The JA Aichi Welfare Federation consists of 8 hospitals, comprising 4 large and 4 mediumsized hospitals. The estimated population of the medical areas that the large hospitals serve has yet to decline notably. In the West Nishimikawa Medical Area, where Anjo Kosei Hospital is located, and in the North Nishimikawa Medical Area, where Toyota Kosei Hospital is located, the population is expected to remain mostly stable even up to 2040. Together with Miyoshi City, Toyota City (population 480,000), where our hospital is located, is in the North Nishimikawa Medical Area and is located to the east of Nagoya City. Due to the Great Heisei Consolidation, the vast mountainous area to the northeast of Toyota City has been incorporated into the city. Then, including the urban area that historically made up the city, this medical area is the largest in Aichi Prefecture. The aging rate is increasing rapidly, and medical demand is expected to increase about 20% (an estimated 140,000 people) by 2040. Therefore, the issue that must be addressed is how to maintain the medical system in the face of rapid population aging in urban areas as well as in the vast mountainous areas,where the population has declined significantly. 　Our hospital opened as Kamo Hospital in 1947. After moving to its current location in 2008, the hospital was renamed Toyota Kosei Hospital. Although net income was significantly negative shortly after the move, total revenue has been steadily increasing since then. Net profit returned to being positive, but the profit margin of medical practice did not readily increase. In the first hospital director's inaugural year, net profit was only 1.5%. Partly because our hospital moved from the center of Toyota City to its northwestern outskirts, the decrease in patients from the city center and the southern part of the city had an effect. 　We are promoting changes in hospital management in line with the Community Medicine Concept, promoting an increase in the number of new patients from adjacent medical areas, increasing the referral rate, and promoting reverse referrals to streamline outpatient care functions. By optimizing the number of outpatients, we are seeking to allocate human resources to inpatient treatment and increase inpatient income. Thanks to these efforts, net profit has exceeded 8% in 5 years up to fiscal year 2019. 　Although we had been aiming to implement reforms to further improve the quality of medical care in the next few years, the impact of the COVID-19 pandemic this year has been immeasurable and has left us struggling. Hospital management has been strongly impacted since April, and no measures have been taken to compensate for the decline in medical income. As the end of the pandemic is unpredictable, the hospital itself needs to change its behavior. At the same time as managing COVID-19 patients in the community, securing income for continuing medical care is an important issue. Community medicine cannot be protected if the hospital cannot survive.

A 42-year-old woman with antiphospholipid syndrome (APLS) secondary to systemic lupus erythematosus (SLE) complicated with thrombocytopenic purpura was successfully treated by mitral valve replacement with a mechanical prosthesis and tricuspid valve annuloplasty for mitral valve stenosis and regurgitation due to Libman-Sacks endocarditis. Intraoperative hemorrhagic oozing due to thrombocytopenia was effectively managed with platelet transfusion. Negative microbial culture and pathological examination of the resected mitral valve demonstrated an atypical sterile verrucose lesion, the findings of which were typically characteristic of Libman-Sacks endocarditis in SLE. She was successfully discharged 31 days after the operation without any hemorrhagic or thromboembolic events. However, 100 days after surgery, she suffered from fatal cerebral infarction caused by poor Coumadin compliance. Regarding the prosthetic valve selection, it is reasonable to select the mechanical valve because 1) anticoagulation therapy is necessary for APLS, 2) the risk of the dialysis induction due to the lupus-induced renal failure leading to a high calcium turnover, which results in accelerated bioprosthetic valve calcification. In case of SLE with APLS, in which anticoagulation and antiplatelet therapy is required to prevent the thromboembolic event and thrombocytopenic purpura, after valve replacement, strict management of anticoagulation plays an essential role to prevent thromboembolic complication.

An 8-year-old girl had been found to have a congenital ventricular septal defect (VSD), based on the presence of a cardiac murmur from birth. She had a history of infective endocarditis and lung abscess when she was 2 years old. Mild aortic regurgitation was revealed by an echocardiogram in August 2004. Right-heart catherization revealed a step up in the oxygen saturation of the right ventricle, aortography showed a deformity of the noncoronary cusp and mild aortic regurgitation, and Doppler color-flow echocardiography detected progression of aortic regurgitation. The patient underwent surgical repair of the VSD with a cardiopulmonary bypass. Following direct suturing combined with pledgets for perimembranous VSD, infusion of cardioplegia revealed the aneurysmal sac extruding from the wall of the right atrium. The final diagnosis was an aneurysm of the sinus of Valsalva from the noncoronary aortic sinus into the right atrium (type IV of Konno). The aneurysm was sutured by polyethylene strings with pledgets. The postoperative course was uneventful, and echocardiography performed before discharge showed no deformity of the sinus of Valsalva and trivial aortic regurgitation which was less than before surgery. She was discharged on the 7th postoperative day.

