Background:Fractional flow reserve (FFR) is used to evaluate the need for percutaneous coronary intervention (PCI) in cases of moderate stenosis of the coronary artery. Recently, diagnostic imaging support with computational fluid dynamics (CFD) analysis has been garnering attention. This study defines the relationship between FFR conducted for cardiac catheterization and CFD analyses conducted using coronary computed tomography (CT) for moderate stenosis, in addition to considering whether wall pressure (WP) and wall shear stress (WSS) can be used to evaluate ischemia.

Methods and Results:Cases in which FFR was measured via coronary CT and cardiac catheterization was performed within 3 months were collected retrospectively. In the CFD analysis, WP and WSS were calculated and compared with FFR. Three groups were created to compare results of CFD analysis and FFR values according to the location of the stenosis: the right coronary artery, the left anterior descending artery, and the left circumflex artery. There was a correlation between FFR and WSS according to CFD analysis for moderate stenosis of the coronary artery, with a cut-off value for treatment able to be calculated.

Conclusions:The results of this study suggest that ischemia can be evaluated by conducting CFD analysis (WSS) using coronary CT.

Background:Oral anticoagulants (OACs) are effective in preventing stroke in patients with atrial fibrillation (AF), but are challenging for elderly patients because of the higher risk of bleeding complications.

Methods and Results:The ANAFIE Registry is a prospective multicenter observational study of elderly (≥75 years) Japanese AF patients. This subanalysis evaluated the current use of OACs. Of 32,713 patients (mean age 81.5 years), 30,068 (91.9%) were receiving OACs, including 8,354 (25.5%) on warfarin and 21,714 (66.4%) on direct OACs (DOACs); 2,645 (8.1%) were not receiving OACs. The most common prescribed dose was a reduced dose for all DOACs. A substantial proportion of patients receiving the reduced dose did not fulfill dose reduction criteria (underdosing): apixaban, 25.1%; rivaroxaban, 26.3%; and edoxaban, 13.7%. Some patients received a lower off-label dose rather than the reduced dose: apixaban, 5.9%; rivaroxaban, 0.3%; edoxaban, 5.3%; and dabigatran, 13.6%. In multivariate analyses, advanced age, history of hemorrhage, paroxysmal AF, and antiplatelet drug use were significantly associated with no OAC. Advanced age, persistent or permanent AF, chronic kidney disease, and concomitant antiplatelet drugs were associated with warfarin rather than DOAC use.

Conclusions:In the ANAFIE Registry, >90% of elderly Japanese AF patients received OAC therapy, mostly DOACs. Inappropriate low doses of DOACs that did not fulfill dose reduction criteria were prescribed in 20–30% of patients.

Background:Early intervention with enteral nutrition (EN) is the standard of care in many medical intensive care units (ICUs). However, few studies have addressed the use of early EN for critically ill patients in the cardiac ICU (CICU). In this study we explored the indications for early EN for patients admitted to a CICU.

Methods and Results:This retrospective observational study included 63 consecutive patients admitted to the CICU who were diagnosed with cardiovascular disease. Early EN was initiated in these patients as per the hospital’s nutrition protocol. Mean Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores at admission were 18.8 and 9.1, respectively. All patients were admitted to the medical CICU with a diagnosis of cardiovascular disease and/or cardiopulmonary arrest. Enteral feeding was initiated in 59 patients (94%) within 5 days of admission. Fifty-two patients (83%) achieved the energy intake goal at Day 7 of their CICU admission either by enteral feeding or oral intake; 49 patients (78%) survived to time of discharge. The patients experienced several minor complications, including minor reflux (4 patients; 6%) and diarrhea (8 patients; 13%). None of the patients developed aspiration pneumonia or bowel ischemia.

Conclusions:The present retrospective observational study indicates that early EN for critically ill patients in a medical CICU can be achieved safely with no major complications.

Background:Whether the dose of loop diuretics can be decreased by administration of a sodium-glucose cotransporter 2 (SGLT2) inhibitor in diabetic outpatients with compensated heart failure (HF) is unclear.

Methods and Results:This study prospectively enrolled 60 diabetic outpatients with compensated HF. Patients were randomly divided into 2 groups: those administered the SGLT2 inhibitor empagliflozin (n=28) and those not (n=30). Changes in the daily dose of loop diuretics, blood sampling data, and urinary renal tubular biomarkers were evaluated 6 months after the intervention. The median (interquartile range) furosemide dose decreased significantly over the 6-month follow-up period in the empagliflozin group (from 40 [20–40] to 20 [10–20] mg), but not in the non-empagliflozin group (from 23 [20–40] to 40 [20–40] mg). Hemoglobin levels increased significantly in the empagliflozin group (from 13.2 [11.9–14.6] to 14.0 [12.7–15.0] g/dL). In addition, excretion of acetyl-β-D-glucosaminidase decreased significantly over the 6-month follow-up in the empagliflozin group (from 4.8 [2.6–11.7] to 3.3 [2.1–5.4] IU/L), especially in the group in which the dose of loop diuretics decreased (from 4.7 [2.5–14.8] to 3.3 [2.1–4.5] IU/L).

Conclusions:Empagliflozin administration decreased the dose of loop diuretics and increased the production of erythropoietin, which may help prevent renal tubular injury in diabetic outpatients with HF.

Background:Angiotensin II receptor blockers (ARBs) are widely used for the management of hypertension in Japan; however, comparative efficacy data within the ARB drug class remain limited.

