A Randomized Controlled Study on the Efficacy of Ultrasound-guided Fistuloplasty in Comparison to Fluoroscopy-guided Fistuloplasty in Patients With Arteriovenous Access Flow Dysfunction
Phase: NA
Conditions: Fistulas Arteriovenous
Sponsor: University of Malaya

 
Page 1 
Study Protocol 
 
A Randomized Controlled Study on the Efficacy of Ultrasound-Guided Fistuloplasty in 
Comparison to Fluoroscopy-Guided Fistuloplasty in Patients with Arteriovenous 
Access Flow Dysfunction 
 
Protocol number, version number and date:  
Protocol number - NMRR ID-23-01273-4HI, Version 1.0, 28 May 2024 
 
Name and Institution of Principal investigator:  
Dr EHAB BIN SAID, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, Wilayah 
Persekutuan Kuala Lumpur. 
 
Name and Institution of Co-Investigators:  
Mr Putera Mas Pian, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, Wilayah 
Persekutuan Kuala Lumpur. 
Mr Ahmad Rafizi Hariz Bin Ramli, University Malaya Medical Centre, Jalan Profesor Diraja 
Ungku Aziz, Lembah Pantai, 59100, Kuala Lumpur, Selangor. 
 
Name and address of Sponsor:  
Self-funded. 
 
Study site/s: 
Hospital Kuala Lumpur. 
University Malaya Medical Centre. 
 

 
Page 2 
Contents 
 
Topic 
Page 
List of Abbreviations 
3 
Research Synopsis 
4 
Background and Significance 
5 
Risk to Participants 
10 
Benefits to Participants 
10 
Risk Benefit Assessment 
10 
General Objective 
4 
Specific Objectives 
4 
Study Endpoints/Outcomes 
4 
Study Design and Methodology 
5 
Study Population 
8 
Sample Size 
10 
Inclusion Criteria 
8 
Exclusion Criteria 
9 
Withdrawal Criteria 
10 
Study Duration and Timeline 
10 
Study Visits and Procedures 
10 
Statistical Analysis Plan 
10 
Ethics of Study 
11 
Informed Consent/Assent Process 
12 
Privacy and Confidentiality 
12 
Conflict of Interest 
12 
Publication Policy 
12 
Termination of Study 
12 
References 
13 
Appendices 
15 
 

 
Page 3 
List of Abbreviations 
 
AV 
Arteriovenous 
AVF 
Arteriovenous fistula 
C-PTA 
Conventional percutaneous transluminal angioplasty 
CI 
Confidence interval 
DCB 
Drug-coated balloon 
HD 
Haemodialysis 
HKL 
Hospital Kuala Lumpur 
n 
Number 
OD 
Odds ratio 
PIS 
Patient information sheet 
POBA 
Plain old balloon angioplasty 
PSV 
Peak systolic velocity 
PTA 
Percutaneous transluminal angioplasty 
SD 
Standard deviation 
SPSS 
Statistical Package for the Social Sciences 
TBD 
To be determined 
UG-PTA 
Ultrasound-guided percutaneous transluminal 
angioplasty 
UMMC 
University Malaya Medical Centre 
USG 
Ultrasonography 
VF 
Volume flow 

