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          Original Investigation
          October?27, 2020

          Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial

          Author Affiliations
          • 1Houston Methodist DeBakey Heart and Vascular Center and Research Institute, Houston, Texas
          • 2Arizona Heart Rhythm Center, Phoenix
          • 3Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
          • 4Keck-USC University Hospital, University of Southern California, Los Angeles
          • 5Emory St Joseph’s Hospital, Emory University, Atlanta, Georgia
          • 6Sharp Memorial Hospital, San Diego, California
          • 7Virginia Commonwealth University School of Medicine, Richmond
          • 8Texas Cardiac Arrhythmia Institute, St David’s Medical Center, Austin
          • 9Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada
          JAMA. 2020;324(16):1620-1628. doi:10.1001/jama.2020.16195
          Visual Abstract.?Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation
          Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation
          Key Points

          Question? Does adding vein of Marshall ethanol infusion to the catheter ablation procedure reduce the recurrence of atrial fibrillation in patients with persistent atrial fibrillation?

          Findings? In this randomized clinical trial that included 343 patients with persistent atrial fibrillation, catheter ablation with vein of Marshall ethanol infusion, compared with catheter ablation alone, resulted in freedom from atrial fibrillation or prolonged atrial tachycardia in 49% vs 38% at both 6 and 12 months, a difference that was statistically significant.

          Meaning? In patients with persistent atrial fibrillation, treatment with combined catheter ablation and vein of Marshall ethanol infusion had better outcomes compared with catheter ablation alone.

          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.

          Trial Registration? ClinicalTrials.gov Identifier: NCT01898221

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