Copyright © American Society of Artificial Internal Organs. Unauthorized reproduction of this article is prohibited. 240 ASAIO Journal 2016 Adult Circulatory Support The percutaneous lead management kit (PLMK) was devel- oped for the HeartMate 2 (HM2) left ventricular assist device (LVAD) to reduce trauma at the exit site and to maintain a clean environment. REduce Driveline Trauma through StabIli- zation and Exit Site ManagemenT (RESIST) was a multicenter, prospective, nonrandomized study designed to evaluate the feasibility of the PLMK for managing the HM2 driveline exit site. Fifty patients were enrolled at five sites at a median of 495 days post-HM2 implant; 92% (46 of 50) of patients used the PLMK for a minimum of 30 days. At 30 days, more patients found the PLMK to be extremely comfortable (80% vs. 37%, p < 0.001) and extremely effective at stabilizing the drive- line (82% vs. 40%, p < 0.001) compared with each center’s standard of care. Frequency of dressing changes was 6–7 days or higher for 85% of the patients with PLMK. Three patients developed driveline infection while on PLMK (6%, 0.15 events per patient year), and 35 patients continued to use the PLMK after 6 months. The PLMK is easy to use, increases patient com- fort, and increases driveline stability with a dressing change frequency of 6–7 days. ASAIO Journal 2016; 62:240–245. Key Words: driveline infection, exit site trauma, driveline stabilization, percutaneous lead Durable circulatory support with a continuous-flow left ven- tricular assist device (LVAD) provides survival and quality-of- life benefits for patients with advanced heart failure. During the past decade, clinical studies have demonstrated progressive improvement in outcomes for patients supported by continuous- flow LVADs partially because of a decline in adverse events. 1–3 However, infection, bleeding, and stroke are potentially lethal complications that continue to limit the overall effectiveness of the therapy. In LVAD patients, preoperative debilitation, exten- sive surgery for device implantation, and frequent hospitaliza- tions are features that predispose to complications, particularly infection. The risk of infection is highest in the early postop- erative time; but the risk continues throughout the course of support because of the presence of the percutaneous driveline that powers the LVAD pump. 4 Continued improvements in sur- vival and quality-of-life outcomes for LVAD-supported patients necessitate further reduction in device-related infections. The driveline exit site is the most susceptible to infection and is the most often precipitated by trauma to the tissue surround- ing the site. 5 For outpatients, suboptimal self-care or trauma at the driveline exit site commonly results in an infection that requires rehospitalization for diagnostic studies, intensive anti- biotic therapy, or, in some case, the need for surgical inter- vention. Driveline stabilization and exit site management are paramount in the prevention of driveline infections. Many cen- ters have devised custom techniques to protect and to keep the exit site clean. However, driveline infections continue to be a major source of morbidity and mortality in both destination therapy (DT) 3,6 and bridge-to-transplantation patients. 7–9 The goal of developing the percutaneous lead management kit (PLMK) was to minimize movement of the driveline and to maintain a clean environment at the exit site, that is comfort- able and easy to use. This feasibility study was conducted to evaluate the comfort and ease of use of the PLMK in a group of patients undergoing long-term LVAD support. Long-term effects on driveline infection were not the goal of this study and have to be evaluated in a separate study. Materials and Methods Percutaneous Lead Management Kit The PLMK was intended to be convenient, comfortable, and easy to use for driveline stabilization and infection mitigation for the HeartMate 2 (HM2; Thoratec Corporation, Pleasanton, CA) LVAD. Each patient was provided with sufficient kits (free of cost) to last the entire study duration (6 months). Ventricular assist device (VAD) coordinators instructed patients and their caregivers on the procedures for driveline care and the use of the PLMK. The kit is composed of commercially available products that are packaged together to be used by the patient or their caregivers for driveline exit site management in the Reduce Driveline Trauma Through Stabilization and Exit Site Management: 30 Days Feasibility Results from the Multicenter RESIST Study MARCIA STAHOVICH,* KARTIK S. SUNDARESWARAN,† SARAH FOX,‡ WILLIAM HALLINAN,§ PEGGY BLOOD,¶ LEWAY CHEN,║ SALPY V. PAMBOUKIAN,¶ RAYMOND CHINN,* DAVID J. FARRAR,† FRANCIS D. PAGANI,‡ AND LAURA BLUE# Copyright © 2016 by the American Society for Artificial Internal Organs DOI: 10.1097/MAT.0000000000000374 From the *Mechanical Circulatory Support Department, Sharp Memo- rial Hospital, San Diego, California; †Research and Scientific Affairs, Thoratec Corporation, Pleasanton, California; ‡Center for Circulatory Support, Department of Cardiac Surgery, University of Michigan Hos- pital and Health Systems, Ann Arbor, Michigan; §Division of Cardiac Surgery, University of Rochester Medical Center, Rochester, New York; ¶Division of Cardiovascular Disease, University of Alabama at Birming- ham, Birmingham, Alabama; ║Department of Cardiology, University of Rochester Medical Center, Rochester, New York; and #Duke Surgery, Duke University School of Medicine, Durham, North Carolina. Submitted for consideration July 13, 2015; accepted for publication in revised form March 7, 2016. Disclosure: RESIST was sponsored by Thoratec Corporation. Marcia Stahovich: Consultant, Thoratec Corporation; Kartik S. Sundareswaran: Employee, Thoratec Corporation; Leway Chen: Speaker Honorarium, Thoratec Corporation; David J. Farrar: Employee, Thoratec Corpora- tion; Laura Blue: Consultant, Thoratec Corporation, HeartWare. The other authors have no conflicts of interest to report. Correspondence: Kartik S. Sundareswaran, PhD, Research and Sci- entific Affairs, Thoratec Corporation, 6035 Stoneridge Drive, Pleasan- ton, CA. Email: KSundareswaran@thoratec.com.