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Because of its superior safety profile and improved outcomes, trans-radial percutaneous coronary intervention (TRI) has become the preferred access in percutaneous coronary intervention (PCI) of native coronary disease. This study investigated the impact of TRI on in-hospital outcomes after PCI for coronary artery bypass graft vessels (GV-PCI). We analyzed patients who underwent GV-PCI in 2019-2022 from the Japanese nationwide registry. Patients were categorized into the TRI and trans-femoral PCI (TFI) groups. We assessed the association between TRI and in-hospital outcomes. The primary outcome was a composite of in-hospital death and major bleeding. In this study, 2,295 patients were analyzed.. The primary outcomes occurred in 29 patients (1.3%), including 17 deaths (0.7%). Major bleeding occurred in 12 patients (0.5%), and access site bleeding in 7 patients (0.3%). The TRI group (n = 1,521) showed lower crude rates of the primary outcome (0.9% vs 1.9%, p = 0.039), major bleeding (0.3% vs 1.0%, p = 0.027), and access site bleeding (0.1% vs 0.6%, p = 0.047) compared with the TFI group (n = 774). Univariable logistic regression demonstrated a significant association of TRI with reduced primary outcome (odd ratio [OR] 0.47, 95% confidence interval [CI] 0.22 to 0.98), major bleeding (OR 0.25, 95% CI 0.07 to 0.80), and access site bleeding (OR 0.20, 95% CI 0.03 to 0.94). In the multivariable analysis, TRI was still significantly associated with a decrease in major bleeding events (OR 0.29, 95% CI 0.07 to 0.93). In conclusion, the use of TRI was associated with a reduction in bleeding events when referenced to TFI in the context of GV-PCI., Competing Interests: Declaration of competing interest Dr. Kohsaka reports a relationship with Bristol-Myers Squibb, Pfizer, Novartis, and AstraZeneca that includes: funding grants and speaking and lecture fees. Dr. Ishii reports a relationship with Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Kowa, Novartis, Nippon Boehringer Ingelheim, Otsuka Pharma, Pfizer, Mochida Pharma, and Tanabe Mitsubishi that includes: speaking and lecture fees. Dr. Amano reports a relationship with Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb that includes: speaking and lecture fees. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

The impact of procedural volume on transcatheter aortic valve replacement (TAVR) outcomes in Japan remains uncertain. Japan has carefully introduced TAVR after the establishment of techniques in Western countries and therefore may not exhibit volume-outcome relations after TAVR. Data on transfemoral TAVR was collected from the Japan Transcatheter Valve Therapy (J-TVT) registry between 2018 and 2020. Hospitals were categorized into quartiles (lowest, lower, high, and highest) based on annual TAVR volume. The primary analysis compared 30-day mortality among different TAVR volume hospitals. A multivariable adjustment analysis was performed to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) of 30-day all-cause mortality with highest-volume hospital as the reference. A total of 2,741 transfemoral TAVR cases from 172 hospitals were included in the analysis. Median hospital TAVR volume was 38 (interquartile range 27 to 60) per year. Unadjusted 30-day mortality was 0.46%, 0.69%, 1.17%, and 1.18% from the lowest to the highest quartile of hospitals, respectively. There was no significant difference in 30-day mortality rates for lowest-volume hospitals (aOR 0.51, 95% CI 0.24 to 1.05, p = 0.07), low-volume hospitals (aOR 0.76, 95% CI 0.46 to 1.26, p = 0.29), or high-volume hospitals (aOR 1.11, 95% CI 0.74 to 1.67, p = 0.60). An analysis from the contemporary national registry in Japan did not find an obvious inverse relation between annual hospital volume and 30-day mortality. Our results suggest that TAVR has now reached a level of procedural maturity, with standardized outcomes observed across hospitals regardless of their annual procedural volume., Competing Interests: Declaration of Competing Interest Dr. Kumamaru reports receiving consultation fee from EPS Corporation, and speaker fee from Chugai Pharmaceutical Co., Ltd. Dr. Kumamaru is affiliated with the Department of Health Quality Assessment at the University of Tokyo, a social collaboration department supported by the National Clinical Database, Johnson & Johnson K.K., Nipro corporation, and Intuitive Surgical Sàrl. Dr. Kohsaka has received an unrestricted research grant from Daiichi Sankyo Co., Ltd., and Novartis Pharmaceutical Co., Ltd. Dr. Hayashida is a proctor for Edwards Lifesciences and Medtronic. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Young patients who underwent percutaneous coronary intervention (PCI) have shown worse long-term outcomes but remain inadequately investigated. We analyzed 1,186 consecutive young patients (aged ≤55 years) from the Keio Cardiovascular PCI registry who were successfully discharged after PCI (2008 to 2019) and compared them to 5,048 older patients (aged 55 to 75 years). The primary outcome was a composite of all-cause death, acute coronary syndrome, heart failure, bleeding, stroke requiring admission, and coronary artery bypass grafting within 2 years after discharge. In the young patients, the mean age was 48.4 ± 5.4 years, acute coronary syndrome cases accounted for 69.6%, and 92 (7.8%) were female. Body mass index; hemoglobin levels; and proportions of smoking, hyperlipidemia, and ST-elevation myocardial infarction were lower and dialysis or active cancer proportions were higher in young female patients than male patients. A higher number of young female than male patients reached the primary end point and all-cause death (15.2% vs 7.1%, p = 0.01; 4.3% vs 1.0%, p = 0.023), mainly because of noncardiac death (4.3% versus 0.5%, p = 0.001). After covariate adjustment, the primary end point rates were higher among young women than men (hazard ratio 2.00, 95% confidence interval 1.03 to 3.89, p = 0.042). Gender did not predict the primary end point among older patients (vs men; hazard ratio 0.84, 95% confidence interval 0.67 to 1.06, p = 0.14). In conclusion, young women showed worse outcomes during the 2-year post-PCI follow-up, but this gender difference was absent in patients aged 55 to 75 years., Competing Interests: Declaration of Competing Interest Dr. Kohsaka has received speaker fees from Bristol Myers Squibb and institutional research grant support from Novartis and AstraZeneca. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

