Use of an Intermittent Pneumatic Compression Device to Promote Vein Dilation in Patients With Kidney Disease to Enable Creation of Arteriovenous Fistulas
Phase: NA
Conditions: Kidney Diseases
Sponsor: University of Chicago

1 
 
 
 
 
Intermittent Pneumatic Compression Device for Vein Dilation in Kidney 
Disease Patients to Enable AVF Creation (FACT)  
NCT04063787 
5-13-2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
Use of an Intermittent Pneumatic Compression Device to Promote Vein 
Dilation in Patients with Kidney Disease to Enable Creation of Arteriovenous 
Fistulas  
 
PRIMARY INVESTIGATOR:  
Mary Hammes DO,  
Associate Professor of Medicine 
Section of Nephrology 
(773) 702-9892 
(773) 702-8301 eFAX 
mhammes@medicine.bsd.uchicago.edu 
 
CO-INVESTIGATORS:  
Nephrology 
Rita McGill, MD  
Tom Blicharski, APN 
Vascular Surgery 
Ross Milner, MD 
Trissa Brabowski, MD  
Matthew Blecha, MD 
Chelsea Dorsey, MD  
Transplant Surgery 
Yolanda Becker, MD  
 
 
 

3 
 
BACKGROUND 
More than 100,000 Americans 
initiate hemodialysis (HD) each year. 
More than 80% of patients use central 
venous catheters (CVC) as their initial 
vascular access, with only a quarter of 
such patients having a concurrent AVF 
(composed of native vessels) or AVG 
(with use of prosthetic vascular graft 
material) which might mature into use.1 
AVF promotion has been part of the 
government’s Healthy People 2010  
and 2020 objectives, and numerous local 
and national initiatives, with only 
incremental improvements.1 The 
proportion of AVF use in new HD patients 
has remained below 20% over the past 
decade (Figure 1.) 
 
 CVC use for HD imposes many 
disadvantages upon patients, some lethal. CVC perform less reliably than AVF or AVG, 
resulting in reduced treatment efficiency. CVC are large devices that damage the veins in 
which they dwell, increasing the risks of thromboembolic events, as well as stenosis, 
occlusion, and superior vena cava syndrome.2 CVC are long-term intravascular devices that 
may also result in central line associated bacteremias (CLABSI), which may be complicated 
by secondary infections such as infectious endocarditis and vertebral osteomyelitis.3 The 
prevalence of each of these complications increases with the duration of CVC use.4  
 
The net effects of all of these disadvantages is markedly decreased survival among HD 
patients using CVC, with increased hospitalization, costs, and suffering. Over the first two years of 
HD, CVC use falls, to approximately 12%. Unfortunately, this apparent ‘improvement’ is due not 
just to conversion from CVC to 
AVF/G, but also due to excess 
mortality among patients with CVC 
(Figure 2). Therefore, strategies that 
avert the need for CVC placement and 
reduce the duration of catheter use 
would both be expected to improve 
the health and survival of people 
receiving hemodialysis. 
Arteriovenous fistulas (AVF) 
are universally acknowledged to be 
the safest way to access the 
bloodstream for hemodialysis5-10. 
Successful AVF require the preservation of native veins, which must dilate after 
surgery. Guidelines suggest that all suitable forearm and upper-arm veins should be 
0
10
20
30
40
50
60
70
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
% of Patients
Year
AVF
AVG
CVC with AVF/G
CVC only
Figure 1: Vascular Access used at 1st HD in the US 
(Data from 2017 US Renal Data System Annual 
0%
20%
40%
60%
80%
100%
0
1
3
6
9
12
18
24
Months
AVF/G
CVC
Death
PD/Tx
Figure 2: Vascular Access and Mortality over the first 
two years of hemodialysis, in the US 1 

4 
 
preserved in patients with chronic kidney disease (CKD) and estimated glomerular 
filtration rates (eGFR) of less than 30 mL/min/1.73 m2, avoiding both peripheral and 
subclavian venipuncture for any reason11.  
 
