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We develop neural-network-based methods for classifying plaque types in clinical intravascular optical coherence tomography (IVOCT) images of coronary arteries. A single IVOCT pullback can consist of > 500 microscopic-resolution images, creating both a challenge for physician interpretation during an interventional procedure and an opportunity for automated analysis. In the proposed method, we classify each A-line, a datum element that better captures physics and pathophysiology than a voxel, as a fibrous layer followed by calcification (fibrocalcific), a fibrous layer followed by a lipidous deposit (fibrolipidic), or other. For A-line classification, the usefulness of a convolutional neural network (CNN) is compared with that of a fully connected artificial neural network (ANN). A total of 4469 image frames across 48 pullbacks that are manually labeled using consensus labeling from two experts are used for training, evaluation, and testing. A 10-fold cross-validation using held-out pullbacks is applied to assess classifier performance. Noisy A-line classifications are cleaned by applying a conditional random field (CRF) and morphological processing to pullbacks in the en-face view. With CNN (ANN) approaches, we achieve an accuracy of 77.7 % ± 4.1 % ( 79.4 % ± 2.9 % ) for fibrocalcific, 86.5 % ± 2.3 % ( 83.4 % ± 2.6 % ) for fibrolipidic, and 85.3 % ± 2.5 % ( 82.4 % ± 2.2 % ) for other, across all folds following CRF noise cleaning. The results without CRF cleaning are typically reduced by 10% to 15%. The enhanced performance of the CNN was likely due to spatial invariance of the convolution operation over the input A-line. The predicted en-face classification maps of entire pullbacks agree favorably to the annotated counterparts. In some instances, small error regions are actually hard to call when re-examined by human experts. Even in worst-case pullbacks, it can be argued that the results will not negatively impact usage by physicians, as there is a preponderance of correct calls.

Generalized arterial calcification of infancy (GACI), or idiopathic infantile arterial calcification, is a rare autosomal-recessive disease recognized aAs an inherited disorder characterized by severe pathologic calcification of large- and medium-sized arteries accompanied by smooth muscle cell (SMC) hyperplasia leading to vascular obstruction [1]. The prognosis is extremely poor, with 85% of affected infants dying within the first 6 months of life. Loss-of-function mutations in the ectonucleotide pyrophosphatase phosphodiesterase 1 (ENPP1) gene is recognized as the main defect associated with GACI [1]. The underlying pathogenesis of osteogenic transition leading to calcification and severe stenosis in GACI, however, is poorly understood. Herein, we present a case of a GACI patient with cardiac complications who exhibited extensive vascular disease at autopsy., (Copyright © 2018. Published by Elsevier Inc.)

