Circulation, Vol 73, 1213-1222, Copyright © 1986 by American Heart Association
P Bloomfield, AH Kitchin, DJ Wheatley, PR Walbaum, W Lutz and HC Miller
From 1975 to 1979, 540 patients undergoing valve replacement were entered
into a randomized trial and received either a Bjork-Shiley (273 patients)
or a porcine heterograft prosthesis (initially a Hancock valve [107
patients] and later a Carpentier-Edwards prosthesis [160 patients]). Two
hundred and sixty-two patients required mitral valve replacement, 210
required aortic valve replacement, 60 required mitral and aortic valve
replacement, and eight also required associated tricuspid valve replacement
(six mitral valve replacement; two mitral plus aortic valve replacement).
Analysis of 34 preoperative and operative variables showed the treatment
groups to be well randomized. In-hospital mortality was not significantly
different among patients receiving the three prostheses for aortic valve
replacement (7.6% overall) and mitral plus aortic valve replacement (10%
overall), but there was a higher in-hospital mortality for patients
undergoing mitral valve replacement with the Carpentier-Edwards prosthesis
(15.5% compared with 8.8% overall; p = .03). This difference could not be
explained on the basis of any preoperative or operative variable. Median
follow-up was 5.6 (range 2.8 to 8.3) years. Actuarial survival after mitral
valve replacement was 56.7 +/- 7.0% at 7 years, that after aortic valve
replacement was 69.6 +/- 9.6% at 7 years, and that after mitral plus aortic
valve replacement was 62.5 +/- 20.0% at 7 years. There was no significant
difference in actuarial survival of patients receiving the three prostheses
within the mitral, aortic, and mitral plus aortic valve replacement groups,
nor was there a difference when these groups were amalgamated. Thirty-seven
patients required reoperation for valve failure (15 with Bjork-Shiley, 12
with Hancock, and 10 with Carpentier-Edwards valves; p = NS) and 11 died at
reoperation (four with Bjork-Shiley, four with Hancock, and three with
Carpentier-Edwards valves; overall operative mortality 29.7%). Up to 7
years after surgery, there was no significant difference in the incidence
of thromboembolism in patients with different prostheses undergoing mitral
or aortic valve replacement. There were too few patients undergoing mitral
plus aortic valve replacement for meaningful comparison. There was no
significant beneficial effect of anticoagulants in patients undergoing
mitral or aortic valve replacement with porcine prostheses, but patients
were not randomly allocated to anticoagulant treatment. All patients with
Bjork-Shiley prostheses received anticoagulants.(ABSTRACT TRUNCATED AT 400
WORDS)
ARTICLES
A prospective evaluation of the Bjork-Shiley, Hancock, and Carpentier- Edwards heart valve prostheses
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