Ventricular Tachycardia Ablation vs. Escalated Antiarrhythmic Drug Therapy in Ischemic Heart Disease - VANISH

Apr 03, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Canadian Institutes of Health Research; additional financial support from St. Jude Medical and Biosense Webster.
Date Published:
05/05/2016
Date Updated:
04/03/2018
Original Posted Date:
05/05/2016
References

Contribution To Literature:

The VANISH trial showed that VT ablation was superior to escalation of drug therapy at reducing death, VT storm, or ICD shocks.

Description:

The goal of the trial was to evaluate ventricular tachycardia (VT) ablation versus escalation of antiarrhythmic drug therapy among individuals with an ischemic cardiomyopathy and implantable cardioverter-defibrillator (ICD) who had VT despite antiarrhythmic drug therapy.

Study Design

  • Randomized
  • Parallel

Patients with VT despite antiarrhythmic drug therapy were randomized to VT catheter ablation (n = 132) versus escalation of drug therapy (n = 127). In the escalation of drug therapy group, patients received amiodarone (at least 300 mg) if another agent had been used previously or mexiletine.

  • Total number of enrollees: 259
  • Duration of follow-up: 27.9 months
  • Patient age: 69 years
  • Percentage female: 7%
  • Percentage with diabetes: 30%

Inclusion criteria:

  • Prior myocardial infarction
  • Ischemic cardiomyopathy and ICD
  • Persistent VT despite antiarrhythmic drug therapy

Exclusion criteria:

  • Acute coronary syndrome (e.g., acute thrombus or dynamic ST-segment changes on electrocardiogram) or another reversible cause of VT (e.g., electrolyte abnormalities, drug-induced arrhythmia)
  • Ineligible to take amiodarone (e.g., active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)
  • Ineligible for ablation (e.g., protruding left ventricular thrombus, or implanted mechanical aortic and mitral valves)
  • Renal failure (creatinine clearance <15 ml/min)
  • New York Heart Association class IV heart failure or Canadian Cardiovascular Society class IV angina
  • Recent ST-elevation myocardial infarction (<1 month)
  • Recent coronary bypass surgery (<3 months) or percutaneous coronary intervention (<1 month)
  • Prior ablation for VT
  • Systemic illness likely to limit survival to <1 year

Principal Findings:

The primary outcome of death, ≥3 episodes of VT within 24 hours, or appropriate ICD shock occurred in 59.1% of the catheter ablation group versus 68.5% of the escalated drug therapy group (p = 0.04).

Secondary outcomes: In the ablation group, there were two cardiac perforations and three major bleeds. In the escalated drug therapy group, there were two deaths from pulmonary toxicity and one death from hepatic dysfunction.

Cost-effectiveness: Ablation was associated with a higher cost compared with escalated drug therapy (difference $4,857). Among those with amiodarone-refractory VT, ablation was associated with lower cost (difference -$769), while those with sotalol-refractory VT were associated with a higher cost (difference $15,422) compared with escalated drug therapy.

Interpretation:

Among individuals with prior myocardial infarction and ischemic cardiomyopathy with persistent episodes of VT, catheter ablation of VT was superior to escalation of antiarrhythmic drug therapy. Ablation appeared to be cost-effective only in those with amiodarone-refractory VT. There were important toxicities, which occurred in the escalated drug therapy group.

References:

Coyle K, Coyle D, Nault I, et al. Cost Effectiveness of Ventricular Tachycardia Ablation Versus Escalation of Antiarrhythmic Drug Therapy: The VANISH Trial. JACC Clin Electrophysiol 2018;Mar 28:[Epub ahead of print].

Sapp JL, Wells GA, Parkash R, et al. Ventricular tachycardia ablation versus escalation of antiarrhythmic drugs. N Engl J Med 2016;375:111-21.

Keywords: Acute Coronary Syndrome, Amiodarone, Anti-Arrhythmia Agents, Arrhythmias, Cardiac, Cardiomyopathies, Catheter Ablation, Defibrillators, Implantable, Heart Failure, Mexiletine, Myocardial Infarction, Secondary Prevention, Shock, Tachycardia, Ventricular


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