Comparison of Clinical Outcomes in Patients with Acute Lower Limb Ischaemia Undergoing Endovascular Therapy and Open Surgical Revascularisation: A Large Scale Analysis in Japan.

OBJECTIVE: The recommended revascularisation methods for acute limb ischaemia (ALI), which is caused by embolism and atherosclerotic thrombosis, include endovascular therapy (EVT) and open surgical revascularisation (OSR); however, treatment choices based on patient characteristics remain controversial. This retrospective analysis from the Japanese Registry of All Cardiac and Vascular Diseases - Diagnosis Procedure Combination database (April 2012 to March 2020) evaluated differences in clinical outcomes and identified prognostic predictors in patients with ALI. METHODS: This study analysed 10 977 patients with lower limb ALI. EVT was defined as catheter directed thrombolysis, percutaneous thrombectomy, or percutaneous angioplasty with balloon dilatation and or stenting. OSR was defined as Fogarty thrombectomy, bypass surgery, or thromboendarterectomy. The EVT and OSR groups were compared after propensity score matching (PSM) considering ten clinical covariates. RESULTS: The EVT group had more patients at higher risk of atherosclerotic disease than the OSR group. The OSR group had more patients at a higher risk of embolism, including atrial fibrillation and atrial flutter, than the EVT group. In the EVT group, 20.4% of patients underwent catheter directed thrombolysis using urokinase, the only thrombolytic agent available in Japan that is covered under insurance. After PSM, in hospital mortality (odds ratio [OR] 1.33, 95% confidence interval [CI] 1.11 - 1.59; p = .002), major amputation rate (OR 1.43, 95% CI 1.19 - 1.72; p < .001), major amputation and or death rate (OR 1.42, 95% CI 1.24 - 1.62; p < .001), and total hospitalisation cost (1.16 vs. 0.97 million yen; p < .001) were statistically significantly higher in the EVT group than in the OSR group. In interaction analyses, peripheral artery disease (PAD) was a factor responsible for reducing OSR efficacy in terms of major amputation and or death rate (with PAD, OR 0.94, 95% CI 0.68 - 1.29; without PAD, OR 1.56, 95% CI 1.34 - 1.82; p = .004). CONCLUSIONS: In Japan, EVT was a less effective primary treatment for patients with ALI than OSR, except for those with PAD.

Correction: Electronic Health Record-Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/40595.].

The association between intraoperative anesthesia methods used during gastric cancer surgery and long-term mortality: A retrospective observational study using a Japanese claims database.

PURPOSE: Various basic and clinical studies have investigated the association between the types of anesthetic agents and prognosis. However, the results have varied among studies and remain controversial. In the present study, we aimed to investigate whether the risk of all-cause mortality differs between inhaled or intravenous anesthetics in patients with gastric cancer undergoing gastrectomy. METHODS: Using a Japanese nationwide insurance claims database, we analyzed patients who underwent gastrectomy under general anesthesia for gastric cancer between January 2005 and September 2019. Postoperative outcomes were compared between two groups: those who received inhaled anesthetics (Sevoflurane, Isoflurane, or Desflurane) and those who received intravenous anesthetics (propofol), using a multivariable Cox proportional hazards model. The primary outcome was overall survival. RESULTS: Among 2671 eligible patients, 2105 were in the inhaled anesthetic group, and 566 were in the intravenous anesthetic group. The median (interquartile range) age was 58 (51-63) years, and 1979 (74.1%) were men. The median follow-up period was 795 days. We identified 56 (2.7%) and 16 (2.8%) deaths during the follow-up period in the inhaled and intravenous anesthetic use groups, respectively. There was no difference in postoperative overall survival between the two groups (hazard ratio, 0.97; 95% confidence interval, 0.56-1.70; P = 0.93). CONCLUSIONS: We found no significant difference in the postoperative risks of overall survival between inhaled and intravenous anesthesia in patients with gastric cancer undergoing gastrectomy.

Electronic Health Record-Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial.

BACKGROUND: Clinical guidelines recommend regular serum lithium monitoring every 3 to 6 months. However, in the real world, only a minority of patients receive adequate monitoring. OBJECTIVE: This study aims to examine whether the use of the electronic health record (EHR)-nested reminder system for serum lithium monitoring can help achieve serum lithium concentrations within the therapeutic range for patients on lithium maintenance therapy. METHODS: We conducted an unblinded, single-center, EHR-nested, parallel-group, superiority randomized controlled trial comparing EHR-nested reminders with usual care in adult patients receiving lithium maintenance therapy for mood disorders. The primary outcome was the achievement of therapeutically appropriate serum lithium levels between 0.4 and 1.0 mEq/L at 18 months after enrollment. The key secondary outcomes are included as follows: the number of serum lithium level monitoring except for the first and final monitoring; exacerbation of the mood disorder during the study period, defined by hospitalization, increase in lithium dose, addition of antipsychotic drugs or mood stabilizers, or addition or increase of antidepressants; adherence defined by the proportion of days covered by lithium carbonate prescription during the study period. RESULTS: A total of 111 patients were enrolled in this study. A total of 56 patients were assigned to the reminder group, and 55 patients were assigned to the usual care group. At the follow-up, 38 (69.1%) patients in the reminder group and 33 (60.0%) patients in the usual care group achieved the primary outcome (odds ratio 2.14, 95% CI 0.82-5.58, P=.12). The median number of serum lithium monitoring was 2 in the reminder group and 0 in the usual care group (rate ratio 3.62; 95% CI 2.47-5.29, P<.001). The exacerbation of mood disorders occurred in 17 (31.5%) patients in the reminder group and in 16 (34.8%) patients in the usual care group (odds ratio 0.97, 95% CI 0.42-2.28, P=.95). CONCLUSIONS: We found insufficient evidence for an EHR-nested reminder to increase the achievement of therapeutic serum lithium concentrations. However, the number of monitoring increased with relatively simple and inexpensive intervention. The EHR-based reminders may be useful to improve quality of care for patients on lithium maintenance therapy, and they have potentials to be applied to other problems. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN000033633; https://tinyurl.com/5n7wtyav.

Effectiveness of intraoperative nicorandil in patients with a history of ischemic heart disease undergoing high-risk noncardiac surgery: a retrospective cohort study.

PURPOSE: Nicorandil is occasionally administered to prevent myocardial ischemia during the perioperative period in patients with ischemic heart disease (IHD); however, its effectiveness has not been clarified. In this study, we examined the effectiveness of intraoperative nicorandil administration in noncardiac surgery. METHODS: We identified patients with a history of IHD who had undergone high-risk noncardiac surgery between April 2015 and March 2020 from a nationwide in-patient database in Japan. The patients were divided into those who received nicorandil (nicorandil group) and those who did not (control group). The primary outcome was the 30-day in-hospital mortality. The secondary outcome was major adverse cardiovascular events (MACE), defined as the composite outcome of the 30-day in-hospital mortality, acute myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting. One-to-one propensity score matching was performed. The outcomes were analyzed using a Cox proportional hazards model. RESULTS: Of 8037 patients, 2886 received nicorandil during surgery. After propensity score matching, 2554 pairs were analyzed. There was no significant difference in the 30-day in-hospital mortality (26 [1.02%] vs. 36 [1.41%]; hazard ratio [HR] 1.36; 95% confidence interval [CI] 0.82-2.26; P = 0.229) or incidence of MACE (42 [1.64%] vs. 55 [2.15%]; HR 1.24; 95% CI 0.86-1.93; P = 0.216) between the control and nicorandil groups. CONCLUSION: The findings of this study suggest that intraoperative nicorandil administration is not associated with the 30-day in-hospital mortality in high-risk noncardiac surgery.

The Association Between Hypouricemia and Cardiometabolic Diseases: Analyzing Nationwide Data From Medical Checkup and Health Insurance Records.

OBJECTIVES: The aims of this study were to evaluate the association between hypouricemia and cardiometabolic diseases, such as hypertension, dyslipidemia, and reduced kidney function, and to explore the sex-specific optimal range for serum uric acid (sUA) associated with the lowest risk for these diseases. METHODS: In this cross-sectional study, we identified individuals with sUA data between April 2018 and March 2019 and recorded the frequency of cardiometabolic comorbidities according to sUA. Univariable and multivariable logistic regression analyses were performed for the overall population and after classifying by sex to assess the association between sUA and cardiometabolic comorbidities. RESULTS: Among 796,508 individuals, a J-shaped association was observed between the sUA level and cardiometabolic diseases in the overall population. The adjusted odds ratios (95% confidence interval) for hypertension, dyslipidemia, and reduced renal function in individuals with sUA ≤1.0 mg/dL compared with those with sUA ranging between 2.1 and 3.0 mg/dL were 1.38 (1.13-1.69), 1.52 (1.30-1.78), and 2.17 (1.47-3.20), respectively. A J-shaped association between sUA and hypertension was observed only in women. The optimal range of sUA associated with the lowest risk for hypertension was assumed to be <6 mg/dL in men and 1-4 mg/dL in women. A J-shaped association between the sUA and dyslipidemia and reduced renal function was observed in both men and women. The optimal range of sUA for dyslipidemia and reduced renal function was approximately 2-5 mg/dL in men and 1-4 mg/dL in women. CONCLUSIONS: Excess and extremely low uric acid levels may be related to an increased cardiometabolic risk.

Appropriateness of Percutaneous Coronary Intervention Performed by Japanese Expert Operators in Patients With Chronic Total Occlusion.

BACKGROUND: The appropriateness of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions has rarely been investigated.Methods and Results: The Japanese CTO-PCI Expert Registry enrolled consecutive patients undergoing CTO-PCI carried out by highly experienced Japanese CTO specialists who performed more than 50 CTO-PCIs per year and 300 CTO-PCIs in total. This study included patients undergoing CTO-PCI between January 2014 and December 2019. The appropriateness, trends, and differences among the procedures performed by the operators using the 2017 appropriate use criteria were analyzed. Furthermore, we performed a logistic regression analysis to assess whether the appropriateness was associated with in-hospital major adverse cardiovascular and cerebrovascular events (MACCE). Of the 5,062 patients who underwent CTO-PCI, 4,309 (85.1%) patients who did not undergo the non-invasive stress test were classified as having no myocardial ischemia. Of the total cases, 3,150 (62.2%) were rated as "may be appropriate," and 642 (12.7%) as "rarely appropriate" CTO-PCI cases. The sensitivity analyses showed that the number (%) of "may be appropriate" ranged from 4,125 (57.8%) to 4,744 (66.4%) and the number of "rarely appropriate" ranged from 843 (11.8%) to 970 (13.6%) among best and worst scenarios. CONCLUSIONS: In a large Japanese CTO-PCI registry, approximately 13% of CTO-PCI procedures were classified as "rarely appropriate". Substantial efforts would be required to decrease the number of "rarely appropriate" CTO-PCI procedures.

Complications associated with the use of enzyme-inducing and non-enzyme-inducing anti-seizure medications in the Japanese population: A retrospective cohort study.

OBJECTIVE: Enzyme-inducing anti-seizure medications (EIASMs) may contribute to the development of complications such as fracture and cardiovascular disease. The objective of the study was to determine whether the use of EIASMs is associated with a higher risk of fracture and cardiovascular outcome in young Japanese patients with epilepsy. METHOD: Adult patients diagnosed with epilepsy and initiated a monotherapy with an anti-seizure medication (ASM) between 2008 and 2018 were included in the study. The primary outcomes were the occurrence of acute myocardial infarction (AMI) or stroke. The secondary outcome was fracture. We performed a propensity score-matched analysis (1:1) to control for imbalances in patient characteristics, and the matched hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional hazards models. RESULT: Of the 7115 eligible patients, 626 (8.79%) initiated treatment with EIASMs. The median age of the patients was 44 years (interquartile range: 31-54 years), and 56.2% were male. Propensity score matching generated 626 matched pairs of patients treated with EIASMs and non-EIASMs. There were no significant differences in the risk of stroke (EIASM group: n = 28[4.47%], non-EIASM group: n = 22[3.51%], HR: 1.47, 95% CI: 0.79-2.72, p = 0.22) or fracture (EIASM group: n = 7[1.12%], non-EIASM group: n = 5[0.80%], HR: 1.00, 95% CI: 0.29-3.45, p = 1.00) between the two groups. The hazard ratio for the occurrence of AMI could not be calculated due to the small number of events (EIASM group: n = 0[0.00], non-EIASM group: n = 2[0.32]). SIGNIFICANCE: Our cohort study did not find increased risk of the occurrence of stroke, AMI, or fracture hospitalization with the use of enzyme-inducing ASMs. Although the findings suggested that exposure to EIASMs does not appear to increase the risk of complications in young patients, caution should be taken as patients with epilepsy tend to take medication in the long run.

