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Innovation for improved outcomes in complex peripheral disease

Gore Arteriovenous (AV) Solutions:
Because vascular access is personal

For hemodialysis patients, a “fistula first” approach has long been the standard. But fistulas can fail, 20 to 60 percent of the time,1-5 subjecting patients to undue hardship and central venous catheter (CVC)-related risks.


In fact, 2019 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines emphasize the need for a more individualized approach to access modality selection. 6


With Gore AV Grafts, you can give patients at risk for arteriovenous fistula (AVF) failure to mature reliable access for the road ahead, and a durable solution to facilitate ongoing access:

GORE® ACUSEAL Vascular Graft

Avoid or reduce CVC dependency with immediate cannulation.7-9

GORE® PROPATEN® Vascular Graft

Proven clinical performance when early cannulation is not required.10

GORE® VIABAHN® Endoprosthesis

High patency and durable outcomes to minimize interventions for your patients.11,12

 

Many patients experience challenges with AVF maturation

50% of AVFs require intervention to mature 68% of patients still on CVC after 3 months

 

More complications compared to patients initiating dialysis with an AVF

 

Addressing AVF maturation challenges

KDOQI guidelines6 highlight the integral role of arteriovenous grafts (AVGs) and stent grafts in optimizing patient outcomes, with a call to:

  • Avoid unnecessary procedures and complications
  • Preserve vessels needed for successful future AV access creation and use

It is about achieving “the right access, in the right patient, at the right time, for the right reasons”

– KDOQI guidelines6

 

See what the KDOQI guidelines say about:

Access creation considerations6

AVF or AVG in preference to CVC in most incident and prevalent hemodialysis patients

AVF or AVG in preference to CVC in most incident and prevalent hemodialysis patients.

Read KDOQI guideline 2.3, page S40

Possible benefit of AVG over AVF in patients with poor vessels and greater comorbidity

Possible benefit of AVG over AVF in patients with poor vessels and greater comorbidity.

Read KDOQI guideline 2, page S43

Early cannulation grafts as a CVC-sparing strategy in appropriate patients

Early cannulation grafts as a CVC-sparing strategy in appropriate patients.

Read KDOQI guideline 4.2, page S49

Target goal of ≤ 2 interventions to use the access

Target goal of ≤ 2 interventions to use the access.

Read KDOQI goals and target chart, page S133

Access maintenance considerations6

Stent grafts in preference to angioplasty alone for recurrent clinically significant stenotic and recurrent thrombotic AVG lesions

Stent grafts in preference to angioplasty alone for recurrent clinically significant stenotic and recurrent thrombotic AVG lesions.

Read KDOQI guideline 15.9, page S192

Avoid use of bare metal stents for the treatment of significant AVG and AVF stenotic lesions

Avoid use of bare metal stents for the treatment of significant AVG and AVF stenotic lesions.

Read KDOQI guideline 15.12, page S192

Target goal of ≤ 3 interventions annually to maintain the access

Target goal of ≤ 3 interventions annually to maintain the access.

Read KDOQI goals and targets chart, page S133

Access and download the KDOQI guidelines6

 

From fistula-first to patient-first: The AVG advantage

As end-stage renal disease (ESRD) becomes more prevalent and patient populations become more complex, achieving successful AVF maturation has become increasingly challenging. Choosing an AVG based on each patient’s individual risk factors – rather than relying on fistula first – can yield numerous potential benefits.

Compared with AVGs,
CVCs are associated
with a 49% higher risk
of fatal infections

due to complications.16

Greater than
50% reduction
in catheter time

with early
cannulation grafts,
compared with
standard grafts17

AVGs are 65% more
likely than AVFs

to mature without
intervention13

46% reduction in
catheter days
and higher
secondary patency
with
AVGs maturing without
intervention, compared
with AVFs requiring
intervention to mature13  

 

We are here to help

With nearly 50 years of leadership in purpose-build innovation, Gore AV Grafts are optimized for improving outcomes in hemodialysis patients. Our proven graft and stent graft technologies are backed by dedicated service and a commitment to help physicians as the patient landscape evolves.

GORE® ACUSEAL Vascular Graft

Recommended for patients who are already on a CVC (allowing early removal), and/or patients who need a new access and must achieve cannulation in under two weeks.

54% fewer CVC dependent days versus standard grafts.

DOWNLOAD THE DATA SUMMARY

GORE® PROPATEN® Vascular Graft

Recommended for patients who are not already on a CVC, and/or patients who need a new access, and can wait at least two weeks before cannulation.

78% reported patency at once year, 20% higher than non-heparin bonded grafts.

