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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, . ,
Language English Country United States
Document type Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
Free Medical Journals
from 2008 to 1 year ago
Open Access Digital Library
from 2008-04-01
- MeSH
- Survival Analysis MeSH
- Defibrillators, Implantable * MeSH
- Adult MeSH
- Ventricular Fibrillation diagnosis mortality surgery MeSH
- Risk Assessment MeSH
- Kaplan-Meier Estimate MeSH
- Catheter Ablation methods mortality MeSH
- Tachycardia, Ventricular diagnosis mortality surgery MeSH
- Middle Aged MeSH
- Humans MeSH
- Body Surface Potential Mapping MeSH
- Death, Sudden, Cardiac prevention & control MeSH
- Coronary Artery Disease diagnosis mortality surgery MeSH
- Statistics, Nonparametric MeSH
- Prognosis MeSH
- Proportional Hazards Models MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study 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
References provided by Crossref.org
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- $a Kuck, Karl-Heinz, $u From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.). k.kuck@asklepios.com. $d 1952- $7 xx0273250
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- $a 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) / $c KH. Kuck, RR. Tilz, T. Deneke, BA. Hoffmann, R. Ventura, PS. Hansen, M. Zarse, SH. Hohnloser, J. Kautzner, S. Willems, . ,
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- $a 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.
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- $a Tilz, Roland Richard $u From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
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- $a Deneke, Thomas $u From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
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- $a Hoffmann, Boris A $u From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
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- $a Ventura, Rodolfo $u From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
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- $a Zarse, Markus $u From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
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- $a Hohnloser, Stefan H $u From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
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- $a Kautzner, Josef $u From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
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