Dr. Kiehl discusses the key content of the lead management indications per the HRS Guidelines. He also will share teaching points/importance of workflow while utilizing the Bridge Occlusion Balloon in your procedures.
Okay. Um Same disclosure slides I showed last night, nothing changed. So um You know guidelines talks can be kind of boring sometimes but it turns out actually the guideline document from 2017 is actually an excellent read. So and it's only about 60 pages of which a lot of it is references. So I'd actually encourage each of you to actually go through and read it and then read the supplemental um references. I've tried to highlight some of the main references from this paper throughout the talk. Um And so Um you know if you're trying to read the FM guidelines it's you know that the document is like 400 pages long but this one's actually quite readable and I think I think very useful. Um So I'm just gonna try and highlight all the extraction indications and then some of the kind of work out documents and figures that are within the main consensus document. So um the green is the you know level of indication. The blue is the level of evidence. And one of the things I wanted to kind of point out as you go through all these slides is that most of the level of evidence um in terms of the supporting documents is from non randomized data. And so you'll see that even things that have class one indications for instance the last one on the slide is you know, c expert opinion, that's what that stands for L. D. Is C. Limited data. Be non randomized data. So just know that there's kind of a posse of randomized control trials for extraction because frankly it's a little difficult to randomize patients in this space. So for infection purposes um complete device and lead removal is recommended for all patients with definite C. I. E. D. System infection. That's pretty straightforward. Right? Um if you have valvular endocarditis so aortic valve endocarditis say but the leads look fine on T. E. It's still recommended to remove the device. I think we all know that as well. Um For patients who have persistent or recurrent bacteria or fungi mia despite appropriate antibiotic therapy and no other identifiable source. These are all level one and then complete removal of that cardio leads and patches is recommended for all patients with confirmed infected peer violence surrounding the entire thoracic portion of lead. It's a little hard sometimes to see from when you're just up in the pocket up here but it's something to consider. So um this is actually a table that I tried to blow up from the document and I think is extremely useful um extremely useful workflow to go through. So if you have a suspected infection whether it's a pocket infection or a systemic infection you get blood cultures you consult I. D. You can kind of go through if you have positive blood cultures and you get A. T. E. And you have a lead vegetation or a valve vegetation. You're going to remove the device you have a negative T. Depending on the microbiology which you'll see in a in a slide to come. You may still remove the device otherwise you may provide antibiotics for several weeks in terms of re implantation. This is a question that comes up very frequently. So when can you re implant the device after you extract it particularly their their dependent um 72 hours is generally the workflow that we'll use but sometimes we'll we'll wait a little bit longer if the patients can if somebody's not dependent, maybe you can get away with actually letting them complete their antibiotic course. So 72 hours is kind of the bare minimum that you would wait um if you have negative blood cultures. Um But you have evidence of erosion. You take the device out. If you have negative blood cultures, no erosion you can observe the patient um and see see how things go. Um When you re implant the device, I don't have slides on this but I would strongly consider using T. Rex pouch in certain patients. Certain patients because you already have a higher risk person that's had one infection. So um and you can you can you know read the rapid study for that. So um so this is a separate table from the same document on back to re mia and a recommended workflow with respect to that. Um So really what I want to point out is that the bug matters. So if you have staph aureus negative staff Canada. It doesn't matter really if you have t evidence of vegetation and lead. Take the device out. Um Same is likely true for strep species as well. Um You see a lot of a callous as well um and so kind of in those fears you're you're taking the device out gram negative rods. Not as not as absolute indication to remove the device. I may have removed some devices for gram negative rod factory mia but um it's not in the guidelines that you have to go straight there. I will tell you this is actually highly tested on ep boards. There is definitely a breakout session on this and the HRS board review of course and I definitely had questions on this on boards in terms of um species driven management. So and as I discussed last night about the EMR used for kind of