Clinical experiences of surgical repair for mitral regurgitation secondary to papillary muscle rupture complicating acute myocardial infarction.

Mitral regurgitation secondary to ischemic heart disease carries a significant mortality even after emergency open heart surgery. From 1993 to 1997, four patients were operated on for ischemic mitral regurgitation secondary to papillary muscle rupture. These patients were between 58 and 69 years of age and all were in class III or IV of the New York Heart Association Classification. The responsible infarction area was located in the lateral wall in 2 patients, and inferior in others. The interval between the onset of acute myocardial infarction and the appearance of mitral regurgitation was from 1 to 10 days. Three patients had partial rupture (defined as only one or several heads of papillary muscle ruptured), and one had total papillary muscle rupture. Primary mitral plasty was performed in 3 patients, including 1 patient who had undergone patch closure of ventricular septal perforation at the onset of acute myocardial infarction. Mitral plasty combined with coronary artery bypass grafting was performed in 1 patient. Only one case, who had total papillary muscle rupture, required reoperation for recurrence of mitral regurgitation. We suggest that even in the case of ischemic mitral regurgitation, when a papillary muscle rupture is partial, mitral repair is performed because of its potential for improving therapeutic results.

A pivot bearing-supported centrifugal pump for a long-term assist heart.

A pivot bearing-supported centrifugal blood pump has been developed. It is a compact, cost effective, and anti-thrombogenic pump with anatomical compatibility. A preliminary evaluation of five paracorporeal left ventricular assist studies were performed on pre-conditioned bovine (70-100 kg), without cardiopulmonary bypass and aortic cross-clamping. The inflow cannula was inserted into the left ventricle (LV) through the apex and the outflow cannula affixed with a Dacron vascular graft was anastomosed to the descending aorta. All pumps demonstrated trouble free performance over a two-week screening period. Among these five studies, three implantations were subjected for one month system validation studies. All the devices were trouble free for longer than 1 month. (35, 34, and 31 days). After achieving one month studies, all experiments were terminated. There was no evidence of device induced thrombus formation inside the pump. The plasma free hemoglobin levels were within normal ranges throughout all experiments. As a consequence of these studies, a mass production model C1E3 of this pump was fabricated as a short-term assist pump. This pump has a Normalized Index of Hemolysis of 0.0007 mg/100L and the estimated wear life of the impeller bearings is longer than 8 years. The C1E3 will meet the clinical requirements as a cardiopulmonary bypass pump. For the next step, a miniaturized pivot bearing centrifugal blood pump P1-601 has been developed for use as a permanently implantable device after design optimization. The evolution from C1E3 to the PI-601 converts this pivot bearing centrifugal pump as a totally implantable centrifugal pump. A pivot bearing centrifugal pump will become an ideal assist pump for the patients with failing heart.

Clinical usefulness of the effective regurgitant orifice area determined by transesophageal echocardiography in patients with eccentric aortic regurgitation.

BACKGROUND AND AIMS OF THE STUDY: The aortic regurgitant jet is frequently eccentric, and Doppler color flow mapping techniques of the distal jet is influenced by this eccentricity. The aim of the present study was to determine whether the effective regurgitant orifice area (EROA), determined by the proximal isovelocity surface area (PISA) method using multiplane transesophageal echocardiography (m-TEE), could be used to evaluate the severity of aortic regurgitation (AR) in patients with an eccentric jet. METHODS: Forty-eight patients with eccentric AR were studied. Values of EROA determined by the PISA method were compared with results from cross-sectional area (CSA), vena contracta (VC) width, aortic angiography, and regurgitant fraction. RESULTS: Values of EROA correlated well with results from CSA (r = 0.73, p < 0.001), VC (r = 0.74, p < 0.001), angiographic grade (rs = 0.90 p < 0.001), and regurgitant fraction (r = 0.84, p < 0.001) in patients with eccentric aortic regurgitation. Values of EROA > 0.27 cm2 were always associated with a regurgitant fraction > 0.4, while EROA values < 0.27 cm2 were always associated with a regurgitant fraction < 0.4. CONCLUSIONS: We conclude that, in patients with an eccentric jet, measurement of EROA values by the PISA method using m-TEE is a reliable method of assessing the severity of AR.

