Keio University Research Articles

PS-C22-7: RENAL FUNCTION AND URINARY PROTEIN 1 YEAR AFTER INITIATION OF ESAXERENONE

Objective: It has been two years since the prescription of esaxerenone was started in Japan, but there are currently limited reports on clinical data after administration. The purpose of this study is to examine the real-world clinical data on renal function, urinary protein, and other clinical data on the esaxerenone-treated group compared to the non-administration group. Design and method: In this study, research subjects were selected from the patient population attending the Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine, Japan between March 1, 2021 and January 31, 2022. 354 patients treated with esaxerenone and 14,480 patients not treated with esaxerenone were compared on clinical indices 1 year after the initiation of treatment. Covariate adjustment by propensity score-matched analysis was carried out. Results: In the analysis of all patients, serum creatinine tended to increase after treatment with esaxerenone compared to before, but the difference was not significant. No consistent trend was observed for urinary protein and serum potassium. Conclusions: We are currently performing propensity score-matched analysis stratifying for blood pressure and urinary albumin to creatinine ratio at the start of treatment. COI: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work in this report.

PS-C26-12: SIGNIFICANCE OF PODOCYTE DNA DAMAGE AND GLOMERULAR DNA METHYLATION IN CKD WITH PROTEINURIA

Objective: Previously we have reported that altered DNA methylation is associated with DNA damage repair in podocytes in CKD, including diabetic nephropathy or IgA nephropathy (Cell Rep 2019, Sci Rep 2020). This study is aim to investigate the association of podocyte DNA damage and DNA methylation with clinical manifestations and renal prognosis in various types of kidney diseases, which has not been adequately investigated. Design and Method: Patients diagnosed with minor glomerular abnormalities (MGA, n = 33), membranous nephropathy (MN, n = 9) or diabetic nephropathy (DN, n = 10), following kidney biopsy at Keio University Hospital from 2015 to 2017 were included. We evaluated podocyte DNA double strand breaks (DSBs) using both long-distance PCR of nephrin gene and γH2AX immunostaining, and glomerular DNA methylation levels by immunostaining of 5mC, and examined the relationship between clinical parameters of patients, and DNA damage and methylation. Results: In MGA patients, both podocyte DNA damage and glomerular DNA methylation was associated with the amount of proteinuria. Moreover, glomerular DNA methylation was also associated with 3-year eGFR decline. We also examined in DN patients, in which podocyte DNA damage has been found to be involved in our previous study. It was demonstrated that podocyte DSBs were associated with a decline in eGFR over 6 months, whereas glomerular DNA methylation was associated with 2 year- and 3 year-eGFR decline. In addition, samples from MN patients were evaluated, in which activation of DNA repair pathways in the glomeruli has been suggested. Interestingly, the association of DNA DSBs or DNA methylation with proteinuria or kidney function was not indicated in MN. Conclusions: To our knowledge, this is the first study to demonstrate the possible association of podocyte DNA damage and glomerular DNA methylation with kidney function and its decline in MGA patients, whereas it was not observed in MN patients, despite a limitation of small sample size. Focusing on podocyte DNA damage and following DNA methylation changes may lead us to novel approaches to estimate renal prognosis in addition to traditional evaluation of renal biopsy as well as to develop novel therapeutic targets in specific types of CKD.

Prevalence of Primary Headache in Nurses in Japan: A Cross-sectional Single-center Study.

Objective This study examined the prevalence of migraine in nurses in Japan, which, to our knowledge, has not been documented in English. Methods From April to May 2021, we administered a questionnaire to 229 nurses working at Keio University Hospital to investigate the prevalence and characteristics of headache among nurses in Japan. Headaches were classified as migraine or tension-type headache (TTH) based on the International Classification of Headache Disorders 3rd edition (ICHD-3). Results In total, 80 patients (34.9%) had primary headaches, including 47 (20.5%) with migraine and probable migraine and 33 (14.4%) with TTH and probable TTH. We found a significant difference in the Numerical Rating Scale score, nausea and vomiting, photophobia, phonophobia, and aggravation by routine physical activity between migraine and TTH. The specificities for a migraine diagnosis were 100% and 93.9% for nausea/vomiting and photophobia, respectively. Only 8.8% of patients had their headaches diagnosed by a physician. Conclusion Migraines have a high prevalence (>20%) among nurses and are often under-diagnosed. In many cases, headache-associated symptoms are more important than laterality or other characteristics for the diagnosis. Many nurses are treated for headaches without a correct diagnosis. Further education regarding primary headaches may be necessary for health practitioners as well as society.

