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在编织涤纶上进行辉光放电聚合未能改善血液透析移植物的性能。

Failure of glow-discharge polymerization onto woven Dacron to improve performance of hemodialysis grafts.

作者信息

Farmer D L, Goldstone J, Lim R C, Reilly L M

机构信息

Department of Surgery, University of California, San Francisco 94143-0222.

出版信息

J Vasc Surg. 1993 Oct;18(4):570-5; discussion 575-6.

PMID:8411464
Abstract

PURPOSE

The ideal conduit for hemodialysis vascular access remains elusive. Autogenous fistulas and prosthetic grafts, most commonly expanded polytetrafluoroethylene (e-PTFE), have adequate long-term patency rates (60% to 80% at 1 year); however, considerable delay in their use (2 to 6 weeks) is required. The Plasma-TFE graft is a recently introduced thin-walled woven Dacron graft to which an ultrathin layer of tetrafluoroethylene is bonded through a process of glow-discharge polymerization. This process purportedly results in a graft with an internal surface of low thrombogenicity. Low thrombogenicity, combined with the healing characteristics of a woven graft, have led to claims of equivalent patency rates even when used for dialysis immediately (within 1 week) after implantation.

METHODS

This concept led us to use this new graft material in 19 fistulas (12 forearm and 7 arm) during a 1-year period.

RESULTS

Although early use was possible, the primary and secondary patency rate at 12 months was only 47.4%. Ten grafts required replacement, five within the first month and two in the second month. Attempts at fistula revision failed because of unsuccessful graft thrombectomy or exuberant intimal hyperplasia. Failure was not associated with early use. During the same time period, 28 PTFE grafts were implanted, with only four failures (primary patency 78.6%; secondary patency 85.7%; p = 0.028). The secondary patency rate was the same for Plasma-TFE grafts (47%) but improved to 85.7% for e-PTFE grafts (p = 0.005). Both groups were comparable with respect to age, diabetes, previous dialysis access procedures, and other comorbid conditions.

CONCLUSIONS

These early results have been sufficiently disappointing that we have abandoned use of this graft approved for hemodialysis by the Food and Drug Administration and cannot recommend it for other clinical indications. Nevertheless, the concept of plasma-discharge polymerization is theoretically attractive and might be useful in future graft configurations.

摘要

目的

理想的血液透析血管通路导管仍未找到。自体动静脉内瘘和人工血管移植物,最常见的是膨化聚四氟乙烯(e-PTFE),具有足够的长期通畅率(1年时为60%至80%);然而,其使用前需要相当长的延迟时间(2至6周)。血浆-TFE移植物是一种最近推出的薄壁编织涤纶移植物,通过辉光放电聚合工艺在其表面结合了一层超薄的四氟乙烯。据称,该工艺可使移植物的内表面具有低血栓形成性。低血栓形成性,再加上编织移植物的愈合特性,使得即使在植入后立即(1周内)用于透析,也有同等通畅率的说法。

方法

这一概念促使我们在1年时间里,将这种新型移植物材料用于19例动静脉内瘘(12例在前臂,7例在手臂)。

结果

虽然可以早期使用,但12个月时的初级和次级通畅率仅为47.4%。10例移植物需要更换,5例在第一个月内,2例在第二个月内。由于移植物取栓术不成功或内膜增生过度,动静脉内瘘修复尝试失败。失败与早期使用无关。在同一时期,植入了28例PTFE移植物,只有4例失败(初级通畅率78.6%;次级通畅率85.7%;p = 0.028)。血浆-TFE移植物的次级通畅率相同(47%),但e-PTFE移植物的次级通畅率提高到85.7%(p = 0.005)。两组在年龄、糖尿病、既往透析血管通路手术以及其他合并症方面具有可比性。

结论

这些早期结果令人非常失望,以至于我们已放弃使用这种经美国食品药品监督管理局批准用于血液透析的移植物,也不能推荐将其用于其他临床指征。尽管如此,等离子体放电聚合的概念在理论上具有吸引力,可能在未来的移植物结构中有用。

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