Objective: Analysis of data from reports of medical device faults in drug-device combinations (DDCs) can prevent adverse events caused by errors and lead to improvements. However, there is a paucity of published articles reporting the analysis of data on faults in DDCs. The aim of this study was to analyze data of faults in these medical devices in Japan.Methods: The review summarized information from the Pharmaceuticals and Medical Devices Agency data on “case reports of suspected failures of the mechanical and instrumental parts of DDCs” reported between 25 November 2014 and 31 July 2022. Information was collected from public documents on “year reported”, “age”, “gender”, “trade name”, “generic name”, “mechanical device part name”, “mechanical device part failure status”, and “hazard” and “outcome”.Results: There were approximately 1,300 reports of medical device faults in DDCs over the study period, with the number increasing year by year. Five device parts (insulin pen injectors, pre-filled syringes, drug and vaccine injectors, disposable hypodermic needles, and intrauterine contraceptive devices) accounted for 90% of the reports. We found that there was a considerable amount of missing data on reportable items such as age and gender of the patient. Our analysis also showed that 90% of the medical device fault reports involving DDCs were related to malfunction or breakage.Conclusion: In order to use DDCs more safely and effectively it is important to review reports and analyse data of faults in these devices.

Open surgery remains the treatment of choice for mycotic abdominal aortic aneurysm (MAAA). However, open surgery for MAAA is often associated with a significant perioperative risk and there have been some reports in which MAAA was successfully treated with endovascular aortic repair (EVAR). We report a case of MAAA treated with EVAR. Gallium scintigraphy was useful in postoperative evaluation of infection. A 61-year-old man presented with back pain. Computed tomography (CT) revealed a 50-mm saccular abdominal aortic aneurysm(AAA). The patient underwent EVAR for symptomatic AAA but developed a high fever 5 days after surgery. Serum C-reactive protein level was elevated and blood culture was positive for Salmonella. Intravenous antibiotics were commenced with a diagnosis of MAAA and the fever and inflammatory parameters subsided with a decrease in the size of the aneurysm. Accumulation of gallium was observed on scintigraphy 1 month after surgery. The patient received intravenous antibiotics for 8 weeks after surgery and was discharged home with oral antibiotics. At 6 months after surgery, accumulation of gallium disappeared. Oral antibiotics were ceased when CT showed disappearance of the aneurysm 9 months after surgery. At present, the patient has been doing well without signs or symptoms of recurrent infection.

Background: Common regional anesthesia approaches for video-assisted thoracoscopic surgery (VATS) include paravertebral block (PVB) and erector spinae plane block (ESPB). PVB is considered a deep nerve block which is contraindicated in antithrombotic therapy. ESPB is effective when administered as a bolus, as well as continuously. However, the recently proposed intertransverse process block (ITPB) ensures more effective diffusion of the local anesthetic into the paravertebral space.Case: We report cases of three patients who received bolus ITPB (costotransverse foramen block and mid-point transverse process-to-pleura block in one and two cases, respectively) combined with continuous ESPB when a deep nerve block could not be administered. Opioids were not required postoperatively, and all postoperative numerical rating scale scores (0–10) at rest were maintained below 4. Conclusions The combination of bolus ITPB and continuous ESPB may be an alternative analgesic method when deep nerve blocks are contraindicated in VATS.

Background/Aims: Natural history of chronic intestinal pseudo-obstruction (CIPO), a rare disease characterized by episodes of non-mechanical obstruction, is unclear in adults. This study evaluates the clinical course of CIPO and palliative care needs of patients. Methods: From October 2010 to September 2021, 74 patients who underwent cine MRI and had a definitive diagnosis of CIPO were prospectively included. We investigated disease etiology and outcomes, age at onset, nutritional status at consultation (body mass index and serum albumin), hydrogen breath test results, and total parenteral nutrition (TPN) during the disease course. Results: Forty-seven patients (64%) were women, with a mean age of 44 years at onset and 49 years at diagnosis. Primary CIPO was observed in 48 patients (65%). Secondary CIPO was observed in 26 cases (35%), of whom 18 (69%) had scleroderma. The mean body mass index, serum albumin level, and hydrogen breath test positivity rate were 17 kg/m2 , 3.8 mg/dL, and 60%, respectively. TPN and invasive decompression therapy were required by 23 (31%) and 18 (24%) patients, respectively. Intestinal sterilization was performed in 51 (69%) patients and was effective in 33 (65%); of these, 28 (85%) were taking metronidazole. Seven (9%) patients used opioids. There were 9 deaths (12%), including 5 (56%) from infection and 2 (22%) from suicide. Of the deaths, 6 (67%) and 4 (44%) underwent TPN management and decompression therapy, respectively. Fifty-one patients (69%) wanted palliative care. Conclusion CIPO is a rare, severe, and under-recognized disease. Standardization of treatment strategies, including palliative care and psychiatric interventions, is desired.

