Clinical judgment versus decision analysis for managing device advisories

PACE - Pacing and Clinical Electrophysiology

Volumn 31, Issue 10, 2008, Pages 1236-1240

  Amin, Mitesh S ^a   Wood, Mark A ^a   Shepard, Richard K ^a   Kalahasty, Gautham ^a   Ellenbogen, Kenneth A ^a  

^a VIRGINIA COMMONWEALTH UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Advisory; Decision analysis; Implantable cardioverter defibrillator; Markov model; Pacemaker; Recall

Indexed keywords

ARTICLE; ARTIFICIAL HEART PACEMAKER; CLINICAL DECISION MAKING; CLINICAL PRACTICE; CONTROLLED STUDY; DEFIBRILLATOR; HEALTH CARE MANAGEMENT; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HUMAN; MAJOR CLINICAL STUDY; MEDICAL INFORMATION; RISK ASSESSMENT;

DECISION SUPPORT TECHNIQUES; DEFIBRILLATORS, IMPLANTABLE; PACEMAKER, ARTIFICIAL; PRODUCT SURVEILLANCE, POSTMARKETING; RISK MANAGEMENT; VIRGINIA;

EID: 51849132596     PISSN: 01478389     EISSN: 15408159     Source Type: Journal    
DOI: 10.1111/j.1540-8159.2008.01171.x     Document Type: Article

References (15)

1. Maisel WH, Moynahan M, Zuckerman BD, Gross TP, Tovar OH, Tillman DB, Schultz DB. Pacemaker and ICD generator malfunctions: Analysis of Food and Drug Administration annual reports. JAMA 2006 295 : 1901 1906.
2. Maisel WH. Pacemaker and ICD generator reliability: Meta-analysis of device registries. JAMA 2006 295 : 1929 1934.
3. Maisel WH. Physician management of pacemaker and implantable cardioverter defibrillator advisories. Pacing Clin Electrophysiol 2004 27 : 437 442.
4. Carlson MD, Wilkoff BL, Maisel WH, Carlson MD, Ellenbogen KA, Saxon LA, Prystowsky EN, et al. Recommendations from the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines endorsed by the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) and the International Coalition of Pacing and Electrophysiology Organizations (COPE). Heart Rhythm 2006 3 : 1250 1273.
5. Santini M, Brachmann J, Cappato R, Davies W, Farrè J, Levy S, Quesada A, et al. Recommendations of the European Cardiac Arrhythmia Society Committee on device failures and complications. Pacing Clin Electrophysiol 2006 29 : 653 669.
6. Auricchio A, Gropp M, Ludgate S, Vardas P, Brugada J, Priori SG Writing Committee for the European Heart Rhythm Association Guidance Document on Cardiac Rhythm Management Product Performance. European Heart Rhythm Association guidance document on cardiac rhythm management product performance. Europace 2006 8 : 313 322.
7. Weinstein MC, Fineberg HV, Elstein AS, Frazier HS, Neuhauser D, Neutra RR, McNeil BJ. Clinical Decision Analysis, Philadelphia, PA, WB Saunders, 1980, pp. 131 166.
8. Sonnenberg FA, Beck JR. Markov models in medical decision making: A practical guide. Med Decis Making 1993 13 : 322 338.
9. Amin MS, Matchar DB, Wood MA, Ellenbogen KA. Management of recalled pacemakers and implantable cardioverter-defibrillators: A decision analysis model. JAMA 2006 296 : 412 420.
10. Gula LJ, Massel D, Krahn AD, Skanes AC, Yee R, Klein GJ. Survival rates as a guide to implanted cardioverter-defibrillator replacement strategies for device recalls-adding statistical insight to clinical intuition. Am Heart J 2007 153 : 253 259.
11. Boston Scientific CRM Product Performance Report, Natick, MA, Boston Scientific, 2008.
12. Cardiac Rhythm Disease Management, Product Performance Report, Minneapolis, MN, Medtronic, 2007.
13. Product Performance Report, Cardiac Rhythm Management, Sylmar, CA, St. Jude Medical, 2007.
14. Gould PA, Krahn AD Canadian Heart Rhythm Society Working Group on Device Advisories. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 2006 295 : 1907 1911.
15. Cuculi F, Herzig W, Kobza R, Erne P. Psychological distress in patients with ICD recall. Pacing Clin Electrophysiol 2006 29 : 1261 1265.