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The Journal of Heart and Lung Transplantation
International Society for Heart and Lung Transplantation.

COMPETENCE Trial: The EVAHEART 2 continuous flow left ventricular assist device

Published:October 18, 2022DOI:https://doi.org/10.1016/j.healun.2022.10.011

      Background

      Continuous flow left ventricular assist devices have improved outcomes in patients with end-stage heart failure that require mechanical circulatory support. Current devices have an adverse event profile that has hindered widespread application. The EVAHEART®2 left ventricular assist device (EVA2) has design features such as large blood gaps, lower pump speeds and an inflow cannula that does not protrude into the left ventricle that may mitigate the adverse events currently seen with other continuous flow devices.

      Methods

      A prospective, multi-center randomized non-inferiority study, COMPETENCE Trial, is underway to assess non-inferiority of the EVA2 to the HeartMate 3 LVAS when used for the treatment of refractory advanced heart failure. The primary end-point is a composite of the individual primary outcomes: Survival to cardiac transplant or device explant for recovery; Free from disabling stroke; Free from severe Right Heart Failure after implantation of original device. Randomization is in a 2:1 (EVA2:HM3) ratio.

      Results

      The first patient was enrolled into the COMPETENCE Trial in December of 2020, and 25 subjects (16 EVA2 and 9 HM3) are currently enrolled. Enrollment of a safety cohort is projected to be completed by third quarter of 2022 at which time an interim analysis will be performed. Short-term cohort (92 EVA2 subjects) and long-term cohort is expected to be completed by the end of 2023 and 2024, respectively.

      Conclusions

      The design features of the EVA2 such as a novel inflow cannula and large blood gaps may improve clinical outcomes but require further study. The ongoing COMPETENCE trial is designed to determine if the EVA2 is non-inferior to the HM3.

      Keywords

      Abbreviations:

      AC (alternating current), AR (aortic regurgitation), CBP (cardiopulmonary bypass), CF (continuous flow), CSU (cool seal unit), DC (direct-current), DCT (double cuff tipless), EVA1 (EVAHEART1 left ventricular assist device), EVA2 (EVAHEART2 left ventricular assist device), GI (gastrointestinal), HM3 (HeartMate3 left ventricular assist device), l/min (liters per minute), LV (left ventricle), LVAD (left ventricular assist device), ml/kg/min (milliliters per kilogram per minute), NYHA (New York Heart Association), PTFE (polytetrafluorethylene), vWF (von Willebrand Factor), VO2 (maximal oxygen consumption), W (watts)
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