TY - JOUR
T1 - The Society of Thoracic Surgeons Intermacs 2019 Annual Report
T2 - The Changing Landscape of Devices and Indications
AU - Teuteberg, Jeffrey J.
AU - Cleveland, Joseph C.
AU - Cowger, Jennifer
AU - Higgins, Robert S.
AU - Goldstein, Daniel J.
AU - Keebler, Mary
AU - Kirklin, James K.
AU - Myers, Susan L.
AU - Salerno, Christopher T.
AU - Stehlik, Josef
AU - Fernandez, Felix
AU - Badhwar, Vinay
AU - Pagani, Francis D.
AU - Atluri, Pavan
N1 - Funding Information:
The authors would like to acknowledge all the centers who participate in the STS Intermacs Database and their efforts collecting and entering data. They would also like to acknowledge the Data Coordinating Center at the Kirklin Institute for Research in Surgical Outcomes at the University of Alabama, Birmingham, for its assistance in preparing the data, performing the statistical analysis, and creating the resulting tables and figures. Lastly, they would like to acknowledge the National Heart, Lung, and Blood Institute through their contract #HHSN268200548198C , which provided support from 2006 and 2017, without which the database would not have been possible. James K. Kirklin is the Director of the Data Coordinating Center for the STS Intermacs Registry.
PY - 2020/3
Y1 - 2020/3
N2 - Background: The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system. Methods: Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices. Results: Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P < .001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P < .001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P < .001). Conclusions: Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution.
AB - Background: The field of mechanical circulatory support has been impacted by the approval of new continuous-flow left ventricular assist devices (LVADs) and changes to the United States heart allocation system. Methods: Primary isolated continuous-flow LVAD implants in The Society of Thoracic Surgeons Intermacs registry from January 2014 through September 2019 were evaluated. Survival and freedom from major adverse events were compared between axial-flow, centrifugal-flow with hybrid levitation (CF-HL), and centrifugal-flow with full magnetic levitation (CF-FML) devices. Results: Of 2603 devices implanted in 2014, 1824 (70.1%) were axial flow and 1213 (46.6%) were destination therapy (DT); through September 2019, 1752 devices were implanted, but only 37 (2.1%) were axial flow and 1230 (70.2%) were DT. Implants were performed in 13,016 patients between 2014 and 2018. Patients receiving implants in 2017-2018 compared with 2014-2016 were more likely to be at Intermacs profile 1 (17.1% vs 14.3%, P < .001) and to have preimplant temporary mechanical circulatory support (34.8% vs 29.3%, P < .001). Overall survival and freedom from major adverse events were higher with CF-FML devices. In multivariable analysis of survival between CF-HL and CF-FML, device type was not a significant early hazard, but the use of CF-HL devices had a late hazard ratio for death of 3.01 (P < .001). Conclusions: Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy. While outcomes with CF-FML devices are promising, comparisons with other devices from nonrandomized registry studies should be made with caution.
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U2 - 10.1016/j.athoracsur.2019.12.005
DO - 10.1016/j.athoracsur.2019.12.005
M3 - Article
C2 - 32115073
AN - SCOPUS:85080053084
VL - 109
SP - 649
EP - 660
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
SN - 0003-4975
IS - 3
ER -