Development of a pivot bearing supported sealless centrifugal pump for ventricular assist.

Since 1991, in our laboratory, a pivot bearing-supported, sealless, centrifugal pump has been developed as an implantable ventricular assist device (VAD). For this application, the configuration of the total pump system should be relatively small. The C1E3 pump developed for this purpose was anatomically compatible with the small-sized patient population. To evaluate antithrombogenicity, ex vivo 2-week screening studies were conducted instead of studies involving an intracorporeally implanted VADs using calves. Five paracorporeal LVAD studies were performed using calves for longer than 2 weeks. The activated clotting time (ACT) was maintained at approximately 250 s using heparin. All of the devices demonstrated trouble-free performances over 2 weeks. Among these 5 studies, 3 implantations were subjected to 1-month system validation studies. There were no device-induced thrombus formations inside the pump housing, and plasma-free hemoglobin levels in calves were within the normal range throughout the experiment (35, 34, and 31 days). There were no incidents of system malfunction. Subsequently, the mass production model was fabricated and yielded a normalized index of hemolysis of 0.0014, which was comparable to that of clinically available pumps. The wear life of the impeller bearings was estimated at longer than 8 years. In the next series of in vivo studies, an implantable model of the C1E3 pump will be fabricated for longer term implantation. The pump-actuator will be implanted inside the body; thus the design calls for substituting plastic for metallic parts.

Ex vivo phase 1 evaluation of the DeBakey/NASA axial flow ventricular assist device.

A small ventricular assist device intended for long-term implantation has been developed by a cooperative effort between the Baylor College of Medicine and the NASA/Johnson Space Center. To date, in vitro tests have been performed to address hemolysis and pump performance issues. In this Phase 1 study, we assessed the durability and atraumatic features aiming for 2 day implantation. Eight pumps were implanted in 2 calves as paracorporeal left ventricular assist devices. The pump running times ranged from 18 to 203 h (78.1 +/- 23.7; mean +/- SEM). All the pump implantations were terminated because of thrombus formation. Plasma-free hemoglobin levels were below 13.7 mg/dl, except for 1 case complicated by inflow cannula obstruction. The pump speed was maintained between 10,100 and 11,400 rpm. Pump outputs were from 3.6 to 5.2 L/min. The electrical power required by the system ranged between 9 and 12 W. Clinically there was no detectable organ dysfunction noted, and postmortem evaluation demonstrated no pump related adverse effects in either calf except for small kidney infarctions. Thrombus deposition was observed mainly at the hub portions and the flow straightener.

Evaluation of the antithrombogenicity of a new microdomain structured copolymer.

A new antithrombogenic material was studied, fluorine-acryl-styrene-urethane-silicone (FASUS) copolymer, the theoretical basis of which attributed to its hydrophilic and hydrophobic microdomain structure. In this series of experiments, the blood compatibility of this copolymer was evaluated in vitro and ex vivo. For the in vitro evaluation, a whole blood clotting test and the microsphere column test were performed. For the ex vivo evaluation, two series of shunt tests in rabbits were performed, one was the arterioartery (A-A) shunt model, and the other was the arteriovenous (A-V) shunt model. The antithrombogenicity was assessed by measuring the shunt obstructive time in the A-A shunt experiment. The A-V shunt experiment was assessed by measuring the circulating platelet counts, platelet aggregability, activated partial thromboplastin time (APTT), and prothrombin time (PT). In the whole blood clotting test, FASUS revealed the significantly longer blood clotting time than that of the control glass tubings (19.7 +/- 1.0 versus 6.5 +/- 0.7 min, p < 0.001). In the microsphere column test, the coated group had a 30% reduction of the platelet number in the eluted blood in contrast with a marked decrease of 70% in the control group (p < 0.05). In the ex vivo A-A shunt experiment, the occlusion time for the FASUS-coated group was significantly longer than that of the control (109.7 +/- 17.3 versus 3.0 +/- 0.4 min, p < 0.05). The A-V shunt experiment showed that the FASUS copolymer suppressed the decrease in platelet counts and tended to improve prolonged APTT compared with that of the control. Clinically, in 25 patients, we placed coated FASUS copolymer into the cannulas for use in percutaneous cardiopulmonary support (PCPS) procedures. There was no evidence of thrombus on the blood contacting surface and no thromboembolism in major organs clinically or upon postmortem examination. In summary, this new copolymer may be effective in preventing thrombus formation in vitro, ex vivo, and in clinical situations.

