OBJECTIVE: To compare survival and outcome in patients receiving a mechanical or bioprosthetic heart valve prosthesis. DESIGN: Randomised prospective trial. SETTING: Tertiary cardiac centre. PATIENTS: Between 1975 and 1979, patients were randomised to receive either a Bjork-Shiley or a porcine prostheses. The mitral valve was replaced in 261 patients, the aortic in 211, and both valves in 61 patients. Follow up now averages 20 years. MAIN OUTCOME MEASURES: Death, reoperation, bleeding, embolism, and endocarditis. RESULTS: After 20 years there was no difference in survival (Bjork-Shiley v porcine prosthesis (mean (SEM)): 25.0 (2.7)% v 22.6 (2.7)%, log rank test p = 0.39). Reoperation for valve failure was undertaken in 91 patients with porcine prostheses and in 22 with Bjork-Shiley prostheses. An analysis combining death and reoperation as end points confirmed that Bjork-Shiley patients had improved survival with the original prosthesis intact (23.5 (2.6)% v 6.7 (1.6)%, log rank test p < 0.0001); this difference became apparent after 8-10 years in patients undergoing mitral valve replacement, and after 12-14 years in those undergoing aortic valve replacement. Major bleeding was more common in Bjork-Shiley patients (40.7 (5.4)% v 27.9 (8.4)% after 20 years, p = 0.008), but there was no significant difference in major embolism or endocarditis. CONCLUSIONS:Survival with an intact valve is better among patients with the Bjork-Shiley spherical tilting disc prosthesis than with a porcine prosthesis but there is an attendant increased risk of bleeding.
RCT Entities:
OBJECTIVE: To compare survival and outcome in patients receiving a mechanical or bioprosthetic heart valve prosthesis. DESIGN: Randomised prospective trial. SETTING: Tertiary cardiac centre. PATIENTS: Between 1975 and 1979, patients were randomised to receive either a Bjork-Shiley or a porcine prostheses. The mitral valve was replaced in 261 patients, the aortic in 211, and both valves in 61 patients. Follow up now averages 20 years. MAIN OUTCOME MEASURES: Death, reoperation, bleeding, embolism, and endocarditis. RESULTS: After 20 years there was no difference in survival (Bjork-Shiley v porcine prosthesis (mean (SEM)): 25.0 (2.7)% v 22.6 (2.7)%, log rank test p = 0.39). Reoperation for valve failure was undertaken in 91 patients with porcine prostheses and in 22 with Bjork-Shiley prostheses. An analysis combining death and reoperation as end points confirmed that Bjork-Shiley patients had improved survival with the original prosthesis intact (23.5 (2.6)% v 6.7 (1.6)%, log rank test p < 0.0001); this difference became apparent after 8-10 years in patients undergoing mitral valve replacement, and after 12-14 years in those undergoing aortic valve replacement. Major bleeding was more common in Bjork-Shiley patients (40.7 (5.4)% v 27.9 (8.4)% after 20 years, p = 0.008), but there was no significant difference in major embolism or endocarditis. CONCLUSIONS: Survival with an intact valve is better among patients with the Bjork-Shiley spherical tilting disc prosthesis than with a porcine prosthesis but there is an attendant increased risk of bleeding.
Authors: K Hammermeister; G K Sethi; W G Henderson; F L Grover; C Oprian; S H Rahimtoola Journal: J Am Coll Cardiol Date: 2000-10 Impact factor: 24.094
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Authors: K E Hammermeister; W G Henderson; C M Burchfiel; G K Sethi; J Souchek; C Oprian; A B Cantor; E Folland; S Khuri; S Rahimtoola Journal: J Am Coll Cardiol Date: 1987-10 Impact factor: 24.094
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