Postoperative cerebral infarction and arrhythmia after pulmonary lobectomy in Japan: a retrospective analysis of 77,060 cases in a national clinical database.

PURPOSE: To investigate the incidence of postoperative cerebral infarction after curative lobectomy, its association with the type of lobectomy, and how postoperative new-onset arrhythmia contributes to postoperative cerebral infarction. METHODS: The subjects of this analysis were 77,060 patients who underwent curative lobectomy for lung cancer between 2016 and 2018 according to the National Clinical Database. Incidences of postoperative cerebral infarction and postoperative new-onset arrhythmia were analyzed. Moreover, mediation analysis was performed to evaluate the causal pathway between postoperative new-onset arrhythmia and postoperative cerebral infarction. RESULTS: Postoperative cerebral infarction occurred in 110 (0.7%) patients after left upper lobectomy and in 85 (0.7%) patients after left lower lobectomy. Left upper lobectomy and left lower lobectomy were associated with a higher likelihood of postoperative cerebral infarction than right lower lobectomy. Left upper lobectomy was the strongest independent predictor of postoperative new-onset arrhythmia. However, in the mediation analysis, the odds ratio for cerebral infarction did not change after the addition of the factor of postoperative new-onset arrhythmia. CONCLUSION: Cerebral infarction occurred significantly more often not only after left upper lobectomy, but also after left lower lobectomy. Postoperative new-onset arrhythmia was less likely to be related to cerebral infarction after left upper lobectomy.

Preoperative Cumulative Smoking Dose on Lung Cancer Surgery in a Japanese Nationwide Database.

BACKGROUND: Smoking is a known risk factor for postoperative mortality and morbidity. However, the significance of cumulative smoking dose in preoperative risk assessment has not been established. We examined the influence of preoperative cumulative smoking dose on surgical outcomes after lobectomy for primary lung cancer. METHODS: A total of 80,989 patients with primary lung cancer undergoing lobectomy from 2014 to 2016 were enrolled. Preoperative cumulative smoking dose was categorized by pack-years (PY): nonsmokers, PY = 0; light smokers, 0 < PY < 10; moderate smokers, 10 ≤ PY < 30; and heavy smokers, 30 ≤ PY. The risk of short-term outcomes was assessed according to PY by multivariable analysis adjusted for other covariates. RESULTS: Postoperative 30-day mortality, as well as pulmonary, cardiovascular, and infectious complications, increased with preoperative PY. Multivariable analysis revealed that the odds ratios (ORs) for postoperative mortality compared with nonsmokers were 1.76 for light smokers (P = .044), 1.60 for moderate smokers (P = .026), and 1.73 for heavy smokers (P = .003). The ORs for pulmonary complications compared with nonsmokers were 1.20 for light smokers (P = .022), 1.40 for moderate smokers (P < .001), and 1.72 for heavy smokers (P < .001). Heavy smokers had a significantly increased risk of postoperative cardiovascular (OR, 1.26; P = .002) and infectious (OR, 1.39; P = .007) complications compared with nonsmokers. CONCLUSIONS: The risk of mortality and morbidity after lung resection could be predicted according to preoperative cumulative smoking dose. These findings contribute to the development of strategies in perioperative management of lung resection patients.

A risk model for prolonged air leak after lobectomy using the National Clinical Database in Japan.

PURPOSE: The objective of our study was to develop a clinical prediction model for prolonged air leak (PAL) after lobectomy for lung cancer using preoperative variables in a large patient dataset from the National Clinical Database (NCD) in Japan. METHODS: The preoperative characteristics of 57,532 and 30,967 patients who had undergone standard lobectomy for lung cancer were derived from the 2014 to 2015 and 2016 NCD datasets, respectively. PAL was defined as air leak persisting ≥ 7 days postoperatively or requiring postoperative interventional treatment, such as pleurodesis or reoperation. Risk models were developed from the 2014 to 2015 dataset and validated using the 2016 dataset. When performing model derivation, the least absolute shrinkage and selection operator (LASSO) method were applied for parameter selection. RESULTS: The rate of PAL was 4.5% in 2014-2015 and 5.3% in 2016. The age, sex, body mass index, comorbid interstitial pneumonia, smoking habits, forced expiratory volume in 1 s, tumor histology, multiple lung cancer, and tumor location were selected as important variables for PAL. Our risk model for predicting PAL was fair with a concordance index of 0.6895. CONCLUSION: The LASSO-based risk model for PAL after lobectomy provided important preoperative variables for PAL and risk weighting for each variable.