Initial clinical experience with the Baylor-Nikkiso centrifugal pump.

Recently, a newly developed centrifugal pump, the Baylor-Nikkiso pump, was approved for clinical use in the United States. This pump is the most compact centrifugal pump with a priming volume of only 25 ml. Although it is small, this pump can provide a flow of 4 L/min against a total pressure head of 300 mm Hg at 3,000 rpm. In vitro and in vivo validation of the Baylor-Nikkiso pump has proved that this pump could effectively reduce blood trauma even under high total head pressure. In addition, 48-h durability tests with biventricular bypass using calves verified the reliability of shaft sealing and antithrombogenicity. Clinical trials of the Baylor-Nikkiso pumps have been initiated in our department. This pump provides flows of 60-70 ml/kg/min with stable hemodynamic conditions. No leakage of thrombus formation was observed. The results of the initial clinical experience of the Baylor-Nikkiso pump suggest that it is suitable for cardiopulmonary bypass surgery.

A thermoconductive and thermoselective leukocyte filter.

Previously, it was reported by our group that the superphysiological temperature of over 43 degrees C affected leukocyte properties. It was speculated that heat treatment might alter the immunological properties of leukocytes. In order to take advantages of this phenomenon, attempts were made to develop a thermoconductive and thermoselective leukocyte filter. A stainless steel fiber was selected for the new material of a leukocyte filter due to its good heat conductance, stability during thermal change, and inertness to any chemicals. Preliminary studies were conducted to evaluate the effect of fiber diameter and temperature on the filtration of blood cells. As a result, more than 99% of white blood cells (WBCs) and platelets were removed utilizing a 4 microns diameter fiber filter. The environmental temperatures of the filtration process were varied to 4, 20, 36, and 50 degrees C for 5 min. Almost 95% of WBCs and platelets were removed at 4, 20, and 36 degrees C. However, the reduction of platelets was remarkably suppressed at 50 degrees C (54%). Additionally, the removal of lymphocytes was significantly lower than that of neutrophils at 50 degrees C (69% vs. 83%; p = 0.0002). These data demonstrate that effective heat treatment and removal of leukocytes are possible with an ultrafine stainless steel fiber filter.

Flow pattern analysis of the Baylor total artificial heart.

To obtain an optimal design of the left blood chamber of the total artificial heart (TAH), flow visualization studies were performed. Information on velocities in critical areas of the left chamber was gathered using sectional pulsed laser light. The flow patterns on the entire pumping duration were photographed frame by frame. The inflow port, the opposite of the inflow and outflow of the pump (bottom area), and the diaphragm/housing junction were the focal areas. The pump conditions, such as chamber pressure, preload and afterload pressure, pumping rate and roller screw, and displacement were recorded. Major stagnations and a low washout effect were observed in the bottom region. The closing of the inflow valve was irregular. In order to solve this problem, the inflow valve angle was changed 20 degrees. A comparison study showed a better valve closing characteristic, and no stagnation areas were observed with this new valve angle. Various velocity profiles confirmed the results. The valve closing characteristics is described in relationship to back flow.

