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Several studies have demonstrated better hemodynamic stability of mechanically expanding valves following transcatheter aortic valve replacement (TAVR). This study aims to assess the expansion or recoil of transcatheter aortic valves using multidetector computed tomography (MDCT). This was a retrospective study. Among 873 patients who underwent TAVR with balloon-expandable (SAPIEN 3) or mechanically expanding valves (LOTUS) at Keio University Hospital between 2013 and 2020, those who underwent serial MDCT and echocardiographic assessment (pre-procedure, discharge, 6 months, 1 year, and 2 years post-TAVR) as our hospital protocol were included in this analysis (N = 30; LOTUS = 12; SAPIEN 3 = 18). The pre- and post-procedural echocardiographic data and the valve expansion rate evaluated by MDCT were compared between the groups. In LOTUS valves, late-phase expansion was observed on computed tomography (mean expansion rate, 83.8% at discharge and 86.8%, 2 years postoperative, p < 0.001), and a gradual increase in the aortic valve area was observed on echocardiography (aortic valve area: 1.45 cm 2 at discharge and 1.51 cm 2 , 2 years postoperative, p = 0.01). Conversely, in SAPIEN 3, valve expansion was not seen in the late phase (mean expansion rate, 84.5% at discharge and 83.8%, 2 years postoperative) with a decrease in the aortic valve area (1.41 cm 2 at discharge and 1.37 cm 2 , 2 years postoperative, p = 0.04). The expansion of the middle portion of the LOTUS valves was attributed to the increase in the aortic valve area. In conclusion, this study demonstrated the greater late-phase expansion and better valve performance of mechanically expanding valves., (© 2022. The Author(s) under exclusive licence to Japanese Association of Cardiovascular Intervention and Therapeutics.)

Background There is significant regional or institutional variation in the use of thrombus aspiration (TA) in patients undergoing percutaneous coronary intervention (PCI). We investigated the temporal trend in TA use and its association with clinical outcomes in acute coronary syndrome using the nationwide J-PCI (Japanese PCI) registry. Methods and Results Between 2016 and 2018, patients with acute coronary syndrome undergoing PCI (n=282 606; median age, 71.0 years; interquartile range, 62.0-79.0 years; women, 24.7%) at 1124 hospitals were stratified on the basis of whether TA was performed (TA and non-TA). The patients were subdivided according to clinical presentation (ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina). Successful PCI, defined as the achievement of TIMI (Thrombolysis in Myocardial Infarction) 3 flow, and in-hospital mortality were assessed. During the study period, 83 422 patients (29.5%) underwent TA (52.9%, 23.5%, and 5.2% for ST-segment-elevation myocardial infarction, non-ST-segment-elevation myocardial infarction, and unstable angina, respectively), and the TA implementation rate remained relatively stable throughout. Patients treated with TA had higher rate of successful PCI than non-TA (98.7% versus 97.8%; P <0.001). TA was not associated with in-hospital death among patients with ST-segment-elevation myocardial infarction (adjusted odds ratio [aOR], 1.02 [95% CI, 0.94-1.12]). However, TA use was associated with higher rates of in-hospital death in patients with non-ST-segment-elevation myocardial infarction ( aOR, 1.51 [95% CI, 1.23-1.86]) or unstable angina ( aOR, 1.95 [95% CI, 1.37-2.79]). Conclusions In our retrospective analysis of the nationwide PCI registry, TA use was associated with a higher achievement of successful PCI without impairing in-hospital mortality among patients with ST-segment-elevation myocardial infarction. Nevertheless, its use should be cautioned in less-established indications (eg, non-ST-segment-elevation myocardial infarction and unstable angina).

Objectives: We sought to provide clinical insights on the usage rate, indications, and in-hospital outcomes of the revived directional coronary atherectomy (DCA) catheter (Atherocut™) in a Japanese nationwide percutaneous coronary intervention (PCI) registry., Background: Debulking devices such as the revived DCA catheter have become increasingly important in the era of complex PCI. However, little is known about PCI outcomes using a novel DCA catheter in contemporary real-world practice., Methods: We analyzed 188,324 patients who underwent PCI in 1112 hospitals from January to December 2018. Baseline characteristics and in-hospital outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without the DCA were analyzed., Results: Overall, 1696 patients (0.9%) underwent PCI with the DCA during the study period, predominantly for left main trunk or proximal left anterior descending artery lesions under a transfemoral approach. Patients in the DCA group were younger and had fewer comorbidities such as hypertension, diabetes mellitus, and chronic kidney disease than patients in the non-DCA group. Stentless PCI using the DCA with drug-coated balloon angioplasty was a preferred treatment strategy in the DCA group (50.0%). Predefined in-hospital adverse outcomes, including mortality (0.2% vs. 0.3%, p = 0.446) and periprocedural complications (1.8% vs. 1.7%, p = 0.697), were comparable between the two groups, whereas the fluoroscopy time was longer and the total contrast volume was higher in the DCA group., Conclusions: In Japan, PCI using the revived DCA catheter is safely performed with low complication rates in patients with stable coronary artery disease or unstable angina., (© 2022 Wiley Periodicals LLC.)

Aims: We examined in-hospital outcomes of patients that required mechanical circulatory support (MCS), such as intra-aortic balloon pumping (IABP), Impella®, or veno-arterial extracorporeal membrane oxygenation (VA-ECMO), for elective percutaneous coronary interventions (PCIs)., Methods and Results: The J-PCI is a prospective Japanese nationwide multicentre registry sponsored by the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) and designed to collect clinical variables and in-hospital outcome data on consecutive patients undergoing PCI. Of the 253 228 patients registered between January 2018 and December 2018, 1627 patients (0.6%) undergoing elective PCI under MCS at 551 sites were analyzed. The mean age of the patients was 74 years, and 25.2% of the patients were females. Multivessel disease and left main disease were observed in 59.0% and 19.7% of the patients, respectively. Majority of patients were treated with IABP alone (86.2%), followed by IABP plus VA-ECMO (6.0%) and Impella alone (3.9%). In-hospital mortality was reported in 134 patients (8.2%). Cardiac death was more common than non-cardiac death (6.8% vs. 1.5%). About 34.6% of the patients receiving VA-ECMO died during hospitalization, whereas 7.2% and 5.3% of patients receiving Impella and IABP died, respectively ( P  < 0.01). The proportion of patients with VA-ECMO or Impella who had major bleeding requiring blood transfusion was higher than that of patients with IABP (14.1% vs. 13.0% vs. 2.8%)., Conclusion: In the setting of elective PCI, in-hospital mortality of patients requiring MCS was considerably high. VA-ECMO or Impella was associated with a higher risk of major bleeding than IABP., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

An accurate prediction of major adverse events after percutaneous coronary intervention (PCI) improves clinical decisions and specific interventions. To determine whether machine learning (ML) techniques predict peri-PCI adverse events [acute kidney injury (AKI), bleeding, and in-hospital mortality] with better discrimination or calibration than the National Cardiovascular Data Registry (NCDR-CathPCI) risk scores, we developed logistic regression and gradient descent boosting (XGBoost) models for each outcome using data from a prospective, all-comer, multicenter registry that enrolled consecutive coronary artery disease patients undergoing PCI in Japan between 2008 and 2020. The NCDR-CathPCI risk scores demonstrated good discrimination for each outcome (C-statistics of 0.82, 0.76, and 0.95 for AKI, bleeding, and in-hospital mortality) with considerable calibration. Compared with the NCDR-CathPCI risk scores, the XGBoost models modestly improved discrimination for AKI and bleeding (C-statistics of 0.84 in AKI, and 0.79 in bleeding) but not for in-hospital mortality (C-statistics of 0.96). The calibration plot demonstrated that the XGBoost model overestimated the risk for in-hospital mortality in low-risk patients. All of the original NCDR-CathPCI risk scores for adverse periprocedural events showed adequate discrimination and calibration within our cohort. When using the ML-based technique, however, the improvement in the overall risk prediction was minimal., (© 2022. The Author(s).)

Background: Coronavirus disease 2019 (COVID-19) has negatively affected access to healthcare systems and treatment timelines. This study was designed to explore the impact of the COVID-19 pandemic on patients who underwent percutaneous coronary intervention (PCI)., Methods: From January 2019 to December 2020, 489,001 patients from 1068 institutions were registered in the Japanese nationwide PCI (J-PCI) registry. We constructed generalized linear models to assess the difference in the daily number of patients and in-hospital outcomes between 2019 and 2020., Findings: In total, 207 institutions (19·3%) had closed or restricted access during the first COVID-19 outbreak in May 2020; the number of closed or restricted institutions had plateaued at a median of 121 institutions (11·3%). The daily case volume of PCI significantly decreased in 2020 (by 6·7% compared with that in 2019; 95% confidence interval [CI], 6·2-7·2%; p  < 0·001). Marked differences in the presentation of PCI patients were observed; more patients presented with ST-segment elevation myocardial infarction (18·3% vs. 17·5%; p  < 0·001), acute heart failure (4·49% vs. 4·30%; p  = 0·001), cardiogenic shock (3·79% vs. 3·45%; p  < 0·001), and cardiopulmonary arrest (2·12% vs. 2·00%; p  = 0·002) in 2020. The excess adjusted in-hospital mortality rate in patients treated in 2020 relative to those treated in 2019 was significant (adjusted odds ratio, 1·054; 95% CI, 1·004-1·107; p  = 0·03)., Interpretation: While the number of patients who underwent PCI substantially decreased during the COVID-19 pandemic, more patients presented with high-risk characteristics and were associated with significantly higher adjusted in-hospital mortality., Funding: The J-PCI registry is a registry led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics. The present study was supported by the Grant-in-Aid from the Ministry of Health and Labour (No. 20IA2002 and 21FA1015), the Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (KAKENHI; No. 21K08064), and the Japan Agency for Medical Research and Development (No. 17ek0210097h000)., Competing Interests: K.Y. reports investigator-initiated grant funding from Abbott. S.K. reports investigator-initiated grant funding from Bayer and Daiichi Sankyo and personal fees from Bristol-Myers Squibb. T.I. has a research grant from Boston Scientific. H.I. receives lecture fees from Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, MSD, Otsuka, and Pfizer. T.A. receives lecture fees from Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb. The rest of the authors have no conflict of interest to report., (© 2022 The Author(s).)

Background The practice pattern and outcome of medical devices following their regulatory approval may differ by country. The aim of this study is to compare postapproval national clinical registry data on transcatheter aortic valve replacement between the United States and Japan on patient characteristics, periprocedural outcomes, and the variability of outcomes as a part of a partnership program (Harmonization-by-Doing) between the 2 countries. Methods and Results The patient-level data were extracted from the US Society of Thoracic Surgeons /American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) and the J-TVT (Japanese Transcatheter Valvular Therapy) registry, respectively, to analyze transcatheter aortic valve replacement outcomes between 2013 and 2019. Data entry for these registries was mandated by the federal regulators, and the majority of variable definitions were harmonized to allow direct data comparison. A total of 244 722 transcatheter aortic valve replacements from 646 institutions in the United States and 26 673 transcatheter aortic valve replacements from 171 institutions in Japan were analyzed. Median volume per site was 65 (interquartile range, 45-97) in the United States and 28 (interquartile range, 19-41) in Japan. Overall, patients in J-TVT were older (United States: mean-age, 80.1±8.7 versus Japan: 84.4±5.2; P <0.001), were more frequently women (45.9% versus 68.1%; P <0.001), and had higher median Society of Thoracic Surgeons Predicted Risk of Mortality (5.27% versus 6.20%; P <0.001) than patients in the United States. Japan had lower unadjusted 30-day mortality (1.3% versus 3.2%; P <0.001) and composite outcomes of death, stroke, and bleeding (17.5 versus 22.5%; P <0.001) but had higher conversion to open surgery (0.94% versus 0.56%; P <0.001). Conclusions This collaborative analysis between the United States and Japan demonstrated the feasibility of international comparison using the national registries coded under mutual variable definitions. Both countries obtained excellent outcomes, although the Japanese had lower 30-day mortality and major morbidity. Harmonization-by-Doing is one of the key steps needed to build global-level learning to improve patient outcomes.

Background: Measuring the quality of care has been central for improving the outcomes of patients undergoing percutaneous coronary intervention (PCI). This study described the performance rates and regional variations in quality metrics for PCI using a representative national Japanese registry., Methods: Overall, 760,854 patients across 714 institutions (2016-2018) were analysed. Quality metrics included preprocedural antiplatelet therapy use, door-to-balloon time ≤90 min for ST-elevation myocardial infarction, transradial approach, and preprocedural noninvasive stress testing for elective cases in 47 Japanese prefectures. Coronary computed tomography angiography (CCTA) and fractional flow reserve (FFR) were also evaluated. Factors associated with preprocedural testing rates were evaluated using multivariable linear regression., Findings: Rates of preprocedural antiplatelet therapy use were high with low variations (96·4% [94·7-97·2%]), but there was still substantial room for improvement in the rates of door-to-balloon time (74·7% [71·2-78·9%]) and transradial approach use (70·9% [65·1-73·4%]). Rates of preprocedural noninvasive stress testing were low with substantial variation (36·6% [27·1-49·7%]). Additionally, we found substantial variations in CCTA (50·0% [39·5-55·1%]) and FFR measurement (15·7% [113·-18·3%]) rates. The number of scintigraphy scanners/ prefecture was associated with the performance of noninvasive stress testing (13·4% [95% CI, 2·45-24·4%] increase for every 1/100,000 population increase in scanners)., Interpretations: We observed substantial regional variation in the use of preprocedural testing, and its performance was directly related to nuclear-scanner availability. These findings suggest the need for targeted efforts in improving testing rates, whether by optimising resource allocation or additional education or feedback mechanisms., Funding: This study was funded by the Japan Society for the Promotion of Science (Grant Nos. 20H03915, 16H05215, 16KK0186, and 20K22883) and by the Ministry of Health, Labor and Welfare Grants-in-Aid for Scientific Research Program (Grant No. 21FA1015). The J-PCI registry is led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics., Competing Interests: Kohsaka has received investigator-initiated grant funding from Daiichi-Sankyo and Bristol-Myers Squibb and has received personal fees from Bristol-Myers Squibb. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2022 The Author(s).)

A new data transformation method for micro-manufacturing using a topological model for a micro-/nano-texture was proposed for a surface-decorated product. Femtosecond laser printing was utilized to form the micro-/nano-textures into the hardened thick layer of dies by plasma nitriding. At first, the plasma-nitrided AISI316L flat substrate was laser-printed as a punch to imprint the tailored nano-textures onto the AA1060 aluminum plate for its surface decoration with topological emblems. Second, the plasma-nitrided SKD11 cylindrical punch was laser-trimmed to form the nanostructures on its side surface. This nano-texture was imprinted onto the hole surface concurrently with piercing a circular hole into electrical steel sheet. The fully burnished surface had a shiny, metallic quality due to the nano-texturing. The plasma nitriding, the laser printing and the CNC (computer numerical control) imprinting provided a way of transforming the tailored textures on the metallic product.

Background: Despite maturing experience, transseptal puncture (TSP) remains a challenging part of percutaneous left atrial appendage closure (LAAC) and has inherent risks and safety concerns in accessing the left atrium (LA). The VersaCross radiofrequency (RF) system (Baylis Medical), a new RF-tipped pigtail wire-based TSP system, may facilitate LA access by serving as an exchange support wire once access is achieved., Methods: We retrospectively compared TSP safety and procedural efficiency in 10 consecutive LAAC cases using the VersaCross RF system to 10 cases using the conventional BRK1-XS mechanical needle (Abbott Vascular). The safety and time from femoral access to delivery of the device sheath were compared to the conventional workflow using BRK1-XS/SL1., Results: We included consecutive 20 cases between July 2019 and November 2019 (12 with WATCHMAN (Boston Scientific, Natick, MA) and 8 with Amulet (St. Jude Medical, St Paul, MN)). Baseline patient characteristics and procedural details were similar in both groups (VersaCross RF system vs. conventional BRK1-XS mechanical needle). All cases were completed successfully with no procedural or in-hospital complications. VersaCross reduced time from femoral access to TSP [4.1 ± 2.5 min vs. 8.4 ± 4.0 min (p = 0.009)] and time from femoral access to delivery sheath access into LA [6.7 ± 2.4 min vs. 13.4 ± 5.4 min (p = 0.002)] compared to BRK1-XS., Conclusions: Combining a starter wire, transseptal needle and exchange guidewire in the VersaCross RF system enabled faster LA access, which potentially leads to efficient workflow. Further investigation with larger sample size is warranted to corroborate our findings., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)

Primary Percutaneous Coronary Intervention (PCI) has significantly contributed to reducing the mortality of patients with ST-segment elevation myocardial infarction (STEMI) even in cardiogenic shock and is now the standard of care in most of Japanese institutions. The Task Force on Primary PCI of the Japanese Association of Cardiovascular Interventional and Therapeutics (CVIT) society proposed an expert consensus document for the management of acute myocardial infarction (AMI) focusing on procedural aspects of primary PCI in 2018. Updated guidelines for the management of AMI were published by the European Society of Cardiology (ESC) in 2017 and 2020. Major changes in the guidelines for STEMI patients included: (1) radial access and drug-eluting stents (DES) over bare-metal stents (BMS) were recommended as a Class I indication, (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. In 2020, updated guidelines for Non-ST-Elevation Myocardial Infarction (NSTEMI) patients, the followings were changed: (1) an early invasive strategy within 24 h is recommended in patients with NSTEMI as a Class I indication, (2) complete revascularization in NSTEMI patients without cardiogenic shock is considered as Class IIa recommendation, and (3) in patients with atrial fibrillation following a short period of triple antithrombotic therapy, dual antithrombotic therapy (e.g., DOAC and single oral antiplatelet agent preferably clopidogrel) is recommended, with discontinuation of the antiplatelet agent after 6 to 12 months. Furthermore, an aspirin-free strategy after PCI has been investigated in several trials those have started to show the safety and efficacy. The Task Force on Primary PCI of the CVIT group has now proposed the updated expert consensus document for the management of AMI focusing on procedural aspects of primary PCI in 2022 version., (© 2022. The Author(s).)

Large-scale registries have demonstrated that in-hospital mortality after percutaneous coronary intervention (PCI) varies widely across institutions. However, whether this variation is related to major procedural complications (e.g., bleeding) is unclear. In this study, institutional variation in in-hospital mortality and its association with PCI-related bleeding complications were investigated. We analyzed 388,866 procedures at 718 hospitals performed from 2017 to 2018, using data from a nationwide PCI registry in Japan. Hospitals were stratified into quintiles according to risk-adjusted in-hospital mortality (very low, low, medium, high, and very high). Incidence of bleeding complications, defined as procedure-related bleeding events that required a blood transfusion, and in-hospital mortality in patients who developed bleeding complications were calculated for each quintile. Overall, 4,048 (1.04%) in-hospital deaths and 1,535 (0.39%) bleeding complications occurred. Among patients with bleeding complications, 270 (17.6%) died during hospitalization. In-hospital mortality ranged from 0.22% to 2.46% in very low to very high mortality hospitals. The rate of bleeding complications varied modestly from 0.27% to 0.57% (odds ratio, 1.95; 95% confidence interval, 1.58-2.39). However, mortality after bleeding complications markedly increased by quintile and was 6-fold higher in very high mortality hospitals than very low mortality hospitals (29.0% vs. 4.8%; odds ratio, 12.2; 95% confidence interval, 6.90-21.7). In conclusion, institutional variation in in-hospital mortality after PCI was associated with procedure-related bleeding complications, and this variation was largely driven by differences in mortality after bleeding complications rather than difference in their incidence. These findings underscore the importance of efforts toward reducing not only bleeding complications but also, even more importantly, subsequent mortality once they have occurred., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Yamaji has received investigator-initiated grant funding from Abbott. Dr. Kohsaka has received investigator-initiated grant funding from Bayer and Daiichi Sankyo and lecture fees from Bristol-Myers Squibb. Dr. Ishii has received lecture fees from Astellas Pharma, AstraZeneca, Bayer, Chugai Pharma Inc., Daiichi Sankyo, and MSD. Dr. Amano has received lecture fees from Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb. Dr. Ikari has received research grants from Boston Scientific and Bayer. Dr. Nakagawa has received investigator-initiated grant funding from Terumo, Abbott, and Boston Scientific and lecture fees from Daiichi Sankyo, Bayer, and Bristol-Myers Squibb. The other authors declare no conflicts of interest associated with this manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Over the last decade, based on evidence from multiple randomized clinical trials, transcatheter aortic valve replacement (TAVR) has become the established treatment for patients with symptomatic severe aortic stenosis. Despite the overwhelming expansion of TAVR in Western countries, the initial uptake and widespread adoption of this procedure have been relatively delayed in Asian countries, owing to the high cost of devices; limited local health and reimbursement policies; and lack of specific training/proctoring program, specialized heart team, or dedicated infrastructure. Furthermore, it has not yet been determined whether there are substantial interracial and ethnic differences in the clinical characteristics, comorbidities, and anatomic features, as well as procedural and long-term outcomes, in patients receiving TAVR. In this review, we provide not only a comprehensive look at the current status and outcomes of TAVR in Asian populations compared with those of Western populations but also a perspective on the future of TAVR in Asia., Competing Interests: Dr Hayashida has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Park has served as a clinical proctor for Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2021 The Authors.)

Background: Fibromuscular dysplasia (FMD) is widely recognized as an important predisposing condition for spontaneous coronary artery dissection (SCAD). However, it remains unclear in SCAD patients with coexistent extracoronary FMD whether SCAD can be attributed to coronary FMD., Methods: We retrospectively analyzed consecutive patients enrolled in our Vancouver SCAD registries between September 2009 and October 2019 who were screened for extracoronary FMD. We reviewed coronary angiograms for manifestations of coronary FMD that were previously described (ie, irregular stenosis, smooth stenosis, dilatation/ectasia, and severe tortuosity). Outcome of interest was major adverse cardiovascular event (MACE)., Results: We included 346 SCAD patients, of these, 250 (72.3%) had extracoronary FMD. Patients with FMD were older (54.6 ± 9.5 vs 51.7 ± 9.8 years) and more likely to have prior history of myocardial infarction (7.2% vs 1.0%, P = 0.047) and stroke (4.4% vs 0%, P = 0.081) compared with non-FMD patients. On coronary angiography, severe tortuosity was more prevalent in patients with extracoronary FMD (58.4% vs 36.5%, P < 0.001). Rates of irregular stenosis, smooth stenosis, and dilatation/ectasia were numerically higher in patients with extracoronary FMD, but differences were not significantly different. The rate of MACE at median follow-up of 807 (interquartile range, 392-1096) days was not different between groups (19.6% vs 15.6%; non-FMD as a reference: hazard ratio 1.44; 95% confidence interval, 0.76-2.71, P = 0.261)., Conclusion: SCAD patients with extracoronary FMD were more likely to have coronary FMD manifestations on angiogram, especially severely tortuous vessels, compared with those without extracoronary FMD, with similar clinical outcomes. This may suggest that SCAD can occur at sites of pre-existent subclinical coronary FMD., (Copyright © 2021. Published by Elsevier Inc.)

Purpose: Cardiac computed tomography angiography (CCTA) is increasingly used for device surveillance after left atrial appendage closure (LAAC). While CT protocols with delayed scans are useful to diagnose thrombus in the LAA, an optimal protocol for post-procedural CCTA has not been established. Therefore, we assessed the role of delayed versus early scans for device surveillance., Methods: We retrospectively reviewed patients who underwent LAAC at Vancouver General Hospital who had follow-up CCTAs using standard (early) and delayed scans. Scans were performed on Toshiba 320-detector (Aquilion ONE). Image quality was interpreted by 2 independent observers for anatomy, LAA contrast patency, and device-related thrombus (DRT) using VitreaWorkstationTM. A Likert scale of 1-5 was used (1= poor quality, 5= excellent) for assessment., Results: We included 27 consecutive LAAC patients (9 Amplatzer, 18 WATCHMAN) with mean age 76.0±7.7 years, mean CHADS2 score 2.8±1.3, CHA2DS2-VASc score 4.4±1.6 and HAS-BLED score 3.4±1.0. Subjective quality assessments by both reviewers favored early scans for assessment of anatomy (reviewer 1: 4.63±0.63 [early] vs. 1.74±0.71 [delayed]; reviewer 2: 4.63±0.63 [early] vs. 1.89±0.64 [delayed]) and DRT (reviewer 1: 4.78±0.42 [early] vs. 3.11±1.16 [delayed]; reviewer 2: 4.70±0.47 [early] vs. 3.04±1.29 [delayed]). Inter-rater variability showed good correlation between reviewers (intraclass correlation 0.61-0.95). Mean LAA/LA attenuation ratios were significantly different between scans, with larger mean percent reduction of contrast opacification from LA to LAA in the early scans (57.0±36.6% reduction for early vs. 29.1±30.8% for delayed; p < 0.001) CONCLUSION: For CT device surveillance post-LAAC early phase imaging provides superior image quality objectively and subjectively compared with delayed scanning.

Objective: Transcatheter aortic valve replacement (TAVR) improves clinical symptoms in most patients with severe aortic stenosis (AS). However, some patients do not benefit from the symptom-reducing effects of TAVR. We assessed the predictors and clinical outcomes of poor symptomatic improvement (SI) after TAVR., Methods: A total of 1749 patients with severe symptomatic AS undergoing transfemoral TAVR were evaluated using the Japanese multicentre TAVR registry. Poor SI was defined as readmission for heart failure (HF) within 1 year after TAVR or New York Heart Association (NYHA) class ≥3 after 1 year. A logistic regression model was used to identify predictors of poor SI. One-year landmark analysis after TAVR was used to evaluate the association between poor SI and clinical outcomes., Results: Among the overall population (mean age, 84.5 years; female, 71.3%; mean STS score, 6.3%), 6.6% were categorised as having poor SI. Atrial fibrillation, chronic obstructive pulmonary disease, Clinical Frailty Scale ≥4, chronic kidney disease and moderate to severe mitral regurgitation were independent predictors of poor SI. One-year landmark analysis demonstrated that poor SI had a higher incidence of all-cause death and readmission for HF compared with SI (p<0.001). Poor SI with preprocedural NYHA class 2 had a worse outcome than SI with preprocedural NYHA class ≥3., Conclusions: Poor SI was associated with worse outcomes 1 year after the procedure. It had a greater impact on clinical outcomes than baseline symptoms. TAVR may be challenging for patients with many predictors of poor SI., Trial Registration Number: This registry, associated with the University Hospital Medical Information Network Clinical Trials Registry, was accepted by the International Committee of Medical Journal Editors (UMIN-ID: 000020423)., Competing Interests: Competing interests: MY, NT, TN, SS, KM, MT, HU, YW and KH are clinical proctors for Edwards Lifesciences and Medtronic. HS and KT are clinical proctors for Edwards Lifesciences., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Acute coronary syndrome (ACS) hospital survivors experience a wide array of late adverse cardiac events, despite considerable advances in the quality of care. We investigated 30-day and 1-year outcomes of ACS hospital survivors using a Japanese nationwide cohort., Methods and results: We studied 20,042 ACS patients who underwent percutaneous coronary intervention (PCI) in 2017: 10,242 (51%) with ST-elevation myocardial infarction (STEMI), 3,027 (15%) with non-ST-elevation myocardial infarction (NSTEMI), and 6,773 (34%) with unstable angina (UA). The mean (±SD) age was 69.6±12.4 years, 77% of the patients were men, and 20% had a previous history of PCI. The overall 30-day all-cause, cardiac, and non-cardiac mortality rates were 3.0%, 2.4%, and 0.6%, respectively. The overall 1-year incidence of all-cause, cardiac, and non-cardiac death was 7.1%, 4.2%, and 2.8%, respectively. Compared with UA patients, STEMI patients had a higher risk of all fatal events, non-fatal ischemic stroke, and acute heart failure, and NSTEMI patients had a higher risk of heart failure., Conclusions: The results from our ACS hospital survivor PCI database suggest the need to improve care for the acute myocardial infarction population to lessen the burden of 30-day mortality due to ACS, heart failure, and sudden cardiac death, as well as 1-year ischemic stroke and heart failure events.

Objectives: We evaluated the in-hospital outcomes of percutaneous coronary intervention (PCI) for bypass graft vessels (GV-PCI) compared with those of PCI for native vessels (NV-PCI) using data from the Japanese nationwide coronary intervention registry., Methods: We included PCI patients (N = 748,229) registered between January 2016 and December 2018 from 1,123 centers. We divided patients into three groups: GV-PCI (n = 2,745); NV-PCI with a prior coronary artery bypass graft (pCABG) (n = 23,932); and NV-PCI without pCABG (n = 721,552)., Results: GV-PCI implementation was low, and most cases of PCI in pCABG patients were performed in native vessels (89.7%) in contemporary Japanese practice. The risk profile of patients with pCABG was higher than that of those without pCABG. Consequently, GV-PCI patients had a significantly higher in-hospital mortality than NV-PCI patients without pCABG after adjusting for covariates (odds ratio [OR] 2.36, 95% confidence interval [CI] 1.66-3.36, p < .001). Of note, embolic protection devices (EPDs) were used in 18% (n = 383) of PCIs for saphenous vein grafts (SVG-PCI) with a significant variation in its use among institutions (number of PCI: hospitals that had never used an EPD vs. EPD used one or more times = 240 vs. 345, p < .001). The EPDs used in the SVG-PCI group had a significantly lower prevalence of the slow-flow phenomenon after adjusting for covariates (OR 0.45, 95% CI 0.21-0.91, p = .04)., Conclusion: GV-PCI is associated with an increased risk of in-hospital mortality. EDP use in SVG-PCI was associated with a low rate of the slow-flow phenomenon. The usage of EPDs during SVG-PCI is low, with a significant variation among institutions., (© 2021 Wiley Periodicals LLC.)

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objective: Data on statin for patients with aortic stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) are limited. The present study aimed to evaluate the impact of statin on midterm mortality of TAVI patients., Design: Observational study., Setting: This study included patients with AS from a Japanese multicentre registry who underwent TAVI., Participants: The overall cohort included 2588 patients (84.4±5.2 years); majority were women (69.3%). The Society of Thoracic Surgeons risk score was 6.55% (IQR 4.55%-9.50%), the Euro II score was 3.74% (IQR 2.34%-6.02%) and the Clinical Frailty Scale score was 3.9±1.2., Interventions: We classified patients based on statin at admission and identified 936 matched pairs after propensity score matching., Primary and Secondary Outcome Measures: The outcomes were all-cause and cardiovascular mortality., Results: The median follow-up was 660 days. Statin at admission was associated with a significant reduction in all-cause mortality (adjusted HR (aHR) 0.76, 95% CI 0.58 to 0.99, p=0.04) and cardiovascular mortality (aHR 0.64, 95% CI 0.42 to 0.97, p=0.04). In the octogenarians, statin was associated with significantly lower all-cause mortality (aHR 0.87, 95% CI 0.75 to 0.99, p=0.04); however, the impact in the nonagenarians appeared to be lower (aHR 0.84, 95% CI 0.62 to 1.13, p=0.25). Comparing four groups according to previous coronary artery disease (CAD) and statin, there was a significant difference in all-cause mortality, and patients who did not receive statin despite previous CAD showed the worst prognosis (aHR 1.33, 95% CI 1.12 to 1.57 (patients who received statin without previous CAD as a reference), p<0.01)., Conclusions: Statin for TAVI patients will be beneficial even in octogenarians, but the benefits may disappear in nonagenarians. In addition, statin will be essential for TAVI patients with CAD. Further research is warranted to confirm and generalise our findings since this study has the inherent limitations of an observational study and included only Japanese patients., Trial Registration Number: UMIN000020423., Competing Interests: Competing interests: MYamam, NT, TN, SS, KM, MTab, HU and YW are clinical proctors for Edwards Lifesciences and Medtronic. HS, KT and KH are clinical proctors for Edwards Lifesciences. TI received a research grant from Boston Scientific., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Current guidelines recommend dual antiplatelet therapy for the first 1 to 6 months after transcatheter aortic valve replacement (TAVR); however, recent studies have reported better outcomes with single antiplatelet therapy than with dual antiplatelet therapy in the occurrence of bleeding events, while not increasing thrombotic events. However, no data exist about optimal single antiplatelet therapy following TAVR., Methods: Patients who underwent TAVR between October 2013 and May 2017 were enrolled from the OCEAN-TAVI Japanese multicenter registry (Optimized Transcatheter Valvular Intervention). After excluding 1759 patients, 829 who received aspirin (100 mg/d) or clopidogrel (75 mg/d) after TAVR were identified and stratified according to the presence or absence of anticoagulation. Propensity score matching was performed to adjust the baseline characteristics between the aspirin and clopidogrel groups. Outcomes of interest were all-cause and cardiovascular deaths, stroke, and life-threatening or major bleeding within 2 years following TAVR., Results: After propensity score matching, 98 and 157 pairs of patients without and with anticoagulation, respectively, were identified. Falsification end points of pneumonia, urinary tract infection, and hip fracture were evaluated, and their rates were not different between groups. All-cause deaths were not statistically different between the groups in patients with (aspirin, 17.5%; clopidogrel, 11.1%; log-rank P=0.07) and without (aspirin, 29.6%; clopidogrel, 20.1%; log-rank P=0.15) anticoagulation at 2 years post-TAVR, whereas clopidogrel was associated with a lower cardiovascular mortality at 2 years in patients with (aspirin, 8.5%; clopidogrel, 2.7%; log-rank P=0.03) and without (aspirin, 18.0%; clopidogrel, 5.2%; log-rank P=0.02) anticoagulation., Conclusions: We demonstrated that clopidogrel monotherapy was associated with a lower incidence of cardiovascular death compared with aspirin monotherapy during the 2-year follow-up after TAVR regardless of anticoagulation use., Registration: URL: https://upload.umin.ac.jp; Unique identifier: UMIN000020423.

Background: Bleeding avoidance strategies (BASs) are increasingly adopted for patients undergoing percutaneous coronary intervention (PCI) due to bleeding complications. However, their association with bleeding events outside of Western countries remains unclear. In collaboration with the National Cardiovascular Data Registry (NCDR) CathPCI registry, we aimed to assess the time trend and impact of BAS utilization among Japanese patients., Methods: Our study included 19,656 consecutive PCI patients registered over 10 years. These patients were divided into 4-time frame groups (T1: 2008-2011, T2: 2012-2013, T3: 2014-2015, and T4: 2016-2018). BAS was defined as the use of transradial approach or vascular closure device (VCD) use after transfemoral approach (TFA). Model performance of the NCDR CathPCI bleeding model was evaluated. The degree of bleeding reduction associated with BAS adoption was estimated via multilevel mixed-effects multivariable logistic regression analysis., Results: The NCDR CathPCI bleeding risk score demonstrated good discrimination in the Japanese population (C-statistics 0.79-0.81). The BAS adoption rate increased from 43% (T1) to 91% (T4), whereas the crude CathPCI-defined bleeding rate decreased from 10% (T1) to 7% (T4). Adjusted odds ratios for bleeding events were 0.25 (95% confidence interval, 0.14-0.45, P< .001) for those undergoing TFA with VCD in T4 and 0.26 (95% confidence interval 0.20-0.35, P< .001) for transradial approach in T4 compared to patients that received TFA without VCD in T1., Conclusions: BAS use over the studied time frames was associated with lower risk of bleeding complications among Japanese. Nonetheless, observed bleeding rates remained higher compared to the US population., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background In patients undergoing transcatheter aortic valve replacement (TAVR), those with small left ventricle (LV) may have an increased risk of poor outcomes, because small LV is associated with low-flow (LF), left ventricular hypertrophy. However, the impact of small LV on patients undergoing TAVR remains unknown. Methods and Results We examined 2584 patients who underwent TAVR between October 2013 and May 2017 using data from the Japanese multicenter registry. On the basis of the American Society of Echocardiography guidelines, small LV was defined as left ventricular end-diastolic dimension <42.0 mm for men or <37.8 mm for women. The 2-year clinical outcomes were compared between patients with and without small LV using multivariable Cox regression analyses and propensity score matching. Subgroup analyses by LF, left ventricular hypertrophy were performed. Of 2584 patients who underwent TAVR, 466 (18.0%) had small LV. Patients with small LV had smaller body size and less comorbidity, and were more likely to have LF status compared with those without. Small LV was associated with a higher 2-year all-cause (20.8% versus 14.3%; adjusted hazard ratio [HR],1.58 [95% CI, 1.20-2.09]; P =0.0013) and cardiovascular mortality (8.8% versus 5.5%; adjusted HR, 1.93 [95% CI, 1.25-2.98]; P =0.0028). Propensity score matching analysis showed consistent findings. In subgroup analyses, LF, left ventricular hypertrophy did not interact with small LV. Conclusions Small LV, determined by a simple echocardiographic parameter, was associated with poorer clinical outcomes after TAVR regardless of LF, left ventricular hypertrophy. LV size may be useful for assessing clinical outcomes after TAVR. Registration URL: https://www.umin.ac.jp/ctr/index.htm; Unique identifier: UMIN000020423.

Abstract: The type of periprocedural antithrombotic regimen that is the safest and most effective in percutaneous coronary intervention (PCI) patients on oral anticoagulant (OAC) therapy has not been fully investigated. We aimed to retrospectively investigate the in-hospital bleeding outcomes of patients receiving OAC and antiplatelet therapies during PCI using Japanese nationwide multicenter registry data. A total of 26,938 patients who underwent PCI with OAC and antiplatelet therapies between 2016 and 2017 were included. We investigated in-hospital bleeding requiring blood transfusion, mortality, and stent thrombosis according to the antithrombotic regimens used at the time of PCI: OAC + single antiplatelet therapy (double therapy) and OAC + dual antiplatelet therapy (triple therapy). The antiplatelet agents included aspirin, clopidogrel, and prasugrel. The OAC agents included warfarin and direct OACs. Adjusting the dose of OAC or intermitting OAC before PCI was at each operator's discretion. In the study population [mean age (SD), 73.5 (9.5) years; women, 21.5%], the double therapy and triple therapy groups comprised 5546 (20.6%) and 21,392 (79.4%) patients, respectively. Bleeding requiring transfusion was not significantly different between the groups [adjusted odds ratio (aOR), 0.700; 95% confidence interval (CI), 0.420-1.160; P = 0.165] (triple therapy as a reference). Mortality was not significantly different (aOR, 1.370; 95% CI, 0.790-2.360; P = 0.258). Stent thrombosis was significantly different between the groups (aOR, 3.310; 95% CI, 1.040-10.500; P = 0.042) (triple therapy as a reference). In conclusion, for patients on OAC therapy who underwent PCI, periprocedural triple therapy may be safe with respect to in-hospital bleeding risks. However, further investigations are warranted to establish the safety and efficacy of periprocedural triple therapy., Competing Interests: T. Inohara received a research grant from Boston Scientific. H. Ishii received lecture fees from Astellas Pharma Inc., AstraZeneca Inc., Bayer Pharma Inc., Bristol-Myers Squibb Inc., Chugai Pharma Inc., Daiichi Sankyo Co., Ltd., and Otsuka Pharma Inc. The remaining authors report no conflicts of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Transseptal access for large sheaths may be encumbered by tissue resistance against the sheath-dilator stepped interface. The ExpanSure Large Access Transseptal Dilator (Baylis Medical) is designed as a single introducer and dilation device with a smooth sheath-dilator transition to support transseptal puncture. It may facilitate ease and efficiency of interatrial crossing., Methods: This study experimentally evaluated the crossing force of ExpanSure relative to a conventional 8.5 F Swartz SL1 transseptal sheath and dilator in a benchtop septum model. Its ability to reduce the subsequent crossing force of a 14 F WATCHMAN delivery sheath was also tested. The clinical use of ExpanSure, including procedure time, was then validated in a series of left atrial appendage closure (LAAC) procedures., Results: In a benchtop septum model (N = 12), less peak force (1.90 ± 0.08 N vs. 2.36 ± 0.09 N; p < .001) and overall work (17.3 ± 1.2 mJ vs. 28.0 ± 1.9 mJ; p < .001) were required to advance ExpanSure relative to a conventional SL1 transseptal sheath and dilator system. Peak force (2.34 ± 0.24 N vs. 2.65 ± 0.21 N; p < .003) and overall work (28.5 ± 3.9 mJ vs. 35.4 ± 2.1 mJ; p < .001) to advance a WATCHMAN sheath were also significantly lower after using ExpanSure than after using a conventional transseptal system. In 19 LAAC procedures, ExpanSure crossed the septum smoothly and integrated readily, which enabled efficient procedure completion (mean total procedure time 37.6 ± 13.5 min), with 100% success and no procedure-related complications., Conclusion: Experimental force measurements, combined with early clinical experience using ExpanSure, suggest that the tapered design with smooth transition without dilator-sheath step-up and the larger diameter, both facilitated ease and efficiency of interatrial crossing., (© 2021 Wiley Periodicals LLC.)

Importance: Although the use of factor Xa (FXa) inhibitors has increased substantially over the past decade, there are limited data on characteristics and outcomes of FXa inhibitor-associated intracerebral hemorrhage (ICH)., Objective: To investigate the association between prior oral anticoagulant use (FXa inhibitors, warfarin, or none) and in-hospital outcomes among patients with nontraumatic ICH., Design, Setting, and Participants: This is a cohort study of 219 701 patients with nontraumatic ICH admitted to 1870 hospitals in the Get With The Guidelines-Stroke registry between October 2013 and May 2018. Data analysis was performed in December 2019., Exposures: Anticoagulation therapy before ICH., Main Outcomes and Measures: The primary outcome was in-hospital mortality. Secondary outcomes were a composite measure of in-hospital mortality or discharge to hospice, discharge home, independent ambulation, and modified Rankin Scale (mRS) score at discharge., Results: Of 219 701 patients (mean [SD] age, 68.2 [15.3] years; 104 940 women [47.8%]), 9202 (4.2%) were taking FXa inhibitors, 21 430 (9.8%) were taking warfarin, and 189 069 (86.0%) were not taking any oral anticoagulant before ICH. Patients taking FXa inhibitors or warfarin were older and had higher prevalence of cardiovascular risk factors. Compared with those not taking an oral anticoagulant (42 660 of 189 069 patients [22.6%]), the in-hospital mortality risk was higher for both FXa inhibitors (2487 of 9202 patients [27.0%]; adjusted odds ratio [aOR], 1.27; 95% CI, 1.20-1.34; P < .001) and warfarin (7032 of 21 430 patients [32.8%]; aOR, 1.67; 95% CI, 1.60-1.74; P < .001). Both FXa inhibitors (3478 of 9202 patients [37.8%]; aOR, 1.19; 95% CI, 1.13-1.26; P < .001) and warfarin (9151 of 21 430 patients [42.7%]; aOR, 1.50; 95% CI, 1.44-1.56; P < .001) were associated with higher odds of death or discharge to hospice compared with not taking oral anticoagulation (58 022 of 189 069 patients [30.7%]). Although the rates of discharge home, independent ambulation, mRS scores of 0 or 1, and mRS scores of 0 to 2 were numerically lower among patients taking FXa inhibitors, these differences were not significant compared with patients not taking oral anticoagulants. In contrast, patients taking FXa inhibitors were less likely to die (aOR, 0.76; 95% CI, 0.72-0.81; P < .001) or to experience death or discharge to hospice (aOR, 0.79; 95% CI, 0.75-0.84; P < .001), more likely to be discharged home (aOR, 1.18; 95% CI, 1.10-1.26; P < .001), and had better mRS scores at discharge (eg, mRS scores of 0-1: aOR, 1.24; 95% CI, 1.09-1.40; P < .001) than those treated with warfarin. Concomitant warfarin and antiplatelet therapy (either single or dual) was associated with worse outcomes compared with taking warfarin alone (eg, in-hospital mortality for dual-antiplatelet agents: aOR, 2.07; 95% CI, 1.72-2.50; P < .001). However, such incremental risk was not significant in patients taking FXa inhibitors., Conclusions and Relevance: In this cohort study, FXa inhibitor-associated ICH was associated with higher risk of mortality or death or discharge to hospice than not taking an oral anticoagulant, but patients taking FXa inhibitors had better outcomes than those with warfarin-related ICH.

Although baseline hemoglobin and renal function are both important predictors of adverse outcomes after percutaneous coronary intervention (PCI), scarce data exist regarding the combined impact of these factors on outcomes. We sought to investigate the impact and threshold value of the hemoglobin to creatinine (Hgb/Cr) ratio, on in-hospital adverse outcomes among non-dialysis patients in a Japanese nationwide registry. We analyzed 157,978 non-dialysis patients who underwent PCI in 884 Japanese medical institutions in 2017. We studied differences in baseline characteristics and in-hospital clinical outcomes among four groups according to their quartiles of the Hgb/Cr ratios. Compared with patients with higher Hgb/Cr ratios, patients with lower ratios were older and had more comorbidities and complex coronary artery disease. Patients with lower hemoglobin and higher creatinine levels had a higher rate of in-hospital adverse outcomes including in-hospital mortality and procedural complications (defined as occurrence of cardiac tamponade, cardiogenic shock after PCI, emergency operation, or bleeding complications that required blood transfusion). On multivariate analyses, Hgb/Cr ratio was inversely associated with in-hospital mortality (odds ratio: 0.91, 95% confidence interval: 0.89-0.92; p < 0.001) and bleeding complications (odds ratio: 0.92, 95% confidence interval: 0.90-0.94; p < 0.001). Spline curve analysis demonstrated that these risks started to increase when the Hgb/Cr ratio was <15, and elevated exponentially when the ratio was <10. Hgb/Cr ratio is a simple index among non-dialysis patients and is inversely associated with in-hospital mortality and bleeding complications after PCI.

Atherosclerosis is a systemic process. As the population ages, increasingly more patients who undergo coronary revascularization are complicated with peripheral artery disease (PAD). However, the large body of evidence in this area has not been limited to analysis from trial-based data from younger and relatively uncomplicated patients in Western countries. The impact of PAD on the outcomes can differ by patient characteristics, and integrated analysis of large-scale data is necessary. J-PCI is a universal (all-comer) nationwide registration system in Japan, regulated and audited by professional society that controls national board-certification system. For the present study, we extracted data of 894,014 percutaneous coronary intervention (PCI) cases performed between 2014 and 2017 (mean age 70.2 years [standard deviation 11.0]). In-hospital outcomes of PAD and Non-PAD patients were compared. PAD was defined as a previous history of stenosis of peripheral arteries or abdominal aortic aneurysm. Primary outcome was in-hospital mortality, and multivariable modeling was performed. A total of 66,891 patients (8.1%) had PAD. Crude in-hospital mortality rate was higher in this group (0.99% vs. 0.67% in Non-PAD group). PAD was associated with an increased risk of in-hospital mortality (odds ratio [OR] 1.383 [95% confidence interval 1.251-1.528]). However, the impact of PAD differed by kidney condition (OR 1.578 [1.370-1.821] for patients with chronic kidney disease [CKD] and OR 1.234 [1.076-1.416] without CKD: P for interaction 0.005), and by clinical presentation: PAD was not associated with an increased risk of in-hospital mortality in patients undergoing PCI for silent ischemia (OR 1.211 [0.8701-1.685]: P for interaction 0.002). Presence of PAD was independently associated with in-hospital mortality in patients receiving PCI. However, its impact varied substantially by the patient background or indication of the procedure., Competing Interests: The authors have read the journal's policies and declare the following competing interests: KS received personal fees from Bayer, AstraZeneca and Bristol-Myers Squibb. TS received funding from Abbott Vascular, Dai-ichi Sankyo, Bayer, Sanofi, and Nipro. TA receives lecture fees from Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb. YS receives Honorarium from·Otsuka Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical,·Mitsubishi Tanabe Pharma, Medtronic Japan and Boehringer Ingelheim Japan, research grant from Edwards Lifesciences, FUJIFILM RI Pharma,·REGiMMUNE, and·Roche Diagnostics, and Scholarship (educational) grant/endowed chair from Otsuka Pharmaceutical, Johnson & Johnson, St. Jude Medical Japan, Daiichi Sankyo,·Takeda Pharmaceutical,·Mitsubishi Tanabe Pharma, Teijin Pharma Limited,·Boehringer Ingelheim Japan, Bayer Yakuhin, BIOTRONIK Japan, Boston Scientific, Medtronic Japan. TM has a research grant from Abbott vascular Japan. YI has research grants from Boston Scientific, Asahi intech, Nipro, Sanofi, Daiichi-Sankyo, and Terumo, and receives lecture fee from Asteras Amgen Biopharma, Astrazeneca, Abbott vascular, Sanofi, Daiichi-Sankyo, Boehringer-Ingerheim, Bayer, and Bristol Meyers-Squib. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Characteristics, treatment pattern, and outcome of spontaneous coronary artery dissection (SCAD) have not been thoroughly investigated, especially in non-Western countries., Methods: Using a nationwide administrative database in Japan, we included all women hospitalized with a diagnosis of myocardial infarction (MI) who underwent coronary angiography between 2012 and 2017. Patients with SCAD were identified using the 10th revision of the International Classification of Diseases code. Patients who underwent iatrogenic procedure-related coronary dissection were excluded. Characteristics, treatment pattern, and in-hospital mortality were compared between SCAD and non-SCAD patients. For the analysis of in-hospital mortality, age-matched and propensity score matched pairs of cohort at a ratio of 1:1 were generated., Results: Of 68,909 women patients with MI, 322 (0.5%) had SCAD. Patients with SCAD were younger (mean ± SD: 52.8 ± 13.5 years vs. 75.2 ± 11.4 years, P < 0.001) and had lower burden of comorbidity than non-SCAD patients. Percutaneous coronary intervention (PCI) was less frequently performed in SCAD patients (54.3% vs. 84.0%, P < 0.001). Among SCAD patients treated with PCI, stenting was performed in 61.7% of patients. The in-hospital mortality was significantly lower in SCAD compared with non-SCAD (2.5% vs. 7.6%, P = 0.001), which was consistent in age-matched (2.5% vs. 7.5%, P = 0.001) and propensity score matched cohorts (2.6% vs. 6.5%, P = 0.033)., Conclusions: In Japan, in-hospital mortality of SCAD patients was lower than non-SCAD patients, and comparable with other international studies. However, more than half of SCAD patients were managed with PCI; further investigation is required to clarify the optimal management for this condition., Competing Interests: Declaration of competing interest Dr. Kohsaka receives grant support from Japan Society for Promotion of Science (16H05215 and 16KK0186), Bayer, Daiichi Sankyo and consultant/lecture fees from Bayer, Bristol Meier Squibb, Pfizer and AstraZeneka. Dr. Saw has received unrestricted research grant supports (from the Canadian Institutes of Health Research, Heart & Stroke Foundation of Canada, National Institutes of Health, AstraZeneca, Abbott Vascular, St Jude Medical, Boston Scientific, and Servier), salary support (Michael Smith Foundation for Health Research), speaker honoraria (AstraZeneca, Abbott Vascular, Boston Scientific, Bayer), consultancy and advisory board honoraria (AstraZeneca, Boston Scientific, Abbott Vascular, Gore and Abiomed), and proctorship honoraria (Abbott Vascular and Boston Scientific). The remaining authors have nothing to disclose., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Adoption of the results of large-scale randomized controlled trials in percutaneous coronary intervention (PCI) may differ internationally, yet few studies have described the potential variations in PCI practice patterns., Objectives: Using representative national registries, we compared temporal trends in procedural volume, patient characteristics, pre-procedural testing, procedural characteristics, and quality metrics in the United States and Japan., Methods: The National Cardiovascular Data Registry CathPCI was used to describe care in the United States, and the J-PCI was used to assess practice patterns in Japan (numbers of participating hospitals: 1,752 in the United States and 1,108 in Japan). Both registries were summarized between 2013 and 2017., Results: PCI volume increased by 15.8% in the United States from 550,872 in 2013 to 637,650 in 2017, primarily because of an increase in nonelective PCIs (p for trend <0.001). In Japan, the volume of PCIs increased by 36%, from 181,750 in 2013 to 247,274 in 2017, primarily because of an increase in elective PCIs (p for trend <0.001). The proportion of PCI cases for elective conditions was >2-fold greater in Japan (72.7%) than in the United States (33.8%; p < 0.001). Overall, the ratio of nonelective PCI (vs. elective PCI; 27.3% vs. 66.2%; p < 0.001) and the performance of noninvasive stress testing in patients with stable disease (15.2% vs. 55.3%; p < 0.001) was lower in Japan than in the United States. Computed tomography angiography was more commonly used in Japan (22.3% vs. 2.0%; p < 0.001)., Conclusions: Elective PCI is more than twice as common in Japan as in the United States in contemporary practice. Computed tomography angiography is much more frequently used pre-procedurally in Japan than in the United States., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Multiple randomized clinical trials have demonstrated that transradial intervention (TRI) improves clinical outcomes after percutaneous coronary intervention (PCI) compared with transfemoral intervention (TFI). However, chronic kidney disease (CKD) patients have more procedure-related complications; TRI is frequently avoided for future creation of arteriovenous fistulas essential for hemodialysis. Therefore, limited information on TRI among CKD patients exists. We aimed to assess the impact of TRI on CKD patients., Methods: Consecutive PCI patients with advanced CKD registered in a multicenter Japanese registry between 2008 and 2017 (N = 20,420) were analyzed. Advanced CKD was defined as estimated glomerular filtration rate <30 mL/min/1.73 m 2 . Outcomes of interest were periprocedural bleeding (transfusion or decreasing hemoglobin by >3.0 g/dL within 72 h after PCI), acute kidney injury (AKI: absolute increase of 0.3 mg/dL or a relative increase of 50% in serum creatinine from baseline), and hemodialysis initiation after PCI. To account for baseline differences between patients with TRI and TFI, 1:1 propensity matching was performed., Results: Overall, 498 patients (3.7%) had advanced CKD, and 199 (40.0%) underwent TRI. After propensity matching, 324 patients were included (age, 74.9 ± 9.9 years; male, 63.6%; ACS, 46.0%). TRI was associated with reduced periprocedural AKI risks (12.4% versus 26.5%; p < 0.01) and hemodialysis initiation (3.1% versus 12.4%; p = 0.01) compared with TFI. TRI showed a trend toward lower rates of bleeding complications than those of TFI, but the difference was not statistically significant (1.9% versus 6.2%; p = 0.15)., Conclusions: TRI might be beneficial over TFI in PCI patients with advanced CKD., Competing Interests: Declaration of competing interest Dr. Inohara received a research grant from Boston Scientific. Dr. Kohsaka received lecture fees and research grants from Pfizer Japan, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background Despite recent progress in the treatment of ST-segment-elevation myocardial infarction, data on geographic disparities application of the evidence-based therapy remain limited. Methods and Results The J-PCI (Japanese Percutaneous Coronary Intervention) registry is a nationwide registry to assure the quality of delivered care. Between January 2014 and December 2018, 209 521 patients underwent percutaneous coronary intervention for ST-segment-elevation myocardial infarction in 1126 institutions. The patients were divided into tertiles according to the population density (PD) of the percutaneous coronary intervention institution location (low: <951.7/km 2 , n = 69 797; medium: 951.7-4729.7/km 2 , n = 69 750; high: ≥4729.7/km 2 , n = 69 974). Patients treated in high PD administrative districts were younger and more likely to be male. No significant correlation was observed between PD and door-to-balloon time (regression coefficients: 0.036 per 1000 people/km 2 ; 95% CI, -0.232 to 0.304; P  = 0.79). Patients treated in low-PD areas had higher crude in-hospital mortality rates than those treated in high-PD areas (low: 2.89%; medium: 2.60%; high: 2.38%; P  < 0.001); PD and in-hospital mortality had a significantly inverse association, before and after adjusting for baseline characteristics (crude odds ratio [OR], 0.983 per 1000/km 2 ; 95% CI, 0.973-0.992; P  < 0.001; adjusted OR, 0.980 per 1000/km 2 ; 95% CI, 0.964-0.996; P  = 0.01, respectively). Higher-PD districts had more operators per institution (low: 6; interquartile range, 3-10; medium: 7; IQR, 3-13; high: 8; IQR, 5-13; P  < 0.001), suggesting an inverse association with in-hospital mortality (OR, 0.992; 95% CI, 0.986-0.999; P  = 0.03). Conclusions Geographic inequality was observed in in-hospital mortality of patients with ST-segment-elevation myocardial infarction who underwent percutaneous coronary intervention. Variation in the number of operators per institution, rather than traditional quality indicators (eg, door-to-balloon time) might explain the difference in in-hospital mortality.

Cardiovascular interventions have achieved a level of excellence, with many outstanding advanced techniques and results. The mission of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) is to further our understanding of cardiovascular intervention and establish its procedural safety. [1] The Japanese Percutaneous Coronary Intervention (J-PCI) registry was established and sponsored by CVIT, and aims to provide basic statistics on the performance of percutaneous coronary interventions (PCI) in Japan. Today, the database has grown to become one of the largest healthcare procedural database with more than 200,000 cases registered annually from approximately 900 institutions in Japan representing over 90% of all PCI hospitals in the nation. Importantly, case registrations in the J-PCI registry are essential for coronary interventionalist and educating hospital certification. The present manuscript aimed to summarize the history of the J-PCI registry and outline the definitions of various items.

Aims: In Japan, reduced-dose prasugrel (loading/maintenance dose, 20/3.75 mg) has been approved for use in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI), because of the higher bleeding risk among East Asians. However, its safety in the real-world population has not been investigated. We aimed to evaluate the effectiveness and safety of reduced-dose prasugrel vs. standard-dose clopidogrel in ACS patients undergoing PCI., Methods and Results: Acute coronary syndrome patients who underwent PCI in 2016, who were treated with either reduced-dose prasugrel or standard-dose clopidogrel in addition to aspirin, were identified from the nationwide Japanese PCI registry. The primary outcome was in-hospital mortality following PCI. Secondary outcomes included stent thrombosis and bleeding complication after PCI. Among 62 737 ACS patients who underwent PCI at any of 986 participating centres across Japan (clopidogrel 31.9%; prasugrel 68.1%), we identified 12 016 propensity score-matched pairs (24 032 patients; age 69.4 ± 12.2 years; female 24.9%; ST-elevation myocardial infarction 42.3%). Compared with standard-dose clopidogrel, reduced-dose prasugrel was associated with increased risk of bleeding [odds ratio (OR) 1.65, 95% confidence interval (CI) 1.10-2.51; P = 0.016], but both had similar rates of mortality (OR 1.11, 95% CI 0.89-1.38; P = 0.371) and stent thrombosis (OR 1.29, 95% CI 0.73-2.30; P = 0.387) as well as similar falsification endpoints of cardiac tamponade and emergent operation., Conclusion: In Japanese ACS patients undergoing PCI, the risk of bleeding is higher when using reduced-dose prasugrel than when using standard-dose clopidogrel, but there is no significant difference in in-hospital mortality and incidence of stent thrombosis between the two antiplatelet regimens., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Subacute or late complications > 24 hours after left atrial appendage closure (LAAC) are infrequent. We therefore created a clinical pathway to enable safe same-day discharge (SDD) after LAAC. Patients were assessed for overall physical conditioning, lack of significant frailty and comorbidities limiting physical abilities, good home support, and patient preference. Of 78 LAACs performed, 24 patients (30.8%) were discharged the same day: 21 were transesophageal echocardiography guided and 3 intracardiac echocardiography guided. SDD clinical pathway patients were discharged 395.4 ± 56.6 minutes after leaving the procedural room. There were no clinical complications at 1 month or in long-term follow-up. SDD is safe and feasible after LAAC, following a dedicated clinical pathway and surveillance in carefully selected patients., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background There is a limited evidence base to support the volume-outcome relationship in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery disease (UPLMD). This study aimed to evaluate the relationship between institutional and operator volume and in-hospital outcomes in patients undergoing PCI for unprotected left main coronary artery disease. Methods and Results We analyzed characteristics and clinical outcomes of 24 320 patients undergoing PCI for unprotected left main coronary artery disease at 1102 hospitals by 7244 operators using data from the Japanese nationwide J-PCI Registry (National PCI Data Registry) between January 2014 and December 2017. We classified institutions and operators into quartiles based on the mean annual volume of PCI. A generalized linear mixed-effects model was used to evaluate the association between institutional and operator PCI volume and in-hospital outcomes. Among the 24 320 patients, 4027 (16.6%), 6147 (25.3%), and 14 146 (58.2%) presented with ST-segment-elevation myocardial infarction, non-ST-segment-elevation acute coronary syndrome, and stable ischemic heart disease; their crude in-hospital mortality was 15%, 3.1%, and 0.3%, respectively. Compared with patients in the lowest quartile of institutional volume (1-216 PCIs/y), the adjusted odds ratio of in-hospital death in patients in the second (217-323 PCIs/y), third (324-487 PCIs/y), and fourth (488-3015 PCIs/y) quartile of institutional volume was 0.75 (95% CI, 0.51-1.10; P =0.14), 0.87 (95% CI, 0.57-1.34; P =0.54), and 0.51 (95% CI, 0.30-0.86; P =0.01), respectively. These findings were consistent in rates of in-hospital death or any complication. Conversely, operator PCI volume was not significantly associated with in-hospital outcomes. Conclusions Institutional rather than operator-based PCI volume was associated with better in-hospital outcomes in patients undergoing PCI for unprotected left main coronary artery disease.

Background: Percutaneous coronary intervention (PCI) is performed in a wide range of institutions. We sought to assess the relationship between coronary artery bypass grafting (CABG) volume relative to PCI volume and clinical outcome using nationally representative PCI and CABG registries in Japan., Methods: This was a collaborative, registry-based cohort study enrolling patients undergoing percutaneous coronary intervention in 2013-2014 using Japanese nationwide registry (J-PCI) with follow up until discharge. The absolute volume of CABG for each hospital was calculated using additional data from Japan CardioVascular Surgery Database (JCVSD). Patients undergoing their first PCI registered in the registry (N = 220,934), at 943 facilities were studied. Main outcomes were in-hospital mortality, and incidence of composite of in-hospital death and postprocedural complications., Results: Among the 220,934 patients, 162,411 were men, with a mean age of 69.7 (SD 11.6) years. Patients underwent PCI at hospitals with varying CABG volume: The overall in-hospital mortality and composite event rate for PCI patients was 0.9% and 2.4%, respectively. CABG volume was associated with the in-hospital mortality of PCI at facilities performing less than 200 PCIs per year, but not at facilities performing 200 or more. Similarly, in-hospital mortality or complication was associated with PCI volume <200 only if no CABG is done at the facility. The result remained largely consistent in subgroup of patients presenting with acute coronary syndrome or even after excluding these institutions with extremely low number of PCI (<50 cases/year) or CABG (<15 cases / year)., Conclusions: In a nationwide registry-based analysis, the surgical volume was associated with patients' clinical outcome after PCI, when limited number of PCIs were performed at the facility.

Background and Purpose- In previous studies, isolated nonspecific ST-segment and T-wave abnormalities (NSSTTAs), a common finding on ECGs, were associated with greater risk for incident coronary artery disease. Their association with incident stroke remains unclear. Methods- The REGARDS (Reasons for Geographic and Racial Differences in Stroke) study is a population-based, longitudinal study of 30 239 white and black adults enrolled from 2003 to 2007 in the United States. NSSTTAs were defined from baseline ECG using the standards of Minnesota ECG Classification (Minnesota codes 4-3, 4-4, 5-3, or 5-4). Participants with prior stroke, coronary heart disease, and major and minor ECG abnormalities other than NSSTTAs were excluded from analysis. Multivariable Cox proportional hazards regression was used to examine calculate hazard ratios of incident ischemic stroke by presence of baseline NSSTTAs. Results- Among 14 077 participants, 3111 (22.1%) had NSSTTAs at baseline. With a median of 9.6 years follow-up, 106 (3.4%) with NSSTTAs had ischemic stroke compared with 258 (2.4%) without NSSTTAs. The age-adjusted incidence rates (per 1000 person-years) of stroke were 2.93 in those with NSSTTAs and 2.19 in those without them. Adjusting for baseline age, sex, race, geographic location, and education level, isolated NSSTTAs were associated with a 32% higher risk of ischemic stroke (hazard ratio, 1.32 [95% CI, 1.05-1.67]). With additional adjustment for stroke risk factors, the risk of stroke was increased 27% (hazard ratio, 1.27 [95% CI, 1.00-1.62]) and did not differ by age, race, or sex. Conclusions- Presence of NSSTTAs in persons with an otherwise normal ECG was associated with a 27% increased risk of future ischemic stroke.

Background: Transcatheter aortic valve replacement (TAVR) is widely used; however, its appropriateness is unknown. We sought to investigate the appropriateness of TAVR., Methods and Results: We assigned appropriateness ratings to patients undergoing TAVR for severe aortic stenosis between October 2013 and May 2017 at 14 Japanese hospitals participating in the optimized transcatheter valvular intervention-transcatheter aortic valve implantation registry according to the US appropriate use criteria for treating severe aortic stenosis. To account for the influence of uncaptured variables on appropriate use criteria ratings, we initially assigned them to a best-case scenario where they were assumed to classify a case to the most appropriate clinical scenario and then to a worst-case scenario where assumed least appropriate. Overall proportion of TAVRs classified as appropriate, maybe appropriate, or rarely appropriate was assessed. In addition, extent of hospital-level variation in rarely appropriate procedures was evaluated. Of 2036 TAVRs (median age [25th, 75th]: 85.0 years [81.0-88.0]; 70.5% female the Society of Thoracic Surgeons Predicted Risk of Mortality score: 6.2% [4.4-8.9]), in the best-case scenario, 177 (8.7%) were not successfully mapped, and 1580 (77.6%) were classified as appropriate, 180 (8.8%) as maybe appropriate, 99 (4.9%) as rarely appropriate, respectively. In the worst-case scenario, the rate of rarely appropriate increased to 6.8%. The majority of rarely appropriate TAVRs was performed in patients with moderate to severe dementia (defined as mini-mental status examination of ≤17), bicuspid aortic valve, or anticipated life expectancy <1 year. There was substantial variation in the proportion of rarely appropriate TAVR across hospitals (median rate of rarely appropriate: 4.9% [3.8-6.6] in the best-case scenario, P <0.001; 6.5% [5.6-8.6] in the worst-case scenario, P <0.001)., Conclusions: In clinical practice, the proportion of rarely appropriate TAVRs ranged from 4.9% to 6.8% with substantial institutional variation. Our study elucidates common clinical scenarios deemed rarely appropriate and clarifies the potential targets of quality improvement. Registration: URL: https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000020423.

Objective: Non-vitamin K oral anticoagulants (NOACs) require dose adjustment for renal function. We sought to investigate change in renal function over time in patients with atrial fibrillation (AF) and whether those on NOACs have appropriate dose adjustments according to its decline., Methods: We included patients with AF enrolled in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry treated with oral anticoagulation. Worsening renal function (WRF) was defined as a decrease of >20% in creatinine clearance (CrCl) from baseline. The US Food and Drug Administration (FDA)-approved package inserts were used to define the reduction criteria of NOACs dosing., Results: Among 6682 patients with AF from 220 sites (median age (25th, 75th): 72.0 years (65.0, 79.0); 57.1% male; median CrCl at baseline: 80.1 mL/min (57.4, 108.5)), 1543 patients (23.1%) experienced WRF with mean decline in CrCl during 2 year follow-up of -6.63 mL/min for NOACs and -6.16 mL/min for warfarin. Among 4120 patients on NOACs, 154 (3.7%) patients had a CrCl decline sufficient to warrant FDA-recommended dose reductions. Of these, NOACs dosing was appropriately reduced in only 31 (20.1%) patients. Compared with patients with appropriately reduced NOACs, those without were more likely to experience bleeding complications (major bleeding: 1.7% vs 0%; bleeding hospitalisation: 2.6% vs 0%) at 1 year., Conclusions: In the US practice, about one-fourth of patients with AF had >20% decline in CrCl over time during 2 year follow-up. As a result, about 3.7% of those treated with NOACs met guideline criteria for dose reduction, but of these, only 20.1% actually had a reduction., Competing Interests: Competing interests: TI: Research Grant from Boston Scientific. LA: Contract with Janssen and Novartis. GF: Consultant/Advisory Board support from Janssen Pharmaceuticals. BJG: Member of a Data Safety Monitoring Board for Mount Sinai St. Lukes, Boston Scientific Corporation, Teva Pharmaceutical Industries, St. Jude Medical, Janssen Research & Development, Baxter Healthcare Corporation and Cardiovascular Research Foundation. Consultant/Advisory Board for Janssen Scientific Affairs, Cipla Limited, Armetheon Inc and Medtronic. EMH: Consultant: Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi-Sankyo, Johnson & Johnson; Research Grant from Bristol-Myers Squibb/Pfizer, Johnson & Johnson. MDE: Consultant/Advisory Board for Boehringer Ingelheim, Daiichi-Sankyo, Pfizer, Bristol-Myers Squibb and Janssen Scientific Affairs. PRK: Consultant for Johnson & Johnson. JAR: Research support from Janssen Pharmaceuticals and Medtronic Inc. Consultancies with Medtronic Inc, Acesion Pharma Aps, and Correvio Pharma Corp. GN: Research Grant from Janssen. Consultant/Advisory Board for Janssen and Daiichi-Sankyo. PC: Employee of Janssen. Consultant for Optum Rx and Johnson & Johnson. KWM: Financial disclosures can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey. DES: Consultant/Advisory Board for Boehringer Ingelheim, Bristol-Myers Squibb, Merck, Johnson & Johnson, Pfizer and Medtronic. Research Grants from Boehringer Ingelheim and Bristol-Myers Squibb. JF: Consultant/Advisory Board for Janssen Scientific. BAS: Research support from Boston Scientific and Janssen. Consult for Janssen. Speakers’ bureau income Biosense Webster. EDP: Research Grant from Janssen Pharmaceuticals and Eli Lilly. Consultant for Janssen Pharmaceuticals and Boehringer Ingelheim. JPP: Research grant from Agency for Healthcare Research and Quality, ARCA biopharma, Boston Scientific, Gilead Sciences, Janssen Pharmaceuticals, Johnson & Johnson, ResMed, Spectranetics and St Jude Medical. Consultant/Advisory Board for BMS/Pfizer, GlaxoSmithKline, Janssen Pharmaceuticals, Johnson & Johnson, Medtronic and Spectranetics., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)