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To assess mid-/long-term postoperative quality of life (QOL) of esophageal atresia (EA) patients.Modified gastrointestinal quality-of-life index surveys were administered to postoperative EA patients who were at least 7 years old at evaluation to assess three topics about general lifestyle (GL), five topics about EA, and four topics about mental health (MH). For MH, caregivers were also interviewed, but separately. Subjects were divided according to age: children (7-12 years old), teenagers (13-19), and adults (20 and over) and compared according to Foker or Kimura elongation (FK) or bougienage stretching (BS).There were 22 patients evaluated. Responses for GL, EA, and MH did not differ significantly between age groups, but MH responses by caregivers for subjects who were children or teenagers scored significantly lower than responses they made themselves. For primary esophageal elongation technique (PET), age at esophagoesophagostomy was significantly higher in FK. Despite FK scoring 15.1 versus 12.4 for BS during EA evaluation, this difference was not statistically significant.Changes in QOL responses according to age were unremarkable. However, discrepancies in MH indicate that subjects felt better than their caregivers thought. PET did not appear to influence QOL.

The range of internal rotation sometimes deteriorates after reverse total shoulder arthroplasty; however, the underlying mechanisms remain unclear. This study aimed to investigate the association between sagittal spinal alignment and internal rotation deterioration after reverse total shoulder arthroplasty.We retrospectively reviewed 52 patients who underwent reverse total shoulder arthroplasty by a single surgeon between October 2014 and December 2018. The sagittal spine was radiographed, and the sagittal spinal alignment was evaluated based on 10 parameters (e.g. C7-HA: the distance between the plumb line from the center of the seventh cervical vertebral body and the center of the hip axis). We divided the patients into two groups, group A (internal rotation deterioration; 23 patients) and B (without internal rotation deterioration; 29 patients). Logistic regression analysis was performed to analyze the association between sagittal spinal alignment and internal rotation deterioration after reverse total shoulder arthroplasty, and a receiver operating characteristic curve was used to analyse the cutoff value of independent variables that was correlated with IR deterioration.Logistic regression analysis demonstrated the correlation between C7-HA and internal rotation deterioration (odds ratio, 1.95; 95% confidence interval, 1.33-2.84; P 0.001). The receiver operating characteristic curve suggested that when C7-HA was at least 2.44 cm, it was strongly correlated with deterioration of internal rotation (sensitivity, 91.3%; specificity, 93.1%; P 0.001; area under the curve, 0.938). Group A was significantly inferior to group B in not only internal rotation but also flexion and abduction.This study suggested that a remarkably positive value in C7-HA was a factor that was correlated with deterioration of internal rotation. In addition, the deformation of sagittal spinal alignment would impact on the range of motion after reverse total shoulder arthroplasty.

Planning a three-dimensional (3D) osteotomy using computed tomography (CT) data is useful especially in cases with complex deformities. Furthermore, CT-based navigation system allows the preoperative virtual planning to be replicated in actual surgery. However, one disadvantage when using navigation systems is that when osteotomies are performed on tracker-attached bone, the bone fragments on the side that were cut away cannot be tracked. This is especially problematic when performing multiple osteotomies on bones with complex deformities. We solved this problem by creating a 3D printed bone model that can be referenced intraoperatively and used in combination with the navigation system. We applied these techniques to perform segmental corrective osteotomy for a complex tibial deformity with intramedullary nail (IMN) fixation case of hereditary vitamin D-resistant hypophosphatemic rickets (HVDRR) in an adult man. Due to the patient's history of multiple surgeries, the affected tibia had a narrow and partially closed medullary canal. Therefore, we planned to use an IMN for correction and fixation of tibial deformity to protect the thin and stretched skin around the deformed tibia. With the assistance of CT-based navigation, we could perform an accurate three-dimensional tibial osteotomy. Moreover, we could perform accurate preparation of closed medullary canal for the IMN placement by referring to the 3D printed bone models. Six months after the operation, the bone union at the osteotomy sites was confirmed and the patient was able to return to his normal life and work.

Aim Elevated serum alkaline phosphatase (ALP) levels have been associated with increased risks of all-cause and cardiovascular mortality in patients receiving hemodialysis. However, little is known about the impact of serum ALP levels on the development of stroke, such as brain hemorrhage and infarction. Methods A total of 3,497 patients receiving maintenance hemodialysis registered in the multicenter observational Q-Cohort Study were analyzed. The primary outcomes were the incidences of brain hemorrhage and infarction. The covariate of interest was serum ALP levels. Patients were divided into tertiles based on their serum ALP levels (U/L) at baseline (T1, ＜69.3; T2, 69.3-98.4; T3, ＞98.4). The risks of brain hemorrhage, brain infarction, and composite stroke were estimated using Cox proportional hazards models and competing risk models with all-cause death as a competing risk. Results A total of 89 patients developed brain hemorrhage and 195 patients developed brain infarction during the 4-year follow-up period. The risk of brain hemorrhage in the highest tertile (T3) was significantly higher than that in the lowest tertile (T1) (multivariable-adjusted hazard ratio [95% confidence interval], 1.93 [1.12-3.35], subdistribution hazard ratio, 1.91 [1.10-3.30]). However, there was no significant association between serum ALP levels and the risk of brain infarction or composite stroke. Conclusions Higher serum ALP levels are associated with an increased risk of brain hemorrhage, but not brain infarction, in patients receiving maintenance hemodialysis. High serum ALP level is thus an important risk factor for brain hemorrhage in hemodialysis patients.

Chronic kidney disease–mineral and bone disorder (CKD–MBD) is a systemic disorder that affects multiple organs and systems and increases the risk of morbidity and mortality in patients with CKD, especially those receiving dialysis therapy. CKD–MBD is highly prevalent in CKD patients, and its treatment is gaining attention from healthcare providers who manage these patients. Additional important pathologies often observed in CKD patients are chronic inflammation and malnutrition/protein-energy wasting (PEW). These two pathologies coexist to form a vicious cycle that accelerates the progression of various other pathologies in CKD patients. This concept is integrated into the term “malnutrition–inflammation–atherosclerosis syndrome” or “malnutrition–inflammation complex syndrome (MICS)”. Recent basic and clinical studies have shown that CKD–MBD directly induces inflammation as well as malnutrition/PEW. Indeed, higher circulating levels of inorganic phosphate, fibroblast growth factor 23, parathyroid hormone, and calciprotein particles, as markers for critical components and effectors of CKD–MBD, were shown to directly induce inflammatory responses, thereby leading to malnutrition/PEW, cardiovascular diseases, and clinically relevant complications. In this short review, we discuss the close interplay between CKD–MBD and MICS and emphasize the significance of simultaneous control of these two seemingly distinct pathologies in patients with CKD, especially those receiving dialysis therapy, for better management of the CKD/hemodialysis population.

Protein-energy wasting (PEW) is a risk factor for mortality in patients undergoing hemodialysis. Recently, a nutritional risk index for Japanese hemodialysis patients (NRI-JH) has been proposed as a surrogate index of PEW. However, no study has determined the association of the NRI-JH with long-term mortality in patients undergoing hemodialysis. Furthermore, the validity of the NRI-JH has not been confirmed. In total, 3046 patients undergoing hemodialysis and registered in the Q-Cohort Study were followed up for 10 years. The NRI-JH was calculated on the basis of body mass index and serum levels of albumin, total cholesterol, and creatinine. The patients were divided into four groups according to the NRI-JH scores: 0–3 (G1, n = 1343), 4–7 (G2, n = 1136), 8–10 (G3, n = 321), and 11–13 (G4, n = 246). We examined the association between the NRI-JH and the 4-year and 10-year risks of all-cause, cardiovascular, and infection-related deaths using the Cox proportional hazards model. During the follow-up period, 647 patients died during the first 4 years, and 1503 patients died within 10 years. The 4-year prognosis was analyzed and compared with the lowest NRI-JH score group. Multivariable-adjusted hazard ratios (95% confidence intervals) for all-cause death were 1.93 (1.57–2.38), 2.68 (2.05–3.50), and 3.16 (2.40–4.16) in the G2, G3, and G4 groups, respectively. Similarly, a higher NRI-JH score was associated with an increased risk of cardiovascular and infection-related deaths. A higher NRI-JH score was associated with an increased risk of long-term mortality in patients undergoing maintenance hemodialysis. The study protocol was registered in the University Hospital Medical Information Network (UMIN) clinical trial registry (UMIN ID: 000000556).