This study aimed to evaluate the incidence, predictors, and outcomes of Impella-assisted patients with cardiogenic shock, stratified by the access site-transaxillary (TX) or trans-subclavian (TS) versus the conventional transfemoral (TF) approach. For this study, we analyzed the cases entered into the Japanese Percutaneous Ventricular Assist Device registry between February 2020 and December 2021. A multivariable logistic regression analysis was conducted to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) to identify the predictors of the TX/TS approach, with reference to those who received the conventional TF approach. A log-rank test was performed to compare the 30-day mortality between the 2 approaches. A total of 2,564 cases of Impella were included in the study, of which 167 (6.5%) were accessed by way of the TX/TS approach. TX/TS approach cases were younger and had a higher percentage of concomitant use of extracorporeal membrane oxygenation or an intra-aortic balloon pump. The predictors of the TX/TS approach included a presentation with the acute coronary syndrome (aOR 0.32, 95% CI 0.16 to 0.63, p <0.001), cardiac arrest (aOR 0.10, 95% CI 0.02 to 0.36, p = 0.003), cardiogenic shock (aOR 0.51, 95% CI 0.33 to 0.79, p = 0.002), and inotropic use (aOR 1.88, 95% CI 1.08 to 3.49, p = 0.033). The 30-day mortality was comparable between TX/TS and TF approaches (29.3% vs 29.6%, respectively; log-rank, p = 0.64). Our analysis revealed that approximately 6% of the Impella-assisted patients with cardiogenic shock received the TX/TS approach as their first access site. These results suggest that the TX/TS approach may be a viable alternative to the TF approach in certain patients requiring Impella support., Competing Interests: Declaration of Competing Interest Dr. Kohsaka has received an unrestricted research grant from Novartis Pharmaceutical Co., Ltd. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

The relation between chronic kidney disease (CKD) and outcomes in patients receiving percutaneous coronary intervention (PCI) is thought to be bidirectional; these patients are at a higher risk of ischemic and bleeding events. From a Japanese nationwide PCI registry, ischemic (cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke) and bleeding events (fatal or nonfatal major bleeding) 1 year after discharge among patients who had second- or newer-generation drug-eluting stent implantation were analyzed. Patients on oral anticoagulants were excluded. Patients were stratified according to their preprocedural renal function: CKD stages 1 to 2 (estimated glomerular filtration rate [eGFR] ≥60 ml/min/1.73 m 2 ), 3 (eGFR 30 to 59), or 4 to 5 (eGFR <30), or those receiving dialysis. Overall, 23,349 patients, including 2,798 patients with CKD 3 to 5 (12.0%) and 1,464 patients on dialysis (6.3%), were investigated. One-year ischemic events were observed in 1.5%, 5.2%, 9.7%, and 5.3% in the CKD stages 1-to-2, 3, 4-to-5, and dialysis groups, respectively; patients with CKD stages 3 or 4 to 5 and those receiving dialysis were associated with higher risks of ischemic events after adjustment of covariates than were patients without CKD. Compared with ischemic events, 1-year bleeding events were low, with incidence rates of 1.5%, 2.0%, 3.4%, and 2.3%, respectively. Furthermore, the presence of CKD or dialysis was not associated with a higher risk of bleeding events after adjustment of covariates. In conclusion, in the contemporary nationwide PCI registry, the presence of CKD and dialysis was independently associated with a higher risk of ischemic events but not with bleeding events, and this suggests a need to alter the models of care delivery in these patients., (Copyright © 2023 Elsevier Inc. All rights reserved.)

A lower institutional primary percutaneous coronary intervention (PCI) volume is associated with a higher risk of postprocedural poor outcomes, particularly in urgent or emergent settings (e.g., PCI for acute myocardial infarction [MI]). However, the individual prognostic impact of PCI volume stratified by indication and the relative ratio remains unclear. Using the Japanese nationwide PCI database, we investigated 450,607 patients from 937 institutions who underwent either primary PCI for acute MI or elective PCI. The primary end point was the observed/predicted in-hospital mortality ratio. The predicted mortality per patient was calculated using the baseline variables and averaged for each institution. The relation between the annual primary, elective, and total PCI volumes and institutional in-hospital mortality after acute MI was evaluated. The association between the primary-to-total PCI volume per hospital and mortality was also investigated. Of the 450,607 patients, 117,430 (26.1%) underwent primary PCI for acute MI, of whom 7,047 (6.0%) died during hospitalization. The median total PCI volume and primary-to-total PCI volume ratio were 198 (interquartile range 115 to 311) and 0.27 (0.20 to 0.36). Overall, the observed in-hospital mortality and observed/predicted mortality ratio in patients with acute MI were higher in institutions with lower primary, elective, and total PCI volumes. The observed/predicted mortality ratio was also higher in institutions with lower primary-to-total PCI volume ratios, even in high-PCI volume hospitals. In conclusion, in this nationwide registry-based analysis, lower institutional PCI volumes, regardless of setting, were associated with higher in-hospital mortality after acute MI. The primary-to-total PCI volume ratio provided independent prognostic information., Competing Interests: Disclosures Dr. Kohsaka reports investigator-initiated grant from Novartis and Daiichi Sankyo and personal fees from Bristol-Myers Squibb. Dr. Ishii receives lecture fees from Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Chugai Pharma, Daiichi Sankyo, Kowa, Novartis Pharma, Nippon Boehringer Ingelheim, Otsuka Pharma, Pfizer (New York, New York), Mochida Pharma, and Tanabe Mitsubishi. Dr. Amano receives lecture fees from Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb. The remaining authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