 
Page 4 
Research Synopsis 
Study title 
A randomized controlled study on the efficacy of ultrasound-
guided fistuloplasty in comparison to fluoroscopy-guided 
fistuloplasty in patients with arteriovenous access flow 
dysfunction. 
Study Population 
All adult patients with arteriovenous access flow dysfunction 
in Hospital Kuala Lumpur and University Malaya Medical 
Centre during the period 1 July 2023 – 30 June 2024. 
Study Design 
A randomized controlled study. Selected subjects will be 
randomized into ultrasound-guided fistuloplasty and 
fluoroscopy-guided fistuloplasty groups in a ratio of 1:1 
General Objective 
To investigate patencies in patients with arteriovenous 
access flow dysfunction receiving ultrasound-guided 
fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 
months 
Specific Objectives 
a. To investigate patencies in patients with arteriovenous 
access flow dysfunction receiving ultrasound-guided 
fistuloplasty versus fluoroscopy-guided fistuloplasty at 
6 months, 
b. To capture data regarding variables that may affect 
patency of arteriovenous access flow dysfunction post 
ultrasound-guided fistuloplasty versus fluoroscopy-
guided fistuloplasty, 
c. To compare technical success in patients with 
arteriovenous access flow dysfunction receiving 
ultrasound-guided fistuloplasty versus fluoroscopy-
guided fistuloplasty, and 
d. To compare complication rates in patients with 
arteriovenous access flow dysfunction receiving 
ultrasound-guided fistuloplasty versus fluoroscopy-
guided fistuloplasty. 
Study 
endpoints/outcomes 
(a) Patency of arteriovenous fistula over a period of six 
months post fistuloplasty; (b) Resolution of symptoms; (c) 
Technical success; (d) Percentage increase in volume flow. 
Sample Size 
54 subjects. 
Study Duration 
1 July 2023 - 31 December 2024. 
 
 
 
 

 
Page 5 
1.Background and Significance 
Arteriovenous fistulas (AVF) are the vascular access of choice for hemodialysis patients. In the 
United States from August 2010 to August 2013, arteriovenous fistula (AVF) use increased 
from 63% to 68% and across 20 other countries in 2013, arteriovenous fistula (AVF) use 
ranged from 49% to 92%.1 Patency and functionality of haemodialysis access influences 
survival and quality of life for patients with chronic renal failure. Progressive narrowing of the 
perianastomotic lumen or a more proximal part of venous circulation as a result of intimal 
proliferation is the main cause of failure of arteriovenous fistula. The use of Doppler 
sonography allows identification of more than 50% arteriovenous fistula stenosis, with 92% 
sensitivity and 84% specificity.2 Percutaneous transluminal fistuloplasty is a well-established 
therapeutic option for patients with haemodialysis vascular access stenosis. It is conventionally 
guided and monitored radiographically, but this carries the risks of ionizing radiation exposure 
and of adverse reaction to contrast media and this is the usual practice in Hospital Kuala 
Lumpur and University Malay Medical Centre. 
 
Recently, we have observed an increasing role of ultrasonography (USG) in imaging of 
arteriovenous fistula. Superficial location of arteriovenous fistula allows for simple and reliable 
visualization of vessels, guidewire, catheter, balloon, etc., with significant technical advantages 
including the ability to directly visualize puncture sites, stenosis, thrombus, spasm, and 
extravascular flow in real time. Recent studies showed that percutaneous transluminal 
fistuloplasty can be performed under only sonographic guidance without using a fluoroscopic 
machine and it is as effective as conventional percutaneous transluminal fistuloplasty as 
shown in Appendix 1. Since more than a decade of described ultrasound-guided fistuloplasty, 
many small series have been published till date, but most of them studied small number 
population and without direct head-to-head comparison with fluoroscopy-guided fistuloplasty 
as shown in Appendix 2. To overcome these limitations and further evaluate the efficacy of the 
procedure, we would like to compare patency of arteriovenous access flow dysfunction post 
ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty. 
 
We would like to research upon the efficacy of ultrasound-guided fistuloplasty as an alternative 
to fluoroscopy-guided fistuloplasty to prolong patency of patients with arteriovenous access 
flow dysfunction. 
 
2. Objective 
To determine the efficacy of ultrasound-guided fistuloplasty compared to fluoroscopy-guided 
fistuloplasty in patients with arteriovenous access flow dysfunction. 
 
 
3. Methodology 
Study design: Multicentre, randomized controlled trial. 
Location: Hospital Kuala Lumpur and University Malaya Medical Centre. 
Population: Vascular clinic patients in Kuala Lumpur Hospital and University Malaya Medical 
Centre. 

