Influence of surgical volume on the mortality and morbidity of gastrointestinal perforation in children.

PURPOSE: To clarify the influence of surgical volume on the mortality and morbidity of gastrointestinal perforation in children in Japan. METHODS: We collected data on pediatric patients with gastrointestinal perforation between 2017 and 2019, from the National Clinical Database. The surgical volumes of various institutions were classified into three groups: low (average number of surgeries for gastrointestinal perforation/year < 1), medium (≥ 1, < 6), and high (≥ 6). The observed-to-expected (o/e) ratios of 30-day mortality and morbidity were calculated for each group using an existing risk model. RESULTS: Among 1641 patients (median age, 0.0 years), the 30-day mortality and morbidity rates were 5.2% and 37.7%, respectively. The 30-day mortality rates in the low-, medium-, and high-volume institutions were 4.9%, 5.3%, and 5.1% (p = 0.94), and the 30-day morbidity rates in the three groups were 26.8%, 39.7%, and 37.7% (p < 0.01), respectively. The o/e ratios of 30-day mortality were 1.05 (95% confidence interval [CI] 0.83-1.26), 1.08 (95% CI 1.01-1.15), and 1.02 (95% CI 0.91-1.13), and those of 30-day morbidity were 1.72 (95% CI 0.93-2.51), 1.03 (95% CI 0.79-1.28), and 0.95 (95% CI 0.56-1.33), respectively. CONCLUSION: Surgical volume does not have significant impact on the outcomes of pediatric gastrointestinal perforation in Japan.

Abdominal Drainage at Appendectomy for Complicated Appendicitis in Children: A Propensity-matched Comparative Study.

OBJECTIVE: The aim of the study was to investigate the effect of abdominal drainage at appendectomy for complicated appendicitis in children. SUMMARY OF BACKGROUND DATA: Although an abdominal drain placement at appendectomy is an option for reducing or preventing postoperative infectious complication, there is controversy regarding its effect for complicated appendicitis. METHOD: The study used the data on appendectomies for complicated appendicitis in children (≤15 years old) that were operated in 2015 and registered in the National Clinical Database, a nationwide surgical database in Japan. One-to-two propensity score matching was performed to compare postoperative outcomes between patients with and without drainage at appendectomy. RESULT: The study included 1762 pediatric appendectomies for complicated appendicitis, 458 of which underwent abdominal drainage at appendectomy. In the propensity-matched analysis, the drainage group showed a significant increase in wound dehiscence [drain (-) vs drain (+); 0.3% vs 2.4%, P = 0.001], and postoperative hospital stay (median: 7 days vs 9 days, P < 0.001). There were no significant differences in the incidence of any complications, organ space surgical site infection, re-admission, and reoperation.Subgroup analyses in perforated appendicitis and perforated appendicitis with abscess, and open and laparoscopic appendectomy all demonstrated that drain placement was not associated with a reduction in any complication or organ space surgical site infection. However, it was significantly associated with longer hospital stays. CONCLUSION: This study suggested that an abdominal drain placement at appendectomy for complicated appendicitis among children has no advantage and can be harmful for preventing postoperative complications.

Real-World Evidence of the Incidence of and Risk Factors for Type 1 Diabetes Mellitus and Hypothyroidism as Immune-Related Adverse Events Associated With Programmed Cell Death-1 Inhibitors.

