[Minimally Invasive Cardiac Surgery for a Left Atrial Myxoma with Atrial Septal Defect:Report of a Case].

A 48-year-old woman presented with abnormal electrocardiogram was diagnosed as having a left atrial tumor by echocardiography. She was asymptomatic and had no history of cardiac abnormality. Transthoracic echocardiography revealed a relatively hyperechoic and heterogenous tumor with the diameter of 5~6 cm originated from the left atrial septum but could not detect atrial septal defect. Transesophageal echocardiography showed atrial septal defect of fossa ovalis but failed to uncover shunt flow behind the tumor. We diagnosed as left atrial myxoma complicated with atrial septal defect, and an operation was performed through small right intercostal thoracotomy. The tumor was excised and the atrial septal defect was completely repaired after pulmonary vein isolation. The post-operative course was uneventful. Cardiac myxoma coexisting atrial septal defect is rare, and preoperative transesophageal echocardiography is considered essential for the diagnosis of coexistent lesions especially in the patients minimally invasive cardiac surgery is planned.was uneventful. Cardiac myxoma coexisting atrial septal defect is rare, and preoperative transesophageal echocardiography is considered essential for the diagnosis of coexistent lesions especially in the patients minimally invasive cardiac surgery is planned.

Potential benefits of immunomodulator use with vedolizumab for maintenance of remission in ulcerative colitis.

BACKGROUND AND AIM: This study aimed to determine the efficacy and safety of vedolizumab treatment with or without concomitant immunomodulator use in Japanese patients with moderate-to-severe ulcerative colitis. METHODS: Among enrolled patients in a phase 3 study conducted in Japan (clinicaltrials.gov, NCT02039505), data from patients allocated to 300-mg intravenous vedolizumab for induction and maintenance phases were used for this exploratory analysis. Efficacy endpoints were clinical response, clinical remission, and mucosal healing at week 10 and clinical remission and mucosal healing at week 60, and disease worsening and treatment failure during the maintenance phase. RESULTS: At week 10, the differences in clinical response, clinical remission, and mucosal healing rates between the subgroups (those with concomitant immunomodulator use minus those without) were 0.7 (95% confidence interval: -14.3, 15.7), 3.3 (95% confidence interval: -8.5, 15.2), and 1.8 (95% confidence interval: -13.0, 16.5), respectively. At week 60, the differences in clinical remission and mucosal healing between the subgroups with and without concomitant immunomodulator use were 26.1 (95% confidence interval: -3.5, 55.6) and 29.9 (95% confidence interval: 1.4, 58.4), respectively. The proportions of patients without treatment failure at day 330 of the maintenance phase were 90.7% with concomitant immunomodulator use and 73.7% without. No marked differences in incidence of infections were observed between subgroups. CONCLUSIONS: This study suggested the possibility that concomitant immunomodulator use may be beneficial to maintain the clinical efficacy of vedolizumab.

[Impending Paradoxical Embolization in a Patient with a Thrombus Straddling the Patent Foramen Ovale].

The patent foramen ovale (PFO) is known as a risk of paradoxical embolism in patients with deep venous thromboses. However, PFO is usually found after systemic embolic symptoms become apparent. A 60-year-old male had complained of dyspnea for two weeks. Ultrasound echocardiography showed a thrombus straddling PFO, and venous echography showed blood clots in the right popliteal and soleus veins. Contrast computed tomography revealed multiple pulmonary embolisms and a thrombus in the right atrium expanding to the left atrium through the atrial septum. The straddling thrombus in the atrium and pulmonary thrombi were extirpated under circulatory arrest with deep hypothermia. An inferior vena cava filter was inserted intravenously four days after surgery. The patient was discharged on the 19th postoperative day without any signs of thromboembolism. Prompt surgery is considered important to prevent thromboembolism in the case of impending paradoxical embolism.

Relationship of Subjective Cognitive Impairment with Psychosocial Function and Relapse of Depressive Symptoms in Patients with Major Depressive Disorder: Analysis of Longitudinal Data from PERFORM-J.

BACKGROUND: Accumulating evidence suggests the presence of cognitive impairment in patients with major depressive disorder (MDD), which affects their psychosocial function and quality of life (QoL). PERFORM-J (Prospective Epidemiological Research on Functioning Outcomes Related to MDD in Japan) is an observational, multicenter study to assess longitudinal changes in depressive symptoms, psychomotor speed, subjective cognitive function, and psychosocial function. METHODS: Five hundred and eighteen Japanese outpatients with MDD initiating new antidepressant monotherapy (first-line or switch from previous drug) as part of their routine medical care participated in this study. Assessments at baseline and over the 6-month observation period included physician-rated depression severity (Montgomery-Åsberg Depression Rating Scale), psychomotor speed (Digit Symbol Substitution Test; DSST), subjective cognition (Perceived Deficits Questionnaire-Depression), psychosocial function (Sheehan Disability Scale), and QoL (EuroQol-5 Dimension-5 Level). RESULTS: Antidepressant treatment for 6 months improved depressive symptoms and subjective cognitive impairment (cognitive complaints), whereas psychomotor speed remained impaired (ie, DSST total score was >1 standard deviation below the norm) in 35.6% of patients at 6 months. Impairment of subjective cognition, but not psychomotor speed at month 2 was associated with poor psychosocial function and QoL at 6 months. There was a trend for higher relapse rates at 6 months in patients with greater subjective cognitive impairment at 2 months. CONCLUSION: These findings highlight the importance of evaluating cognitive difficulties to predict long-term outcomes in patients with MDD. Early intervention for cognitive complaints may decrease the relapse rate, which warrants further study.

Week 2 Symptomatic Response with Vedolizumab as a Predictive Factor in Japanese Anti-TNFα-Naive Patients with Ulcerative Colitis: A post hoc Analysis of a Randomized, Placebo-Controlled Phase 3 Trial.

BACKGROUND AND AIM: To evaluate the onset of symptomatic response with vedolizumab in patients with moderate-to-severe ulcerative colitis in Japan. METHODS: Patients were randomized to receive vedolizumab 300 mg or placebo at Weeks 0, 2, and 6. Mayo subscores were analyzed in patients with baseline stool frequency (SF) ≥1 and rectal bleeding (RB) ≥1. In patients with baseline SF ≥2 and RB ≥1, the proportion who achieved SF ≤1 and RB = 0 was determined. RESULTS: Patients were randomized to vedolizumab (n = 164) or placebo (n = 82). Decrease from baseline in mean SF subscore was greater with vedolizumab versus placebo from Week 2 (-6.6%; 95% confidence interval [CI], -16.2, 3.0), with a greater difference in anti-tumor necrosis factor (TNF)α-naive patients (vedolizumab vs. placebo, -13.2%; 95% CI, -29.7, 3.3). Mean percentage decrease from baseline RB subscore was numerically greater with vedolizumab versus placebo from Week 6 in anti-TNFα-naive patients (-10.7%; 95% CI, -33.0, 11.5). More patients in the anti-TNFα-naive subgroup achieved SF ≤1 and RB = 0 with vedolizumab versus placebo at Week 2 (14.8%; 95% CI, 2.5, 27.0) and Week 6 (20.3%; 95% CI, 4.4, 36.2). Patients with SF ≤1 and RB = 0 at Week 2 had higher clinical response, clinical remission, and mucosal healing rates at Week 10 than those without. CONCLUSIONS: Our results indicate that vedolizumab induces a rapid symptomatic response, particularly in anti-TNFα-naive patients, and suggest that early symptomatic improvement predicts treatment response at Week 10 (NCT02039505).

Safety profile of brentuximab vedotin in Japanese patients with relapsed/refractory Hodgkin lymphoma or systemic anaplastic large cell lymphoma: a post-marketing surveillance study.

