JACC. Clinical electrophysiology · 2025
Pulmonary Vein Isolation Only for Atrial Fibrillation With Heart Failure (POLAR-HF).
СтатьяНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Boehmer Andreas A, Rothe Moritz, Andrade Jason G, Wiedenmann Lilli, Spork Pascal, Schneider Katia Y, Nussbaum Elena, Keim Christoph, Weiss Peter, Dobre Bianca C, Feickert Sebastian, Ruckes Christian, Dyrda Katia, Kaess Bernhard M, Nattel Stanley, Ehrlich Joachim R
Аннотация
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).
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).