Reduce Driveline Trauma Through Stabilization and Exit Site Management: 30 Days Feasibility Results from the Multicenter RESIST Study.
The percutaneous lead management kit (PLMK) was developed 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 StabIlization 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 driveline (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 comfort, and increases driveline stability with a dressing change frequency of 6-7 days.
From the *Mechanical Circulatory Support Department, Sharp Memorial Hospital, San Diego, California; †Research and Scientific Affairs, Thoratec Corporation, Pleasanton, California; ‡Center for Circulatory Support, Department of Cardiac Surgery, University of Michigan Hospital 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 Birmingham, Birmingham, Alabama; ‖Department of Cardiology, University of Rochester Medical Center, Rochester, New York; and #Duke Surgery, Duke University School of Medicine, Durham, North Carolina.
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Kartik S
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Pamboukian
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D000328:Adult; D005260:Female; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016459:Prosthesis-Related Infections / Q000209:etiology / Q000517:prevention & control*; D012648:Self Care / Q000295:instrumentation* / Q000379:methods