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圣犹达医疗公司Epic猪异种移植物用于主动脉瓣、二尖瓣和双瓣膜置换后的中期结果。

Midterm results after St Jude Medical Epic porcine xenograft for aortic, mitral, and double valve replacement.

作者信息

Jawad Khalil, Lehmann Sven, Koziarz Alex, Dieterlen Maja, Feder Stefan, Misfeld Martin, Garbade Jens, Rao Vivek, Borger Michael

机构信息

Department of Cardiac Surgery, Heart Center, Leipzig University, Leipzig, Germany.

Department of Cardiac Surgery, Peter Munk Cardiac Center, Toronto, Canada.

出版信息

J Card Surg. 2020 Aug;35(8):1769-1777. doi: 10.1111/jocs.14554. Epub 2020 Jun 29.

DOI:10.1111/jocs.14554
PMID:32598528
Abstract

BACKGROUND

The aim of this study was to evaluate the results after stented porcine xenograft implantation (Epic, SJM, St Paul, MN) with Linx anticalcification treatment in elderly patients at our high-volume tertiary care center.

METHODS

A total of 3825 patients undergoing aortic (AVR = 2441), mitral (MVR = 892), or double valve (DVR = 492) replacement between 11/2001 and 12/2017 with Epic xenografts were evaluated. Outcomes were assessed by reviewing the prospectively acquired hospital database results, and regular annual follow-up information was acquired from questionnaires or telephone interviews.

RESULTS

For patients undergoing AVR, MVR, DVR, age at surgery were 76.4 ± 6, 71.2 ± 9, 72.9 ± 8 years; active endocarditis was an indication for valve surgery in 4.5%, 20.7%, 19.7%; and the predicted median (interquartile range [IQR]) mortality risk (EuroSCORE II) was 5.2% (3.1%-9.4%), 7.5% (3.9%-16.2%), 9.9% (6.0%-19.6%), respectively. Median follow-up was 3.04 (IQR: 0.18-5.21). Thirty-day survival was 91.2% ± 0.6%, 87.6% ± 0.1.1%, 84.7% ± 1.6%; and 10-year survival was 56.7% ± 1.0%, 59.4% ± 2.5%, 50.45% ± 3.1%, respectively. Patients who underwent MVR versus AVR were at significant increased risk for reoperation for endocarditis (adjusted odds ratio; 2.2, 95% confidence interval; 1.29-3.7; P = .003). There was no significant difference in all-cause mortality at midterm in AVR vs MVR in the matched cohort (P = .85).

CONCLUSIONS

Implantation of the Epic stented porcine xenograft is associated with acceptable survival and freedom from valve-related complications or reoperation due to structural valve disease at midterm follow-up.

摘要

背景

本研究的目的是评估在我们这家大型三级医疗中心,老年患者植入带支架猪异种移植物(Epic,圣犹达医疗公司,圣保罗,明尼苏达州)并接受林克斯抗钙化治疗后的结果。

方法

对2001年11月至2017年12月期间共3825例行主动脉瓣置换术(AVR = 2441例)、二尖瓣置换术(MVR = 892例)或双瓣膜置换术(DVR = 492例)且使用Epic异种移植物的患者进行评估。通过回顾前瞻性获取的医院数据库结果评估结局,并通过问卷或电话访谈获取定期年度随访信息。

结果

接受AVR、MVR、DVR的患者,手术年龄分别为76.4±6岁、71.2±9岁、72.9±8岁;活动性心内膜炎作为瓣膜手术指征的比例分别为4.5%、20.7%、19.7%;预测的中位(四分位间距[IQR])死亡风险(欧洲心脏手术风险评估系统II)分别为5.2%(3.1% - 9.4%)、7.5%(3.9% - 16.2%)、9.9%(6.0% - 19.6%)。中位随访时间为3.04(IQR:0.18 - 5.21)。30天生存率分别为91.2%±0.6%、87.6%±1.1%、84.7%±1.6%;10年生存率分别为56.7%±1.0%、59.4%±2.5%、50.45%±3.1%。接受MVR的患者与接受AVR的患者相比,因心内膜炎再次手术的风险显著增加(调整优势比;2.2,95%置信区间;1.29 - 3.7;P = 0.003)。在匹配队列中,AVR与MVR的中期全因死亡率无显著差异(P = 0.85)。

结论

在中期随访中,植入Epic带支架猪异种移植物与可接受的生存率以及无瓣膜相关并发症或因结构性瓣膜疾病再次手术相关。

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