Section of tissue or prosthetic valve. A five-year prospective, randomized comparison.

After considerable experience, controversy persists between the selection of a tissue or prosthetic valve. In order to provide a nonbiased comparison, we designed a prospective, randomized study in September of 1970. Ninety-nine consecutive patients with isolated primary single valve replacement were randomized to tissue or prosthetic valves. The Tissue Bank supplied homografts which were either mounted for mitral replacement or used as free grafts for patients with small aortic roots. Starr-Edwards cloth-covered prostheses were used for comparison. There was an even distribution of patients by age, sex, valve lesion, and New York Heart Classification attesting to the accuracy of the random selection. Anticoagulants were used in 33 patients who had operative or embolic evidence of atrial clot or else history of thromboembolism. Thirty-five patients have undergone postoperative catheterization. Causes of death and valve failure are presented on an actuarial basis. Death in the Starr-Edwards patient group was sudden or due to fabric wear with subsequent thromboembolism, hemorrhage, or infection. We conclude that the tissue valve is a better choice for valve replacement. While there is no significant functional or hemodynamic apparent difference between the tissue and prosthetic valve, there is improvement in patient morbidity and mortality rate with the use of homografts, particularly in the aortic position. The primary cause of complications in the homograft is tissue deterioration, and this problem has been markedly reduced with the advent of glutaraldehyde fixation. No such advance in solving the problem of host incompatability with the prosthesis has been forthcoming.