Nineteen-Millimeter Aortic St. Jude Medical Heart Valve Prosthesis: Up to Sixteen Years’ Follow-up

Background. Prosthetic valve replacement in a small aortic root without annulus enlargement raises concern about its long-term benefits. Methods. Between July 1979 and June 1994, 104 (18%) of 593 patients underwent aortic valve replacement using the 19-mm St. Jude Medical heart valve prosthesis. There were 93 women and 11 men, with a mean age of 66.2 ± 10.6 years. Forty-four patients (42%) were 70 or more years old. The mean body surface area was 1.61 ± 0.16 m2 (range, 1.2 to 2.1 m2). Forty-nine patients (47%) underwent concomitant procedures; 23 patients (22%) required coronary artery bypass grafts and 25 patients (24%), mitral valve replacement. Ninety-eight patients (94%) presented in New York Heart Association class III and IV. Results. The operative mortality was 7.6% (8 patients). Follow-up was 100% with a mean of 5.48 ± 3.73 years (range, 1 to 16 years) and a total of 708 patient-years. There were 18 late deaths, with a mortality of 2.5% patient-years. The incidence of thromboembolism was 0.4% patient-years (3 patients) and anticoagulant-related morbidity was 0.85% patient-years (6 patients). Long-term survival in the two groups with a body surface area of less than 1.7 m2 and 1.7 m2 or more was not statistically different (p = 0.30). The univariate analysis with body surface area as a predictor of mortality showed that a larger body surface area had no effect on the long-term mortality (χ2 p value = 0.36). Survival for 5 and 10 years with the 95% confidence interval was 80.6% ± 8.3% and 61.6% ± 15%. Freedom from thromboembolism was 96.3% ± 4.2% and anticoagulant-related hemorrhage was 91.8% ± 6.8% at the end of 16 years. Cox proportional hazards model, with time-dependent covariates, showed that events of thromboembolism, anticoagulant-related hemorrhage, and myocardial infarction during follow-up increased the risk of late death (risk ratio, 9.5, 10.3, and 32.8, respectively). The age at operation was an independent risk factor, with decreased survival with age 70 or more years (p = 0.0002). However, body surface area (p = 0.97) and concomitant cardiac procedures (p = 0.86) were not statistically significant predictors of death. Conclusions. The long-term performance of the 19-mm St. Jude Medical heart valve prosthesis in the small aortic root is satisfactory irrespective of the body surface area, and it is a viable alternative for such patients.