The purpose of this study was to evaluate the effects of high tibial osteotomy (HTO) on the biological status of knee osteoarthritis (OA) using joint markers in synovial fluid (SF)., Fifty patients with medial compartmental OA of the knee who underwent opening wedge HTO were enrolled. Paired SF samples from the affected knee and arthroscopic evaluation of articular cartilage were collected at the time of HTO surgery and the time of plate removal (postoperative 17±4 months). The concentrations of the following SF biomarkers were measured: interleukin (IL)-1β, IL-6, IL-8, IL-10, tumour necrosis factor-α, matrix metalloproteinase (MMP)-2, MMP-3, MMP-9, MMP-13, vascular endothelial growth factor (VEGF), and cartilage oligomeric matrix protein (COMP). The Knee Society Score (KSS) and hip-knee-ankle (HKA) angle were assessed before and 2 years after HTO., The KSS knee and function scores were significantly improved after HTO (mean changes of 36.4 and 23.7, respectively). The mean HKA angle was altered from mechanical varus (-8.6°) to valgus (5.2°). Concentrations of IL-6, IL-8, MMP-2, MMP-3, MMP-13, VEGF, and COMP in SF were significantly decreased after HTO (mean changes of-49.1%,-30.2%,-31.1%,-26.3%,-30.8%,-42.5%, and-13.7% from preoperative baseline, respectively). The cartilage status was improved in 19 cases (38%) after HTO. However, changes of all biomarkers were not significantly different between subjects with and without an improved cartilage status., SF levels of biochemical markers for cartilage degradation and synovial inflammation were altered after HTO, suggesting an improvement in the OA disease state.

To determine whether medialization of the proximal tibia due to a varus deformity is related to lateralization of the tibial tuberosity in varus knee osteoarthritis (OA)., A total of 120 knees that underwent osteotomies around the knee for varus knee OA were enrolled. Mechanical medial proximal tibial angle (mMPTA) was measured on radiographs. The angle between the mechanical and anatomical axes of the tibia (angle MA) and the distance between the centre of the tibial plateau and the anatomical axis (distance MA) were measured in the coronal plane on computed tomography images. The tibial tuberosity-posterior cruciate ligament (TT-PCL) distance, the distance between the midpoint of the tibial tuberosity and the centre of the tibial plateau (TT-centre distance), and the angle between the line through the midpoint of the tibial tuberosity and the centre of the tibial plateau and the anteroposterior axis (TT-centre angle) were measured in the axial plane. The correlations of these parameters were evaluated., mMPTA correlated negatively with angle MA (r=-0.37, P, Medialization of the proximal tibia due to a varus deformity may induce lateralization of the tibial tuberosity.

To assess mid-/long-term quality of life (QOL) of total colonic aganglionosis (TCA) patients.Modified pre-existing QOL assessment tools for general lifestyle (GL), bowel function (BF), and mental health (MH) were administered to postoperative TCA patients from five institutions, who were at least 7 years old to compare Duhamel (with pouch) and Swenson/Soave (without pouch) techniques between children (Ch 7-12 years old), teenagers (Tn 13-19), and adults (Ad 20 and over). For MH, caregivers were also interviewed, but separately. Maximum scores were 12 for GL/MH and 18 for BF.There were 32 subjects. GL and BF scores increased significantly from Ch (GL 4.8 ± 2.5, BF: 11.3 ± 4.6) to Tn (GL 7.8 ± 2.6, BF 16.2 ± 3.0); scores for MH did not change significantly. Mean caregiver MH scores were significantly lower than mean subject MH scores for all age groups (subject scores: 10.1, 10.7, 10.7 versus caregiver scores: 6.8, 7.8, 8.1 for Ch, Tn, Ad, respectively). PT technique/presence of a pouch did not influence the incidence of enterocolitis or QOL scores.MH responses showed subjects felt better than caregivers believed. This discrepancy could cause conflict despite steadily improving GL/BF. QOL was unaffected by PT technique/presence of a pouch.

Background The purpose of this study was to evaluate the reproducibility of planned component positioning including tibial rotational alignment in patient-specific instrumentation (PSI) for total knee arthroplasty (TKA). Methods A total of 100 knees of 100 patients underwent TKA using PSI (n = 50) or the conventional method (n = 50). Full-length anteroposterior radiographs of the lower limb were taken in the standing position, and the coronal alignments of the femoral and tibial components were measured. Computed tomography (CT) images of the lower limb were obtained preoperatively and postoperatively, and the rotational alignments of the femoral and tibial components were measured. The difference from the preoperative planning in tibial rotational alignment was measured using three-dimensionally merged pre- and postoperative images. The mean values and rates of outliers in each measurement were compared between the PSI group and the conventional group. Results There were no significant differences in coronal alignment of the femoral and tibial components and rotational alignment of the femoral component between the two groups. With respect to rotational alignment of the tibial component from the preoperatively planned reference axis, the PSI group showed a lower rate of outliers (internal rotation > 10°) than the conventional group (p Conclusions This study demonstrated that the difference from the preoperative planning in tibial rotational positioning was accurately evaluated using novel three-dimensional measurement method, and PSI could reduce outliers in rotational alignment of the tibial component (internal rotation > 10°). PSI is a useful technique for improving the reproducibility of the planned tibial rotational positioning in TKA.

Normalized protein catabolic rate (nPCR) is used as a surrogate for daily dietary protein intake and nutritional status in patients receiving maintenance hemodialysis. It remains uncertain whether the nPCR level is associated with the incidence of bone fracture.A total of 2869 hemodialysis patients registered in the Q-Cohort Study, a multicenter, prospective, observational study, were followed up for 4 years. The primary outcome was bone fracture at any site. The main exposure was the nPCR level at baseline. Patients were assigned to four groups based on their baseline nPCR levels (G1:0.85, G2: 0.85≤,0.95, G3: 0.95≤,1.05 [reference], G4: ≥1.05 g/kg/day). We examined the relationship between the nPCR levels and the risk for bone fracture using Cox proportional hazards models.During the follow-up period, 136 patients experienced bone fracture at any site. In the multivariable analyses, the risk for bone fracture was significantly higher in the lowest (G1) and highest (G4) nPCR groups than the reference (G3) group (hazard ratio [95% confidence intervals]: G1, 1.93 [1.04-3.58]; G2, 1.27 [0.67-2.40]; G3 1.00 (reference); G4, 2.21 [1.25-3.92]). The association remained almost unchanged, even when patients were divided into sex-specific nPCR quartiles, when analysis was limited to patients with a dialysis vintage ≥2 years, assumed to have lost residual kidney function, or when a competing risk model was applied.Our results suggest that both lower and higher nPCR levels are associated with an increased risk for bone fracture in hemodialysis patients.

CD47, a 50 kDa transmembrane protein, facilitates integrin-mediated cell adhesion and inhibits cell engulfment by phagocytes. Since CD47 blocking promotes engulfment of cancer cells by macrophages, it is important to clarify the mechanism of CD47 signaling in order to develop treatments for diseases involving CD47-overexpressing cancer cells, including breast cancer and lymphoma. Here, we show that CD47 plays an essential role in T-cell lymphoma metastasis by up-regulating basal RhoA activity independent of its anti-phagocytic function. CD47 interacts with AKAP13, a RhoA-specific guanine nucleotide exchange factor (GEF), and facilitates AKAP13-mediated RhoA activation. Our study shows that CD47 has a novel function on the AKAP13-RhoA axis and suggests that CD47–AKAP13 interaction would be a novel target for T-cell lymphoma treatment.

