Japanese Multicenter Registry Research Articles

Midterm Results of a Japanese Prospective Multicenter Registry of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Above-the-Knee Femoropopliteal Bypass.

This study prospectively analyzed the midterm results of above-the-knee femoropopliteal bypass (AKb) using bioactive heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft in patients with femoropopliteal occlusive disease.Methods and Results:This prospective, multicenter, non-randomized study reviewed limbs undergoing AKb with HB-ePTFE graft for femoropopliteal lesion in 20 Japanese institutions between July 2014 and October 2017. Primary efficacy endpoints were primary, primary assisted, and secondary graft patency. Safety endpoints included any major adverse limb event and perioperative mortality. During the study period, 120 limbs of 113 patients (mean age, 72.7 years) underwent AKb with HB-ePTFE grafts. A total of 45 patients (37.5%) had critical limb ischemia and 17 (15.0%) were on hemodialysis (HD). Median duration of follow-up was 16 months (range, 1-36 months). Estimated 1- and 2-year primary, primary assisted, and secondary graft patency rates were 89.4% and 82.7%, 89.4% and 87.2%, and 94.7% and 92.5%, respectively. On univariate analysis of 2-year primary graft patency, having 3 run-off vessels, cuffed distal anastomoses, no coronary artery disease, and no chronic kidney disease requiring HD were significantly associated with favorable patency. AKb using HB-ePTFE grafts achieved favorable 2-year graft patency. AKb using HB-ePTFE grafts may therefore be an acceptable, highly effective treatment option for femoropopliteal artery lesions.

Impact of the Fibrosis-4 Index on Risk Stratification of Cardiovascular Events and Mortality in Patients with Atrial Fibrillation: Findings from a Japanese Multicenter Registry.

Background: Liver diseases drive the development and progression of atrial fibrillation (AF). The Fibrosis-4 (FIB4) index is a non-invasive scoring method for detecting liver fibrosis, but the prognostic impact of using it for AF patients is still unknown. Herein, we evaluated using the FIB4 index as a risk assessment tool for cardiovascular events and mortality in patients with AF. Methods: We performed a post-hoc analysis of a prospective, observational multicenter study. A total of 3067 patients enrolled in a multicenter Japanese registry were grouped as first tertile (FIB4 index < 1.75, n = 1022), second tertile (1.75 ≤ FIB4 index < 2.51, n = 1022), and third tertile (FIB4 index ≥ 2.51, n = 1023). Results: The third tertile had statistically significant results: older age, lower body mass index, increased heart failure prevalence, and lower clearances of hemoglobin and creatinine (all p < 0.05). During the follow-up period, incidences of major bleeding, cardiovascular events, and all-cause mortality were significantly higher for the third tertile (all p < 0.05). After multivariate adjustment, the third tertile associated independently with cardiovascular events (HR 1.72; 95% CI 1.31–2.25) and all-cause mortality (HR 1.43; 95% CI 1.06–1.95). Adding the FIB4 index to a baseline model with CHA2DS2-VASc score improved the prediction of cardiovascular events and all-cause mortality, as shown by the significant increase in the C-statistic (all p < 0.05), net reclassification improvement (all p < 0.001), and integrated discrimination improvement (all p < 0.001). A FIB4 index ≥ 2.51 most strongly associated with cardiovascular events and all-cause mortality in AF patients with high CHADS2 scores (all p < 0.001). Conclusions: The FIB4 index is independently associated with risks of cardiovascular events and all-cause mortality in AF patients.

Importance of combined assessment of skeletal muscle mass and density by computed tomography in predicting clinical outcomes after transcatheter aortic valve replacement.

Skeletal muscle mass (SMM) as calculated by computed tomography (CT) is a predictor of all-cause mortality after transcatheter aortic valve replacement (TAVR), but it remains unclear whether using CT-determined density of skeletal muscle has additive prognostic value. We utilized the Japanese multicenter registry data of 1375 patients who underwent CT prior to TAVR. Sarcopenia status was defined by the CT-derived SMM index (threshold: men, 55.4cm2/m2; women, 38.9cm2/m2). The threshold for high and low CT density was based on the median value of the entire cohort (men: 33.4 HU; women: 29.5 HU). Sarcopenia was observed in 802 patients (58.3%) overall. Patients were categorized into non-sarcopenia and high-CT density (n = 298), non-sarcopenia and low-CT density (n = 275), sarcopenia and high-CT density (n = 399), and sarcopenia and low-CT density (n = 403) groups, and procedural outcomes and mortality compared. The cumulative 3-year mortality rates in these groups were 18%, 27%, 24%, and 32%, respectively. Cox-regression multivariate analysis revealed that low-CT density (compared with high-CT density) and sarcopenia and low-CT density (compared with non-sarcopenia and high-CT density as reference) increased mortality after TAVR (hazard ratios [HR]: 1.35 and 1.43, 95% confidence intervals [Cis]: 1.06-1.72 and 1.00-2.08, p = 0.01, and 0.049, respectively). However, sarcopenia alone was not related to an increased risk of mortality (HR 1.30, 95% CI 0.99-1.69, p = 0.52). In conclusion, CT density-based skeletal muscle quality assessment combined with the SMM index improves prediction of adverse outcomes after TAVR.

Relationship between the Renal Function and Adverse Clinical Events in Patients with Atrial Fibrillation: A Japanese Multicenter Registry Substudy.

Background: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist, but the real-world data after approval of direct oral anticoagulants (DOACs) are still lacking in Japan. We investigated the association of the baseline renal function and adverse clinical events and risk of adverse clinical events with DOACs compared to warfarin for each renal functional level in Japanese AF patients. Methods: The present substudy was based on the SAKURA AF Registry, a Japanese multicenter observational registry (median follow-up period: 39 months). The creatinine clearance (CrCl) values were estimated by the Cockcroft–Gault formula, and divided into normal renal function, and mild and moderate-severe CKD (CrCl ≥ 80, 50–79, <50 mL/min). Results: In the SAKURA AF Registry, the baseline CrCl data were available for 3242 patients (52% for DOAC and 48% for warfarin user). The relative risk of adverse clinical events was significantly higher in the patients with a CrCl < 50 mL/min as compared to those with a CrCl ≥ 80 mL/min (adjusted HRs: 2.53 for death, 2.53 for cardiovascular [CV] events, 2.13 for strokes, and 1.83 for major bleeding). Risks of all adverse clinical events were statistically even between DOAC and warfarin users for each renal function level. Conclusion: Moderate–severe CKD was associated with a higher mortality, CV events, strokes, and major bleeding than normal renal function. The safety and effectiveness of DOACs over warfarin were similar for each renal function level. By a worsening renal function, the incidence of adverse clinical events increased, especially deaths and CV events as compared to strokes and major bleeding.

Clinical outcomes of SeQuent Please paclitaxel-coated balloons for de novo small coronary artery lesion in a Japanese multicenter post-approval registry.

Drug-coated balloon (DCB) angioplasty has emerged as an effective management strategy worldwide. In June 2016, DCB became available for the treatment of de novo small coronary lesions in Japan; however, there has been no multicenter analysis in a post-approval real-world clinical setting to date. The aim of this study was to evaluate the efficacy of DCB for de novo small coronary lesions based on a Japanese multicenter registry. From June 2016 to July 2017, a total of 111 lesions (102 patients) treated with DCB for de novo small coronary lesions were enrolled at six Japanese institutions. The primary endpoint was the rate of target lesion revascularization (TLR) at 12 months. Angiographic follow-up endpoints were binary restenosis and late lumen loss (LLL). Clinical follow-up data at 12 months were available for 106 lesions, excluding five lesions that required bailout stenting. The TLR rate was 5.7% (6/106 lesions). No cardiac death or target lesion thrombosis was observed. The binary restenosis rate was 14.4% and LLL was 0.0017 ± 0.37 mm. DCB angioplasty for de novo small coronary lesions in the real-world environment in Japan is effective with acceptable 12-month outcomes.

