Kaufman J L, Garb J L, Berman J A, Rhee S W, Norris M A, Friedmann P
Division of Vascular Surgery, Baystate Medical Center, Springfield, MA 01199, USA.
J Am Coll Surg. 1997 Jul;185(1):74-9.
The function and patency of standard 6-mm Goretex (W.L. Gore and Associates, Flagstaff, AZ) and Impra (Impra, Inc., Tempe, AZ) expanded polytetrafluoroethylene (e-PTFE) grafts for hemodialysis as radial-antecubital linear arteriovenous fistulae for dialysis are compared.
A randomized clinical trial was conducted in two community dialysis centers and in one hospital-based center serviced by one vascular surgical practice, that performed the access surgery. Selection of linear forearm access, as opposed to other hemodialysis graft configurations, was at the discretion of the surgeon. Candidates for linear grafts had palpable radial pulses with a normal Allen test and normal digital Doppler flow in the hand. Linear grafts were placed using end-to-side anastomoses to the artery and vein, and the graft type was determined by randomization. Primary patency was determined by first episode of thrombosis, first revision, or angioplasty of the graft. Secondary patency after thrombectomy, revision, or angioplasty was determined when the graft was no longer clinically usable, and a new graft needed to be placed as a parallel conduit in the forearm or in another site. Statistical analysis was by actuarial life-table methods.
There were 131 linear forearm grafts in 117 patients. The Impra and Goretex groups were equally matched for gender and major risk factors, except for smoking, which was more common in the Goretex group. Minimum followup was 24 months. Life table primary patencies at 1 year (Impra 43%, Goretex 47%) and at 2 years (Impra 30%, Goretex 26%) were not statistically different (p = 0.78); secondary patency was also equal at 1 year (Impra 49%, Goretex 69%) and at 2 years (Impra 33%, Goretex 41%) (p = 0.15). Discontinuance of use of a patent graft, complications, episodes of thrombosis, and the need to replace the original graft occurred in the two groups without a statistically significant difference.
In the linear forearm position from the radial artery to an antecubital vein, there is no difference in the performance of 6-mm standard e-PTFE grafts on the basis of manufacturer, whether Goretex or Impra. On the basis of performance, linear forearm dialysis grafts are an acceptable method for hemodialysis access.
比较标准的6毫米戈尔特斯（W.L. 戈尔公司，弗拉格斯塔夫，亚利桑那州）和英普拉（英普拉公司，坦佩，亚利桑那州）的膨体聚四氟乙烯（e-PTFE）移植物作为用于透析的桡动脉-肘前线性动静脉内瘘进行血液透析时的功能和通畅性。
在两个社区透析中心和一个由一个血管外科诊所服务的医院透析中心进行了一项随机临床试验，该血管外科诊所进行血管通路手术。与其他血液透析移植物构型不同，线性前臂血管通路的选择由外科医生自行决定。线性移植物的候选者桡动脉搏动可触及，艾伦试验正常，手部数字多普勒血流正常。线性移植物采用端侧吻合术与动脉和静脉相连，移植物类型通过随机化确定。主要通畅性通过移植物首次发生血栓形成、首次翻修或血管成形术来确定。当移植物不再具有临床可用性，并且需要在前臂或其他部位放置新的移植物作为平行导管时，确定血栓切除术、翻修或血管成形术后的次要通畅性。采用精算生命表方法进行统计分析。
117例患者中有131条线性前臂移植物。英普拉组和戈尔特斯组在性别和主要危险因素方面匹配良好，但吸烟情况除外，吸烟在戈尔特斯组更为常见。最短随访时间为24个月。1年时的生命表主要通畅率（英普拉组43%，戈尔特斯组47%）和2年时（英普拉组30%，戈尔特斯组26%）无统计学差异（p = 0.78）；1年时的次要通畅率（英普拉组49%，戈尔特斯组69%）和2年时（英普拉组33%，戈尔特斯组41%）也相等（p = 0.15）。两组中专利移植物的停用、并发症、血栓形成发作以及更换原移植物的必要性无统计学显著差异。
在从桡动脉到肘前静脉的线性前臂位置，基于制造商（无论是戈尔特斯还是英普拉）的6毫米标准e-PTFE移植物的性能没有差异。基于性能，线性前臂透析移植物是一种可接受的血液透析血管通路方法。