Certified thoracic surgeons in Japan: a national database survey on risk-adjusted mortality associated with lung resection.

PURPOSE: We investigated the association between the number of certified general thoracic surgeons (GTSs) and the mortality after lung cancer surgery, based on the data from the National Clinical Database (NCD). METHODS: We analyzed the characteristics and operative and postoperative data of 120,946 patients who underwent lung cancer surgery in one of the 905 hospitals in Japan. The number of GTSs in each hospital was categorized as 0, 1-2, or 3 or more. Multivariable analysis was applied to adjust the patients' preoperative risk factors, as identified in a previous study. We calculated 95% confidence intervals (CI) for the mortality rate based on the odds ratios (ORs). RESULTS: The patients' characteristics were distributed almost uniformly regardless of the number of GTSs. Crude mortality according to the number of GTSs of 0, 1-2, or 3 or more was 0.9%, 0.8%, and 0.7%, respectively (p = 0.03). However, after adjustment, the ORs for 1-2 and 3 or more GTSs (reference: 0) were 0.86 (p = 0.23, 95% CI: 0.67-1.10) and 0.84 (p = 0.18, 95% CI: 0.64-1.09), respectively. The number of GTSs did not have a significant association with mortality. Similar results were observed for patients in the lobectomy cohort. CONCLUSION: Low surgical mortality was consistent, regardless of the number of GTSs in each hospital.

Current status of surgery for clinical stage IA lung cancer in Japan: analysis of the national clinical database.

PURPOSE: As the number of cases of early lung cancer in Japan grows, an analysis of the present status of surgical treatments for clinical stage IA lung cancer using a nationwide database with web-based data entry is warranted. METHODS: The operative and perioperative data from 47,921 patients who underwent surgery for clinical stage IA lung cancer in 2014 and 2015 were obtained from the National Clinical Database (NCD) of Japan. Clinicopathological characteristics, surgical procedure, mortality, and morbidity were analyzed, and thoracotomy and video-assisted thoracic surgery (VATS) were compared. RESULTS: The patients comprised 27,208 men (56.8%) and 20,713 women (43.2%); mean age, 69.3 years. Lobectomy was performed in 64.8%, segmentectomy in 15.2%, and wedge resection in 19.8%. The surgical procedures were thoracotomy in 12,194 patients (25.4%) and a minimally invasive approach (MIA) in 35,727 patients (74.6%). MIA was divided into VATS + mini-thoracotomy (n = 13,422, 28.0%) and complete VATS (n = 22,305, 46.5%). The overall postoperative mortality rate was 0.4%, being significantly lower in the MIA group than in the thoracotomy group (0.3% vs 0.8%, P < 0.001). CONCLUSIONS: Our analysis of data from the NCD indicates that MIA has become the new standard treatment for clinical stage IA lung cancer.

Contributions of information and communications technology to future health systems and Universal Health Coverage: application of Japan's experiences.

BACKGROUND: Demographic changes in the pattern of disease burden, escalating health expenditures and inequitable access to healthcare are global challenges. Irrespective of their level of development, all countries need to reform their health systems to prepare for the future emerging health needs, in order to meet their commitments of health systems strengthening, universal health coverage (UHC) and explicit targets in the Sustainable Development Goals (SDGs). We propose three core principles for the future health system as described herein. A health system is not simply a 'cure delivery machine' but part of a 'social security system' that engages all stakeholders through a shared vision and value of health and well-being, not merely an absence of diseases. The future health system shall provide people-centred, affordable care, tailored to the individual's needs, accessible at any time and any place, and reflect the notion of leaving no one behind through a life course approach - underpinned by the SDGs. Information and communications technology (ICT) offers the potential to facilitate the realisation of these principles by improving the information flow between different parts of the health system through electronic means. We introduce Japan's new data platform - Person-centred Open PLatform for wellbeing (PeOPLe) - planned to be introduced in 2020 as one example of an ICT-based intervention to realise the three proposed principles. PeOPLe integrates data collected throughout the life course to enable all people to receive affordable, personalised health and social care at any time and any place throughout their lifetime. Furthermore, we discuss the applicability of these principles and PeOPLe to the health systems context of Thailand and the Philippines, including elaborations on ICT transformation challenges. CONCLUSION: Current rising momentum and scale for ICTs in the UHC era offers a great opportunity to make a difference for countries. The PeOPLe concept is not only relevant to resource-rich countries; its applicability to other Asian countries could be feasible though it will need to be adapted to the various country contexts. We hope that this paper contributes to wider discussion around policy choices of ICT application for future health systems strengthening and UHC in order to achieve the SDGs.