In-hospital outcome in patients presenting with acute coronary syndrome with left main coronary artery disease: A report from Japanese prospective multicenter percutaneous coronary intervention registry

BackgroundPatients presenting with acute coronary syndrome (ACS) from left main (LM) disease are at a high risk for mortality despite recent advancement in devices and techniques during percutaneous coronary interventions (PCI). We aimed to evaluate patient characteristics, clinical presentations, and key clinical characteristics associated with adverse in-hospital outcomes among ACS patients undergoing LM-PCI. MethodsWe retrospectively identified 280 LM-ACS patients (3.7 %) from 7608 ACS patients in the prospective multicenter Japan Cardiovascular Database-Keio Inter-Hospital Cardiovascular Studies registry from March 2009 to May 2016 and divided them into those with/without PCI/coronary artery bypass grafting. We compared baseline demographics, coronary lesion characteristics, PCI details, and short-term outcomes, including in-hospital mortality and periprocedural complications, between the two groups. ResultsAmong LM-ACS patients, 38.6 % presented with ST elevation myocardial infarction, 29.6 % with cardiogenic shock (CS), and 15.4 % with cardiac arrest. The observed in-hospital mortality rate was 18.9 % with presence of CS [odds ratio (OR): 10.16, 95 % confidence interval (CI): 4.51–22.91, p<0.001] and absence of prior revascularization (de novo patients; OR: 4.31, 95 % CI: 1.43–12.94, p=0.009) was independently associated with higher incidence of in-hospital mortality. Notably, the observed mortality rate was substantially higher among de novo patients than the predicted mortality rate with a contemporary risk model (observed: 25.1 %; predicted: 11.6 %). ConclusionsPrior revascularization act as a protective factor among LM-ACS patients in the contemporary era of PCI. Further studies to detect those at higher risk for LM coronary lesion progression are needed to fully implement these findings into clinical practice.

1g versus 2\u2009g daily intravenous ceftriaxone in the treatment of community onset pneumonia \u2013 a propensity score analysis of data from a Japanese multicenter registry

BackgroundCommunity-onset pneumonia (COP) is a combined concept of community acquired pneumonia and the previous classification of healthcare-associated pneumonia. Although ceftriaxone (CRO) is one of the treatment choices for COP, it is unclear whether 1 or 2 g CRO daily has better efficacy. We compared the effectiveness of 1 g with 2 g of CRO for COP treatment. We hypothesized that 1 g CRO would show non-inferiority over 2 g CRO.MethodsThis study was an analysis of prospectively registered data of the patients with COP from four Japanese hospitals (the Adult Pneumonia Study Group-Japan: APSG-J). We included subjects who were initially treated solely with 1 or 2 g of CRO. The propensity score was estimated from the 33 pre-treatment variables, including age, sex, weight, pre-existing comorbidities, prescribed drugs, risk factors for aspiration pneumonia, vital signs, laboratory data, and a finding from chest xrays. The primary endpoint was the cure rate, for which a non-inferiority analysis was performed with a margin of 0.05. In addition, we performed three sensitivity analyses; using data limited to the group in which CRO solely was used until the completion of treatment, using data limited to inpatient cases, and performing a generalized linear mixed-effect logistic regression analysis to assess the primary outcome after adjusting for random hospital effects.ResultsOf the 3817 adult subjects with pneumonia who were registered in the APSG-J study, 290 and 216 were initially treated solely with 1 or 2 g of CRO, respectively. Propensity score matching was used to extract 175 subjects in each group. The cure rate was 94.6 and 93.1% in the 1 and 2 g CRO groups, respectively (risk difference 1.5%; 95% confidence interval − 3.1 to 6.0; p = 0.009 for non-inferiority). The results of the sensitivity analyses were consistent with the primary result.ConclusionsThe propensity score-matched analysis of multicenter cohort data from Japan revealed that the cure rate for COP patients treated with 1 g daily CRO was non-inferior to that of patients treated with 2 g daily CRO.

The Predictors of Peri-Procedural and Sub-Acute Cerebrovascular Events Following TAVR from OCEAN-TAVI Registry

