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Patients with atrial fibrillation and stable coronary artery disease were assigned to receive either rivaroxaban monotherapy or combination therapy with rivaroxaban plus a single antiplatelet agent. At 2 years, monotherapy was noninferior to combination therapy with respect to ischemic events and superior with respect to major bleeding.

Catheter-based micro-axial ventricular assist device Impella® (Abiomed, Danvers, MA) has been used in Japanese patients with drug-refractory acute heart failure (AHF) since 2017. This is the first interim analysis of the ongoing Japan Registry for Percutaneous Ventricular Assist Device (J-PVAD) to investigate the safety and efficacy of Impella support. Between October 2017 and January 2020, 823 Japanese patients, who were treated with the Impella 2.5, CP, or 5.0 pump, were enrolled. The primary endpoints were safety profiles and cumulative 30-day survival. Among them, 44.8% of patients were acute myocardial infarction with cardiogenic shock. The Impella pumps were unable to implant in 4 patients. The Impella 2.5, CP, and 5.0 pumps were used in 72.4%, 6.2%, and 16.6%, respectively, and mean support duration was 8.1 ± 10.2 days. Combination use of Impella and venoarterial extracorporeal membrane oxygenation (VA-ECMO) was applied for 387 patients (47.3%). Pump stop occurred 22 patients (2.7%). Major adverse events included hemolysis (11.2%), hemorrhage/hematoma (6.1%), peripheral ischemia (1.6%), and stroke (1.6%). The overall 30-day survival was 62.2%. Survival of patients with single Impella support was significantly higher than patients with Impella combined with VA-ECMO support (81.1% vs 49.6%; p  < 0.01), who had lower blood pressure, lower left ventricular ejection fraction, and higher degree of inotropic support. Results suggest that short-term outcome of Impella support for Japanese patients was favorable with acceptable safety profiles.

Background There have been scarce data comparing cardiovascular outcomes between individual sodium-glucose cotransporter-2 (SGLT2) inhibitors. We aimed to compare the subsequent cardiovascular risk between individual SGLT2 inhibitors. Methods We analyzed 25,315 patients with diabetes mellitus (DM) newly taking SGLT2 inhibitors (empagliflozin: 5302, dapagliflozin: 4681, canagliflozin: 4411, other SGLT2 inhibitors: 10,921). We compared the risks of developing heart failure (HF), myocardial infarction (MI), angina pectoris (AP), stroke, and atrial fibrillation (AF) between individual SGLT2 inhibitors. Results Median age was 52 years, and 82.5% were men. The median fasting plasma glucose and HbA1c levels were 149 (Q1-Q3:127–182) mg/dL and 7.5 (Q1-Q3:6.9–8.6) %. During a mean follow-up of 814 ± 591 days, 855 HF, 143 MI, 815 AP, 340 stroke, and 139 AF events were recorded. Compared with empagliflozin, the risk of developing HF, MI, AP, stroke, and AF was not significantly different in dapagliflozin, canagliflozin, and other SGLT inhibitors. For developing HF, compared with empagliflozin, hazard ratios of dapagliflozin, canagliflozin, and other SGLT2 inhibitors were 1.02 (95% confidence interval [CI] 0.81–1.27), 1.08 (95% CI 0.87–1.35), and 0.88 (95% CI 0.73–1.07), respectively. Wald tests showed that there was no significant difference in the risk of developing HF, MI, AP, stroke, and AF among individual SGLT2 inhibitors. We confirmed the robustness of these results through a multitude of sensitivity analyses. Conclusion The risks for subsequent development of HF, MI, AP, stroke, and AF were comparable between individual SGLT2 inhibitors. This is the first study comparing the wide-range cardiovascular outcomes of patients with DM treated with individual SGLT2 inhibitors using large-scale real-world data.

Canagliflozin (Cana), a sodium-glucose cotransporter 2 (SGLT2) inhibitor with additional affinity for SGLT1, has demonstrated cardioprotective effects. However, its role in modulating ventricular electrophysiology and structural remodeling under stress conditions remains insufficiently characterized. We have previously reported electrical and structural remodeling in a rat model of isoproterenol (ISP)-induced myocardial injury. In this study, we investigated the protective effects of Cana and its underlying mechanism in an ISP-induced myocardial injury model using Sprague Dawley rat hearts and in neonatal rat ventricular cardiomyocytes (NRVCMs). Our data revealed that Cana significantly suppressed ISP-induced prolongation of electrophysiological parameters, reduced oxidative stress, preserved mitochondrial function, and elevated ketone body levels. In NRVCMs, Cana -rather than β-hydroxybutyrate (βOHB)- improved mitochondrial integrity, attenuated apoptosis, and downregulated SGLT1, sodium–calcium exchanger 1 (NCX1), and sodium–hydrogen exchanger 1 (NHE1) expression. These effects were at least partly abolished by phosphoinositide 3-kinase (PI3K)/ protein kinase B (Akt) inhibition. Collectively, these findings suggest that Cana modulates electrical remodeling and exerts cardioprotective effects by enhancing mitochondrial function and regulating calcium transport. These results underscore the therapeutic potential of Cana in cardiovascular diseases.

