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Abstract Background Despite the positive impact of implantable cardioverter defibrillators (ICDs) and wearable cardioverter defibrillators (WCDs) on prognosis, their implantation is often withheld especially in Japanese heart failure patients with reduced left ventricular ejection fraction (HFrEF) who have not experienced ventricular tachycardia (VT) or ventricular fibrillation (VF) for uncertain reasons. Recent advancements in heart failure (HF) medications have significantly improved the prognosis for HFrEF. Given this context, a critical reassessment of the treatment and prognosis of ICDs and WCDs is essential, as it has the potential to reshape awareness and treatment strategies for these patients. Methods We are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all‐cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints. Results Not applicable. Conclusion This study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.

Background: Older candidates for transcatheter aortic valve replacement (TAVR) frequently present with both cardiac and noncardiac comorbidities. There are few risk scores that evaluate a wide range of comorbidities. Methods: Patients who underwent TAVR for severe aortic stenosis were retrospectively evaluated. A new prediction model (Cardiac and nonCardiac Comorbidities risk score: 3C score) was determined based on coefficient in the multivariate Cox regression analysis for two-year all-cause mortality. C-statistics were assessed to compare the predictive abilities of the 3C score, the Charlson Comorbidities Index (CCI) score, the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II, and the Model for End-stage Liver Disease eXcluding International normalized ratio (MELD-XI) score. Results: The present study included 226 patients (age, 86 ± 5 years; males, 38 %). The values of the CCI score, EuroSCORE II, and MELD-XI score were 2 (1–3), 3.36 (2.12–4.58), and 5.35 (3.05–8.55), respectively. Multivariate Cox regression analysis identified two cardiac (left ventricular ejection fraction [LVEF]

Abstract The right ventricular (RV) impairment can predict clinical adverse events in patients following transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). Limited reports have compared impact of the left ventricular (LV) and RV disorders. This retrospective study evaluated two-year major adverse cardiac and cerebrovascular events (MACCE) in patients following TAVR for severe AS. RV sphericity index was calculated as the ratio between RV mid-ventricular and longitudinal diameters during the end-diastolic phase. Of 239 patients, 2-year MACCE were observed in 34 (14%). LV ejection fraction was 58 ± 11%. Tricuspid annular plane systolic excursion (TAPSE) and RV sphericity index were 20 ± 3 mm and 0.36 (0.31–0.39). Although the univariate Cox regression analysis demonstrated that both LV and RV parameters predicted the outcomes, LV parameters no longer predicted them after adjustment. Lower TAPSE (adjusted hazard ratio per 1 mm, 0.84; 95% confidence interval, 0.75–0.93) and higher RV sphericity index (adjusted hazard ratio per 0.1, 1.94; 95% confidence interval, 1.17–3.22) were adverse clinical predictors. In conclusion, the RV structural and functional disorders predict two-year MACCE, whereas the LV parameters do not. Impact of LV impairment can be attenuated after development of RV disorders.

Background: High-intensity plaque (HIP) on magnetic resonance imaging (MRI) has been documented as a powerful predictor of periprocedural myocardial injury (PMI) following percutaneous coronary intervention (PCI). Despite the recent proposal of three-dimensional HIP quantification to enhance the predictive capability, the conventional pulse sequence, which necessitates the separate acquisition of anatomical reference images, hinders accurate three-dimensional segmentation along the coronary vasculature. Coronary atherosclerosis T1-weighted characterization (CATCH) enables the simultaneous acquisition of inherently coregistered dark-blood plaque and bright-blood coronary artery images. We aimed to develop a novel HIP quantification approach using CATCH and to ascertain its superior predictive performance compared to the conventional two-dimensional assessment based on plaque-to-myocardium signal intensity ratio (PMR). Methods: In this prospective study, CATCH MRI was conducted before elective stent implantation in 137 lesions from 125 patients. On CATCH images, dedicated software automatically generated tubular three-dimensional volumes of interest on the dark-blood plaque images along the coronary vasculature, based on the precisely matched bright-blood coronary artery images, and subsequently computed PMR and HIP volume (HIPvol). Specifically, HIPvol was calculated as the volume of voxels with signal intensity exceeding that of the myocardium, weighted by their respective signal intensities. PMI was defined as post-PCI cardiac troponin-T > 5 × the upper reference limit. Results: The entire analysis process was completed within 3 min per lesion. PMI occurred in 44 lesions. Based on the receiver operating characteristic curve analysis, HIPvol outperformed PMR for predicting PMI (C-statistics, 0.870 [95% CI, 0.805–0.936] vs. 0.787 [95% CI, 0.706–0.868]; p = 0.001). This result was primarily driven by the higher sensitivity HIPvol offered: 0.886 (95% CI, 0.754–0.962) vs. 0.750 for PMR (95% CI, 0.597–0.868; p = 0.034). Multivariable analysis identified HIPvol as an independent predictor of PMI (odds ratio, 1.15 per 10-μL increase; 95% CI, 1.01–1.30, p = 0.035). Conclusions: Our semi-automated method of analyzing coronary plaque using CATCH MRI provided rapid HIP quantification. Three-dimensional assessment using this approach had a better ability to predict PMI than conventional two-dimensional assessment.

