Heart failure (HF) is the leading cause of death in the United States, affecting nearly six million people at a cost over $31 billion. Clinically-approved mechanical circulatory support (MCS) therapy, such as left ventricular assist devices (LVADs), continue to improve as a viable treatment option for patients with advanced heart failure as evidenced by over 13,000 implants over the past five years. However, MCS device therapy can be surgically invasive, time consuming, prone to adverse events, and often requires a median sternotomy, cardiopulmonary bypass (CPB), and partial clamping (cross-clamping) of the aorta to facilitate anastomosis of the outflow graft. These procedures are associated with adverse events including risk of post-operative infection, bleeding, pulmonary complications, post-operative neurological complications, and potential aortic dissection. Conventional manual suturing techniques are currently used to attach a MCS device outflow graft to the ascending aorta, and for which CPB support and aortic clamping time may increase risk of post-operative adverse events. To improve clinical outcomes, MAST (Louisville, KY) is developing a sutureless anastomotic graft connection device (sG2A) to eliminate the need for manual suturing and CPB during MCS device surgery. Several sutureless vascular connection devices have been proposed and/or developed; however, most of these devices were designed for smaller graft and vessel sizes (< 5mm diameter) that are primarily used for coronary artery bypass graft (CABG) procedures. Many surgical adhesives have also been proposed and/or developed as an alternative to suturing techniques for achieving vascular connection and hemostatic sealing, but have not achieved clinical acceptance due to poor strength and toxicity concerns. The MAST sG2A system is unique in that it is designed to attach large diameter grafts (10-15mm diameter) to large vessels (18-28 mm diameter) using a hybrid polymer-mechanical seal to achieve hemostasis. The sG2A device is a nitinol winged connector attached to the distal end of an outflow graft and an external polymer-flanged cuff that covers the end-to-side intersection of the aortotomy and outflow graft. The super-elastic properties of annealed nitinol allow for the winged connector to be deformed and compressed for loading into the delivery-aortotomy tool, and restored to its functional shape when deployed, potentially enabling distal graft anastomosis via a less- invasive surgical approach. In this SBIR phase I proposal, we will demonstrate feasibility of the sG2A system, and then plan to submit a phase II proposal to complete engineering development to achieve a design freeze of the sG2A system and complete pre-clinical testing to demonstrate efficacy, safety, and reliability. The phase II experimental data will be used to support an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) for clinical trials.
Investigators at MAST (Louisville, KY) and the University of Louisville (UofL) are developing a sutureless graft to aorta (sG2A) anastomotic device to facilitate minimally-invasive surgery for implant of mechanical circulatory support (MCS) devices. The sG2A system will enable surgeons to connect the MCS device outflow graft more efficiently, which should result in shorter procedures with improved patient outcomes and better quality of life.