Association between antiulcer agents and Clostridioides difficile infection in patients receiving antibiotics: A retrospective cohort study using the diagnosis procedure combination database in Japan.

OBJECTIVES: To evaluate baseline risk for hospital onset Clostridioides difficile infection (HO-CDI) and the association with the use of antiulcer agents among patients undergoing antibiotic therapy in Japan. METHODS: We conducted a retrospective cohort study using Japanese Diagnosis Procedure Combination database. Between July 2018 and January 2019, patients aged ≥18 years were included if they started antibiotics within two days of hospital admission. We defined exposure as proton pump inhibitors or histamine 2 receptor antagonists starting from day 2 to day 4 and the primary outcome as HO-CDI within 30 days. We performed multivariable analyses with complete cases using the propensity score (inverse probability treatment weighting [IPTW]) and several sensitivity analyses. RESULTS: In total, 87,137 patients were included. The median age was 78 years; 52.0% were men, and 23.6% received antiulcer agents. Within 30 days of admission, HO-CDI were observed in 0.41% and 0.26% of the antiulcer agent and control groups, respectively. IPTW revealed a positive association between antiulcer agents and HO-CDI (adjusted odds ratio, 1.33; 95% confidence interval [CI]: 1.13, 1.56). In the IPTW method, the risk difference was smaller (0.09%, 95% CI: 0.04%, 0.15%). CONCLUSION: The use of antiulcer agents in patients with antibiotics was associated with HO-CDI in Japan. However, the baseline risk and the difference in HO-CDI event rates were small; thus, as per several clinical practice guidelines, it is important to monitor antiulcer agent use and discontinue unnecessary use. The baseline risk should be considered when clinically evaluating the association between antiulcer agents and HO-CDI.

Eating and drinking habits and its association with obesity in Japanese healthy adults: retrospective longitudinal big data analysis using a health check-up database.

Few longitudinal studies have evaluated the association between eating and drinking habits and the risk of obesity. Therefore, we conducted a 5-year longitudinal big data analysis for evaluating various eating and drinking habits and the risk of obesity. We analysed individuals without obesity who received medical check-ups from 2008 to 2012 and 5 years later from the JMDC Health check-up database. The primary outcome was the incidence of obesity (BMI ≥ 25 kg/m2), and the secondary outcome was the incidence of abdominal obesity (waist circumference ≥ 85 cm for men and 90 cm for women). Age- and sex-adjusted, and multivariate logistic regression analyses were conducted. Of 123 182 individuals without obesity at baseline, the median age was 45 (interquartile range 40, 51) years and 76 965 (62·5 %) were men. After 5 years, 7133 (5·8 %) people developed obesity and 12 725 (10·3 %) people developed abdominal obesity. Among six eating and drinking habits, skipping breakfast was associated with a higher risk of obesity (OR 1·21; 99 % CI 1·10, 1·34). In contrast, occasional (OR 0·86; 99 % CI 0·78, 0·94) or daily (OR 0·79; 99 % CI 0·68, 0·91) drinking of alcoholic beverages was associated with a lower risk of obesity. According to the 5-year longitudinal data, eating and drinking habits such as mild to moderate alcohol consumption and avoiding skipping breakfast may result in better obesity prevention. However, excess alcohol consumption would be harmful and should be avoided.

Intergenerational comparison of 5-HT3RA in the prevention of chemotherapy-induced nausea and vomiting in gastric cancer patients receiving cisplatin-based chemotherapy: an observational study using a Japanese administrative claims database.

