Karl-Heinz Kuck1, Roland Richard Tilz2, Thomas Deneke2, Boris A Hoffmann2, Rodolfo Ventura2, Peter Steen Hansen2, Markus Zarse2, Stefan H Hohnloser2, Josef Kautzner2, Stephan Willems2. 1. 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. 2. 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.).
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 assignedcatheter ablation plus ICD implantation (ablation group: 68±8 years; 47 men), whereas 57 were assignedICD 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.
RCT Entities:
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.
Authors: Edmond M Cronin; Frank M Bogun; Philippe Maury; Petr Peichl; Minglong Chen; Narayanan Namboodiri; Luis Aguinaga; Luiz Roberto Leite; Sana M Al-Khatib; Elad Anter; Antonio Berruezo; David J Callans; Mina K Chung; Phillip Cuculich; Andre d'Avila; Barbara J Deal; Paolo Della Bella; Thomas Deneke; Timm-Michael Dickfeld; Claudio Hadid; Haris M Haqqani; G Neal Kay; Rakesh Latchamsetty; Francis Marchlinski; John M Miller; Akihiko Nogami; Akash R Patel; Rajeev Kumar Pathak; Luis C Saenz Morales; Pasquale Santangeli; John L Sapp; Andrea Sarkozy; Kyoko Soejima; William G Stevenson; Usha B Tedrow; Wendy S Tzou; Niraj Varma; Katja Zeppenfeld Journal: J Interv Card Electrophysiol Date: 2020-10 Impact factor: 1.900
Authors: Edmond M Cronin; Frank M Bogun; Philippe Maury; Petr Peichl; Minglong Chen; Narayanan Namboodiri; Luis Aguinaga; Luiz Roberto Leite; Sana M Al-Khatib; Elad Anter; Antonio Berruezo; David J Callans; Mina K Chung; Phillip Cuculich; Andre d'Avila; Barbara J Deal; Paolo Della Bella; Thomas Deneke; Timm-Michael Dickfeld; Claudio Hadid; Haris M Haqqani; G Neal Kay; Rakesh Latchamsetty; Francis Marchlinski; John M Miller; Akihiko Nogami; Akash R Patel; Rajeev Kumar Pathak; Luis C Sáenz Morales; Pasquale Santangeli; John L Sapp; Andrea Sarkozy; Kyoko Soejima; William G Stevenson; Usha B Tedrow; Wendy S Tzou; Niraj Varma; Katja Zeppenfeld Journal: Europace Date: 2019-08-01 Impact factor: 5.214
Authors: Jens Cosedis Nielsen; Yenn-Jiang Lin; Marcio Jansen de Oliveira Figueiredo; Alireza Sepehri Shamloo; Alberto Alfie; Serge Boveda; Nikolaos Dagres; Dario Di Toro; Lee L Eckhardt; Kenneth Ellenbogen; Carina Hardy; Takanori Ikeda; Aparna Jaswal; Elizabeth Kaufman; Andrew Krahn; Kengo Kusano; Valentina Kutyifa; Han S Lim; Gregory Y H Lip; Santiago Nava-Townsend; Hui-Nam Pak; Gerardo Rodríguez Diez; William Sauer; Anil Saxena; Jesper Hastrup Svendsen; Diego Vanegas; Marmar Vaseghi; Arthur Wilde; T Jared Bunch; Alfred E Buxton; Gonzalo Calvimontes; Tze-Fan Chao; Lars Eckardt; Heidi Estner; Anne M Gillis; Rodrigo Isa; Josef Kautzner; Philippe Maury; Joshua D Moss; Gi-Byung Nam; Brian Olshansky; Luis Fernando Pava Molano; Mauricio Pimentel; Mukund Prabhu; Wendy S Tzou; Philipp Sommer; Janice Swampillai; Alejandro Vidal; Thomas Deneke; Gerhard Hindricks; Christophe Leclercq Journal: Europace Date: 2020-08-01 Impact factor: 5.214