Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas.
Arizona Heart Rhythm Center, Phoenix.
JAMA. 2020 Oct 27;324(16):1620-1628. doi: 10.1001/jama.2020.16195.
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.
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.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT01898221.
导管消融持续性心房颤动（AF）的成功率有限。肺静脉隔离以外的程序策略未能一致改善结果。Marshall 静脉含有可以通过逆行乙醇输注消融的神经支配和 AF 触发。
确定当Marshall 静脉乙醇输注添加到导管消融中时，是否可以改善持续性 AF 的消融结果。
设计、地点和参与者：Marshall 静脉乙醇治疗未经治疗的持续性 AF（VENUS）试验是由美国国立卫生研究院资助的一项由调查员发起的、随机的、单盲试验，在美国 12 个中心进行。从 2013 年 10 月至 2018 年 6 月，招募了因首次消融而接受治疗的持续性 AF 患者（N=350）。2019 年 6 月结束随访。
患者被随机分配接受单独导管消融（n=158）或导管消融联合 Marshall 静脉乙醇输注（n=185），以 1:1.15 的比例分配，以适应 15%的 Marshall 静脉乙醇输注技术失败。
主要结果是在没有抗心律失常药物的情况下，单次手术 30 秒以上无 AF 或心房扑动的无 AF/心房扑动率，分别在 6 个月和 12 个月时进行评估。结果评估对随机分组治疗是盲法的。共有 12 个次要结果，包括 AF 负荷、多次手术后无 AF、周边阻滞等。
在 343 名随机患者中（平均[SD]年龄，66.5[9.7]岁；261 名男性），316 名（92.1%）完成了试验。在 185 名患者中，155 名成功输送了 Marshall 静脉乙醇。在 6 个月和 12 个月时，与单独导管消融组（38%，60/158）相比，导管消融联合 Marshall 静脉乙醇输注组的单次手术无 AF/心房扑动率的患者比例为 49.2%（185/185）（差异，11.2%[95%CI，0.8%-21.7%]；P=0.04）。在 12 个次要结果中，有 9 个没有显著差异，但 AF 负荷（零负荷分别为 78.3%和 67.9%；差异，10.4%[95%CI，2.9%-17.9%]；P=0.01）、多次手术后无 AF 率（65.2%和 53.8%；差异，11.4%[95%CI，0.6%-22.2%]；P=0.04）和达到周边阻滞成功率（80.6%和 51.3%；差异，29.3%[95%CI，19.3%-39.3%]；P<0.001）在 Marshall 静脉治疗组显著改善。两组的不良事件相似。
在持续性 AF 患者中，与单独导管消融相比，导管消融联合 Marshall 静脉乙醇输注增加了 6 个月和 12 个月时无 AF 或心房扑动的可能性。需要进一步研究以评估更长期的疗效。
ClinicalTrials.gov 标识符：NCT01898221。
