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The Journal of Thoracic and Cardiovascular Surgery, Vol 91, 555-565, Copyright © 1986 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association

ARTICLES

Carpentier-Edwards supra-annular porcine bioprosthesis. Clinical experience and implantation characteristics

WR Jamieson, AN Gerein, GF Tyers, MT Janusz, AI Munro, AJ Jyrala, RT Miyagishima and P Allen

The investigational Carpentier-Edwards supra-annular valve was implanted in 592 patients from November, 1981, to February, 1984 (aortic valve replacement in 286, mitral valve replacement in 259, and multiple valve replacement in 47, for a total of 638 prostheses). A previous cardiac operation had been performed in 77 patients (13%). Concomitant procedures were performed in 202 patients (34.1%), including coronary artery bypass in 163 patients. The patient evaluation was 98.6% complete. The early mortality was 7.4% (44 patients) and the late mortality was 6.2% per patient-year (41 patients). The valve-related causes of late mortality were thromboembolism (five), anticoagulant-related hemorrhage (one), and prosthetic valve endocarditis (one). The overall patient survival, including operative death, was 85% at 2 years. The linearized occurrence rate for valve-related complications was 5.6% per patient- year (37 events)--thromboembolism 2.7% per patient-year (18) anticoagulant-related hemorrhage 1.2% (eight), prosthetic valve endocarditis 0.8% (five), and periprosthetic leak 0.9% per patient-year (six). There were no cases of primary tissue failure or structural failure. At 2 years, the freedom from valve-related complications was 86.9%, from valve-related mortality, 98.7%, and from valve-related mortality and reoperation, 97.7%. This valve is fixed in glutaraldehyde at low pressure and is designed to improve durability. It has provided a low incidence of valve-related complications without structural failure. The structural design of the prosthesis does not always conform to the anatomy of bicuspid aortic valves.

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				W. R. E. Jamieson, L. J. Rosado, A. I. Munro, A. N. Gerein, L. H. Burr, R. T. Miyagishima, M. T. Janusz, and G. F. O. Tyers Carpentier-Edwards Standard Porcine Bioprosthesis: Primary Tissue Failure (Structural Valve Deterioration) by Age Groups Ann. Thorac. Surg., August 1, 1988; 46(2): 155 - 162. [Abstract] [PDF]