PS-BPC08-6: CLINICAL AND BIOCHEMICAL OUTCOMES OF PATIENTS WITH ALDOSTERONE-PRODUCING ADENOMA AFTER RADIOFREQUENCY ABLATION THERAPY AT KEIO UNIVERSITY HOSPITAL: 2022 REPORT

Objectives: Total adrenalectomy of an affected adrenal gland is the standard therapy of aldosterone-producing adenoma (APA), a curable subtype of primary aldosteronism. However, the APA is occasionally inoperable in cases with bilateral adenomas or high-risk patients under general anesthesia. Computed tomography (CT)-guided radiofrequency ablation (RFA) of the adrenal gland is a less invasive, cortical-sparing therapy, and may become a treatment of choice for such cases. A multicenter clinical trial of RFA was conducted in patients with APA in Japan from 2015 to 2016. To establish its long-term efficacy and safety, the study subjects enrolled in Keio University Hospital have been annually followed up. Following the progress report at ISH 2018, here we update clinical and biochemical outcomes of this cohort of patients 6 years after the RFA treatment. Methods: Follow-up medical interviews, blood pressure measurements, blood tests, and urinalysis were done annually. In addition, at least one CT scan was performed since 2018. Data on antihypertensive medication, blood pressure, hormone and electrolyte levels, urinary albumin, and tumor size were collected and analyzed. Results: 10 cases of APA were treated with RFA between June 2015 and March 2016. As of April 2022, 6 cases were successfully followed up. Of these patients, the aldosterone-to-renin ratio (ARR) remained normalized in 5 cases (83%), albeit above the upper limit in 1 case (17%). In this particular patient, serum potassium level remained normalized and antihypertensive medication was not needed. Antihypertensive medication was needed in 1 case (17%), while urinary albumin levels were improved in all cases. Of note, follow-up CT scan showed that the tumor was undetectable in 1 case (17%), reduced in size in 3 cases (50%) and unchanged in 2 cases (33%). None of the cases have developed adrenal insufficiency since the RFA. Conclusion: The follow-up study on APA patients 6-year after the RFA revealed no cases of recurrence. RFA is likely to be effective and safe in patients with APA.

Real-world evidence of galcanezumab for migraine treatment in Japan: a retrospective analysis

ObjectiveTo evaluate the efficacy and safety of galcanezumab in patients with migraine in a real-world setting in Japan.BackgroundGalcanezumab is the first anti-calcitonin gene-related peptide monoclonal antibody approved in Japan. To the best of our knowledge, no real-world studies on galcanezumab have been published in any international journal from Japan.MethodsWe retrospectively examined patients with migraine who received three doses of galcanezumab between August 2021 and February 2022 at the Keio University Hospital. We assessed changes in monthly migraine days, responder rate, and migraine-associated and premonitory symptoms. We also investigated injection site reactions and adverse events.ResultsFifty-two patients received three doses of galcanezumab during the study period. Compared with those at baseline, the monthly migraine days decreased by 5.9 days (95% confidence interval, 4.2–7.7) at 3 months. The 50% responder rate was 61.5% at 3 months. A total of 64.9%, 50.0%, and 63.9% of patients showed improvement in the severity of photophobia, phonophobia, and nausea/vomiting, respectively. Premonitory symptoms without subsequent headache were reported in 62.5% of patients. Moreover, injection site reaction was the most common adverse event (34.6%).ConclusionThis study revealed the efficacy and safety of galcanezumab for migraineurs in Japan. Galcanezumab also improved migraine-associated symptoms. However, despite a reduction in headaches, premonitory symptoms without subsequent headache were reported in > 50% of the patients at 3 months.

Intertwining the Physical and Digital Experience at University Museum A Case Study from Keio Museum Commons, Japan

Keio University, the oldest institute of western higher education in Japan, opened its first university museum, named Keio Museum Commons (KeMCo) in April 2021. To facilitate cultural encounters and interactions among the students, academics, as well as broader public audiences, KeMCo challenges in weaving the physical museum visit and the online digital experience. This paper aims to explore the practices and experiences we have acquired from the development and implementation and further clarify the fundamental principles of how university museums can create digital-physical hybrid experiences across the academic-public sphere.

