Clinical outcomes with the epicholorohydrin-modified porcine aortic heart valve: a 15-year follow-up.

Abstract

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. 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. 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. The epichlorohydrin-modified porcine valve has excellent durability and clinical performance in long-term follow-up.