HeRO Graft (Hemodialysis Reliable Outflow) is the only fully subcutaneous AV access solution clinically capable of maintaining long-term access in haemodialysis patients with central venous stenosis. HeRO Graft is classified by the US FDA as a graft, but differs from a conventional AV graft in that it has no venous anastomosis. It consists of two primary components:

A patented arterial implant component made of ePTFE

The HeRO Graft arterial implant component has an inner diameter (ID) of 6 mm, an outer diameter (OD) of 7.4 mm and a length of 53 cm, including connector. It consists of an ePTFE haemodialysis implant with PTFE ribbing to provide kink resistance in the vicinity of the patented titanium connector. The titanium connector attaches the arterial implant component to the venous outflow component. The arterial implant component is cannulated using a standard technique according to KDOQI guidelines.

A patented venous outflow component

The HeRO Graft venous outflow component has an ID of 5 mm, an OD of 19F (6.3 mm) and is 40 cm long. It consists of radio-opaque silicone with braided nitinol reinforcement (for resistance to bending and crushing) and a radio-opaque marker at its distal end.

Main benefits
Fewer infections: infection rate reduced by 69% compared to catheters (1).
Superior adaptation to dialysis: 1.7 Kt/V: 16% to 32% improvement over catheters (1).
High patency rates: up to 87% 2-year cumulative patency (1,2).
Cost savings: average savings of 23% per year compared to catheters (3).

1. Katzman et al, J Vasc Surg, 2009; Comparisons to catheters are from literature review on file.
2. Gage et al., EJVES 2012.
3. Dageforde et al., JSR 2012.

Hero Graft Procedura Chirurgica

Indications for use

Hero Graft is indicated for haemodialysis patients with chronic renal failure who have exhausted all peripheral access routes. See Instructions for Use for full indications and contraindications. RX only.

FDA Classification

HeRO Graft is classified by the FDA as Vascular Graft.

Surgical Procedure

1. Using endovascular Seldinger technique, the intravenous component is placed in the upper third of the right atrium

2. At the level of the deltoid-pectoral groove, the titanium connector is connected to the endovascular component.

3. Standard anastomosis between ePTFE graft and target artery (>3mm).

Patient identification

hero graft nefrologia

Control and observation of dialysis vascular access:
Failure of AVF or AVG?
Is the patient catheter dependent or about to become catheter dependent?
Is the currently measured Kt/V less than 1.4?
Does the patient have swollen arms, limb oedema or prominent collateral veins on the chest?
Has the patient undergone many operations (e.g. angioplasty)?
Does the patient have central vessel stenosis?
If the answer is yes to any of the above specifications, a Central Venography is recommended to assess the status of central venous stenosis.

Surgical evaluation for Hero Graft:
Bilateral Central Venography to confirm central venous stenosis;
Vessel mapping to confirm artery diameter is ≥ 3mm;
Medical treatment for hypercoagulation;
Ejection fraction ≥ 20%;
Systolic pressure ≥ 100mmHg;
Infection-free patient.