Purpose: Accelerated atherosclerosis is a major complication in patients with end-stage renal disease and it plays an important role in the pathogenesis of erectile dysfunction (ED). However, the association between aortic calcification burden and the severity of ED remains unclear. The aim of the present study was to investigate this association in men undergoing dialysis. Materials and Methods: This cross-sectional study included 71 men undergoing peritoneal dialysis and/or hemodialysis between July 2016 and May 2018 at Mutsu General Hospital. ED was assessed with the Sexual Health Inventory for Men (SHIM). Patients were divided into the mild/moderate (SHIM score ≥8) and severe ED groups (SHIM score ≤7). Aortic calcification index (ACI) was examined as a clinical indicator of abdominal aortic calcification. Multivariable logistic regression analysis was performed to identify the significant factors associated with severe ED. Results: The median age of the study participants was 64 years; all had ED, with 64.8% having severe ED. In the multivariable analyses, a slight association was observed between ankle-brachial index and severe ED (odds ratio [OR], 0.058; p=0.072), whereas ACI was significantly associated with severe ED (OR, 1.022; p=0.022). Conclusions Aortic calcification burden was independently associated with severe ED.

Purpose: To evaluate the impact of severe erectile dysfunction (ED) on future major adverse cardiovascular events (MACE) in men on dialysis. Materials and Methods: This prospective cohort study included 71 men on dialysis. ED was assessed using the Sexual Health Inventory for Men (SHIM). Men were divided into the mild/moderate ED (SHIM score ≥8) and severe ED (SHIM score ≤7) groups. The primary endpoint was MACE-free survival. MACE was a composite of myocardial infarction, cardiovascular death, and stroke. The secondary endpoints were cardiac event-free survival and overall survival (OS). Moreover, the predictive abilities of severe ED for 5-year MACE, 5-year cardiac events, and 5-year overall mortality were evaluated. Results: The median age and follow-up period of the included men were 64 years and 58 months, respectively. The median SHIM score was 4.0; all had a degree of ED, and 64.7% had severe ED. In the background-adjusted multivariable analyses, severe ED was not significantly associated with shorter MACE-free survival (hazard ratio [HR], 1.890; 95% confidence interval [CI], 0.533–6.706; p=0.324), cardiac event-free survival (HR, 2.081; 95% CI, 0.687–6.304; p=0.195), and OS (HR, 0.817; 95% CI, 0.358–1.863; p=0.630). Severe ED did not significantly improve the predictive abilities for 5-year MACE, 5-year cardiac events, and 5-year overall mortality (p=0.110, p=0.101, and p=0.740, respectively). Conclusions ED severity was not associated with shorter MACE-free survival, cardiac event-free survival, or OS, and ED severity could not improve the predictive abilities for these outcomes in men undergoing dialysis.

Background: With improvements in the safety and stability of surgeries, the number of orthognathic surgeries is increasing. Most patients who undergo orthognathic surgeries are younger, and the number of orthognathic surgeries for patients with comorbidities is also increasing. We report a survey and clinical investigation of patients with comorbidities who underwent orthognathic surgeries at our department to improve the safety of orthognathic surgery. Results: The participants included 296 men and 712 women, with a mean age of 28 years (13–19 years, n=144; 20–29 years, n=483; 30–39 years, n=236; 40–49 years, n=102; 50–59 years, n=39; ≥60 years, n=4). In total, 347 patients underwent one-stage Le Fort type I osteotomy and sagittal split ramus osteotomy (SSRO), 243 underwent SSRO, 287 underwent plate removal, 126 underwent genioplasty and plate removal, and five underwent other surgeries. In total, 529 patients had comorbidities (52%), including allergic diseases (n=220, 33%), respiratory diseases (n=107, 16%), neurologic and psychiatric diseases (n=69, 10%), gynecologic diseases (n=28, 4%), hematologic diseases (n=27, 4%), cardiovascular diseases (n=24, 4%), digestive diseases (n=22, 3%), metabolic and endocrine diseases (n=18, 3%), spinal diseases (n=11, 2%), ophthalmologic diseases (n=11, 2%), renal and urological diseases (n=9, 1%), and other diseases (n=117, 18%). Among the patients with comorbidities, 11 with hemorrhagic diatheses (hemophilia and von Willebrand disease), arrhythmia (atrioventricular block), psychiatric disease (adjustment disorder), and metabolic disease (diabetes) required cautious perioperative management. The patient with hemophilia was managed with regular low-dose recombinant factor VIII replacement therapy, and the patient with type I diabetes mellitus was administered continuous insulin infusion and sliding-scale insulin therapy; both patients had an uneventful course. Conclusions The study findings suggest that with the increase in orthognathic surgeries, oral and maxillofacial surgeons should adequately manage cases requiring cautious perioperative control and highlight the importance of preoperative screening. Despite the well-established safety and postoperative stability of orthognathic surgeries, oral surgeons should adopt appropriate additional preventive measures for patients with comorbidities.

