Glickman M H, Stokes G K, Ross J R, Schuman E D, Sternbergh W C, Lindberg J S, Money S M, Lorber M I
Virginia Vascular Associates, Norfolk 23502, USA.
J Vasc Surg. 2001 Sep;34(3):465-72; discussion 472-3. doi: 10.1067/mva.2001.117330.
The purpose of this study was to compare in a randomized, prospective, and controlled study, the performance of a multilayered, self-sealing polyurethane vascular access graft (PVAG) and expanded polytetrafluoroethylene (ePTFE) vascular access grafts in hemodialysis applications. Performance measures included graft survival, complications, time to early cannulation, and hemostasis times after cannulation.
A total of 142 patients were randomized equally to receive one of the two grafts after meeting all eligibility requirements. All patients were followed up prospectively to 12 months or to the end of secondary patency. Specifically, this study documented the performance of the PVAG and ePTFE grafts by determining the patencies and complications for both grafts.
Patient characteristics between the two groups were similar with respect to risk factors and demographic characteristics (P >.05). Life-table patencies from the date of first dialysis were primary patency: PVAG 55% versus ePTFE 47% (6 months) and PVAG 44% versus ePTFE 36% (12 months) and secondary patency: PVAG 87% versus ePTFE 90% (6 months) and PVAG 78% versus ePTFE 80% (12 months). None of these differences were significant (P >.05). Both primary and secondary patencies were also not significantly different when the date of implantation was the starting point. Adverse events and complications were similar for the two groups, except the PVAG group had a higher incidence of technical complications manifested by graft kinking when compared with the control cohort (P <.05). Additionally, there was no significant difference in complication rates between these two groups with regard to infection and bleeding. When the time to hemostasis after cannulation was compared at 5minutes or less, there were more PVAG cannulation sites that achieved hemostasis compared with ePTFE sites, and this difference was significant (P <.0001). When time to first dialysis access was compared between the two grafts, 53.9% of all PVAG grafts were cannulated before 9 days versus none with the ePTFE grafts (P <.001). However, long-term graft survival was not significantly different when PVAG patients were stratified into early (< 9 days) and the late access (9 >/= days) groups (P =.29).
The PVAG graft allows for early access without compromising long-term performance. Both PVAG and standard ePTFE grafts have similar long-term outcomes, despite early access with the PVAG vascular access grafts.
本研究旨在通过一项随机、前瞻性和对照研究，比较多层自密封聚氨酯血管通路移植物（PVAG）和膨体聚四氟乙烯（ePTFE）血管通路移植物在血液透析应用中的性能。性能指标包括移植物存活情况、并发症、首次插管时间以及插管后的止血时间。
共有142例患者在满足所有入选标准后被随机均分为两组，分别接受两种移植物中的一种。所有患者均进行前瞻性随访，随访时间为12个月或直至二级通畅期结束。具体而言，本研究通过确定两种移植物的通畅情况和并发症来记录PVAG和ePTFE移植物的性能。
两组患者在危险因素和人口统计学特征方面的特征相似（P>.05）。从首次透析日期开始计算的生命表通畅率，一级通畅率：PVAG为55%，ePTFE为47%（6个月）；PVAG为44%，ePTFE为36%（12个月）。二级通畅率：PVAG为87%，ePTFE为90%（6个月）；PVAG为78%，ePTFE为80%（12个月）。这些差异均无统计学意义（P>.05）。以植入日期为起点计算时，一级和二级通畅率也无显著差异。两组的不良事件和并发症相似，但与对照组相比，PVAG组因移植物扭结导致的技术并发症发生率更高（P<.05）。此外，两组在感染和出血方面的并发症发生率无显著差异。当比较插管后5分钟及以内实现止血的时间时，PVAG插管部位实现止血的数量多于ePTFE部位，且这一差异具有统计学意义（P<.0001）。当比较两种移植物首次建立透析通路的时间时，所有PVAG移植物中有53.9%在9天内进行了插管，而ePTFE移植物无一例在9天内插管（P<.001）。然而，将PVAG患者分为早期（<9天）和晚期通路（≥9天）两组时，长期移植物存活情况无显著差异（P =.29）。
PVAG移植物可实现早期通路建立且不影响长期性能。尽管PVAG血管通路移植物能实现早期通路建立，但PVAG和标准ePTFE移植物的长期结局相似。
