Clinical experience of 473 patients with the omnicarbon prosthetic heart valve.
OBJECTIVE
The long-term clinical experience of patients receiving Omnicarbon heart valve prostheses between January 1985 and December 1996 was investigated.


METHODS
In total, 473 patients (255 males, 218 females; mean age 57.5 +/- 10.1 years (range: 20n-73 years) received 523 prostheses. These included 253 mitral (MVR), 170 atrial (AVR) and 50 double (DVR) valve replacements.


RESULTS
The 30-day mortality rate was 4.7% (n = 22); in addition eight patients died more than 30 days after surgery, but during the same hospital stay. Mean follow up was 3.9 years (maximum 11 years and 7 months). Cumulative follow up was 1,750.1 patient-years (pt-yr); follow up was 97.5% complete. Among 39 late deaths, 20 were valve-related (seven cerebral infarction, seven cerebral bleeding, six endocarditis) and four cardiac-related. The overall five-year cumulative survival rate (excluding early mortality) was 90.2 +/- 11.7% (MVR 88.0 +/- 2.5%, AVR 93.1 +/- 2.3%, DVR 93.7 +/- 4.8%). At 10 years, the overall survival rate was 76.4 +/- 7.7%. Valve-related complications included thromboembolism (n = 13, 0.7%/pt-yr), anticoagulation-related hemorrhage (n = 12, 0.7%/pt-yr) and endocarditis (n = 7, 0.4%/pt-yr). Neither mechanical failure nor clinical hemolysis was observed. The overall valve-related event-free rate after five years was 89.3 +/- 2.0% (MVR 89.8 +/- 2.4%, AVR 93.5 +/- 2.6%, DVR 89.4 +/- 5.7%) and after 10 years it was 87.6 +/- 2.6% (MVR 85.4 +/- 3.7%, AVR 93.5 +/- 2.6%, DVR 82.5 +/-10.1%).


CONCLUSIONS
These long-term results with the Omnicarbon valve are excellent; especially satisfactory results were achieved in terms of the low rate of thromboembolic complication.
Iguro
Y
Y
Second Department of Surgery, Kagoshima University, Kagoshima City, Japan.
Moriyama
Y
Y
Yamaoka
A
A
Yamashita
M
M
Shimokawa
S
S
Toyohira
H
H
Taira
A
A
D000328:Adult; D000368:Aged; D018572:Disease-Free Survival; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve; D011183:Postoperative Complications / Q000401:mortality; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome