Hemodynamic effect of supra-annular implantation of SAPIEN 3 balloon expandable valve.

The hemodynamic impact of the implantation depth for balloon-expandable valves is under-investigated, especially with higher implantation techniques. We assessed the hemodynamic performance of supra-annular SAPIEN 3 valve implantation. This retrospective study involved consecutive patients who underwent transcatheter aortic valve replacement (TAVR) using the SAPIEN 3. The device implantation depth and transcatheter heart valve (THV) leaflet-nadir position were angiographically analyzed, and supra-annular implantation was defined as a higher leaflet-nadir position than the original annular line. The Doppler hemodynamic status was evaluated at patient discharge. Among 184 patients, 120 (65%) underwent supra-annular implantation, and their mean implantation depth was significantly lower than that of intra-annular implantation (1.1 vs. 5.2 mm, p < 0.001). No patients developed valve embolization or coronary occlusion, and none required the TAV-in-TAV procedure. Two (1.6%) patients in the supra-annular implantation group had a mild or greater paravalvular leak. Echocardiography demonstrated that supra-annular implantation had better hemodynamic performance, showing a larger indexed effective orifice area (iEOA) compared with intra-annular implantation (1.09 vs. 0.97 cm2/m2, p < 0.01). There was a weak but negative correlation between the implantation depth and iEOA (r = - 0.27, p < 0.01). Moderate or severe prosthesis-patient mismatch (PPM) was found in 35.9% of the intra-annular group and 9.2% of supra-annular of the supra-annular group (p < 0.01). In the multivariable analysis, supra-annular implantation was an independent predictor of better THV function (iEOA > 0.85). Supra-annular SAPIEN 3 implantation provides beneficial hemodynamic effects and reduces the PPM risk.

Long-term Major Adverse Cardiac Event Prediction by Computed Tomography-derived Plaque Measures and Clinical Parameters Using Machine Learning.

Objectives The present study evaluated the usefulness of machine learning (ML) models with the coronary artery calcification score (CACS) and clinical parameters for predicting major adverse cardiac events (MACEs). Methods The Nationwide Gender-specific Atherosclerosis Determinants Estimation and Ischemic Cardiovascular Disease Prospective Cohort study (NADESICO) of 1,187 patients with suspected coronary artery disease (CAD) 50-74 years old was used to build a MACE prediction model. The ML random forest (RF) model was compared with a logistic regression analysis. The performance of the ML model was evaluated using the area under the curve (AUC) with the 95% confidence interval (CI). Results Among 1,178 patients from the NADESICO dataset, MACEs occurred in 103 (8.7%) patients during a median follow-up of 4.4 years. The AUC of the RF model for MACE prediction was 0.781 (95% CI: 0.670-0.870), which was significantly higher than that of the conventional logistic regression model [AUC, 0.750 (95% CI, 0.651-0.839)]. The important features in the RF model were coronary artery stenosis (CAS) at any site, CAS in the left anterior descending branch, HbA1c level, CAS in the right coronary artery, and sex. In the external validation cohort, the model accuracy of ensemble ML-RF models that were trained on and tuned using the NADESICO dataset was not similar [AUC: 0.635 (95% CI: 0.599-0.672)]. Conclusion The ML-RF model improved the long-term prediction of MACEs compared to the logistic regression model. However, the selected variables in the internal dataset were not highly predictive of the external dataset. Further investigations are required to validate the usefulness of this model.

Assessment of the safety and efficacy of catheter ablation for atrial fibrillation in very elderly patients: insight from the national prospective registry study.

