Cryoablation safe, effective in persistent AF
Ablation with a cryoballoon was safe and effective in patients with persistent atrial fibrillation, according to the results of the CRYO4PERSISTENT AF study.
Catheter ablation involving pulmonary vein isolation is recommended in guidelines as a first-line therapy for patients with paroxysmal AF, but its safety and efficacy is less known in patients with persistent AF, Serge Boveda, MD, co-director of the department of cardiac arrhythmias at Clinique Pasteur in Toulouse, France, said during a presentation at EHRA 2018.
Boveda and colleagues conducted a prospective, multicenter, nonrandomized, single-arm study of 101 patients (mean age, 62 years; 74% men) with symptomatic persistent AF and 100% AF burden pre-ablation who underwent pulmonary vein isolation alone with the cryoballoon (Arctic Front Advance, Medtronic).
The primary outcome was freedom from all atrial arrhythmias, including AF, atrial flutter and atrial tachycardia, at 12 months. Repeat ablations at any time during patient follow-up were defined as failures.
Mean procedure time was 53 minutes and mean fluoroscopy time was 18 minutes.
At 12 months, 60.7% of patients were free from all atrial arrhythmias, Boveda reported, noting that 5.9% of those who achieved sinus rhythm remained on antiarrhythmic drugs at 12 months.
In terms of safety outcomes, 4% of patients had major events which were all procedure-related: two had vascular pseudoaneurysm, one had transient ST elevation and one had pericardial effusion without need for a drainage. Additionally, 2% of patients had device-related events, both cases of phrenic nerve injury, which resolved before discharge, Boveda said, noting there were no clinical sequelae and no device- or procedure-related atrial-esophageal fistulae, pulmonary vein stenosis, strokes/transient ischemic attacks or deaths.
“The findings demonstrate the benefits of cryoablation therapy in reducing the significant burden patients experience once AF progresses, and hold promise for physicians to realize efficient procedure times and a low rate of adverse events for their persistent AF patients,” Boveda said in a press release. “The results are encouraging and demonstrate the reproducibility of the cryoballoon procedure even in patients with persistent AF.”
The device is not approved for treating persistent AF in the United States. – by Erik Swain
Boveda S, et al. Abstract 740. Presented at: EHRA: The Annual Congress of the European Heart Rhythm Association; March 18-20, 2018; Barcelona, Spain.
Disclosure: The study was sponsored by Medtronic. Boveda reports he received compensation for services from Medtronic.