A 5-1/2-YEAR EXPERIENCE WITH THE ST-JUDE-MEDICAL CARDIAC-VALVE PROSTHESIS - EARLY AND LATE RESULTS OF 737 VALVE REPLACEMENTS IN 671 PATIENTS

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  • 1 January 1985
    • journal article
    • research article
    • Vol. 90  (1) , 137-144
Abstract
Between June 12, 1978, and June 12, 1983, 737 St. Jude Medical valves were implanted in 671 patients (431 males, 240 females) ranging in age from 9 mo. to 82 yr (mean 55 yr); 16 of these patients (2.3%) were .ltoreq. 15 yr and 82 (12.2%) were .gtoreq. 70 yr. Associated procedures were performed in 28.2% of the 500 aortic valve replacements, 13.3% of the 105 mitral valve replacements and 10.6% of the 66 double mitral and aortic valve replacements. Hospital mortality (.ltoreq. 30 days) was 3.6% (18/500 patients) for aortic, 4.7% (5/105 patients) for mitral and 0% for double valve replacement. Only one of these 23 hospital deaths was possible valve-related. Complete follow-up was achieved during Dec., 1983 and Jan., 1984, to provide a minimum follow-up of 6 mo. Follow-up has been 100% for a total of 1,619 patients-years, with a mean follow-up of 2 1/2 yr. There were 41 late deaths (6.1%); 30 in the aortic group, 8 in the mitral group and 3 in the double valve replacement group. Of these late deaths 14 (34.2%) were considered valve-related. At 5 1/2 yr, the actuarial survival rate, hospital mortality excluded, is 91% for aortic, 90% for mitral and 95% for double valve replacement. Functional improvement of these patients is quite satisfactory; preoperatively, 60.3% were in Class III or IV of the New York Heart Association, whereas postoperatively, 99.5% of the patients are in Class I or II. As 78 patients (65 aortic, 10 mitral and 3 double valve replacement) did not receive anticoagulation therapy for a total period of 84 patient-years, the incidence of valve thrombosis, systemic embolism and sudden or suspicious deaths in this group was compared with that in a group of 630 patients (including 60 patients from the first group who were given anticoagulants afterwards) subjected to long-term anticoagulation for a total period of 1,535 patients-years. A significantly higher incidence of valve thrombosis and systemic embolism was observed in the absence of anticoagulation. Anticoagulant-related complications occurred in 10 patients, with an incidence of 0.65/100 patient-years. On the basis of this 5 1/2 yr of experience, the St. Jude Medical valve appears to be an excellent mechanical prosthesis for cardiac valve replacement, in terms of hemodynamic performance and low thrombogenicity, in patients receiving anticoagulants.

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