Methods and Results:This systematic literature review identified randomized controlled trials (RCT) indexed in PubMed and Ichushi in Japanese patients with hypertension receiving ARB monotherapy (azilsartan, candesartan cilexetil, irbesartan, losartan potassium, olmesartan medoxomil, telmisartan, valsartan) in at least 1 arm. Of 763 RCTs identified, 77 met the eligibility criteria; of which, 37 reported mean change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline in the office setting and were used to construct the network. A fixed-effects model (FEM) showed the effect of each drug vs. the reference, azilsartan. Using the FEM, the mean (95% credible interval) change from baseline in SBP/DBP for candesartan cilexetil, irbesartan, losartan potassium, olmesartan medoxomil, telmisartan, and valsartan was 3.8 (2.9–4.8)/2.6 (2.0–3.1), 4.8 (2.0–7.5)/3.7 (1.8–5.6), 3.0 (0.8–5.1)/1.9 (0.5–3.3), 3.2 (1.2–5.1)/2.7 (1.3–4.1), 3.2 (0.8–5.6)/2.0 (0.3–3.6), and 3.1 (1.1–5.1)/2.4 (1.1–3.8) mmHg, respectively.

Conclusions:The results of this meta-analysis provide evidence that azilsartan has a more favorable efficacy profile than the other ARBs in reducing SBP and DBP.

Background:In the era of big data, the utilization and analysis of large amounts of clinical data are imperative. The standardized structured medical information exchange version 2 (SS-MIX2) is a standard data storage format used in Japan to share clinical data from various vendor-derived hospital information systems. This storage format is divided into 2 categories: standardized and extension storage. Although the standardized storage includes clinical data such as basic patient data, prescriptions, and laboratory results, all other data are stored in the extension storage, because their formats are not standardized.

Methods and Results:In 2015, the Japanese Circulation Society developed the standard export data format (SEAMAT) for electrocardiography (ECG), ultrasound cardiography (UCG), and catheterization (CATH) data for the SS-MIX2 extension storage. Using physical examination and catheter report systems in accordance with the SEAMAT, specific cardiological data such as ECG, UCG, and CATH can be transferred to the SS-MIX2 extension storage, resulting in efficient secondary use of these data for research purposes.

Conclusions:SEAMAT can aid in the effective establishment of a nationwide clinical database, and reduce tedious manual data input by clinicians and clinical research coordinators. Moreover, a program that enables the conversion of comma-separated data from information systems into SEAMAT can provide a useful and economical tool for transferring huge clinical data to the SS-MIX2.

Background:Transcatheter aortic valve implantation (TAVI) has been widely used as a valued alternative to surgical aortic valve replacement. In cardiovascular surgeries, discharge disposition has been widely investigated. We examined the prevalence and predictors of non-home discharge after TAVI, and the prognosis based on discharge destination.

Methods and Results:We retrospectively analyzed 732 consecutive patients undergoing TAVI, and divided them into 2 groups: the home group (discharged directly home; n=678 [92.6%]) and the non-home group (n=54 [7.4%]). From baseline and procedural characteristics, peripheral artery disease (PAD; odds ratio [OR] 2.73; 95% confidence interval [CI] 1.25–5.97; P=0.012), previous stroke (OR 2.57; 95% CI 1.03–6.45; P=0.045), albumin level (OR 0.16 per 1-g/dL increase; 95% CI 0.07–0.39; P<0.001), and procedural stroke (OR 31.6; 95% CI 10.9–91.7; P<0.001) were independently associated with non-home discharge. In Kaplan-Meier analysis, the non-home group had worse survival than the home group (log-rank, P=0.001). In multivariate analysis, male sex, atrial fibrillation or atrial flutter, and low albumin concentrations were associated with all-cause mortality, but non-home discharge was not (P=0.18).

Conclusions:Non-home discharge was recorded for 7.4% of patients undergoing TAVI, and was associated with PAD, nutritional status, and previous and procedural stroke. Non-home discharge reflects worse baseline characteristics, and may be a marker of mid-term outcome after TAVI.

Background:The 6th World Symposium on Pulmonary Hypertension proposed that precapillary pulmonary hypertension (PH) be defined as mean pulmonary arterial pressure (mPAP) >20 mmHg instead of mPAP ≥25 mmHg. Peak tricuspid regurgitation velocity (TRV) >3.4 m/s is widely used to predict PH, but it is unclear whether this value remains reliable for the new definition of PH.

Methods and Results:We found that the optimal cut-off value of peak TRV for 511 PH patients was >2.8 m/s, with a sensitivity of 89.5%, specificity of 73.4%, and area under the curve of 0.89 (P<0.001).

Conclusions:Based on the new definition of PH, TRV >2.8 m/s can be considered to indicate a high probability of PH.

Background:Patients with thromboangiitis obliterans (TAO) can develop critical limb-threatening ischemia (CLTI) and require limb amputation. Smoking cessation and exercise therapy are recommended as standard treatments, and revascularization by bypass surgery or endovascular therapy (EVT) is required for patients with CLTI. However, there are many cases in which revascularization is difficult because of vascular characteristics, and the patency rate after revascularization remains unsatisfactory. Therapeutic angiogenesis using bone marrow-derived mononuclear cell (BM-MNC) implantation is used clinically, with many trials demonstrating long-term efficacy and safety of the technique in patients with CLTI, especially that caused by TAO. To expand the use of BM-MNCs implantation in clinical practice, further evidence is required in patients with CLTI caused by TAO.

Methods and Results:This trial is a multicenter, prospective, non-randomized interventional trial of an Advanced Medicine B treatment approach. We aim to enroll 25 patients aged 20–80 years with Fontaine classification Stage III or IV, who will undergo BM-MNC implantation. The primary endpoint is the improvement in skin perfusion pressure of the target limb 180 days after BM-MNC implantation, whereas secondary endpoints are improvements in rest pain or ulcer size. We will also investigate rates of major or minor amputation, survival, and adverse events during follow-up.

Conclusions:BM-MNC implantation is expected to be an efficacious and feasible treatment for patients with CLTI caused by TAO.