PURPOSE: In chemotherapy-induced nausea and vomiting (CINV), the superiority of the second-generation 5-hydroxytryptamine-3 receptor antagonist (5-HT3RA) over the first-generation 5-HT3RA is shown in the delayed emesis in cycle 1. We evaluate the antiemetic efficacy in real-world clinical practice that has not been sufficiently investigated in clinical trials. METHODS: We included patients who were diagnosed with gastric cancer between April 2012 and June 2017 from the medical claims databases and were treated with cisplatin (≥ 50 mg/m2) and standard antiemetic therapy (5-HT3RA + neurokinin-1 receptor antagonist [NK1RA] + dexamethasone). We compared the second-generation 5-HT3RA (2nd group) and the first-generation 5-HT3RA (1st group) groups to evaluate the additional antiemetic drug as the CINV event. RESULTS: In total, 3798 patients were extracted; 1440 and 2358 patients were included in the 1st and 2nd groups, respectively. The clinical and demographic characteristics did not differ between the groups. In the overall (days 1-6) in cycle 1, 51.7% and 44.3% of patients in the 1st and 2nd groups, respectively, had a CINV event. In the acute phase (days 1-2), 38.7% and 30.2% and in the delayed phase (days 3-6), 35.8% and 32.1% of patients in the 1st and 2nd groups, respectively, had a CINV event. Furthermore, the CINV event trend was the same as in cycles 1 to 5. CONCLUSION: The proportion of CINV events in the 2nd group was smaller than that in the 1st group at any cycle. These findings may suggest consistent antiemetic efficacy of second-generation 5-HT3RA throughout the cycle.

Risk factors of venous thromboembolism in patients with nephrotic syndrome: a retrospective cohort study.

BACKGROUND: Nephrotic syndrome is associated with an increased risk of venous thromboembolism (VTE). However, the risk factors of VTE in nephrotic syndrome, other than hypoalbuminemia and severe proteinuria, are not well established. Therefore we aimed to investigate the risk factors of VTE in patients with nephrotic syndrome. METHODS: This retrospective cohort study used data from a Japanese nationwide claims database. We identified patients ≥18 years of age hospitalized with nephrotic syndrome. Through multivariable logistic regression, we determined the risk factors of VTE in patients with nephrotic syndrome during hospitalization. RESULTS: Of the 7473 hospitalized patients with nephrotic syndrome without VTE, 221 (3.0%) developed VTE. In the VTE group, 14 (6.3%), 11 (5.0%) and 198 (89.6%) patients developed pulmonary embolism, renal vein thrombosis and deep vein thrombosis, respectively. We found that female sex {odds ratio [OR] 1.39 [95% confidence interval (CI) 1.05-1.85]}, body mass index (BMI) ≥30 [OR 2.01 (95% CI 1.35-2.99)], acute kidney injury [AKI; OR 1.67 (95% CI 1.07-2.62)], sepsis [OR 2.85 (95% CI 1.37-5.93)], lupus nephritis [OR 3.64 (95% CI 1.58-8.37)] and intravenous corticosteroids use [OR 2.40 (95% CI 1.52-3.80)] were associated with a significantly higher risk of developing VTE. CONCLUSIONS: In patients with nephrotic syndrome, female sex, BMI ≥30, AKI, sepsis, lupus nephritis and intravenous corticosteroid use may help evaluate the risk of VTE.

Short-term exposure to desert dust and the risk of acute myocardial infarction in Japan: a time-stratified case-crossover study.

Particulate matter from natural sources such as desert dust causes harmful effects for health. Asian dust (AD) increases the risk of acute myocardial infarction (AMI). However, little is known about the risk of myocardial infarction with nonobstructive coronary arteries (MINOCA), compared to myocardial infarction with coronary artery disease (MI-CAD). Using a time-stratified case-crossover design and conditional logistic regression models, the association between short-term exposure to AD whereby decreased visibility (< 10 km) observed at each monitoring station nearest to the hospitals was used for exposure measurements and admission for AMI in the spring was investigated using a nationwide administrative database between April 2012 and March 2016. According to presence of revascularization and coronary atherosclerosis, AMI patients (n = 30,435) were divided into 2 subtypes: MI-CAD (n = 27,202) or MINOCA (n = 3233). The single lag day-2 was used in AD exposure based on the lag effect analysis. The average level of meteorological variables and co-pollutants on the 3 days prior to the case/control days were used as covariates. The occurrence of AD events 2 days before the admission was associated with admission for MINOCA after adjustment for meteorological variables [odds ratio 1.65; 95% confidence interval (CI) 1.18-2.29], while the association was not observed in MI-CAD. The absolute risk difference of MINOCA admission was 1.79 (95% CI 1.21-2.38) per 100,000 person-year. These associations between AD exposure and the admission for MINOCA remained unchanged in two-pollutant models. This study provides evidence that short-term exposure to AD is associated with a higher risk of MINOCA, but not MI-CAD.

Follow-up tests and outcomes for patients undergoing percutaneous coronary intervention: analysis of a Japanese administrative database.

Follow-up tests after percutaneous coronary intervention (PCI) are considered inappropriate for asymptomatic patients. Despite this perception, many cardiologists conduct follow-up tests as routine practice. The objective of this study was to investigate the survival benefits of follow-up testing after PCI in a real-world setting in Japan. A nationwide Japanese administrative database was used to identify unselected patients who underwent PCI with stent implantation between January 2010 and December 2013. We used time-dependent Cox proportional hazards models to evaluate the association between follow-up testing and outcomes. The primary outcome was the composite of all-cause death and acute myocardial infarction (AMI). Among a total of 21,409 patients, 15,095 (70.5%) completed follow-up testing, of whom 9814 (45.0%) underwent coronary angiography. During a median of 2.7 years of observation, the primary outcome occurred less frequently for patients who underwent follow-up testing (1.21 vs. 4.51% per year; adjusted hazard ratio, 0.59; 95% CI 0.52-0.67; p < 0.001). Individual rates of all-cause death and AMI were also lower for the patients who underwent follow-up testing. Follow-up testing was associated with a lower risk of all-cause death and/or AMI. However, because of the unexpectedly large effect and many limitations of the administrative data, our findings should be further investigated to assess the net benefit of follow-up tests. In addition, we do not intend to encourage routine follow-up tests for patients without clear clinical indications. Follow-up tests should be conducted in accordance with clinical indications.

Effect of Regular Exercise and Functional Beverages on Changes in Body Weight and Waist Circumference in Healthy Japanese Subjects.

Background and objectives: The effects on anthropometry of several lipid-related foods for specified health uses (FOSHU) approved in Japan are not well known. We examined the effects of regular exercise and lipid-related FOSHU beverages on changes in body weight (BW) and waist circumference (WC) among factory and office workers. Materials and Methods: A total of 3002 subjects aged 20 years or older (2497 men and 505 women) received health check-ups in 2015 and 2016 and completed a lifestyle questionnaire. The association between regular exercise or lipid-related FOSHU beverage intake and changes in BW or WC were evaluated using trend test and linear regression analysis. Results: Regular exercise (≥1/week) was reported by 774 subjects (25.8%), and regular consumption of lipid-related FOSHU beverages (≥1/week) was reported by 1168 subjects (38.9%). The significant association between lipid-related FOSHU beverage intake and changes in BW was only observed among subjects with regular exercise (p for trend = 0.042). In the multivariable analysis, sex, older age, baseline weight, baseline body mass index (BMI), and regular exercise behavior were significantly associated with smaller changes in BW (p < 0.05). In WC, only the baseline values of WC and BMI were associated with one-year changes of WC. Conclusions: The combination of regular exercise and lipid-related FOSHU may be effective in maintaining BW.

Treatment for patients with autosomal dominant polycystic kidney disease in the chronic kidney disease without kidney replacement therapy in real-world clinical practice: a descriptive retrospective cohort study.

BACKGROUND: In real-world clinical practice, treatments selected for patients with autosomal dominant polycystic kidney disease (ADPKD) in the chronic kidney disease (CKD) without kidney replacement therapy (KRT) have not been reported. This study investigated the oral treatments used in these patients and the changes in their use in recent years. Additionally, we studied the factors affecting tolvaptan dose reduction or discontinuation. METHODS: This retrospective cohort study was conducted using the medical records of 160 hospitals in Japan. Patients with ADPKD or polycystic kidney disease registered on the database between January 2014 and December 2020 were selected. Changes in prescription proportions over time were assessed using the Cochran-Armitage test. We focused on patients prescribed with >15 mg of tolvaptan daily to identify the factors related to its dose reduction or discontinuation and used Multivariate Cox regression analysis to evaluate them. RESULTS: Tolvaptan use in patients with ADPKD in the CKD without KRT stage has increased. As of 2020, 25% of patients were treated with tolvaptan. Overall, 3639 patients with ADPKD were enrolled in the database, of whom 156 were treated with tolvaptan. Of these, 64 patients (41%) reduced or discontinued tolvaptan during the observation period. The presence of an estimated glomerular filtration rate <60 mL/min/1.73 m2 at the beginning of the treatment was associated with a higher risk of tolvaptan dose reduction or discontinuation. CONCLUSION: The proportion of patients with ADPKD treated with high-dose tolvaptan is increasing. However, patients with late-stage CKD tended to reduce or discontinue tolvaptan.

