CarboMedics and monostrut valves: Clinical and hemodynamic outcomes in a randomized study

Background and aim of the study: Our aim was to compare the CarboMedics (CM ) and Monostrut (M) mechanical heart valve prostheses in the aortic positio n. These prostheses have been studied extensively in the past, both have we ll-defined characteristics, and have not been modified for many years. Methods: This randomized, prospective study included 200 consecutive patien ts; 100 received the CM prosthesis and 100 the M prosthesis. Both groups we re statistically similar in terms of age, aortic valve lesion, and preopera tive clinical and surgical characteristics. Mean follow up was 5.58 years ( range: 2 months to 11 years); total follow up was 1095 patient-years (pt-yr ) (CM 5.33 years, 528 pt-yr; M 5.85 years, 567 pt-yr). Results: Early mortality rates were 1% in the CM group and 3% in the M grou p. Late mortality rates were 7% and 9%, respectively. Mean (+/- SD) surviva l rates at 11 years were 80.51 +/- 7.36% for the CM group and 79.62 +/- 5.5 9% for the M group. There were no cases of mechanical valve failure in eith er group. The linearized rates of major thromboembolism were 1.03% and 0.20 % per pt-yr for the CM and M groups, respectively; the rates of major bleed ing-events were 0.71% and 0.61% per pt-yr, respectively. The rate of parava lvular leak was 0.35% and 0% per pt-yr in the CM and M groups, respectively . Postoperative NYHA class was I-II in 95.83% of CM patients, and in 94.37% of M patients. Conclusion: Clinical results with CarboMedics and Monostrut prostheses are highly satisfactory, but no superiority of one valve over the other can be identified.