Importance 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. Objective 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. Exposure 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. Main Outcomes and Measures 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). Results 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). Conclusion and Relevance Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.

中文翻译：

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心房颤动脉冲场消融后按性别划分的临床结果。

重要性 先前的研究使用射频或冷冻消融等传统热消融方式治疗房颤 (AF)，评估患者性别与临床结果之间的关系，但由于结果参差不齐，因此存在争议。脉冲场消融 (PFA) 是一种新颖的 AF 消融能量方式，已证明具有独特的安全性，可优先消融心肌组织。目的 比较脉冲场消融批准后临床使用方法、功效和安全性多国调查 (MANIFEST-PF) 登记中接受 PFA 治疗 AF 的患者的性别差异。设计、设置和参与者这是一项 MANIFEST-PF 注册数据的回顾性队列研究，其中包括 2021 年 3 月至 2022 年 5 月期间接受监管批准后使用 PFA 治疗 AF 的连续患者，中位随访时间为 1 年。MANIFEST-PF 是一个跨国、回顾性分析、前瞻性登记的患者级注册中心，包括 24 个欧洲中心。该研究包括所有因阵发性或持续性 AF 首次接受 PFA 的连续注册患者（年龄≥18 岁）。对 AF 患者进行暴露 PFA。所有患者均接受了肺静脉隔离和额外消融，这是由操作者自行决定进行的。主要结果和措施 主要有效性结果是在 3 个月的空白期后 30 秒或更长时间内不再出现临床记录的房性心律失常。主要安全性结局是急性（术后<7天）和慢性（>7天）主要不良事件（MAE）的综合结果。结果 在 1568 名接受 PFA 的 AF 患者（平均 [SD] 年龄，64.5 [11.5] 岁；1015 名男性 [64.7%]）中，女性患者与男性患者相比年龄较大（平均 [SD] 年龄，68 [SD] 岁）。 10] 岁 vs 62 [12] 岁；P < .001），阵发性 AF 较多（70.2% [553 人中的 388 人] vs 62.4% [1015 人中的 633 人]；P = .002），但冠心病等合并症较少（9% [553 人中的 38 人] 对比 15.9% [1015 人中的 129 人]；P < .001）、心力衰竭（10.5% [553 人中的 58 人] vs 16.6% [1015 人中的 168 人]；P = .001）和睡眠呼吸暂停（4.7% [553 人中的 18 人] vs 11.7% [1015 人中的 84 人]；P < .001）。99.8% 的女性（553 例中的 552 例）和 98.9% 的男性（1015 例中的 1004 例；P = .90）患者进行了肺静脉隔离。22.4% 的女性患者（553 例中的 124 例）和 23.1% 的男性患者（1015 例中的 235 例；P = .79）进行了额外消融。男性和女性患者 1 年无房性心律失常的 Kaplan-Meier 估计相似（79.0%；95% CI，76.3%-81.5% vs 76.3%；95% CI，72.5%-79.8%；P = . 28）。各组之间的急性主要 AE 也没有显着差异（男性，1.5% [1015 人中的 16 人]，女性为 2.5% [553 人中的 14 人]；P = .19）。结论和相关性 该队列研究的结果表明，PFA 治疗 AF 后，临床有效性或安全性事件不存在显着的性别差异。