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  • Title: Long-term outcome after valve replacement with the omnicarbon prosthesis.
    Author: di Summa M, Poletti G, Brero L, Centofanti P, La Torre M, Patanè F, Raggio JM, Sanchez FG, Maroñas JM, Torregrosa S, Valera FJ, Caffarena J.
    Journal: J Heart Valve Dis; 2002 Jul; 11(4):517-23. PubMed ID: 12150300.
    Abstract:
    BACKGROUND AND AIM OF THE STUDY: The study aim was to determine whether long-term prognosis was affected by valve replacement with a tilting-disc prosthesis. METHODS: Surgical data were recorded prospectively for all (n = 153) valve replacement cases with the Omnicarbon prosthesis during the period February 1985 to January 1986. A rheumatic valvular pathology was present in 105 patients (68.6%). There were 78 (51%) aortic (AVR), 51 (33%) mitral (MVR) and 24 (16%) double (DVR) valve replacements. The follow up was 99% complete (n = 151). RESULTS: Mean follow up was 10.2+/-4.4 years (total 1,472 patient-years (pt-yr)). Survival at 10 years was 68+/-4% (71+/-5% AVR, 61+/-7% MVR), and this fell to 57+/-4% at 14 years. No structural failure was observed. Thromboembolic and hemorrhagic events were rare, with actuarial freedom from thromboembolism of 94+/-2% and 91+/-3% at 10 and 14 years, respectively. This low incidence of thromboembolism encouraged an ease in anticoagulation; hence the AVR and MVR cohorts had a median INR of 2.8, but a higher INR (3.4) was maintained in DVR patients. All prostheses had acceptable hemodynamic performance. No cases of hemolytic anemia were detected, and mean blood counts were within normal ranges. Lactate dehydrogenase values indicated minimal hemolysis, and were lowest after AVR (median LDH 93% normal) and highest after DVR (median LDH 136% normal). Functional evaluation showed an improvement in NYHA class that remained stable over 14 years. At follow up, 95% (75/79) of patients were in NYHA class I or II. CONCLUSION: Survival and quality of life after Omnicarbon valve implantation exceeded the authors' expectations. Functional capacity remains good, and valve-related complication rates are low. The Omnicarbon tilting-disc valve has been shown to provide reliable and satisfactory service in the long term.
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