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In this discussion, Miguel Leal, MD, and Robert Schaller, DO, discuss current and evolving indications of lead extraction, as well as how to establish a relationship with the cardiothoracic surgical team, how to prepare for complications, and how to mitigate risks during high-risk cases.

Miguel Leal, MD: Hello everyone, it is a pleasure to be here at Heart Rhythm 2024 in Boston. My name is Miguel Leal, and I am an associate professor of medicine at Emory University in Atlanta. It is a pleasure to be here with a good friend and colleague, Rob Schaller, and we are going to be talking about the world of lead extractions as we see it today. Rob? 

Robert Schaller, DO: Yes, this has been a wonderful meeting so far, with a lot of good science about lead extraction. As always, lead extractors are in a small community, so it is always wonderful to get to know and get to see what everyone else has been up to, because we all function in our own little silos. I have known Miguel for a long time. I think we graduated around the same year, so we have similar experiences. So, why don't you tell us a little about your extraction program and what type of procedures you're doing a lot of these days? 

Miguel Leal, MD: Thanks, Rob. I completely relate to what you said about our graduation times, because we both started practices at a time when you had happenstances like the Fidelis and Riata recalls, and tens of thousands of patients who carried those leads with them. Obviously, not everybody needed an extraction, but many of them did, either therapeutically or prophylactically, so that ended up allowing certain programs to grow in numbers. An extraction, like any other procedure, depends on that. You do want to ideally have a high-volume center with high-volume experienced operators, and we are not just talking about the electrophysiologists, but the entire team—the nurses, perfusionists, and technicians involved. In my case, it started in Wisconsin. At the time, I was at the University of Wisconsin-Madison. We were doing approximately 30 to 40 extractions per year, so it was a very modest volume. This was back in 2009 or 2010. Then, as those leads became a reality in our field and we started developing protocols to approach those patients to be proactive about their care, the numbers grew to a point where we plateaued at around 150-170 extractions per year, which is how the program has consolidated itself in the region. After my move to Emory, it was a similar experience, growing numbers but not just for the sake of making the program bigger, but hopefully also better in terms of quality outcomes, identifying at-risk patients sooner, and having procedures that are not as costly to the patient and the system as a whole. But how about yourself? Tell me a little about how extraction grew into becoming a big part of your practice today. 

Robert Schaller, DO: That is a lot of extractions that you did! You grew a very big program out there. I had a similar experience. When I joined the University of Pennsylvania, we were doing about 30 to 40 extractions per year, and most of them were infections or cases in which patients had vascular occlusions and needed upgrades. It slowly and organically started to grow as the procedures became more predictable in terms of safety and efficacy. However, you grew from 40 to 170, which means that the vast majority of those were probably noninfectious. So, is that an indication change, or just more referrals to your center? 

Miguel Leal, MD: That is a great question, Rob, because it was a little of both. The referral base expanded. Graphically, Wisconsin was and still is a state where you do not have a lot of extractors, and some of them either retired or phased out of practice. So again, organically almost without trying to make a big effort in that direction, the referrals began to come. But you're right when you say that it was not just infectious cases. In fact, that is something we tell our trainees today, that for class I indications for extraction, those patients do need to receive that procedure to do better clinically. But then there are other indications that are the so-called class II or IIa, that you as an operator may choose to undergo or take under your care, because that will cause 2 things. First, it will increase your numbers in a safe and controlled fashion, so you will develop the experience and know-how needed to build a strong program. In addition to that, you are also allowing these patients to undergo procedures in a safer environment, because many of those IIa indications may evolve towards a class I indication 8-12 years later. So, the notion of proactive lead management and not having patients become victims of lead mismanagement is something that guided our practice. I think those factors together contributed to a semi-exponential increase in cases until things reached a plateau. Then, during that process, we also tried to improve our risk stratification models in terms of which patient is up-front low risk, intermediate, or high, because as you know, there are lots of logistical details, some of them quite important that limit the expansion of lead extraction programs across the country and beyond. So, one question that I want to ask you, and I have admired your talks on this topic, is how have you been able to establish a relationship with your surgical teams and how do you see that evolving as we gain not only more knowledge but also better tools to perform extractions with? 

