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

Non-evidence-based ICD implantations in the United States

Sana M Al-Khatib  1 , Anne Hellkamp, Jeptha Curtis, Daniel Mark, Eric Peterson, Gillian D Sanders, Paul A Heidenreich, Adrian F Hernandez, Lesley H Curtis, Stephen Hammill
Affiliations
Comparative Study

Non-evidence-based ICD implantations in the United States

Sana M Al-Khatib et al. JAMA. .

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.

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Figures

Figure 1
Figure 1
Rates of non–evidence-based ICD implants across sites.
Figure 2
Figure 2
Temporal changes in non–evidence-based ICD implants. The 2009 data are for the first 6 months only.
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References

    1. Moss AJ, Zareba W, Hall WJ, et al. Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346(12):877–883. - PubMed
    1. Kadish A, Dyer A, Daubert JP, et al. Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004;350(21):2151–2158. - PubMed
    1. Bardy GH, Lee KL, Mark DB, et al. Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352(3):225–237. - PubMed
    1. Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004;351(24):2481–2488. - PubMed
    1. Steinbeck G, Andresen D, Seidl K, et al. IRIS Investigators. Defibrillator implantation early after myocardial infarction. N Engl J Med. 2009;361(15):1427–1436. - PubMed

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