Long-term Results in 1375 Patients Undergoing Valve Replacement with the Starr-Edwards Cloth-covered Steel Ball Prosthesis

The two principal considerations with prosthetic valves are durability and thromboembolism. With the widespread interest in recently developed prosthetic valves (porcine, tilting disc, Cooley), the long-term results at one institution with a single prosthesis were considered of particular importance. Accordingly, a 97% follow-up has been completed on 1375 patients (pts) undergoing prosthetic valve replacement with the Starr-Edwards cloth-covered steel ball prosthesis at New York University between October 1967 and December 1975. Operative procedures were as follows: aortic valve replacement (AVR): 470 pts; mitral valve replacement (MVR): 362 pts; combined AVR and MVR: 129 pts; other combined procedures: 414 pts. Overall operative deaths were 13.7%, 9% for AVR, 10.8% for MVR, and 18.6% for combined AVR and MVR. At seven years, AVR survival was 64%, and MVR survival 64.5%. There has been widespread pessimism, usually without significant data, about the cloth-covered prosthesis, because of concern of cloth wear, hemolysis and other complications. Therefore, a particularly significant finding by actuarial analysis was that 85% of surviving patients with isolated AVR remained free of emboli for five years. In pts surviving isolated MVR, 80% remained free of emboli for five years. Of those having embolic episodes, 33% were not on anticoagulants. Fatal hemorrhage from anticoagulants occurred in 0.8% of pts. Endocarditis occurred in 5.7% of the entire group, with 1.3% requiring reoperation. Clinically significant hemolysis occurred in 5.1% of the group, with only 0.2% requiring reoperation. Hence, the total frequency of clinically significant cloth-wear was less than 0.5%. These data indicate both the reliability and the limitations of the Starr-Edwards cloth-covered steel ball valve and can be used in comparing experiences with the more recently developed prostheses.