1. Impact of Substrate Modification by Catheter Ablation on Implantable Cardioverter-Defibrillator Interventions in Patients With Unstable Ventricular Arrhythmias and Coronary Artery Disease: Results From the Multicenter Randomized Controlled SMS (Substrate Modification Study).
- Author
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Kuck KH, Tilz RR, Deneke T, Hoffmann BA, Ventura R, Hansen PS, Zarse M, Hohnloser SH, Kautzner J, and Willems S
- Subjects
- Adult, Aged, Body Surface Potential Mapping, Catheter Ablation mortality, Coronary Artery Disease diagnosis, Coronary Artery Disease mortality, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Prognosis, Proportional Hazards Models, Risk Assessment, Severity of Illness Index, Statistics, Nonparametric, Survival Analysis, Tachycardia, Ventricular diagnosis, Tachycardia, Ventricular mortality, Treatment Outcome, Ventricular Fibrillation diagnosis, Ventricular Fibrillation mortality, Catheter Ablation methods, Coronary Artery Disease surgery, Death, Sudden, Cardiac prevention & control, Defibrillators, Implantable, Tachycardia, Ventricular surgery, Ventricular Fibrillation surgery
- Abstract
Background: The implantable cardioverter-defibrillator (ICD) is the standard therapy to prevent sudden cardiac death in patients with coronary artery disease and unstable ventricular tachyarrhythmias. The prospective multinational SMS (Substrate Modification Study) was designed to assess whether prophylactic ablation of the arrhythmogenic substrate reduces or prevents the recurrence of ventricular tachycardia/ventricular fibrillation in such patients., Methods and Results: Of 111 patients included in an intention-to-treat analysis, 54 were randomly assigned catheter ablation plus ICD implantation (ablation group: 68±8 years; 47 men), whereas 57 were assigned ICD implantation without catheter ablation (ICD-only group: 66±8 years; 46 men). Primary study end point was the time to first recurrence of ventricular tachycardia/ventricular fibrillation. ICD episodes were assessed and verified by an independent board. Patients were followed up for 2.3±1.1 years. The primary end point was reached by 25 ablation patients and 26 ICD-only patients. Two-year event-free survival was estimated at 49.0% (95% confidence interval, 33.3%-62.9%) in the former and 52.4% (36.7%-65.9%) in the latter groups. Comparison of episode incidence revealed no significant difference in the primary end point ( P =0.84). In an Andersen-Gill regression model with multiple end point recurrences, the difference between the study arms significantly favored catheter ablation for both the primary end point and all but one of the predefined subgroups of detected arrhythmia events., Conclusions: SMS failed to meet the primary end point of time to first ventricular tachycardia/ventricular fibrillation recurrence. However, catheter ablation did reduce the total number of ICD interventions during the duration of follow-up., Clinical Trial Registration: https://clinicaltrials.gov. Unique identifier: NCT00170287., (© 2017 American Heart Association, Inc.)
- Published
- 2017
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