Minimally Invasive Delivery of Hydrogels to the Heart

Introduction: Hydrogels are a new treatment strategy for cardiovascular diseases. Hydrogels can act directly as therapeutics or can deliver stem cells, biologics, or pharmaceuticals to the heart. Currently there is no... [ view full abstract ]

Introduction: Hydrogels are a new treatment strategy for cardiovascular diseases. Hydrogels can act directly as therapeutics or can deliver stem cells, biologics, or pharmaceuticals to the heart. Currently there is no minimally invasive, safe, and precise method to deliver hydrogels to the heart. Current minimally invasive delivery methods could lead to vascular obstruction, infarction, embolization, or arrhythmia.
Methods: We reviewed characteristics of hydrogels in large animal and clinical trials and designed a device to deliver hydrogels to the heart through the pericardial space. We built the device using industry standard techniques and tested it in pigs (n=3). We evaluated the effects of the device and procedure on hemodynamics by invasive intra-cardiac measurements, and inflammation by histology. Animal studies were approved by the T3 Labs IAUCC.
Results: From the sub-xiphoid approach we placed our hydrogel delivery device over the left atrium in the pericardial space of pigs (n=3). The device formed a circular ‘fence’ and was secured to the epicardium as the ‘floor’ and pericardium as ‘ceiling’ using gentle suction. Gel components were combined outside the device in this temporary compartment. The delivery device was then unwound from around the gel and removed from the pericardial space. There were no hemodynamic effects of pericardial access nor hydrogel delivery. No significant inflammatory response was seen.
Conclusions: We have developed a translatable, minimally invasive technique to precisely delivery hydrogels to the heart through the pericardial space that shows no adverse hemodynamic or inflammatory effects in a large animal model.