Listen and Learn more about the following:
• Lead Management indications and how to apply them to your practice
• Bridge Occlusion Balloon and Complication Intervention
• Transitioning to practice and how to introduce Lead Management to your new facility.
morning everyone. First of all, it's such a pleasure to sort of meet everyone in person after a long time with the covid pandemic. Some of a lot of these programs are, most of these programs were shut down. So as Tony mentioned, it's great to see people in person. I want to thank Tony Elliott, Elliott and chris Buchanan and the phillips team for setting up this program and for inviting me to speak Um as someone that's been in electrophysiology for over 20 years and I've been a fellowship director for the last 11 years. I think one of the gaps in fellowship training is lead management and a program like this is extremely valuable because the exposure that I think fellows have to lead management varies depending upon the center that he or she works in. Now. I know in Chicago, there are a lot of great extractors and lead management professionals, but that's not always the case. And so it's always good to take a step back and go over wise, lead management extremely important. What do we need to know as electro physiologists about lead management and then why is setting up a lead extraction program? Something to seriously think about when you practice medicine, whether you're an academic medicine or in this, you know, quote unquote private practice world? Certainly I tell my fellows when they train with me. Listen, you know, on day one, when you become an attending no one's gonna, you know, hand you an ablation catheter and say, hey oblate this epic. Our govt. But you will get a call from your device nurse saying, hey I have an impedance of you know 3000 on this pastry lead, what do you want to do? And so these things will come up very very commonly and so this is why a program like this is extremely valuable. So let's get started. This is the disclaimer that we're obligated to show. So this morning as Tony mentioned we're going to start with the didactic and the didactic gonna cover a number of issues. # one the growing need for lead management. Why is this an important part of electrophysiology expanding indications which helps answer that first question. What are the risks of Capping vs extraction? Is their their data behind one versus the other. Talking about the safety and efficacy of lead extraction. I think amongst sort of referring physicians and referring cardiologist, lead extraction is considered by many to be this high risk procedure. I'd like to show you some data and compared to the common other procedures we do in in cardio cardiology and I think everyone will realize the lead extraction is actually very safe and effective procedure. And then one of the research interests that I have had over the last few years is can we incorporate imaging into lead extraction? How can imaging help us to become better and safer extractors to the growing need for lead management. What does that mean? Well as you can imagine there are a number of situations that come up today that would require lead management. So for example malfunction every few months I get an email or I get a phone call from one of my device partners that says, hey, you know, we're releasing a warning or God forbid even a recall on certain types of devices and our leads and this is what our recommendation is. Listen, everyone knows everyone who implants, devices knows that the achilles heel of trans venous side therapy is the lead itself. And so lead malfunction, whether it's lead fracture, uh insulation issues or the actual breakdown of components of the lead is an important part of what we do when we talk about lead management. Certainly infection is probably the most common reason why leads are and devices are taken out and infection. I'll show you I'll share with you some data to say that the rate of infection is increasing exponentially when you compare it to the rate of C. I. D. Implantation and we'll talk about the reasons behind that. It is easy to kappa League and add leads. Why? Because many electro physiologists don't perform lead extraction were like, you know what? I'm just gonna add a couple of leads to this system. I'm not going to send this person out for lead extraction, I'm gonna take care of it myself. Well there's risks to capping leads and risks of leaving leads in because of redundancy. And so here's a graphic of just leads. This kind of moving from one area to the other in the heart. You have an. RV lead with a big loop that's now in the pulmonary artery. New technologies. Right? So patients for example may have a dual chamber device they need to get upgraded to C. R. T. D. And there's issues with vascular occlusion. So you may need to extract one of the leads in order to provide room for another lead occlusion. So S. V. C syndrome patients that are who have end stage renal disease who may have a V fistulas who may have devices placed on that side. The devices can lead to thrombosis meaning the leads in the subclavian vein can lead to thrombosis that can affect a V. Fistula formation and or function and that might interfere. So patients might need to get extracted for that reason having multiple leads in the vascular space, especially having 4 to 5 leads in the sbc. Higher risk for developing S. V. C. Syndrome. And so vascular occlusion issues are an important part to think about when you get referred referred with patients with that issue and then M. R. M. R. I. Conditionality certainly I think there's going to be an evolving trend to probably do more and more non memory conditional devices. Certainly we do at the University of Chicago we scan almost everyone and I think we've had some good data on actually scanning patients with abandoned leads but that's because we are familiar and comfortable with that. But you know technically right now M. R. I scans and abandoned leads are a no no and so there are folks that will then remove those leads in order for M. R. M. R. E conditionality to occur. So you can see that there's a number of different clinical scenarios that you're gonna run into as electro physiologists where lead management and potentially illegal extraction will play an important role. Remember that over the last decade there are more and more devices being implanted. So currently in the United States there's around three million C. I. E. D. S that are in place And in worldwide close to eight million in the United States alone. Close to half a million new devices are being implanted Now as I talked about the achilles heel of device therapy right now is the lead 14 million leads worldwide. 