Six-minute walk distance (6MWD) of 300 and 400 m are important targets of functional capacity. The present study was performed to determine cutoff values of physical function associated with 6MWD < 300 m and < 400 m in elderly patients with heart failure (HF). 6MWD, handgrip strength, quadriceps isometric strength (QIS), one-leg standing time (OLST), and 5-times sit-to-stand (5STS) before hospital discharge were evaluated in 1001 patients > 65 years (median age, 75: interquartile range, 71–80, 607 men) with HF. 6MWD < 300 and < 400 m were seen in 323 patients (32.3%) and 658 patients (65.7%), respectively. Handgrip strength, QIS, OLST, and 5STS were associated with 6MWD < 300 and < 400 m, respectively ( P  < 0.001). The cutoff values of handgrip strength, QIS, OLST, and 5STS were 18.9 kg, 35.0% body mass (BM), 9.1 s, and 9.5 s for 6MWD < 300 m, and 21.9 kg, 40.0% BM, 12.0 s, and 8.8 s for < 400 m, respectively. The cutoff values of physical function could be used to set cardiac rehabilitation goals and limiting determinants of reduced functional capacity in a clinical setting in elderly patients with HF.

Little is known regarding the relationship between self-reported gait speed and the subsequent risk of heart failure (HF) and cardiovascular disease (CVD). We sought to clarify the clinical utility of self-reported gait speed in primary CVD prevention settings. This is an observational cohort study using the JMDC Claims Database, which is an administrative health claims database. Data were collected between January 2005 and April 2020. Medical records of 2,655,359 participants without a prior history of CVD were extracted from the JMDC Claims Database. Gait speed was assessed using information from questionnaires provided at health check-ups, and study participants were categorized into fast or slow gait speed groups. The primary outcome was HF. The secondary outcomes included myocardial infarction (MI), angina pectoris (AP), and stroke. The median age was 45.0 years, and 55.3% of participants were men. 46.1% reported a fast gait speed. The mean follow-up period was 1180 ± 906 days. HF, MI, AP, and stroke occurred in 1.9%, 0.2%, 1.9%, and 1.0% of participants, respectively. Multivariable Cox regression analyses showed that, compared with slow gait speed, fast gait speed was associated with a lower incidence of HF, MI, AP, and stroke. The discriminative predictive ability for HF significantly improved by adding self-reported gait speeds to traditional risk factors (net reclassification improvement 0.0347, p  < 0.001). In conclusion, our analysis demonstrated that subjective gait speed could be a simple method to stratify the risk of HF and other CVD events in the general population. Further investigations are required to clarify the underlying mechanism of our results and to develop a novel approach for primary CVD prevention.

The post-intensive care syndrome (PICS) encompasses multiple, diverse conditions, such as physical disability, cognitive impairment, and depression. We sought to evaluate whether conditions within PICS have similar associations with mortality among survivors of critical illness. In this retrospective cohort study, we identified 248 critically ill patients with intensive care unit stay ≥72 hours, who underwent PICS evaluation. Patients with disability in activities of daily living, cognitive impairment, or depression before hospitalization were excluded. We defined PICS using established measures of physical disability (usual gait speed), cognitive impairment (Mini-Cog test), and depression (Patient Health Questionnaire-2) at hospital discharge. The endpoint was all-cause mortality. Patients had a median age of 69 years and Acute Physiology and Chronic Health Evaluation (APACHE) II score of 16. One hundred thirty-two patients were classified as having PICS, and 19 patients died. 81/248 (34%) patients had physical disability, 42/248 (19%) had cognitive impairment, and 44/248 (23%) had depression. After adjusting for covariates on multivariable Cox regression analyses, PICS was significantly associated with all-cause mortality (hazard ratio [HR] 3.78, 95% confidence interval [CI] 1.02 - 13.95; P = 0.046). However, the association between PICS and all-cause mortality was related to physical disability and cognitive impairment (P = 0.001 and P = 0.027, respectively), while depression was not (P = 0.623). While PICS as a syndrome has been useful in gaining attention to the sequelae of critical illness, its relationship with long-term mortality is driven largely by physical disability and cognitive impairment and not depression.

