000			04937nam a22005297a 4500
008			190621s20192019 xxu||||| |||| 00| 0 eng d
022			_a1053-2498
040			_aOvid MEDLINE(R)
099			_a31147187
245			_aEffects of a fully magnetically levitated centrifugal-flow or axial-flow left ventricular assist device on von Willebrand factor: A prospective multicenter clinical trial.
251			_aJournal of Heart & Lung Transplantation. 38(8):806-816, 2019 08.
252			_aJ Heart Lung Transplant. 38(8):806-816, 2019 08.
252			_zJ Heart Lung Transplant. 2019 May 17
253			_aThe Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation
260			_c2019
260			_fFY2020
265			_saheadofprint
265			_sppublish
266			_d2019-06-21
268			_aJournal of Heart & Lung Transplantation. 2019 May 17
520			_aBACKGROUND: Increased shear stress conferred upon the circulation by continuous-flow pumps is associated with hemocompatibility-related adverse events, principally bleeding within the gastrointestinal system, and linked to the degradation of high-molecular-weight multimers (HMWMs) of von Willebrand factor (vWF). We evaluated the structure and functional characteristics of vWF HMWMs in patients with the fully magnetically levitated centrifugal-flow HeartMate 3 (HM3) and the continuous axial-flow HeartMate II (HMII) pump. Findings were correlated with bleeding events.
520			_aCONCLUSIONS: This prospective, multicenter comparative analysis study demonstrates that the fully magnetically levitated centrifugal-flow HM3 left ventricular assist device is associated with greater preservation of the structure of vWF HMWMs than the HMII mechanical bearing axial-flow pump.
520			_aCopyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
520			_aMETHODS: In a prospective, multicenter, comparative cohort study, 60 patients from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 Continued Access Protocol (NCT02892955) with an HM3 pump were compared with 30 randomly selected HMII patients from the PREVENtion of HeartMate II Pump Thrombosis study (NCT02158403) biobank. The primary end point was the difference in the normalized vWF HMWM ratio (ratio of the HMWMs to the intermediate- and low-molecular-weight multimers, normalized to pooled plasma from healthy volunteers) between the HM3 and the HMII pump at 90 days after implantation. Assay tests for vWF activity, vWF antigen, vWF activity to antigen ratio, coagulation factor VIII activity, and ADAMTS13 activity were measured by using standard protocols. Differences in these markers were compared in the context of clinical characteristics and correlated with adjudicated bleeding events within the HM3 group.
520			_aRESULTS: Of 51 and 29 evaluable patients in the HM3 and HMII arms, respectively, those implanted with the HM3 pump exhibited greater preservation of the vWF HMWM ratio than those with the HMII pump at 90 days after implantation (54.1% vs 42.4%, p < 0.0001). Laboratory values for all vWF assays (antigen, activity, and coagulation factor VIII activity) remained within the normal functional range with no significant differences observed between the pumps at 90 days after implantation. At baseline, there was a decrease in the structural integrity of vWF HMWMs that correlated with increasing heart failure severity as measured by the Interagency Registry for Mechanically Assisted Circulatory Support profile. Multivariable modeling identified the HM3 pump as the only independent variable that determined post-implantation preservation of the structural integrity of vWF HMWMs.
546			_aEnglish
650			_a*Heart-Assist Devices
650			_a*von Willebrand Factor/an [Analysis]
650			_aAdult
650			_aAged
650			_aCentrifugation
650			_aFemale
650			_aHumans
650			_aMagnetic Phenomena
650			_aMale
650			_aMiddle Aged
650			_aProspective Studies
650			_aProsthesis Design
650			_aProtein Multimerization
651			_aMedStar Heart & Vascular Institute
657			_aJournal Article
700			_aNajjar, Samer S
790			_aAdler ED, Bansal A, Bhimaraj A, Chen D, Cleveland JC Jr, Colombo PC, Connors JM, Crandall DL, Dembitsky WP, Goldstein DJ, Lanfear DE, Long JW, Mehra MR, Najjar SS, Narisetty K, Somo SI, Stulak JM, Uriel N
856			_uhttps://dx.doi.org/10.1016/j.healun.2019.05.006 _zhttps://dx.doi.org/10.1016/j.healun.2019.05.006 _zhttps://dx.doi.org/10.1016/j.healun.2019.05.006
856			_uhttps://dx.doi.org/10.1016/j.healun.2019.05.006 _zhttps://dx.doi.org/10.1016/j.healun.2019.05.006 _zhttps://dx.doi.org/10.1016/j.healun.2019.05.006
942			_cART _dArticle
999			_c4306 _d4306