2.6 million new leads annually. It's a lot of leads going into a lot of people. The complexity of the devices are also changing. So maybe about two decades ago the vast majority of the type of devices that were being implanted amongst patients were pacemakers. Makes sense with I. C. D. Technology sort of increasing in terms of indications and in terms of acceptability we now have a lot more patients being implanted with what we call high power devices now patients overall live longer which is a good thing for our patients. So more patients are getting indicated for this type of therapy Like I said the therapy and in fact now in the last decade 35% of all new implants are now either I. C. D. S. Or C. R. T. D. S. Once again requiring multiple leads certainly in the C. R. T. D. Population because more I C. D. S are being implanted and because the I. C. D. Lead is a lot more complicated than pacemaker leads and I cd patients are a lot sicker overall in terms of higher comorbidities. Were now extracting or managing I. C. D. Leads more than we did maybe two decades ago. Why is that? Well there's a number of reasons you know I see the leads when they failed can cause a lot of problems. Certainly pacemaker leads when they fail cause problems but I C. D. Leads when they fail can lead to inappropriate shocks. We know that certainly loss of pacing output which you would see in a pacemaker lead as well, inability to deliver effective therapy. Right? So if somebody has a lead issue and that said the I. C. D. Lead shock impedance is elevated and that patient goes into VT VF the device may not deliver therapy because it's going to do a quick check before delivers therapy, sees that the impedance is off and may withhold therapy. So I see these do pose a lot of problems when the leads do malfunction or fail. Now as time progresses we know that leads tend to fail with time. And so the annual failure rate of I. C. D. Leads increasing increases progressively over time. And in I. CD leads that reached 10 11 12 years there's significant potential for malfunction. There are a lot of patients that are indicated to receive lead management and potentially lead extraction that don't even get to us as electro physiologists. And so there should be an educational program that we need to do with our colleagues with patients with referring physicians about hey send us these patients we would like to see them because we can offer a lot of effective therapy. For example even infection you would think there would be a slam dunk for a referring physician to send you a patient that may have a C. I. D. Infection. Well in fact six out of 10 patients are under utilized or under treated. Why is that? Because infection may present in many different ways? Right. So obviously plus coming out of the pocket that's pretty straightforward most of the time you're going to get those referrals. But if the pockets a little red so maybe a little tender of the skin is getting a little fixated. Many referring physicians will sit on that because they're not aware that that's a sign of impending infection or impending erosion patients can get admitted with a U. T. I. Or they may get admitted with pneumonia and they'll get back to remake and that bacteria will be staff and they'll say oh it's a staph pneumonia will just treat it with antibiotics. Staff factory Mia. Especially M. R. S. A. Back tularemia is by pretty much definition in someone with a device probably going to be a C. I. D. Infection because there's no way you're going to be able to clear that M. R. S. A. Bacteria with just antibiotics alone. Those patients can get sit on and then they'll come back six months later with recurring back torrie Mia and maybe then you'll get involved but by then that patients quite sick. So M. R. S. A. Back dream in the setting of of of of an elderly patient that carries a high mortality. What about malfunction? Well we talked about the fact that leads can fail. Especially I. C. D. Leads. The one of the easiest ways to manage that for some some referring physicians is to say I'm just going to cap this I'll add another lead in. So now you have another lead. You have hardware that's not being utilized. You have another I. C. D. Through the trike trike husband valve or the vascular space may cause higher tr and so that might be an issue for patients conclusion unless somebody's having S. V. C. Syndrome. They have a little bit of swelling in their arms. I'm just going to sort of treat it with some anti coagulation. Let's see how that goes. And then of course you know these advisory leads I'm still getting referred patients who may have Fidelis leads in place and I'll share with you some data about the risk of Fidelis lead fracture as time goes on. So the teaching point here is that there are a lot of patients that don't even get to us as lead management specialists that we need to then take that next step and educate our colleagues about hey please send us these patients. These are important things that we need to think about. Well the guidelines also support the idea that lead management is extremely valuable and extremely important and I want to go with go over with you some classroom indications on lead management that are in our Hrs guidelines. And this was an update in 2017. So not too long ago. So infection as I said is the most common reason why leads are removed in the United States and probably worldwide and it's a classroom indication to think about removing the entire system and doing and removing the entire system when you have a C. I. D. System infections. Whether that is a pocket infection or whether that is a you know Bactrim IQ or a systemic infection, right? Endocarditis. So there's valvular endocarditis then by definition if you have valvular endocarditis in the setting of a C. I. E. D. Trans venus. C. I. D. The leads are also going to be infected. So you have lied endocarditis. You may not see the infection on the leads on T. E. But you have to presume that they're there because it's a biofilm that develops on those leads. Certainly we talked about staff factory mia as a sign that okay the system is likely infected no class. What indications also recommend? Hey these types of patients should get a consultation by an electrophysiology who specializes in lead management. That's you guys. And so once again E. P. Needs to be involved in those type of patients. Talk about getting two sets of blood cultures just to make sure that we can capture the diagnosis. And then certainly sometimes imaging can be useful in sort of evaluating the pockets if the pocket looks a little swollen, sometimes you get an ultrasound or a ct just to confirm that there is some swelling, maybe a cero more maybe some maybe some infectious material. We talked about the idea that when you have C. I. D. Infection, whether it's pocket or systemic, the entire system needs to be removed. And the reason is that the idea of sort of salvaging the pocket or doing something different that just doesn't work. And I'm gonna share with you data behind the numbers on that strategy. Are there other indications for extraction? Certainly there are patients that develop intractable pain in the pacemaker pocket or device pocket area. I have seen a number of those types of patients over the years and no matter what you do whether they develop a neuropathic type of pain picture or and in some cases it's just a smoldering infection that we just don't catch either way. That's an indication for removal. We've talked about thrombosis and occlusion. There are patients that develop extreme swelling in their arms, subclavian vein thrombosis that