Castro Ana Coutinho, Neri Mauro, Nayak Karopadi Akash, Lorenzin Anna, Marchionna Nicola, Ronco Claudio
Department of Nephrology, Dialysis and Transplantation, Centro Hospitalar do Porto, Porto, Portugal.
International Renal Research Institute of Vicenza (IRRIV), Vicenza, Italy.
Clin Kidney J. 2018 Sep 19;12(2):300-307. doi: 10.1093/ckj/sfy086. eCollection 2019 Apr.
Since 2005, three human clinical trials have been performed with the Wearable Artificial Kidney (WAK) and Wearable Ultrafiltration (WUF) device. The lack of an adequate vascular access (VA) has been pointed out as the main limitation to their implementation. Based on the current level of understanding, we will make the first conceptual proposal of an adequate VA suitable for the WAK and the WUF.
All the literature related to WAK and WUF was reviewed. Based on eight main publications the VA major characteristics were defined: a mean blood flow of 100 mL/min; the capability to allow prolonged and frequent dialysis treatments, without interfering in activities of daily living (ADL); safe and convenient connection/disconnection systems; reduced risk of biofilm formation and coagulation; high biocompatibility. A research was done in order to answer to each necessary technological prerequisites.
The use of a device similar to a CVC with a 5Fr lumen, seems to be the most feasible option. Totally subcutaneous port devices, like the LifeSite(R) or Dialock (R) systems can be a solution to allow WAK or WUF to operate continuously while patients carry out their ADL. Recently, macromolecules that reduce the risk of thrombosis and infection and are integrated into a CVC have been developed and have the capability of overcoming these major limitations.
With an adequate VA, portable HD devices can be acceptable options to address several unmet clinical needs of HD patients.
自2005年以来,已对可穿戴人工肾(WAK)和可穿戴超滤(WUF)设备进行了三项人体临床试验。缺乏足够的血管通路(VA)被指出是其实施的主要限制因素。基于目前的理解水平,我们将首次提出适合WAK和WUF的适当VA的概念性建议。
回顾了所有与WAK和WUF相关的文献。基于八篇主要出版物,定义了VA的主要特征:平均血流量为100毫升/分钟;能够允许进行长时间和频繁的透析治疗,而不干扰日常生活活动(ADL);安全方便的连接/断开系统;降低生物膜形成和凝血的风险;高生物相容性。为了满足每个必要的技术先决条件进行了一项研究。
使用类似于具有5Fr内腔的中心静脉导管(CVC)的设备似乎是最可行的选择。完全皮下端口设备,如LifeSite®或Dialock®系统,可以成为一种解决方案,使WAK或WUF在患者进行ADL时能够持续运行。最近,已经开发出了能够降低血栓形成和感染风险并集成到CVC中的大分子,并且有能力克服这些主要限制。
有了足够的VA,便携式血液透析设备可以成为满足血液透析患者几个未满足的临床需求的可接受选择。