Heart rhythm · 2026
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.
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Vijayaraman Pugazhendhi, Mason Pamela K, Liu Xingbin, Jastrzebski Marek, Denman Russell, Schloss Edward J, Whinnett Zachary I, Kron Jordana, Hussin Azlan, Zakaib John S, Philippon François, Afzal Muhammad, Pokharel Parash, Richardson Travis D, Burrell James, Tanner Jocelyn, Stadler Robert W, Geelen Tessa, Butler Kiah, Crossley George H, LEADR LBBAP Trial Investigators
Аннотация
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.
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.