Tatsuki Fujiwara

New Generation Extracorporeal Membrane Oxygenation With MedTech Mag-Lev, a Single-Use, Magnetically Levitated, Centrifugal Blood Pump: Preclinical Evaluation in Calves

We have evaluated the feasibility of a newly developed single-use, magnetically levitated centrifugal blood pump, MedTech Mag-Lev, in a 3-week extracorporeal membrane oxygenation (ECMO) study in calves against a Medtronic Bio-Pump BPX-80. A heparin- and silicone-coated polypropylene membrane oxygenator MERA NHP Excelung NSH-R was employed as an oxygenator. Six healthy male Holstein calves with body weights of about 100 kg were divided into two groups, four in the MedTech group and two in the Bio-Pump group. Under general anesthesia, the blood pump and oxygenator were inserted extracorporeally between the main pulmonary artery and the descending aorta via a fifth left thoracotomy. Postoperatively, both the pump and oxygen flow rates were controlled at 3 L/min. Heparin was continuously infused to maintain the activated clotting time at 200-240 s. All the MedTech ECMO calves completed the study duration. However, the Bio-Pump ECMO calves were terminated on postoperative days 7 and 10 because of severe hemolysis and thrombus formation. At the start of the MedTech ECMO, the pressure drop across the oxygenator was about 25 mm Hg with the pump operated at 2800 rpm and delivering 3 L/min flow. The PO2 of the oxygenator outlet was higher than 400 mm Hg with the PCO2 below 45 mm Hg. Hemolysis and thrombus were not seen in the MedTech ECMO circuits (plasma-free hemoglobin [PFH] < 5 mg/dL), while severe hemolysis (PFH > 20 mg/dL) and large thrombus were observed in the Bio-Pump ECMO circuits. Plasma leakage from the oxygenator did not occur in any ECMO circuits. Three-week cardiopulmonary support was performed successfully with the MedTech ECMO without circuit exchanges. The MedTech Mag-Lev could help extend the durability of ECMO circuits by the improved biocompatible performances.

Influence of procedural differences on mitral valve configuration after surgical repair for functional mitral regurgitation: in which direction should the papillary muscle be relocated?

BackgroundAfter restrictive mitral annuloplasty (RMAP) for functional mitral regurgitation (MR), the MR frequently recurs. Papillary muscle relocation (PMR) should reduce the recurrence rate. We assessed the influence of procedural differences in PMR on the postoperative mitral valve configuration.MethodsThirty-nine patients who underwent mitral valve repair for functional MR were enrolled. In limited tethering cases, RMAP alone was performed (RMAP group; n = 23). In severe tethering cases, in addition to RMAP, bilateral papillary muscles were relocated in the direction of the posterior annulus (posterior PMR group; n = 10) or anterior annulus (anterior PMR group; n = 6). We performed pre- and postoperative transthoracic echocardiographic studies, introducing a new index, mitral inflow angle (MIA), to assess the diastolic mitral leaflet excursion. MIA was measured as the angle between the mitral annular plane and the bisector of the anterior and posterior leaflets.ResultsPostoperative MR grade was significantly reduced in each group (P < 0.001). Follow-up echocardiography showed recurrent MR in 13% of the patients in RMAP group. In contrast, no recurrent MR was observed in either the anterior PMR or the posterior PMR group. After surgery, MIA was significantly reduced in both the RMAP group (P < 0.01) and the posterior PMR group (P < 0.001), but was preserved in the anterior PMR group (NS). None of the postoperative variables showed any significant difference between the early and late postoperative phases.ConclusionsIn the surgical treatment of functional MR, a PMR procedure in addition to RMAP was effective in reducing systolic MR. However, mitral valve opening assessed by MIA was restricted even after RMAP alone. The restriction was severely augmented after additional posterior PMR, but was attenuated after additional anterior PMR. The papillary muscle should be relocated in the direction of the anterior annulus to preserve the diastolic opening of the mitral valve.

Real-Time Observation of Thrombus Growth Process in an Impeller of a Hydrodynamically Levitated Centrifugal Blood Pump by Near-Infrared Hyperspectral Imaging

Understanding the thrombus formation in cardiovascular devices such as rotary blood pumps is the most important issue in developing more hemocompatible devices. The objective of this study was to develop a hyperspectral imaging (HSI) method to visualize the thrombus growth process within a rotary blood pump and investigate the optical properties of the thrombus. An in vitro thrombogenic test was conducted using fresh porcine blood and a specially designed hydrodynamically levitated centrifugal blood pump with a transparent bottom. The pump rotating at 3000 rpm circulated the blood at 1.0 L/min. The bottom surface of the pump was illuminated with white light pulsed at the same frequency as the pump rotation, and the backward-scattered light was imaged using the HSI system. Using stroboscopic HSI and an image construction algorithm, dynamic spectral imaging at wavelengths ranging from 608 to 752 nm within the rotating pump was achieved. After completing the experiment, we collected the red thrombus formed in the pump impeller and quantified the thrombus hemoglobin concentration (Hbthrombus ). The spectrum changed around the center of the impeller, and the area of change expanded toward the impeller flow path. The shape corresponded approximately to the shape of the thrombus. The spectrum change indicated that the light scattering derived from red blood cells decreased. The Hbthrombus was 4.7 ± 1.3 g/dL versus a total hemoglobin of 13 ± 0.87 g/dL. The study revealed that Hbthrombus was reduced by the surrounding blood flow.

