Hemodialysis Reliable Outflow Device Research Articles

Contemporary Comparison Between the Hemodialysis Reliable Outflow Device and Femoral Arteriovenous Graft

Contemporary Comparison Between the Hemodialysis Reliable Outflow Device and Femoral Arteriovenous Graft

Hemodialysis Reliable Outflow graft: A valid option in patients with central venous stenosis.

Central venous stenosis can be the main obstacle to the creation of an autologous vascular access in the upper limbs. The Hemodialysis Reliable Outflow graft was developed to provide an upper limb vascular access option to such patients, avoiding alternative, less advantageous options, such as lower limb vascular accesses or central venous catheters. Its advantages include catheter avoidance and, in case of lower limbs accesses, reduction of the ischemic risk and iliac vein thrombosis, potentially compromising a future kidney transplant. Revision of the clinical files of the four patients who were placed a Hemodialysis Reliable Outflow device in our Center, including demographic variables, implantation technique characteristics, surgical complications, episodes of infection and thrombosis of the access, and need to place a transitory central venous catheter to undergo hemodialysis treatment. Four Hemodialysis Reliable Outflow grafts were placed, which resulted in a significant improvement in the dialysis efficacy in all patients, with a median raise in the Kt/V of 36.7%. Two cases needed thrombectomy, one of which was unsuccessful. The actual time of patency varies between 3 and 28 months. Our experience with the Hemodialysis Reliable Outflow device showed that it was a safe option for patients with central venous stenosis and was associated with good clinical and analytic outcomes.

Primary and secondary patencies of transposed femoral vein fistulas are significantly greater than with the HeRO graft

For access-challenged patients with bilateral upper extremity central venous stenosis, solutions include the Hemodialysis Reliable Outflow (HeRO) device or an autogenous AV fistula in the lower limb. We evaluated HeRO grafts and transpositions of the femoral vein in maintaining primary and secondary patency. We retrospectively analyzed 40 patients with a HeRO device and 18 patients with superficial femoral artery to transposed femoral vein autogenous arteriovenous fistula (SFA-tFV). All patients had bilateral central venous obstruction. All procedures were outpatient performed by a single surgeon at one center between 2009-2015. Operative details, intraoperative flows, and flows at the first-week postoperative visit were analyzed, as were primary and secondary patency and intervention rates. Complications were compared between groups. The one-year cumulative primary patency was 30% for HeRO grafts and 79% for SFA-tFV fistulas (p = 0.0001); secondary patency was 71% for HeRO grafts and 93% for SFA-tFV fistulas (p = 0.03). To maintain patency, HeRO patients required a mean 2.1 interventions per year and thigh fistula patients required a mean 0.4 interventions per year. Thirty-seven percent of thigh fistula patients had a hematoma or seroma versus 5% of HeRO patients and 17% of thigh fistula patients experienced delayed wound healing versus 2.5% of HeRO patients (p<0.05). None of the thigh fistula patients had distal ischemia. HeRO patients had lower primary and secondary patency rates versus thigh fistula patients and HeRO grafts required five-fold more interventions to maintain secondary patency. However, patients with thigh fistulas had significantly more wound healing problems. Thus, the SFA-tFV has become our access of choice for patients with bilateral central venous stenosis.

Balloon-assisted over-the-wire technique for placement of the venous outflow component of the Hemodialysis Reliable Outflow (HeRO) device

A modified technique for placement of the venous outflow component (VOC) of the Hemodialysis Reliable Outflow (HeRO) device (Hemosphere Inc, Minneapolis, Minn) is described. The purpose of the technique is to improve the system's trackability and facilitate device insertion in patients with central venous occlusion. Device preparation requires placement of a 6-mm × 4-cm angioplasty balloon within the leading end of the VOC. The leading 2 cm of the balloon are placed just distal to the radiopaque marker of the VOC. The balloon is inflated to profile and locked in this position within the leading end of the VOC. The VOC and balloon combination is advanced over the wire through the 20F peel-away sheath provided by the manufacturer. The described technique was used to successfully implant the HeRO device in 12 patients with central venous occlusion. This technique is recommended for placement of the VOC of the HeRO device in patients with central venous occlusions.

