Safety and long-term performance of the Medtronic 3830 lead in His-bundle vs. Left bundle branch area pacing: A single-center 5-year experience.

Abstract

BACKGROUND The short-term safety, feasibility, and performance of the Medtronic SelectSecure 3830-69 cm pacing lead for conduction system pacing (CSP) has been reported; however, its longer-term performance is not well established. OBJECTIVE: The purpose of this study is to examine the long-term performance of the 3830 lead for His Bundle Pacing (HBP) and Left Bundle Branch Area Pacing (LBBAP). METHODS: We retrospectively reviewed all cases of CSP performed with the Medtronic SelectSecure 3830-69 cm pacing lead at Cleveland Clinic Florida between May 2016 and October 2021. RESULTS: Of 515 attempts, HBP achieved an 85% success rate (340 cases), while LBBAP demonstrated a higher success rate of 97.4% (150 cases). The mean follow-up was 28 months for HBP and 14 months for LBBAP, with patient ages averaging 75 and 77 years, respectively. Only 7% of the cohort had an ejection fraction below 50%. The primary indications for HBP were sick sinus syndrome (35.5%), atrioventricular block (35.2%), cardiac resynchronization therapy (10%), and refractory atrial fibrillation (18.8%), with similar distributions for LBBAP. The HBP group's capture threshold at implant was 1.3 ± 0.8 V at 0.8 ± 0.2 ms, which significantly increased at chronic follow-up to 1.68 ± 1.3 V at 0.7 ± 0.3 ms (p <0.001), whereas the LBBAP group's capture threshold remained stable from 0.8 ± 0.5 V at 0.5 ± 0.3 ms to to 0.9 ± 0.5 V at 0.5 ± 0.3 ms, (p= 0.35). Lead revisions were more common in the HBP group (50 cases) than in the LBBAP group (5 cases), with exit block rates of 11.7% and 3%, respectively. CONCLUSION: Using the 3830 lead for HBP can result in significantly elevated thresholds, loss of His-bundle capture, and frequent lead revision rates at long-term follow-up. These issues are less commonly seen when the lead is used for LBBAP.

Competing Interest Statement

Dr. Baez-Escudero, serve as a consultant to Abbott and Aziyo biologics. All other authors have reported that they have no relationships relevant to the content of this paper to disclose.

Funding Statement

After beginning our work we came to know of an opportunity for funding via Medtronic's investigator-initiated research program to which we were accepted. However, we assure you that any potential conflict of interest has not influenced the design, execution, or reporting of this study, and our findings are presented objectively.

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I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Institutional Review Board Cleveland Clinic Foundation 9500 Euclid Avenue Cleveland, OH 44195 Telephone: 800.223.2273 Fax: 216.445.4094

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Data Availability

Data will be made available upon reasonable request.

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