Clinical experience of 473 patients with the omnicarbon prosthetic heart valve

BACKGROUND AND AIM OF THE STUDY: 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.