Lovenox

Lovenox^® and Clexane^®, the innovator versions of enoxaparin marketed in the U.S. and Europe were purchased from Sanofi-Aventis (Bridgewater, NJ). Generic versions of Lovenox^® were provided by three different manufactures (three current lots of each). Online hydrophilic interaction chromatography (HILIC) Fourier transform mass spectrometry (FTMS) was performed as previous described [4 (link)]. Briefly, enoxaparin injections were diluted into 1 μg/μL and directly injected into a HILIC column (2.0 mm × 150 mm, 200 Å, Phenomenex, Torrance, CA) by an Agilent 1200 autosampler. The LC column was directly connected online to the standard ESI source of LTQ-Orbitrap XL FT-MS (Thermo Fisher Scientific, San-Jose, CA). The enoxaparin intact chain compositions were analyzed under the negative mode. Following raw data acquisition, charge deconvolution was auto-processed using DeconTools [14 –15 (link)] software. Enoxaparin structural assignment was performed by automatic processing with GlycReSoft 1.0 software, developed at Boston University (http://code.google.com/p/glycresoft/downloads/list) [4 (link),12 (link)]. The output on enoxaparin composition from GlycReSoft was then processed using GlycCompSoft to provide automated relative quantification of intact chains present in enoxaparin.

The post-operative course in the ICU included deep vein thrombosis (DVT) prophylaxis by enoxaparin (Lovenox^®, Sanofi, USA), 30 mg twice daily starting within 24–48 h of admission, and screening by duplex ultrasound for venous thromboembolism (VTE). When needed, patients had early tracheostomy for ventilator support and percutaneous gastroenterostomy for nutrition. When fully weaned from ventilator support, the patients were transferred to rehabilitation centers. While in the ICU, daily neurological examination including digital rectal examination was performed to determine ASIA motor score and evidence for AIS grade conversion. Following discharge, the patients returned at 6 weeks, 3 months, 6 months, and 12 months (or longer) for follow-up neurological examinations. Certified neurologists, rehabilitation specialists, the principal investigator, senior residents, and nurse practitioners performed neurological examinations to document any change in ASIA motor score and AIS grade conversion.^{18 (link),35 (link)}

All patients accepted a weight-based (1 mg/kg) twice-a-day regimen of LMWH (Lovenox; Sanofi, Paris, France) before and after CDT. During CDT, for the sub-TPDA group, LMWH were given at a fixed-dose of 40 mg every 12 h, while the TPDA group was administered the same weight-based (1 mg/kg) twice-a-day regimen.

This is a two-center retrospective analysis of 250 consecutive patients with end-stage heart failure undergoing either HVAD (HeartWare International Inc., Framingham, MA), HeartMate II or HeartMate III (Abbott Corporation; Plymouth, MN) LVAD implantation between January 2017 and December 2018 at The University of Kansas Health System in Kansas City, Kansas and at Ascension St. Vincent in Indianapolis, Indiana. Patients were stratified according to the anticoagulation strategy used in enoxaparin (Lovenox; Sanofi) or UFH groups and timing of bridging (index hospitalization [immediate postoperative] vs within 3-months follow-up [early postoperative]). Patients were bridged with LMWH either on index admission, during the 3 month follow up period (should that have been required) or both. Patients with suspected or confirmed heparin induced thrombocytopenia were excluded from the study. Patients were followed daily in the inpatient setting and in planned clinic visits per each institution protocol post LVAD implantation. Data were collected in a retrospective manner from KUMC and St. Vincent prospective LVAD registries and supplemented by chart review of patients’ electronic medical records.