title: Effects of cardiac resynchronization therapy with or without a defibrillator on survival and hospitalizations in patients with New York Heart Association class IV heart failure.
abstract: BACKGROUND
  Cardiac resynchronization therapy (CRT) alone or combined with an implantable defibrillator (CRT-D) has been shown to improve exercise capacity and quality of life and to reduce heart failure (HF) hospitalizations and mortality in patients with New York Heart Association (NYHA) class III and IV HF. There is concern that the device procedure may destabilize these very ill class IV patients. We sought to examine the outcomes of NYHA class IV patients enrolled in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial to assess the potential benefits of CRT and CRT-D.
  
  
  RESULTS
  The COMPANION trial randomized 1520 patients with NYHA class III and IV HF to optimal medical therapy, CRT, or CRT-D. In the class IV patients (n=217), the primary end point of time to death or hospitalization for any cause was significantly improved by both CRT (hazard ratio [HR], 0.64; 95% CI, 0.43 to 0.94; P=0.02) and CRT-D (HR, 0.62; 95% CI, 0.42 to 0.90; P=0.01). Time to all-cause death and HF hospitalization was also significantly improved in both CRT (HR, 0.57; 95% CI, 0.37 to 0.87; P=0.01) and CRT-D (HR, 0.49; 95% CI, 0.32 to 0.75; P=0.001) Time to all-cause death trended to an improvement in both CRT (HR, 0.67; 95% CI, 0.41 to 1.10; P=0.11) and CRT-D (HR, 0.63; 95% CI, 0.39 to 1.03; P=0.06). Time to sudden death appeared to be significantly reduced in the CRT-D group (HR, 0.27; 95% CI, 0.08 to 0.90; P=0.03). There was a nonsignificant reduction in time to HF deaths for both CRT (HR, 0.68; 95% CI, 0.34 to 1.37; P=0.28) and CRT-D (HR, 0.79; 95% CI, 0.41 to 1.52; P=0.48).
  
  
  CONCLUSIONS
  CRT and CRT-D significantly improve time to all-cause mortality and hospitalizations in NYHA class IV patients, with a trend for improved mortality. These devices should be considered in ambulatory NYHA class IV HF patients similar to those enrolled in COMPANION.
authors.affiliation: Department of Medicine, University of Colorado Health Sciences Center, 4200 E. Ninth Ave, Denver, CO 80262, USA. joann.lindenfeld@uchsc.edu
authors.forename: JoAnn
authors.initials: J
authors.lastname: Lindenfeld
authors.forename: Arthur M
authors.initials: AM
authors.lastname: Feldman
authors.forename: Leslie
authors.initials: L
authors.lastname: Saxon
authors.forename: John
authors.initials: J
authors.lastname: Boehmer
authors.forename: Peter
authors.initials: P
authors.lastname: Carson
authors.forename: Jalal K
authors.initials: JK
authors.lastname: Ghali
authors.forename: Inder
authors.initials: I
authors.lastname: Anand
authors.forename: Steve
authors.initials: S
authors.lastname: Singh
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Steinberg
authors.forename: Brian
authors.initials: B
authors.lastname: Jaski
authors.forename: Teresa
authors.initials: T
authors.lastname: DeMarco
authors.forename: David
authors.initials: D
authors.lastname: Mann
authors.forename: Patrick
authors.initials: P
authors.lastname: Yong
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Galle
authors.forename: Fred
authors.initials: F
authors.lastname: Ecklund
authors.forename: Michael
authors.initials: M
authors.lastname: Bristow
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002304:Cardiac Pacing, Artificial / Q000379:methods / Q000401:mortality*; D017147:Defibrillators, Implantable; D005260:Female; D006333:Heart Failure / Q000145:classification* / Q000401:mortality* / Q000628:therapy; D017052:Hospital Mortality; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009518:New York; D015996:Survival Rate