Evaluation of floating impeller phenomena in a Gyro centrifugal pump.

The Gyro centrifugal pump developed as a totally implantable artificial heart was designed with a free impeller, in which the rotational shaft (male bearing) of the impeller was completely separated from the female bearing. For this type of pump, it is very important to keep the proper magnet balance (impeller-magnet and actuator-magnet) in order to prevent thrombus formation and/or bearing wear. When the magnet balance is not proper, the impeller is jerked down into the bottom bearing. On the other hand, if magnet balance is proper, the impeller lifted off the bottom of the pump housing within a certain range of pumping conditions. In this study, this floating phenomenon was investigated in detail. The floating phenomenon was proved by observation of the impeller behavior using a transparent acrylic pump. The impeller floating phenomenon was mapped on a pump performance curve. The impeller floating phenomenon is affected by the magnet-magnet coupling distance and rotational speed of the impeller. In order to keep the proper magnet balance and to maintain the impeller floating phenomenon at the driving condition of right and left pump, the magnet-magnet coupling distance was altered by a spacer which was installed between the pump and actuator. It became clear that the same pump could handle different conditions (right and left ventricular assist), by just changing the thickness of the spacer. When magnet balance is proper, the floating impeller phenomenon occurs automatically in response to the impeller rev. It is called "the dynamic RPM suspension".

Reduction in surgical site infection in patients treated with microbial sealant prior to coronary artery bypass graft surgery: a case-control study.

Surgical site infection (SSI) is a serious complication after cardiac surgery. This case-control study investigated the effect of a cyanoacrylate-based microbial skin sealant (InteguSeal) applied preoperatively on the SSI rate in patients undergoing coronary artery bypass graft (CABG) surgery. Of 676 patients who underwent CABG surgery with or without concomitant procedure(s) between March and November 2007, 545 received standard preoperative care and 131 also received pretreatment with the microbial sealant. Of these, 90 cases pretreated with microbial sealant and 90 controls were matched using established preoperative and intraoperative risk factors for SSI. Preoperative risk scores for SSI were 9.9+/-4.3 and 9.7+/-4.0 (P=0.747) for the microbial sealant and the control group, respectively, and combined preoperative-intraoperative risk scores were 9.7+/-4.1 and 8.7+/-3.5 (P=0.080), respectively. Carotid artery disease (P=0.019), congestive heart failure (P=0.019), acute myocardial infarction (P=0.001) and emergency surgery (P=0.026) were significantly more common in the microbial sealant group. Follow-up was 100% for both groups. Superficial or deep sternal infection 30 days post surgery developed in seven patients (7.8%) in the control group compared with one patient (1.1%) in the microbial sealant group (odds ratio 7.5). In summary, the inclusion of microbial sealant in preoperative patient preparation seems to reduce the incidence of SSI following CABG surgery; further larger studies are needed before firm conclusions can be drawn.

Clinical experience with the 3F stentless aortic bioprosthesis: one-year follow up.

BACKGROUND AND AIM OF THE STUDY: The 3F equine aortic bioprosthesis is a new stentless valve which is currently undergoing evaluation in a multicenter clinical trial and is considered to have superior hemodynamic performance. Herein is reported the authors' initial experience with the 3F valve, focusing on the hemodynamic performance of the device. METHODS: Between March 2002 and October 2003, 35 patients (age range 61-86 years) underwent aortic valve replacement with the 3F valve implanted in the subcoronary position. Evaluation of valve hemodynamic performance was assessed at discharge (postoperative day 5 +/- 2), at 3-6 months, and at 11-14 months' follow up by means of transthoracic echocardiography. The mean preoperative transvalvular pressure gradient was 63 +/- 14 mmHg. Before surgery, all patients were in NYHA class III or IV, despite aggressive medical treatment. Five patients underwent concomitant coronary artery bypass grafting. RESULTS: The implanted valve sizes ranged from 21 to 29 mm. There were no operative deaths and no major perioperative complications. After 12 months, mean pressure gradients for the 23-, 25-, 27- and 29-mm valves were 13, 13, 12 and 9 mmHg, respectively. Mean systolic pressure gradients and NYHA class were improved significantly after surgery. Mild signs of hemolysis and minimal central regurgitation were detected in some patients, but were of no clinical importance. Valve dysfunction or mechanical failure did not occur during the follow up period. CONCLUSION: Because of its flexible structure, the 3F aortic bioprosthesis is simple to implant, and no major adverse effects have been associated with such valve implantation at the authors' center. Transprosthetic gradients appeared to regress at 6-12 months' follow up. The durability of the device is yet to be established in ongoing long-term trials.