The advances in the integrated management of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) have reduced subsequent cardiovascular events. Nonetheless, sudden cardiac death (SCD) remains a major concern. Therefore, we aimed to investigate the time trend in SCD incidence after PCI and to identify the clinical factors contributing to SCD. From a prospective, multicenter cohort registry in Japan, 8,723 consecutive patients with coronary artery disease undergoing PCI between 2009 and 2017 were included. We evaluated the SCD incidence 2 years after PCI; all death events were adjudicated, and SCD was defined as unexpected death without a noncardiovascular cause in a previously stable patient within 24 hours from the onset. The Fine and Gray method was used to identify the factors associated with SCD. Overall, the mean age of the patients was 68.3 ± 11.3 years, and 1,173 patients (13.4%) had heart failure (HF). During the study period, the use of second-generation drug-eluting stents increased. The 2-year cumulative incidence of all-cause mortality and SCD was 4.29% and 0.45%, respectively. All-cause mortality remained stable during the study period (p for trend = 0.98), whereas the crude incidence of SCD tended to decrease over the study period (p for trend = 0.052). HF was the strongest predictor associated with the risk of SCD (crude incidence [vs non-HF] 2.13% vs 0.19%; p <0.001). In conclusion, the incidence of SCD after PCI decreased over the last decade, albeit the high incidence of SCD among patients with HF remains concerning., Competing Interests: Disclosures Dr Kohsaka reports investigator-initiated grant funding from Bayer and Daiichi Sankyo. The remaining authors have no conflicts of interest to declare. Dr. Ikemura received an unrestricted research grant for the Department of Cardiology, Keio University School of Medicine from Bristol Myer Squibb., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Patients with atrial fibrillation (AF) at the highest risk of progression to heart failure (HF) need to be identified. We investigated whether QRS duration can stratify patients with AF at risk for poor clinical outcomes, including health-related quality of life (HR-QoL). We analyzed data from a multicenter registry-based cohort study of patients with AF. Patients were grouped according to the QRS duration (narrow: <120 ms; wide: ≥120 ms) at registration (baseline). The primary outcome was a composite of all-cause death and HF hospitalizations during a 2-year follow-up. In addition, the AF effect on the quality-of-life overall summary score was compared between the groups. In 3,269 patients, 302 (9.2%) had a wide QRS; these patients were more likely to be older, male, and have higher CHA 2 DS 2 -VASc scores than those with a narrow QRS. The incidence of the composite outcome was higher in patients with a wide QRS than those with a narrow QRS (13.1% vs 4.9%, p <0.001). After adjustment, a wide QRS was an independent predictor of the primary outcome (adjusted hazard ratio 1.58, 95% confidence interval 1.09 to 2.29, p = 0.016), and the results persisted after the exclusion of patients with bundle branch block or cardiac implantable electronic devices. Regarding HR-QoL outcomes, patients with a wide QRS were less likely to improve AF effect on quality-of-life overall summary scores at 1 year than those with a narrow QRS (adjusted difference -2.31, 95% confidence interval -4.06 to -0.57, p = 0.009). QRS prolongation, even for a nonspecific conduction disturbance, was an independent predictor of adverse outcomes and worse HR-QoL in patients with AF., Competing Interests: Disclosures Dr. Kohsaka received an unrestricted research grant for the Department of Cardiology at Keio University School of Medicine from Bayer Pharmaceutical and Daiichi Sankyo; received grants from Bayer Yakuhin, Ltd. and Daiichi Sankyo; and received personal fees from Bristol-Myers Squibb. Dr. Kimura received grants from Bayer Yakuhin, Ltd. Dr. Takatsuki received grants and personal fees from Bayer and received personal fees from Daiichi Sankyo and Bristol-Myers Squibb. The remaining authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Chronic kidney disease (CKD) increases the risk of death and other poor outcomes in patients with cardiovascular diseases. This study investigated the relation between the institutional CKD percutaneous coronary intervention (PCI) volume and in-hospital clinical outcomes in patients with CKD. Among 1,199,901 patients who underwent PCI in 2014 to 2018 from the Japanese nationwide registry, we analyzed 220,509 patients with CKD. Patients were classified into quartiles (Q) according to the mean annual institutional CKD-PCI volume (Q1 <42 PCIs/year, Q2 <74 PCIs/year, Q3 <124 PCIs/year, Q4 ≥125 PCIs/year). The primary outcome was a composite of in-hospital death and periprocedural complications. The mean age of patients was 73 ± 10 years, and 36% (n = 78,332) were on dialysis. PCI was more likely to be performed with rotational atherectomy devices in high-volume institutions. Contrast volume was lower, the rate of radial access PCI was higher, and door-to-balloon time (for ST-elevation myocardial infarction) was shorter in the highest quartile institutions. Primary outcomes were observed in 6,539 patients (3.0%). The crude rate of the primary outcome was lowest in institutions with the highest PCI volume (Q1 3.4%, Q2 3.0%, Q3 3.0%, Q4 2.4%, p <0.001); higher PCI volume was associated with reduced frequency of the primary outcome (odds ratio [95% confidence interval] relative to Q1:Q2, 0.89 [0.83 to 0.96]; Q3 0.90 [0.84 to 0.97]; and Q4 0.76 [0.84 to 0.97]). In conclusion, the procedural characteristics and outcomes of PCI differed significantly by institutional volume in patients with CKD. When considering revascularization among these patients, institutional CKD-PCI volume needs to be incorporated in decision-making., Competing Interests: Disclosures Shun Kosaka reports relations with Bayer, Daiichi Sankyo, Bristol-Myers Squibb that includes consulting or advisory and funding grants. Hideki Ishii reports relations with Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Chugai Pharma, Daiichi Sankyo, Otsuka Pharma, Pfizer, Mochida Pharma, Merck Sharp & Dohme that includes speaking and lecture fees. Tetsuya Amano reports relations with Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb that includes speaking and lecture fees. Yuji Ikari reports relations with Boston Scientific Corp that includes funding grants. The remaining authors have no conflicts of interest to declare., (Copyright © 2021 Elsevier Inc. All rights reserved.)

