Development and Initial Testing of a Permanently Implantable Centrifugal Pump

Abstract: To be able to salvage heart failure patients, the need for an economical permanent ventricular assist device is increasing. To meet this increasing demand, a miniaturized centrifugal blood pump has been developed as a permanently implantable device. The Gyro permanently implantable model (PI-601) incorporates a sealless design with a blood stagnation free structure. The pump impeller is magnetically coupled to the driver magnet in a sealless manner. This pump is atraumatic and antithrombogenic and incorporates a double pivot bearing system. A miniaturized actuator 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 and 65 mm in diameter, 145 ml of displacement volume, and 305 g in weight. Testing to date has included in vitro hydraulic performance and hemolysis. This pump can provide 5 L/min against a 110 mm Hg total pressure head at 2,000 rpm and 8 Limin against 150 mm Hg at 2,500 rpm. The normalized index of hemo-lysis (NIH) value of this pump was 0.0028 g/100 L at 5 Limin against 100 mm Hg. A preliminary anatomical study revealed the possibility of the implantability of 2 such systems in biventricular bypass at a preperitoneal location. This system is feasible for use as a permanently implantable biventricular assist device.     

Downward deviation of progressive addition lenses in a myopia control trial

PURPOSE: To clarify how the downward deviation of progressive addition lenses (PALs) reduces their near-addition effect in schoolchildren participating in a myopia control trial. METHODS: Among 95 schoolchildren wearing PALs for 6 months (age range: 6-12 years; refractive error range: -6.00 to -1.25 D), facial images were captured with a digital still camera placed 60 cm in front of the eyes while he or she was looking ahead with natural head posture. The vertical deviations of PALs from their ideal position (mm) were evaluated by analysing these images. RESULTS: The mean (+/-SD) downward deviations of PALs for the right and left eyes were 3.7 +/- 2.3 and 3.7 +/- 2.0 mm, respectively, and the largest downward deviation was 10.2 mm. For simulations using the average downward deviation, the near-addition effect of PALs was reduced to 30 and 63% of the expected value at the 10 degrees and 20 degrees downward eye positions, respectively. CONCLUSIONS: The downward deviation of PALs is a significant factor in reducing their therapeutic effect for near-addition. To ensure the proper alignment of PALs in children, the conventional spectacle-frame-fitting procedure is not sufficient, and repeated confirmation using a testing method similar to that used in this study is required.     

Prediction of morbidity after lung resection with risk factors using treadmill exercise test.

OBJECTIVE: To predict accurate morbidity after lung resection using treadmill exercise test. METHODS: A total of 130 patients (108 men and 22 women, with mean age 67.1+/-11.4 years (range, 34-78 years)) of 1129 patients underwent standard lobectomy were performed both treadmill exercise test and spirometry preoperatively. We measured maximum oxygen uptake/body weight (VO2max/BW) and change in arterial blood oxygen pressure from rest to symptom-limited maximum loading (delta aPaO2) and calculated exercise-induced hypoxemia (delta PaO2/delta VO2/BW), and retrospectively compared these parameters for patients with and without complications. RESULTS: There were five patients with severe postoperative complications, including three requiring use of a respirator, two with home oxygen therapy. %Vital capacity, VC (%, 80.2+/-13.2 vs. 92.5+/-20.9, P=0.026), delta PaO2 (Torr, -29.3+/-4.3 vs. -13.2+/-10.8, P=0.0004), VO2max/BW (ml/min/kg, 16.5+/-2.9 vs. 20.6+/-5.1, P=0.018) and delta PaO2/delta VO2/BW (Torr/ml/min/kg, -1.98+/-0.26 vs. -0.57+/-0.47) were significantly associated with worse outcome. All the five patients with complications had delta PaO2/delta VO2/BW<-1.7. CONCLUSIONS: Treadmill exercise testing is a good method for assessment of cardiopulmonary reserve. Limited resection must be performed if delta PaO2/delta VO2/BW is under -1.7.     

