Experimental evaluation and early clinical results of a new low-profile bileaflet aortic valve

We performed an experimental and clinical evaluation of a new low-profile bileaflet aortic valve (Regent, St. Jude Medical Inc., St. Paul, MN, U.S.A.). Common valve sizes were experimentally tested for leakage volume, pressure drop, and transvalvular hemodynamics using a pulse duplicator. Thirty patients (mean age 60 +/- 7 years, predominant valve stenosis n = 25) received the Regent prosthesis for initial clinical evaluation. In vitro evaluation revealed equivalent leakage volumes, larger performance indices (0.552 versus 0.513), and lower pressure drops in comparison to SJM hemodynamic plus valve controls. Clinically, 21 mm (n = 9), 23 mm (n = 12), and 25 mm (n = 9) valves were implanted with no significant perioperative complications. Echocardiography revealed low transvalvular flow velocities (2.2 +/- 0.4 m/s) and low pressure gradients (20 +/- 6 mm Hg) postoperatively and at 6 months follow-up. In vitro testing and early clinical results are promising; however, long-term performance has to be proven.     

Comparison of a pulsatile blood pump and a peristaltic roller pump during hemoperfusion treatment in a canine model of paraquat poisoning

Abstract:  This study examined the treatment efficacy and the damage to the blood during hemoperfusion for treating paraquat poisoning using two blood pump mechanisms. Paraquat-poisoned animal models were prepared. A conventional hemodialysis machine, AK90, with a peristaltic roller pump and a cardiopulmonary support system, T-PLS, with a pulsatile blood pump were used during the animal experiments. A total of 12 dogs were treated with hemoperfusion using a charcoal column. Six dogs were treated with hemoperfusion and T-PLS, and the other six were treated with AK90. A paraquat dose of 30 mg/kg was administrated by an intravenous injection. Both pumps maintained blood flow rates of 125 mL/min measured by an ultrasonic flowmeter. For anticoagulation, heparin was administrated by an initial bolus (250 IU/kg) and a continuous injection (100 IU/kg/h). During the experiments, T-PLS and AK90 showed a similar toxin removal efficacy. Both devices decreased the plasma paraquat concentration to 10% of the initial dose within 4-h hemoperfusion. The two pumps showed similar hemolysis properties with acceptable levels. Although T-PLS was developed as a cardiopulmonary bypass system, it can also be used as a hemoperfusion treatment device.     

Development of a totally implantable pulsatile centrifugal pump as a ventricular assist device

The Taita No. 1 ventricular assist device (T-VAD) is a totally implantable pulsatile impeller centrifugal pump driven by a magnetically suspended motor. The flow can achieve 2.01 +/- 0.17 L/min against a pressure of 100 mm Hg under 0.266 +/- 0.017 amp and 13.55 +/- 0.41 voltage. The speed was around 3,500 rpm. It consumed less than 6 W of power, resulting in less heat production and mechanical bearing complications. The impeller vane was designed to have both radial and axial curves according to the stream surface and stream lines to reduce thrombosis and hemolysis. Eight calves weighing 80 to 100 kg (mean 87 +/- 12 kg) were used for experiments. With the calves under general anesthesia, left posterolateral thoracotomy was performed to connect the inflow tube with the atrial appendage and to anastomose the outflow tube with the descending aorta. The calves usually awoke and stood up within hours after discontinuation of anesthetics. The mean survival of the calves was 75 +/- 42 days (range 33-148 days). The terminations of experiments were mainly due to infection. During the course of pumping, no significant deterioration of liver or renal function was noted. The evaluation of serum samples from the implanted calves indicated that hemolysis was not associated with use of the T-VAD. The average daily free hemoglobin level was 8.08 +/- 3.05 mg/dl, which was less than the set limit of 20 mg/dl. The red blood cell and platelet count and hemoglobin of implanted animals were within the normal range. In our results, the T-VAD provided competent pulsatile function without severe blood damage or organ dysfunction.     