Brentuximab vedotin (BV) was initially approved in Japan for the treatment of relapsed/refractory (R/R) CD30-positive Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). As requested by the Japanese Ministry of Health, Labour and Welfare, we conducted a post-marketing surveillance (PMS) study to assess the safety of BV in Japanese patients with R/R HL or sALCL. PMS forms were collected from 284 patients (182 with HL, 101 with sALCL and one with another lymphoma) treated between April and September 2014. The median age was 62 (range 14-93) years and the median number of treatment cycles was 5.5 for HL and 4 for sALCL. Adverse drug reactions (ADRs) were reported in 74.3% of patients. The most commonly observed ADRs included peripheral sensory neuropathy (39.1%; grade ≥ 3, 6.3%), neutropenia (34.5%; grade ≥ 3, 22.2%) and lymphopenia (7.0%; grade ≥ 3, 5.3%). Ten patients had fatal ADRs including interstitial lung disease (n = 3). This study showed that BV has an acceptable safety profile in Japanese patients with R/R HL and R/R sALCL in the clinical practice setting. However, close monitoring rare, but potentially fatal, ADRs such as pulmonary toxicity may be warranted, especially in patients with prior or ongoing pulmonary disorders.

Vascular compression of the left bronchus in a patient with funnel chest.

We present a case of 5 year-old female with funnel chest, by which cardiovascular structures were displaced into the left chest cavity. This caused left bronchial compression by the pulmonary artery and the descending aorta, for which an external stenting was successfully performed. The patient had features suggestive of skeletal dysplasia with tracheobronchial malacia. One possible mechanism of vascular compression could be an association of fragility of the thoracic cavity and inspiratory dyspnea, causing thoracic deformity.

Surgical repair in a patient with Berry syndrome.

Berry syndrome is a trilogy involving an aorto-pulmonary window, right pulmonary artery from ascending aorta and an interrupted aortic arch. Surgical repair for this anomaly is associated with a high mortality rate and incidence of right pulmonary arterial stenosis. Herein, we present the case of a patient with Berry syndrome, who underwent a rapid two-stage repair involving bilateral pulmonary arterial banding and complete repair. Postoperative computed tomography scan showed well-repaired great vessels free of obstruction.

The safety and effectiveness of vonoprazan-based Helicobacter pylori eradication therapy; a prospective post-marketing surveillance.

Background: The safety and effectiveness of vonoprazan-based Helicobacter pylori (H. pylori) eradication therapy in routine clinical practice, and patient characteristics that influence safety and effectiveness, have not been well investigated.Methods: H. pylori-positive patients with gastric ulcer, duodenal ulcer, idiopathic thrombocytopenic purpura, history of endoscopic treatment of early gastric cancer, and gastritis were enrolled. Patients received vonoprazan 20 mg, amoxicillin (AMPC) 750 mg, and clarithromycin (CAM) 200-400 mg twice daily for 7 days for the first-line eradication. For the second-line eradication, vonoprazan, AMPC, and metronidazole (MTZ) 250 mg were administered. The incidence of adverse drug reactions (ADRs) and eradication rates were evaluated.Results: The incidences of ADRs with vonoprazan/AMPC/CAM and vonoprazan/AMPC/MTZ were 3.22% (16/497) and 1.89% (1/53), respectively. Commonly reported ADRs were diarrhea, nausea, dysgeusia, feces soft, and rash. The eradication rates of the first-line therapy and the second-line therapy were 91.24% (427/468) and 95.45% (42/44), respectively. No notable differences in ADRs and eradication rates were observed when stratified by patient demographic characteristics.Conclusion: No new safety concerns were observed, and the effectiveness of vonoprazan-based triple therapy was confirmed in routine clinical practice.Trial registration: This study is registered at the Japan Pharmaceutical Information Center Clinical Trials Information (JapicCTI-153003).

Relationship of cognitive impairment with depressive symptoms and psychosocial function in patients with major depressive disorder: Cross-sectional analysis of baseline data from PERFORM-J.

BACKGROUND: Evidence is accumulating for the presence of cognitive impairment in patients with major depressive disorder (MDD). The Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder in Japan (PERFORM-J) study is a 6-month, non-interventional, prospective, multicenter, epidemiological study. Using baseline data, the relationship between cognitive symptoms and psychosocial function was analyzed in Japanese patients with MDD. METHODS: A total of 518 Japanese outpatients (aged 18-65 years) with MDD initiating new antidepressant monotherapy (first-line or switch from a previous drug) participated. Assessment measures were: physician-rated Montgomery-Asberg Depression Rating Scale (MADRS) (depression severity); Digit Symbol Substitution Test (DSST) (objective cognition); and patient-rated Perceived Deficits Questionnaire - Depression (PDQ-D) (subjective cognition); Sheehan Disability Scale (SDS); Work Productivity and Activity Impairment questionnaire (WPAI) (psychosocial function); and EuroQol-5 Dimension-5 Level (quality of life). RESULTS: Over half of patients exhibited a greater than 1 standard deviation decline below norm in objective cognition, as measured by the DSST. Severity of depressive symptoms correlated positively with subjective (PDQ-D), but not objective (DSST) cognition. Depression severity and subjective cognition were significantly associated with psychosocial function, as measured by the SDS and WPAI (except the absenteeism items). Conversely, the association between objective cognition and psychosocial function was not significant. LIMITATIONS: Only outpatients were recruited. Occupations and job-related stress levels were not taken into account. CONCLUSIONS: Japanese patients with MDD presented a high incidence of cognitive impairment. The relationships between cognitive and psychosocial function in these patients suggest a need for therapeutics targeting cognitive impairment of MDD.

Hand-sewn trileaflet valve in the right ventricular outflow tract.

A 4-year-old girl with pulmonary regurgitation after complete repair of tetralogy of Fallot, underwent an alternative surgical repair for pulmonary valve replacement. Hand-sewn trileaflet valve reconstruction using expanded polytetrafluoroethylene membrane is a feasible method for pulmonary regurgitation in such a young child in whom a large-sized bioprosthetic valve cannot be implanted.

Log-transformed B-type natriuretic peptide as a prognostic predictor in patients undergoing cardiovascular surgery.

OBJECTIVE: This study was performed to explore the association between circulating B-type natriuretic peptide (BNP) and other mortality-related factors in patients undergoing cardiovascular surgery. METHODS: In this observational study, multilevel linear regression analysis and multilevel survival analysis were performed to measure the log-transformed BNP (lnBNP) value at four time points in 197 patients with 788 repeated data measurements. Effects of the interaction between the time points and the two intervention groups (cardiac surgery and vascular surgery) were also investigated. Six models were evaluated to identify the best fit for the data. Stata/MP® version 14.2 (Stata Corp., College Station, TX, USA) was used to analyze the two-level variance component model fitting. RESULTS: There were significant differences in the fixed-effect parameters of lnBNP, such as the time point, age, body mass index, emergency operation, prognostic nutritional index, and estimated glomerular filtration rate. According to the multilevel survival analysis for all-cause death and vascular death, lnBNP significantly differed and was a common prognostic marker. CONCLUSION: As lnBNP increased by 1 point, all-cause death increased 2.07 times and vascular death increased 3.10 times. lnBNP is an important prognostic predictor and quantitative biochemical marker in patients undergoing cardiovascular surgery.

Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder in Japan (PERFORM-J): Protocol for a Prospective Cohort Study.