LW-8 TREATMENT STRATEGY FOR OLIGODENDROGLIOMAS WITH NEOADJUVANT STRATEGY AND STAGED RESECTION UTILIZING THEIR CHEMOTHERAPEUTIC RESPONSIVENESS

Abstract Background In glioma surgery, both of functional preservation and maximal safe resection are critical, however, neoadjuvant strategy has never been used because of difficulty of tissue sampling without craniotomy. Method In Keio University Hospital, oligodendrogliomas, i.e., diffuse gliomas with IDH mutation and 1p/19q codeletion, with incomplete initial resection have been treated by upfront chemotherapy and subsequent resection after tumor volume decrease (second look resection, SLR) since 2006 (J Neurooncol 124:127-35, 2015). At first, initial radiotherapy was prescribed immediately after chemotherapy or SLR only for the cases with aggressive clinical course or subarachnoid infiltration, however, cases with residual FLAIR abnormality after upfront chemotherapy or SLR were also subjected to initial radiotherapy since 2018. Cases 1) with IDH mutation and 1p/19q codeletion, and 2) without history of either chemotherapy or radiotherapy, and 3) treated with upfront chemotherapy and subsequent resection strategy, were included. Results Thirty nine cases of oligodendroglioma have been treated with the above strategy since 2006. Tumor volume decrease following upfront chemotherapy was 30-35% (median), and 19 tumors underwent SLR. Among the total 39 cases, PFS and OS after initiation of upfront chemotherapy were 81 months and not reached, respectively, and were 64 months and not reached, respectively, among the 32 cases with deferred radiotherapy. Importantly, the majority of tumor recurrence occurred at the residual FLAIR abnormality following upfront chemotherapy. Conclusions Treatment of oligodendrogliomas utilizing neoadjuvant strategy enables 1) decrease of resection volume as compared with initial maximal safe resection, 2) more precise resection, 3) confirmation of the necessity of initial radiotherapy based on the observed efficacy of chemotherapy. Moreover, the study also suggested that 4) invasion front of oligodendroglioma likely withdraw by alkylating agents, and 5) cases with residual FLAIR abnormality following chemotherapy may be appropriate subjects for initial radiotherapy.

Amyloid status prediction by combining plasma p‐tau181 and NfL cut‐offs

AbstractBackgroundPlasma biomarkers have emerged as a promising tool for screening Alzheimer's disease(AD). However, no externally defined cut‐off values for any plasma biomarkers yet to exist to predict amyloid β (Aβ) status.MethodTaking advantage of the different plasma p‐tau181 and NfL increase profiles, we used the two plasma biomarkers to establish preliminary cut‐off values (two cut‐offs for p‐tau181, one for NfL) for screening Aβ positivity. Participants with a clinical diagnosis of AD(N=20), mild cognitive impairment(MCI)(N=12), other neurodegenerative disorders(N=19), psychiatric disorders(N=3 with depression, N= 1 with delusional disorder), and healthy controls(N=37) were recruited from the Memory Clinic at Keio University Hospital. Static 18F‐Florbetaben (FBB) PET was conducted on all the participants. A trained neuroradiologist visually assessed the acquired images to determine Aβ positivity. Each participant's p‐tau181 value was plotted against NfL values. After visualizing their distribution stratified by the Aβ status, we conducted an exhaustive search to predict Aβ positivity. We first created a ROC curve for p‐tau181 alone and then made a 'quasi‐ROC' curve by combining two p‐tau181 cut‐offs(i.e., the higher and lower cut‐offs) and one NfL cut‐off. The optimal cut‐off values for each ROC curve were determined by the Youden Index.ResultOf the 92 participants, 30(32.6%) were Aβ‐positive(Aβ+). Mean ages were 68.7 years(SD8.2) for Aβ‐ and 72.4(SD9.3) for Aβ+ group (p=0.02). Mean p‐tau181 values were 1.72pg/ml (SD0.75) for Aβ‐ and 3.58pg/ml (SD1.09) for Aβ+ group (p<0.001), whereas mean NfL values were 24.47pg/ml(SD13.77) vs 27.24(SD9.96) (p=0.01). The ROC curves yielded each found the optimal cut‐off values as follows: for plasma p‐tau181 alone, ptau‐181 value, true positive rate(tpr) and false positive rate(fpr) were 5.8 pg/ml, 0.767 and 0.065, respectively. For a combination of higher and lower p‐tau181 cut‐offs and one NfL cut‐off, each biomarker value and the corresponding tpr and fpr were 3.0pg/ml, 2.0/g/ml, 35pg/ml, 0.933, and 0.177, respectively.ConclusionOur results suggest combining two cut‐off values for plasma p‐tau181 and one cut‐off for NfL may yield an excellent discriminant capacity for Aβ positivity. Further research is needed to validate the result.

