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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)
KH. Kuck, RR. Tilz, T. Deneke, BA. Hoffmann, R. Ventura, PS. Hansen, M. Zarse, SH. Hohnloser, J. Kautzner, S. Willems, . ,
Jazyk angličtina Země Spojené státy americké
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
NLK
Free Medical Journals
od 2008 do Před 1 rokem
Open Access Digital Library
od 2008-04-01
- MeSH
- analýza přežití MeSH
- defibrilátory implantabilní * MeSH
- dospělí MeSH
- fibrilace komor diagnóza mortalita chirurgie MeSH
- hodnocení rizik MeSH
- Kaplanův-Meierův odhad MeSH
- katetrizační ablace metody mortalita MeSH
- komorová tachykardie diagnóza mortalita chirurgie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mapování potenciálů tělesného povrchu MeSH
- náhlá srdeční smrt prevence a kontrola MeSH
- nemoci koronárních tepen diagnóza mortalita chirurgie MeSH
- neparametrická statistika MeSH
- prognóza MeSH
- proporcionální rizikové modely MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
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.
Department of Cardiology Aarhus University Hospital Denmark
From the Department of Cardiology Asklepios Klinik St Georg Hamburg Germany
Institute for Clinical and Experimental Medicine Prague Czech Republic
University Heart Center Department of Cardiology Electrophysiology Hamburg Germany
University Heart Center University Hospital Bergmannsheil Bochum Germany
Citace poskytuje Crossref.org
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