Work

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

Year: 2025

Type: article

Abstract: 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: = .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.

Source: Annals of Thoracic Surgery Short Reports

DOI: 10.1016/j.atssr.2025.08.011

Authors: Evelio Rodriguez, Arnar Geirsson, Sabet Hashim, Patrick McCarthy

Institutions: Saint Thomas West Hospital, Columbia University Irving Medical Center, Hartford Hospital, Northwestern University, Northwestern Medicine

Language: English

Topic: Atrial Fibrillation Management and Outcomes

Subfield: Cardiology and Cardiovascular Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $975