Asynchronous rotational-speed modulation of a continuous-flow left ventricular assist device (LVAD) can increase pulsatility; however, the feasibility of hemodynamic modification by asynchronous ...modulation of an LVAD has not been sufficiently verified. We evaluated the acute effect of an asynchronous-modulation mode under LVAD support and the accumulated effect of 6 consecutive hours of driving by the asynchronous-modulation mode on hemodynamics, including both ventricles, in a coronary microembolization-induced acute-myocardial injury sheep model. We evaluated 5-min LVAD-support hemodynamics, including biventricular parameters, by switching modes from constant-speed to asynchronous-modulation in the same animals (“acute-effect evaluation under LVAD support”). To determine the accumulated effect of a certain driving period, we evaluated hemodynamics including biventricular parameters after weaning from 6-hour (6 h) LVAD support by constant-speed or asynchronous-modulation mode (“6h-effect evaluation”). The acute-effect evaluation under LVAD support revealed that, compared to the constant-speed mode, the asynchronous-modulation mode increased vascular pulsatility but did not have significantly different effects on hemodynamics, including both ventricles. The 6 h-effect evaluation revealed that the hemodynamics did not differ significantly between the two groups except for some biventricular parameters which did not indicate negative effects of the asynchronous-modulation mode on both ventricles. The asynchronous-modulation mode could be feasible to increase vascular pulsatility without causing negative effects on hemodynamics including both ventricles. Compared to the constant-speed mode, the asynchronous-modulation mode increased pulsatility during LVAD support without negative effects on hemodynamics including both ventricles in the acute phase. Six hours of LVAD support with the asynchronous-modulation mode exerted no negative effects on hemodynamics, including both ventricles, after weaning from the LVAD.
An implantable, compact rotary blood pump has been newly developed using an axial flow turbo pump with hydrodynamic bearings. The rotating impeller, which is hydrodynamically levitated with the ...assistance of repulsive magnetic force, has no contact with the inner surface of the pump. To evaluate the hemodynamic performance and biocompatibility, the pump was installed into four calves for up to 90 days. The pump was installed in the left heart bypass fashion, and placed paracorporeally in the first two calves and in the thoracic cavity in the other two calves. All calves received anticoagulation and antiaggregation therapy during the study. Aortic pressure, heart rate and pump-operating parameters were continuously measured. Hematologic and biochemical tests to evaluate anemia, hepato-renal function and the extent of hemolysis were performed on schedule. Each calf was killed at the termination of the experiments, and pathological analysis for the biocompatibility of the pump system was performed, including the thrombi in the device, emboli in the systemic organs and signs of infection. The pump stably produced a flow of 5 l/min. Each calf was supported for 78, 50, 90 and 90 days, respectively, with no incidence of hemorrhage, organ failure or significant hemolysis. No thrombus formation or mechanical wearing was observed inside the pump. There was no evidence of heat injury around the pump. Device-related infections were observed, but the severity of infection was mild in the implant case compared to the paracorporeal case. The pump demonstrated acceptable hemodynamic performance and biocompatibility in the initial in vivo testing.
Recent progress in the development of implantable rotary blood pumps realized long‐term mechanical circulatory support (MCS) for bridge to transplant, bridge to recovery, or a destination therapy. ...Meanwhile, a short‐term MCS system is becoming necessary for bridge to decision. We developed a novel inflow cannula for the short‐term MCS system, which gives sufficient bypass flow with minimal invasion at insertion, and evaluated its hydrodynamic characteristics. The novel inflow cannula, named the Lantern cannula, is made of elastic silicone reinforced with metal wires. The cannula tip has six slits on the side. This cannula tip can be extended to the axial direction by using an introducer and can be reduced in diameter, and the Lantern cannula enables easy insertion into the left ventricle apex with minimal invasion. The sufficient bypass flow rate can be obtained due to low pressure loss. Moreover, this Lantern shape also resists suction complication around the cannula tip. The pressure loss through the Lantern cannula was measured using a mock circulation and compared with two commercially available venous cannulae (Sarns4882, Terumo, Tokyo, Japan and Stockert V122‐28, Sorin Group, Tokyo, Japan), which have almost same diameter as the Lantern cannula. Moreover, the flow patterns around the cannula tip were numerically analyzed by computational fluid dynamics (CFD). Acute animal experiment was also performed to confirm the practical effectiveness of the Lantern cannula. The pressure loss of the Lantern cannula was the lowest compared with those of the commercially available venous cannulae in in vitro experiment. CFD analysis results demonstrated that the Lantern cannula has low pressure loss because of wide inflow orifice area and a bell mouth, which were formed via Lantern shape. The highest bypass flow was obtained in the Lantern cannula because of the low pressure loss under pulsatile condition in in vivo experiments. The Lantern cannula demonstrated superior hydrodynamic characteristics as the inflow cannula in terms of pressure loss due to its specially designed Lantern shape.