leads to discomfort or maybe a potential interference with any type of graphs they may have on that side. And certainly S. V. C. Syndrome can be as an important clinical feature or clinical syndrome. To think about when you have a patient needs a lead extraction. Remember, just like we do with Taverns, just like we do with Watchman devices or any other type of procedures that we do, even a defibrillation. We need to have that shared decision making process. So sitting down with a patient and say, listen, let me tell you about the options that we have to manage this issue that you have. Well, let's say it's a lead malfunction. You can say, listen, I believe that we need to remove this lead. This leads not doing you any favors extra hardware that's not working the more hardware we have in you the worst off you're going to be and I'm gonna share with you that data. So you can tell patients that we can certainly add more hardware or remove this hardware that you don't need. Certainly as electro physiologists, we talk about pros and cons of each approach, but it's that shared decision making that's extremely important to a, not only talk to patients about it but then document that as well. There's some other sort of reasons why you may want to remove leads. And I've seen these handful of these over the years for example um you know we have a very vigorous cancer program at U. Chicago and invariably there are patients that have lung cancer that's sitting right underneath the device and many times we have to remove the system in order for radiation therapy to occur. And so I've had moved I've had taken out systems from sort of the left side and place it on the right side for some of those patients um abandoned leads that cause redundancy. Certainly I have a couple of cases of that where the leads are now sitting across the track, spit valve causing torrential tr and we need to remove those type of leads. Okay let's talk a little bit and dive deep a little bit into C. I. D. Infection because I think that's something that all of you see right now in training. So as I mentioned over the last I'd say 1 to 2 decades we have seen an increase in C. I. C. D. And C. R. T. D. Implantation compared to pacemaker implantation. And you can see that on that first. Top graphic And 25% of all patients undergoing device implantation are now over age 80 and that second graphic shows the trend of C. I. D. Infection. So the C. I. D. Infection rate is outpacing the implantation rate. Well why is that? Our patients are older that are getting devices implanted because they're older they have a lot more comorbidities, more diabetes, more immunocompromised state older patients generally have poor tissue in terms of healing issues and so we see a lot more infection. The number of patients with end stage renal disease and CKD are also increasing in terms of implantation rates. Now close to 60,000 plus patients develop an infection annually. There's pocket infections, there's systemic infections and then patients present with both. So for example a pocket infection if left untreated can lead to back tree mia and a systemic infection. And rarely when you have endocarditis have left untreated or not recognized. Sometimes I can see the pocket. Sometimes it's it's hard to know what came first. Remember that if you have a C. I. D. Infection, a classroom recommendation is to remove all hardware device plus leads. Okay And we talked about the fact that six out of 10 patients are undertreated because they don't even get to lead management professionals like yourselves in order to get this therapy done. Now the vast majority of the infections you will encounter is clinic electro physiologist is probably a pocket infection. I talked about the reasons behind that and the reason why a lot of folks are not referred to you is that sometimes this the signs and symptoms are quite subtle. Um Now when a patient has a device implantation or a device intervention for example like a generator change If they develop an infection nine or 10 months later after that incident sort of intervention we still assume that the infection was due to that intervention. We generally give a about a year. Now if it's let's say a year out or three or four years out then it's probably not related to the procedure that was done. But within that year we have to assume there was maybe some sort of introduction of bacteria coagulates negative staph aureus as an indolent organism. Many times it was viewed previously as a contaminant. It's no longer really a contaminant when it deals with C. I. D. Infection. Cons infections are very smoldering. They take a long time to present. So think of that when a patient has an infection within a year of an intervention it's probably related to that intervention. What's often difficult for many of us. And many referring physicians to understand is, well you know this person had a pneumonia and they had back tree mia probably from the pneumonia. Well that's great that the pneumonia is better that you've treated the pneumonia and potentially the back tree mia. But depending upon the organism sometimes it's too late. Especially M. R. S. A. Your staff. Now if you have let's say a grab negative organism and you have a clearly defined source G. I. G. U. Ut I it's a different story maybe that can be treated and then we can sit tight and wait and see what happens. But think about staff and staff staph aureus M. R. S. A. If you see a back tree mia in the setting of the device we're not going to be able to treat that with antibiotics alone. So what are you going to see in clinical electrophysiology? Right. You've probably already seen these types of presentations. So dry erosion classic coagulates negative staph aureus type of infection smoldering over time. Pocket opens up or and then it's generally painless and usually patients present with leeds hanging out device visible draining sinus. That's usually uh either some sort of staph organism or strep organism. There's a connection or a communication from the pocket to the skin. There's just pus coming out slowly that's a draining sinus abscess. Certainly this was a patient that had a gram negative infection who this patient was immunocompromised and his presentation was very very subtle but then came in one day was just swelling in the pocket. And of course we opened the pocket and there's just pus coming out with the advent of remote monitoring which is a wonderful thing associated with with reduction in morbidity and mortality in our patients. You know we're now the HRS guidelines recommend remote monitoring every in remote interrogation. Every three months with our high powered devices and patients should be seen yearly. That means we don't see patients every three months anymore or every six months anymore. And so we're not looking at their incisions like we used to. So when I have a patient in remote monitoring I say to them listen I I need you to check your incision on a regular basis. And if you see things like fixation of the skin redness, if the corner of the device feels a little hard if you see dimpling, let us know or send us a picture because we'd like to see that. And so I