Division of Nephrology, Department of Medicine, University Health Network, Toronto, Ontario; University of Toronto, Toronto, Ontario.
University of Toronto, Toronto, Ontario; Division of Vascular & Interventional Radiology, Department of Medical Imaging, Peter Munk Cardiac Center, University Health Network, Toronto, Ontario.
Am J Kidney Dis. 2017 Oct;70(4):486-497. doi: 10.1053/j.ajkd.2017.03.026. Epub 2017 Jun 14.
Hemodialysis arteriovenous fistulas (AVFs) are suboptimally used primarily due to problems with maturation, early thrombosis, and patient nonacceptance. An endovascular approach to fistula creation without open surgery offers another hemodialysis vascular access option.
Prospective, single-arm, multicenter study (Novel Endovascular Access Trial [NEAT]).
SETTINGS & PARTICIPANTS: Consecutive adult non-dialysis-dependent and dialysis-dependent patients referred for vascular access creation at 9 centers in Canada, Australia, and New Zealand.
Using catheter-based endovascular technology and radiofrequency energy, an anastomosis was created between target vessels, resulting in an endovascular AVF (endoAVF).
Safety, efficacy, functional usability, and patency end points.
Safety as percentage of device-related serious adverse events; efficacy as percentage of endoAVFs physiologically suitable (brachial artery flow ≥ 500mL/min, vein diameter ≥ 4mm) for dialysis within 3 months; functional usability of endoAVFs to provide prescribed dialysis via 2-needle cannulation; primary and cumulative endoAVF patencies per standardized definitions.
80 patients were enrolled (20 roll-in and 60 participants in the full analysis set; the latter are reported). EndoAVFs were created in 98% of participants; 8% had a serious procedure-related adverse event (2% device related). 87% were physiologically suitable for dialysis (eg, mean brachial artery flow, 918mL/min; endoAVF vein diameter, 5.2mm [cephalic vein]). EndoAVF functional usability was 64% in participants who received dialysis. 12-month primary and cumulative patencies were 69% and 84%, respectively.
Due to the unique anatomy and vessels used to create endoAVFs, this was a single-arm study without a surgical comparator.
An endoAVF can be reliably created using a radiofrequency magnetic catheter-based system, without open surgery and with minimal complications. The endoAVF can be successfully used for hemodialysis and demonstrated high 12-month cumulative patencies. It may be a viable alternative option for achieving AVFs for hemodialysis patients in need of vascular access.
血液透析动静脉瘘（AVF）的使用并不理想，主要是因为成熟、早期血栓形成和患者不接受等问题。一种无需开放性手术的血管腔内方法为血液透析提供了另一种血管通路选择。
前瞻性、单臂、多中心研究（新型血管腔内通路试验 [NEAT]）。
连续的成年非透析依赖和透析依赖患者，在加拿大、澳大利亚和新西兰的 9 个中心因血管通路创建而被转介。
使用基于导管的血管内技术和射频能量，在目标血管之间创建吻合，从而形成血管内动静脉瘘（endoAVF）。
安全性、有效性、功能可用性和通畅性终点。
与器械相关的严重不良事件的设备相关严重不良事件百分比；3 个月内生理上适合透析的 endoAVF 百分比（肱动脉流量≥500mL/min，静脉直径≥4mm）；通过双针穿刺提供规定透析的 endoAVF 功能可用性；根据标准化定义的主要和累积 endoAVF 通畅率。
80 名患者入组（20 名滚动入组和 60 名全分析集参与者；报告后者）。98%的参与者成功创建了 endoAVF；8%发生严重的与操作相关的不良事件（2%与器械相关）。87%的患者生理上适合透析（例如，平均肱动脉流量为 918mL/min；endoAVF 静脉直径为 5.2mm[头静脉]）。接受透析的参与者中，endoAVF 的功能可用性为 64%。12 个月的主要和累积通畅率分别为 69%和 84%。
由于独特的解剖结构和用于创建 endoAVF 的血管，这是一项没有手术对照的单臂研究。
使用基于射频磁导管的系统可以可靠地创建 endoAVF，无需开放性手术，且并发症最小。endoAVF 可成功用于血液透析，并显示出 12 个月的高累积通畅率。对于需要血管通路的血液透析患者来说，它可能是一种可行的替代选择。