Educational Exhibit Abstract No. 272 - Review of the HeRO (hemodialysis reliable outflow) device: a novel approach for hemodialysis

Learning Objectives 1. Introduce and describe this relatively novel approach to hemodialysis. 2. Discuss post implantation surveillance and complication management. 3. Emphasis will be placed on the interventional radiologist's role with the HeRO device. Background Over half a million people in the United States suffer from chronic kidney disease requiring either renal transplantation or hemodialysis. When a transplant is unavailable, the currently preferred order of providing hemodialysis access is as follows: arteriovenous fistula, graft and central venous catheter. A recently developed alternative for hemodialysis is the HeRO device which is a hybrid access that incorporates a surgically created arterial graft that is connected to a completely subcutaneous central venous catheter. Clinical Findings/Procedure Details This educational exhibit will introduce and describe this new device for hemodialysis and will review indications and appropriate patient selection, including preprocedural patient evaluation. A clinical case example of a HeRO device implantation will be used to illustrate the procedural steps in successfully implanting the device. An algorithm for appropriate clinical and imaging surveillance, maintenance of device patency and management of post-insertion complications such as graft thrombosis will be reviewed. The potential pitfalls, clinical and technical success rates will also be discussed, followed by a summary of the medical literature regarding the HeRO catheter. Conclusion and/or Teaching Points The HeRO device is intended for patients who have exhausted other means of hemodialysis as a result of failed fistulas and/or grafts or for those patients with poor venous outflow (e.g. proximal venous stenoses/occlusions). On the continuum of the preferred order of providing hemodialysis access, this device falls between dialysis grafts and tunneled catheters. The infection rate and incidence of venous stenoses is lower when using this device, as compared to central venous catheters. Secondary intervention rates are lower than central venous catheters, are equivalent to those of arteriovenous grafts and exceed those associated with AV fistulas.

Experience of HeRO Dialysis Graft Placement in a Challenging Population

To assess the outcomes of the hemodialysis reliable outflow (HeRO) device in a subset of hemodialysis access-challenged patients with central venous obstruction. Retrospective analysis of a series of patients in 2 centers who underwent placement of the HeRO device between September 2009 and November 2010. Patients' demographics, access history, HeRO patency, and number of reinterventions were analyzed. Eleven patients underwent 12 HeRO implantations. The average duration of dialysis prior to HeRO placement was 5.55 ± 3.64 years. Primary and secondary patencies at 6 months and 1 year were 36.4% and 54.5% and 9.1% and 45.5%, respectively. In the end-stage renal disease population with central venous occlusive disease, the HeRO device offers the best long-term dialysis option when an arteriovenous fistula or graft is not possible. Close follow-up and subsequent aggressive interventions can prolong the use of the HeRO and avoid the last resort of dialysis catheters.

Percutaneous Interventions on the Hemodialysis Reliable Outflow Vascular Access Device

PurposeTo determine the outcomes of percutaneous interventions for prolonging the patency of the Hemodialysis Reliable Outflow (HeRO) device. Materials and MethodsBetween January 2007 and August 2011, 73 percutaneous interventions were performed on 26 HeRO devices in 25 patients. The graft was implanted in the upper arm with the outflow catheter tip in the superior vena cava or right atrium. Procedural reports, angiographic images, and clinical notes were retrospectively reviewed. The primary and secondary patency rates after intervention were calculated using the Kaplan-Meier method. ResultsThe mean time from HeRO implantation to initial dysfunction or thrombosis was 171 days. In 60 (82%) procedures, the HeRO device was thrombosed. An intragraft stenosis was the most common lesion identified (59%; n = 43) followed by an arterial anastomosis stenosis identified in 18% (n = 13). In 22% (n = 16) of procedures in which the HeRO device was thrombosed, an underlying cause was not identified after thrombectomy. The 3-, 6-, and 12-month primary patency rates after intervention were 47%, 37%, and 26% for first-time interventions. The secondary patency rates were 80%, 70%, and 64%. The only complication was pulmonary embolism resulting in death 2 days after HeRO thrombectomy. ConclusionsPercutaneous interventions on thrombosed and failing HeRO devices yielded acceptable primary and secondary patency rates after intervention in these patients with few, if any, alternatives for hemodialysis access.

