title: Non-evidence-based ICD implantations in the United States.
abstract: BACKGROUND
  Practice guidelines do not recommend use of an implantable cardioverter-defibrillator (ICD) for primary prevention in patients recovering from a myocardial infarction or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure.
  
  
  OBJECTIVE
  To determine the number, characteristics, and in-hospital outcomes of patients who receive a non-evidence-based ICD and examine the distribution of these implants by site, physician specialty, and year of procedure.
  
  
  METHODS
  Retrospective cohort study of cases submitted to the National Cardiovascular Data Registry-ICD Registry between January 1, 2006, and June 30, 2009.
  
  
  METHODS
  In-hospital outcomes.
  
  
  RESULTS
  Of 111,707 patients, 25,145 received non-evidence-based ICD implants (22.5%). Patients who received a non-evidence-based ICD compared with those who received an evidence-based ICD had a significantly higher risk of in-hospital death (0.57% [95% confidence interval {CI}, 0.48%-0.66%] vs 0.18% [95% CI, 0.15%-0.20%]; P <.001) and any postprocedure complication (3.23% [95% CI, 3.01%-3.45%] vs 2.41% [95% CI, 2.31%-2.51%]; P <.001). There was substantial variation in non-evidence-based ICDs by site. The rate of non-evidence-based ICD implants was significantly lower for electrophysiologists (20.8%; 95% CI, 20.5%-21.1%) than nonelectrophysiologists (24.8% [95% CI, 24.2%-25.3%] for nonelectrophysiologist cardiologists; 36.1% [95% CI, 34.3%-38.0%] for thoracic surgeons; and 24.9% [95% CI, 23.8%-25.9%] for other specialties) (P<.001 for all comparisons). There was no clear decrease in the rate of non-evidence-based ICDs over time (24.5% [6908/28,233] in 2006, 21.8% [7395/33,965] in 2007, 22.0% [7245/32,960] in 2008, and 21.7% [3597/16,549] in 2009; P <.001 for trend from 2006-2009 and P = .94 for trend from 2007-2009).
  
  
  CONCLUSIONS
  Among patients with ICD implants in this registry, 22.5% did not meet evidence-based criteria for implantation.
authors.affiliation: Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA. alkha001@mc.duke.edu
authors.forename: Sana M
authors.initials: SM
authors.lastname: Al-Khatib
authors.forename: Anne
authors.initials: A
authors.lastname: Hellkamp
authors.forename: Jeptha
authors.initials: J
authors.lastname: Curtis
authors.forename: Daniel
authors.initials: D
authors.lastname: Mark
authors.forename: Eric
authors.initials: E
authors.lastname: Peterson
authors.forename: Gillian D
authors.initials: GD
authors.lastname: Sanders
authors.forename: Paul A
authors.initials: PA
authors.lastname: Heidenreich
authors.forename: Adrian F
authors.initials: AF
authors.lastname: Hernandez
authors.forename: Lesley H
authors.initials: LH
authors.lastname: Curtis
authors.forename: Stephen
authors.initials: S
authors.lastname: Hammill
mesh_terms: D000368:Aged; D002309:Cardiology / Q000706:statistics & numerical data; D015331:Cohort Studies; D001026:Coronary Artery Bypass; D016757:Death, Sudden, Cardiac / Q000209:etiology / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D019317:Evidence-Based Medicine; D005260:Female; D019983:Guideline Adherence; D006333:Heart Failure / Q000150:complications*; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications*; D018579:Patient Selection; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011322:Primary Prevention; D012042:Registries; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States