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  • Title: Clinical outcomes with the epicholorohydrin-modified porcine aortic heart valve: a 15-year follow-up.
    Author: Wei X, Yi W, Chen W, Ma X, Lau WB, Wang H, Yi D.
    Journal: Ann Thorac Surg; 2010 May; 89(5):1417-24. PubMed ID: 20417754.
    Abstract:
    BACKGROUND: The epichlorohydrin (ECH) modified porcine aortic heart valve, first clinically utilized in 1989, obtained 2006 approval from the State Food and Drug Administration in China. This study analyzes the 15-year follow-up data of patient recipients of the ECH-modified valve. METHODS: From 1989 to 2002, 227 patients underwent ECH valve replacement at Xijing Hospital, consisting of mitral (129), aortic (57), tricuspid (26), and double (mitral and aortic[15]) valvular replacements. The mean age of patients was 42 +/- 7.9 years, and 50% were in New York Heart Association class III or IV. Follow-up included 8,885 patient-years, and was 96.5% complete. RESULTS: At 15 years, actuarial survival and freedom from valve-related death were, respectively, 58.1% +/- 13.7% and 90.0% +/- 6.8% (aortic group), 49.0% +/- 15.4% and 89.2% +/- 5.7% (mitral group), 65.3% +/- 12.4% and 83.6% +/- 10.8% (tricuspid group), and 40.7% +/- 16.0% and 83.3% +/- 15.2% (double-valve replacement group). Actuarial freedom from structural valve deterioration was 91.1% +/- 6.2%, 88.3% +/- 8.1%, 100%, and 66.7% +/- 27.2% in the aortic, mitral, tricuspid, and double-valve groups, respectively. Actuarial freedom from reoperation necessity was 95.7% +/- 4.3%, 85.8% +/- 10.4%, 80.4% +/- 13.4%, and 55.6% +/- 24.8% in the aortic, mitral, tricuspid, and double-valve groups, respectively. Actuarial freedom from incidence of prosthetic valve endocarditis was 97.5% +/- 2.5%, 93.4% +/- 4.9%, 90.0% +/- 9.5%, and 83.3 +/- 15.2% in the aortic, mitral, tricuspid, and double-valve groups, respectively. Actuarial freedom from thromboembolism was 89.4% +/- 7.7%, 92.1% +/- 4.7%, 77.9% +/- 14.1%, and 50.0% +/- 25.0% in the aortic, mitral, tricuspid, and double-valve groups, respectively. CONCLUSIONS: The epichlorohydrin-modified porcine valve has excellent durability and clinical performance in long-term follow-up.
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