美国华盛顿大学医学中心Nazem Akoum团队联合杜兰大学医学院Nassir F. Marrouche团队比较了MRI引导下纤维化消融与常规导管消融对持续性心房颤动患者房性心律失常复发的影响。相关论文于2022年6月21日发表在《美国医学会杂志》上。

持续性心房颤动（AF）的消融仍然是一个挑战。左房纤维化在AF的病理生理学中起着重要作用，并与不良的手术预后相关。

为了探讨磁共振成像（MRI）检测心房纤维化靶向治疗在减少持续性AF房性心律失常复发方面的疗效和不良事件，研究组进行了一项延迟增强MRI引导下纤维化消融与常规房颤导管消融的疗效对比试验，这是一项由研究者发起的多中心随机临床试验，涉及10个国家的44个学术和非学术中心。2016年7月至2020年1月，共有843名有症状或无症状的持续性AF患者接受房颤消融治疗，随访至2021年2月19日。

将持续性AF患者随机分组，其中421例接受肺静脉隔离（PVI）加MRI引导的心房纤维化消融，422例接受单纯PVI。两组均在消融前进行延迟增强MRI以评估基线心房纤维化，并在消融后3个月评估消融瘢痕。主要终点是术后90天空白期后首次房性心律失常复发的时间。主要安全性综合结局由术后30天内发生以下一种或多种事件来确定：中风、PV狭窄、出血、心力衰竭或死亡。

843名随机分组的患者平均年龄为62.7岁，178名为女性（21.1%），815名（96.9%）完成了90天的空白期，并参与了疗效分析。两组间房性心律失常复发率无显著差异，其中纤维化引导消融加PVI组有175例（43.0%），单纯PVI组有188例（46.1%），危险比（HR）为0.95。纤维化引导消融加PVI组有9例（2.2%）患者发生安全性结局，显著高于PVI组（0%）。纤维化引导消融加PVI组有6名患者（1.5%）发生缺血性卒中，而单纯PVI组无缺血性卒中。2例死亡发生在纤维化引导消融加PVI组，第一例可能与手术有关。

研究结果表明，对于持续性AF患者，MRI引导下纤维化消融加PVI与单纯PVI导管消融相比，房性心律失常复发率无显著差异。研究结果不支持使用MRI引导下的纤维化消融治疗持续性房颤。

附：英文原文

Title: Effect of MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The DECAAF II Randomized Clinical Trial

Author: Nassir F. Marrouche, Oussama Wazni, Christopher McGann, Tom Greene, J. Michael Dean, Lilas Dagher, Eugene Kholmovski, Moussa Mansour, Francis Marchlinski, David Wilber, Gerhard Hindricks, Christian Mahnkopf, Darryl Wells, Pierre Jais, Prashanthan Sanders, Johannes Brachmann, Jeroen J. Bax, Leonie Morrison-de Boer, Thomas Deneke, Hugh Calkins, Christian Sohns, Nazem Akoum, DECAAF II Investigators, Ahmad Abdul Karim, Alexander Costea, Alexander Leber, Andrzej Lubinski, Arif Elvan, Bengt Herweg, Bruce Koplan, Chris Jones, Christian Mahnkopf, Christian Sohns, Darryl Wells, David Wilber, Doug Packer, Emile Daoud, Felipe Atienza, Felipe Bisbal, Francis Marchlinski, Gerhard Hindricks, Gianluca Pontone, Heidi Estner, Helmut Puererfellner, Hemanth Ramanna, Hugh Calkins, Johannes Brachmann, Jon Kalman, Juergen Siebels, Lucas Boersma, Marco Gotte, Margot Vloka, Mattias Duytschaever, Mont Lluís, Moussa Mansour, Nassir Marrouche, Nazem Akoum, Oussama Wazni, Peter Kistler, Pierre Jais, Prashantan Sanders, Reza Wakili, Rukshen Weerasooriya, Saman Nazarian, Sandep Gautam, Suneet Mittal, Thomas Deneke, Thomas Maurer, Thomas Neumann, Vivek Reddy, William Spear

Issue&Volume: 2022/06/21

Abstract:

Importance  Ablation of persistent atrial fibrillation (AF) remains a challenge. Left atrial fibrosis plays an important role in the pathophysiology of AF and has been associated with poor procedural outcomes.

Objective  To investigate the efficacy and adverse events of targeting atrial fibrosis detected on magnetic resonance imaging (MRI) in reducing atrial arrhythmia recurrence in persistent AF.

Design, Setting, and Participants  The Efficacy of Delayed Enhancement-MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation of Atrial Fibrillation trial was an investigator-initiated, multicenter, randomized clinical trial involving 44 academic and nonacademic centers in 10 countries. A total of 843 patients with symptomatic or asymptomatic persistent AF and undergoing AF ablation were enrolled from July 2016 to January 2020, with follow-up through February 19, 2021.

Interventions  Patients with persistent AF were randomly assigned to pulmonary vein isolation (PVI) plus MRI-guided atrial fibrosis ablation (421 patients) or PVI alone (422 patients). Delayed-enhancement MRI was performed in both groups before the ablation procedure to assess baseline atrial fibrosis and at 3 months postablation to assess for ablation scar.

Main Outcomes and Measures  The primary end point was time to first atrial arrhythmia recurrence after a 90-day blanking period postablation. The primary safety composite outcome was defined by the occurrence of 1 or more of the following events within 30 days postablation: stroke, PV stenosis, bleeding, heart failure, or death.

Results  Among 843 patients who were randomized (mean age 62.7 years; 178 [21.1%] women), 815 (96.9%) completed the 90-day blanking period and contributed to the efficacy analyses. There was no significant difference in atrial arrhythmia recurrence between groups (fibrosis-guided ablation plus PVI patients, 175 [43.0%] vs PVI-only patients, 188 [46.1%]; hazard ratio [HR], 0.95 [95% CI, 0.77-1.17]; P=.63). Patients in the fibrosis-guided ablation plus PVI group experienced a higher rate of safety outcomes (9 [2.2%] vs 0 in PVI group; P=.001). Six patients (1.5%) in the fibrosis-guided ablation plus PVI group had an ischemic stroke compared with none in PVI-only group. Two deaths occurred in the fibrosis-guided ablation plus PVI group, and the first one was possibly related to the procedure.

Conclusions and Relevance  Among patients with persistent AF, MRI-guided fibrosis ablation plus PVI, compared with PVI catheter ablation only, resulted in no significant difference in atrial arrhythmia recurrence. Findings do not support the use of MRI-guided fibrosis ablation for the treatment of persistent AF.

DOI: 10.1001/jama.2022.8831

Source: https://jamanetwork.com/journals/jama/article-abstract/2793452