Background: Intracoronary imaging improves clinical outcomes after stenting of complex coronary bifurcation lesions (CBLs), but the impact of Medina classification-based CBL distribution on outcomes of imaging-guided bifurcation stenting is unclear. Methods: In this integrated analysis of four previous studies, in which all CBLs were treated with drug-eluting stents under intravascular ultrasound or optical coherence tomography guidance, the distribution of 763 CBLs was assessed using angiographic Medina classification. Major adverse cardiac events (MACE), including target lesion revascularization (TLR), myocardial infarction, stent thrombosis, and cardiac death, were investigated at 1-year follow-up. Results: The most and least prevalent Medina subtypes were 0-1-0 (27.9 %) and 0-0-1 lesions (2.8 %). The most and least frequent MACE/TLR rates were 18.2 %/18.2 % for 0-0-1 lesions and 4.1 %/2.8 % for 0-1-0 lesions. Risks were higher for 0-0-1 lesions than for 0-1-0 lesions for both MACE (hazard ratio [HR]: 4.04, 95 % confidence interval [CI]: 1.21–13.45, p = 0.02) and TLR (HR: 6.19, 95 % CI: 1.69–22.74, p = 0.006). MACE rates were similar for true and non-true CBLs excluding 0-0-1 lesions (8.2 % and 5.9 %, HR 1.54, 95 % CI: 0.86–2.77, p = 0.15), while MACE (HR: 3.25, 95 % CI: 1.10–9.63, p = 0.03) and TLR (HR: 4.24, 95 % CI: 1.38–12.96, p = 0.01) risks were higher for 0-0-1 lesions. Conclusions: This integrated analysis of imaging-guided bifurcation stenting demonstrated similar clinical outcomes in true and non-true CBLs, except for 0-0-1 lesions, which had a significantly higher risk of MACE/TLR.

Background The prognostic impact of optical coherence tomography–diagnosed culprit lesion morphology in acute coronary syndrome (ACS) has not been systematically examined in real‐world settings. Methods and Results This investigator‐initiated, prospective, multicenter, observational study was conducted at 22 Japanese hospitals to identify the prevalence of underlying ACS causes (plaque rupture [PR], plaque erosion [PE], and calcified nodules [CN]) and their impact on clinical outcomes. Patients with ACS diagnosed within 24 hours of symptom onset undergoing emergency percutaneous coronary intervention were enrolled. Optical coherence tomography–guided percutaneous coronary intervention recipients were assessed for underlying ACS causes and followed up for major adverse cardiac events (cardiovascular death, myocardial infarction, heart failure, or ischemia‐driven revascularization) at 1 year. Of 1702 patients with ACS, 702 (40.7%) underwent optical coherence tomography–guided percutaneous coronary intervention for analysis. PR, PE, and CN prevalence was 59.1%, 25.6%, and 4.0%, respectively. One‐year major adverse cardiac events occurred most frequently in patients with CN (32.1%), followed by PR (12.4%) and PE (6.2%) (log‐rank P

Objective Transcatheter balloon aortic valvuloplasty (BAV) remains an important alternative treatment for severe, symptomatic aortic stenosis. With increasing numbers of BAVs being performed, the need for large-scale volume-outcome relationship assessments has become evident. Here, we aimed to explain such relationships by analysing consecutive, patient-level BAV data recorded in a prospective Japanese nationwide multicentre registry.Design Prospective study.Setting Data of 1920 BAVs performed in 200 Japanese hospitals from January 2015 to December 2019.Participants The mean patient age was 85 years, and 36.9% of procedures involved male patients.Methods The efficacy of BAV was assessed by reducing the mean transaortic valve gradient after the procedure. We also assessed in-hospital complication rates, including in-hospital death, bleeding, urgent surgery, distal embolism, vessel rupture and contrast-induced nephropathy. Based on the distribution of case volume (median 20, IQR 10–46), we divided the patients into high-volume (≥20) and low-volume (