  
Despite this, construction of a viable AVF is often complicated or prevented by 
veins of insufficient diameter or quality.6,7,12 An AVF must ‘mature’ after creation, which 
means that the vessel must dilate sufficiently to carry a high blood flow, and the walls 
of the outflow vein must thicken and become strong enough to endure repetitive 
needle cannulation and vein dilation in order to remain patent and accommodate 
repetitive needle cannulation.9-16 Vein dilation is one of the key requirements for AVF 
maturation, although blood flow rates, vessel depth, and the length of the accessible 
segment of vein are also important. Most surgeons require that the target vein for an 
AV fistula have a diameter of at least 2.5-3.0 mm in either the upper or lower arm. 
Unfortunately, many arm veins fail to dilate and enlarge sufficiently after AVF creation, 
which exposes the constricted vein to arterial flow and associated high wall shear 
stress. When AVF fail to mature, patients are exposed to the risks of CVC for longer 
periods, and are subjected to additional surgery and invasive percutaneous 
procedures, resulting in hospital readmissions, delayed care, and increased costs.17-
21 In a carefully performed multicenter study, the 49% of AVF matured, and another 
22% required additional procedures; 28% failed outright.22 Many studies have 
concluded that it is hard to predict which veins will enlarge to the appropriate size for 
dialysis use even after preoperative vein mapping studies.11,22-25 Clinicians try to refer 
patients for AVF 6 months prior to the need for HD, to allow for these uncertainties, 
but this is may not be a realistic approach for all patients.  
 
Another popular approach is to encourage patients to develop their veins by 
exercising their arms before and after AVF surgery, with the expectation that exercise 
will increase blood flow to the limb and that this will dilate veins. Patients have 
traditionally been instructed to apply intermittent compression to the upper arm with 
elastic bands, to perform hand exercises (e.g. squeezing a soft rubber device) and 
isometric exercises of the entire arm.26-27 Studies have shown some benefits of 
exercise in promoting vein dilation and possible fistula maturation.28-29 The data are 
more extensive for beneficial effects of intermittent compression, handgrip training, 
external heat application, and topical agents like nitric oxide on vessel dilation.25-33 
Effects of pneumatic compression on venous flow have been widely studied, and are 
standard of care for the management of lymphedema, prevention of perioperative 
deep venous thrombosis, and therapy for venous stasis ulcerations.34-38 
 
There is an urgent need to find more effective methods to promote vein 
dilation and develop cost effective, non-invasive devices to help mature fistulae 
clinically, and help AVF mature. The Fist Assist® device (US Patent 8231558) is an 
external medical intermittent pneumatic compression device that can apply 
intermittent pressure to the arm. Aside from the direct hemodynamic effects of 
pneumatic compression, there is evidence for effects on wall shear stress and wall 

5 
 
tensile stress for both arteries and veins, which may stimulate the endothelium to 
produce nitric oxide that enhances venous dilation.39-41 This research will evaluate 
the effects of using the Fist Assist® device to develop veins prior to AVF surgery. 
 
Device: 
 The Fist Assist® [Figure 1] is a self-contained, miniaturized, wearable intermittent 
pneumatic compression device.  The small control unit is integrally attached to an 
inflatable cuff that is held to the upper extremity using a hook and loop attachment. 
Patients are able to apply and remove the device themselves using only the 
contralateral hand.  It is battery operated and has a single control to turn it on or off.  
All pressure and timing parameters are preset at the factory. The bladder is inflated to 
a pressure of 60 mmHg and held for 20 seconds then deflated to 10 mm Hg pressure 
for 55 seconds before the next inflation.  
 
  The Fist Assist® device applies 60 mmHg of compression to the limb, which 
shuts off after 20 seconds; the device cycles every 75 seconds. In comparison, when 
a blood pressure is measured as part of routine medical care, pressures of 160-180 
mmHg are applied for approximately 45-60 seconds, and a lymphedema garment 
applies unremitting pressure of 40 mm Hg to an arm for 8-12 hours at a time.  
 
