Lead Management
Dr. Oussama Wazni, Section Head, Electrophysiology and Pacing, leads a discussion with Drs. Bruce Wilkoff and Thomas Callahan on lead management: indications for lead extraction including infection and dysfunction; lead abandonment vs. extraction; strategies to decrease complications during extraction and rescue strategies if complications occur. Last, they provide an overview of the team approach to extraction and post extraction treatment planning.
Learn more about Electrophysiology and Pacing
You can also view this as a video
Subscribe: Apple Podcasts | Podcast Addict | Buzzsprout | Spotify
Lead Management
Podcast Transcript
Announcer:
Welcome to Cleveland Clinic Cardiac Consult. Brought to you by the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute at Cleveland Clinic.
Oussama Wazni, MD:
All right, good morning, everyone. And welcome once more to another podcast from the EP section here at the Cleveland Clinic. It is my pleasure and honor to talk about lead extractions or lead management today with Dr. Wilkoff, who is the Director of Electrical Therapies here in our section, and also Dr. Callahan, who's the Director of Inpatient Services in the EP section. And so we're going to talk about lead extractions and management. And this now is to our colleagues, our physicians who are out there. So thank you for joining and joining in. So Dr. Callahan, what are the main indications for having a lead extraction or a device extraction?
Thomas Callahan, MD:
Traditionally, the indications for lead extraction broadly have fallen into either infectious indications or lead dysfunction, right? So, as we all know, pacemaker and a defibrillator lead infection is relatively uncommon, but, a real risk with these devices. And if a patient has an infected device, it's almost always required that we extract these leads only in the most frail patients, do we sort of consider chronic suppressive therapy. So, infectious indications certainly account for a lot of the extractions, and then lead dysfunction is another major category. So, patients who have leads that are no longer functioning appropriately and need to be replaced. There's also, of course, some lead extractions that will occur at the time of a device upgrade. So you're going from a pacemaker to a defibrillator. So, but those are the broad categories.
Oussama Wazni, MD:
So we'll talk to Dr. Wilkoff now about lead dysfunction and their management. So, Dr. Wilkoff, now I have a lead. It's dysfunctional. It's not working. The vein is open. Why can't I just implant another lead and abandon that dysfunctional lead or another situation comes in. The patient has a pacemaker, but now has an indication for a defibrillator. I can abandon the right ventricular lead and add an ICD lead. Now, could you tell us why this may or not be an attractive strategy?
Bruce Wilkoff, MD:
So, to start off with, I think you have to understand that this is a lifelong situation, that you have to plan for the future. Many of these patients start with their need for a pacemaker or defibrillator when they're quite a bit younger, sometimes even children, but their therapy will last for decades. And I like to call this lead management, because I'm managing the patient's life, their device therapy for their lifetime. So considering what happens today is not the only consideration, but what happens tomorrow, 10 years from now, 20 years from now, and these leads do fail. Now, as the leads go in, they start to deteriorate over time and they deteriorate in their function normally, but they also deteriorate in their ability to be removed. And so, if I choose to upgrade a patient, the vein is open. I can do it. I can get them through today, but the problem is, I'm leveraging tomorrow.
Bruce Wilkoff, MD:
I am putting some... kicking the can down the road a bit. And then later on, I'm putting them at much more risk. We did a study, a very good study that looked at the times where it was elected, not to remove versus the times where we did extract at the time of upgrade. And we found out that if you kick the can down the road, you were kicking down things like more time, more effort, less success, more complications. So, these are really bad things to leave for the future. And we need to work on this. We are talking about 10, 20, 30 years sometimes more.
Oussama Wazni, MD:
I mean, basically the abandoned lead will become an older lead. They'll have more adherence. They'll have more fibrosis. And if the patient, because we're talking about decades, gets an infection along the road, it's so much harder and riskier to remove that abandoned lead 10 years from now, then today, for example, if we did it right now.
Thomas Callahan, MD:
Yeah, I think that's a great point. I mean, removing a lead today may be difficult, but 10 years from now, it'll certainly be more difficult. And, Dr. Wilkoff can speak to some of the patients that we've seen who come in with, six or seven leads, abandoned leads on one side, a new system on the other side, and that's truly leveraging the patient's future.
Oussama Wazni, MD:
So, this brings us to the next part of our discussion is that, well, why do people abandon leads? And part of it has to do with the perception of extraction. And so let's talk about now the risk of an extraction and what that entails. So, we start with with Tom. Tom, tell us, what the risk of an extraction is. And then we'll talk with Dr. Wilkoff about how we have mitigated that risk at the Clinic.
Thomas Callahan, MD:
It's interesting. I think the risk of extraction is often sort of, it's patients, or even some referring physicians really, think that the risk is much greater than it actually is. We have patients that have presented for lead extraction and have been told that, "Oh the, the risk is maybe 50% risk of major complication of mortality." And really it's nowhere near. In the right setting with the right preparation and the right team, the risk of lead extraction is really very low. So major complications may be on the order of say 2 to 4% with lead extraction. Risk of mortality is less than a percent, especially if done in a high volume center that is prepared to take care of the complications when they occur.
Oussama Wazni, MD:
So, Dr. Wilkoff, could you tell us a little bit about what we have done to decrease this risk. And, one decrease the risk, and two if it happens, what do we can do about it to the rescue the patient?
Bruce Wilkoff, MD:
Yes. So we've always taken it seriously, but, now we have a very systematic way that we work up our patients. We have to know about the leads. We need to have the right radiographic information. We get a gated CT scan, which we've been studying and find that we can grade the fibrosis in the veins, which helps us to plan the extraction attempt. We do it, the procedure, in the hybrid operating room with a cardiothoracic surgeon in the room or in the prep room outside, with a cardiothoracic anesthesia, with the ability to put a person on pump. So we have the team ready and we know what to expect beforehand. We do it with transesophageal echocardiography. Sometimes we'll do it with an intracardiac ultrasound when TEE is not appropriate. We now have participated in the development of what's called a bridge balloon.