BackgroundCerebrovascular events (CVEs) are not uncommon complications of transcatheter aortic valve replacement (TAVR). Our study aimed to determine the predictors of peri-procedural and sub-acute CVEs following TAVR. MethodsUsing the Japanese multicenter registry, we evaluated 1613 patients undergoing TAVR between October-2013 and July-2016. Occurrences of 24-hour and 1- to 30-day CVEs were evaluated to clarify the predictors of CVEs following TAVR. ResultsThe mean age was 84.4 years and mean Society of Thoracic Surgeons score was 8.3%. Overall 24-hour and 30-day CVE rates were 1.2% and 2.7%, respectively. A multivariate analysis demonstrated that independent predictor of 24-hour CVEs was index aortic valve area (iAVA) [adjusted OR (adjusted-OR), 0.001; 95% CI, 0.001–0.13; p = .005]. The receiver operator curve derived cut-off value of iAVA for the prediction of 24-hour CVEs was 0.40 cm2/m2. In contrast, independent predictors of 1- to 30-day CVEs were paroxysmal atrial fibrillation (PAF; adjusted-OR, 3.35; 95% CI, 1.36–8.27; p = .009) and iAVA after TAVR (adjusted-OR, 0.11; 95% CI, 0.02–0.66; p = .02). Consequently, independent predictors of 30-day CVEs were prior stroke (adjusted-OR, 2.18; 95% CI, 1.07–4.45; p = .03), PAF (adjusted-OR, 2.18; 95% CI, 1.05–4.56; p = .04), and prior coronary artery disease (adjusted-OR, 1.88; 95% CI, 1.01–3.48; p = .05). ConclusionsWithin 24 h, small iAVA impacted the increased risk of CVEs, whereas PAF and iAVA after TAVR impacted the increased risk of 1- to 30-day CVEs following TAVR. The mechanism of CVEs might differ according to onset.

Clinical effectiveness and safety of additional administration of tacrolimus in rheumatoid arthritis patients with an inadequate response to abatacept: A retrospective cohort study.

Abatacept (ABT) demonstrates good clinical efficacy and retention in rheumatoid arthritis (RA) patients. However, no rescue treatment option against inadequate response to ABT exists. Since tacrolimus (TAC) and ABT suppress T lymphocytes via different mechanisms and a combination of these agents could potentially be effective, this study aimed to examine the efficacy and safety of add-on TAC therapy in RA patients with inadequate response to ABT. Of 550 patients treated with ABT and registered in a Japanese multicenter registry, 25 consecutive patients who underwent add-on TAC therapy and were followed for longer than 24weeks were included in this study. Mean patient age was 67.0years, disease duration was 16.2years, and duration of ABT treatment was 1.2years at the initiation of add-on TAC therapy. Mean TAC dose was 1.2mg/d at baseline and 1.6mg/d at week 24. Mean Disease Activity Score of 28 joints - erythrocyte sedimentation rate was significantly improved at week 24 (3.35) relative to baseline (4.97). The proportion of patients who achieved low disease activity or remission was 40.0%, and the European League Against Rheumatism moderate or good response was 72.0%. ABT retention rate was 92.0% at week 24, as calculated by Kaplan-Meier analysis. Only one patient discontinued add-on TAC therapy due to an adverse event (itching sensation). This is the first report describing the efficacy and safety profile of add-on TAC therapy with a focus on RA patients with inadequate response to ABT. Our findings suggest that add-on TAC therapy is a worthwhile complementary treatment option in daily clinical practice.

P5480Impact of Silent Myocardial Ischemia on One Year Mortality after Successful Coronary Intervention: Data from Japanese Multicenter (KICS) Registry

Abstract Introduction Under the awareness of appropriate use criteria, the significance of PCI for the patients with silent myocardial ischemia (SMI) decreases. On the other hand, the prognoses of SMI patients have been reported to be equivalent to those of symptomatic effort angina pectoris (EAP) patients. We aimed to clarify the prognosis of SMI after PCI and elucidate the factors influencing the mortality. Methods The Kumamoto Intervention Conference Study is multicenter registry enrolling consecutive patients undergoing PCI in 16 centers in Japan. Overall, 17,688 consecutive patients were enrolled during April 2008 to March 2017. To compare the clinical events between SMI and EAP, 8,278 subjects, excluding acute coronary syndrome, post successful PCI were enrolled with 1-year follow-up data. Results In this study, 2,071 patients were classified as SMI and 6,207 patients were EAP. Male, lower body mass index (BMI), diabetes, chronic kidney disease (CKD), smoking habits, prior myocardial infarction (MI), composite of cerebrovascular disease and composite of peripheral arterial disease were all significantly higher in the SMI group. Although nonfatal MI and stent thrombosisduring 12-monthswere comparable between the 2 groups, all-cause mortality and cardiac death during 12-months were significantly higher in the SMI group than in the EAP group (3.9% vs 1.8%, p&lt;0.001, 1.4% vs 0.5%, p&lt;0.001, respectively). On the other hand, Repeat Revascularization rate during 12-months was significantly lower in the SMI group than in the EAP group (15.7% vs 19.5%, p&lt;0.001).Kaplan-Meier analysis for cardiac death showed a significant difference between the 2 groups (Figure). In a multiple logistic regression analysis, in addition to lower BMI and CKD, SMI was an independent predictor for cardiac death. Even after adjustment by propensity-score matching with predictive factors for cardiac event, SMI showed a higher cardiac death rate compared with EAP (1.4% vs 0.5%, p=0.004), and it remained as a significant predictor. Conclusion In this study, SMI itself was associated with higher mortality after PCI. Strict follow-up and assessment of residual ischemia should be necessary for SMI patients.

