Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation - VENUS

Mar 29, 2020
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Presenter/Author:
Miguel Valderrabano, MD, FACC
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institutes of Health/National Heart, Lung, and Blood Institute
Date Presented:
03/29/2020
Original Posted Date:
03/29/2020
References

Contribution To Literature:

The VENUS trial showed that concomitant VOM alcohol ablation among patients with persistent AF undergoing catheter ablation is superior to standard catheter ablation alone in reducing AT/AF burden and recurrence.

Description:

The goal of the trial was to compare the safety and efficacy of adding vein of Marshall (VOM) ethanol infusion to de novo catheter ablation among patients with persistent atrial fibrillation (AF).

Study Design

Eligible patients were randomized in a 1:1.15 single-blind fashion to either catheter ablation + VOM ablation (n = 180) vs. standard catheter ablation (n = 156). VOM ablation was performed prior to catheter ablation (during same procedure) with ethanol, and was successful in 85% of patients.

  • Total screened: 350
  • Total number of enrollees: 343
  • Duration of follow-up: 12 months
  • Mean patient age: 66.5 years
  • Percentage female: 26%

Inclusion criteria:

  • Patients between 18 and 85 years of age
  • Symptomatic persistent AF (sustained, lasting >7 days)
  • Refractory to at least one antiarrhythmic agent

Exclusion criteria:

  • Previous AF ablation attempts
  • Left atrial (LA) diameter or volume exceeding 65 mm or 200 ml
  • Ejection fraction <30%

Other salient features/characteristics:

  • LA diameter: 46 mm, LA volume: 112 ml
  • CHA2DS2-VASc score: 2.8
  • Time from AF diagnosis >2 years: 52%

Principal Findings:

The primary outcome, freedom from atrial tachycardia (AT)/AF ≥30 seconds after 3 months for VOM ablation + catheter ablation vs. standard catheter ablation: 49.2% vs. 38% (p = 0.037)

  • Clinical AT/AF recurrence: 31.3% vs. 37.3% (p = 0.24)

Secondary endpoints (VOM ablation + catheter ablation vs. standard catheter ablation):

  • Freedom from AT/AF at 90 days: 62.2% vs. 53.8% (p = 0.09)
  • Zero AT/AF on 6- and 12-month monitoring: 76.1% vs. 67.8% (p = 0.029)
  • Need for repeat ablation: 17.3% vs. 25.3% (p = 0.044)
  • Total procedure time: 215.9 vs. 190.3 min (p = 0.001)
  • Safety: Intraprocedural pericardial effusion: 2 vs. 2; fluid overload: 2 vs. 14

Interpretation:

The results of this single-center, single-blind trial indicate that concomitant VOM alcohol ablation among patients with persistent AF undergoing catheter ablation is superior to standard catheter ablation alone. This approach results in a lower total burden and recurrent episodes of AT/AF, with reasonable safety and procedural success (~85%). Intraprocedural times were longer, but need for repeat procedures was lower.

These are important findings and will need to be validated in larger studies. Future studies will also need to identify optimal candidates for this technique, ways to improve procedural success, and the learning curve and skill sets necessary for successful completion of the procedure.

References:

Presented by Dr. Miguel Valderrábano at the American College of Cardiology Virtual Annual Scientific Session Together With World Congress of Cardiology (ACC 2020/WCC), March 29, 2020.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Pericardial Disease, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: acc20, ACC Annual Scientific Session, Anticoagulants, Anti-Arrhythmia Agents, Arrhythmias, Cardiac, Atrial Fibrillation, Catheter Ablation, Ethanol, Pericardial Effusion, Tachycardia, Supraventricular


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