about how do you when you're dealing with an unknown? How do you actually? most safely invest and if you think of your patient population as your investment portfolio and each one of your patients as an asset and Then apply basic investment popular Principles you may actually be able to to do some good for your folks. So what is one thing? Well, you should diversify don't put all your eggs in one basket. Don't adopt one lead and use it a hundred percent You're you're taking an enormous chance not on each individual patient, but on your population and you will regret that if you do do research Don't start putting something in unless you picked it up held it in your hands ask questions Looked at what past similar leads of how they behaved And know know what you're getting into because you will be able to predict failures that way I have and others have Watch for signals when things happen case reports chatter somebody telling you about a case a tweet a tweet you name it watch those and consider those and and then Consider what you're going to do with the next case when you see such signals And then if you think in terms of investing you want to prioritize value you're not looking for a big hit You're not looking for the your each individual patient isn't looking for the home run You just want steady growth and performance. So you don't want to take a lot of chances Unless the chances is a really likely one that's going to pay off big So as I thought about this topic I realized there's probably three buckets that we can go into that will cover most if not all Leads that ultimately turn out to be lemons none of these look that way at the beginning at least they Shouldn't it it would have never gotten on the market one is new materials Something you haven't seen before maybe it's better, but until it's been in the body for a while you may not know Another is a revolutionary design Lead that's constructed in a manner That's unusual maybe to try to make do make up for the problems with prior leads sometimes those turn out to be worse than what? you started with and The third would be the evolution of a suspect design so when when a lead fails And then the engineers go back and and add something or change something about the lead and the next generation comes out Is that one going to be better than the one before? And if if you're dealing with something that's not in one of these three categories. You're most of the time going to be safe Anytime you pick one of these leads up something that's new that hasn't been used before you need to ask yourself Is it better than what we already have? And if it's not measurably better than what you already have why would you use it? Why would you take the chance because most of us agree? I hope we all agree that predicting you know a long-term stability of a lead is perhaps the most important parameter we have And And you're not going to know that with a brand new lead so ask yourself at any time So let's go through some some examples of what we would probably all agree are lemon leads So the Medtronic series of polyurethane leads these were ADA leads in the 1990s late 80s were designed to try to Overcome some of the faults with silicon leads at the time which were quite thick and sticky and it was difficult to do single lead sticks leads would stick to each other so the engineers Came up with with a new design with with polyurethane which hadn't been used before and what happened with this particular polyurethane is Environmental stress cracking which was more cosmetic, but then also this metal ion oxidation Which would in the body over time result in breakdown of the polyurethane and ultimately? Inner insulation fractures were the most common presentation So that was a new new design a new Material that we'd never seen before and it looked good coming out of the gate I was not putting in leads at that point have been around long a while But not that long and for two years everything looked fine on the survival curve It's only after the two years that failure start happening, so if you decided hey I'm gonna kind of sit tight and wait and see how this new stuff works out and deal with the problems with Silicon you might have missed a fair amount of these If you'd sat on the sidelines for a little while if you went all-in you're gonna be in trouble So revolutionary design I was around for this I was a Fellow at the time that the telectronics active fixed lead came out, and they presented to us. Well. Here's a lead it's an active fixation lead that has a Preform J, and I asked myself Why do I need a preform J with an active fixation lead well apparently some people? did and the way the telectronics active fix lead was designed is there was a a wire inside the outer insulation Which is help holding this J in place and then what happened and you can see in these two images a few months after implant This wire can break and spring out and that wire would then cause pericardial tamponade here it is in a In an extracted specimen, so if you ask yourself. This is a revolutionary design I'm not sure what that wires is it going to be helpful to me Is it is it better than what we already have and decide? I'm gonna Stick with what I know works and see how this shakes out then you might have missed the the problems what we have with the With the active fix lead, so there's a nice picture of that So the third category evolution of a suspect design, so here's the Riata ST lead which I don't have enough time to really get into this, but on the left is a Riata on the right as a Riata ST basic similar design Of the structure of the lead in the internal issues with the lead and The the problems that we saw with Riata with externalization internal lead disruption We saw also with Riata ST probably a little bit less, but as we got to this smaller lead We introduced a new problem Which and we just heard the last two talks how to avoid a making a hole in the heart how to make avoid making a hole In the lung well here's a situation. We're actually have done both hole in the heart and hole in the lung and Probably hole in the chest wall all because this lead is is stiff and perforated so we saw these late dislodge or late Perforations with this lead so there was a new design that it turned out to be Not better certainly than than the one that preceded it, so what's next so what about things that are out there on the market right? Now I'm not gonna label any leads that are on the market right now as lemons That's that's really not mine to make that determination But I think we should all look carefully about how we decide decide on our implant choices based on what we already know so So new materials, so here's here's a lead with a new material now optum is a is a silicon polyurethane copolymer it's been around for a little while, but putting it on the outside of a lead next to Conductor is a relatively new phenomenon, so how's that going to behave well? There have been quick chatter if you will this is from Twitter