Rationale and design for a study using intravascular ultrasound to evaluate effects of rosuvastatin on coronary artery atheroma in Japanese subjects: COSMOS study (Coronary Atherosclerosis Study Measuring Effects of Rosuvastatin Using Intravascular Ultrasound in Japanese Subjects).

BACKGROUND: There have been few multicenter studies using intravascular ultrasound (IVUS) to assess the process of atherosclerosis in a Japanese population with hypercholesterolemia that is being treated with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors for control of low-density lipoprotein-cholesterol. METHODS AND RESULTS: An open-label multicenter study is planned to evaluate with IVUS whether treatment with rosuvastatin for 76 weeks results in regression of coronary artery atheroma volume in patients who have coronary heart disease (CHD) and hypercholesterolemia. Sample size is 200 subjects with CHD who are to undergo percutaneous coronary intervention. The planned duration is between October 2005 and October 2008. CONCLUSIONS: The COSMOS study will be the first multicenter cardiovascular study in a Japanese population and may provide new evidence on the effects of rosuvastatin on the progression of coronary atherosclerotic lesions.     

Production and characterization of monoclonal antibodies against amino-terminus of human alpha-atrial natriuretic polypeptide

Monoclonal antibodies directed against human, alpha-atrial natriuretic polypeptide (alpha-ANP; Human, 1-28) were obtained by somatic cell fusion between P3-X63-Ag8.653 myeloma cells and spleen cells from a BALB/c mouse immunized with human, alpha-ANP selectively coupled to keyhole limpet hemocyanin. From the analysis of polyclonal sera with respect to determinant specificity before the fusion, the strategy was primarily used to pick up monoclonal antibody specific for the N-terminal residues of human, alpha-ANP. Screening of antibodies in the hybridoma culture supernatants were performed by binding to iodinated synthetic human, alpha-ANP. Two stable clones producing anti-human, alpha-ANP antibodies, designated 13A1 and 10B1, were obtained by the limiting dilution technique. The ability of ANP(Rat, 1-28) to inhibit binding of 125I-human, alpha-ANP to these antibodies was almost equipotent to ANP(human, 1-28). However, ANP fragments (Human, 7-28) and (18-28) did not compete the binding completely. These results suggest that both 13A1 and 10B1 monoclonal antibodies can specifically recognized N-terminus of human, alpha-ANP, and may be a useful tool to investigate receptor binding of human, alpha-ANP by the antagonizing effect.     

Prediction of spinal cord ischemia with a retrievable stent graft on endovascular treatment for a case of thoracic aortic aneurysm

Multiple aortic aneurysms in Behçet’s disease were repaired with transluminaly placed endovascular stent grafts. Before deploying the stent graft device for permanent implantation for the saccular aneurysm located in the descending thoracic arota, from which feeding arteries for the spinal cord possibly branched, a retrievable stent graft was inserted and evoked spinal cord potential (ESP) were monitored in order to predict spinal cord ischemia. The original retrievable stent graft, constructed of a self-expandable Z-shaped stainless steel stent covered with e-PTFE, can be easily withdrawn into a 18 Fr. sheath after deployment. Blood flow into intercostal arteries branching from that part of the descending aorta where the permanent stent graft is planned to be implanted, is intercepted by the retrievable stent graft. A change of ESP during the temporary implantation of the device indicates that spinal cord ischemia would be caused by permanent implantation of the stent graft. In this case, no change of ESP was observed and the patient showed no postoperative paraplegia.The retrievable stent graft was useful for prediction of spinal cord ischemia before endoluminal stent graft repair of the descending aortic aneurysm. However, the device is not flexible enough to fit a severely tortuous aorta, therefore we are obliged to select patients to some extent. Further improvement of the device is required to make prediction of spinal cord ischemia with the retrievable stent graft possible in all cases.