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
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.
