Abstract 11445: Safety and Efficacy of Cryoballoon Ablation for Atrial Fibrillation Performed at Community Hospitals with Low to Medium Case Numbers: Acute and First Long Term Results of the German "regional" Registry

Introduction: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is a guideline recommended treatment for symptomatic paroxysmal and persistent atrial fibrillation. Little is known on performance data of CBA in low to medium volume hospitals. Hypothesis: To determine safety and efficacy of PVI using CBA performed at community hospitals with limited annual case numbers. Methods: This prospective registry included 1004 consecutive patients (pts) who had CBA performed for symptomatic paroxysmal (n=563) or persistent AF (n=441) at 20 hospitals, each with <100 PVI / year. CBA procedures were performed according to local standards. Procedural data, efficacy and complication rates were determined. Results: The mean number of CBA / year / center was 59±25. CBA was performed by a total of 22 operators (1.1/center), 12/20 operators were board certified for invasive electrophysiology. Average procedure time was 90.1±31.6 min, fluoroscopy time was 19.2±11.4 min. Isolation of all pulmonary veins was reached in 97.9% of pts, the most frequent reason for not achieving complete isolation was development of phrenic nerve palsy (PNP). No hospital deaths were observed. 2 pts (0.2%) suffered a clinical stroke. Pericardial effusion occurred in 6 pts (0.6%), 2 (0.2%) required pericardial drainage. Vascular complications occurred in 24 pts (2.4%), 2 pts (0.2%) underwent vascular surgery. PNP occurred in 48 pts (4.8%) and persisted up to discharge in 6 pts (0.6%). The results were independant for board certification status of the operator and independant for the number of enrolled patients per center (if > or < 60 pts). Follow up data at 12 months were available from 14 centers and 75,2 % of their pts so far. Recurrent atrial arrhythmias after a 3 months blanking period were found in 177/536 pts. (33%), 152 (85,9%) were symptomatic. 71 (40%) pts with recurrence were still on antiarrhythmic drugs, 42 (23.7%) underwent Re-PVI. One phrenic nerve palsy persisted, there were no further access site complications and no esophago-atrial fistula. Conclusions: PVI for paroxysmal or persistant AF using CBA can be safely performed at community hospitals with high acute efficacy, low complication rates and good recurrence data after 1 year despite low and moderate annual case numbers.