[Valve replacement with the Omnicarbon valve prosthesis. A 10-year follow-up].

Objective: We retrospectively examined the outcomes of 264 patients who underwent consecutive Omnicarbon valve implantation surgery between April 1985 and May 1995.

Methods: At the time of surgery, patients who received this mechanical prosthesis averaged 57+/-11 years of age. Omnicarbon valves were placed in the aortic position in 36% of the cases, in the mitral position in 44%, and in both positions in 20%. Follow-up was carefully performed, with most patients undergoing physical examination at our clinic. While taking the case history, cardiac physicians specifically questioned the patient about valve-related complications.

Results: Accumulated total patient-years is 1291, with a mean follow-up time of 5.4 years. Survival at 10 years is 79.4+/-3.9%, including all causes of death and early mortality. Complications recorded during the 11-year study include: thromboembolism (0.1%), hemorrhage (0.4%), endocarditis (0.2%), and nonstructural failure (1.2%). No hemolytic anemia, valve thrombosis, or structural failure was detected during this long-term experience. Functional capability of these patients was subjectively assessed by the NYHA classification system. With follow-up time averaging over 5 years, 97% of our Omnicarbon valve patients are in NYHA I or II.

Conclusion: The Omnicarbon mechanical prosthesis provides a good clinical performance for up to 10 years in both the aortic and mitral positions. Results indicated a low incidence of thromboembolism and of hemorrhagic complications.