Endovascular vs Surgical Techniques for Dialysis Fistula Creation

(ESAVFO Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Age below 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 0-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of creating arteriovenous fistulas (AVFs), the preferred access points for dialysis. One method involves traditional surgery, while the other uses a newer, less invasive technique called endovascular (inside the vessel) creation. The trial aims to determine which method is more successful and easier for patients. It suits those who need an AVF and are using or about to start dialysis with a catheter. As an unphased trial, it allows patients to contribute to advancements in dialysis access techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these techniques are safe for dialysis fistula creation?

Research shows that the endo-vascular AVF, a newer method for creating dialysis access, received FDA approval in 2018. This approval indicates a certain level of safety, and patients across the U.S. have used it. Studies indicate that endo-AVF is generally well-tolerated, with high success rates and few complications.

In comparison, surgical AVFs are the traditional method and have been in use for a long time. Both methods aim to create a reliable access point for dialysis, though issues like early blockages can sometimes occur. Overall, both techniques are considered safe, with only minor differences in results. Patients should consult their healthcare provider to determine the best option for their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these techniques for dialysis fistula creation because they offer new ways to connect blood vessels for dialysis patients. Unlike traditional surgical arteriovenous fistulas (AVFs), which require open surgery, the endo-vascular AVF is created using a minimally invasive approach with a catheter, which could mean less recovery time and potentially fewer complications. This endo-vascular method might provide patients with an option that improves comfort and convenience while maintaining effectiveness. By comparing these two approaches, researchers aim to understand which method provides better outcomes for patients, especially those with advanced chronic kidney disease.

What evidence suggests that this trial's techniques could be effective for dialysis fistula creation?

This trial will compare endo-vascular AVF and surgical AVF for creating arteriovenous fistulas (AVFs) for dialysis. Research has shown that both methods are promising. Participants in the endo-vascular AVF arm will undergo a less invasive procedure, which has successfully remained open for use. Some studies suggest that endo-vascular AVFs are a safe and effective alternative to traditional surgical AVFs. Participants in the surgical AVF arm will undergo the traditional method, which has been used longer and has a success rate of up to 76% within 12 months, indicating that most become ready for dialysis over time. Both methods have their advantages, but endo-vascular AVFs offer a less invasive option. The choice between them often depends on the specific needs and circumstances of the patient. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need an arteriovenous fistula (AVF) for dialysis and can have either an endovascular AVF or a surgical upper arm AVF, as shown by preoperative ultrasound. It's not for those under 18 or patients eligible only for a low forearm AVF.

Inclusion Criteria

My ultrasound before surgery showed I can have a special type of vein access for dialysis.

I am 18 or older and scheduled for an arteriovenous fistula procedure.

Exclusion Criteria

I am under 18 years old.

I am eligible for a specific type of arm vein access for dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either surgical AVF creation or endo-vascular AVF creation

0-6 weeks

1 visit (in-person) for procedure

Follow-up

Participants are monitored for fistula maturity and survival

2 years

Regular visits for ultrasound assessments

What Are the Treatments Tested in This Trial?

Interventions

• Endo-vascular AVF
• Surgical AVF

Trial Overview The study compares two methods of creating dialysis access: the traditional surgery (Surgical AVFs) and a newer, less invasive technique using catheters (Endo-AVFs). Participants will be randomly assigned to one of these techniques at the University of Alabama at Birmingham.

How Is the Trial Designed?

Group I: Endo-vascular AVF Experimental Treatment 1 Intervention

Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an endo-vascular AVF intervention group that will undergo a per-cutaneous AVF creation.

Group II: Surgical AVFs Active Control 1 Intervention

Participants who initiated dialysis with a catheter or have advanced chronic kidney disease ,these patients who an Surgical AVF intervention group that will undergo a routine surgical AVF creation.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Hemodialysis is the primary treatment for end-stage renal disease, and creating a good vascular access through an arteriovenous (AV) fistula is crucial for successful treatment.

