Pulsed field ablation with the variable loop circular catheter in patients across the age and body mass index spectrum: acute results from the prospective multi-centre VARIPURE post-market study
P Sommer, F Bessiere, D Scherr, S Ernst, A AlmoradAbstract
Background
The safety and effectiveness of pulsed field ablation (PFA) with the variable loop circular catheter (VLCC) have been evaluated in investigational and real-world studies.
Purpose
We report acute safety and effectiveness of VLCC PFA across the spectrum of age and body mass index (BMI) in a real-world setting.
Methods
Patients undergoing atrial fibrillation (AF) ablation with the VLCC at 22 European centres (Apr 2024–Aug 2025) were prospectively enrolled in the observational post-market VARIPURE study. The primary effectiveness endpoint was acute success, defined as entrance block confirmation in all VLCC-ablated PVs. The primary safety endpoint was the occurrence of primary adverse events (PAEs). Analyses were performed in the full cohort and in age (≥80 or ≤45 years) and BMI (≥35 or ≤20 kg/m2) subgroups, which were not mutually exclusive. Data were summarized descriptively.
Results
A total of 1,167 patients were enrolled in the analysis, including 1,022 de novo (DN; age 64.9±10.7 yrs, BMI 27.8±4.9 kg/cm2, 36.7% female, 63.5% paroxysmal AF) and 145 repeat (age 63.5±9.4 yrs, BMI 27.8±4.4, 26.9% female, 39.3% paroxysmal AF). In DN patients, 8 (0.8%) PAEs were reported (3 device-related; 7 procedure-related) and acute success was achieved in 99.8% of patients. The repeat patients had 0 PAEs and 100% acute success. Age subgroups included 63 patients ≥80 years (Older) and 60 patients ≤45 years (Younger). Acute success was 100% in both subgroups. Two (3.2%) PAEs occurred in the Older group, including 1 cardiac tamponade/perforation (procedure- and device-related) and 1 major vascular access complication/bleeding (procedure-related only). Both events occurred in DN paroxysmal AF patients and resolved without clinical sequalae. No PAEs occurred in the Younger group. BMI subgroups included 91 patients ≥35 kg/m2 (Higher BMI) and 36 patients ≤20 kg/m2 (Lower BMI). Acute procedure success was achieved in all, except for 1 Lower-BMI DN patient. No PAEs occurred in the Higher BMI group, while 1 PAE (3.1%) occurred in the Lower BMI group (pericarditis: procedure- and device-related), which subsequently resolved. No coronary spasm, ST-elevation, or acute kidney injury were observed in the age or BMI subgroups. Additional data is reported in Table 1.
Conclusion
Real-world AF ablation with the VLCC is feasible in patients across the spectrum of age and BMI, showing good safety profile and acute procedure success. Outcomes from more patients, notably repeat cases, will be explored upon 12-month follow-up completion.Table 1