OBJECTIVE: The incidence of type 1 diabetes mellitus (T1DM) and hypothyroidism as immune-related adverse events (irAEs) after programmed cell death-1 inhibitor (PD-1i) administration has not yet been sufficiently evaluated in a real clinical setting. To assess the incidence of T1DM and hypothyroidism among PD-1is and to identify the risk factors associated with hypothyroidism using a large claims database. METHODS: This cohort study used the Shizuoka Kokuho database in Japan from 2012 to 2018, including approximately 2.2 million people. We enrolled 695 PD-1i-treated patients. T1DM and hypothyroidism as irAEs were identified using International Classification of Diseases 10th Revision and Anatomical Therapeutic Chemical classification codes. Risk factors for hypothyroidism were explored using the multivariable Fine and Gray regression model after adjusting for age group and sex, treating death as a competing risk. RESULTS: The cumulative incidences of T1DM and hypothyroidism were 0.3% and 8.3%, respectively. We described the detailed onset timing of irAEs in patients with T1DM and hypothyroidism; hypothyroidism was observed evenly within 1 year of the PD-1i prescription. Sex and certain cancer types, such as lung and urothelial cancers, were significantly associated with subdistribution hazard ratio (sHR) (female: sHR, 2.04 [95% CI, 1.20-3.47]; lung cancer: sHR, 0.55 [95% CI, 0.32-0.95]; and urothelial carcinoma: sHR, 2.40 [95% CI, 1.05-5.49]). CONCLUSION: The incidence of T1DM and hypothyroidism as irAEs and associated risk factors identified in this analysis were comparable to those found in previous studies. The use of a large claims database to detect irAEs, such as T1DM and hypothyroidism, may lead to safer use of PD-1is.

Current Surgical Outcomes of Congenital Heart Surgery for Patients With Down Syndrome in Japan.

BACKGROUND: Current surgical outcomes of congenital heart surgery for patients with Down syndrome are unclear.Methods and Results:Of 29,087 operations between 2008 and 2012 registered in the Japan Congenital Cardiovascular Surgery Database (JCCVSD), 2,651 were carried out for patients with Down syndrome (9%). Of those, 5 major biventricular repair procedures [ventricular septal defect repair (n=752), atrioventricular septal defect repair (n=452), patent ductus arteriosus closure (n=184), atrial septal defect repair (n=167), tetralogy of Fallot (TOF) repair (n=108)], as well as 2 major single ventricular palliations [bidirectional Glenn (n=21) and Fontan operation (n=25)] were selected and their outcomes were compared. The 90-day and in-hospital mortality rates for all 5 major biventricular repair procedures and bidirectional Glenn were similarly low in patients with Down syndrome compared with patients without Down syndrome. On the other hand, mortality after Fontan operation in patients with Down syndrome was significantly higher than in patients without Down syndrome (42/1,558=2.7% vs. 3/25=12.0%, P=0.005). CONCLUSIONS: Although intensive management of pulmonary hypertension is essential, analysis of the JCCVSD revealed favorable early prognostic outcomes after 5 major biventricular procedures and bidirectional Glenn in patients with Down syndrome. Indication of the Fontan operation for patients with Down syndrome should be carefully decided.

Long-Term Results of Bilateral Pulmonary Artery Banding Versus Primary Norwood Procedure.

Bilateral pulmonary artery banding (PAB) has emerged to be an attractive option as an initial procedure for the treatment of hypoplastic left heart syndrome (HLHS), and some centers report excellent survival. However, its usage is variable among institutions and its true efficacy is unknown due to reporting biases. We aimed to describe the results of bilateral PAB use, preoperative risk factors, and long-term outcomes compared with primary Norwood procedure, using a national database. Infants who underwent bilateral PAB or Norwood procedure as an initial palliation for HLHS between January 2008 and December 2012 listed in the Japan Congenital Cardiovascular Surgery Database (JCCVSD) were included. The total number of patients diagnosed with HLHS was 334. Bilateral PABs were performed for 256 patients and primary Norwood procedures for 78 patients, as an initial procedure. Actuarial 5-year survival was 59.0%. The primary Norwood procedure group had better 5-year survival [75.5%; 95% confidence interval (CI) 63.2-84.1] than the bilateral PAB group (75.5 vs. 54.0%, log-rank p < 0.001). However, the bilateral PAB group had more significant risk factors. When the risk-adjusted outcomes were evaluated, there was no significant difference between the primary Norwood group and the bilateral PAB group (76.4 vs. 78.1%, log-rank p = 0.87) in higher volume institutions. The primary Norwood group had better 5-year survival than the bilateral PAB group, but preoperative risk was higher in the bilateral PAB group. Because outcomes are comparable when performed at higher HLHS volume institutions, proper patient selection is important in achieving good long-term result.

