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The Journal of Thoracic and Cardiovascular Surgery, Vol 80, 824-833, Copyright © 1980 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association
PE Oyer, DC Miller, EB Stinson, BA Reitz, RJ Moreno-Cabral and NE Shumway
The principal feature of the Hancock xenograft bioprosthesis which remains
to be completely defined is long-term durability. This report provides
extended data regarding valve durability derived from a data base of 1,407
patients (707 aortic [AVR] and 700 mitral [MVR] replacements) who received
Hancock bioprostheses between 1971 and 1979; cumulative duration of
follow-up was 1,732 patient-years for AVR and 1,843 for MVR patients, with
a maximum follow-up duration of 8.4 years. One hundred seventy-nine
patients were followed for more than 5 years and 67 for more than 6 years.
Valve failure was defined on the basis of one or more of the following
criteria: (1) postoperative development of a new regurgitant murmur, (2)
thrombotic valvular occlusion, (3) infective endocarditis resulting in
reoperation or death, and (4) hemodynamic valvular dysfunction confirmed by
catheterization and resulting in reoperation or death. Twenty-one such
failures occurred among all AVR patients and 23 among all MVR patients. The
actuarial probability of freedom from valve failure (all causes) was 95.4%
+/- 1.2% (+/- SEM) for adult AVR patients 5 years postoperatively and 90.9%
+/- 2.6% for adult MVR patients 6 years postoperatively. The probability of
freedom from primary tissue failure in adults was 99% +/- 1% in AVR
patients at 5 years and 94.3% +/- 2.4% in MVR patients at 6 years. The
linearized incidence of primary tissue failure in children (< 15 years
old) was 9.8% per patient-year (combined AVR and MVR patients), compared to
0.2% per patient-year among all adult patients in the analysis. The
combined actuarial incidence of primary tissue failure among adults with
AVR and MVR was 98.6% +/- 0.7% at 5 years and 94.2% +/- 2.3% at 6 years;
thus there appears to be a slight acceleration in the rate of valve tissue
failure between 5 and 6 years after operation. The incidence of failure,
however, remains acceptably low through 6 years of follow-up, and continued
clinical use of the xenograft bioprosthesis seems warranted.
ARTICLES
Clinical durability of the Hancock porcine bioprosthetic valve
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