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Risk Models for Prediction of Implantable Cardioverter-Defibrillator Benefit: Insights From the DANISH Trial
Søren Lund Kristensen1, Wayne C Levy2, Ramin Shadman3
1Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.
Insights
Implantable cardioverter-defibrillators (ICDs) benefit nonischemic heart failure patients with a high predicted risk of sudden cardiac death (SCD), as identified by the Seattle Proportional Risk Model (SPRM). Patients with lower SPRM scores did not show a mortality benefit from ICDs.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- The efficacy of implantable cardioverter-defibrillators (ICDs) for primary prevention in nonischemic heart failure remains debated.
- Established risk prediction models can help identify patients most likely to benefit from ICD implantation.
Purpose of the Study:
- To determine if patients with nonischemic heart failure benefit from ICD implantation based on risk stratification using the Seattle Heart Failure Model (SHFM) and Seattle Proportional Risk Model (SPRM).
Main Methods:
- The study analyzed 1,116 patients from the Danish study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on mortality (DANISH) trial.
- Patients were stratified by median scores from the SHFM and SPRM.
- The effect of ICD implantation on all-cause mortality and sudden cardiac death (SCD) was evaluated.
Main Results:
- ICD implantation significantly reduced all-cause mortality in patients with SPRM scores above the median (HR: 0.63; 95% CI: 0.43 to 0.94).
- No significant mortality benefit was observed in patients with lower SPRM scores (HR: 1.08; 95% CI: 0.78 to 1.49; p for interaction = 0.04).
- A significant interaction was found for combined high SPRM and high SHFM scores, where ICDs reduced mortality (HR: 0.45; 95% CI: 0.25 to 0.80).
Conclusions:
- Nonischemic heart failure patients with a higher predicted likelihood of sudden cardiac death (SCD), indicated by a higher SPRM score, appear to benefit from ICD implantation.
- Risk stratification using models like SPRM may help personalize ICD therapy decisions in nonischemic heart failure.
Objectives:
This study aims to identify patients with nonischemic heart failure who are more likely to benefit from implantable cardioverter-defibrillator (ICD) implantation by use of established risk prediction models.
Background:
It has been debated whether an ICD for primary prevention reduces mortality in patients with nonischemic heart failure.
Methods:
The Seattle Heart Failure Model (SHFM) predicts all-cause mortality whereas the Seattle Proportional Risk Model (SPRM) predicts the proportion of sudden cardiac death (SCD) versus nonsudden death, with a higher score indicating a greater proportion of SCD. We report the effect of ICD implantation on all-cause mortality and SCD, according to median SPRM and SHFM scores in all 1,116 patients enrolled in the DANISH (Danish study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on mortality) trial.
Results:
Among patients with an SPRM score above the median (n = 558), ICD implantation reduced all-cause mortality (hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.43 to 0.94), whereas patients with lower SPRM scores (n = 558) had no effect (HR: 1.08; 95% CI: 0.78 to 1.49, p for interaction = 0.04). The corresponding numbers for SHFM score above and below the median were HR: 0.84; 95% CI: 0.62 to 1.13 and HR: 0.82; 95% CI: 0.53 to 1.28, respectively (p for interaction = 0.980). In 177 patients with upper SPRM/upper SHFM, ICD implantation reduced all-cause mortality (HR: 0.45; 95% CI: 0.25 to 0.80) when compared to 381 patients with lower SPRM/upper SHFM (HR: 1.09; 95% CI: 0.76 to 1.55) (p for interaction <0.001).
Conclusions:
Nonischemic heart failure patients with high predicted relative likelihood of SCD, as estimated by higher SPRM score, seemed to benefit from ICD implantation. (DANISH [Danish ICD Study in Patients With Ditaled Cardiomyopathy]; NCT00542945).
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