村松 崇

Aims: The study aimed to examine five-year clinical outcomes of complete (CR), partially complete (PCR), and incomplete revascularisation (ICR) in patients with unprotected left main coronary artery (ULMCA) disease treated with drug-eluting stents (DES). Completeness of revascularisation, defined as revascularisation of all vessels >= 1.5 or 2.5 mm in diameter, has been shown to correlate with outcomes after percutaneous coronary intervention (PCI). There are no data to compare revascularisation strategies on long-term clinical outcomes in patients undergoing PCI of ULMCA disease. Methods and results: This prospective registry enrolled 910 consecutive patients with ULMCA disease undergoing PCI with DES implantation. CR included patients who had a successful revascularisation of all diseased segments with diameter >= 1.5 mm. PCR included patients who had successful revascularisation of all diseased segments with diameter >= 2.5 mm. ICR included patients who did not achieve revascularisation for all diseased segments of diameter >= 2.5 mm. The primary endpoint was the incidence of major adverse cardiac events (MACE: a composite of cardiac death, myocardial infarction and repeat revascularisation) at five-year follow-up. CR was achieved in 386 (42.4%), PCR in 227 (25.0%), and ICR in 297 (32.6%) patients. Patients with ICR had a significantly higher rate of MACE (29.6% vs. 22.5% and 15.5%, p<0.001) and all-cause mortality (12.5% vs. 7.0% and 6.2%; p=0.006) than those with CR and PCR at five-year follow-up. After propensity score matching, patients with CR vs. PCR had similar incidences of MACE (hazard ratio [HR]: 1.16, 95% confidence interval [CI]: 0.78-1.74, p=0.46), mortality (HR: 1.27, 95% CI: 0.61-2.63, p=0.53), and cardiac death (1.8% vs. 4.5%; HR: 2.56, 95% CI: 0.80-8.17, p=0.11). On multivariable logistic regression analysis, ICR appears to be an outcome of poor clinical characteristics, comorbidities and complex coronary anatomy. Conclusions: In the treatment of patients with ULMCA disease, ICR was associated with worse long-term clinical outcomes than CR and PCR. PCR has clinical outcomes similar to CR in patients with ULMCA disease treated with DES. Clinical outcomes of complete, partially complete, and incomplete revascularisation at five-year follow-up after percutaneous intervention of unprotected left main coronary artery disease with drug-eluting stents (PDF Download Available). Available from: https://www.researchgate.net/publication/308978848_Clinical_outcomes_of_complete_partially_complete_and_incomplete_revascularisation_at_five-year_follow-up_after_percutaneous_intervention_of_unprotected_left_main_coronary_artery_disease_with_drug-elut [accessed May 13, 2017].

Calculation of fractional flow reserve (FFR) based on computational fluid dynamics (CFD) requires reconstruction of patient-specific coronary geometry and estimation of hyperemic flow rate. Coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) are two dominating imaging modalities used for the geometrical reconstruction. Our aim was to investigate the impact of image resolution as inherently associated with these two imaging modalities on geometrical reconstruction and subsequent FFR calculation. Patients with mild or intermediate coronary stenoses who underwent both CCTA and ICA were included. CCTA images were acquired either by 320-row area detector CT or by 128-slice dual-source CT. Two geometrical models were reconstructed separately from CCTA and ICA, from which FFRCTA and FFRQCA were subsequently calculated using CFD simulations, applying the same hyperemic flow rate derived from the ICA images at the inlet boundaries. A total of 57 vessels in 41 patients were analyzed. Average diameter stenosis was 43.4 +/- A 10.8 % by 3D QCA. Reasonably good correlation between FFRCTA and FFRQCA was observed (r = 0.71, p < 0.001). The difference between FFRCTA and FFRQCA was correlated with the deviation between minimal lumen areas by CCTA and by ICA (rho = 0.34, p = 0.01), but not with plaque volume (rho = -0.09, p = 0.51) or calcified plaque volume (rho = 0.01, p = 0.95). Applying the cutoff value of a parts per thousand currency sign0.8 to both FFRCTA and FFRQCA, the agreement between FFRCTA and FFRQCA in discriminating functional significant stenoses was moderate (kappa 0.47, p < 0.001). Disagreement was found in 10 (17.5 %) vessels. Acceptable correlation between FFRCTA and FFRQCA was observed, while their agreement in distinguishing functional significant stenosis was moderate. Our results suggest that image resolution has a significant impact on FFR computation.

ObjectiveThis study investigated the diagnostic accuracy of three-dimensional quantitative coronary angiography (3D-QCA) compared with conventional 2D-QCA for predicting functional severity assessed by fractional flow reserve (FFR) for true bifurcation lesions. MethodsBased on pooled data from the randomized DK-CRUSH II, III, and IV trials, we evaluated the patients with true bifurcation lesions who underwent coronary angiography together with functional evaluations using FFR in both the main vessel and the side branch. Off-line 2D- and 3D-QCA analyses were conducted using dedicated bifurcation QCA analysis software. Measurements of minimum lumen diameter (MLD), percentage diameter stenosis (% DS), and minimum lumen area (MLA) were compared between 2D- and 3D-QCA, and we evaluated their predictive values of functionally significant FFR. ResultsNinety patients were eligible for enrollment in the present study. In the main vessel, MLA measured by 3D-QCA was the most accurate predictor of FFR <0.75 (C statistic 0.85, P<0.001), while MLD measured by 2D-QCA was a similarly accurate predictor (C statistic 0.85, P<0.001). In the side branch, the best metrics for predicting FFR <0.75 were % DS measured by 2D-QCA with a C statistic value of 0.91 (P<0.001) and MLA measured by 3D-QCA with a C statistic value of 0.81 (P<0.001). However, both 2D- and 3D-QCA metrics exhibited low accuracies for predicting FFR <0.75 in intermediate bifurcation lesions. Conclusions3D-QCA analysis for true bifurcation lesions did not improve the predictive accuracy of functionally significant FFR compared with 2D-QCA analysis. In lesions with intermediate stenosis, the diagnostic performance of both 2D- and 3D-QCA-derived measurements in differentiating functional severity is limited. (c) 2016 Wiley Periodicals, Inc.

Introduction and objectives: The Absorb bioresorbable vascular scaffold has been shown to decrease total plaque areas in the treated segment. However, it is unknown whether plaque size is modified in scaffolded segments only or whether the modification extends to other coronary segments. Methods: Absorb Cohort A is a single-arm, prospective study, with safety and imaging endpoints, in which 30 patients underwent percutaneous coronary intervention with the first generation Absorb bioresorbable vascular scaffold. Noninvasive multislice computed tomography imaging was performed in 18 patients at 18 months and 5 years of follow-up. The present study was an intrapatient comparison of matched segments (normalized by the segment length) of the scaffolded region with nonintervened segments for lumen volume, vessel volume, plaque volume, plaque burden, and percent change in plaque atheroma volume. Results: All 18 scaffolded segments could be analyzed. In the nonintervened segments, 1 of 72 segments had a motion artifact and was excluded. Serial comparison showed that the scaffolded segments showed no significant change in the mean plaque burden, total atheroma volume, total lumen volume, or vessel volume between 18 months and 5 years. Conversely, the untreated segments showed a significant increase in plaque burden (2.7 +/- 6.5%; P < .01) and normalized plaque volumes (8.0 +/- 22.8 mm(3); P < .01). This resulted in a significant difference in plaque burden between scaffolded and nonintervened segments (P = .03). Conclusions: In this small series, the Absorb bioresorbable vascular scaffold showed the potential to provide an additional benefit to pharmacological therapy in locally reducing progression of percent plaque burden. These findings need to be confirmed in larger studies. (C) 2015 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.

Very late stent thrombosis (VLST) is a catastrophic complication after implantation of a drug-eluting stent (DES). It has been reported that VLST is associated with pathological changes, which often include late acquired incomplete stent apposition (LAISA) with thrombus formation. In addition, the vascular response to the stent (evaginations, neointimal growth, and thrombosis) and the incidence of LAISA are reported to vary among the different types of DES. We experienced a patient with cardiogenic shock induced by simultaneous VLST of both the left anterior descending artery (LAD) and the left circumflex artery (LCX) at 3 years after implantation of two sirolimus-eluting stents. Intravascular ultrasound (IVUS) showed LAISA of both arteries. A paclitaxel-eluting stent, which had been implanted in the right coronary artery 3 years earlier, did not show such a finding. IVUS revealed "different vascular reactions" to "different types of DES" in this patient.

BackgroundThree-dimensional (3D) quantitative coronary angiography (QCA) provides more accurate measurements by minimizing inherent limitations of two-dimensional (2D) QCA. The aim of this study was to compare the measurements between 2D and 3D QCA analyses in bifurcation lesions. Methods and ResultsA total of 114 cases with non-left main bifurcation lesions in the TRYTON pivotal IDE Coronary Bifurcation Trial (: NCT01258972) were analyzed using a validated bifurcation QCA software (CAAS 5.10, Pie Medical Imaging, Maastricht, the Netherlands). All cases were analyzed in matched projections between pre- and post-procedure. The 2D analysis was performed using one of two angiographic images used for 3D reconstruction showing a larger distal bifurcation angle. In the treated segments (stent and balloon), there were no differences in minimal luminal diameter (MLD) between 2D and 3D, while diameter stenosis (DS) was significantly higher in 2D compared to 3D both pre-procedure and post-procedure (53.9% for 2D vs. 52.1% for 3D pre-procedure, P<0.01; 23.2% for 2D vs. 20.9% for 3D post-procedure, P=0.01). In the sub-segment level analysis, lengths of proximal main branch, distal main branch, and side branch were consistently shorter in 2D compared to 3D both pre-procedure and post-procedure. Using 3D QCA, the anatomic location of the smallest MLD or the highest DS was relocated to a different bifurcation sub-segment in a considerable proportion of the patients compared to when 2D-QCA was used (kappa values: 0.50 for MLD, 0.55 for DS). ConclusionsOur data showed differences in addressing anatomical severity and location of coronary bifurcation lesions between in vivo 2D and 3D QCA analyses. More studies are needed to investigate potential clinical benefits in using 3D approach over 2D QCA for the assessment of bifurcation lesions. (c) 2015 Wiley Periodicals, Inc.

OBJECTIVES This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury. METHODS In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2x the upper limit of normal with creatine kinase-myocardial band rise. RESULTS Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002). CONCLUSIONS There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281). (C) 2015 by the American College of Cardiology Foundation.

BackgroundAn increased body mass index (BMI) is associated with a high risk of cardiovascular disease and reduction in life expectancy. However, several studies reported improved clinical outcomes in obese patients treated for cardiovascular diseases. The aim of the present study is to investigate the impact of BMI on long-term clinical outcomes after implantation of zotarolimus eluting stents. MethodsIndividual patient data were pooled from the RESOLUTE Clinical Program comprising five trials worldwide. The study population was sorted according to BMI tertiles and clinical outcomes were evaluated at 2-year follow-up. ResultsData from a total of 5,127 patients receiving the R-ZES were included in the present study. BMI tertiles were as follow: I tertile ( 25.95 kg/m(2)Low or normal weight) 1,727 patients; II tertile (>25.9529.74 kg/m(2)overweight) 1,695 patients, and III tertile (>29.74 kg/m(2)obese) 1,705 patients. At 2-years follow-up no difference was found for patients with high BMI (III tertile) compared with patients with normal or low BMI (I tertile) in terms of target lesion failure (I-III tertile, HR [95% CI]=0.89 [0.69, 1.14], P=0.341; major adverse cardiac events (I-III tertile, HR [95% CI]=0.90 [0.72, 1.14], P=0.389; cardiac death (I-III tertile, HR [95% CI]=1.20 [0.73, 1.99], P=0.476); myocardial infarction (I-III tertile, HR [95% CI]=0.86 [0.55, 1.35], P=0.509; clinically-driven target lesion revascularization (I-III tertile, HR [95% CI]=0.75 [0.53, 1.08], P=0.123; definite or probable stent thrombosis (I-III tertile, HR [95% CI]=0.98 [0.49, 1.99], P=0.964. ConclusionsIn the present study, the patients' body mass index was found to have no impact on long-term clinical outcomes after coronary artery interventions. (c) 2015 Wiley Periodicals, Inc.