Objectives: The purpose of this study was to assess neoatherosclerosis in a registry of prospectively enrolled patients presenting with stent thrombosis using optical coherence tomography., Background: In-stent neoatherosclerosis was recently identified as a novel disease manifestation of atherosclerosis after coronary stent implantation., Methods: Angiography and intravascular optical coherence tomography were used to investigate etiologic factors of neoatherosclerosis in patients presenting with stent thrombosis >1 year after implantation (very late stent thrombosis [VLST]). Clinical data were collected according to a standardized protocol. Optical coherence tomographic acquisitions were analyzed in a core laboratory. Cox regression analysis was performed to identify factors associated with the formation of neoatherosclerosis and plaque rupture as a function of time., Results: Optical coherence tomography was performed in 134 patients presenting with VLST. A total of 58 lesions in 58 patients with neoatherosclerosis were compared with 76 lesions in 76 patients without neoatherosclerosis. Baseline characteristics were similar between groups. In-stent plaque rupture was the most frequent cause (31%) in all patients presenting with VLST. In patients with neoatherosclerosis, in-stent plaque rupture was identified as the cause of VLST in 40 cases (69%), whereas uncovered stent struts (n = 22 [29%]) was the most frequent cause in patients without neoatherosclerosis. Macrophage infiltration was significantly more frequent in optical coherence tomographic frames with plaque rupture compared with those without (50.2% vs. 22.2%; p < 0.0001), whereas calcification was more often observed in frames without plaque rupture (17.2% vs. 4%; p < 0.0001). Implantation of a drug-eluting stent was significantly associated with the formation of neoatherosclerosis (p = 0.02), whereas previous myocardial infarction on index percutaneous coronary intervention was identified as a significant risk factor for plaque rupture in patients with neoatherosclerosis (p = 0.003). No significant difference was observed in thrombus composition between patients with or without neoatherosclerosis., Conclusions: Neoatherosclerosis was frequently observed in patients with VLST. Implantation of a drug-eluting stent was significantly associated with neoatherosclerosis formation. In-stent plaque rupture was the prevailing pathological mechanism and often occurred in patients with neoatherosclerosis and previous myocardial infarction at index percutaneous coronary intervention. Increased macrophage infiltration heralded plaque vulnerability in our study and might serve as an important indicator., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: This study evaluated the views of the cardiology community on the clinical use of coronary intravascular imaging (IVI)., Methods and Results: A web-based survey was distributed to 31,893 individuals, with 1,105 responses received (3.5% response rate); 1,010 of 1,097 respondents (92.1%) self-reported as interventional cardiologists, 754 (68.7%) with >10 years experience. Overall, 96.1% had personal experience with IVI (95.5% with intravascular ultrasound [IVUS], 69.8% with optical coherence tomography [OCT], and 7.9% with near-infrared spectroscopy); 34.7% of respondents were from Europe and 52.0% were from Asia (45.4% from Japan). The most commonly reported indications for IVI were optimization of stenting (88.5%), procedural/strategy guidance (79.6%), and guidance of left main interventions (77.0%). Most respondents reported perceived equipoise regarding choice between IVUS and OCT for guidance of coronary intervention. High cost (65.9%) and prolongation of the procedure (35.0%) were the most commonly reported factors limiting use. IVI was used more frequently (>15% of cases guided by IVI) in Japan than Europe (96.6% vs. 10.4%, respectively; P<0.001) and by operators with longer interventional experience., Conclusions: In a sample of predominantly experienced interventional cardiologists, there was a high rate of personal experience with IVI in clinical practice. The most commonly identified indications for IVI were optimization of stenting, procedural/strategy guidance, and guidance of left main interventions. Variability in practice patterns is substantial according to geographic region and interventional experience.

Aims: Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Pathology data suggest durable polymer (DP) of DES to play a major role in this process. Whether biodegradable polymer (BP) may address these issues is uncertain. We compared in vivo vessel healing and NA of current generation BP- or DP-DES using serial optical coherence tomography (OCT) assessments., Methods and Results: Ninety patients with multivessel coronary artery disease were randomized 1:1 to BP everolimus-eluting stents (EES, Synergy) or DP zotarolimus-eluting stents (ZES, Resolute Integrity). Co-primary endpoints were the maximum length of uncovered struts at 3 months (powered for non-inferiority) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority) as measured by OCT. The maximum length of uncovered struts at 3 months was 10 ± 8 mm in the BP-EES group and 11 ± 7 mm in the DP-ZES group (mean difference -1 mm; upper 97.5% confidence interval +2 mm; P = 0.05 for non-inferiority; P = 0.45 for superiority). The percentage of patients presenting with frames of NA at 18 months was low and similar between BP-EES and DP-ZES groups (11.6% vs. 15.9%; P = 0.56). There was no stent thrombosis in both groups at 24 months., Conclusion: BP-EES and DP-ZES showed a similar healing response at 3 months and a low incidence of NA at 18 months. Biocompatible polymers, regardless of whether they are durable or biodegradable, may favourably impact the long-term vascular response to current-generation DES.

Percutaneous aortic balloon valvuloplasty as a bridge-to-decision strategy was performed in an 89-year-old woman with multiple comorbidities and cachexia. The patient did well; after 2 weeks, she was discharged home and referred for possible TAVR.