Optical Dynamic Analysis of Thrombus Inside a Centrifugal Blood Pump During Extracorporeal Mechanical Circulatory Support in a Porcine Model.

Complications due to pump thrombus remain the weak point of mechanical circulatory support (MCS), such as the use of a left ventricular assist device (LVAD) or extracorporeal membrane oxygenation, leading to poor outcomes. Hyperspectral imaging (HSI) is an effective imaging method using a hyperspectral (HS) camera, which comprises a spectrophotometer and a charge-coupled device camera to discriminate thrombus from whole blood. Animal experiments were conducted to analyze dynamic imaging of thrombus inside a prototype of a hydrodynamically levitated centrifugal blood pump using an HSI system. Six pigs were divided into a venous circulation group (n = 3) and an arterial circulation group (n = 3). Inflow and outflow cannulae were inserted into the jugular veins in the venous circulation group. The latter simulated an LVAD application. To create thrombogenic conditions, pump flow was maintained at 1 L/min without anticoagulation. An image of the bottom surface of the pump was captured by the HS camera every 4 nm over the wavelength range of 608-752 nm. Real-time dynamic images of the inside of the pump were displayed on the monitor. Appearance of an area displaying thrombus was detected within 24 h after the start of the circulation in every experiment. This imaging system also succeeded in determining the origins of pump thrombus: from inside the pump in two cases, and from outside in four cases. Two main possible sources of pump thrombus originating outside the pump were identified on autopsy: wedge thrombus around the inflow cannula; and string-like thrombus at the junction between the pump inlet and circuit tube. The results of this study from close observation of the changing appearance of pump thrombus may contribute to improvements in the safety of extracorporeal MCS.

Development of an Optical Detector of Thrombus Formation on the Pivot Bearing of a Rotary Blood Pump.

Continuous optical monitoring of thrombus formation in extracorporeal mechanical circulatory support (EMCS) devices will contribute to safe, long-term EMCS. A clinically applicable optical detector must be able to distinguish among the optical characteristics of oxygen saturation (SaO2 ), hematocrit (Hct), and thrombus formation. In vitro studies of spectral changes at wavelengths from 400 to 900 nm associated with SaO2 , Hct, and thrombus formed around the top pivot bearing of a Gyro C1E3 pump were conducted. Fresh porcine blood anticoagulated with sodium citrate was circulated in a mock circuit using the pump. The SaO2 , Hct, and anticoagulation activity were altered using an oxygenator, autologous plasma, and calcium chlorite injection, respectively. Light from a xenon lamp was guided by an incident fiber perpendicularly fixed on the top bearing. This light was scattered by blood pooled between the male and female pivots. The detection fiber was perpendicularly fixed against the incident fiber, and the side-scattered light was detected and guided to a spectrophotometer. As a result, light at two different wavelengths, 420 and 810 nm, was identified as suitable for thrombus detection because it was negligibly influenced by SaO2 and was able to detect the optical characteristics of fibrin. The light at these two wavelengths responded more quickly to thrombus formation than the inlet or outlet pressure, and flow rate change. The optical changes showed the changes in Hct around the top pivot bearing, which is caused by the reduction in density of fibrin-trapped red blood cells (RBCs) due to the RBCs being swept away by the surrounding blood flow. The proposed method was also able to detect fibrin production by extracting subtle differences in the optical characteristics between the Hct and thrombus formation.

Easy and Safe Total Debranching of Arch Aneurysms Using Axilloaxillary Arterial Bypass

Techniques used in hybrid repair of proximal aortic arch diseases are associated with perioperative complications such as cerebrovascular emboli. We present an easy and safe technique of total debranching thoracic endovascular aortic repair for arch diseases using axilloaxillary arterial bypass. The placement of the axilloaxillary arterial bypass enables perfusion of the brachiocephalic artery even when the artery is clamped. After reconstruction of the brachiocephalic artery and the left common carotid artery, the left subclavian artery is proximally ligated, and it is perfused through the bypass. This procedure is simple, safe, and useful for the prevention of neurologic complications.

MedTech Mag-Lev, single-use, extracorporeal magnetically levitated centrifugal blood pump for mid-term circulatory support.

