Heart rhythm · 2026
Pulsed field ablation with a variable loop circular catheter in atrial fibrillation: Acute outcomes from the VARIPURE multicenter study.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Almorad Alexandre, Sebag Frederic A, Kronborg Mads Brix, Sohns Christian, De Potter Tom, Adragão Pedro, Bessière Francis, Chierchia Gian-Battista, Duytschaever Mattias, Szeplaki Gabor, Di Monaco Antonio, Reichlin Tobias, Yap Sing-Chien, Wong Tom, Lepièce Caroline, Linz Dominik, Gallagher Mark M, Pappone Carlo, Sommer Philipp, Ernst Sabine, Pürerfellner Helmut, Scherr Daniel, VARIPURE Investigators
Аннотация
BACKGROUND: The safety and effectiveness of the variable loop circular catheter (VLCC) pulsed field ablation (PFA) system was shown in atrial fibrillation (AF) registrational trials.
OBJECTIVE: Assess acute safety and effectiveness of first-time pulmonary vein isolation (PVI) with the VLCC in standard clinical practice in the VARIPURE substudy of the ongoing, prospective, multicenter, observational SECURE postmarket follow-up study.
METHODS: Data were extracted from Electronic Data Capture and the CARTONET data analytics software. Primary safety was the incidence of primary adverse events related to the VLCC and/or procedure. Primary effectiveness was acute procedural success, confirmed by electrical isolation of all targeted PVs.
RESULTS: Among 1022 AF patients (mean age 64.9 years, 63.3% male, 63.5% paroxysmal AF; mean CHA2DS2-VASc 2.2; 22 European centers, 74 operators), 29.5% underwent ablations beyond the PVs (PVI+). The mean ± standard deviation procedure, left atrial dwell, and fluoroscopy times were 60.1 ± 21.9, 38.0 ± 15.6, and 5.2 ± 5.6 minutes, respectively. The primary adverse event rate was 0.8%, with no stroke, cerebrovascular accident, or transient ischemic attack. No ST elevation, coronary spasm, or acute kidney injury were reported. Acute reconnection was assessed per physician preference in a subset of patients (18.5% [78/421]). Acute PVI was achieved in 99.8% of patients. Using CARTONET (868 cases), the recommended workflow of 16-28 ablations for PVI was followed in 83.1% of patients with a 4-PV anatomy.
CONCLUSION: In the largest real-world VLCC yet, PFA with the VLCC exhibits favorable safety, high acute efficacy, procedural efficiency, and recommended workflow adherence. Results may provide a strong foundation for future studies of this PFA technology upon 12-month follow-up completion.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04750798 (https://clinicaltrials.gov/study/NCT04750798).
OBJECTIVE: Assess acute safety and effectiveness of first-time pulmonary vein isolation (PVI) with the VLCC in standard clinical practice in the VARIPURE substudy of the ongoing, prospective, multicenter, observational SECURE postmarket follow-up study.
METHODS: Data were extracted from Electronic Data Capture and the CARTONET data analytics software. Primary safety was the incidence of primary adverse events related to the VLCC and/or procedure. Primary effectiveness was acute procedural success, confirmed by electrical isolation of all targeted PVs.
RESULTS: Among 1022 AF patients (mean age 64.9 years, 63.3% male, 63.5% paroxysmal AF; mean CHA2DS2-VASc 2.2; 22 European centers, 74 operators), 29.5% underwent ablations beyond the PVs (PVI+). The mean ± standard deviation procedure, left atrial dwell, and fluoroscopy times were 60.1 ± 21.9, 38.0 ± 15.6, and 5.2 ± 5.6 minutes, respectively. The primary adverse event rate was 0.8%, with no stroke, cerebrovascular accident, or transient ischemic attack. No ST elevation, coronary spasm, or acute kidney injury were reported. Acute reconnection was assessed per physician preference in a subset of patients (18.5% [78/421]). Acute PVI was achieved in 99.8% of patients. Using CARTONET (868 cases), the recommended workflow of 16-28 ablations for PVI was followed in 83.1% of patients with a 4-PV anatomy.
CONCLUSION: In the largest real-world VLCC yet, PFA with the VLCC exhibits favorable safety, high acute efficacy, procedural efficiency, and recommended workflow adherence. Results may provide a strong foundation for future studies of this PFA technology upon 12-month follow-up completion.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04750798 (https://clinicaltrials.gov/study/NCT04750798).