The prognostic impact of anemia, especially mild anemia, in atrial fibrillation (AF) remains unclear. We examined clinical burdens of mild anemia on the quality of life (QoL) and clinical outcomes of 1,677 AF patients. Patients were divided into a non-anemia (hemoglobin [Hb] ≥13 g/dl for men and Hb ≥12 g/dl for women) and a mild anemia group (10≤ Hb <13 g/dl for men and 10≤ Hb <12 g/dl for women). At baseline, 22.5% of patients (n = 378) had anemia; patients in the mild anemia group had higher CHA 2 DS 2 -VASc scores (3.7 vs 2.7; p <0.01) and brain natriuretic peptide levels (253.5 vs 159.6 pg/ml; p <0.01) and were more likely to develop chronic kidney disease (64.2 vs 42.9%; p <0.01) than those in the non-anemia group. During follow-up (mean 1.7 ± 0.4 years), patients with mild anemia had a higher risk of heart failure hospitalization and major bleeding events than those without (12.2 vs 3.8%; p <0.01 and 5.6 vs 2.5%; p <0.01, respectively). Mild anemia was an independent risk factor for heart failure hospitalization (adjusted hazard ratio: 1.67, 95% confidence interval 1.06 to 2.62, p = 0.03) but not for major bleeding (adjusted hazard ratio: 1.44, 95% confidence interval 0.80 to 2.62, p = 0.23). QoL improvement was less likely in the mild anemia group during follow-up, despite the lack of significant differences at baseline. In conclusion, the presence of even mild anemia was associated with increased risks of heart failure hospitalization and poor QoL improvement., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Clinical presentation of stent thrombosis (ST) and its sequela under contemporary practice have not been fully elucidated largely due to rare incidence of ST. We sought to assess the characteristics in patients with clinical presentation of ST and their in-hospital outcomes, utilizing nationwide registration system for percutaneous coronary interventions (J-PCI). The present study included acute coronary syndrome (ACS) patients undergoing PCI with clinical findings of definite ST from January 2014 to December 2016. Patients' characteristics, in-hospital mortality and its composite with periprocedural complications were evaluated. Full match comparison was performed. During the study period, 256,610 ACS patients (37.9% of total PCI cases) underwent PCI and 1,367 ST patients (1.9%) were identified from 73,241 ACS patients' records who had a history of previous PCI. Overall, patients with ST were younger but had higher incidence of previous myocardial infarction, compared with those without. In addition, ST patients had increased rate of crude in-hospital death (4.8% vs 1.1%, p <0.001). After full match comparison, the incidence of recurrent ST (post-PCI) was significantly higher in ST patients when compared with ACS patients presenting without ST (4.3% vs 0.9%, p <0.001). Despite younger age, patients with ST had significantly higher incidence of in-hospital mortality and cardiovascular complications, including recurrent ST, compared with those without., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Recently, cluster analysis was used to identify unique clinically relevant phenotypes of atrial fibrillation (AF) in a cohort from the United States (US) and classified clusters according to the presence of comorbid behavioral disorders, those with conduction disorders, or atherosclerotic comorbidities. Whether these phenotypes are consistent in AF cohorts outside the US remains unknown. Thus, we sought to conduct a cluster analysis in a cohort of Japanese AF patients. We conducted a cluster analysis of phenotypic data (46 variables) in an AF patient cohort recruited from 11 Japanese sites participating in the KiCS-AF Registry. Overall, 2,458 AF patients (median [IQR] age, 68.0 [60.0 to 76.0]; 30.3% female; median [IQR] CHA 2 DS 2 -Vasc, 2 [1, 3]) were analyzed. Similar to the US cohort, atherosclerotic comorbidities were identified as distinguishing factors to characterize clusters. Distribution of AF type and left atrial (LA) size substantially varied and was the key feature for cluster formation. CHA 2 DS 2 -Vasc score also contributed to cluster formation, although behavioral disorders and/or conduction disorders did not readily characterize clusters. Subsequently, the cohort was classified into 3 clusters: (1) Younger paroxysmal AF (n = 1,190); (2) Persistent/permanent AF with LA enlargement (n = 1,143); and (3) Atherosclerotic comorbid AF in elderly patients (N = 125). In conclusion, conventional classifications, such as atherosclerotic risk factors and CHA 2 DS 2 -Vasc score contributed to cluster formation in mutually, whereas in nonatherosclerotic clusters, AF type or LA size rather than the presence or absence of behavior risk factors or sinus node dysfunction (tachy-brady syndrome) seemed to contribute to cluster formation in the Japanese cohort., (Copyright © 2019 Elsevier Inc. All rights reserved.)

