A PVI-only approach using cryoballoon ablation in patients with HFrEF was noninferior to those without HFrEF for atrial arrhythmia recurrence (HR 1.01; 95% CI -∞ to 1.24; P=0.005 for noninferiority).
Observational (n=1,420)
No
Does a PVI-only approach using cryoballoon ablation provide noninferior rhythm control in patients with atrial fibrillation and HFrEF compared to those without HFrEF?
A PVI-only cryoballoon ablation strategy for atrial fibrillation provides noninferior rhythm control and similar procedural safety in patients with HFrEF compared to those without HFrEF.
Hazard Ratio: 1.01
Absolute Event Rate: 43.7% vs 43.6%
p-value: p=0.005 for noninferiority
BACKGROUND: Atrial fibrillation (AF) and heart failure with reduced ejection fraction (HFrEF) are both associated with increased morbidity and mortality. Ablation-based rhythm control, particularly using radiofrequency ablation with disparate strategies, has demonstrated clinical benefit. However, prospective data evaluating a pulmonary vein isolation (PVI)-only strategy in HFrEF are lacking, and no studies have directly compared ablation efficacy between patients with and without HFrEF. OBJECTIVES: This study sought to assess whether a PVI-only approach using cryoballoon ablation in patients with HFrEF (LVEF ≤40%) is noninferior to PVI-only in patients without HFrEF regarding rhythm control efficacy, and to describe safety outcomes. METHODS: We conducted a prospective, investigator-initiated, single-center, noninferiority, observational study with propensity score matching. The primary efficacy endpoint was the first documented recurrence of any atrial arrhythmia after a 90-day blanking period. Safety endpoints included death, cerebrovascular events, and procedure-related adverse events. RESULTS: A total of 1,420 patients (paroxysmal and persistent AF) underwent PVI. With propensity score matching, 1,044 patients were analyzed in a 1:5 ratio. Over a mean follow-up of 2 years, the primary efficacy endpoint occurred in 76 (43.7%) of 174 patients with HFrEF and in 379 (43.6%) of 870 without HFrEF (HR: 1.01; 95% CI: -∞ to 1.24; P = 0.005 for noninferiority). The incidence of all-cause mortality was numerically higher in patients with HFrEF (6.3% vs 3.4%; P = 0.07), while rates of procedure-related safety events were similar between groups (2.9% vs 4.1%; P = 0.53). CONCLUSIONS: In patients with AF undergoing ablation, a PVI-only approach shows noninferior rhythm control efficacy and comparable procedural safety in patients with HFrEF compared with those without HFrEF. (Cryoballoon Pulmonary Isolation for Atrial Fibrillation With Heart Failure POLAR-HF; NCT04461691).
Boehmer et al. (Thu,) conducted a observational in Atrial fibrillation and heart failure with reduced ejection fraction (n=1,420). PVI-only approach in HFrEF (LVEF ≤40%) vs. PVI-only approach without HFrEF was evaluated on First documented recurrence of any atrial arrhythmia after a 90-day blanking period (HR 1.01, 95% CI -∞ to 1.24, p=0.005 for noninferiority). A PVI-only approach using cryoballoon ablation in patients with HFrEF was noninferior to those without HFrEF for atrial arrhythmia recurrence (HR 1.01; 95% CI -∞ to 1.24; P=0.005 for noninferiority).
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