Modeling preoperative risk factors for potentially lethal morbidities using a nationwide Japanese web-based database of patients undergoing distal gastrectomy for gastric cancer.

BACKGROUND: Most risk models for mortality and morbidity after distal gastrectomy have been created based on relatively small retrospective studies, and a model originating from nationwide database has been lacking. This study aimed to identify preoperative risk factors that predict the postoperative morbidities closely associated with mortality in gastric cancer patients undergoing distal gastrectomy, using data from the National Clinical Database (NCD), a nationwide web-based database in Japan. METHODS: We analyzed records from the NCD for 65,906 patients who underwent distal gastrectomy in 1,986 hospitals during 2011 and 2012. Using 80 % of these patients, we identified independent preoperative predictors for morbidities closely related with mortality. These risk factors were then validated using the remaining 20 % of patients from 2011 to 2012 and the further 35,575 records from 2013. RESULTS: Operative mortality was 1.07 % and overall morbidity was 14.2 % for the development data set. We selected eight morbidities that were closely associated with postoperative mortality, and then identified between 13 and 25 independent preoperative risk factors for each of the eight morbidities. Of these, old age, female gender, and poor ADL were the factors most frequently associated with the morbidities. The C-indices for each morbidity from the 2011 to 2012 validation data set were favorable as follows: unplanned intubation (0.797), pneumonia (0.784), systemic sepsis (0.748), renal failure (0.832), cardiac events (0.728), large blood transfusions (0.700), central nervous system (CNS) events (0.779), and anastomotic leakage (0.658). Similar C-indices were obtained for each mortality using the 2013 validation data set. CONCLUSIONS: In this study, we successfully constructed an acceptable risk model using preoperative risk factors to predict eight postoperative morbidities highly associated with mortality in gastric cancer patients. This risk model could help to tailor perioperative management and improve clinical outcomes for patients who undergo distal gastrectomy.

Association between the participation of board-certified surgeons in gastroenterological surgery and operative mortality after eight gastroenterological procedures.

PURPOSE: The aim of this study is to evaluate the association between the participation of board-certified surgeons in gastroenterological surgery (BCS-Gs) and the surgical outcomes of gastroenterological surgery. METHODS: Data from the National Clinical Database on patients who underwent eight major gastroenterological procedures were analyzed retrospectively. First, the ratio of cases in which BCS-G were involved to the total cases was calculated for each procedure, and the impact of BCS-G involvement on surgical outcome was assessed by comparing mortality rates in the group with BCS-G involvement vs. the group without BCS-G involvement. Second, the differences in the observed/expected ratio were assessed among four hospital categories according to the available BCS-G number. Finally, the impact of the hospital BCS-G number on mortality was evaluated. RESULTS: The ratio of BCS-G involvement ranged from 59.0 % for acute diffuse peritonitis to 89.1 % for hepatectomy, and the mortality rate was significantly lower for three procedures when BCS-Gs participated as the operator or assistant. The observed/expected ratio of hospitals with four or more BCS-Gs was less than 1.0 for all the procedures assessed. A multivariable logistic regression model showed that the hospital BCS-G number was a predictor of operative mortality. CONCLUSIONS: BCS-Gs contribute to favorable outcomes of gastroenterological surgery in Japan. The hospital BCS-G number is a surrogate marker of operative mortality.

Challenges and prospects of a clinical database linked to the board certification system.

In Japan, the National Clinical Database (NCD) was founded in April 2010 as the parent body of the database system linked to the board certification system. Registration began in 2011, and to date, more than 3,300 facilities have enrolled and more than one million cases are expected to enroll each year. Given the broad impact of this database initiative, considering the social implications of their activities is important. In this study, we identified and addressed issues arising from data collection and analysis, with a primary focus on providing high-quality healthcare to patients and the general public. Improvements resulting from NCD initiatives have been implemented in clinical settings throughout Japan. Clinical research using such database as well as evidence-based policy recommendations can impact businesses, the government and insurance companies. The NCD project is realistic in terms of effort and cost, and its activities are conducted lawfully and ethically with due consideration of its effects on society. Continuous evaluation on the whole system is essential. Such evaluation provides the validity of the framework of healthcare standards as well as ensures the reliability of collected data to guarantee the scientific quality in clinical databases.