think remote monitoring is great. But we have to then now educate our patients to take a look at their incisions in their pocket areas. Because many times if you start to see things you could potentially intervene or at least get to them earlier then maybe when they present with just sort of the device being visible and of course systemic infection. This is a picture of a vegetation that's sitting on a lead. This is lead undercard itis. If you see that in the setting of substance syndrome then you know that this person has a systemic C. C. I. D. Infection. We know that complete system extraction is far superior to antibiotics alone or this idea of salvaging the pocket. So what do I mean by salvaging the pocket. So here's a clinical case of you know an 80 year old gentleman who comes in with skin erosion and poor healing and pockets visible otherwise asymptomatic. Well it's in the past it was very easy for certain physicians to say all right well I'm just gonna go ahead and open up the pocket and clean it out. I'm going to go ahead and bury that device deep within your muscle close up. See what happens. That's a failed strategy. That's just gonna buy you time. It might buy you a few weeks to a few months but eventually that patients going to come back with infection. In fact in many instances that device is gonna find its way out somehow. When you have a pocket infection. All system hardware should be rude. Of course unless of course the comorbidities of that patient are so high that there's just no possible way that patient is going to be able to undergo an extraction procedure. Those are rare though because you have to have you have basically competing risks of death. You have the risk of death from just infection alone versus the potentially the risk of morbidity and mortality from the procedure itself. That type of scenario comes rarely the vast majority of the patients that you will see. You will be able to get them through a successful system removal and I'm gonna share with you data behind the safety and efficacy of lead extraction. If left alone. Certainly we know that the mortality with C. I. D. Infection is extremely high especially in those that are infected with staph bacteria mia. So let's take a look at that. If you compare antibiotics alone and these salvage type of strategies to actually full system removal. You can see that in terms of relapse rates far higher in those that just receive antibiotics. Right? It's a failed strategy that patient's gonna have recurrent infection. We already know this in terms of procedural risk. Overall we know that lead extraction is extremely safe procedure that the procedural mortality associated with extraction is quite quite low. Now we looked at this in terms of data In terms of you know what is this idea of salvaging and infected device? What does that mean for patients? How do they do? And so this was a review of the experience and 10 academic centers Patients were followed prospectively close to 433 And they found that 80% of patients failed this this salvage approach And close to 25% of these patients ended up dying from c. i. d. infection. And so one of the take home message is today is you don't sit on an infected device as an as an electro physiologist. As a lead management professional. As a lead management expert like you are guys are going to be push to get the system removed. It's going to help with the patient in terms of both reduction in morbidity and mortality. How can you identify these patients? Right? Certainly as electro physiologists you know we rely on getting referrals from our cardiology, colleagues from our primary care physicians or family physicians or internal medicine and colleagues even I look forward to getting consultation from infectious disease professionals. And in fact I've reached out to my I. D. Department and had discussions with them, gave lectures to their group about the importance of recognizing C. I. D. Infection and why it's important to get electrophysiology involved early. And all these are all the things that I would recommend you do when you start your practices. You know, gather the people that are sort of involved in taking care of these patients and and educate them about why these patients ought to be referred to you. There's another way to go about this and and one of them, this is actually something that we started in Chicago maybe about a year and a half ago I think or so and is too. So we have Epic and Epic can be configured to send you or your designate a epic message when a patient with a C. I. D. C. I. E. D. Has backed tree Mia. So Epic can kind of put those two terms together and then you get an alert saying john smith, you know, M R N. C I. D. And back tree Mia. That will then allow you to sort of as in terms of quality, take a look and see what's going on. You can investigate what's going on with that patient. You can reach out to the physician taking care of that patient and say hey listen I as an electro physiologist that's that's an expert and lead management. I got this alert and what's going on with this patient? Can I help? So that's something that you can think about. It's relatively easy to set up. It's not that cumbersome and I think it took our I. D. Department maybe an hour or two to kind of set up. And if you guys are interested in doing that in your practice is just reach out to phillips and they can contact you contact your I. T. Department with their I. T. Department and sort of this sort of almost a sheet of things like a list of things that can be done. That makes it very easy. Now let's take a step back and talk about noninfectious indication. So we infection relatively straightforward high mortality associated with the lead extraction is recommended classroom indication. System removal. What about non infectious causes? Well what do I mean by that lead failure installation break yesterday. Sarah and I did a case together of a gentleman that had an atrial lead fracture from subclavian crush and on Flora Skopje. We clearly saw dis continuity of the lead. Unfortunately this patient was actually dependent and when this patient's lead fractured it stopped working and the patient was v pacing developed pacemaker syndrome and then it was referred for evaluation. And so this person was young and we said listen this lead has failed. Let's just remove this lead will put an ad a new lead in the patient underwent a successful lead removal and reinsertion. And so one of the, I'm glad that this patient was referred to us because I think he got the best approach. But in some instances that patient could have easily just gotten an additional atrial lead put in. Right? So one additional lead in the vascular space. One additional lead, certainly in the sec. So what is the downside of placing abandoned leads? Right. And so in some its estimates, they suggest that many maybe as many as 600,000 patients in the us today have abandoned leads. But what's so wrong with that? Well, there's a number of things that have been associated with abandoned leads. One is infection and I'm going to show you some data behind that one is future extraction difficulty. Remember the longer the leads