Concomitant Cryoablation for Atrial Fibrillation: FREEZE-AFIB Post-Market Study

Background: Surgical ablation is the gold standard for atrial fibrillation treatment. Cryothermal-only surgical ablation is used in clinical practice with an increasing body of published outcomes. Methods: FREEZE-AFIB (NCT05089877) was a post-market, multicenter, retrospective-prospective study to evaluate performance and safety of a commercially available cryoablation probe (cryoICE cryoFORM; AtriCure Inc.) to treat patients with nonparoxysmal atrial fibrillation. Consented patients ≥18 years who received concomitant Cox-Maze III lesions using the cryoICE cryoFORM device during cardiac surgery and returned for a prospective 12-month follow-up visit were included. Primary performance was freedom from any atrial arrhythmia >30 seconds at last follow-up without class I/III antiarrhythmic drugs. Primary safety was freedom from protocol-defined surgical ablation procedure-related serious adverse events (SAEs) (death, stroke, myocardial infarction, and major bleeding) within 30 days. Results: Thirty-three patients from 4 US sites had a mean age of 68.7 years, mean body mass index of 27.5 kg/m2, 76% were male, and 94% were White. Primary safety was achieved, with 100% (33 of 33) free from predefined SAEs within 30 days (95% CI, 89.42%-100%; P < .0001). Ninety-seven percent of patients (32 of 33) were free from SAEs and permanent pacemaker implantation through 12 months (95% CI, 84.24%-99.92%; P < .0001). Of 28 patients with evaluable 24-hour Holter data at 12 months, 89% (25 of 28) of patients were free from atrial arrhythmias off antiarrhythmic drugs (95% CI, 71.77%-97.73%; P = .001), meeting primary performance. Conclusions: Cryothermal-only surgical ablation with cryoICE cryoFORM was safe and effective, with 89% of patients free from atrial arrhythmias at 12 months off antiarrhythmic drugs and a low SAE rate.