Real-time analysis of heart rate variability during aerobic exercise in patients with cardiovascular disease.

Exercise therapy for cardiovascular disease (CVD) is mainly evaluated based on the heart rate (HR) or Borg scale. However, these indices can be unreliable depending on the patient's medication or their subjective decisions; thus, alternative methods are required for easier and safer implementation of aerobic exercise. Here, we examined whether real-time analysis of HR variability (HRV) can help maintain exercise intensity at the ventilatory threshold (VT) during exercise. Twenty-eight patients with CVD treated at Keio University Hospital between August 2018 and March 2020 were enrolled. Initially, oxygen uptake (VO2) and HR at the VT were determined using the cardiopulmonary exercise test. Patients then performed aerobic exercise on a stationary bicycle for 30min while a parameter of HRV, the high-frequency (HF) component, was monitored in real time using an electrocardiograph. The work rate during exercise was adjusted every 2min to maintain the HF range between 5 and 10. The VO2 and HR values, recorded every 2min during exercise, were compared with those at VT. The Bland-Altman method was used to confirm similarity. VO2 and HR during exercise were closely correlated with those at VT (e.g., 19min after exercise initiation; VO2: r=0.647, HR: r=0.534). The Bland-Altman plot revealed no bias between the mean values (e.g., 19min; VO2: -0.22mL/kg/min; HR: -0.07/min). Real-time HRV analysis with electrocardiograph alone during exercise can provide continuous and non-invasive exercise intensity measurements at VT, promoting safer and effective exercise strategies.

<p>An Analysis of the Impact of Urban Married Women's Employment on Household Consumption</p>

The realistic problem of the continuous downturn of Chinese residents' consumption has a long history. The tsunami like covid-19 has further worsened the consumption situation of the Chinese people. Using the questions and contents of the "Japan Household Panel Survey" (JHPS) questionnaire of Keio University, and taking the employment rate of other married women with the same income level in the same community as a tool variable, this paper empirically examines the impact of urban married women's employment on household consumption. The results show that the employment of married women in cities and towns significantly increases household consumption; Through the verification of the mechanism, it is found that the increase of total household income and the increase of marginal propensity to consume are important mechanisms for married women to obtain employment to promote urban household consumption, in which the increase of income plays a greater role in the improvement of low-income household consumption, and the increase of marginal propensity to consume plays a greater role in the improvement of high-income household consumption; The employment of married women has a positive impact on all kinds of household consumption, but it plays a greater role in promoting developmental consumption.

Androgen deprivation therapy duration is significantly associated with Testosterone recovery in Japanese patients with prostate cancer.

Due to the fear generated by COVID-19 in Spring 2020, many patients postponed their scheduled outpatient visits. To differentiate those patients with prostate cancer (PCa) whose androgen deprivation therapy (ADT) injection treatment can be postponed, we investigated the characteristics of testosterone (T) recovery in Japanese patients after they received combined ADT and radiation therapy (RT). We included 81 patients with PCa treated with ADT and RT at Keio University Hospital from January 2013 to December 2018. T-recovery was defined as the time interval between the last ADT injection and 3-6months after T-normalization. The Kaplan-Meier method was used to estimate time to T-recovery. Cox proportional hazards models identified T-recovery predictors. The 50% cumulative incidence of T-recovery was 7.0months for the 6-short-term group (defined as patients having ≤6months of ADT therapy) versus 13.0months for the 6-long-term group (>6months of therapy) (p < 0.001). The incidence was 7.0months for the 12 short-term-ADT (ST) group versus 18.0months for the 12 long-term-ADT (LT) group (p < 0.001). Multivariate analysis revealed that a shorter duration of ADT was associated with a shorter time to T-recovery (hazard ratio, 0.253; 95% CI, 0.138-0.465; p < 0.001). No other factors were significant predictors of T-recovery. Androgen deprivation therapy duration is significantly associated with T-recovery in Japanese patients with PCa. If a patient undergoes ADT for more than 6 or 12months, it is possible to postpone their outpatient visits for 13 and 18months, respectively.