Long-term Prognostic Significance of Admission Tricuspid Regurgitation Pressure Gradient in Hospitalized Patients With Heart Failure With Preserved Ejection Fraction: A Report From the Japanese Real-World Multicenter Registry

BackgroundDoppler-estimated peak systolic tricuspid regurgitation pressure gradient (TRPG) is a representative noninvasive parameter for evaluating pulmonary artery systolic pressure, which can be a determinant of adverse outcomes in chronic heart failure with preserved ejection fraction (HFpEF). However, the prognostic implications of TRPG at admission for hospitalized patients with HFpEF are undetermined. Methods and ResultsWe examined 469 consecutive hospitalized patients with decompensated HFpEF (left ventricular ejection fraction ≥ 50%) who underwent TRPG measurement at admission in our HFpEF multicenter registry. The primary outcome of interest was all-cause death. Admission TRPG was significantly correlated with estimated pulmonary capillary wedge pressure and left atrial dimension (r = 0.24, P < 0.001 and r = 0.21, P < 0.001, respectively). During a median follow-up period of 748 (IQR 540–820) days, 83 patients died. Higher TRPG was significantly associated with higher mortality compared to lower TRPG (log-rank; P = 0.007). Multivariable analysis revealed that elevated TRPG was an independent determinant of mortality (HR 1.02, 95% CI 1.01–1.04, P = 0.008) after adjustment for prespecified confounders and renal function. ConclusionsElevated TRPG at admission was an independent determinant of mortality in hospitalized patients with HFpEF, indicating that TRPG at admission could be a useful marker for risk stratification in these patients.

Worsening renal function, adverse clinical events and major determinants for changes of renal function in patients with atrial fibrillation: a Japanese multicenter registry substudy

Objective: To explore factors related to changing renal function and the prognostic effect of worsening renal function in patients with atrial fibrillation (AF).Methods: The present substudy was based on the SAKURA AF Registry, a Japanese multicenter prospective observational registry that includes 3267 AF patients from 63 institutions in the Tokyo area. Worsening renal function was defined as an estimated glomerular filtration rate (eGFR) decrease equaling more than 20% of the patient’s baseline eGFR.Results: During a median 39.3 month follow-up period, patients’ eGFR decreased annually by a mean value of 1.07 mL/min/1.73 m2. Multivariable analysis showed that age ≥75 years, body weight ≤50 kg, a history of heart failure and initially preserved renal function (creatinine clearance [CrCl] ≥ 60 mL/min) were significantly associated with a decrease in eGFR, whereas a history of AF ablation was associated with a maintain in eGFR. The 194 patients with worsening renal function were at significantly increased risk of death, stroke and major bleeding (adjusted hazard ratios [HRs]: 2.06, 1.97 and 2.23, respectively).Conclusion: Age ≥75 years, body weight ≤50 kg, a history of heart failure and initially preserved renal function appear to promote renal dysfunction in patients with AF, but a history of AF ablation seems to have a favorable effect. Worsening renal function seems to increase AF patients’ risk of adverse clinical events. Renal function can decline quickly; thus, early intervention including AF ablation is warranted.