referrals and using epic to identify patients. This is kind of why you could do that so and dr love alluded to this last night. Um that timing matters and so I mentioned last night that the way we have our extraction schedule set up on Tuesdays and Fridays that we wouldn't go more than 72 hours without removing a device. This is a nice paper from Jackie P. In 2000 and 21 from U. C. S. D. And they basically looked at delayed versus early extraction of devices and they defined Early as seven days or less and late as seven days or more and that's from the time they're hospitalized at the time they're extracted. So not from the time detected from the time extracted and this is 13 years worth of data. They roughly had 50% in the late 50% in the early Um 20 233 patients. And what you can see is clearly on the K. M. curves is a significant survival difference between Early and delayed extraction. If you look at the absolute risk reduction there in terms of mortality you're talking about 20% Difference is the number needed to treat is only five. So um important to get these devices out out early. So this is a patient study from Vanderbilt with staph aureus bacteria mia and device infection with. And and sorry uh staph aureus bacteria miA. And patients who have devices but don't have clear evidence of of elite infection or pocket infection. And so this is kind of empirical device removal for um for staph aureus bacteria mia with device and what you can see again is that less reduction. Less relapse back dreamy a reduction in Mortality with empirical removal. And interestingly in this study when they kind of look through only 10% of their patients underwent extraction empirically um And of those not going extraction, undergoing extraction. Similar risk reduction or I guess in this case risk increase for those not receiving extraction. Um The question that comes up and this is a little bit off the guidelines but I thought were interesting things to look at. So if you have a patient who is dependent how do you go about bridging them? Um So we do a lot of temp perms where I am. So basically we'll screw in a we just use 50 76 leads from medtronic or for with you know Abbott we use the appropriate pacing lead and we'll screw it in through right I. J. And then hook it up to an externalized re sterilized can and allows patients to at least by our protocol not be in the I. C. U. They can move around a little bit more freely stay active And it gives us more time if we want to wait more than 72 hours or not using passive leads here. Um It's a good method of keeping patients out of the ICU in that way. Micro actually both as a short term bridge and a long term bridge actually has a lot of data as well Smalling studies but these three studies if you want to review them the slides will be available later. But as you know 36 total patients who had concurrent micro implanted for infection and did not um did not have signs of recurrent infection. Some of them had their micro's removed because it wasn't the best device for them long term in terms of the limited capacity of micro but but I think that's a decent option as well. I've done it once or twice but but not a significant amount of times. Alright Any questions about infectious stuff before I go in. So non infectious there's a bunch of other things and this is not an exhaustive list but I thought would be the things worth uh worth bringing up. So um patients who have sbcs stenosis or occlusion and they need another lead that's pretty straightforward. Right? This is your kind of occlusion indication patients that have chronic pain at the device site or the lead insertion. Um So you know this exact example scenario this would be say um a young patient who had intermittent baby block and had a um trans venous system placed. Um And they have pocket pain. You could either supposed bury the pocket or bear the device deeper in the pocket sub muscular see if that improves things Or perhaps they're a better candidate for a mike. Or you could take the device out and put a microphone in. Um Yeah. Yeah jesus talked to them about what their expectations are with that operation because the people who have like fibromyalgia, scientist things like that. They're the they're the worst ones. So I will try the neuroleptics. I'll try gabapentin. I'll try him tripling things like that. This woman has been everything she's done OxyContin even and she's still miserable but you have to have and she needs the device she's got sarcoidosis. She's got an I. C. D. And she's got runs of E. T. And has had had one appropriate shock already. So what are the options here? So one of the options of course is to bury the advice deeper move it to the other side. But you have to have that talk and document it at that clinic visit and pre operatively in your pre op note that there's no guarantee that what you're gonna do is make them feel any better because they will come out to you afterwards and you told me this was gonna fix me and I'm still having all this pain. So very very important to document. Yeah I would say that I rarely extract for a device pain usually it's something else