Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York.
Cardiology Department, Na Homolce Hospital, Homolka Hospital, Prague, Czechia.
JAMA Cardiol. 2023 Dec 1;8(12):1142-1151. doi: 10.1001/jamacardio.2023.3752.
Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile.
To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry.
DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF.
PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator.
The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs).
Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19).
Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.
先前使用射频或冷冻消融等常规热消融模式评估患者性别与房颤 (AF) 临床结局之间关系的研究存在争议，原因是结果不一致。脉冲场消融 (PFA) 是一种新型的房颤消融能量模式，具有独特的安全特性，可优先消融心肌组织。
在多中心经批准后临床使用脉冲场消融（MANIFEST-PF）注册研究中，比较接受 PFA 治疗 AF 的患者中男女之间的差异。
设计、地点和参与者： 这是一项回顾性队列研究，使用 MANIFEST-PF 注册研究数据，该研究纳入了 2021 年 3 月至 2022 年 5 月期间接受监管后批准的 PFA 治疗阵发性或持续性 AF 的连续患者，中位随访时间为 1 年。MANIFEST-PF 是一项多中心、回顾性分析、前瞻性入组的患者水平注册研究，包括 24 个欧洲中心。该研究纳入了所有接受首次阵发性或持续性 AF 的 PFA 治疗的连续注册患者（年龄≥18 岁）。
在 AF 患者中进行 PFA。所有患者均接受肺静脉隔离和其他消融治疗，具体治疗方案由术者决定。
主要有效性结局是在 3 个月空白期后 30 秒或更长时间内无临床记录的心房心律失常。主要安全性结局是急性（<7 天）和慢性（>7 天）主要不良事件（MAE）的综合结果。
在 1568 名接受 PFA 的 AF 患者中（平均[标准差]年龄 64.5[11.5]岁；1015 名男性[64.7%]），与男性患者相比，女性患者年龄更大（平均[标准差]年龄 68[10]岁比 62[12]岁；P<0.001），阵发性 AF 更多（70.2%[388/553]比 62.4%[633/1015]；P=0.002），但合并症较少，如冠心病（9%[38/553]比 15.9%[129/1015]；P<0.001）、心力衰竭（10.5%[58/553]比 16.6%[168/1015]；P=0.001）和睡眠呼吸暂停（4.7%[18/553]比 11.7%[84/1015]；P<0.001）。99.8%（552/553）的女性患者和 98.9%（1004/1015）的男性患者接受了肺静脉隔离。22.4%（124/553）的女性患者和 23.1%（235/1015）的男性患者接受了其他消融治疗。男性和女性患者 1 年的 Kaplan-Meier 估计无心律失常率相似（79.0%；95%CI，76.3%-81.5%比 76.3%；95%CI，72.5%-79.8%；P=0.28）。两组之间的急性 MAE 也无显著差异（男性，1.5%[16/1015]比女性，2.5%[14/553]；P=0.19）。
这项队列研究结果表明，在接受 AF 的 PFA 治疗后，在临床疗效或安全性事件方面，男女之间没有显著差异。
