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Contribution of stent underexpansion to recurrence after sirolimus-eluting stent implantation for in-stent restenosis Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance Positive remodeling at 3 year follow up is associated with plaque-free coronary wall segment at baseline: a serial IVUS study Long-term results after PCI of unprotected distal left main coronary artery stenosis: the Bifurcations Bad Krozingen (BBK)-Left Main Registry Differential prognostic impact of treatment strategy among patients with left main versus non-left main bifurcation lesions undergoing percutaneous coronary intervention: results from the COBIS (Coronary Bifurcation Stenting) Registry II Percutaneous Coronary Intervention vs Coronary Artery Bypass Grafting in Patients With Left Main Coronary Artery Stenosis: A Systematic Review and Meta-analysis Long-term outcome of prosthesis-patient mismatch after transcatheter aortic valve replacement Regurgitant Volume/Left Ventricular End-Diastolic Volume Ratio: Prognostic Value in Patients With Secondary Mitral Regurgitation Successful bailout stenting strategy against lethal coronary dissection involving left main bifurcation Usefulness of intravascular ultrasound to predict outcomes in short-length lesions treated with drug-eluting stents
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Clinical TrialJune 2018

JOURNAL：JACC Clin Electrophysiol. Article Link

Improving the Use of Primary Prevention Implantable Cardioverter-Defibrillators Therapy With Validated Patient-Centric Risk Estimates

WC Levy, AS Hellkamp, DB Mark et al. Keywords: heart failure; ICD; non-sudden death; prognosis; proportional risk; regression analysis; risk prediction model; sudden death

ABSTRACT

OBJECTIVES - The authors previously developed the Seattle Proportional Risk Model (SPRM) in systolic heart failure patients without implantable cardioverter-defibrillators (ICDs)to predict the proportion of deaths that were sudden. They subsequently validated the SPRM in 2 observational ICD data sets. The objectives in the present study were to determine whether this validated model could improve identification of clinically important variations in the expected magnitude of ICD survival benefit by using a pivotal randomized trial of primary prevention ICD therapy.


BACKGROUND - Recent data show that <50% of nominally eligible subjects receive guideline- recommended primary prevention ICDs.

METHODS - In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), a placebo-controlled ICD trial in 2,521 patients with an ejection fraction ≤35% and symptomatic heart failure, we tested the use of patient-level SPRM-predicted probability of sudden death (relative to that of non-sudden death) as a summary measurement of the potential for ICD benefit. A Cox proportional hazards model was used to estimate variations in the relationship between patient-level SPRM predictions and ICD benefit.

RESULTS - Relative to use of mortality predictions with the Seattle Heart Failure Model, the SPRM was much better at partitioning treatment benefit from ICD therapy (effect size was 2- to 3.6-fold larger for the ICD×SPRM interaction). ICD benefit varied significantly across SPRM-predicted risk quartiles: for all-cause mortality, a +10% increase with ICD therapy in the first quartile (highest risk of death, lowest proportion of sudden death) to a decrease of 66% in the fourth quartile (lowest risk of death, highest proportion of sudden death; p = 0.0013); for sudden death mortality, a 19% reduction in SPRM quartile 1 to 95% reduction in SPRM quartile 4 (p < 0.0001).

CONCLUSIONS - In symptomatic systolic heart failure patients with a Class I recommendation for primary prevention ICD therapy, the SPRM offers a useful patient-centric tool for guiding shared decision making.
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