 
Page 6 
1. Treatment group: Patients who underwent ultrasound-guided fistuloplasty for 
arteriovenous access flow dysfuntion are assessed prospectively for a period of 6 
months. 
2. Control group: Patients who underwent fluoroscopy-guided fistuloplasty for 
arteriovenous access flow dysfuntion are assessed prospectively for a period of 6 
months. 
Sampling method: Simple random sampling. 
 
3.1 Study Type and Design 
This is an experimental study employing a prospective randomized controlled trial. 
 
The primary outcome would be to compare the patency of arteriovenous fistula at one, three 
and six months. 
Secondary outcomes shall include: 
• To capture data regarding variables that may affect patency of arteriovenous access 
flow dysfunction post ultrasound-guided fistuloplasty versus fluoroscopy-guided 
fistuloplasty, 
• To compare technical success (defined as clinical palpable thrill, radiographic finding of 
less than 30% recoil and ultrasonographic finding of continuous segment of dilated vein 
to 5-6mm and continuous flow rate of more than 500ml/min) in patients with 
arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus 
fluoroscopy-guided fistuloplasty and 
• To compare complication rates in patients with arteriovenous access flow dysfunction 
receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty 
 
Patients are randomized using simple randomization method. Treatment plans are divided 
equally between ultrasound-guided fistuloplasty and fluoroscopy-guided fistuloplasty. An 
application “sealedenvelope.com” is used for this purpose. The application does this via a built 
in random number generator. 
 
After assessing for eligibility, patients will be radomized equally with a ratio 1:1 to ultrasound-
guided fistuloplasty group and fluoroscopy-guided fistuloplasty group. 
 
Both interventions will be done in operation theatre to maintain sterility. After cleaning and 
draping the area of interest, local anaesthesia is given to the puncture site. A puncture needle 
is used to gain access to the arteriovenous fistula followed by a guide wire. Then, a sheath 
with an appropriate size is placed and a balloon catheter of adequate size is inserted over the 
guide wire and inflated for 2 minutes. Ultrasound is used in the subject group to monitor 
technical success. On table visualization of continuous segment of dilated vein to 5-6mm and 
continuous flow rate of more than 500ml/min signifies the end points of the procedure. 
Fluoroscopy is used in the control group to assess for technical success. On table fistulogram 
visualization of less than 30% recoil of the target lesion signifies technical success. After a 
satisfactory result, a figure of 8 suture is placed with manual inflow occlusion. Post procedure, 
patients will be observed for any signs of haematoma or bleeding. If there are no immediate 
complications, patients will be discharged on the same day. 
 

 
Page 7 
These procedures will be performed either by vascular surgeons or interventional radiologists 
below tabled: 
OPERATOR 
FISTULOPLASTY 
CENTRE 
DESIGNATION 
ULTRASOUND-
GUIDED 
FLUOROSCOPY-
GUIDED 
Mr Ahmad Rafizi 
Hariz Ramli 
√ 
 
University 
Malaya Medical 
Centre 
Vascular 
surgeon 
TBD 
 
√ 
University 
Malaya Medical 
Centre 
Interventional 
radiologist 
Mr Putera Mas 
Pian 
√ 
√ 
Hospital Kuala 
Lumpur 
Vascular 
surgeon 
 
Cases with serious complications such as extravascular leak or significant pseudoaneurysm 
will be admitted for monitoring. If the complications are resolved then, the patient will be 
discharged. Follow-up may be scheduled earlier. 
 
Follow-up will be done at two weeks, one month, three months and six months. 
Assessment during follow-up includes: 
• Resolution of symptoms (prolonged post dialysis bleeding or difficult access 
cannulation). 
• Reduction of venous dialysis pressure to below predefined threshold values. (the 
acceptable value is less than 150mmHg) 
• Measurement of the volume flow (the acceptable value is more than 500ml/min), flow 
characteristics (the acceptable characteristic is laminar flow) and diameter of the target 
lesion (the acceptable diameter is between 5-6mm) using duplex ultrasound. 
 
