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Background In Japan, ventricular assist devices (VADs) have been used for patients with severe heart failure as a bridge to transplantation (BTT) since 1992. However, it was not until 1997, when the Organ Transplant Law was enacted, that medical devices received approval by the national health insurance system for that use. To encourage research and development of innovative medical devices, the Pharmaceuticals and Medical Devices Agency has established a public–private partnership in collaboration with academic societies, hospitals and manufacturers. Methods The Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) is a prospective registry designed to be harmonized with the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS). Participation in J-MACS is mandatory for device manufacturers to meet the conditions of approval as well as for hospitals to obtain authorization for reimbursement from the national health insurance system. Results From June 2010 to April 2015, 476 patients were registered at 31 hospitals. Of these, analysis of primary VAD patients ( n = 332) revealed that their overall 360-day survival was 91% (implantable 93%, extracorporeal 84%). Conclusions This initial report from J-MACS focuses on patients’ demographics, device types, survival, competing outcomes, adverse events and successful examples of system failure detection. [ABSTRACT FROM AUTHOR]

We investigated haemostatic management, frequency of postoperative bleeding, and prognosis of patients who had left ventricular assist devices, and who were having oral surgical procedures between April 2002 and March 2014, to identify risk factors for bleeding and find out which were the best methods of haemostasis. Medical records were examined retrospectively and we recorded details of the patients, and frequency of bleeding together with factors associated with it. Twenty-nine patients had 39 oral operations, and there were 17 bleeds (44%). The first procedure for each patient was used for statistical calculations. Duration of bleeding tended to be longer for patients with implantable devices (median (interquartile range, IQR) 12.0 (3-18) days) than for those with extracorporeal devices (median (IQR) 3.0 (1-4) days; p = 0.079). There was a significantly greater difference in prothrombin time-international normalised ratio (PT-INR) before and after operation in patients who bled, whose median (range) was 0.85 (0.2-1.81), than in those who did not (median (IQR) 0.16 (-0.09-0.31) (p = 0.015). There were moderate correlations with postoperative bleeding were seen for the difference between preoperative and postoperative PT-INR (r = 0.479, p = 0.012) and PT-INR value when bleeding (r = 0.407, p = 0.035). In conclusion, postoperative bleeding occurred after oral operations in 17/29 patients with left ventricular assist devices by a median (IQR) of 0.85 (0.2-1.81) of the preoperative value. [ABSTRACT FROM AUTHOR]

Background: Infection during left ventricular assist device (LVAD) support is associated with a high mortality. This study investigated the effect of bloodstream infection on survival of patients with LVAD support and assessed risk factors for survival in LVAD patients with bloodstream infection. Methods: Between 1999 and 2010, 109 consecutive patients with end-stage heart failure were supported by an LVAD as a bridge to transplantation. Overall survival was compared between those with and without a bloodstream infection. Risk factors for survival of patients with bloodstream infection were analyzed. Results: A bloodstream infection developed in 65 patients (60%) during 584 ± 389 days of LVAD support. Compared with patients without a bloodstream infection, overall survival was significantly worse in those with bloodstream infection (68% vs 84% at 2 years after LVAD implantation, p = 0.0117). However, of 22 patients bridged to transplantation, none had bloodstream infection recurrence after transplantation, and their 3-year survival rate after transplantation was 100%. Cox multivariate analysis (hazard ratio [95% confidence interval]) identified postoperative right ventricular failure (2.890 [1.238 to 6.757]; p = 0.0141) and bloodstream infection caused by a pathogen other than gram-positive cocci (3.336 [1.390 to 8.006] p = 0.0070) as significant risk factors for death in LVAD patients with a bloodstream infection. Conclusions: Bloodstream infection had a significant effect on survival after LVAD implantation. Our results suggest that urgent cardiac transplantation should be considered for LVAD patients with a bloodstream infection based on the causative organism and right ventricular function. [ABSTRACT FROM AUTHOR]