Robert Schaller, DO: Yes, you still require surgical backup for lead extraction cases and that probably is not going to change anytime soon. So, we are placed into a difficult situation where we need our cardiothoracic (CT) colleagues to back us up in case we need them, but we rarely need them, so we really rely on the kindness of our CT surgery colleagues to give some of their time and effort to facilitate the procedures that we are doing. It is harder in some institutions than it is in others. At the University of Pennsylvania, we tend to have wonderful surgeons who are very gracious with their time, and they are operating all the time, so you know they are going to be there, but it does not mean they want to back us up. So, we have meetings to talk about mutual patients, the goals of the health care system, and how to tackle all the different procedures that one would find in a cardiovascular institute. There are trade-offs and compromises. What do we do? We ask them to help us, but we set ourselves and the surgeons up for success. We thank them and want them to know that they are doing us a favor. We schedule the cases first thing in the morning so that they do not have to stay late. In the case of a surgical rescue, we ask what tools they need in our EP laboratory to save our patient, and we get those. We run mock drills once a year to make sure that there are not any problems that we have not thought about. In the case of high-risk patients, sometimes we will utilize the hybrid operating room (OR) just to be geographically closer to the surgeon. So, that is a collaboration that really is more in one direction, but on the other hand, it is good for the patient, it is healthy for the health care system, and it is really the only way to continue to grow the program, I think.

Miguel Leal, MD: Yes, I hear you. At Emory, we have a similar reality. The surgeons are very busy, so we try to adapt our routine to theirs to foster this collaboration that was just described. In terms of the geographical distribution of cases, I think it is clear that the more familiar the surgeon is with the environment, the better. So, in some institutions, they will work in the EP laboratory if it is spacious enough and the infrastructure is allowed. In other institutions, it may have to be a hybrid laboratory or a hybrid OR, and there are still some programs that rely exclusively on OR availability with the understanding that this may limit the ability to do the procedure at a regular time. Unfortunately, we see a lot of places where extractions take place in the evening or towards the night or weekends, and it always brings up the concern that you may not have your top A+ team ready and in position to deal with emergencies should they come. It is clear that emergencies now are less numerous than ever before, and that is a wonderful thing to celebrate, but it should never make us complacent. I really like when you said that this need for surgical backup is unlikely to change anytime soon, because the last thing we want to transmit to colleagues or trainees is the notion that because our tools are better now, we do not have to be as concerned as we have always been with the complications that might happen.

Robert Schaller, DO: Yes, complications are an important thing to think about. Can you talk a little about the complications that you prepare for and how you mitigate those risks during your high-risk cases? 

Miguel Leal, MD: Certainly. So, one of the things we always do is a lot of preprocedural planning. Oftentimes, we have the benefit of imaging, and nowadays it is really important to establish the notion that CT angiography can give you a lot of information that we would not be looking for initially. When we talked about this 5-10 years ago, we were underutilizing imaging tools. Now, that includes not only CT angiography, but also intracardiac echocardiography (ICE) and other imaging modalities that can help you understand how much binding and relationship there is between the lead and the tissue. We all know how precious the endovascular space is. It is a shame when we see that space occupied by 3, 4, or 5 leads that now suddenly need to be removed because of infection or some other issue that arose that involved the patient’s overall well-being. So here we are devoted to extracting those leads one by one and aware that any of them could impose the risk of a laceration or perforation, and we know that if those complications occur, unless you have taken preemptive measures such as deploying superior vena cava (SVC) protective balloons, which are now finally and thankfully available for use, those complications used to cause the patient's demise in a matter of minutes. That is why lead extractions for many years, even decades, carried this horrendous reputation of being equal to a death sentence. We know that other procedures in EP have similar morbidity to lead extractions, but the reason why extractions have such an impact in everybody's mind, both concrete and theoretical, is the fact that those lacerations could be incredibly lethal. They give very little forgiveness and room for the surgeon to come and repair. So, the SVC balloon has been a tool that we have been using more and more since its inception almost 10 years ago, and it has really helped. I have had at least a pair of cases where we suspected a laceration may have taken place. The balloon was deployed until the hemodynamics stabilized, and one of them did require a surgical repair without complications beyond that, and in the other one, the surgical repair was not necessary either because the process self-tamponaded or was not even there to begin with. But both circumstances allowed us to exercise better judgment without being in a rush to open a patient's chest and bring everybody into the room. So, we definitely prepared for those. We also tried to anticipate what the patient's needs were. Now, there is a difference between procedural and clinical success. We always strive for both, but sometimes leaving a 2-inch lead fragment behind in a buried endocardial area is absolutely fine as long as the patient receives the device that he or she needs, be it an upgraded version of the existing device or a replacement device. So, we always take into consideration the intrinsic risk of the procedure and what the end product should look like, so that when you talk to the patient and their family the next evening or the next day, the mission that you entitled yourself to accomplish has been done, and safely so. 