Abstract Adenosine occasionally overestimates fractional flow reserve (FFR) values (i.e., insufficient adenosine-induced hyperemia), leading to low non-hyperemic pressure ratios (NHPR)–high FFR discordance. We investigated the impact of insufficient adenosine-induced hyperemia on NHPR–FFR discordance and the reclassification of functional significance. We measured resting distal-to-aortic pressure ratio (Pd/Pa) and FFR by using adenosine (FFRADN) and papaverine (FFRPAP) in 326 patients (326 vessels). FFRADN overestimation was calculated as FFRADN − FFRPAP. We explored determinants of low Pd/Pa − high FFRADN discordance (Pd/Pa ≤ 0.92 and FFRADN > 0.80) versus high Pd/Pa − low FFRADN discordance (Pd/Pa > 0.92 and FFRADN ≤ 0.80). Reclassification of functional significance was defined as FFRADN > 0.80 and FFRPAP ≤ 0.80. Multivariable analysis identified FFRADN overestimation (p = 0.002) and heart rate at baseline (p = 0.048) as independent determinants of the low Pd/Pa–high FFRADN discordance. In the low Pd/Pa–high FFRADN group (n = 26), papaverine produced a further decline in the FFR value in 21 vessels (81%) compared with FFRADN, and the reclassification was observed in 17 vessels (65%). Insufficient adenosine-induced hyperemia is a major determinant of the low resting Pd/Pa–high FFR discordance. Physicians should bear in mind that the presence of low NHPR–high FFR discordance may indicate a false-negative FFR result.

BackgroundHealed plaque, characterized by distinct layers of organizing thrombus and collagen, is the hallmark of tissue self-repair. However, the efficacy of excimer laser coronary angioplasty (ELCA) followed by drug-coated balloon (DCB) angioplasty in patients with healed plaques is not fully understood.Case summaryA 42-year-old woman with a history of anxiety disorder was admitted to our institution with worsening chest pain and subsequently diagnosed with anterior non-ST-elevation myocardial infarction. Coronary angiography revealed severe stenosis in the proximal left anterior descending artery (LAD) despite Thrombolysis in Myocardial Infarction (TIMI) grade 3. Optical coherence tomography (OCT) showed healed plaques with partial macrophage accumulation and no fresh thrombus. Plaque disruption and thin-cap fibrous atheroma were not identified in the culprit lesions. Intravascular ultrasound (IVUS) confirmed high-intensity marginal irregular masses at the culprit site, suggesting that the thrombus was formed by plaque erosion rather than lipid plaque or necrotic tissue. With lesion modification using ELCA prior to DCB angioplasty, OCT examination of the LAD after ELCA showed a significant reduction in plaque burden and preserved lumen size. Post-percutaneous coronary intervention angiography revealed no stenosis with TIMI grade 3. A follow-up coronary computed tomography scan showed no angiographic restenosis, and the patient remained symptom-free.ConclusionsHere we describe a case in which OCT and IVUS evaluation suggested organizing thrombus due to erosion healing, and a favorable outcome was achieved with the combination of ELCA and DCB. The combination use of ELCA and DCB might be a potential strategy for acute coronary syndrome patients with organizing thrombus.

Abstract Adenosine occasionally results in overestimation of fractional flow reserve (FFR) values, compared with other hyperemic stimuli. We aimed to elucidate the association of overestimation of FFR by adenosine with anatomically significant but functionally non-significant lesions (anatomical–functional mismatch) and its influence on reclassification of functional significance. Distal-to-aortic pressure ratio (Pd/Pa) was measured using adenosine (Pd/PaADN) and papaverine (Pd/PaPAP) in 326 patients (326 vessels). The overestimation of FFR was calculated as Pd/PaADN–Pd/PaPAP. The anatomical–functional mismatch was defined as diameter stenosis > 50% and Pd/PaADN > 0.80. Reclassification was indicated by Pd/PaADN > 0.80 and Pd/PaPAP ≤ 0.80. The mismatch (n = 72) had a greater overestimation of FFR than the non-mismatch (n = 99): median 0.02 (interquartile range 0.01–0.05) versus 0.01 (0.00–0.04), p = 0.014. Multivariable analysis identified the overestimation of FFR (p = 0.003), minimal luminal diameter (p = 0.001), and non-left anterior descending artery (LAD) location (p