Background: and Purpose To assess the long-term outcomes of intracranial dural arteriovenous fistula (DAVF) treated with stereotactic radiosurgery (SRS) alone or embolization and SRS (Emb-SRS) and to develop a grading system for predicting DAVF obliteration. Methods: This multi-institutional retrospective study included 200 patients with DAVF treated with SRS or Emb-SRS. We investigated the long-term obliteration rate and obliteration-associated factors. We developed a new grading system to estimate the obliteration rate. Additionally, we compared the outcomes of SRS and Emb-SRS by using propensity score matching. Results: The 3- and 4-year obliteration rates were 66.3% and 78.8%, respectively. The post-SRS hemorrhage rate was 2%. In the matched cohort, the SRS and Emb-SRS groups did not differ in the rates of obliteration (P=0.54) or post-SRS hemorrhage (P=0.50). In multivariable analysis, DAVF location and cortical venous reflux (CVR) were independently associated with obliteration. The new grading system assigned 2, 1, and 0 points to DAVFs in the anterior skull base or middle fossa, DAVFs with CVR or DAVFs in the superior sagittal sinus or tentorium, and DAVFs without these factors, respectively. Using the total points, patients were stratified into the highest (0 points), intermediate (1 point), or lowest (≥2 points) obliteration rate groups that exhibited 4-year obliteration rates of 94.4%, 71.3%, and 60.4%, respectively (P<0.01). Conclusions SRS-based therapy achieved DAVF obliteration in more than three-quarters of the patients at 4 years of age. Our grading system can stratify the obliteration rate and may guide physicians in treatment selection.

Background: Type 1 diabetes mellitus induced by immune-checkpoint inhibitors (ICI-T1DM) is a rare critical entity. However, the etiology of ICI-T1DM remains unclear. Methods: In order to elucidate risk factors for ICI-T1DM, we evaluated the clinical course and immunological status of patients with ICI-T1DM who had been diagnosed during 2016 to 2021. Results: Seven of 871 (0.8%, six men and one woman) patients developed ICI-T1DM. We revealed that the allele frequencies of human leukocyte antigen (HLA)-DPA1*02:02 and DPB1*05:01 were significantly higher in the patients with ICI-T1DM In comparison to the controls who received ICI (11/14 vs. 10/26, P=0.022; 11/14 vs. 7/26, P=0.0027, respectively). HLA-DRB1*04:05, which has been found to be a T1DM susceptibility allele in Asians, was also observed as a high-risk allele for ICI-T1DM. The significance of the HLA-DPB1*05:01 and DRB1*04:05 alleles was confirmed by an analysis of four additional patients. The absolute/relative neutrophil count, neutrophils-lymphocyte ratio, and neutrophil-eosinophil ratio increased, and the absolute lymphocyte count and absolute/relative eosinophil count decreased at the onset as compared with 6 weeks before. In two patients, alterations in cytokines and chemokines were found at the onset. Conclusion Novel high-risk HLA alleles and haplotypes were identified in ICI-T1DM, and peripheral blood factors may be utilized as biomarkers.

Objectives: This study aimed to determine the relationship between the number of board-certified physiatrists and the amount of inpatient rehabilitation delivered.Materials and Methods: We analyzed open data from 2017 in the National Database of Health Insurance Claims and Specific Health Checkups of Japan and compared the volume of inpatient rehabilitation services between prefectures to examine regional disparities. We also examined the relationship between the volume of rehabilitation services provided and the number of board-certified physiatrists.Results: The population-adjusted number of inpatient rehabilitation units per prefecture ranged from a maximum of 659,951 to a minimum of 172,097, a disparity of 3.8-fold. The population-adjusted number of board-certified physiatrists was 4.8 in the highest region and 0.8 in the lowest region, a disparity of 5.8-fold. The population-adjusted number of board-certified physiatrists was significantly correlated with the population-adjusted total number of inpatient rehabilitation units (r=0.600, P<0.001). Correlations were between the number of board-certified physiatrists and the number of rehabilitation units in cerebrovascular and orthopedic services, but not in cardiovascular, respiratory, or oncology services.Conclusion: Large regional disparities manifested in the amount of inpatient rehabilitation provided in Japan. An association was found between the number of board-certified physiatrists and rehabilitation units delivered. It may be necessary to train more BCPs in regions with fewer units to eliminate these disparities.