The purpose of this study was to evaluate the area of the osteotomy surface, including the flange and wedge volume, in open wedge high tibial osteotomy (OWHTO), distal tibial tuberosity osteotomy (DTO), and distal tibial tuberosity arc osteotomy (DTAO) using tibial sawbones. It was hypothesized that the area of the osteotomy surface, including the flange, in DTAO was larger than that in OWHTO and DTO and that the wedge volume in DTAO was smaller than that in OWHTO and DTO. Fifteen tibial sawbones were divided equally into three groups: OWHTO, DTO, and DTAO. The total area of the osteotomy surface in OWHTO, DTO, and DTAO was compared using image analysis software. The contact area of the flange and the wedge volume at wedge heights of 5, 10, and 15 mm were compared among osteotomy types. One-way repeated-measures analysis of variance was used to compare the total area of the osteotomy surface, the contact area of the flange, and the wedge volume at 5, 10, and 15 mm in OWHTO, DTO, and DTAO. The total area of the osteotomy surface in DTO and DTAO was significantly larger than that in OWHTO (P

In the era of a trillion sensors, a tremendous number of sensors will be consumed to collect information for big data analysis. Once they are installed in a harsh environment or implanted in a human/animal body, we cannot easily retrieve the sensors; the sensors for these applications are left unattended but expected to decay after use. In this paper, a disposable temperature sensor that disappears with contact with water is reported. The gel electrolyte based on an ionic liquid and a water-soluble polymer, so-called ionic gel, exhibits a Young's modulus of 96 kPa, which is compatible with human muscle, skin, and organs, and can be a wearable device or in soft robotics. A study on electrical characteristics of the sensor with various temperatures reveals that the ionic conductivity and capacitance increased by 12 times and 4.8 times, respectively, when the temperature varies from 30 to 80 °C. The temperature sensor exhibits a short response time of 1.4 s, allowing real-time monitoring of temperature change. Furthermore, sensors in an array format can obtain the spatial distribution of temperature. The developed sensor was found to fully dissolve in water in 16 h. The water-dissolvability enables practical applications including healthcare, artificial intelligence, and environmental sensing.

Peripheral artery disease (PAD) is mainly caused by atherosclerosis and is a critical cardiovascular complication in patients undergoing hemodialysis. Although hyperphosphatemia is a risk factor for cardiovascular events, whether serum phosphate concentration is associated with PAD remains unclear. This study was performed to clarify the relationship between serum phosphate concentration and the risk of intervention for PAD in patients undergoing hemodialysis.In total, 3505 patients undergoing hemodialysis registered in the Q-Cohort Study were followed up for 10 years. The primary outcome was the incidence of major adverse limb events (MALE) as a surrogate endpoint of intervention for PAD. The patients were divided into quartiles according to the baseline serum phosphate concentration: Q1 (n = 886),4.2 mg/dL; Q2 (n = 837), 4.2-4.8 mg/dL; Q3 (n = 909), 4.9-5.6 mg/dL; and Q4 (n = 873), ≥5.7 mg/dL. A multivariable-adjusted Cox proportional hazards risk model was employed to examine the association between the serum phosphate concentration and the risk of MALE.During a median follow-up period of 8.2 years, 257 patients required intervention with MALE. The Cox proportional hazards risk model showed that the risk of MALE in Q4 was significantly higher than that in Q1 (hazard ratio, 1.81; 95% confidence interval, 1.25-2.63). Every 1-mg/dL increase in serum phosphate concentration was also significantly associated with the increased incidence of MALE (hazard ratio, 1.24; 95% confidence interval, 1.10-1.39).An elevated serum phosphate concentration was associated with an increased risk of MALE in patients undergoing hemodialysis.

This study investigated the relationship between femoral shaft bowing and the orientation of the surgical transepicondylar axis (TEA) in the coronal plane in varus knee osteoarthritis (OA). A total of 82 knees scheduled to undergo total knee arthroplasty (TKA) for the treatment of varus knee OA were enrolled. The hip–knee-ankle angle (HKA) was measured preoperatively on anteroposterior whole-leg standing radiographs. The lateral angle between the TEA and the mechanical axis of the femur (MA-TEA) was measured in the coronal plane from preoperative computed tomography (CT) images. Femoral shaft bowing was measured on CT images. Pearson’s correlation coefficient was used to examine the correlation of the MA-TEA with the HKA and femoral shaft bowing. The MA-TEA correlated negatively with the HKA (r = − 0.321, P

The aim of this study was to investigate whether the tibial tuberosity–trochlear groove (TT–TG) distance and lateral patellar tilt, which induce patellofemoral osteoarthritis (OA), are related to the coronal deformity of the lower limb in varus knee OA. It was hypothesized that varus inclination of the tibia was negatively correlated with the TT–TG distance and lateral patellar tilt in Japanese female patients with moderate knee OA. A total of 104 female patients (139 knees) scheduled to undergo knee osteotomy for varus knee OA were enrolled. The coronal lower limb alignment was measured on anteroposterior whole-leg radiographs. The TT–TG distance, patellar tilt angle, and the patellofemoral joint space were measured both medially and laterally on computed tomography images. The correlations between coronal lower limb alignment and the TT–TG distance or patellar tilt angle, and the correlations between the TT–TG distance or patellar tilt angle and patellofemoral joint space were evaluated. The medial proximal tibial angle was negatively correlated with the TT–TG distance (r = − 0.383, P

A 71-year-old woman was hospitalized for the treatment of fatigue, fever, and cough. On admission, she showed increased serum inflammation markers, severe anemia, pulmonary hemorrhage, and advanced acute kidney injury requiring hemodialysis. Her serum anti-glomerular basement membrane (GBM) antibody titer was found to be extremely high on the 7th hospital day. She was eventually diagnosed with anti-GBM disease. She was treated with a combination of corticosteroid pulse therapy, oral prednisolone and cyclophosphamide, and plasma exchange, but continued to require maintenance hemodialysis for end-stage kidney disease. During her treatment, she suddenly developed headache, blindness, seizure, and consciousness disturbance. She was diagnosed by magnetic resonance imaging with posterior reversible encephalopathy syndrome (PRES) with subcortical cerebral hemorrhage. Both the PRES and cerebral hemorrhage subsided soon after control of her hypertension and reinforcement of immunosuppressive treatment. PRES, particularly when accompanied by cerebral hemorrhage, may cause irreversible and lethal neurological abnormalities, and nephrologists should, therefore, be aware of the potential risk of PRES in patients with anti-GBM disease. We discuss the current case in the light of the previous literature.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. In primary analysis, enzalutamide plus androgen deprivation therapy (ADT) improved radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC); however, overall survival data were immature. In the phase III, double-blind, global ARCHES trial (ClinicalTrials.gov identifier: NCT02677896 ), 1,150 patients with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg once daily) plus ADT or placebo plus ADT, stratified by disease volume and prior docetaxel use. Here, we report the final prespecified analysis of overall survival (key secondary end point) and an update on rPFS, other secondary end points, and safety. After unblinding, 180 (31.3%) progression-free patients randomly assigned to placebo plus ADT crossed over to open-label enzalutamide plus ADT. As of May 28, 2021 (median follow-up, 44.6 months), 154 of 574 patients randomly assigned to enzalutamide plus ADT and 202 of 576 patients randomly assigned to placebo plus ADT had died. Enzalutamide plus ADT reduced risk of death by 34% versus placebo plus ADT (median not reached in either group; hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P < .001). Enzalutamide plus ADT continued to improve rPFS and other secondary end points. Adverse events were generally consistent with previous reports of long-term enzalutamide use. In conclusion, enzalutamide plus ADT significantly prolongs survival versus placebo plus ADT in patients with mHSPC.

