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J Am Coll Cardiol, 2008; 51:288-296, doi:10.1016/j.jacc.2007.08.058
© 2008 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: HEART RHYTHM DISORDER

Risk Stratification for Primary Implantation of a Cardioverter-Defibrillator in Patients With Ischemic Left Ventricular Dysfunction

Ilan Goldenberg, MD*,1,*, Anant K. Vyas, MD, MPH{dagger},1, W. Jackson Hall, PhD{ddagger},1, Arthur J. Moss, MD*, Hongyue Wang, PhD{ddagger}, Hua He, MA{ddagger}, Wojciech Zareba, MD, PhD*, Scott McNitt, MS*, Mark L. Andrews, BBA* for the MADIT-II Investigators

* Cardiology Unit of the Department of Medicine, University of Rochester Medical Center, Rochester, New York
{ddagger} Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York
{dagger} Cardiovascular Division of the Department of Medicine, University of Buffalo, Buffalo, New York.

Manuscript received May 31, 2007; revised manuscript received July 27, 2007, accepted August 20, 2007.

* Reprint requests and correspondence: Dr. Ilan Goldenberg, Heart Research Follow-up Program, Box 653, University of Rochester Medical Center, Rochester, New York 14642. (Email: Ilan.Goldenberg{at}heart.rochester.edu).

Objectives: The study was designed to develop a simple risk stratification score for primary therapy with an implantable cardioverter-defibrillator (ICD).

Background: Current guidelines recommend primary ICD therapy in patients with a low ejection fraction (EF). However, the benefit of the ICD in the low EF population may not be uniform.

Methods: Best-subset proportional-hazards regression analysis was used to develop a simple clinical risk score for the end point of all-cause mortality in patients allocated to the conventional therapy arm of MADIT (Multicenter Automatic Defibrillator Implantation Trial)-II after excluding a pre-specified subgroup of very high-risk (VHR) patients (defined by blood urea nitrogen [BUN] ≥50 mg/dl and/or serum creatinine ≥2.5 mg/dl). The benefit of the ICD was then assessed within risk score categories and separately in VHR patients.

Results: The selected risk score model comprised 5 clinical factors (New York Heart Association functional class >II, age >70 years, BUN >26 mg/dl, QRS duration >0.12 s, and atrial fibrillation). Crude mortality rates in the conventional group were 8% and 28% in patients with 0 and ≥1 risk factors, respectively, and 43% in VHR patients. Defibrillator therapy was associated with a 49% reduction in the risk of death (p < 0.001) among patients with ≥1 risk factors (n = 786), whereas no ICD benefit was identified in patients with 0 risk factors (n = 345; hazard ratio 0.96; p = 0.91) and in VHR patients (n = 60; hazard ratio 1.00; p > 0.99).

Conclusions: Our data suggest a U-shaped pattern for ICD efficacy in the low-EF population, with pronounced benefit in intermediate-risk patients and attenuated efficacy in lower- and higher-risk subsets.

Abbreviations and Acronyms
  BUN = blood urea nitrogen
  EF = ejection fraction
  ICD = implantable cardioverter-defibrillator
  LBBB = left bundle branch block
  MI = myocardial infarction
  NYHA = New York Heart Association
  VHR = very high risk


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