First-in-human transcatheter endocardial alginate-hydrogel implantation for the treatment of heart failure

Abstract

A 55-year-old male with dilated cardiomyopathy presented with decompensated heart failure (HF). Magnetic resonance imaging (MRI) revealed left ventricular (LV) enlargement (Panel A). The LV ejection fraction (LVEF), end-diastolic volume index (EDVI), and end-systolic volume index (ESVI) were 16%, 234 and 196.8 mL/m², respectively. The heart team enrolled him in our clinical trial (NCT04781660), designed to evaluate the feasibility and safety of transcatheter endocardial alginate hydrogel implantation (TEAi) for treating HF. The concept of LV augmentation with the alginate hydrogel (AH) uses Laplace's law (Panel B), which increases the LV wall's thickness, reduces the wall stress, and improves cardiac function.^1–5 Three-dimension printing techniques were used to evaluate the LV wall thickness (Panels C and D) and to simulate the procedure (Panel F). An 18-F guiding catheter was inserted via the femoral artery and guided crossing the aortic valve under fluoroscopy. Injections were performed with a steerable, dual-lumen needle catheter (Panel E). Transesophageal echocardiography was used to locate the injection sites. The tip of the catheter reached the endocardium (Panel G, arrow), and contrast was injected into the LV wall to identify no leakage or perforation (Panel H). The AH was injected into the myocardium at the mid-LV free wall for 10 sites and 3 ml (Panels I, arrow). Six-month following the procedure, the patient's clinical status was significantly improved (NYHA Class II). MRI confirmed that the LVEF was 22%, with a reduction in EDVI (188.25 mL/m²) and ESVI (146.36 mL/m²). This case demonstrated that TEAi could be effectively and safely performed.