NN&I - August 2010

Vascular Access 30 Nephrology News & Issues August 2010Subscribe to our free eNewsletter at www.nephronline.com Results of a customer-based, post-market surveillance survey of the HeRO access deviceBy Maureen Fusselman, RN, MS, CCRPAbstract In order to supplement post-market surveillance data on the HeRO vascu-lar access device, a non-scientific cus-tomer survey was conducted to obtain quantitative data from dialysis provid -ers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were con-tacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the sur -vey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any perfor -mance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-relat -ed performance issue with 18 patients (27.7%) experiencing 25 occlusive epi-sodes. The majority of the patients who had an occlusion (66.7%) only experi-enced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical expe-rience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical stud -ies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published stud-ies with the device. Ms. Fusselman is the Product Evaluation Specialist for Hemosphere, Inc., manufacturers of the HeRO device. The company is based in Eden Prairie, Minn. The HeROThis subcutaneous surgical implant pro-vides arteriovenous access with con-tinuous outflow into the central venous system. The HeRO device received 510(k) clearance from the Food and Drug Administration in January 2008 and, as of February 2010, has been implanted in over 1,000 patients. The device is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted reasonable peripheral venous access sites suitable for fistulas or grafts (see Table 1 for crite-ria for determining if a patient is eligible to be implanted with the HeRO device). The HeRO device is contraindicated for patients who have a brachial artery internal diameter of less than 3 mm, inter -nal jugular or other targeted veins which cannot be dilated to accommodate the device's outflow component, arterial occlu- sive disease that would preclude safe placement of an upper arm graft, known or suspected allergy to device materials, and patients with a known or suspected implantation site or systemic infection, bacteremia, or septicemia. Patients should also not have an ejection fraction that is less than 20% or a systolic blood pressure, which is less than 100 mmHg. The HeRO device is comprised of two components: a standard ePTFE graft and a nitinol-reinforced outflow component (see Figure 1). The ePTFE arterial graft com-ponent is usually placed in the upper arm over the biceps muscle and the venous outflow component is placed in a similar manner to a tunneled dialysis catheter with the distal tip placed in the right atrium (see Figure 2). The two components are brought Patient eligibility criteria for the HeRO vascular access devicePatient is catheter-dependent \037 or is approaching catheter-dependency (i.e., have exhausted all other reasonable access options for AV grafts and fistulas). Patient is not a candidate for \037 upper extremity fistulas or grafts due to poor venous outflow. Patient has a failing fistula or \037 graft due to poor venous outflow. Patient has a compromised \037 central venous system or central venous stenosis.TABLE 1 FIGURE 2 The HeRO device placement VascularAccess_0810_14.indd 30 7/16/10 3:39:23 PM