Modified use of the Hemodialysis Reliable Outflow (HeRO) graft for salvage of threatened dialysis access

The Hemodialysis Reliable Outflow (HeRO) graft (Hemosphere Inc, Eden Prairie, Minn) offers a new option to provide upper extremity arteriovenous (AV) dialysis access in patients with central venous occlusive disease. Creative use of this device can allow for salvage of failing or threatened AV fistulas and grafts. We present two patients who underwent a modified implantation of the HeRO device for immediate salvage of a malfunctioning AV access. Ipsilateral central venous occlusions were successfully overcome by anastomosing a HeRO device to the existing AV access and tunneled across the chest to the contralateral internal jugular vein.

SS23. Outcomes Comparison of HeRO and Lower-Extremity Arteriovenous Graft in Patients with Long-Standing Renal Failure

The HeRO (Hemodialysis Reliable Outflow) graft is becoming a recognized alternative to Lower Extremity AV Grafts (LEAVG) as an option for patients who have exhausted traditional upper extremity access; however it is unclear which should be applied preferentially. A retrospective review of LEAVG and HeRO implants from January 2006 to August 2010 was performed. Patient demographics, medical history, procedural data and outcomes were evaluated. Within the time periods, 62 HeRO's were placed in 61 patients and 23 LEAVG were placed in 21 patients. Demographics were similar between the two groups for gender, age, BMI, and race. Average follow-up was 14.6 months. The HeRO patients underwent a mean of 6.4 previous TDCs and 3.1 previous AVG/AVFs. The LEAVG patients underwent a mean of 4.1 previous TDCs and 2.8 previous AVG/AVFs. The principal difference was a 1 year primary patency of 26% for the HeRO group and 60% for the LEAVG group (P = .01). The number of interventions to maintain patency was 6.2 per year in the HeRO group and 3.7 per year in the AVG group (P = .40). Secondary patency at 1 year was 61% for the HeRO patients and 66% for the AVG patients (P = .56). The HeRO group and LEAVG had no difference in infection rate (31% vs. 30%) or mortality rate (33% vs 21% respectively) at 1 year. In access challenged patients, LEAVG and HeRO offer a higher incidence of infection, mortality and loss of patency compared to traditional upper extremity access. The LEAVG offers improved primary patency rate over the HeRO device.

Multi-center Experience of 164 Consecutive Hemodialysis Reliable Outflow [HeRO] Graft Implants for Hemodialysis Treatment

ObjectiveTo report a multi-center experience with the novel Hemodialysis Reliable Outflow (HeRO) vascular access graft. Materials and methodsFour centers conducted a retrospective review of end stage renal disease patients who received the HeRO device from implant to last available follow-up. Data is available on 164 patients with an accumulated 2092.1 HeRO implant months. ResultsAt 6 months, HeRO primary and secondary patency is 60% and 90.8%, respectively and at 12 months, 48.8% and 90.8%, respectively. At 24 months, HeRO had a primary patency of 42.9% and secondary patency was 86.7%. Interventions to maintain or re-establish patency have been required in 71.3% of patients (117/164) resulting in an intervention rate of 1.5/year. Access related infections have been reported in 4.3% patients resulting in a rate of 0.14/1000 implant days. ConclusionsIn our experience the HeRO device has performed comparably to standard AVGs and has proven superior to TDCs in terms of patency, intervention, and infection rates when compared to the peer-reviewed literature. As an alternative to catheter dependence as a means for hemodialysis access, this graft could reduce the morbidity and mortality associated with TDCs and have a profound impact on the costs associated with catheter related infections and interventions.

