Clinical performance of biological and mechanical prostheses.
Prosthetic valve replacement remains the most viable alternative for the treatment of severely diseased heart valves. The cumulative experience of mechanical protheses and bioprostheses was evaluated for a 10-year performance comparison: Carpentier-Edwards standard porcine bioprosthesis (CE-S), 1,214 operations; Carpentier-Edwards supraannular porcine bioprosthesis (CE-SAV), 2,489; and mechanical prostheses, 1,364 operations (St. Jude Medical, Carbomedics, Duromedics, and Björk-Shiley Monostrut). The freedom from thromboembolism and hemorrhage at 10 years was 82% for CE-S, 78% for CE-SAV, and 65% for mechanical prostheses (p < 0.05). The relationship existed for major thromboembolism and hemorrhage, 91% (CE-S), 87% (CE-SAV), and 88% (mechanical) (p < 0.05), without clinical relevance. The freedom from structural valve deterioration and valve-related reoperation favored mechanical prostheses (p < 0.05) at 10 years (structural failure: 78% for CE-S, 81% for CE-SAV, and 99% for the mechanical group; reoperation: 74% for CE-S, 76% for CE-SAV, and 88% for mechanical prostheses). The freedom from fatal reoperation was not clinically different: 96% for CE-S, 99% for CE-SAV, and 99% for mechanical prostheses (p < 0.05) at 10 years. The freedom from valve-related mortality was not different (p = not significant) at 10 years: 87% for CE-S; 92% for CE-SAV; and 91% for mechanical. The freedom from permanent impairment or residual morbidity, primarily from thromboembolism, was 95% for CE-S, 92% for CE-SAV, and 95% for mechanical group (p < 0.05) but not clinically relevant.(ABSTRACT TRUNCATED AT 250 WORDS)
Fradet
G J
GJ
Division of Cardiovascular and Thoracic Surgery, University of British Columbia, Vancouver, Canada.
Jamieson
W R
WR
Abel
J G
JG
Lichtenstein
S V
SV
Miyagishima
R T
RT
Ling
H
H
Tyers
G F
GF
D000206:Actuarial Analysis; D000925:Anticoagulants / Q000009:adverse effects; D001705:Bioprosthesis / Q000009:adverse effects / Q000401:mortality; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000401:mortality; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications; D011475:Prosthesis Failure; D012086:Reoperation; D015996:Survival Rate; D013923:Thromboembolism / Q000209:etiology
D000925:Anticoagulants