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Postmarket Experience With HeartMate 3 Left Ventricular Assist Device: 30-Day Outcomes From the ELEVATE Registry

Wednesday, January 30, 2019

Submitted by

Claire Vernon

Source

Source Name: The Annals of Thoracic Surgery

Source URL: https://doi.org/10.1016/j.athoracsur.2018.07.092

Author(s)

Jens Garbade, Finn Gustafsson, Steven Shaw, Jacob Lavee, Diyar Saeed, Yuriy Pya, Thomas Krabatsch, Jan D. Schmitto, Michiel Morshuis, Joyce Chuang, Daniel Zimpfer

Garbade and colleagues compared outcomes reported during the European Conformity (CE) Mark clinical trial of the HeartMate 3 left ventricular assist device (LVAD) to outcomes for patients treated since the device came to market. Patients treated after device approval, from the ELEVATE registry, were more severely ill, were older, and underwent more concomitant valve procedures than those treated in the CE Mark trial. After adjusting for baseline differences between the groups, the authors found comparable 30-day survival. Rates of bleeding, infection, and stroke were also similar between the two groups, and no instances of pump thrombosis were recorded.