Novel temporary left ventricular assist system with hydrodynamically levitated bearing pump for bridge to decision: initial preclinical assessment in a goat model.

The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. We developed a new temporary left ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing. We used three adult goats (body weight, 58-68 kg) to investigate the 30-day performance and hemocompatibility of the newly developed left ventricular assist system, which included the pump, inflow and outflow cannulas, the extracorporeal circuit, and connectors. Hemodynamic, hematologic, and blood chemistry measurements were investigated as well as end-organ effect on necropsy. All goats survived for 30 days in good general condition. The blood pump was operated at a rotational speed of 3000-4500 rpm and a mean pump flow of 3.2 ± 0.6 L min. Excess hemolysis, observed in one goat, was due to the inadequate increase in pump rotational speed in response to drainage insufficiency caused by continuous contact of the inflow cannula tip with the left ventricular septal wall in the early days after surgery. At necropsy, no thrombus was noted in the pump, and no damage caused by mechanical contact was found on the bearing. The newly developed temporary left ventricular assist system using a disposable centrifugal pump with hydrodynamic bearing demonstrated consistent and satisfactory hemodynamic performance and hemocompatibility in the goat model.

[Surgical Experience of Total Arch Replacement Using Frozen Elephant Trunk, for Type B Acute Aortic Dissection].

Recently, advanced technique and device of thoracic endovascular aortic repair (TEVAR) enabled surgical intervention for type B acute aortic dissection (BAD). However, BAD have often serious complications;cerebral infarction, spinal cord infarction, multi-organ ischemia or necrosis, and retrograde type A acute aortic dissection. TEVAR is performed for complicated BAD for the aim of life saving in such a failure case of conservative treatment. Here we reported our surgical experience of total arch replacement using frozen elephant trunk (FET) by median sternotomy, for BAD with failed conservative treatment. There are 3 advantages;brain protection using selective cerebral perfusion, main entry closure using FET, and prevention of retrograde type A acute aortic dissection following prosthetic graft replacement. We examined how to select a FET product size and described operative procedures.

Changing pulsatility by delaying the rotational speed phasing of a rotary left ventricular assist device.

Continuous-flow left ventricular assist devices (LVADs) have improved the prognosis of end-stage heart failure. However, continuous-flow LVADs diminish pulsatility, which possibly result in bleeding, aortic insufficiency, and other adverse effects. We previously developed a novel control system for a continuous-flow LVAD (EVAHEART®; Sun Medical), and demonstrated that we could create sufficient pulsatility by increasing its rotational speed (RS) in the systolic phase (Pulsatile Mode) in the normal heart model. Here, we aimed to evaluate differences between systolic assist with advanced and delayed loads by shifting the timing of increased RS. We implanted EVAHEART in six goats (55.3 ± 4.3 kg) with normal hearts. We reduced their heart rates to <60 bpm using propranolol and controlled the heart rates at 80 and 120 bpm using ventricular pacing. We shifted the timing of increasing RS from -60 to +60 ms in the systolic phase. We found significant increases in all the following parameters when assessments of delayed timing (+60 ms) were compared with assessments of advanced timing (-60 ms): pulse pressure, mean dP/dt max of aortic pressure, and energy-equivalent pulse pressure. During continuous-flow LVAD support, pulsatility can be controlled using a rotary pump. In particular, pulsatility can be shifted by delaying increased RS.

What Is the Optimal Setting for a Continuous-Flow Left Ventricular Assist Device in Severe Mitral Regurgitation?