Background: Left ventricular assist system (LVAS) implantation is an established treatment for patients with advanced heart failure. We investigated the clinical implication of serial changes in renal function after LVAS implantation. Methods: This study included 110 patients who underwent pulsatile LVAS implantation intended as a bridge to transplantation and were alive more than 2 weeks after implantation. Data collection of demographic and hematologic values was performed 1 day before (baseline) and 2 weeks after implantation. All patients were monitored for 2 years or until death. Results: The 2-year postimplantation mortality rate was 31.8%. Multivariate Cox regression analysis showed the baseline estimated glomerular filtration rate (eGFR) was an independent predictor of death (hazard ratio, 0.90 for each 10 mL/min increase, p < 0.05). The eGFR significantly increased at 2 weeks after LVAS implantation (70.5 ± 37.8 to 121.0 ± 78.8 mL/min, p < 0.01). Kaplan-Meier curves with log-rank tests showed significantly poorer event-free survival rates in the group with an inframedian value of change in eGFR at 2 weeks after implantation (ΔeGFR; p = 0.03) as well as in the group with the lowest tertile of eGFR at 2 weeks after implantation (2w-eGFR; p < 0.01). Multivariate Cox regression analysis showed that ΔeGFR (hazard ratio, 0.89 for each 10 mL/min increase) and 2w-eGFR (hazard ratio, 0.92 for each 10 mL/min increase) were independent predictors of death (p < 0.01, respectively). Conclusions: Impaired renal function, and in particular, a poor response of eGFR to LVAS implantation, may have a strong association with worse outcome. [ABSTRACT FROM AUTHOR]

Background: Management of native aortic insufficiency (AI) during left ventricular assist device (LVAD) support is challenging. We investigated the occurrence of de novo AI during long-term LVAD support to identify its effect on late clinical and echocardiographic outcomes. Methods: Left ventricular assist devices were implanted in 99 patients with dilated cardiomyopathy, of whom 47 without preoperative AI were investigated using serial echocardiography examinations for more than 1 year after the operation. Results: The mean duration of LVAD support was 838 ± 327 days, and 26 patients (55%) were supported for more than 2 years. Twenty-nine patients (62%) had no AI (group A), whereas de novo AI developed in the remaining 18 (38%; group B) at 1 year after LVAD implantation (≥ grade 2 in 5, grade 1 in 13). The LV end-diastolic diameter was significantly reduced after LVAD implantation in both groups, with no significant difference between them. Overall survival was better in group A (p = 0.0195). Multivariate analysis revealed that preoperative mitral regurgitation of more than grade 2 (odds ratio, 7.8; 95% confidence interval, 1.2 to 48.6; p = 0.028) and an aortic valve that remained closed at 1 month after implantation (odds ratio, 6.7; 95% confidence interval, 1.0 to 43.9; p = 0.048) were significant independent predictors of de novo AI at 1 year after LVAD implantation. Conclusions: Survival was significantly worse when de novo AI developed in patients during long-term LVAD. Our findings indicate that preoperative functional mitral regurgitation and postoperative aortic valve opening are related to the progression of AI during long-term LVAD support. [ABSTRACT FROM AUTHOR]

