Retrieval analysis of mechanical heart valves: Impact on design and clinical practice

Artificial Organs

Volumn 22, Issue 9, 1998, Pages 794-799

  Cromheecke, Manon E ^a   Overkamp, Peter J B ^b   De Mol, Bas A J M ^a,b   Van Gaalen, Geerda L ^a,b   Becker, Anton E ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b DELFT UNIVERSITY OF TECHNOLOGY   (Netherlands)

Author keywords

Mechanical failure; Mechanical heart valve prosthesis; Retrieval analysis

Indexed keywords

RISK ASSESSMENT; VALVES (MECHANICAL);

CLINICAL PRACTICES; DESIGN PRACTICE; INFORMATION CONCERNING; MECHANICAL FAILURES; MECHANICAL HEART VALVE PROSTHESIS; MECHANICAL HEART VALVES; PATIENT POPULATION; RETRIEVAL ANALYSIS; RISK OF FAILURE; VALVE DESIGN;

FAILURE (MECHANICAL);

ARTICLE; BIOMECHANICS; CLINICAL PRACTICE; EXPLANT; HEART VALVE PROSTHESIS; IMPLANT; INFORMATION RETRIEVAL; PRIORITY JOURNAL; SAINT JUDE HEART VALVE PROSTHESIS; SURVIVAL;

EID: 0031784355     PISSN: 0160564X     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1525-1594.1998.06172.x     Document Type: Article

References (23)

1. Black J. Implant retrieval: An overview of goals and perspectives. Int J Risk Saf Med 1996;8:99-105.
2. de Mol BA. Retrieval analysis of cardiovascular implants. Int J Risk Saf Med 1996;8:119-23.
3. Fielder JH, Black J. But doctor, it's my hip! The fate of failed medical devices. Kennedy Inst Ethnics J 1995;5(2):113-31.
4. Fielder JH. Getting the bad news about your artificial heart valve. Hastings Ctr Report 1993;23(2):22-8.
5. Gutheil TG, Bursztajn H, Brodsky A. Malpractice prevention through the sharing of uncertainty. New Engl J Med 1984;311: 49-52.
6. de Mol BAJM, Overkamp PJ, van Gaalen GL, Becker AE. Non-destructive assessment of 62 Dutch Björk-Shiley convexo-concave heart valves. Eur J Cardiothorac Surg 1997;11: 703-9.
7. van der Graaf Y, de Waard F, van Herwerden LA, Defauw JJ. Risk of strut fracture of Björk-Shiley valves. Lancet 1992;339: 257-61.
8. de Mol BA, Kallewaard M, McLellen RB, van Herwerden LA, Defauw JJ, van der Graaf Y. Single-leg fractures in explanted Björk-Shiley valves. Lancet 1994;343:9-12.
9. Walker AM, Funch DP, Bianchi L, Blot WJ. Shop order fracture rate as a risk factor for struct fracture in Björk-Shiley CC 60 degree heart valves. J Heart Valve Dis 1997;6:264-7.
10. Klepetko W, Moritz A, Mlczoch J, Schurawitzki H, Domanig E, Wolner E. Leaflet fracture in Edwards-Duromedics bileaflet valves. J Thorac Cardiovasc Surg 1989;97:90-4.
11. Bodnar E. The Medtronic Parallel valve and the lessons learned. J Heart Valve Dis 1996;5:572-3.
12. Gross JM, Shu MC, Dai FD, Ellis J, Yoganathan AP. A microstructural flow analysis within a bileaflet mechanical valve hinge. J Heart Valve Dis 1996;5:581-90.
13. Hasenkam JM, Pasquino E, Stacchino C, Arru P, Vallana F, Paulsen PK. Wear patterns in the Sorin Bicarbon mechanical heart valve: A clinical explant study. J Heart Valve Dis 1997; 6:105-14.
14. Koornneef F, van Gaalen GL, de Mol BA. A risk assessment and control model for the failing Björk-Shiley convexoconcave heart valve. Int J Technol Assess Health Care 1996; 12:141-5.
15. de Mol BA, van Gaalen GL. The editor's corner: Biomaterials crisis in the medical device industry: Is litigation the only cause? J Biomater Res 1996;33:53-4.
16. Laffel G, Blumenthal D. The case for using industrial quality management science in health care organizations. JAMA 1989;262:2869-73.
17. Leape LL. Error in Medicine. JAMA 1994;272:1851-7.
18. Cao H, Richard G, Macris M, Conger J. An in-vivo characterization of myocardial annular loads on prosthetic heart valves. Am Soc Int Artif Organs J 1995;41:40.
19. Hasenkam JM, Nygaard H, Paulsen PK, Kim WY, Hansen OK. What force can the myocardium generate on a prosthetic mitral ring? An animal experimental study. J Heart Valve Dis 1994;3:324-9.
20. Reason J. A systems approach to organizational error. Ergonomics 1995;38:1708-21.
21. Fielder JH. More bad news about Björk-Shiley c/c heart valves. IEEE Eng Med Biol 1994;182-4.
22. Fatigue and wear in mechanical heart valves. J Heart Valve Dis 1996;5(Suppl.):1.
23. Perrow CH. Normal accidents. Living with high-risk technologies. New York: Basic Book Publishers, Inc., Wiley and Sons, 1987.