[Asymptomatic Left Atrial Appendage Aneurysm:Report of a Case].

We successfully performed resection of a large asymptomatic left atrial appendage aneurysm( LAAA) under non-cardiac arrest. Although the patient was asymptomatic, chest X-ray showed projection of the third left aortic arch, and computed tomography angiography showed a huge left atrial appendage aneurysm. Therefore, we decided to perform LAAA resection via a partial median sternotomy. Aneurysmectomy was performed by placing the patient on pump beating heart. The size of the resected aneurysm was approximately 80 mm in diameter. Because the base of the LAAA was constricted and the tissue was not fragile, resection was performed using an automatic excision anastomosis device( Echelon Flex). The patient's postoperative course was uneventful. Left atrial appendage aneurysm is believed to be congenital;however, it is often detected in adulthood. Long-term follow-up is necessary to ensure maintenance of optimal cardiac function.

Influence of social isolation and loneliness on the prognosis of advanced lung cancer patients: a prospective cohort study.

PURPOSE: The purpose of this study was to investigate the impact of social isolation and loneliness on the overall survival and death at home in patients with lung cancer. METHODS: This prospective cohort study was conducted in a Japanese tertiary hospital. The enrollment period was from April 2018 to March 2020. Patients with pathologically diagnosed advanced lung cancer were included in this study. The primary outcome was overall survival, whereas the secondary outcome was death at home. The exposures were social isolation and loneliness. RESULTS: A total of 211 patients were enrolled and divided into two groups and further into quartiles according to their social isolation and loneliness level, respectively. The hazard ratios of social isolation were 1.65 (95% confidence interval; 1.12 to 2.44) and 1.87 (95% confidence interval; 1.15 to 3.03) in the univariate analysis, while 1.40 (95% confidence interval; 0.92 to 2.13) in the multivariate analysis with complete case and multiple imputation. The odds ratio of death at home with social isolation was 3.47 (95% confidence interval; 1.08 to 11.1) in the multivariate analysis with multiple imputation. Loneliness was not associated with overall survival or death at home. CONCLUSIONS: Our study suggests that social isolation may be related to overall survival and death at home among patients with advanced lung cancer. More attention should be given to such patients at the time of diagnosis.

Influence of loneliness and social isolation on the diagnosis and treatment of Japanese patients with advanced lung cancer: a prospective cohort study.

BACKGROUND: Social determinants of health (SDHs) are social factors that affect human health; loneliness and social isolation are core SDH factors. There is a possibility that SDHs are related to passive decision-making. However, few studies have evaluated SDHs, especially social isolation and loneliness, among lung cancer patients. This study aims to investigate the effects of social isolation and loneliness on the diagnosis and treatment of Japanese lung cancer patients. METHODS: This is a prospective cohort study that was conducted in a tertiary referral hospital in Japan (University Hospital Medical Information Network registration: UMIN000031810). The enrollment period was between April 2018 and March 2020. Patients with clinical and/or pathological diagnosis of lung cancer were enrolled in this study. Exposures were social isolation and loneliness, and main outcomes were diagnosis methods and whether the initial treatment involved active therapy or best supportive care (BSC). The confounding factors were defined as sex, age, smoking status, respiratory symptoms, weight loss, presentation with any symptoms, Eastern Cooperative Oncology Group (ECOG) performance status, tumor nodes metastasis (TNM) classification, driver gene mutations [i.e., epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK)], and programmed death-ligand 1 (PD-L1) tumor proportion score. RESULTS: The study enrolled 264 patients who were divided into quartiles according to their loneliness scores and into two groups according to the social isolation level. Univariate analysis, complete case analysis, and multivariate analysis with multiple imputation failed to detect significant differences in diagnostic method or initial treatment strategy according to loneliness or social isolation level. CONCLUSIONS: Physicians may not need to consider a patient's loneliness and/or social isolation when diagnosing lung cancer and selecting treatment under universal health insurance coverage. Further studies are needed to understand the influences of loneliness and social isolation on the prognosis of lung cancer patients.

Alternative pulmonary artery reconstruction technique in the arterial switch operation.

OBJECTIVES: Late complications of arterial switch operations (ASO) for transposition of the great arteries, such as neo-pulmonary artery (PA) stenosis and/or neoaortic regurgitation, have been reported. We developed an alternative reconstruction method called the longitudinal extension (LE) method to prevent PA bifurcation stenosis (PABS). METHODS: We identified 48 patients diagnosed with transposition of the great arteries and performed ASO using the Lecompte manoeuvre for neo-PA reconstruction. In 9 consecutive patients (from 2014), the LE method was performed (LE). Before 2014, conventional techniques were performed in 39 patients (C). The median body weight and age in the LE and C groups were 3.0 and 3.1 kg and 12 and 26 days, respectively. In the LE group, 1 patient underwent bilateral PA banding before ASO. In C, PA banding and arch repair were performed in 1 patient each. Patients who received concomitant procedures were included. RESULTS: The median follow-up in LE and C groups was 1.9 and 10.1 years, respectively. Early mortality/late death was not found in group LE and in 1 patient in group C. Only 1 case required ascending aorta sliding plasty in LE, and 8 patients needed PA augmentation for PABS in C. The median velocity of right/left PA was measured as 1.6/1.9 m/s in LE and 2.1/2.3 m/s in C, so it showed a lower value in LE. CONCLUSIONS: Excellent mid-term results were obtained with the LE method. It was considered a useful procedure in preventing PABS, which is a primary late complication of ASO. Further follow-up and investigations are needed.

Renal replacement therapy with a cytokine-adsorbing hemofilter after neonatal open-heart surgery.

Two neonates with right atrial isomerism, single right ventricle, common atrioventricular valve regurgitation, and obstructive extra-cardiac total anomalous pulmonary venous connection underwent emergent total anomalous pulmonary venous connection repair combined with adjustment of pulmonary blood flow soon after birth. After the operation, both patients developed serious capillary leak syndrome, acute kidney injury, and lethal lactic acidosis with hemodynamic instability. Continuous renal replacement therapy was initiated with a cytokine-adsorbing hemofilter of polymethyl methacrylate membrane and a double lumen dialysis catheter inserted directly into the atrium. Elevated serum lactate levels were successfully decreased, and blood pressure was immediately increased.

Long-term Outcomes of Extracardiac Total Cavopulmonary Connection for Apicocaval Juxtaposition.

BACKGROUND: The long-term outcomes of a total cavopulmonary connection (TCPC) with an extracardiac conduit (ECC) for patients with apicocaval juxtaposition (ACJ) remain unclear. METHODS: A total of 38 patients with ACJ who underwent TCPC with ECC between 1998 and 2014 were enrolled in this study. For 19 patients with a superior vena cava - inferior vena cava contralateral position, a long-curved route rounding the opposite side of the apex was selected (CC group). For 11 patients with a superior vena cava-inferior vena cava ipsilateral position, a long-curved route was principally selected (IC group); however, a short, straight route was selected for 8 patients because there was sufficient space behind the ventricular apex (IS group). RESULTS: Follow-up was completed in all patients, with a mean follow-up duration of 13.2 ± 4.9 years. The angles of the caudal conduit anastomosis site measured from the frontal view of cineangiography had significantly straightened in the CC group from 1 year to 15 years (P < .05) and in the IC group from 1 year to 10 years (P < .05). There were 2 late mortalities and 6 reoperations during follow-up. Overall survival and freedom from reoperation rates at 15 years were 95% and 82%, respectively. There were no conduit-related or route-related complications such as death, reoperations, pulmonary venous obstructions, conduit obstructions, or pulmonary arteriovenous malformations in any of the groups. CONCLUSIONS: Even though chronologic geometric changes of curved ECCs were observed, TCPC with ECC for patients with ACJ can be safely applied without conduit- or route-related complications in long-term follow-up.

Factors Influencing Social Isolation and Loneliness Among Lung Cancer Patients: A Cross-sectional Study.

BACKGROUND/AIM: Previous reviews of Social determinants of health in lung cancer patients have not examined essential factors such as social isolation and loneliness. This study aimed to explore the factors affecting social isolation and loneliness among lung cancer patients. PATIENTS AND METHODS: A cross-sectional study was conducted. Social isolation, loneliness, and the presence of dementia were measured using Japanese adaptations of the Lubben Social Network Scale, UCLA Loneliness Scale, and Life Function Evaluation for Care Provision, respectively. RESULTS: From March 2019 to March 2020, 264 patients were included. Social isolation was significantly higher for patients receiving welfare (adjusted OR=5.28, 95% CI=2.24-12.4). Loneliness was significantly higher for patients receiving welfare (beta coefficient=0.52, 95% Cl=0.13-0.90) with symptoms of dementia (beta coefficient=0.28, 95% Cl=0.03-0.54). CONCLUSION: Results showed that receiving welfare was associated with experiencing social isolation. Receiving welfare and symptoms of dementia were associated with experiencing loneliness.

Interstage management of pulmonary blood flow after the Norwood procedure with right ventricle-to-pulmonary artery conduit.

OBJECTIVES: Our goal was to assess the efficacy of managing pulmonary blood flow from the Norwood procedure with a right ventricle-to-pulmonary artery (RV-PA) conduit until stage 2 palliation (S2P). METHODS: Among 48 consecutive patients undergoing the Norwood procedure between 2008 and 2018, 40 (83.3%) patients who survived to discharge were included in this study. The primary diagnosis was hypoplastic left heart syndrome in 28 (70%) patients and hypoplastic left heart syndrome variant in 12 (30%) patients. All patients received bilateral pulmonary artery banding. The median age and weight at the time of the Norwood procedure were 41 (25th-75th percentiles: 27-89) days and 3.2 (2.7-3.9) kg, respectively. In keeping with institutional strategy, S2P was undertaken when body weight exceeded 5.0 kg, and normal gross motor development was confirmed. RESULTS: The RV-PA conduit was clipped in 28 (70%) patients during the perioperative period of the Norwood procedure, then partial unclipping was performed in 8 (20%) patients and full unclipping was performed in 20 (50%) patients. Before S2P, the median pulmonary-to-systemic blood flow ratio was 1.0 (0.7-1.3). The median age and weight at the time of S2P were 10.7 (9.0-12.9) months and 6.3 (5.5-7.1) kg, respectively. The survival rate 5 years after Norwood discharge was 85.3%. Pre-S2P pulmonary-to-systemic blood flow ratio was linearly correlated with greater interstage changes in systemic atrioventricular valve regurgitation (R2 = 0.223, P = 0.004). CONCLUSIONS: Interstage management of pulmonary blood flow by RV-PA conduit clipping and gradual unclipping provided good interstage outcomes. The median pulmonary-to-systemic blood flow ratio could be controlled to 1.0 at pre-S2P catheter examination.

Serial changes of tricuspid regurgitation after anatomic repair for congenitally corrected transposition.

OBJECTIVES: The aim of this study was to reveal the serial changes in tricuspid regurgitation (TR) after anatomic repair for congenitally corrected transposition of great arteries. METHODS: Between 1995 and 2018, 48 patients underwent anatomic repair (atrial/arterial switch in 14 patients, atrial switch and Rastelli in 34 patients). The mean age and weight of the patients during anatomic repair was 33 (interquartile range 21.8-62.1) months and 12 (10.3-16.3) kg. The preoperative TR was less than mild in 15 patients (31.3%), mild-to-moderate in 29 patients (60.4%) and more-than-moderate in 4 patients (8.3%). Ebsteinoid dysplasia of the tricuspid valve (TV) was observed in 7 patients (14.6%). During the study period, no patient underwent TV surgery or bidirectional Glenn anastomosis at the time of anatomic repair. RESULTS: There was 1 in-hospital death and 1 late death. The follow-up was completed by other surviving patients, with a median follow-up period of 12.1 years (5.9-18.1). The overall survival, reoperation-free survival and freedom from permanent pacemaker implantation rate at 15 years were 94.3%, 74.3% and 81.5%, respectively. The mean TR grade was 2.0 (1.0-2.6) preoperatively, 2.0 (1.0-2.0) at 1 year, 2.0 (2.0-2.0) at 5 years and 2.0 (2.0-2.0) at 10 years after anatomic repair. A Cox proportional hazards model showed that association of Ebsteinoid dysplasia of the TV, type of anatomic repair and previous pulmonary artery banding did not affect freedom from death or the more-than-moderate TR rate. There were 2 patients who underwent TV surgery after the anatomic repair for severe TR; TV repair was successfully done for 1 patient, the other required semi-closure of TV and one and one-half ventricle conversion. CONCLUSIONS: TR remained subclinical or improved in the majority of patients after anatomic repair without TV repair. However, there were a few patients whose TR progressed to severe or massive, then required TV surgery after anatomic repair. Although exposure was difficult, TR was sometimes repairable following atrial switch, otherwise, one and one-half ventricle repair conversion would be the choice of treatment.

Application of modified bicaval technique for pediatric heart transplant with oversized donor heart.

Whereas bicaval technique is an effective surgical method, standard bicaval technique for younger age and donor/recipient caval mismatch was reported to have a risk of superior vena caval obstruction. Between 2016 and 2019, three patients with dilated cardiomyopathy aged 10 years or younger underwent orthotropic heart transplantation with modified bicaval technique at our institute. Donor/recipient body weight and height ratios were 2.36, 0.77, and 2.61 and 1.37, 0.94, and 1.51, respectively. All patients were preoperatively supported by a left ventricular assist device: Excor Pediatric in two patients and Jarvik 2000 in one. Duration of LVAD support was 180, 238, and 220 days. One patient required revision of pulmonary anastomosis during the operation; accordingly, the chest was closed 3 days later. There was no mortality. Caval obstructions were not observed. Three months after the operation, tricuspid regurgitation was mild in two patients and trivial in one.

Impact of Phrenic Nerve Palsy on Late Fontan Circulation.

BACKGROUND: Although adverse effects of phrenic nerve palsy (PNP) on early Fontan circulation have been reported, detailed late impact remains unclear. METHODS: Of 218 patients undergoing extracardiac total cavopulmonary connection between 1995 and 2008, 160 who all underwent cardiac catheter examination, spirometry, and exercise capacity testing 10 years after the operation were enrolled. The cohort was divided into 2 groups: with (N = 21) or without PNP (control group, N = 139). The patients with PNP were further divided into the recovered PNP group (n = 10) and the persistent PNP group (n = 11). All but 2 patients who developed PNP (90.9%) underwent diaphragmatic plication. There was no difference in hemodynamic indices at pre-Fontan evaluation among the three groups. RESULTS: Ten years after the Fontan procedure, the averaged forced vital capacity was 81% ± 18% of predicted in the control group, 86% ± 17% in the recovered PNP group, and 56% ± 12% in the persistent PNP group (P < .001). Peak oxygen consumption was linearly correlated to the forced vital capacity (r = 0.222, P = .009). There was no significant difference in the peak oxygen consumption between groups. Significant veno-venous collaterals into the diaphragm from lower body to pulmonary vein(s) or atria more frequently developed in patients who underwent diaphragmatic plication compared with those who did not (P < .001). CONCLUSIONS: Persistent PNP resulted in reduced forced vital capacity; however, its influence on exercise intolerance could not be identified. Diaphragmatic plication should be reserved for patients who experience clinically significant respiratory or hemodynamic sequelae of PNP.

Long-term therapeutic effect of Fontan conversion with an extracardiac conduit.