　　Hyperbaric oxygen (HBO) therapy for acute carbon monoxide (CO) poisoning is performed after oxygen therapy and breathing therapy. The usefulness of HBO therapy in emergency treatment has been reported. In this study, we examined the effectiveness of HBO for CO poisoning that was performed at our hospital over the past 5 years. Subjects were 23 patients who had HBO therapy for CO poisoning in the period January 2008-November 2013. The male to female ratio of the cases was 14:9 and the mean age was 54.6±20.8 years. The cause was suicide in 39.1% of cases and accident in 60.9%. The mean number of treatments was 5.4±6.8. The atmosphere absolute was 2ATA:2.8ATA=12:11. The ratio of direct conveyance of the patient to our hospital to indirect conveyance of the patient from another hospital was 15:8. The effectiveness of HBO therapy at the time of discharge was 73.9%. However, delayed neuropsychiatric sequelae (DNS) was detected in 3 of the 23 cases of CO poisoning. No correlations were found between elapsed time after CO inhalation and various blood parameters. However, time to start of therapy is important for DNS, and our results suggest that early treatment at a hospital with a hyperbaric chamber is necessary.

MHLW released a guideline for Risk Management Plan (RMP) in April 2012, in order to manage the risk of pharmaceutical products from the development stage towards post marketing period. The guideline suggests to determine Safety Specification and to develop Pharmacovigilance Plan (PVP) and Risk Minimization Plan aligned to the ICH E2E guideline. However, in some of the RMPs, which had been published online (as of August 2014), conventional (Special) Drug Use Results Surveys are planned as a “universal” PVP regardless of the impact, severity and characteristics of the risks. Our JPMA taskforce (Data Science Expert Committee) summarized report and published in August 2014. In this report, we explained how to evaluate safety events based on evidence level for safety specification and how to develop PVP. Also, we would like to propose KAIZEN activities for RMP improvement as follows:
1. In order to clarify the research question, rationale and evidence for safety specification should be evaluated carefully.
2. It is essential to be considered in advance how to collect and analyze the safety data for detecting safety specification during clinical development.
3. Safety profiles should be discussed thoroughly on DSUR development among stakeholders in order to clarify safety specification at NDA. Research questions for each different risk and missing information should be established according to PECO, which will flow into appropriate PVP planning.
4. Continuous PDCA cycling is critical for RMP. The first survey or research will bring you next research question (s).
We expect all stakeholders, including clinical development specialists in industry, regulatory authorities, and academia, to have better understating of RMP principle and to manage and implement it more appropriately in a scientific manner.

Continuous blood purification (CBP) therapy, chiefly represented by continuous hemodiafiltration (CHDF), is performed mainly in the field of intensive care and is a vital component of acute blood purification therapy. In addition to renal indications, the scope of indications for CBP has been expanded to include non-renal conditions such as severe acute pancreatitis and liver failure. However, at present, hospitals carry out CBP on a trial and error basis. Here, we conducted the tenth questionnaire survey (2019) to investigate the current status of CBP in the Tokai and Hokuriku regions. The 30-item questionnaire included questions on the number of cases managed per year, type of membranes used, set up conditions, management during set up, activated clotting time, and clinical engineer duty system. A total of 83 facilities participated in the survey, including 69 in Tokai (Aichi, Gifu, Mie, and Shizuoka) and 14 in Hokuriku. It appears that many hospitals depend on the clinical engineer duty system for exchange of drug solutions, adjusting CBP conditions, and trouble-shooting issues in CBP management. Our findings suggest the importance of continued proactive involvement in the 24-h management system and in the standardization of CBP therapy.

We present the case of a 72-year-old man with constrictive pericarditis due to tuberculous pericarditis, who was treated with the waffle procedure via left anterolateral thoracotomy. The preoperative catheterization study showed the dip-and-plateau pattern, and the echocardiographic study shown the thickened pericardium and dilatation impairment. The surgery was able to be performed without cardiopulmonary bypass. The thickened pericardium was abraded with a Harmonic Scalpel. The waffle procedure was effective in this patient. The postoperative course was good, with improvement of NYHA status and cardiac pressure study results. We suggest that this procedure is useful for the patients with constrictive pericarditis.

This case report describes our first experience performing percutaneous epicardial catheter ablation for Burugada syndrome in our hospital. We describe the good results achieved in this case. The patient was a man in his 30s with no remarkable medical history. However, his family history was notable for the sudden death of his grandfather at age 37 years and his father at age 27 years. While asleep, the patient experienced convulsions and lost consciousness. During emergency transportation, defibrillation was performed 7 times by the ambulance crew. When the patient arrived at our hospital, sinus rhythm was observed on ECG. During resuscitation, Burugada syndrome was diagnosed based on ECG findings. On hospital day 6, an internal cardioverter defibrillator was implanted. After discharge, the defibrillator operated 10 times, so we opted for ablation treatment. Fractionated potential of over 150 ms was confirmed in the right ventricular outflow tract. A low voltage zone of <1 mV could be mapped, and the same site was cauterized a total of 46 times. As a result, ST segment amplitude decreased significantly in lead V1 on ECG. Percutaneous epicardial catheter ablation performed with reference to Nademanee’s report achieved good results in this case of Burugada syndrome.