title: The pericardial valve in the aortic position ten years later.
abstract: To assess the behavior of the pericardial valve at 10 years after implantation, the cases of 240 patients who had undergone aortic valve replacement with the standard Ionescu-Shiley (Shiley, Inc., Irvine, Calif.) bovine pericardial valve between February 1977 and December 1983 were reassessed. Follow-up of the 224 hospital survivors was 99.6% complete. Fifty-seven valve-related events occurred. Fourteen were thrombotic events (1.2%/patient-year), 28 were intrinsic tissue failures (2.4%/patient-year), 13 were cases of prosthetic valve endocarditis (1.1%/patient-year), and 2 were paravalvular leaks (0.17%/patient-year). The linearized rate for death, reoperation, or both resulting from valve-related events was 3.6%/patient-year. Time-related hazard function for the instantaneous risk of death and/or reoperation resulting from valve-related events demonstrated an exponential increase after 80 months. These data, in conjunction with our previous reports on the histologic changes in pericardial collagen and the incidence of calcification (26/28), should be considered regarding new and future generations of pericardial bioprostheses. Although this device provides good hemodynamics and carries a low incidence of thromboembolism, it has a limited durability. New generations of pericardial valves may have improved structural features, but the behavior of glutaraldehyde-fixed, formaldehyde-stored bovine pericardium as currently selected and prepared is unlikely to change.
authors.affiliation: Department of Surgery, Robert Wood Johnson University Hospital, New Brunswick, N.J.
authors.forename: L
authors.initials: L
authors.lastname: Gonzalez-Lavin
authors.forename: J
authors.initials: J
authors.lastname: Gonzalez-Lavin
authors.forename: S
authors.initials: S
authors.lastname: Chi
authors.forename: B
authors.initials: B
authors.lastname: Lewis
authors.forename: S
authors.initials: S
authors.lastname: Amini
authors.forename: D
authors.initials: D
authors.lastname: Graf
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001705:Bioprosthesis; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D010496:Pericardium; D012044:Regression Analysis; D012086:Reoperation; D012307:Risk Factors; D015996:Survival Rate