In the event of a negative outcome during the first post fistuloplasty follow-up, it will be 
determined whether it is due to: 
• a missed stenotic segment invisible to ultrasound or 
• it is a case of severe stenotic segment refractory to fistuloplasty. 
Patients belonging to the former category will cross-over to the fluoroscopic-guided 
fistuloplasty group. In the latter case, there is no reason to repeat the fistuloplasty regardless 
of the imaging method (ultrasound or fluoroscopy). Ideally, these particular patients should 
receive drug-coated balloon (DCB) fistuloplasty which is beyond the scope of this study. 
There is no alternative apart from switching to fluoroscopic-guided fistuloplasty. 
 
Although patients on anticoagulants are excluded from this study, subjects may well be 
prescribed anticoagulants should they consult family doctors. As a precaution, a paragraph in 
the patient information sheet (PIS) clearly advised patients against consuming anticoagulants. 
 
Consort Flowchart 
 

 
Page 8 
 
 
 
3.2 Study Population 
All adult patients with arteriovenous access flow dysfunction in Hospital Kuala Lumpur and 
University Malaya Medical Centre during the period 1 July 2023 – 30 June 2024. 
 
3.3 Inclusion Criteria 
 
NO. INCLUSION CRITERIA 
EVALUATION METHOD. 
1 
Patient able to comprehend English or Malay language. Speak to patient. 
2 
Patient aged ⩾18 years and ⩽80 years. 
Examine patient personal data. 
3 
Patient is willing to comply with protocol. 
Ask the patient. 
4 
Native AVF that is able to provide prescribed dialysis 
consistently with 2 needles for >2/3 of dialysis sessions 
within 4 consecutive weeks. 
Ask the patient & examine 
dialysis record. 
5 
Patient has a reasonable expectation of remaining on 
haemodialysis for 6 months. 
Ask the patient. 
Assess for 
eligibility 
Enrollment 
Randomised 
Allocate to 
ultrasound-guided 
fistulplasty 
(n=44) 
Allocate to 
fluoroscopy-
guided fistulplasty 
(n=44) 
Follow-up for 6 
months 
Analysis 
Follow-up for 6 
months 
Cases who experience 
technical glitch will cross-
over to fluoroscopy-guided 
fistuloplasty group 

 
Page 9 
6 
Dampened thrill or pulsatile flow. 
Palpate the arteriovenous 
fistula. 
7 
Volume flow (VF) <500 ml/min. 
Ultrasound doppler 
measurement. 
8 
Severe stenosis (>50%) of arteriovenous (AV) access 
measured on color image and confirmed by peak 
systolic velocity (PSV) ratio of ≥3 in the inflow artery, 
anastomosis, or in the outflow vein. 
Ultrasound doppler 
measurement. 
 
3.4 Exclusion Criteria 
 
NO. EXCLUSION CRITERIA 
EVALUATION METHOD. 
1 
Prior history of fistuloplasty. 
Ask the patient and examine 
hospital record. 
2 
Thrombosed or completely occluded fistula or outflow 
vein. 
Palpate the arteriovenous 
fistula and by using ultrasound 
doppler. 
3 
Non-mature AVF. 
Palpate the arteriovenous 
fistula and by using ultrasound 
doppler. 
4 
Arteriovenous grafts. 
Ask the patient, examine 
hospital record and by using 
ultrasound doppler. 
5 
Suspected central vein stenosis/ cephalic arch stenosis 
- arm edema or Doppler detected suspicion of the 
same. 
Ultrasound doppler 
measurement 
6 
Non consenting patient. 
Ask the patient 
7 
Metastatic cancer or terminal medical condition. 
Ask the patient and examine 
hospital record. 
8 
Limited life expectancy (<6 months). 
Ask the patient and examine 
hospital record. 
9 
Blood coagulation disorders (haemophilia/ Von 
Willebrand disease/ clotting factor deficiencies/ liver 
disease). 
Ask the patient and examine 
hospital record. 
10 
Connective tissue disease (rheumatoid arthritis/ lupus). 
Ask the patient and examine 
hospital record. 
11 
Sepsis or active infection. 
Ask the patient and examine 
for any signs of infection. 
12 
Planned access abandonment within 6 months (eg, 
peritoneal dialysis or transplant). 
Ask the patient. 
13 
Pregnant women or women of childbearing potential 
who are not following an effective method of 
contraception. 
Ask the patient and obtain 
urine pregnancy test. 
14 
Allergy or other known contraindication to iodinated 
media contrast. 
Ask the patient and examine 
hospital record. 
15 
Patient enrolled in another access maintenance trial. 
Ask the patient. 