Objective: Cardiopulmonary bypass is known to induce systemic inflammatory responses that injure multiple organs, especially the lungs. Activated protein C has been demonstrated to play an important role in the regulation of inflammation in addition to coagulation. We investigated the anti-inflammatory effects of activated protein C in a rat model of cardiopulmonary bypass. Methods: Rats were randomized to receive an intravenous bolus of vehicle (control), 0.1 mg/kg diisopropyl fluorophosphate-activated protein C, or 0.1 mg/kg activated protein C 10 minutes before the initiation of cardiopulmonary bypass. Rats underwent cardiopulmonary bypass for 60 minutes followed by another 60-minute observation. Results: The activated protein C group showed significantly higher mean arterial oxygen pressure and lower mean lung wet-to-dry weight ratio after cardiopulmonary bypass than the control and diisopropyl fluorophosphate-activated protein C groups. Furthermore, lung pathology revealed minimal inflammatory change in the activated protein C group. A marked increase in CD11b expression and a decrease in CD62L expression after cardiopulmonary bypass were observed in the control and diisopropyl fluorophosphate-activated protein C groups. However, administration of activated protein C significantly attenuated these changes. Lung content of tumor necrosis factor-α and interleukin-1β in the activated protein C group tended to be lower than in the other groups. Lung content of macrophage inflammatory protein-2 in the activated protein C group was significantly lower than in the diisopropyl fluorophosphate-activated protein C group. Conclusions: Administration of activated protein C before cardiopulmonary bypass attenuates acute lung injury induced by cardiopulmonary bypass at least in part through the inhibition of neutrophil activation and possibly via the attenuation of proinflammatory cytokine production in this rat model of cardiopulmonary bypass. [ABSTRACT FROM AUTHOR]

Summary: Background and purpose: The majority of heart transplant (HTx) candidates require left ventricular assist device (LVAD) support for more than 2 years before transplantation in Japan. However, the only currently available device is the extracorporeal pulsatile LVAD. The long-term management of extracorporeal LVAD support has improved remarkably over the years. To determine which post-operative management factors are related to the long-term survival of patients on such LVAD, we retrospectively compared the incidence of complications and their management strategies between the initial and recent eras of LVAD use, classified by the year of LVAD surgery. Methods: Sixty-nine consecutive patients supported by extracorporeal pulsatile LVAD as a bridge to HTx between 1994 and 2007 were reviewed retrospectively. The patients were assigned according to the time of LVAD surgery to either group A (n =30; between 1994 and 2000) or group B (n =39; between 2001 and 2007). Results: Patients in group B survived significantly longer on LVAD support than those in group A (674.6 vs. 369.3 days; p <0.001). The 1- and 2-year survival rates were significantly higher in group B than that in group A (82% vs. 48%, p <0.0001; 68% vs. 23%, p <0.0001, respectively). The proportion of deaths due to cerebrovascular accidents was lower (17% vs. 50%, p <0.001) in group B compared with group A. The incidences of systemic infection were similar in both groups, but the proportions of patients alive and achieving transplant surgery after systemic infection were higher in group B than those in group A (55% vs. 14%, p <0.01; 14% vs. 36%, p <0.05, respectively). Conclusions: The long-term survival of patients even on “first-generation” extracorporeal LVAD has improved significantly in the recent era. Careful management of cerebrovascular accidents and systemic infection will play important roles in the long-term LVAD management. [ABSTRACT FROM AUTHOR]

Abstract: Thermal therapy for heart failure is recognized to improve clinical symptoms. We describe our experience with appendicular thermal therapy applied to a patient fitted with an extracorporeal left ventricular assist device (LVAD) who was wait-listed for a heart transplant. A 21-year-old male with end-stage heart failure due to dilated cardiomyopathy was fitted with a LVAD. His general condition stabilized after LVAD placement and the status of his heart failure has remained at NYHA class II for the past 13 months. However, his cardiac function did not sufficiently recover to discontinue LVAD support. We conducted appendicular thermal therapy using a steam foot bath and heated gloves for 2 weeks. Immediately after thermal therapy, his average sublingual temperature increased from 36.3 to 37.0°C and the grade of mitral regurgitation, as well as LV ejection fraction and endothelial function improved. Furthermore, levels of oxidative and anti-oxidative stress markers decreased and increased, respectively, after 2 weeks of therapy. No complications developed. We conclude that appendicular thermal therapy was safe in this patient waiting for a heart transplant and who had an extracorporeal LVAD, and that the procedure might be beneficial for others with end-stage heart failure. [Copyright &y& Elsevier]