Background To evaluate the anterolateral cortex distance between the lateral edge of the flange and hinge point in surgical simulations of biplanar open wedge high tibial osteotomy (OWHTO) using computed tomography (CT) images. Methods A total of 110 knees treated with OWHTO for medial knee osteoarthritis with varus malalignment were enrolled. Surgical simulations of biplanar OWHTO, including the transverse and ascending cuts, were performed in the standard manner using preoperative CT images. The distance between the lateral edge of the flange and the hinge point was measured. In addition, another plane of the ascending cut was defined through the hinge point. The angle between these two planes of the ascending cut was measured in the axial plane. Results The mean anterolateral cortex distance was 9.4 ± 4.6 mm (range, − 1.5 mm – 20.3 mm). In 3 knees, osteotomy of the anterolateral cortex was not needed. The mean value of the angle between the two ascending cut planes was 8.4 ± 3.6° (range, − 2.1° – 14.8°), which meant that osteotomy of anterolateral cortex was not needed when the ascending cut was performed at this angle. Moreover, these two values increased when the flange thickness was changed from one-third to one-fourth of the anteroposterior tibial diameter or the angle between the transverse and ascending cuts was changed from 110° to 120°. Conclusions In biplanar OWHTO, anterolateral cortex osteotomy would be required. However, the range of the required anterolateral cortex osteotomy distance varied widely and the required anterolateral cortex osteotomy distance depended on the flange thickness and the angle between the transverse and ascending cuts. In addition, change of the ascending cut plane can change the necessity of anterolateral cortex osteotomy.

High serum alkaline phosphatase (ALP) levels are associated with excess all-cause and cardiovascular mortality in patients undergoing hemodialysis (HD). However, the long-term relationship between serum ALP levels and infection-related mortality remains unclear.A total of 3502 maintenance HD patients were registered in the Q-Cohort Study, an observational cohort study in Japan. The primary outcome was infection-related mortality during a 10-year follow-up period. The covariate of interest was serum ALP levels at baseline. The association between serum ALP levels and infection-related mortality was calculated using a Cox proportional hazards model and a Fine-Gray subdistribution hazards model with non-infection-related death as a competing risk.During the follow-up period, 446 patients died of infection. According to their baseline serum ALP levels, the patients were categorized into sex-specific quartiles (Q1-Q4). Compared with patients in the lowest serum ALP quartile (Q1), those in the highest quartile (Q4) had a significantly higher multivariable-adjusted hazard ratio (HR) of 1.70 [95% confidence interval (CI) 1.24-2.32] for infection-related mortality. Furthermore, the HR for every 50 U/L increase in serum ALP levels was 1.24 (95% CI 1.12-1.36) for infection-related mortality. These associations remained consistent in the competing risk model: subdistribution HR, 1.47; 95% CI 1.07-2.03 for Q4 compared with Q1.Higher serum ALP levels were significantly associated with a higher risk of infection-related mortality in patients undergoing HD.

Background To evaluate the difference in surgical planning of osteotomies around the knee between preoperative standing and supine radiographs and to identify risk factors for discrepancies in surgical planning. Methods This study included 117 knees of 100 patients who underwent osteotomies around the knee for knee osteoarthritis with genu varum. Surgical planning was performed so that the target point of the postoperative weight-bearing line (WBL) ratio was 62.5% in preoperative standing and supine radiographs. If the opening gap would be > 13 mm in open-wedge high tibial osteotomy (OWHTO), closed-wedge HTO (CWHTO) was planned. If the postoperative mMPTA would be > 95° in isolated HTO, double-level osteotomy (DLO) was planned. In DLO, lateral closed-wedge distal femoral osteotomy was performed so that the postoperative mechanical lateral distal femoral angle (mLDFA) was 85°, and any residual varus deformity was corrected with HTO. Results Surgical planning differed between standing and supine radiographs in 43.6% of cases. In all knees for which surgical planning differed between standing and supine radiographs, a more invasive type of osteotomy was suggested by standing radiographs than by supine radiographs. The risk factors for discrepancies in surgical planning were a lower WBL ratio in standing radiographs and a lower joint line convergence angle in supine radiographs. Conclusions Surgical planning of DLO, CWHTO and OWHTO, in standing radiographs differed from that in supine radiographs in nearly half of the cases. Surgical planning based on standing radiographs leads to more invasive surgical procedures compared to supine radiographs.

Enzalutamide significantly improved clinical outcomes compared with placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) with disease progression despite androgen deprivation therapy (ADT) in the PREVAIL study. However, few patients from Asia were enrolled. Our study (NCT02294461) aimed to evaluate the safety and efficacy of enzalutamide in this disease setting in patients in mainland China, Korea, Taiwan, and Hong Kong.In this double-blind, phase III study, patients with asymptomatic/mildly symptomatic metastatic prostate cancer and disease progression despite ADT were randomized to enzalutamide (160 mg/day) or placebo. The primary endpoint was time to prostate-specific antigen (PSA) progression. Secondary endpoints included overall survival, radiographic progression-free survival, time to first skeletal-related event (SRE), time to initiation of cytotoxic chemotherapy, PSA response ≥ 50%, best overall soft-tissue response, and safety. Pre-planned interim analysis was scheduled following approximately 175 PSA-progression events (67% of targeted total of 261 events). An additional 5-year landmark analysis of overall survival, time to antineoplastic therapy, and safety was performed.The double-blind study period was stopped after interim analysis owing to the benefit of enzalutamide over placebo. Overall, 388 patients were randomized (enzalutamide, n = 198; placebo, n = 190). Baseline characteristics were balanced between treatment groups. Enzalutamide significantly reduced risk of PSA progression vs placebo (hazard ratio 0.38; 95% CI 0.27-0.52; P 0.0001). Median time to PSA progression was 8.31 months with enzalutamide and 2.86 months with placebo. Secondary endpoints, including 5-year overall survival, were significantly improved with enzalutamide, except time to first SRE. Adverse-event incidence was similar between enzalutamide and placebo. Fatigue was the most common drug-related adverse event in both treatment groups.Enzalutamide significantly reduced risk of PSA progression, improved secondary efficacy endpoints, and was well tolerated in chemotherapy-naïve Asian patients with mCRPC with disease progression despite ADT.www.gov NCT02294461.

The purpose of this study was to assess early postoperative loss of achieved correction and associated factors after opening wedge high tibial osteotomy (OWHTO). OWHTO was performed in 121 patients with osteoarthritis of the knee (mean age 66 years, 154 knees). Anteroposterior radiographs of the knee and full-length leg, and varus and valgus stress radiographs of the knee were taken, and the femorotibial angle (FTA), joint line convergence angle (JLCA), and medial proximal tibial angle (MPTA) were measured. The changes in the FTA, JLCA, and MPTA were defined as ΔFTA, ΔJLCA, and ΔMPTA. The ΔFTA and ΔJLCA at postoperative 0–2 days were − 1.8 ± 1.2° and − 1.9 ± 1.4°, respectively. The ΔFTA, ΔJLCA and ΔMPTA at postoperative 1–12 months were 0.9 ± 1.3°, 0.2 ± 1.2° and − 0.8 ± 0.8°, respectively. A positive correlation was found between ΔFTA and ΔJLCA at postoperative 0–2 days (ρ = 0.642, P