Pericardial effusion after congenital heart surgery.

Objective: Pericardial effusion after cardiac surgery remains an important cause of morbidity and mortality. We describe the risk factors of pericardial effusion after congenital heart surgery through analyzing data from a nationwide, multi-institutional registry. Methods: The Japan Congenital Cardiovascular Surgery Database, which reflects routine clinical care in Japan, was used for this retrospective cohort study. Multivariable regression analysis was done after univariable comparison of patients with pericardial effusion and no pericardial effusion. Results: The study enrolled 64,777 patients registered with the Japan Congenital Cardiovascular Surgery Database between 2008 and 2016; 909 of these had postoperative pericardial effusion (1.4%) and were analyzed along with 63,868 patients without pericardial effusion. Univariable analysis found no difference between the groups in terms of gender, early delivery, or preoperative mechanical ventilatory support. In the pericardial effusion group, cardiopulmonary bypass use was lower (58.4% vs 62.1%), whereas the cardiopulmonary bypass time (176.9 vs 139.9 minutes) and aortic crossclamp time (75.1 vs 62.2 minutes) were longer, and 30-day mortality was higher (4.1% vs 2.2%). Multivariable analysis identified trisomy 21 (odds ratio, 1.54), 22q.11 deletion (odds ratio, 2.17), first-time cardiac surgery (odds ratio, 2.01), and blood transfusion (odds ratio, 1.43) as independent risk factors of postoperative pericardial effusion. In contrast, neonates, infants, ventricular septal defect, atrial septal defect, tetralogy of Fallot repair, and arterial switch operation were correlated with a low risk of pericardial effusion development. Conclusions: The incidence of postoperative pericardial effusion in congenital cardiac surgery was 1.4%. Trisomy 21, 22q.11 deletion, first-time cardiac surgery, and blood transfusion were identified as the principal factors predicting the need for pericardial effusion drainage.

Status of cardiovascular surgery in Japan between 2017 and 2018: A report based on the Japan Cardiovascular Surgery Database. 4. Thoracic aortic surgery.

AIM: We aimed to analyze the current treatment status of thoracic/thoracoabdominal aortic diseases in Japan. METHODS: Using the Japan Cardiovascular Surgery Database, the number of cases, operative mortality, and major morbidities (stroke, renal failure, pneumonia, paraplegia) of thoracic and thoracoabdominal aortic surgery in 2017 and 2018 were analyzed by surgical site (root-ascending, arch, descending, thoracoabdominal aorta), surgical procedure, and age group. RESULTS: The total number of cases was 39,391 (50.1% aortic dissections, 49.9% non-dissections). The number of cases was highest in patients aged in their 70s. In elderly patients, the rates of root replacement (particularly valve-sparing procedures) in the root-ascending aorta and open-chest surgery in the arch and the descending and thoracoabdominal aorta were decreased. The outcome by procedure analysis showed the lowest mortality and morbidity rates for valve-sparing in the root-ascending region, and lower mortality and morbidity (cerebral infarction, renal failure, pneumonia) in non-open-chest procedures (thoracic endovascular aortic repair with/without branch reconstruction) than in open-chest procedures in the arch, descending, and thoracoabdominal regions. With regards to age, operative mortality in patients aged 80 years or older was significantly higher than in those under 80 years of age for all surgical procedures in the root-ascending, arch, and descending regions. CONCLUSIONS: Thoracic and thoracoabdominal aortic surgery in Japan was most commonly performed in elderly patients in their 70s, with a good overall mortality rate of 5.3%. Mortality and postoperative morbidity rates in patients aged 80 years or older were still high. In the future, further improvements in surgical outcomes are needed.

Development of Bayesian Mortality Categories for Congenital Cardiac Surgery in Japan.

