Comparative Outcomes of Autologous Stem Cell-Derived Cardiomyocyte Patches Vs. Left Ventricular Assist Devices (LVADS) in End-Stage Heart Failure

Background: Left Ventricular Assist Devices (LVADs) are currently the standard of care for bridge-to-transplant or destination therapy in end-stage heart failure (HF). However, mechanical complications and driveline infections remain significant burdens. This study investigates a regenerative alternative: 3D-bioprinted autologous stem cell-derived cardiomyocyte (CM) patches.

Methods: In a non-inferiority trial, 60 patients with NYHA Class IV heart failure were randomized to receive either an LVAD ($n=30$) or a multi-layered, pre-vascularized CM patch ($n=30$) surgically epicardial-affixed. The primary endpoint was the change in Left Ventricular Ejection Fraction (LVEF) at 12 months.

Results: The CM patch group showed a mean LVEF increase from 16.2% to 29.5% ($\pm 4.2\%$), compared to the LVAD group’s functional bypass. While LVADs provided superior immediate hemodynamic stability, the CM patch group exhibited zero incidences of thromboembolism or driveline infection, with a 92% survival rate at one year.

Conclusion: Autologous CM patches represent a viable biological "bridge-to-recovery," offering a potential shift away from permanent mechanical dependence in heart failure management.

Keywords: Ventricular Assist Devices, Heart Failure, Cardiomyocyte, Ejection Fraction.