Summary Introduction Testicular torsion (TT), as per the reported incidences in children and preadolescents, is an emergency medical condition that requires prompt surgical treatment. In cases of TT, early and accurate diagnosis of acute scrotum (AS) is important to preserve testicular fertility. In this study, the authors aimed to determine the incidence, clinical examination, etiology, clinical predictors, and treatment of patients with AS and TT. Material and methods The authors retrospectively reviewed all children (age, ≤15 years) with AS who visited their hospital between January 2012 and June 2019. Data on age and diagnosis, clinical findings, mode of treatment, and blood examination results were collected. Results The authors examined 165 children aged between 0 days and 15 years (mean age, 9.4 years). Final diagnosis identified 72 patients with torsion of the appendix testis, 44 patients with epididymitis, and 38 patients with TT. Testes were salvaged in 23 of the 38 patients with TT (60.5%). Statistically significant variables revealed that the risk factors of TT were age (older than 12 years), white blood cell (WBC) count (>12,000 cells/mm3), and laterality (left side). The level of C-reactive protein (CRP), duration of symptoms, and degree of torsion were significantly higher in the non-salvageable testis group than in the salvageable testis group. Furthermore, the significant predictive factor for non-salvageable testis was the level of CRP >1.0 mg/dl. Conclusion The study results indicates that age, WBC count, and laterality are key factors to distinguish TT from AS. Salvageability largely depended on the duration of symptoms and the degree of TT. The salvage rate of the testis can be improved by educating pediatricians, parents, patients, and medical staff about the early diagnosis and treatment of torsion. Table 1 . Details of patients with AS (n = 165). Age (yrs) 9.4 ± 0.6 Final diagnosis Surgical treatment Conservative treatment Torsion of the appendix testis 72 (43.6%) 51 21 Epididymitis 44 (26.7%) 19 25 TT 38 (23.0%) 38 0 Torsion of the appendix epididymis 5 (3.0%) 5 0 Scrotal dermatitis 2 (1.2%) 0 2 Torsion of the epididymis 1 (0.6%) 1 0 Tumor of the spermatic cord 1 (0.6%) 1 0 Acute hydrocele 1 (0.6%) 0 1 Trauma 1 (0.6%) 0 1 Total 165 (100%) 115 50 Laterality Right side 66 (40.0%) Left side 93 (56.4%) Both sides 6 (3.6%) First diagnosis TT Not TT Final diagnosis TT 38 0 Not TT 23 127 Sensitivity 38/38 (100%) Specificity 127/150 (84.7%)

Objective: This study evaluated the effect of surgical intervention on disease activity and factors associated with postoperative disease activity in patients with rheumatoid arthritis (RA).Methods...

Preserving residual kidney function (RKF) is important in the management of patients on peritoneal dialysis. However, few studies have examined the association between serum albumin level and the risk of RKF loss. We prospectively recruited 104 patients who began peritoneal dialysis treatment at our hospital between 2006 and 2016. The primary outcome was complete RKF loss, defined as urine volume < 100 mL/day. Serum albumin level at baseline was the main exposure. During a median observation period of 24 months, 33 patients developed RKF loss. A Cox proportional hazards model showed that hypoalbuminemia was associated with an increased risk of RKF, even after adjustments for potential confounding factors. Multivariable-adjusted linear regression analysis also showed that hypoalbuminemia was associated with greater rates of decline in 24-h urine volume and in renal Kt/V urea. Our findings suggest that hypoalbuminemia is associated with an increased risk of RKF loss in patients with peritoneal dialysis.

Patient: Female, newborn Final Diagnosis: Coronary arterial fistula Symptoms: Respiratory distress Medication: — Clinical Procedure: — Specialty: Cardiology • Pediatrics and Neonatology Objective: Congenital defects/diseases Background: Although large coronary artery fistulas are uncommon; they lead to substantial over-circulation in the pulmonary vascular beds and left heart system. Fistula occlusions are achieved via surgical or transcatheter technique; however, reports on successful outcomes of transcatheter treatment during the neonatal period are limited. Case Report: A female infant was born at the gestational age of 37 weeks with a birth weight of 2615 grams via normal vaginal delivery. Cardiac auscultation revealed a loud continuous murmur emanating from the fourth right intercostal space. A right coronary artery-to-right ventricle fistula was confirmed using transthoracic echocardiography. The newborn developed respiratory distress 3 days after birth and was administered continuous positive airway pressure to assist breathing. On day 8, the ventilator was used through tracheal intubation due to gradual worsening of dyspnea. A 6-mm Amplatzer Vascular Plug 4 (AGA Medical Corporation, Plymouth, MN) was chosen, as the minimum diameter of the coronary artery fistula was 5 mm. In view of the risk of myocar-dial ischemia with additional devices, the procedure was stopped despite persistent shunting. The newborn’s clinical condition significantly improved following the procedure and she was eventually weaned off ventilator support. Conclusions: A self-expanding occlusion device was useful for relieving this life-threatening condition. Complete elimination of shunting is not always necessary, to avoid compromising myocardial circulation.

Background To evaluate the long-term efficacy of switching of the nucleos(t)ide analog used for treatment from entecavir (ETV) to tenofovir alafenamide fumarate (TAF) in patients with chronic HBV infection. Methods A total of 103 patients with serum HBsAg levels of ≥100 IU/mL who had received ETV were enrolled. The nucleos(t)ide analog used for the treatment was switched from ETV to TAF, and the changes in serum HBsAg levels during the 144-week period before and after the drug switching were compared in 74 patients who had received ETV at least for 192 weeks. Results Significant decreases of serum HBsAg levels were observed during both the ETV and the TAF administration period, although the degree of reduction was greater during the latter period than during the former period (P Conclusion Switching of the nucleos(t)ide analog used for treatment from ETV to TAF merits consideration in patients with chronic HBV infection, since the extent of reduction of the serum HBsAg level was greater during the TAF treatment period than during the ETV treatment period.

BackgroundThe purpose of this study was to evaluate return to sports (RTS) after opening wedge high tibial osteotomy (OWHTO) in elderly patients and associated factors affecting RTS.MethodsSeventy-four patients (mean age 68 years) who underwent OWHTO were enrolled. Clinical outcomes were evaluated using the Knee Society Score (KSS). Patients were asked regarding types of sports activities and their levels of participation within preoperative 1 year and postoperative 1 year. Levels of participation in sports and recreational activities were examined using the Tegner activity scale. The outcomes were compared between two age groups (≥ 70 years vs. ResultsOf the 74 patients overall, 59 participated in at least one sport preoperatively, and 55 returned to sports postoperatively (RTS 93%). The KSS knee score and function score were significantly improved after surgery in both age groups (P P P = 0.16), respectively. RTS was reported by 24 of 25 (96.0%) in the age ConclusionsThe rate of RTS after OWHTO was high in patients aged 70 years and older with low-impact level. OWHTO is a preferred surgical option for elderly patients who desire RTS.

Purpose: The aim of this study was to assess differences in clinical outcomes and postoperative cartilage repair between opening wedge high tibial osteotomy (OWHTO) and closed wedge HTO (CWHTO) for medial osteoarthritis (OA) of the knee. Methods: A total of 90 knees of 76 patients who underwent OWHTO (45 knees of 40 patients) and CWHTO (45 knees of 36 patients) was followed-up for 2 years. Cartilage repair at the medial compartment was arthroscopically classified into the following stages: Stage 1 (no reparative change); Stage 2 (partial coverage with white cartilaginous tissue); and Stage 3 (full coverage with white cartilaginous tissue). Clinical outcomes were assessed using Knee Society scores, and radiographic assessment was carried out by anatomical femorotibial angle (aFTA). Results: Regarding preoperative OA grade, varus alignment, and function score, CWHTO patients showed more advanced OA status than OWHTO patients. Knee scores and function scores were significantly improved after surgery with both HTO procedures (P < 0.05), with no significant difference between the two procedures. Cartilage repair of stage 2 or 3 was found in more than 80% of the subjects in the medial femoral condyle and more than 60% in the medial tibial condyle. However, there were no significant differences between the two HTO procedures. Multivariate logistic regression analysis showed that preoperative International Cartilage Repair Society (ICRS) grade was the only factor affecting cartilage repair. Conclusions: CWHTO improved clinical outcomes and cartilage status as much as OWHTO. Although the effects of cartilage repair on clinical outcomes are unknown, HTO is an effective treatment option even for severe medial OA of the knee.