BACKGROUND: Patients with major depressive disorder may exhibit cognitive dysfunction that can affect functional outcomes. However, the prevalence and burden of cognitive dysfunction in Japanese patients with MDD have not been thoroughly examined. OBJECTIVE: To investigate the time course (over 6 months) of several functional outcomes during treatment with antidepressants in Japanese patients with major depressive disorder. The primary objective is to assess longitudinal changes in cognitive function and depressive symptoms, using both clinician-rated and patient-rated scales. The study incorporates assessments of cognitive function and other functional outcomes (functional capacity, disability, work productivity and impairments of activity, and quality of life), as well as depressive symptoms. METHODS: PERFORM-J (Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder in Japan) is a 6-month, prospective, multi-center, epidemiological cohort study. Participants are Japanese outpatients aged 18-65 years with a recurrent or new diagnosis of a major depressive episode (according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR]), who are initiating a new antidepressant as monotherapy (either as first-line therapy or after switching from a previous antidepressant). Eligible patients are evaluated objectively during four visits (at baseline and at Months 1, 2, and 6) using physician-rated assessments of severity of depressive symptoms, cognitive function, and functional capacity. Subjective, patient-reported, outcomes are also assessed as indicators of depressive symptoms, disability, work productivity or impairments of activity, and perceived cognitive dysfunction. RESULTS: The study began in September 2016. Patient enrollment was completed on June 30, 2017, with 523 patients having been enrolled from 48 study sites. As of October, 2017, 279 patients had completed the study. CONCLUSIONS: PERFORM-J is expected to provide valuable information on the longitudinal relationship between cognitive dysfunction, depressive symptoms, and other functional outcomes in Japanese patients with major depressive disorder who initiate monotherapy with antidepressants. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000024320; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000028011 (Archived by WebCite at http://www.webcitation.org/70K7W9PgC). REGISTERED REPORT IDENTIFIER: RR1-10.2196/9682.

Trileaflet pulmonary valve reconstruction for pulmonary regurgitation in childhood.

A 6-year-old boy with pulmonary regurgitation after complete repair of congenital heart disease underwent an alternative surgical repair for pulmonary valve replacement. Trileaflet pulmonary valve reconstruction using expanded polytetrafluoroethylene membrane is a clinically feasible technique for pulmonary regurgitation in such a young child in whom large-sized bioprosthetic valves cannot be implanted.

Formation of Single-Digit Nanometer Scale Silica Nanoparticles by Evaporation-Induced Self-Assembly.

There are emerging demands for single-digit nanoscale particles in multidisciplinary fields, such as nanomedicine, optics, catalysis, and sensors, to create new functional materials. Here, we report a novel route to prepare silica nanoparticles less than 3 nm in size via the evaporation-induced self-assembly of silicate species and quaternary trialkylmethylammonium surfactants, which usually form reverse micelles. The solvent evaporation induces a local concentration increase and simultaneous polycondensation of silicate species within the hydrophilic region of the surfactant mesophases. Extremely small silica nanoparticles in the silica-surfactant mesostructures can be stably dispersed in organic solvents by destroying the mesostructure, which is in clear contrast to the preparation of silica nanoparticles using the conventional reverse micelle method. The surface chemical modification of the formed silica nanoparticles is easily performed by trimethylsilylation. The particle size is adjustable by changing the ratio of the surfactants to the silica source because the hydrophobic/hydrophilic ratio determines the curvature and diameter of the resulting spherical silica-surfactant domains in the mesostructure. The versatility of this method is demonstrated by the fabrication of very small titania nanoparticles. These findings will increase the designability of oxide nanoparticles at the single-digit nanoscale because conventional methods based on the generation and growth of nuclei in a solution cannot produce such nanoparticles with highly regulated sizes.

Validation of circulating BNP level >1000 pg/ml in all-cause mortality: A retrospective study.

AIM: To determine the primary diseases and prognoses of patients with highly elevated levels of B-type natriuretic peptide (BNP; >1000 pg/ml), with or without heart failure. METHODS: Medical records and echocardiograms of patients with BNP levels that fell within one of three predetermined categories (>1000 pg/ml, 200-1000 pg/ml and <200 pg/ml) were retrospectively reviewed. RESULTS: There were no significant between-group differences in duration of hospitalization. Patients with BNP levels >1000 pg/ml (n = 103) or 200-1000 pg/ml (n = 100) had significantly worse 3-year survival than those with BNP levels <200 pg/ml (n = 100). The majority of patients (64/103) in the BNP >1000 pg/ml group had heart failure. The main cause of death in patients with other causes of BNP levels >1000 pg/ml (39/103) was community acquired pneumonia. CONCLUSION: A BNP level >1000 pg/ml has clinical importance in primary care medicine and hospital settings.

