Hemodialysis Access Failure
Conditions
Keywords
Hemodialysis fistula, Failure to mature, Collateral vein
Brief summary
Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is narrowing of the artery or vein (stenosis). Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. Some believe that occluding these veins might help maturation of those failing AVFs. To evaluate if this actually works, patients with FTM will be randomly assigned to side branch vein ligation (or not), and rates of AVF maturation of the two groups will be compared.
Detailed description
Arteriovenous fistulas (AVFs) for hemodialysis often fail to become usable due to failure to mature (FTM). The most common cause is stenosis of the artery or vein. Another potential cause is the presence of collateral or side branch veins that steal blood flow from the main fistula channel. The utility of ligating these veins to improve maturation of those failing AVFs is controversial. To evaluate this, 35 patients presenting for fistulograms for evaluation of AVFs with FTM, found to have side branch veins will be prospectively enrolled. After management of stenoses (if present), they will be randomly assigned to ligation of the venous side branches or not. Maturation rates for each group will be prospectively assessed. For patients assigned to the control group who have persistent failure to mature, a cross-over intervention will be performed and side branch ligation will be offered.
Interventions
PROCEDURECollateral vein ligation
Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Patients with upper extremity autogenous AVF presenting with FTM with evidence of collaterals on ultrasound and/or clinical exam.
Exclusion criteria
* Age under 18 years * Pregnant women * Prior endovascular or surgical procedure in the fistula after its creation (with the exception of surgical superficialization or mobilization) * Clinical evidence of infection associated with the AVF * Uncorrectable coagulopathy (International Normalized Radio \>2.5, platelet count \<50.000/μL) * Absence of significant venous side branches on angiogram (defined as those that arise in the initial 10 cm, including the future cannulation zone, and have maximal diameter greater than or equal to one third of the widest diameter of the fistula's main venous channel in this segment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula maturation rate | 8 weeks after randomization | Proportion of patients with usable arteriovenous fistula at the end of the study (being able to deliver the prescribed dialysis dose 75% of the sessions in the first 4 weeks of use via 2 needles) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZubin Irani, MD
Massachusetts General Hospital
Outcome results
None listed