Long‐Term Clinical and Hemodynamic Evaluation of the Ionescu‐Shiley Pericardial Xenograft Heart Valve

Abstract

Pericardial xenograft heart valves have been used in 469 patients for single or multiple valve replacement. Early in the series, valves were made in-house, but since May 1976, valves have been made by Shiley Laboratories, Inc. During the eight-year observation period, there were 7% early and 7.9% late deaths. Although no anti-coagulants were used on a long-term basis, there were only eight mild embolic episodes. Preoperatively, 56--98% of all patients were in class III or IV of the NYHA classification; postoperatively, all surviving patients have been found to have improved by at least one classification.

Cardiac Valve Replacement. Problems Solved and Unsolved

“…A similarly low degradation rate was found in glutaraldehyde-treated pericardial xenografts (36), and promising results are also reported for glyceroltreated dura mater allografts (74).…”

“…None of the mitral valve prostheses are free of gradients at rest, indicating that conversion of the naturally expansible mitral annulus into a fixed diameter orifice (71) and/or a variable resistance to valve opening (inertia of occluder, stiffness of leaflets) may play a role. During exercise mitral valve gradients increase in all prostheses, the older disc valves (34,35,58,59,72) showing distinctly higher differentials than the Starr-Edwards ball (39), the Björk-Shiley (12,50), the Lillehei-Kaster (30,34,35,50), and the stented homografts (29,35) and xenografts (31,36). No significant differences can be noted among the bioprostheses, perhaps with the exception of slightly higher gradients in the pericardial xenografts (36).…”

“…Average resting pressure for aortic xenografts were reported by several authors to range between 16-19 mmHg (18,20,21,23,31,42,47), but only limited data are available on exercise gradients (31,36,37). The exercise data shown in Table 1 warrant the conclusion that xenografts, with the possible exception of the pericardial variety, due to their heavy mounting frame, are no less obstructive than the mechanical valves now used in the aortic position.…”

“…A number of investigators (10,31,36,37,39,41) as well as ourselves (33,64) have measured aortic valve gradients at rest and during exercise as shown in Table 1. From this clinical material, comprising a variety of valve sizes, it appears that the LilleheiKaster prostheses and the Hancock porcine xenograft produce higher exercise gradients than either the Starr-Edwards or the Björk-Shiley variety.…”

“…From this clinical material, comprising a variety of valve sizes, it appears that the LilleheiKaster prostheses and the Hancock porcine xenograft produce higher exercise gradients than either the Starr-Edwards or the Björk-Shiley variety. Very low values were reported for the Ionescu pericardial xenograft (36). However, no significant differences in postoperative resting and exercise gradients were found between the Lillehei-Kaster and the Björk-Shiley prostheses in tissue annulus sizes greater than 20 mm (3).…”