Replacement of the left-side valves of an implanted total artificial heart

Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
ASAIO Journal (Impact Factor: 1.52). 07/2006; 52(4):368-72. DOI: 10.1097/01.mat.0000227731.46835.1e
Source: PubMed

ABSTRACT The MagScrew total artificial heart (TAH) is under development. Despite its anticipated durability and reliability, the possibility of a bioprosthetic valve malfunction exists. As a result, the potential for valve replacement surgery, instead of device replacement, would be desirable after a TAH implant. In two of our 90-day animal experiments, we successfully replaced the left-side valves through a left thoracotomy opposite to the right-sided incision site for the initial TAH implant. The results of these cases suggest that the left-side valves could also be replaced through a left thoracotomy approach in humans. To confirm the ability to access the left-side valves in humans, four human cadaver studies were performed with the use of a mock pump designed for human application. This report describes the operative techniques for left-side valve replacement in animals and discusses the advantages of a left thoracotomy in clinical situations, based on results from the human cadaver studies.

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    ABSTRACT: We are developing a very small, innovative, continuous-flow total artificial heart (CFTAH) that passively self-balances left and right pump flows and atrial pressures without sensors. This report details the CFTAH design concept and our initial in vitro data. System performance of the CFTAH was evaluated using a mock circulatory loop to determine the range of systemic and pulmonary vascular resistance (SVR and PVR) levels over which the design goal of a maximum absolute atrial pressure difference of 10 mm Hg is achieved for a steady-state flow condition. Pump speed was then modulated at 2,600 +/- 900 rpm to induce flow and arterial pressure pulsation to evaluate the effects of speed pulsations on the system performance. An automatic control mode was also evaluated. Using only passive self-regulation, pump flows were balanced and absolute atrial pressure differences were maintained at <10 mm Hg over a range of SVR (750 to 2,750 and PVR (135 to 600 values far exceeding normal levels. The magnitude of induced speed pulsatility affected relative left/right performance, allowing for an additional active control to improve balanced flow and pressure. The automatic control mode adjusted pump speed to achieve targeted pump flows based on sensorless calculations of SVR and CFTAH flow. The initial in vitro testing of the CFTAH with a single, valveless, continuous-flow pump demonstrated its passive self-regulation of flows and atrial pressures and a new automatic control mode.
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