杂交心外膜与心内膜消融术对比心内膜消融术治疗持续性和长期持续性心房颤动患者的疗效及安全性：一项随机对照试验
Efficacy and safety of hybrid epicardial and endocardial ablation versus endocardial ablation in patients with persistent and longstanding persistent atrial fibrillation: a randomised, controlled trial.
作者信息
Doll Nicolas, Weimar Timo, Kosior Dariusz A, Bulava Alan, Mokracek Ales, Mönnig Gerold, Sahu Jonathan, Hunter Steven, Wijffels Maurits, van Putte Bart, Rüb Norman, Nemec Petr, Ostrizek Tomas, Suwalski Piotr
机构信息
Schüchtermann-Klinik, Bad Rothenfelde, Germany.
Eberhard Karls University School of Medicine, Tuebingen, Germany.
出版信息
EClinicalMedicine. 2023 Jun 22;61:102052. doi: 10.1016/j.eclinm.2023.102052. eCollection 2023 Jul.
BACKGROUND
Endocardial catheter ablation (CA) has limited long-term benefit for persistent and longstanding persistent atrial fibrillation (PersAF/LSPAF). We hypothesized hybrid epicardial-endocardial ablation (HA) would have superior effectiveness compared to CA, including repeat (rCA), in PersAF/LSPAF.
METHODS
CEASE-AF (NCT02695277) is a prospective, multi-center, randomized controlled trial. Nine hospitals in Poland, Czech Republic, Germany, United Kingdom, and the Netherlands enrolled eligible participants with symptomatic, drug refractory PersAF and left atrial diameter (LAD) > 4.0 cm or LSPAF. Randomization was 2:1 to HA or CA by an independent statistician and stratified by site. Treatment assignments were masked to the core rhythm monitoring laboratory. For HA, pulmonary veins (PV) and left posterior atrial wall were isolated with thoracoscopic epicardial ablation including left atrial appendage exclusion. Endocardial touch-up ablation was performed 91-180 days post-index procedure. For CA, endocardial PV isolation and optional substrate ablation were performed. rCA was permitted between days 91-180. Primary effectiveness was freedom from AF/atrial flutter/atrial tachycardia >30-s through 12-months absent class I/III anti-arrhythmic drugs except those not exceeding previously failed doses. It was assessed in the modified intention-to-treat (mITT) population who had the index procedure and follow-up data. Major complications were assessed in the ITT population who had the index procedure. Thirty-six month follow-up continues.
FINDINGS
Enrollment began November 20, 2015 and ended May 22, 2020. In 154 ITT patients (102 HA; 52 CA), 75% were male, mean age was 60.7 ± 7.9 years, mean LAD was 4.7 ± 0.4 cm, and 81% had PersAF. Primary effectiveness was 71.6% (68/95) in HA versus 39.2% (20/51) in CA (absolute benefit increase: 32.4% [95% CI 14.3%-48.0%], p < 0.001). Major complications through 30-days after index procedures plus 30-days after second stage/rCA were similar (HA: 7.8% [8/102] versus CA: 5.8% [3/52], p = 0.75).
INTERPRETATION
HA had superior effectiveness compared to CA/rCA in PersAF/LSPAF without significant procedural risk increase.
FUNDING
AtriCure, Inc.
背景
心内膜导管消融术（CA）对持续性和长期持续性心房颤动（PersAF/LSPAF）的长期益处有限。我们假设，与CA（包括再次消融，rCA）相比，心外膜-心内膜联合消融术（HA）在PersAF/LSPAF中具有更高的有效性。
方法
CEASE-AF（NCT02695277）是一项前瞻性、多中心、随机对照试验。波兰、捷克共和国、德国、英国和荷兰的九家医院招募了符合条件的有症状、药物难治性PersAF且左心房直径（LAD）>4.0 cm或LSPAF的参与者。由独立统计学家以2:1的比例将参与者随机分配至HA组或CA组，并按地点进行分层。治疗分配情况对核心心律监测实验室保密。对于HA组，通过胸腔镜心外膜消融术隔离肺静脉（PV）和左心房后壁，包括排除左心耳。在首次手术后91-180天进行心内膜补充消融。对于CA组，进行心内膜PV隔离和可选的基质消融。允许在第91-180天之间进行rCA。主要有效性指标为在不使用I/III类抗心律失常药物（除非不超过之前无效剂量）的情况下，12个月内无持续时间>30秒的房颤/房扑/房性心动过速。在接受了首次手术并具有随访数据的改良意向性治疗（mITT）人群中进行评估。在接受了首次手术的意向性治疗（ITT）人群中评估主要并发症。36个月的随访仍在继续。
研究结果
入组于2015年11月20日开始，2020年5月22日结束。在154例ITT患者（102例HA组；52例CA组）中，75%为男性，平均年龄为60.7±7.9岁，平均LAD为4.7±0.4 cm，81%患有PersAF。HA组的主要有效性为71.6%（68/95），而CA组为39.2%（20/51）（绝对获益增加：32.4%[95%CI 14.3%-48.0%]，p<0.001）。首次手术后30天加第二阶段/rCA后30天的主要并发症相似（HA组：7.8%[8/102]，CA组：5.8%[3/52]，p=0.75）。
解读
在PersAF/LSPAF中，HA与CA/rCA相比具有更高的有效性，且手术风险没有显著增加。
资助
AtriCure公司
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