The unnatural history of valvular heart disease: late results with silastic ball valve prostheses.

The development of prosthetic heart valves successfully arrested the dismal natural history of valvular heart disease for thousands of patients. The experiences of numerous investigators provided a setting wherein the design and implantation of the silastic ball valves led to improved survival with both aortic and mitral valve replacement. Refinement of the caged-ball design was based on clinical and laboratory findings. In the mitral position, valve related thromboembolism was reduced from 38% to 3%. With the aortic prostheses the problem of ball variance was overcome by reducing trauma to the poppet and altering its heat curing process. In 1967 a completely cloth covered valve was introduced to reduce further the thromboembolic rate. Significant improvement in the embolus-free rate was ultimately found to be dependent on the year of operation with introduction of the time-frame concept. The current mitral silastic ball valve, Model 6120, yields an actuarial survival of 72 (+/- 3%), 54 (+/- 5%), and 37 (+/- 5%) for five, ten and fifteen years respectively. For aortic valve replacement, current Model 1260, the actuarial survival is 71 (+/- 2%), 58 (+/- 3%) and 48 (+/- 4%) for five, ten and fifteen years respectively. Late results are compared to other valvular prostheses.