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. 2024 Oct;10(10):2224-2233.
doi: 10.1016/j.jacep.2024.06.018. Epub 2024 Aug 14.

Long-Term Safety and Efficacy of Intraoperative Leadless Pacemaker Implantation During Valve Surgery

Connor P Oates  1 , Karel T N Breeman  2 , Marc A Miller  3 , Percy Boateng  4 , Aarti Patil  4 , Daniel R Musikantow  1 , Elbert Williams  4 , Ismail El-Hamamsy  4 , Morgan L Montgomery  5 , Benjamin S Salter  5 , Chartaroon Rimsukcharoenchai  4 , Dimosthenis Pandis  4 , Menachem M Weiner  5 , Srinivas R Dukkipati  1 , Anelechi Anyanwu  4 , Vivek Y Reddy  1 , David H Adams  4 , Ahmed M El-Eshmawi  4
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Free article

Long-Term Safety and Efficacy of Intraoperative Leadless Pacemaker Implantation During Valve Surgery

Connor P Oates et al. JACC Clin Electrophysiol. 2024 Oct.
Free article

Abstract

Background: Intraoperative implantation of leadless cardiac pacemakers (LCPs) under direct visualization during cardiac surgery is a novel strategy to provide pacing to patients with an elevated risk of postoperative conduction disorders or with a preexisting pacing indication undergoing valve surgery.

Objectives: This study sought to evaluate the long-term safety and efficacy of intraoperative LCP implantation in 100 consecutive patients.

Methods: Retrospective single-center cohort study of consecutive patients (n = 100) who underwent intraoperative LCP implantation during valve surgery. Safety and efficacy were assessed at implantation and follow-up visits.

Results: A total of 100 patients (age 68 ± 13 years, 47% female) underwent intraoperative LCP implantation. The surgery involved the tricuspid valve in 99 patients (99%), including tricuspid valve repair in 59 (59%) and tricuspid valve replacement in 40 (40%). Most of the patients (78%) underwent multivalve surgery. The indication for LCP implantation was elevated risk of postoperative atrioventricular block in 54% and preexisting bradyarrhythmias in 46%. LCP implantation was successful in all patients. During a median of 10.6 months (IQR: 2.0-22.7 months) of follow-up, no device-related complications occurred. At 12-month follow-up, the pacing thresholds were acceptable (≤2.0 V at 0.24 milliseconds) in 95% of patients.

Conclusions: Intraoperative LCP implantation under direct visualization is a safe strategy to provide permanent pacing in patients undergoing valve surgery, with a postoperative electrical performance comparable to percutaneously placed LCPs.

Keywords: efficacy; leadless cardiac pacemaker; permanent pacemaker; safety; valve surgery.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Reddy has received research grants and served as a consultant for Medtronic, the manufacturer of the leadless pacemaker used in this series. Dr Miller has served as a consultant for Medtronic. Dr Adams declares that The Icahn School of Medicine at Mount Sinai receives royalty payments from Medtronic for intellectual property related to the development of 2 tricuspid valve repair rings. Medtronic is the manufacturer of the leadless pacemaker used in this study. Dr Breeman has received an unrestricted research grant from Medtronic and funding from the KNAW Medical Sciences Fund, Royal Netherlands Academy of Arts & Sciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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