Heart rhythm · 2024
Safety and performance of conduction system pacing: Real-world experience from a product surveillance registry.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Vijayaraman Pugazhendhi, West Michael, Dresing Thomas, Oren Jess, Abbey Sélim, Zimmerman Patrick, Bauer Rebecca, Butler Kiah, Mangrolia Hardik
Аннотация
BACKGROUND: Conduction system pacing (CSP), including His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP), has been used as an alternative for pacemaker indicated patients requiring ventricular pacing.
OBJECTIVE: The purpose of this study was to characterize the safety and performance of HBP and LBBAP among patients enrolled in the Medtronic product surveillance registry (PSR).
METHODS: This observational analysis included patients who underwent pacemaker implantations for HBP or LBBAP with a Medtronic Model 3830 lead between January 2019 and December 2023 in the Medtronic PSR. The primary outcomes were lead-related complications and pacing capture threshold. Baseline characteristics, R-wave amplitude, impedance, and all-cause mortality were summarized.
RESULTS: A total of 2342 patients were included across 77 centers (mean age 74 years; 38.9% female). Of the patients implanted with a 3830 lead for CSP, 64.1% (n = 1502) had LBBAP placement and 35.9% (n = 840) had HBP placement. The most commonly reported indications for CSP were sinus node dysfunction (67.0%) and atrioventricular block (57.2%). LBBAP had lower pacing thresholds, higher R-wave sensing, and higher impedance (all P <.001) through 30 months. At 36 months postimplant, the lead complication rate for LBBAP and HBP was 2.5% and 6.3%, ,respectively with no difference in all-cause mortality.
CONCLUSION: In a multicenter cohort of LBBAP and HBP patients treated with the catheter-delivered 3830 lead, lead-related complication rates were low and electrical parameters were stable through 30 months.
OBJECTIVE: The purpose of this study was to characterize the safety and performance of HBP and LBBAP among patients enrolled in the Medtronic product surveillance registry (PSR).
METHODS: This observational analysis included patients who underwent pacemaker implantations for HBP or LBBAP with a Medtronic Model 3830 lead between January 2019 and December 2023 in the Medtronic PSR. The primary outcomes were lead-related complications and pacing capture threshold. Baseline characteristics, R-wave amplitude, impedance, and all-cause mortality were summarized.
RESULTS: A total of 2342 patients were included across 77 centers (mean age 74 years; 38.9% female). Of the patients implanted with a 3830 lead for CSP, 64.1% (n = 1502) had LBBAP placement and 35.9% (n = 840) had HBP placement. The most commonly reported indications for CSP were sinus node dysfunction (67.0%) and atrioventricular block (57.2%). LBBAP had lower pacing thresholds, higher R-wave sensing, and higher impedance (all P <.001) through 30 months. At 36 months postimplant, the lead complication rate for LBBAP and HBP was 2.5% and 6.3%, ,respectively with no difference in all-cause mortality.
CONCLUSION: In a multicenter cohort of LBBAP and HBP patients treated with the catheter-delivered 3830 lead, lead-related complication rates were low and electrical parameters were stable through 30 months.