Heart Failure With Midrange Ejection Fraction in Patients Admitted for Acute Decompensation: A Report from the Japanese Multicenter Registry

Patients having heart failure with midrange ejection fraction (HFmrEF: 40% ≤ EF < 50%) are increasingly being considered a new subset of the population with heart failure. Despite recent advances in heart-failure treatment strategies, the prognosis of these patients has not improved substantially over time. In addition, the significance of this new phenotype in hospitalized patients with acute decompensated heart failure (ADHF), another population whose prognosis has not improved, also remains poorly understood. This study aimed to describe the clinical characteristics, prognosis and treatment responses of patients with HFmrEF hospitalized for ADHF. On the basis of consecutive inpatient data from a multicenter ADHF registry, 651 of 3572 patients (17.1%) were classified as having HFmrEF. Prognostic factors predicting composite outcomes, defined as all-cause death and heart failure readmission, as well as all-cause death alone, were analyzed. In the median follow-up duration of 724 days, both composite endpoints and all-cause death alone were comparable in those with heart failure with preserved ejection fraction, HFmrEF and heart failure with reduced ejection fraction. Age, anemia, hyponatremia, elevated blood urea nitrogen, chronic kidney disease, and elevated plasma brain natriuretic peptide levels were significant predictors of composite outcomes in HFmrEF. Roughly one-sixth of the patients with ADHF had HFmrEF. The long-term prognosis of patients with HFmrEF was not significantly different from that of patients with heart failure with preserved ejection fraction and heart failure with reduced ejection fraction in the population with ADHF. Risk factors for adverse outcomes in HFmrEF were also similar to those for heart failure with preserved ejection fraction and HFmrEF in the hospitalized population with ADHF.

Concomitant methotrexate has little effect on clinical outcomes of abatacept in rheumatoid arthritis: a propensity score matching analysis.

To compare the clinical outcomes of abatacept between rheumatoid arthritis patients with and without concomitant methotrexate (MTX) treatment in daily clinical practice. A retrospective cohort study was performed using data from a multicentre registry. A total of 176 consecutive rheumatoid arthritis patients treated with abatacept were included. The propensity score based on multiple baseline characteristic variables was calculated, and 41 of 86 patients treated without MTX (MTX(-)) and 41 of 90 patients treated with concomitant MTX (MTX(+)) were statistically extracted and analysed. Clinical outcomes were evaluated and compared between the two groups over a 52-week period. Baseline characteristics were statistically comparable. No significant differences were observed in the following clinical outcomes from baseline throughout the 52-week period: drug retention rate (MTX(-)/MTX(+) 79.1%/80.5%), mean change in disease activity score based on 28 joints (DAS28-CRP) from baseline (- 1.35/- 1.54), low disease activity rate (48.8%/43.9%), clinical remission rate (31.7%/36.6%), moderate European League Against Rheumatism (EULAR) response rate (68.3%/68.3%), and good EULAR response rate (36.6%/41.1%) at 52weeks. In rheumatoid arthritis patients with similar background characteristics undergoing abatacept treatment, concomitant MTX does not seem to affect clinical outcomes. Abatacept would be a suitable treatment option in daily clinical practice in patients with contraindications to MTX. • This is the first study to directly compare the clinical efficacy and safety of abatacept between patients with and without concomitant methotrexate (MTX) treatment in 'real-world' settings using the propensity score matching method. • There were no significant differences in clinical outcomes of abatacept between patients with and without concomitant MTX treatment. • We used data from a large Japanese multicentre registry for biologics in rheumatoid arthritis, thereby decreasing selection bias based on the personal preferences of physicians.

Intracranial pressure management and neurological outcome for patients with mild traumatic brain injury who required neurosurgical intervention: a Japanese database study

ABSTRACTPurpose: Among mild traumatic brain injuries (mTBI; a Glasgow Coma Scale score ≥13 on arrival), few result in severe neurological deficit, especially when they needed neurosurgical intervention. We investigated the association of intracranial pressure (ICP) control management with neurological outcome in patients with mTBI who needed neurosurgical intervention.Methods: From 1,092 records of the Japan Neurotrauma Data Bank during 2009–2011, we retrospectively identified 195 patients with neurosurgical intervention for mTBI. Using the Glasgow Outcome Scale, we grouped records into two: favorable and poor outcome. We analyzed neurological outcomes using a logistic regression analysis adjusted for ICP control managements.Results: Seventy patients had a poor outcome. Logistic regression analysis revealed that sedatives, hyperosmotic agents, and hyperventilation therapy were significantly associated with poor outcome (odds ratio [OR]: 2.36, 95% confidence interval [CI]: 1.31–4.26; OR: 2.81, 95% CI: 1.17–6.75; OR: 9.36, 95% CI: 1.81–48.35). However, temperature management was significantly related with favorable outcome (OR: 0.26, 95% CI: 0.10–0.66).Conclusions: Our study, using a Japanese multicenter brain trauma registry, suggested that requirement of sedatives, hyperosmotic agents, and hyperventilation is associated with poor neurological outcome for patients with mTBI who underwent neurosurgical intervention, although temperature management was associated with favorable neurological outcome.