BACKGROUND: Surgery requires a complexity-based ranking system that provides critical information for surgeons to perform strategic operations. However, we still use professional panel systems such as the Risk Adjustment for Congenital Heart Surgery category and the Aristotle Basic Complexity score for this purpose, both of which are subjective. The present study, inspired by more recent development of The Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery mortality scores and categories, applied a Bayesian statistical method to the Japanese nationwide congenital heart registry by estimating inhospital mortality to construct a data-driven, more scientific rating system based on complexity. METHODS: The study used a 5-year dataset from the Japan Cardiovascular Surgery Database congenital section to construct a Bayesian estimation model. There were 25,968 operations with 186 cardiovascular procedures. To validate the model, we used an independent 2-year dataset with 14,904 operations. RESULTS: The model-based inhospital mortality estimation provided a complexity rating system that replicated the past study that had proposed a five-category system based on the estimated mortality scores. The C-index with the validation dataset for the mortality score and category was 0.80 and 0.79, respectively. CONCLUSIONS: The data-driven approach to complexity rating systems for congenital cardiovascular surgery is recommended, as it has better scientific advantages and more convenient updating features.

Laparoscopic Versus Open Appendectomy for Acute Appendicitis in Children: a Nationwide Retrospective Study on Postoperative Outcomes.

PURPOSE: Our aim was to compare postoperative outcomes of laparoscopic and open appendectomies for acute appendicitis in children under the circumstance of widespread use of laparoscopic surgery. METHOD: This study included data on laparoscopic and open appendectomies in children with acute appendicitis from the National Clinical Database, which is a Japanese nationwide surgical database, in 2015. The occurrence rates of complications within 30 days after the surgery and postoperative hospital stay were compared by univariate and multivariate analyses. p < 0.05 was considered statistically significant. RESULTS: This study included 4489 appendectomies, of which 3166 surgeries (70.5%) were performed laparoscopically. Appendectomy was performed for complicated and uncomplicated appendicitis in 1765 (39.3%) and 2724 cases (60.7%), respectively. Postoperative complications within 30 days were observed in 246 operations (5.5%). Organ-space surgical site infection (SSI), deep wound SSIs, and superficial wound SSIs were observed in 2.3%, 1.0%, and 2.4% of operations, respectively. On multivariate analysis, the incidence of postoperative complications (odds ratio 1.21, 95% CI 0.90-1.64, p = 0.207) and the length of hospital stay (median 4 days in both groups, p = 0.835) were not significantly different between patients who underwent laparoscopic or open appendectomy. Subgroup analysis in complicated and uncomplicated appendicitis cases also demonstrated no significant differences in the incidence of postoperative complications between those who underwent laparoscopic or open appendectomy. CONCLUSION: This study suggested that the occurrence of postoperative complication and the length of hospital stay in pediatric patients who underwent laparoscopic appendectomy are similar with those in pediatric patients who underwent open appendectomy for acute appendicitis.

Status of cardiovascular surgery in Japan: A report based on the Japan Cardiovascular Surgery Database 2017-2018. 1. Congenital heart surgery.

OBJECTIVES: We aimed to analyze the mortality and morbidity associated with congenital heart surgery in Japan. METHODS: Data on congenital heart surgeries performed between January 2017 and December 2018 were obtained from Japan Cardiovascular Surgery Database. The 20 most frequent procedures were selected, and mortalities and major morbidities associated with the procedures were analyzed. All procedures were classified into Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery Congenital Heart Surgery mortality categories, and mortalities in each category were also analyzed. RESULTS: The mortality rates in atrial septal defect repair and ventricular septal repair were 0% and 0.2%, respectively. The mortality rates in more complex cases (tetralogy of Fallot repair, complete atrioventricular repair, bidirectional Glenn, and total cavopulmonary connection) were 2%-3%. The mortality rates in systemic-to-pulmonary shunt, total anomalous pulmonary venous connection repair, and the Norwood procedure were 4.9%, 11.1%, and 15.7%, respectively, which were not different from those reported in 2015-2016. The mortalities according to the Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery categories 1-5 were 0.3%, 2.7%, 2.9%, 5.9%, and 15.5%, respectively, and comparable to those of the Society of Thoracic Surgeons database (2013-2016). CONCLUSION: The mortality rates and frequency of complications in major surgical procedures for congenital heart disease in Japan in 2017-2018 will play an important role as a basis for trends in Japan and for comparison with results from other countries.

