Table 1: Proposed Standards for Reporting Long-term Outcomes after VT Ablation For Clinical Trials.
Required Follow-up Duration |
• VT recurrence* (minimum follow-up duration of 6–12 months) |
• Mortality (minimum follow-up duration of 1 year) |
Efficacy Endpoints |
• Spontaneous recurrence of any sustained VT |
• Freedom from VT in absence of antiarrhythmic drug use (follow-up begins 5 half-lives after drug discontinuation, or 3 months after stopping amiodarone) |
• Death |
Other Outcomes that should be Reported if Possible |
• Number of VT recurrences during follow-up period |
• Recurrence of monomorphic VT (as opposed to VF or polymorphic VT) |
• Freedom from VT with previously ineffective antiarrhythmic therapy |
• Improvement in VT frequency (i.e. >75 % decrease in VT frequency for 6-month monitoring period before and after ablation) |
• Quality of life |
• Cost-effectiveness |
*Ventricular tachycardia (VT) recurrence = any VT episode lasting >30 s or requiring implantable cardioverter-defibrillator intervention.