Current status on the development of a totally implantable biventricular assist device: the Baylor Gyro BVAD.

OBJECTIVE: The Baylor Gyro BVAD is under development with the final goal of establishing a totally implantable biventricular assist system (BVAD). The aim of this study was to evaluate the safety, reliability, and effectiveness of the device in a long-term in vivo model. METHODS: The BVAD was implanted into eight calves for longer than 4 weeks in a biventricular bypass fashion, with the native heart remaining. Pump performance was assessed with the system's digital data acquisition unit. Postoperatively, anticoagulation was maintained with i.v. heparin perfusion (ACT< or = 250 sec) gradually replaced by coumadin. Treadmill exercise tests were performed daily following a 10-day reconvalescence period after surgery. RESULTS: The animals were kept alive for 37-90 days. The pumps yielded average flows of 5.3 +/- 1.1 l/min and 4.9 +/- 0.7 l/min for the LVAD and RVAD, respectively. Power consumption was 8.2 +/- 2.7 W and 9.6 +/- 4.7 W at 1935 +/- 123 rpm and 2015 +/- 365 rpm, respectively. All cases exhibited low hemolysis; renal and liver function were kept normal throughout the experiments. The animals demonstrated no thromboembolic neurological symptoms and tolerated moderate treadmill exercise. CONCLUSION: The Baylor Gyro BVAD demonstrated effective and reliable in vivo performance with acceptable biocompatibility. Based on these studies, we conclude that the system will be suitable as a long-term totally implantable BVAD for uses intended for longer than two years.

Evaluation of floating impeller phenomena in a gyro centrifugal pump.

The Gyro centrifugal pump, developed as a totally implantable artificial heart, was designed with a free impeller in which the rotational shaft (male bearing) of the impeller was completely separated from the female bearing. For this type of pump, it is very important to keep the proper magnet balance (impeller-magnet and actuator-magnet balance) to prevent thrombus formation or bearing wear. When the magnet balance is not proper, the impeller is jerked down into the bottom bearing. On the other hand, if magnet balance is proper, the impeller is lifted off the bottom of the pump housing within a certain range of pumping conditions. In this study, this floating phenomenon was investigated in detail. The floating phenomenon was proven by observation of the impeller behavior by means of a transparent acrylic pump. The impeller floating phenomenon was mapped on a pump performance curve. The impeller floating phenomenon is affected by the magnet-magnet coupling distance and the rotational speed of the impeller. To keep the proper magnet balance and to maintain the impeller floating phenomenon at the driving conditions of right and left pumps, the magnet-magnet coupling distance was altered by a spacer that was installed between the pump and actuator. It became clear that the same pump could handle different conditions (right and left ventricular assist) by changing the thickness of the spacer. When magnet balance is proper, the floating impeller phenomenon occurs automatically in response to the impeller revolution. This is called "the dynamic revolutions per minute suspension."

Operating point control system for a continuous flow artificial heart: in vitro study.

We proposed and developed a practical and effective servo control system for rotary blood pumps. A rotary blood pump for assisting the failing natural heart should be operated only in physiologically acceptable conditions. The operation of a rotary blood pump is based on the rotational speed of the impeller and pressure head. If the pump flow and the pressure head are set within an acceptable range, the driving condition is deemed normal condition, and this control system maintains the preset operating point by applying proportional and detective control (PD control). If the pump flow or pressure head is outside the acceptable range, the driving condition is determined to be abnormal condition, and this system operates the pump in a recovery fashion. If the driving condition is kept under abnormal conditions of sudden decrease of the flow, the condition is termed a suction condition. The controller releases the pump from the suction condition and later returns it to the normal condition. In this study, we evaluated these servo control modes of the centrifugal pump and confirmed whether the performance of this proposed operating point control system was practical.

In vitro comparison of blood pump induced platelet microaggregates between a centrifugal and roller pump during cardiopulmonary bypass.

UNLABELLED: Platelets are consumed during cardiopulmonary bypass (CPB) and mechanical ventricular assistance, at least partly as a result of the formation of platelet microaggregates in the blood pump. There is no commonly accepted method currently available to detect platelet microaggregates during the use of CPB or left ventricular assist devices (LVAD). The purpose of this study was to develop a flow cytometric method for the quantification of platelet microaggregates generated in blood pumps, and to evaluate the effect of cellular fragments from hemolyzed erythrocytes on the perioperative assessment of platelet counts during CPB. METHOD: Fresh human anticoagulated blood (1IU heparin/mL, activated clotting time 250+/-24 sec.) was circulated for 120 minutes in an artificial circulatory system, containing either a centrifugal pump (CP) or roller pump (RP). Whole blood was used to quantify platelet consumption and to detect circulating platelet microaggregates in a flow cytometer. Platelet consumption was additionally analyzed using an automated "Coulter" blood cell counter. Hemolysis was analyzed by measurement of plasma free hemoglobin (fHb), as well a by flow cytometric detection of red blood cell (RBC) fragments. RESULTS: Flow cytometric analysis demonstrated significantly more circulating platelet aggregates and platelet consumption in the RP than in the CP (p<0.01). Quantification of RBC fragments and plasma free hemoglobin (fHb) levels also indicated significantly increased hemolysis in the RP than in the CP (p<0.01). In contrast, the Coulter count data indicated less platelet consumption in the PP compared to the CP. CONCLUSION: Fragments from hemolyzed erythrocytes have the same size distribution as intact platelets and the number of RBC fragments correlates with the extent of pump-induced hemolysis during CPB. Our data suggest that assessment of platelets by "Coulter counting" cannot distinguish platelets from RBC fragments and may underestimate platelet consumption in the presence of hemolysis during CPB. We conclude that flow cytometry is more accurate in the perioperative assessment of platelet count and platelet aggregation during CPB and LVAD support.

Development of the Baylor Gyro permanently implantable centrifugal blood pump as a biventricular assist device.

The Baylor Gyro permanently implantable centrifugal blood pump (Gyro PI pump) has been under development since 1995 at Baylor College of Medicine. Excellent results were achieved as a left ventricular assist device (LVAD) with survival up to 284 days. Based on these results, we are now focusing on the development of a biventricular assist device (BVAD) system, which requires 2 pumps to be implanted simultaneously in the preperitoneal space. Our hypothesis was that the Gyro PI pump would be an appropriate device for an implantable BVAD system. The Gyro PI 700 pump is fabricated from titanium alloy and has a 25 ml priming volume, pump weight of 204 g, height of 45 mm, and pump diameter of 65 mm. This pump can provide 5 L/min against 100 mm Hg at 2,000 rpm. In this study, 6 half-Dexter healthy calves have been used as the experimental model. The right pump was applied between the infundibular of the right ventricle and the main pulmonary artery. The left pump was applied between the apex of the left ventricle and the thoracic descending aorta. As for anticoagulation, heparin was administered at the first postoperative week and then converted to warfarin sodium from the second week after surgery. Both pump flow rates were controlled maintaining a pulmonary arterial flow of less than 160 ml/kg/min for the sake of avoidance of pulmonary congestion. Blood sampling was done to assess visceral organ function, and the data regarding pump performance were collected. After encountering the endpoint, which the study could not keep for any reasons, necropsy and histopathological examinations were performed. The first 2 cases were terminated within 1 week. Deterioration of the pump flow due to suction phenomenon was recognized in both cases. To avoid the suction phenomenon, a flexible conduit attached on the inlet conduit was designed and implanted. After using the flexible inflow conduit, the required power and the rotational speed were reduced. Furthermore, the suction phenomenon was not observed except for 1 case. There was no deterioration regarding visceral organ function, and pulmonary function was maintained within normal range except for 1 case. Even though the experimental animal survived up to 45 days with the flexible inflow conduit, an increase in power consumption due to thrombus formation behind the impeller became a problem. Lower rotational speed, which was probably produced by the effectiveness of the flexible inflow conduit, was speculated to be one of the reasons. And the minimum range of rotational speed was 1,950 rpm in these 6 BVAD cases and the previous 3 cases of LVAD. In conclusion, 6 cases of BVAD implantation were performed as in vivo animal studies and were observed up to 45 days. The flexible inflow conduit was applied in 4 of 6 cases, and it was effective in avoiding a suction phenomenon. The proper rotational speed of the Gyro PI 700 pump was detected from the viewpoint of antithrombogenicity, which is more than 1,950 rpm.

Direct detection of red blood cell fragments: a new flow cytometric method to evaluate hemolysis in blood pumps.

Pump induced hemolysis is presently evaluated by measuring plasma free hemoglobin (fHb). However, this method has disadvantages because quantification of fHb depends on hematocrit (HCT) and hemoglobin (Hb) levels. The aim of this work was to devise a hemoglobin independent method, capable of quantifying cell trauma directly by measuring the number of red blood cell (RBC) fragments. Whole blood flow cytometry was used to quantify circulating RBC fragments derived from a roller pump (Sarns, Inc. Model 2 M 6,002) and a centrifugal pump (Gyro C1E3, Kyocera Corp.). The pumps were tested in a mock circuit for 2 hr (5 L/min flow against 100 mm Hg pressure head). Red blood cell fragments were quantified by a phycoerythrin (PE) labeled glycophorin A antibody specific for erythrocytes. Red blood cell fragments were smaller than the intact RBC population and overlapped in size with the platelet population (based on forward- and side-light scattering measurements). For the roller pump, the values for RBC fragments increased from 1,090 +/- 260/microl at 0 min to 14,880 +/- 5,900/microl after 120 min. In contrast, using the centrifugal pump, there was little increase in RBC fragments (from 730 +/- 270/microl at 0 min to 1,400 +/- 840/microl after 120 min). Flow cytometry can be used for the rapid, sensitive, hemoglobin independent evaluation of pump induced RBC trauma.

Blood trauma induced by clinically accepted oxygenators.

Hemolysis remains one of the most serious problems during cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), and percutaneous cardiopulmonary support (PCPS). However, the hemolytic characteristics associated with oxygenators are not well defined. A specialized hemolysis test protocol for oxygenators was developed. A comparative study was performed following this protocol to determine the hemolytic characteristics of the clinically available oxygenators during CPB; pressure drop measurements in the blood chamber were also performed. Four oxygenators (Medtronic Affinity, Cobe Optima, Terumo Capiox SX25, and Bard Quantum) were evaluated. Fresh blood from healthy Dexter calves anticoagulated with citrate phosphate dextrose adenine solution was used. The blood flow was fixed at 5 L/min, similar to that used in CPB. The Normalized Index of Hemolysis for Oxygenators (NIHO) has been modified according to the American Society of Testing and Materials (ASTM) standards. The NIH value, which was obtained from the circuit without an oxygenator, was subtracted from the primary NIH value, obtained from the circuit with an oxygenator to eliminate the effects of a centrifugal pump or other artifacts. The NIHO value was the lowest in the Affinity (0.0116 +/- 0.0017) and increased from Affinity < Optima (0.0270 +/- 0.0038) < Capiox (0.0335 +/- 0.0028) < Quantum (0.0416 +/- 0.0015 g/100 L). The Optima and Capiox did not demonstrate a significant difference. In addition, this NIHO value has a close relationship to the pressure drop. In conclusion, this new evaluation method is suitable to compare the biocompatibility performance of different types of clinically available oxygenators for CPB usage.

Gas transfer performance of a hollow fiber silicone membrane oxygenator: ex vivo study.

Based on the results of in vitro studies of many experimental models, a silicone hollow fiber membrane oxygenator for pediatric cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) was developed using an ultrathin silicone hollow fiber with a 300 microm outer diameter and a wall thickness of 50 microm. In this study, we evaluated the gas transfer performance of this oxygenator simulating pediatric CPB and ECMO conditions. Two ex vivo studies in a pediatric CPB condition for 6 h and 5 ex vivo studies in an ECMO condition for 1 week were performed with venoarterial bypass using healthy calves. At a blood flow rate of 2 L/min and V/Q = 4 (V = gas flow rate, Q = blood flow rate) (pediatric CPB condition), the O2 and CO2 gas transfer rates were maintained at 97.44 +/- 8.88 (mean +/- SD) and 43.59 +/- 15.75 ml/min/m2, respectively. At a blood flow rate of 1 L/min and V/Q = 4 (ECMO condition), the O2 and CO2 gas transfer rates were maintained at 56.15 +/- 8.49 and 42.47 +/- 9.22 ml/min/m2, respectively. These data suggest that this preclinical silicone membrane hollow fiber oxygenator may be acceptable for both pediatric CPB and long-term ECMO use.

Development of a new hollow fiber silicone membrane oxygenator: in vitro study.

An experimental silicone hollow fiber membrane oxygenator for long-term extracorporeal membrane oxygenation (ECMO) was developed in our laboratory using an ultrathin silicone hollow fiber. However, the marginal gas transfer performances and a high-pressure drop in some cases were demonstrated in the initial models. In order to improve performance the following features were incorporated in the most recent oxygenator model: increasing the fiber length and total surface area, decreasing the packing density, and modifying the flow distributor. The aim of this study was to evaluate the gas transfer performances and biocompatibility of this newly improved model with in vitro experiments. According to the established method in our laboratory, in vitro studies were performed using fresh bovine blood. Gas transfer performance tests were performed at a blood flow rate of 0.5 to 6 L/min and a V/Q ratio (V = gas flow rate, Q = blood flow rate) of 2 and 3. Hemolysis tests were performed at a blood flow rate of 1 and 5 L/min. Blood pressure drop was also measured. At a blood flow rate of 1 L/min and V/Q = 3, the O2 and CO2 gas transfer rates were 72.45 +/- 1.24 and 39.87 +/- 2.92 ml/min, respectively. At a blood flow rate of 2 L/min and V/Q = 3, the O2 and CO2 gas transfer rates were 128.83 +/- 1.09 and 47.49 +/- 5.11 ml/min. Clearly, these data were superior to those obtained with previous models. As for the pressure drop and hemolytic performance, remarkable improvements were also demonstrated. These data indicate that this newly improved oxygenator is superior to the previous model and may be clinically acceptable for long-term ECMO application.

Hemodynamic exercise response in calves with an implantable biventricular centrifugal blood pump.

An implantable biventricular assist device (BVAD) has been developed at Baylor College of Medicine using 2 centrifugal blood pumps. The aim of this study was to investigate the exercise-reflex response during nonpulsatile biventricular assistance and to evaluate to which degree the autoregulation of the system would accommodate the changed hemodynamic situation during physical exercise. The Baylor Gyro PI 710 BVAD has been implanted into 2 calves (strain half-Dexter) in a biventricular bypass fashion with native heart remaining. Allowing a 10 day convalescence, 2 animals were subjected to incremental exercise tests. The speed of the treadmill was increased at zero slope from 0.7 mph to 1.5 mph with increments of 0.2 mph every 3 min. During the exercise the pump flows were maintained at a fixed rate (6.93 +/- 0.01 L/min for the left ventricular assist device and 5.36 +/- 1.44 L/min for the right ventricular assist device). Hemodynamic parameters and pump performance were recorded continuously. The cardiac output (CO) and heart rate (HR) increased significantly during the exercise. CO increased from 11.1 +/- 0.3 to 13.1 +/- 0.4 L/min, and HR increased from 99 +/- 7.1 to 114 +/- 2.8 bpm, respectively. Mean aortic pressure, central venous pressure, and left arterial pressure did not change significantly. Also, no change was observed for the left and right pump flows. This totally implantable BVAD showed excellent long-term performance without any mechanical problems. It is feasible to operate without impairment under physical activity. However, the natural heart dominated the hemodynamic response during exercise under BVAD support. The left and the right pump flows did not increase spontaneously with exercise. We therefore conclude that a servo CO control system is necessary to regulate pump flows even during moderate exercise.

Analysis of the arterial blood pressure waveform during left ventricular nonpulsatile assistance in animal models.

When the rotary blood pump is used as a left ventricular assist device (LVAD), the arterial blood pressure waveform changes with the LVAD condition. Based on evidence from an in vitro study, the change of the arterial blood pressure waveform during left ventricular assistance was evaluated using animal models. After the left pleural cavity was opened through the fifth intercostal space under general anesthesia, a rotary blood pump was implanted as an LVAD into 6 healthy calves. The direct left carotid arterial blood pressure waveform was measured and recorded by an oscilloscope. The Fast Fourier Transform technique was utilized to analyze the arterial blood pressure waveform and calculate the pulsatility index (PI) and the pulse power index (PPI). Similar to the in vitro study, the PI and PPI decreased exponentially with the increase of the LVAD assist ratio. By using this analysis methodology, a physiologically effective ventricular assistance might be achieved.

Impeller design for a miniaturized centrifugal blood pump.

The impeller design for a miniature centrifugal blood pump is an important consideration since the small diameter impeller requires higher rotational speed, which may cause more blood trauma compared to the larger diameter impeller. Three different impeller vanes (straight vanes with a height of 4 mm and 8 mm, and 8 mm curved vanes) of which the diameter was 35 mm were subjected to hydraulic performance and hemolysis tests in the same pump housing. Both straight vane impellers attained left ventricular assist condition (5 L/min against 100 mm Hg) at 2,900 rpm while the curved vane required 3,280 rpm. There was no significant hemolysis difference between the tall and short vanes. The curved impeller vanes did not exhibit sufficient hydraulic performance when compared to the straight vanes. The straight vane impellers, even with different heights, were incorporated into the same pump housings, and the vane heights did not drastically change the hydraulic performance or hemolysis.

Gyro pump wear and deformation analysis in vivo study: creep deformation.

The Gyro pump has a double pivot bearing system to support its impeller. In this study, the integrity of the bearing system was examined after ex vivo studies. The pumps were implanted into calves and evaluated for different periods as a paracorporeal left ventricular assist device (LVAD). One pump was subjected to a test of 30 days, 1 for 15 days, 4 for 14 days, 1 for 10 days, 1 for 7 days, 2 for 4 days, and 4 for 2 days. One additional pump was subjected to percutaneous cardiopulmonary support (PCPS) condition for 6 days (total pressure head 500 mm Hg with a pump flow rate of 3 L/min). The anticoagulation treatment consisted of a continuous administration of heparin to maintain an achieved clotting time (ACT) of 200-250 s during the LVAD study and 250-300 s during the PCPS study. After the experiment, the pumps were disassembled, and the wear and deformation of male and female bearings were analyzed. There were no dimensional changes on male bearings but there were on female bearings. Wear and deformation of the female bearings were calculated as follows: wear and deformation = (depth of female before pumping) - (depth after pumping). Thirteen assembled Gyro pumps were disassembled to measure the depth of the female bearings before pumping. There was no statistical relationship between the wear and deformation and the motor speed x driving period. From these results, the deformation was not due to wear but to the creep or elastic deformation. This study suggested that the double pivot bearing system of the Gyro pump is highly durable.

Right ventricular assist system feedback flow control parameter for a rotary blood pump.

At least 25-30% of patients with a permanent implantable left ventricular assist device (LVAD) experience right ventricular failure; therefore, an implantable biventricular assist system (BiVAS) with small centrifugal pumps is being developed. Many institutions are focusing and developing a control system for a left ventricular assist system (LVAS) with rotary blood pumps. These authors feel that the right ventricular assist system (RVAS) with rotary blood pumps should be developed simultaneously. A literature search indicated no recent reports on the effect of hemodynamics and exercise with this type of nonpulsatile implantable RVAS. In this study, a calf with an implantable right ventricular assist system (RVAS) was subjected to 30 min of exercise on a treadmill at 1.5 mph, resulting in excellent hemodynamics. The input voltage remained unchanged. Hemodynamic recordings were taken every 5 min throughout the testing period, and blood gas analysis was done every 10 min. Oxygen uptake (VO2), oxygen delivery (DO2), and oxygen extraction (O2ER) were calculated and analyzed. Two different pump flows were investigated: Group 1 low assist (<3.5 L/min) and Group 2 high assist (>3.5 L/min). In both groups, the RVAS flow rates were unchanged while the pulmonary artery (PA) flow increased during exercise; also, the heart rate and right atrial pressure (RAP) increased during exercise. There were no significant differences in the 2 groups. The PA flow correlates to the heart rate during exercise. In all of the tests, the VO2 and DO2 increased during exercise. Regarding VO2, no changes were observed during the different flow conditions; however, the DO2 of Group 2 was higher than that of Group 1. Because the implantable RVAS did not have pump flow changes during the test conditions, it was necessary to incorporate a flow control system for the implantable RVAS. During exercise with an implantable RVAS rotary blood pump, incorporating the heart rate and VO2 as feedback parameters is feasible for controlling the flow rate.