you know that I think they would be better served long term with another device or something like that. So um this is kind of similar to the occlusion um indication but if you already have four leads on one side or five total um the risk of occlusion going up for S. V. C. Syndrome increases. And so you could extract unnecessary leads at that time when you have to put a new lead in to try and kind of make room um lead removal can be considered for patients with leads due to their design or failure. So so this is kind of you know recall leads you know whether they are having problems now or in the future that kind of gives you the the ability to extract regattas and Fidelis. Although it's been a while now um lead removal for non recalled pacing, defibrillation leads after shared decision making. So that that kind of gives you the capacity to kind of make a clinical decision. So there's there's some certain open endedness and you can see this so these last three that are all to be there see limited data c expert opinion. So it's allowing the opportunity for for providers to make a decision that they think is the right decision for the patient but you need to have an informed discussion. Um The last one removal to facilitate access for M. R. I. I'm finding this to be less of an issue. Most big centers have come up with M. R. I. Protocols. Um And so it's still on there but there are ways to get around it without having to extract the one thing that's not on here that I would say and I mentioned this last night that I'm doing a little bit more of is I'm actually extracting for track speed valve interventions not for the purposes of taking the lead out to hope that the tr gets better. That's not what I'm saying. But to allow try custard clipping or um ah you know a mitral and trusted position from with structural heart. Um And so they have some techniques where they can kind of get the leads out sometimes to clip but for for trans catheter valves it's a little bit harder. Um So miscellaneous things that I just when I was going through, I thought it would highlight. Um So we talked a little bit about abandoned leads being a higher risk feature. And and after the talk last night, I was getting a couple of questions about that. So leaving the lead in a condition that will permit future extraction uh is an important thing. So if you are, even though this is a talk about extraction and a conference about extraction, there are gonna be times when you think the right thing to do is abandon the lead. So you don't want to cut the lead and let it retract in. That's a problem. You want to leave the lumen intact, You want to leave the pin intact. You want to put a cap on the top, you want to secure it so that the lack of better term junk doesn't get in there and you actually have something later down the road. You need to extract that lead that you have as as an intact of elite as you possibly can. I can't reiterate how important that is. If you're extracting for infection, try and allow your infectious disease colleagues as much information as possible. So send the tissue from the pocket, send the leads and the generator, try not to put the generator on the table, try and put it directly into a specimen cup to try and keep it sterile and then t. E. Is useful during procedures for infection to look at other potential commitment sources of infection. Um There's a lot of programmatic commentary in the uh document that I think is extremely worth reading. Um But one of the things as I mentioned last night is that it is important to have data management for your extraction program. In terms of your success rates, you're complication rates so that you can have those discussions with patients and try and have them at a level that you can Say a two year old lead isn't the same as a 20 year old lead. It's hard to provide that level of data but you can kind of do it in terms of there's a lot of commentary about imaging um CT imaging whether to um you know be in the E. P. Lab or the hybrid O. R. There's some documentation and the document about that. There's a lot of commentary about what is surgical rescue and I'm sure in litigation this comes up all the time as you mentioned last night but um they want you to be able to go On pump within 5 to 10 minutes with the chest open. Um And so I'm not gonna kind of reiterate all the things I said last night but having blood in the O. R. T. Use of T. E. Arterial lines, large bore resuscitation. She's um profusion cannula Bridget collusion balloon. These are all referenced in the in the document as well. Um We talked a little bit about volume. Um and so there are guidelines in there about how many leads a fellow should do during training and then how many you should do as an operator in practice. And the numbers are actually quite small and it's it's in leeds, not in systems. All the numbers I showed you my own individual stuff last night was systems But it's in fellowship it's greater than or equal to 40 leads. Um or once you're out in practice is greater than or equal to 20 leads per year. That was that was politically driven. I was one of the authors on