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Advanced heart failure is characterized by profound limitations in survival, functional status, and quality of life despite treatment with evidence-based therapies.1 Left ventricular assist devices (LVADs) offer patients with this condition a therapeutic option that provides circulatory support while they are awaiting heart transplantation or that can serve as a permanent alternative to transplantation (i.e., “destination therapy”).
The Food and Drug Administration (FDA) approved one continuous-flow LVAD with an axial-flow design for destination therapy after outcomes with the device were shown to be superior to those with older, pulsatile LVAD technology.2 Despite the efficacy of the approved axial-flow LVAD, adverse events still lead to substantial morbidity and mortality and represent an unmet need for the development of long-term support devices that have improved efficacy and safety.3,4
We report the results of a randomized clinical trial evaluating outcomes in patients who were ineligible for heart transplantation and were treated with either the FDA-approved axial-flow device or a centrifugal-flow LVAD that is smaller (50-cc displacement, vs. 65-cc displacement for the axial-flow device), lies entirely within the pericardial space, and incorporates a bearingless design with magnetic and hydrodynamic levitation of the internal rotor.5,6
Methods
Trial Objective and Organization
The purpose of the ENDURANCE trial was to assess the safety and effectiveness of the centrifugal-flow LVAD relative to those of a control, axial-flow LVAD in patients with advanced heart failure. The trial was designed by the sponsor (HeartWare) in consultation with FDA and clinical investigators. The trial was conducted at 48 U.S. sites (a list is provided in the Supplementary Appendix, available with the full text of this article at NEJM.org) and was supervised by the sponsor and an independent clinical research organization (ICON) that was paid by the sponsor. ICON managed the electronic data-capture system, conducted all statistical analyses of the primary end point, and provided the final data listings. Coordinators at each site captured all trial data electronically. The sponsor had access to the safety data that were required for regulatory monitoring. The authors had unrestricted access to the data and attest to the completeness and accuracy of the data and to the fidelity of the trial to the protocol, which is available at NEJM.org. A data and safety...