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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Risk stratification for primary implantation of a cardioverter-defibrillator in patients with ischemic left
Ilan Goldenberg1, Anant K Vyas, W Jackson Hall
1Department of Medicine, University of Rochester Medical Center, Rochester, New York 14642, USA. Ilan.Goldenberg@heart.rochester.edu
Insights
A new risk score helps identify patients with low ejection fraction who benefit most from an implantable cardioverter-defibrillator (ICD). The score shows ICDs are most effective in intermediate-risk patients, not those at very low or very high risk.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Risk Stratification
Background:
- Current guidelines recommend implantable cardioverter-defibrillators (ICDs) for primary prevention in patients with low ejection fraction (EF).
- The uniform benefit of ICDs in this low EF population is uncertain.
Purpose of the Study:
- To develop a simple clinical risk stratification score for primary ICD therapy.
- To assess ICD benefit across different risk categories in patients with low EF.
Main Methods:
- A best-subset proportional-hazards regression model was used.
- The analysis included patients from the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II conventional therapy arm, excluding very high-risk (VHR) patients.
- Risk score categories were defined, and ICD benefit was evaluated within these strata and in VHR patients.
Main Results:
- A 5-factor risk score was developed (NYHA class, age, BUN, QRS duration, atrial fibrillation).
- Mortality rates varied significantly by risk score in the conventional therapy group (8% for 0 factors, 28% for >=1 factor, 43% for VHR).
- ICD therapy reduced mortality by 49% in patients with >=1 risk factor, but showed no benefit in patients with 0 risk factors or VHR patients.
Conclusions:
- A U-shaped pattern of ICD efficacy was observed in the low EF population.
- Intermediate-risk patients (>=1 risk factor) demonstrated the most pronounced benefit from ICD therapy.
- ICD efficacy was attenuated in both lower-risk (0 risk factors) and higher-risk (VHR) patient subsets.
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] >or=50 mg/dl and/or serum creatinine >or=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 >or=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 >or=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.
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