Background:The wearable cardioverter defibrillator (WCD) has been available since 2014 in Japan, and its benefit in the in-hospital acute phase at high risk of ventricular tachyarrhythmia (VTA) has been established, but its clinical use in the outpatient setting remains unclear, especially in Japan.

Methods and Results:The subjects consisted of 43 consecutive patients with WCD use in the outpatient setting from April 2014 to October 2019 at the present institute. Event alerts and wearing compliance were checked via the remote monitoring system, and a dedicated WCD training team contacted the patients if necessary. The median observation period was 51 days (IQR, 37–68 days) and the median daily wearing time was 23.1 h/day (IQR, 22.0–23.6 h/day). WCD was prescribed for primary prevention of VTA in 7 patients (16%), and for secondary prevention in 36 (84%). The common reason for WCD use was preventive therapy and/or clinical observation. Two appropriate and one inappropriate shock were observed. Eleven patients were not indicated for ICD because of successful catheter ablation optimal medical therapy, VTA in early onset of heart disease and refusal. The remaining 32 patients, however, underwent ICD implantation.

Conclusions:In the present real-world study, the WCD wearing compliance was well-maintained in the outpatient setting. WCD is useful for patients at high risk of VTA.

Background:Heart rate (HR) reduction by β-blocker might not benefit patients with heart failure and reduced ejection fraction (HFrEF) with atrial fibrillation (AF).

Methods and Results:The J-CHF study was a prospective randomized multicenter trial that assigned 360 HFrEF patients to a 2.5 mg/5 mg/20 mg target dose of carvedilol. Carvedilol was uptitrated over 8 weeks and then the dose was fixed. Of 321 patients available for analysis, AF was identified in 65 (20%). Using the median absolute change in HR at 32 weeks (∆HR), the subjects were further divided into group A (∆HR >−6 beats/min) and B (∆HR ≤−6 beats/min). Both in sinus rhythm (SR) and AF, baseline characteristics and achieved carvedilol dose were similar between groups A and B. In SR, the time-dependent change in left ventricular EF (LVEF) and LV end-diastolic dimension (LVEDD) over 56 weeks was more favorable in B compared with A (∆LVEF, P=0.036; ∆LVEDD, P=0.047), and ∆HR was independently associated with ∆LVEF (P=0.040). Group B had a lower rate of the primary endpoint, defined as a composite of death and hospitalization due to cardiovascular causes including acute decompensated HF at 3 years (P=0.002). ∆HR was an independent predictor of the primary endpoint (P=0.01), but this was not observed in AF.

Conclusions:Response to the carvedilol HR reduction might differ in HFrEF between SR and AF.

Background:The onset of acute myocardial infarction (AMI) is related to weather conditions, but the impact of age on gender differences in the AMI onset–weather association has not been elucidated.

Methods and Results:We analyzed the Oita AMI Registry and obtained data for 403 enrolled patients. To examine the impact of age, we categorized the patients into 4 groups: young (age ≤65 years) women (n=20); young men (n=123); elderly (age >65 years) women (n=84); and elderly men (n=176). The analyzed meteorological factors were maximum and minimum temperature, intraday temperature difference, average humidity, and average atmospheric pressure. The young women group had a higher minimum temperature (17.7±5.7℃ vs. 13.8±8.2℃, P=0.04), lower intraday temperature difference (7.0±2.6℃ vs. 8.4±2.9℃, P=0.03), higher average humidity (74.5±12.1% vs. 68.1±12.0%, P=0.03), and lower average atmospheric pressure (1,009.5±5.0 hPa vs. 1,012.9±5.8 hPa, P=0.01) than the young men group on the onset day. In the elderly groups, there was no significant difference in meteorological variables except for the intraday temperature difference 2 days before AMI onset.

Conclusions:AMI onset appears to be more sensitive to weather conditions (i.e., minimum temperature, average atmospheric pressure, and average humidity) in young patients than in elderly patients. In particular, young women had AMI on days with low intraday temperature difference and high humidity relative to men.

Background:Direct-activated factor X (FXa) plays an important role in thrombosis and is also involved in inflammation via the protease-activated receptor (PAR)-1 and PAR-2 pathway. We hypothesized that rivaroxaban protects against cardiac remodeling after myocardial infarction (MI).

Methods and Results:MI was induced in wild-type mice by permanent ligation of the left anterior descending coronary artery. At day 1 after MI, mice were randomly assigned to the rivaroxaban and vehicle groups. Mice in the rivaroxaban group were provided with a regular chow diet plus rivaroxaban. We evaluated cardiac function by echocardiography, pathology, expression of mRNA and protein at day 7 after MI. Rivaroxaban significantly improved cardiac systolic function, decreased infarct size and cardiac mass compared with the vehicle. Rivaroxaban also downregulated the mRNA expression levels of tumor necrosis factor-α, transforming growth factor-β, PAR-1 and PAR-2 in the infarcted area, and both A-type and B-type natriuretic peptides in the non-infarcted area compared with the vehicle. Furthermore, rivaroxaban attenuated cardiomyocyte hypertrophy and the phosphorylation of extracellular signal-regulated kinase in the non-infarcted area compared with the vehicle.

Conclusions:Rivaroxaban protected against cardiac dysfunction in MI model mice. Reduction of PAR-1, PAR-2 and proinflammatory cytokines in the infarcted area may be involved in its cardioprotective effects.

