Derval Nicolas, Tixier Romain, Duchateau Josselin, Bouteiller Xavier, Loock Timothé, Denis Arnaud, Chauvel Rémi, Bouyer Benjamin, Arnaud Marine, Yokoyama Masaaki, Kowalewski Christopher, Monaco Cinzia, Ascione Ciro, Sacher Frédéric, Hocini Mélèze, Jaïs Pierre, Haïssaguerre Michel, Pambrun Thomas
IHU Liryc, Electrophysiology and Heart Modeling Institute, Fondation Bordeaux Université, France (N.D., R.T., J.D., X.B., R.C., B.B., M.A., M.Y., C.K., C.M., C.A., F.S., M. Hocini, P.J., M. Haïssaguerre, T.P.).
Bordeaux University Hospital (CHU), Cardio-Thoracic Unit, France (N.D., R.T., J.D., X.B., T.L., R.C., M.Y., C.K., C.M., C.A., T.P.).
Circ Arrhythm Electrophysiol. 2025 May;18(5):e013427. doi: 10.1161/CIRCEP.124.013427. Epub 2025 May 20.
BACKGROUND: Beyond pulmonary vein (PV) isolation, the optimal ablation strategy for persistent atrial fibrillation (AF) remains poorly defined. The purpose of this study was to compare 2 ablation strategies in the treatment of patients with persistent AF: a comprehensive ablation strategy based on anatomic considerations versus PV isolation alone. METHODS: The Marshall-Plan trial is a prospective, randomized, parallel-group, controlled clinical trial of superiority conducted at the Bordeaux University Hospital. Consecutive patients with symptomatic, documented persistent AF were included and randomized into 2 arms: Marshall-Plan consisting of PV isolation with additional ablation including vein of Marshall ethanol infusion, and lines of block at the mitral, dome, and cavotricuspid isthmuses versus PV isolation alone. The main outcome was the 1-year freedom from any arrhythmia (atrial fibrillation/atrial tachycardia >30 seconds) after a single ablation procedure with or without any antiarrhythmic medication at 12 months. RESULTS: A total of 120 patients were included (age 65±8 years; 21 women). Two patients were excluded from analysis. All PVs were successfully isolated in both groups. In the Marshall-Plan group, vein of Marshall ethanol infusion was completed in 57 (97%) patients. Conduction block across linear lesions was obtained in 93%, 92%, and 93% of the mitral, dome, and cavotricuspid isthmuses, respectively. The full lesion set was successfully completed in 52 (88%) patients in the Marshall-Plan group and 59 (100%) patients in the PV isolation group. At 12 months, freedom from recurrence of atrial arrhythmia >30 seconds after 1 ablation procedure, with or without antiarrhythmic medication, had occurred in 51 of the 59 (86.4%) patients assigned to the Marshall-Plan approach, and 39 of the 59 (66.1%) patients assigned to PV isolation only (=0.012). CONCLUSIONS: In this prospective randomized controlled trial, the Marshall-Plan strategy was significantly superior to a PV isolation strategy at 12 months. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04206982.
背景：除肺静脉隔离外，持续性心房颤动（房颤）的最佳消融策略仍不明确。本研究的目的是比较两种消融策略治疗持续性房颤患者的效果：基于解剖学考虑的综合消融策略与单纯肺静脉隔离。 方法：马歇尔计划试验是在波尔多大学医院进行的一项前瞻性、随机、平行组、优效性对照临床试验。纳入有症状、记录在案的持续性房颤连续患者，并随机分为两组：马歇尔计划组，包括肺静脉隔离及额外消融，如马歇尔静脉乙醇注射，以及在二尖瓣、穹窿和腔静脉峡部进行阻滞线消融；另一组为单纯肺静脉隔离组。主要结局是在单次消融术后12个月，无论是否使用抗心律失常药物，1年内无任何心律失常（房颤/房性心动过速>30秒）。 结果：共纳入120例患者（年龄65±8岁；21例女性）。2例患者被排除在分析之外。两组患者的所有肺静脉均成功隔离。在马歇尔计划组中，57例（97%）患者完成了马歇尔静脉乙醇注射。二尖瓣、穹窿和腔静脉峡部线性病变的传导阻滞分别在93%、92%和93%的患者中获得。马歇尔计划组52例（88%）患者和肺静脉隔离组59例（100%）患者成功完成了完整的消融病灶。在12个月时，接受马歇尔计划消融的59例患者中有51例（86.4%）、仅接受肺静脉隔离的59例患者中有39例（66.1%）在单次消融术后，无论是否使用抗心律失常药物，均无>30秒的房性心律失常复发（P=0.012）。 结论：在这项前瞻性随机对照试验中，马歇尔计划策略在12个月时显著优于肺静脉隔离策略。 注册信息：网址：https://www.clinicaltrials.gov；唯一标识符：NCT04206982。
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