Left ventricular assist devices (LVADs) are increasingly applied to treat advanced heart failure, demonstrating improvement of morbidity/mortality and quality of life. Right heart failure (RHF) affects up to 40% of LVAD patients and significantly contributes to their morbidity and mortality. One third of them require right ventricular assist device (RVAD) which needs a second open chest procedure for installation and a third one for its removal. A percutaneous RVAD (pRVAD) is required to eliminate these two major surgeries. The current TandemHeartTM Cannula-based pRVAD requires two major venous cannulations and a high resistance long circuit, resulting in restricted patient mobility and compromised blood flow affecting RVAD performance. Our ultimate goal is to develop a single-site percutaneous RVAD (pRVAD) system that achieves full right heart support, avoiding two additional open chest surgeries. The enabling technology will be a percutaneous double lumen cannula (DLC) that will drain venous blood from the right atrium (RA) and infuse blood directly into the pulmonary artery (PA). Our objective in this Phase I SBIR is to develop and fabricate a working prototype of a DLC assembly for pRVAD and to test prototype performance in adult sheep. We hypothesize that the pre-curved DLC, coupled with any commercially available blood pump, can be easily deployed in the right heart and the PA for percutaneous total right heart support, reversing RHF.
The Specific Aim will be to develop a DLC Assembly for RVAD/OxyRVAD and to test our prototype pRVAD DLC for percutaneous deployment and 6h in vivo performance. In this SBIR I proposal, we will design and fabricate a working prototype of a percutaneous DLC to assist RHF and design and fabricate a working prototype of the balloon guided introducer to facilitate DLC deployment. The DLC consists of main DLC body extension infusion cannula. The drainage lumen opens in the RA to drain total venous return from both the SVC and IVC, while the infusion cannula extends from the main DLC membrane sleeve infusion lumen. The bench test measurements will include how well the introducer fits inside the infusion lumen/extension infusion cannula and in vitro DLC flow dynamic performance. The in vivo sheep experiments (n=5) are designed to test the DLC assembly for percutaneous insertion, advancement and deployment, and for in vivo hemodynamic performance. Upon this SBIR grant completion, the commercialized DLC will provide pRVAD to RHF patients. This minimally invasive technology will lower the threshold of RVAD application and have significant impact on LVAD application in advanced heart failure by decreasing RHF associated mortality and mobility. pRVAD can also be applied to other RHF patients, secondary to pulmonary hypertension, right heart infarction induced carcinogenic shock, and postcardiotomy. Furthermore addition of an artificial lung to the circuit will convert pRVAD to OxyRVAD for combined RHF and lung failure. Such wide application will benefit patients around the world, as well as the American economy.
We are proposing to develop a double lumen cannula for percutaneous right ventricular assist device to bridge critical right heart failure patient to recovery, transplantation and advance treatment.