title: Predicting Risk Versus Predicting Potential Survival Benefit Using 123I-mIBG Imaging in Patients With Systolic Dysfunction Eligible for Implantable Cardiac Defibrillator Implantation: Analysis of Data From the Prospective ADMIRE-HF Study.
abstract: BACKGROUND
  Cardiac (123)I-metaiodobenzylguanidine ((123)I-mIBG) imaging improves prognostication in patients with left ventricular (LV) dysfunction. Whether (123)I-mIBG can identify optimal candidates for implantable cardiac defibrillator (ICD) placement is unclear. We examined whether (123)I-mIBG enhances risk assessment and identifies patients with enhanced survival with ICD in a patient cohort with reduced LV function who were candidates for ICD implantation.
  
  
  RESULTS
  We identified 777 patients (66 sites, 12 countries) without ICD at the time of enrollment in Adreview Myocardial Imaging for Risk Evaluation in Heart Failure (ADMIRE-HF) and index (123)I-mIBG study. Patients completed prescribed study protocol and follow-up. Heart-to-mediastinum (H/M) ratio was determined from (123)I-mIBG results. Survival modeling used a Cox proportional hazards mixed-effects model, including a propensity score, to adjust for nonrandomized ICD implantation after (123)I-mIBG. All-cause death occurred in 75 patients (9.6%), and 196 (25%) patients had ICD implantation on follow-up. After adjusting for multiple factors, although the H/M ratio added incremental prognostic value and enhanced reclassification, neither H/M results, BNP levels, nor left ventricular ejection fraction interacted with ICD use in the survival model, indicating that these variables did not identify patients with enhanced survival with ICD implantation. Nonetheless, H/M results did identify the number of lives saved by ICD use per 100 treated.
  
  
  CONCLUSIONS
  We found that although (123)I-mIBG imaging enhances the risk stratification of patients with left ventricular dysfunction who are ICD candidates, it does not identify which patients may have improved survival with ICD placement. However, (123)I-mIBG identifies the absolute benefit gained with ICD use, thus may play a role in optimizing the cost-effectiveness of this intervention.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00126425 and NCT00126438.
authors.affiliation: From the Cardiovascular Imaging Section, Department of Cardiovascular Medicine Heart and Vascular Institute (R.H., V.M., M.D.C.), Department of Quantitative Health Science (B.N.), and Department of Nuclear Medicine, Imaging Institute (M.D.C.), Cleveland Clinic, OH. hachamr@ccf.org.
authors.forename: Rory
authors.initials: R
authors.lastname: Hachamovitch
authors.affiliation: From the Cardiovascular Imaging Section, Department of Cardiovascular Medicine Heart and Vascular Institute (R.H., V.M., M.D.C.), Department of Quantitative Health Science (B.N.), and Department of Nuclear Medicine, Imaging Institute (M.D.C.), Cleveland Clinic, OH.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Nutter
authors.affiliation: From the Cardiovascular Imaging Section, Department of Cardiovascular Medicine Heart and Vascular Institute (R.H., V.M., M.D.C.), Department of Quantitative Health Science (B.N.), and Department of Nuclear Medicine, Imaging Institute (M.D.C.), Cleveland Clinic, OH.
authors.forename: Venu
authors.initials: V
authors.lastname: Menon
authors.affiliation: From the Cardiovascular Imaging Section, Department of Cardiovascular Medicine Heart and Vascular Institute (R.H., V.M., M.D.C.), Department of Quantitative Health Science (B.N.), and Department of Nuclear Medicine, Imaging Institute (M.D.C.), Cleveland Clinic, OH.
authors.forename: Manuel D
authors.initials: MD
authors.lastname: Cerqueira
mesh_terms: D019797:3-Iodobenzylguanidine; D000368:Aged; D016009:Chi-Square Distribution; D003661:Decision Support Techniques; D017147:Defibrillators, Implantable; D018572:Disease-Free Survival; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005060:Europe; D005260:Female; D006333:Heart Failure / Q000000981:diagnostic imaging* / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017711:Nonlinear Dynamics; D009656:North America; D018579:Patient Selection; D011237:Predictive Value of Tests; D057216:Propensity Score; D016016:Proportional Hazards Models; D011446:Prospective Studies; D019275:Radiopharmaceuticals; D018570:Risk Assessment; D012307:Risk Factors; D013599:Systole; D013997:Time Factors; D015899:Tomography, Emission-Computed, Single-Photon; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging* / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016277:Ventricular Function, Left
chemical_list: D019275:Radiopharmaceuticals; D019797:3-Iodobenzylguanidine
keywords: defibrillators; heart failure; prognosis; radioisotopes; survival