Excessive left ventricular (LV) volume unloading can affect right ventricular (RV) function by causing a leftward shift of the interventricular septum in patients with mitral regurgitation (MR) receiving left ventricular assist device (LVAD) support. Optimal settings for the LVAD should be chosen to appropriately control the MR without causing RV dysfunction. In this study, we assessed the utility of our electrocardiogram-synchronized rotational speed (RS) modulation system along with a continuous-flow LVAD in a goat model of MR. We implanted EVAHEART devices after left thoracotomy in six adult goats weighing 66.4 ± 10.7 kg. Severe MR was induced through inflation of a temporary inferior vena cava filter placed within the mitral valve. We evaluated total flow (TF; the sum of aortic flow and pump flow [PF]), RV fractional area change (RVFAC) calculated by echocardiography, left atrial pressure (LAP), LV end-diastolic pressure (LVEDP), LV end-diastolic volume (LVEDV), and LV stroke work (LVSW) with a bypass rate (PF divided by TF) of 100% under four conditions: circuit-clamp, continuous mode, co-pulse mode (increased RS during systole), and counter-pulse mode (increased RS during diastole). TF tended to be higher in the counter-pulse mode. Moreover, RVFAC was significantly higher in the counter-pulse mode than in the co-pulse mode, whereas LAP was significantly lower in all driving modes than in the circuit-clamp condition. Furthermore, LVEDP, LVEDV, and LVSW were significantly lower in the counter-pulse mode than in the circuit-clamp condition. The counter-pulse mode of our RS modulation system used with a continuous-flow LVAD may offer favorable control of MR while minimizing RV dysfunction.

Influence of a Rotational Speed Modulation System Used With an Implantable Continuous-Flow Left Ventricular Assist Device on von Willebrand Factor Dynamics.

We have developed a rotational speed (RS) modulation system for a continuous-flow left ventricular assist device (EVAHEART) that can change RS in synchronization with a patient's electrocardiogram. Although EVAHEART is considered not to cause significant acquired von Willebrand syndrome, there remains a concern that the repeated acceleration and deceleration of the impeller may degrade von Willebrand factor (vWF) multimers. Accordingly, we evaluated the influence of our RS modulation system on vWF dynamics. A simple mock circulation was used. The circulation was filled with whole bovine blood (650 mL), and the temperature was maintained at 37 ± 1°C. EVAHEART was operated using the electrocardiogram-synchronized RS modulation system with an RS variance of 500 rpm and a pulse frequency of 60 bpm (EVA-RSM; n = 4). The pumps were operated at a mean flow rate of 5.0 ± 0.2 L/min against a mean pressure head of 100 ± 3 mm Hg. The continuous-flow mode of EVAHEART (EVA-C; n = 4) and ROTAFLOW (ROTA; n = 4) was used as controls. Whole blood samples were collected at baseline and every 60 min for 6 h. Complete blood counts (CBCs), normalized indexes of hemolysis (NIH), vWF antigen (vWF:Ag), vWF ristocetin cofactor (vWF:Rco), the ratio of vWF:Rco to vWF:Ag (Rco/Ag), and high molecular weight multimers (HMWM) of vWF were evaluated. There were no significant changes in CBCs throughout the 6-h test period in any group. NIH levels of EVA-RSM, EVA-C, and ROTA were 0.0035 ± 0.0018, 0.0031 ± 0.0007, and 0.0022 ± 0.0011 g/100 L, respectively. Levels of vWF:Ag, vWF:Rco, and Rco/Ag did not change significantly during the test. Immunoblotting analysis of vWF multimers showed slight degradation of HMWM in all groups, but there were no significant differences between groups in the ratios of HMWM to low molecular weight multimers, calculated by densitometry. This study suggests that our RS modulation system used with EVAHEART does not have marked adverse influences on vWF dynamics. The low NIH and the absence of significant decreases in CBCs indicate that EVAHEART is hemocompatible, regardless of whether it is operated with the RS modulation system.

Effects of feeding state on anticoagulation in adult goats treated with warfarin.