 
Page 10 
 
3.5 Withdrawal Criteria 
Subjects can choose to withdraw at any time. Subjects may be withdrawn if the investigator 
deems that it is detrimental or risky for the subject to continue. All withdrawn subjects should 
attend the final study visit. Withdrawn subjects will not be replaced. 
 
3.6 Sample Size   
Based on a power of 80% (β=0.2), alpha of 0.05, a response anticipated difference of 90% in 
ultrasound-guided fistuloplasty group and 52.4% in fluoroscopy-guided fistuloplasty group, the 
calculated sample size for each group is 22 patients. Allowing for 20% dropout, a final sample 
size of 27 per group will be used. 
 
 
3.7 Study Duration and Timeline  
• Stage 1, data collection and data analysis - 8-12 months. 
• Stage 2, follow-up - 6 months. 
• Stage 3, presentation and publication - 6-12 months. 
The participation duration for each subject is 6 months. 
 
3.8 Study Visits and Procedures 
Follow-up will be done at two weeks, one month, three months and six months. 
Assessment during follow-up includes: 
• Resolution of symptoms (prolonged post dialysis bleeding or difficult access 
cannulation). 
• Reduction of venous dialysis pressure to below predefined threshold values. (the 
acceptable value is less than 150mmHg) 
• Measurement of the volume flow (the acceptable value is more than 500ml/min), flow 
characteristics (the acceptable characteristic is laminar flow) and diameter of the target 
lesion (the acceptable diameter is between 5-6mm) using duplex ultrasound. 
 
3.9 Statistical Analysis Plan 
The data analysis will be done using the SPSS version 26.0 Descriptive date will be expressed 
as mean ± standard deviation (SD) for numerical data and frequency (percentage) for 
categorical data. Independent t-test will be used to analyse the primary objective. Secondary 
objective will be analyzed using logistic regression. A value of P < 0.05 is considered 
statistically significant. The data collected will be analyzed using an per protocol basis. 
 
3.10 Risk and benefit to study participants 
As stated in the literature above, there are no serious side effects known to be caused by the 
investigational procedure. The study procedures are all routine procedures for the 
disease/condition studied. There is thus minimal risk for subjects. 
 
This study may avoid radiation hazard and eliminates contrast-related hazards in already renal 
compromised patient. The equipment required is readily available. It can be accomplished in 
daycare setting, thus reducing the burden on theaters or catheter laboratories. It is 
instrumental in achieving rapid turnover with decreased in-hospital duration for patients. 

 
Page 11 
 
3.11 Risk Benefit Assessment 
As stated above, there is minimal risk from the investigational study procedures. Study findings 
shall avoid radiation hazard and eliminates contrast-related hazards in already renal 
compromised patient. The expected benefit outweighs the minimal risk to subjects and thus 
this study should be supported. If any injuries do occur as a direct result of participating in the 
study, treatment for such injuries shall be provided. 
 
