Galt Spencer, Crawford Mark, Blebea John, Ladenheim Eric, Browne Barry
Mountain Medical Physician Specialists, Murray, Utah; Vital Access Corporation, Salt Lake City, Utah.
Vital Access Corporation, Salt Lake City, Utah.
J Vasc Surg. 2016 Sep;64(3):708-14. doi: 10.1016/j.jvs.2016.03.425. Epub 2016 May 27.
The Venous Window Needle Guide (VWING; Vital Access Corp, Salt Lake City, Utah) is a surgically implanted titanium device designed to facilitate cannulation of uncannulatable dialysis access arteriovenous fistulas (AVFs) because of excessive depth, aneurysm formation, or tortuosity but that exhibit sufficient flow volume to support hemodialysis. We report the 18-month fistula patency, functionality, and complications of the use of the VWING device.
This retrospective study examined AVF patency, VWING functionality, interventions, and device infections at 18 months after VWING implantation. The study population comprised the eligible patients enrolled in the VWING Salvage of AV Fistula (SAVE) trial.
Fifty-four patients were originally enrolled in the SAVE trial, and 35 were enrolled in the follow-up study. At 18 months, when considering surgical or percutaneous interventions at the VWING site(s) only, the primary AVF patency rate was 78%. Interventions elsewhere on the AVF, outside the boundaries of the VWING, resulted in a primary patency rate of 38%. The VWING accounted for 13% loss of AVF primary patency compared with 53% loss from the remaining AVFs. The overall AVF assisted primary patency rate was 91%, and the primary patency rate was 21%. VWING secondary functionality, the continued ability to access the fistula through the VWING using a constant site cannulation technique, was 65%. During the 12 months after the SAVE Study 80% of patients did not require the use of a central venous catheter. Eleven VWING devices were removed from eight patients, all but one for cannulation difficulties. One device was removed during the SAVE trial because of infection. No device or systemic infection was identified in the ensuing 12 months, for an overall systemic infection rate of 0.014 per device-year. An intervention rate of 0.32 per device-year was required to maintain device functionality during the 18-month follow-up period.
Implantation of the VWING device is a safe and effective means of establishing hemodialysis access in an otherwise functional but uncannulatable AVF. The device infection rate is acceptably low.
静脉窗穿刺针引导器（VWING；Vital Access Corp，盐湖城，犹他州）是一种通过手术植入的钛制装置，旨在便于对因深度过大、形成动脉瘤或迂曲而难以穿刺的透析用动静脉内瘘（AVF）进行穿刺，但这些内瘘具有足够的血流量以支持血液透析。我们报告了使用VWING装置18个月后的内瘘通畅情况、功能及并发症。
这项回顾性研究在植入VWING装置18个月后检查了AVF的通畅情况、VWING的功能、干预措施及装置感染情况。研究人群包括参与VWING动静脉内瘘挽救（SAVE）试验的符合条件的患者。
最初有54例患者参与了SAVE试验，35例患者参与了随访研究。在18个月时，仅考虑在VWING部位进行的手术或经皮干预，原发性AVF通畅率为78%。在VWING边界之外的AVF其他部位进行的干预，原发性通畅率为38%。与其余AVF导致的53%的通畅率丧失相比，VWING导致AVF原发性通畅率丧失13%。总体AVF辅助原发性通畅率为91%，原发性通畅率为21%。VWING的二级功能，即使用固定部位穿刺技术通过VWING持续穿刺内瘘的能力，为65%。在SAVE研究后的12个月内，80%的患者无需使用中心静脉导管。从8例患者身上取出了11个VWING装置，除1例因穿刺困难外，其余均是如此。在SAVE试验期间，有1个装置因感染被取出。在随后的12个月内未发现装置或全身性感染，总体装置年感染率为0.014。在18个月的随访期内，维持装置功能所需的干预率为每年每装置0.32。
植入VWING装置是在其他方面功能正常但难以穿刺的AVF中建立血液透析通路的一种安全有效的方法。该装置感染率低至可接受水平。
