MADIT II (Second Multicenter Automated Defibrillator Implantation Trial) Debate: Risk Stratification, Costs, and Public Policy

Circulation

Volumn 108, Issue 15, 2003, Pages 1779-1783

  Reynolds, Matthew R ^b   Josephson, Mark E ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMIODARONE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT;

CLINICAL TRIAL; DEFIBRILLATOR; HEALTH CARE COST; HEALTH CARE POLICY; HEART EJECTION FRACTION; HEART ELECTROPHYSIOLOGY; HEART PACING; HEART VENTRICLE ARRHYTHMIA; HUMAN; MEDICAID; META ANALYSIS; MULTICENTER STUDY; PRIORITY JOURNAL; QRS COMPLEX; REVIEW; RISK ASSESSMENT;

ARRHYTHMIA; COST-BENEFIT ANALYSIS; DEFIBRILLATORS, IMPLANTABLE; ELECTRIC COUNTERSHOCK; HUMANS; INSURANCE, HEALTH, REIMBURSEMENT; MEDICAID; MEDICARE; MULTICENTER STUDIES; RANDOMIZED CONTROLLED TRIALS; RISK; UNITED STATES;

EID: 0142021962     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.CIR.0000086777.82110.F5     Document Type: Review

References (40)

1. Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877-883.
2. Centers for Medicare and Medicaid Services. National coverage analysis: implantable cardioverter defibrillators (#CAG-00157N). Tracking sheet. Available at: http://www.cms.hhs.gov/ncdr/trackingsheet.asp?id=39. Accessed September 5, 2003.
3. Centers for Medicare and Medicaid Services. Administrative file CAG: decision memorandum: implantable cardioverter defibrillators (# 00157N). June 6, 2003. Available at: http://www.cms.hhs.gov/ncdr/ memo.asp?id=39. Accessed June 9, 2003.
4. Buxton AE. The clinical use of implantable cardioverter defibrillators: where are we now? Where should we go? Ann Intern Med. 2003;138: 512-514.
5. Gregoratos G, Abrams J, Epstein AE, et al. ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). Circulation. 2002;106:2145-2161.
6. Centers for Medicare and Medicaid Services. Transcript of the Medicare Coverage Advisory Committee open session, February 12, 2003. Available at: http://www.cms.hhs.gov/mcac/id39-5.pdf. Accessed June 9, 2003.
7. Ezekowitz JA, Armstrong PW, McAlister FA. Implantable cardioverter defibrillators in primary and secondary prevention: a systematic review of randomized, controlled trials. Ann Intern Med. 2003;138:445-452.
8. Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted defibrillator in patients with coronary artery disease at high risk for ventricular arrhythmia. N Engl J Med. 1996;335:1933-1940.
9. Buxton AE, Lee KL, Fisher JD, et al. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med. 1999;341:1882-1890.
10. Sesselberg HW, Moss AJ, Steinberg J, et al. Factors associated with inducibility in the MADIT-II study population. Am J Cardiol. 2003;91: 1002-1004.
11. Moss AJ. Requestor's presentation: Guidant Corporation. Centers for Medicare and Medicaid Services: Medicare Coverage Advisory Committee open session, February 12, 2003. Available at: http:// www.cms.hhs.gov/mcac/id39-5.pdf. Accessed September 25, 2003.
12. Ware JH. The national emphysema treatment trial: how strong is the evidence? N Engl J Med. 2003;348:2055-2056.
13. Buxton AE, Lee KL, Hafley GE, et al. Relation of ejection fraction and inducible ventricular tachycardia to mode of death in patients with coronary artery disease: an analysis of patients enrolled in the Multicenter Unsustained Tachycardia Trial. Circulation. 2002;106:2466-2472.
14. Richards DAB, Byth K, Ross DL, et al. What is the best predictor of spontaneous ventricular tachycardia and sudden death after myocardial infarction? Circulation. 1991;83:756-763.
15. Buxton AE, Lee KL, DiCarlo L, et al. Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden death. N Engl J Med. 2000;342:1937-1945.
16. Schmidt G, Malik M, Barthel P, et al. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999;353:1377-1379.
17. Bailey JJ, Berson AS, Handelsman H, et al. Utility of current risk stratification tests for predicting major arrhythmic events after myocardial infarction. J Am Coll Cardiol. 2001;38:1902-1911.