Leskovar et al.3 reported 93% technical success with minor complications that were self-
limiting and can be managed successfully by direct pressure. Complications include: 
1. venous rupture (3.5%), 
2. post-procedural thrombosis (1%), 
3. balloon rupture with conversion to surgical procedure (0.5%), 
4. guide wire false route (0.5%), and 
5. pseudo-aneurysm at puncture site (0.5%). 
Given that the intervention procedure is the exact same technique, as long as a minimum 
image quality is available, the outcome would essentially be the same for either imaging 
techniques. Complications arising from image quality would no longer matter. 
In the case of venous rupture: tiny venous rupture of pseudoaneurysm can be managed by 
direct hand compression for 20 minutes and balloon occlusion or by placing covered stent. 
Extravascular leak or significant pseudyaneurysm require emergency surgical repair. 
Cases of acute thrombotic occlusion at access and plasty site can be managed successfully 
by giving additional heparin, thromboaspiration and over-the-wire Fogarty catheter. 
Difficulty in recovering ruptured balloon requires either surgical removal or using ultrasound-
guided snare. 
We provide a comparison between the two visual modalities of fistuloplasty, as reported by 
Cho et al.4 in the table below. 
NO. COMPLICATIONS 
FISTULOPLASTY 
MITIGATION 
ULTRASOUND-
GUIDED 
FLUOROSCOPY 
GUIDED 
1 
Vessel rupture 
2/53 (3.8%) 
1/90 (2.2%) 
Successfully managed 
by balloon tamponade 
technique 
2 
Access thrombosis 
1/53 (1.9%) 
1/90 (2.2%) 
- 
3 
Aneurysm 
development 
- 
1/90 (2.2%) 
- 
4 
Sheath haematoma 
- 
1/90 (2.2%) 
- 
 
3.12 Ethics of Study 
The study will be conducted in compliance with ethical principles outlined in the Declaration of 
Helsinki and Malaysian Good Clinical Practice Guideline 

 
Page 12 
Potentially vulnerable subjects (for example, pregnant and lactating women, children, 
prisoners, cognitively impaired and critically ill subjects) will be excluded from the study. 
 
3.13 Informed Consent/Assent Process 
Patients shall be informed of the study during their usual clinic visits. If they are interested, 
they will be briefed on it and given a copy of the Patient information sheet to read. If need be, 
they can take it home where they will be able to read through it properly and at leisure. No time 
limit is imposed. Once a patient agrees, an appointment will be made for him/her to meet with 
the principal investigator during which time the patient will again be briefed and given the 
opportunity to ask questions and to be clear about any remaining doubt. Given the patients 
willingness, the consent form will then be duly filled, signed and dated. 
 
3.14 Privacy and Confidentiality 
All information obtained in this study are subject to all applicable data security and confidentiality 
laws of Malaysia. As such, they will be treated in a manner respecting this fact. Your identity will 
thus be protected. 
Raw data will be entered in hard copy data collection form. These will be kept safe at “Unit 
Rekod” of Hospital Kuala Lumpur and University Malaya Medical Centre.  
The same data will be entered in a password-protected excel file in the Principal Investigator’s 
computer for the purpose of analysis. Identification numbers instead of patient identifiers will 
be used on subject data sheets. Upon completion of the study, soft copies of the data will be 
kept on CDs and erased from computer hard drives. Both soft and hardcopies of the data will 
be archived in the respective hospital record offices for a minimum of seven years after which, 
they will be destroyed. 
Subjects will not be allowed to view their personal study data. Subjects can write to the 
investigators to request access to study findings. 
 
3.15 Conflict of Interest 
The investigators declare they have no conflict of interest. 
 
3.16 Publication Policy 
No personal information will be disclosed and subjects will not be identified when the findings 
of the survey are published. 
 
3.17 Termination of Study 
Subjects will be informed if the study is terminated and follow-up visits will be arranged if 
needed. 
 
 