Fetal growth restriction and a single umbilical artery are independent predictors of hypospadias during pregnancy

IntroductionLittle is known about the association between hypospadias and small fetuses, as well as the pathological implications of fetal growth restriction (FGR). Thus, we aimed to investigate the association between hypospadias and small fetuses using a database of fetal ultrasound and obstetric events. MethodsA cohort of male singleton infants delivered after 22 weeks of gestation at Keio University Hospital between 2013 and 2019 was retrospectively reviewed. FGR was defined according to the Delphi criteria. Logistic regression analysis was performed to identify the significant predictors of hypospadias. Placental pathology was reviewed in cases with hypospadias. ResultsOf the 2,040 male infants included in the present study, 23 had hypospadias. The prevalences of a single umbilical artery (SUA), small for gestational age, maternal hypertensive disorders of pregnancy, and a small placenta, were significantly higher in infants with hypospadias. Multiple logistic regression analysis revealed that FGR (odds ratio [OR] = 9.39; 95% confidence interval [CI], 2.50–35.3) and the presence of a SUA (OR = 33.4; 95% CI, 8.00–139.5) were independently and significantly associated with hypospadias. When FGR was stratified by the time of onset, its association with hypospadias was significant regardless of the time of onset. Moreover, placental histological findings suggested that fetal vascular malperfusion might play a role in hypospadias. DiscussionFGR and SUAs are independent prenatal predictors of the development of hypospadias, and fetal vascular malperfusion of the placenta may be involved in the etiology of hypospadias.

Effects of Aging on Rheumatoid Factor and Anticyclic Citrullinated Peptide Antibody Positivity in Patients With Rheumatoid Arthritis.

We investigated the factors that affect rheumatoid factor (RF) and anticyclic citrullinated peptide antibody (anti-CCP) positivity in patients with rheumatoid arthritis (RA). The study included all consecutive patients with RA treated at Keio University Hospital between 2016 and 2017. We recorded age at diagnosis, sex, smoking habit, BMI (kg/m2), and family history, and investigated the association between these variables and RF and anti-CCP positivity. We recruited 1685 patients with RA. The mean age at diagnosis was 51.9 years, and 83.4% of the patients were women. Positivity rates of RF and anti-CCP almost linearly decreased along with the increase in age at RA diagnosis (grouped by decade) after ≥ 30 years of age (RF: 80.5%, 84.2%, 81.1%, 78%, 74.6%, 62.6%, 51.4%, P < 0.001; anti-CCP: 79.9%, 87.4%, 81.7%, 74%, 70.5%, 60.2%, 37.1%; P < 0.001). Multivariable analysis revealed that age was independently associated with seronegativity in women (RF: odds ratio [OR] 0.98, 95% CI 0.97-0.99, P < 0.001; anti-CCP: OR 0.97, 95% CI 0.96-0.98; P < 0.001), nonsmoking history (RF: OR 0.98, 95% CI 0.97-0.99, P < 0.001; anti-CCP: OR 0.97, 95% CI 0.96-0.98; P < 0.001), and BMI < 25 (RF: OR 0.98, 95% CI 0.97-0.99; P < 0.001; anti-CCP: OR 0.97, 95% CI 0.97-0.98; P < 0.001). Aging is an independent contributor for seronegative RA in patients who are female, have a nonsmoking history, and a BMI < 25.

Distinct impact of malignancy and allergy on the clinical and immunological features of IgG4-related disease.

To clarify the clinical and immunological characteristics of IgG4-RD based on the underlying diseases. Consecutive patients with IgG4-RD treated at Keio University Hospital between 2010 and 2021 were divided according to the presence of malignancy or allergy into three groups. The clinical characteristics and 56 immune cell subsets in the peripheral blood were compared among the groups. Among 123 patients, 18 (14.6%) had malignancy including 4 with allergy (malignancy group), 57 (46.3%) had allergy alone (allergy group), and 48 (39.0%) had neither (idiopathic group). In the malignancy group, the patients were older (70.1 vs. 54.4 vs. 64.9 years, p<0.001), male-dominant (83.3 vs. 42.1 vs. 54.2%, p=0.008), and had smoking habits (77.8 vs. 42.1 vs. 43.8%, p=0.02). They also had significant involvement of the aorta/large vessels (33.3 vs. 7.0 vs. 20.8%, p=0.02), while the patients in the allergy group tended to have orbital/lacrimal gland involvement. Remission and relapse rates were not different between the groups; however, overall survival was significantly poorer in the malignancy group (p=0.02). Comprehensive immunophenotyping of the peripheral blood revealed that the increase in CXCR5+CD2-double negative T cells and the decrease in naive CD8 T cells were characteristic of the malignancy group. The clinical and immunological phenotypes of IgG4-RD differ among those with underlying diseases.