The end-to-side anastomosis technique between the radial artery and cephalic vein for creating a radiocephalic AV fistula has demonstrated excellent outcomes, emphasizing the importance of proper surgical methods and preoperative imaging for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief overview of surgical aspect of autologous arterio-venous fistula for dialysis access. Kashyap, NK., Danish, AF., Magatapalli, K., et al.[2021]

The endovascular creation of arteriovenous fistulas (endoAVF) shows a high technical success rate of 98% and a maturation rate of 87%, indicating it is an effective option for patients with renal failure based on a systematic review of 19 studies involving 1,929 patients.

The safety profile of endoAVF is comparable to traditional surgical methods, with a complication rate of 7%, but further randomized controlled trials are needed to strengthen the evidence for clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous endovascular arteriovenous fistula: A systematic review and meta-analysis. Sun, JB., Liu, CC., Shen, X., et al.[2022]

In a pilot study involving 36 older adults with end-stage kidney disease, both arteriovenous fistulas (AVF) and arteriovenous grafts (AVG) showed a primary access failure rate of 31%, indicating similar initial outcomes for both types of vascular access.

Successful cannulation rates were slightly higher for AVG (62%) compared to AVF (50%), but the differences were not substantial enough to favor one method over the other, suggesting that further research with larger sample sizes is needed to determine the best option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. Robinson, T., Geary, RL., Davis, RP., et al.[2022]

Endovascular arteriovenous fistula (AVF) creation is a minimally invasive procedure with a high technical success rate of 97.5% and a 90-day maturation rate of 89.3%, based on a systematic review of 7 studies involving 300 patients.

The procedure has a low complication rate of 5.5%, indicating it is a safe alternative to traditional surgical AVF creation, although its efficacy compared to surgical methods has not been directly established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review, meta-analysis, and meta-regression of the efficacy and safety of endovascular arteriovenous fistula creation. Yan Wee, IJ., Yap, HY., Tang, TY., et al.[2020]

Systemic anticoagulation during surgical access formation for dialysis significantly increases the risk of bleeding complications, with a risk ratio of 7.18 based on four trials involving 411 participants.

While systemic anticoagulation did not improve overall access patency rates, it did show a significant improvement in patency for arteriovenous fistulas (AVF) alone, with a risk ratio of 0.57, indicating a potential benefit for this specific type of access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of systemic intraoperative anticoagulation during arteriovenous access formation for dialysis. Smith, GE., Souroullos, P., Cayton, T., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12550679/

Impact of interventions in endovascular arteriovenous fistula ... Six (40%) patients were on dialysis using endoAVF and 3 (20%) were awaiting to start a haemodialysis program with endoAVF. Three patients underwent kidney ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04404985

Endovascular vs Surgical Arteriovenous Fistula Outcomes Endo-AVF, a novel per-cutaneous technique of AVF creation, was approved by the FDA in 2018, and has been used in U.S. hemodialysis patients . In contrast to the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949912724001119

Study protocol for a French multicenter randomized ... This study will compare the cost effectiveness of endovascular AVF creation using Ellipsys and WaveLinQ devices versus traditional surgical arteriovenous ...

4. academic.oup.com academic.oup.com/ckj/article/18/4/sfaf063/8043268

Comparative outcomes of surgical versus percutaneous ... The results of our study showed endoAVFs may be a safe and effective alternative to RC AVFs, showing high rates of technical success and patency.

5. jvascsurg.org jvascsurg.org/article/S0741-5214(23)02208-5/fulltext

Cost-effectiveness analysis of endovascular vs surgical ... EndoAVF is not cost effective compared with sAVF when modeling 5-year outcomes. The main driver of sAVF remaining cost effective is the four times higher up- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10811914/

Evaluating patient perspectives of endovascular created ... We provide a useful initial patient reported experience and perspectives on comparative functional use of radiologically and surgically created AVFs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8612838/

Endovascular Arteriovenous Fistula Creation: A Review - PMC This review analyzes the anatomy, pre- and postoperative considerations, fistula creation methods, and outcomes associated with endoAVF. Currently, data are ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0272638617306923

Endovascular Proximal Forearm Arteriovenous Fistula for ... Hemodialysis arteriovenous fistulas (AVFs) are suboptimally used primarily due to problems with maturation, early thrombosis, and patient nonacceptance.