are in the more difficult it's likely going to be to remove them So you can kick the can down the road and say, Okay I'm gonna go ahead and add a lead in. But if that fails, maybe I'll bring him back in 10 years and try to move remove everything. Well that lead that's been in that's failed is now 25 years old versus it being maybe 10 years old. Right and so long as leads in the heart the heart it's going to be for you venus burden. Right? More leads in the vascular space, more chances of thrombosis, more chances of developing clotting and R. S. V. C. Syndrome. And then we talked about the idea of M. R. I. Conditionality currently in the guidelines having abandoned leads is a no no for MRI's. And you might say, well, I just won't do an M. R. I. L. To do a cT scan. You'd you'd be surprised how Mrm has become so important in the specialties outside of cardiology, in the surgery world, in the neuro world, the neurosurgery world in the cancer world. And we're even doing MRI's now in patients who have had heart transplants to gauge whether or not they're rejecting as opposed to doing biopsy. So even within cardiovascular medicine, mm ri scanning has become important. The most compelling data about capping versus extracting comes from a study that was published in circulation not too long ago. Now, this is a difficult issue to really study because you can't really do it prospective. It would be very difficult to do it perspectively, it'd be very difficult to do it randomized. So we're looking back at sort of a series of patients that were compared to, for example, looking back patients that we had abandoned leads were compared to patients that underwent extraction and the folks that actually had capped leads and that were abandoned. The most compelling information here is that they had a much higher risk of infection. And so you can see on that red bar that reached significance in terms of favoring extraction. The other sort of crossed the line of continuity. But there was some trends towards favoring extraction. But the most significant finding was the fact that having abandoned leads or Kathleen's lead it to infection for these patients. And we talked about the idea that having leads in for a longer period of time just makes the procedure more difficult. And we sometimes equate difficulty with risk. So the more fibrosis that you have an elite potentially the higher the risk of potential lead and vasculature binding would potentially make that procedure more difficult, more risky. And so we know that if we can get the leads early, get them removed when they're you know the lead dwell time is on the lower side. Our procedures are going to be more successful. Procedure is gonna be a lot safer. Class. One indication, shared decision making. You know, lead extraction is a black box, not not only with patients but with referring physicians as well. And so sitting down with that patient one on one and really talking about your expertise one of the things and shared decision making is not just well we can do this, we can do this but it's like listen I've been doing this now for a number of years. I'm an expert and lead management. This is I've done a number of these cases. This is my success rate. This is how we're gonna make this procedure successful and safe for you. That's part of shared decision making. So you should talk about your expertise. Should talk about your experience when you talk to these patients about what you're planning on doing what you're recommending advisory leads. So we're going to be dealing with this given the fact that more and more leads are being implanted. We talked about the idea of more and more defibrillator leads are being implanted in our population and defibrillator leads are complex leads and they can fail. They can malfunction. Right? So let's there's two sort of leads that we think about when we talk about advisory leads or or recall leads talked about the Rihanna. So I think the Rihanna recall was in 2007 if I'm not mistaken a little later. I have some data on that. We know the issue with Rihanna. The issue is the loss of loss of insulation and then externalization of the cables. And here's an example here on this graphic of this externalized cable floating into the R. V. O. T pulmonary artery. When that lead was removed. You can see all this jumble here. This is the extreme case most of the time. You know when you have a Riad, a patient you see sort of bulging, you might see some externalization and that lead might just remain that way. This is sort of an extreme version The Rihanna eight F 8 French lead. Had more rates of externalization than the seven French lead. Now, you might say, well, if I see externalization, what does that mean? Well remember right now, it's recommended that patients undergo yearly Flora Skopje to assess whether or not the externalization has increased. The last thing you want to do is get that externalized lead where all those cables are floating in the R. V. O. T. And pulmonary artery causing pR or tr we know that the rate of externalization can increase with time. So it's still recommended to evaluate those leads via Flora Skopje. A certain percentage of those leads will show electrical failure. Now, what's difficult about that is to say, well, is it the externalization that's causing an electrical failure or is it just that the lead failed? Because leads do fail. That's a difficult thing to tease out. But certainly when you have a Riad, a patient now, that's a patient that you need to follow longitudinal sprint for Dallas. So, sprint Fidelis came out and that was just a horrible thing. And I was, you know, practicing at the time when the sprint Fidelis recall happened. And it was just a horrible thing for patients because when the lead failed patients got inappropriate shocks and at that point we were just like, oh my God, what are we gonna do for these cases? And so the failure rate for the sprint Fidelis is much higher than the failure rate for the regatta in terms of electrical failure. In fact, as time goes on, that failure rate will increase. And so at 126 months, according to the data from Medtronic is close to a 26-27% failure rate with around 3% per year. Now you might say, well if I have a patient that has the sprint Fidelis lead Hasn't failed yet, it's been now 10, 12, 15 years. What are the chances of it failing? I'm just gonna go ahead and do jen change because they're up for jen change and let's see what happens. Problem is that for some reason, when you intervene on that Fidelis lead at the time of gen change, it increases the risk of failure and so you may run into trouble that the patient's been doing okay, you do a generator change and you keep the Fidelis lead in the system, there's going to be a much, much higher risk of that lead failing in the next six months to a year. So keep that in mind. The good news in all of this, I would say if there is good news is that the sprint Fidelis lead is highly extractable is manufactured in a way that can't, that would meet the specifications for good extraction sort of physics. And so it is one of the leads that I think we feel comfortable in managing well with lead