A magnetically levitated centrifugal blood pump with a simple-structured disposable pump head

Abstract:  A magnetically levitated centrifugal blood pump (MedTech Dispo) has been developed for use in a disposable extracorporeal system. The design of the pump is intended to eliminate mechanical contact with the impeller, to facilitate a simple disposable mechanism, and to reduce the blood-heating effects that are caused by motors and magnetic bearings. The bearing rotor attached to the impeller is suspended by a two degrees-of-freedom controlled radial magnetic bearing stator, which is situated outside the rotor. In the space inside the ringlike rotor, a magnetic coupling disk is placed to rotate the rotor and to ensure that the pump head is thermally isolated from the motor. In this system, the rotor can exhibit high passive stiffness due to the novel design of the closed magnetic circuits. The disposable pump head, which has a priming volume of 23 mL, consists of top and bottom housings, an impeller, and a rotor with a diameter of 50 mm. The pump can provide a head pressure of more than 300 mm Hg against a flow of 5 L/min. The normalized index of hemolysis of the MedTech Dispo is 0.0025 ± 0.0005 g/100 L at 5 L/min against 250 mm Hg. This is one-seventh of the equivalent figure for a Bio Pump BPX-80 (Medtronic, Inc., Minneapolis, MN, USA), which has a value of 0.0170 ± 0.0096 g/100 L. These results show that the MedTech Dispo offers high pumping performance and low blood trauma.     

Development of rear‐impeller axial flow blood pump for realization of axial flow blood pump installed at aortic valve position

In this study, rear‐impeller axial flow blood pumps (RIAFBP) were developed to realize a trans‐valve axial ventricular assist device (VAD) which consists of the latter blood pump and a polymer monomembrane aortic valve, such as the jellyfish valve. The motor of the RIAFBP is installed in the left ventricle, and its impeller is placed at the aortic valve position. In the prototype RIAFBP, the rotation of the motor is sustained by polyethylene bushings. The RIAFBP has a length of 50 mm and diameter of 19.6 mm. The miniature RIAFBP has the same construction as that of the prototype; however, it employs a ceramic bearing and fin bearing to improve endurance and to reduce blood stagnation. The miniature RIAFBP has a length of 63 mm and diameter of 12 mm. Both RIAFBPs were examined by an in vitro experiment using a 33% glycerin solution. The prototype RIAFBP achieved a maximum pump outflow of 8.5 L/min against a pump head of 100 mm Hg at a rotational speed of 12 000 rpm. The miniature RIAFBP achieved 7 L/min against a pump head of 70 mm Hg at a rotational speed of 21 600 rpm. In conclusion, the miniature RIAFBP has enough pump performance to realize the trans‐valve axial VAD.     

Completely pulsatile high flow circulatory support with a constant-speed centrifugal blood pump: mechanisms and early clinical observations

OBJECTIVE: Various types of rotary blood pumps (axial flow, centrifugal) have been introduced into clinical use recently. These pumps have different pressure-flow characteristics, and some investigators have noted that a limited pump flow rate and less pulsatility are the problems with the axial flow devices. METHODS: A new implantable centrifugal blood pump was developed that has an extremely flat pressure-flow curve and is able to produce a significantly high pump flow rate of 20 l/min at a low pressure of 10-30mmHg. When the pressure difference between the left ventricle and aorta decreases during systole, an instant high peak flow is achieved, which results in a higher peak pressure in the aorta (systolic pressure). During the diastolic phase, the left ventricle-aorta pressure difference increases to maximum, and the pump flow rate decreases to minimum. Thus, the pump flow rate becomes completely pulsatile, and the high peak flow provides a higher mean pump flow rate. This pump was applied to two end-stage heart failure patients (dilated cardiomyopathy, New York Heart Association (NYHA) class IV, inotrope-dependent). RESULTS: The pump was observed to provide completely pulsatile high flow assistance of 6-9 l/min with a constant pump speed. Both patients are currently in NYHA class I after 1 year on the device with no major adverse events. CONCLUSION: The new centrifugal blood pump provides completely pulsatile high-flow circulatory support with a constant pump speed, which solves the current clinical problems with rotary blood pumps.     

