Pulsed Field Ablation With a Variable Loop Circular Catheter in Atrial Fibrillation: Acute Outcomes From the VARIPURE Multicenter Study.
Publisher DOI
PubMed ID
42392466
Abstract
Background
The safety/effectiveness of the variable loop circular catheter (VLCC) pulsed field ablation (PFA) system was shown in atrial fibrillation (AF) registrational trials.Objectives
Assess acute safety/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 incidence of primary adverse events (PAEs) 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±SD procedure, left atrial dwell, and fluoroscopy times were 60.1±21.9, 38.0±15.6, and 5.2±5.6 minutes, respectively. The PAE 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.Conclusions
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).
The safety/effectiveness of the variable loop circular catheter (VLCC) pulsed field ablation (PFA) system was shown in atrial fibrillation (AF) registrational trials.Objectives
Assess acute safety/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 incidence of primary adverse events (PAEs) 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±SD procedure, left atrial dwell, and fluoroscopy times were 60.1±21.9, 38.0±15.6, and 5.2±5.6 minutes, respectively. The PAE 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.Conclusions
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).
Date Issued
2026
Publication Type
Article
Subject(s)
Subjects
VARIPULSE
•
atrial fibrillation
•
pulsed field ablation
•
safety
•
variable loop circular catheter
•
workflow
Language(s)
en
Author(s)
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 | |
Yap, Sing-Chien | |
Wong, Tom | |
Lepièce, Caroline | |
Linz, Dominik | |
Gallagher, Mark M | |
Pappone, Carlo | |
Sommer, Philipp | |
Ernst, Sabine | |
Pürerfellner, Helmut | |
Scherr, Daniel |
Additional Credits
Journal
Heart Rhythm
Publisher
Elsevier
ISSN
1556-3871
1547-5271
Access(Rights)
embargo