extraction, the regatta leads a little different story with the externalized externalization of the cables that can make lead extraction difficult. And that's something that you know, when you go through the workstation, we talk about all the tools and techniques. You'll sort of see whether it's grabbing the cables um upsizing on the sheets. We'll talk about that in the simulator and and the workstation area. But the reality leads do need to be approached in a slightly different way than sprint Fidelis. So we're going to have a number of leads down the road fail. That's just how it is. Like I said, the achilles heel of trans venous side therapy is the lead. So we talked about Fidelis, we'll talk about Rihanna but you know, leads from other manufacturers fail all the time by a tronic. Is that recalls, you know, certainly boston scientific mike report all of them have lead issues and they will have lead issues moving forward. So we talked about the idea that there's a number of clinical situations where lead management and lead extraction are extremely important. Right? So as a lead management expert, you are now going to be offering lead extraction to your patients. And then it's also important to offer them this data about how safe and effective lead extraction is. So there's been a number of longitudinal studies done and these are published in high end journals indicating that lead extraction is a safe and effective procedure. Plexus study lexicon study studying thousands of patients showing that the procedural mortality associated elite extraction is very, very low. In one city, you can see it's .65% .6%. In the Lexicon study was .28%. Um Major adverse events were also significantly low Compared to for example, to show you a graphic of when you compare the extraction to other types of procedures that are done in cardiovascular medicine. Now you might say, well listen, you know, this was done in 2009. Yes, A lot of these cases were pacemakers that were removed. And I talked about the fact that more defibrillator leads are being implanted. But we've had smaller studies. Maybe not looking at thousands of patients, but smaller studies looking back at a more current population of patients undergoing lead extraction. Also indicating that lead extraction is overall a safe procedure. So based on the studies done in the last two decades, 97.7 clinical success rate. So you can effectively remove these leads safely. How is that? How is that possible? What you know, we are as electro physiologist. We we work in the field that extremely driven by technology and I love that fact about what we do and certainly phillips has been a leader in providing the tools that we need to perform this procedure safely and effectively. And so with laser sheets, guide light tight rail, which is the mechanical system and you'll get your hands on that today. If you already have an experienced or used it. Lead locking devices come in different sizes and strengths Vizi sheet, which allows you to see things clear clear on Flora Skopje and of course the I think the newest advance in terms of safety is the bridge balloon. I'm shared with your data on how that bridge balloon has saved lives in patients undergoing lead extraction. So the bridge balloon, remember that the S. V. C. R. A junction is the most common area of injury during trans venous lead extraction. And the reason behind that is physics. So you can see that the leads sort of take that bend around the S. P. C. R. A. Junction. And so sometimes there are a lot more right angles. When you perform lead extraction, potentially you might run into that the area or the the vessel wall in that region is extremely thin. And so when this happens, it's a emergency, right? That's why we have surgical backup during lead extraction because if there is a vascular terror perforation, that surgeon will often need to intervene and fix that tear. The surgeon has to be immediately available in order to save this patient. The bridge balloon essentially buys time. And so the bridge balloon is a balloon that we place into the S. V. C. R. A region that the area that we're concerned about. And in the event of perforation, we can then inflate the bridge balloon that will Tampa nod that area once again, buying time allowing that surgeon more time to access the chest access the area of terror perforation in order to to so that area up and fix that area. And so even though the risk of S. VCR injury is extremely low when it does happen it is an emergency. And so having this this sort of bridge balloon as a way to buy time is extremely important. There's been now great data published in the medical literature showing that having bridge balloon in place or at least that type of therapy That can increase overall survival when an SBC tear occurs. In fact from 56 to 88 when when the bridge balloon technology was utilized, here's an example of what I'm talking about. So here's that bridge balloon inflated. So you can imagine if there is a terrace right here at the S. P. C. R. A junction inflating that bridge balloon will Tampa nod that area. So where would you utilize this? Well, certainly at the uchicago we place a bridge wire. Pretty much an over 99% of patients. Right. We don't necessarily always place the bridge balloon into the vascular space. Like in the ibc. When when would you want to do that? Well think about it if you have for example leads that have been for been in for a long time where you number one you think there's going to be a large area of fibrosis. If you have an I. C. D. Lead that has a dual coil system. We know that having an sbc coil increases fibrosis in that region. That might be a reason why you may want to have that bridge wire ready to go higher risk cases. So for example patients with multiple leads highly dwell time. What if you're starting off on your program? You know you're finishing fellowship, you're recruited to go to a center that says hey you know we want you to do lead extraction. We want to start a program. We want you to supplement a program that's there. You know maybe in your first case you certainly should have all the tools and techniques that you know you're going to have a safe outcome. So I think having this bridge balloon is extremely useful and and and I think every extraction program now has it. Now. I talked about the idea of when you compare lead extraction to the other things that happened in cardiovascular medicine in terms of procedures. I think it's important to put this into perspective. So take a look at this graphic. So we're talking about procedural, you know major adverse events, procedural mortality. Here's lead extraction. This is based on the lexicon study. If you take a look at where lead extraction sits. Certainly Tavern has a higher morbidity and mortality. P. C. I. S. Have a higher morbidity mortality and no one would bat an eyelash. And you say I'm going to refer this patient for an elective stent. Well there's consequences to things as well. Ablation is probably one of the most common procedures we do in electrophysiology and that's kind of right behind lead extraction. So if you think about the safety and efficacy of a procedure, what's