Hemodialysis Reliable Outflow (HeRO) device in end-stage dialysis access: a decision analysis model

BackgroundThe Hemodialysis Reliable Outflow (HeRO) dialysis access device is a permanent tunneled dialysis graft connected to a central venous catheter and is used in patients with end-stage dialysis access (ESDA) issues secondary to central venous stenosis. The safety and effectiveness of the HeRO device has previously been proven, but no study thus far has compared the cost of its use with tunneled dialysis catheters (TDCs) and thigh grafts in patients with ESDA. Materials and methodsA decision analytic model was developed to simulate outcomes for patients with ESDA undergoing placement of a HeRO dialysis access device, TDC, or thigh graft. Outcomes of interest were infection, thrombosis, and ischemic events. Baseline values, ranges, and costs were determined from a systematic review of the literature. Total costs were based on 1year of post-procedure outcomes. Sensitivity analyses were conducted to test model strength. ResultsThe HeRO dialysis access device is the least costly dialysis access with an average 1-year cost of $6521. The 1-year cost for a TDC was $8477. A thigh graft accounted for $9567 in a 1-year time period. ConclusionsThe HeRO dialysis access device is the least costly method of ESDA. The primary determinants of cost in this model are infection in TDCs and leg ischemia necessitating amputation in thigh grafts. Further study is necessary to incorporate patient preference and quality of life into the model.

Modified Use of the HeRO Device for Immediate Salvage of a Threatened Dialysis Graft

The Hemodialysis Reliable Outflow (HeRO) device provides an additional access option for hemodialysis in patients with central venous occlusions. The HeRO device is a subcutaneously tunneled dialysis access device comprised of a standard 6mm ePTFE graft coupled to a nitinol reinforced 5mm venous outflow component. Standard placement involves tunneling the venous outflow component to the right atrium via the internal jugular vein and anastamosing the graft component to the brachial artery. This case illustrates a modified technique, employing the device for immediate salvage of a malfunctioning upper extremity dialysis graft with ipsilateral central venous occlusion. We report successful salvage of a failing arteriovenous graft by utilizing a HeRO device anastomosed to the graft and tunneled to the contralateral internal jugular vein. A 69-year-old male on hemodialysis for five years presented complaining of right upper extremity edema and pain worsened during hemodialysis. His dialysis access consisted of a right upper extremity 4-7 mm tapered brachio-axillary arteriovenous ePTFE graft (AVG) created two years prior to this admission (Figure, AVG). He had previously undergone a left basilic vein transposition and left brachio-axillary graft with subsequent removal of the graft due to infection. Despite adequate flow rates through the existing dialysis graft, his symptoms prompted a diagnostic fistulogram that demonstrated a patent right axillary vein (Figure, AXV), and occlusion of the right subclavian vein. Endovascular attempts at recanalization of the subclavian vein were unsuccessful. Central venography from a femoral vein approach demonstrated a right internal jugular vein occlusion, but patent superior vena cava, left innominate vein, and left internal jugular vein. Using ultrasound, the left internal jugular vein was accessed and a wire was passed into the right atrium under fluoroscopy. After establishing central venous access to the superior vena cava, the venous outflow component of the HeRO device was introduced following serial dilation of the tract. The device was then tunneled subcutaneously along the anterior chest wall to a counter incision at the right (contralateral) deltopectoral groove where the 6mm HeRO ePTFE graft was coupled to the venous outflow component (Figure, arrow). A 2.5 cm incision was made at the distal (venous) end of the AVG, and the HeRO ePTFE graft was further tunneled from the coupler incision site to the AVG incision site. The new ePTFE-HeRO system was finally anastamosed in end-to-side fashion to the AVG. A completion fistulogram was performed through the fistula, which revealed brisk flow via the HeRO, into the central venous system and right atrium (Figure, composite fistulogram). Dialysis was instituted the following day with flow rates of approximately 400 ml/min. The patient has successfully continued hemodialysis via his HeRO device for eight months without complications and with relief of his preoperative symptoms. This unique approach with the HeRO device allows graft salvage with immediate use while obviating the need for complex surgical reconstruction for dialysis access.

