Ventricular Tachycardia Antiarrhythmics or Ablation in Structural Heart Disease 2 - VANISH2

Nov 16, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Anthony A. Bavry, MD,MPH,FACC
Trial Sponsor:
Canadian Institutes of Health Research
Date Presented:
11/16/2024
Date Published:
11/16/2024
Original Posted Date:
11/16/2024
References

Contribution To Literature:

The VANISH2 trial showed that in patients with ischemic cardiomyopathy and VT, first-line therapy with catheter ablation resulted in fewer VT episodes requiring ICD shock or medical intervention compared with antiarrhythmic therapy.

Description:

The goal of the trial was to compare endocardial catheter ablation with conventional antiarrhythmic drug (AAD) therapy as a first-line treatment for infarct-related ventricular tachycardia (VT) in ischemic cardiomyopathy.

Study Design

  • International
  • Randomized
  • Open-label

Patients with VT and prior myocardial infarction (MI) were randomized in a 1:1 fashion to undergo catheter ablation (n = 203) or AAD therapy (n = 213) with sotalol or amiodarone. Sotalol was used in patients with estimated glomerular filtration rate ≥30 mL/min/1.73 m2, New York Heart Association functional class I-II, left ventricular ejection fraction (LVEF) ≥20%, and without history of torsades de pointes, QT prolongation, or VT storm.

  • Total number of enrollees: 416
  • Median duration of follow-up: 4.3 years
  • Mean patient age: 68 years
  • Percentage female: 6%

Inclusion criteria:

  • Age ≥18 years
  • Prior MI
  • ≥1 of the following events in prior 6 months off AAD therapy: sustained monomorphic VT terminated by pharmacologic or electrical cardioversion, ≥3 VT episodes treated with antitachycardia pacing (ATP) with symptoms, ≥5 VT episodes treated with ATP, ≥1 appropriate implantable cardioverter-defibrillator (ICD) shock, ≥3 VT episodes in 24 hours

Exclusion criteria:

  • Active myocardial ischemia
  • Acute coronary syndrome <30 days prior
  • Percutaneous coronary intervention (PCI) <30 days or coronary artery bypass grafting <90 days prior
  • Prior VT catheter ablation
  • Protruding LV thrombus
  • Mechanical aortic or mitral valve prosthesis

Other salient features/characteristics:

  • Mean time since last MI: 14 years
  • Mean LVEF: 34%
  • Prior ICD: 88%
  • Sotalol eligibility: 48%

Principal Findings:

The primary outcome, composite of all-cause death, VT storm, appropriate ICD shock, or sustained VT below ICD detection rate requiring treatment, for catheter ablation vs. AAD, was: 50.7% vs. 60.6% (hazard ratio [HR] 0.75, 95% CI 0.58-0.97), p = 0.03.

Secondary outcomes for catheter ablation vs. AAD:

  • All-cause death: 22.2% vs. 25.4% (HR 0.84, 95% CI 0.56-1.24)
  • Appropriate ICD shock: 29.6% vs. 38.0% (HR 0.75, 95% CI 0.53-1.04)
  • VT storm: 21.7% vs. 23.7% (HR 0.95, 95% CI 0.63-1.42)
  • Sustained VT below ICD detection rate requiring treatment: 4.4% vs. 16.4% (HR 0.26, 95% CI 0.13-0.55)

Post-procedure adverse events at 30 days in catheter ablation arm:

  • Death: 1%
  • Nonfatal adverse events: 11.3%
  • Major bleeding: 1%
  • Cardiac perforation: 0.5%

AAD-related adverse events in AAD arm:

  • Fatal pulmonary toxicity: 0.5%
  • Nonfatal adverse events: 21.6%
  • Pulmonary infiltrates or fibrosis: 3.3%
  • Thyroiditis: 3.3%

Interpretation:

In the first VANISH trial, catheter ablation decreased recurrent VT events compared with AAD escalation in patients with ischemic cardiomyopathy and on baseline AAD therapy. The current data go further to support the role of catheter ablation as a preferred initial treatment strategy over AADs in such patients. The safety profile of catheter ablation naturally differed from noninvasive treatment but resulted in fewer nonfatal adverse events. Although overall mortality was high and comparable in both arms, appropriate ICD shocks and medical intervention for sustained VT was decreased with catheter ablation and may contribute significantly to quality of life. These findings do not extend to patients with nonischemic cardiomyopathy, in which multiple VT foci may be present and in whom rates of long-term recurrence and mortality following ablation are higher. However, in patients with ischemic cardiomyopathy and VT, especially in those who may be at higher risk for AAD-related adverse events or toxicity, catheter ablation alone may be a reasonable first-line therapy.

References:

Sapp JL, Tang AS, Parkash R, et al., for the VANISH2 Study Team. Catheter Ablation or Antiarrhythmic Drugs for Ventricular Tachycardia. N Engl J Med 2024;Nov 16:[Epub ahead of print].

Presented by Dr. John L. Sapp at the American Heart Association Scientific Sessions, Chicago, IL, November 16, 2024.

Clinical Topics: Arrhythmias and Clinical EP, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, EP Basic Science, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Anti-Arrhythmia Agents, Cardiomyopathies, Catheter Ablation, Tachycardia, Ventricular, AHA24, AHA Annual Scientific Sessions


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