BACKGROUND AND AIMS: This study evaluated the safety and efficacy of catheter ablation in treating atrial fibrillation (AF) among the elderly population. METHODS: A total of 170 017 AF ablation procedures prospectively enrolled from 482 facilities between 2017 and 2020 were analysed. They were stratified into six age groups, ranging from < 65 to ≥ 85 years, in 5-year increments. A cut-off of 80 years was set for dividing participants into two groups. The primary endpoints included procedure-related complications and 1-year arrhythmia recurrence after a 3-month blanking period. RESULTS: Patients ≥ 80 years constituted 7.2% of procedures in 2017, which significantly increased to 9.6% by 2020 (p < 0.001). This older group predominantly comprised women, with smaller stature and body mass index, a higher prevalence of paroxysmal AF, and a higher rate of initial ablation procedures. The overall complication rate was 2.8%, showing a positive correlation with age (p < 0.001), peaking at 4.3% for patients ≥ 85 years. Older age remained a significant independent risk factor for complications (odds ratio: 1.36 [1.24, 1.49], p < 0.001). Cardiac tamponade, ischemic stroke, and sick sinus syndrome were more common in the elderly. The recurrence rate in the total population was 16.0% and did not differ significantly between age groups (log-rank p = 0.473), remaining consistent even after adjusting for multiple variables. CONCLUSIONS: Although age increases complication risk, recurrence rates remained steady across age groups, suggesting that AF ablation is a reasonable option for elderly individuals, contingent on careful patient selection for safety. (ClinicalTrials.gov: NCT03729232).

A randomized controlled study to evaluate the safety and feasibility of concomitant transluminal injection of foam sclerosant combined with endovenous laser ablation in patients with incompetent small saphenous veins.

OBJECTIVES: To compare foam sclerotherapy through the access sheath (transluminal foam sclerotherapy [TLFS]) combined with endovenous laser ablation (EVLA) with EVLA alone in terms of safety and one-year venous clinical severity score (VCSS) changes in patients with small saphenous vein incompetence. METHODS: During EVLA, the sheath tip was placed around the targeted tributary vein, and the sclerosant was injected via the side port. Outcomes assessed at 1 day, 1 week, 1 month, and 1 year included VCSS changes, residual or recurrent reflux, the need for secondary interventions, and other related complications. RESULTS: The change in VCSS did not reach the minimum clinically important difference. Otherwise, TLFS reduced residual or recurrent reflux of the tributary using the TLFS (3/74 legs) compared with the EVLA alone (12/77 legs) (p = .027). CONCLUSIONS: TLFS is a safe and feasible procedure that reduces residual or recurrent reflux of the tributary vein compared with truncal EVLA alone.

Severity, Outcomes, and their Secular Changes in 33,870 Ischemic Stroke Patients with Atrial Fibrillation in a Hospital-Based Registry: Japan Stroke Data Bank.

AIM: Severity, functional outcomes, and their secular changes in acute atrial fibrillation (AF)-associated stroke patients were determined. METHODS: Acute ischemic stroke patients with AF in a hospital-based, multicenter, prospective registry from January-2000 through December-2020, were compared with those without AF. The co-primary outcomes were the initial severity assessed by the NIH Stroke Scale (NIHSS) score and favorable outcome assessed by the modified Rankin Scale scores 0-2 at hospital discharge. RESULTS: Of the 142,351 patients studied, 33,870 had AF. AF patients had higher NIHSS scores (median 9 vs. 3, adjusted coefficient 5.468, 95% CI 5.354-5.582) than non-AF patients. Favorable outcome was less common in AF patients than in non-AF patients in the unadjusted analysis (48.4% vs. 70.4%), but it was more common with adjustment for the NIHSS score and other factors (adjusted OR 1.110, 95% CI 1.061-1.161). In AF patients, the NIHSS score decreased throughout the 21-year period (adjusted coefficient -0.088, 95% CI -0.115 - -0.061 per year), and the reduction was steeper than in non-AF patients (P＜0.001). In AF patients, favorable outcome became more common over the period (adjusted OR 1.018, 95% CI 1.010-1.026), and the increase was steeper than in non-AF patients (P＜0.001); the increase was no longer significant after further adjustment by reperfusion therapy. CONCLUSIONS: Initial stroke severity became milder and functional outcomes improved in AF patients over the 21-year period. These secular changes were steeper than in non-AF patients, suggesting that AF-associated stroke seemed to reap more benefit of recent development of stroke care than stroke without AF.

