COMMENTARY

Lead Extraction, Leadless Pacemakers, and Other EP Novelties

John M. Mandrola, MD

Disclosures

July 14, 2016

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Editor's Note:
Charles J. Love, MD, professor of medicine in the Division of Cardiology, New York University (NYU) School of Medicine, and director of Cardiac Rhythm Device Services, Division of Cardiology, NYU Langone Medical Center, New York, speaks with John M. Mandrola, MD, about his experience with mechanical lead extraction and other issues in electrophysiology.

New Tools for Our Toolbox

Dr Mandrola: Hi, everyone. This is John Mandrola from the theheart.org on Medscape. I am here at Cardiostim 2016, the European Heart Rhythm Association meeting. I am with Dr Charles Love, professor of medicine at the New York University Langone Medical Center. Chuck is a friend of mine and I am pleased to have him here. We are going to talk about a lot of different topics in pacing and defibrillation today. Welcome, Chuck.

Dr Love: Thank you, John. It's great to be here with you.

Dr Mandrola: You are here to present an abstract on a new extraction technique.[1]

Dr Love: Yes. There is a new tool that has been out for almost 2 years, called the TightRail™ (Spectranetics; Colorado Springs, Colorado). It is a mechanical lead extraction device that we use to remove the fibrous adhesions that grow around a lead, holding it in place in the body. If you have a situation where you have to remove a lead owing to malfunction or infection, we can hopefully remove it safely without damaging the vasculature or the myocardium.

Dr Mandrola: Were the results positive?

Dr Love: Yes; they were very positive. It is another tool in our toolbox. A very important concept for people to understand is that there is no single tool. We have a lot of different tools out there. People ask, "Which one is the best one?"

You wouldn't go to fix a car with one wrench or one screwdriver. You need a whole set of tools to be successful in repairing a car. The same applies to lead extraction. You need a set of tools, and you need to know how to use those tools properly in the right patients to be successful and safe.

Dr Mandrola: That was the lead-in to my next question: You do a ton of extractions. Has extraction changed much for you as an expert in the past few years?

Dr Love: The basic precepts on how we extract the lead has not changed much, but the tools have expanded. We not only have new tools for removing devices (such as the TightRail and the Evolution® RL (Cook Medical; Bloomington, Indiana), which allows you to bore these leads out), but also a very exciting item has just come along in the past several weeks—a balloon to occlude the vena cava should we get a tear in it.

One of the most devastating complications we have in lead extraction is a tear in the vena cava. The patient can exsanguinate into the right chest. The idea behind this balloon is that we leave a guide wire up in the vena cava and, if we do get a tear, we can advance this balloon up quickly. It's a large balloon and very compliant, so it's squishy. We can blow this up to essentially put a finger in the dike to seal off the hemorrhage until a cardiac surgeon can go in and close it off.

We have had excellent results in animal trials,[2] and it is now approved by the US Food and Drug Administration (FDA). We have it available to us on all cases.

Dr Mandrola: It's like a bridge.

Dr. Love: In fact, that is the name of the device: It's called the Bridge™ Occlusion Balloon (Spectranetics).

Indications for Lead Extraction

Dr Mandrola: What is the most common indication that you do extractions for now?

Dr Love: I would say that the most common indication is still lead failure, in my world. The most important indication is probably going to be infection. Infection is an extremely important reason for taking out leads.

We all learn in medical school and our surgical rotations that if there is a foreign body in an infected area, get the foreign body out. The infection will usually clear up, even on its own, in many cases. If you have a pocket infection and you see people trying to salvage the pocket by moving the device to a different plane and using lots of antibiotics, this is a setup for failure. They almost always fail.

Not only that, but a local infection can become a systemic infection, and then you have a very, very sick patient. Endocarditis is absolutely a class 1 indication for taking a lead out. Pocket infection—not just a little cellulitis postoperatively, but truly a pocket infection—is a class 1 indication. Get that device out. The longer you wait, the higher the morbidity and mortality.

It's a significant issue. We see so many people late into therapy after weeks of antibiotics, and it just doesn't work. You have to get those leads out.

 
If you have a pocket infection and you see people trying to salvage the pocket by moving the device to a different plane and using lots of antibiotics, this is a setup for failure.
 

Dr Mandrola: Patients are getting older, and we are doing more generator changes. A generator change has 10-year-old leads in it, and then if they get an infection, it's a real problem.

Dr Love: You bring up a great point in terms of those older pockets and generator changes. What do we start our fellows off on when training them in electrophysiology for devices? The first thing is the "simple generator change." It's associated with the highest degree of complication of anything that we do in terms of infection: 2%-4%, [according to] most decent studies[3,4] that are out there. If you get an infection, all of a sudden you are taking a patient who is quite stable and exposing him or her to endocarditis and the risk associated with lead extraction on top of that, which is not so great.

People have this perception that the risk for complications is about 5% for a lead extraction and the death rates are 1% or 2%. They're actually quite a bit lower than that. The major adverse event rate for a lead extraction is around 1.5% or so, and the death rate is around 0.3% at high-quality institutions.[5]

Dr Mandrola: I was going to push you on that a little bit. I was going to ask whether the increase in supply of extractors or extraction centers has been a good thing.

Dr Love: Experience is such a big issue, not only for lead extraction but also for any other procedure that we do. Nobody would go and have an angioplasty or a coronary stent placed by someone who does one [procedure] per month or one every 2 months. Yet, we have people going in for these very complex procedures, which in good hands have excellent outcomes and excellent safely profiles, to people who have seen a few done or who have minimal experience. Most of the time, it works out well. Clearly, experience leads to better complete extraction rates and lower complication rates.

