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The Journal of Thoracic and Cardiovascular Surgery, Vol 90, 137-144, Copyright © 1985 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association
EM Baudet, CC Oca, XF Roques, MN Laborde, AS Hafez, MA Collot and IM Ghidoni
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
months to 82 years (mean 55 years); 16 of these patients (2.3%) were less
than or equal to 15 years and 82 (12.2%) were greater than or equal to 70
years. 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
(less than or equal to 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 possibly valve-related. Complete follow-up
was achieved during December, 1983, and January, 1984, to provide a minimum
follow- up of 6 months. Follow-up has been 100% for a total of 1,619
patient- years, with a mean follow-up of 2 1/2 years. There were 41 late
deaths (6.1%): 30 in the aortic group, eight in the mitral group, and three
in the double valve replacement group. Fourteen (34.2%) of these late
deaths have been considered valve-related. At 5 1/2 years, 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 three 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 patient-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 years 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.
ARTICLES
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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