Pericardial biopsy revealed gastric signet-ring cell cancer.

We describe the case of an 85-year-old man who presented with a large pericardial effusion. The patient was admitted because of anorexia and general malaise. Chest X-ray revealed an increased cardiothoracic ratio and a small amount of bilateral pleural effusion. Two-dimensional ultrasonographic echocardiography showed pericardial effusions with atrial and right ventricular early diastolic collapse, establishing the diagnosis of cardiac tamponade. Signet-ring cell cancer with pericardial involvement was diagnosed by subxiphoid pericardiostomy. The clear fluid was removed through pericardial drainage. The signet-ring cell carcinoma of the stomach was revealed by gastric fiberscope examination after pericardial biopsy proved malignancy. Virchow lymph node metastasis was also found. We diagnosed the patient with gastric cancer stage IV and suggested him the best supportive therapy. He died of cardiac arrest 1 month after best supportive care.

Lifestyle factors and efficacy of lifestyle interventions in gastroesophageal reflux disease patients with functional dyspepsia: primary care perspectives from the LEGEND study.

OBJECTIVE: Although gastroesophageal reflux disease (GERD), a very common disorder worldwide, is considered to be a lifestyle disease, the pathogenic role of lifestyle factors and consequently the efficacy of lifestyle interventions, remains controversial. Lifestyle factors associated with GERD and the beneficial effect of specific recommended lifestyle interventions in the primary care setting were evaluated as a post-hoc analysis of the LEGEND study which investigated the effect of lansoprazole in patients with GERD who reported dyspeptic symptoms. METHODS: GERD patients with dyspepsia were treated with lansoprazole 15 mg or 30 mg daily for four weeks. Reflux and dyspeptic symptoms were evaluated using patient-reported questionnaires before and four weeks after the administration of lansoprazole. RESULTS: Among 12,653 patients, "feelings of continued stress" was the most common lifestyle factor (45.6% of patients), and >30% of the patients reported "eating sweet foods at least once every two to three days," "eating greasy foods at least once every two to three days" and "drinking coffee almost daily." Introducing lifestyle interventions had a significant effect on both reflux and dyspeptic symptoms. CONCLUSION: Lifestyle interventions are thus considered to be important in GERD patients with dyspepsia who receive a proton pump inhibitor.

Demography and treatment response in patients with predominant non-erosive reflux disease or functional dyspepsia.

BACKGROUND AND AIM: Non-erosive reflux disease (NERD) and functional dyspepsia (FD) share some common features, and the appropriateness of managing these diseases independently has been questioned. A post-hoc subgroup analysis of the LEGEND study was performed to compare demographics and treatment response between patients with NERD and patients with FD. METHODS: Patients with reflux and dyspepsia symptoms who had no endoscopic evidence of mucosal breaks and/or erosions were included and divided into groups with predominant NERD (n = 1546) or FD (n = 614). Patients received lansoprazole for 4 weeks, and their symptoms were evaluated using questionnaires. RESULTS: FD patients were significantly younger than NERD patients (54 vs 60 years), more likely to have a body mass index < 25 kg/m(2) (72.4% vs 67.1%), less likely to have a hiatal hernia (24.0% vs 31.2%), and more likely to feel continuous stress (54.7% vs 48.0%). After 4 weeks of treatment, > 60% of both patients reported an improvement in reflux symptoms and in most dyspepsia symptoms. The improvement rate for reflux symptoms was lower in FD patients than in NERD patients (P < 0.05), whereas the improvement rate for dyspepsia symptoms did not differ between patient groups. CONCLUSION: Although no clinically significant differences in pathophysiology exist between NERD and FD, there are some between-group differences in demographic characteristics and improvement rates for reflux symptoms after treatment with lansoprazole. It remains to be discussed whether it is necessary to make a strict differential diagnosis between these two conditions.