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Randomized Controlled Trial
. 2015 Sep;8(5):927-37.
doi: 10.1161/CIRCHEARTFAILURE.115.002414. Epub 2015 Jul 29.

Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators

Douglas S Lee  1 , Judy Hardy  2 , Raymond Yee  2 , Jeffrey S Healey  2 , David Birnie  2 , Christopher S Simpson  2 , Eugene Crystal  2 , Iqwal Mangat  2 , Kumaraswamy Nanthakumar  2 , Xuesong Wang  2 , Andrew D Krahn  2 , Paul Dorian  2 , Peter C Austin  2 , Jack V Tu  2 ; Investigators of the Ontario ICD Database
Collaborators, Affiliations
Randomized Controlled Trial

Clinical Risk Stratification for Primary Prevention Implantable Cardioverter Defibrillators

Douglas S Lee et al. Circ Heart Fail. 2015 Sep.

Abstract

Background: A conceptualized model may be useful for understanding risk stratification of primary prevention implantable cardioverter defibrillators considering the competing risks of appropriate implantable cardioverter defibrillator shock versus mortality.

Methods and results: In a prospective, multicenter, population-based cohort with left ventricular ejection fraction ≤35% referred for primary prevention implantable cardioverter defibrillator, we developed dual risk stratification models to determine the competing risks of appropriate defibrillator shock versus mortality using a Fine-Gray subdistribution hazard model. Among 7020 patients referred, 3445 underwent defibrillator implant (79.7% men, median, 66 years [25th, 75th: 58-73]). During 5918 person-years of follow-up, appropriate shock occurred in 204 patients (3.6 shocks/100 person-years) and 292 died (4.9 deaths/100 person-years). Competing risk predictors of appropriate shock included nonsustained ventricular tachycardia, atrial fibrillation, serum creatinine concentration, digoxin or amiodarone use, and QRS duration near 130-ms peak. One-year cumulative incidence of appropriate shock was 0.9% in the lowest risk category, and 1.7%, 2.5%, 4.9%, and 9.3% in low, intermediate, high, and highest risk groups, respectively. Hazard ratios for appropriate shock ranged from 4.04 to 7.79 in the highest 3 deciles (all P≤0.001 versus lowest risk). Cumulative incidence of 1-year death was 0.6%, 1.9%, 3.3%, 6.2%, and 17.7% in lowest, low, intermediate, high, and highest risk groups, respectively. Mortality hazard ratios ranged from 11.48 to 36.22 in the highest 3 deciles (all P<0.001 versus lowest risk).

Conclusions: Simultaneous estimation of risks of appropriate shock and mortality can be performed using clinical variables, providing a potential framework for identification of patients who are unlikely to benefit from prophylactic implantable cardioverter defibrillator.

Keywords: cardiac arrhythmia; death; decision making; decision support techniques; sudden cardiac death; ventricular fibrillation; ventricular tachycardia.

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Figures

Figure 1.
Figure 1.
Patient flow diagram. AAD indicates antiarrhythmic drug; ARVC, arrythmogenic right ventricular cardiomyopathy; HCM, hypertrophic cardiomyopathy; ICD, implantable cardioverter defibrillator; LQTS, long QT syndrome; LVEF, left ventricular ejection fraction; and QRSD, QRS duration.
Figure 2.
Figure 2.
Cumulative incidence of appropriate shock.
Figure 3.
Figure 3.
Cumulative incidence of death.
Figure 4.
Figure 4.
Depiction of conceptual model of predicted risks of appropriate shock vs death using quadrants; number of patients in quadrants I (n=86), II (n=262), III (n=250), and IV (2847). ICD indicates implantable cardioverter defibrillator.
See this image and copyright information in PMC

Comment in

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