New device for assessment of endothelial function: plethysmographic flow-mediated vasodilation (pFMD).

Measurement of flow-mediated vasodilation (FMD) in the brachial artery by using ultrasound is a well-established technique for evaluating endothelial function. To make the measurement quicker and simpler than the measurements of conventional ultrasound FMD (uFMD), we have developed a new noninvasive method, plethysmographic FMD (pFMD), to assess vascular response to reactive hyperemia in the brachial artery. The aim of this study was to determine the accuracy of measurement of pFMD in comparison to that of measurement of conventional uFMD. This study was a multi-center, cross-sectional study. We compared pFMD by a new device using cuff pressure and volume with conventional uFMD using ultrasound in 50 men (mean age, 41 ± 9 years). pFMD significantly correlated with conventional uFMD (ß = 0.59, P < 0.001). In Bland-Altman plot analysis of pFMD and conventional uFMD, the mean difference of pFMD and conventional uFMD was 0.78%, and limits of agreement (mean difference ±2 standard deviations of the difference) ranged from -4.53% to 6.11%. We demonstrated validity of the new method for measurement of pFMD, which can automate the evaluation of endothelial function in a short time. Measurement of pFMD is simpler than measurement of conventional uFMD and may have reduced artificial bias compared to that of conventional uFMD measurement (URL for Clinical Trial: https://ethics.hiroshima-u.ac.jp/site/wp-content/uploads/2022/12/eki_giji20221213.pdf . Registration Number for Clinical Trial: E2022-0131).

Tip Detection-Antegrade Dissection and Re-Entry With New Puncture Wire in CTO Intervention: Revolution Through 3D-Wiring.

Background: The authors devised the tip detection (TD) method and developed AnteOwl WR intravascular ultrasound to standardize intravascular ultrasound-based 3-dimensional wiring for intraplaque tracking in chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). The TD method also allowed antegrade dissection and re-entry (ADR). Combining TD-ADR with Conquest Pro 12 Sharpened Tip (CP12ST) wire, a new ADR wire with the strongest penetration force developed to date, enabled re-entry anywhere except calcification sites. Objectives: This study investigated the efficacy and feasibility of TD-ADR by comparison of procedural outcomes with Stingray-ADR in CTO-PCI. Methods: Twenty-seven consecutive CTO cases treated by TD-ADR with CP12ST wire between August 2021 and April 2023 and 27 consecutive CTO cases treated by Stingray-ADR with Conquest 8-20 (CP20) wire between March 2018 and July 2021 were retrospectively enrolled as the TD-ADR by CP12ST wire group and Stingray-ADR by CP20 wire group, respectively, from 4 facilities that could share technical information on these procedures. Results: The success rate of the ADR procedure was significantly improved (27 of 27 cases [100%] vs 18 of 27 cases [67%], respectively; P = 0.002) and total procedural time was significantly reduced (median procedural time: 145.0 [Q1-Q3: 118.0-240.0] minutes vs 185.0 [Q1-Q3: 159.5-248.0] minutes, respectively; P = 0.028) in the TD-ADR by CP12ST wire group compared to the Stingray-ADR by CP20 wire group. There were few in-hospital major adverse cardiac and cerebrovascular events or no complications in either group. Conclusions: TD-ADR by CP12ST wire can standardize highly accurate ADR in CTO-PCI.

Clinical impact of cardiovascular calcifications on stroke incidence in primary prevention: analysis in NADESICO study.

