AV Graft vs. Surgical Fistula for Kidney Failure

Not currently recruiting at 9 trial locations

Overseen By Brindusa Burciu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Severe cardiac disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 4 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two surgical options for creating a reliable access point for dialysis in people with severe kidney failure. It will evaluate the effectiveness and safety of each method: one uses a natural blood vessel (fistula), and the other uses a synthetic tube (known as an AV Graft). The trial seeks participants who are on dialysis through a central line, have been recommended for surgery by their kidney doctor, and have conditions like heart disease or diabetes. As an unphased trial, this study offers participants the chance to contribute to important research that may improve future dialysis treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these arteriovenous access placements are safe for older adults with end stage kidney disease?

Research has shown that both arteriovenous grafts (AVGs) and surgeries to create a fistula present safety concerns for people with kidney failure. Studies suggest that older patients using AV grafts might face a higher risk of health issues, including lower survival rates and more frequent problems with the graft itself.

Conversely, creating a fistula through surgery is often safer in some respects. Research indicates that fistula surgeries usually result in fewer complications. These procedures tend to cause fewer immediate post-surgery problems and often lead to better long-term outcomes. However, both options involve surgery, which always carries some risk.

In summary, while both treatments are widely used and researched, AV grafts may pose a higher risk of complications compared to fistulas. It is crucial for individuals to consult with a healthcare provider to determine the best option for their specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing AV grafts and surgical fistulas for kidney failure because it aims to pinpoint which method offers better long-term results for patients needing hemodialysis. Unlike current options, this trial directly compares the durability and effectiveness of AV grafts, known for quicker usability post-surgery, against surgical fistulas, which are often preferred for their longer-lasting functionality. The study could provide crucial insights into optimizing dialysis access, potentially improving patient outcomes and quality of life for those with kidney failure.

What evidence suggests that this trial's treatments could be effective for end stage kidney disease?

This trial will compare the effectiveness of two surgical options for permanent hemodialysis access: arteriovenous grafts and surgically placed fistulas. Studies have shown that older patients face a 50-65% higher risk of initial failure with arteriovenous fistulas and an 80% higher risk of complications later compared to grafts. These findings come from a meta-analysis, which combines results from several studies. Conversely, research indicates that fistulas become fully functional 67% of the time at 6 months and 76% of the time at 12 months. Both options—grafts and fistulas—have their pros and cons, and their effectiveness can vary based on individual patient conditions. It is important to consider both options and discuss them with a healthcare provider. ^{1 6 7 8 9}

Who Is on the Research Team?

Mariana Murea, MD

Principal Investigator

Wake Forest Health Sciences

Matthew P Goldman, MD

Principal Investigator

Wake Forest University Health Sciences

Michael Allon, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for older adults aged 60 or above with end-stage kidney disease on hemodialysis, specifically those using a central venous catheter and having cardiovascular disease, peripheral vascular disease, or diabetes. Candidates must be deemed suitable for AV access surgery by their surgeon and referred by a nephrologist. Exclusions include severe cardiac conditions, anticipated kidney transplant within the year, or plans to switch to peritoneal dialysis.

Inclusion Criteria

You currently rely only on a central venous catheter for hemodialysis.

I am 60 years old or older.

I am on long-term hemodialysis for kidney failure.

Exclusion Criteria

I expect to start peritoneal dialysis within the next year.

I am scheduled for a procedure to create a connection between an artery and vein using methods other than stitches or clips.

I have severe heart issues, including very low heart pump function, a heart transplant, or a device to help my heart pump.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical placement of either a fistula or graft for permanent hemodialysis access

Up to 4 years

Regular visits for dialysis and monitoring

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction with vascular access

4 years

Visits at baseline, Months 1, 6, 12, and annually

Outcome Assessment

Assessment of catheter-free dialysis days, infections, and patient-reported outcomes

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• AV Graft
• Surgical Intervention for Creation of a Fistula

Trial Overview

The study compares two surgical methods for creating arteriovenous access in patients: an AV graft versus a fistula. It aims to determine which is more effective and safer for older adults with multiple chronic conditions who are undergoing long-term hemodialysis treatment.

How Is the Trial Designed?

Group I: fistula surgically placed Experimental Treatment 1 Intervention

Randomized group to have surgically placed fistula for permanent hemodialysis access

Group II: graft surgically placed Active Control 1 Intervention

Randomized group to have surgically placed graft for permanent hemodialysis access

AV Graft is already approved in United States, European Union for the following indications:

Approved in United States as Arteriovenous Graft for:

• End-stage renal disease (ESRD)
• Hemodialysis access

Approved in European Union as AV Graft for:

• Chronic kidney disease
• Renal failure requiring dialysis

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The AV Access Study is a prospective, multicenter, randomized controlled trial involving 262 older adults (≥60 years) with chronic hemodialysis to compare the clinical outcomes of arteriovenous fistulas (AVFs) versus arteriovenous grafts (AVGs) over an average follow-up of 2 years.

The primary outcome will measure the rate of central venous catheter (CVC)-free days, while the primary safety outcome will assess severe infections related to vascular access, aiming to provide robust evidence for optimizing vascular access care in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial. Murea, M., Gardezi, AI., Goldman, MP., et al.[2023]

In a study of 136 surgical salvage procedures for arteriovenous fistulas (AVFs), the cumulative patency rates were high at 91% at 3 months, 83% at 6 months, and 77% at 12 months, indicating effective long-term outcomes.