the original on all three of the documents and that was politically driven by HRS leadership, not by the writing committee. That's because all these things have to be approved by the board of HRS. And the original recommendations that we made would have precluded many members of the board from doing lead extraction. So they dumped it down so leads and and those of us that do a lot of extraction. Clearly recognize that if you average two leads per case which is actually probably even conservative, that means you're doing 10 operations a year, which is probably not a sufficient number to maintain good proficiency for you or your team. One last thing for this slide is you guys are gonna get some practice on simulators later this this morning simulators have been shown, fellows have been trained on simulators have been shown to have better outcomes basically. I think what the simulator is most useful for is is making you realize that pushing is bad. Um, and getting the right amount of push pull balance in terms of risk prediction. There's a lot of uh, documents in there in terms of, you know, how you can have discussions with patients, what are high risk features. I'm not going to go through all these with you. I think we have some of those subsequent slides, um, if you want to read one paper about this and this is maybe being a little bit of a homer since Cleveland clinic person, but there's a great paper by Mike bruner who's on the left and then Bruce Volkoff was, I think the lead author on the paper um where they basically went through the entire Cleveland clinic experience over many, many years and they kind of went through what are, what are risks for that? It's not a hard read either. So I'm sure any of you who have done a fair amount of extraction have used the bridge balloon before, but essentially, um, this is a video of basically a wire that's up in kind of on its way up into the right, iJ kind of coiling into the right subclavian and, and you can see the balloon being inflated and then on the right, you can see these are not my slides, but you can see someone injecting contrast and seeing that it doesn't make it down with the included balloon. So that's inclusive. Who should be considered for for the bridge balloon. So I mentioned uh if you're in your first year out from practice is very reasonable to to use the bridge balloon. Um Female patients these are all kind of risk factors from that trial. I do that study I just referred to low B. M. I. Female low E. F. Dual coil I. C. D. Leads multiple leads combined lead age. Um You know if the C. T. Has high risk features that's not something that's on the slide but obviously that would be something to consider as well. Why do we use it? Okay so this is eric can you explain what you mean by staging the balloon? Oh sure sure. So and I've got some slides in this in a second. So um actually I think yeah I'll get I'll get back to that. I think I have a step by step balloon balloon slide. So why we use the bridge balloon basically this is a trial that looked at especie tears and they stratified in terms of either non bridge use or improper proper use of the balloon. We'll talk about what that means in a second versus using the balloon properly and the survival with good neurologic outcome in the bridge balloon appropriate use arm was 88%. Whereas in the um In the non bridge balloon arm is 43%. So Obportunly two times difference in mortality. Um And of this is from 2016 to 2018 mod data. If you actually look at the six. Mortalities in the bridge arm, two of the six had delayed repairs. It may not have been that the bridge was the problem, may have been just the surgeons weren't available and all the patients who were discharged had good neurologic outcomes. So that's that's I mean that's stark data. I mean the number needed to treat there as to so um if you look at the time to delay time to deploy, this is kind of the idea of pre staging the balloon that we'll get to in a second basically if you already had it prophylactically staged. And all you had to do is push the balloon up which again I'll show you in a slide versus if you just had um 12 french sheath in place and if you had a tear where you're gonna grab the balloon and put it up there, there was a 700 cc difference in in blood loss between those two which is dramatic. So this is my kind of slide and workflow and how how I prestaged the bridge blend. So the first thing I do is I get ultrasound guided access. I do ultrasound guided access for all ephemeral, everything venus and arterial. But um I get ultrasound guided access. I try and use the right femoral as opposed to the left femoral just because it's less tortuous. Um Those of you who are you know ice catheters. I usually put my ice catheter through the left and sometimes you end up having to use a long chief. So similar idea with the balloon um Then I advanced J. Wire up to the uh I. J. Or subclavian contra lateral to the device site. So normally attempt to. So normally the devices are on the left side. So I'll try and go for the right I. J. Uh the right subclavian. Sometimes you know it's a stiff wire and sometimes