Objective The purpose of this study was to evaluate the postoperative status of spontaneous osteonecrosis of the knee (SONK) after high tibial osteotomy (HTO) with concomitant bone marrow stimulation (BMS) using synovial fluid (SF) biomarkers. Design Twenty patients with SONK who underwent opening wedge HTO were enrolled. Paired SF samples from the affected knee were collected at the time of HTO surgery and at the time of plate removal. SF concentrations of interleukin (IL)-6, IL-8, and matrix metalloproteinase (MMP)-13 were measured by enzyme-linked immunosorbent assays. The Knee Society Score (KSS) and hip-knee-ankle (HKA) angle were assessed before and 2 years after HTO. Results The KSS knee and function scores were significantly improved after HTO (mean changes of 33.8 and 29.4, respectively). The mean HKA angle was changed from mechanical varus (−8.6°) to valgus (5.2°). Concentrations of IL-6, IL-8, and MMP-13 were significantly decreased after HTO (mean changes of −73.7%, −32.4%, and −47.9% from preoperative baseline, respectively). Significant correlations were found between lesion size and concentrations of biomarkers, except for preoperative MMP-13. Conclusions SF levels of biomarkers of inflammation and cartilage degradation were reduced after HTO with a concomitant BMS procedure, suggesting a biological improvement in SONK.

Although the mortality rate in patients on hemodialysis remains extremely high, detailed information on causes of death over long-term periods is limited. The aim of this study was to clarify the underlying causes of death in patients undergoing maintenance hemodialysis in Japan. This was a 10-year, multicenter, observational study of 3528 outpatients undergoing maintenance hemodialysis in Japan. Clinical outcomes were analyzed and causes of death were classified into six broad categories including cardiovascular diseases, infectious diseases, malignant neoplasms, cachexia, trauma/accidents, and other diseases, and more detailed subcategories. During the 10-year follow-up period, 1748 (49.5%) patients died. The most frequent causes of death were cardiovascular diseases (36.1%), followed by infectious diseases (25.8%) and malignant neoplasms (13.5%). In a detailed classification, sudden death, pulmonary infection, and lung cancer were the most common causes of death in cardiovascular diseases, infectious diseases, and malignant neoplasms, respectively. Our study determined details on causes of death in Japanese hemodialysis patients during the 10-year follow-up period. Cardiovascular disease, especially sudden death is noticeable cause of death among patients on hemodialysis.

Background Superior capsular reconstruction (SCR) has recently gained popularity as a surgical solution for patients with massive rotator cuff tears or shoulder pseudoparalysis (PPS). Good clinical outcomes have been reported after SCR; however, the factors that influence its clinical outcomes remain unclear. Therefore, in this study, we aimed to clarify the factors influencing postoperative outcomes after SCR using tensor fascia lata graft, for which we evaluated the Hamada grade, patients with or without PPS, and the status of the subscapularis tendon (SSC). Methods In total, 54 consecutive patients with irreparable rotator cuff tears or PPS who underwent SCR between June 2014 and October 2018 were included. The enrolled patients were grouped and compared as follows: (1) Hamada grade 2 (11 patients) and Hamada grade 3 (43 patients) and (2) non-PPS (22 patients), moderate PPS (16 patients), and severe PPS (16 patients). For subanalysis, the 32 PPS patients were divided into 3 groups: intact SSC (11 patients), repairable SSC (16 patients), and irreparable SSC (5 patients). To assess shoulder function, the American Shoulder and Elbow Surgeons (ASES) score was evaluated before surgery and at 24 months postoperatively; shoulder range of motion was evaluated at 2, 3, 4, 5, 6, 8, 10, 12, and 24 months postoperatively. Results No significant differences in postoperative ASES scores and shoulder range of motion were observed between the Hamada grade 2 and grade 3 groups or between the non-PPS, moderate PPS, and severe PPS groups. However, significant differences in postoperative shoulder elevation and ASES scores were observed between the intact SSC and irreparable SSC groups (P = .006) and between the repairable SSC and irreparable SSC groups (P = .003). Conclusions This study demonstrated that the status of the SSC, rather than the Hamada grade or the presence or absence of PPS, influences the clinical outcomes after SCR. Therefore, reparability or intactness of the SSC is an important factor in considering the surgical indication for SCR.

Backgrounds and aims The geriatric nutritional risk index (GNRI), which is calculated using the serum albumin level and body mass index, is a nutritional marker associated with an increased risk of cardiovascular events in patients who are receiving hemodialysis. However, no studies have examined the association between the GNRI level and the incidence of stroke in this population. Methods Three thousand forty-five patients were registered in the Q-Cohort Study, which is a multicenter, observational cohort of hemodialysis patients. The main outcomes were brain infarction and brain hemorrhage. The main exposure was GNRI levels at baseline. Patients were divided into quartiles on the basis of baseline GNRI levels: Q1, 99.8. The risk of brain infarction or hemorrhage was estimated using the multivariable-adjusted Cox proportional hazard risk models and restricted cubic spline analyses. Results During the 10-year follow-up period, 326 patients developed brain infarction and 149 patients developed brain hemorrhage. Cox proportional hazard risk models showed that the risk of brain infarction and hemorrhage in Q1 was significantly higher than that in Q4 group. The hazard ratios [95% confidence intervals] were 1.49 [1.05–2.12] and 1.89 [1.11–3.20], respectively. Restricted cubic spline curves showed that a lower GNRI was incrementally associated with an increased risk for both brain infarction and brain hemorrhage. Conclusions Our results suggest that a lower GNRI is an independent risk factor for both brain infarction and hemorrhage in patients who are receiving maintenance hemodialysis.

Background The purpose of this study was to investigate the correction error associated with soft tissue balance in high tibial osteotomy (HTO) and the difference between opening wedge HTO (OWHTO) and closed wedge HTO (CWHTO). Methods A total of 170 knees of 130 patients (85 knees of 68 patients in OWHTO and 85 knees of 62 patients in CWHTO) were evaluated. Anteroposterior radiographs of the knee and full-length leg were taken preoperatively, immediately under general anesthesia postoperatively, 2 days, and 1 and 12 months postoperatively. The femorotibial angle (FTA), joint line convergence angle (JLCA), and medial proximal tibial angle (MPTA) were measured. Results The postoperative FTA was decreased from 170.5 ± 2.1° at 0 day to 168.6 ± 2.2° at 2 days in OWHTO (P < 0.05), whereas it was not changed from 168.7 ± 2.4° at 0 day to 168.1 ± 2.8° at 2 days in CWHTO. The JLCA was 4.8 ± 1.8° preoperatively, 4.2 ± 1.9° at 0 day, 2.2 ± 1.8° at 2 days (P < 0.05 vs 0 day), 2.6 ± 1.7° at 1 month, and 2.7 ± 1.6° at 12 months in OWHTO, and 7.1 ± 3.2° preoperatively, 4.1 ± 2.4° at 0 day (P < 0.05 vs preoperative), 3.4 ± 2.5° at 2 days, 3.9 ± 2.3° at 1 month, and 4.2 ± 2.6° at 12 months in CWHTO. Multiple regression analysis showed that preoperative factors affecting change of the JLCA from preoperative to postoperative 1 month were the correction angle in OWHTO (P = 0.001) and the preoperative standing JLCA in OWHTO (P < 0.001) and CWHTO (P < 0.001). Conclusions A significant decrease of the JLCA occurred immediately after osteotomy under anesthesia in CWHTO, whereas in OWHTO there was no decrease under anesthesia, but it decreased several days postoperatively.

