Non–Evidence-Based ICD Implantations in the United States | Cardiology | JAMA | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
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):877-88311907286PubMedGoogle ScholarCrossref
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):2151-215815152060PubMedGoogle ScholarCrossref
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):225-23715659722PubMedGoogle ScholarCrossref
Hohnloser SH, Kuck KH, Dorian P,  et al; DINAMIT Investigators.  Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction.  N Engl J Med. 2004;351(24):2481-248815590950PubMedGoogle ScholarCrossref
Steinbeck G, Andresen D, Seidl K,  et al; IRIS Investigators.  Defibrillator implantation early after myocardial infarction.  N Engl J Med. 2009;361(15):1427-143619812399PubMedGoogle ScholarCrossref
Bigger JT Jr.Coronary Artery Bypass Graft (CABG) Patch Trial Investigators.  Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary-artery bypass graft surgery.  N Engl J Med. 1997;337(22):1569-15759371853PubMedGoogle ScholarCrossref
Zipes DP, Camm AJ, Borggrefe M,  et al; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society.  ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.  Circulation. 2006;114(10):e385-e48416935995PubMedGoogle ScholarCrossref
Epstein AE, DiMarco JP, Ellenbogen KA,  et al.  ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons.  Circulation. 2008;117(21):e350-e40818483207PubMedGoogle ScholarCrossref
 National Cardiovascular Data Registry. Accessed December 12, 2010
Heart Rhythm Society.  The ICD Registry Program. Accessed August 15, 2010
National Cardiovascular Data Registry.  ICD Registry. Accessed August 15, 2010
Curtis JP, Luebbert JJ, Wang Y,  et al.  Association of physician certification and outcomes among patients receiving an implantable cardioverter-defibrillator.  JAMA. 2009;301(16):1661-167019383957PubMedGoogle ScholarCrossref
Hammill SC, Kremers MS, Kadish AH,  et al.  Review of the ICD Registry's third year, expansion to include lead data and pediatric ICD procedures, and role for measuring performance.  Heart Rhythm. 2009;6(9):1397-140119716099PubMedGoogle ScholarCrossref
Farmer SA, Kirkpatrick JN, Heidenreich PA, Curtis JP, Wang Y, Groeneveld PW. Ethnic and racial disparities in cardiac resynchronization therapy.  Heart Rhythm. 2009;6(3):325-33119251206PubMedGoogle ScholarCrossref
Hernandez AF, Fonarow GC, Liang L,  et al.  Sex and racial differences in the use of implantable cardioverter-defibrillators among patients hospitalized with heart failure.  JAMA. 2007;298(13):1525-153217911497PubMedGoogle ScholarCrossref
Al-Khatib SM, Greiner MA, Peterson ED, Hernandez AF, Schulman KA, Curtis LH. Patient and implanting physician factors associated with mortality and complications after implantable cardioverter-defibrillator implantation, 2002-2005.  Circ Arrhythm Electrophysiol. 2008;1(4):240-24919169382PubMedGoogle ScholarCrossref
Original Contribution
January 5, 2011

Non–Evidence-Based ICD Implantations in the United States

Author Affiliations

Author Affiliations: Duke Clinical Research Institute (Drs Al-Khatib, Mark, Peterson, Sanders, and Hernandez and Ms Hellkamp), Center for Clinical and Genetic Economics (Dr L. Curtis), and the Divisions of Cardiology (Drs Al-Khatib, Peterson, and Hernandez) and General Internal Medicine (Dr L. Curtis), Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Division of Cardiovascular Medicine, Department of Medicine, Yale University, New Haven, Connecticut (Dr J. Curtis); Division of Cardiology, VA Palo Alto Healthcare System, Palo Alto, California (Dr Heidenreich); and Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota (Dr Hammill).

JAMA. 2011;305(1):43-49. doi:10.1001/jama.2010.1915

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.