背景:对于需要机械循环支持的终末期心力衰竭患者,持续流动左心室辅助装置改善了预后。当前装置具有阻碍广泛应用的不良事件概况。EVAHEART®2左心室辅助装置(EVA2)具有大的血液间隙、较低的泵速度和不突入左心室的流入套管,可以减轻目前使用其他连续流装置看到的不良事件。
方法:前瞻性,多中心随机非劣效性研究,能力审判,正在评估EVA2用于治疗难治性晚期心力衰竭时对HeartMate3LVAS的非劣效性。主要终点是个体主要结局的复合:心脏移植或装置外植体存活恢复;无致残性中风;植入原始装置后无严重右心衰竭。随机化的比例为2:1(EVA2:HM3)。
结果:首例患者于2020年12月参加了能力试验,目前纳入了25名受试者(16名EVA2和9名HM3)。安全性队列的招募预计将在2022年第三季度完成,届时将进行中期分析。短期队列(92名EVA2受试者)和长期队列预计分别于2023年底和2024年底完成。
结论:EVA2的设计特点,如新型流入套管和大的血液间隙,可能会改善临床结果,但需要进一步研究。正在进行的能力试验旨在确定EVA2是否低于HM3。
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.
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.
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.
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.