BACKGROUND AND AIM OF THE STUDY: Our aim was to compare the CarboMedics (CM) and Monostrut (M) mechanical heart valve prostheses in the aortic position. These prostheses have been studied extensively in the past, both have well-defined characteristics, and have not been modified for many years. METHODS: This randomized, prospective study included 200 consecutive patients; 100 received theCM prosthesis and 100 the M prosthesis. Both groups were statistically similar in terms of age, aortic valve lesion, and preoperative 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 group. Late mortality rates were 7% and 9%, respectively. Mean (+/- SD) survival rates at 11 years were 80.51 +/- 7.36% for the CM group and 79.62 +/- 5.59% for the M group. There were no cases of mechanical valve failure in either 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 bleeding-events were 0.71% and 0.61% per pt-yr, respectively. The rate of paravalvular 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.
RCT Entities:
BACKGROUND AND AIM OF THE STUDY: Our aim was to compare the CarboMedics (CM) and Monostrut (M) mechanical heart valve prostheses in the aortic position. These prostheses have been studied extensively in the past, both have well-defined characteristics, and have not been modified for many years. METHODS: This randomized, prospective study included 200 consecutive patients; 100 received the CM prosthesis and 100 the M prosthesis. Both groups were statistically similar in terms of age, aortic valve lesion, and preoperative 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 group. Late mortality rates were 7% and 9%, respectively. Mean (+/- SD) survival rates at 11 years were 80.51 +/- 7.36% for the CM group and 79.62 +/- 5.59% for the M group. There were no cases of mechanical valve failure in either 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 bleeding-events were 0.71% and 0.61% per pt-yr, respectively. The rate of paravalvular 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.