Conversion of Tunneled Hemodialysis Catheter into HeRO Device Can Provide Immediate Access for Hemodialysis

Patients with central venous occlusion who are ''tunneled catheter dependent'' are a challenge for hemodialysis access. A relatively new option for them is the hemodialysis reliable outflow (HeRO) device that can be totally implanted subcutaneously. However, patients still require a tunneled hemodialysis catheter that is used until the HeRO device is mature, 4 to 6 weeks later. Here, we describe a conversion of an existing tunneled hemodialysis catheter into a HeRO device, which was combined with a ''self-sealing'' Flixene graft. This allowed almost immediate use of the HeRO device without the need for placement of a catheter.

Long‐Term Performance of the Hemodialysis Reliable Outflow (HeRO) Device: The 56‐Month Follow‐Up of the First Clinical Trial Patient

The Hemodialysis Reliable Outflow (HeRO) Vascular Access Device is a novel long-term subcutaneous dialysis graft, ideally suited for catheter-dependent patients and patients dialyzing with failing fistulas or grafts due to venous outflow stenosis. This case presentation depicts the clinical course of the first patient to enter a Food and Drug Administration approved clinical trial and receive the HeRO device. The course of this patient over 56 months of follow-up provides the longest experience with the HeRO device to-date. In this patient, the HeRO device provided long-term dialysis access patency in conjunction with adequate dialysis and a low intervention rate.

Percutaneous Endovascular Management of Occluded HeRO Dialysis Access Device

The Hemodialysis Reliable Outflow (HeRO) device is a novel alternative for dialysis access in patients with no suitable veins in the upper extremities. We placed a HeRO device in a 67-year-old woman with end-stage renal disease and 2 months later, it was being used for hemodialysis. After 1 month of uneventful use, the device thrombosed and it was rescued with a percutaneous endovascular approach. The device remains patent 6 months after the intervention.

Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients

The effects of a new long-term subcutaneous vascular access device were studied in access-challenged patients who were poor candidates for fistulas or grafts due to venous obstruction. Bacteremia rates, patency, and function of the Hemodialysis Reliable Outflow (HeRO) Vascular Access Device (Hemosphere Inc, Minneapolis, Minn) were evaluated. The HeRO device consists of a 6-mm expanded polytetrafluoroethylene graft attached to a 5-mm nitinol-reinforced silicone outflow component designed to bypass venous stenoses and enter the internal jugular vein directly, providing continuous arterial blood flow into the right atrium. The HeRO device was studied in a multicenter clinical trial to test the hypothesis that access-challenged patients would experience a statistically significant reduction in bacteremia rates compared with a tunneled dialysis catheter (TDC) literature control of 2.3/1000 days. HeRO-related bacteremia rates, adequacy of dialysis, patency, and adverse events were analyzed. The HeRO device was implanted in 36 access-challenged patients who were followed for a mean 8.6 months (9931 HeRO days). The HeRO-related bacteremia rate was 0.70/1000 days. All HeRO-related bacteremias occurred during the bridging period when a TDC was still implanted before HeRO graft incorporation. HeRO adequacy of dialysis (mean Kt/V) was 1.7. HeRO primary patency was 38.9%, and secondary patency was 72.2%. In access-challenged patients, a statistically significant reduction in HeRO-related bacteremia was noted compared with TDC literature. The device had similar function and patency compared with conventional arteriovenous graft literature.