Application and comparison of the FADES, MADIT, and SHFM-D risk models for risk stratification of prophylactic implantable cardioverter-defibrillator treatment

Aims 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. Methods and 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]. Conclusion 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.

[1]  P. Lambiase,et al.  Prediction of Nonarrhythmic Mortality in Primary Prevention Implantable Cardioverter-Defibrillator Patients With Ischemic and Nonischemic Cardiomyopathy. , 2015, JACC. Clinical electrophysiology.

[2]  S. Adabag,et al.  Application of the Multicenter Automatic Defibrillator Implantation Trial II risk score in a nontrial setting. , 2013, The American journal of cardiology.

[3]  Arthur A M Wilde,et al.  The ICD for Primary Prevention in Patients With Inherited Cardiac Diseases: Indications, Use, and Outcome: A Comparison With Secondary Prevention , 2013, Circulation. Arrhythmia and electrophysiology.

[4]  Wojciech Zareba,et al.  Applicability of a risk score for prediction of the long-term (8-year) benefit of the implantable cardioverter-defibrillator. , 2012, Journal of the American College of Cardiology.

[5]  Jeroen J. Bax,et al.  Clinical prediction model for death prior to appropriate therapy in primary prevention implantable cardioverter defibrillator patients with ischaemic heart disease: the FADES risk score , 2012, Heart.

[6]  Jeroen J. Bax,et al.  Long-term follow-up of primary and secondary prevention implantable cardioverter defibrillator patients. , 2011, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[7]  Jeroen J. Bax,et al.  Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. , 2011, Journal of the American College of Cardiology.

[8]  S. Themistoclakis,et al.  European utilization of the implantable defibrillator: has 10 years changed the 'enigma'? , 2010, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[9]  D. Mozaffarian,et al.  Maximizing Survival Benefit With Primary Prevention Implantable Cardioverter-Defibrillator Therapy in a Heart Failure Population , 2009, Circulation.

[10]  M. Josephson,et al.  A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. , 2008, Journal of the American College of Cardiology.

[11]  D. Mark,et al.  Prognostic importance of defibrillator shocks in patients with heart failure. , 2008, The New England journal of medicine.

[12]  M. Pencina,et al.  Evaluating the added predictive ability of a new marker: From area under the ROC curve to reclassification and beyond , 2008, Statistics in medicine.

[13]  A. Moss,et al.  Risk stratification for primary implantation of a cardioverter-defibrillator in patients with ischemic left ventricular dysfunction. , 2008, Journal of the American College of Cardiology.

[14]  Peter C Austin,et al.  Effect of cardiac and noncardiac conditions on survival after defibrillator implantation. , 2007, Journal of the American College of Cardiology.

[15]  H Putter,et al.  Tutorial in biostatistics: competing risks and multi‐state models , 2007, Statistics in medicine.

[16]  D. Mark,et al.  The high cost of implantable defibrillators. , 2007, European heart journal.

[17]  J. Ornato,et al.  ACC/AHA/ESC PRACTICE GUIDELINES ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death , 2006 .

[18]  Dan M. Roden,et al.  ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: A report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines , 2006 .

[19]  Douglas L Packer,et al.  Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. , 2005, The New England journal of medicine.

[20]  A. Khasnis,et al.  Prophylactic Defibrillator Implantation in Patients With Nonischemic Dilated Cardiomyopathy , 2004 .

[21]  H. Wellens,et al.  Out-of-hospital cardiac arrest in the 1990's: a population-based study in the Maastricht area on incidence, characteristics and survival. , 1997, Journal of the American College of Cardiology.

[22]  Andrea Mazzanti,et al.  [2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death]. , 2015, Kardiologia polska.

[23]  T. Stijnen,et al.  SPECIAL SERIES: MISSING DATA Review: A gentle introduction to imputation of missing values , 2006 .

[24]  Wojciech Zareba,et al.  Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. , 2002, The New England journal of medicine.