Background: Distal transradial access in the anatomical snuffbox has advantages over standard access in terms of patient and operator comfort levels and risk of ischemia. Radial artery preservation could be a relevant issue in patients requiring multiple radial artery procedures and coronary bypass with the use of a radial graft. One relevant drawback is the challenging puncture of a small and weak artery, with a steeper learning curve., Aim: The study was aimed at proving feasibility and safety of right and left transradial access in the anatomical snuffbox., Methods: All 52 consecutive patients assigned to only one operator program underwent diagnostic or procedural intervention through distal transradial access in the anatomical snuffbox., Results: The overall feasibility was 90%, greater than expected in our early clinical experience, with 47 successful accesses out of 52 patients. Failures were due to proximal radial artery occlusion and hypoplastic/vasospastic distal radial artery., Conclusion: Distal transradial access in the anatomical snuffbox is an appealing and feasible option for both patients and operators. Further studies are needed to evaluate the clinical benefits conferred by this approach.

Objectives: The aim of this study was to determine if spotty calcification decreases the response of plaque progression to statin therapy., Background: Previous studies showed that the presence of spotty calcification is a marker of vulnerable plaque. However, the relationship between spotty calcification and plaque progression is not clear., Methods: Ninety-six nonculprit lipid-rich plaques in 69 patients who received serial optical coherence tomography (OCT) imaging were included. Plaques were divided into three groups: spotty calcification (n = 38), calcified (n = 12) and noncalcified (n = 46) plaques. Spotty calcification was identified by the presence of a lesion <4 mm in length with an arc of calcification <90°. Changes in plaque characteristics and fibrous cap thickness (FCT) at 6 and 12 months under statin therapy were analyzed by OCT., Results: The increase of FCT was sustained from baseline to 6 and 12 months in three groups: spotty calcification (62.8 ± 20.9, 126.4 ± 84.9, and 169.2 ± 81.6 μm, respectively; P < .001), calcified (59.8 ± 17.0, 93.4 ± 51.4, and 155.2 ± 61.7 μm, respectively; P < .001) and noncalcified (60.0 ± 17.2, 125.5 ± 62.1, and 161.0 ± 80.5 μm, respectively; P < .001). Intensive statin induced a greater change in FCT at 12 months than moderate statin in the spotty calcification group (P = 0.034). The mean lipid arc decreased significantly at 12 months from baseline in the three groups (P = 0.004, P = 0.023, and P < .001, respectively)., Conclusions: Statin therapy was effective for plaque stabilization in plaques with and without spotty calcification. Patients with spotty calcification benefitted more from intensive statin than from moderate statin therapy., (© 2018 Wiley Periodicals, Inc.)

