Mechanical circulatory support (MCS) is an emerging therapy for acute heart failure (AHF) or cardiogenic shock (CS) patients unresponsive to medicinal treatment. In China, common treatments using short-term MCS include IABP and VA-ECMO, both found their limitations. A complementary strategy shall be proposed to improve patients’ prognosis, such as extracorporeal VAD (Extra VAD). Here, we reported results from a prospective, multicenter, single arm clinical trial involving forty patients conducted from July 2021 to Feb 2023, which aims to evaluate the efficacy and safety of MoyoAssist® Extra-VAD system.

MoyoAssist® is based on magnetically levitated pump technology to temporarily support the left, right or biventricular circulation of AHF and CS patients. Postcardiotomy cardiogenic shock (PCCS)-50% and bridge-to-transplant (BTT)-32.5% were the top indications. Median sternotomy (22.5%), peripheral cannulation (52.5%), and intercostal mini-incision (25%) were employed as cannulation techniques. Notably, jugular vein cannulation was introduced as a pioneering approach to enable patients’ early ambulation and recovery. MoyoAssist® provided stable and sufficient circulation support without severe device-associated adverse events. The mean support duration was 7d16hrs, with 30-day survival rate of 62.5%. Hemodynamic improvements were observed with increased MAP, reduced CVP, significantly decreased lactate (3.95 vs. 1.05, p<0.05), and significantly decreased AST (67.10 vs. 56.17, p<0.05) in the survival group. During the support, three patients with peripheral cannulation and two patients with mini-incision were able to ambulate early.

In conclusion, MoyoAssist® Extra-VAD has demonstrated its efficacy and safety, and potential clinical value for short-to-mid-term support of patients with acute heart failure and cardiogenic shock.