John L Sapp1, Ratika Parkash2, George A Wells2, Elizabeth Yetisir2, Martin J Gardner2, Jeffrey S Healey2, Bernard Thibault2, Laurence D Sterns2, David Birnie2, Pablo B Nery2, Soori Sivakumaran2, Vidal Essebag2, Paul Dorian2, Anthony S L Tang2. 1. From the Department of Medicine, Division of Cardiology, Dalhousie University, Halifax, NS, Canada (J.L.S., R.P., M.J.G.); Department of Medicine (G.A.W.), Cardiovascular Research Methods Centre (E.Y.), and Department of Medicine, Division of Cardiology (D.B., P.B.N.), University of Ottawa Heart Institute, ON, Canada; Department of Medicine, Division of Cardiology, Population Health Research Institute, Hamilton, ON, Canada (J.S.H.); Department of Medicine, Montreal Heart Institute, QC, Canada (B.T.); Department of Medicine, Division of Cardiology, Royal Jubilee Hospital, Victoria, BC, Canada (L.D.S.); Department of Medicine, Division of Cardiology, University of Alberta, Edmonton, Canada (S.S.); Department of Medicine, Division of Cardiology, McGill University Health Centre and Hopital Sacre Coeur de Montreal, Quebec, Canada (V.E.); Department of Medicine, Division of Cardiology, University of Toronto, ON, Canada (P.D.); and Division of Cardiology, Department of Medicine, Western University, London, Canada (A.S.L.T.). John.sapp@cdha.nshealth.ca. 2. From the Department of Medicine, Division of Cardiology, Dalhousie University, Halifax, NS, Canada (J.L.S., R.P., M.J.G.); Department of Medicine (G.A.W.), Cardiovascular Research Methods Centre (E.Y.), and Department of Medicine, Division of Cardiology (D.B., P.B.N.), University of Ottawa Heart Institute, ON, Canada; Department of Medicine, Division of Cardiology, Population Health Research Institute, Hamilton, ON, Canada (J.S.H.); Department of Medicine, Montreal Heart Institute, QC, Canada (B.T.); Department of Medicine, Division of Cardiology, Royal Jubilee Hospital, Victoria, BC, Canada (L.D.S.); Department of Medicine, Division of Cardiology, University of Alberta, Edmonton, Canada (S.S.); Department of Medicine, Division of Cardiology, McGill University Health Centre and Hopital Sacre Coeur de Montreal, Quebec, Canada (V.E.); Department of Medicine, Division of Cardiology, University of Toronto, ON, Canada (P.D.); and Division of Cardiology, Department of Medicine, Western University, London, Canada (A.S.L.T.).
Abstract
BACKGROUND: The RAFT (Resynchronization in Ambulatory Heart Failure Trial) demonstrated that cardiac resynchronization therapy (CRT) reduced both mortality and heart failure hospitalizations in patients with functional class II or III heart failure and widened QRS. We examined the influence of CRT on ventricular arrhythmias in patients with primary versus secondary prophylaxis defibrillator indications. METHODS AND RESULTS: All ventricular arrhythmias among RAFT study participants were downloaded and adjudicated by 2 blinded reviewers with an overreader for disagreements and committee review for remaining discrepancies. Incidence of ventricular arrhythmias among patients randomized to CRT-D versus implantable cardioverter defibrillator (ICD) were compared within the groups of patients treated for primary prophylaxis and for secondary prophylaxis. Of 1798 enrolled patients, 1764 had data available for adjudication and were included. Of these, 1531 patients were implanted for primary prophylaxis, while 233 patients were implanted for secondary prophylaxis; 884 patients were randomized to ICD and 880 to CRT-D. During 5953.6 patient-years of follow-up, there were 11 278 appropriate ICD detections of ventricular arrhythmias. In the primary prophylaxis group, CRT-D significantly reduced incidence ventricular arrhythmias in comparison to ICD (hazard ratio, 0.86; 95% confidence interval, 0.74-0.99; P=0.044). This effect was not seen in the secondary prophylaxis group (hazard ratio, 1.14; 95% confidence interval, 0.82-1.58; P=0.45). CRT-D was not associated with significant differences in overall ventricular arrhythmia burden in either group. CONCLUSIONS:CRT reduced the rate of onset of new ventricular arrhythmias detected by ICDs in patients without a history of prior ventricular arrhythmias. This effect was not observed among patients who had prior ventricular arrhythmias. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251251.
RCT Entities:
BACKGROUND: The RAFT (Resynchronization in Ambulatory Heart Failure Trial) demonstrated that cardiac resynchronization therapy (CRT) reduced both mortality and heart failure hospitalizations in patients with functional class II or III heart failure and widened QRS. We examined the influence of CRT on ventricular arrhythmias in patients with primary versus secondary prophylaxis defibrillator indications. METHODS AND RESULTS: All ventricular arrhythmias among RAFT study participants were downloaded and adjudicated by 2 blinded reviewers with an overreader for disagreements and committee review for remaining discrepancies. Incidence of ventricular arrhythmias among patients randomized to CRT-D versus implantable cardioverter defibrillator (ICD) were compared within the groups of patients treated for primary prophylaxis and for secondary prophylaxis. Of 1798 enrolled patients, 1764 had data available for adjudication and were included. Of these, 1531 patients were implanted for primary prophylaxis, while 233 patients were implanted for secondary prophylaxis; 884 patients were randomized to ICD and 880 to CRT-D. During 5953.6 patient-years of follow-up, there were 11 278 appropriate ICD detections of ventricular arrhythmias. In the primary prophylaxis group, CRT-D significantly reduced incidence ventricular arrhythmias in comparison to ICD (hazard ratio, 0.86; 95% confidence interval, 0.74-0.99; P=0.044). This effect was not seen in the secondary prophylaxis group (hazard ratio, 1.14; 95% confidence interval, 0.82-1.58; P=0.45). CRT-D was not associated with significant differences in overall ventricular arrhythmia burden in either group. CONCLUSIONS: CRT reduced the rate of onset of new ventricular arrhythmias detected by ICDs in patients without a history of prior ventricular arrhythmias. This effect was not observed among patients who had prior ventricular arrhythmias. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251251.
Authors: Arjan Sammani; Rutger R van de Leur; Michiel T H M Henkens; Mathias Meine; Peter Loh; Rutger J Hassink; Daniel L Oberski; Stephane R B Heymans; Pieter A Doevendans; Folkert W Asselbergs; Anneline S J M Te Riele; René van Es Journal: Europace Date: 2022-10-13 Impact factor: 5.486
Authors: Andreea Maria Ursaru; Antoniu Octavian Petris; Irina Iuliana Costache; Ana Nicolae; Adrian Crisan; Nicolae Dan Tesloianu Journal: J Cardiovasc Dev Dis Date: 2022-04-16