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螺旋层流人工血管搭桥移植物:首例人体结构化注册研究的中期结果

Spiral laminar flow prosthetic bypass graft: medium-term results from a first-in-man structured registry study.

作者信息

Stonebridge Peter A, Vermassen Frank, Dick John, Belch Jill J F, Houston Graeme

机构信息

Division of Cardiovascular Research, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland.

出版信息

Ann Vasc Surg. 2012 Nov;26(8):1093-9. doi: 10.1016/j.avsg.2012.02.001. Epub 2012 Jun 8.

DOI:10.1016/j.avsg.2012.02.001
PMID:22682930
Abstract

BACKGROUND

A number of surgical strategies and graft enhancements have been trialled to improve the performance of prosthetic grafts. Neointimal hyperplasia may, in part, be a normal cellular response to an abnormal (turbulent) flow environment. This first-in-many study assesses the safety and medium-term patency performance of a new graft designed to induce stable laminar flow through the distal anastomosis.

METHOD

Forty patients who required an infrainguinal bypass graft were recruited/registered from a number of centers in Belgium and The Netherlands. Thirty-nine received a Spiral Laminar Flow graft as part of a standard treatment protocol (23 above-the-knee and 16 below-the-knee bypasses). Kaplan-Meier analyses were used to calculate primary and secondary patency rates.

RESULTS

The 12-, 24-, and 30-month primary patency rates were 86%, 81%, and 81% for above-the-knee bypasses and 73%, 57%, and 57% for below-the-knee bypasses, respectively. In the case of secondary patency rates, numbers were unchanged for above-the-knee bypasses and were 86%, 64%, and 64%, respectively, for below-the-knee bypasses. There were no amputations in the study population.

CONCLUSION

This first-in-man series shows potential for the idea of spiral flow-enhanced prosthetic grafts. As always, randomized studies are required to explore the role of different enhanced prosthetic grafts.

摘要

背景

已经尝试了多种手术策略和移植物增强方法来提高人工血管移植物的性能。内膜增生在一定程度上可能是对异常(湍流)血流环境的正常细胞反应。这项首次进行的多项研究评估了一种新型血管移植物的安全性和中期通畅性能,该移植物旨在通过远端吻合口诱导稳定的层流。

方法

从比利时和荷兰的多个中心招募/登记了40名需要进行腹股沟下血管搭桥移植物手术的患者。39名患者接受了螺旋层流血管移植物,作为标准治疗方案的一部分(23例膝上搭桥和16例膝下搭桥)。采用Kaplan-Meier分析来计算一期和二期通畅率。

结果

膝上搭桥的12个月、24个月和30个月一期通畅率分别为86%、81%和81%,膝下搭桥的一期通畅率分别为73%、57%和57%。二期通畅率方面,膝上搭桥的数字不变,膝下搭桥的二期通畅率分别为86%、64%和64%。研究人群中没有截肢病例。

结论

这一首次人体系列研究显示了螺旋流增强人工血管移植物理念的潜力。一如既往,需要进行随机研究来探索不同增强人工血管移植物的作用。

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