Performance characteristics of the Starr-Edwards Model 1260 aortic valve prosthesis beyond ten years.

The Starr-Edwards non-cloth-covered silicone ball (Model 1260) aortic valve prosthesis has been widely used for over 15 years and remains a standard against which newer values are compared. To define more completely the performance characteristics of this prosthesis, this study (including 449 patients) analyzed the long-term function of this specific valve over a cumulative total of 2,896 patient-years (pt-yrs) of follow-up which extended beyond 13 years. Expressed in both actuarial (% [+/- standard error of the mean] free at 10 years) and linearized (%/pt-yr) terms, respectively, valve-related complications occurred at the following rates: thromboembolism, 76 +/- 3 and 2.7; anticoagulant-related hemorrhage, 74 +/- 3 and 3.1; prosthetic valve endocarditis, 92 +/- 2 and 0.9; reoperation, 90 +/- 2 and 1.1; valve failure, 82 +/- 2 and 2.2; all valve-related morbidity and mortality, 51 +/- 3 and 6.0; and valve-related death, 88 +/- 2 and 1.3. Thirteen percent of hospital and 18% of late deaths were due to valve-related causes. No case of structural failure was documented. This prosthesis has an admirable structural durability record out to 13 years, and its long-term performance is satisfactory, albeit not optimal. Despite the indestructable design and construction of this mechanical valve substitute, 12% +/- 2% of patients had died of valve-related complications by 10 years, and fully 49% +/- 3% had had some form of serious valve-related complication. The long-term data reported herein can be used for analytical comparison when follow-up of patients with newer mechanical prostheses and tissue bioprostheses reaches 10 years to elucidate whether or not these newer valves truly represent improvements and which type of valve substitute proffers the most possible net benefit to the patient.