October 1, 2026European Heart Journal
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
Key result
Pulsed field ablation with VLCC achieves ~100% acute success with minimal adverse events in AF.
- n=1,167
Why the study?
The acute safety and effectiveness of pulsed field ablation with the variable loop circular catheter across the spectrum of age and BMI in a real-world setting needed to be evaluated.
Does pulsed field ablation with the variable loop circular catheter achieve high acute success and a safe profile in patients with atrial fibrillation across the age and body mass index spectrum?
Key Points
- To assess the acute safety and effectiveness of pulsed field ablation using a variable loop circular catheter across the spectrum of age and body mass index in a real-world setting.
- Prospective, multicenter, observational post-market VARIPURE study conducted across 22 European centers between April 2024 and August 2025.
- Enrolled 1,167 patients undergoing atrial fibrillation ablation (1,022 de novo and 145 repeat cases), stratified into subgroups of age (≥80 or ≤45 years) and body mass index (≥35 or ≤20 kg/m²).
- Assessed primary effectiveness by acute entrance block confirmation in all ablated pulmonary veins and primary safety by the incidence of primary adverse events.
- Acute procedural success was 99.8% in de novo patients with an 0.8% primary adverse event rate (8/1,022; 3 device-related, 7 procedure-related), whereas repeat cases achieved 100% success with 0 adverse events.
- Age subgroups achieved 100% acute success in both older (≥80 years, n=63) and younger (≤45 years, n=60) cohorts, with 2 (3.2%) adverse events occurring in older patients and 0 in younger patients.
- Body mass index subgroups demonstrated 100% acute success in higher BMI (≥35 kg/m², n=91; 0 adverse events) and success in all but one patient in lower BMI (≤20 kg/m², n=36; 1 [3.1%] adverse event of resolved pericarditis).
Study Design
Type
Observational (n=1,167)
Multicenter
Yes
Structured PICO
Does pulsed field ablation with the variable loop circular catheter achieve high acute success and a safe profile in patients with atrial fibrillation across the age and body mass index spectrum?
P
Population
1,167 patients (1,022 de novo, 145 repeat) undergoing atrial fibrillation ablation with the variable loop circular catheter at 22 European centers, assessed for acute outcomes across age and BMI subgroups.
E
Exposure
Pulsed field ablation (PFA) with the variable loop circular catheter (VLCC)
O
Outcome
Primary effectiveness endpoint: acute success, defined as entrance block confirmation in all VLCC-ablated pulmonary veins (PVs). Primary safety endpoint: occurrence of primary adverse events (PAEs).
Real-world pulsed field ablation using a variable loop circular catheter demonstrates high acute procedural success (99.8%-100%) and low primary adverse event rates across extreme age and BMI subgroups.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“An overall 0.6 percent primary adverse event rate with no strokes, coronary spasm, or other PFA-related complications demonstrates a favorable safety profile when using the VARIPULSE™ Platform. These outcomes, observed in nearly 800 patients across varying procedural workflows, demonstrate the platform’s consistent application and adaptability in this study.”
DSDaniel ScherrCardiologist, Medical University of Graz
“The VARIPURE results adds important real-world evidence demonstrating that pulsed field ablation with the VARIPULSE Platform can deliver both durable effectiveness and a consistently strong safety profile across a broad AFib population. What is particularly compelling is the combination of sustained 12-month outcomes and strong safety profile, which are critical indicators of long-term treatment success in everyday clinical practice.”
Implication
Supports real-world pulsed field ablation with variable loop catheter across age/BMI extremes in AF; extends prior data but leaves randomized trials needed.
Abstract
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.
Discussion
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Cite This Study
Sommer et al. (2026) conducted an observational in Atrial fibrillation (n=1,167). Pulsed field ablation with the variable loop circular catheter (VLCC) was evaluated on Acute success (entrance block confirmation in all VLCC-ablated PVs) and occurrence of primary adverse events (PAEs). Pulsed field ablation with the VLCC achieved 99.8% acute success with a 0.8% primary adverse event rate in de novo AF patients, and 100% success with 0% adverse events in repeat patients.