Leadless Pacemaker with Transcatheter Aortic Valve Implantation: A Single Center Experience

Background The safety and efficacy of leadless pacemakers (LP) in transcatheter aortic valve implant (TAVI) patients is not well known due to paucity of data. Herein, we compared outcomes between leadless pacemakers to traditional dual chamber pacemakers (DCP) following TAVI. Methods A single-center retrospective study was conducted, including a total of 27 patients with LP and 33 patients with DCP after TAVI between November 2013 to May 2021. We compared baseline demographics, pacemaker indications, percent pacing, ejection fractions, and pacemaker related complication rates. Results Leading indications for pacemaker implant were complete heart block (74% LP, 73% DCP) and high degree atrioventricular block (26% LP, 21% DCP). No significant differences were observed between LP and DCP in device usage and ejection fraction at 1, 6, and 12 months. Within each pacemaker group, we did not observe a significant reduction in percent ventricular pacing or ejection fraction at follow up. Three DCP patients required rehospitalization for pocket related complications. Conclusion From this single-center study, TAVI patients appear to have comparable pacemaker usage and ejection fraction between LP and DCP groups, suggesting that LP may be a reasonable alternative where single ventricular pacing is indicated. Larger studies are required to validate these findings. ### Competing Interest Statement 1) Feng Gao: no disclosures. 2) Riyad Kherallah: no disclosures. 3) Mackenzie Koetting: no disclosures. 4) Leo Simpson: no disclosures. 5) John Seger: consultant and speaker fees from Janssen Pharmaceuticals, Medtronic, Boehringer Ingelheim, Pfizer. 6) Srikanth Koneru: no disclosures. 7) Joseph Coselli: consulting and speaker fees from W. L. Gore & Associates, Bolton Medical Inc. 8) Ourania Preventza: consulting fees from W. L. Gore & Associates. 9) Vicente Orozco-Sevilla: none. 10) Nastasya Manon: none. 11) Guilherme V Silva: consulting and speaker fees from Medtronic, Abiomed, Ancora Heart. ### Funding Statement This study did not receive any funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee/Institutional Review Board of Baylor College of Medicine and Affiliated Hospitals (BCMIRB) gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors.