A proprietary Venous Outflow Component
The HeRO Venous Outflow Component has a 5mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone with braided nitinol reinforcement (for kink and crush resistance) and a platinum-iridium radiopaque marker band at the distal tip. back to top
What is the life expectancy of HeRO?
The limiting factor in the life expectancy of the HeRO device is the life of the ePTFE Arterial Graft Component. Literature reports ePTFE graft life expectancy at approximately 2 years. Rotation of needle sites can help extend the life of the HeRO graft. Further, the graft portion can be replaced or revised without removing the Venous Outflow Component.
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What patient selection considerations must a patient meet?
The following patient selection considerations should be evaluated prior to initiating the implant procedure:
- Ensure proper patient selection via vessel mapping
- If vessel mapping indicates that a viable fistula or graft can be placed, consider these options first.
- The target artery must be at least 3mm to provide adequate arterial inflow to support the graft.
- Verify the ejection fraction is greater than 20%.
- Verify systolic blood pressure is at least 100mmHg.
- Obtain screening blood cultures in advance of the procedure to rule out existing systemic infection. In the event blood cultures are positive, postpone implant of the HeRO device pending antibiotic treatment and confirmation of infection resolution.
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How extensive is the implant surgery?
The placement is similar to both tunneled cuff catheter placement and graft placement. It can be more complex if the patient requires angioplasty of the central veins prior to placement of the Venous Outflow Component. The HeRO implant can be done under general anesthesia or conscious sedation.
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Is there Medicare reimbursement for HeRO? How does the reimbursement rate compare to grafts?
The HeRO Arterial Graft Component is reported using CPT® 36830. The Venous Outflow Component is reported with CPT® 36558 (procedure-to-device edit C1750, Catheter, Hemodialysis, Long-term). Payments have been reported as equal to a graft payment and part of a catheter payment. Details can be found in our 2010 Reimbursement Brochure.
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Is special training required to implant the HeRO Vascular Access Device?
Interested access surgeons may contact Hemosphere Customer Service directly at 888.313.8233. Each access surgeon is typically certified by Hemosphere staff with a minimum of 5 cases prior to commencing independent implantation of the device.
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Where is the device intended to be implanted?
Please consult the HeRO Vascular Access Device Instructions for Use.
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Is the device sutured for stabilization?
The HeRO graft portion is anastamosed to the artery and will incorporate like a standard ePTFE graft. The Venous Ouflow Component is connected to the graft via a titanium connector. No other forms of stabilization are required.
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Are there any contraindications for placement of a HeRO Vascular Access Device?
Implantation of the HeRO Device is contraindicated if:
- The brachial or target artery ID is less than 3mm.
- The internal jugular vein (IJV) or target vasculature cannot be dilated to accommodate the 19F HeRO Outflow Component.
- There is significant arterial occlusive disease that would preclude safe placement of an upper extremity hemodialysis access.
- There is known or suspected allergy to device materials (i.e., ePTFE, silicone, titanium, nitinol).
- The patient has a topical or subcutaneous infection associated with the implantation site.
- The patient has known or suspected systemic infection, bacteremia, or septicemia.
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Where is the temporary bridging catheter typically placed?
59% of the clinical trial patients had a femoral catheter due to presence of pacemaker leads, defibrillator leads or stenotic vessels in the chest. It is preferable to place HeRO in one side of the chest and the tunneled cuff catheter contra laterally. Femoral catheters may carry a higher risk of infection, but can be used if necessary during the maturation period.
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What is the benefit to using the HeRO temporary tattoo?
The temporary tattoo is designed to be placed on the HeRO device recipient’s hand or wrist immediately following the surgery. The HeRO symbol on the tattoo will assist the dialysis provider in identifying the access as a HeRO device, as well as identifying the access arm.
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How long is the incorporation period after surgical implantation?
Hemosphere recommends following KDOQI graft guidelines of 2-4 weeks for incorporation.
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Should an antibiotic regimen be continued after surgical implantation?
If a course of Vancomycin and Gentamicin is prescribed during the implant, the antibiotics will stay in the patient’s system for 7 days without dialyzing out during their dialysis treatments. If a patient has a history of “chronic infection,” the nephrologist might consider keeping the patient on an antibiotic course until the bridging catheter is removed.
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Will HeRO clot?
HeRO patency was clinically proven to be equivalent to a standard ePTFE graft. The expected intervention rate is approximately 2 per year. Additional clinical trial information and a comparison of HeRO to other AV accesses can be viewed here Clinical-citations.
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Are there known differences in the occlusion rates in left vs. right-sided implants?