Using one rotary blood pump to produce separate pulsatile circulations in the upper and lower halves of the body

Separate systemic circulations with pulsatile flow were obtained using 1 rotary blood pump as a left ventricular assist device. The outlet of the pump was divided into 2 conduits, 1 connected to the upper half of the body and the other connected to the lower half. An electric actuator that clamped the 2 outlet conduits alternately provided pulsatile flows. An in vitro experiment showed that the pulsatility phases of the upper and lower halves of the body were complementary with pulsatile flow, and an in vivo experiment showed that controlled flow distributions of continuous flows could be obtained.     

Disposable magnetically levitated centrifugal blood pump: design and in vitro performance

A magnetically levitated (MagLev) centrifugal blood pump (CBP) with a disposable pump head has been designed to realize a safe, easy-to-handle, reliable, and low-cost extracorporeal blood pump system. It consisted of a radial magnetic-coupled driver with a magnetic bearing having a two-degree freedom control and a disposable pump head unit with a priming volume of 24 mL. The easy on-off disposable pump head unit was made into a three-piece system consisting of the top and bottom housings, and the impeller-rotor assembly. The size and weight of the disposable pump unit were 75 mm x 45 mm and 100 g, respectively. Because the structure of the pump head unit is easily attachable and removable, the gap between the electromagnets of the stator and the target material in the rotor increased to 1.8 mm in comparison to the original integrated bearing system of 1.0 mm. The pump performance, power requirements, and controllability of the magnetic bearing revealed that from 1400 to 2400 rpm, the pump performance remained fairly unchanged. The amplitudes of the X- and Y-axis rotor oscillation increased to +/- 24 microm. The axial displacement of the rotor, 0.4 mm, toward the top housing was also observed at the pump rpm between 1400 and 2400. The axial and rotational stiffness of the bearing were 15.9 N/mm and 4.4 Nm/rad, respectively. The MagLev power was within 0.7 Watts. This study demonstrated the feasibility of a disposable, magnetically suspended CBP as the safe, reliable, easy-to-handle, low-cost extracorporeal circulation support device.     

Clinical effectiveness of centrifugal pump to produce pulsatile flow during cardiopulmonary bypass in patients undergoing cardiac surgery

Although the centrifugal pump has been widely used as a nonpulsatile pump for cardiopulmonary bypass (CPB), little is known about its performance as a pulsatile pump for CPB, especially on its efficacy in producing hemodynamic energy and its clinical effectiveness. We performed a study to evaluate whether the Rotaflow centrifugal pump produces effective pulsatile flow during CPB and whether the pulsatile flow in this setting is clinically effective in adult patients undergoing cardiac surgery. Thirty-two patients undergoing CPB for elective coronary artery bypass grafting were randomly allocated to a pulsatile perfusion group (n = 16) or a nonpulsatile perfusion group (n = 16). All patients were perfused with the Rotaflow centrifugal pump. In the pulsatile group, the centrifugal pump was adjusted to the pulsatile mode (60 cycles/min) during aortic cross-clamping, whereas in the nonpulsatile group, the pump was kept in its nonpulsatile mode during the same period of time. Compared with the nonpulsatile group, the pulsatile group had a higher pulse pressure (P < 0.01) and a fraction higher energy equivalent pressure (EEP, P = 0.058). The net gain of pulsatile flow, represented by the surplus hemodynamic energy (SHE), was found much higher in the CPB circuit than in patients (P < 0.01). Clinically, there was no difference between the pulsatile and nonpulsatile groups with regard to postoperative acute kidney injury, endothelial activation, or inflammatory response. Postoperative organ function and the duration of hospital stay were similar in the two patient groups. In conclusion, pulsatile CPB with the Rotaflow centrifugal pump is associated with a small gain of EEP and SHE, which does not seem to be clinically effective in adult cardiac surgical patients.     

