Abstract 15087: First Clinical Trial in China to Evaluate the Efficacy and Safety of Moyoassist® Extra-VAD System

Abstract

Cardiogenic shock(CS)is associated with significant morbidity and mortality. For patients unresponsive to medicinal treatment, an alternative is a mechanical circulatory support (MCS) system. In China, common treatments using short-term MCS include IABP and VA-ECMO, both methods found their limitations. Therefore, a better strategy must be proposed to improve prognosis in CS patients, such as extracorporeal VAD (Extra VAD). Here, we reported 40 patients' data collected from a prospective, multicenter, single group clinical trial conducted from July 2021 to Feb 2023, which aims to evaluate the efficacy and safety of MoyoAssist® Extra-VAD system. MoyoAssist® is developed based on fully magnetically levitated pump technology to temporarily support the left, right, or biventricular circulation of patients with acute heart failure and cardiogenic shock of all causes. Patients were recruited for various indications, with PCCS (50%) and BTT (32.5%) being the top two causes. A combination of median sternotomy (22.5%), peripheral venous cannulation (52.5%) and mini-incision (25%) were employed to implant the device. Especially, jugular vein cannulation was a pioneering approach proposed to enable patients’ early ambulation and recovery. MoyoAssist® Extra-VAD has demonstrated stable and sufficient circulation support without severe device associated adverse events. The mean support duration was 7d16hrs, and overall survival rate at 30-day follow up was 62.5%. Hemodynamics indicated improvement with increased MAP and reduced CVP in all sub-groups. Lactate has shown a significant decrease in the PCCS-survival group (3.95 vs. 1.05, p<0.05), indicating improved reperfusion of organ tissues. While AST has shown a significant drop in the BTT-survival group (67.10 vs. 56.17, p<0.05), indicating improved liver function. During the support, 3 patients with peripheral cannulation and 2 patients with mini-incision were able to ambulate early. The types of complication seen were similar to those reported with CentriMag, but the rates of bleeding (15%) and hemolysis (0%) were much lower. In conclusion, MoyoAssist® Extra-VAD has demonstrated its safety and efficacy for short-to-mid-term support of patients with acute heart failure and cardiogenic shock.