Background: This study evaluated the ability of a newly developed integrated backscatter intravascular ultrasound (IB-IVUS) system (VISIWAVE, Terumo, Tokyo, Japan) to detect optical coherence tomography (OCT)-verified thin cap fibroatheroma (TCFA) and assessed the correlation with peri-procedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI). Methods and Results: One hundred culprit lesions in 100 consecutive patients with ischemic heart disease who consented to repeated IVUS and OCT prior to PCI were studied. Of 100 lesions, 48 had OCT-verified TCFA with a cap thickness <65 mu m. Such lesions had larger percentage lipid area and lipid angle >2 quadrants on IB-IVUS. A lipid core abutting lumen (LCAL) was defined as a lipid core pool in the plaque area, directly contacting with the lumen regardless of its circumferential extension. IB-IVUS-identified TCFA defined as a combination of percentage lipid area >= 53.6%, remodeling index >= 1.03, and the presence of LCAL was the best predictor of OCT-verified TCFA with sensitivity, specificity, positive and negative predictive values, and accuracy of 72.9%, 90.4%, 87.5%, 78.3%, and 82.0%, respectively. IB-IVUS-identified TCFA as well as OCT-verified TCFA were significant independent predictors of PMI, after adjusting for other predictors on multivariate analysis. Conclusions: IB-IVUS can be used to identify plaques with a high prevalence of TCFA. Such techniques can therefore potentially be used to identify lesions with an elevated risk of PMI after PCI.

Aims: To investigate the extent and the circumferential distribution of the neointima tissue developed following an Absorb bioresorbable vascular scaffold (BVS) implantation. Methods and results: Twenty-three patients who were treated with the Absorb BVS and had optical coherence tomographic examination after scaffold implantation, at six-month and at two-year follow-up, were included in the current analysis. The lumen and the scaffold borders were detected and the circumferential thickness of the neointima was measured at one degree intervals. The symmetry of the neointima was defined as: minimum/maximum thickness. The lumen area was decreased at six months compared to baseline but it did not change between six-month and two-year follow-up (baseline: 7.49 [6.13-8.00] mm(2), six months: 6.31 (4.75-7.06) mm(2), two years: 6.01 [4.67-7.11] mm(2), p=0.373). However, the mean neointima thickness (six months: 189 [173-229] mu m, two years: 258 [222-283] mu m, p<0.0001) and the symmetry index of the neointima (six months: 0.06 [0.02-0.09], two years: 0.27 [0.24-0.36], p<0.0001) were increased at two years. Full circumferential coverage of the vessel wall by neointima tissue was seen in 91% of the studied frames at two years. Conclusions: This study demonstrates that after an Absorb BVS implantation neointima tissue develops that covers almost the whole circumference of the vessel wall. In contrast to the metallic stents, the neointima tissue does not compromise the luminal dimensions. Further research is required to evaluate the neointimal characteristics and assess the potential value of the device in passivating high-risk plaques.

Aims: The long-term follow-up of the first-in-man ABSORB Cohort B trial showed that angiographic binary restenosis can occur early, late or very late after implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS). Since the mechanical support of the scaffold decreases during bioresorption, the mechanism of in-segment restenosis (ISR) of the Absorb BVS might be different from that of metallic stents. The objective of the current analysis was to review the multimodality imaging of cases with binary restenosis to elucidate the mechanism of ISR after Absorb BVS implantation. Methods and results: The ABSORB Cohort B trial enrolled 101 patients with a maximum of two de novo coronary lesions. At the three-year imaging and clinical follow-up, there were six cases of in-segment binary restenosis: two early ISR (<6 months), one late ISR (6-12 months) and three very late ISR (>12 months). Three of these ISR cases seemed to be induced by anatomical or procedural factors. In the other three cases, intravascular imaging (IVUS/OCT) demonstrated that the main mechanism of restenosis was significant intra-scaffold tissue growth, while the structural circularity and diameter of the scaffold were not affected. Conclusions: Early and late restenosis after implantation of the Absorb bioresorbable scaffold could be related to anatomical or procedural factors. In this small cohort of patients late or very late restenosis seems to be attributed to pure intra-scaffold tissue growth without extrinsic encroachment of the scaffold.

