Mortality analysis of arterial switch operation for transposition of the great arteries with and without ventricular septal defect.

OBJECTIVES: We aimed to evaluate the 90-day mortality and effect of rescue or urgent coronary revascularization in children undergoing arterial switch operation for transposition of the great arteries with and without ventricular septal defect. METHODS: The 90-day mortality, risk factors for mortality and outcome of rescue or urgent coronary revascularization were analysed using 8 years of data from the Japan Cardiovascular Surgical Database. We only included patients with full data for all analyses. RESULTS: A total of 1084 patients (median weight: 3.0 kg; interquartile range: 2.8-3.3) underwent arterial switch operation at a median age of 10 days (interquartile range: 7-14). The 90-day mortality (5.2%, n = 56) was ∼1.6-fold higher than 30-day mortality (3.2%, n = 35). The cause was cardiac origin in 84% of non-survivors. Fifty-nine of the 1034 patients (5.7%) required extracorporeal membrane oxygenation (ECMO), with successful weaning in 44% (n = 26). Univariable or multivariable analyses revealed the following risk factors for mortality: body weight at operation <2.5 kg, aortic cross-clamp time, cardiac events and ECMO (P < 0.005-0.001). Ventricular septal defect was not a risk factor.Thirteen patients (1.2%) had either rescue or urgent coronary revascularization with salvage rates of 25% (2/8) and 100% (5/5), respectively. Only 5 ECMO patients (8%) underwent coronary revascularization with 1 survivor. CONCLUSIONS: The 90-day mortality represented perioperative outcomes better than 30-day mortality. Patients on ECMO, which extended the survival time, had 56% 90-day mortality. Coronary revascularization showed a salvaging effect, although the case number was small.

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.

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.

[Long Term Patency of Saphenous Vein Graft Using the Automated Proximal Anastomosis System Compared with the Hand-sewn Anastomosis System].

Backgrounds：The purpose of this study was to compare the long term patency of PAS-Port system with other hand-sewn anastomosis system. METHODS: From 2009 to 2018, a total of 79 anastomoses were done in coronary bypass surgery with PAS-Port system, and a total of 252 anastomoses with Enclose Ⅱ. Among them, 76 anastomoses with PAS-Port system (group P) and 246 anastomoses of enclose Ⅱ (group E) were evaluated using angiography or multislice computer tomography. We compared age, gender, emergency rate, hospital death and cerebral infarction between the 2 groups and evaluated the patency of the grafts from post-operative day 5 to year 10 to obtain their long term graft patency. RESULTS: Group P was significantly older, more male, and higher emergency rate. One patient in group P died of septic multiorgan failure and 1 died in group E of intestinal tract necrosis. Early patency rates of the graft were 97.4% in Group P and 93.9% in Group E. Long term patency rates were also comparable, but PAS-Port system showed tendency toward a higher rate of patency( log rank p=0.057). CONCLUSIONS: The long term patency rate of PAS-Port automated proximal anastomosis is comparable with that of hand-sewn anastomosis.

[Reconstruction Using a Saphenous Vein for Anomalous Origin of the Left Coronary Artery from the Pulmonary Artery in an Adult;Report of a Case].

Anomalous left coronary artery from the pulmonary artery (ALCAPA) is an uncommon congenital heart disease. Such anomaly causes myocardial ischemia, heart failure, and sudden death. Most of such cases require surgical intervention. We report a successful surgical correction for ALCAPA in an adult. A 31-year-old woman with progressive exertional dyspnea was referred to our institution because of abnormal electrocardiogram showing ST depression( V3-V6). Computed tomography revealed the left main trunk (LMT) arising at the right lateral wall of the main pulmonary trunk. Interposition of a saphenous vein graft was performed between the ascending aorta and the LMT. The postoperative course was uneventful.

[The Third Operation for Prosthetic Valve Detachment Caused by Aortitis Syndrome without Aortic Ectasia;Report of a Case].

We report a surgical case of a 58-year-old woman with aortitis syndrome is presented. The patient had undergone aortic valve replacement (AVR) with a mechanical prosthesis. Five months later, re-AVR was performed because of prosthetic valve detachment and severe regurgitation. Five years after the re-operation, valve detachment with severe perivalvular leakage was noted again. The 3rd AVR was performed with a biological prosthesis. This time, the prosthetic valve was fixed by 2-0 Ticron sutures buttressed with a felt strip from outside of the aorta at the site of detachment. Administration of prednisolone has been continued for 16 years since the 1st operation. No valve detachment has been noted for 8 years since the 3rd operation.

Current status of cardiovascular surgery in Japan, 2015 and 2016: a report based on the Japan Cardiovascular Surgery Database. 1-congenital heart surgery.

OBJECTIVES: We analyzed the mortality and morbidity of congenital heart surgery in Japan by using Japan Cardiovascular Surgery Database (JCVSD). METHODS: The data on congenital heart surgery performed between January 2015 and December 2016 were obtained from JCVSD. From the data obtained, the most frequent 20 procedures were selected, and the mortalities and major morbidities were analyzed. In addition, the institutions were classified into three groups according to the number of cardiopulmonary cases for a year, and the distribution of the major operations was calculated. RESULTS: The mortality of ASD repair and VSD repair was under 1% and the mortality of TOF repair, complete AVSD repair, Rastelli operation, CoA complex repair, bidirectional Glenn and TCPC was 2-3%. The mortality of Norwood procedure and TAPVC repair were over 10%. These difficult operations were mainly performed at relatively high-volume institutions. CONCLUSION: Using the data from JCVSD, the national data of congenital heart surgery, including postoperative complications, were analyzed. Neonatal surgery still has considerable complication rates and further improvement is desired. In addition, it was shown that complicated operations tended to be performed at large volume institutions.

The effect of body weight in infants undergoing ventricular septal defect closure: A report from the Nationwide Japanese Congenital Surgical Database.

OBJECTIVE: In infants with ventricular septal defect (VSD) who undergo surgical intervention, body weight, along with age, is frequently thought to be the decisive predictor of morbidity and mortality after surgery; however, its information on quantitative risk assessment is limited. METHODS: All infants (<1 year old) with a fundamental diagnosis of VSD who underwent surgical VSD closure or pulmonary artery banding between 2012 and 2016 were identified from the Japan Cardiovascular Surgery Database Congenital Section. The outcome of interest was a composite end point of all-cause death and major complications within 30 days after surgery. We evaluated the association between body weight at surgery and composite end point using logistic regression models. RESULTS: A total of 4947 cases were analyzed (median age, 125; interquartile range [IQR], 79-193 days; median body weight, 4.94 [IQR, 4.00-6.00] kg), including 4310 cases (87.1%) treated with surgical VSD closure and 637 (12.9%) treated with pulmonary artery banding. The surgical course was uncomplicated in 94.2% of cases, 23 (0.5%) died, and 283 (5.7%) experienced major complications. The risk of the composite end point was higher along with lower body weight (adjusted odds ratio, 1.56 for every -1 kg; 95% confidence interval, 1.30-1.88; P < .001) and plateaued at body weight of approximately >4.5 kg via smoothing spline curve. Importantly, cases with approximately <4.5 kg of body weight had higher predicted risk regardless of age. CONCLUSIONS: Surgical intervention for infants with VSD was safely performed in contemporary practice; however, caution is warranted in lower body weight infants, particularly for infants with approximately <4.5 kg.

Mid-term result of atrioventricular valve replacement in patients with a single ventricle.

OBJECTIVES: Atrioventricular valve replacement is the last option to treat the atrioventricular valve regurgitation in single ventricle. This study investigates the mid-term outcomes of the atrioventricular valve replacement based on the Japan Cardiovascular Surgery Database registry. METHODS: From 2008 to 2014, 56 patients [34 males (61%) and 22 females (39%)] with a single ventricular circulation, underwent atrioventricular valve replacement. Questionnaires were collected to review operative data, mid-term mortality, morbidity and redo replacement. Risk factor analysis was performed by the Cox regression model for death and redo replacement. RESULTS: Heterotaxy, a right systemic ventricle and a common atrioventricular valve was present in 46% (26/56), 64% and 57% of patients, respectively. The most common timings for atrioventricular valve replacement were the interstage between the second and third palliations (34%) and after the Fontan operation (34%). Twenty died during the 3.7 ± 2.6-year follow-up. Eleven received redo atrioventricular replacement. The cumulative incidences of redo atrioventricular valve replacement and survival at 3 years were 20% [95% confidence interval (CI) 9-30] and 66% (95% CI 55-80), respectively. Univariable Cox regression analysis revealed that a tricuspid valve was a risk factor for redo valve replacement [hazard ratio (HR) 6.76, 95% CI 1.79-25.6; P = 0.005] and that young age was a risk factor for death (HR 0.77, 95% CI 0.62-0.96; P = 0.019). Fourteen patients required a pacemaker implantation. CONCLUSIONS: Valve replacement for uncontrollable atrioventricular valve regurgitation in single ventricular circulation was associated with a moderately high risk of death, redo replacement and pacemaker implantation, whereas valve replacement at a later period and with a larger prosthetic valve size was associated with low mortality.

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.

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.

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.

Current status of cardiovascular surgery in Japan 2013 and 2014: A report based on the Japan Cardiovascular Surgery Database. 2: Congenital heart surgery.

OBJECTIVES: We analyzed the mortality and morbidity of congenital heart surgery in Japan using the Japan Cardiovascular Surgery Database (JCVSD). METHODS: Data regarding congenital heart surgery performed between January 2013 and December 2014 were obtained from JCVSD. The 20 most frequent procedures were selected and the mortality rates and major morbidities were analyzed. RESULTS: The mortality rates of atrial septal defect repair and ventricular septal defect repair were less than 1%, and the mortality rates of tetralogy of Fallot repair, complete atrioventricular septal defect repair, bidirectional Glenn, and total cavopulmonary connection were less than 2%. The mortality rates of the Norwood procedure and total anomalous pulmonary venous connection repair were more than 10%. The rates of unplanned reoperation, pacemaker implantation, chylothorax, deep sternal infection, phrenic nerve injury, and neurological deficit were shown for each procedure. CONCLUSION: Using JCVSD, the national data for congenital heart surgery, including postoperative complications, were analyzed. Further improvements of the database and feedback for clinical practice are required.

The current trends of mortality following congenital heart surgery: the Japan Congenital Cardiovascular Surgery Database.

OBJECTIVES: Whereas surgical outcomes of congenital heart surgery have improved during the past two decades, there are still measurable postoperative mortalities in this field. This study is aimed at evaluating the current situation of mortality following congenital heart surgery. METHODS: Data on all registered 28 810 patients in The Japan Congenital Cardiovascular Surgery Database (JCCVSD) between 2008 and 2012 were analysed, except for patients with degenerative cardiomyopathy including dilated, restrictive and hypertrophic cardiomyopathy, and pathologically or histologically malignant cardiac tumours. The number of registered cases increased every year, and reached ∼9000 cases in 2012. The median age at surgery was 0.8 years (range, 0-82). More than half of the patients (54%) who underwent surgery were <1 year old, and 6.0% of all patients were over 18 years old (adults). In this study, all mortalities within 90 days after the operation and mortality at discharge beyond 90 days of hospitalization were defined as '90-day and in-hospital mortality'. RESULTS: The 30-, 90-day and in-hospital mortality rates were 2.3, 3.5 and 4.5%, respectively. The mean and median durations from surgery to death were 61 ± 89 and 28 days (range, 0-717), respectively. Whereas 658 mortalities (51%) occurred within 30 days of surgery, 265 (21%) occurred later than 90 days after surgery. A total of 3630 patients (13%) were hospitalized for more than 90 days after the operation; of those, 3365 patients survived at discharge (93%). Cardiac problems were the most frequent causes of death after the surgery at any point in time, and 7.1 per 1000 patients died at over 30 days after the operation due to solely cardiac. CONCLUSIONS: The investigation of JCCVSD revealed that about a half of mortalities occurred later than 30 days; hence 90-day and in-hospital mortality would be a good discriminator that accurately represented the current situation of mortality after congenital heart surgery. Mortalities long after the operation due to post-cardiotomy heart failure without any other lethal complications were still not rare.

Indocyanine green lymphography and lymphaticovenous anastomosis for generalized lymphatic dysplasia with pleural effusion and ascites in neonates.

BACKGROUND: The fatality rate of generalized lymphatic dysplasia (GLD) with chylous pleural effusion and ascites is particularly high when it persists over a prolonged period. The purpose of this report was to determine the utility of indocyanine green (ICG) lymphography and lymphaticovenous anastomosis (LVA) in GLD with chylous pleural effusion and ascites in neonates. METHODS: We tested the lymphatic function in the 4 extremities for 8 GLD neonate patients using ICG lymphography, and on the basis of the results, we performed LVA for 5 of them. LVA was performed at the extremities under general anesthesia using incisions <1 cm in length. The outcome of LVA was evaluated with the amount of ascites discharged from thoracostomy tube or abdominal tube, except for 1 patient who had no drainage tube. RESULTS: In all cases, ICG lymphography showed varying degrees of dermal backflow in the limbs with lymphostasis. After LVA surgery, effusion stopped in 2 cases and decreased in 1 case. In the cases where effusion stopped, backflow as observed with ICG lymphography was minimal, and in the case where effusion decreased but did not stop, backflow was moderate. CONCLUSIONS: The application of ICG and LVA could possibly be used to diagnose and treat lymphatic pleural effusion or ascites.

Predictors of 90-day mortality after congenital heart surgery: the first report of risk models from a Japanese database.

