Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2
VANISH 2
Lead PI & Sponsor
Dr. John Sapp, Halifax, NS
Local PI
Dr. Lorne Gula
Research Staff
Keza Motlana
Objective
Catheter ablation will, in comparison to antiarrhythmic drug therapy reduce the composite outcome of death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days or treated sustained ventricular tachycardia below the detection rate of the ICD for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia.
Target Number of Patients
10
Currently Enrolled
1
Primary Outcomes
- To determine whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia
Secondary Outcomes
- All-cause mortality
- Appropriate antitachycardia pacing from ICD at any time or after 14 days
- Ventricular tachycardia storm at any time or after 14 days
- Sustained VT not treated by ICD at any time or after 14 days
- Sustained VT treated with appropriate external/internal/ manual/pharmacologic conversion at any time or after 14days
- Inappropriate ICD shocks at any time or after 14 days
- Any ICD shock at any time or after 14 days
- Quality of life
- Cost-effectiveness
Inclusion Criteria
- Prior myocardial infarction: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischemic injury) AND;
- One of the following monomorphic VT events while not being treated with amiodarone, sotalol, or another class I or class III antiarrhythmic drug) within the last 6 months (sustained monomorphic VT, > 3 episodes of monomorphic VT, > 5 episodes of monomorphic VT, > 1 appropriate ICD shocks or > 3 monomorphic VT episodes within 24 hours)
Exclusion Criteria
- Unable or unwilling to provide informed consent
- Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina
- Are ineligible to take the antiarrhythmic drug to which they would be assigned due to allergy, intolerance or contraindication
- Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves
- Have had a prior catheter ablation procedure for VT
- Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)
- Are in renal failure (Creatinine clearance <15 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to <1 year
- Are pregnant
Implantable Defibrillators (ICDs) reduce sudden death and can terminate some VT without shocks, but they don’t prevent VT; the most appropriate strategy to suppress VT remains unknown. Two randomized clinical trials have suggested that catheter ablation can significantly reduce the incidence of subsequent VT in patients after an initial episode. Neither trial, however, compared catheter ablation to active antiarrhythmic drug therapy. Randomized trials of antiarrhythmic drug therapy have demonstrated that therapy with either sotalol or amiodarone can reduce recurrent VT. Both antiarrhythmic drug and ablation therapy suffer from imperfect efficacy and the potential for significant side-effects. No study has compared ablation to drug therapy for first-line treatment. The VANISH study which compared ablation to aggressive antiarrhythmic drug therapy for patients who have failed initial drug therapy was published in May 2016, and demonstrated that for patients with drug-refractory VT, catheter ablation was superior to escalation of antiarrhythmic drug therapy. Benefits were seen in the group which had VT despite amiodarone. Event rates were similar between amiodarone and sotalol for patients with VT occurring despite sotalol, who were randomized to either new initiation of amiodarone or catheter ablation. These results do not address the critical clinical question of the most appropriate first line therapy for persons with VT. Emerging evidence has suggested that early treatment for VT may result in significantly better outcomes.