Objectives: High platelet reactivity (HPR) was studied in patients presenting with ST-segment elevation myocardial infarction (STEMI) due to stent thrombosis (ST) undergoing immediate percutaneous coronary intervention (PCI)., Background: HPR on P2Y 12 inhibitors (HPR-ADP) is frequently observed in stable patients who have experienced ST. The HPR rates in patients presenting with ST for immediate PCI are unknown., Methods: Consecutive patients presenting with definite ST were included in a multicenter ST registry. Platelet reactivity was measured before immediate PCI with the VerifyNow P2Y 12 or Aspirin assay., Results: Platelet reactivity was measured in 129 ST patients presenting with STEMI undergoing immediate PCI. HPR-ADP was observed in 76% of the patients, and HPR on aspirin (HPR-AA) was observed in 13% of the patients. HPR rates were similar in patients who were on maintenance P2Y 12 inhibitor or aspirin since stent placement versus those without these medications. In addition, HPR-ADP was similar in patients loaded with a P2Y 12 inhibitor shortly before immediate PCI versus those who were not. In contrast, HPR-AA trended to be lower in patients loaded with aspirin as compared with those not loaded., Conclusions: Approximately 3 out of 4 ST patients with STEMI undergoing immediate PCI had HPR-ADP, and 13% had HPR-AA. Whether patients were on maintenance antiplatelet therapy while developing ST or loaded with P2Y 12 inhibitors shortly before undergoing immediate PCI had no influence on the HPR rates. This raises concerns that the majority of patients with ST have suboptimal platelet inhibition undergoing immediate PCI., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Stent thrombosis (ST) is a serious complication following coronary stenting. Intravascular optical coherence tomography (OCT) may provide insights into mechanistic processes leading to ST. We performed a prospective, multicenter study to evaluate OCT findings in patients with ST., Methods: Consecutive patients presenting with ST were prospectively enrolled in a registry by using a centralized telephone registration system. After angiographic confirmation of ST, OCT imaging of the culprit vessel was performed with frequency domain OCT. Clinical data were collected according to a standardized protocol. OCT acquisitions were analyzed at a core laboratory. Dominant and contributing findings were adjudicated by an imaging adjudication committee., Results: Two hundred thirty-one patients presenting with ST underwent OCT imaging; 14 (6.1%) had image quality precluding further analysis. Of the remaining patients, 62 (28.6%) and 155 (71.4%) presented with early and late/very late ST, respectively. The underlying stent type was a new-generation drug-eluting stent in 50.3%. Mean reference vessel diameter was 2.9±0.6 mm and mean reference vessel area was 6.8±2.6 mm 2 . Stent underexpansion (stent expansion index <0.8) was observed in 44.4% of patients. The predicted average probability (95% confidence interval) that any frame had uncovered (or thrombus-covered) struts was 99.3% (96.1-99.9), 96.6% (92.4-98.5), 34.3% (15.0-60.7), and 9.6% (6.2-14.5) and malapposed struts was 21.8% (8.4-45.6), 8.5% (4.6-15.3), 6.7% (2.5-16.3), and 2.0% (1.2-3.3) for acute, subacute, late, and very late ST, respectively. The most common dominant finding adjudicated for acute ST was uncovered struts (66.7% of cases); for subacute ST, the most common dominant finding was uncovered struts (61.7%) and underexpansion (25.5%); for late ST, the most common dominant finding was uncovered struts (33.3%) and severe restenosis (19.1%); and for very late ST, the most common dominant finding was neoatherosclerosis (31.3%) and uncovered struts (20.2%). In patients presenting very late ST, uncovered stent struts were a common dominant finding in drug-eluting stents, and neoatherosclerosis was a common dominant finding in bare metal stents., Conclusions: In patients with ST, uncovered and malapposed struts were frequently observed with the incidence of both decreasing with longer time intervals between stent implantation and presentation. The most frequent dominant observation varied according to time intervals from index stenting: uncovered struts and underexpansion in acute/subacute ST and neoatherosclerosis and uncovered struts in late/very late ST., (© 2017 The Authors.)

Although it is the method used by most interventional cardiologists to assess the severity of coronary artery disease and guide treatment, coronary angiography has many known limitations, particularly the fact that it is a lumenogram depicting foreshortened, shadowgraph, planar projections of the contrast-filled lumen rather than imaging the diseased vessel itself. Intravascular imaging-intravascular ultrasound and more recently optical coherence tomography-provide a tomographical or cross-sectional image of the coronary arteries. These techniques are clinically useful to answer questions such as whether the stenosis is clinically relevant; the identification of the culprit lesion; or whether the plaque (or patient) is at high risk of future adverse events. They can also be used to optimise stent implantation to minimise stent-related adverse events, provide answers to the likelihood of distal embolisation or peri-procedural myocardial infarction during stent implantation, and provide reasons for stent thrombosis or restenosis. This review considers the usefulness of intravascular imaging in day-to-day practice., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

By providing valuable information about the coronary artery wall and lumen, intravascular imaging may aid in optimizing interventional procedure results and thereby could improve clinical outcomes following percutaneous coronary intervention (PCI). Intravascular optical coherence tomography (OCT) is a light-based technology with a tissue penetration of approximately 1 to 3 mm and provides near histological resolution. It has emerged as a technological breakthrough in intravascular imaging with multiple clinical and research applications. OCT provides detailed visualization of the vessel following PCI and provides accurate assessment of post-procedural stent performance including detection of edge dissection, stent struts apposition, tissue prolapse, and healing parameters. Additionally, it can provide accurate characterization of plaque morphology and provides key information to optimize post-procedural outcomes. This manuscript aims to review the current clinical and research applications of intracoronary OCT and summarize the analytic OCT imaging software packages currently available. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Background: Optimal strut coverage and early vascular healing are important factors to reduce the risk of stent thrombosis. Data on early vascular healing with the new bioresorbable vascular scaffolds (BVS) are lacking. Further, healing response after BVS implantation in different clinical presentation has not been fully investigated., Methods and Results: We assessed with optical coherence tomography (OCT) the early vascular response to BVS implantation in 26 consecutive patients presenting with acute coronary syndrome (ACS) or stable angina (SA). Images from 16 BVSs (17,166 struts) in ACS patients and 17 BVSs (23,045 struts) in SA patients were analyzed. The mean implanted BVS diameter and length was 3.1 ± 0.4 mm and 20.4 ± 5.8 mm. At mean 47.6 ± 6.3 days, overall 99% of BVS struts were covered. There were no differences between ACS and SA on the amount of tissue coverage per strut (0.09 ± 0.02 mm vs. 0.09 ± 0.01 mm; P = 0.86, respectively) and lumen area stenosis (24.2 ± 19.3% vs. 22.3 ± 22.0%; P = 0.78, respectively). However, a numerically higher proportion of protruding (ACS 1.2 ± 2.7%; SA 4.2 ± 6.5%; P = 0.11) and malapposed (ACS 0.4 ± 0.5%; SA 2.4 ± 5.8%; P = 0.18) struts were observed in SA compared to ACS, with trendy better healing score in ACS (1.87 ± 1.67 vs. 5.28 ± 7.28, P = 0.08)., Conclusion: Early after BVS implantation almost complete scaffold strut coverage without any thrombi was observed by OCT, independent by the clinical presentation at index coronary intervention. However, BVS in ACS lesions were associated with easier strut penetration and a trendy better healing score compared with SA., (© 2016, Wiley Periodicals, Inc.)

Aims: The intermediate-term incidence of strut malapposition (SM) and uncovered struts (US), and the degree of neointimal thickness (NIT) according to stent type have not been characterized., Methods and Results: All studies of >50 patients in which optical coherence tomography was performed between 6 and 12 months after stent implantation were included. The incidences of SM and US were the co-primary end points, while NIT was the secondary end point. A total of 458 citations were initially appraised at the abstract level, and 11 full-text studies (280 652 analysed struts, 921 patients) were assessed. The 6-12 months incidences of SM and US were 5.0 and 7.8%, respectively, and the mean NIT was 206 μm. Biolimus-eluting stents (BES) and bioresorbable vascular scaffolds (BVS) had the highest SM rates (2.7 and 3.8%, respectively), while everolimus-eluting stents (EES) and fast-release zotarolimus-eluting stents (ZES) had the lowest SM rates (0.9 and 0.1%, respectively). BES and sirolimus-eluting stents (SES) had the highest US rates (7.7 and 8.8%, respectively), while bare metal stents (BMS) and ZES had the lowest US rates (0.3 and 0.3%, respectively). BMS had the greatest NIT (340 μm), while SES, EES, and BES had the least NIT., Conclusion: Second-generation drug-eluting stents (DES) have better intermediate-term strut apposition and coverage than first-generation DES, BVS, and BMS. EES demonstrate the overall best combination of healing with suppression of neointimal hyperplasia at 6-12 months. Further studies with clinical correlation are warranted to determine the implications of these findings., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Objectives: To compare angiographic and optical coherence tomography (OCT) data pertinent to thrombi, along with the histologic characteristics of aspirated thrombi in patients presenting with ST elevation myocardial infarction (STEMI) with or without inflammation, as assessed by C-reactive protein (CRP) and myeloperoxidase (MPO)., Methods: In the OCTAVIA (Optical Coherence Tomography Assessment of Gender Diversity in Primary Angioplasty) study, 140 patients with STEMI referred for primary percutaneous intervention were enrolled. The patients underwent OCT assessment of the culprit vessel, along with blood sampling of CRP and MPO, and histologic analysis of the thrombus., Results: Biomarkers were available for 129 patients, and histology and immunohistochemistry of the thrombi were available for 78 patients. Comparisons were made using the median thresholds of CRP and MPO (2.08 mg/L and 604.124 ng/mL, respectively). There was no correlation between CRP and MPO levels in the whole population (p = 0.685). Patients with high CRP levels had higher thrombus grades and more frequent TIMI flow 0/1 compared with those with low CRP levels (5 [1st quartile 3; 3rd quartile 5] vs. 3.5 mg/L [1; 5], p = 0.007, and 69.3 vs. 48.5%, p = 0.04, respectively). Patients with high MPO levels more commonly had early thrombi than had those with low MPO levels (42.5 vs. 20.0%, p = 0.04)., Conclusions: CRP and MPO were not correlated in STEMI patients, possibly reflecting different pathogenic mechanisms, with CRP more related to thrombus burden and MPO to thrombus age., (© 2016 S. Karger AG, Basel.)

