CORRESPONDENCE: LETTER TO THE EDITOR
Reply
Andrew E. Epstein, MD*
* The University of Alabama at Birmingham, Division of Cardiovascular Disease, Department of Medicine, THT 321, 1530 3rd Avenue South, Birmingham, Alabama 35294-0006 (Email: aepstein{at}cardmail.dom.uab.edu).
Improving patient outcomes requires therapy proven to enhance quality of life and survival in a cost-effective fashion. Mindful of this universally accepted notion in contemporary health care, I welcome the opportunity to respond to Dr. Stamato's comments on the articles by Tung et al. (1) and Epstein (2) regarding evidence supporting implantable cardioverter-defibrillator (ICD) therapy.
First, Dr. Stamato observes that because beta-blocker use is similarly underused in clinical trials and clinical practice, he concludes that although ICD therapy prolongs life, underutilization "does cast some doubt on this conclusion." The issue is not whether ICDs prolong life. Multiple prospective randomized trials have unequivocally shown that ICDs prolong life in selected patient populations (3). The real issue is that guidelines are not followed, including both pharmacologic and nonpharmacologic therapies. To improve outcomes, including quality of life and survival, practice must be evidence based; physicians must "get with the guidelines." The best available data regarding quality of life and cost effectiveness support ICD use (4,5).
Second, the use of ICDs in "fewer than the predicted number of patients" is noted by Dr. Stamato. Initial enthusiasm for most new therapies tends to be tempered by the outcomes in clinical medicine compared with clinical trails. Optimistic projections on the implantation rate of ICDs were based on the prevalence rather than incidence of primary prevention ICD candidates. Media focus on device and lead reliability was not balanced with context or perspective on the risks and benefits of ICD therapy. In true context, many more patients have been hurt by unnecessary device removal and underutilization than injured by device failure (6).
Finally, all physicians agree that we need to more accurately identify not only patients who will benefit from device therapy but also those who will not, as discussed in my commentary. The excellent articles by Buxton et al. (7) and Goldenberg et al. (8) using retrospective data from the MUSTT (Multicenter UnSustained Tachycardia Trial) and MADIT II (Multicenter Automatic Defibrillator Implantation Trial II) trials have moved us in this direction. Currently there are ongoing trials addressing this concern (M2Risk [Risk Stratification in MADIT II Type Patients], CARISMA [Cardiac Arrhythmias and Risk Stratification After Myocardial Infarction], and the VEST/PREDICTS [Evaluating the Effectiveness of the LifeVest Defibrillator and Improving Methods for Determining the Use of Implantable Cardioverter Defibrillators] study) (9–11).
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References
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1. Tung R, Zimetbaum P, Josephson ME. State of the art: a critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death J Am Coll Cardiol 2008;52:1111-1121.[Abstract/Free Full Text]2. Epstein AE. Benefits of the implantable cardioverter-defibrillator J Am Coll Cardiol 2008;52:1122-1127.[Abstract/Free Full Text] 3. 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) J Am Coll Cardiol 2008;51:2085-2105.[Free Full Text] 4. Mark DB, Anstrom KJ, Sun JL, et al. Quality of life with defibrillator therapy or amiodarone in heart failure N Engl J Med 2008;359:999-1008.[Abstract/Free Full Text] 5. Sanders GD, Hlatky MA, Owens DK. Cost-effectiveness of implantable cardioverter-defibrillators N Engl J Med 2005;353:1471-1480.[Abstract/Free Full Text] 6. Gould PA, Krahn AD. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories JAMA 2006;295:1907-1911.[Abstract/Free Full Text] 7. Buxton AE, Lee KL, Hafley GE, et al. Limitation of ejection fraction for prediction of sudden death risk in patients with coronary artery disease J Am Coll Cardiol 2007;50:1150-1157.[Abstract/Free Full Text] 8. Goldenberg I, Vyas AK, Hall WJ, et al. Risk stratification for primary implantation of a cardioverter-defibrillator in patients with left ventricular dysfunction J Am Coll Cardiol 2008;51:288-296.[Abstract/Free Full Text] 9. Zareba W. Risk Stratification in MADIT II Type Patients. Grant R01 HL077478-01A1. 10. Evaluating the effectiveness of the LifeVest defibrillator and improving methods for determining the use of implantable cardioverter defibrillators (the VEST/PREDICTS study) NCT00628966
www.clinicaltrials.gov 2008Accessed November 20, 2008. 11. CARISMA. Cardiac arrhythmias and risk stratification after myocardial infarction NCT00145119
www.clinicaltrials.gov 2008Accessed November 20, 2008.
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