Ten-year follow-up study of patients who had double valve replacement with the St. Jude Medical prosthesis.

Records of 100 consecutive patients who had received double valve replacement were reviewed (41 men, 59 women, mean age, 60.86 +/- 13.0 years). The early death rate was 6% (six patients). A completed follow-up rate of 93% was accomplished in these 94 patients who left the hospital (mean, 309.8 patient-years). Twenty-three of these patients died. The late death rate was 26.4%. Four patients experienced thromboembolic episodes (one transient and three permanent; all were minor). One patient had a paravalvular leak (mitral), and another had thrombosis of the tricuspid valve. There was no clinical evidence of hemolysis, infective endocarditis, or structural failure or anticoagulant-related bleeding. One of those 23 patients who died was the patient who had thrombosis of the tricuspid valve. Another three patients died of sudden and unknown causes, 15 of cardiac-related problems and four of noncardiac problems. Of those patients who survived, New York Heart Association functional class improved significantly (from 66% class III before to 85% class I after). Linearized rates for thromboembolism and thrombosis were 1.29 +/- 0.65 and 0.32 +/- 0.32 per 100 patient-years, respectively. The actuarial estimates of incidence free of all complications and valve-related deaths were 77.9% +/- 10.6%. Despite the advanced heart disease involving two native valves, the patients who had double valve replacement with the St. Jude Medical prosthesis had very good results over a 10-year period.