published in the medical literature supports the idea that once again I may sound like a broken record player but that lead extraction is a safe and effective procedure for most of your patients. Okay. This is something that I'm really interested in. No one would ever now consider doing an A fib ablation without inter cardiac echo. Right 20 years ago an eighth of liberation started and we had no inter cardiac echo. Everything was done using Flora Skopje. But now we use inter cardiac echo all the time for a fib ablation. VT ablation. We use inter cardiac echo to guide lesion placement to safely perform a trans septal puncture, monitored for complications. Well, it stands to reason that imaging can can offer the same benefits in trans venous lead extraction. So remember that the most common location for vascular injury as I mentioned was that the S. V. C. R. A junction. And the question is can imaging identify areas of binding or fibrosis in that region. Well, how do we currently define risk of a procedure or difficulty of a procedure when it comes to lead extraction. What patients do we kind of worry about this is going to be a tougher case or this might be a higher risk case? Well we use a number of clinical features or risk factors. Right? So the longer the lead has been in that's called lead well type the higher the chances of fibrosis occurring with the lead and then fibrosis comes in two flavors. There's lead on lead binding. Right? So many times we see leads kind of stuck together and there's lead on vascular your binding. Both are important components of something called intravascular lead adherence having an S. V. C. Coil dual coil system having that spc coil and that coil is a night is for fibrosis. We know that those patients will probably have a more difficult extraction multiple leads in the vascular space, right? Lots of lead on lead binding. More difficulty getting through those leads. We think that younger people have a more fi broderick response than older people. That's gone back and forth in the medical literature. We think that women tend to be more fi broderick than men. Once again, that's gone back and forth in the medical literature but certainly lead dwell time. Sbc coil multiple leads has been borne out in a number of studies saying that's associated with high fibrosis. Well these risk factors have limitation. We've all seen cases where we were expecting a difficult extraction. There's no binding at all leads sometimes slide out a few pulses of energy underneath the clavicle leads come out the question is can imaging sort of distinguish what we consider a high difficult population versus a low difficult population. So what imaging techniques currently exist? Well there's pre procedural C. T. And this is being processed as perspectively studied in a number of studies. One of them is the miles trial. And that's a that's one of the studies that's going on. There's phased array ice phased array ice. Is the ice that we use during during a failed ablation of VT ablation and then there's radial ice called intravascular ultrasound. So here's an example of seti and so this requires contrast. Certainly this is done before the procedure when patients excuse me when patients are referred for lead extraction and what you're looking for of course are these leads in the vascular space. So you can see this lead is intravascular. These leads are intravascular. These leads looks like there may be butting against the vascular space. This might be an intravascular, this is a radio. This is a still image of intravascular ultrasound and the intravascular ivy's catheter. You often use that in in coronary cases but there's an I. V. Catheter that can be utilized where you place it in the vascular space. Here's the ivies catheter here are the two leads outlined. You get a 360 view and you get a sense that, okay most likely there's black areas behind this lead. That means there's there's a blood flow and this lead might be contiguous or next to the vascular space here. Thank you. So sometimes intravascular ultrasound can identify areas of binding where where you may need to be careful. So here's the downside of C. T. So here's an example of C. T. Being compared directly to Ibis. And you can see here, alright, based on the ct image looks like there's 12, maybe three leads sitting here. They look like the intravascular ah this image correlative. This is not a good thing when you see this you're like oh my goodness the leaves look like they're outside the vascular space. How is that possible? Well unfortunately remember you're the C. T. Image is only going to be valid if the contrast is able to sort of fill the entire looming. When that doesn't happen. It looks and it appears as if the leads are sitting outside that contrast lumen. In fact using intravascular ultrasound, you can see the leads are entirely intravascular. So there are some limitations with ct. Same thing here. It looks like, oh my God that looks like it's protruding outside the wall of the sbc. Well in fact in my visits probably contiguous to its probably not protruding. And so this is a work in progress and we're excited to see what seti is going to be offering us. Um I will share with you that I think that intra cardiac imaging with intra cardiac echo and ct are going to be complementary. Think there's gonna be times where they're gonna be despaired findings. Well we'll see here's the work that we've done on using intravascular ultrasound. So we studied Close to 60 patients perspectively and we performed intravascular ultrasound and all these patients undergoing lead extraction. This was published in Circe E. And the last year. And what we wanted to do was to compare our ibis findings of lead adherence to certain metrics in terms of difficulty of extraction. So when we have this image to everybody, we divided them into sort of two groups a group that had high adherence or low adherence. And we used metrics like time to get across a binding site or the number of pulses of energy that were delivered. And we found that when we compared it to clinical risk factors, I've added more information. So there was a group of patients for example that had what we called low clinical risk factors. So leads been in only for three or four years, there's only one lead in the vascular space. Well that probably makes sense that this is going to be a less difficult extraction and I was really what's correlated with that. So if you have low risk factors for lead adherents I've this is probably not going to be useful but if you have patience for example we found a group of patients where clinical risk factors portended a more difficult procedure. So a woman that had had a 10 year old I. C. D. Lead dual coil system and a natural lead had developed an infection that patient needed to get an extraction by clinical risk factors? We would have pretended or predicted a higher more difficult procedure turned out the IV's findings show that everything all the leads were intravascular and so there's a group of patients that were able to identify that potentially would be what we consider a low difficulty or lowest population. And then there were always