Abstract: PO2634
Intermittent Pneumatic Compression Promotes Presurgery Cephalic Vein Dilation: Preliminary FACT Trial Results
Session Information
- Late-Breaking Clinical Trials Posters
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 10:00 AM
Category: Dialysis
- 704 Dialysis: Vascular Access
Author
- Singh, Tej M., El Camino Hospital, Mountain View, California, United States
Background
Arteriovenous fistulas (AVF) are the preferred for hemodialysis access with suitable (2.0-2.5 mm) veins. AVF maturation has been poor globally and often leads to increased catheter contact time and costs. Intermittent compression of upper arm veins may aid in forearm vein dilation pre-surgery to assist in AVF placement and maturation with size expectations and effectiveness.
Methods
This is was a prospective, IRB approved trial. A novel intermittent pneumatic compression device [Fist Assist® (FA)] was applied to upper arms below the shoulder to allow cyclic compression of 60 mm Hg four hours daily for 90 days. Sixteen (n=16) Stage 4 chronic renal failure (CRF) patients were in the study arm to test arm cephalic vein dilation. Vein size was measured and recorded at baseline and after 90 days by duplex measurement of the cephalic vein with a tourniquet. Clinical results: vein dilation at particular locations was recorded and tested for significance using a paired-difference t-test.
Results
Sixteen (n=16) mostly African American patients were involved in the first interim evaluation of the device in a USA FACT trial. All patients were in compliance with the study and followed the study protocol. No major complications or adverse effects were noted in any patient except one non-device related rash. Differences were noted with the measurements done with a cuff in the vein sizes in the forearm (FA) and upper arm (UA). Both were significant.
FA3M : 3-Month- Vein diameter (AP), with cuff, at 5 cm from radial bone
UA3M : 3-Month- Vein diameter (AP), with cuff, at 1 cm above elbow
UA : Enrollment-Vein diameter (AP), with cuff, at 1 cm above elbow
FA : Enrollment-Vein diameter (AP), with cuff, at 5 cm from radial bone
Difference between mean of (UA3M-UA) : t = 1.74, p-value = 0.05
Difference between mean of (FA3m-FA) : t = 1.72, p-value = 0.04
For Clinical Effectiveness:
FA: 18% > 2.5 mm and 33% reached 2.0 mm or greater
UA: 44% >2.5mm and 20% reached 3.0 mm or greater
Conclusion
Early application of a novel, intermittent pneumatic compression device may be successful in preparing forearm veins in Stage 4 CRF patients. The early study results of the FACT trial show statistical significance in vein size improvement, distensibility, and clinical effectiveness to reach predetermined size goals.