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通过稳定化和出口部位管理减少传动系统创伤:多中心RESIST研究的30天可行性结果

Reduce Driveline Trauma Through Stabilization and Exit Site Management: 30 Days Feasibility Results from the Multicenter RESIST Study.

作者信息

Stahovich Marcia, Sundareswaran Kartik S, Fox Sarah, Hallinan William, Blood Peggy, Chen Leway, Pamboukian Salpy V, Chinn Raymond, Farrar David J, Pagani Francis D, Blue Laura

机构信息

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.

出版信息

ASAIO J. 2016 May-Jun;62(3):240-5. doi: 10.1097/MAT.0000000000000374.

Abstract

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.

摘要

经皮导线管理套件(PLMK)是为HeartMate 2(HM2)左心室辅助装置(LVAD)开发的,旨在减少出口部位的创伤并维持清洁环境。通过稳定和出口部位管理减少驱动线创伤(RESIST)是一项多中心、前瞻性、非随机研究,旨在评估PLMK管理HM2驱动线出口部位的可行性。5个中心共纳入50例患者,中位时间为HM2植入术后495天;92%(50例中的46例)的患者使用PLMK至少30天。与各中心的标准护理相比,在30天时,更多患者认为PLMK极其舒适(80%对37%,p<0.001),并且在稳定驱动线方面极其有效(82%对40%,p<0.001)。使用PLMK的患者中,85%的患者换药频率为6 - 7天或更高。3例患者在使用PLMK期间发生驱动线感染(6%,每位患者每年0.15次事件),35例患者在6个月后继续使用PLMK。PLMK易于使用,可提高患者舒适度,并以6 - 7天的换药频率提高驱动线稳定性。

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