The ICE-AFIB Trial: A multicenter prospective investigational device exemption (IDE) trial using cryosurgical ablation for atrial fibrillation during concomitant cardiac surgery.
Academic Article
Overview
abstract
OBJECTIVE: Surgical treatment for atrial fibrillation (AF) has transitioned from cut-and-sew to cryothermal and radiofrequency ablation. ICE-AFIB is the first prospective, multicenter investigational device exemptions (IDE) trial to evaluate cryothermy as a sole energy source to perform concomitant Cox-Maze III procedures for patients with non-paroxysmal AF. METHODS: ICE-AFIB is a single-arm, Bayesian adaptive design, IDE study (NCT03732794). Patients ≥18 years with persistent/longstanding persistent AF (LSPAF) underwent concomitant cryosurgical Cox-Maze III. Primary effectiveness was freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) from 6- to 12-months post-procedure. Primary safety was composite major adverse event (myocardial infarction, stroke, major bleeding, death) rate within 30-days. Rhythm assessment was with periodic 24-hour Holter monitoring. RESULTS: One hundred fifty patients were treated at 14 sites, with median age 69.0 (SD 8.85) years, median BMI 31.0 (SD 6.90) kg/m2, CHA2DS2-VASc=3.0 (SD 1.67), median left atrial diameter 5.2 (SD 0.83) cm, 66.0% were male, median current/most recent AF episode was 5.7 (SD 25.86) months in duration (63.3% persistent AF, 36.7% LSPAF). Concomitant procedures were mitral valve (67.3%), tricuspid valve (42.0%), coronary artery bypass grafting (29.3%), and aortic valve (18.7%); 59.3% had multiple concomitant procedures. Primary effectiveness was met with 70% freedom from AF/AFL/AT from 6 through 12-months (posterior probability: 0.9997; 95% credible interval [CrI] 62-77%) and 77% (95% confidence interval: 68.7%, 84.5%) at 12-months off Class I/III AADs. Primary safety at 30-days was achieved with a major MAE rate of 9.3% (posterior probability: 0.974; 95% CrI: 14.2%), including 2.7% stroke, 5.3% major bleeding, 2% operative mortality - all unrelated to surgical ablation/device. CONCLUSIONS: The ICE-AFIB trial demonstrated safety and effectiveness of single procedure cryothermal-only Cryomaze procedure in patients with persistent and longstanding persistent atrial fibrillation.