Update on the clinical impact of mild aortic regurgitation after transcatheter aortic valve implantation: Insights from the Japanese multicenter OCEAN‐TAVI registry

This study aimed to compare the clinical impact of mild postprocedural aortic regurgitation (post-AR) to that of none-trivial post-AR after transcatheter aortic valve implantation (TAVI) and to identify the vulnerability factors to mild post-AR. Moderate-severe post-AR, associated with increased mortality, is an important issue. However, the clinical impact of mild post-AR remains controversial. We analyzed data from 1,572 consecutive patients (1,026 of none-trivial post-AR and 546 of mild post-AR) obtained from the Optimized transCathEter vAlvular Intervention (OCEAN-TAVI) Japanese multicenter registry. We evaluated the 1-year cumulative cardiovascular death and re-hospitalization rates for heart failure (HF) after TAVI according to the degree of post-AR. Kaplan-Meier curves showed no significant difference between "none-trivial post-AR" and "mild post-AR" in terms of cardiovascular death, but a significant difference was noted in the cumulative incidence of re-hospitalization for HF between the two groups (hazard ratio 1.57, 95% confidence interval 1.02-2.41, p = .04). In the stratified analysis, only in patients with not more than 50% of left ventricular ejection fraction (LVEF), concentric left ventricular hypertrophy (LVH), and none-trivial pre-procedural aortic regurgitation (pre-AR), mild post-AR resulted in a higher incidence of re-hospitalization for HF. In this study, the clinical impact of mild post-AR compared to none-trivial post-AR tended to be augmented in the presence of reduced LVEF, concentric LVH, and none-trivial pre-AR. Pre-procedure echocardiographic findings including LVEF, left ventricular geometry, and pre-AR may help to judge the necessity of postdilatation in case of mild post-AR just after the bioprosthesis deployment.

Transcatheter aortic valve replacement outcomes in Japan: Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry.

We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan. Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction. We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4). Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7-9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk. Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure.

1975. 1 g vs. 2 g Daily Intravenous Ceftriaxone in the Therapy of Community-onset Pneumonia: A Propensity Score Analysis From a Data of Japanese Multicenter Registry

BackgroundCommunity-acquired pneumonia (CAP) is one of the most common infectious diseases and is an important cause of mortality and morbidity worldwide. The prognosis of CAP in adults is associated with factors such as age, comorbidities, vital signs, laboratory data, and other factors on admission. Usually, ceftriaxone (CTRX) is used to treat CAP. However, whether 1 or 2 g of CTRX daily has better efficacy remains unclear.MethodsThis study is an analysis of prospectively registered data from four Japanese hospitals for patients with community-onset pneumonia (COP) from September 2011 to August 2014 (the Adult Pneumonia Study Group-Japan: APSG-J). Subjects who were initially treated solely with 1 g or 2 g of CTRX were enrolled. Propensity score was estimated from the 33 pretreatment variables including age, sex, weight, comorbidities, medications, risk factors for aspiration, whether background was consistent with CAP or not, vital signs, laboratory data, and findings of a chest x-ray. The primary endpoint was cure rate, for which a noninferiority analysis was performed with a margin of 0.05. The secondary outcomes included in-hospital mortality, duration of antibiotic treatment, and length of hospital stay, which were assessed using superiority analyses.ResultsOf the 3,817 adult subjects with pneumonia who were registered in the APSG-J study, 290 and 216 were initially treated solely with 1 g or 2 g of CTRX, respectively. Propensity score matching was used to finally extract 175 subjects in each group. Overall, the cure rate was 94.6% in the 1 g group and 93.1% in the 2 g group (risk difference, 1.5 percentage points; 95% confidence interval [CI], −3.1 to 6.0; P = 0.009 for noninferiority). The in-hospital mortality rate was 4.7% and 4.0% (P = 0.740 for superiority), length of hospital stay was 17 and 26 days (P < 0.001 for superiority), and duration of antibiotic treatment was 8 and 10 days (P = 0.002 for superiority) in the 1 g and 2 g groups, respectively.ConclusionPropensity score-matched analysis of multicenter cohort data from Japan revealed that the cure rate for COP patients treated with 1 g of CTRX was noninferior to that in the patients treated with 2 g of CTRX.Disclosures All authors: No reported disclosures.

