title: Application and comparison of the FADES, MADIT, and SHFM-D risk models for risk stratification of prophylactic implantable cardioverter-defibrillator treatment.
abstract: OBJECTIVE
  Implantable cardioverter-defibrillator (ICD) treatment is beneficial in selected patients. However, it remains difficult to accurately predict which patients benefit most from ICD implantation. For this purpose, different risk models have been developed. The aim was to validate and compare the FADES, MADIT, and SHFM-D models.
  
  
  RESULTS
  All patients receiving a prophylactic ICD at the Leiden University Medical Center were evaluated. Individual model performance was evaluated by C-statistics. Model performances were compared using net reclassification improvement (NRI) and integrated differentiation improvement (IDI). The primary endpoint was non-benefit of ICD treatment, defined as mortality without prior ventricular arrhythmias requiring ICD intervention. A total of 1969 patients were included (age 63 ± 11 years; 79% male). During a median follow-up of 4.5 ± 3.9 years, 318 (16%) patients died without prior ICD intervention. All three risk models were predictive for event-free mortality (all: P < 0.001). The C-statistics were 0.66, 0.69, and 0.75, respectively, for FADES, MADIT, and SHFM-D (all: P < 0.001). Application of the SHFM-D resulted in an improved IDI of 4% and NRI of 26% compared with MADIT; IDI improved 11% with the use of SHFM-D instead of FADES (all: P < 0.001), but NRI remained unchanged (P = 0.71). Patients in the highest-risk category of the MADIT and SHFM-D models had 1.7 times higher risk to experience ICD non-benefit than receive appropriate ICD interventions [MADIT: mean difference (MD) 20% (95% CI: 7-33%), P = 0.001; SHFM-D: MD 16% (95% CI: 5-27%), P = 0.005]. Patients in the highest-risk category of FADES were as likely to experience ICD intervention as ICD non-benefit [MD 3% (95% CI: -8 to 14%), P = 0.60].
  
  
  CONCLUSIONS
  The predictive and discriminatory value of SHFM-D to predict non-benefit of ICD treatment is superior to FADES and MADIT in patients receiving prophylactic ICD treatment.
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, PO Box 9600, 2300 RC Leiden, The Netherlands.
authors.forename: Aafke C
authors.initials: AC
authors.lastname: van der Heijden
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, PO Box 9600, 2300 RC Leiden, The Netherlands.
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Rees
authors.affiliation: Department of Cardiology, University of Washington, Seattle, WA, USA.
authors.forename: Wayne C
authors.initials: WC
authors.lastname: Levy
authors.affiliation: Department of Clinical Epidemiology, Leiden University Center, Leiden, The Netherlands.
authors.forename: Johanna G
authors.initials: JG
authors.lastname: van der Bom
authors.affiliation: Department of Clinical Epidemiology, Leiden University Center, Leiden, The Netherlands.
authors.forename: Suzanne C
authors.initials: SC
authors.lastname: Cannegieter
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, PO Box 9600, 2300 RC Leiden, The Netherlands.
authors.forename: Mihàly K
authors.initials: MK
authors.lastname: de Bie
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, PO Box 9600, 2300 RC Leiden, The Netherlands.
authors.forename: Lieselot
authors.initials: L
authors.lastname: van Erven
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, PO Box 9600, 2300 RC Leiden, The Netherlands m.j.schalij@lumc.nl.
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Schalij
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, PO Box 9600, 2300 RC Leiden, The Netherlands.
authors.forename: C Jan Willem
authors.initials: CJ
authors.lastname: Borleffs
mesh_terms: D000046:Academic Medical Centers; D000368:Aged; D000066491:Clinical Decision-Making; D016757:Death, Sudden, Cardiac / Q000209:etiology / Q000517:prevention & control*; D003661:Decision Support Techniques; D017147:Defibrillators, Implantable / Q000009:adverse effects; D018572:Disease-Free Survival; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D018579:Patient Selection; D011237:Predictive Value of Tests; D011322:Primary Prevention / Q000295:instrumentation*; D012042:Registries; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: Implantable cardioverter-defibrillator; Primary prevention; Risk stratification