you keep getting caught in the paddock or you can't get up to the I. V. C. What I'll do in those situations is I actually get a Jr for some coronary catheter. Then I'll use a wooly wire which is you know a little bit of you know more flexible and I can use that to get up and then I'll get my JR. Four up over the wooly wire to whatever branch I want. And then I'll then I'll put the stiff wire in through. Then you advance the balloon up over the sheath up to the position that I showed you on the prior video you don't want to have you want to be able to cover the sbc but you're not trying to include the R. A. Per se. And what what you do is you fill the balloon with 12 CCs of contrast and 48 CCs of sailing. It's important to not make it all just contrast. Otherwise it's very difficult to deflate the balloon. Then you'll inflate it. That's actually you want to fill the syringe. Yeah. Sorry. The syringe. Yes. And then you inject the syringe through the balloon. Thanks for correcting me there. So um when you position the balloon, you should inflate and then see how how many CCs of that combined mix it takes to have stability and inclusion of the S. V. C. Without the without the balloon actually retracting into the R. A. And so what I do is I call out what that number is. It's 60 CCs to start and I'll say 30 or 40. And that means this is the number of CCs I had to inject. And I actually have my surgical tech write it down because if you're in a tear, you want to be able to just know this is how much I need to inject. So I record that down and then before before I retract, so deflate the balloon. But before I retract the balloon actually get a, you know, like a lidocaine sticker or whatever. You know, some sort of adhesive. I wipe down the actual balloon wire because usually there's some key more contrast in that area and it's a little, it won't stick as well and actually stick it around the balloon itself. The, you know, the the balloon connector, it's not actually the balloon itself, but and where it is inserting into the sheath. Okay? And then once it's fully deflated, I retract it back to the iBc. And so basically what that means is that if you have a terror, all you have to do is move the floor. Oh out. Somebody can be doing that. Another person. The wire stays in place isn't is advancing the balloon right to where the mark was. And then you're just injecting exactly the amount of CCS you had before. So there's you don't have to think about it all. So you can be doing all that while the surgeon is getting ready to open the chest and it saves you time. Don't over inflate the balloon because again then it's not going to cover where you need to we call it watermelon seed like it'll just squirt right out of the vessel. Any additions to that work for you. Just a couple of couple of minor things. So you can call out how much how much contrast and sailing you're pushing in. But I do the exactly what you do with marking the shaft of the of the balloon. But I marked the syringe as well. I just put you know if it's going to be 30 CCs. I just put that same sticker right at that mark. So I just again, everybody's you know the floor is moving out of the way that somebody's getting into the open the chest, they're doing cpR you just shove that catheter into the mark, blow it up to that to the mark, or whatever the number of CCS is, and clamp it down so it doesn't go anywhere. The other thing that we found out is that you can get clots forming on these balloons. So, what you wanna do is, is not stage it when you're just putting everything into the groin at the very beginning of the case, but you want to do your staging right before you're ready to extract right before you get going chief, and then when you're done, pull it back out of the of the catheter so that you don't have this balloon sitting in there, and that has been deployed. Now, it's, you know, it's kind of a little unfurled and it can clot rob. Schaller has done a really good job of showing that up in philadelphia. So you don't wanna do your CS upgrade with the balloon still in, That's that's the point. So, just before you're moving to the upgrade stages and it can take a long time to dissect out the leads and everything too. So, if you're gonna stage it do it right before you're ready to rock and roll with the sheets. So, I'm gonna hand it over to dr love now, but again, this is my cell phone, my personal email and my work email if you need them. Okay, sorry, any questions at all about this? Talk. Okay, 1/2, they're gonna give you the mic. So if you have a question, raise your hand. So is it common that you ever have an inclusion in the S. V. C. Where you can't pass a bridge balloon? I've had one case like that. Yeah. It can happen clearly. You can have an included superior vena cava. And if you can't get you can't get the good news is though, if you're gonna come through with a sheet or something, it's kinda unlikely that you're going to slice something open and have this massive hemorrhage into the pleural space. So it's kind of a, you know, a good news, bad news situation with that. I yeah, you can do it for me. RJ, too.