 
Page 13 
 
References 
1. Pisoni RL, Arrington CJ, Albert JM, Ethier J, Kimata N, Krishnan M, Rayner HC, Saito A, 
Sands JJ, Saran R, Gillespie B, Wolfe RA, Port FK. Facility hemodialysis vascular 
access use and mortality in countries participating in DOPPS: an instrumental variable 
analysis. Am J Kidney Dis. 2009 Mar;53(3):475-91. doi: 10.1053/j.ajkd.2008.10.043. 
Epub 2009 Jan 15. PMID: 19150158. 
2. Tordoir JH, de Bruin HG, Hoeneveld H, Eikelboom BC, Kitslaar PJ. Duplex ultrasound 
scanning in the assessment of arteriovenous fistulas created for hemodialysis access: 
comparison with digital subtraction angiography. J Vasc Surg. 1989 Aug;10(2):122-8. 
doi: 10.1067/mva.1989.0100122. PMID: 2668564. 
3. Leskovar B, Furlan T, Poznič S, Potisek M, Adamlje A, Ključevšek T. Ultrasound-guided 
percutaneous endovascular treatment of arteriovenous fistula/graft. Clin Nephrol. 2017 
Supplement 1;88(13):61-64. doi: 10.5414/CNP88FX15. PMID: 28655388. 
4. Cho S, Lee YJ, Kim SR. Clinical experience with ultrasound guided angioplasty for 
vascular access. Kidney Res Clin Pract. 2017 Mar;36(1):79-85. doi: 
10.23876/j.krcp.2017.36.1.79. Epub 2017 Mar 31. PMID: 28393000; PMCID: 
PMC5331978. 
5. Ghanwat SP, Yeramsetti S, Sahu T, Sheorain V, Grover T, Parakh R. A prospective 
observational study to evaluate utility of USG (ultrasound)-guided arteriovenous 
fistuloplasty in our institute. Indian J Vasc Endovasc Surg 2021;8:66-71 
6. Wakabayashi M, Hanada S, Nakano H, Wakabayashi T. Ultrasound-guided 
endovascular treatment for vascular access malfunction: results in 4896 cases. J Vasc 
Access. 2013 Jul-Sep;14(3):225-30. doi: 10.5301/jva.5000126. Epub 2013 Jan 8. PMID: 
23334852 
7. Gorin DR, Perrino L, Potter DM, Ali TZ. Ultrasound-guided angioplasty of autogenous 
arteriovenous fistulas in the office setting. J Vasc Surg. 2012 Jun;55(6):1701-5. doi: 
10.1016/j.jvs.2011.12.016. Epub 2012 Jan 23. Erratum in: J Vasc Surg. 2012 
Nov;56(5):1488. PMID: 22265799. 
8. Ascher E, Hingorani A, Marks N. Duplex-guided balloon angioplasty of failing or 
nonmaturing arterio-venous fistulae for hemodialysis: a new office-based procedure. J 
Vasc Surg. 2009 Sep;50(3):594-9. doi: 10.1016/j.jvs.2009.03.061. PMID: 19595550. 
9. Marks N, Hingorani A, Ascher E. New office-based vascular interventions. Perspect 
Vasc Surg Endovasc Ther. 2008 Dec;20(4):340-5. doi: 10.1177/1531003508327921. 
Epub 2008 Nov 19. PMID: 19022786. 
10. Marks N, Ascher E, Hingorani AP. Duplex-guided repair of failing or nonmaturing 
arterio-venous access for hemodialysis. Perspect Vasc Surg Endovasc Ther. 2007 
Mar;19(1):50-5. doi: 10.1177/1531003506298144. PMID: 17437980. 
11. Bacchini G, Cappello A, La Milia V, Andrulli S, Locatelli F. Color doppler 
ultrasonography imaging to guide transluminal angioplasty of venous stenosis. Kidney 
Int. 2000 Oct;58(4):1810-3. doi: 10.1046/j.1523-1755.2000.00344.x. PMID: 11012917. 
12. Karmota AG. Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) 
fistuloplasty for failing dialysis access. Ann R Coll Surg Engl. 2020 Oct;102(8):601-605. 
doi: 10.1308/rcsann.2020.0121. Epub 2020 Jun 15. PMID: 32538115; PMCID: 
PMC7538728. 