The most common salvage procedures included re-anastomosis (37.2%) and AVF declotting (34.1%), highlighting the effectiveness of these techniques in managing complicated AVFs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Salvage of vascular access: a case study from the Columbus nephrology division, Rome, Italy]. Ferraro, PM., Lombardi, G., D'Ascenzo, F., et al.[2013]

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]

In a study of 9,291 kidney transplant patients, the type of vascular access used during hemodialysis (AVF, AVG, or CVC) did not show a significant association with all-cause mortality or overall allograft loss after transplantation.

However, patients who used central venous catheters (CVC) had a 30% higher risk of allograft loss from causes other than death compared to those who used arteriovenous fistulas (AVF), indicating that CVCs may pose a greater risk for certain complications post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Type of Vascular Access Used in Hemodialysis Patients and Subsequent Kidney Transplant Outcomes. Airy, M., Lenihan, CR., Ding, VY., et al.[2023]

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]

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]

In a study of patients starting hemodialysis in 1999, only 22% had an arteriovenous (AV) fistula placed, with only 14% using it for their first treatment, highlighting significant barriers to optimal vascular access.

Many patients were referred to nephrologists too late for timely AV fistula placement, but there is potential for improvement, as 25% of those who initially used a catheter switched to an AV fistula within 6 months, suggesting that earlier referrals could enhance access outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unraveling the realities of vascular access: the Network 11 experience. Besarab, A., Adams, M., Amatucci, S., et al.[2019]

The incidence of arteriovenous fistula (AVF) after kidney allograft biopsy in Japanese transplant recipients was found to be 2.6%, with a median time to diagnosis of 7 days, highlighting the need for monitoring after biopsies.

Transcatheter embolization (TE) was shown to be a safe and effective treatment for AVF, with no complications reported and stable allograft function maintained for up to 12 months post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arteriovenous fistulas after ultrasound-guided needle biopsy of kidney allografts and treatment outcomes after transcatheter embolization: A single-center experience in Japan. Osako, K., Yazawa, M., Terashita, M., et al.[2021]

In a study of 473 hemodialysis patients in Northern England, arteriovenous fistulae showed a 1-year survival rate of 85.1%, with significant variability in survival rates across different centers, ranging from 76.1% to 91.6%.

The findings suggest that while various factors affect fistula survival, the lack of mandatory surgical training for access procedures may contribute to these differences, indicating a need for a review of surgical practices in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival of arteriovenous fistula for dialysis at different centers in the North of England. Shrestha, PC., Asher, J., Shrestha, SM., et al.[2019]

In a study of 112 patients with chronic kidney disease, early creation of arteriovenous (AV) fistulas significantly reduced the failure rate, with 83.3% of failures occurring in the late access creation group.

The study suggests that timely referral to nephrologists and early vascular access creation can improve the success rate of AV fistulas, ultimately enhancing the quality of life for patients undergoing haemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus late arterio-venous fistulae: impact on failure rate. Farooq, Z., Mehmood, A., Saeed, S., et al.[2012]

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]

A new web-based application has been developed to predict blood flow outcomes for arteriovenous fistula (AVF) surgeries based on preoperative ultrasound evaluations, which could enhance surgical planning.

By using this numerical tool, surgeons may reduce the risk of AVF non-maturation and complications, leading to better vascular access for hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational model for prediction of fistula outcome. Remuzzi, A., Manini, S.[2017]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7298797/

A randomized pilot study to evaluate graft versus fistula ...

A meta-analysis of 13 studies concluded that older patients have 50-65% higher odds of primary AV fistula failure and 80% higher odds of secondary AV fistula ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03645681

Evaluating the Safety and Effectiveness of the InnAVasc ...

Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure ... Kidney Failure, ChronicRenal Dialysis.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772687825000285

Comparing the outcomes of femoral vein transposition ...

Finding suitable vascular access for dialysis is a significant challenge in advanced kidney failure. Patients with end-stage renal disease (ESRD) need ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9960188/

Study protocol of a randomized controlled trial of fistula vs ...

A meta-analysis of 13 studies concluded that older patients have a 50–65% higher risk of primary AVF failure and 80% higher risk of secondary ...

5.

ectrx.org

ectrx.org/detail/current/2023/21/6/0/487/0

FULL TEXT

... failure. In total, 68.1% of arteriovenous fistula ligations ... vascular access in patients with hemodialysis-dependent end-stage renal disease.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10375446/

Outcomes of arteriovenous graft vs. fistula for haemodialysis ...

These results suggested that in elderly patients undergoing haemodialysis, AVG was associated with reduced overall survival and access survival, and higher ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666688X2200003X

Five Year Outcomes in Patients with End Stage Renal ...

Graft and fistula failure can force patients to rely on central venous catheters, which are associated with higher rates of infection, all cause mortality, and ...

8.

usrds-adr.niddk.nih.gov

usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/4-vascular-access

Vascular Access - Annual Data Report | USRDS - NIH

In this chapter, we describe vascular access use and outcomes among patients receiving HD. We first examine access use in incident patients initiating HD. We ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0895796724000656

Management of dialysis access in the post-transplantation ...

Arteriovenous fistula (AVF) has historically been regarded as the gold standard for hemodialysis (HD) access in patients with end-stage renal disease (ESRD).