Robert Schaller, DO: My mentor, Josh Cooper, used to put that sentiment nicely by saying, "Always remember what the priority of the case is; usually that is to get the patient a functioning system. Everything else is gravy or secondary priorities.” So, it is never really wrong to stop a procedure. Of course, your threshold might change in an infectious indication, but it is really never wrong. What you have touched on also kind of touches on another topic that is always interesting in lead extraction, which is the future of lead extraction. Where are we going? Where did we come from, what do we need, and what are our goals? I think that always has to do with safety as well as with where these procedures are going to take place. Two important parts of the future of lead extraction are the use of ICE, because that is a modality that all the young extractors are used to and there are so many opportunities to use that above and beyond transesophageal echocardiography (TEE) to really get a sense of what is going on with the leads and not to have a giant probe down the chest, and also doing the procedures in the EP laboratory rather than the OR. I think the time has come for these procedures to be done by default in the EP laboratory but with appropriate fail-safes in place. You must have CT surgical backup and systems in place to save that patient if needed. But the reason that I am so passionate about that is not so that we can do things when we want or that we are comfortable, it is because we know that if we wait to extract patients who are infected, no matter what type of infection that they have, mortality and morbidity goes up. So, I would much rather work in a well-thought-out EP laboratory with surgical backup on Monday when a patient is admitted on Sunday, then wait for the OR at 10 PM on Friday. What do you think? 

Miguel Leal, MD: I could not agree more. We have good evidence to suggest that those incremental days of delay cost precious morbidity and mortality percentages to our patients. I think most of us now operate in EP laboratories that should have at least the infrastructure that would allow for a safe surgical intervention, particularly utilizing measures like the balloon that I was referring to, because now you do have the ability to intervene within a 5- to 10-minute horizon as opposed to a 1- to 2-minute horizon. As small as those margins may sound, they make a world of difference for the electrophysiologist and surgeon in a place where they are both geographically familiar with. I like what you said about your annual drills. I think regardless of where you choose to take place, if the entire team is aware of what he or she should do in the case of an emergency or urgent action or reaction, that is important. No matter how awkward those drills might feel, once you impart on your team—your nurses and techs—about the importance of them, they will play along and partner with you. The drill is not going to be a simulation exercise—it is taken seriously. It is taken with the gravity and the seriousness that it deserves. I am glad to hear that you do this routinely. We do it as well, and every institution should ideally look into that. I think in the future, in addition to being able to attend to these patients in a timely manner, in the right setting, I would also love to see better tools. I think some of them are in the pipeline. We have better snares that are coming up. You and I have been using relatively rudimentary snares that have been around for a decade or more, but it is interesting to appreciate that maybe some magnetic tip snares or other products that are currently in development may help us, particularly in those retained fragments, or when you have to extract a lead that has been partially extracted by somebody else, then you no longer have the benefit of the proximal segment here in the upper chest. I think we ultimately will be learning more about how the conduction system pacing leads behave. That is another box that we are opening right now that maybe in a few years you and I can come going to discuss in more detail. But it is a promising future for lead extractions, for sure.

Robert Schaller, DO: For sure. I think we could talk about this all day if we were given the opportunity. I thank you for your perspective, and thank EP Lab Digest for the opportunity. 

Miguel Leal, MD: Yes, thank you, Rob, and thank you for the opportunity. 

The transcripts have been edited for clarity and length.