Although several randomized clinical trials have reported the potential benefit of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in reducing blood pressure (BP), whether SGLT2i can reduce incident hypertension is unknown. We analyzed individuals with diabetes who were newly prescribed SGLT2i or dipeptidyl peptidase 4 inhibitors (DPP4i) in a large-scale epidemiological database. The primary outcome was the incidence of hypertension. A propensity score matching algorithm was employed to compare the subsequent development of hypertension between the SGLT2i and DPP4i groups. After propensity score matching, 5708 well-balanced pairs of SGLT2i and DPP4i users were identified. SGLT2i administration was associated with a reduced risk of hypertension (HR 0.91, 95% CI: 0.84–0.97). The advantage of SGLT2i use over DPP4i use for incident hypertension was generally consistent in several sensitivity analyses, and subgroup analyses showed that SGLT2i use was significantly associated with a lower risk of hypertension in men, patients with baseline HbA1c of <7.5%, and baseline systolic blood pressure ≥127 mmHg. Our investigation using nationwide real-world data demonstrated the potential advantage of SGLT2i over DPP4i in reducing the development of hypertension in individuals with diabetes.

Cognitive function is an important factor for secondary prevention in elderly patients with cardiovascular diseases. The objective of this study was to evaluate the impact of cardiac rehabilitation (CR) on the improvement of cognitive function. A total of 66 consecutive elderly patients (≥70 years old) with cardiovascular diseases were prospectively enrolled. The change in cognitive function during 6 months was compared between the patients with monthly CR (at least once per month; n = 27) and those without monthly CR (n = 39). Cognitive function was evaluated using the Mini-mental State Examination (MMSE) and Frontal Assessment Battery (FAB). There was no significant difference in baseline characteristics between the 2 groups. The change in the MMSE score was significantly greater in patients with monthly CR than in those without monthly CR (2.3 ± 0.4 vs. -0.1 ± 0.3 points; p <0.001). Among the MMSE items, the change in temporal orientation and attention and calculation was significantly greater in the monthly CR group than in the non-monthly CR group (0.8 ± 0.7 vs. -0.1 ± 0.8 points [p <0.001] and 1.0 ± 1.5 vs. -0.1 ± 0.1 points [p <0.001], respectively). The general linear model revealed that monthly CR (effect estimate, 1.455; 95% confidence interval, 0.747-2.163; p <0.001) was independently associated with the change in the MMSE score. Cognitive function may improve with regular CR. These results might partly explain the efficacy of CR for secondary prevention.

Although physical activity (PA) decreases dramatically during hospitalization, an effective intervention method has not yet been established for this issue. We recently developed a multiperson PA monitoring system using information and communication technology (ICT) that can provide appropriate management and feedback about PA at the bedside or during rehabilitation. This ICT-based PA monitoring system can store accelerometer data on a tablet device within a few seconds and automatically display a graphical representation of activity trends during hospitalization. This randomized pilot study aims to estimate the feasibility and effect size of an educational PA intervention using our ICT monitoring system for in-hospital patients undergoing cardiac rehabilitation. A total of 41 patients (median age 70 years; 24 men) undergoing inpatient cardiac rehabilitation were randomly assigned to 2 groups as follows: wearing an accelerometer only (control) and using both an accelerometer and an ICT-based PA monitoring system. Patients assigned to the ICT group were instructed to gradually increase their step counts according to their conditions. Adherence to wearing the accelerometer was defined as having enough wear records for at least 2 days to allow for adequate analysis during the lending period. An analysis of covariance was performed to compare the change in average step count during hospitalization as a primary outcome and the 6-minute walking distance at discharge. The median duration of wearing the accelerometer was 4 days in the ICT group and 6 days in the control group. Adherence was 100% (n=22) in the ICT group but 83% (n=20) in the control group. The ICT group was more active (mean difference=1370 steps, 95% CI 437-2303) and had longer 6-minute walking distances (mean difference=81.6 m, 95% CI 18.1-145.2) than the control group. Through this study, the possibility of introducing a multiperson PA monitoring system in a hospital and promoting PA during hospitalization was demonstrated. These findings support the rationale and feasibility of a future clinical trial to test the efficacy of this educational intervention in improving the PA and physical function of in-hospital patients. University Hospital Medical Information Network UMIN000043312; http://tinyurl.com/m2bw8vkz.