Abstract
The rate of patients requiring left ventricular assist device (LVAD) implantation remains at a pace exceeding 2000 per year worldwide. Children and small adult patients, with a body surface ...area <1.5 m2, are at a disadvantage for receiving an implantable LVAD because of its large pump size. Preoperative simulation of the results of various LVAD implantation methods and devices in such challenging cases will be helpful for surgeons. Herein, we introduce a preoperative LVAD simulation method using image processing software and present a case in which we obtained satisfactory results.
The effect of the hydraulic force on magnetically levitated (maglev) pumps should be studied carefully to improve the suspension performance and the reliability of the pumps. A maglev centrifugal ...pump, developed at Ibaraki University, was modeled with 926 376 hexahedral elements for computational fluid dynamics (CFD) analyses. The pump has a fully open six-vane impeller with a diameter of 72.5 mm. A self-bearing motor suspends the impeller in the radial direction. The maximum pressure head and flow rate were 250 mmHg and 14 l/min, respectively. First, a steady-state analysis was performed using commercial code STAR-CD to confirm the model’s suitability by comparing the results with the real pump performance. Second, transient analysis was performed to estimate the hydraulic force on the levitated impeller. The impeller was rotated in steps of 1° using a sliding mesh. The force around the impeller was integrated at every step. The transient analysis revealed that the direction of the radial force changed dynamically as the vane’s position changed relative to the outlet port during one circulation, and the magnitude of this force was about 1 N. The current maglev pump has sufficient performance to counteract this hydraulic force. Transient CFD analysis is not only useful for observing dynamic flow conditions in a centrifugal pump but is also effective for obtaining information about the levitation dynamics of a maglev pump.
Impella is a mechanical circulatory support device of a catheter-based intravascular microaxial pump for left ventricular support and unloading. However, nonclinical studies assessing the effects of ...the extended duration of left ventricular unloading on cardiac recovery are lacking. An animal model using Impella implanted with a less invasive procedure to enable long-term support is required. This study aimed to evaluate the feasibility of an animal model for long-term support with Impella 5.5 implanted through carotid artery access in sheep.Impella 5.5 was implanted in four sheep through the proximal region of the left carotid artery without a thoracotomy, and myocardial injuries were induced by coronary microembolization. Support by Impella 5.5 was maintained for 4 weeks, and the animals were observed. The position of Impella 5.5 and cardiac function was evaluated using cardiac computer tomography at 2 and 4 weeks after implantation.All four animals completed the 4-week study without major complications. The discrepancy in the Impella 5.5 flow rate between the conscious and anesthetized states was observed depending on the device's position. Animals in whom the inflow was above the left ventricular papillary muscle had a relatively high flow rate under the maximum performance level without a suction alarm during the conscious state. Pathological changes in the aortic valve were observed. Cardiac function under the minimum performance level was observed with no remarkable deterioration.The animal model with myocardial injuries supported for 4 weeks by Impella 5.5 implanted through carotid artery access in sheep was feasible.