Quality improvement in cardiovascular surgery: results of a surgical quality improvement programme using a nationwide clinical database and database-driven site visits in Japan.

BACKGROUND: In 2015, an academic-led surgical quality improvement (QI) programme was initiated in Japan to use database information entered from 2013 to 2014 to identify institutions needing improvement, to which cardiovascular surgery experts were sent for site visits. Here, posthoc analyses were used to estimate the effectiveness of the QI programme in reducing surgical mortality (30-day and in-hospital mortality). METHODS: Patients were selected from the Japan Cardiovascular Surgery Database, which includes almost all cardiovascular surgeries in Japan, if they underwent isolated coronary artery bypass graft (CABG), valve or thoracic aortic surgery from 2013 to 2016. Difference-in-difference methods based on a generalised estimating equation logistic regression model were used for pre-post comparison after adjustment for patient-level expected surgical mortality. RESULTS: In total, 238 778 patients (10 172 deaths) from 590 hospitals, including 3556 patients seen at 10 hospitals with site visits, were included from January 2013 to December 2016. Preprogramme, the crude surgical mortality for site visit and non-site visit institutions was 9.0% and 2.7%, respectively, for CABG surgery, 10.7% and 4.0%, respectively, for valve surgery and 20.7% and 7.5%, respectively, for aortic surgery. Postprogramme, moderate improvement was observed at site visit hospitals (3.6%, 9.6% and 18.8%, respectively). A difference-in-difference estimator showed significant improvement in CABG (0.29 (95% CI 0.15 to 0.54), p<0.001) and valve surgery (0.74 (0.55 to 1.00); p=0.047). Improvement was observed within 1 year for CABG surgery but was delayed for valve and aortic surgery. During the programme, institutions did not refrain from surgery. CONCLUSIONS: Combining traditional site visits with modern database methodologies effectively improved surgical mortality in Japan. These universal methods could be applied via a similar approach to contribute to achieving QI in surgery for many other procedures worldwide.

Correction to: Risk assessments for broncho-pleural fistula and respiratory failure after lung cancer surgery by National Clinical Database Japan.

In the original publication of this article, Tables 1 and 2 were published incorrectly. The correct tables are given in this correction.

Surgical Repair of Post-Infarction Ventricular Septal Defect　- Findings From a Japanese National Database.

BACKGROUND: Ventricular septal defect (VSD) after myocardial infarction (MI) is a rare but fatal complication. We report patients' characteristics and operative outcomes after surgical repair of post-MI VSD using a national database of Japan.Methods and Results:This was a retrospective review of the Japan Adult Cardiovascular Surgery Database (JCVSD) to identify adults (age ≥18 years) who underwent surgical repair of post-MI VSD between 2008 and 2014. The primary outcome was operative death. We identified 1,397 patients (671 male [48%], 74.1±9.3 years old) undergoing surgical repair of post-MI VSD among 288,736 patients undergoing cardiac surgery enrolled in the JCVSD during the same period. Of these, 1,075 (77.0%) were supported preoperatively with an intra-aortic balloon pump. Surgical status was urgent in 391 (28.0%) and emergency/salvage in 731 (52.3%). Concomitant coronary artery bypass grafting was performed in 475 (34.0%). Overall 30-day and operative mortalities were 24.3% and 33.0%, respectively. Operative mortality varied according to surgical status: 15.6% in elective, 30.9% in urgent, and 40.6% in emergency/salvage cases. Multivariable analysis identified advanced age and emergency/salvage status as being strongly associated with increased odds of operative death. CONCLUSIONS: Post-MI VSD remains a devastating complication in Japan as well as in the USA and Europe.

Risk assessments for broncho-pleural fistula and respiratory failure after lung cancer surgery by National Clinical Database Japan.