In recently published research, The Fist Assist® device was applied for six hours 
a day for 30 days to 43 patients with new radiocephalic and brachiocephalic AVF, 
starting one week after surgery. Acceptance of the device was excellent, and no 
patient suffered fistula thrombosis, or reported pain, skin reactions, or bleeding from 
the AVF cannulation sites.42 In this initial pilot study, significant dilation of AVF outflow 
veins was demonstrated in patients using the Fist Assist® device, compared to control 
patients using a sham device (P <0.05).42-43 
 
 
This first proposal of presurgery vein dilation outlines important research that 
will help to determine optimal roles of the Fist Assist® device in improving vascular 
access outcomes in patients receiving HD, by investigating the effects of the device 
used both before and after AVF surgery. Early use of this device could potentially allow 
for vein dilation in patients with advanced chronic kidney disease, preparing veins for 
AVF creation and improving primary AVF outcomes. Post-surgical use of the device 
may promote further vein dilation and  AVF maturation and reduce the need for 
secondary procedures to assist maturation. Investigation with this device may uncover 
a safe and noninvasive way to improve outcomes for ESRD patients, and provide 
important insights into the biology of successful AVF maturation.  
 
Fist Assist Safety Features: The device has many safety features to prevent patient 
complications. These include:  

6 
 
1. Patient being able to remove it with ease as its velco and can be easily taken off 
2.  The device having incorporated firmware to  monitor the pressure to ensure it never 
goes over 60 mm Hg with auto-inflate and auto-vent features. This will ensure steady 
pressure at 60 mm Hg. 
3.  A battery monitoring system that ensures there is enough battery power to vent the 
balloon and turn off the device as the battery decreases to a low level. As the battery 
deceases to low levels, the device will save enough power to ensure total balloon 
venting and shut down.OBJECTIVE: To determine whether use of the Fist Assist® 
device facilitates vein dilation before AVF creation. 
Hypotheses:  
Use of the Fist Assist® before AVF creation will enhance superficial vein dilation, 
resulting in increased absolute vein diameters at three months when compared to 
baseline values.   
SPECIFIC AIM:  
To determine whether the use of the Fist Assist® device for 360 hours over 90 days by 
patients with advanced CKD prior to AVF surgery results in significant increases in 
cephalic vein diameters prior to AVF surgery.  
SUBJECTS:  
Population:  
Inclusion criteria: Patients followed in the Nephrology Clinic who are expected to 
initiate HD will be approached for participation in the study. We will consider all patients 
with eGFR<30 mL/min.1.73m2.39 Patients will be assigned to treatment with the Fist 
Assist®. 
 
Exclusion criteria: Refusal/inability to give informed consent, inability to comply with 
trial requirements, arm infections, and skin disorders that require frequent medical 
attention. In addition, we will exclude patients with obvious scarring from IV drug use 
or  previous phlebitis. Patients will be excluded if they have previous occluded 
arteriovenous grafts or fistulae, arterial aneurysms, or arm deep vein thrombosis or 
any previous vascular surgery on their non-dominant arm. Patients will be excluded 
they have limited cognitive ability. Patients will be excluded if they have any motor or 
sensory deficits in their upper arms.  
 Patients will have a preliminary evaluation of their cephalic vein, measured 5 cm 
proximal to the styloid process of the radius, and also at the antecubital fossa. Patients 
will be excluded if there are no detectable superficial veins of at least 1.0 mm diameter, 
and also if a superficial vein of more than 3.0 mm is present in this lower arm location. 
LOCATION: The study will be conducted in the Ambulatory Care facilities at the 
University of Chicago Medical Center (UCMC).  
 
METHODOLOGY:   

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Medical History: 
Medical records of enrolled patients will be reviewed to collect:  
date of birth, height, weight, ethnicity, and medical history related to factors which may 
affect vascular health, including but not limited to: dialysis history, diabetes, 
hypertension, systemic lupus erythromatosis, coronary artery disease, peripheral 
vascular disease, medication history, and any other factors that contribute to vascular 
health.  
 