In-hospital complications and their predictors in acute coronary syndrome (ACS) patients with cardiogenic shock (CS) have not been fully investigated, particularly in those who underwent invasive revascularization procedures. This study investigated the in-hospital outcomes, along with the volume-outcome relationship of ACS patients with CS, using a contemporary large-scale nationwide percutaneous coronary intervention (PCI) registry in Japan. We analyzed PCI procedural data on ACS patients treated between 2014 and 2016 in a nationwide Japanese PCI registry. Predictors of in-hospital death and major bleeding complications requiring transfusion were identified via multivariable logistic regression analysis. The association of bleeding complications with in-hospital death was also analyzed. This study enrolled 253,355 patients who underwent PCI for ACS, of whom 17,549 (6.9%) were with CS. The rates of in-hospital mortality and access/nonaccess site bleeding complications in CS patients were 13.2%, 1.2%, and 1.3%, respectively. Age, gender, and baseline kidney condition, along with presentation status (e.g., cardiopulmonary arrest and/or acute heart failure) or the number and location of diseased vessels (e.g., left main lesion), were associated with in-hospital mortality and bleeding complications. Of note, the in-hospital mortalities decreased in parallel with the increasing institutional PCI volumes. In-hospital mortality also differed by the presence of concomitant bleeding complications (43.1% and 48.3% with access or nonaccess site bleeding, and 12.9% and 12.7% without, respectively). In conclusion, in-hospital mortality was 13.2% in ACS patients with CS who underwent contemporary PCI. Other than traditional predictors of PCI complications, lower institutional PCI volumes, and concurrent bleeding were associated with higher in-hospital mortality., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Scarce data exist regarding the relation between baseline hemoglobin and in-hospital outcomes after percutaneous coronary intervention (PCI). We studied 13,010 cases of PCI in a Japanese multicenter registry from 2008 to 2016. Patients were divided into 5 groups according to 2-g/dl increments in their preprocedural hemoglobin (from <10 to >16 g/dl). Patients with lower hemoglobin levels were older and had higher proportions of females and co-morbidities, including diabetes mellitus and renal failure, than those with higher hemoglobin levels. In-hospital complications were observed more frequently in patients with lower than higher levels. After adjustment, baseline hemoglobin was inversely associated with total procedural complications (odds ratio [OR] 0.87, 95% confidence interval [CI] 0.84 to 0.90, p <0.001), in-hospital mortality (OR 0.82, 95% CI 0.77 to 0.87, p <0.001), and bleeding complications (OR 0.93, 95% CI 0.88 to 0.98, p = 0.007). Categorically, reverse J-shaped curvilinear correlations were present between baseline hemoglobin and in-hospital adverse outcomes. When the reference group comprised patients with a baseline hemoglobin of 12 to 14 g/dl, patients within the lowest hemoglobin levels (<10 g/dl) were at the highest risk of total procedural complications (OR 2.57, 95% CI 2.07 to 3.17, p <0.001), in-hospital mortality (OR 3.46, 95% CI 2.34 to 5.11, p <0.001), and bleeding complications (OR 2.36, 95% CI 1.70 to 3.25, p <0.001). In subgroup analyses, similar trends were observed in both men and women, and in both patients with acute coronary syndrome and stable coronary artery disease. In conclusion, a low baseline hemoglobin is a simple and powerful predictor of poor outcomes in patients who undergo PCI., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Plasma B-type natriuretic peptide (BNP) is an important prognostic marker in patients with acute heart failure (AHF). However, it is unclear which BNP parameter, on admission, at discharge, or change during hospitalization, has the highest predictive performance for long-term adverse outcomes, and whether its prognostic impact differs according to the new European heart failure (HF) phenotype classification by left ventricular ejection fraction: heart failure with reduced ejection fraction (HFrEF), heart failure with mid-range ejection fraction (HFmrEF), and heart failure with preserved ejection fraction (HFpEF). We examined 1,792 patients with AHF consisting of 860 (48%) HFrEFs, 318 (18%) HFmrEFs, and 614 (34%) HFpEFs. Prognostic performance of each BNP parameter was assessed by the Harrell c-index. During a median follow-up of 664 days, 344 (19%) patients died. Discharge BNP had the highest c-index (0.69) for mortality among all BNP parameters (p <0.001). In multivariate Cox proportional hazard modeling, discharge BNP was associated with mortality in HFrEF, HFmrEF, and HFpEF patients with significant interaction (hazard ratio [HR] 1.95, 95% confidence interval [CI] 1.57 to 2.41; HR 1.76, 95% CI 1.10 to 2.82; HR 1.46, 95% CI 1.12 to 1.91, respectively; p = 0.011 for interaction). Moreover, the c-index of discharge BNP for mortality in HFrEF patients (0.72) was higher than that in HFmrEF patients (0.68) and HFpEF patients (0.65). Similar results were obtained for mortality or HF rehospitalization as alternative outcomes, except there was no statistically significant interaction among HF phenotypes. In conclusion, discharge BNP is a more reliable marker than other BNP parameters on long-term outcome prediction in patients with AHF, but its prognostic impact may be weakened in HFmrEF and HFpEF compared with HFrEF., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The onset of acute heart failure is known to be associated with increased physical activity and other specific behaviors that can trigger hemodynamic deterioration. This analysis aimed to describe the distribution of triggers in patients hospitalized for acute heart failure, and investigate their effects on in-hospital outcomes., Methods: Consecutive patients hospitalized for acute heart failure between 2010 and 2014 were registered in a multicenter data registration system (72 institutions within Tokyo, Japan). Baseline demographics and in-hospital mortality were extracted from 17,473 patients. Patients with a trigger were grouped based on their triggering event: those with onset during (a) physical activity; (b) sleeping; (c) eating or watching television; (d) bathing or excretion (use of restrooms); and (e) engaging in other activities. These patients were compared