CRYO4PERSISTENT AF Evaluates Medtronic's Arctic Front Advance Cryoballoon
August 28, 2018—Medtronic announced that new findings from the CRYO4PERSISTENT AF clinical trial were presented at the European Society of Cardiology Congress 2018 held August 25–29 in Munich, Germany.
CRYO4PERSISTENT AF evaluated 12-month clinical outcomes of cryoballoon ablation for isolating the pulmonary veins, without additional ablation in the left atrium, using the Arctic Front Advance cryoballoon system (Medtronic) to treat patients with symptomatic 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. CRYO4PERSISTENT AF is designed as a prospective, single-arm, interventional, multicenter, nonrandomized clinical trial.
Before the procedure, enrolled patients were monitored to ensure they 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.
According to the company, the CRYO4PERSISTENT AF results demonstrated improved quality of life, reduced symptoms from abnormal heart rhythms, and low incidence of reinterventions and repeat ablation procedures.
Medtronic reported that patients treated with cryoballoon ablation experienced clinically meaningful changes in quality-of-life scores, with a 7.1-point average improvement in physical quality and a 3.3-point average improvement in mental health quality component scores (using the SF-36 Short Form Health Survey).
Patients experienced a significant reduction in symptoms: 92% of patients had symptoms such as dizziness, palpitations, and fatigue before cryoablation, and at 1 year after treatment, only 16% of patients had arrhythmia-related symptoms (P < .0001).
The severity of symptoms also decreased after cryoballoon treatment, from 2.1 to 1.3 (P < .01) using the European Heart Rhythm Association AF Symptom Score; also, New York Heart Association class improved by one or more functional classes in 47% of patients from baseline to 12 months.
In Medtronic's announcement, study Co-Investigator K.R. Julian Chun, MD, commented, "These findings highlight the advantage of cryoballoon ablation in patients with persistent AF, demonstrating that patients have fewer symptoms after treatment and a significant improvement in their quality of life. Paired with the study data showing a low incidence of reinterventions, it's clear to see the benefit for both patients and health care providers."
Although patients entering this study already had progressed to an advanced AF disease stage that traditionally has been more difficult to treat, the study found that only 17 of the 101 patients in the trial required a repeat ablation at the time of an arrhythmia recurrence. In addition, direct current cardioversion was only required for eight patients at the time of recurrence. Further, only three patients in sinus rhythm remained on antiarrhythmic medication at the completion of the study.
Medtronic advised that the primary CRYO4PERSISTENT AF study results were presented earlier this year and recently published online by Serge Boveda, MD, et al in Journal of the American College of Cardiology: Clinical Electrophysiology. These results demonstrated that 60.7% of patients were free from all atrial arrhythmias (adjudicated AF, atrial flutter, or atrial tachyarrhythmias) at 1 year after a single pulmonary vein isolation-only cryoballoon ablation procedure. The study findings also demonstrated short and predictable procedure times of 53 ± 22 minutes with the cryoballoon and a low complication rate of 4%.
The Arctic Front Advance cryoablation system is approved in Europe for the treatment of AF. In the United States, the device is approved for the treatment of drug-refractory, recurrent, symptomatic paroxysmal AF.