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

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.

Improving quality of life and decreasing readmissions in heart failure patients in a multidisciplinary transition-to-care clinic.

OBJECTIVES: The purpose was to pilot the feasibility and impact of a 4-week transition-to-care program on quality of life for heart failure patients. BACKGROUND: The transition from the acute care to the outpatient setting has been shown to be a critical time with heart failure patients. METHODS: A pre- and post-test design was used. Quality of Life, measured by the Minnesota Living with Heart Failure Questionnaire, and hospital readmissions were the outcomes. A convenience sample of 50 persons was recruited into a multidisciplinary transition-to-care program for heart failure patients following hospitalization. Thirty-six (72%) completed the study. RESULTS: There was a significant improvement in quality of life. Men reported greater improvement in physical symptoms and less emotional distress when compared to women. Only 2 participants were readmitted within 30 days. CONCLUSIONS: Study findings support improved quality of life and decreased readmission rates following a multidisciplinary transition-to care program for heart failure patients.