In vivo performance and biocompatibility of the MagScrew ventricular assist device.

Currently available ventricular assist devices (VADs) have limitations in long-term durability and blood compatibility. We evaluated a prototype of a pulsatile MagScrew VAD for in vivo hemodynamic performance and biocompatibility. The device is composed of an actuator, blood pump housing, diaphragm, pusher plate, and bioprosthetic valves. Its protein-coated ("biolized") blood-contacting surface inhibits clot formation. Forces between moving parts of the actuator are transmitted magnetically, eliminating a primary source of friction and wear. The pump fills passively and is highly preload sensitive. The device was implanted into three calves for 90, 10, and 57 days, respectively. No anticoagulants were given postoperatively. The device functioned without technical problems during the entire course of each experiment, with mean device flow ranging between 5.4 and 9.0 L/min. Autopsy of the first two calves revealed no sign of embolization and clean blood-contacting surfaces of the devices. The third experiment was complicated by a prosthetic valve endocarditis with infectious embolization, and a few small depositions were found in the pump. In conclusion, the MagScrew VAD has demonstrated a high level of performance and biocompatibility in three calves studied for 10-90 days. Vigorous development is in progress to bring this device to preclinical readiness and thus provide surgeons with the VAD of choice for permanent implantation.

Membraneless dialysis--is it possible?

Direct contact between uremic blood and a fluid capable of receiving uremic toxins is possible. Such contact by itself is, however, not beneficial because the selection of molecules that are removed is dependent on diffusion coefficients in blood. This selection is inadequate and would result in the exhaustion of a patient's albumin pool before useful reduction in the urea pool was achieved. Direct contact that is accomplished by sandwiching blood between two layers of a sheathing fluid, followed by diafiltration of the sheathing fluid through conventional membranes and recirculation of the sheathing fluid, is possible. This adaptation of membraneless transport of molecules from blood eliminates almost all contact of blood with solid artificial surfaces and the subsequent diafiltration and recirculation of the sheathing fluid allows precise control of what is removed from the system. Slightly hyperosmotic protein is carried back by the recirculating sheathing fluid. Only solutes and water that pass the diafilter, which operates on a cell-free fluid, are able to leave the system. The system depends strongly on the ability to keep cells out of the sheathing fluid. Preliminary results and earlier reports indicate that this separation is possible and more precise measurements are underway. A quantitative design of a wearable dialyzer based on a circulating sheathing fluid is presented.

MagScrew total artificial heart in vivo performance above 200 beats per minute.

PURPOSE: Downsizing pulsatile devices requires an increase of beat rate if flow capacity is to be maintained. We applied this concept to the preclinical MagScrew total artificial heart (TAH). DESCRIPTION: The device fills passively with a stroke volume of 45 ml and beat rates up to 250 beats per minute (bpm). EVALUATION: Stable hemodynamics were observed during a 30-day bovine implant with a flow of 8.7 +/- 1.2 L/min at beat rates of 204 +/- 18 bpm. Device filling was exceptional up to 250 bpm generating flow of greater than 12 L/min. Beat rate adapted to preload in a way similar to a Frank-Starling response. Left and right atrial pressures were balanced. The aortic pulse pressure was 49-70 mm Hg, which translates to a pulsatility index of 0.49-0.77. Organ functions were preserved and blood damage did not occur. CONCLUSIONS: Increasing the beat rate while downsizing the MagScrew TAH was successful with strong flow generation by passive filling. Pulsatility was maintained at high beat rates. This innovative approach may be used to develop small pulsatile pumps.