The utility of assessment of cardiovascular calcifications for predicting stroke incidence remains unclear. This study assessed the relationship between cardiovascular calcifications including coronary artery calcification (CAC), aortic valve (AVC), and aortic root (ARC) assessed by coronary computed tomography (CT) and stroke incidence in patients with suspected CAD. In this multicenter prospective cohort study, 1187 patients suspected of CAD who underwent coronary CT were enrolled. Cardiovascular events including stroke were documented. Hazard ratio (HR) and confidence interval (CI) were assessed by Cox proportional hazard model adjusted for the Framingham risk score. C statistics for stroke incidence were also examined by models including cardiovascular calcifications. A total of 980 patients (mean age, 65 ± 7 years; females, 45.8%) were assessed by the CAC, AVC, and ARC Agatston scores. During a median follow-up of 4.0 years, 19 patients developed stroke. Cox proportional hazard model showed severe CAC (Agatston score ≥ 90th percentile [580.0 value]) and presence of AVC and ARC were associated with stroke incidence (HR; 10.33 [95% CI; 2.08-51.26], 3.08 [1.19-7.98], and 2.75 [1.03-7.30], respectively). C statistic in the model with CAC and AVC severity for predicting stroke incidence was 0.841 (95% CI; 0.761-0.920), which was superior to the model with CAC alone (0.762 [95% CI; 0.665-0.859], P < 0.01). CAC, AVC, and ARC were associated with stroke incidence in patients suspected of CAD. Assessment of both CAC and AVC may be useful for prediction of stroke incidence.

Changes in Cardiac Function Following Fulminant Myocarditis.

BACKGROUND: The natural history of myocardial dysfunction in patients with fulminant myocarditis is poorly understood. This study aims to evaluate changes in cardiac function in patients with fulminant myocarditis using a nationwide registry in Japan. METHODS: This retrospective cohort study included patients with biopsy-proven fulminant myocarditis and available for left ventricular ejection fraction (LVEF). We described the LVEF on admission, at discharge, and 1 year after discharge. We divided patients into 2 groups based on LVEF at discharge (reduced ejection fraction of <50% or preserved ejection fraction of ≥50%) and analyzed changes in LVEF and prognosis according to groups. RESULTS: We included 214 patients (the median [first-third quartiles] age of the cohort was 48 [35-62] years, and 63 [38%] were female). Of 153 patients available for LVEF at 1 year, the median (first-third quartiles) LVEF increased from 33% (21-45%) on admission to 59% (49-64%) at discharge and further to 61% (55-66%) at 1 year. Of 153 patients, 45 (29%) and 22 (14%) had LVEF <50% at discharge and at 1 year, respectively. Comparisons between patients with LVEF <50% and those with LVEF ≥50% demonstrated that the former group had a higher adjusted probability of death or heart transplantation (hazard ratio, 8.19 [95% CI, 2.13-31.5]; P=0.002). CONCLUSIONS: Some patients with fulminant myocarditis had left ventricular dysfunction in the chronic phase. Patients with reduced left ventricular function at discharge had a worse prognosis than those with preserved left ventricular function. REGISTRATION: URL: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045352; Unique identifier: UMIN000039763.

Two-Year Clinical Outcome of MitraClip Transcatheter Edge-to-Edge Repair From the J-MITRA Registry Data.

BACKGROUND: The introduction of transcatheter edge-to-edge repair for moderate-to-severe or severe mitral regurgitation (MR) utilizing the MitraClip system became reimbursed and clinically accessible in Japan in April 2018. This study presents the 2-year clinical outcomes of all consecutively treated patients who underwent MitraClip implantation in Japan and were prospectively enrolled in the Japanese Circulation Society-oriented J-MITRA registry. METHODS AND RESULTS: Analysis encompassed 2,739 consecutive patients enrolled in the J-MITRA registry with informed consent (mean age: 78.3±9.6 years, 1,550 males, STS risk score 11.7±8.9), comprising 1,999 cases of functional MR, 644 of degenerative MR and 96 in a mixed group (DMR and FMR). The acute procedure success rate was 88.9%. After MitraClip implantation, >80% exhibited an MR grade ≤2+ and the trend was sustained over the 2 years. Within this observation period, the mortality rate was 19.3% and the rate of heart failure readmissions was 20.6%. The primary composite endpoint, inclusive of cardiovascular death and heart failure readmission, was significantly higher in patients with functional MR than in with degenerative MR (32.0% vs. 17.5%, P<0.001). CONCLUSIONS: The 2-year clinical outcomes after MitraClip implantation were deduced from comprehensive data within an all-Japan registry.