Bruce Wilkoff, MD:
The most vulnerable area is the superior vena cava, which if there's a tear, bleeds into the thoracic space and the person can exsanguinate quite quickly, 500 CCs every minute. So, it doesn't take long under those circumstances. So, what we do is we put a guidewire from the femoral vein up to the internal jugular up through the brachiocephalic. And we put this very soft pillow, like a balloon, into the superior vena cava. If there's a problem. That sort of tamponades the tear and gives us certain time to open up the chest. This is taken from a discussion of potential death, to just making it a controlled situation where we can do this. Now, of course we have blood available and other things, and not everybody is the same. I mean, we have everything from congenital heart disease to other problems. People post-surgical situations, we have occluded veins. So there are many considerations. So thoroughly prepping the patient, having the support structure to have this, and also considering how we're going to restore therapy after we're done, whether we should, whether we shouldn't or how that gets...
Oussama Wazni, MD:
And we're going to talk about that. So, just to summarize the risk of a major complication is really very low. And even if it happens, we are set up in a way that we can rescue most patients. Actually, it's been a long time since we've had major, major mortality from this and our rescue efforts have been, thankfully, very, very successful. So, that's the main message. Again, we encourage all our physicians to try not to abandon leads, because these are so much more difficult to take out later on. Send them to us. We can extract them safely. And God forbid, if something bad happens, we have the team and the tools to save the patient and rescue the patient.
Oussama Wazni, MD:
Now, let's move on to the options of post extraction. The patient had the extraction. It went successfully. There was nothing going on and no complications. Now is the post extraction therapy. And Tom, we'll start with you. So, just take us, we're not going to cover everything, but some scenarios where we can even think about different devices for different sorts of patients.
Thomas Callahan, MD:
Sure. So really that post extraction period, it's critical to plan for that well before the extraction. I think that's the first piece that we need to talk about. Really there has to be a good understanding of what's the game plan going forward after the extraction, because that can inform what you do during the extraction. But, to your point, we have so many more options over the past few years to manage patients after extraction. Many patients say they're having a device upgraded and so forth. They'll continue with a transvenous system. But, certainly we always look at the patient carefully and try to make a careful decision as to whether they still need a pacing or defibrillator system. And if they do, would they be better served perhaps, with say a lead-less pacemaker system or some extra vascular, say a subcutaneous defibrillator system? So, all of that is part of the thought process before the patient even arrives for their extraction.
Oussama Wazni, MD:
And then maybe, Dr. Wilkoff, if you can expand on a team approach with our infectious disease doctors and the rest of the team to go through a successful journey for the patients.
Bruce Wilkoff, MD:
So, it's a larger team than even that. So imaging in preparation is extraordinarily important, both and during the procedure as well. So, we're talking about chest x-ray, getting CT scans with contrast, if possible, using the ability... certainly the fluoroscopy and everything else that goes along with that. So, the imaging physicians are very important. The infectious disease doctors help us to understand that the bacteriology and the nature of the infection, how long to treat. We certainly use intravenous medications, usually afterwards, but not always. And sometimes we'd be more conservative, but generally speaking, we work with all of the patients, seeing the infectious disease physicians as well.
Bruce Wilkoff, MD:
And perhaps our most important collaboration for extraction is with the cardiothoracic surgeons and the operating room, who it turns out talking, like we said, planning for reimplantation, sometimes the right answer is to take things out surgically. That either because of the length of implantation or because of the issues with the either with the length of implantation or with the issues about vegetations. We cannot reimplant, let's say you have a pacemaker dependent patient. You have large vegetations. You're not going to be able to reimplant maybe you can put in a lead-less pacemaker for a while, but it's going to delay things. Maybe the right thing to do is to take them to the operating room, clean everything out, place epicardial leads on. And so there's a time to do transvenous lead extraction, and there's a time to do surgical extraction. And certainly we need their help in a rescue at times, as rare as that may be.
Oussama Wazni, MD:
So, that is excellent. I mean, that's really fundamentally what differentiates the Clinic from, I think, many, many, many other centers is this collaborative effort. And exactly what Dr. Wilkoff just mentioned, sometimes we, the best approach is a completely surgical approach where the devices are removed. The valve is fixed and to put an epicardial system for the patient.
Oussama Wazni, MD:
And these are all things that we think about, frankly, before we even embark on an extraction on a procedure or an operation. And that's what a differentiates...sets us apart from other places. And we take the holistic picture with the patient. And we have the capabilities, we have the technology, we have the instruments, and we have the personnel, the people now to take care of the patients. So, in summary, I want to thank you all for joining me today. And I hope you found this helpful and informative. And I want to thank Dr. Wilkoff and Dr. Callahan for joining me and imparting on us this information. Thank you very much, until we meet next time. Thank you.
Bruce Wilkoff, MD:
Thank you.
Thomas Callahan, MD:
Thank you.
Outro:
Thank you for listening. We hope you enjoyed the podcast. We welcome your comments and feedback. Please contact us at heart@ccf.org. Like what you heard? Subscribe wherever you get your podcasts or listen at clevelandclinic.org/cardiacconsultpodcast.
Cardiac Consult
A Cleveland Clinic podcast exploring heart, vascular and thoracic topics of interest to healthcare providers: medical and surgical treatments, diagnostic testing, medical conditions, and research, technology and practice issues.