OBJECTIVES: The aim of this study was to identify the long-term therapeutic effect of total cavopulmonary connection (TCPC) conversion with an extracardiac conduit. METHODS: Between 1991 and 2014, 36 patients underwent TCPC conversion with an extracardiac conduit. Half of these patients were diagnosed with tricuspid atresia or its variant. The left ventricle was dominant in 26 patients (72.2%). Median age at conversion and interval from initial Fontan operation to conversion were 24.1 years (interquartile range 18.9-29.2) and 17.8 years (15.4-20.9), respectively. Surgical cryoablation was concomitantly performed in 32 patients (88.9%). Cardiac catheter examination was performed preoperatively (36 patients, 100%) and at 1 year (31 patients, 86%), 5 years (25 patients, 69%) and 10 years (13 patients, 36%) after TCPC conversion. Symptom-limited treadmill exercise with expired gas analysis was performed preoperatively (32 patients, 88.9%) and at 1 year (27 patients, 75.0%), 5 years (20 patients, 55.6%) and 10 years (12 patients, 33.3%) after conversion. RESULTS: All patients received follow-up; the mean follow-up period was 8.2 ± 4.8 years. Actuarial survival rate, protein-losing enteropathy-free survival rate and rate of survival with sinus rhythm maintenance at 10 years were 79.2%, 67.8% and 48.5%, respectively. The survival curve declined steeply when the duration of Fontan circulation exceeded 25 years. New cases of protein-losing enteropathy developed postoperatively in 2 patients. Permanent pacemakers were implanted in 12 patients (33%), but atrial tachyarrhythmia was not sustained in any of the remaining patients. Pulmonary arterial pressure (11.0 ± 3.1 to 9.5 ± 3.6 mmHg, P = 0.003), pulmonary vascular resistance (2.1 ± 0.7 to 1.3 ± 0.5 WU/m2, P < 0.0001) and cardiac index (2.0 ± 0.3 to 2.9 ± 0.6 l/min/m2, P < 0.0001) significantly improved from preoperative evaluation to 1 year after the conversion, and these improvements were maintained during the entire follow-up period. Peak oxygen uptake remained unchanged from the preoperative evaluation (49.7 ± 11.5% predicted) to 1 year (52.5 ± 12.0%), 5 years (56.2 ± 9.6%) and 10 years (51.2 ± 9.4%) after conversion (P = 0.19). CONCLUSIONS: Owing to its anti-arrhythmic effect and Fontan pathway recruitment effect, TCPC conversion with an extracardiac conduit prevented the natural decline of exercise tolerance that is seen in classic Fontan patients.

Systemic Atrioventricular Valve Replacement in Patients With Functional Single Ventricle.

To review the outcome after atrioventricular valve replacement in single ventricle patients. The medical records of 37 consecutive patients who underwent initial valve replacement between 2001 and 2016 were reviewed. Actuarial survival rates were 73%, 65%, and 59% at 1, 5, and 10 years, respectively. Multivariate analysis indicated body surface area <0.28 m2 (P = 0.007; hazard ratio, 31.1), preoperative inotropic support (P < 0.001; hazard ratio, 24.5), primary valve replacement (P = 0.044; hazard ratio, 6.1), oversized prosthesis (P = 0.001; hazard ratio, 14.5), and intra- or postoperative extracorporeal membrane oxygenation support (P < 0.001; hazard ratio, 53.2) were the risk factors for mortality. Cumulative incidences of redo replacement were 11%, 17%, and 17% at 1, 5, and 10 years, respectively. There was no risk factor for redo replacement. Among 11 patients undergoing valve replacement before or at the time of bidirectional cavopulmonary shunt, all 4 patients who reached Fontan completion survived. Among 13 patients undergoing valve replacement after bidirectional cavopulmonary shunt, only 3 patients reached Fontan completion. Among 11 patients undergoing valve replacement after Fontan completion, there were 3 operative mortalities and 2 late mortalities. For 7 of 8 hospital survivors, cardiac index improved from 2.2 L/min/m2 (interquartile range, 2.0-2.4) to 3.4 (2.8-3.7) (P = 0.002). Atrioventricular valve replacement was a reasonable choice of treatment for single ventricle patients. For small patients with impaired ventricular function who had no choice other than valve replacement, commercially available valves were oversized and outcomes remained poor.

Long-term results of ventricular septation for double-inlet left ventricle†.

OBJECTIVES: To review the long-term surgical outcomes of ventricular septation for double-inlet left ventricle and reconsider the possibility of ventricular septation as an option of surgical treatments. METHODS: Between 1978 and 1994, 22 patients with double-inlet left ventricle underwent ventricular septation. The mean age at operation was 5.3 years (range 0-22 years). Follow-up was carried out in 20 of 22 patients (91%) and the mean follow-up period was 14.7 years (range 0-39 years). RESULTS: Actuarial survival and reoperation-free survival rates at 30 years were 49% and 21%, respectively. To date, 8 patients have been followed up. Among them, atrioventricular valve replacement and permanent pacemaker were required in 4 and 7 patients, respectively. Late cardiac catheter examination at 25.5 years after surgery showed that the median cardiac index was 2.6 l/min/m2 (range 2.1-3.4 l/min/m2), left ventricular end-diastolic pressure was 7 mmHg (range 4-11 mmHg), left ventricular ejection fraction was 50% (range 27-63%), right ventricular ejection fraction was 53% (range 31-66%) and central venous pressure was 6 mmHg (range 4-11 mmHg). At the latest follow-up, the New York Heart Association Functional Classification was I for 5 patients, II for 2 patients and III for 1 patient. The median peak oxygen uptake was 52.9% (range 44.1-93.5%). CONCLUSIONS: Some patients with double-inlet left ventricle were able to maintain low central venous pressure and a sufficient cardiac index long after ventricular septation. Although the single ventricle strategy remains a first-line treatment, ventricular septation can be a surgical treatment option.

Surgical Outcomes of Biventricular Repair for Hypoplastic Left Ventricle With Congenital Mitral Valve Stenosis.

OBJECTIVE: Surgical outcomes of biventricular repair for hearts with hypoplastic left ventricle with congenital mitral valve stenosis are described. Serial changes of left ventricular geometry and clinical features after biventricular repair were reviewed. METHODS: Eight patients with hypoplastic left ventricle and congenital mitral valve stenosis who underwent first surgical intervention for biventricular circulation in neonatal or infantile period between 2001 and 2014 comprise the study population. Serial change in left ventricular end-diastolic diameter, left ventricular mass index, and relative wall thickness after biventricular repair were evaluated by two-dimensional echocardiography. RESULTS: The median Z-scores of left ventricular end-diastolic diameter and mitral valve diameter before the first surgical intervention were -3.0 (range, -4.8 to -2.0) and -1.0 (-2.9 to 2.1), respectively. Mitral valves were surgically treated in five patients; they were replaced in two and repaired in three patients. Left ventricular end-diastolic diameter Z-score at five years after biventricular repair was 0.1 (-3.0 to 1.0), which was significantly larger than before first surgical intervention ( P = .005). Left ventricular mass index, on the other hand, did not change, but relative wall thickness significantly decreased ( P = .009). Postoperative catheter study showed pulmonary hypertension with high left ventricular end-diastolic pressure in more than half of survivors. CONCLUSIONS: Left ventricle increased in size after the biventricular repair with appropriate mitral valve procedures before progression of pulmonary hypertension. Left ventricular mass, however, did not accompany the increase. Some patients may have suffered from mild, but certain restrictive left ventricular physiology and subsequent pulmonary hypertension as the result of abnormal remodeling process of the myocardium.

Left Ventricular Function After Repair of Totally Anomalous Pulmonary Venous Connection.

BACKGROUND: Poor left ventricular (LV) growth and diastolic dysfunction long after simple total anomalous pulmonary venous connection (TAPVC) repair has been well documented and is believed to originate from insufficient preoperative volume preload. The objective of the study was to confirm these findings. METHODS: Of 61 patients undergoing simple TAPVC repair between 1996 and 2016, 42 patients undergoing postoperative catheter examinations were enrolled. The mean age at the time of repair was 39 ± 117 days. Postoperative catheter examinations were conducted at a mean duration of 1.1 years after the repair. LV end-diastolic volume (LVEDV) was calculated by biplane cineangiography with the use of Simpson's method as a Graham modification. RESULTS: LV ejection fraction, LV end-diastolic pressure (LVEDP), and cardiac index were 72% ± 5%, 10.3 ± 2.7 mm Hg, and 4.0 ± 0.7 L •·min-1 • m-2, respectively. LVEDV was 102% ± 16% of the predictive normal value, and it strongly correlated with the predictive normal value of LV end-diastolic diameter (LVEDd) calculated by two-dimensional echocardiography (R2 = 0.29, p = 0.005). LVEDd maintained a normal range thereafter during the entire follow-up period. LVEDP correlated linearly with age at the time of TAPVC repair (R2 = 0.18, p = 0.007) but not with LVEDV (p = 0.67). CONCLUSIONS: LV size maintained a normal range after the repair of simple TAPVC. High LVEDP was frequently observed a year after repair; it did not correlate with LV size but had a strong negative correlation with age at the time of repair.

Influence of social determinants of health on patients with advanced lung cancer: a prospective cohort study.

INTRODUCTION: Socioeconomic factors with an influence on human health are known as social determinants of health (SDH). There are some SDH studies in patients with lung cancer, but important exposures such as social isolation and loneliness have not been adequately investigated. This study will assess the influence of SDH, particularly social isolation and loneliness, on patients with advanced lung cancer in Japan. METHODS AND ANALYSIS: The inclusion criteria for this prospective cohort study will be as follows: a diagnosis of advanced lung cancer; unsuitability for curative surgery; and willingness to participate. The primary outcome will be the initial choice of treatment and the secondary outcomes will be overall survival, changes in disease staging or performance status, route to diagnosis and place of death. The exposures will be social isolation, loneliness, employment, insurance type, education and dementia. The study enrolment period will be 1 year and the follow-up duration will be 2 years. The log-rank test will be used to compare overall survival between patients when grouped according to the study exposures and multivariate analysis will be performed using Cox proportional hazards regression. The Χ2 test will be used to compare the initial treatment, changes in disease stage and place of death, and logistic regression will be used for multivariate analysis of these factors. A p value <0.05 will be considered statistically significant. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board at Hyogo Prefectural Amagasaki General Medical Center (No 29-164). A manuscript summarising the outcome of this study will be submitted to a peer-reviewed journal and the data will be presented at conferences. TRIAL REGISTRATION NUMBER: UMIN000031810.

Prevalence of and Predictive Factors for Scoliosis After Surgery for Congenital Heart Disease in the First Year of Life.

BACKGROUND: The surgical treatment of congenital heart disease is reported to be associated with a high prevalence of scoliosis, although the detailed etiology is unknown. Surgical interventions involving the rib cage are considered to increase the risk of scoliosis. However, whether the cardiac condition or the procedure performed makes patients more susceptible to the development of spinal deformity is controversial. METHODS: The present study included 483 patients who underwent surgery for the treatment of congenital heart disease with use of procedures involving the immature rib cage (sternotomy and/or thoracotomy) during the first year of life, followed by the evaluation of standing chest radiographs at ≥10 years of age. Patients with congenital spinal deformity and potential neuromuscular disease were excluded. The prevalence of and predictive factors for scoliosis were evaluated. The presence of scoliosis (Cobb angle ≥10° to <20°, ≥20° to <30°, ≥30° to <45°, ≥45°), the convex side of the curve, and the location of the curve were evaluated radiographically. Potential predictive factors that were analyzed included the age at the time of surgery, surgical approach, use of cardiopulmonary bypass, postoperative heart failure and/or cyanosis, New York Heart Association (NYHA) class, cardiomegaly, and age at the time of radiography. RESULTS: The mean age at the time of surgery was 112 days, and the mean age at the time of radiography was 14.4 years. The prevalence of scoliosis was 42.4%, and the prevalences of ≥10° to <20°, ≥20° to <30°, ≥30° to <45°, and ≥45° scoliosis were 31.7%, 5.8%, 2.5%, and 2.5%, respectively. Three patients underwent surgery for the treatment of progressive scoliosis. Multivariate analysis indicated that the predictive factors were female sex, left thoracotomy, bilateral thoracotomy, NYHA class, and age at the time of radiography for ≥10° scoliosis; cardiomegaly, NYHA class, and age at the time of radiography for ≥20° scoliosis; cardiomegaly, number of surgical procedures, and age at the time of radiography for ≥30° scoliosis; and cardiomegaly for ≥45° scoliosis. Age at the time of radiography was a predictor of <45° scoliosis; however, the relative association was small. CONCLUSIONS: Surgery for the treatment of congenital heart disease during the first year of life was associated with a high prevalence of scoliosis (≥40%). While female sex was one of several predictors of ≥10° scoliosis, cardiomegaly was the sole predictor of ≥45° scoliosis. LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Utility of a super-flexible three-dimensional printed heart model in congenital heart surgery.

