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Safety, efficacy, and functional outcomes using a novel small-diameter defibrillation lead for left bundle branch area pacing: Final results of the LEADR LBBAP clinical trial

Year: 2026

Type: article

Abstract: BACKGROUND: Therapeutic delivery with left bundle branch area pacing (LBBAP) has continued to grow. However, limited data exist with LBBAP in patients with a de novo indication for an implantable cardioverter-defibrillator or cardiac resynchronization therapy - defibrillator (CRT-D). OBJECTIVE: The aim of this analysis was to assess longer-term outcomes with the OmniaSecure defibrillation lead for LBBAP in patients indicated for an implantable cardioverter-defibrillator and CRT-D. METHODS: The Kaplan-Meier method was used to determine the study lead-related major complications and appropriate therapy delivery rates up to 12 months postimplantation. Electrical performance was summarized. QRS duration (QRSd), left ventricular ejection fraction, indexed left ventricular end-systolic volume, and quality of life were characterized in patients receiving LBBAP-optimized CRT (LOT-CRT) at baseline and 6 months. RESULTS: A total of 316 patients had an LBBAP implantation attempt (mean age 64.9 ± 12.2 years; 29.1% female (n=92)). Pacing capture threshold, impedance, and R-wave amplitude remained stable (follow-up 9.9 ± 4.0 months). Freedom from study lead-related major complications at 6 and 12 months was 97.7% and 96.8%, respectively. At 1 year, 7.9% of patients received appropriate therapy (shock or antitachycardia pacing), and the inappropriate shock rate was 2.1%. In patients receiving LOT-CRT (47.7%, n = 143), there was a significant reduction in paced QRSd at 6 months compared with intrinsic QRSd (P < .001), improved left ventricular ejection fraction from baseline to 6 months (P < .001), and reduced indexed left ventricular end-systolic volume from baseline to 6 months (P < .001). In addition, quality of life improved from baseline to 6 months (Kansas City Cardiomyopathy Questionnaire: P < .001; clinical composite score: 85% improved or stabilized). CONCLUSION: The final study results of the lead evaluation for defibrillation and reliability in left bundle branch area pacing (LEADR LBBAP) clinical trial demonstrate continued stable electrical performance, a low rate of lumenless defibrillation lead-related major complications, and the benefit of LOT-CRT when a lumenless defibrillation lead is implanted for LBBAP.

Source: Heart Rhythm

DOI: 10.1016/j.hrthm.2026.08.030