ACC.24 Case Report: Leadless Pacemaker Extractions, with José López, MD

A study detailing a case series is offering clinicians additional perspective into an evolving area: leadless pacemaker extraction.

Presented by at the American College of Cardiology 2024 (ACC.24) Annual Scientific Sessions on the 8-year anniversary of the FDA’s first approval for a leadless pacemaker, the study details 2 cases of Micra leadless pacemaker extraction followed by immediate Aveir leadless pacemaker reimplantation and was presented by José López, MD.

“With leadless pacemakers extractions, because they're a relatively new technology and therapeutic option we haven't run into many instances where we have to remove them,” said Lopez, cardiology fellow at the University of Miami JFK Medical Center, in an interview with HCPLive. “So, our experience with extracting these pacemakers is very young as compared to extracting transvenous pacemaker, which can be very hard to remove because of the fibrosis that forms around the leads that is a very risky procedure.”

A relatively new technology, the US Food and Drug Administration issued their first approval for a leadless pacemaker to the Micra Transcatheter Pacing System for patients with atrial fibrillation or dangerous arrhythmias. With the prospect of fewer complications and the lack of chest incision or visible pacemaker pocket, the cardiology community welcomed the new technology.

The community witnessed the approval of the second leadless pacemaker in the form of Abbott’s Aveir in April 2022. An inevitable reality for the field subsequent to these approvals would be the eventual need for extraction and reimplantation of these devices for which there is a scarcity of contemporary evidence relative to removal of traditional pacemakers.

In both cases presented by Lopez, a Micra leadless pacemaker was extracted and followed by immediate reimplantation with an Aveir leadless pacemaker. In the first case, Lopez and colleagues describe a situation involving a patient requiring removal due to right ventricular perforation. In this patient, multidisciplinary team opted for Micra extraction and Aveir reimplantation due to the patient's comorbidities, which resulted in mini thoracotomy and snaring being the optimal approach.

The second case included a patient requiring extraction due to a device malfunction. In each case, the patient chose Micra VR extraction and Aveir implantation following discussion on the risks and benefits. In both cases, extraction was performed via femoral snaring and the extracted devices were found to be intact, with reimplantations occurring without complications.

For more perspective on this case series and the evolving landscape of cardiac device management, check out our Q&A with Lopez from the floor of ACC.24.

HCPLive Cardiology: Can you elaborate just a little bit on the specific challenges and complexities involved in leafless pacemaker extraction?

Lopez: With leadless pacemakers extractions, because they're a relatively new technology and therapeutic option we haven't run into many instances where we have to remove them. So, our experience with extracting these pacemakers is very young as compared to extracting transvenous pacemaker, which can be very hard to remove because of the fibrosis that forms around the leads that is a very risky procedure. With a leadless pacemaker our experience is very young, but I think that's why this case series is interesting because it illustrates 2 cases where we're able to extract a Micra leadless pacemaker using the removal sheath from another company's which is the AVEIR leadless pacemaker. We were able to remove that and then just implant an AVEIR leadless pacemaker next. We had to use that sheath because there's no proper device that has been designed exactly to remove the Micra leadless pacemaker, but it was a relatively easy procedure to do.

HCPLive Cardiology: How do you foresee the role of leadless pacemaker technology evolving in the coming years, specifically as it pertains to extraction techniques and patient outcomes?

Lopez: I think as we implant more of leadless pacemakers, as their indications grow, as we're able to use them for dual chamber pacemaker, I think that it will grow and become more and more utilized. A major barrier is we don't have many more uses for them, but I think as it's utilization grows and they grow old, then we have to remove them. I think that's where we're going to really experience evolution because these patients, we have had the leadless pacemakers in place for a relatively short period of time, but we don't know how that extraction process is going to differ in a patient that maybe has one of those leadless pacemakers implanted for 10, 15, or 20 years. Also, there is the possibility and thought that you could just implant the leadless pacemaker and if you need another one in the future when the battery has run out, you can just implant another, and you don't need to take out the old one. So, I think that's something we're going to learn as time goes by out and we'll use the technology.

HCPLive Cardiology: What are the key factors you think cardiologist should consider when deciding between leadless pacemaker extraction and reimplantation versus traditional methods?

Lopez: I think if it's a patient like in our case series, who had the leadless pacemaker implanted relatively recently, I think it's totally feasible and safe to do an extraction using sheath and snare to just pull it out. I think it was a relatively easy and safe procedure. However, as time passes by, we don't know if there could be endothelialization or fibrosis of this lead. So, in the future, if a patient has had it for a long time, whether we can do the same or not is something we’re not sure of at the moment.

References:

1. Tuarez F, Lopez J, Mark J, et al. A WIRELESS FUTURE: IMPORTANT CONSIDERATIONS FOR LEADLESS PACEMAKER EXTRACTION. J Am Coll Cardiol. 2024 Apr, 83 (13_Supplement) 2961. https://doi.org/10.1016/S0735-1097(24)04951-9.
2. FDA’s Office of the Commissioner. FDA approves first leadless pacemaker to treat heart rhythm disorders. U.S. Food and Drug Administration. April 6, 2016. Accessed April 10, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-leadless-pacemaker-treat-heart-rhythm-disorders.
3. Abbott MediaRoom. Abbott receives FDA approval for AveirTM VR leadless pacemaker system to treat patients with slow heart rhythms. Abbott MediaRoom. April 4, 2022. Accessed April 10, 2024. https://abbott.mediaroom.com/2022-04-04-Abbott-Receives-FDA-Approval-for-Aveir-TM-VR-Leadless-Pacemaker-System-to-Treat-Patients-with-Slow-Heart-Rhythms.