For the continued development of improved mechanical circulatory systems, longer term evaluation of new devices in animal model experiments may be critical. The effects of anticoagulants in adult goats have not been well studied. We assessed the effects of oral warfarin in three adult goats during fasting or after feeding. The goats [weighing 57.8 ± 8.1 kg (53.0-67.2 kg)] were administered warfarin orally beginning at a dose of 5 mg/day and then increasing to 10, 20, 40, and 60 mg every 2 weeks. One goat (receiving 10 mg/day warfarin) was killed on day 27 because of the inability to stand. After administration of 60 mg warfarin, the remaining goat received no warfarin for 4 days to return to coagulated state. The goats were then fasted and treated with 40 mg warfarin. During warfarin administration, both goats required a dose of 60 mg/day to achieve International Normalized Ratios (INRs) of approximately 2.5; however, when, the animals were in the fasted condition, precipitous extension of INR was observed in 5 days. After resuming feeding, the INR was reduced to the proper range. We showed the tendency that warfarin therapy in goats required higher doses than the doses administered to human patients and that the effects of therapy were related to the feeding state. The results of this study provide important information for development of anticoagulation protocols to assess mechanical circulatory support devices for long-term use in preclinical examination.

Shifting the pulsatility by increasing the change in rotational speed for a rotary LVAD using a native heart load control system.

We have previously developed a native heart load control system for a continuous-flow left ventricular assist device (LVAD) ((EVAHEART®; Sun Medical) and demonstrated that the rotational speed (RS) in synchronization with the cardiac cycle can alter pulsatility and left ventricular (LV) load under general anesthesia. In this study, we assessed the effects of different levels of increase in RS on pulsatility and LV load in the chronic awake phase. We implanted the EVAHEART via left thoracotomy in 7 normal goats (59.3 ± 4.6 kg). Two weeks after implantation, we examined the effects of co-pulse mode (increased RS in the systolic phase) and counter-pulse mode (increased RS in the diastolic phase), as well as shifting the change in RS from 250 to 500 rpm, and 750 rpm in both modes on pulsatility and LV load. Pulsatility was assessed using pulse pressure and mean dP/dt max of aortic pressure. LV load was assessed using stroke work and left ventricle end-diastolic volume determined from LV pressure-volume loops. In the co-pulse mode, pulsatility values increased as the change in RS increased. By contrast, in the counter-pulse mode, these values decreased as the change in RS increased. LV load increased significantly in the co-pulse mode compared with the counter-pulse mode, but there were no significant differences among the three levels of RS increase in either mode. Increasing RS to varying degrees with our newly developed system could contribute to pulsatility. However, it appeared to have little effect on LV load in normal hearts.

Pulsatile support using a rotary left ventricular assist device with an electrocardiography-synchronized rotational speed control mode for tracking heart rate variability.

We previously developed a novel control system for a continuous-flow left ventricular assist device (LVAD), the EVAHEART, and demonstrated that sufficient pulsatility can be created by increasing its rotational speed in the systolic phase (pulsatile mode) in a normal heart animal model. In the present study, we assessed this system in its reliability and ability to follow heart rate variability. We implanted an EVAHEART via left thoracotomy into five goats for the Study for Fixed Heart Rate with ventricular pacing at 80, 100, 120 and 140 beats/min and six goats for the Study for native heart rhythm. We tested three modes: the circuit clamp, the continuous mode and the pulsatile mode. In the pulsatile mode, rotational speed was increased during the initial 35 % of the RR interval by automatic control based on the electrocardiogram. Pulsatility was evaluated by pulse pressure and dP/dt max of aortic pressure. As a result, comparing the pulsatile mode with the continuous mode, the pulse pressure was 28.5 ± 5.7 vs. 20.3 ± 7.9 mmHg, mean dP/dt max was 775.0 ± 230.5 vs 442.4 ± 184.7 mmHg/s at 80 bpm in the study for fixed heart rate, respectively (P < 0.05). The system successfully determined the heart rate to be 94.6 % in native heart rhythm. Furthermore, pulse pressure was 41.5 ± 7.9 vs. 27.8 ± 5.6 mmHg, mean dP/dt max was 716.2 ± 133.9 vs 405.2 ± 86.0 mmHg/s, respectively (P < 0.01). In conclusion, our newly developed the pulsatile mode for continuous-flow LVADs reliably provided physiological pulsatility with following heart rate variability.

