Objective: to evaluate the performance of a new ball valve prosthesis.
Design: set up of two groups of patients who underwent mitral valve replacement with two different prosthesis: the Macchi prosthesis under evaluation and the well known Starr-Edwards model prosthesis. The chi-square test was used to compare the results.
Patients: Patients referred for valvular surgery.
Interventions: One group of 98 consecutive patients who underwent isolated mitral valve replacement with a Macchi prosthesis from January 1984 to June 30 1986 was compared to a matched group of 49 patients who received a Starr-Edwards prosthesis in the same period of time. Follow-up data were available from 99% patients in the Macchi group 96% in the Starr-Edwards group, with a mean follow-up time of 35.2 (2-57) and 42.9 (4-62) months, respectively.
Results: There was no statistical difference in the incidence per 100 patients--month of prosthetic complications--thromboembolism, hemorrhagic events, prosthetic endocarditis, reoperation and mechanical failure.
Conclusions: In our experience and with the available follow-up data the Macchi prosthesis is a good cost effective option when there is indication for a ball valve prosthesis.