Risk analysis for patients with a functionally univentricular heart after systemic-to-pulmonary shunt placement.

OBJECTIVES: To investigate risk factors for mortality after systemic-to-pulmonary (SP) shunt procedures in patients with a functionally univentricular heart using the Japan Cardiovascular Surgery Database registry. METHODS: Clinical data from 75 domestic institutions were collected. Overall, 812 patients with a functionally univentricular heart who underwent initial SP shunt palliation were eligible for analysis. Patients with pulmonary atresia with an intact ventricular septum and patients with a SP shunt as part of the Norwood procedure were excluded. Risk factors for 30- and 90-day mortalities were analysed using a logistic regression model. RESULTS: Median age and body weight at SP shunt placement were 41 days and 3.6 kg, respectively. Modified Blalock-Taussig shunt, central shunt and other types of SP shunts were applied in 689 (84.9%), 94 (11.8%) and 30 (3.7%) patients, respectively. Cardiopulmonary bypass was utilized in 410 patients (51%) for 128 min (median, 19-561). There were 411 isolated SP shunt procedures. Median hospital stay was 27 days, and 742 (91.4%) patients were discharged. The 30- and 90-day mortality rates were 3.4% and 6.0%, respectively. Placement of a central shunt was identified as a risk factor for 30-day mortality, while lower body weight, preoperative ventilator support, right atrial isomerism and coexistence of major aortopulmonary collateral arteries and an unbalanced atrioventricular septal defect were identified as risk factors for 90-day mortality. CONCLUSIONS: SP shunt carries a high mortality rate in patients with a functionally univentricular heart when it is performed in smaller patients with complex cardiac anomalies.

Utility of Self-Administered Questionnaires for Identifying Individuals at Risk of COPD in Japan: The OCEAN (Okinawa COPD casE finding AssessmeNt) Study.

Purpose: A considerable proportion of patients with chronic obstructive pulmonary disease (COPD) remain undiagnosed and untreated even though they may have a burden of respiratory symptoms that impact quality of life. The OCEAN study assessed the ability of screening questionnaires to identify individuals with, or at risk of, COPD by comparing questionnaire outcomes with spirometric measures of lung function. Methods: This observational study included participants ≥40 years of age presenting for their annual health examination at a single medical center in Okinawa, Japan. Participants completed COPD screening questionnaires (CAPTURE and COPD-Q), the Chronic Airways Assessment Test (CAAT), and general demographic and health-related questionnaires. The performance characteristics of CAPTURE and COPD-Q were compared with spirometry-based airflow limitation by calculating the area under the receiver operating characteristic (ROC-AUC) curve. Results: A total of 2518 participants were included in the study; 79% of whom were <60 years of age (mean 52.0 years). A total of 52 (2.1%) participants had airflow limitation defined as forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.7, and 420 (16.7%) participants were classified as Preserved Ratio Impaired Spirometry (PRISm). Among participants with PRISm, 75 (17.9%) had a CAAT total score ≥10. Airflow limitation and PRISm were more prevalent in current smokers versus past smokers. For the CAPTURE questionnaire, ROC-AUC for screening airflow limitation, PRISm, and PRISm with a CAAT total score ≥10 were 0.59, 0.55, and 0.69, respectively; for COPD-Q, these three clinical features were 0.67, 0.58 and 0.68, respectively. Conclusion: This study demonstrated that CAPTURE and COPD-Q appear to be effective screening tools for identifying symptomatic individuals with undiagnosed, or at risk of developing COPD in adults ≥40 years of age in Okinawa. Furthermore, early diagnosis and management of PRISm is important to improve future outcomes and the societal burden of disease.

Prevalence and Characteristics of Individuals with Preserved Ratio Impaired Spirometry (PRISm) and/or Impaired Lung Function in Japan: The OCEAN Study.

