導管消融術聯合馬歇爾靜脈乙醇輸注治療持續性房顫患者療效顯著
作者：
小柯機器人發布時間：2020/10/31 19:02:47
美國休斯頓衛理公會醫院德貝基心臟和血管中心Neal S. Kleiman團隊，比較了馬歇爾靜脈滴注無水乙醇聯合導管消融與單純導管消融治療持續性房顫的療效。2020年10月27日，該研究發表在《美國醫學會雜誌》上。
導管消融術治療持續性房顫（AF）效果有限。肺靜脈隔離以外的手術策略未能持續改善結局。馬歇爾靜脈包含神經支配和房顫觸發器，可通過逆行乙醇灌注消融。
為了確定馬歇爾靜脈乙醇輸注聯合導管消融治療持續性房顫是否可以改善消融效果，研究組進行了一項由研究人員發起、美國國立衛生研究院資助、隨機、單盲試驗，在美國12個中心進行。2013年10月至2018年6月，共招募了350名初手術的持續性AF患者，並隨訪至2019年6月。
將350例患者按1：1.15的比例隨機分配，其中158名接受導管消融術，185名接受導管消融聯合馬歇爾靜脈乙醇輸注。主要結局為在單次手術後的6個月和12個月，在不使用抗心律失常藥物的情況下，無房顫發作或房性心動過速不超過30秒。
343名接受隨機分組患者的平均年齡為66.5歲，其中261名為男性，共有316名（92.1％）完成了試驗。185例患者中有155例成功進行了馬歇爾靜脈乙醇輸注。在6個月和12個月時，聯合組中有49.2％（91/185）的患者達到主要結局，顯著高於單純導管消融組（38％，60/158）。
在12項次要結局中，有9項兩組間沒有顯著差異，但聯合組中AF零負擔、多次手術後無房顫、成功環向阻滯的發生率均顯著高於單純導管消融組。兩組間的不良事件發生率相差不大。
總之，導管消融術聯合馬歇爾靜脈乙醇輸注治療持續性房顫患者，與單純進行導管消融相比，可顯著降低6個月和12個月內發生房顫或房性心動過速的風險。
附：英文原文
Title: Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial
Author: Miguel Valderrábano, Leif E. Peterson, Vijay Swarup, Paul A. Schurmann, Akash Makkar, Rahul N. Doshi, David DeLurgio, Charles A. Athill, Kenneth A. Ellenbogen, Andrea Natale, Jayanthi Koneru, Amish S. Dave, Irakli Giorgberidze, Hamid Afshar, Michelle L. Guthrie, Raquel Bunge, Carlos A. Morillo, Neal S. Kleiman
Issue&Volume: 2020/10/27
Abstract:
Importance Catheter ablation of persistent atrial fibrillation (AF) has limited success. Procedural strategies beyond pulmonary vein isolation have failed to consistently improve results. The vein of Marshall contains innervation and AF triggers that can be ablated by retrograde ethanol infusion.
Objective To determine whether vein of Marshall ethanol infusion could improve ablation results in persistent AF when added to catheter ablation.
Design, Setting, and Participants The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial was an investigator-initiated, National Institutes of Health–funded, randomized, single-blinded trial conducted in 12 centers in the United States. Patients (N=350) with persistent AF referred for first ablation were enrolled from October 2013 through June 2018. Follow-up concluded in June 2019.
Interventions Patients were randomly assigned to catheter ablation alone (n=158) or catheter ablation combined with vein of Marshall ethanol infusion (n=185) in a 1:1.15 ratio to accommodate for 15% technical vein of Marshall ethanol infusion failures.
Main Outcomes and Measures The primary outcome was freedom from AF or atrial tachycardia for longer than 30 seconds after a single procedure, without antiarrhythmic drugs, at both 6 and 12 months. Outcome assessment was blinded to randomization treatment. There were 12 secondary outcomes, including AF burden, freedom from AF after multiple procedures, perimitral block, and others.
Results Of the 343 randomized patients (mean [SD] age, 66.5 [9.7] years; 261 men), 316 (92.1%) completed the trial. Vein of Marshall ethanol was successfully delivered in 155 of 185 patients. At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%]; P=.04). Of the 12 secondary outcomes, 9 were not significantly different, but AF burden (zero burden in 78.3% vs 67.9%; difference, 10.4% [95% CI, 2.9%-17.9%]; P=.01), freedom from AF after multiple procedures (65.2% vs 53.8%; difference, 11.4% [95% CI, 0.6%-22.2%]; P=.04), and success achieving perimitral block (80.6% vs 51.3%; difference, 29.3% [95% CI, 19.3%-39.3%]; P<.001) were significantly improved in vein of Marshall–treated patients. Adverse events were similar between groups.
Conclusions and Relevance Among patients with persistent AF, addition of vein of Marshall ethanol infusion to catheter ablation, compared with catheter ablation alone, increased the likelihood of remaining free of AF or atrial tachycardia at 6 and 12 months. Further research is needed to assess longer-term efficacy.
DOI: 10.1001/jama.2020.16195
Source: https://jamanetwork.com/journals/jama/article-abstract/2772281