Heart rhythm · 2025
Performance of an active fixation stylet-driven lead in left bundle branch area pacing: Results from INSIGHT-LBBA.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Friedman Daniel J, Shadrin Ilya, Goldbarg Seth, Trulock Kevin M, Patel Apoor, Loring Zak, Coles Sara A, Gandhi Gaurang, Upadhyay Gaurav A, Wold Nicholas, Jones Paul W, Ruble Stephen B, Weinstock Jonathan, Latanich Christopher A
Аннотация
BACKGROUND: Left bundle branch area pacing (LBBAP) has been rapidly adopted despite a lack of leads with approved indications for LBBAP.
OBJECTIVE: This study aims to analyze the performance of a 6Fr active fixation, stylet-driven lead in LBBAP.
METHODS: The multicenter INSIGHT-LBBA registry analyzed consecutive LBBAP implant attempts with INGEVITY+ leads. Data were retrospectively collected with standardized entry via REDCap. Prespecified safety (lead-related complication [LRC]-free rate with performance goal >90% at 3 months) and effectiveness (pacing capture threshold [PCT] ≤2 V@ 0.4 ms and R-waves ≥5 mV; 3-month performance goal = 80%) endpoints were analyzed. External validation of lead effectiveness was performed on a separate cohort of LBBAP patients from the LATITUDE remote monitoring database.
RESULTS: The study enrolled 1122 single- or dual-chamber pacemaker patients from 8 US sites (mean age 76 ±10 years, 43% female, 48% atrioventicular [AV] block, 40% sinus node dysfunction). Those successfully implanted had a median follow-up of 302 days. Left bundle or left septal capture was achieved in 95.6% of patients (1073 of 1122) and 89.6% of leads (1073 of 1197, 1.07 leads per patient). The 3-month LRC-free rate was 97.7% (lower confidence limit [LCL] 96.6%) with an LRC-free rate of 97.2% at 24 months. At 3 months, 98.8% (LCL 97.7%) of PCTs were ≤2 V, and 94.8% (LCL 92.7%) of sensed amplitudes were ≥ 5 mV. Results were stable through 24 months; 864 LBBAP implants were analyzed in the external validation cohort, and lead effectiveness was clinically indistinguishable across datasets.
CONCLUSION: In this study of an active fixation, stylet-driven lead, all prespecified performance goals for pacing, sensing, and LRC rates were met when used for LBBAP. External validation demonstrated concordant results.
CLINICAL TRIAL REGISTRATION: NCT06014866.
OBJECTIVE: This study aims to analyze the performance of a 6Fr active fixation, stylet-driven lead in LBBAP.
METHODS: The multicenter INSIGHT-LBBA registry analyzed consecutive LBBAP implant attempts with INGEVITY+ leads. Data were retrospectively collected with standardized entry via REDCap. Prespecified safety (lead-related complication [LRC]-free rate with performance goal >90% at 3 months) and effectiveness (pacing capture threshold [PCT] ≤2 V@ 0.4 ms and R-waves ≥5 mV; 3-month performance goal = 80%) endpoints were analyzed. External validation of lead effectiveness was performed on a separate cohort of LBBAP patients from the LATITUDE remote monitoring database.
RESULTS: The study enrolled 1122 single- or dual-chamber pacemaker patients from 8 US sites (mean age 76 ±10 years, 43% female, 48% atrioventicular [AV] block, 40% sinus node dysfunction). Those successfully implanted had a median follow-up of 302 days. Left bundle or left septal capture was achieved in 95.6% of patients (1073 of 1122) and 89.6% of leads (1073 of 1197, 1.07 leads per patient). The 3-month LRC-free rate was 97.7% (lower confidence limit [LCL] 96.6%) with an LRC-free rate of 97.2% at 24 months. At 3 months, 98.8% (LCL 97.7%) of PCTs were ≤2 V, and 94.8% (LCL 92.7%) of sensed amplitudes were ≥ 5 mV. Results were stable through 24 months; 864 LBBAP implants were analyzed in the external validation cohort, and lead effectiveness was clinically indistinguishable across datasets.
CONCLUSION: In this study of an active fixation, stylet-driven lead, all prespecified performance goals for pacing, sensing, and LRC rates were met when used for LBBAP. External validation demonstrated concordant results.
CLINICAL TRIAL REGISTRATION: NCT06014866.