Prognostic Significance of Asymptomatic Cerebral Infarction in Patients After Cardiac Catheterization.

Recent studies have showed that asymptomatic cerebral infarction (ACI) developed in a reasonable number of patients after cardiac catheterization. However, no study has investigated the long-term prognostic impact of ACI after cardiac catheterization. We investigated whether ACI after cardiac catheterization affects long-term mortality and subsequent cardiovascular events.We retrospectively enrolled patients who underwent cardiac catheterization before cardiac surgery and cerebral diffusion-weighted magnetic resonance imaging (DWI). The incidence and clinical features of ACI were investigated. The long-term prognosis, including all-cause mortality and subsequent major cardiovascular events (MACE; all-cause mortality, stroke, acute myocardial infarction, fatal arrhythmia, and hospitalized heart failure), was also assessed.A total of 203 patients were enrolled. Of these, 10.3% had ACI diagnosed by DWI. There were no differences in baseline characteristics between patients with and without ACI, except more frequent history of symptomatic stroke in patients with ACI. In the Kaplan-Meier analysis during a median follow-up of 1009 days, the patients with ACI showed worse mortality and a slightly higher occurrence of MACE compared with those without ACI (P = 0.01 and P = 0.08, respectively). In addition, ACI was a prognostic marker independent of age, surgery type, and history of stroke.ACI after cardiac catheterization frequently developed and was also associated with long-term prognosis. It may be an independent prognostic marker in high-risk patients who underwent subsequent cardiac surgery.

Improvement of Functional Outcomes in Patients with Stroke who Received Alteplase for Over 15 Years: Japan Stroke Data Bank.

AIM: The nationwide verification of intravenous thrombolysis (IVT) was rarely performed after the extension of the therapeutic time window of alteplase or after the expansion of mechanical thrombectomy (MT). We aimed to examine the long-term change in accurate real-world outcomes of IVT in patients with acute ischemic stroke (AIS) using the Japan Stroke Databank, a representative Japan-wide stroke database. METHODS: We extracted all patients with AIS who received IVT with alteplase between October 11, 2005, the approval date for alteplase use for AIS in Japan, and December 31, 2020. Patients were categorized into three groups using two critical dates in Japan as cutoffs: the official extension date of the therapeutic time window for IVT to within 4.5 h of symptom onset and the publication date of the revised guideline, where the evidence level of MT was heightened. We assessed the yearly trend of IVT implementation rates and the secular changes and three-group changes in clinical outcomes at discharge. RESULTS: Of 124,382 patients with AIS, 9,569 (7.7%) received IVT (females, 41%; median age, 75 years). The IVT implementation rate has generally increased over time and plateaued in recent years. The proportion of favorable outcomes (modified Rankin Scale score of 0-2) increased yearly over 15 years. The results of the changes in the outcomes of the three groups were similar to those of the annual changes. CONCLUSIONS: We revealed that IVT implementation rates in patients with AIS increased, and the functional outcome in these patients improved over 15 years. Therefore, the Japanese IVT dissemination strategy is considered appropriate and effective.

Oral anticoagulation after atrial fibrillation catheter ablation: benefits and risks.