OBJECTIVE: The purpose of this study was to develop risk models for congenital heart surgery short-term and midterm outcomes from a nationwide integrated database drawn from hospitals in Japan. METHODS: The Japan Congenital Cardiovascular Surgery Database collects clinical information from institutions throughout Japan specializing in congenital heart surgery. Variables and definitions used in the Japan Congenital Cardiovascular Surgery Database are almost identical to those of the Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery database for congenital heart surgery. We used logistic regression to develop risk models, which were then validated through spilt-sample validation. In addition to procedural complexity categories by Risk Adjustment in Congenital Heart Surgery (RACHS-1) score, we incorporated patient characteristics to predict surgical outcome. RESULTS: Among 8923 congenital heart operations performed at 69 sites with cardiac surgical programs, 30-day mortalities by RACHS-1 category were as follows: I, 0.1% (n=1319); II, 0.5% (n=3211); III, 2.2% (n=3285); IV, 4.3% (n=818); and V and VI, 8.6% (n=290). From the test data set (n=7223), we developed 3 risk models (30-day mortality, 90-day mortality, and 90-day and in-hospital mortality) with 11 variables, including age category, RACHS-1 category, preoperative risk factors, number of surgical procedures, unplanned reoperations, status of surgery, surgery type, asplenia, and prematurity (<35 weeks). For the performance metrics of the risk models, C statistic values of 30-day, 90-day, and 90-day and in-hospital mortalities for the test data set were 0.85, 0.85, and 0.84, respectively. When only the RACHS-1 score was used for discrimination, the C statistic values of 30-day, 90-day, and 90-day and in-hospital mortalities for the validation data set were 0.73, 0.73, and 0.77, respectively. CONCLUSIONS: The proposed risk scores and categories have high discrimination power for predicting mortality, demonstrating improvement relative to existing consensus-based methods. Risk models incorporating these measures may be useful for comparing mortality outcomes cross institutions or countries with mixed cases.

The national clinical database as an initiative for quality improvement in Japan.

The JCVSD (Japan Cardiovascular Surgery Database) was organized in 2000 to improve the quality of cardiovascular surgery in Japan. Web-based data harvesting on adult cardiac surgery was started (Japan Adult Cardiovascular Surgery Database, JACVSD) in 2001, and on congenital heart surgery (Japan Congenital Cardiovascular Surgery Database, JCCVSD) in 2008. Both databases grew to become national databases by the end of 2013. This was influenced by the success of the Society for Thoracic Surgeons' National Database, which contains comparable input items. In 2011, the Japanese Board of Cardiovascular Surgery announced that the JACVSD and JCCVSD data are to be used for board certification, which improved the quality of the first paperless and web-based board certification review undertaken in 2013. These changes led to a further step. In 2011, the National Clinical Database (NCD) was organized to investigate the feasibility of clinical databases in other medical fields, especially surgery. In the NCD, the board certification system of the Japan Surgical Society, the basic association of surgery was set as the first level in the hierarchy of specialties, and nine associations and six board certification systems were set at the second level as subspecialties. The NCD grew rapidly, and now covers 95% of total surgical procedures. The participating associations will release or have released risk models, and studies that use 'big data' from these databases have been published. The national databases have contributed to evidence-based medicine, to the accountability of medical professionals, and to quality assessment and quality improvement of surgery in Japan.

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.

Results of data verification of the Japan congenital cardiovascular database, 2008 to 2009.

BACKGROUND: Since 2008, data concerning pediatric cardiovascular surgeries performed in Japan have been collected in the Japan Congenital Cardiovascular Surgery Database (JCCVSD). We assessed the quality of the JCCVSD data through data verification activities conducted in 2010. METHODS: During 2008 to 2009, 3345 patients with 4327 procedures at 25 hospitals were registered in the JCCVSD. Among them, six sites were selected for data verification. The completeness of case registration was assessed by comparison with original operational logs. Also, data accuracy of patient demographics, surgical outcomes, and processes were assessed with 10% of the registered cases by comparison with medical records. RESULTS: Verification of case registration completeness involved 968 (28.9%) patients and 1279 (29.1%) procedures. As to completeness, we confirmed 1266 (99.0%) of the 1279 procedures. Data accuracy was verified for 129 (3.9%) patients. Accuracy of status of discharge and 30 and 90 days after surgery were very high (99.2%, 100%, and 100%, respectively). Data items with numeric information exhibited lower exact accuracy due to typing error and inconsistent use of rounding; however, the differences between the submitted and the original data were not statistically significant. CONCLUSIONS: High completeness and acceptable range of data accuracy were verified for the data submitted to the JCCVSD in 2008 to 2009. The high accuracy regarding follow-up outcomes was especially noteworthy. The initial success of the JCCVSD should be strengthened through further sophistication of registration protocol, continual training of data managers and auditors, and rigorous expansion of verification activities.

[Utilization of clinical database for quality improvement in health care].

Measurement and feedback of clinical performance is one of the important activities in clinical database. In addition, clinical database is used for developing medical guidelines, research for public policy and clinical research, and also various kinds of information can be provided to the public. On the other hand, risk adjustment for data analysis is a key issue in the clinical database. From these viewpoints, this article described the activities for quality improvement, examples of research, and planning of clinical research using the clinical database.