Patients with chronic kidney disease (CKD) are at increased risks of both sarcopenia and fragility fractures. However, information on the association between skeletal muscle mass (SMM) and the risk of bone fractures in patients with CKD is lacking. We performed a cross-sectional analysis of 4146 patients with CKD using the baseline dataset of the Fukuoka Kidney disease Registry Study, as a multicenter, prospective cohort study of pre-dialysis CKD patients. The main measure was estimated SMM (eSMM) calculated using an equation validated by bioelectrical impedance analysis with two independent datasets of 100 and 81 CKD patients. The main outcome was historical bone fractures. The associations between sex-specific quartiles (Q1–Q4) of eSMM and fracture history were assessed by logistic regression analyses. The prevalence of a history of fractures increased and eSMM decreased with progressive CKD stages. Among the 4146 patients, 249 had prior bone fractures, including 111 patients in Q1 (lowest quartile), 65 in Q2, 46 in Q3, and 27 in Q4 (highest quartile). A multivariable-adjusted model revealed that patients in Q1 had a significantly higher odds ratio (95% confidence interval) for bone fracture history than those in Q4 (reference): Q1, 2.77 (1.32–5.80); Q2, 1.95 (1.05–3.65); and Q3, 1.57 (0.90–2.75) (P-value for trend

Background Recent studies have reported the clinical effectiveness of tuberosity healing after reverse total shoulder arthroplasty in patients with proximal humeral fractures with respect to joint stability, long-term survival, and postoperative range of motion. However, it is challenging to achieve robust fixation of the fragile bone fragments in elderly patients. This study aimed to report on the radiographic and clinical outcomes of patients who underwent reverse total shoulder arthroplasty for acute proximal humeral fractures using a Turned stem Tension Band technique–a simple suture configuration that can apply a compressive force on both tuberosities at the same time. Methods Eighteen patients who underwent reverse total shoulder arthroplasty for complex proximal humeral fractures (age 80.4 ± 4.7 years, range 70–87 years), using our Turned stem Tension Band technique, were included in this study and evaluated postoperatively for range of motion, American Shoulder and Elbow Surgeons score, Numerical Rating Scale, and tuberosity healing, with minimum 2-years follow-up (mean 34.5 months, range 24–60 months). Results At the final follow-up, mean range of motion results were active flexion, 119 ± 34°; active abduction, 116 ± 35°; active external rotation, 27 ± 12°; and active internal rotation, L3. Six of 11 (55%) patients with 4-part dislocated fractures had neurological disorders from the time of injury; of these, three patients obtained shoulder elevation under 90° at the final follow-up. The mean American Shoulder and Elbow Surgeons score was 77.3 ± 10.7, and the mean Numerical Rating Scale was 1.2 ± 0.9. Fifteen of 18 (83%) patients were satisfied with the results. The tuberosity healing rate was 100% (18 of 18). Conclusions The Turned stem Tension Band technique in reverse total shoulder arthroplasty for proximal humeral fractures provides a robust fixation, regardless of the fracture pattern, which results in a high tuberosity healing rate.

Aim: We reviewed intraoperative video recordings (IVRs) of laparoscopic percutaneous extraperitoneal closure (LPEC) for inguinal hernia in children blindly to assess performance. Methods: IVRs of 1...

Sudden death is one of the most common causes of death among patients on hemodialysis. Although hyperphosphatemia is a well-known risk factor for cardiovascular and all-cause deaths, the studies focusing on the relationship between serum phosphate levels and the risk of sudden death are limited. This study aimed to clarify the relationship between serum phosphate levels and the risk of sudden death in patients on hemodialysis.This is a multicenter, longitudinal, and observational study. A total of 3505 patients, registered in the Q-Cohort Study, who underwent maintenance hemodialysis, and were followed up for 10 years, were included. Patients were divided into quartiles on the basis of baseline serum phosphate levels: Q1 (n = 886),4.2 mg/dL; Q2 (n = 837), 4.2-4.8 mg/dL; Q3 (n = 908), 4.9-5.6 mg/dL; and Q4 (n = 874), ≥5.7 mg/dL. Associations between baseline serum phosphate levels and sudden death were analyzed using the Cox proportional hazards model and the Fine-Gray regression model.During the follow-up period, 227 patients died from sudden death. The risk for sudden death was significantly higher in the highest quartile (Q4) than in the lowest quartile (Q1) as the reference group (multivariable-adjusted hazard ratios and 95% confidence intervals: Q1, 1.00; Q2, 1.15 [0.77-1.70], Q3, 1.31 [0.89-1.93], and Q4, 1.72 [1.14-2.59]; hazard ratio for every 1-mg/dL increase in the serum phosphate level, 1.23 [1.09-1.39]; p 0.001).Hyperphosphatemia is independently associated with an elevated risk of sudden death in patients on hemodialysis.

Background Parathyroid hormone (PTH) has been associated with cardiovascular disorders; however, it is unknown whether plasma PTH concentrations are associated with atrial fibrillation (AF) in patients with chronic kidney disease (CKD).Methods and Results:The present cross-sectional study analyzed baseline data of 3,384 patients registered in the Fukuoka Kidney Disease Registry Study, a Japanese multicenter prospective cohort study of patients with non-dialysis-dependent CKD. The outcome was prevalence of AF, and the main risk factor was plasma intact PTH concentration. Associations between plasma intact PTH concentration quartiles (Q1-Q4, from lowest to highest) and the presence of AF were analyzed using logistic regression. In all, 185 patients had AF; 22, 34, 59, and 70 patients were in Q1, Q2, Q3, and Q4 of PTH concentrations, respectively. The prevalence of AF increased incrementally with increases in plasma intact PTH. In the logistic regression model, patients with higher plasma intact PTH concentrations (Q2-Q4) had higher adjusted odds ratios (95% confidence intervals) for the prevalence of AF relative to the reference group (Q1), namely 1.33 (0.76-2.34), 1.82 ([1.06-3.13), and 1.99 (1.08-3.64), respectively (P=0.016). Conclusions Higher plasma intact PTH concentrations were significantly and incrementally associated with an increased prevalence of AF in non-dialysis-dependent CKD patients.

Purpose This open-label, single-dose study evaluated the pharmacokinetic profiles of enzalutamide and its major metabolites and the safety of enzalutamide in healthy, Chinese male volunteers. Methods Fourteen volunteers (median age, 28.5 years) received a single oral dose of enzalutamide (160 mg) under fasting conditions on day 1 and were followed for 50 days. Pharmacokinetic profiles were obtained for enzalutamide and its major metabolites, carboxylic acid metabolite (M1; inactive metabolite) and N-desmethyl enzalutamide (M2; active metabolite), on day 1 up to 1176 hours (49 days). Safety data were also collected. Findings Enzalutamide plasma concentration rapidly increased (median Tmax, 1.5 hours) followed by a slow decrease (mean t½, 90.7 hours). M1 and M2 plasma concentrations increased gradually with a median Tmax of 72.0 and 121 hours, respectively. M1 and M2 mean metabolite-to-parent ratios were 0.2 and 1.3, respectively. Mean AUC0–∞ of enzalutamide plus M2 was 828 μg h/mL versus 368 μg h/mL for enzalutamide alone. Mean t½, maximum concentration, and Tmax of enzalutamide plus M2 were comparable with those of enzalutamide. Drug-related treatment-emergent adverse events were reported in 4 men (28.6%): 1 each of upper respiratory tract infection, chest discomfort, increased blood bilirubin, and decreased white blood cell count. No deaths or serious treatment-emergent adverse events were observed. Implications The pharmacokinetic profiles of enzalutamide, M1, M2, and enzalutamide plus M2 in healthy Chinese men were generally consistent with those in white men. No new safety concerns were found. Chinese Clinical Trial Registration identifier: CTR20150635.