Comparison of Endovascular Therapy and Open Surgical Revascularization in Patients With Acute Superior Mesenteric Artery Occlusion: A Large-Scale Analysis Based on the JROAD-DPC Database.

BACKGROUND: Acute mesenteric ischemia is rare, and few large-scale trials have evaluated endovascular therapy (EVT) and open surgical revascularization (OS). This study aimed to assess clinical outcomes after EVT or OS for acute superior mesenteric artery occlusion and identify predictors of mortality and bowel resection. METHODS AND RESULTS: Data from the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination (JROAD-DPC) database from April 2012 to March 2020 were retrospectively analyzed. Overall, 746 patients with acute superior mesenteric artery occlusion who underwent revascularization were classified into 2 groups: EVT (n=475) or OS (n=271). The primary clinical outcome was in-hospital mortality. The secondary outcomes were bowel resection, bleeding complications (transfusion or endoscopic hemostasis), major adverse cardiovascular events, hospitalization duration, and cost. The in-hospital death or bowel resection rate was ≈30%. In-hospital mortality (22.5% versus 21.4%, P=0.72), bowel resection (8.2% versus 8.5%, P=0.90), and major adverse cardiovascular events (11.6% versus 9.2%, P=0.32) were comparable between the EVT and OS groups. Hospitalization duration in the EVT group was 6 days shorter than that in the OS group, and total hospitalization cost was 0.88 million yen lower. Interaction analyses revealed that EVT and OS had no significant difference in terms of in-hospital death in patients with thromboembolic and atherothrombotic characteristics. Advanced age, decreased activities of daily living, chronic kidney disease, and old myocardial infarction were significant predictive factors for in-hospital mortality. Diabetes was a predictor of bowel resection after revascularization. CONCLUSIONS: EVT was comparable to OS in terms of clinical outcomes in patients with acute superior mesenteric artery occlusion. Some predictive factors for mortality or bowel resection were obtained. REGISTRATION: URL: www.umin.ac.jp/ctr/; Unique Identifier: UMIN000045240.

Health-Related Quality of Life After Percutaneous Coronary Intervention for Stable Ischemic Heart Disease: A Systematic Review and Meta-analysis.

BACKGROUND: There has been no meta-analysis of whether percutaneous coronary intervention (PCI) with optimal medical therapy (OMT) improves health-related quality of life (HRQL) compared with OMT alone in patients with stable ischemic heart disease (SIHD). METHODS: We searched MEDLINE, Cochrane Central Registry of Controlled Trials, Embase, ClinicalTrials.gov, and International Clinical Trials Registry Platform in November 2022. We included randomized controlled trials (RCTs) that compared PCI with OMT vs OMT alone with HRQL in patients with SIHD. The primary outcome was the aggregated physical HRQL, including physical functioning using the Short Form (SF)-36 or RAND-36, physical limitation using the Seattle Angina Questionnaire (SAQ) or SAQ-7, McMaster Health Index Questionnaire, and Duke Activity Status Index within 6 months. Data were analyzed using a random effects model when substantial heterogeneity was identified or a fixed effect model otherwise. RESULTS: Among 14 systematically reviewed RCTs, 12 RCTs with 12,238 patients were meta-analyzed. Only 1 trial had a low risk of bias in all domains. PCI with OMT improved aggregated physical HRQL (standardized mean difference, 0.16; 95% confidence interval [CI], 0.1-0.23; P < 0.0001) at 6 months. Also, PCI with OMT improved physical functioning on the SF-36/RAND-36 (mean difference 3.65; 95% CI, 1.88-5.41) and physical limitation on the SAQ/SAQ-7 (mean difference, 3.09; 95% CI, 0.93-5.24) compared with OMT alone at 6 months. However, all of the aggregated physical HRQL domains were classified into small effects, and no HRQL domain exceeded the prespecified minimal clinically important difference. CONCLUSIONS: These findings showed that PCI with OMT improved HRQL compared with OMT alone in patients with SIHD, but the benefit was not large.