Does hematocrit affect in vitro hemolysis test results? Preliminary study with Baylor/NASA prototype axial flow pump.

The effect of hematocrit (Ht) on in vitro hemolysis test results (i.e., index of hemolysis) was evaluated using a Baylor/NASA prototype axial flow pump. Red blood cell suspensions of six different Ht (5, 10, 15, 20, 30, 40%; n = 30) were prepared and used for this evaluation. The pump was operated for 60 min under 5 L/min flow conditions, and blood samples were taken every 10 min to measure plasma free hemoglobin levels. The normalized index of hemolysis (NIH) was calculated using the regression line slope between time and plasma free hemoglobin level, and relationships between NIH and Ht or hemoglobin (Hb) were checked. NIH and Ht had a statistically significant (p < 0.0001) correlation with a coefficient of fit of 0.976, and NIH and Hb had a statistically significant (p < 0.0001) correlation with a coefficient of fit of 0.976. To reduce the effect of Ht, NIH/Ht was proposed and compared with a modified index of hemolysis (MIH), which was normalized by the Hb level of blood. NIH/Ht and MIH had a poor correlation with Ht (coefficient of fit, 0.608) and Hb (coefficient of fit, 0.577), respectively. When blood that has a wide range of Ht or Hb values is used for in vitro hemolysis tests, NIH/Ht is suggested for use as an index of hemolysis to evaluate the hemolysis characteristics of rotary blood pumps because MIH has no dimension and it requires Hb values. In contrast, NIH/Ht has a dimension of g/100 L, which is quite understandable, and it does not require measurement of Hb levels of blood; it is therefore cost-effective.

Development and evaluation of antithrombogenic centrifugal pump: the Baylor C-Gyro Pump Eccentric Inlet Port Model.

The Baylor C-Gyro Pump Eccentric Inlet Port Models (C1E) have been developed aiming for a long-term centrifugal ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. The eccentric inlet port models are characterized by their unique inlet port and secondary impeller vanes. An inlet female pivot bearing, which was fixed to a supporting bar in the prototype model, is directly embedded into the ceiling of the pump casing. An inlet port is then placed off-center to avoid the bearing area, and it is angled between 0 to 90 degrees from the upright position. In addition, small secondary vanes were incorporated into the impeller bottom to accelerate the washout flow behind the impeller. These features attained design objectives proposed for higher antithrombogenicity: a seal-less pump chamber, no stationary parts in the blood path, and acceleration of the secondary flow behind the impeller. The first in vivo experiment using C1E pumps showed excellent antithrombogenicity for up to 18 days when the experiment ceased due to severe infection in the calf.

The Baylor total artificial heart. Flow visualization studies.

To analyze the flow patterns of the left blood chamber of the Baylor total artificial heart (TAH) and to evaluate influences of the inflow valve angle to the flow patterns, flow visualization studies were performed. The inflow valve angle of the left housing was changed by 20 degrees orthogonal to the inflow tube, and comparison studies of the modified and unmodified models were made. For evaluating sectional flow patterns, a laser light was used, the clear transparent housing was scanned segmentally, and flow patterns were recorded on high contrast film for measuring flow velocities. A signal was used that synchronized the timing of the camera shutter to the pusher-plate movement signal. With the modified 20 degree inflow valve direction, there were better closing characteristics of the inflow valve leaflets. At the same time, we could successfully reduce the vortex formation at the inflow port, which may cause thrombus formation. We also have improved the washout during the diastolic phase in not only the bottom area, but in the entire pumping chamber. This flow visualization setup is simple and inexpensive. It is useful not only for validation of global flow patterns, but also for validation of local flow velocities of various blood pumps.

An ultimate, compact, seal-less centrifugal ventricular assist device: Baylor C-Gyro pump.

