Pulmonary vein isolation-only ablation in AF patients with HFrEF showed non-inferior rhythm control efficacy (HR 1.03) versus those without HFrEF over 2 years.
Does a PVI-only approach using cryoballoon ablation provide non-inferior rhythm control in patients with atrial fibrillation and HFrEF compared to those without HFrEF?
A PVI-only cryoballoon ablation strategy for atrial fibrillation in patients with HFrEF achieves non-inferior rhythm control and comparable procedural safety compared to patients without HFrEF.
Absolute Event Rate: 0% vs 0%
Abstract Background Atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF) are associated with increased morbidity and mortality. Radiofrequency ablation-based rhythm control has demonstrated clinical benefit by reducing all-cause mortality and heart failure events. However, no prospective data exist evaluating a pulmonary vein isolation (PVI)-only approach in patients with HFrEF or comparing ablation efficacy between patients with and without HFrEF. Methods This prospective, investigator-initiated, single-center, non-inferiority, observational study with propensity score matching aimed to assess whether a PVI-only approach using cryoballoon ablation in patients with HFrEF (LVEF ≤40%) is non-inferior to PVI-only in patients without HFrEF. The primary efficacy end point was the first documented recurrence of an atrial arrhythmia following a 90-day blanking period. The pre-specified non-inferiority margin was a hazard ratio of 1.39. Safety endpoints included all-cause death, cerebrovascular events, and procedure-related complications. Results A total of 1402 patients were enrolled and underwent PVI. After propensity score matching, 972 patients were analyzed in a 1:5 ratio. Over a mean follow-up of 2 years, the primary efficacy endpoint occurred in 75 of 162 patients with HFrEF and in 338 of 810 without HFrEF (Kaplan–Meier event rate estimates, 46.3% and 41.7%; HR 1.03; 90%CI, 0.83-1.28; P=0.01 for non-inferiority). All-cause mortality was higher in patients with HFrEF (8% vs. 3.7%, P=0.002), while no difference was observed in the incidence of procedure-related safety endpoints between patients with and without HFrEF (3.7% vs. 5.1%, P=0.50). Conclusion In patients with AF and HFrEF undergoing ablation, a PVI-only approach achieves comparable rhythm control efficacy to that in patients without HFrEF. While all-cause mortality is higher among patients with HFrEF, procedural safety is comparable between both groups. (POLAR-HF, ClinicalTrials.gov number NCT 04461691)
Boehmer et al. (Sat,) reported a other. Pulmonary vein isolation-only ablation in AF patients with HFrEF showed non-inferior rhythm control efficacy (HR 1.03) versus those without HFrEF over 2 years.