Prospective Randomised Comparison Of Carbomedics And St Jude Medical Bileaflet Mechanical Heart Valve Prostheses: 10 Year Follow-up
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Objective: This is a final report of a randomised study comparing the clinical performance of CarboMedics (CM) and St Jude Medical (SJM) heart valve prostheses 10 years after surgery.
Methods: Between 1992 and 1996, 485 patients undergoing mechanical valve replacement were randomised to receive either CM (n=234) or SJM (n=251) prostheses for aortic (n=288), mitral (n=160) or double (n=37) valve replacements. Patients were followed annually to the end of Dec 2004.
Results: Demographics, pre-operative clinical status and operative characteristics were similar between the two groups. The median follow-up was 10 years in both groups (interquartile range 9-11 years). Follow-up was complete for 98.2% of the CM group and 98.0% of the SJM group, yielding a total of 3877 patient years of follow-up. In total 162 patients died, 25 from valve-related causes. The 5 and 10 year survival rates were 82.1% (95%CI 76.5-86.4) and 66.8% (95%CI 60.1-72.7) in the CM group and 80.7% (95%CI 75.2-85.1) and 65.6% (95%CI 58.9-71.5) in the SJM group (p=0.96). The 10-year linearised survival rates were 4.2% (95%CI 3.3-5.3) and 4.1% (95%CI 3.3-5.2) in the CM and SJM groups respectively. Freedom at 10-years from valve-related mortality was 95.0% (95%CI 91.5-97.4) in the CM group and 94.8% (95%CI 91.4-97.0) in the SJM group. During follow-up 52 patients had a thromboembolism, 212 haemorrhaged at least once and 36 suffered other non-structural valve dysfunction. There were no differences between the groups (pâ„0.32; freedom from thromboembolism, haemorrhage and non-structural valve dysfunction at 10 years was 86.7%, 95%CI 81.0-90.7; 50.8%, 95%CI 43.3-57.9 and 90.3%, 95%CI 84.5-94.1 in the CM group and 88.0%, 95%CI 82.6-91.8; 45.8%, 95%CI 38.6-52.7 and 90.6%, 95%CI 85.4-94.1 in the SJM group. Linearised survival rates per patient-year were: thromboembolism CM 1.6% SJM 1.4%; haemorrhage CM 7.6%, SJM 8.9%; non-structural valve dysfunction CM 1.0% SJM 1.0%. No statistically significant inter-group differences in International Normalised Ratio values were detected during the study period.
Conclusions: This randomised study confirms that at 10 years there were no differences in clinical outcome with respect to these two mechanical bileaflet prostheses.
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