The Carpentier-Edwards standard porcine bioprosthesis: long-term evaluation of the high pressure glutaraldehyde fixed prosthesis.
The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1,000 operations (988 patients with 1,092 valves) between 1975 and 1981. The mean age of the patients was 56.8 years (range 8 to 85 years). During the years 1975 and 1981, approximately 97% of the total valvular surgery population received the prosthesis. The early mortality was 7.8% (including patients with concomitant procedures including coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 3.8% per patient-year. The total cumulative follow-up was 5,937 years. Thromboembolism (TE) was 1.3% per patient-year (fatal 0.4%/patient-year) (minor 0.4%; major 0.9%); antithromboembolic therapy-related hemorrhage (ATH) 0.5% (fatal 0.1%); prosthetic valve endocarditis (PVE) 0.5% (fatal 0.2%); periprosthetic leak (PPL) 0.4% (fatal 0.2%); clinical valve dysfunction (CVD) 0.2% (fatal 0.02%); and structural valve deterioration (SVD)/primary tissue failure 1.6% per patient-year (fatal 0.2%/pt-yr). Thromboembolism and SVD occurring primarily between the sixth and tenth year of evaluation, were the significant complications. The overall patient survival was 60.5% +/- 2.4% at 10 years. The patients were classified as 93.5% NYHA functional Class III and IV, preoperatively and 93.1% Class I and II, postoperatively. The freedom at 10 years from TE was 82.9% +/- 2.7%; SVD 76.9% +/- 2.9%; and reoperation 70.8% +/- 3.1%. Freedom from all valve-related complications at 10 years was 54.3% +/- 3.1%; valve-related mortality 86.4% +/- 2.3%; mortality and reoperation (valve failure) 64.0% +/- 3.2%; mortality and residual morbidity (treatment failure) 82.3% +/- 2.6%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 60.6% +/- 3.2%. There were 61 valve-related deaths of a total 352 deaths (early 7, late 54) (TE 21; ATH 7; CVD 1; PVE 12; PPL 9; and SVD 11). Valve-related reoperations were performed in 128 patients (TE 3; CVD 4; PVE 14; PPL 17; and SVD 90). The standard Carpentier-Edwards porcine bioprosthesis has provided very satisfactory clinical performance and afforded patients excellent quality of life. Primary tissue failure is the significant long-term complication.
Jamieson
W R
WR
Division of Cardiovascular and Thoracic Surgery, University of British Columbia, Vancouver, Canada.
Janusz
M T
MT
Miyagishima
R T
RT
Munro
A I
AI
Gerein
A N
AN
Allen
P
P
Burr
L H
LH
MacNab
J
J
Chan
F
F
Tyers
G F
GF
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001705:Bioprosthesis / Q000592:standards*; D001955:British Columbia / Q000453:epidemiology; D002423:Cause of Death; D002648:Child; D005500:Follow-Up Studies; D005976:Glutaral / Q000627:therapeutic use*; D006349:Heart Valve Diseases / Q000145:classification / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000401:mortality / Q000592:standards*; D006785:Hospitals, University; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000401:mortality; D011475:Prosthesis Failure; D012086:Reoperation / Q000706:statistics & numerical data; D015996:Survival Rate; D014021:Tissue Preservation / Q000379:methods / Q000592:standards*
D005976:Glutaral