CRYO4PERSISTENT AF Study Evaluates Medtronic's Arctic Front Advance Cryoballoon Ablation System
April 9, 2018—Medtronic recently announced that 1-year results from the CRYO4PERSISTENT AF study were presented at the European Heart Rhythm Association scientific sessions 2018 held March 18–20 in Barcelona, Spain.
CRYO4PERSISTENT AF is a prospective, single-arm, interventional, multicenter, nonrandomized clinical trial that evaluated the 12-month clinical outcomes of cryoballoon ablation for isolating pulmonary veins, without additional ablation strategies, using Medtronic's Arctic Front Advance cryoballoon system to treat patients with persistent atrial fibrillation (AF).
Eligible patients were defined as having documented symptomatic persistent AF at baseline lasting longer than 7 days and up to 180 days. Before the procedure, enrolled patients were monitored using 18-hour Holter recorders to ensure all investigated patients met the 100% persistent AF documentation criteria. Per protocol, a total of 101 patients were analyzed and followed for 12 months at 11 medical centers throughout Europe.
Medtronic reported that at 1 year after a single ablation procedure with the Arctic Front Advance system, 60.7% of persistent AF patients were free from all atrial arrhythmias (adjudicated AF, atrial flutter, or atrial tachyarrhythmias) lasting more than 30 seconds. The company noted that 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 mean procedure times of 53 ± 22 minutes with the cryoballoon and a low device- and/or procedure-related complication rate of 4%.
In Medtronic's press release, the trial's Coprincipal Investigator Serge Boveda, MD, commented, “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. These results are encouraging and demonstrate the reproducibility of the cryoballoon procedure even in patients with persistent AF.” Dr. Boveda is Codirector of the Cardiac Arrhythmias Department at Clinique Pasteur in Toulouse, France.
The Arctic Front Advance cryoablation system is approved in Europe for the treatment of AF. In the United States, the system is approved for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF. It is not approved in the United States for treating persistent AF.
On April 6, additional data from CRYO4PERSISTENT AF were presented by Andreas Metzner, MD, during a late-breaking clinical trial session at the German Society of Cardiology meeting in Mannheim, Germany. Treatment with the Arctic Front Advance demonstrated a clinically significant improvement in quality of life and arrhythmia-related symptoms from baseline to 12 months postablation.
The company reported that 83 of the trial’s 101 patients completed the SF-36 short-form, 36-item quality-of-life survey that demonstrated statistical improvements in both physical and mental components. Physical component summary scores increased approximately 7.1 percentage point from 46.9% to 53.9%—a change of ≥ 5 is considered a clinically meaningful improvement in quality of life. Mental component summary scores increased 3.3 percentage points from 47.3% to 50.6%.
Of the 101 patients, 85 were assessed for arrhythmic symptoms. There were statistically significant reductions for all symptoms except syncope (2% to 0%). These reductions included (all, P < .01): dizziness (from 14% of patients to 2%), palpitations (from 68% of patients to 8%), rapid heartbeat (from 27% of patients to 5%), dyspnea (from 53% of patients to 6%), and fatigue (42% of patients to 4%). The median number of symptoms at baseline was two compared to none at 12 months postablation (P < .0001), reported Dr. Metzner.