In-hospital mortality and cardiovascular treatment during hospitalization for heart failure among patients with schizophrenia: a nationwide cohort study.

AIMS: Schizophrenia is associated with cardiovascular disease (CVD) risk, and patients with schizophrenia are more likely to receive suboptimal care for CVD. However, there is limited knowledge regarding in-hospital prognosis and quality of care for patients with schizophrenia hospitalized for heart failure (HF). This study sought to elucidate the association between schizophrenia and in-hospital mortality, as well as cardiovascular treatment in patients hospitalized with HF. METHODS: Using the nationwide cardiovascular registry data in Japan, a total of 704,193 patients hospitalized with HF from 2012 to 2019 were included and stratified by age: young age, > 18 to 45 years (n = 20,289); middle age, >45 to 65 years (n = 114,947); and old age, >65 to 85 years (n = 568,957). All and 30-day in-hospital mortality as well as prescription of cardiovascular medications were assessed. After multiple imputation for missing values, mixed-effect multivariable logistic regression analysis was performed using patient and hospital characteristics with hospital identifier as a variable with random effects. RESULTS: Patients with schizophrenia were more likely to experience prolonged hospital stays, and incur higher hospitalization costs. In-hospital mortality for non-elderly patients with schizophrenia was significantly worse than for those without schizophrenia: the mortality rate was 7.6% vs 3.5% and the adjusted odds ratio (OR) was 1.96 (95% confidence interval (CI): 1.24-3.10, P = 0.0037) in young adult patients; 6.2% vs 4.0% and 1.49 (95% CI: 1.17-1.88, P < 0.001) in middle-aged patients. Thirty-day in-hospital mortality was significantly worse in middle-aged patients: the mortality rate was 4.7% vs 3.0% and an adjusted OR was 1.40 (95% CI: 1.07-1.83, P = 0.012). In-hospital mortality in elderly patients did not differ between those with and without schizophrenia. Prescriptions of beta-blockers and angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers were significantly lower in patients with schizophrenia across all age groups. CONCLUSION: Schizophrenia was identified as a risk factor for in-hospital mortality and reduced prescription of cardioprotective medications in non-elderly patients hospitalized with HF. These findings highlight the necessity for differentiated care and management of HF in patients with severe mental illnesses.

Association between patient volume to cardiologist, process of care, and clinical outcomes in heart failure.

AIMS: The impact of hospital volume on clinical performance has been investigated by many researchers to date and thought that it is associated with quality of care and outcome for patients with heart failure (HF). This study sought to determine whether annual admissions of HF per cardiologist are associated with process of care, mortality, and readmission. METHODS AND RESULTS: Among the nationwide registry 'Japanese registry of all cardiac and vascular diseases - diagnostics procedure combination' data collected from 2012 to 2019, a total of 1 127 113 adult patients with HF and 1046 hospitals were included in the study. Primary outcome was in-hospital mortality, and secondary outcome was 30 day in-hospital mortality and readmission at 30 days and 6 months. Hospital and patient characteristics and process of care measures were also assessed. Mixed-effect logistic regression and Cox proportional-hazards model was used for multivariable analysis, and adjusted odds ratio and hazard ratio were evaluated. Process of care measures had inverse trends for annual admissions of HF per cardiologist (P < 0.01 for all measures: prescription rate of beta-blocker, angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, mineralocorticoid receptor antagonist, and anticoagulant for atrial fibrillation). Adjusted odds ratio for in-hospital mortality was 1.04 (95% confidence interval (CI): 1.04-1.08, P = 0.04) and 30 day in-hospital mortality was 1.05 (95% CI: 1.01-1.09, P = 0.01) for interval of 50 annual admissions of HF per cardiologist. Adjusted hazard ratio for 30 day readmission was 1.05 (95% CI: 1.02-1.08, P < 0.01) and 6 month readmission was 1.07 (95% CI: 1.03-1.11, P < 0.01). Plots of the adjusted odds indicated 300 as the threshold of annual admissions of HF per cardiologist for substantial increase of in-hospital mortality risk. CONCLUSIONS: Our findings demonstrated that annual admissions of HF per cardiologist are associated with worse process of care, mortality, and readmission with the threshold for mortality risk increased, emphasizing the optimal proportion of patients admitted with HF to cardiologist for better clinical performance.