Abstract Some asymptomatic patients with diabetes mellitus (DM) have critical coronary artery disease (CAD), although the guidelines do not recommend aggressive screening for CAD in asymptomatic patients. Chronic kidney disease (CKD) is among the serious co-morbidities of severe systemic atherosclerosis. Thus, CKD may be associated with potential myocardial ischaemia. Therefore, the present study aimed to determine the impact of CKD on the incidence of silent myocardial ischaemia (SMI) and the long-term outcomes in asymptomatic patients with DM. This study investigated 461 consecutive patients with DM. All patients who were asymptomatic and self-sufficient in daily life underwent the ergometer exercise (ERG) test. Coronary angiography was performed if the stress test was positive, or if the patient did not achieve 90% of the target heart rate. The primary end point included major adverse cardiac and cerebrovascular events (MACCE) including death, non-fatal myocardial infarction and stroke. The median follow-up duration after study enrolment was 35 months for the entire cohort of 461 patients. Eighty-one patients were diagnosed with SMI. The estimated glomerular filtration rate was significantly lower in the SMI group (70.5 ± 23.8 vs. 81.8 ± 30.0 mL/min/1.73 m2, P stage 3a in the SMI subgroup. Urinary albumin (mg/gCr) was associated with MACCE in the SMI subgroup [HR 3.37, 95%CI (1.170–9.521), P = 0.025] after adjusting for age, sex, and conventional risk factors. SMI was more prevalent in patients with CKD and the incidence was proportional to the CKD stage in asymptomatic patients with DM. Those Patients with CKD and SMI exhibited poor clinical outcomes. CKD may be a key factor for the identification and management of SMI in asymptomatic patients with DM in routine clinical practice. Trial Registration: UMIN000038340.

Abstract Background The severity of pulmonary arterial hypertension (PAH) is classified based on mean pulmonary artery pressure (mPAP) levels. However, other markers have not been elucidated. Fibrinolytic markers, such as total plasminogen activator inhibitor-1 (tPAI-1) and thrombomodulin (TM), are known to reflect arterial endothelial function. However, the relationship between serum tPAI-1, TM and pulmonary circulation has not been completely determined. Methods This study included 100 consecutive patients (38 men), with a mean age of 68.9 ± 12.0 years, with cardiac diseases who underwent right heart catheterization. Serum coagulation and fibrinolytic marker levels were measured. Results The average mPAP value was 25.1 ± 13.1 mmHg for all patients. The mPAP levels revealed a significant positive correlation with serum tPAI-1 (ρ = 0.24, p = 0.042) and uric acid (ρ = 0.29, p = 0.0031) levels. In the group with mPAP levels less than 25 mmHg (n = 58, ave. 17.3 ± 4.3 mmHg), mPAP levels showed a significant positive correlation with serum tPA-1 (ρ = 0.34, p = 0.034) and TM (ρ = 0.34, p = 0.043) values. The mean tPAI-1 (29.8 ± 23.3 ng/ml, p = 0.047) and uric acid (5.7 ± 1.8 mg/dl, p = 0.026) levels were significantly less in those with lower mPAP levels. A multivariate analysis revealed that tPAI-1 alone was a significant independent characteristic marker of PAH (odds ratio 1.02, 95%CI 1.000–1.036, p = 0.034). Conclusions These results indicate that serum tPAI-1 and TM may be useful predictors of severity, similar to mPAP in patients with PAH. They could be beneficial in predicting PAH among patients in the early stage of the disease.

Background Coronary artery disease (CAD) patterns play an essential role in the decision‐making process about revascularization. The pullback pressure gradient (PPG) quantifies CAD patterns as either focal or diffuse based on fractional flow reserve (FFR) pullbacks. The objective of this study was to evaluate the impact of CAD patterns on acute percutaneous coronary intervention (PCI) results considered surrogates of clinical outcomes. Methods and Results This was a prospective, multicenter study of patients with hemodynamically significant CAD undergoing PCI. Motorized FFR pullbacks and optical coherence tomography (OCT) were performed before and after PCI. Post‐PCI FFR >0.90 was considered an optimal result. Focal disease was defined as PPG >0.73 (highest PPG tertile). Overall, 113 patients (116 vessels) were included. Patients with focal disease were younger than those with diffuse CAD (61.4±9.9 versus 65.1±8.7 years, P=0.042). PCI in vessels with high PPG (focal CAD) resulted in higher post‐PCI FFR (0.91±0.07 in the focal group versus 0.86±0.05 in the diffuse group, P

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

Abstract Aims/Introduction Glucose fluctuation (GF) is a residual risk factor for coronary artery disease (CAD). We investigated whether GF influenced clinical outcomes and progression of coronary stenosis in stable CAD patients. Materials and Methods In this prospective study, 101 consecutive lipid‐controlled stable CAD patients underwent percutaneous coronary intervention were enrolled, and GF was expressed as the mean amplitude of glycemic excursion (MAGE) obtained by continuous glucose monitoring before the procedure was evaluated. At 9 months after enrollment, culprit and non‐culprit (mild‐to‐moderate stenosis without ischemia) lesions were serially assessed by angiography. Cardiovascular events (CVE) consisting of cardiovascular death, non‐fatal myocardial infarction or ischemia‐driven revascularization during 2‐year follow up, rapid progression in non‐culprit lesions (defined as ≥10% luminal narrowing progression in lesions with stenosis ≥50%, ≥30% luminal narrowing progression in non‐culprit lesions with stenosis

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

Background: The jailing strut configuration with link-free and distal guidewire recrossing (LFD) at the side branch orifice (SBO) reduces incomplete stent apposition (ISA) after kissing balloon technique (KBT) in crossover stenting of coronary bifurcation lesions (CBLs). However, data regarding vascular healing after KBT are lacking. We investigated vascular healing 9 months after crossover stenting followed by KBT with optical coherence tomography (OCT) guidance in a prospective multicenter registry. Methods: Fifty-nine patients with CBLs (LFD, 35 patients; non-LFD, 24 patients) were studied. The jailing configuration of the SB and the wire-recrossing position, incidence of ISA and uncovered struts, and neointima unevenness score (NUS) in the main vessel (MV) after 9 months were determined by off-line 3D-OCT in the core laboratory. Results: The ISA rate was significantly higher at the SB ostium and distal MV after KBT in the non-LFD group, compared to the LFD group. After 9 months, incidence of ISA (18.3 ± 18.2 vs. 6.0 ± 8.7%, p

Background: Right ventricular (RV) afterload is widely assessed by pulmonary vascular resistance (PVR). However, RV afterload is underestimated because PVR does not account for the pulsatile load. The pulsatile load is often evaluated by pulmonary arterial compliance (PAC). The RC (resistance-compliance) time, which is calculated from the product of PVR and PAC, is considered to remain constant under medical therapy. However, little is known on how RC time is affected by invasive therapy in chronic thromboembolic pulmonary hypertension (CTEPH). This study aimed to evaluate change of RC time in patients underwent pulmonary endarterectomy (PEA). Furthermore, we investigated the clinical relevance of RC time. Methods: We reviewed consecutive 50 patients except for death case underwent PEA. Baseline clinical parameters including RC time before performing PEA and follow-up were evaluated. Patients was classified as decrease or non-decrease according to change of RC time. Furthermore, we classified patients into a NYHA I group who had no symptom after treatment and a residual symptom group in order to investigate the relationship of RC time to residual symptoms. Results: RC time was significantly decreased after PEA (0.54 ± 0.16 to 0.45 ± 0.12 sec, p

Abstract Tolvaptan is a key drug for patients with heart failure. Here, we present a 92‐year‐old woman, whose PT‐INR/dose increased from 1.74 to 3.30 after warfarin and tolvaptan co‐administration, and resulted in a large cerebral infarction after warfarin dose down. Therefore, the interaction between these two drugs may be clinically significant.

Platypnea-orthodeoxia syndrome (POS) is a rare condition wherein the magnitude of the interatrial shunt changes between the sitting and supine positions. We diagnosed POS in a case initially considered to be of embolic stroke of undetermined source and performed emergency foramen ovale closure as definitive management for the patient. In this case, additional risk factors for POS include spinal deformity, meandering of the aorta, and exclusion of the right atrium due to overextension. Transcranial color flow imaging is recommended for the diagnosis of POS because of its sensitivity, specificity, and non-invasiveness. Although POS is an important barrier to effective rehabilitation, early diagnosis and definitive management lead to dramatic clinical improvement.

Background Balloon pulmonary angioplasty (BPA), a novel technique initially introduced as a treatment for inoperable chronic thromboembolic pulmonary hypertension, is now increasingly being performed in a broader spectrum of patients. Here, we performed a time-trend analysis of the characteristics and in-hospital outcomes of patients who underwent BPA in Japan, using data extracted from nationwide procedure-based registration system.Methods The Japanese Structural Heart Disease (J-SHD) registry was established and sponsored by the Japanese Association of Cardiovascular Intervention and Therapeutics and aims to provide basic statistics on the performance of structural interventions in Japan. J-SHD registers cases from approximately 200 institutions, representing more than 90% of SHD intervention-performing hospitals in the nation. We analysed the registered BPA data elements from January 2015 to December 2018. Successful BPA was defined as a session in which a physician successfully treated all targeted lesions.Results There were a total of 2512 BPA sessions; the number of institutions and registered sessions increased from 30 to 50 sites and from 479 to 852 sessions during the study period, respectively. The average age of the patients was 66±13 years, and 72.1% were women. In-hospital death was observed in 0.2%, and the total complications rate was 5.3%. The preoperative and postoperative mean pulmonary artery pressure were 32±11 mm Hg and 30±10 mm Hg, respectively.Conclusion The number of BPA sessions increased during the study period, with an acceptable in-hospital complication rate.

Background: The mechanisms and clinical impact of acute kidney injury (AKI) after acute myocardial infarction (AMI) may differ depending on whether AKI develops during the early or late phase after AMI. The present study assessed the timing of AKI onset and the prognostic impact on long-term outcomes in patients hospitalized with AMI. Methods: The present study enrolled consecutive AMI survivors who had undergone successful percutaneous coronary interventions at admission. AKI was defined as an increase in the serum creatinine level of ≥0.3 mg/dL above the admission value within 7 days of hospitalization. AKI patients were further divided into two subgroups (early-phase AKI: within 3 days vs. late-phase AKI: 4 to 7 days after AMI onset). The primary endpoint was all-cause death. Results: In total, 506 patients were included in this study, with 385 men and a mean age of 69.5 ± 13.5 years old. The mean follow-up duration was 1289.5 ± 902.8 days. AKI developed in 127 patients (25.1%). Long-term mortality was significantly higher in the AKI group than in the non-AKI group (log-rank p

Abstract Background Lower-extremity peripheral artery disease (LE-PAD) and coronary artery disease (CAD) are both pathologically rooted in atherosclerosis, and their shared clinical features regarding the exposure to cardiovascular risk factors have been emphasized. However, comparative data of the two cardiovascular diseases (CVDs) were so far lacking. The purpose of this study was to directly compare the clinical profile between cases undergoing endovascular therapy (EVT) for LE-PAD and those undergoing percutaneous coronary intervention (PCI). Methods Data were extracted from the nationwide procedural databases of EVT and PCI in Japan (J-EVT and J-PCI) between 2012 and 2017. A total of 1,121,359 cases (103,887 EVT cases for critical limb ischemia [CLI] or intermittent claudication and 1,017,472 PCI cases for acute coronary syndrome [ACS] or stable angina) were analyzed. Heterogeneity in clinical profile between CVDs was evaluated using the C statistic of the logistic regression model for which dependent variable was one CVD versus another, and explanatory variables were clinical profile. When two CVDs were completely discriminated from each other by the developed model, the C statistic (discrimination ability) of the model would be equal to 1, indicating that the two CVDs were completely different in clinical profile. On the other hand, when two CVDs were identical in clinical profile, the developed model would not discriminate them at all, with the C statistic equal to 0.5. Results Mean age was 73.5 ± 9.3 years in LE-PAD patients versus 70.0 ± 11.2 years in CAD patients (P

IntroductionManagement of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, medical treatment involving pulmonary vasodilators (such as soluble guanylate-cyclase stimulators) is recommended, primarily for ameliorating symptoms. More recently, balloon pulmonary angioplasty (BPA) has been developed as alternative treatment for inoperable CTEPH. This study aimed to compare the efficacy and safety of BPA and riociguat (a soluble guanylate-cyclase stimulator) as treatments for inoperable CTEPH.Methods and analysisThis study is a multicentre randomised controlled trial. Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment. The primary endpoint will be the change in mean pulmonary arterial pressure from baseline to 12 months after initiation of treatment. For primary analysis, we will estimate the least square means difference and 95% CI for the change of pulmonary arterial pressure between the groups at 12 months using the analysis of covariance adjusted for allocation factors.Ethics and disseminationThis study and its protocols were approved by the institutional review board of Keio University School of Medicine and each participating institution. Written informed consent was obtained from all participants. Results will be disseminated at medical conferences and in journal publications.Trial registration numberUniversity Hospital Medical Information Network Clinical Trial Registry (UMIN000019549); Pre-results.

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.

Data presented in this article are supplementary material to our research article entitled “Impact of CD14++CD16+ monocytes on coronary plaque vulnerability assessed by optical coherence tomography in coronary artery disease patients” [1]. This article contains the data of study population, diagnostic ability of CD14++CD16+ monocytes to identify thin-cap fibroatheromas, and association between laboratory variables and plaque properties.

This article comprised the data related to the research article entitled “Feasibility and usefulness of three-dimensional optical coherence tomography guidance for optimal side branch treatment in coronary bifurcation stenting” (Nagoshi et al., In press) [1].In this article we reports details about two patterns of guide wire (GW) recrossing position after crossover stenting in bifurcation lesion classified with three-dimensional optical coherence tomography (3D-OCT) (Okamura et al., 2014) [2] and follow-up data about the treatment with percutaneous coronary intervention(PCI) for bifurcation lesion in terms of the two- (2D) or 3D-OCT guidance. Subgroup analysis about differences in the parameters between the proximal and the distal GW recrossing patterns are analyzed here. Keywords: Optical coherence tomography, Bifurcation stenting, Kissing balloon inflation, Three-dimensional

Clinical efficacy of combination therapy using vasodilators for pulmonary arterial hypertension (PAH) is well established. However, information on its safety are limited. We experienced a case of primary Sjogren's syndrome associated with PAH where the patient developed pulmonary edema immediately after the introduction of upfront triple combination therapy. Although the combination therapy successfully stabilized her pre-shock state, multiple ground glass opacities (GGO) emerged. We aborted the dose escalation of epoprostenol and initiated continuous furosemide infusion and noninvasive positive pressure ventilation (NPPV), but this did not prevent an exacerbation of pulmonary edema. Chest computed tomography showing diffuse alveolar infiltrates without inter-lobular septal thickening suggests the pulmonary edema was unlikely due to cardiogenic pulmonary edema and pulmonary venous occlusive disease. Acute respiratory distress syndrome was also denied from no remarkable inflammatory sign and negative results of drug-induced lymphocyte stimulation tests (DLST). We diagnosed the etiological mechanism as pulmonary vasodilator-induced trans-capillary fluid leakage. Following steroid pulse therapy dramatically improved GGO. We realized that overmuch dose escalation of epoprostenol on the top of dual upfront combination poses the risk of pulmonary edema. Steroid pulse therapy might be effective in cases of vasodilator-induced pulmonary edema in Sjogren's syndrome associated with PAH. Keywords: Steroid therapy, Ground glass opacity, Inter-lobular septal thickening, Epoprostenol, Acute respiratory distress syndrome, Trans-capillary fluid leakage

Abstract Background Previously, we have reported that daily glucose fluctuations could affect coronary plaque vulnerability, but the underlying mechanisms remained unclear. This study sought to investigate the impact of CD14++CD16+ monocytes on plaque vulnerability, as assessed by virtual histology intravascular ultrasound (VH-IVUS), as well as their relationship to fluctuating glucose levels in patients with asymptomatic coronary artery disease (CAD). Methods Fifty-one patients with asymptomatic CAD, who were undergoing lipid-lowering therapy and underwent VH-IVUS evaluation for angiographically mild to moderate lesions, were enrolled in the study. Standard VH-IVUS parameters, including the percentage volume of the necrotic core (%NC) within the plaque and the presence of a virtual histology thin-cap fibroatheroma (VH-TCFA), were then evaluated. Additionally, monocyte subsets were assessed by flow cytometry, and daily glucose fluctuations were analyzed by measuring the mean amplitude of glycemic excursion (MAGE). Results Among 82 plaques from 22 diabetes mellitus (DM) patients and 29 non-DM patients, 15 VH-TCFAs were identified. CD14++CD16+ monocyte counts significantly correlated with both %NC and the presence of VH-TCFA (%NC: r = 0.339, p = 0.002; VH-TCFA: p = 0.003). Multivariate logistic regression analysis revealed that CD14++CD16+ monocyte counts were independently associated with VH-TCFA (odds ratio = 1.029, p = 0.004). Furthermore, CD14++CD16+ monocyte counts were significantly correlated with the MAGE score in the non-DM patients (r = 0.544, p = 0.005). Conclusions CD14++CD16+ monocyte levels are associated with coronary plaque vulnerability and can serve as a biomarker for VH-TCFA in patients with CAD undergoing lipid-lowering therapy. In patients without DM, glucose fluctuations may alter the balance of monocyte subsets. Trial registration UMIN Registry number: UMIN000021228