We have developed a compact, seal-less, all-purpose centrifugal pump, the Baylor C-Gyro pump, which is intended as a long-term ventricular assist device (VAD) as well as a cardiopulmonary bypass pump. In attaining this goal, we began with eliminating the shaft seals by adopting a pivot bearing system at the impeller shaft. In addition, a ring magnet encased in the bottom of the impeller was coupled magnetically to a driver magnet placed outside the pump housing (C1 Prototype). This first model yielded satisfactory performance in vitro with a flow rate of 8 L/min against 250 mm Hg at 2,400 rpm, and an index of hemolysis (IH) of 0.0083 g/100 L using bovine blood. In the second model, the C1 Eccentric Inlet Port Model, the inlet bearing support bar in the prototype were eliminated without reducing the prototype's performance. These designs for antithrombogenicity are being tested by the first in vivo experiment, which has lasted for more than 2 weeks.

Successful thermal management of a totally implantable ventricular assist system.

Thermal management of the implantable ventricular assist system (VAS) is important not only from the pathophysiological point of view but also from the standpoint of system endurance. The heat distribution within the Baylor VAS was measured using different motor housing materials and environmental conditions. The temperature of the circulating water in the mock loop was set at 37 degrees and 42 degrees C. A polycarbonate motor housing was not a suitable material because of the high temperature development in the actuation system. An anodized aluminum housing demonstrated excellent heat conductivity. The surface temperature of this motor housing was 41.6 degrees C when immersed in circulating water at 42 degrees C. Heat conduction from the motor to the circulating blood revealed an effective thermal path. In the worst case, the heat flux of the motor to the circulating blood revealed an effective thermal path. In the worst case, the heat flux of the motor housing was calculated to be less than 0.062 W/cm2--an acceptable level for the surrounding tissues.

In vitro and in vivo validation tests for total artificial heart.

Properly planned in vitro and in vivo studies are mandatory to validate blood pump performance. However, standard procedures for in vitro and in vivo tests of total artificial heart (TAH) performance still do not exist. At Baylor College of Medicine, standard tests procedures for performance validation of the totally implantable TAH have been established. In this paper, these in vitro tests protocols (performance mapping tests, accelerated endurance test, hemolysis test, flow visualization tests, etc.) are described as well as in vivo test procedures (TAH implantation procedure, including surgical technique, postoperative management and tests, etc.). In addition, pathological protocols are presented. In our experience, these procedures are very simple, easy to perform, and inexpensive. These protocols are proposed as standard in vitro and in vivo tests for a TAH.

Flow visualization in the Baylor total artificial heart.

To analyze the flow patterns of the left and right blood chambers of the total artificial heart (TAH), flow visualization studies were performed. Two setup levels were used for the flow visualization studies. For estimating the global flow patterns, the pumps were illuminated using incandescent light, and the patterns were recorded by either videotape or photography. To evaluate sectional flow patterns, a laser light was applied, and the pump could be scanned segmentally. The flow patterns were recorded by a high-speed camera. A signal was also used that synchronized the timing of the camera shutter to the pusher-plate movement signal. In the left pump chamber, major stagnations were observed in the middle area of the inflow site. To solve this problem, a modification was made that changed the inflow direction appropriately. After evaluation of the inflow port direction, a proper flow pattern was obtained, which was validated by a global flow visualization study. Furthermore, both pump chambers indicated excellent flow patterns as obtained by a segmental flow visualization study method utilizing a laser light. The Baylor TAH demonstrated excellent flow patterns in flow visualization studies, with antithrombogenicity expected. These flow visualization studies are very useful not only for validations of global flow patterns but also for validations of local areas of stagnation in various blood pumps.

Totally implantable total artificial heart and ventricular assist device with multipurpose miniature electromechanical energy system.

