title: Developing a risk model for in-hospital adverse events following implantable cardioverter-defibrillator implantation: a report from the NCDR (National Cardiovascular Data Registry).
abstract: OBJECTIVE
  To better inform patients and physicians of the expected risk of adverse events and to assist hospitals' efforts to improve the outcomes of patients undergoing implantable cardioverter-defibrillator (ICD) implantation, we developed and validated a risk model using data from the NCDR (National Cardiovascular Data Registry) ICD Registry.
  
  
  BACKGROUND
  ICD prolong life in selected patients, but ICD implantation carries the risk of periprocedural complications.
  
  
  METHODS
  We analyzed data from 240,632 ICD implantation procedures between April 1, 2010, and December 31, 2011 in the registry. The study group was divided into a derivation (70%) and a validation (30%) cohort. Multivariable logistic regression was used to identify factors associated with in-hospital adverse events (complications or mortality). A parsimonious risk score was developed on the basis of beta estimates derived from the logistic model. Hierarchical models were then used to calculate risk-standardized complication rates to account for differences in case mix and procedural volume.
  
  
  RESULTS
  Overall, 4,388 patients (1.8%) experienced at least 1 in-hospital complication or death. Thirteen factors were independently associated with an increased risk of adverse outcomes. Model performance was similar in the derivation and validation cohorts (C-statistics = 0.724 and 0.719, respectively). The risk score characterized patients into low- and-high risk subgroups for adverse events (≤10 points, 0.3%; ≥30 points, 4.2%). The risk-standardized complication rates varied significantly across hospitals (median: 1.77, interquartile range 1.54, 2.14, 5th/95th percentiles: 1.16/3.15).
  
  
  CONCLUSIONS
  We developed a simple model that predicts risk for in-hospital adverse events among patients undergoing ICD placement. This can be used for shared decision making and to benchmark hospital performance.
authors: Division of Aging, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts.
authors: John A
authors: JA
authors: Dodson
authors: Division of Cardiology, Lahey Hospital and Medical Center, Burlington, Massachusetts.
authors: Matthew R
authors: MR
authors: Reynolds
authors: Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors: Haikun
authors: H
authors: Bao
authors: Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.
authors: Sana M
authors: SM
authors: Al-Khatib
authors: Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.
authors: Eric D
authors: ED
authors: Peterson
authors: Mid Carolina Cardiology, Charlotte, North Carolina.
authors: Mark S
authors: MS
authors: Kremers
authors: Fort Wayne Cardiology, Parkview Health System, Fort Wayne, Indiana.
authors: Michael J
authors: MJ
authors: Mirro
authors: Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut. Electronic address: jeptha.curtis@yale.edu.
authors: Jeptha P
authors: JP
authors: Curtis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000628:therapy*; D016208:Databases, Factual; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D058028:Research Report; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D014481:United States / Q000453:epidemiology
keywords: complication; implantable cardioverter-defibrillator; quality of care; registry