 
Intervention:   The Fist Assist® device will be assigned to each enrolled subject by 
randomization code. All subjects will be asked to use their assigned device twice daily, 
for two 2-hour sessions, once in the morning and once in the evening. Patients will 
apply the device to the non-dominant arm above the level of the elbow, and to keep a 
written log to record use, complications and any problems.  
 
Blood Draws:  10 mL of blood will be obtained from patients being enrolled at the time 
of their next routine standard of care phlebotomy.These samples will be frozen for 
future assays of endothelial biomarkers of nitric oxide production and venous dilation, 
such as asymmetric dimethyl arginine (ADMA) and its metabolites. 
Doppler:   Patients will undergo examination of their cephalic veins in the Nephrology 
Clinic, using a portable vascular ultrasound device operated by a co-investigator 
trained by the UCMC Vascular Lab in this technique. The cephalic vein, a superficial 
vein originating in the wrist, is the most common vein used for AVF creation. In order 
to standardize these measurements, the diameter of the cephalic vein and vein wall 
thickness will be measured in both arms at: (a) 5 cm proximal to the styloid process of 
the radius,  and (b) at the antecubital fossa. The diameter and thickness of the vein 
will be measured using a B-mode image acquired using a standard ultrasound 
machine with vascular probe going from outer walls per protocol. Patients will be 
seated with arms supported at the level of the heart on an exam table with in a room 
with a temperature of at least 20 degrees Celsius. A layer of at least 1 cm of gel will 
be applied locally to optimize the ultrasound image quality. Vascular Doppler 
measurements will be obtained on both arms at the time of consent (baseline), and at 
the conclusion of therapy. Measurements will be recorded. 
 
Follow Up: Those who are subsequently able to undergo successful AVF creation will 
be followed clinically for up to 12 months.  
Protocol:  Informed consent will be obtained by the co-investigators using a written 
consent form approved by the Institutional Review Board. After informed consent is 
obtained, patients will receive: physical examination of both forearms; and a vascular 
Doppler to determine cephalic vein diameters of the nondominant arm.. A 10 mL blood 
sample will be drawn at the next routine phlebotomy.  
Patients will be asked to apply the Fist Assist® to the upper half of the non-dominant 
arm. Patients will be asked to use the device twice daily for two 2-hour periods, and 
report any complications or problems, using a log (see log attached at end of 
References). Patients will have follow up examinations with measurement of cephalic 
vein diameter at three months after enrollment. 
 
Outcomes:  The primary outcome will be the difference in vein diameter before and 
after Fist Assist® use. Secondary outcomes include: whether or not an AVF was 
created (versus a synthetic graft or use of a central venous catheter), whether the 

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resultant vascular access matured sufficiently to be used for HD, and the subsequent 
exposure of patients to central venous catheters during their first year of HD.  
 
 

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DURATION OF STUDY:  All subjects will be enrolled and treated for three months. 
The duration of the study including data analysis and statistical analysis is expected 
to be 6-9 months.   
Table 1. Timeline for Study  
Measurement 
Baseline 
Post-Rx 
H & P 
X 
 
Clinical 
examinations  
X 
X 
Blood sample 
X 
X 
Doppler 
X 
X 
 
DATA MANAGEMENT: Study data will be collected and managed using REDCap 
electronic data capture tools hosted at The University of Chicago. 
STATISTICAL ANALYSES:  The primary outcome of interest will be the difference in 
the diameter of the cephalic vein between baseline (Pre) and 3 months (Post) in 
patients treated with the Fist Assist® device. Based on prior work, mean vein diameters 
at baseline are anticipated to be approximately 1.8 mm with a standard deviation of 
0.5 mm,44 and we anticipate that the standard deviation of the change in diameter is 
likely to be approximately 0.75 mm.  
 
