Martin H Ruwald1, Scott D Solomon2, Elyse Foster2, Valentina Kutyifa2, Anne-Christine Ruwald2, Saadia Sherazi2, Scott McNitt2, Christian Jons2, Arthur J Moss2, Wojciech Zareba2. 1. From the Heart Research Follow-up Program, Division of Cardiology, University of Rochester Medical Center, Rochester, NY (M.H.R., V.K., A.-C.R., S.S., S.M., A.J.M., W.Z.); Department of Cardiology, Gentofte Hospital, Hellerup, Denmark (M.H.R., A.-C.R., C.J.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S.); and Division of Cardiology, Department of Medicine, University of California, San Francisco (E.F.). mruwald@hotmail.com. 2. From the Heart Research Follow-up Program, Division of Cardiology, University of Rochester Medical Center, Rochester, NY (M.H.R., V.K., A.-C.R., S.S., S.M., A.J.M., W.Z.); Department of Cardiology, Gentofte Hospital, Hellerup, Denmark (M.H.R., A.-C.R., C.J.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S.); and Division of Cardiology, Department of Medicine, University of California, San Francisco (E.F.).
Abstract
BACKGROUND: Appropriate guideline criteria for use of implantable cardioverter-defibrillators (ICDs) do not take into account potential recovery of left ventricular ejection fraction (LVEF) in patients treated with CRT-defibrillator. METHODS AND RESULTS: Patients randomized to CRT-defibrillator from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT) trial who survived and had paired echocardiograms at enrollment and at 12 months (n=752) were included. Patients were evaluated by LVEF recovery in 3 groups (LVEF ≤35% [reference], 36%-50%, and >50%) on outcomes of ventricular tachyarrhythmias (VTAs), VTA ≥200 bpm, ICD shock, heart failure or death, and inappropriate ICD therapy by multivariable Cox models. A total of 7.3% achieved LVEF normalization (>50%). The average follow-up was 2.2±0.8 years. The risk of VTA was reduced in patients with LVEF >50% (hazard ratio [HR], 0.24; 95% confidence interval [CI], 0.07-0.82; P=0.023) and LVEF of 36% to 50% (HR, 0.44; 95% CI, 0.28-0.68; P<0.001). Among patients with LVEF >50%, only 1 patient had VTA ≥200 bpm (HR, 0.16; 95% CI, 0.02-1.51), none were shocked by the ICD, and 2 died of nonarrhythmic causes. The risk of HF or death was reduced with improvements in LVEF (LVEF >50%: HR, 0.29; 95% CI, 0.09-0.97; P=0.045; and LVEF of 36%-50%: HR, 0.44; 95% CI, 0.28-0.69; P<0.001). For inappropriate ICD therapy, no additional risk reduction for LVEF>50% was seen compared with an LVEF of 36% to 50%. A total of 6 factors were associated with LVEF normalization, and patients with all factors present (n=42) did not experience VTAs (positive predictive value, 100%). CONCLUSIONS: Patients who achieve LVEF normalization (>50%) have very low absolute and relative risk of VTAs and a favorable clinical course within 2.2 years of follow-up. Risk of inappropriate ICD therapy is still present, and these patients could be considered for downgrade from CRT-defibrillator to CRT-pacemaker at the time of battery depletion if no VTAs have occurred. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180271.
RCT Entities:
BACKGROUND: Appropriate guideline criteria for use of implantable cardioverter-defibrillators (ICDs) do not take into account potential recovery of left ventricular ejection fraction (LVEF) in patients treated with CRT-defibrillator. METHODS AND RESULTS:Patients randomized to CRT-defibrillator from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT) trial who survived and had paired echocardiograms at enrollment and at 12 months (n=752) were included. Patients were evaluated by LVEF recovery in 3 groups (LVEF ≤35% [reference], 36%-50%, and >50%) on outcomes of ventricular tachyarrhythmias (VTAs), VTA ≥200 bpm, ICD shock, heart failure or death, and inappropriate ICD therapy by multivariable Cox models. A total of 7.3% achieved LVEF normalization (>50%). The average follow-up was 2.2±0.8 years. The risk of VTA was reduced in patients with LVEF >50% (hazard ratio [HR], 0.24; 95% confidence interval [CI], 0.07-0.82; P=0.023) and LVEF of 36% to 50% (HR, 0.44; 95% CI, 0.28-0.68; P<0.001). Among patients with LVEF >50%, only 1 patient had VTA ≥200 bpm (HR, 0.16; 95% CI, 0.02-1.51), none were shocked by the ICD, and 2 died of nonarrhythmic causes. The risk of HF or death was reduced with improvements in LVEF (LVEF >50%: HR, 0.29; 95% CI, 0.09-0.97; P=0.045; and LVEF of 36%-50%: HR, 0.44; 95% CI, 0.28-0.69; P<0.001). For inappropriate ICD therapy, no additional risk reduction for LVEF>50% was seen compared with an LVEF of 36% to 50%. A total of 6 factors were associated with LVEF normalization, and patients with all factors present (n=42) did not experience VTAs (positive predictive value, 100%). CONCLUSIONS:Patients who achieve LVEF normalization (>50%) have very low absolute and relative risk of VTAs and a favorable clinical course within 2.2 years of follow-up. Risk of inappropriate ICD therapy is still present, and these patients could be considered for downgrade from CRT-defibrillator to CRT-pacemaker at the time of battery depletion if no VTAs have occurred. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180271.
Authors: Norman C Wang; Aliza Hussain; Evan C Adelstein; Andrew D Althouse; Michael S Sharbaugh; Sandeep K Jain; Alaa A Shalaby; Andrew H Voigt; Samir Saba Journal: Ann Noninvasive Electrocardiol Date: 2018-09-28 Impact factor: 1.468
Authors: Anne-Christine Ruwald; Mehmet K Aktas; Martin H Ruwald; Valentina Kutyifa; Scott McNitt; Christian Jons; Suneet Mittal; Jonathan S Steinberg; James P Daubert; Arthur J Moss; Wojciech Zareba Journal: Ann Noninvasive Electrocardiol Date: 2017-09-20 Impact factor: 1.468
Authors: Selcuk Adabag; Kristen K Patton; Alfred E Buxton; Thomas S Rector; Kristine E Ensrud; Kairav Vakil; Wayne C Levy; Jeanne E Poole Journal: JAMA Cardiol Date: 2017-07-01 Impact factor: 14.676