title: Outcome of Patients with Advanced Heart Failure Who Receive Device-Based Therapy for Primary Prevention of Sudden Cardiac Death: Insights from the Israeli ICD Registry.
abstract: BACKGROUND
  Randomized clinical trials have shown conflicting data on the benefit of implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death in patients with more advanced heart failure (HF) symptoms. Using the Israeli ICD Registry data, we sought to examine the effect of HF functional class on the outcome of patients who receive device therapy in a real-world setting.
  
  
  METHODS
  The association between HF functional class (categorized as baseline New York Heart Association [NYHA] functional class I and II in [61%] vs class III and IV in [39%]) and clinical outcomes was assessed among 913 patients who received an ICD (n = 514) or a cardiac resynchronization therapy with a defibrillator (CRT-D; n = 399) device and were prospectively followed in the Israeli ICD Registry between July 2011 and June 2013.
  
  
  RESULTS
  The risk associated with advanced HF functional class was significantly different in ICD and CRT-D recipients. In the former group, patients with NYHA classes III and IV experienced >3-fold increased risk of HF or death (hazard ratio [HR] = 3.28; P < 0.001), whereas among CRT-D recipients the risk was similar between patients with NYHA III/IV and those with less advanced HF symptoms (HR = 0.97 [95% confidence interval (CI) 0.54-1.78]; P = 0.42; P value for NYHA functional class by device type interaction = 0.002). The risk for ventricular arrhythmia (VA) was significantly lower among patients with more advanced NYHA functional class, regardless of device type (overall HR = 0.52; 95% CI 0.33-0.91; P = 0.04).
  
  
  CONCLUSIONS
  Our findings suggest that patients with less advanced HF symptoms experience a greater risk for VA and the development of HF is attenuated in CRT-D recipients with more advanced NYHA functional class.
authors.affiliation: Rambam Health Care Campus, Haifa, Israel.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Suleiman
authors.affiliation: Chaim Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Ilan
authors.initials: I
authors.lastname: Goldenberg
authors.affiliation: Beni Tzion Medical Center, Haifa, Israel.
authors.forename: Nimer
authors.initials: N
authors.lastname: Samniah
authors.affiliation: Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Raphael
authors.initials: R
authors.lastname: Rosso
authors.affiliation: Rambam Health Care Campus, Haifa, Israel.
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Marai
authors.affiliation: Ziv Medical Centers, Zefat, Israel.
authors.forename: Alexander
authors.initials: A
authors.lastname: Pekar
authors.affiliation: Barzilai Medical Center, Ashkelon, Israel.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Khalameizer
authors.affiliation: Carmel Medical Center, Haifa, Israel.
authors.forename: Arie
authors.initials: A
authors.lastname: Militianu
authors.affiliation: Chaim Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Michael
authors.initials: M
authors.lastname: Glikson
mesh_terms: D000368:Aged; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D005260:Female; D006333:Heart Failure / Q000150:complications* / Q000628:therapy*; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D011322:Primary Prevention; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome
keywords: cardiac resynchronization; defibrillator; heart failure; outcomes