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Published on: February 28, 2012
A validated risk model for 1-year mortality after primary prevention implantable cardioverter defibrillator placement
Paul A Heidenreich1, Vivian Tsai2, Jeptha Curtis3
1VA Palo Alto Healthcare System, Palo Alto, CA, 94304.
Insights
A new risk score helps identify heart failure patients unlikely to benefit from an implantable cardioverter defibrillator (ICD). This tool predicts 1-year mortality risk, aiding treatment decisions for primary prevention.
Area of Science:
- Cardiology
- Medical Devices
- Public Health
Background:
- Implantable cardioverter defibrillators (ICDs) are used for primary prevention in heart failure patients.
- Clinical trials suggest that ICDs may not benefit patients with a 1-year mortality risk near 20%.
Purpose of the Study:
- To determine survival rates for heart failure patients receiving an ICD for primary prevention in the U.S.
- To develop a predictive model for mortality risk in this population.
Main Methods:
- Utilized data from the ICD Registry (2007-2009) for patients undergoing ICD implantation.
- Developed two mortality risk scores: one including B-type natriuretic peptide (BNP) and one for all patients.
- Employed logistic regression and classification and regression trees for score derivation and validation.
Main Results:
- Identified six key predictors of 1-year mortality in patients with available BNP: age ≥75, BNP ≥700 pg/mL, chronic lung disease, dialysis, BUN ≥30 mg/dL, and systolic blood pressure <120 mmHg.
- Mortality ranged from 3.3% (zero risk factors) to 66.7% (all six risk factors).
- Approximately 24% of patients with ≥3 risk factors had a 25.8% 1-year mortality; a similar score was developed without BNP.
Conclusions:
- A validated risk score can effectively stratify patients into high- and low-risk categories for 1-year mortality post-ICD placement.
- A significant proportion of U.S. patients receiving ICDs for primary prevention exhibit high 1-year mortality, potentially not benefiting from the device.
Objective:
We sought to determine survival for patients with heart failure after an implantation of an implantable cardioverter defibrillator (ICD) for primary prevention in the United States and to develop a simple model that would predict mortality risk.
Background:
Clinical trials have found that patients with heart failure with a 1-year mortality risk near 20% may not benefit from an ICD.
Methods:
We identified patients from the ICD Registry of the National Cardiovascular Disease Registries who underwent ICD implantation for primary prevention from 2007 to 2009. Two risk scores for mortality were developed in 2 cohorts: one limited to those with a B-type natriuretic peptide (BNP) value and a second for all patients. The scores were obtained from derivation datasets and tested in a validation sets using logistic regression models and classification and regression trees.
Results:
In a primary prevention population with BNP available (18,725) the 6 variables most predictive of 1-year mortality were age ≥75, BNP ≥700 pg/mL, chronic lung disease, dialysis, blood urea nitrogen ≥30 mg/dL, and systolic blood pressure <120 mmHg. Patients with zero risk factors had a 3.3% one-year mortality compared to a 66.7% one-year mortality for those with all 6 risk factors. Those with ≥3 risk factors (24.0% of the population) had a 25.8% one-year mortality. A second score using a larger cohort that did not consider BNP identified similar risk factors.
Conclusions:
A simple validated risk score can identify patients at high and low risk for death within a year after ICD placement. A large fraction of those currently implanted with an ICD in the United States have a high 1-year mortality and may not benefit from ICD therapy.
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