Clinical and hemodynamic results with the St. Jude Medical cardiac valve prosthesis. A three-year experience.

Two hundred thirty-two consecutive patients (October 3, 1977, through December, 31, 1980) underwent aortic (AVR), mitral (MVR), or double (DVR) valve replacement with the St. Jude Medical (SJM) prosthesis. Operative mortality for the entire group was 7.3%. There was 100% follow-up. Warfarin (Coumadin) anticoagulation was recommended for all patients. There were no cases of mechanical failure. The incidence of thromboembolism was 0.6/1,000 patient-months for those with AVR, 3/1,000 patient-months for those with MVR, and 0% for those with DVR. Thrombosis of a prosthesis occurred in two patients with DVR. Clinically significant hemolysis occurred in three patients with paravalvar leaks following MVR. Late postoperative prosthetic infection has not occurred. Postoperative catheterization studies in 33 patients revealed no transvalvular gradient at rest in 21 patients. The remainder of the patients catheterizd had low transvalvular gradients. There was a minimal increase in transvalvular gradient with exercise. The SJM cardiac valve is a viable alternative in the surgical therapy of valvular heart disease.