Background and purpose: Many patients with atrial fibrillation (AF) and coronary artery stent deployment are given both antiplatelet drug and warfarin. Little information is available as to the relationship between the antithrombotic therapies in the late phase after stenting and the clinical outcomes of these patients. We examined the clinical outcomes of AF patients 12 months after coronary artery stenting. Methods: We retrospectively examined 146 patients and classified them into three groups according to the antithrombotic therapies [dual antiplatelet therapy (DAPT), single antiplatelet therapy (SAPT) plus warfarin, and DAPT plus warfarin] 12 months after stenting. We defined the primary endpoint as Thrombolysis in Myocardial Infarction major bleeding and the secondary endpoint as a composite of adverse events (CAE: all-cause death, nonfatal myocardial infarction, intracranial bleeding, and cerebral infarction). Results: During a median follow-up of 37 months, major bleeding and CAE were observed in 14(9.6%) and 46 (31.5%) patients, respectively. DAPT plus warfarin was an independent risk factor for major bleeding in a multivariate Cox hazard regression model after adjustment for age, gender, and the type of AF (hazard ratio: 4.20; 95% confidence interval: 1.13-17.27; p = 0.033). No significant clinical variables were found for CAE. Conclusions: Prolonged use of DAPT with warfarin significantly increases the risk of major bleeding in AF patients after coronary artery stenting. Individualized antithrombotic treatment is required in these patients to prevent major bleeding. (C) 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Background: We prospectively investigated the prognostic value of the combined use of cardiac troponin T (TnT), B-type natriuretic peptide (BNP), and high-sensitivity C-reactive protein (CRP) for long-term mortality in hemodialysis (HD) patients. Methods and Results: Baseline measurements of TnT, BNP, and CRP were performed in 516 patients on chronic HD. Patients were followed up for 10 years. Using the Cox multivariate model with these 3 biomarkers as variables categorized into tertiles for mortality, a simplified score was obtained by underscoring individual biomarkers based on the adjusted hazard ratio (HR). The multimarker score was defined as the sum of these points. TnT, BNP, and CRP levels were individually independent predictors for mortality (P<0.05). Among low-risk (multimarker score <4), intermediate-risk (multimarker score 4-7), and high-risk (multimarker score >= 7) groups, 10-year survival rates were 83.3%, 54.3%, and 27.2% (P<0.0001), respectively. After adjusting for other confounders, the multimarker score had strong predictive power for mortality (HR: 4.26; P<0.0001 for high-risk vs. low-risk group). Furthermore, adding the multimarker score to a baseline model with established risk factors improved the C-index (P<0.01), net reclassification improvement (P<0.0001), and integrated discrimination improvement (P<0.0001) greater than that of any single biomarker or baseline model alone. Conclusions: The multimarker approach (ie, simultaneous assessment of TnT, BNP, and CRP, which individually independently predict prognosis) may improve the prediction of long-term mortality in HD patients.

Introduction: Although bioresorbable vascular scaffolds (BVS) have been used with promising results in patients with stable and unstable angina, little is known about the acute vascular response following BVS implantation in myocardial infarction. We present angiographic and OCT findings from the first patients undergoing bioresorbable vascular scaffold (BVS) implantation for non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) in our institution. Methods: The first 5 patients with NSTEMI and the first 5 patients with STEMI who underwent BVS implantation in our institution, followed by optical coherence tomography (OCT) imaging of the treated culprit vessel, were included in this series. All patients underwent angiographic analysis pre-and post- BVS implantation, as well as OCT analysis, including qualitative and quantitative assessment. Results: Implantation was successful in all cases, as assessed by angiography and OCT. There were no cases with coronary spasm, distal embolization or no-reflow. No adverse clinical events were recorded in any patient at the 6-month follow up. Specific illustrative cases demonstrating the challenges of BVS implantation in myocardial infarction are presented. Conclusions: BVS implantation can potentially be used in the setting of thrombotic lesions encountered in myocardial infarction; however, the role of this treatment approach warrants systematic evaluation in prospective studies.

Background: Despite the frequent use of spectral analysis of intravascular ultrasound radiofrequency data (VH (R) IVUS) in clinical studies, the assessment for reproducibility using this with high frequency IVUS remains unexplored. Purpose: The aim of this study was to examine the reproducibility of VH IVUS using 45-MHz rotational IVUS in ex vivo human coronary arteries. Methods: Data were collected using 45-MHz VH IVUS (Revolution (R), Volcano Corporation, San Diego, CA, USA) via a series of pullbacks from eight human coronary artery specimens. Imaging data were analyzed by two independent observers. Intraobserver and interobserver reproducibility were assessed using five pullbacks from five vessels. The intercatheter reproducibility was assessed using three different catheters in each of the five vessels. The intracatheter reproducibility was assessed between the two sequential pullbacks from each of the 15 catheters used in the intercatheter assessment. Results: Geometrical measurements consistently showed low variability (relative difference <10%) and excellent intraclass correlation coefficients (ICCs), ranging from 0.88 to 1.00. With respect to the compositional measurements, the relative differences were predominantly higher than those of geometrical measurements. In particular, fibrous-fatty area showed a higher relative difference (17.5% in intercatheter assessment) compared to fibrous, necrotic core, and dense calcium areas (6.5%, 8.4%, and 6.4%, respectively). However, each compositional measurement also showed acceptable reproducibility (ICCs ranging from 0.82 to 1.00). Conclusions: The 45-MHz rotational VH IVUS technology had acceptable reproducibility with respect to geometrical and compositional assessments in ex vivo human coronary arteries. These data are crucial when designing future longitudinal studies addressing geometrical measurements and plaque characterization by 45-MHz VH IVUS. (C) 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

With the advance of optical coherence tomography (OCT) technology, three-dimensional (3D) reconstruction based on the optical coherence tomography has become feasible. In bifurcation lesions, 3D OCT may guide positioning of the wire through the appropriate (distal) cells. The early studies suggested that such a guidance strategy could reduce the incidence of malapposition in bifurcation lesions. The pre-installed "real-time" 3D OCT on the console will promote the utilisation of 3D assessment in bifurcation treatment and possibly establish the clinical benefit of such guidance in the near future when investigated in a prospective study.

OBJECTIVES This study sought to describe the frequency and clinical impact of acute scaffold disruption and late strut discontinuity of the second-generation Absorb bioresorbable polymeric vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, California) in the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) cohort B study by optical coherence tomography (OCT) post-procedure and at 6, 12, 24, and 36 months. BACKGROUND Fully bioresorbable scaffolds are a novel approach to treatment for coronary narrowing that provides transient vessel support with drug delivery capability without the long-term limitations of metallic drug-eluting stents. However, a potential drawback of the bioresorbable scaffold is the potential for disruption of the strut network when overexpanded. Conversely, the structural discontinuity of the polymeric struts at a late stage is a biologically programmed fate of the scaffold during the course of bioresorption. METHODS The ABSORB cohort B trial is a multicenter single-arm trial assessing the safety and performance of the Absorb BVS in the treatment of 101 patients with de novo native coronary artery lesions. The current analysis included 51 patients with 143 OCT pullbacks who underwent OCT at baseline and follow-up. The presence of acute disruption or late discontinuities was diagnosed by the presence on OCT of stacked, overhung struts or isolated intraluminal struts disconnected from the expected circularity of the device. RESULTS Of 51 patients with OCT imaging post-procedure, acute scaffold disruption was observed in 2 patients (3.9%), which could be related to overexpansion of the scaffold at the time of implantation. One patient had a target lesion revascularization that was presumably related to the disruption. Of 49 patients without acute disruption, late discontinuities were observed in 21 patients. There were no major adverse cardiac events associated with this finding except for 1 patient who had a non-ischemia-driven target lesion revascularization. CONCLUSIONS Acute scaffold disruption is a rare iatrogenic phenomenon that has been anecdotally associated with anginal symptoms, whereas late strut discontinuity is observed in approximately 40% of patients and could be viewed as a serendipitous OCT finding of a normal bioresorption process without clinical implications. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856) (C) 2014 by the American College of Cardiology Foundation.

The Annual Congress of the European Society of Cardiology (ESC) was held in Barcelona from 30th August to 3rd September 2014. More than 30,300 attendees from around the world shared the latest original research, including 27 clinical Hot Line studies, 12 basic science Hot Lines, 15 clinical trial updates, 19 registry studies, and 4,597 abstracts. Many important issues were presented, including novel treatment strategies for heart failure, acute coronary syndrome, interventional treatment for structural heart disease, renal denervation, novel anticoagulant therapies, atrial fibrillation and so on. In addition, 5 new ESC clinical practice guidelines (ie, myocardial revascularization, non-cardiac surgery, acute pulmonary embolism, hypertrophic cardiomyopathy, and aortic disease) were launched. It should be noted that Japan has recently been ranked in the top position in terms of the number of abstract submissions. Based on these activities, the ESC Congress has been recognized as the dominant scientific and educational forum for healthcare professionals in cardiology. We report the highlights and several key presentations of the ESC Congress 2014. The scientific activities and growing contributions of Japanese cardiologists or cardiovascular surgeons enhance the favorable relationship between the ESC and the Japanese Circulation Society.

Bioresorbable vascular scaffolds (BRS) represent a novel approach to provide transient vessel support to drug-delivery capability without the long-term limitations of metallic drug-eluting stents (DES). The technology has the potential to overcome many of the safety concerns associated with metallic DES and possibly even convey further clinical benefit. In particular, the BRS are designed to provide short-term lumen support, and after being completely bioresorbed, eliminate the permanent caging typical of metallic DES. However, this technology has required new imaging modalities and methodologies for its assessment because the design, degradation rate, loss of mechanical property, and drug deliverability may affect its safety and efficacy. We provide an overview of all existing methods for assessing bioresorbable devices, from noninvasive to invasive, from light to sound based, and from morphological to functional parameters. (C) 2014 by the American College of Cardiology Foundation.

Aims: The study sought to compare the acute gain and two-year follow-up late lumen loss (LLL) between the Absorb bioresorbable vascular scaffold (BVS) and the analogous everolimus-eluting metallic stent (EES). Methods and results: The current analysis included all the patients recruited in the ABSORB Cohort B and SPIRIT II trials implanted with a single 3.0x18 mm device (Absorb BVS or EES) who underwent serial angiographic examinations at baseline and at two-year follow-up. The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD). The in-stent/scaffold LLL was calculated as the difference in stent/scaffold segment between the post-procedural MLD and follow-up MLD. Thirty-three patients (33 lesions) implanted with the Absorb BVS, and 26 patients (28 lesions) implanted with the EES were studied. The acute gain was similar in the Absorb BVS group (1.23 +/- 0.38 mm) compared to the EES group (1.32 +/- 0.26 mm, p=0.29). The in-stent/scaffold LLL at two-year follow-up in the Absorb BVS group (0.26 +/- 0.19 mm) was also similar compared to the EES group (0.22 +/- 0.22 mm, p=0.29). Although the two groups had similar two-year clinical outcomes (major adverse cardiac events: Absorb BVS: 6.1% vs. EES: 0.0%), patients treated with the Absorb BVS exhibited a significantly lower two-year in-stent/scaffold MLD compared to the EES (2.02 +/- 0.26 mm vs. 2.22 +/- 0.34 mm, p=0.01). Conclusions: Although BVS and EES demonstrated similar two-year clinical outcomes, patients treated with the Absorb BVS exhibited a significantly lower two-year in-stent/scaffold MLD compared to patients treated with the EES. Appropriately powered randomised trials are necessary to confirm these exploratory results and evaluate their prognostic and clinical significance.

Aims To investigate the incidence of incomplete stent apposition and to explore the impact of the presence of thrombus and protruding plaque after stent implantation on neointima formation at follow-up in ST-segment elevation myocardial infarction (STEMI) patients with serial optical frequency domain imaging (OFDI) investigations. Methods and results In a multi-centre study, 141 patients with ST elevation myocardial infarction <12 h from onsetwere randomized to either PPCI with thrombectomy (TB) using an Eliminate catheter (TB: n = 71) or without TB (non-TB: n = 70). OFDI after drugeluting stenting was performed using TERUMOOFD I system. Per protocol, at follow-up 49 patients segments were reimaged. At post-procedure and follow-up, there were no differences in stent and lumen areas between the two groups. At follow-up, per strut-level analysis, percentage of incompletely apposed struts was 0.42 +/- 0.94 vs. 0.38 +/- 0.77% (P = 0.76), and percentage of covered struts was 92.7 +/- 7.2 vs. 94.4 +/- 9.2% (P = 0.47) in the TB and non-TB groups, respectively. There was a positive correlation between intra-stent structure (ISS) volume at post-procedure and the neointima volume at 6-month follow-up (Pearson's r = 0.409, P = 0.04). Up to 12 months, there have been two and four patients having target vessel failure in the TB and in the non-TB groups, respectively. Conclusions In patients with STEMI, there were no significant differences in OFDI parameters between TB and non-TB groups at both post-procedure and 6-month follow-up. However, ISS volume at post-procedure was positively associated with neointimal volume at 6-month follow-up.