PURPOSE: Many individuals with obstructive airway disease (OAD), including chronic obstructive pulmonary disease (COPD) and asthma, remain undiagnosed, despite the potential for reducing disease burden through early detection and treatment. OCEAN aimed to determine the prevalence of, and characteristics associated with, impaired lung function in a Japanese population, with the goal of improving strategies for early OAD detection. METHODS: OCEAN was an observational, cross-sectional study in sequentially recruited Japanese individuals ≥40 years of age undergoing routine health examinations. Participants completed screening questionnaires and spirometry testing. Airflow limitation was defined as forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) <0.7 by pre-bronchodilator spirometry. Preserved ratio impaired spirometry (PRISm) was defined as FEV1/FVC ≥0.7 and FEV1 <80% predicted. The primary endpoint was prevalence of spirometry-based airflow limitation and PRISm. The characteristics of study participants were reported as secondary endpoints. RESULTS: Overall, 2518 individuals were included; 79% were <60 years of age (mean 52.0 years). Airflow limitation and PRISm were observed in 52 (2.1%) and 420 (16.7%) participants, respectively. FEV1 in the PRISm group was between that in the no airflow limitation/PRISm and airflow limitation groups, FVC was similar in the PRISm and airflow limitation groups. The PRISm group had higher mean body mass index and a higher proportion of comorbid metabolic disease compared with the airflow limitation group. The prevalence of airflow limitation and PRISm was highest among current smokers (3.9% and 21.3%, respectively) versus former or never smokers. CONCLUSION: A significant proportion of Japanese individuals <60 years of age attending their annual health examination had impaired lung function (airflow limitation and PRISm); prevalence was highest among current smokers. These findings support screening of current or former smokers ≥40 years of age using patient-reported questionnaires to inform the need for spirometry to confirm an OAD diagnosis.

Mortality, morbidity, and failure to rescue in hepatopancreatoduodenectomy: An analysis of patients registered in the National Clinical Database in Japan.

BACKGROUND: The high operative mortality rate after hepatopancreatoduodenectomy (HPD) is still a major issue. The present study explored why operative mortality differs significantly due to hospital volume. METHOD: Surgical case data were extracted from the National Clinical Database (NCD) in Japan from 2011 to 2014. Surgical procedures were categorized as major (≥2 sections) and minor (<2 sections) hepatectomy. Hospitals were categorized according to the certification system by the Japanese Society of Hepato-Biliary-Pancreatic Surgery (JSHBPS) based on the number of major hepato-biliary-pancreatic surgeries performed per year. The FTR rate was defined as death in a patient with at least one postoperative complication. RESULTS: A total of 422 patients who underwent HPD were analyzed. The operative mortality rates in board-certified A training institutions, board-certified B training institutions, and non-certified institution were 7.2%, 11.6%, and 21.4%, respectively. Multiple logistic regression showed that certified A institutions, major hepatectomy, and blood transfusion were the predictors of operative mortality. Failure to rescue rates were lowest in certified A institutions (9.3%, 17.0%, and 33.3% in certified A, certified B, and non-certified, respectively). CONCLUSIONS: To reduce operative mortality after HPD, further centralization of this procedure is desirable. Future studies should clarify specific ways to improve the failure-to-rescue rates in certified institutions.

Procedure- and Hospital-Level Variation of Deep Sternal Wound Infection From All-Japan Registry.

BACKGROUND: The outcome of cardiovascular surgery has been improving over time, but the treatment of postoperative complications such as deep sternal wound infection (DSWI) still needs critical attention. A nationwide surgical registry was analyzed for procedural details and hospital factors related to DSWI. METHODS: The study used the Japan Adult Cardiovascular Surgery Database, which captured data from 82% of all the hospitals performing cardiac surgery in Japan. A total of 109,717 surgical cases (34,980 coronary artery bypass grafting, 43,602 valve operations, 31,135 thoracic aortic operations) were included in the study. RESULTS: The overall incidence of DSWI was 1738 (1.6%). The 30-day mortality and operative mortality were 3311 (3.0%) and 5155 (4.7%), respectively. Across the 3 procedures, thoracic aortic operation showed the highest odds ratio (2.61; 95% confidence interval [CI], 2.32 to 2.94) for operative mortality but the lowest (0.91; 95% CI:,0.73 to 1.13) for DSWI incidence. Conversely, coronary artery bypass grafting showed the lowest odds ratio (1.36; 95% CI, 1.24 to 1.49) for operative mortality but the highest (1.52; 95% CI, 1.32 to 1.76) for DSWI. There was also hospital-level variation: Correlation was statistically significant between the observed-to-expected ratio of DSWI incidence and the observed-to-expected mortality ratio of cardiovascular procedures across the hospitals, but the coefficient was small (r = .24, P < .001). CONCLUSIONS: Hospitals that have a lower risk-adjusted mortality rate of cardiovascular procedures do not always have a lower risk-adjusted DSWI occurrence rate. In addition, the incidence of DSWI varies across hospitals. We need to consider DSWI independently of surgical mortality, whereas for treatment we should consider both the specific hospital environment and the multidisciplinary care.

