Initial experience with the Varipulse pulsed-field ablation system: procedural performance and clinical outcomes at one-year follow-up

Background

Pulsed-field ablation (PFA) has recently emerged as a novel non-thermal strategy for atrial fibrillation. The Varipulse™ system, integrated with an electroanatomical mapping platform, represents one of the most advanced PFA technologies, enabling precise and tissue-selective ablation.

Purpose

To describe procedural performance, clinical characteristics, and one-year follow-up outcomes in real-world practice.

Methods

Single-centre, prospective, observational study conducted in Spain between October 2024 and October 2025. All consecutive patients underwent PFA using the Varipulse™ system supported by the CARTO 8.0 electroanatomical mapping platform, performed by four operators. Clinical characteristics, procedural parameters, and follow-up data were collected prospectively, with at least two evaluations (within 3 months and at 1 year). Recurrences were documented via emergency department ECGs or device diagnostics in carrier patients. Statistical analysis was performed using SPSS v30.

Results

A total of 102 patients underwent Varipulse™ PFA. Patients were predominantly male (72.2%), with a mean age of 56 ± 10.7 years. Paroxysmal, persistent, and long-standing persistent AF were present in 56.9%, 29.4%, and 13.7%, respectively. Comorbidities included obesity (56.7%; BMI 30.14 ± 4.52 kg/m²), hypertension (49%), dyslipidemia (55.9%), type 2 diabetes (19.6%), and active smoking (22.5%). Structural heart disease was present in 34.3%. Mean LVEF was 56.65 ± 9.51%. Echocardiography showed a left atrial 2-chamber diameter of 41.45 ± 9.37 mm and a left atrial area of 23.22 ± 7.53 cm². Before ablation, 84.3% of patients were receiving antiarrhythmic drugs.

Ablation was performed under deep sedation with propofol in 98.3% of cases. Most procedures were first-time ablations (88.1%), whereas 7.8% were re-do procedures (8.8% post-RF and 1.1% post-cryo). In re-do cases, 2–3 pulmonary vein reconnections were typically identified. Four independent pulmonary veins were observed in 72.5% of patients; a left common trunk in 17.6%; and less frequent anatomies included five veins (5.9%), six veins (3.0%), and a right common inferior trunk (1.0%). Median fluoroscopy time was 8.6 min (IQR 6.5–12), fast-mapping time 8 min (IQR 5–14), mean application time 33.53 ± 8.65 min, and total skin-to-skin time 92.96 ± 20.40 min.

At one year, 65 patients (63.7%) remained free from recurrence, while 18 (17.6%) experienced AF recurrence. During the blanking period, 62 patients (75.6%) remained arrhythmia-free, whereas 20 (25.4%) had arrhythmic episodes. Acute complications included major access-site bleeding in 3 patients (2.9%) and cardiac tamponade in 1 patient (1.0%).

Conclusions

In our experience, Varipulse™ PFA provided efficient procedures with a low rate of acute complications, and most patients remained arrhythmia-free at one year. Further data from larger registries will help define its long-term performance across different AF substrates.