A pilot randomized trial of arteriovenous fistula versus arteriovenous graft in elderly patients with advanced kidney disease

摘要： 背景：老年人群是透析人群中增长最快的部分。临床实践 指南和医疗保险支付绩效政策支持动静脉瘘（AVF）超过动静脉瘘 移植物（AVG）作为透析的首选血管通路。老年人的AVF发生率较高， 成熟和原发性AVF失败导致需要进一步手术。因此， 老年人的血管通路尚不清楚。血管通路放置和血管内治疗的影响 实现对患者功能状态的访问功能的过程是未知的。放置 透析通路以及随后实现和维持通路功能所需的程序可 导致这一已经虚弱的人群的功能进一步下降，并可能降低生活质量。高 心血管疾病的负担，不同的预期寿命和可变的健康目标可能使 与一般透析人群相比，75岁及以上人群血管通路的理想选择不同。 方法：一项90例受试者的初步、单中心、随机试验，评估并发症发生率和功能 75岁及以上的受试者接受血管通路置入后状态下降。受试者将 随机分配至AVF组（n = 45）与AVG组（n = 45），置于血管通路监测方案中，以及 在6个月内进行步态速度、握力和自我报告功能的测量。主 待检验的假设是AVF放置将导致较高比例的主动脉通路失败， 由凝血通路或未成熟通路或非功能性通路的复合主要终点定义 与AVG置入相比，在6个月时测量。此外，该研究将评估AVF是否 放置和更多的接入程序将导致功能状态的更大下降， 通过6个月内步态速度、握力和自我报告功能的平均变化测量， 通过手臂、肩部和手部残疾调查进行评估。 结论：我们汇集了肾脏病学、血管外科、老年病学、老龄化研究和 职业治疗合作这项研究。通过这种合作，我们能够接近 多学科方法在老年人群中首选血管通路的问题 需要.鉴于美国老年人群中终末期肾病的高发病率，和 该政策目前仅支持AVF作为首选血管通路，本研究有可能 从根本上改变肾脏病学的临床实践。这项试点研究将提供关键的初步数据， 作为NIH应用程序的基础，在大型多中心研究中评估AVF和AVG的使用 在老年人群中，有足够的随访时间来支持入路选择对 通路相关并发症、透析开始时通路、功能状态、生活质量和死亡率。

Abstract: Background: The elderly population is the fastest growing segment of the dialysis population. Clinical practice guidelines and Medicare pay for performance policy support arteriovenous fistulas (AVFs) over arteriovenous grafts (AVGs) as the preferred vascular access for dialysis. Older adults have higher rates of AVF non- maturation and primary AVF failure leading to the need for further procedures. Thus, the preferred choice of vascular access in the elderly is unclear. The effects of vascular access placement and endovascular procedures to achieve access functionality on a patient’s functional status are unknown. Placement of a dialysis access and the procedures subsequently required to achieve and maintain access functionality could result in further declines of function in this already frail population and potentially reduce quality of life. High burdens of cardiovascular disease, heterogeneous life expectancy and variable health goals may make the ideal choice of vascular access different in those age 75 years and older than the general dialysis population. Methods: A pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 75 years and older referred for vascular access placement. Subjects will be randomized to AVF (n = 45) versus AVG (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of gait speed, grip strength, and self-reported function over 6 months. The primary hypothesis to be tested is that AVF placement will result in a higher proportion of primary access failure as defined by a composite primary endpoint of a clotted access or an immature access or a non-functional access measured at 6 months compared to AVG placement. In addition, the study will evaluate whether AVF placement and a greater number of access procedures will result in a greater decline in functional status as measured by the mean change over 6 months in gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm, Shoulder and Hand Survey. Conclusion: We have brought together experts in nephrology, vascular surgery, geriatrics, ageing research and occupational therapy to collaborate on this study. Through this collaboration, we are able to approach the question of the preferred vascular access in the elderly population with the multi-disciplinary approach it requires. Given the high incidence rates of end stage renal disease in the elderly population in the U.S., and that policy currently supports only AVF as the preferred vascular access, this study has the potential to fundamentally change clinical practice in nephrology. This pilot study will provide critical preliminary data to serve as the foundation for a NIH application evaluating the use of AVF and AVG in a large, multi-center study in the elderly population with adequate follow-up time to support investigation of the effect of access choice on access related complications, access at the start of dialysis, functional status, quality of life and mortality.