Early Experience of a Fully Magnetically Levitated Temporary Ventricular Assist Device in China: A Multicenter Single-Arm Study.

Abstract

Mechanical circulatory support (MCS) is an important option for patients unresponsive to medical therapy. This prospective, multicenter, single-arm study assessed the safety and efficacy of the newly developed MoyoAssist extracorporeal ventricular assist device (magAssist, Suzhou, China) in Chinese patients with cardiogenic shock (CS). Forty patients from seven national centers received temporary left, right, or biventricular support for acute heart failure and CS. Major indications were postcardiotomy cardiogenic shock (PCCS, 50%) and bridge-to-transplant (BTT, 32.5%). Cannulation was performed via sternotomy (22.5%), peripheral access (52.5%), or mini-thoracotomy (25%). MoyoAssist provided effective short-term circulatory support with no severe device-related adverse events or malfunctions. Complication profiles did not differ by cannulation approach. The mean support duration was 8.2 days, with an overall 30 day success rate of 62.5%. Hemodynamic improvements included increased mean arterial pressure, decreased central venous pressure, reduced lactate in the PCCS-success subgroup, and reduced aspartate aminotransferase in the BTT-success subgroup. Success rates exceeded the target in both PCCS (75%) and BTT (70%) groups. MoyoAssist demonstrated reliable short-term support and favorable outcomes in patients with CS, especially in PCCS and BTT populations, highlighting its clinical value as a temporary MCS option.