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

Educational Objective
To learn about procedures for the treatment of persistent atrial fibrillation (AF).

1 Credit CME

JAMA

Published Online: October 27, 2020

Original Investigation

Article Information and Disclosures

Miguel Valderrábano, MD¹;

Leif E. Peterson, PhD¹;

Vijay Swarup, MD²;

Paul A. Schurmann, MD^1,3;

Akash Makkar, MD²;

Rahul N. Doshi, MD⁴;

David DeLurgio, MD⁵;

Charles A. Athill, MD⁶;

Kenneth A. Ellenbogen, MD⁷;

Andrea Natale, MD⁸;

Jayanthi Koneru, MD⁷;

Amish S. Dave, MD, PhD¹;

Irakli Giorgberidze, MD³;

Hamid Afshar, MD³;

Michelle L. Guthrie, RN¹;

Raquel Bunge, RN¹;

Carlos A. Morillo, MD⁹;

Neal S. Kleiman, MD¹

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

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Gaurav A. Upadhyay, MD; Francis J. Alenghat, MD, PhD

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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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Article Information

Corresponding Author: Miguel Valderrábano, MD, Division of Cardiac Electrophysiology, Department of Cardiology, Houston Methodist Hospital, 6550 Fannin St, Ste 1801, Houston, TX 77030 (mvalderrabano@houstonmethodist.org).

Accepted for Publication: August 10, 2020.

Author Contributions: Drs Valderrábano and Peterson had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Valderrábano, Peterson, Schurmann, Natale, Dave, Afshar, Morillo.

Acquisition, analysis, or interpretation of data: Valderrábano, Peterson, Swarup, Schurmann, Makkar, Doshi, DeLurgio, Athill, Ellenbogen, Koneru, Dave, Giorgberidze, Afshar, Guthrie, Bunge, Kleiman.

Drafting of the manuscript: Valderrábano, Peterson, Schurmann, Athill, Ellenbogen, Afshar, Guthrie.

Critical revision of the manuscript for important intellectual content: Peterson, Swarup, Schurmann, Makkar, Doshi, DeLurgio, Athill, Ellenbogen, Natale, Koneru, Dave, Giorgberidze, Bunge, Morillo, Kleiman.

Statistical analysis: Valderrábano, Peterson, Morillo.

Obtained funding: Valderrábano.

Administrative, technical, or material support: Valderrábano, Schurmann, Makkar, DeLurgio, Ellenbogen, Giorgberidze, Guthrie, Bunge.

Supervision: Valderrábano, Natale, Giorgberidze, Afshar, Bunge, Morillo.

Other—data collection and review: Swarup.

Conflict of Interest Disclosures: Dr Valderrábano reported serving as a consultant for Biosense Webster; a speaker for Boston Scientific; research support member for Circa Scientific; and consultant and speaker for Baylis Medical. Dr Swarup reported providing research and consulting services to Biosense Webster, Boston Scientific, and Abbott outside the submitted work. Dr Athill reported receiving grants and other funding from Methodist Hospital Research Institute during the conduct of the study and grants and personal fees from Boston Scientific and Abbott Laboratories; grants from Biosense Webster; and personal fees from Janssen Pharmaceutical and Zoll Medical outside the submitted work. Dr Natale reported receiving personal fees from Biosense Webster, Biotronik, Medtronic, Boston Scientific, and Abbott during the conduct of the study and outside the submitted work. Dr Dave reported serving as a consultant to Abbott outside the submitted work. Dr Bunge reported receiving grants from Houston Methodist Research Institute during the conduct of the study. Dr Morillo reported receiving personal fees from Medtronic and serving as a member of the steering committee of the STAR AF trials for Abbott outside the submitted work. No other disclosures were reported.

Funding/Support: This study was funded by grant R01HL115003 from the National Institutes of Health/National Heart, Lung, and Blood Institute. Additional support came from Charles Burnett III and Lois and Carl Davis Centennial Chair endowments (Dr Valderrábano) and Houston Methodist Research Institute.

Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.