Comparison of hand-sewn and circular stapled esophagogastric anastomoses in the neck after esophagectomy for thoracic esophageal cancer: a propensity score-matched analysis.

Esophagectomy is a highly invasive surgical procedure; however, anastomotic leakage is one of the major surgical complications that should be prevented. Institutions have their own inherited or specialized anastomosis methods. The superior anastomosis procedure remains unknown despite the many studies to determine the optimal method. The present study enrolled 341 patients who underwent esophagectomy at Keio University Hospital, Tokyo, Japan, between January 2009 and January 2019. The anastomosis method was changed from circular stapled anastomosis to hand-sewn anastomosis in February 2014 to reduce the risk of anastomotic leakage. We retrospectively compared short-term results (anastomotic leakage and stricture) between hand-sewn and circular stapled anastomoses. Analysis of heterogeneity after propensity score matching between the 107 patients in the hand-sewn anastomosis group and 107 patients in the circular stapled anastomosis group revealed almost equal distributions. The incidence rate of anastomotic leakage was significantly lower in the hand-sewn anastomosis group than in the circular stapled anastomosis group (9 vs. 20%, hazard ratio: 2.521; 95% confidence interval: 1.112-5.716; P = 0.027). No significant difference was found in the incidence of anastomotic stricture (16 vs. 18%, P = 0.844). Furthermore, no significant difference was found in the incidence of anastomotic leakage in any of the tumor locations between the two anastomosis procedures. For esophagogastric anastomosis in the neck after esophagectomy, hand-sewn anastomosis is superior to circular stapled anastomosis with regard to reducing the risk of anastomotic leakage.

Advantage of POLARx over ARCTIC FRONT ADVANCE PRO during pulmonary vein isolation for paroxysmal atrial fibrillation

Abstract Introduction The electrical pulmonary vein (PV) isolation has been established as a curative therapy for paroxysmal atrial fibrillation (AF). Arctic Front™cryoballoon has been used worldwide for AF cryoablation. Recently, a new cryoballoon, POLARxTM CRYOABLATION system have been introduced, of which material of the balloon is softer and the N2O gas flow rate is higher. Purpose The aim was to investigate the procedural parameter and efficacy of POLARx comparing with Arctic Front. Methods This retrospective single center study included 101 consecutive patients who underwent paroxysmal AF ablation using cryoballoon at Keio University hospital from April 2021 to March 2022. The procedural data including the cryoballoon temperature and the number and duration of cryoablation were compared between POLARx (POLARx group) and ARCTIC FRONT ADVANCE PRO (AFA group). After the cryoablation, we added the radiofrequency application in order to maximize the isolated area when the voltage was remained inside PV (Figure 1). The necessities of the additional radiofrequency applications were also compared. Results In the present study, 64 patients in AFA group and 37 patients in POLARx group were analyzed. POLARx group included younger population and less females (62.8±9.9 vs 67.5±9.4 year of age, P=0.02; 13.5 vs 32.8%, P=0.04). There was no significant difference in comorbidities and examination data such as left atrium diameter or brain natriuretic peptide level. The minimal cryoballoon temperatures reached in POLARx group were lower than AFA group (−59.3±6.2 vs −47.7±7.5°C, P&amp;lt;0.01). No difference was found in the total number and duration of cryoablation and the time to isolate PV (6.1±2.1 vs 5.9±1.6, P=0.69; 790.2±256.1 vs 776.1±235.0 sec, P=0.69; 41.8±21.3 vs 47.1±29.6 sec, P=0.44, respectively). With regard to individual PVs, the total number and duration were tended to be larger at right superior PV in POLARx group (1.9±1.1 vs 1.4±0.7, P=0.01; 231.8±123.8 vs 193.2±83.0 sec, P=0.07), while there was no significant difference at the other PVs. The rate of successful PV isolation by a single cryo-application was not different between AFA and POLARx group (54.3 vs 61.4%, P=0.17). The additional radiofrequency applications were more frequent in AFA group (14.8 vs. 4.9%, P=0.003). There was a significant difference at right inferior PV (32.8 vs 8.1%, P=0.01), while not at left superior PV, left inferior PV and right superior PV (9.4 vs 2.9%, P=0.42; 9.4 vs 5.7%, P=0.71; 7.8 vs 2.7%, P=0.41). Phrenic nerve injury was occurred 1 case in both group and esophageal ulcer was occurred in 1 case in AFA group. No other complication including cardiac tamponade was occurred. Conclusion The total number and duration of cryoablation were not significantly different between AFA and POLARx group, except for right superior PV. There was an advantage in largely isolating right inferior PV in POLARx group comparing with AFA group. Funding Acknowledgement Type of funding sources: None.

