Department of Vascular Surgery, Groupe Hospitalier Paris Saint Joseph, Paris, France.
Department of Vascular Surgery, Groupe Hospitalier Paris Saint Joseph, Paris, France.
J Vasc Surg. 2021 Jul;74(1):209-216. doi: 10.1016/j.jvs.2020.12.086. Epub 2021 Feb 4.
The aim of the present study was to compare the results between percutaneous arteriovenous fistulas (p-AVFs) created with the Ellipsys device (Ellipsys Vascular Access System; Avenu Medical, San Juan Capistrano, Calif) and surgical arteriovenous fistulas (s-AVFs).
A single-center retrospective comparative study of the first 107 patients who had undergone p-AVF creation with the Ellipsys system from May 2017 to May 2018 with an equal number of consecutive patients who had undergone s-AVF creation in our center during the same period. The primary endpoints included the maturation and patency rates. The secondary endpoints were reintervention, risk of infection, and the incidence of steal syndrome and aneurysm formation.
The demographic, hypertension, and diabetes data were similar for both groups. The only difference between the two groups was that more p-AVF patients had already been receiving hemodialysis (61% vs 47%; P < .05). The p-AVFs showed superior maturation rates at 6 weeks (65% vs 50%; P = .01). The primary patency rates were greater for the s-AVFs at 12 months (86% vs 61%; P < .01). However, primary patency was comparable between the two groups at 24 months (52% vs 55%; P = .48). No significant difference was found in the secondary patency rates at 12 (90% vs 91%) and 24 (88% vs 91%) months. At the 2-year follow-up point, the rate of percutaneous reintervention was similar; however, the s-AVFs had required more frequent surgical revision (36% vs 17%; P = .01). Issues with wound healing and infection were also more frequent with s-AVFs (9% vs 0.9%; P < .01).
Fistulas created percutaneously with the Ellipsys system showed superior maturation rates and similar patency with s-AVFs created in an experienced high-volume vascular surgery practice. p-AVFs had a lower risk of wound healing issues, infection, and surgical revision. Larger, prospective, randomized multicenter studies are needed to confirm these findings.
本研究旨在比较 Ellipsys 装置（Ellipsys 血管通路系统；Avenu Medical，加利福尼亚州圣胡安卡皮斯特拉诺）与手术动静脉瘘（s-AVF）创建的经皮动静脉瘘（p-AVF）的结果。
回顾性比较 2017 年 5 月至 2018 年 5 月期间在本中心接受 Ellipsys 系统创建 p-AVF 的前 107 例患者与同期在本中心接受连续患者 s-AVF 手术的患者的结果。主要终点包括成熟率和通畅率。次要终点包括再介入、感染风险以及窃血综合征和动脉瘤形成的发生率。
两组患者的人口统计学、高血压和糖尿病数据相似。两组唯一的区别是更多的 p-AVF 患者已经接受血液透析（61%比 47%；P<.05）。6 周时，p-AVF 的成熟率更高（65%比 50%；P=.01）。12 个月时，s-AVF 的原发性通畅率更高（86%比 61%；P<.01）。然而，24 个月时两组的原发性通畅率相当（52%比 55%；P=.48）。12 个月（90%比 91%）和 24 个月（88%比 91%）的二级通畅率无显著差异。在 2 年的随访点，经皮再介入率相似；然而，s-AVF 需要更频繁的手术修正（36%比 17%；P=.01）。s-AVF 还更频繁地出现伤口愈合和感染问题（9%比 0.9%；P<.01）。
使用 Ellipsys 系统经皮创建的瘘管成熟率较高，与经验丰富的高容量血管外科实践中创建的 s-AVF 具有相似的通畅率。p-AVF 发生伤口愈合问题、感染和手术修正的风险较低。需要更大、前瞻性、随机多中心研究来证实这些发现。