Aortoiliac aneurysm with congenital right pelvic kidney.

The association of congenital pelvic kidney with abdominal aortoiliac aneurysm is an extremely rare clinical finding. Previous reports have described various methods of aneurysm repair with successful preservation of the function of pelvic kidney. However, to our knowledge, reconstruction of more than two renal arteries has not been established. We report a case of abdominal aortic aneurysm complicated by congenital right pelvic kidney in a 72-year-old man. Computed tomography (CT) revealed an abdominal aortic aneurysm with a maximum diameter of 54 mm and a right common iliac aneurysm of 45 mm. In addition, he had a congenital right pelvic kidney and CT angiography identified three right pelvic renal arteries. The upper artery originated from the bifurcation of the terminal aorta and the lower two originated from the right common iliac artery. Three-dimensional CT was helpful for the accurate planning of the operation. Open surgical repair of the aortoiliac aneurysm with a Dacron bifurcated graft replacement was decided and reimplantation of all three right pelvic kidney arteries to the right limb of the graft was also performed. For renal preservation, the right pelvic kidney arteries were perfused with cold Ringer's lactate using a rapid infusion pump and coronary perfusion cannula. The patient's postoperative course was uneventful, and worsening of renal function was not observed. The perfusion of renal arteries with cold Ringer's solution was thought to be a simple and appropriate procedure for renal protection.

Impact of bypass flow rate and catheter position in veno-venous extracorporeal membrane oxygenation on gas exchange in vivo.

The clinical use of veno-venous extracorporeal membrane oxygenation (VVECMO) in adult patients with respiratory failure is rapidly increasing. However, recirculation of blood oxygenated by ECMO back into the circuit may occur in VVECMO, resulting in insufficient oxygenation. The cannula position and bypass flow rate are two major factors influencing recirculation, but the relationship and ideal configuration of these factors are not fully understood. In the present study, we attempted to clarify these parameters for effective gas exchange. VVECMO was performed in eight adult goats under general anesthesia. The position of the drainage cannula was fixed in the inferior vena cava (IVC), but the return cannula position was varied between the IVC, right atrium (RA), and superior vena cava (SVC). At each position, the recirculation rates calculated, and the adequacy of oxygen delivery by ECMO in supplying systemic oxygen demand was assessed by measuring the arterial oxygen saturation (SaO2) and pressure (PaO2). Although the recirculation rates increased as the bypass flow rates increased, SaO2 and PaO2 also increased in any position of return cannula. The recirculation rates and PaO2 were 27 ± 2% and 162 ± 16 mmHg, 36 ± 6% and 139 ± 11 mmHg, and 63 ± 6% and 77 ± 9 mmHg in the SVC, RA and IVC position at 4 L/min respectively. In conclusion, the best return cannula position was the SVC, and a high bypass flow rate was advantageous for effective oxygenation. Both the bypass flow rates and cannula position must be considered to achieve effective oxygenation.

Sutureless aortic valve replacement using a novel autologous tissue heart valve with stent (stent biovalve): proof of concept.

We developed an autologous, trileaflet tissue valve ("biovalve") using in-body tissue architecture technology to overcome the disadvantages of current bioprosthetic valves. We designed a novel biovalve with a balloon-expandable stent: the stent biovalve (SBV). This study evaluated the technical feasibility of sutureless aortic valve replacement using the SBV in an orthotopic position, as well as the functionality of the SBV under systemic circulation, in an acute experimental goat model. Three adult goats (54.5-56.1 kg) underwent sutureless AVR under cardiopulmonary bypass (CPB). The technical feasibility and functionality of the SBVs were assessed using angiography, pressure catheterization, and two-dimensional echocardiography. The sutureless AVR was successful in all goats, and all animals could be weaned off CPB. The mean aortic cross-clamp time was 45 min. Angiogram, after weaning the animals off CPB, showed less than mild paravalvular leakage and central leakage was not detected in any of the goats. The mean peak-to-peak pressure gradient was 6.3 ± 5.0 mmHg. Epicardial two-dimensional echocardiograms showed smooth leaflet movement, including adequate closed positions with good coaptation; the open position demonstrated a large orifice area (average aortic valve area 2.4 ± 0.1 cm2). Sutureless AVR, using SBVs, was feasible in a goat model. The early valvular functionalities of the SBV were sufficient; future long-term experiments are needed to evaluate its durability and histological regeneration potential.

