One-year results from the CRYO4PERSISTENT AF study of ablation with the Arctic Front Advance Cryoballoon to isolate the pulmonary veins in patients with symptomatic persistent atrial fibrillation (AF). The Arctic Front Advance Cyroablation System is not approved for treating persistent AF in the United States.
The study results, presented at the European Heart Rhythm Association (EHRA) Scientific Sessions 2018 in Barcelona, Spain, showed 60.7% of persistent AF patients were free from all atrial arrhythmias (adjudicated AF, atrial flutter or atrial tachyarrhythmias) lasting more than 30 seconds, at one year following a single ablation procedure. These clinically meaningful results are on par with outcomes seen in the FIRE AND ICE trial of paroxysmal AF patients (approximately 70% at 12 months), and are encouraging given these patients are in a more advanced disease state.
The study findings also demonstrated short and predictable procedure times of 53±22 minutes with the cryoballoon and a low device- and/or procedure-related complication rate of 4%.
“The findings demonstrate the benefits of cryoablation therapy in reducing the significant burden patients experience once AF progresses, and hold promise for physicians to realise efficient procedure times and a low rate of adverse events for their persistent AF patients,” said Serge Boveda, co-director of the Cardiac Arrhythmias Department in Clinique Pasteur, Toulouse, France, and co-principal investigator in the trial. “These results are encouraging and demonstrate the reproducibility of the cryoballoon procedure even in patients with persistent AF.”
“This is the first study of its kind to closely observe patients with persistent AF using a PVI-only strategy with the cryoballoon,” said Pascal Defaye, Arrhythmia Unit, Department of Cardiology, Grenoble-Alpes University Hospital, Grenoble, France, and co-principal investigator in the trial. “The results are noteworthy and provide valuable insights for the physician community.”