NN&I - August 2010

Vascular Access August 2010 Nephrology News & Issues 33Subscribe to our free eNewsletter at www.nephronline.com infection rate (0.38 per 1,000 patient days) was significantly lower than the literature reported rate of infections associated with the use of hemodialysis catheters (2.3 per 1,000 patient days).3 These results are consistent with previ -ous reports of reduced infection rates associated with the use of the HeRO device compared to catheters, and rep-resents an 83% reduction in infectious complications compared to the litera -ture reported infection rate for hemo -dialysis catheters. It is important to note that the data from this survey should be viewed with some caution due to the non-scientific manner in which it was collected. The intent of this survey was not to replace evidence-based data collected from prospective studies but to supplement spontaneously reported post-market performance issues associated with the HeRO device to aid in the identification of opportunities to improve device per -formance and safety. Conclusion The results of our customer survey suggest that the post-market perfor -mance of the HeRO device is associated with complication rates no greater than what was reported in the initial clini-cal registration studies for the device. Over half of the patients included in the survey did not experience a single device performance issue. Similar to AV grafts, device occlusion was the Device performance issues (number of patients affected)Occlusion (n=18) Infection (n=4) Bleeding/cannulation issue (n=3) Steal syndrome (n=1) Low arterial flow (n=1) Nerve damage (n=1)TABLE 3 Factors which potentially contribute to occlusions of the HeRO deviceHypotension during and post \037dialysisA history of clotted accesses \037 Incomplete thrombus removal in \037previous thrombectomies A small brachial artery (e.g., less \037than 3 mm) Insufficient arterial inflow or \037inflow stenosis A coagulability disorder \037 Inadequate anticoagulation \037therapy A kinked graft mechanical com \037pression (i.e., spring loaded hemostatis stasis clamps) Intra-graft stenosis at site of \037repeated puncturesTABLE 4most commonly reported performance issue associated with the HeRO device. The rate of occlusions reported in this survey was less than what has been reported in published studies with the device. Acknowledgements Special thanks to Michelle Girsch, RN, Peggy Crowley, and Toni Golden, RN, without whose assistance this proj-ect would not have been possible. References1. FDA Center for Devices and Radiologic Health, Ensuring the Safety of Marketed Medical Devices: CDRH's Medical Device Postmarket Safety Program; 2006 2. Nassar G. The HeRO device versus conventional arteriovenous grafts in dialysis patients (abstract). American Society of Diagnostic and Interventional Radiology 6th Annual Meeting, Orlando, Fla.; 2010 3. Katzman HE, McLafferty RB, Ross JR, Glickman MH, Peden EK, Lawson JH. Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. J Vasc Surg 50:600-7, 2009 4. Bryant J, Husum K, Miller M, Smith TP, Kim CY, et al. Preliminary experience with percutane- ous interventions on thrombosed "HeRO" arterio-venous grafts. Society for Interventional Radiology Annual Scientific Meeting, Tampa, Florida; 2010 able to determine the readiness of the fistula as well as develop a can-nulation plan that can be communi -cated to the dialysis center. NN&I: Do you have a vein preserva -tion program? Lee: Yes. My rule is IV access and phlebotomy should be performed in the arm opposite the one planned for vascular access. The patients should be educated about this as well. Furthermore, I think to make a greater impact, hospitals need edu-cation programs discouraging the use of PICC lines in advanced CKD patients by emphasizing that dialy -sis access will be the future lifeline for these patients. NN&I: What data will you track? Lee: The percentage of incident patients initiating hemodialysis with a fistula; time from referral from the nephrologist to the surgeon, and time to fistula creation; and time from the fistula creation to start of hemodialysis. We will also study the GFR when vessel mapping occurs and when surgery occurs. We will also look at fistula type and second-ary interventions per patient access. [ DR. LEE INTERVIEW , continued from page 29 ] VascularAccess_0810_14.indd 33 7/16/10 3:37:46 PM