Clinical experience with the Björk-Shiley integral monostrut heart valve prosthesis in the aortic and mitral position.

From May 1982 to May 1985, 174 Björk-Shiley integral monostrut (BSIM) heart valve prostheses were implanted in 160 patients. Eighty-eight valves were placed in mitral and 86 in aortic position. There were 92 males and 78 females with a mean age of 54.1 years (140 patients were in NYHA class III or IV (87.5%]. Single valve replacement was performed in 116 (72%) patients, 30 (19%) underwent multiple valve procedures and in 14 (9%) valve replacement was combined with coronary artery bypass surgery. There were no intraoperative deaths. Six patients died within the first month after surgery. One hundred and fifty-two (98.7%) patients were followed for a total of 190 patient years (average 14.8 months per patient). There were 8 late deaths (4.2 per 100 patient-years), 5 of these were valve related. Valve related complications were observed in 9 patients (4.5 per 100 patient-years). The overall incidence of peripheral embolization was 2.6 per 100 patient years. At the time of the follow-up study 136 (94%) patients were in functional class I and II. Fourteen patients with isolated AVR and six with MVR underwent hemodynamic evaluation on an average of 12 and 10 months after surgery. The early results suggest that the BSIM prosthesis represents a promising alternative in heart valve replacement, because there were no mechanical failures, thromboembolic complications are rare and hemodynamic performance is good.