Aims: To develop a simplified approach of virtual functional assessment of coronary stenosis from routine angiographic data and test it against fractional flow reserve using a pressure wire (wire-FFR). Methods and results: Three-dimensional quantitative coronary angiography (3D-QCA) was performed in 139 vessels (120 patients) with intermediate lesions assessed by wire-FFR (reference standard: <0.80). The 3D-QCA models were processed with computational fluid dynamics (CFD) to calculate the lesion-specific pressure gradient (AP) and construct the AP flow curve, from which the virtual functional assessment index (vFAI) was derived. The discriminatory power of vFAI for ischaemia-producing lesions was high (area under the receiver operator characteristic curve [AUC]: 92% [95% CI: 86-96%]). Diagnostic accuracy, sensitivity and specificity for the optimal vFAI cut-point (<= 0.82) were 88%, 90% and 86%, respectively. VirtualFAT demonstrated superior discrimination against 3D-QCA derived % area stenosis (AUC: 78% [95% CI: 70-84%]; p<0.0001 compared to vFAI). There was a close correlation (r=0.78, p<0.0001) and agreement of vFAI compared to wire-FFR (mean difference: 0.0039+0.085, p=0.59). Conclusions: We developed a fast and simple CFD-powered virtual haemodynamic assessment model using only routine angiography and without requiring any invasive physiology measurements/hyperaemia induction. Virtual-FM showed a high diagnostic performance and incremental value to QCA for predicting wireFFR; this "less invasive" approach could have important implications for patient management and cost.

Aims: Bioresorbable scaffolds are increasingly used in patients with coronary artery disease undergoing percutaneous coronary interventions. ABSORB EXTEND is an ongoing study that will recruit 800 patients. This report evaluates acute and late scaffold failure in the first 450 patients enrolled in ABSORB EXTEND who have completed 12 months follow-up. Methods and results: Clinical event data from the first 450 patients enrolled in ABSORB EXTEND have demonstrated low rates of ischaemia-driven MACE (4.2%) and target vessel failure (4.7%) at 12 months. There have been seven cases of device failure in this study: three cases of scaffold dislodgement (0.67%) and four cases of subacute or late scaffold thrombosis (0.89%). All scaffold dislodgements occurred in the left circumflex (LCX), and in two cases dislodgement was observed after reinsertion of the same device. Two cases of subacute scaffold thrombosis and two late scaffold thromboses were observed. Two out of four cases of scaffold thrombosis seemed to be related to either premature discontinuation of dual antiplatelet therapy (DAPT) or resistance to clopidogrel. Conclusions: This is the first report specifically describing the incidence and the potential mechanisms of scaffold dislodgement and scaffold thrombosis as seen in the ABSORB EXTEND trial.

Background: To examine the association of intrahepatic fat with homeostasis model assessment-insulin resistance (HOMA-IR), a marker of insulin resistance, in Japanese adults, and whether intrahepatic fat is associated with insulin resistance independent of waist circumference and other measures of obesity.Methods: Fifty-three individuals aged 37-69 were studied. Spectrum obtained using a 3-T magnetic resonance imager was analysed with LC Model to quantify intrahepatic fat. Blood levels of insulin, glucose and other biochemical markers were obtained after 8 h or more fasting. Percent body fat was estimated by a bioelectrical impedance analyzer. HOMA-IR and intrahepatic fat content were log-transformed in the analysis.Results: We found a positive correlation between intrahepatic fat and HOMA-IR, which was independent of the anthropometric measures of obesity. In contrast, significant and positive correlations of body mass index, percent body fat, and waist circumference with HOMA-IR were largely explained by their associations with intrahepatic fat. Intrahepatic fat was positively associated with alanine transaminase and triglyceride seven after adjustment for HOMA-IR.Conclusion: Intrahepatic fat was associated with insulin resistance independent of age, sex, and measures of obesity in Japanese adults. Hypertriglyceridemia and liver injury may directly occur subsequent to intrahepatic fat accumulation. (C) 2013 Asian Oceanian Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

Background: The prevalence and clinical sequelae of optical frequency domain imaging (OFDI)-detected intimal flaps caused by vessel trauma or plaque rupture in the proximal native coronary arteries have not been described. Methods and Results: OFDI investigation was performed following stent implantation in patients with ST-segment elevation myocardial infarction (STEMI). We defined a flap-like structure (FS) as a disruption or discontinuation of the endoluminal vessel surface, and classified as actual flap or artifact. FS in the left main stem, or maximally 20mm distal to the guiding catheter in the proximal right coronary artery were assessed. A total of 8,931 frames in 97 patients were analyzed in a frame-by-frame fashion (0.125-mm interval). OFDI identified 8 FS in 7 patients, none of which was evident angiographically. All FS were left untreated because the operators per protocol were blinded to the OFDI images. A total of 5 FS in 5 patients (5.1%) appeared to be actual flaps in which only the intima was involved (mean distance from guiding catheter: 4.8 +/- 2.7 mm). The remaining 3 FS in 3 patients were artifacts; namely, residual blood and interface light reflectivity. There were no adverse cardiac events during 6-months follow-up. Conclusions: In 5.1% of STEM patients, post-procedural OFDI identified flaps with minimal involvement of the intima in the proximal coronary arteries. A precise interpretation of FS may help decision making to avoid unnecessary procedures. (Clinical Trial Registration Information: ClinicalTrials.gov identifier: NCT01271361.)

Background: Ginsenoside Rg1, an important and active ingredient of Panax ginseng, has been shown to exert cardioprotective effects in vivo. The present study aimed to test the hypothesis that ginsenoside Rg1 attenuates cardiac dysfunction in a transverse aortic constriction (TAC)-induced left ventricular hypertrophy in vivo via proangiogenic and antifibrotic effects. Methods: This study investigated the effects of ginsenoside Rg1 in a rat model of TAC-induced left ventricular hypertrophy. Cardiac function was assessed by echocardiography. The antifibrotic and proangiogenic effects were assessed by histopathology and mRNA expression of procollagen I, III, and vascular endothelial growth factor (VEGF) through quantitative real-time PCR. The expression of phosphorylation of Akt, p38 mitogen-activated protein kinase (MAPK), hypoxia inducible factor-1 (HIF-1), and VEGF proteins were examined by Western blotting. Results: Ginsenoside Rg1 treatment significantly decreased TAC-induced myocardial fibrosis and left ventricular hypertrophy, and preserved cardiac function. Ginsenoside Rg1 administration enhanced angiogenesis by increasing the expression of HIF-1 and VEGF. These cardioprotective effects of ginsenoside Rg1 are partially related to the activation of phospho-Akt and inhibition of p38 MAPK. Conclusions: Ginsenoside Rg1 exhibited protective effect against TAC-induced left ventricular hypertrophy and cardiac dysfunction, which is potentially associated with phospho-Akt activation and p38 MAPK inhibition.

Background: The impact of the sampling rate (SR) of optical frequency domain imaging (OFDI) on quantitative assessment of in-stent structures (ISS) such as plaque prolapse and thrombus remains unexplored. Methods and Results: OFDI after stenting was performed in ST-segment elevation myocardial infarction (STEMI) patients using a TERUMO OFDI system (Terumo Europe, Leuven, Belgium) with 160 frames/s and pullback speed of 20 mm/s. A total of 126 stented segments were analyzed. ISS were classified as either attached or non-attached to stent area boundaries. The volume, mean area and largest area of ISS were assessed according to 4 frequencies of SR, corresponding to distances between the analyzed frames of 0.125, 0.25, 0.50 and 1.0 mm. ISS volume was calculated by integrating cross-sectional ISS areas multiplied by each sampling distance using the disk summation method. The volume and mean area of ISS became significantly larger, while the largest area became significantly smaller as sampling distance became larger (1.11 mm(2) for 0.125 mm vs. 1.00 mm(2) for 1.0 mm, P for trend=0.036). In addition, variance of difference was positively associated with increasing width of sampling distance. Conclusions: Quantification of ISS is significantly influenced by the applied frequency of SR. This should be taken into account when designing future OFDI studies in which quantitative assessment of ISS is critical for the evaluation of STEMI patients. (Circ J 2012; 76: 2822-2831)

Background: Body fat percentage (BF%) determined by bioelectrical impedance analysis is widely used at home and in medical check-ups. However, the clinical significance of measuring BF% has not been studied in detail. Methods and Results: A cross-sectional study was carried out on a cohort of 10,774 middle-aged Japanese men who had undergone an annual check-up in 2008. Cut-off points were evaluated for body mass index (BMI), waist circumference (WC), and BF% for detecting participants with cardiovascular disease (CVD) risk factors (diabetes mellitus, hypertension, dyslipidemia), and effectiveness compared for each marker's cut-off point. Additionally, the effects of smoking on cut-off points were evaluated. The cut-off points of BMI, WC, and BF% for detecting participants with 1 or more CVD risk factors were 22.7 kg/m(2), 81.4cm, and 20.3%, respectively. The cut-off points of BF% for 1 or more CVD risk factors classified 3.43% more subjects into correct categories than those of BMI (P<0.001). The cut-off points of BMI, WC, and BF% for detecting individuals with 3 CVD risk factors in current smokers were 24.9 kg/m(2), 87.8 cm, and 23.7%, while those in non-smokers were 23.3 kg/m(2), 83.9 cm, and 22.3%, respectively. Conclusions: BF% could be more effective in detecting individuals with early stage CVD risk accumulation than BMI. The cut-off points for current smokers were lower than those for non-smokers in all markers. (Circ J 2012; 76: 2435-2442)

Background: Smoking is still a major health problem among males in Japan. The effects of smoking and quitting on mortality and cardiovascular disease (CVD) need updating. Methods and Results: This was a prospective cohort study with a median follow-up of 7.5 years of a total of 25,464 healthy male Japanese workers aged 20-61 years who were not on any medication. The adjusted hazard ratios (HR; 95% confidence interval) for all-cause death were 1.51 (0.73, 2.94), 1.68 (1.07, 2.70), 1.30 (0.70, 2.34), and those for total CVD events 1.91 (0.72, 4.67), 2.94 (1.65, 5.63), and 3.25 (1.69, 6.54) for light smokers (1-10 cigarettes/day), moderate smokers (11-20/day), and heavy smokers (>= 21/day) compared to never-smokers, respectively. Total CVD events increased dose-dependently as the number of cigarettes/day increased. Acute myocardial infarction was increased at any level of smoking. Stroke was increased at a moderate level of smoking. Quitting for >= 4 years, compared with continuing smokers, reduced the HR for all-cause death to 0.64 (0.38, 1.01), and total CVD events to 0.34 (0.17, 0.62). Conclusions: In healthy young- and middle-aged Japanese males, a significant increase in HR for total CVD events was confirmed for a smoking level of 11-20 cigarettes/day. Quitting reduced the HR for total CVD events, with quitting for >= 4 years being statistically significant. A similar trend was observed for all-cause mortality. (Circ J 2011; 75: 2885-2892)

Aim: The association between subjects with metabolic syndrome (MS) who were considered not to require medication by their attending physicians and all-cause mortality, ischemic heart disease (IHD) and cardiovascular disease (CVD) remains unknown and should be clarified. Methods and results: This is an observational longitudinal cohort study with a median follow-up of 7.5 years performed for 25,471 Japanese men aged 20–61 years who were not on medication. We used a modified definition of MS from the Japanese Society of Internal Medicine and the NCEP ATPIII, both of which employed body mass index instead of waist circumference. MS was associated with increased rates of all-cause death (adjusted hazard ratio (HR): 4.88 [95% confidence interval, 2.96–7.66]), IHD (3.17 [1.06–7.65]), and CVD (2.63 [1.32–4.72]). In contrast, overweight subjects with no component or one component had similar rates to subjects of normal weight. Any combination of the three MS components was associated with significantly greater rates of all-cause mortality (HR: 3.18–11.2) and IHD (HR: 3.17–8.24), whereas blood pressure elevation plus dyslipidaemia was associated with a significantly higher rate of CVD (HR: 3.27). In any endpoint, MS defined by Japanese criteria had higher HRs than defined by NCEP ATP III criteria. Conclusion: Young and middle-aged Japanese men with MS who had been viewed as not needing medication already showed increased rates of all-cause mortality, IHD and CVD. Additionally, the event rate depended on the specific combination of metabolic syndrome components. © 2011, European Society of Cardiology. All rights reserved.

