We present a very rare case of abdominal aortic aneurysm associated with paraplegia. A 68-year-old man developed paraplegia following resection of a infrarenal abdominal aortic aneurysm. The aorta was clamped just below the renal arteries. In this case interruption of the radicular artery magna (RAM; Adamkiewicz artery) might have caused serious ischemia of the spinal cord. Spinal cord ischemia is a very rare and unpredictable complication in surgery of infrarenal abdominal aortic aneurysms because the spinal cord is generally protected from irreversible ischemia during infrarenal aortic occlusion by the presence of the RAM which arises above the renal artery (Even if RAM interruption might arise, the lower renal artery, and other radicular arteries are usually present above the renal arteries). We feel that reducing aortic cross-clamping time as short as possible and avoiding intra- and postoperative hypotensive episodes to keep adequate blood flow of collaterals seem to be the most important factors to prevent spinal cord ischemia.

The patient was a 71-year-old man who had been treated for Parkinson's disease for 21 years. He was admitted because nocturnal dyspnea occurred several times. Echocardiography revealed congestive heart failure because of combined mitral and aortic regurgitation. Double valve replacement was planned. There was a risk of the occurrence of neuroleptic malignant syndrome (NMS) if his drugs for Parkinson's disease were stopped suddenly, so careful control of drug doses was required. Although the patient developed aggravation of his Parkinson's symptoms, careful observation and adjustment of medications prevented the occurrence of NMS.

A 38-year-old woman was referred to our hospital for treatment of infective endocarditis associated with abscesses in the brain and the left lower limb. A causative organism had not been detected by serial blood cultures. Preoperative brain CT revealed mycotic aneurysms and echocardiography showed a mobile vegetation (8mm in size) on the anterior leaflet of the mitral valve. We performed resection of the vegetation together with a small triangle of the anterior leaflet, after which the margins of the defect were approximated. Then bilateral Kay procedures and reinforcement with autologous pericardium were done to obtain proper coaptation. The patient's fever, left lower limb pain, and intracerebral mycotic aneurysms resolved after surgery. The brain abscess also became smaller. Mitral valve plasty should sometimes be considered in the active phase of endocarditis, even in patients with cerebral complications and without congestive heart failure.

A study was conducted to evaluate the clinical and hemodynamic performance of the 19-mm Medtronic Mosaic Valve (MMV) in the aortic position, which is a third-generation stented porcine bioprosthesis. Between 2003 and 2006, 9 patients underwent AVR using the 19-mm MMV. None of the patients were suitable for a 19-mm Perimount bioprosthetic valve due to having a small annulus and sinotubular junction. The patients included 3 men and 6 women with a mean age of 73.2±4.97 years and mean body surface area of 1.35±0.11m². Preoperatively, 8 patients were in New York Heart Association class II and 1 was in class III. The reason for surgery was aortic stenosis in 8 patients and aortic regurgitation due to infective endocarditis in 1 patient. Four patients had chronic renal failure and were on hemodialysis, while 1 patient had Crohn's disease. Concomitant coronary artery bypass grafting was performed in 3 patients, and tricuspid valve annuloplasty was done in 1 patient. The follow-up period was 12.0±7.71 months. No deaths occurred, but there was 1 cerebral infarction. Postoperatively, the peak pressure gradient decreased from 81.3±32.7 to 40.3±16.3mmHg (p<0.01). The mean pressure gradient also decreased significantly from 48.8±11.6mmHg to 23.9±9.32mmHg (p<0.01). Left ventricular end-diastolic diameter was 47.9±3.82mm preoperatively and 45.1±7.53mm postoperatively, showing no significant change. The left ventricular mass index also improved from 217.3±46.9 to 160±54.9g/m² (p<0.05). The ejection fraction was 72.0±8.93% preoperatively and 67.6±6.37% postoperatively, showing no difference. Although the postoperative indexed effective orifice area (EOAI) was 0.90±0.11cm²/m², mild patient-prosthesis mismatch (EOAI 0.77cm²/m²) was noted in 1 patient. In conclusion, the early clinical and hemodynamic performance of the 19-mm MMV in small elderly patients was acceptable.