Influence of a novel electrocardiogram-synchronized rotational-speed-change system of an implantable continuous-flow left ventricular assist device (EVAHEART) on hemolytic performance.

We developed a novel controller for a continuous-flow left ventricular assist device (EVAHEART) that can change the pump's rotational speed (RS) in synchronization with a patient's myocardial electrocardiogram (ECG) with the aim of facilitating cardiac recovery. We previously presented various applications of this system in animal models, but there remained a concern that the repeated acceleration and deceleration of the impeller may induce additional hemolysis. In this study, we evaluated the blood trauma and motor power consumption induced by our system in a mock circulation. We evaluated our system with a 60-bpm pulse frequency and a variance between the high and low RSs of 500 rpm (EVA-P; n = 4). The continuous modes of EVAHEART (EVA-C; n = 4) and ROTAFLOW (n = 4) were used as controls. The pumps were examined at a mean flow rate of 5.0 ± 0.2 L/min against a mean pressure head of 100 ± 3 mmHg for a 4-h period. As a result, the normalized indexes of the hemolysis levels of EVA-P and EVA-C were 0.0023 ± 0.0019 and 0.0023 ± 0.0025, respectively, and their difference was not significant. The estimated mean motor power consumptions of EVA-C and EVA-P were 6.24 ± 0.33 and 7.19 ± 0.93 W, respectively. When a novel ECG-synchronized RS-change system was applied to EVAHEART, the periodic RS change with a 500-rpm RS variance did not affect the hemolysis at a 60-bpm pulse frequency.

[Graft replacement under percutaneous cardiopulmonary system for traumatic aortic rupture with multiple injuries].

We report a case of traumatic aortic rupture with multiple injuries. A 20-year-old man was transferred to our hospital. He was suffering from traumatic thoracic aortic rupture with multiple injuries (femoral fracture, pelvis fracture and so 4th) due to a traffic accident. Enhanced computed tomography revealed leakage from the aortic isthmus and hematoma in the surrounding area. Emergency operation was performed. The left 4th intercostal thoracotomy was performed and a lacerated foramen was observed across the lesser curvature of the aortic isthmus. The affected site was replaced by a prosthetic graft under percutaneous cardiopulmonary system. He was treated with open fixation of the right femur 11 days after the 1st operation. The postoperative recovery was generally uneventful and he was discharged on the 51st hospital day.

Dexmedetomidine for dyspnoea.

Dexmedetomidine is a selective α2-adrenoreceptor agonist with a broad range of effects, including easily controllable sedation, analgesia and anxiolysis. Because of these favorable features, it has replaced traditional sedatives, such as benzodiazepines, and is becoming the first-line sedative for the patients in intensive care units. Terminally ill patients often need sedatives for symptom management, especially for dyspnoea. However, the use of dexmedetomidine in a palliative care setting has rarely been recognised to date. We experienced a patient nearing the end of life due to uncontrollable pulmonary haemorrhage on ventilator, whose dyspnoea was successfully managed by dexmedetomidine in addition to continuous intravenous infusion of oxycodone.

[Thoracic endovascular stent graft for late pseudoaneurysm formation after patch aortoplasty; report of a case].

We report a case of a 51-year-old man presenting with pseudoaneurysm associated with a knitted Dacron patch used to repair coarctation of the aorta. At the age of 15 years, he underwent patch angioplasty for coarctation of the aorta. However the computed tomography( CT) scan, taken after 36 years, demonstrated pseudoaneurysm of the thoracic aorta at the anastmotic site. He was treated by endovascular stent graft using Gore-TAG 3115. His postoperative course was uneventful. Follow-up CT scan demonstrated no recurrence of pseudoaneurysm.

