Non-evidence-based ICD implantations in the United States

JAMA. 2011 Jan 5;305(1):43-9. doi: 10.1001/jama.2010.1915.

Abstract

Context: 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.

Design, setting, and patients: Retrospective cohort study of cases submitted to the National Cardiovascular Data Registry-ICD Registry between January 1, 2006, and June 30, 2009.

Main outcome measure: 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).

Conclusion: Among patients with ICD implants in this registry, 22.5% did not meet evidence-based criteria for implantation.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Cardiology / statistics & numerical data
  • Cohort Studies
  • Coronary Artery Bypass
  • Death, Sudden, Cardiac / etiology
  • Death, Sudden, Cardiac / prevention & control*
  • Defibrillators, Implantable / statistics & numerical data*
  • Evidence-Based Medicine
  • Female
  • Guideline Adherence*
  • Heart Failure / complications*
  • Hospital Mortality*
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / complications*
  • Patient Selection*
  • Practice Patterns, Physicians' / statistics & numerical data
  • Primary Prevention
  • Registries
  • Retrospective Studies
  • Treatment Outcome
  • United States