Individualizing Decisions for Patients With Prophylactic Implantable Cardiac Defibrillators Subject to Device Advisories: A Commentary

American Journal of Cardiology

Volumn 98, Issue 9, 2006, Pages 1291-1293

  Bigger, J Thomas ^a   Kleiger, Robert E ^b  

^a Columbia University College of Physicians and Surgeons ^*  (United States)

^b WASHINGTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BRAIN NATRIURETIC PEPTIDE;

ARTICLE; CARDIOMYOPATHY; DECISION MAKING; DEFIBRILLATOR; EVALUATION; FOOD AND DRUG ADMINISTRATION; HEART VENTRICLE TACHYCARDIA; HUMAN; MEDICAL LITERATURE; MORBIDITY; MORTALITY; PACEMAKER; PRIORITY JOURNAL; UNITED STATES;

EID: 33750045471     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjcard.2006.07.022     Document Type: Note

References (24)

1. Centers for Medicare and Medicaid Services. Decision memo for implantable defibrillators (CAG-00157R3). Baltimore, MD: Centers for Medicare and Medicaid Services, January 27, 2005. Available at: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=148. Accessed December 16, 2005.
2. Maisel W.H. Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. JAMA 294 (2005) 955-958
3. Gould P.A., Krahn A.D., and Canadian Heart Rhythm Society Working Group on Device Advisories. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 295 (2006) 1907-1911
4. Maisel W.H., Moynahan M., Zuckerman B.D., Gross T.P., Tovar O.H., Tillman D.-B., and Schultz D.B. Pacemaker and ICD generator malfunctions. Analysis of food and drug administration annual reports. JAMA 295 (2006) 1901-1906
5. Maisel W.H. Pacemaker and ICD generator reliability. Meta-analysis of device registries. JAMA 295 (2006) 1929-1934
6. Wilkoff B.L. Pacemaker and ICD malfunction-an incomplete picture. JAMA 295 (2006) 1944-1946
7. Heart Rhythm Society Task Force on Device Performance Policies and Guidelines. Draft recommendations report. Available at: http://www.hrsonline.org. Accessed on September 13, 2006.
8. Moss A.J., Zareba W., Hall W.J., Klein H., Wilber D.J., Cannom D.S., Daubert J.P., Higgins S.L., Brown M.W., Andrews M.L., and 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 346 (2002) 877-883
9. Bardy G.H., Lee K.L., Mark D.B., Poole J.E., Packer D.L., Boineau R., Domanski M., Troutman C., Anderson J., Johnson G., 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 352 (2005) 225-237
10. Al-Khatib S.M., Sanders G.D., Mark D.B., Lee K.L., Bardy G.H., Bigger J.T., Buxton A.E., Connolly S., Kadish A., Moss A.J., et al., expert panel participating in a Duke Clinical Research Institute-sponsored conference. Implantable cardioverter defibrillators and cardiac resynchronization therapy in patients with left ventricular dysfunction: randomized trial evidence through 2004. Am Heart J 149 (2005) 1020-1034
11. Buxton A.E., Lee K.L., Hafley G.E., Wyse D.G., Fisher J.D., Lehmann M.H., Pires L.A., Gold M.R., Packer D.L., Josephson M.E., et al., MUSTT Investigators. 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 106 (2002) 2466-2472
12. Gehi A., Haas D., and Fuster V. Primary prophylaxis with the implantable cardioverter-defibrillator. The need for improved risk stratification. JAMA 294 (2005) 958-960
13. Hunt S.A., Abraham W.T., Chin M.H., Feldman A.M., Francis G.S., Ganiats T.G., Jessup M., Konstam M.A., Mancini D.M., Michl K., et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult-summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). Circulation 112 (2005) 1825-1852
14. Cleland J.G.F., Daubert J.-C., Erdmann, Freemantle N., Gras D., Kappenberger L., Tavazzi L., and Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 352 (2005) 1539-1549
15. Jarcho J.A. Resynchronizing ventricular contraction in heart failure. N Engl J Med 352 (2005) 1594-1597
16. Gehi A.K., Stein R.H., Metz L.D., and Gomes J.A. Microvolt T-wave alternans for the risk stratification of ventricular tachyarrhythmic events: a meta-analysis. J Am Coll Cardiol 46 (2005) 75-82
17. Bloomfield D.M., Bigger J.T., Steinman R.C., Namerow P.B., Parides M.K., Curtis A.B., Kaufman E.S., Davidenko J.M., Shinn T.S., and Fontaine J. Microvolt T-wave alternans and the risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol 47 (2006) 456-463
18. Chow T., Kereiakes D.J., Bartone C., Booth T., Schloss E.J., Waller T., Chung E.S., Menon S., Nallamothu B.K., and Chan P.S. Prognostic utility of microvolt T-wave alternans in risk stratification of patients with ischemic cardiomyopathy. J Am Coll Cardiol 47 (2006) 1820-1827
19. Gold M.R., Bloomfield D.M., Anderson K.P., El-Sherif N.E., Wilber D.J., Groh W.J., Estes N.A.M., Kaufman E.S., Greenberg M.L., and Rosenbaum D.S. A comparison of T-wave alternans, signal averaged electrocardiography and programmed ventricular stimulation for arrhythmia risk stratification. J Am Coll Cardiol 36 (2000) 2247-2253
20. Ikeda T., Saito H., Tanno K., Shimizu H., Watanabe J., Ohnishi Y., Kasamaki Y., and Ozawa Y. T-wave alternans as a predictor for sudden cardiac death after myocardial infarction. Am J Cardiol 89 (2002) 79-82
21. Kaufman E.S., Bloomfield D.M., Steinman R.C., Namerow P.B., Costantini O., Cohen R.J., and Bigger J.T. "Indeterminate" microvolt T-wave alternans tests predict high risk of death or sustained ventricular arrhythmias in patients with left ventricular dysfunction. J Am Coll Cardiol 48 (2006) 1399-1404
22. Pinamonti B., Zecchin M., Di Lenarda A., Gregori D., Sinagra G., and Camerini F. Persistence of restrictive left ventricular filling pattern in dilated cardiomyopathy: an ominous prognostic sign. J Am Coll Cardiol 29 (1997) 604-612
23. Nishimura R.A., and Tajik A.J. Evaluation of diastolic filling of left ventricle in health and disease: Doppler echocardiography is the clinician's Rosetta stone. J Am Coll Cardiol 30 (1997) 8-18
24. Abramson S.V., Burke J.F., Kelly Jr. J.J., Kitchen III J.G., Dougherty M.J., Yih D.F., McGeehin III F.C., Shuck J.W., and Phiambolis T.P. Pulmonary hypertension predicts mortality and morbidity in patients with dilated cardiomyopathy. Ann Intern Med 116 (1992) 888-895