title: A ten-year study of the Ionescu-Shiley low-profile bioprosthetic heart valve.
abstract: Seven hundred and eight adults (age > or = 16 years) with isolated aortic (n = 433) or mitral (n = 275) Ionescu-Shiley Low-Profile (ISLP) pericardial valves were followed at 14 implanting centres in Canada, the United Kingdom, and the United States for a mean of 6.7 years, providing 4,729 patient-years of clinical data. The operative mortality rate was 3.0% for aortic valve replacement (AVR) and 5.5% for mitral valve replacement (MVR) (p = ns). Actuarial patient survival following AVR at 5 years was 81.6%, and 62.9% at 10 years; for MVR patients it was 78.1% at 5 years and 59.6% at 10 years. The ISLP valve appears to have durability comparable to other contemporary bioprosthetic valves. For aortic prostheses, the freedom from structural deterioration was 96.5% at 5 years and 73.7% at 10 years, and 89.7% at 5 years and 62.4% at 10 years for mitral prostheses. Structural deterioration was significantly more frequent following MVR than after AVR (p < 0.05). Structural deterioration was the principal cause for reoperation, but sudden deterioration precluding safe reoperation was not a dominant feature of this series. The ISLP valve appeared to engender more thrombo-embolic events than would be anticipated from earlier studies of pericardial bioprostheses, but was indistinguishable from other tissue valves in its incidence of other valve-related complications. We conclude that ISLP valves now implanted for 7 years or more are entering a phase of increasing structural deterioration, indicating the need for regular clinical and echocardiographic surveillance, and that long-term anticoagulation should be instituted for relatively minimal indications in these patients.
authors: Department of Cardiothoracic Surgery, Glasgow Royal Infirmary, Scotland, UK.
authors: D J
authors: DJ
authors: Wheatley
authors: F A
authors: FA
authors: Crawford
authors: P H
authors: PH
authors: Kay
authors: J G
authors: JG
authors: Chandler
authors: M D
authors: MD
authors: Strong
authors: J A
authors: JA
authors: Strom
authors: P M
authors: PM
authors: Shah
authors: W J
authors: WJ
authors: Keon
authors: G
authors: G
authors: Copeland
authors: S S
authors: SS
authors: Lewis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001705:Bioprosthesis / Q000009:adverse effects / Q000401:mortality; D005069:Evaluation Studies as Topic; D005260:Female; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D012086:Reoperation; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome