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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.)

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.)

Fragmented care following elective surgery has been associated with poor outcomes. The association between fragmented care and outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. We examined patients who underwent TAVI from 2011 to 2015 at 374 sites in the STS/ACC TVT Registry, linked to Center for Medicare and Medicaid Services claims data. Fragmented care was defined as at least one readmission to a site other than the implanting TAVI center within 90 days after discharge, whereas continuous care was defined as readmission to the same implanting center. We compared adjusted 1-year outcomes, including stroke, bleeding, heart failure, mortality, and all-cause readmission in patients who received fragmented versus continuous care. Among 8,927 patients who received a TAVI between 2011 and 2015, 27.4% were readmitted within 90 days of discharge. Most patients received fragmented care (57.0%). Compared with the continuous care group, the fragmented care group was more likely to have severe chronic lung disease, cerebrovascular disease, and heart failure. States that had lower TAVI volume per Center for Medicare and Medicaid Services population had greater fragmentation. Patients living > 30 minutes from their TAVI center had an increased risk of fragmented care 1.07 (confidence interval [CI] 1.06 to 1.09, p < 0.001). After adjustment for comorbidities and procedural complications, fragmented care was associated with increased 1-year mortality (hazards ratio 1.18, CI 1.04 to 1.35, p = 0.010) and all-cause readmission (hazards ratio 1.08, CI 1.00 to 1.16, p = 0.051. In conclusion, fragmented readmission following TAVI is common, and is associated with increased 1-year mortality and readmission. Efforts to improve coordination of care may improve these outcomes and optimize long-term benefits yielded from TAVI., (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.)

Systolic blood pressure (SBP) and its association with clinical outcomes in atrial fibrillation (AF) patients in community practice are poorly characterized. In patients with AF, we sought to (1) examine the prevalence of baseline uncontrolled hypertension and the overall change in SBP control, (2) identify predictors of uncontrolled SBP over 2 years of follow-up, and (3) determine the relation between SBP and clinical outcomes. We analyzed 10,132 patients with AF at 176 clinics in the ORBIT-AF registry between 2010 and 2014, classified as: (1) no history of hypertension; (2) controlled hypertension (baseline SBP <140 mm Hg); (3) and uncontrolled hypertension (baseline SBP >140 mm Hg). Predictors of SBP >140 mm Hg at baseline or in follow-up were identified with pooled logistic regression. Random effects Cox regression models were used to compare cardiovascular outcomes and major bleeding as a function of continuous, time-dependent SBP. Overall 8,383 (83%) of patients with AF had hypertension. Of these, 24.2% (n = 2032) had uncontrolled baseline SBP, with little change over 2 years. Predictors of elevated follow-up SBP included uncontrolled baseline SBP, females, previous percutaneous coronary intervention, and diabetes. For every 5 mm Hg increase in follow-up SBP, the adjusted risk of stroke or systemic embolism or transient ischemic attack (adjusted hazard ratio [aHR] 1.05, 95% confidence interval [CI] 1.01 to 1.08, p = 0.01), myocardial infarction (aHR 1.05, 95% CI 1.00 to 1.11, p = 0.04), and major bleeding (aHR 1.03, 95% CI 1.00 to 1.06, p = 0.04) increased modestly. In conclusion, in patients with AF, higher SBP was associated with increasing adverse events; therefore, more rigorous blood pressure control should be emphasized., (Copyright © 2019 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.)

Complications after transcatheter aortic valve implantation (TAVI) remain an important issue. This study aimed to evaluate the impact of systematic postprocedural multidetector computed tomography (MDCT) to detect subclinical complications after TAVI. From October 2013 to August 2015, a total of 135 patients who underwent transfemoral TAVI (n = 116) or transapical TAVI (n = 19) with Sapien XT and MDCT preprocedure and postprocedure were enrolled. Postprocedural MDCT findings were compared with the preprocedural MDCT findings. Cardiovascular complications were observed in 25.9% of patients, including 6 cases (4.5%) with major complications. Of those, clinically apparent major complications were reported in 2 cases including rupture of the sinus of Valsalva and iliac rupture. The complications in the remaining 4 cases (3.0%) included aortic dissection, aortic intramural hematoma, and left ventricular apical pseudoaneurysm, which were totally asymptomatic and only detected by MDCT. The apical pseudoaneurysm required surgical repair. Minor complications were observed in 21.5% of patients, 50% of which were subclinical. Only 1 case with femoral pseudoaneurysm required an additional procedure. Noncardiovascular findings were detected in 27.4% of patients; the most frequent were pleural effusions and atelectasis, which were predominantly observed in those treated through a transapical approach. Contrast-induced acute kidney injury after postprocedural MDCT was reported in 1 patient whose clinical course was complicated by sepsis. In conclusion, postprocedural MDCT was useful in detecting important subclinical complications that may affect the clinical course without deterioration of renal function., (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.)

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.)