READ THE STUDY

Contact a Field Sales Associate to learn more

The information provided is intended to be general guidance based on current medical practices in the field. The steps described here may not be complete, and are not intended to be a replacement for the Instructions for Use or the education, training and professional judgment of healthcare providers (HCP). Licensed HCPs remain responsible for making decisions about patient care and the use of medical technologies.

GORE® VIABAHN® Endoprosthesis
INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® Endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm, in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm, and in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts.

CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis is contraindicated for noncompliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

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References

  1. Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney International 2002;62(4):1109-1124.
  2. Allon M, Imrey PB, Cheung AK, et al; Hemodialysis Fistula Maturation (HFM) Study Group. Relationships between clinical processes and arteriovenous fistula cannulation and maturation: a multicenter prospective cohort study.  American Journal of Kidney Diseases 2018;71(5):677-689.
  3. Dember LM, Beck GJ, Allon M, et al; Dialysis Access Consortium Study Group. Effect of Clopidogrel on early failyer of arteriovenous fistulas for hemodialysis. A randomized controlled trial.  Journal of the American Medical Association 2008;2299(18):2164-2171.
  4. Allon M. Vascular access for hemodialysis patients: new data should guide decision making. Clinical Journal of the American Society of Nephrology 2019;14(6):954-961.
  5. Wish JK. Catheter last, fistula not-so-first. Journal of the American Society of Nephrology 2015;26(1):5-7.
  6. Lok CE, Huber TS, Lee T, et al; KDOQI Vascular Access Guideline Work Group. KDOQI Clinical Practice Guideline for Vascular Access: 2019 update. American Journal of Kidney Diseases 2020;75(4)Supplement 2:S1-S164.
  7. Glickman MH, Burgess J, Cull D, Roy-Chaudhury P, Schanzer H. Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis. Journal of Vascular Surgery 2015;62(2):434-441.
  8. Tozzi M, Franchin M, Ietto G, et al; Initial experience with the Gore® Acuseal graft for prosthetic vascular access. Journal of Vascular Access 2015;16(6):467-471.
  9. Maytham GGD, Sran HK, Chemla ES. The use of the early cannulation prosthetic graft (AcusealTM) for angioaccess for haemodialysis. Journalof Vascular Access 2015;62(2):434-441.
  10.  Davidson I, Hackerman C, Kapadia A, Minhajuddib A. Heparin bonded hemodialysis e-PTFE grafts result in 20% clot free survival benefit.
  11.  Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators. Clinical and economic benefits of stent grafts in dysfunctional and thrombosed hemodialysis access graft circuits in the REVISE Randomized Tril. Journal of Vascular & Interventional Radiology 2019;30(2):203-211.e4.
  12.  Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of falling or thrombosed prosthetic hemodialysis grafts. Journal of Vascular Surgery 2013;64(5):1400-1410.e1. https://wwww.sciencedirect.com/science/arcle/pii/S074152141630156. Accessed August 23, 2021.
  13.  Harms J, Rangarajan S, Young CJ, Barker-Finkel J, Allon M. Outcomes of arteriovenous fistulas and grafts with or without intervention before successful use. Journal of Vascular Surgery 2016;64(1):155-162.
  14.  USRDS Annual Data Report: Epidermiology of Kidney Disease in the United States United States Renal Data System (USRDS) website. 2020. United States Renal Data System (USRDS) website. National Institute of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD 2020. https://adr.usrds.org/2020. Accessed April 20, 2021.
  15.  Al-Balas A, Shariff S, Lee T, Young C, Allon M. Clinical outcomes and economic impact of starting hemodialysis with a catheter after predialysis arteriovenous fistula creation. American Journal of Nephrology.
  16.  Ravani P, Palmer SC, Oliver MJ et al. Associations between hemodialysis access type and clinical outcomes: a systematic review. Journal of the American Society of Nephrology 2013;24(3):465-473.
  17.  Mohapratra A, You TH, Lowenkamp MN, et al. Cost-effectiveness analysis of immediate access arteriovenous grafts versus standard grafts for hemodialysis. Journal of Vascular Surgery 2021;73(2):581-587.
  18.  Quinn B, Cull DL, Carsten CG. Hemodialysis access: placement and management complications. In: Hallet JW Jr, Mills JL, Earnshaw J, Reekers JA, Rooke T, eds. Comprehensive Vascular & Endovascular Surgery. 2nd ed. Philadelphia, PA: Mosby; 2009;(26):429-462.
  19.  Shingarev R, Mayal D, Barker-Finkel J, Allon M. Arteriovenous graft placement in predialysis patients: a potential catheter-sparing strategy. American Journal of Kidney Diseases 2011;58(2):243-247.