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We defined by removing all the components of the lead but clinical success if we have an infected device and we leave a lead tip less than four cm that doesn't negatively impact the patient because they're not going to get septic from it. We still describe as a clinical success. So indications for lead extraction are broad on the left you can see is what an infected pocket looks like. And that's the greatest majority of devices that we extract about 60 to 80% functional lead. So as DR Cannell Unmentioned venus inclusive disease is something we see a lot. So patients who may have indwelling pacemakers that require upgrade to cardiac re synchronization therapy or patients with I. C. D. S who require upgrades or patients who have developed a low ef that need a defibrillator lead. But the vein is the nautical and so we can't enter into that vein and so we would have to extract a lead, put down a couple of wires and then retain access and then put in a new lead through that and then nonfunctional leads. So these are the most controversial in younger patients we refer who have lead fractures or insulation failures. They may require extraction because the lifetime risk of later on removing it as much higher than when the lead is younger. Um And in older patients we may decide to abandon that and that varies from operator to operator. So the growing C. I. D. Infection pandemic as you can see from both of these Kaplan meier curves um in we're implanting more and more C. I. E. D. S. But the infection rate is growing and you can see from the numbers at the bottom about it's 12% and 25 years. And the reason for that is patients are more sicker so they have more comorbidities. Um And then it requires multiple generator changes. So anytime you do a generator change, the risk of infection is higher. And so we're seeing more and more infected devices. We're also seeing an increase in lead malfunction over time. So patients, this was a registry done in europe basically looking at as the longer the lead stays in the body. The rates of failure whether it's from lead fracture or insulation is higher and so we need to be able to extract these leads over time. And so here's the problem though. And here's the registry that Sean Pokorny and john Pacini did at Duke using the Medicare registry data, they looked at a million patients with implanted pacemakers and defibrillators. And what they found was at least 80% did not get an extraction when the device by guidelines should have been removed completely, 80% or not getting them extracted 5% had extra Action between seven and 30 days and 13% had extraction within six days. And as you can see from the bottom numbers, looking at the mortality data, 20% mortality is way different than 32.4%. So recognizing that infection is being seen earlier and and referring these patients for extraction earlier is very important. And conservative management doesn't work. So multiple studies, if you look at these graphs, you can see that if you just wash out the pocket, the relapse rates much higher and they have a seven times increased mortality. So you can't just if you see an infected device, you see back to re mia that's resistant or Marseilles or staff factory mia. You have to extract the whole thing because just washing it out doesn't work. This is a study done by U. C. San Diego. And what you can see from this is on the left. They on the left, they looked at patients with persistent back to remand on the right. They looked at patients with isolated pocket infections. So where we didn't see with Eco guidance, we didn't see evidence of vegetation or evidence of lead infection. But what they found was earlier extraction, reduced mortality, which is very important. And so this is data which I published a long time ago. We've evolved as a group in the field from more of an open to our economy approach back in the day when we saw vegetation. Um we used to do or the surgeons used to do open to our economy to remove the entire lead. Now we've involved we we've evolved this specialized tools so you can see here on the left as lasers, which is the main workhorse. It comes in three different sizes of 12, 14 and 16 french, which uses laser energy to cut through the fibrosis. Around the lead. On the right is a mechanical tight trail. So it uses cutting technology. It has a bevel shape sort of like a blade that cuts through the fibrosis tissue. And what you can see from this is per Catania's techniques have involved. And even the surgeons now if you look at dr Carrillo or Dr Barreiro here um trans venous approach is usually the primarily preferred method because it reduces length of stay um lower mortality and on the right you can see, we looked at time to death. The open chest group even after you controlled for comorbidities and vegetation size did worse than the close chest group. So why are we missing patients for extraction? I think one of the things is education um other providers don't know that these devices need to be extracted. There's lack of referral pathways so they're not built in currently in our electronic medical record. Um We don't have experience enough operators. They're not there are only a handful of operators around the country um that do lead extraction and then perceived risk. So one of the perceived risk we can see here is what we call an S. V. C. Terror as you can see from the video on the left is the laser is pushing against the S. V. C. And the lateral part of the S. V. C. Usually you would want to you would want to bring this lead towards the medial aspect where the tear rates are much lower. And so this one goes against the S. V. C. And you can see we use a lot of T. E. Guidance. A pericardial effusion has formed and usually if the patient's unstable we would just recommend the surgeon to open up the chest because this S. V. C. Tear won't be fixed by a per catania's drain. However our rates are very low. So if we look at when dr kiel joined the group and this is mostly from doctor keel and Barreiro you can see that our rates are the complexity of our cases has increased. So over the years the the lead age now is 17.6 from 13.1. A lot of these are dual coil I. C. D. Lead. So you can see here this is a dual coil lead where this coil at the S. V. C. Is a higher risk because it sticks against that S. V. C. Um but our success rates are very high so 97.2% with the majority requiring power tools and our injury rates are very low. So our vascular injury 0.8%. And we've had one mortality during that time of 0.4%. So these are lower complication rates than seen in the lexicon study which is a multi center large extraction study and mirror those seen at large extraction center. So our experience here is similar to other large experience centers like North Well um and Cleveland clinic. So extracting physicians, you have doctors kill Barrera on the left who have really pioneered a lot of the work and dr Hedley and I have joined to help burden take off some of the burden from them. So building the right team. Um I'm a big Duke fan unfortunate to the