some surprises. Right? We always have I'm sure you've been in cases where the lead has been in four years and it should be relatively straightforward. It's probably leads may even slide out. Mhm leads are socked in there so I this is able to sort of distinguish and individualized for each patient. How difficult or easy this extraction is going to be. So once again I work in progress. Something that I'm definitely interested in in in adding to the literature. Then of course phased array intra cardiac echo can also look at this area just in a different way. It can give you the 360 view but it can give you an idea of binding unfortunately may not be able to quantify the amount of binding But one of the advantages of Phase three ice of course is looking at other neighboring structures for example to try to spit valve it's often an area that we don't really focus it on. Are we damaging the drunk husband valve during lead extraction? Are there ways to many minimize damage to the valve during lead extraction? So all the things that I think phased array ice is really good at looking at will be able to explore. So once again I know my partners in the lead extraction world are using a phased array is to look at those structures as well. So as future. Yeah electro physiologist as future lead management professionals and experts having the skill set. Having the mindset of lead management is going to be of great benefit to you in your future practice. I've shared with you data on number one the number of patients undergoing trans venous lead implantation is only increasing. We know that the rate of C. I. D. Infection is far outpacing the rate of implantation. So you're going to be seeing those patients in your clinics having the skill set and having the expertise to manage those patients, you're going to be quite busy. And so Number one you'll be able to provide quality care for these patients. You want to be able to manage these patients well by improving their morbidity and reducing the morbidity and mortality by being active and recognizing these infections malfunctions from both these events. We know that lead extraction from the literature is a safe and effective procedure and having the skill set can differentiate you from others. Having this skill set in this program and your practices can differentiate your practice and your hospital from the others that are in the region. And all of the things that we've talked about, the need for lead extraction when it comes to infection. Are all classroom indications from the guidelines. The guidelines are very supportive of this type of management. So I think one of the take home message is our is that you know if you're interested in being a lead management professional, definitely try to do that during your training, come out with that skill set, it's going to serve you well. And I think while the risks of lead extraction we know are low the shared decision that we need to make with each of our patients having the tools at your disposal to give you the best result will be key. So when you start a lead extraction program you need to meet with all the individuals that are involved. You need to meet with the surgeons, you can do this procedure without them. You need to meet with the people at the hospital in terms of what resources can I have here, whether it's nursing profusion as backup. Um Meet with the value analysis team to make sure that everything is in your E. P. Lab that you need. For example I need to have mechanical tools. I need to have snares. I need to have L. L. D. S. I need to have you know special tools and technology. The bridge balloon that has to be there in order for me to do this procedure successfully in order me to launch this program successfully and I'm sure that wherever you go to practice uh the phillips team will be able to connect you with the right individuals to make sure that that happens. So sounds a bit cliche take the lead, right? So remember you are a lead manager lead professional lead expert, remember that as I said this is going to be something that's going to distinguish you from others in the community that you're gonna be working in. And I'm excited that you'll have the opportunity this morning to actually get your hands on these tools that we talked about from the mechanical sheets, the laser sheets. The simulator is fantastic. I've been on the simulator and it really comes close to what you would sort of feel when you're pulling on leads and advancing the tools. And so I'm excited that we're gonna get some time to spend with each of you on the workstations coming up thank you for your attention and I'll be happy to take any questions. Thanks. Yeah so that is um so you are going to let's say the concept is let's say you have a pacemaker lead or a defibrillator lead and you don't want to refer that patient to a lead extractor and you don't perform lead extraction. The tendency is I'm just going to cut the lead short and I'm gonna try to just bury it the problem is when you cut the lead short and you just might cap it. There were inner coil retracts and so let's say that patient then develops an infection from your generator change or adding your lead and then you refer that patient for extraction. That extractor is going to be handcuffed because he may not be able to get purchase of that lead from the pocket. That's gonna make that procedure a lot more difficult. That's that extractor we have to snare the lead from below and pull it down adding to the complexity of the procedure. So listen, if you're going to uh let's say you have a shared decision discussion with the patient, patient said, you know, I just add a lead in or something like that, preserve the abandoned lead for future extraction. That's what the guidelines are trying to say lengthen the pocket capping it, making it accessible for future extraction. Great. All right. Yes, I guess this might be something that will probably be as conduction system. It's do you have the first game overseas? Current those great question. So there is data on removing his bundle pacing leads and that was published maybe about a year and a half ago and those leads come out relatively straightforward, relatively easy with the same tools and techniques we use now. Um I've actually removed his bundle lead and it it really didn't take much to remove that lead the lead been in for about 2.5 years and as you know, one of the downsides of his bundle pacing is the increasing thresholds with time. Uh The left bundle area leads, we'll see, I mean if you think about it, the leads are embedded into the septum, so in terms of safety will be able to get our sheets and and and tools really close to the tip of those leads, right? Because if we need to push we're pushing against the septum as opposed to a free wall lead. And so I think we should be, I think they're going to come out fine. There isn't anything in the literature talking about removing those type of leads, but I think that we're going to be okay. All right, excellent. Alright, well I think we're gonna take a break and then we'll go to the workstations. Thanks again guys.
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