Björk-Shiley and Carpentier-Edwards valves. A comparative analysis.

Between January 1977 and December 1982, 986 Björk-Shiley and 744 Carpentier-Edwards valves were implanted in 774 and 620 patients, respectively, at the same institution. All Björk-Shiley patients and 57% of patients with a Carpentier-Edwards valve in the mitral position received long-term anticoagulation. Mean follow-up was 3.2 years (range 0 to 8.8) in the Björk-Shiley patients and 3.5 years (range 0 to 8.2) in the Carpentier-Edwards group. There was no significant difference between the two groups in hospital mortality (Björk-Shiley 7.6%; Carpentier-Edwards 6.0%), overall incidence of embolism (Björk-Shiley 1.4 per 100 patient-years; Carpentier-Edwards 1.6% py), endocarditis (Björk-Shiley 0.6% py; Carpentier-Edwards 0.8% py), periporsthetic leak (Björk-Shiley 1.6% py; Carpentier-Edwards 1.4% py), anticoagulant-related complications (Björk-Shiley 0.3% py; Carpentier-Edwards 0.1% py), valve failure (Björk-Shiley 0.78% py; Carpentier-Edwards 0.68% py), reoperation for complication (Björk-Shiley 1.68% py; Carpentier-Edwards 1.22% py), and late mortality (Björk-Shiley 3.1% py; Carpentier-Edwards 3.0% py). Actuarial freedom from valve-related events was similar in the two groups. In the aortic position, freedom from embolism was significantly better in the Björk-Shiley group than the Carpentier-Edwards group (Björk-Shiley 99% at 3 and 5 years; Carpentier-Edwards 96% and 92% at 3 and 5 years; p = 0.023). In the mitral position, the overall incidence of reoperation was higher in the Björk-Shiley group (1.78% py) than in the Carpentier-Edwards group (0.48% py) (p = 0.004). Actuarial analysis shows this difference to be confined to the first 6 years of follow-up. The commonest indication for reoperation was valve failure in both groups. However, when analysis is confined to this indication, the difference between the reoperation incidence in the mitral position becomes insignificant (Björk-Shiley 0.85% py; Carpentier-Edwards 0.29% py; p = 0.085). This study confirms the satisfactory performance of both the Carpentier-Edwards and Björk-Shiley valves in the short and middle term and indicates no clear-cut advantage for either prosthesis.