Development of a disposable magnetically levitated centrifugal blood pump (MedTech Dispo) intended for bridge-to-bridge applications--two-week in vivo evaluation

Last year, we reported in vitro pump performance, low hemolytic characteristics, and initial in vivo evaluation of a disposable, magnetically levitated centrifugal blood pump, MedTech Dispo. As the first phase of the two-stage in vivo studies, in this study we have carried out a 2-week in vivo evaluation in calves. Male Holstein calves with body weight of 62.4–92.2 kg were used. Under general anesthesia, a left heart bypass with a MedTech Dispo pump was instituted between the left atrium and the descending aorta via left thoracotomy. Blood-contacting surface of the pump was coated with a 2-methacryloyloxyethyl phosphorylcholine polymer. Post-operatively, with activated clotting time controlled at 180–220 s using heparin and bypass flow rate maintained at 50 mL/kg/min, plasma-free hemoglobin (Hb), coagulation, and major organ functions were analyzed for evaluation of biocompatibility. The animals were electively sacrificed at the completion of the 2-week study to evaluate presence of thrombus inside the pump,together with an examination of major organs. To date, we have done 13 MedTech Dispo implantations, of which three went successfully for a 2-week duration. In these three cases, the pump produced a fairly constant flow of 50 mL/Kg/min. Neurological disorders and any symptoms of thromboembolism were not seen. Levels of plasma-free Hb were maintained very low. Major organ functions remained within normal ranges. Autopsy results revealed no thrombus formation inside the pump. In the last six cases, calves suffered from severe pneumonia and they were excluded from the analysis. The MedTech Dispo pump demonstrated sufficient pump performance and biocompatibility to meet requirements for 1-week circulatory support. The second phase (2-month in vivo study) is under way to prove the safety and efficacy of MedTech Dispo for 1-month applications.     

A method for control of an implantable rotary blood pump for heart failure patients using noninvasive measurements

We propose a deadbeat controller for the control of pulsatile pump flow (Q(p) ) in an implantable rotary blood pump (IRBP). Noninvasive measurements of pump speed and current are used as inputs to a dynamical model of Q(p) estimation, previously developed and verified in our laboratory. The controller was tested using a lumped parameter model of the cardiovascular system (CVS), in combination with the stable dynamical models of Q(p) and differential pressure (head) estimation for the IRBP. The control algorithm was tested with both constant and sinusoidal reference Q(p) as input to the CVS model. Results showed that the controller was able to track the reference input with minimal error in the presence of model uncertainty. Furthermore, Q(p) was shown to settle to the desired reference value within a finite number of sampling periods. Our results also indicated that counterpulsation yields the minimum left ventricular stroke work, left ventricular end diastolic volume, and aortic pulse pressure, without significantly affecting mean cardiac output and aortic pressure.     

Investigation of materials for blood-immersed bearings in a microaxial blood pump

Rotary blood pumps are gaining popularity among cardiothoracic surgeons. This article presents an in vitro investigation for choosing a suitable mechanical bearing system in a medium-long term microaxial pump. Different metallic, polymeric, and ceramic components are introduced. Polymers displayed mechanical insufficiency for the application, whereas certain ceramics displayed an inconsistent pattern of failure. We are in search of a compromise in properties that would favor a durable material combination.     