Development and validation of risk models for mortality and morbidity in 12 major pediatric surgical procedures: A study from the National Clinical Database-Pediatric of Japan.

PURPOSE: To establish and validate risk models of mortality and morbidity associated with 12 major pediatric surgical procedures using the National Clinical Database-Pediatric (NCD-P) data. METHODS: We used the NCD-P data for the development and validation datasets. By using multivariate logistic regression to analyze the development dataset, we created a prediction model for 30-day mortality and morbidity in 12 major pediatric surgical procedures, including tracheoplasty, pneumonectomy, fundoplication, total/subtotal excision of malignant tumor, and surgeries for Hirschsprung disease, anorectal malformation, biliary atresia, choledocal cyst, midgut volvulus, funnel chest, gastrointestinal perforation, and intestinal obstruction. We selected variables that were almost identical to those used in the American College of Surgeons National Surgical Quality Improvement Program-Pediatric (NSQIP-P). The primary outcomes were 30-day mortality and composite morbidity. We assessed the obtained models using the C-indices of the development and validation datasets. RESULTS: Overall, 10 and 21 variables were identified for mortality and morbidity, respectively. C-indices of mortality were 0.940 and 0.924 in the development and validation datasets, respectively. C-indices of morbidity were 0.832 and 0.830 in the development and validation datasets, respectively. CONCLUSIONS: Based on the NCD-P data, we developed satisfactory risk models for mortality and morbidity prediction in major pediatric surgeries. LEVEL OF EVIDENCE: Level I (Prognosis Study).

5-Aminosalicylic acid intolerance is associated with a risk of adverse clinical outcomes and dysbiosis in patients with ulcerative colitis.

BACKGROUND/AIMS: 5-Aminosalicylic acid (ASA) causes intolerance reactions in some patients. This study was performed to examine the prognosis of patients with ulcerative colitis (UC) and 5-ASA intolerance, and to evaluate the potential interaction between 5-ASA intolerance and the intestinal microbiota. METHODS: We performed a retrospective cohort study of patients with UC who visited participating hospitals. The primary endpoint was to compare the incidence of hospitalization within 12 months between the 5-ASA intolerance group and the 5-ASA tolerance group. The secondary endpoint was to compare the risk of adverse clinical outcomes after the start of biologics between the 2 groups. We also assessed the correlation between 5-ASA intolerance and microbial change in an independently recruited cohort of patients with UC. RESULTS: Of 793 patients, 59 (7.4%) were assigned to the 5-ASA intolerance group and 734 (92.5%) were assigned to the 5-ASA tolerance group. The admission rate and incidence of corticosteroid use were significantly higher in the intolerance than tolerance group (P< 0.001). In 108 patients undergoing treatment with anti-tumor necrosis factor biologics, 5-ASA intolerance increased the incidence of additional induction therapy after starting biologics (P< 0.001). The 5-ASA intolerance group had a greater abundance of bacteria in the genera Faecalibacterium, Streptococcus, and Clostridium than the 5-ASA tolerance group (P< 0.05). CONCLUSIONS: In patients with UC, 5-ASA intolerance is associated with a risk of adverse clinical outcomes and dysbiosis. Bacterial therapeutic optimization of 5-ASA administration may be important for improving the prognosis of patients with UC.