We developed a new coating material (Toyobo-National Cardiovascular Center coating) for medical devices that delivers high antithrombogenicity and long-term durability. We applied this coating to an ...extracorporeal membrane oxygenation (ECMO) system, including the circuit tube, cannulae, a seal-less centrifugal pump, and a diffusion membrane oxygenator, to realize prolonged cardiopulmonary support with trivial anticoagulant infusion. The oxygenator consisted of a hollow-fiber membrane made of polymethylpentene, which allows the transfer of gas by diffusion through the membrane. The centrifugal pump was free of seals and had a pivot bearing. We performed a venoarterial bypass in a goat using this ECMO system, and the system was driven for 151 days with trivial anticoagulant infusion. Plasma leakage from the oxygenator did not occur and sufficient gas-exchange performance was well maintained. In the oxygenator, thrombus formation was present around the top and the distributor of the inlet portion and was very slight in the outlet portion. In the centrifugal blood pump, there was some wear in the female pivot region and quite small amounts of thrombus formation on the edge of the shroud; the pivot wear seemed to be the cause of the hemolysis observed after 20 weeks of perfusion and which resulted in the termination of the perfusion. However, no significant amounts of thrombus were observed in other parts of the system. This ECMO system showed potential for long-term cardiopulmonary support with minimal use of systemic anticoagulants.
Extracorporeal membrane oxygenation (ECMO) is a respiratory or cardiac life support consisting of a vascular access cannula, a blood pump, and an artificial lung that removes carbon dioxide and adds ...oxygen. Venovenous ECMO is typically used for various forms of critical respiratory failure including severe pneumonia due to the new coronavirus, whereas venoarterial (VA) ECMO sees greater utilization in the patient with heart failure such as cardiac arrest or other clinical states in which cardiac dysfunction is a significant component of illness. The transference of gases occurs due to diffusion across the hollow fiber membranes packed in the module of the oxygenator. Emergence of microporous membrane tremendously enhanced gas diffusion, and currently microporous membrane with a dense layer on the blood-contacting surface is widely used for longer period of usage over weeks. As the usage period for respiratory failure is getting longer, development of more durable ECMO system is required in the future.
The Toyobo-National Cardiovascular Center pneumatic ventricular assist device (Toyobo-NCVC VAD) is widely used in Japan; however, the current pneumatic drivers have some drawbacks, including their ...large size, heavy weight, and high power consumption. These issues cause difficulty with mobility and contribute to an unsatisfactory quality of life for patients. Because it is urgently necessary to improve patients' safety and quality of life, we have developed a compact, low-noise, portable VAD driver by utilizing an electrohydraulic actuator consisting of a brushless DC motor and a regenerative pump. This unit can be actuated for as long as 2 h with two rechargeable lightweight batteries as well as with external AC power. It is compact in size (33 x 25 x 43 cm) and light in weight (13 kg), and the unit is carried on a mobile wheeled cart. In vitro testing with a Toyobo-NCVC VAD demonstrated a sufficient pumping capacity of up to 8 l/min. We conclude that this newly-developed compact portable driver can provide a better quality of life and improved safety for patients using protracted pneumatic VAD support.
The purpose of this study was to develop a compact wearable pneumatic drive unit for a ventricular assist device (VAD). This newly developed drive unit, 20 × 8.5 × 20 cm in size and weighing ...approximately 1.8 kg, consists of a brushless DC motor, noncircular gears, a crankshaft, a cylinder-piston, and air pressure regulation valves. The driving air pressure is generated by the reciprocating motion of the piston and is controlled by the air pressure regulation valves. The systolic ratio is determined by the noncircular gears, and so is fixed for a given configuration. As a result of an overflow-type mock circulation test, a drive unit with a 44% systolic ratio connected to a Toyobo VAD blood pump with a 70-ml stroke volume achieved a pump output of more than 7 l/min at 100 bpm against a 120 mmHg afterload. Long-term animal tests were also performed using drive units with systolic ratios of 45% and 53% in two Holstein calves weighing 62 kg and 74 kg; the tests were terminated on days 30 and 39, respectively, without any malfunction. The mean aortic pressure, bypass flow, and power consumption for the first calf were maintained at 90 × 13 mmHg, 3.9 × 0.9 l/min, and 12 × 1 W, and those for the second calf were maintained at 88 × 13 mmHg, 5.0 × 0.5 l/min, and 16 × 2 W, respectively. These results indicate that the newly developed drive unit may be used as a wearable pneumatic drive unit for the Toyobo VAD blood pump.
PDF
