Satoshi Ohtsubo

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 an-tithrombogenicity, ex vivo 2-week screening studies were conducted instead of studies involving an intracorpore-ally 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.

Initial experience with the Nikkiso centrifugal pump during thoracoabdominal aortic aneurysm repair

PURPOSE Several centers use atriodistal bypass (ADB) as a protective adjunct against distal ischemia during extensive thoracoabdominal aortic aneurysm (TAAA) repair. Most current ADB circuits use indirect-drive centrifugal pumps. The purpose of this report is to describe our initial clinical experience with the Nikkiso pump, a more compact direct-drive centrifugal pump recently developed at Baylor, for ADB during TAAA repair. METHODS The Nikkiso pump was used for ADB perfusion in 10 consecutive patients during graft repair of TAAAs (six Crawford extent I and four extent II). Two patients had aortic dissection. In the four patients who had extent II repairs, selective renal and visceral perfusion was also performed with the Nikkiso pump. RESULTS No mechanical pump malfunctions or adverse events related to the device occurred. All 10 patients survived and were discharged from the hospital. No patient had paraplegia after surgery. Two patients had delayed lower extremity weakness after undergoing extent I repairs; both recovered and were ambulating at the time of discharge. No complications were associated with bleeding or cerebral, respiratory, renal, or hepatic function. CONCLUSIONS Our initial experience with the Nikkiso centrifugal pump during TAAA repair demonstrated excellent pump function that provided sufficient flow for both distal aortic and selective organ perfusion. The prevention of permanent spinal cord injury and distal organ failure was successful in this group.

Comparison of Centrifugal and Roller Pump Hemolysis Rates at Low Flow

We compared in vitro rates of hemolysis for a recently developed centrifugal pump with a conventional roller pump (10-10-00; Stöckert, Munich, Germany). Flow rates of 0.3 L/min and 1 L/min and a pressure of 200 mm Hg were chosen to simulate conditions during neonatal extracorporeal membrane oxygenation (ECMO). There was no significant difference in hemolysis rates between centrifugal and roller pumps (p = 0.57) nor between high and low flow (p = 0.86). The centrifugal pump caused no more blood trauma than the roller pump at the low-flow/high-pressure conditions required for neonatal ECMO. The Nikkiso pump is superior to roller pumps in size and priming volume (25 ml) and may permit development of a smaller and simpler ECMO system.

Clinical Comparative Study of Cardiopulmonary Bypass with Nikkiso and BioMedicus Centrifugal Pumps

The Nikkiso centrifugal pump was evaluated in elective adult open heard surgery in comparison with the BioMedicus pump. Ten patients using the Nikkiso pump (Group N), and 10 patients using the BioMedicus pump (Group B) were examined for (or to determine) hemato-biologic parameters and patient outcome data as well as pump controllability. During cardiopulmonary bypass (CPB), both pumps maintained systemic perfusion satisfactorily without any mechanical adverse event. Rotation speed of the Nikkiso centrifugal pump (3,580 ± 100 rpm) was significantly higher than that of the BioMedicus pump (3,170 ± 100 rpm; p < 0.05) whereas changes in free plasma hemoglobin, platelet count, blood urea nitrogen, and creatinine levels showed no significant differences between the two groups. Urine output in Group N for 30 min after the initiation of CPB (7.10 ± 1.50 ml/kg/h) was significantly higher than that in Group B (3.23 ± 0.46 ml/kg/h; p < 0.05). Patient outcome data were similar in both groups, such as duration of intensive care unit stay, hospital stay, postoperative intubation time, amount of postoperative bleeding, and amount of blood transfused. These equivalent results with the BioMedicus pump suggested that the Nikkiso pump can be used in open heart surgery as a reliable and atraumatic CPB pump.

Recent advances in the gyro centrifugal ventricular assist device

The gyro pump was developed as an intermediate-term assist pump (C1E3) as well as a long-term centrifugal ventricular assist device (VAD). The antithrombogenic design concept of this pump was confirmed throughout three 1 month ex vivo studies. The normalized index of hemolysis (NIH) of this gyro C1E3 model was lower than that of the BP-80. In the next step, a miniaturized centrifugal blood pump (The Gyro permanently implantable model PI-601) has been developed for use as a permanently implantable device after design optimization. A special motor design of the magnet circuit was utilized in this system in collaboration with the University of Vienna. The priming volume of this pump is 20 ml. The overall size of the pump actuator package is 53 mm in height, 65 mm in diameter, 145 ml of displacement volume, and 305 g in weight. This pump can provide 5 L/min against 120 mm Hg total pressure head at 2,000 rpm. The NIH value of this pump was comparable to that of the BP-80. The gyro PI-601 model is suitable for a VAD. The expected life from the endurance study is approximately 8 years. The evolution from C1E3 to the PI-601 converts this pump to a totally implantable centrifugal pump. Recent technologic advances in continuous flow devices are likely to realize a miniaturized and economical totally implantable VAD.

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 PI-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.

Development of an Implantable Centrifugal Ventricular Assist Device (CVAD)

The centrifugal ventricular assist device (CVAD) was developed for long-term circulatory support, and is capable of either intracorporeal implantation or paracorporeal placement. The pump was designed based on our antithrombogenic concepts: (1) sealless pump casing, (2) elimination of stationary parts, and (3) blood flow acceleration under the impeller. To meet conditions (1) and (2), a pivot bearing system was adopted to support the impeller. The inlet port was placed slightly off-center and inclined 60° towards the same direction as the outlet port. This port configuration not only yielded a space where an inlet cup bearing could be directly embedded but also allowed for a significant reduction of the pump height, hence, resulting in easier placement inside the body cavity. Two small secondary vanes were installed in the bottom of the impeller to satisfy condition (3). Five paracorporeal left ventricular (LV) AD studies, using calves, were performed to evaluate the antithrombogenic design of the pump. The first two cases were subjected to 2-week tests. With the activated clotting time (ACT) kept at 250 s with heparin, the initial two cases had trouble-free performances over the 2 weeks. Following these successful results, another three cases were subjected to 1-month validation studies, in which there was no device-induced thrombus formation inside the pump housing. These results confirm that the CVAD, the C1E3, meets the requirements for a 1-month paracorporeal LVAD.

Comparison of Nikkiso and Bio-Medicus Pumps in Thoracoabdominal Aortic Surgery

Left heart bypass reduces the risk of ischemic complications during the repair of extensive thoracoabdominal aortic aneurysms. This prospective study compared the performance of the recently developed Nikkiso centrifugal pump with the well-established Bio-Medicus pump during left heart bypass for thoracoabdominal aortic aneurysm surgery. Thirty-five consecutive patients undergoing graft repair of extensive thoracoabdominal aortic aneurysms were prospectively assigned to have left heart bypass using either the Bio-Medicus (in the first 19 patients) or Nikkiso pump (in the next 16 patients). There were no significant differences in pump flow rates or patient hemodynamics between the two groups and there was no evidence of pump malfunction. All patients survived and none developed postoperative coagulopathy, myocardial infarction, or left heart failure. Paraparesis developed in 2 patients in the Nikkiso group (12.5%); there were no neurologic complications in the Bio-Medicus group (p = 0.202). One patient in the Bio-Medicus group developed renal failure (5.3%; p = 1.000 vs. Nikkiso group). Overall, no significant differences were found in the incidence of postoperative complications. Although a small series, this comparison demonstrates that the Nikkiso centrifugal pump is as effective and safe in providing left heart bypass during thoracoabdominal aortic aneurysm repair as the widely-used Bio-Medicus model.