BACKGROUND: Broncho-pleural fistula (BPF) and respiratory failure (RF) are life-threatening complications after lung cancer surgery and can result in long-term hospitalization and decreased quality of life. Risk assessments for BPF and RF in addition to mortality and major morbidities are indispensable in surgical decision-making and perioperative care. METHODS: The characteristics and operative data of 80,095 patients who had undergone lung cancer surgery were derived from the 2014 and 2015 National Clinical Database (NCD) of Japan datasets. After excluding 1501 patients, risk models were developed from these data and validated by another dataset for 42,352 patients derived from the 2016 NCD dataset. Receiver operating characteristic curves were generated for postoperative BPF and RF development. The concordance-index was used to assess the discriminatory ability and validity of the model. RESULTS: BPF and RF occurred in 259 (0.3%) and 420 patients (0.5%), respectively, in the model development dataset and in 129 (0.3%) and 198 patients (0.5%), respectively, in the model validation dataset. Characteristic variables including types of surgery and comorbidities were identified as risk factors for BPF and RF, respectively. The concordance indexes of assessments for BPF and RF were 0.847 (p < 0.001) and 0.848 (p < 0.001), respectively, for the development dataset and 0.850 (p < 0.001) and 0.844 (p < 0.001), respectively, for the validation dataset. CONCLUSIONS: These models are satisfactory for predicting BPF and RF after lung cancer surgery in Japan and could guide preoperative assessment and optimal measures for preventing BPF and RF.

Verification of Data Accuracy in Japan Congenital Cardiovascular Surgery Database Including Its Postprocedural Complication Reports.

BACKGROUND: Japan Congenital Cardiovascluar Surgical Database (JCCVSD) is a nationwide registry whose data are used for health quality assessment and clinical research in Japan. We evaluated the completeness of case registration and the accuracy of recorded data components including postprocedural mortality and complications in the database via on-site data adjudication. METHODS: We validated the records from JCCVSD 2010 to 2012 containing congenital cardiovascular surgery data performed in 111 facilities throughout Japan. We randomly chose nine facilities for site visit by the auditor team and conducted on-site data adjudication. We assessed whether the records in JCCVSD matched the data in the source materials. RESULTS: We identified 1,928 cases of eligible surgeries performed at the facilities, of which 1,910 were registered (99.1% completeness), with 6 cases of duplication and 1 inappropriate case registration. Data components including gender, age, and surgery time (hours) were highly accurate with 98% to 100% concordance. Mortality at discharge and at 30 and 90 postoperative days was 100% accurate. Among the five complications studied, reoperation was the most frequently observed, with 16 and 21 cases recorded in the database and source materials, respectively, having a sensitivity of 0.67 and a specificity of 0.99. CONCLUSIONS: Validation of JCCVSD database showed high registration completeness and high accuracy especially in the categorical data components. Adjudicated mortality was 100% accurate. While limited in numbers, the recorded cases of postoperative complications all had high specificities but had lower sensitivity (0.67-1.00). Continued activities for data quality improvement and assessment are necessary for optimizing the utility of these registries.

Model of lung cancer surgery risk derived from a Japanese nationwide web-based database of 78 594 patients during 2014-2015.

OBJECTIVES: Using data obtained from a Japanese nationwide annual database with web-based data entry, we developed a risk model of mortality and morbidity after lung cancer surgery. METHODS: The characteristics and operative and postoperative data from 80 095 patients who underwent lung cancer surgery were entered into the annual National Clinical Database of Japan data sets for 2014 and 2015. After excluding 1501 patients, the development data set for risk models included 38 277 patients entering in 2014 and the validation data set included 40 317 patients entering in 2015. Receiver-operating characteristic curves were generated for the outcomes of mortality and composite mortality/major morbidity. The concordance index was used to assess the discriminatory ability and validity of the model. RESULTS: The 30-day mortality and overall mortality rates, including in-hospital deaths, were 0.4% and 0.8%, respectively, in 2014, and 0.4% and 0.8%, respectively, in 2015. The rate of major morbidity was 5.6% in 2014 and 5.6% in 2015. Several risk factors were significantly associated with mortality, namely, male sex, performance status, comorbidities of interstitial pneumonia and liver cirrhosis, haemodialysis and the surgical procedure pneumonectomy. The concordance index for mortality and composite mortality/major morbidity was 0.854 (P < 0.001) and 0.718 (P < 0.001), respectively, for the development data set and 0.849 (P < 0.001) and 0.723 (P < 0.001), respectively, for the validation data set. CONCLUSIONS: This model was satisfactory for predicting surgical outcomes after pulmonary resection for lung cancer in Japan and will aid preoperative assessment and improve clinical outcomes for lung cancer surgery.