Vein Histology in Arteriovenous Fistulas and Its Effect on Fistula Surgery Success

A Cohort Study of the Histopathological Changes Evident in Vein Wall at the Time of Arteriovenous Dialysis Access Fistulas and the Effects of Such Changes on Biomechanical Compliance and Patient's Clinical Outcomes in a University Teaching Hospital.

Patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. In order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. This forms what is known as an arteriovenous fistula. The fistula causes an increase in the flow of blood through the vein and the vein reacts to this by becoming bigger and thicker, making it easier to connect the patient to the machine.

The success rate for the operation is relatively low and only approximately 65 from every 100 operations is still working after a year. It is thought that one factor that may cause problems with the fistula is the ability of the vein to stretch in response to increased blood flow. Previous research has shown that veins in kidney failure patients look different to those of people whose kidneys are working when viewed under a microscope.

The investigators aim to study the structure of the vein that is used in making fistulas with a microscope and also to test it in an engineering laboratory to see how much it will stretch. The investigators hope that gaining information about the structure of the vein and its ability to stretch will help determine what it is about the vein that affects how well it works as part of a fistula. This information may help surgeons select the best possible vein in a given patient to give the best chance of a working fistula in the future.

Study Overview

• Status: Completed
• Conditions: Renal Replacement Therapy; Arteriovenous Fistula

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Yorkshire
    • Hull, Yorkshire, United Kingdom, HU3 2JZ
      • Academic Vascular Surgery Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patient referred for access formation

Description

Inclusion Criteria:

1. Patients referred to vascular consultants for AV fistula formation for haemodialysis access.
2. Ability to give informed written consent
3. Aged over 18 at time of referral

Exclusion Criteria:

1. Veins identified on preoperative ultrasound scanning to be of a calibre too small to allow sufficient material to be obtained for biomechanical testing (<3mm diameter).
2. Inability to give informed written consent
3. Aged under 18 at time of referral
4. Inability to attend follow-up appointments

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observed cohort; All patients recruited. Observed for clinical outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary failure of access - Immediate/early thrombosis or failure to mature.	Failure to mature or thrombosis of fistula	within 30 days of formation

Secondary Outcome Measures

Outcome Measure	Time Frame
Duplex findings of evidence of stenosis and correlation to compliance or histological findings	6 months
Correlation between biomechanical compliance and histological measures of pre existing venous pathology	6 months
Correlation between biomechanical compliance testing and clinical outcomes	6 months
Assisted primary and secondary patency rates at 3 and 6 months post fistula formation	6 months
Functional primary patency	6 months

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Collaborators: University of Hull
• Investigators: Principal Investigator: Ian C Chetter, MBChB FRCS, University of Hull

Publications and helpful links

General Publications

• Smith GE, Gohil R, Chetter IC. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012 Mar;55(3):849-55. doi: 10.1016/j.jvs.2011.07.095. Epub 2011 Nov 8.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 5, 2010
• First Submitted That Met QC Criteria: April 5, 2010
• First Posted (Estimate): April 6, 2010

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Dialysis; Compliance; Histology; vein; Arteriovenous access fistula
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: Access 4