Background:The aim of this study was to identify a relationship between zinc (Zn) deficiency and clinical outcome in patients with critical limb ischemia (CLI).

Methods and Results:Forty-five limbs from 44 patients with CLI who underwent de novo infrainguinal bypass grafting (IBG) were retrospectively reviewed. The patients were divided into a Zn deficiency group (ZD group: Zn <60 µg/dL) and a Zn sufficiency group (ZS group: Zn ≥60 µg/dL). Graft patency, limb salvage (LS), amputation-free survival (AFS), and wound healing were compared between the groups. LS and AFS were examined to identify whether Zn deficiency was an independent predictor. The preoperative factors potentially predictive of Zn deficiency were also analyzed. Twenty-four limbs were categorized into the ZD group. Patients in the ZD group were more likely to have undergone hemodialysis (HD) and have lower serum albumin. The surgical procedures were not significantly different between the groups. Patency, LS, AFS, and complete wound healing rates were significantly lower in the ZD group. Zn deficiency was a negative predictor of LS. Age >75 years and HD were identified as predictors of Zn deficiency.

Conclusions:Zn deficiency was associated with poor clinical outcome. Zn supplementation may improve clinical outcomes during IBG for CLI.

Background:Balloon pulmonary angioplasty (BPA) is an alternative therapy for chronic thromboembolic pulmonary hypertension (CTEPH). Right heart catheterization (RHC) is essential to evaluate the efficacy of BPA. Cardiac magnetic resonance imaging (CMR) is also now used to assess the structure and function of the right heart non-invasively. The aim of this study was to correlate improvement in CMR with that on RHC, and compared with improvement in other non-invasive findings after BPA.

Methods and Results:Forty-two patients underwent BPA between July 2012 and March 2015, and CMR, electrocardiography (ECG), and echocardiography were performed at the same time before and 6 months after BPA. Median pulmonary vascular resistance (PVR) was improved from 5.7 Wood units (IQR, 3.1–7.9 Wood units) to 2.7 Wood units (IQR, 1.6–3.9 Wood units; P<0.001). Changes in PVR were correlated with the changes in 5 CMR, 9 ECG, and 5 echocardiography parameters. On logistic analysis to identify the indicators of improving PH (i.e., PVR <3 Wood units), 4 CMR parameters were independently correlated with PVR change, one of which was median septal inversion ratio (SIR; 0.59; IQR, 0.54–0.63 to 0.54; IQR, 0.50–0.58, P<0.0001). SIR was the best predictor of PH (OR, 1.27; P<0.05).

Conclusions:CMR can be used to estimate hemodynamic changes after BPA, and SIR is useful to predict alleviation of PH.

Background:The aim of this study was to investigate the impact of anatomical site status and major vascular complication (MVC) severity on the outcome of transfemoral transcatheter aortic valve replacement (TF-TAVR).

Methods and Results:The FinnValve registry enrolled consecutive TAVR patients from 2008 to 2017. MVC was divided into 2 groups: non-access site-related MVC (i.e., MVC in aorta, aortic valve annulus or left ventricle); and access site-related MVC (i.e., MVC in iliac or femoral arteries). Severity of access site-related MVC was measured as units of red blood cell (RBC) transfusion. Of 1,842 patients who underwent TF-TAVR, 174 had MVC (9.4%; non-access site related, n=29; access site related, n=145). Patients with MVC had a significantly higher 3-year mortality than those without MVC (40.8% vs. 24.3%; HR, 2.01; 95% CI: 1.16–3.62). Adjusted 3-year mortality risk was significantly increased in the non-access site-related MVC group (mortality, 77.8%; HR, 4.30; 95% CI: 2.63–7.02), but not in the access site-related MVC group (mortality, 32.6%; HR, 1.38; 95% CI: 0.86–2.15). In the access site-related MVC group, only those with RBC transfusion ≥4 units had a significantly increased 3-year mortality risk (mortality, 51.8%; HR, 2.18; 95% CI: 1.19–3.89).

Conclusions:In patients undergoing TF-TAVR, MVC was associated with an increased 3-year mortality risk, incrementally correlating with anatomical site and bleeding severity.

Background:ETNA-VTE-Japan is a prospective, observational study conducted as part of a postmarketing study regarding the safety and effectiveness of edoxaban in Japanese patients with venous thromboembolism (VTE). The results of the final analysis of data collected at 1 year are presented.

Methods and Results:A total of 1,732 patients were included in this study. The safety and effectiveness were evaluated in 1,702 patients (safety analysis set; SAS) and in 1,698 patients (effectiveness analysis set). In the SAS, 39.4% of patients were aged ≥75 years, 58.2% had body weight ≤60 kg, and 22.2% had creatinine clearance <50 mL/min. Approximately 90% of patients received a dose recommended on the package insert. A total of 46.1% of patients continued treatment for 1 year, with mean and median treatment periods of 235.8 and 263.0 days, respectively. The incidence of bleeding adverse events (AE) was 10.3%; major bleeding, 2.6%; and VTE recurrence, 1.8%. The risk factor commonly associated with bleeding AE and VTE recurrence was cancer. The safety and effectiveness profiles of edoxaban in patients receiving the appropriate low dose (30 mg/day), generally used in patients with high bleeding risk, were similar to those for the appropriate standard dose (60 mg/day).

Conclusions:At 1 year of treatment, there were no major concerns regarding the safety and effectiveness of edoxaban in Japanese patients with VTE.