Pulsed field ablation with a variable loop circular catheter in atrial fibrillation: Acute outcomes from the VARIPURE multicenter study.

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).