Data Sheet 1_Catheter ablation of atrial fibrillation in women with heart failure with preserved ejection fraction.docx

BackgroundHeart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF) often coincide. Female sex is associated with both increased prevalence of HFpEF and reduced therapeutic efficacy of catheter ablation of AF. This sub-analysis of the previously published AFFECT-study evaluates outcome after cryoballoon-ablation in women with and without HFpEF.
MethodsOne-hundred-and-two patients (LVEF ≥ 50%) scheduled for cryoballoon-ablation of AF were prospectively enrolled. Forty-two were female. Comprehensive baseline assessment included echocardiography, stress echocardiography, six-minute-walk-test, biomarker- and quality-of-life-assessment (QoL, SF-36), and was repeated at follow-up ≥12 months after AF-ablation. Baseline parameters, procedural characteristics and outcome after AF-ablation were compared between women with and without HFpEF.
ResultsWomen with HFpEF (n = 20) were characterized by higher median left atrial volume index (35.8 ml/m2 vs. 25.8 ml/m2, P < 0.001), left ventricular hypertrophy (median left ventricular mass index: 92.0 g/m2 vs. 83.0 g/m2, P = 0.027), reduced distance in the 6-min-walk-test (median: 453 m vs. 527 m, P = 0.008) and higher left atrial pressures (median: 14.0 mmHg vs.9.5 mmHg, P = 0.008) compared to women without HFpEF (n = 21). During follow-up, HFpEF-patients more often experienced AF-related re-hospitalization (36.8% vs. 9.1%, P = 0.039) and numerically higher AF-recurrence-rates (57.9% vs. 31.1%, P = 0.109). There was no significant improvement of heart failure-related symptoms, echocardiographic parameters and cardiac biomarkers levels. QoL showed no significant improvement in both subgroups. Women with HFpEF still exhibited a lower SF-36 Physical Component Summary Score vs. women without HFpEF (median: 41.2 vs. 52.1, P < 0.001).
ConclusionWomen with HFpEF constitute a distinct subgroup with high rates of AF-related events after AF-ablation, and persistence of both symptoms and functional hallmarks of HFpEF. Consideration of sex-specific cardiac co-morbidities is crucial for personalization and optimization of AF-therapy.
Clinical Trial RegistrationClinicalTrials.gov Identifier NCT05603611.

背景：射血分数保留型心力衰竭（Heart failure with preserved ejection fraction, HFpEF）与心房颤动（atrial fibrillation, AF）常合并存在。女性性别与射血分数保留型心力衰竭患病率升高及心房颤动导管消融治疗疗效降低均存在相关性。本研究针对已发表的AFFECT研究进行亚组分析，旨在评估合并与未合并射血分数保留型心力衰竭的女性患者接受冷冻球囊消融（cryoballoon-ablation）术后的预后情况。
方法：本研究前瞻性纳入102例拟接受心房颤动冷冻球囊消融治疗的患者（左心室射血分数（Left Ventricular Ejection Fraction, LVEF）≥50%），其中女性患者42例。基线综合评估包括超声心动图、负荷超声心动图、6分钟步行试验、生物标志物检测及生活质量评估（QoL, SF-36量表），并在心房颤动消融术后≥12个月的随访阶段重复上述评估流程。对比合并与未合并射血分数保留型心力衰竭的女性患者的基线参数、手术操作特征及心房颤动消融术后的预后情况。
结果：与未合并射血分数保留型心力衰竭的女性患者（n=21）相比，合并该病的女性患者（n=20）具有以下特征：左心房容积指数更高[中位数：35.8 ml/m² vs. 25.8 ml/m²，P<0.001]、左心室肥厚更显著[中位数左心室质量指数：92.0 g/m² vs. 83.0 g/m²，P=0.027]、6分钟步行试验距离更短[中位数：453 m vs. 527 m，P=0.008]以及左心房压力更高[中位数：14.0 mmHg vs. 9.5 mmHg，P=0.008]。随访期间，合并射血分数保留型心力衰竭的患者更常出现心房颤动相关再住院事件（36.8% vs. 9.1%，P=0.039），且心房颤动复发率数值上更高（57.9% vs. 31.1%，P=0.109）。心力衰竭相关症状、超声心动图参数及心脏生物标志物水平均未出现显著改善。两个亚组患者的生活质量均未出现显著提升；合并射血分数保留型心力衰竭的女性患者的SF-36生理成分总结评分仍低于未合并者[中位数：41.2 vs. 52.1，P<0.001]。
结论：合并射血分数保留型心力衰竭的女性患者是一类独特的亚组，其在心房颤动消融术后心房颤动相关不良事件发生率较高，且心力衰竭相关症状与功能特征持续存在。针对性别特异性心脏共病进行考量，对于心房颤动治疗的个体化与优化至关重要。
临床试验注册：ClinicalTrials.gov 标识符NCT05603611。