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A practical example of strengthening governance in Japanese College Tennis Clubs

In 2019, the Japan Sports Agency formulated the Sports Organizations Governance Code, a code not directly applicable to college sports clubs. However, as seen in the scandal of the American football club of Nihon University, it is necessary to strengthen the governance of all college sports clubs, including tennis. Therefore, we conducted a governance survey at 268 Japanese college tennis clubs in 2021. The representatives of each college were asked to report their demographics and respond to the assessment measures regarding the governance of college tennis clubs. A simple tabulation and cross-analysis were conducted, and the Chi-square test or Fisher’s exact test were used at a significance level of five percent. Based on the results of the survey, we developed a “Governance Self-Assessment Sheet” for college tennis clubs. In this study, we introduce the outline of the results of the survey by comparing the governance of sports organizations in different countries. Moreover, a practical case study of Keio University in Japan, which is the world’s first university to use the Sheet, will be discussed based on the results of a new survey conducted in 2022.

Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University.

The mRNA-1273 Moderna COVID-19 vaccine was introduced to combat the COVID-19 global pandemic in 2020. Although the safety of the vaccine has been investigated worldwide, real-world safety data is scarce in Japan. An online, real-time survey of adverse events following immunization (AEFIs) with mRNA-1273 was conducted in the setting of a workplace vaccination program at the School of Pharmacy, Keio University from 26 June 2021, to 11 June 2022. Participants were requested to take four surveys during a seven-day follow-up period after each of the first, second, and third booster doses. The maximum number of responses, from 301 respondents, was obtained on day 0 (vaccination date) for the first dose. 98% of respondents reported local and systemic AEFIs for the second dose on day 1. No noticeable difference in local reactions was seen among the three doses. Females reported more AEFIs than males, and the young group (18–29 years) reported a higher rate than the middle age group (≥30 years) after the first dose. Age and gender differences in rates decreased at the second and third doses. This survey confirmed that the safety profile of mRNA-1273 in a real-world setting was similar to that derived from the clinical trials, and that the agent was well-tolerated.

Improvement in Disability Mediates the Effect of Self-Efficacy on Pain Relief in Chronic Low Back Pain Patients with Exercise Therapy

Background The biopsychosocial mechanism by which exercise leads to improvement in chronic low back pain (CLBP) remains unstudied. This prospective cohort study was performed to examine the effectiveness of exercise on pain, disability, and psychological status for CLBP. We also tested path analytic models in which changes in these variables were included. Methods CLBP patients who visited the Interdisciplinary Pain Center of Keio University Hospital from July 2018 to April 2020 were included. The propensity score matching was performed between patients who underwent exercise (the exercise group) and those who did not (the control group). At the first visit and at the 3-month follow-up, pain (Numerical Rating Scale (NRS)), disability (Pain Disability Assessment Scale (PDAS)), and psychological status (Pain Self-Efficacy Questionnaire (PSEQ), and Pain Catastrophizing Scale (PCS)) were assessed. Changes in pain and disability at the follow-up were compared between the groups. The relationships between changes in pain, disability, and psychological variables were examined using Pearson's correlation and mediation analysis. Results A significantly larger decrease in the PDAS was observed in the exercise group (N = 49) than in the control (N = 49) (p < 0.05). Increased PSEQ scores were significantly correlated with decreased NRS scores in both groups. In the exercise group, decreased PDAS fully mediated the relationship between increased PSEQ and decreased NRS (P < 0.05). Conclusion Exercise improved disability, and the improved disability by exercise mediated the effect of increased self-efficacy on pain relief in CLBP patients.