BACKGROUND AND AIMS: Few recent large-scale studies have evaluated the risks and benefits of continuing oral anticoagulant (OAC) therapy after catheter ablation (CA) for atrial fibrillation (AF). This study evaluated the status of continuation of OAC therapy and the association between continuation of OAC therapy and thromboembolic and bleeding events according to the CHADS2 score. METHODS: This retrospective study included data from the Japanese nationwide administrative claims database of patients who underwent CA for AF between April 2014 and March 2021. Patients without AF recurrence assessed by administrative data of the treatment modalities were divided into two groups according to continuation of OAC therapy 6 months after the index CA. The primary outcomes were thromboembolism and major bleeding after a landmark period of 6 months. After inverse probability of treatment weighting analysis, the association between OAC continuation and outcomes was determined according to the CHADS2 score. RESULTS: Among 231 374 patients included, 69.7%, 21.6%, and 8.7% had CHADS2 scores of ≤1, 2, and ≥3, respectively. Of these, 71% continued OAC therapy at 6 months. The OAC continuation rate was higher in the high CHADS2 score group than that in the low CHADS2 score group. Among all patients, 2451 patients (0.55 per 100 person-years) had thromboembolism and 2367 (0.53 per 100 person-years) had major bleeding. In the CHADS2 score ≤1 group, the hazard ratio of the continued OAC group was 0.86 [95% confidence interval (CI): 0.74-1.01, P = .06] for thromboembolism and was 1.51 (95% CI: 1.27-1.80, P < .001) for major bleeding. In the CHADS2 score ≥3 group, the hazard ratio of the continued OAC group was 0.61 (95% CI: 0.46-0.82, P = .001) for thromboembolism and was 1.05 (95% CI: 0.71-1.56, P = 0.81) for major bleeding. CONCLUSIONS: This observational study suggests that the benefits and risks of continuing OAC therapy after CA for AF differ based on the patient's CHADS2 score. The risk of major bleeding due to OAC continuation seems to outweigh the risk reduction of thromboembolism in patients with lower thromboembolic risk.

The Japanese Catheter Ablation Registry (J-AB): Annual report in 2021.

The Japanese Catheter Ablation (J-AB) registry, started in August 2017, is a voluntary, nationwide, multicenter, prospective, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center using a Research Electronic Data Capture system. The purpose of this registry is to collect the details of target arrhythmias, the ablation procedures, including the type of target arrhythmias, outcomes, and acute complications in the real-world settings. During the year of 2021, we have collected a total of 89 609 procedures (mean age of 66.1 years and 65.9% male) from 506 participant hospitals. Detailed data are shown in Figures and Tables.

Management and Outcomes of Acute Heart Failure Hospitalizations in Japan.

BACKGROUND: Heart failure (HF) is a global burden on healthcare systems, but the literature regarding nationwide trends in the care and outcomes of HF hospitalization in Japan is limited. Therefore, we aimed to investigate the trends in patient characteristics, treatment patterns, and outcomes of patients hospitalized with acute HF.Methods and Results: We used data from the Japanese Registry of All Cardiac and Vascular Diseases and the Diagnosis Procedure Combination database between April 2012 and March 2021 to analyze 840,357 patients aged ≥18 years who were hospitalized with an acute HF diagnosis. Over the study period (2012-2020), the mean (±standard deviation) age increased from 78.9 (±11.9) years to 80.9 (±11.8) years (P for trend <0.001), the proportion of female patients decreased from 48.7% to 47.5% (P for trend=0.02), crude in-hospital mortality rate decreased from 11.5% to 10.9%, and 30-day HF readmissions decreased from 7.4% to 7.0% (both P for trend <0.001). The reduction in outcomes was more apparent in the older age groups. The standardized outcomes demonstrated the same trends as the crude outcomes. CONCLUSIONS: Our nationwide hospital admission analysis clarified that patients hospitalized with acute HF were getting older, but mortality and readmission rates also decreased, especially in older patients during the 2010s.

Cardiovascular Hospitalizations and Hospitalization Costs in Japan During the COVID-19 Pandemic.

Background: During the COVID-19 pandemic, cardiovascular hospitalizations decreased and in-hospital mortality for ST-elevation myocardial infarction and heart failure increased. However, limited research has been conducted on hospitalization and mortality rates for cardiovascular disease (CVD) other than ischemic heart disease and heart failure. Methods and Results: We analyzed the records of 530 certified hospitals affiliated with the Japanese Circulation Society obtained from the nationwide JROAD-DPC database between April 2014 and March 2021. A quasi-Poisson regression model was used to predict the counterfactual number of hospitalizations for CVD treatment, assuming there was no pandemic. The observed number of inpatients compared with the predicted number in 2020 was 88.1% for acute CVD, 78% for surgeries or procedures, 77.2% for catheter ablation, and 68.5% for left ventricular assist devices. Furthermore, there was no significant change in in-hospital mortality, and the decrease in hospitalizations for catheter ablation and valvular heart disease constituted 47.6% of the total decrease in annual hospitalization costs during the COVID-19 pandemic. Conclusions: Cardiovascular hospitalizations decreased by more than 10% in 2020, and the number of patients scheduled for left ventricular assist device implantation decreased by over 30%. In addition, in response to the COVID-19 pandemic, annual cardiovascular hospitalization costs were reduced, largely attributed to decreased catheter ablation and valvular heart disease.