Development of the MEDOS/HIA DeltaStream extracorporeal rotary blood pump

The DeltaStream blood pump has been developed for extracorporeal circulation with one focus on potential integration into simplified bypass systems (SBS). Its small size and an embedded electric motor are the basic pump properties. A variation of the impeller design has been performed to optimize hydraulic and hematologic characteristics. A simple impeller design was developed which allows flow and pressure generation for cardiopulmonary bypass applications. The option of a pulsatile flow mode for ventricular assist device applications also was demonstrated in vitro. Impeller washout holes were implemented to improve nonthrombogenicity. The pump was investigated for potential thermal hazards for blood caused by the integrated electric motor. It could be demonstrated that there is no thermal risk associated with this design. Durability tests were performed to assess the lifetime of the pump especially with regard to the incorporated polymeric seal. Seal lifetimes of up to 28 days were achieved using different blood substitutes. In animal tests using either the pump as a single device or in an SBS setup, biocompatibility, low hemolysis, and nonthrombogenicity were demonstrated. In summary, the DeltaStream pump shows great potential for different extracorporeal perfusion applications. Besides heart-lung machine and SBS applications, ventricular assist and extracorporeal membrane oxygenation up to several days also appear promising as potential applications.     

Pediatric physiologic pulsatile pump enhances cerebral and renal blood flow during and after cardiopulmonary bypass

Controversy over benefits of pulsatile flow after pediatric cardiopulmonary bypass (CPB) continues. Our study objectives were to first, quantify pressure and flow waveforms in terms of hemodynamic energy, using the energy equivalent (EEP) formula, for direct comparisons, and second, investigate effects of pulsatile versus nonpulsatile flow on cerebral and renal blood flow, and cerebral vascular resistance during and after CPB with deep hypothermic circulatory arrest (DHCA) in a neonatal piglet model. Fourteen piglets underwent perfusion with either an hydraulically driven dual-chamber physiologic pulsatile pump (P, n = 7) or a conventional nonpulsatile roller pump (NP, n = 7). The radiolabeled microsphere technique was used to determine the cerebral and renal blood flow. P produced higher hemodynamic energy (from mean arterial pressure to EEP) compared to NP during normothermic CPB (13 +/- 3% versus 1 +/- 1%, p < 0.0001), hypothermic CPB (15 +/- 4% versus 1 +/- 1%, p < 0.0001) and after rewarming (16 +/- 5% versus 1 +/- 1%, p < 0.0001). Global cerebral blood flow was higher for P compared to NP during CPB (104 +/- 12 ml/100g/min versus 70 +/- 8 ml/100g/min, p < 0.05). In the right and left hemispheres, cerebellum, basal ganglia, and brainstem, blood flow resembled the global cerebral blood flow. Cerebral vascular resistance was lower (p < 0.007) and renal blood flow was improved fourfold (p < 0.05) for P versus NP, after CPB. Pulsatile flow generates higher hemodynamic energy, enhancing cerebral and renal blood flow during and after CPB with DHCA in this model.     

A small pulsatile blood pump for ventricular support during end-stage heart failure

A displacement blood pump to support the natural heart of patients for recovery from end-stage heart failure has been developed. This electromechanical pusher plate pump has a very compact and extremely flat design. The design goal was achieved by developing a novel gear system based on the principle of a swash plate. The blood pump and cannulae can be placed within the thoracic cavity between the lungs and ribcage. The first labtype model delivers an output of 3.1 L/min against an aortic pressure of 100 mm Hg at 120 bpm.     

A new method of providing pulsatile flow in a centrifugal pump: assessment of pulsatility using a mock circulatory system

Abstract:  Previous studies have demonstrated the potential advantages of pulsatile flow as compared with continuous flow. However, to date, physiologic pumps have been technically complex and their application has therefore remained in the experimental field. We have developed a new type of centrifugal pump, which can provide pulsatile as well as continuous flow. The inner wall of a centrifugal pump is pulsed by means of a flexible membrane, which can be accurately controlled by means of either a hydraulic or pneumatic driver. The aim of this study was to assess the hydraulic behavior of the new pump in terms of surplus hemodynamic energy (SHE). We conducted experiments using a mock circulatory system including a membrane oxygenator. No differences were found in the pressure–flow characteristics between the new pump and a conventional centrifugal pump, suggesting that the inclusion of the flexible membrane does not alter hydraulic performance. The value of SHE rose when systolic volume was increased. However, SHE dropped when the percentage of ejection time was reduced and also when the continuous flow (programed by the centrifugal console) increased. Mean flow matched well with the continuous flow set by the centrifugal console, that is, the pulsatile component of the flow was exclusively controlled by the pulsatile console, and was therefore independent of the continuous flow programed by the centrifugal console. The pulsatility of the new pump was ∼25% of that created with a truly pulsatile pump.     

