CLINICAL STUDY Percutaneous Interventions on the Hemodialysis Reliable Outflow Vascular Access Device Thomas A. Gebhard, MD, Joshua A. Bryant, MD, J. Adam Grezaffi, MD, Waleska M. Pabon-Ramos, MD, Shawn M. Gage, PA, Michael J. Miller, MD, Kurt W. Husum, MD, Paul V. Suhocki, MD, David R. Sopko, MD, Jeffrey H. Lawson, MD, PhD, Tony P. Smith, MD, and Charles Y. Kim, MD ABSTRACT Purpose: To determine the outcomes of percutaneous interventions for prolonging the patency of the Hemodialysis Reliable Outflow (HeRO) device. Materials and Methods: Between 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. Results: The 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 ¼ 43) followed by an arterial anastomosis stenosis identified in 18% (n ¼ 13). In 22% (n ¼ 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. Conclusions: Percutaneous 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. ABBREVIATIONS AV = arteriovenous, HeRO = Hemodialysis Reliable Outflow The Hemodialysis Reliable Outflow (HeRO) Vascular Access Device (Hemosphere, Eden Prairie, Minnesota) was approved by the U.S. Food and Drug Administration in April 2008 as a permanent access device for use in patients with renal failure in whom peripheral venous access sites suitable for traditional fistulas or grafts have been exhausted (1). The HeRO device is a standard polytetrafluoroethylene tube graft connected to a nitinol- reinforced silicone catheter for outflow. The catheter out- flow component is inserted into the central venous system with the tip terminating in the right atrium. The device provides continuous arterialized blood flow into the right atrium, forming a completely subcutaneous hybrid arter- iovenous (AV) access graft that bypasses central venous stenoses and the need for a graft-to-vein anastomosis. The HeRO device has a similar incidence of dysfunction and thrombosis compared with standard prosthetic AV grafts (2). However, the venous anastomosis and outflow veins of a prosthetic AV graft are the most frequent sites of stenosis resulting in dysfunction and thrombosis, whereas the HeRO device is continuous to the right atrium without a venous anastomosis (3,4). To date, endovascular main- tenance of HeRO patency has been described only in small case reports (5,6). The purpose of this study was to determine the outcomes of percutaneous interventions for prolonging the patency of the HeRO device. & SIR, 2013 J Vasc Interv Radiol 2013; 24:543–549 http://dx.doi.org/10.1016/j.jvir.2012.12.027 From the SIR 2010 Annual Meeting and SIR 2011 Annual Meeting. J.H.L. and S.M.G. are paid consultants for Hemosphere, Inc. None of the other authors have identified a conflict of interest. From the Division of Vascular and Interventional Radiology (T.A.G., J.A.G., W.M.P.-R., M.J.M., P.V.S., D.R.S., T.P.S., C.Y.K.), Department of Radiology, and Division of Vascular Surgery (S.M.G., J.H.L.), Duke University Medical Center, Box 3808, Duke North, Room 1502, Durham, NC 27710; Advanced Medical Imaging (J.A.B., K.W.H.), Denver, Colorado. Received June 14, 2012; final revision received December 26, 2012; accepted December 30, 2012. Address correspondence to C.Y.K.; E-mail: charles.kim@dm.duke.edu