No significant differences in occlusion were noted in the clinical trial.
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Are there any specific methods or training that must be used when performing a thrombectomy on HeRO?
Please consult the HeRO Access Device Thrombectomy Guideline Brochure.
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What do we do if we receive a transient patient with HeRO and it is not patent?
Interventions should be performed by the specialist performing graft interventions. A detailed thrombectomy guide is available: Thrombectomy Guideline Brochure.
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Does fibrin sheath build within HeRO?
No fibrin sheath formation is expected around the tip of the HeRO Venous Outflow Component due to continuous arterial flow.
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Is anticoagulant therapy (such as Plavix) required after an implant? If so, for how long?
PTT and drug levels should be checked per standard treatment course prior to HeRO implant, and anticoagulants or Plavix prescribed prior to the HeRO implant should continue after surgery. After HeRO surgery, many physicians prescribe a course of “proactive prophylaxis” for the first 30 days and then re-evaluate.
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Is there a maximum blood flow recommendation for HeRO?
Hemosphere recommends following the provider/facility policy for setting blood flow rates. There is no special requirement for HeRO.
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When cannulating HeRO for the first time, can blood pump speeds of 350 to 400ml/min. be used immediately?
HeRO should be treated in the same manner as conventional ePTFE grafts. Flow rates of 450-500ml/min. are usually achieved.
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Are small gauge needles required for the initial HeRO cannulations?
It is not necessary to start with small needles. The provider/facility protocol should be followed as with other ePTFE grafts.
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Can fistula clamps be used on the HeRO Vascular Access Device?
To achieve hemostasis after puncture, Hemosphere recommends use of moderate finger pressure rather than mechanical fistula clamps.
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What happens if the outflow component of the HeRO is mistakenly punctured?
Puncture of the outflow component is highly unlikely due to its location.
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When prepping cannulation sites, which anti-bacterial is preferred? Can Betadine or alcohol be used?
Hemosphere recommends following KDOQI guidelines for access assessment and preparation.
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Why is using a light tourniquet recommended on the graft?
A light tourniquet will assist in palpating the graft making HeRO feel more like a standard graft. The rationale for using a light tourniquet is related to the lack of a venous anastomosis with HeRO. It is similar to using a tourniquet for a native fistula as there is also no venous anastomosis with a fistula.
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What is the risk to the graft if a tourniquet is applied too tight or left on too long?
As with any peripheral access, a tourniquet left on too long, or one that is applied too tightly, may constrict flow and increase clotting. The tourniquet should only be used for initiating cannulation and removed immediately when treatment begins.
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Can all hemodialysis staff cannulate HeRO?
Follow your provider/facility policies with regards to graft cannulation.
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If infiltration occurs, is it more serious than infiltration with a regular graft?
As the HeRO Arterial Graft Component is a standard ePTFE graft, infiltration is expected to be as serious as with other standard grafts or fistulas.
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How does a dialysis clinic know when a patient has received HeRO?
Dialysis facilities may receive an implant notification fax form from the implanting surgeon’s office, or the nephrologist may have communicated the access surgery is scheduled to occur. If either of these have occurred and you have not been offered educational support, please contact Hemosphere Customer Service at 888.313.8233.
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Will the field sales team visit each dialysis facility with a HeRO graft?
Educational opportunities are made available to each clinic via on-line learning, brochures, and telephone education. A small group of clinical educators support the entire United States, which may limit in-person inservice opportunities.
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Are there any activity limitations for a new HeRO device recipient?
The limitations are similar to other new AV accesses. The Patient Information brochure addresses how the patient should take care of the HeRO access after implant.
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In what situations will the device be removed?
If the device is abandoned for any reason, we recommend removal of the Venous Outflow Component. The HeRO graft would typically not be removed due to maturation/incorporation of surrounding tissue into the ePTFE material.
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How do I obtain a copy of the patient education materials or the Care & Cannulation guide?
Both can be found in the Document Library where PDF versions of our educational materials are available for download. You may also call Customer Service at 888.313.8233.
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Will HeRO recipients be able to participate in access flow testing?
HeRO graft/outflow may be tested in the same manner as other access devices.
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I know an access-challenged patient. How do I refer him/her to a certified access surgeon?
Contact a HeRO implanting surgeon via our Find An Implant Surgeon section located in the Patient Information menu. HeRO implanting surgeons are organized by state, complete with contact information. It is important to ask the surgeon if he/she wants vessel mapping done prior to seeing the patient or if they will complete this at the time of the visit. If you are unable to locate an implanting surgeon near you, please contact Hemosphere Customer Service at 888.313.8233 for assistance.
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General Questions: