Performance profile of the Starr-Edwards aortic cloth covered valve, track valve, and silastic ball valve.

Abstract

The Starr-Edwards aortic ball valve has passed 30 years of clinical follow-up. A detailed account of the long-term performance from a large series could thus give valuable guidance in managing patients who are still alive, depict the total remaining life-span after aortic valve replacement (AVR) for the average patient, and set a record yet to be matched by modern disc valves. A detailed follow-up to a maximum of 31.1 years was performed for 717 patients who underwent their first AVR during 1965-1993 with a Starr-Edwards silastic ball valve (N = 355), a cloth covered valve (N = 164) or a track valve (N = 198) with a total of 7254 patient-years at risk. Patients who received a silastic ball valve were older (average 60 vs. 58 years), had more endocarditis (9%) and more secondary kidney failure (24%) preoperatively than the other patients. The three valve types did not differ as regards long-term survival or freedom from complications and only 15% of late deaths were related to the valve. For the silastic ball valve cumulative freedoms at 10 and 25 years were 59 and 20% from all deaths (crude survival), 85 and 80% from thromboembolism, 87 and 70% from bleeding, 98 and 94% from endocarditis, 96 and 95% from redo AVR and 68 and 51% from all valve related complications joined. There were no instances of structural failure apart from wear of the cloth covering the cage struts of the cloth covered valves. Incidences of haemolysis (0.10%/patient-year) and valve thrombosis (0.06%/patient-year) were low for the silastic ball valve. Analysis of relative survival for the silastic ball valve indicated excess mortality relative to a matched background population only during 1st and 13th postoperative year. Apart from heart related factors and age, independent incremental risk factors for mortality and the various complications included, not valve type, but valve size index (valve size divided by body surface area) < or = 13 mm/m2. The Starr-Edwards aortic ball valves, not least the currently available silastic ball valve, are durable through the remaining life time of the patients and able to secure near normal age and sex specific survival provided valve and patient size mismatch is avoided.