Multicentered European Study on Safety and Effectiveness of the On-X Prosthetic Heart Valve: Intermediate Follow-Up

Annals of Thoracic Surgery

Volumn 83, Issue 1, 2007, Pages 40-46

  Palatianos, George M ^a   Laczkovics, Axel M ^b   Simon, Paul ^c   Pomar, Jose Luis ^d   Birnbaum, Dietrich E ^e   Greve, Hans H ^f   Haverich, Axel ^g  

^a ONASSIS CARDIAC SURGERY CENTER   (Greece)

^b RUHR UNIVERSITY BOCHUM   (Germany)

^c UNIVERSITY OF VIENNA   (Austria)

^d UNIVERSITY OF BARCELONA   (Spain)

^e UNIVERSITY HOSPITAL REGENSBURG   (Germany)

^f Klinikum Krefeld   (Germany)

^g HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

LACTATE DEHYDROGENASE;

AORTA VALVE REPLACEMENT; ARTICLE; BLEEDING; BLOOD CELL COUNT; CLINICAL TRIAL; ENDOCARDITIS; FEMALE; FOLLOW UP; HEART VALVE PROSTHESIS; HEMOLYSIS; HUMAN; LACTATE DEHYDROGENASE BLOOD LEVEL; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MITRAL VALVE REPLACEMENT; MORTALITY; MULTICENTER STUDY; PATIENT SAFETY; POSTOPERATIVE COMPLICATION; PRESSURE GRADIENT; PRIORITY JOURNAL; REOPERATION; SUDDEN DEATH; THROMBOEMBOLISM; THROMBOSIS; VALVULAR HEART DISEASE;

AGED; AORTIC VALVE; ECHOCARDIOGRAPHY; FEMALE; FOLLOW-UP STUDIES; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HEMOLYSIS; HUMANS; MALE; MIDDLE AGED; MITRAL VALVE; PROSPECTIVE STUDIES; SAFETY;

EID: 33845509902     PISSN: 00034975     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.athoracsur.2006.08.010     Document Type: Article

References (22)

1. Ely J.L., Emken M.R., Accuntius J.A., et al. Pure pyrolytic carbon: preparation and properties of a new material, On-X carbon for mechanical heart valve prostheses. Heart Valve Dis 7 (1998) 626-632
2. Ma L., and Sines G.H. Unalloyed pyrolytic carbon for implanted mechanical heart valves. J Heart Valve Dis 8 (1999) 578-585
3. Ma L., and Sines G. Fatigue behavior of a pyrolytic carbon. J Biomed Mater Res 51 (2000) 61-68
4. Hwang N.H., Reul H., and Reinhard P. In vitro evaluation of the long-body On-X bileaflet heart valve. J Heart Valve Dis 7 (1998) 561-568
5. Edmunds Jr. L.H., Clark R.E., Cohn L.H., Grunkemeier G.L., Miller D.C., and Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg 62 (1996) 932-935
6. Gohlke-Barwolf C., Acar J., Burckhardt D., et al. Guidelines for prevention of thromboembolic events in valvular heart disease. J Heart Valve Dis 2 (1993) 398-410
7. Bonow R.O., Carabello B., de Leon A.C., et al. ACC/AHA guidelines for the management of patients with valvular heart disease. Executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. (Committee on Management of Patients With Valvular Heart Disease). J Heart Valve Dis 7 (1998) 672-707
8. Akins C.W. Results with mechanical cardiac valvular prostheses. Ann Thorac Surg 60 (1995) 1836-1844
9. Jamieson W.R., Edwards F.H., Schwartz M., Bero J.W., Clark R.E., and Grover F.L. Risk stratification for cardiac valve replacement. National Cardiac Surgery Database. Ann Thorac Surg 67 (1999) 943-951
10. Bortolotti U., Milano A., D'Alfonso A., et al. Evaluation of valve-related complications in patients with Sorin Bicarbon prosthesis: a seven-year experience. J Heart Valve Dis 10 (2001) 795-801
11. US Food and Drug Administration. ATS open pivot bileaflet heart valve. Summary of safety and effectiveness data. October 13, 2000, pp 1-15. Available at: http://www.fda.gov/edrh/pdf/p990046.html.
12. Vitale N., Cappabianca G., Visicchio G., et al. Midterm evaluation of the Sorin Bicarbon heart valve prosthesis: single-center experience. Ann Thorac Surg 77 (2004) 527-531
13. Lim K.H., Caputo M., Ascione R., et al. Prospective randomized comparison of CarboMedics and St. Jude Medical bileaflet mechanical heart valve prostheses: an interim report. J Thorac Cardiovasc Surg 123 (2002) 21-32
14. Hannan E.L., Racz M.J., Jones R.H., et al. Predictors of mortality for patients undergoing cardiac valve replacements in New York State. Ann Thorac Surg 70 (2000) 1212-1218
15. Emery R.W., Van Nooten G.J., and Tesar P.J. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. Ann Thorac Surg 75 (2003) 444-452
16. Wang Z., Grainger N., and Chambers J. Doppler echocardiography in normally functioning replacement heart valves: a literature review. J Heart Valve Dis 4 (1995) 591-614
17. McNicholas K.W., Ivey T.D., Metras J., et al. North American multicenter experience with the On-X prosthetic heart valve. J Heart Valve Dis 15 (2006) 73-79
18. Bach D.S., Goldbach M., Sakwa M.P., Petracek M., Errett L., and Mohr F. Hemodynamics and early performance of the St. Jude Medical Regent aortic valve prosthesis. J Heart Valve Dis 10 (2001) 436-442
19. Butchart E.G. Prosthetic heart valves. In: Verstraete M., Fuster V., and Topol E.J. (Eds). Cardiovascular thrombosis: thrombocardiology and thromboneurology. 2nd ed. (1998), Lippincott-Raven Publishers, Philadelphia, PA 395-414
20. Skoularigis J., Essop M.R., Skudicky D., Middlemost S.J., and Sareli P. Frequency and severity of intravascular hemolysis after left-sided cardiac valve replacement with Medtronic Hall and St. Jude Medical prostheses, and influence of prosthetic type, position, size and number. Am J Cardiol 71 (1993) 587-591
21. Mecozzi G., Milano A.D., De Carlo M., et al. Intravascular hemolysis in patients with new-generation prosthetic heart valves: a prospective study. J Thorac Cardiovasc Surg 123 (2002) 550-556
22. Rodler S.M., Moritz A., Schreiner W., End A., Dubsky P., and Wolner E. Five-year follow-up after heart valve replacement with the CarboMedics bileaflet prosthesis. Ann Thorac Surg 63 (1997) 1018-1025