Clinical Experience of 473 Patients with the Omnicarbon
Prosthetic Heart Valve
Yoshifumi Iguro MD, Yukinori Moriyama MD, Akihiro Yamaoka MD,
Masafumi Yamashita MD, Shinji Shimokawa MD, Hitoshi Toyohira MD,
Akira Taira MD

The long-term clinical experience of 473 patients (255 males, 218 females; mean age 57.5 ± 10.1 years) who received 523 Omnicarbon heart valve prostheses between January 1985 and December 1996 was investigated. Patients received a total of 253 mitral (MVR), 170 aortic (AVR) and 50 double (DVR) valve replacements. 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); cumulative follow up was 1750.1 pt-yr. Among 39 late deaths, 20 were valve-related and four cardiac-related. The 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%); the overall 10-year 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). No defective valve or clinical hemolysis was observed. The 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 87.6 ± 2.6% at 10 years. These long-term results with the Omnicarbon valve are excellent; especially satisfactory results were achieved with regard to the low rate of thromboembolic complications.