Pulmonary vein isolation with the radiofrequency balloon catheter: long-term results and predictors of ablation success

The novel multielectrode radiofrequency balloon catheter (RFB) has been demonstrated to achieve safe and effective pulmonary vein isolation (PVI). However, data on long-term ablation outcomes is lacking.

This single-centre study aimed to evaluate the efficacy of the RFB beyond 1-year follow-up and define predictors of arrhythmia recurrence.

All consecutive patients with symptomatic paroxysmal atrial fibrillation (AF) undergoing first-time PVI with the RFB between January 2021 and November 2022 were prospectively included. Post-ablation remapping was systematically employed to confirm PVI at the end of the procedure. Procedural failure was defined as any atrial tachyarrhythmias (ATas) lasting >30 s occurring during the follow-up after a 3-month blanking period (BP). Patient characteristics, procedural parameters, and ATas recurrence during BP were analysed with respect to ablation outcome.

A total of 120 consecutive patients (50 female, 42%; mean age 65±12 years) were enrolled. After a mean follow-up of 16.1±7.9 months, ATas recurrence occurred in 30 patients (25%). ATas were adjudicated as AF in 25 patients (83.3%) and as atrial tachycardia/atrial flutter in 5 patients (16.7%). The mean time from the index procedure to ATas recurrence was 203±130 days. A redo procedure was performed in 17 patients (56.7%) and at least one PV reconnection was observed in 12 patients (70.6%). Patients with ATas recurrence presented higher values of body mass index (31.0 ±5.7 vs. 28.1±4.9 kg/m2, p=0.048), larger left atria (43±11 vs. 35±9 ml/m2, p=0.003), and increased rates of ATas recurrence during the BP (53.3% vs. 2.2 %, p<0.001) compared to patients with persistent sinus rhythm. At multivariable Cox regression analysis, left atrial end-systolic volume index and ATas recurrence during the BP were independently associated with procedural failure (HR 1.05, 95%CI 1.00-1.11, p=0.048 and HR 23.88, 95%CI 7.71-73.99, p<0.001, respectively).

At 16 months follow-up, PVI with the RFB resulted in freedom from arrhythmia relapse in 75% of patients. Left atrial end-systolic volume index and ATas recurrence during the BP were independent predictors of arrhythmia recurrence.

ATas-free survival