with patients without identifiable triggers. Multiple imputation was used for missing data., Results: Patients were predominantly men (57.1%), with a mean age of 76.0 ± 13.0 years; a triggering event was present in 49.1%. No significant difference in baseline characteristics was noted between groups except for younger age, higher blood pressure, and prevalence of signs of congestion in the trigger-positive group. In-hospital mortality rate was 7.9%. Presence of triggers was positively associated with a reduced risk of in-hospital mortality (adjusted odds ratio 0.79; 95% confidence interval, 0.70-0.90; P = .0003). In a delta-adjusted pattern mixture model, the effect of a triggering event on in-hospital mortality remained consistently significant., Conclusion: Triggering events for acute heart failure can provide additional information for risk prediction. Efforts to identify the triggers should be made to classify patients according to risk group., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Both the obesity paradox and blood pressure (BP) paradox remain ill defined. Because both obesity and hypertension are well-known predictors of coronary artery disease (CAD) and acute heart failure (HF), in the present study, we compared the obesity paradox and the BP paradox between patients with acute HF with and without a history of CAD. A multicenter retrospective study was conducted on 3,204 consecutive patients with acute HF. Potential risk factors for in-hospital mortality were selected by univariate analyses; multivariate Cox regression analysis with backward stepwise selection was then used to identify significant factors. Kaplan-Meier survival curves and log-rank testing were used to compare in-hospital mortality between groups. Across the study cohort, 27% of patients had a history of CAD, and the all-cause in-hospital mortality rate was 5%. In-hospital mortality was significantly lower for patients with obesity than in those without obesity (log-rank, p = 0.033). However, this obesity paradox disappeared in the group with HF and CAD (log-rank, p = 0.740). In contrast, in-hospital mortality was significantly lower for patients with high BP at admission, regardless of the presence of a history of CAD (log-rank, p <0.001 for both groups). In conclusion, a history of CAD canceled the obesity paradox in patients with acute HF, whereas the BP paradox persisted regardless of a history of CAD., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Performance measures (PMs) are used to accelerate translation of scientific evidence into clinical practice. However, it remains unknown how they are applied in the real world and whether the compliance to these metrics will lead to improved patient's outcome in atrial fibrillation (AF). Within the Japanese multicenter AF registry (n = 1,874), adherence of the AF PMs (based on 2016 American Heart Association/American College of Cardiology criteria) and its association with quality of life scaling and clinical outcomes was evaluated. The patient was deemed "adherent" when all applicable components of the PMs for outpatient settings (CHA 2 DS 2 -VASc risk score documentation [PM-4], anticoagulation prescribed [PM-5], and monthly international normalized ratio (INR) for warfarin treatment [PM-6]) were satisfied. The Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire was assessed at baseline and 1 year. About a half of patients (46.1%) were adherent to the AF PMs. PMs were more frequently achieved in patients managed with rhythm control compared with rate control. The achievement rate for each component was 53.9% for PM-4, 85.6% for PM-5, and 90.3% for PM-6, respectively. Although AFEQT global scores at baseline were similar (median 79.2 [interquartile ranges 66.7 to 88.5] vs 77.1 [64.8 to 88.0], p = 0.227), AFEQT global scores at 1-year follow-up were significantly greater in adherence group than those in nonadherence group (89.2 [78.5 to 96.6] vs 86.7 [76.7 to 95.0], p = 0.021). This tendency was consistent regardless of therapeutic strategies. There remains an important opportunity to improve the quality of care in patients with AF. Adherence to the AF PMs might lead to the improvement of patient's quality of life., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Details on the characteristics and outcomes in patients with acute coronary syndrome (ACS) complicated with cardiopulmonary arrest (CPA) have been limited. We evaluated inhospital outcomes after percutaneous coronary intervention in these patients. From 2008 to 2014, 5,943 patients with ACS including 2,973 patients with ST-elevation myocardial infarction (STEMI) and 2,970 patients with non-STEMI or unstable angina (NSTE-ACS) were registered. In total, 264 patients experienced CPA within 24 hours of admission. Patients with CPA presented more frequently with cardiogenic shock (CS) (79.0% vs 7.7% in STEMI; 78.0% vs 1.1% in NSTE-ACS; p <0.001, respectively) and had a higher mortality rate (26.2% vs 3.8% in STEMI; 36.0% vs 1.6% in NSTE-ACS; p <0.001, respectively) than those without. On multivariate analysis, both age (odds ratio [OR] 1.04, 95% confidence interval [CI] 1.02 to 1.07, p = 0.002) and presence of CS (OR 5.54, 95% CI 2.19 to 17.13, p <0.001) were independent predictors of inhospital mortality in patients with ACS complicated with CPA and adjusted ORs increased exponentially under the presence of these variables (age ≥75 years: OR 3.16, 95% CI 2.14 to 4.70; CS: OR 18.70, 95% CI 12.40 to 28.40; presence of both these factors: OR 33.80, 95% CI 21.13 to 54.23). In conclusion, the mortality rate after percutaneous coronary intervention remains high in patients with ACS complicated with CPA. Older age and shock status were strongly associated with inhospital mortality in these patients., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Previous studies have reported that women have worse outcomes than men after percutaneous coronary intervention (PCI), especially in patients with ST-elevation myocardial infarction. However, gender-related differences in patients with non-ST-elevation acute coronary syndromes (NSTE-ACS) have not been thoroughly investigated. In the Japanese nationwide registry, a total of 43,239 patients with NSTE-ACS from 861 hospitals underwent PCI in 2014. Overall, 11,326 patients (26.2%) were women. The women were older (75.0 ± 10.3 vs 68.7 ± 11.4 years, p <0.001) and had a higher prevalence of hypertension (p <0.001), hyperlipidemia (p = 0.003), and heart