Acute and Long-term Outcomes of Cryoballoon Ablation in Patients with Atrial Fibrillation. Primary Results of the Spanish Cryoballoon Ablation Registry (RECABA)

Abstract

Background Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. Objectives The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Methods Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. Theprimary endpoint was ≥ 30 sec freedom from AF at 12-mo after a 3-mo blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. Results In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryoapplications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 seconds. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryoapplication. Mean procedural time was 113 ± 41 minutes. Acute complications occurred in 4.4% of the cases21. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). Conclusions RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.