Clinical outcomes with the epicholorohydrin-modified porcine aortic heart valve: a 15-year follow-up.
Clinical outcomes with the epicholorohydrin-modified porcine aortic heart valve: a 15-year follow-up.
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表氯醇修饰猪主动脉心脏瓣膜的临床结果：15 年随访。
DOI：
10.1016/j.athoracsur.2010.02.009
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发表时间：
2010
期刊：
影响因子：
--
通讯作者：
Dinghua Yi
中科院分区：
文献类型：
--
作者：
Xufeng Wei;W. Yi;Wensheng Chen;Xinliang Ma;W. Lau;Hongbing Wang;Dinghua Yi
背景环氧氯丙烷修饰猪主动脉瓣膜于1989年首次临床应用，2006年获得国家食品药品监督管理局中国批准。方法1989年至2002年，在西京医院接受ECH瓣膜置换术的患者227例，其中二尖瓣置换术129例，主动脉瓣置换术57例，三尖瓣置换术26例，双瓣置换术(二尖瓣和主动脉瓣置换术)15例。平均年龄42±7.9岁，其中50%为纽约心脏协会III级或IV级。随访8885人年，成功率为96.5%。结果15年来，主动脉组的精算生存率和瓣膜相关性死亡的生存率分别为58.1%±13.7%和90.0%±6.8%，二尖瓣组为49.0%±15.4%和89.2%±5.7%。三尖瓣组分别为65.3%±12.4%和83.6%±10.8%，双瓣组分别为40.7%±16.0%和83.3%±15.2%。主动脉瓣、二尖瓣、三尖瓣和双瓣组结构瓣膜恶化的精算生存率分别为91.1%±6.2%、88.3%±8.1%、100%和66.7%±27.2%。主动脉瓣组、二尖瓣组、三尖瓣组和双瓣组的再手术成功率分别为95.7%±4.3%、85.8%±10.4%、80.4%±13.4%和55.6%±24.8%。主动脉瓣组、二尖瓣组、三尖瓣组和双瓣组的人工瓣膜心内膜炎发生率分别为97.5%±2.5%、93.4%±4.9%、90.0%±9.5%和83.3%±15.2%。动脉组、二尖瓣组、三尖瓣组和双瓣组的血栓栓塞率分别为89.4%±7.7%、92.1%±4.7%、77.9%±14.1%和50.0%±25.0%。结论环氧氯丙烷修饰的猪瓣膜具有良好的耐久性和长期的临床性能。
BACKGROUNDThe 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.METHODSFrom 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.RESULTSAt 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.CONCLUSIONSThe epichlorohydrin-modified porcine valve has excellent durability and clinical performance in long-term follow-up.
DOI：
10.1016/s0022-5223(94)70186-5
发表时间：
1994-11-01
影响因子：
6
作者：
SCHOEN, FJ;HIRSCH, D;LEVY, RJ
通讯作者：
LEVY, RJ