Short- to mid-term extracorporeal ventricular assist devices (VADs) are recommended for critical cardiogenic shock patients. We have designed a preclinical, single-use MedTech Mag-Lev VAD for one-month extracorporeal use. The impeller-rotor of the pump was suspended by a two degree-of-freedom active magnetic bearing in a 300 &mgr;m fluid gap, where the computational fluid dynamics analysis predicted a secondary flow of about 400–500 ml/min at a pump speed of 1800–2200 rpm. Three eddy current sensors were employed to implement noise- and drift-free magnetic levitation. The pump components were injection molded using polycarbonate for smooth surfaces as well as improved reproducibility, followed by coating with a biocompatible 2-methacryloyl-oxyethyl phosphorylcholine polymer. Chronic animal experiments were performed in nine calves. Three of the nine calves were excluded from analysis for problems with the circuit. Five of the six (83.3%) completed the 60 day duration of the study, while one prematurely died of massive bleeding due to inflow port detachment. The pump did not stop due to magnetic-levitation malfunction. Neither pump thrombosis nor major organ infarction was observed at autopsy. In comparison to machined surfaces, the injection-molded pump surfaces were thrombus-free after 60 day implantation. This study demonstrates the feasibility of MedTech Mag-Lev VAD for 60 day circulatory support.

Management of Right Gastroepiploic Arterial Coronary Grafts in Subsequent Abdominal Surgeries

BACKGROUND The right gastroepiploic artery (GEA) is utilized as an excellent in situ arterial graft conduit to right coronary artery territory for coronary artery bypass grafting (CABG). However, there remain great concerns regarding the management of patients with a patent in situ GEA during abdominal surgery following CABG. METHODS From 1995 to 2016, GEA was used for CABG in 278 patients at our institution. Of the patients, 14 abdominal surgeries were performed for subsequent abdominal diseases in 11 patients with a patent in situ GEA for CABG. We investigated the results of the surgeries and how to manage the GEAs in abdominal surgery. RESULTS Laparotomy was required for gastric cancer in 3 patients, pancreatic cancer in 3, hepatic cancer in 2, cholangiocarcinoma in 1, duodenal papillary head cancer in 1, and cholecystitis in 1; multiple abdominal surgeries were needed in 2 patients for cancer recurrence and ileus. The intraabdominal adhesions around the GEAs were minimal in all patients. No graft injury occurred at the time of opening of the abdomen, and the planned procedures were completed without any circulatory problems. In 3 patients undergoing pancreaticoduodenectomy, intraabdominal off-pump rerouting of the GEA with a short saphenous vein was necessary for en bloc resection of the cancers and lymph nodes. There was neither operative mortality nor graft-related cardiac event except for 1 due to multiple organ failure. CONCLUSIONS Although intraabdominal rerouting of GEA is necessary for pancreaticoduodenectomy, abdominal surgery can be safely performed in patients with a patent in situ GEA coronary graft.

Development of real-time and quantitative monitoring of thrombus formation in an extracorporeal centrifugal blood pump

We developed an optical detector of thrombus formed on the pivot bearing of an extracorporeal centrifugal blood pump (MERA HCF-MP23; Senko Medical Instrument Mfg. Co., Ltd., Tokyo, Japan) which is frequently used for long-term extracorporeal circulation support to bridge to an implantable artificial heart, which in turn is used for bridge to heart transplantation in Japan. In this study, we investigated the quantitative performance of the thrombus formation in acute animal experiments. A total of three experiments of extracorporeal left ventricular assist using Japanese specific pathogen-free pigs were conducted. The optical fibers were set in the pump driver unit. The incident light at nearinfrared wavelength aiming at the pivot bearing and the resulting scattered light were guided to respective fibers. The detected signal was analyzed to obtain thrombus formation level (TFL) calculated by a specially developed software. When the increase in TFL was confirmed, the pump was exchanged and the extracorporeal circulation was restarted. The number of pump exchanges were four times at each experiment so a total of twelve pumps were evaluated. 3-dimentional data surrounding the pivot bearing and the adhered thrombus was captured by a 3-dimantional surface measurement system to calculate the thrombus surface area (TSA) formed on the pivot bearing. As a result, the correlation coefficient between TFL and TSA was 0.878. The accuracy of TSA estimated by the optical detector was 3.6±2.3 mm2. This was small enough to not have the pump exchanged in clinical judgement. The developed detector would be useful for optimal anti-coagulation management.

Development of a real-time and quantitative thrombus sensor for an extracorporeal centrifugal blood pump by near-infrared light

We developed an optical thrombus sensor for a monopivot extracorporeal centrifugal blood pump. In this study, we investigated its quantitative performance for thrombus detection in acute animal experiments of left ventricular assist using the pump on pathogen-free pigs. Optical fibers were set in the driver unit of the pump. The incident light at the near-infrared wavelength of 810 nm was aimed at the pivot bearing, and the resulting scattered light was guided to the optical fibers. The detected signal was analyzed to obtain the thrombus formation level. As a result, real-time and quantitative monitoring of the thrombus surface area on the pivot bearing was achieved with an accuracy of 3.6 ± 2.3 mm2. In addition, the sensing method using the near-infrared light was not influenced by changes in the oxygen saturation and the hematocrit. It is expected that the developed sensor will be useful for optimal anticoagulation management for long-term extracorporeal circulation therapies.