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. 2025 Jul 9:S1547-5271(25)02633-5.
doi: 10.1016/j.hrthm.2025.07.004. Online ahead of print.

Two-year follow-up of the safety and clinical outcomes of stylet-driven leads for left bundle branch area pacing compared with right ventricular pacing in the Medicare population

Pugazhendhi Vijayaraman  1 , Parikshit S Sharma  2 , Brett D Atwater  3 , Devi Nair  4 , Jacqueline Joza  5 , Francesco Zanon  6 , Wenwen Li  7 , Jeeyun A Kim  7 , Yelena Nabutovsky  7 , Kwangdeok Lee  7 , Robert D Schaller  8
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Free article

Two-year follow-up of the safety and clinical outcomes of stylet-driven leads for left bundle branch area pacing compared with right ventricular pacing in the Medicare population

Pugazhendhi Vijayaraman et al. Heart Rhythm. .
Free article

Abstract

Background: Stylet-driven leads have been increasingly used for left bundle branch area pacing (LBBAP). The long-term outcomes associated with LBBAP by stylet-driven leads have not been reported in a large cohort.

Objective: The purpose of this study was to compare the safety and clinical outcomes of stylet-driven leads placed at LBBAP vs right ventricular pacing (RVP) locations in dual-chamber (DC) pacemaker patients using large real-world data.

Methods: Medicare Fee-for-Service claims and Abbott device registration databases were linked to identify patients who had de novo DC pacemaker implants with the Tendril STS or UltiPace leads (Abbott, Abbott Park, IL) from January 1, 2020, to June 30, 2024, at LBBAP or RVP locations. The unadjusted and propensity score overlap weight-adjusted rates of complications, reinterventions, heart failure hospitalizations (HFHs), incident HFHs, and all-cause mortality at 2 years post-implantation were compared between the 2 groups.

Results: A total of 2341 patients with LBBAP and 68,241 patients with RVP were identified. There was no difference in the rates of 30-day acute complications (hazard ratio [HR] 1.01; P = .95), chronic complications (HR 0.92; P = .51), or reinterventions (HR 0.76; P = .06) at 2 years between patients with LBBAP and RVP. The LBBAP group experienced significantly lower rates of HFHs (HR 0.72; P = .015), incident HFHs (HR 0.54; P = .04), and all-cause mortality (HR 0.64; P < .0001) at 2 years than did the RVP group.

Conclusion: DC pacemaker patients with LBBAP using Tendril STS or UltiPace stylet-driven leads experienced significantly lower rates of HFH and all-cause mortality, with similarly low complication rates compared with RVP over 2 years of follow-up in this large Medicare population.

Keywords: Complications; Hospitalizations; Left bundle branch area pacing; Outcomes; Right ventricular pacing; Stylet-driven lead.

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Conflict of interest statement

Disclosures Dr Vijayaraman has received honoraria and research and fellowship support from and served as a consultant for Medtronic; has served as a consultant for and received honoraria from Abbott, Biotronik, and Boston Scientific; and holds a patent for an His bundle pacing delivery tool. Dr Sharma has received honoraria from Medtronic and served as a consultant for Medtronic, Abbott, and Biotronik. Dr Atwater has received honoraria and research support from and served as a consultant for Medtronic; served as a consultant for Abbott; and received honoraria from Johnson & Johnson, Pfizer, and Bristol Myers Squibb. Dr Nair has received honoraria and received research support from and served as a consultant for Abbott. Dr Joza has served as a consultant for Abbott and received research grants from Medtronic. Dr Zanon has received honoraria from Abbott, Biotronik, Boston Scientific, Medtronic, and MicroPort. Dr Schaller has received honoraria from and served as a consultant for Abbott. Dr Li, Ms Kim, Ms Nabutovsky, and Dr Lee are employees of Abbott.

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