Use of a Novel, Intermittent Pneumatic Compression Device to Promote Perforator Vein Dilation in Patients with Chronic Renal Failure: The pFACT Trial

Objective. Arteriovenous fistula (AVF) creation is an important procedure for hemodialysis in chronic renal failure (CRF) patients. Recent advancements in vascular access have resulted in endovascular AVF (endoAVF) creations. EndoAVFs are less invasive and less expensive when placed. The dilation of the perforator vein pre-procedure is crucial to consistent, successful endoAVF placement. The Fist Assist Model FA-1 (Fist Assist Devices, LLC) device is an external, intermittent, pneumatic compression device. The objective of this study was to analyze the effects of the device on perforator vein dilation. Methods. Three centers enrolled CRF subjects from 2019 to 2021. Baseline Doppler measurements of the perforator in the forearm with and without a blood pressure cuff were recorded. Patients were instructed to use the Fist Assist Model FA-1 on their nondominant arm for up to 4 hours daily for 90 days. The primary endpoint was perforator enlargement compared to baseline measurements, with the secondary endpoint of perforator vein greater than 3.0 mm. Results. Nineteen subjects were enrolled and completed the trial with perforator measurements. The data collected reviewed the initial mean perforator vein dilation and the mean perforator vein dilation after 90 days of using the Fist Assist Model FA-1 device. Diameter measurements of the perforator vein showed significant enlargement backed by one-tail, paired-difference t-tests (P<.05). Conclusions. The use of the Fist Assist Model FA-1 device was successful in enhancing dilation of the perforator vein in patients with chronic kidney disease. Perforator veins increased by an average of 0.6 mm after 3 months of Fist Assist Model FA-1 application. The Fist Assist Model FA-1 employed intermittent pneumatic compression resulting in perforator vein enlargement, which can assist in successful endoAVF outcomes and cost savings.