noise on a optum 2088 Coded lead and then responses from other people saying they're seeing the same thing And then a week later another similar report of noise on this lead And more chatter of yes, I've seen these things that led to a Shortly afterwards last year's HRS an abstract showing increased failure rate of this lead from the Emory group And in the conclusions they thought it was likely related to to degradation of the optum insulation outer outer insulation So there's a new material that May or may not be the problem here. I think it's still up in the air What's what's going on with with 2088 TC, but there are more of these findings, and there's a couple more abstracts This this month thankfully this doesn't appear to be a catastrophic failure mechanism But you could ask yourself right now would I want to put this lead in does it offer me something over and above what? I already have with other similar leads, and you can make your judgments based on your thoughts on that So here's another degree that just got market released Which would be the Boston Scientific Forefront lead now? I would call this evolution of a reliable design so the reliance traditionally which is here on the right or on the left Is is is a lead that we we've had for a very long time We've got very long track record date on and it does seem to perform quite nicely The forefront lead is a little smaller, but the base same basic internal Design and so far not very much, but so far it appears to behave well in 48 year months of low numbers here, but 48 months of The follow-up, so I asked myself I'm gonna be facing this little it'll show up in the bag pretty soon should I put one of these in well, okay? Maybe it's gonna be just fine, but what am I getting at? It's like a smaller lead And I don't know that that's gonna help me too much so for my personal philosophies I'll probably wrote these rotate this in fairly slowly as I have done with similar leads like this in the past So the Dorada lead which I would call an evolution on a suspect design We just saw Riyada ST. So Riyada ST is here on the left, Dorada on the right The main change is the addition of this Optum outer insulation It doesn't change the internal issues and that we know from inside out abrasion you can have internal disruption these leads When the Riyada lead first came out I went to the Riyada summit in Minneapolis and asked a question about these internal disruptions could they result in high voltage failure? And it was an open question right now if we'd have issues. I was worried about shocking coils Touching shocking coils and shorting out when a VF shock is delivered and two years later sure enough It actually happened to one of my patients. This is the return product analysis. This patient was Survived a VF arrest when their their Dorada shorted out internally. We wrote it up And published it and and then after that we've seen other of these Bob Hauser amassed this 12 of these internal insulation breaches from Dorada which result in No therapy delivery when a shock is delivered. It's otherwise Undetectable you don't see it on any of the diagnostics. That's a schematic of what happens this this lead breaches through the inner insulation And then hits the hits the shocking coil where there isn't any any Optum to help you out This is a failure mechanism that could have been and was predicted from previous designs So, how can we avoid the next lemon lead some basic principles that that we should all take home with us One is to adopt new leads slowly. I don't think there's any reason to dive right in and and go Whole hog with a brand new lead. I know when when Fidelis came out Within a year or so. It was 95% adopted by our community Thankfully, I wasn't one of those people I was actually very slow to adopt Fidelis and I didn't get burned and I think We should not do that. I mean, whatever however good it looks up front unless you get something really good out of the deal Don't adopt it quickly If the newly doesn't offer significant advantages consider sitting it out entirely I know I know docs that I've worked with or around that that use the same lead until there's literally none left on the shelf I had there was a doc in Cincinnati used 5024 M's from Medtronic literally until the last one was was no longer Manufactured and I think he was smart about it Keep using well-performed legacy leads as long as you can. I guess I just said that I didn't have the bullet point up Rotate through multiple lead vendors. That's the diversification process that I shared is a good way to go Understand your lead design so you know how to avoid things Maybe you could avoid the next Telectronics accu fix that should have been predictable and then watch for signs if you see things going on chatter Social media issues case reports and such then then pay attention to those So that's that's my talk. I've got a couple minutes. If anybody has any questions. I'd love to hear from you Jay I have a question of it. You're an avid user of social media. I'm sure what do you think? If you put that aside for people who are not using social media, but I will report in system Well, any any comments about why why do we wait until we have this massive amount of? Observation. Well, what do you think we can do to make it better? Well, I mean, I it's interesting with 2088t broke, which I heard about on social media. I went back And talked to my partner Ted Waller and I said, you know, this is interesting about the 2088tc. Oh, yeah Oh, he says oh jay. He's not on twitter. He says. Oh, yeah, jay. That's a noisy lead. I'm like seriously So yeah, yeah, I see noise on it all the time Yeah, and it's not so you don't need social media. You can just ask around you can ask around and the comment that I'm You can ask around and the comment that i'm yeah, but that's not always easy and true you often we had other observation about During battery changes certain device just goes dead On you and somebody's dependent and you first you you get You feel like you're getting the blame. Well, you didn't know what to do or it's you it's not the lead and all of a sudden It's this mass amount of so I I agree with you. I think we should talk to each other What you might want to do in those settings is if you've ever dove into mod database, it's really not that hard um, if you see something funny dive into mod and see if it if it's already been reported because you know, There's there's scads of these that show up in mod before anything ever gets published Yeah, I just wanted to echo what you said about adopting slowly I I had a situation once where I put in a fidelis it fractured. I took it out I put in another fidelis and it fractured. Yeah, and so You know a good thing. I didn't put in a riata at that time That would have been the trifecta is a good idea. Yeah. Thanks. Thank you Thank you. Oh, yeah. Thanks everyone

lemon leads

caution in lead adoption

diversifying lead choices

research and questioning new leads

issues with leads