When one is performing superior capsular reconstruction (SCR), graft thickness is an important factor for achieving sufficient glenohumeral stability. However, when a graft of sufficient length and thickness is prepared and inserted into the subacromial space, it is often challenging to secure the field of view arthroscopically. To solve this problem, we devised a mini-open SCR technique. This study aimed to compare the clinical effectiveness of this technique with that of arthroscopic SCR.This retrospective cohort study included 46 consecutive patients with Hamada classification grade 2-3b who were treated between June 2014 and February 2018 with SCR performed by a single surgeon for irreparable rotator cuff tears (grade 3 or higher according to the Goutallier classification) using autologous tensor fascia lata. We evaluated the duration of the operation, length of the skin incision of the lateral portal used to insert the graft, graft size (length, width, and thickness), American Shoulder and Elbow Surgeons score, range of motion, and graft retear rate.This study included 46 patients who underwent arthroscopic SCR (n = 20) or mini-open SCR (n = 26). The mean follow-up period was 36.5 months (range, 24-66 months). The operative duration was significantly longer in the arthroscopic SCR group than in the mini-open SCR group (175 ± 48 minutes vs. 133 ± 25 minutes, P.001); however, no significant difference was noted in the length of the skin incision (2.4 ± 0.2 cm vs. 2.5 ± 0.1 cm) and graft size. At the final follow-up, no significant differences were observed in American Shoulder and Elbow Surgeons scores, all ranges of motion (flexion, P = .60; abduction, P = .60; external rotation, P = .20; and internal rotation, P = .54), and graft retear rates (5% [1 case] vs. 3.8% [1 case], P.999).Good clinical outcomes were obtained in both the arthroscopic and mini-open SCR groups. The surgical stress experienced by the patients who underwent mini-open SCR was similar to that experienced by those who underwent the arthroscopic technique, as no significant difference was noted in the length of the skin incision. This study shows that mini-open SCR, which contributes to reductions in operative duration and difficulty associated with the surgical technique, is an effective and alternative method to arthroscopic SCR.

Background: Eldecalcitol (ELD) is an active vitamin D3 analog that is widely used in Japan for the treatment of osteoporosis. The most common adverse drug reaction of ELD is hypercalcemia. However, few reports have focused on acute kidney injury (AKI) associated with ELD-induced hypercalcemia. Materials and methods: We retrospectively reviewed the medical records at our hospital for cases of hypercalcemia-induced AKI between April 2013 and February 2018. Among them, we focused on patients who developed AKI secondary to ELD-induced hypercalcemia. Results: Among 69 patients who developed hypercalcemia-induced AKI, 32 patients (46.4%) developed AKI associated with ELD-induced hypercalcemia. Their mean age was 82 ± 5 years, 97% of them were female, mean corrected serum calcium level was 12.2 ± 1.5 mg/dL, serum creatinine level was 2.5 ± 2.2 mg/dL, and estimated glomerular filtration rate was 23.9 ± 14.4 ml/min/1.73 m2 on admission. ELD administration was discontinued in all patients and some of them were treated with hydration with or without calcitonin, which was followed by a normalization of serum calcium level. Corrected serum calcium level on admission was significantly higher (p

Introduction: Angiotensin receptor blockers (ARBs) are preferably used in hypertensive patients with CKD. Azilsartan is a strong antihypertensive ARB, but its antiproteinuric effects are not well understood. We compared the antiproteinuric effect of azilsartan and candesartan in CKD patients in an open-label, randomized, crossover trial. Methods: A total of 111 patients were treated with 20 mg of azilsartan daily for 2 months as a run-in period. After the run-in period, patients were randomized into 2 arms and received either 20 mg of azilsartan or 8 mg of candesartan daily for 3 months in a crossover trial. The primary outcome was the percent change in urinary protein-to-Cr ratio (UPCR). Results: Ninety-five patients completed the trial. The mean age was 64.3 years. The estimated glomerular filtration rate (eGFR) and UPCR were 41.5 mL/min/1.73 m2 and 1.8 g/gCr, respectively. The baseline systolic and diastolic blood pressures were 131.4 and 71.0 mm Hg, respectively. The mean percent change in the UPCR was −3.8% in the azilsartan group and 30.8% in the candesartan group at the 1st endpoint (p = 0.0004), and 6.1% in the azilsartan group and 25.8% in the candesartan group at the 2nd (final) endpoint (p = 0.029). The incidence of adverse events, including eGFR levels and serum potassium levels, was not significantly different between the groups. Conclusion: A 20 mg azilsartan dose had potent antiproteinuric effects compared with an 8 mg candesartan dose, without an increase in adverse events. Azilsartan may provide renal protection in addition to antihypertensive effects in CKD patients.

The geriatric nutritional risk index (GNRI) and creatinine (Cr) index are indexes often used as nutritional surrogates in patients receiving hemodialysis. However, few studies have directly compared the clinical characteristics of these two indexes. We investigated 3,536 hemodialysis patients enrolled in the Japan DOPPS phases 4 and 5. The primary outcome was all-cause mortality and the main exposures were the GNRI and Cr index. We confirmed and compared the association between these indexes and mortality risk as estimated by a multivariable-adjusted Cox proportional hazards model. During the median 2.2-year follow-up period, 414 patients died of any cause. In the multivariable-adjusted model, lower GNRI and Cr index were both associated with increased risk of all-cause mortality, and these associations were further confirmed by restricted cubic spline curves. The predictability of all-cause mortality, as represented by the c-statistic, was comparable between the two indexes. Furthermore, baseline nutritional surrogates that corresponded with lower GNRI or Cr index values were comparable between the two indexes. Given that calculating the GNRI is simpler than calculating the Cr index, our data suggest that the GNRI may be preferable to the Cr index for predicting clinical outcomes in patients undergoing maintenance hemodialysis.

Some peritoneal dialysis (PD)-related peritonitis cases are thought to be caused by the pathogens in the oral cavity; however, the relationship between peritonitis and oral hygiene habits is unclear. In this study, we retrospectively examined the relationship between oral hygiene habits and peritonitis in patients who agreed to a questionnaire survey. Of the 75 patients, 37 patients developed PD-related peritonitis during the observation period. Peritonitis-free survival was significantly higher in patients who spent more time on oral hygiene daily and in patients who replaced their toothbrush more frequently (P < 0.05). According to multivariable analysis, increased daily oral hygiene duration and more frequent toothbrush replacement were associated with a significantly (P < 0.01) lower risk for peritonitis (hazard ratio [HR] 0.37 [95% CI, 0.18-0.77] and HR 0.35 [95% CI, 0.17-0.70], respectively). In conclusion, PD patients with superior oral hygiene habits showed a lower risk for PD-related peritonitis.

Acute kidney injury (AKI) is one of the most severe complications after cardiothoracic surgery (CTS). However, diagnosis of AKI by elevation of serum creatinine (SCr) misses a critical time period for prevention and treatment of AKI. We have observed that patients who develop AKI show a smaller SCr decrease after CTS than those without AKI. Hence, we hypothesized that the magnitude of the SCr change (ΔSCr) measured early after CTS can predict subsequent AKI. We conducted a retrospective analysis from January 2014 to December 2016 to examine the association of ΔSCr with AKI. ΔSCr was calculated as follows: (early postoperative SCr on intensive care unit [ICU] admission) − (preoperative SCr). Established risk factors and demographics were included in the multivariate-adjusted logistic regression model. AKI was defined by SCr criteria of the Kidney Disease: Improving Global Outcomes group. Among 252 patients who underwent CTS, 69 developed AKI. The median ΔSCr was − 0.14 mg/dL (range − 0.96–0.45). Patients were divided into three groups based on ΔSCr: Group 1, ≤ − 0.2 mg/dL (n = 84); Group 2, > − 0.2 to