Background We evaluated the importance of high‐density lipoprotein (HDL) functionality for target‐lesion revascularization in patients treated with coronary stents using a rapid cell‐free assay system to evaluate the functional capacity of HDL to accept additional cholesterol (cholesterol‐uptake capacity; CUC). Methods and Results From an optical coherence tomography (OCT) registry of patients treated with coronary stents, 207 patients were enrolled and their HDL was functionally evaluated by measuring the CUC. Follow‐up OCT was performed (median duration, 24.5 months after stenting) to evaluate the presence of neoatherosclerosis. Clinical follow‐up was performed to assess target‐lesion revascularization for a median duration of 42.3 months after stent implantation. Neoatherosclerosis was identified in 37 patients (17.9%). Multivariate logistic regression analysis revealed that a decreased CUC was independently associated with neoatherosclerosis (odds ratio, 0.799; P

Background: Clinical efficacy of balloon pulmonary angioplasty (BPA) to the patients with non-operable chronic thromboembolic pulmonary hypertension (CTEPH) for improving pulmonary hemodynamics and exercise tolerance has been reported in these several years. However, reperfusion pulmonary injury (RPI) remains to be a major complication of BPA to overcome. This study elucidated the local predictor of RPI. Methods: Twenty-eight consecutive patients with non-operable CTEPH underwent BPA for lesions in the segmental or sub-segmental vessels. Pre- and post-BPA pulmonary arterial pressures at proximal (Pp) and distal (Pd) to the stenosis were measured by a 0.014-in. pressure wire. Positive or negative RPI was evaluated by chest computed tomography in each re-perfused segment separately 4 h after BPA. Results: Pressure measurements pre- and post-BPA were obtained from 110 lesions, where Pd and pressure ratio (Pd/Pp) increased after BPA in all lesions. Among them, RPI was observed in 49 lesions (44.5%). In the RPI-positive lesions, post-BPA Pd and post-BPA Pd/Pp were higher compared with the RPI-negative lesions. Multivariate logistic analysis revealed that the post-BPA Pd was independently associated with RPI incidence. Receiver operating characteristic curve analysis demonstrated the best cut-off value of 19.5 mm Hg for post-BPA Pd to predict RPI. Conclusions: High reperfusion pressure after BPA could be a predictor of RPI. Monitoring local pressure during BPA procedure may have a potential to reduce the incidence of RPI.

Background Residual symptoms after pulmonary endarterectomy (PEA) remain as the clinical issues to be solved. Additional balloon pulmonary angioplasty (BPA) after PEA showed its efficacy with symptoms in a case series, although long‐term spontaneous recovery of exercise ability after PEA was also reported. However, no studies have validated the clinical efficacy of additional BPA by directly comparing PEA with and without BPA. The aim of this study was to retrospectively evaluate the efficacy of additional BPA as a sequential hybrid therapy for chronic thromboembolic pulmonary hypertension after PEA. Methods and Results Among 44 patients with chronic thromboembolic pulmonary hypertension, 20 patients had residual symptoms after PEA. Of those, 10 patients underwent additional BPA (hybrid group) and were compared with the other 10 patients, who were followed up without BPA (PEA group). The period from PEA to additional BPA was 7.3±2.3 months. In hybrid group, mean pulmonary arterial pressure was significantly improved by PEA (40.6±1.8 to 26.9±3.1 mm Hg, P=0.001) and improved further (to 16.7±1.8 mm Hg, P=0.002) with additional BPA, which resulted in remarkable improvement in World Health Organization (WHO) functional class (pre‐ to post‐BPA: class I/II/III/IV, 0/5/4/1 to 7/3/0/0; P

Inhaled iloprost efficiently improves pulmonary hemodynamics, exercise capacity, and quality of life in patients with pulmonary arterial hypertension (PAH). However, the process of inhalation is laborious for patients suffering from resting dyspnea. We describe a 75-year-old man with idiopathic PAH and a low gas transfer. Investigations excluded significant parenchymal lung disease and airflow obstruction (presuming FEV1/FVC ration > 70%). The patient struggled to complete iloprost inhalation due to severe dyspnea and hypoxemia. As such, we optimized the methods of oxygen supply from the nasal cannula to the trans-inhalator during the inhalation. We successfully shortened the inhalation duration that effectively reduced the laborious efforts required of patients. We also recorded pulmonary hemodynamics during inhalation of nebulized iloprost. This revealed significant hemodynamic improvement immediately following inhalation but hemodynamics returned to baseline within 2 hours. We hope that this optimization will enable patients with severe PAH to undergo iloprost inhalation.