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LITERATURE

  1. Vascular Access Work Group. National Kidney Foundation KDOQI clinical practice guidelines for vascular access. Guideline 1: patient preparation for permanent hemodialysis access. Am J Kidney Dis 2006;48(1Suppl1):S188-91.
  2. Lucas, George 2007. Scientific Review of Adverse Events related to the use of Chronic Hemodialysis Catheters (not including infections). On file at Hemosphere, Inc.
  3. Lucas, George F. 2007. Scientific Review of Adverse Events in Hemodialysis Grafts. On file at Hemosphere, Inc.
  4. Oliver, M., Lynch, L. 2005. Estimate of the Risk and Rate of Hemodialysis Catheter-Related On file at Hemosphere, Inc.
  5. Hajjar J, Girard R, Marc JM, et al. [Surveillance of infections in chronic hemodialysis patients (Article in French)]. Nephrologie 2004;25:133-40.
  6. Duszak R, Haskal ZJ, Thomas-Hawkins C, et al. Replacement of failing tunneled hemodialysis catheters through pre-existing subcutaneous tunnels: a comparison of catheter function and infection rates for de novo placements and over-the-wire J Vasc Interv Radiol 998;9:321-7.
  7. Hodges TC, Fillinger MF, Zwolak RM, et al. Longitudinal comparison of dialysis access methods: risk factors for failure. J Vasc Surg 1997;26:1009-19.
  8. Lund GB, Trerotola SO, Scheel PF, et al. Outcome of tunneled hemodialysis catheters placed by Radiology 1996;198:467-72.
  9. Schwab SJ, Weiss MA, Rushton F, et Multicenter clinical trial results with the LifeSite hemodialysis access system. Kidney Int 2002;62:1026-33.
  10. Trerotola SO, Johnson MS, Harris VJ, et al. Outcome of tunneled hemodialysis catheters placed via the right internal jugular vein by interventional radiologists. Radiology 1997;203:489-95.
  11. Richard HM III, Hastings GS, Boyd-Kranis RL, et al. A randomized, prospective evaluation of the Tesio, Ash split, and Opti-flow hemodialysis J Vasc Interv Radiol 2001;12/31/1899 12:00:00 PM431-5.
  12. Perini S, LaBerge JM, Pearl JM, et Tesio catheter: radiologically guided placement, mechanical performance, and adequacy of delivered dialysis. Radiology 2000;215:129-37.
  13. Huber TS, Carter JW, Carter RL, et al. Patency of autogenous and polytetrafluoroethylene upper extremity arteriovenoushemodialysis accesses: a systematic J Vasc Surg 2003;38:1005-11.
  14. Bosman PJ, Blankestijn PJ, van der Graaf Y, et al. A comparison between PTFE and denatured homologous vein grafts for haemodialysis access: a prospective randomised multicentre trial. Eur J Vasc Endovasc Surg 1998;12/31/1899 4:00:00 PM126-32.
  15. Dammers R, Planken RN, Pouls KPM, et Evaluation of 4-mm to 7-mm versus 6-mm prosthetic brachialantecubital forearm loop access for hemodialysis: results of a randomized multicenter clinical trial. J Vasc Surg 2003;37:143-8.
  16. Sehgal AR, Snow RJ, Singer ME, et al. Barriers to adequate delivery of hemodialysis. Am J Kidney Dis 1998;31:593-601.
  17. Centers for Medicare & Medicaid Services. 2007 Annual Report, end stage renal disease clinical performance measures project. Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Clinical Standards &Quality, Baltimore, Maryland, December
  18. Centers for Medicare and Medicaid Services, Kinney R. 2005 Annual Report: , end stage renal disease clinical performance measures Am J Kidney Dis 2006;48(4Suppl2):S1-S106.
  19. 2001 Annual Report: ESRD clinical performance measures project. Am J Kidney Dis 2002;39 (5Suppl3):S4-S98.
  20. Pastan S, Soucie JM, McClellan Vascular access and increased risk of death among hemodialysis patients. Kidney Int 2002;62:620-26.
  21. Tonelli M, Muirhead Access type as a predictor of dialysis adequacy in chronic hemodialysis patients. ASAIO J 2000;46:27982.
  22. Hemodialysis Adequacy 2006 Work National Kidney Foundation KDOQI clinical practice guidelines for hemodialysis adequacy, update 2006. Am J Kidney Dis 2006;48(Suppl 1):S2-S90.
  23. Lynch, 2007. Pulmonary Embolism Literature Summary. On file at Hemosphere, Inc.
  24. Seliger SL, Gillen DL, Longstreth WT Jr, et Elevated risk of stroke among patients with end- stage renal disease. Kidney Int 2003;64:603-9.
  25. Shah, 2010. Impact of Missing Hemodialysis sessions on Arteriovenous Access Thrombosis. On file at Hemosphere, Inc.
  26. Illig Management of Central Vein Stenosis and Occlusions: The Critical Importance of the Costoclavicular Junction. Semin Vasc Surg 24:113-118, 2011.
  27. Katzman (2009). Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. Journal Vascular Surgery, 600-607.
  28. Nassar (2013). A comparison between the HeRO® Graft and conventional arteriovenous grafts in hemodialysis patients. Seminars in Dialysis, in press.

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