Perivalvular leakage (PVL) is one of the serious complications of mitral valve replacement. Between 1991 and 2006, 9 patients with mitral PVL underwent reoperation. All of them had severe hemolytic anemia before surgery. The serum lactate dehydrogenase (LDH) level decreased from 2,366±780 IU/l to 599±426 IU/l after surgery. The site of PVL was accurately defined in 7 patients by echocardiography. PVL occurred around the posterior annulus in 3 patients, anterior annulus in 2, anterolateral commissure in 1, and posteromedial commissure in 1. The most frequent cause of PVL was annular calcification in 5 patients. Infection was only noted in 1 patient. In 4 patients, the prosthesis was replaced, while the leak was repaired in 5 patients. There was one operative death, due to multiple organ failure, and 4 late deaths. The cause of late death was cerebral infarction in 1 patient, subarachnoid hemorrhage in 1, sudden death in 1, and congestive heart failure (due to persistent PVL) in 1. Reoperation for PVL due to extensive annular calcification is associated with a high mortality rate and high recurrence rate, making this procedure both challenging and frustrating for surgeons.

Objective：To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design：Web based-questionnaire surveyMethods：This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results：［Background］ Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5％) have “experienced in utilization of RWD”, and 12 (11.8％) have “experienced in considering utilization of RWD”. ［Utilization by RWD Type］ By data source, hospital-based claim data was the most frequently used (65 cases, 63.7％), followed by insurance-based claim data (61 cases, 59.8％), surveys (38 cases, 37.3％), and EMR (36 cases, 35.3％) in experienced RWD utilization. Conclusion：This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.

Objective：To investigate the purposes, reasons, and issues of Real World Data (RWD) utilization by data source among pharmaceutical companies in Japan. In this study, we focus on RWDs such as Electronic Medical Records (EMR), Personal Health Records, and registries, which are expected to be utilized in the future. Design：Web based-questionnaire surveyMethods：This questionnaire survey was conducted on 68 companies affiliated with Clinical Evaluation Expert Committee in Japan Pharmaceutical Manufacturers Association from January 18th to February 14th in 2022. In principle, the survey covered four divisions (Clinical development, Pharmacovigilance, Medical Affairs, Health Economics & Outcomes Research) of each company, and other cross-functional divisions were also acceptable to answer. Results：［Background］ Of 40 companies out of 68 companies, 102 respondents were responded to this survey. Overall, 75 respondents (73.5％) have “experienced in utilization of RWD”, and 12 (11.8％) have “experienced in considering utilization of RWD”. ［Utilization by RWD Type］ By data source, hospital-based claim data was the most frequently used (65 cases, 63.7％), followed by insurance-based claim data (61 cases, 59.8％), surveys (38 cases, 37.3％), and EMR (36 cases, 35.3％) in experienced RWD utilization. Conclusion：This study revealed the current status and issues related to the utilization of each type of RWDs in Japan. It is expected that data linkage among multiple RWDs and data standardization enable further utilization of RWDs in future.

A 78-year-old man was diagnosed with adult T-cell leukemia/lymphoma (ATL) and was started on standard chemotherapy 1 year earlier. However, treatment was discontinued because of adverse drug reactions and worsening delirium. Thereafter, he remained stable and was followed up while receiving etoposide. He then visited our hospital because of acute abdominal pain and underwent surgery with a diagnosis of gastrointestinal perforation. Intraoperative observation showed a reddened, concentric wall thickening measuring 4 cm and a perforation site in the ileum, and thus partial resection of the small bowel was performed. The histological diagnosis was small bowel perforation due to tumor cell invasion. Two months postoperatively, he started a less intensive chemotherapy regimen along with palliative care, and died due to the primary disease approximately 5 months postoperatively. ATL involves systemic organs because of its high organ-affinity. Once it involves the gastrointestinal tract, various gastrointestinal symptoms can occur. Patients with ATL are at risk of developing gastrointestinal perforation at any time during the clinical course. Therefore, clinicians should be aware that once gastrointestinal perforation develops, the prognosis becomes extremely poor. Assessment of the disease state, early detection of gastrointestinal lesions, and prevention of opportunistic infections appear to be important in the management of patients with ATL.