failure (p <0.001) compared with men. For inpatient outcomes, women had a higher rate of overall complications (3.3% vs 2.4%, p <0.001) and bleeding complications that required blood transfusion (0.6% vs 0.2%, p <0.001). On multivariate analysis, female gender was an independent predictor of overall (odds ratio [OR] 1.20, 95% CI 1.04 to 1.38; p = 0.011) and bleeding complications (OR 1.94, 95% CI 1.35 to 2.79; p <0.001) after adjustment but was not associated with in-hospital mortality (OR 1.05, 95% CI 0.79 to 1.40; p = 0.747). In conclusion, in patients with NSTE-ACS who underwent PCI, women were at greater risk than men for in-hospital complications, especially in bleeding complications., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Effects of daily fluctuation of ambient temperature and concentrations of air pollutants on acute cardiovascular events have not been well studied. From January 2011 to December 2012, a total of 56,863 consecutive ST-segment elevation myocardial infarction (STEMI) patients who underwent primary percutaneous coronary intervention were registered from 929 institutes with median interinstitutional distance of 2.6 km. We constructed generalized linear mixed models in which the presence or absence of patients with STEMI per day per institute was included as a binomial response variable, with daily meteorologic and environmental data obtained from their respective observatories nearest to the institutes (median distance of 9.7 and 5.6 km) as the explanatory variables. Both lower mean temperature and increase in maximum temperature from the previous day were independently associated with the STEMI occurrence throughout the year (odds ratio [OR] 0.925, 95% confidence interval [CI] 0.915 to 0.935, per 10°C, p <0.001; and OR 1.012, 95% CI 1.009 to 1.015, per °C, p <0.001, respectively). Decrement in minimum temperature from -4 days to -3 days before the event date was marginally associated with the STEMI occurrence, only during the wintertime (OR 0.991, 95% CI 0.982 to 0.999, per °C, p = 0.03). As for the air pollutants, nitrogen oxides and suspended particle matter were not correlated with the occurrence of STEMI after adjusting for the meteorologic and livelihood variables. Both the absolute value and relative change in the ambient temperature were associated with the occurrence of STEMI; the associations with the air pollutant levels were less clear after adjustment for these meteorologic variables in Japan., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Little is known about the outcomes and indications of chronic total occlusion percutaneous coronary intervention (CTO-PCI), other than in high-volume centers. We sought to provide a real-world overview of the clinical outcomes and appropriateness of PCI for CTO. The analysis included 4,950 consecutive PCIs for nonacute indications registered in the multicenter Japanese PCI registry in collaboration with the US National Cardiovascular Data Registry (Cath-PCI). Data included demographics, clinical outcomes (procedural success and complication rates), and the indication appropriateness, based on the 2012 appropriate use criteria for revascularization. The overall procedural success and major adverse cardiac event rates of 501 cases with CTO-PCI (10.1%) were 76% and 3.2%, respectively. Based on the criteria, mapping failures occurred in 2,521 procedures; the remaining 2,429 PCIs were successfully mapped. The CTO-PCIs were performed for more appropriate indications than PCIs for lesions without CTO. The rate of inappropriate indications was significantly lower in CTO-PCIs than in non-CTO-PCIs (23.0% vs 31.4%, p = 0.04). Only 17% of CTO-PCIs were directly assigned to CTO-specific scenarios because such scenarios are only intended for "Lone" CTO; the rest of the CTO-PCI cases were secondarily mapped to non-CTO-specific scenarios. In conclusion, as many as 10% of the elective PCIs were performed for CTO lesions in a contemporary multicenter Japanese PCI registry; CTO-PCI was associated with lower procedural success and higher complication rates than non-CTO-PCI. Its indication was relatively appropriate; however, our findings emphasize the need for more rigorous evaluation in terms of the present insufficient CTO-related clinical scenarios., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Previous models for contrast-induced acute kidney injury (CI-AKI) after percutaneous coronary intervention (PCI) include procedure-related variables in addition to pre-procedural variables. We sought to develop a risk model for CI-AKI based on pre-procedural variables and compare its predictability with a conventional risk model and also to develop an integer score system based on selected variables. A total of 5,936 consecutive PCIs registered in the Japanese Cardiovascular Database were analyzed (derivation cohort, n = 3,957; validation cohort, n = 1,979). CI-AKI was defined as an increase in serum creatinine of 50% or 0.3 mg/dl compared with baseline. From the derivation cohort, 2 different CI-AKI risk models were generated using logistic regression analyses: a pre-procedural model and a conventional model including both pre-procedural and procedure-related variables. The predictabilities of the models were compared by c-statistics. An integer score was assigned to each variable in proportion to each estimated regression coefficient for the final model. In our derivation cohort, the proportion of CI-AKI was 9.0% (n = 358). Predictors for CI-AKI included older age, heart failure, diabetes, previous PCI, hypertension, higher baseline creatinine level, and acute coronary syndrome. Presence of procedure-related complications and insertion of intra-aortic balloon pumping were included as procedure-related variables in the conventional model. Both the conventional model (c-statistics 0.789) and the pre-procedural model (c-statistics 0.799) demonstrated reasonable discrimination. The integer risk-scoring method demonstrated good agreement between the expected and observed risks of CI-AKI in the validation cohort. In conclusion, the pre-procedural risk model for CI-AKI had acceptable discrimination compared with the conventional model and may aid in risk stratification of CI-AKI before PCI., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Current guidelines recommend shorter door-to-balloon times (DBTs) (<90 minutes) for patients with ST-elevation myocardial infarction (STEMI). Clinical factors, including patient or hospital