Clinical outcomes with the epicholorohydrin-modified porcine aortic heart valve: a 15-year follow-up.
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.
Wei
Xufeng
X
Institute of Cardiovascular Surgery, Xijing Hospital, 4th Military Medical University, Xi'an, Shaanxi Province, China.
Yi
Wei
W
Chen
Wensheng
W
Ma
Xinliang
X
Lau
Wayne Bond
WB
Wang
Hongbing
H
Yi
Dinghua
D
D000328:Adult; D000818:Animals; D001021:Aortic Valve / Q000601:surgery*; D001705:Bioprosthesis; D015331:Cohort Studies; D004811:Epichlorohydrin; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000601:surgery*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality*; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D011474:Prosthesis Design; D012189:Retrospective Studies; D018570:Risk Assessment; D015996:Survival Rate; D013552:Swine; D013997:Time Factors; D016896:Treatment Outcome; D014261:Tricuspid Valve / Q000601:surgery
D004811:Epichlorohydrin