Antithrombogenicity evaluation of a centrifugal blood pump.

The Gyro C1E3 pump was developed not only for cardiopulmonary bypass but also as a short-term assist device. The main purpose of this study was to examine the correlation between the thrombus formation factor and the Gyro C1E3 pumps. Seven pumps were implanted into 3 calves and evaluated for different periods of duration as a paracorporeal left ventricular assist device (LVAD). One pump was subjected to percutaneous cardiopulmonary support condition (PCPS) (total pressure head 500 mm Hg with a pump flow rate of 3 L/min). The anticoagulation treatment consisted of a continuous administration of heparin to maintain an activated clotting time (ACT) of 200-250 during the LVAD study and 250-300 during the PCPS study. After the experiment, the pumps were disassembled and examined. In cases where there were any blood-derived deposits inside the pumps, the dry weight of these thrombi that adhered to the bearing area of the pump was measured. A multiple correlation was attempted to speculate possible thrombus formation. The estimated dry weight of thrombi was calculated from pump flow rate, pumping day, motor speed, and activated clotting time. This equation was estimated dry weight of thrombi = 1.140 x pump flow rate -0.001 motor speed + 1.652 pumping time -0.041 x ACT + 2.198 R2 = 0.944. This study suggested that there was a possibility to calculate the amount of adhered thrombus formation from pump flow rate, motor speed, pumping day, and ACT.

Analysis of the arterial blood pressure waveform using Fast Fourier Transform technique during left ventricular nonpulsatile assistance: in vitro study.

The arterial blood pressure waveform is variable during left ventricular assistance. The aim of this study is to examine the correlation between the left ventricular assist device (LVAD) condition and the arterial blood pressure waveform in a fixed cardiac output condition using a mock circuit. This mock circulation loop was composed of an aortic compliance chamber, a left atrial compliance chamber, a pneumatic pulsatile pump as a native heart, and a rotary blood pump representing the LVAD with left atrial drainage. The Fast Fourier Transform technique was utilized to analyze the arterial blood pressure waveform and calculate the pulsatility index (PI) and the pulse power index (PPI). The PI and PPI decreased with the increase of the LVAD rotational speed, exponentially. There was a significant negative correlation between the PI, PPI, and the LVAD rotational speed, flow rate, and assist ratio. The best correlation was observed between the PPI and the assist ratio (r = 0.986). From this viewpoint, an ideal LVAD condition may be estimated from the pulsatility change of the arterial blood pressure waveform.

Preclinical evaluation of a hollow fiber silicone membrane oxygenator for extracorporeal membrane oxygenator application.

A silicone membrane hollow fiber oxygenator applicable for use as an extracorporeal membrane oxygenator (ECMO) has been developed in our laboratory. This silicone hollow fiber displays astonishing mechanical stability, is barely compressible or stretchable, and assembles easily while maintaining good gas permeability. The priming volume is 140 cc with a surface area of 0.8 m2. This study evaluated the gas transfer performances and biocompatibility of the oxygenator under ECMO and CPB conditions. In vitro studies that were performed at a blood flow rate of 2 L/min, and revealed O2 and CO2 gas transfer rates of 82.35 +/- 0.56 ml/m2/L/min and 38.72 +/- 2.88 ml/m2/L/min, respectively. The commercially available Kolobow (Avecor 1500) oxygenator was used as the control, and had O2 and CO2 gas transfer rates of 53.8 +/- 0.5 ml/m2/L/min and 24.7 +/- 2.0 ml/m2/L/min. To evaluate blood trauma, Normalized Index of Hemolysis (NIH) was measured according to American Society of Testing and Materials (ASTM) standards. The NIH findings were 0.0112 g/100L at a blood flow of 1 L/min, and 0.0152 g/100L at 5 L/min. Three ex vivo experiments, using a blood flow rate of 1 L/min, were performed with venoarterial bypass, and O2 transfer rate and CO2 transfer rate of the oxygenators were well maintained. This indicates that this preclinical silicone membrane hollow fiber oxygenator has superior efficiency, less blood trauma, and is smaller when compared with the only clinically available Kolobow oxygenator.