Radiographic Detection of Strut Separations in Björk–Shiley Convexo-Concave Mitral Valves

Patients undergoing heart-valve replacement may receive a mechanical prosthesis, necessitating lifelong anticoagulant treatment, or a porcine bioprosthesis, which involves no absolute need for anticoagulants. We carried out a randomized, prospective trial to compare the durability of the Bjork-Shiley mechanical prosthesis (spherical tilting-disk model) and the incidence of valve-related complications with those variables in the Hancock and the Carpentier-Edwards porcine prostheses. The mitral valve was replaced in 261 patients, the aortic valve in 211, and both in 61; the survivors have been followed up for a mean of 12 years. We found a trend toward improved actuarial survival after 12 years with the Bjork-Shiley prosthesis, but this trend was not statistically significant (group with Bjork-Shiley valve vs. group with porcine valve [mean +/- SE], 51.5 +/- 3.2 vs. 44.4 +/- 3.2 percent; P = 0.08). There was no significant difference in the actuarial incidence of reoperation after 5 years, but after 12 years significantly more patients with a porcine prosthesis had undergone reoperation (8.5 +/- 2.0 vs. 37.1 +/- 4.1 percent, P less than 0.001). An analysis combining death and reoperation as end points for an actuarial assessment of survival with the original prosthesis intact confirmed that the patients with Bjork-Shiley Shiley prostheses had improved survival (48.6 +/- 3.2 vs. 30.0 +/- 3.0 percent after 12 years, P less than 0.001). Bleeding requiring hospitalization or blood transfusion was significantly more frequent in the patients with Bjork-Shiley prostheses (18.6 +/- 3.2 vs. 7.1 +/- 2.3 percent after 12 years, P less than 0.01). There was no significant difference after 12 years in the actuarial occurrence of embolism (Bjork-Shiley vs. porcine, 21.1 +/- 3.1 vs. 26.4 +/- 3.5 percent) or endocarditis (3.7 +/- 1.4 vs 4.6 +/- 1.6 percent). Survival with an intact valve is better among patients with the Bjork-Shiley spherical tilting-disk prosthesis than among patients with porcine bioprostheses, but use of the Bjork-Shiley valve carries an attendant increased risk of bleeding associated with the need for anticoagulant treatment.

Fifty-three (3.6%; actuarially 4.1% at 48 months) of 1465 consecutive in-hospital survivors of valve replacement from 1975 to July 1979 (aortic, mitral, or aortic and mitral, only one untraced) developed prosthetic valve endocarditis (PVE). Incremental risk factors for developing PVE were native valve endocarditis (p less than .0001), black race (p = .0001), mechanical prosthesis (vs bioprosthesis) (p = .005), male sex (p = .04), and longer cardiopulmonary bypass time (p = .09). In general, the hazard function for developing PVE was greatest at 3 weeks after valve replacement. Patients with native valve endocarditis had a tendency to develop PVE early after valve replacement, as did patients in whom mechanical prostheses were used. PVE associated with Staphylococcus epidermidis tended to appear within 6 months of valve replacement, whereas streptococcal PVE tended to appear later after valve replacement. PVE took an atypical form in some patients, but patients with possible PVE (n = 6) had the same findings as those with certain PVE (n = 47). In 11 patients bacteriologic confirmation of PVE was not obtained. The typical prosthetic and periprosthetic characteristics of PVE were present in 30 of the 40 cases in which observations were possible. PVE is a serious condition; 34 (64%) of our 53 patients died. Most deaths occurred within 3 months of the first evidence of PVE. Recovery of some patients is possible with appropriate medical and surgical treatment, but more intense preventive measures are indicated.