NN&I - August 2010

Vascular Access August 2010 Nephrology News & Issues 31Subscribe to our free eNewsletter at www.nephronline.com Introduction Physicians and hospitals are encour -aged to voluntarily report adverse events and other information related to the quality, effectiveness, and safety of FDA-regulated products to the man-ufacturer. These reports allow compa -nies to assess device performance and, if warranted, implement potential edu -cational initiatives and design chang -es to address any performance issues. Since these reporting systems are spon-taneous by nature, under-reporting of events remains a common problem.1 The HeRO device (see sidebar for description) is a vascular access alternative for chronic hemodialysis patients who have exhausted reason -able peripheral venous access sites suitable for fistulas or grafts, and are therefore often high-risk patients with multiple comorbidities. As a result, a high number of adverse events would be expected in this population. In order to determine how the device was per -forming in the field, in addition to what was already being reported, we proac-tively initiated a customer survey for post-market surveillance data. The clinical efficacy of the HeRO device has been documented by two multicenter, prospective studies. The initial study was a randomized clini -cal trial comparing the HeRO device to conventional ePTFE grafts in a graft-eligible patient population.2 This study reported that the use of the HeRO device was equivalent to ePTFE grafts in terms of dialysis adequacy, primary patency, secondary patency, rates of intervention, and adverse events at 12 months. The time to loss of second-ary patency, however, was significantly improved (HeRO group vs. the control group, 238.0 vs. 102.5 days respectively; p = 0.032). The second study was a non-ran-domized clinical trial of the HeRO device that compared dialysis adequa -cy, bacteremia rates, patency, and the need for interventions using prospec -tive data for the HeRO device and liter -ature reported rates for tunneled dialy -sis catheters.3 The bacteremia rate for the HeRO device during this study (0.7 per 1,000 patient days) was significant -ly lower than catheter-related infec -tion rates reported in the literature (2.3 per 1,000 patient days). All HeRO device-related bacteremias occurred while a bridging catheter was in place. Adequacy of dialysis for the HeRO Information collected for surveyDate device was implanted \037 Date of last follow-up or last use \037 of device Current patient status \037 - Still dialyzing via HeRO device - Dialyzing via alternative vascular access option - Deceased Device-related performance \037TABLE 2together subcutaneously with a titanium connector via a counter incision at the del-topectoral groove. The HeRO device has been classified as a graft by the FDA and is cannulated in the same manner as a conventional ePTFE graft. device (mean Kt/V = 1.7) was higher than literature reported adequacy for tunneled dialysis catheters. There were no unanticipated safety concerns asso-ciated with use of the HeRO device for long-term vascular access during each of these studies. Survey methodology A telephone survey was conduct -ed to collect quantitative data from dialysis providers caring for patients implanted with the HeRO device as of October 2009. The objective of this survey was to gain additional insight on the post-implant performance of the device. Table 2 lists the information collected as a part of these telephone surveys. The survey was administered to dialysis nurses involved in the care of HeRO patients. The dialysis units and patients were selected at random, and unique patient identifiers were not utilized or recorded as a part of the survey. The desired sample size was 10% of the total patient population that had received the HeRO device when the survey was conducted. Results Thirty-eight dialysis units elected to participate in the survey. These units provided quantitative information for 65 HeRO patients (1.71 patients per dialysis unit), which represented 10% of the 650 patients who had received the FIGURE 1 The HeRO access device VascularAccess_0810_14.indd 31 7/16/10 3:39:36 PM