Influence of suspended inorganic particles (kaolinite) on eggs and larvae of the pelagic shrimp Lucensosergia lucens.

The pelagic shrimp Lucensosergia lucens is a commercially important species in Japan, predominantly harvested in Suruga Bay. It has been suggested that a marked decrease in the wild population over recent years is associated with an increased concentration of suspended particles. We tested the hypothesis that suspended inorganic particles (kaolinite) negatively affect the hatching ratio of fertilized eggs, and the survival, growth, and metamorphosis of nauplius and elaphocaris larvae. The relative hatching ratio of eggs decreased from 100 to 57.7% at 139 mg L-1 of kaolinite particles. Similarly, the relative survival ratio of nauplius larvae progressively decreased from 100% in filtered seawater to 73.6% after 72 h of exposure to 139 mg L-1 of kaolinite particles. Consequently, the survival ratio of elaphocaris larvae was greatly reduced at high particle concentrations. Exponential growth in the standard lengths of elaphocaris larvae occurred at particle concentrations < 6.9 mg L-1, but growth was inhibited at kaolinite concentrations > 20 mg L-1.

Perforation of the right atrial appendage during implantation of a leadless pacemaker.

We report a case of perforation of the right atrial appendage during implantation of a leadless pacemaker in a 94 years old woman. We performed emergency surgery to repair the perforation site. To our konwledge, there are few reports of right atrial perforation during a leadless pacemaker indwelling.

[Simultaneous coronary artery bypass grafting and the ascending aorta to bifemoral bypass].

OBJECTIVE: Coronary artery disease and arteriosclerosis obliterans (ASO) frequently coexist. Concomitant revascularization procedures may be required because harvest of the internal thoracic artery (ITA) in patients with ASO carries a risk of leg ischemia. This study reports our experience with combined coronary and femoral revascularization using the ascending aorta to bifemoral bypass. PATIENTS: Seven male patients (including 4 high aortic occlusions) underwent concomitant aorto-femoral bypass and coronary revascularization between 1990 and 2007. Mean age was 66 years old. RESULTS: Coronary artery bypass grafting (CABG) was performed on-pump in 5 cases and off-pump in 2 cases. The number of bypass grafts were 2.4 +/- 0.9. We harvested ITA in all cases. The prosthetic tube graft was positioned behind the muscles of the abnominal wall. One hospital death was related to mediastinitis. Perfect patency of the aorta-femoral grafts was obtained in all cases. CONCLUSIONS: The ascending aorta is a good source of inflow to femoral arteries and the ascending aorta to bifemoral bypass did not require an intraperitoneal procedure. Therefore the simultaneous operation can be performed in shorter time, and it is an interesting alternative in cases with ischemic heart disease and leg ischemia.

Chimney Endografting for Zone 2 Thoracic Endovascular Aortic Repair Using The Reorientation Technique.

The purpose of this report was to describe the reorientation of the chimney graft technique to downsize brachial artery access during thoracic endovascular aortic repair and thus preserve left subclavian artery flow. In the case described herein, the chimney graft was advanced not from the brachial or axillary artery, but from the common femoral artery, over a brachiofemoral pull-through wire. The chimney graft was then turned out into the ascending aorta by balloon dilatation via percutaneous brachial access ("reorientation"). Despite the use of a large-diameter chimney graft, the chimney technique with percutaneous brachial access was successfully performed using the reorientation technique.

Recurrence of cardiac myxoma in the right atrium with Carney complex following resection of myxomas in both ventricles.

We describe a case of Carney complex (CNC), a rare hereditary condition, that resulted in the development of cardiac myxomas. We would like to emphasize that we detected the first myxomas in both ventricles, followed by the second myxoma in the right atrium, although cardiac myxomas often originate in the left atrium. We highlight the heightened risk of recurrence and emphasize the importance of performing regular ultrasonic cardiac echography to preclude such outcomes.