OBJECTIVES: The objective of this study was to assess the utility of 3D printed heart models of congenital heart disease for preoperative surgical simulation. METHODS: Twenty patient-specific 3D models were created between March 2015 and August 2017. All operations were performed by a young consultant surgeon who had no prior experience with complex biventricular repair. All 15 patients with balanced ventricles had outflow tract malformations (double-outlet right ventricle in 7 patients, congenitally corrected transposition of great arteries in 5, transposition of great arteries in 1, interrupted aortic arch Type B in 1, tetralogy of Fallot with pulmonary atresia and major aortopulmonary collateral arteries in 1). One patient had hypoplastic left heart complex, and the remaining 4 patients had a functional single ventricle. The median age at operation was 1.4 (range 0.1-5.9) years. Based on a multislice computed tomography data set, the 3D models were made of polyurethane resins using stereolithography as the printing technology and vacuum casting as the manufacturing method. RESULTS: All but 4 patients with a functional single ventricle underwent complete biventricular repair. The median cardiopulmonary bypass time and aortic cross-clamp time were 345 (110-570) min and 114 (35-293) min, respectively. During the median follow-up period of 1.3 (0.1-2.5) years, no mortality was observed. None of the patients experienced surgical heart block or systemic ventricular outflow tract obstruction. CONCLUSIONS: Three-dimensional printed heart models showed potential utility, especially in understanding the relationship between intraventricular communications and great vessels, as well as in simulation for creating intracardiac pathways.

Survey on the Status of Smoking Inside Eating Establishments in the Cities of Kobe and Amagasaki.

BACKGROUND: The Hyogo Prefectural Government has been enforcing a smoking ban ordinance since April 2013. The present survey was conducted to determine the extent to which the smoking ban has been successfully implemented in eating establishments in Kobe City and Amagasaki City.Methods and Results:The Health and Welfare Department of the Hyogo Prefectural Government provided a list of eating establishments in Kobe and Amagasaki City. From these, we chose 1,300 from each city using random number generation. Responses were obtained from 310 establishments in Kobe City (response rate: 23.8%) and 297 in Amagasaki City (22.8%). Overall, 58.1% of the establishments surveyed in Kobe City were aware of the ordinance, a recognition rate significantly higher than that of Amagasaki City, where only 45.5% of eateries were aware of the ordinance (P=0.003). Of the Kobe City eateries, 31.7% had succeeded in implementing a complete ban on smoking. In Amagasaki City, the rate was significantly lower, at just 13.4% (P<0.001). A logistic regression analysis showed that coffee shops, Japanese-style taverns, bars, and eating establishments that served alcohol were the independent significant predictors of low compliance. Kobe City restaurants, women, and families were the independent significant predictors of high compliance with the complete smoking ban. CONCLUSIONS: The rates of recognition and implementation of the complete smoking ban were significantly lower in Amagasaki City than in Kobe City. There needs to be a strong and continuous socialization campaign to promote the ordinance.