characteristics, associated with prolonged DBT have been identified, but angiographic variables such as culprit lesion location have not been thoroughly investigated. We aimed to evaluate the effect of culprit artery location on DBT of patients with STEMI who underwent percutaneous coronary intervention (PCI). Data were analyzed from 1,725 patients with STEMI who underwent PCI from August 2008 to March 2014 at 16 Japanese hospitals. Patients were divided into 3 groups according to culprit artery location, right coronary artery (RCA), left anterior descending artery (LAD), and left circumflex artery (LC), and associations with DBT were assessed. The LC group had a trend toward a longer DBT among the 3 groups (97.1 [RCA] vs 98.1 [LAD] vs 105.1 [LC] minutes; p = 0.058). In-hospital mortality was also significantly higher in patients with a left coronary artery lesion (3.5% [RCA] vs 6.3% [LAD] vs 5.4% [LC]; p = 0.041). In-hospital mortality for patients with DBT >90 minutes was significantly higher compared with patients with DBT ≤90 minutes (6.5% vs 3.6%; p = 0.006). Multivariate logistic regression analysis revealed that the LC location was an independent predictor for DBT >90 minutes (odds ratio, 1.45; 95% confidence interval, 1.04 to 2.01; p = 0.028). In conclusion, LC location was an independent predictor of longer DBT. The difficulties in diagnosing LC-related STEMI need further evaluation., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Understanding the perspective of early-career cardiologists is important to design effective responses to the challenges in modern cardiovascular (CV) training programs. We conducted a web-based survey on a total of 272 early-career cardiologists (within 10 postgraduate years) who registered for the 2011 annual Japanese Circulation Society Meeting. Main outcome measures were satisfaction with their training, confidence in their clinical skills, and professional expectations, scaled from 0 to 10. The median training time was 6 years, with 2 years for internal medicine and 4 years for CV disease. Most received their training in university hospitals at some point during their career (79.5%) and were interested in a subspecialty training, such as interventional cardiology (38.6%), electrophysiology (15.1%), and advanced heart failure (10.3%); only 9.6% showed interest in general cardiology. The respondents felt comfortable in managing common CV conditions such as coronary artery disease (average score 6.3 ± 2.4 on an 11-point Likert scale) but less so in peripheral arterial disease (3.8 ± 2.8), arrhythmias (3.7 ± 2.3), and congenital heart disease (2.9 ± 2.2). Their satisfaction rate with their CV training positively correlated with their clinical proficiency level and was associated with volume of coronary angiograms, percutaneous coronary interventions, and echocardiograms completed. In conclusion, the current young cardiologists have a positive perception of and interest in procedure-based subspecialty training, and their training satisfaction was related to volume of cardiac procedures. Additional effort is needed in enforcing the training in underappreciated subspecialty areas., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Although coronary revascularization is common in both Japan and the United States (US), no direct comparison has been performed to demonstrate differences in the clinical characteristics and long-term outcomes of patients in these 2 countries. We analyzed the preprocedural, in-hospital, and long-term data from the Coronary Revascularization Demonstrating Outcome registry (Kyoto, Japan) and the Texas Heart Institute Research Database (Houston, Texas) of 16,100 patients who had undergone elective, initial percutaneous coronary intervention or coronary artery bypass grafting. The Japanese procedures were performed from 2000 to 2002 (n = 8,871, follow-up period 3.5 years, interquartile range 2.6 to 4.3) and the US procedures from 1999 to 2003 (n = 7,229, follow-up period 5.2 years, interquartile range 3.8 to 6.5). The Japanese patients tended to be older (mean age 67.2 vs 62.7 years; p <0.001), to smoke (52.9% vs 46.0%; p <0.001), and to have diabetes (39.2% vs 31.0%; p <0.001) and stroke (16.4% vs 5.0%; p <0.001). The US patients were more obese (body mass index 23.7 vs 29.3 kg/m(2); p <0.001), with greater rates of systemic atherosclerotic disease. Both groups had a similar in-hospital mortality rate (Japanese patients 0.9% vs US patients 1.1%; p = 0.19) and crude long-term mortality rate (Japanese patients 27.7/1,000 person-years, US patients 28.2/1,000 person-years; p = 0.35). After adjustment for known predictors, the US group had greater long-term mortality than the Japanese group (hazard ratio 1.71, 95% confidence interval 1.50 to 1.95; p <0.001). This finding was consistent among all high-risk subgroups. In conclusion, the 2 registries showed similar crude outcomes but important differences in patient risk factors such as obesity. In the adjusted analysis, the Japanese patients had better outcomes than did the US patients. Additional study is needed to assess the effect of ethnic and risk factor variations on coronary artery disease.

We sought to assess the microbiologic profile of patients with suspected sepsis who participated in the SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK? (SHOCK) trial, a randomized controlled trial of early coronary revascularization in patients with cardiogenic shock complicating acute myocardial infarction. A protocol-mandated SEPSIS form was completed prospectively for 54 patients (18%) with fever or leukocytosis suggestive of sepsis. These patients were divided further into those with positive (n = 40) or negative (n = 14) culture results. The predominant pathogen isolated in patients with positive culture results was Staphylococcus aureus (32%), followed by Klebsiella pneumoniae and Pseudomonas aeruginosa. Patients with both positive and negative culture results had longer median durations of mechanical ventilation (p <0.001 and p = 0.02), intra-aortic balloon pump (IABP) support (p = 0.074 and p = 0.021), and hospital stay (p <0.001 and p = 0.048) than controls. Sepsis was predicted by both duration of IABP support (p = 0.007) and use of multiple central catheters (p = 0.026). In conclusion, clinical sepsis is common after cardiogenic shock complicating acute myocardial infarction, particularly in patients who received prolonged IABP support or had multiple central catheters.