Background: Extracorporeal life support (ECLS) using percutaneous extracorporeal membrane oxygenation (ECMO) is now considered an important means of resuscitation for patients suffering from refractory cardiogenic shock. The indications for the use of ECLS have yet to be established, however, and its use for elderly patients is still controversial. We retrospectively evaluated the impact of ECLS on the survival of patients with cardiogenic shock to determine the validity of using ECLS in elderly patients (≥75 years of age). Methods: Between 2000 and 2004, 91 patients were emergently placed on percutaneous ECMO. The patients were divided into two groups by age (group 1, n = 79: less than 75 years; group 2, n = 12: 75 years or older), which were compared for clinical outcome. Logistic regression analysis of the variables was performed to identify predictors of ability to be weaned from ECLS. Results: Weaning from ECLS was achieved in 50 patients in group 1 (63.3%) and 6 patients in group 2 (50%; p = 0.37). Thirty-five patients in group 1 (44.3%) and 5 patients in group 2 (41.7%) were discharged from the hospital (p = 0.86). Logistic regression analysis revealed that patients with a body surface area of more than 1.50 m2, patients with cardiomyopathy, and patients who underwent interventions under ECMO support were more likely to be successfully supported by ECMO. Conclusions: Extracorporeal life support using percutaneous ECMO systems provides excellent cardiac support. It is also effective in resuscitating elderly patients, yielding hospital survival similar to that for younger patients. [Copyright &y& Elsevier]

Background: We assessed the clinical outcome and conducted an angiographic study of total arterial off-pump coronary artery bypass grafting for revascularization of the total coronary system.Methods: Of 382 consecutive patients who underwent off-pump coronary artery bypass between April 2000 and December 2002, 235 patients (193 men and 42 women, mean age 66 ± 9 years) with three-vessel disease underwent off-pump coronary artery bypass with all arterial grafts. A total of 872 vessels were bypassed (average number of grafts 3.7 ± 0.8). The internal thoracic arteries, radial arteries, and gastroepiploic arteries were used for revascularization of 306, 542, and 24 coronary arteries, respectively. Two hundred twenty-five patients underwent revascularization with composite grafts that were connected to the in situ internal thoracic artery (Y configuration 181, I configuration 55, K configuration 27, X configuration 3, T configuration 1); 10 patients underwent revascularization with all in situ grafts.Results: Three (1.3%) hospital deaths and 1 late death occurred. There were no occurrences of clinical underperfusion syndrome or new intraaortic balloon pump insertion. Cerebral infarction occurred in 2 patients (0.8%). Early postoperative angiography was performed on 833 grafts in 223 patients (95%); the overall patency rate was 98%. Stratified by coronary distribution, the patency rate was 99% (218/221) in the left anterior descending artery, 97% (84/87) in the diagonal artery, 99% (70/71) in the obtuse marginal artery, 98% (262/268) in the posterolateral artery, 98% (167/170) in the posterior descending artery, and 100% (16/16) in the right coronary artery.Conclusions: Total arterial off-pump coronary artery bypass yielded good clinical results and an excellent patency rate of revascularization for the total coronary system. [Copyright &y& Elsevier]

A stereograph of atomic arrangement was displayed directly on the screen of display-type spherical-mirror analyzer without any computer-aided conversion process for the first time. This stereoscopic photograph enables viewing three-dimensional atomic arrangement. This technique was realized taking advantage of the phenomenon of circular dichroism in photoelectron angular distribution. The azimuthal shifts of forward focusing peaks in a photoelectron angular distribution taken with left and right helicity light in a special arrangement are the same as the parallaxes in a stereo view of atoms. Hence a stereoscopic recognition of three-dimensional atomic arrangement is possible, when the left eye and the right eye respectively view the two images obtained by left and right helicity light simultaneously. [Copyright &y& Elsevier]

