Jeffrey J Teuteberg1, Joseph C Cleveland2, Jennifer Cowger3, Robert S Higgins4, Daniel J Goldstein5, Mary Keebler6, James K Kirklin7, Susan L Myers8, Christopher T Salerno9, Josef Stehlik10, Felix Fernandez11, Vinay Badhwar12, Francis D Pagani13, Pavan Atluri14. 1. Division of Cardiovascular Medicine, Department of Medicine, Stanford University, Stanford, California. Electronic address: jeff.teuteberg@stanford.edu. 2. Division of Cardiothoracic Surgery, Department of Surgery, University of Colorado, Aurora, Colorado. 3. Division of Cardiovascular Medicine, Department of Medicine, Henry Ford Hospitals, Detroit, Michigan. 4. Department of Surgery, Johns Hopkins University, Baltimore, Maryland. 5. Department of Cardiothoracic and Vascular Surgery, Montefiore Hospital, Bronx, New York. 6. Cardiovascular Institute, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. 7. Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama. 8. James and John Kirklin Institute for Research in Surgical Outcomes, University of Alabama at Birmingham, Birmingham, Alabama. 9. Department of Cardiothoracic Surgery, St. Vincent Heart Center of Indiana, Indianapolis, Indiana. 10. Division of Cardiovascular Medicine, Department of Medicine, University of Utah, Salt Lake City, Utah. 11. Division of Cardiovascular Surgery, Department of Surgery, Emory University, Atlanta, Georgia. 12. Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, West Virginia. 13. Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan. 14. Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania.
Abstract
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.
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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