Effect =[(DSPost)-(DSPre)]  
 We would consider calculated effect sizes of 0.25-1.0 mm to be clinically meaningful 
changes that would increase the numbers of patients with vein diameters that meet 
commonly accepted thresholds for surgical suitability (normally 2.5-3.0 mm). Sample 
size calculations for a variety of effects are presented in table 1 (below), based on 
paired t-tests with alpha error of 0.05, standard deviation of the effect size of 0.75 mm, 
for power of 80% and 90%.  
Table 2. Sample size required to 
compare vein size before and after 
treatment 
Effect size mm) 
80% 
power 
90% 
power 
0.25 
73 
97 
0.50 
21 
27 
0.75 
11 
14 
1.00 
  8 
  9 
1.25 
  6 
  7 
1.50 
  5 
  6 
 
A secondary aim will be to compare the proportions of treated patients who achieve 3-
month vein diameters of 2.5 mm and 3.0 mm, to proportions achieved among controls. 
Given a normal distribution around a mean vein diameter of 1.8 mm with a standard 
deviation of 0.5 mm, the probability of an untreated wrist vein exceeding 2.5 mm (or 
3.0 mm) would be 8.1% and 0.8%, respectively.  Given that the standard deviation of 

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the diameter of treated veins is at least 0.75, then the observed probabilities of a 
treated vein exceeding either 2.5 mm or 3.0 mm can be calculated, and is shown in 
the table below, any of which could be shown to be a significantly different proportion 
from the baseline state. The sample sizes required to demonstrate a difference in 
proportions were calculated using a McNemar test of paired proportions, with the very 
conservative assumption that 10% of veins that are adequate on preliminary 
measurement may fall below the cut-off value, due to variation in measurements. 
Table 3.  Sample sizes required to demonstrated increased proportions of 
surgically adequate veins 
Effect 
size 
% veins 
>2.5 mm 
Required sample 
%veins 
>3.0 mm 
Required sample 
80% 
power 
90% 
power 
80%  
power 
90% 
power 
0.25 
27.4 
42 
55 
10.2 
83 
110 
0.50 
39.6 
24 
31 
17.6 
45 
  59 
0.75 
47.5 
19 
24 
27.4 
28 
  36 
1.00 
68.8 
11 
14 
39.6 
18 
  23 
1.25 
77.9 
  9 
11 
47.5 
15 
  18 
1.50 
85.3 
  8 
  9 
68.8 
  9 
  11 
 
We intend to study 90 patients, and anticipate effects which should be more than 
adequate for these purposes. 
POTENTIAL RISKS AND BENEFITS TO SUBJECTS:  The benefit to the subjects will 
be that this research could identify interventions that are more likely to result in 
vascular access patency. The primary risk is that patients may find the device irritating 
or annoying to wear.  The patients will be given a 90 day log with check boxes to 
determine if any complications occur (see attached log at end of references). All 
patients enrolled will give informed consent about the study and device to ensure their 
full understanding and participation.  
PAYMENT TO THE SUBJECT:  The subject will not incur any cost as a result of 
participating in the study. The subject will not receive payment for participation in the 
study. No advertisement will be used to recruit subjects. 
PROCESS OF CONSENT:  The patient will give informed written consent approved 
by the IRB prior to participation.  
CONFIDENTIALITY: All records will be kept confidential.  The subjects will be 
assigned an identification number prior to entering any information into the computer 
database.  Only study personnel will have access to the database.  All forms will be 
stored and locked in the primary investigator's office immediately.  Data will not be 
shared outside of the University of Chicago. 
 
 

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14 
 
Fist Assist® Trial Log   
 
Patient Name: _______________________  Date:__________ 
 
AM Session 
 
 
 
           PM Session 
Time On: ____________  
 Time On: ____________ 
Time Off: ____________  
 Time Off: ____________ 
 
Complications (check all that apply):  
     Arm pain  
     Arm swelling 
     Arm numbness  
     Arm weakness 
      Skin irritation  
      Skin rash  
  
Other Complications/Comments: 
 
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