Characteristics and outcomes of unknown onset stroke: The Japan Stroke Data Bank.

BACKGROUND: Clinical outcomes of unknown onset stroke (UOS) are influenced by the enlargement of the therapeutic time window for reperfusion therapy. This study aimed to investigate and describe the characteristics and clinical outcomes of patients with UOS. METHODS: Patients with acute ischemic stroke (AIS) who were admitted within 24 h of their last known well time, from January 2017 to December 2020, were included. Data were obtained from a long-lasting nationwide hospital-based multicenter prospective registry: the Japan Stroke Data Bank. The co-primary outcomes were the National Institutes of Stroke Scale (NIHSS) scores on admission and unfavorable outcomes at discharge, corresponding to modified Rankin Scale (mRS) scores of 3-6. RESULTS: Overall, 26,976 patients with AIS were investigated. Patients with UOS (N = 5783, 78 ± 12 years of age) were older than patients with known onset stroke (KOS) (N = 21,193, 75 ± 13 years of age). Age, female sex, higher premorbid mRS scores, atrial fibrillation, and congestive heart failure were associated with UOS in multivariate analysis. UOS was associated with higher NIHSS scores (median = 8 [interquartile range [IQR]: 3-19] vs. 4 [1-10], adjusted incidence rate ratio = 1.37 [95% CI: 1.35-1.38]) and unfavorable outcomes (52.1 vs. 33.6%, adjusted odds ratio = 1.27 [1.14-1.40]). Intergroup differences in unfavorable outcomes were attenuated among females (1.12 [0.95-1.32] vs. males 1.38 [1.21-1.56], P = 0.040) and in the subgroup that received reperfusion therapy (1.10 [0.92-1.33] vs. those who did not receive therapy 1.23 [1.08-1.39], P = 0.012). CONCLUSIONS: UOS was associated with unfavorable outcomes but to a lesser degree among females and patients receiving reperfusion therapy.

Long-Term Follow-up Study of Hospitalizations for Acute Coronary Syndrome in Kobe-City and Other Districts Under the Hyogo Smoking Ban Legislation　- A Nationwide Database Study.

BACKGROUND: Hyogo Prefecture has managed smoking ban legislation with partial restrictions in public places (Hyogo-L) since 2013. Previous studies have reported a significant decrease in admissions for acute coronary syndrome (ACS) in Kobe-city, but not in other districts of Hyogo Prefecture in the 2 years after Hyogo-L. The aim of the present study was to define the long-term effect of Hyogo-L.Methods and Results: The JROAD-DPC dataset was used to collect information on the number of hospitalizations for ACS in Hyogo Prefecture, and in Osaka-city without smoking ban legislation, from April 2013 to March 2020. Poisson regression analysis was performed to calculate incident rate ratios (IRRs) and 95% confidence intervals (CIs). ACS records of 3,101 in Kobe-city, 11,375 in areas of Hyogo Prefecture other than Kobe-city and 11,079 in Osaka-city were collected for admissions. The incidence of ACS reduced significantly over time in Kobe-city [IRR (95% CI); 0.96 (0.94-0.97)], but did not reduce in the others. The decrease in Kobe-city was observed in ACS patients without smoking, hypertension, and hyperlipidemia, but not in those with such risk factors. CONCLUSIONS: The long-term ACS reduction or non-reduction under Hyogo-L was determined at the initial period and the same scenario continued, supporting the importance of legislation and compliance with the smoking ban. The lowering effect was remarkable in ACS patients without risk factors such as non-smoking.