Comparison of hemolytic properties of different shapes of occlusion of blood sac in occlusive-type pulsatile blood pump

Abstract:  The occlusive-type pulsatile extracorporeal blood pump (T-PLS, Seoul National University, Seoul, Korea) received the Communauté Européenne mark of the European Directives (2003) and Korea Food and Drug Administration approval (2004) for short-term application as an extracorporeal life support system. The pump system was recently upgraded in the ameliorated actuator head for reducing hemolysis, rather than in the existing actuator head. In this study, the hemolytic performance of the new pump system (assessed as the degree of occlusiveness of the blood sac) was compared with the existing one. A roller pump, the Stockert S3 (Stockert Instrumente GmbH, Munchen, Germany), was selected as a control device. Five tests were conducted for each pump, with each of these tests lasting for 6 h. A pump flow of 3 L/min with 50 beats per minute was included in the hemolytic test conditions. The lowest hemolytic results were obtained by the new pump system yielding a normalized index of hemolysis of less than 0.005 g/100 L, and this result was one-fourth that of the roller pump, Stockert S3.     

Development of a flow-transformed pulsatile total artificial heart for total implantation

To realize a totally implantable total artificial heart (TAH), a new pulsatile TAH, the flow-transformed pulsatile TAH (FTPTAH), was developed. The system was composed of a single centrifugal pump (CFP) and two three-way valves. One port of each three-way valve was connected to the inlet and outlet of a CFP. The other two ports of each valve were connected to the right and left atrium, and the pulmonary artery and aorta. The CFP can perfuse the pulmonary and systemic circulation alternately with pulsatile flow by switching the two three-way valves. A prototype and the secondary model in which the solenoid valves and a spool valve were included, respectively, were connected to a mock circulatory unit with the results that a pulsatile TAH with physiological flow wave form could be obtained from a single CFP, about 5 L/min of pulsatile output could be obtained alternately on the right and left side by switching the solenoid valves or a spool valve, and flow balance between the right and left could be easily controlled by the switching duration. The system is feasible for a totally implantable TAH because it does not need a compliance chamber and can be miniaturized.     

Centrifugal blood pump with a magnetically suspended impeller

A centrifugal blood pump with a magnetically suspended impeller has been developed. It has a single inlet and outlet, and it generates centrifugal forces by the rotating impeller. The fluid-dynamical design for inflow and outflow through the impeller leads to elimination of the axial force and unbalanced radial force acting on the impeller. Consequently, three-component control systems, instead of five-component ones, are enough to position the impeller. The magnetically suspended impeller rotates by the magnetic coupling with the permanent magnets embedded in the outer rotator of the motor. This pump has enough performance to function as a blood pump. Further research on the null-power magnetic suspension and the generation of an efficient rotating magnetic field is in progress.     

Development of a magnetic fluid shaft seal for an axial-flow blood pump

A rotating impeller in a rotary blood pump requires a supporting system in blood, such as a pivot bearing or magnetic suspension. To solve potential problems such as abrasive wear and complexity of a supporting system, a magnetic fluid seal was developed for use in an axial-flow blood pump. Sealing pressures at motor speeds of up to 8,000 rpm were measured with the seal immersed in water or bovine blood. The sealing pressure was about 200 mm Hg in water and blood. The calculated theoretical sealing pressure was about 230 mm Hg. The seal remained perfect for 743 days in a static condition and for 180+ days (ongoing test) at a motor speed of 7,000 rpm. Results of measurement of cell growth activity indicated that the magnetic fluid has no negative cytological effects. The specially designed magnetic fluid shaft seal is useful for an axial-flow blood pump.