Injectable Hydrogels: A Novel Catheter-based Approach to Tissue Engineering in Advanced Heart Failure

Multiple approaches have been attempted to augment myocardial performance for advanced HF. Despite encouraging preclinical results, the use of injectable biopolymers in this patient population has been limited. Algisyl®, an inert, viscous permanent implantable hydrogel composed of sodium and calcium alginate, has been tested pre-clinically (canine HF model) and clinically as a concomitant or sole therapy in advanced HF of ischemic or non-ischemic etiology. In the one-year follow up of a controlled randomized study, Algisyl® was found to be superior to standard medical therapy for improving functional capacity and clinical outcomes in these patients. The hydrogel was administered solely by trans-epicardial injection. We now present delivery of Algisyl® hydrogel through a trans-femoral catheter-delivery system for the intra-myocardial injection. Consisting of three components (for navigation, needle localization and aspiration), the device has undergone preliminary safety and efficiency stusies in a porcine model. Early findings of these studies will be presented.