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The Journal of Thoracic and Cardiovascular Surgery, Vol 109, Issue 5 858-870, Copyright © 1995 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association
NOTE: The fulltext of this article is not available online.
E. M. Baudet, V. Puel, J. T. McBride, J. P. Grimaud, F. Roques, F. Clerc, X. Roques and N. Laborde
To assess with truly long follow-up the long-term results of valve
replacement with the St. Jude Medical prosthesis (St. Jude Medical, Inc.,
St. Paul, Minn.), we reviewed the case histories of the first 1112 patients
undergoing 1244 valve replacements with this valve between June 12, 1978,
and June 12, 1987: 690 male (62%) and 422 female patients, mean age 56
years. A total of 773 patients (69%) had the aortic valve replaced, 207
(19%) the mitral valve, and 132 (12%) the aortic and mitral valves. There
were 42 hospital deaths (3.8%). Follow-up was 97.5% complete (8988
patient-years). There were 213 late deaths. Ninety-one (43%) were
considered valve-related: sudden death, n = 27; anticoagulant-related
hemorrhage, n = 22; thromboembolism, n = 19; prosthetic valve endocarditis,
n = 13; valve thrombosis, n = 9; and noninfectious perivalvular leak, n =
1. Overall actuarial survival, including hospital mortality, was 68% +/- 6%
(95% confidence limits) 14 years after the operation. Linearized rates of
late valve-related events were as follows: thromboembolism, 1.09% per
patient-year; anticoagulant-related hemorrhage, 0.94% per patient-year;
prosthetic valve endocarditis, 0.32% per patient-year; valve thrombosis,
0.33% per patient-year; and perivalvular leak, 0.19% per patient-year.
Actuarial freedom, at 14 years, from thromboembolism was 89% +/- 3%,
anticoagulant-related hemorrhage 83% +/- 8%, valve thrombosis 97% +/- 1%,
and reoperation 95% +/- 3%. Actuarial freedom from all valve-related deaths
and valve-related morbidity and mortality, at 14 years, was 84% +/- 6% and
61% +/- 8%, respectively. We conclude that, because of its low
thrombogenicity, low incidence of valve-related events, and low
valve-related mortality, the St. Jude Medical valve is one of the best
performing mechanical prosthesis currently available. Nevertheless, the
late valve-related complications and deaths illustrate that the quest for a
"perfect" prosthesis remains unfulfilled.
CLINICAL TRIAL
Long-term results of valve replacement with the St. Jude Medical prosthesis
Department of Cardiovascular and Pediatric Cardiac Surgery, Haut-Leveque Heart Hospital, Bordeaux, France.
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J. T. Ellis and A. P. Yoganathan A COMPARISON OF THE HINGE AND NEAR-HINGE FLOW FIELDS OF THE ST JUDE MEDICAL HEMODYNAMIC PLUS AND REGENT BILEAFLET MECHANICAL HEART VALVES J. Thorac. Cardiovasc. Surg., January 1, 2000; 119(1): 83 - 93. [Abstract] [Full Text] [PDF]
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 E. W. Steyerberg, M. Kallewaard, Y. Van Der Graaf, L. A. Van Herwerden, and J.D. F. Habbema Decision Analyses for Prophylactic Replacement of the Bjork-Shiley Convexo-concave Heart Valve:: An Evaluation of Assumptions and Estimates Med Decis Making, January 1, 2000; 20(1): 20 - 32. [Abstract] [PDF]
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O. Lund, H. K. Pilegaard, L. B. Ilkjaer, S. L. Nielsen, and H. Arildsen Performance profile of the Starr-Edwards aortic cloth covered valve, track valve, and silastic ball valve Eur. J. Cardiothorac. Surg., October 1, 1999; 16(4): 403 - 413. [Abstract] [Full Text] [PDF]
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M. Ura, R. Sakata, Y. Nakayama, and H. Fukui Bileaflet mechanical valve (St. Jude Medical valve) replacement in long-term dialysis patients Ann. Thorac. Surg., September 1, 1999; 68(3): 870 - 873. [Abstract] [Full Text] [PDF]
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W.R. E. Jamieson, R. T. Miyagishima, G. L. Grunkemeier, E. Germann, C. Henderson, G. J. Fradet, L. H. Burr, and S. V. Lichtenstein Bileaflet mechanical prostheses performance in mitral position Eur. J. Cardiothorac. Surg., June 1, 1999; 15(6): 786 - 794. [Abstract] [Full Text] [PDF]
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J. E. Rubay, M. Buche, G. A. El Khoury, J.-L. J. Vanoverschelde, T. Sluysmans, B. Marchandise, J.-C. Schoevaerdts, and R. A. Dion The Ross operation: mid-term results Ann. Thorac. Surg., May 1, 1999; 67(5): 1355 - 1358. [Abstract] [Full Text] [PDF]
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J. Craver CarboMedics(R) Prosthetic Heart Valve Eur. J. Cardiothorac. Surg., January 1, 1999; 15(suppl_1): 3 - 11. [Abstract] [Full Text] [PDF]
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J.-P. Remadi, P. Bizouarn, O. Baron, O. Al Habash, P. Despins, J.-L. Michaud, and D. Duveau Mitral valve replacement with the St. Jude medical prosthesis: a 15-year follow-up Ann. Thorac. Surg., September 1, 1998; 66(3): 762 - 767. [Abstract] [Full Text] [PDF]
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X. M. Mueller, H. T. Tevaearai, F. Stumpe, A. P. Fischer, M. Hurni, P. Ruchat, and L. v. Segesser Long-term results of mitral-aortic valve operations J. Thorac. Cardiovasc. Surg., June 1, 1998; 115(6): 1298 - 1302. [Abstract] [Full Text] [PDF]
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W.R. E. Jamieson, A. I. Munro, R. T. Miyagishima, G. L. Grunkemeier, L. H. Burr, S. V. Lichtenstein, and G. F. O. Tyers Multiple mechanical valve replacement surgery comparison of St. Jude Medical and CarboMedics prostheses Eur. J. Cardiothorac. Surg., February 1, 1998; 13(2): 151 - 159. [Abstract] [Full Text] [PDF]
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J. Ninet, F. Tronc, J. Robin, A. Curtil, I. Aleksic, and G. Champsaur Mechanical versus biological isolated aortic valvular replacement after the age of 70: equivalent long-term results Eur. J. Cardiothorac. Surg., January 1, 1998; 13(1): 84 - 89. [Abstract] [Full Text] [PDF]
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J. M. Bernal, J. M. Rabasa, F. Gutierrez-Garcia, C. Morales, J. F. Nistal, and J. M. Revuelta The CarboMedics Valve: Experience With 1,049 Implants Ann. Thorac. Surg., January 1, 1998; 65(1): 137 - 143. [Abstract] [Full Text] [PDF]
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M. F. Pompili, J. H. Stevens, T. A. Burdon, L. C. Siegel, W. S. Peters, G. H. Ribakove, and B. A. Reitz PORT-ACCESS MITRAL VALVE REPLACEMENT IN DOGS J. Thorac. Cardiovasc. Surg., November 1, 1996; 112(5): 1268 - 1274. [Abstract] [Full Text]
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 St. Jude Valve: Still Good, Could Be Better Journal Watch Cardiology, July 1, 1995; 1995(701): 6 - 6. [Full Text]
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