Abstract

Background Atrial Fibrillation (AF) and heart failure (HF) often co-exist and increase cardiovascular mortality. Radiofrequency ablation is safe and effective in patients with AF and HF. There is evidence for a reduction in mortality in treated patients (CASTLE, NEJM 2019), and the European Society of Cardiology recommends catheter ablation (class 1A), particularly in patients with tachycardiomyopathy. However, there is no large-scale prospective study evaluating efficacy and safety of cryoballoon pulmonary vein isolation (cryoPVI) in patients with AF and HF. Objective Prospective comparison of cryoPVI in patients with and without HF (defined as LVEF ≤ 40%) regarding efficacy and safety. Methods POLAR-HF trial is an investigator-initiated, single-center, prospective, non-inferiority, interventional study. Follow-up was performed at 3, 6 and 12, 18 and 24 months after ablation. Endpoints were: symptomatic AF recurrence for efficacy and bleeding, stroke or death for safety. Periprocedural parameters were observed. Results: We analyzed 668 consecutive patients who underwent cryoPVI. Of these 581 had normal LVEF (age 69±10 years, CHA2DS2-VASc Score 2.7±1.5, 54% male) while 87 patients (13%) suffered from HF (age 70±10 years, CHA2DS2-VASc Score 3.3±1.4, 70% male). After 24 months primary efficacy endpoint occurrence was similar in normal LVEF and HF group (34.1 % vs. 35.6%, P=0.66, Figure). Safety endpoint occurred in form of pericardial effusion or transient phrenic nerve injury in six patients with normal LVEF (1.2%) and none in HF group. No deaths or strokes were observed in either group. Conclusion The interim results of the POLAR-HF study suggest that cryoPVI is a safe and effective ablation method for patients with atrial fibrillation and heart failure.

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