P985Single procedure outcomes, quality of life, NYHA improvement, and reduced symptoms 12 months post cryoballoon ablation in persistent atrial fibrillation: results from the CRYO4PERSISTENT AF Study

Abstract

Background/Introduction: PVI is recognized as the cornerstone of AF ablation, including ablation of persistent AF. To our knowledge, this is the first prospective multicenter study reporting long-term outcomes after a single PVI-only ablation procedure with the cryoballoon in PersAF patients using Arctic Front Advance. Arrhythmia recurrence, quality of life, EHRA AF Symptom Score, NYHA class, and 12-month outcomes were evaluated. Purpose: The CRYO4PERSISTENT AF study (NCT02213731) is a prospective, multicenter, non-randomized, single arm study to assess single procedure outcomes of pulmonary vein antrum isolation using the cryoballoon. Methods: The study enrolled patients with persistent AF (diagnosis within 12 months of consent, 100% AF burden of 7-180 days, and/or AF requiring cardioversion) at 11 European sites. The primary endpoint was freedom from AF/AFL/AT recurrence at 12 months, defined as arrhythmias ≥30 seconds or reintervention for AF, excluding a 3-month blanking period. After enrollment, patients without 100% AF burden (18-hour Holter or 3 consecutive ECG recordings in a timeframe ≥14 days) were exited. Patients were followed at 3, 6, and 12 months, with 48-hour Holters at 6 and 12 months. Quality of life, NYHA class, and arrhythmic symptoms were evaluated at 12 months. An independent core lab adjudicated arrhythmia recurrence and adverse events were adjudicated by an independent committee. Results: A total of 101 patients (62±11 years, 74% male, LVEF 56±8%, LAD 43±5 mm) meeting criteria, undergoing a cryoballoon ablation, with follow-up data, were included in the analysis. At 12 months post-ablation 16% of patients had arrhythmic symptoms compared to 92% at baseline (p<0.0001). Arrhythmiarelated symptom reduction was statistically significant 12 months post-ablation for all symptoms except syncope (2% to 0%): dizziness (14% to 2%), palpitations (68% to 8%), rapid heartbeat (27% to 5%), dyspnea (53% to 6%), and fatigue (42% to 4%), all p<0.01. The symptomatic reduction was supported by significant improvement in SF-36v2 scores at 12 months and EHRA AF Symptom Score. The mean normalized SF-36 physical component score improved from 46.9 to 53.9 (p<0.0001) and the mental component score improved from 47.3 to 50.6 (p=0.008). The EHRA AF Symptom Score decreased from 2.1 to 1.3 (p<0.01). NYHA class improvement of ≥1 was observed in 47% of patients at 12 months. Freedom from AF/AFL/AT recurrence was 60.7% at 12 months (1-sided lower 95% confidence bound: 51.1%). The only cryoballoon device related event was transient PNI, observed in 2 patients (2%), with resolution pre-discharge. Conclusion(s): Persistent AF patients treated with the second generation cryoballoon demonstrated a significant reduction in arrhythmia-related symptoms, improved QOL, a reduced EHRA AF Symptom Score, improvement in NYHA class, and 61% single procedure success rate at 12 months post-ablation. No patients experienced PNI post-discharge.