18. Gomes JA, Cain ME, Buxton AE, et al. Prediction of long-term outcomes by signal-averaged electrocardiography in patients with unsustained ventricular tachycardia, coronary artery disease, and left ventricular dysfunction. Circulation. 2001;104:436-441.
19. Ikeda T, Sakata T. Takami M, et al. Combined assessment of T-wave alternans and late potentials used to predict arrhythmic events after myocardial infarction: a prospective study. J Am Coll Cardiol. 2000;35: 722-730.
20. Klingenheben T, Zabel M, D'Agostino RB, et al. Predictive value of T-wave alternans for arrhythmic events in patients with congestive heart failure, Lancet. 2000;356:651-652.
21. Sheldon R, Connolly S, Krahn A, et al. Identification of patients most likely to benefit from implantable cardioverter-defibrillator therapy: the Canadian Implantable Defibrillator Study. Circulation. 2000;101: 1660-1664.
22. Every N, Hallstrom A, McDonald KM, et al. Risk of sudden versus nonsudden cardiac death in patients with coronary artery disease. Am Heart J. 2002;144:390-396.
23. Cain ME. NASPE/Heart Rhythm Society concerned with CMS ruling limiting ICDs for select patients. Available at: http://www.naspe.org/ naspe_in_action/washington_advocacy/view/?id=8746. Accessed June 9, 2003.
24. Shamim W, Francis DP, Yousufuddin M, et al. Intraventricular conduction delay: a prognostic marker in chronic heart failure. Int J Cardiol. 1999;70:171-178.
25. Baldasseroni S, Opasich C, Gorini M, et al. Left bundle-branch block is associated with increased 1-year sudden and total mortality rate in 5517 outpatients with congestive heart failure: a report from the Italian network on congestive heart failure. Am Heart J. 2002;143:398-405.
26. a. Josephson ME, Buxton AE, Lee KL, et al. Prognostic value of the ECG in MUSST patients. Circulation. 2000;102(suppl 11):11-494.
27. Pires LA, Lehmann MH, Buxton AE, et al. Differences in inducibility and prognosis of in-hospital versus out-of-hospital identified nonsustained ventricular tachycardia in patients with coronary artery disease: clinical and trial design implications. J Am Coll Cardiol. 2001;38: 1156-1162.
28. Bigger JT, the 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;337:1569-1575.
29. Sim I, McDonald KM, Lavori PW, et al. Quantitative overview of randomized trials of amiodarone to prevent sudden cardiac death. Circulation. 1997;96:2823-2829.
30. Connolly SJ. Evidence-based analysis of amiodarone efficacy and safety. Circulation. 1999;100:2025-2034.
31. Boutitie F, Boissel JP, Connolly SJ, et al. Amiodarone interaction with β-blockers: analysis of the merged EMIAT and CAMIAT databases. Circulation. 1999;99:2268-2275.
32. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337:1576-1584.
33. Iglehart JK. The Centers for Medicare and Medicaid Services. N Engl J Med. 2001;345:1920-1924.
34. Weinstein MC, Siegel JE, Gold MR, et al. Recommendations of the Panel on Cost-effectiveness in Health and Medicine. JAMA. 1996;276: 1253-1258.
35. Mushlin AI, Hall WJ, Zwanziger J, et al. The cost-effectiveness of automatic implantable cardiac defibrillators: results from MADIT. Circulation. 1998;97:2129-2135.
36. Larsen G, Hallstrom A, McAnulty J, et al. Cost-effectiveness of the implantable cardioverter-defibrillator versus antiarrhythmic drugs in survivors of serious ventricular tachyarrhythmias: results of the Antiarrhythmics Versus Implantable Defibrillators (AVID) economic analysis sub-study. Circulation. 2002;105:2049-2057.
37. Moss AJ, Hall WJ, Zareba W. Implantable cardiac defibrillators. N Engl J Med. 2002;347:366-367. Letter.
38. Sanders GD, Hlatky MA, Every NR, et al. Potential cost-effectiveness of prophylactic use of the implantable cardioverter defibrillator or amiodarone after myocardial infarction. Ann Intern Med. 2001;135:870-883.
39. Owens DK, Sanders GD, Heidenreich PA, et al. Effect of risk stratification on cost-effectiveness of the implantable cardioverter defibrillator. Am Heart J. 2002;144:440-448.
40. National Emphysema Treatment Trial Study Group. Cost effectiveness of lung-volume-reduction surgery for patients with severe emphysema. N Engl J Med. 2003;348:2092-2102.