U. V. A. Or U. N. C. Fans and coach K. Had this thing about what makes a great team is communication, trust, collective responsibility, caring and pride. And so I think if you have a team you need all of these five qualities and we rely on all of these things when we look for extractions. So we rely on our colleagues and ep to recognize device infections or lead failures or patients who may be younger that they should recommend extraction rather than abandon abandoning and capping the lead. We rely on device clinic nurses um and the device clinic too look for increasing thresholds. Rising impedance is or lower impedance is. We rely on non ep cardiology. We we rely a lot on the surgeons because they can they can tell us what the surgical risk are and whether we're better off capping or extracting the lead. If the surgical risk is low as a backup then we would we would prefer extraction. We rely on I. D. Who recognizes infection and persistent factory mia because sometimes the um people may miss that. The blood cultures have been positive for four days. We will rely on hospitalists who coordinate the care and help us when consult us when they recognize this patient needs an extraction. And we rely sometimes on the electronic medical record. Once we're in in the in the O. R. Extracting we rely on each other for help for techniques especially if it's a difficult extraction. We rely on the text of the nurses especially who help us out a lot the device reps and the phillips and cooks reps are instrumental into helping us realize where we're getting caught up. Maybe switching to another tool and the surgical team which includes the ct surgeon who helps us when they're scrubbed in the anesthesia, colleagues with the T. And anesthesia support the surgical assistance, scrub text and perfusion. So it's a much bigger team than what we're used to dealing with in ep while we're putting in pacemakers are doing a simple ablation And we also prepare for the worst but we expect the best. What that means is we do a lot of homework prepping up to lead extraction case. So it's not just an add on pacemaker at three p.m. It's you really have to know the leads because different leads have different make. So a 38 30 is a luminous lead. Maybe your approach to extracting may be different than a Fidelis or riyadh. A lead. You look at the x ray because you find stuff from x rays like how did the lead fracture? Can I identify a lead fracture from an X ray And that may change your approach. CT scan which I'll talk about which I co led with Bruce will cough is going to be importantly important is going to increasingly become more important. The hybrid O. R. Is where we do most of our extractions because the surgeon is most comfortable and we feel like the rest of the team it's a much better place to do these extractions than the smaller E. P. Lab if stuff goes bad and so that's why we do most of these in the hybrid or we do a pre procedural huddle we use the bridge balloon and I'll show some data on that. We we use T guidance and then we confirm with cts what's the rescue strategy. So as an immediate step anatomy or lateral thoracotomy. We have blood ready. We have profusion ready in case we need to go on bypass. And then hypothermia has been shown to be importantly effective if we have an S. V. C. Tear. So this is uh the newest data which I lead with Bruce will cough where we used five leading extraction center. So Cleveland clinic Elina health in Minneapolis, Duke North. Well and assigned in Germany where we we basically enrolled patients into cT guided approach where CT readers were blinded to the reading of the ct and operators were blinded and you can see here we were most worried about fibrosis in the S. V. C. On panel a you can see the leads are in central lumen of the S. V. C. And so this is a fairly what should be an easy extraction if we just graded by C. T. On the right panel you can see the lead is outside of the lumen of the S. V. C. And you can see because of the outside we predict by this that the fibrosis should be higher. And what we found was that was true. So in when we graded C. T. Scoring with fibrosis we found that power cheats. So laser mechanical tool was much higher in ones with higher fibrosis scores on C. T. And the extraction was much higher and I think this will play an important role because if your kidney function is normal or the radiation risk is small, especially in these patients with comorbidities. Why not have more information um for the patient or you're planning purposes you may block off more O. R. Time or you may if you're on the fence of extracting or not it may change your opinion in an infected case or if the lead is very old and you're you've decided to extract. I don't think seti is going to change your mind but on cases where you're on the fence I think it will be an important role. The bridge balloon. Um So I show this because the bridge balloon um is controversial because you can't randomize the data for this kind of study. So it's a little biased towards the bridge balloon but we use it a lot. And the reason for that is we stage it before the procedure. If we go down with the laser here, what the bridge balloon does is if there's a tear and bleeding starts the bridge balloon gives the surgeon time to find the hole where the bleeding is. And you can see here from this study that patients with the bridge balloons survived significantly longer than patients without the bridge balloon. But it's a biased study and there will unfortunately never be a randomized trial looking at this. So I would take it with a grain of salt. So conclusions lead extraction has involved from an open approach to trans venus approach and I think it's gonna be more trans venus. So even with patients with large vegetation now people are using angio vac to suck out the vegetation and then doing a trans venus approach. Um I think sometimes we take a step back if the patient has significant valve disease um or if they have other kind of valve repair that needs to be done. The open approach is the way to go for that. Um But I think with angie a vac trans venous approach will only grow early identification of infected devices is important. And so that's the teaching point. I think if there's one thing I would tell you guys as you leave this talk is if you see an infected device or staff factory mia, I think it's important to refer to ep and an extraction center. The planning of the procedure is just as important as the actual procedure and nothing can be done without the support of the team, which has led to a lot of successful extraction here and low complication rates with newer studies and safer tools, their their companies developing rotational where you can steer the laser in different directions. Um And there's a laser and mechanical combination coming out. We expect an already safe procedure only gets safer as the years passed until that is leaderless pace making becomes the norm Published Created by Related Presenters Divyang Patel, M.D. Sentara Cardiology Specialists View Full Profile
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