Clinical Manifestations and Long-Term Mortality in &lt;i&gt;Lamin A/C&lt;/i&gt; Mutation Carriers From a Japanese Multicenter Registry

Mutation in the lamin A/C gene (LMNA) is associated with several cardiac phenotypes, such as cardiac conduction disorders (CCD), atrial arrhythmia (AA), malignant ventricular arrhythmia (MVA) and left ventricular dysfunction (LVD), leading to sudden cardiac death (SCD) and/or end-stage heart failure. We investigated how these phenotypes are associated with each other and which of them are most important for total mortality. Methods and Results: A multicenter registry included 110 LMNA mutation carriers (age, 43±15 years, male: 62%) from 60 families. After genetic diagnosis of LMNA mutation (missense: 27%, non-missense: 73%), patients or subjects were followed to evaluate the manifestations of their phenotypes and the risk of total mortality; 90 patients could be followed (median: 5 [0-35] years). Prevalence of the 4 clinical phenotypes was significantly increased during follow-up. Among these phenotypes, AA was significantly associated with MVA. CCD was significantly associated with LVD. LVD, meanwhile, was significantly associated with CCD and MVA. Male sex was significantly associated with MVA. Furthermore, during follow-up, 17 patients died: 12 end-stage heart failure, 4 SCD and 1 stroke. LVD was the only independent predictor for all-cause death (OR: 41.7, 95% CI: 4.1-422.3; P=0.0016). Several cardiac phenotypes were age-dependently increased in LMNA mutation carriers, suggesting that ICD or CRT-D could suppress SCD after middle age; however, LVD leading to end-stage heart failure was the only independent predictor for total mortality.

Impact of catheter-induced iatrogenic coronary artery dissection with or without postprocedural flow impairment: A report from a Japanese multicenter percutaneous coronary intervention registry.

Despite the ever-increasing complexity of percutaneous coronary intervention (PCI), the incidence, predictors, and in-hospital outcomes of catheter-induced coronary artery dissection (CICAD) is not well defined. In addition, there are little data on whether persistent coronary flow impairment after CICAD will affect clinical outcomes. We evaluated 17,225 patients from 15 participating hospitals within the Japanese PCI registry from January 2008 to March 2016. Associations between CICAD and in-hospital adverse cardiovascular events were evaluated using multivariate logistic regression. Outcomes of patients with CICAD with or without postprocedural flow impairment (TIMI flow ≤ 2 or 3, respectively) were analyzed. The population was predominantly male (79.4%; mean age, 68.2 ± 11.0 years); 35.6% underwent PCI for complex lesions (eg. chronic total occlusion or a bifurcation lesion.). CICAD occurred in 185 (1.1%), and its incidence gradually decreased (p < 0.001 for trend); postprocedural flow impairment was observed in 43 (23.2%). Female sex, complex PCI, and target lesion in proximal vessel were independent predictors (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.53–3.10; OR, 2.19; 95% CI, 1.58–3.04; and OR, 1.55; 95% CI, 1.06–2.28, respectively). CICAD was associated with an increased risk of in-hospital adverse events (composite of new-onset cardiogenic shock and new-onset heart failure) regardless of postprocedural flow impairment (OR, 10.9; 95% CI, 5.30–22.6 and OR, 2.27; 95% CI, 1.20–4.27, respectively for flow-impaired and flow-recovered CICAD). In conclusion, CICAD occurred in roughly 1% of PCI cases; female sex, complex PCI, and proximal lesion were its independent risk factors. CICAD was associated with adverse in-hospital cardiovascular events regardless of final flow status. Our data implied that the appropriate selection of PCI was necessary for women with complex lesions.