Transcatheter Aortic Valve Replacement Patients and Pacemakers

Dr Mandrola: Let me shift gears a little bit. One of the most common consultations that we get now is for our transcatheter aortic valve replacement (TAVR) team about pacemakers and when to do pacemakers. You had a paper on that today.

Dr Love: One of the things we learned even as young cardiologists was, for example, after an inferior wall myocardial infarction (MI), to wait awhile. Many people who develop complete heart block after an inferior MI eventually reassociate their conduction and do not need a pacemaker.

We are finding out that the same is true for many of our TAVR patients. We conducted a retrospective study[6] at NYU just to see what the numbers were—to see whether there were any fish in that pool, so to speak. Of the patients who appeared to have complete heart block and were completely pacemaker-dependent, more than 40% of them had reestablished atrioventricular (AV) conduction when we looked at their follow-up in the device clinic 4-5 weeks later. That is an amazing number.

Perhaps we should wait. How long? I don't know. Patients can't sit around the hospital for days or weeks waiting to reassociate. I think we should wait at least a couple of days, perhaps, before we say that we absolutely need a pacemaker.

The First Leadless Pacemaker

Dr Mandrola: The first leadless pacer just got FDA approval. No leads, no wire, and it's put in through a femoral venous sheath. What are your thoughts on this?

Dr Love: I think it is an incredible device. There are two devices now available. Both are phenomenal in terms of the technology. The original hockey-puck devices required thoracotomy and a week in the hospital, and they lasted a year. We now have something that weighs less than an ounce; you can mail it with a first-class stamp. It will last 7-10 years, providing VVIR pacemaker therapy. It's phenomenal. You do it without an incision. You can do it all through a needle poke in the groin. It is amazing.

I think an important issue is to recognize that these are VVIR devices. They do not provide AV synchrony. Patients who might be prone to pacemaker syndrome—patients who need dual-chamber pacing—are still going to need a wired device.

Dr Mandrola: What kind of clinical impact do you think it will make in the next year or two?

Dr Love: It will probably shift the implant numbers from some of the leaded devices to the leadless pacemakers. I don't think it's going to open up new markets, at least not in the United States. However, it will allow, for example, a patient who developed endocarditis with a leaded system and had it removed to have a leadless device implanted in the right ventricular apex and hopefully avoid the issue of endocarditis.

Dr Mandrola: The future has leadless pacing, perhaps in a subcutaneous implantable cardioverter-defibrillator (ICD). I saw an abstract for a sheep study showing that it was feasible.[7] What do you say about that, and what do you think about getting there soon?

Dr Love: This whole concept of the subcutaneous ICD has been a real revolution. For young patients, you don't want to put leads across the valves or into their vessels because the leads are going to break over some period. Now you don't have to extract them. It'll put me out of business. It's a good thing if you do it that way.

But now we have a problem. We have a nontransvenous system that is great at shocking patients, but it does not have the ability to deliver antitachycardia pacing or significant bradycardia backup pacing.

What about this abstract that you saw today? It has been published already that in animal studies, you can communicate between a leadless pacemaker and a subcutaneous ICD.[8] The ICD detects the ventricular tachycardia, communicates with the leadless pacemaker, tells it to deliver a burst pace, and terminates the tachycardia. It has been shown that that can be done. It is a question of running through the technology and the regulatory hoops to make it a reality. It's absolutely going to be coming in the next few years.

Dr Mandrola: People are working on this.

Dr Love: Not only that, but leadless dual-chamber devices and maybe even leadless biventricular pacing as well. There is lots of stuff coming.

Dr Mandrola: Atrial pacing is going to be a bigger challenge for leadless, isn't it?

Dr Love: The fixation is going to be a problem. With the current two devices that are out, one uses a screw and the other has little tines to bite into the myocardium. That works pretty well in the ventricle, which is certainly a lot thicker than the atrium. Now, you don't want those tines or screws piercing through the atrial wall. They have a little work to do to figure out that fixation.

Dr Mandrola: His-Purkinje pacing was featured at the American College of Cardiology (ACC) [meeting].[9] I've done a few cases trying to pace on the His [bundle] instead of in the ventricle. What are your thoughts on this?

Dr Love: It is not that hard to do once you learn the technique. We like to place a His catheter in from below so that you can identify where the His-Purkinje signal is, and then aim right for that bipole. It is not that difficult to do. What is hard, sometimes, is finding a stable position where you can screw into that also has decent capture thresholds.

Dr Mandrola: Avoiding right ventricular (RV) apical pacing and the whole wide QRS that goes with that is a big deal.

Dr Love: It is a big deal. I think that we have learned so much over the past decade about RV apical pacing. We know that left bundle branch block is a bad thing, but here we are giving a patient a left bundle. On one hand, having a QRS of a left bundle is better than having no QRS at all.

Dr Mandrola: Yes.

Dr Love: We can also consider cardiac resynchronization therapy (CRT) pacing; left ventricular (LV) pacing only; or His bundle pacing, which I think is really a great idea. It does take more time, but it doesn't take that much more expertise with the preshaped sheath that you can utilize. It is probably a great thing to do, certainly in these younger patients who are going to be paced for a very long time.

Dr Mandrola: Chuck, thank you for being with me.

Dr Love: Delightful as always, John.

Dr Mandrola: That's it from Cardiostim in Nice, France. This is John Mandrola, from theheart.org on Medscape.

Disclosures: Charles J. Love, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant for: Spectranetics; Medtronic; St Jude Medical

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