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Aims Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is mainly reserved for patients with drug-refractory or drug-intolerant symptomatic atrial fibrillation. We evaluated a large cohort of patients treated in a real-world setting and examined the safety and efficacy profile of CBA when applied as a first-line treatment for atrial fibrillation. Methods In total, 249 patients (23% women; 56 ± 13 years; mean left atrial diameter 41 ± 7 mm; 73.5% paroxysmal atrial fibrillation; and 26.5% persistent atrial fibrillation) underwent an index PVI by CBA. Data were collected prospectively in the framework of the 1STOP ClinicalService project, involving 26 Italian cardiology centers. Results Median procedure and fluoroscopy times were 90.0 and 21.0 min, respectively. Acute procedural success was 99.8%. Acute/periprocedural complications were observed in seven patients (2.8%), including: four transient diaphragmatic paralyses, one pericardial effusion (not requiring any intervention), one transient ischemic attack, and one minor vascular complication. The Kaplan--Meier freedom from atrial fibrillation recurrence was 86.3% at 12 months and 76% at 24 months. Seventeen patients (6.8%) had a repeat catheter ablation procedure during the follow-up period. At last follow-up, 10% of patients were on an anticoagulation therapy, whereas 6.8% were on an antiarrhythmic drug. Conclusion In our multicenter real-world experience, PVI by CBA in a first-line atrial fibrillation patient population was well tolerated, effective, and promising. CBA with a PVI strategy can be used to treat patients with paroxysmal and persistent atrial fibrillation with good acute procedural success, short procedure times, and acceptable safety. Clinical Trial Registration clinicaltrials.gov (NCT01007474).

This model of implementation of available evidence to clinical practice via a group-based, multi-disciplinary counselling provides a shared and coherent decision pathway and yielded a very low rate of recurrent events and therapy-related complications. This approach could be replicated in specific protocols for other complex or neglected clinical problems.

Background: Pulmonary vein isolation (PVI) is an accepted strategy for paroxysmal atrial fibrillation (PAF) and persistent AF (PerAF) ablation. Limited data are available on outcomes of cryoballoon (CB) PVI in patients with structural heart disease (SHD). The purpose is to assess the clinical efficacy of a single CB-PVI procedure in patients with PAF or PerAF who also have SHD. Methods: From April 2012, 460 AF patients with concomitant SHD underwent CB-PVI and were followed prospectively in the framework of the 1STOP ClinicalService 1 project. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. Out of 460 subjects, 282 patients (61%) had PAF and 178 (39%) PerAF. Results: SHD patients were predominantly male (80.9%), old (62.8 AE 8.9 years), with preserved functional capacity (New York Heart Association class >1: 39.4%), high cardioembolic risk (CHA 2 DS 2 VASc score !2: 69.3%), and conserved left ventricular ejection fraction (56.5 AE 8% LVEF). Both subjects with PAF and PerAF had similar baseline clinical characteristics except for left atrial diameter (43.8 AE 7 vs. 45.7 AE 7 mm) and area (22.9 AE 5.2 vs. 25.1 AE 4.4 cm 2 ), respectively. Procedure time and fluoroscopic time as well as the rate of procedural complications were not different between subjects with PAF and PerAF. After a mean follow-up of 12 months, antiarrhythmic drug therapy had dropped from 71.7% before ablation to 33.6% post-ablation (p < 0.001) and the freedom from symptomatic AF recurrence was 78% for PAF and 77% for PerAF (p = 0.793). Furthermore, atrial arrhythmia recurrence rate was not related to SHD.