Eosinophilic chronic rhinosinusitis (ECRS) is a subtype of chronic rhinosinusitis. Clinical markers for ECRS disease activity and treatment strategies have not been sufficiently established. Although semaphorins are originally identified as neuronal guidance factors, it is becoming clear that they play key roles in immune regulation and inflammatory diseases. We sought to investigate the pathological functions and therapeutic potential of semaphorin 4D (SEMA4D) in ECRS. Serum soluble SEMA4D levels in patients with paranasal sinus diseases were measured by ELISA. The expression of SEMA4D in blood cells and nasal polyp tissues was assessed by flow cytometry and immunohistochemistry, respectively. Generation of soluble SEMA4D was evaluated in matrix metalloproteinase-treated eosinophils. Endothelial cells were stimulated with recombinant SEMA4D, followed by eosinophil transendothelial migration assays. Allergic chronic rhinosinusitis was induced in mice using Aspergillus protease with ovalbumin. The efficacy of treatment with anti-SEMA4D antibody was evaluated histologically and by nasal lavage fluid analysis. Serum soluble SEMA4D levels were elevated in patients with ECRS and positively correlated with disease severity. Tissue-infiltrated eosinophils in nasal polyps from patients with ECRS stained strongly with anti-SEMA4D antibody. Cell surface expression of SEMA4D on eosinophils from patients with ECRS was reduced, which was due to matrix metalloproteinase-9–mediated cleavage of membrane SEMA4D. Soluble SEMA4D induced eosinophil transendothelial migration. Treatment with anti-SEMA4D antibody ameliorated eosinophilic infiltration in sinus tissues and nasal lavage fluid in the ECRS animal model. Eosinophil-derived SEMA4D aggravates ECRS. Levels of serum SEMA4D reflect disease severity, and anti-SEMA4D antibody has therapeutic potential as a treatment for ECRS. [ABSTRACT FROM AUTHOR]

In patients on high-level anticoagulant therapy (prothrombin time–international normalized ratio [PT-INR] ≥ 4.5), surgical procedures can be carried out with bridging therapy using heparin. However, surgical treatment options are severely limited in patients on high-level anticoagulant therapy and who have heparin-induced thrombocytopenia (HIT), as heparin use is contraindicated. We performed tooth extraction using prothrombin complex concentrate (PCC) in 2 HIT patients on high-level anticoagulation therapy (PT-INR ≥ 4.5). Five hundred units of PCC were administered intravenously, and after 15 minutes, it was confirmed that PT-INR was less than 2.0. Tooth extraction was then performed and sufficient local hemostasis was achieved. At 3 hours after tooth extraction, PT-INR was 2.0 or higher and later increased to 4.0 or higher, but postoperative bleeding was mostly absent. When performing tooth extraction in HIT patients on high-level anticoagulant therapy, favorable hemostatic management was achieved through sufficient local hemostasis and transient warfarin reversal using PCC. [ABSTRACT FROM AUTHOR]

Summary: We report a case of 45-year-old man, who was diagnosed with arrhythmogenic right ventricular cardiomyopathy (ARVC) and presented with right ventricular (RV) enlargement with a global decrease in RV contractility accompanied by impairment of left ventricular function. He was placed on the heart transplant waiting list. Endomyocardial biopsy from RV septal wall did not show any evidence of sarcoidosis or inflammatory change. Four years after he was put on the heart transplant waiting list, a computed tomography chest scan for the purpose of anatomical evaluation for coronary sinus prior to biventricular pacing lead implantation incidentally showed bilateral hilar lymphadenopathy, which suggested the possibility of sarcoidosis. Biopsy of the inguinal lymph node pathologically was consistent with sarcoidosis. The 2[18F]fluoro-2-deoxy-d-glucose positron emission tomography scanning (FDG-PET) demonstrated intense uptake in the myocardium, and the patient was finally diagnosed as having cardiac sarcoidosis. After steroid treatment, the abnormal FDG-PET uptake disappeared. The patient therefore represented a case of cardiac sarcoidosis masquerading as ARVC. It should be recognized that RV involvement is one of the manifestations in cardiac sarcoidosis. [Copyright &y& Elsevier]