 
Page 14 
13. Banerjee S, Patel HM, Sahu T, Sheorain VK, Grover T, Parakh R. Ultrasound-guided 
fistuloplasty: A novel office-based technique for arteriovenous fistula salvage. Indian J 
Vasc Endovasc Surg 2017;4:58-62. 
14. Fox D, Amador F, Clarke D, Velez M, Cruz J, Labropoulos N, Ryan M, Gelman L. 
Duplex guided dialysis access interventions can be performed safely in the office 
setting: techniques and early results. Eur J Vasc Endovasc Surg. 2011 Dec;42(6):833-
41. doi: 10.1016/j.ejvs.2011.04.020. Epub 2011 May 4. PMID: 21531585. 
15. Kim JC, Cho JS. Ultrasonography-guided balloon angioplasty in an autogenous 
arteriovenous fistula. J Korean Soc Ultrasound Med 2007;26:129-36. 
16. Wittenberg G, Kellner M, Kenn W, Obert A, Schultz G, Trusen A, Tschammler A, Götz 
R, Hahn D. Erste Erfahrungen mit der Dilatation von Dialyseshunts unter farbkodierter 
duplexsonographischer Kontrolle [Initial experiences with dilatation of dialysis shunts 
with color-coded duplex ultrasonography monitoring]. Rofo. 1996 Jan;164(1):38-41. 
German. doi: 10.1055/s-2007-1015605. PMID: 8630358.

 
Page 15 
Appendix 1 
Study details 
Primary patency (%) 
Investigators 
Intervention or comparison 
1-month 
3-month 
6-month 
Ghanwat et al.,5 2021 
USG-guided fistuloplasty 
100 
88.1 
77.6 
Wakabayashi et al.,6 2013 
USG-guided fistuloplasty 
94.4 
- 
- 
Gorin et al.,7 2011 
USG-guided fistuloplasty 
93 
93 
 
Ascher et al.,8 2009 
USG-guided fistuloplasty 
96 
76 
53 
Marks et al.,9 2008 
USG-guided fistuloplasty 
- 
90 
90 
Marks et al.,10 2008 
USG-guided fistuloplasty 
100 
100 
90 
Bacchini et al.,11 2000 
USG-guided fistuloplasty 
100 
- 
- 
Karmota et al.,12 2020 
Fluoroscopy-guided 
fistuloplasty 
- 
100 
90 
 
Appendix 2 
Investigators 
Study type 
Intervention or comparison 
n 
Technical success 
Ghanwat et 
al.,5 2021 
Prospective cohort 
study 
USG-guided fistuloplasty 
67 
100% 
Leskovar et 
al.,3 2017 
Prospective cohort 
study 
USG-guided fistuloplasty 
228 
93% 
Banerjee et 
al.,13 2017 
Prospective cohort 
study 
USG-guided fistuloplasty 
43 
36/43 (84%) 

 
Page 16 
Appendix 2 
Investigators 
Study type 
Intervention or comparison 
n 
Technical success 
Cho et al.,4 
2017 
Case control study 
USG-guided fistuloplasty vs 
conventional fistuloplasty 
143 
UG-PTA: 51/53 (96.2%); C-
PTA: 84/90 (93.3%)  
Wakabayashi 
et al.,6 2013 
Prospective cohort 
study 
USG-guided fistuloplasty 
2342 
4288/4414 (97.1%) 
Fox et al.,14 
2011 
Prospective cohort 
study 
USG-guided fistuloplasty 
223 
219/223 (98.2%) 
Gorin et al.,7 
2011 
Case control study 
USG-guided fistuloplasty 
31 
- 
Ascher et al.,8 
2009 
Prospective cohort 
study 
USG-guided fistuloplasty 
32 
- 
Marks et al.,9 
2008 
Prospective cohort 
study 
USG-guided fistuloplasty 
20 
- 
Kim et al.,15 
2007 
Prospective cohort 
study 
USG-guided fistuloplasty 
45 
10/10 (100%) 
Marks et al.,10 
2007 
Prospective cohort 
study 
USG-guided fistuloplasty 
10 
100% 
Bacchini et 
al.,11 2000 
Prospective cohort 
study 
USG-guided fistuloplasty 
12 
12/12 (100%) 
Wittenberg et 
al.,16 1996 
Prospective cohort 
study 
USG-guided fistuloplasty 
39 
38/39 (97%)