A multipurpose miniature electromechanical energy system has been developed to yield a compact, efficient, durable, and biocompatible total artificial heart (TAH) and ventricular assist device (VAD). Associated controller-driver electronics were recently miniaturized and converted into hybrid circuits. The hybrid controller consists of a microprocessor and controller, motor driver, Hall sensor, and commutation circuit hybrids. The sizing study demonstrated that all these components can be incorporated in the pumping unit of the TAH and VAD, particularly in the centerpiece of the TAH and the motor housing of the VAD. Both TAH and VAD pumping units will start when their power line is connected to either the internal power pack or the external battery unit. As a redundant driving and diagnostic port, an emergency port was newly added and will be placed in subcutaneous location. In case of system failure, the skin will be cut down, and an external motor drive or a pneumatic driver will be connected to this port to run the TAH. This will minimize the circulatory arrest time. Overall efficiency of the TAH without the transcutaneous energy transmission system was 14-18% to deliver pump outputs of 4-9 L/min against the right and left afterload pressures of 25 and 100 mm Hg. The internal power requirement ranged from 6 to 13 W. The rechargeable batteries such as NiCd or NiMH with 1 AH capacity can run the TAH for 30-45 min. The external power requirement, when TETS efficiency of 75% was assumed, ranged from 8 to 18 W. The accelerated endurance test in the 42 degrees C saline bath demonstrated stable performance over 4 months. Long-term endurance and chronic animal studies will continue toward a system with 5 years durability by the year 2000.

Baylor Gyro Pump: a completely seal-less centrifugal pump aiming for long-term circulatory support.

A seal-less centrifugal pump aiming for long-term circulatory support has been developed. In this model, shaft seals that cause thrombus formation and blood leakage were eliminated. A brushless direct current motor was incorporated as a driving unit, and pivot bearings were used to support the impeller. With reference to its motor-driven system, this pump was named the M-Gyro Pump. The first model (M1) yielded an index of hemolysis of 0.005 g/100 L using bovine blood and demonstrated satisfactory performance as a right heart assist for 2 days (4 L/min, 60 mm Hg, 1,800 rpm). The second model (M2) has been developed for left heart assist by employing a stronger motor. The pump capacity was improved to 6 L/min against 240 mm Hg at 1,800 rpm, but significant heat generation was observed. By optimization of motor efficiency, the M2 model can be improved to meet the requirements of a pump for left heart assist.

Development of the Baylor-Nikkiso centrifugal pump with a purging system for circulatory support.

The Baylor-Nikkiso centrifugal pump is a magnetically coupled system with a V-ring seal separating the pump and the actuator chamber. To prevent thrombus formation behind the impeller and to extend the life of the pump to 2 weeks of continuous operation, we incorporated a purging chamber behind the V-ring seal. An external pump connected to this purging chamber infused fluid at a constant rate to wash the shaft-seal area. To evaluate the effectiveness of the purging system, we have carried out biventricular bypass experiments using calves. The purging system was successful in reducing the level of thrombus formation after 2 weeks of operation. The results of these studies confirmed that the Baylor-Nikkiso centrifugal pump with this purging system is suitable for at least 2 weeks of continuous operation as a circulatory support system.

The Baylor-ABI electromechanical total artificial heart. Accelerated endurance testing.

To test the durability of each part or assembled component of the Baylor-ABI total artificial heart (TAH), the authors performed an endurance test under severe conditions. The TAH was immersed in a saline bath at 42 degrees C, which is 4-5 degrees C higher than normal body temperature. This is an accelerated endurance test because of the elevated temperatures. In this accelerated endurance test loop, the 42 degrees C heated saline was circulated not only in the pump but also outside the pump. During pumping, temperatures of the motor and outside surface of the centerpiece were continuously measured. This testing showed that during almost 4 months of pumping no electromechanical troubles were observed. Both inside (motor) and outside temperatures were stable and the differences in both temperatures were only 3-4 degrees C, demonstrating that heat generation is not a problem. The voltage and current required in this system remained constant, indicating stable and reliable performance. Based on these results, this pump is expected to run continuously over a long duration in a normal physiologic environment. This accelerated endurance test system is very suitable for estimating the influence of heat generation by the actuator of blood pumps. It is also quite useful in validating the durability of various cardiac prosthesis.