A 6-month, twice weekly, well-rounded exercise program (47 sessions in total) comprised of a combination of aerobic, resistance and flexibility training was provided for institutionalized older adults aged 60 to 93. We analyzed the data of 18 older adults who could stand and had attended more than 10% of the classes (mean participation rate: 54%) to examine changes in activities of daily living (ADL), physical fitness tests and depressive moods. The mean (+/- standard deviation, range) age of the participants was 71.3 (+/- 15.6, 60-93) in men and 85.9 (+/- 5.8, 72-93) in women. Significant improvement in ADL of the hand manipulation domain and borderline significant improvement in ADL of the mobility domain were observed (McNemar test p = 0.011 and 0.072, respectively). A 6-minute walk distance increased significantly from 151.6 m to 236.6 m (p = 0.01, paired t-test), and the result of the Soda Pop test, which tests hand-eye coordination, also improved significantly from 35.2 sec to 25.3 sec (p = 0.01, paired t-test). These findings suggest that such a program could be effective in improving the ADL and physical fitness of the elderly.

Background: Experimental studies have reported that allopurinol protects hypertensive rats from left ventricular hypertrophy (LVH) with negligible effects on blood pressure (BP). Uric acid (UA) was thought to induce cardiomyocyte growth and interstitial fibrosis of the heart, partly via activation of the renin-angiotensin system. In the present study, the relationship between serum UA levels and electrocardiographically-diagnosed LVH (ECG-LVH) was examined in Japanese men not taking medication for hypertension (HTN), which could confound the association. Methods and Results: A total of 3,305 male workers aged 35-66 years (mean age +/- SD, 48.0 +/- 7.1) were studied. LVH was defined as meeting the ECG criteria (ie, Sokolow-Lyon voltage and/or Cornell voltage QRS duration product). Subjects were divided into 3 groups by tertile of serum UA level. The highest tertile (UA range 0.39-0.65mmol/L or 6.6-11.0 mg/dl) had a significantly increased prevalence of LVH compared with the lowest tertile independent of age, body mass index, serum creatinine level, HTN, diabetes and hyperlipidemia (odds ratio 1.58, 95% confidence interval 1.23-2.02, P<0.001). Similar results were obtained in both the normal and high BP subgroups. Conclusions: UA concentration independently and positively associated with ECG-LVH in Japanese men. (Circ J 2009; 73: 667-672)

Electrical isolation of the pulmonary veins (PV) has become a curative treatment for patients with atrial fibrillation (AF). Recently, there have been many reports that circumferential PV isolation (CPI) on the atrial side has a better outcome than segmental ostial PV isolation (SOPI). However, reports on the combination of CPI using electoroanatomic mapping and SOPI using a circular mapping catheter have been few. The aim of the present study was to investigate the efficacy and safety of a combined therapy using CPI and supplemental SOPI for the treatment of AF. We performed CPI in 120 patients with drug-refractory AF. In 27 of those patients CPI resulted in a disconnection between the left atrium (LA) and PVs. In the remaining patients, supplemental SOPI completed the LA-PV disconnection. After an average follow-up period of 10.4 months, 81.7%, 90.5% and 71.4% of the patients with paroxysmal, persistent and chronic AF, respectively, have been free of AF. In 14.1% of the patients with paroxysmal AF, a greatly reduced frequency and/or duration of the episodes of AF were observed after the ablation. No fatal complications were encountered. The present results suggest that the combination of CPI and supplemental SOPI is efficient and safe for the treatment of AF. © 2006, Japanese Heart Rhythm Society. All rights reserved.

Aims We assessed the effects of cardiac re-synchronization therapy (CRT) in patients who developed otherwise unexplained heart failure (HF) during right ventricular apical (RVA)-pacing for acquired complete atrioventricular block (CAVB). Methods and results Eighteen consecutive CAVB patients with HF during RVA-pacing were assessed with haemodynamic studies immediately and 12 months after CRT-upgrade. Ten patients had idiopathic CAVB and 13 showed normal left ventricular (W) function at RVA-pacemaker implantation. HF developed after 81 +/- 10 months. RVA-pacing duration correlated (r = 0.49, P < 0.05) with LV ejection fraction (LVEF) deterioration. Biventricular- (BiV) and W-pacing acutely improved the systolic function comparably, but only BiV improved diastolic function. One-year post-CRT-initiation, New York Heart Association classification improved 35 +/- 3% (P < 0.05) and the number of hospitalizations decreased 85 +/- 3% (P < 0.0001). CRT decreased LV end-diastolic diameter (LVEDd) 7 +/- 2% (P < 0.01) and increased LVEF by 23 +/- 7% (P < 0.01). The CRT-induced reduction in LVEDd tended to be greater in patients with RVA-pacing for < 5 years vs. > 5 years (7.7 +/- 2.5 vs. 3.6 +/- 1.0 mm, P = 0.08). Conclusion CRT-upgrade improves the cardiac function and symptoms in CAVB patients with HF progression related to RVA-pacing. Because adverse W-remodelling may be partly irreversible, consideration should be given to BiV- and W-pacing upgrade as soon as possible after the indications appear, and prospective studies of the optimal timing of CRT-upgrade may be useful.