Women are frequently reported to have increased morbidity after presentation with acute coronary syndromes and myocardial infarction; however, whether a greater thrombotic tendency contributes to gender differences in clinical outcomes of urgent percutaneous coronary intervention is unknown. Intraprocedural Thrombotic Events (IPTEs) are defined as new or increasing thrombus, abrupt vessel closure, no reflow or slow reflow, or distal embolization at any time during percutaneous coronary intervention. IPTEs were evaluated in this pooled analysis of 6,591 patients with stent implantation and blinded quantitative coronary angiography (QCA) analysis, from the ACUITY and HORIZONS-AMI trials. We compared major adverse cardiac events (MACE) at in-hospital, 30-day, and 1-year follow-up and major bleeding at 30 days according to gender and the presence or absence of IPTE. IPTE was identified in 507 patients (7.7%), with 119 of 1,744 (6.8%) occurring in women and 388 of 4,847 (8.0%) in men (p = 0.12). IPTE, but not gender, was independently associated with MACE at in-hospital and 30-day follow-up. At 1-year follow-up, the adjusted hazard of MACE was higher in women and in patients with IPTE; however, the risk of MACE associated with IPTE was similar among women and men. There was no significant interaction between IPTE and gender for 1-year MACE or 30-day bleeding. IPTE predicted major bleeding only in women. In conclusion, in acute coronary syndromes, women have increased risk of adverse outcome at 1 year. IPTEs are common, occur at similar frequency, and are associated with similar degree of increased MACE in both genders at short- and long-term follow-up. Higher thrombotic propensity does not offer a mechanistic explanation for the worse outcomes noted in women., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone., Methods: In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25-3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm 2 ), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586., Findings: Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 [34%] in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The final median minimum stent area was 5·79 mm 2 (IQR 4·54-7·34) with OCT guidance, 5·89 mm 2 (4·67-7·80) with IVUS guidance, and 5·49 mm 2 (4·39-6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI -0·70 mm 2 ; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37)., Interpretation: OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance., Funding: St Jude Medical., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Decision making on lesion preparation and stent/scaffold optimization are cornerstones of patient outcome. Intravascular imaging recently emerged as a critical modality to achieve better results of stent/scaffold implantation and superior clinical outcomes compared with coronary angiography alone. Optical coherence tomography (OCT), a light-based intravascular imaging modality with high frame rate in acquisition and very high speed pullback, can interrogate the target vessel in a couple of seconds, and immediately display a pristine longitudinal lumen contour with automatic detection of lesion severity, site and lumen/stent areas. Further, OCT provides pivotal information on sites of calcium, with accurate measurements of the minimum distance from the lumen, a major determinant of stent/scaffold underexpansion, malapposition and eccentricity. Finally, to guide the PCI procedure using OCT without operator misjudgment, a real-time point-to-point correspondence between angiographic and OCT images has been recently created. Co-registration of OCT with angiography with direct tableside control of acquisition and analysis enables the operator to plan and map optimal stent/scaffold implantation. To prove the clinical relevance of OCT-guided PCI, simple, standardized interventional planning, including pre- and postprocedural automatic lumen detection metrics, has to be translated into effective treatment flow algorithms. A similar OCT algorithm is being tested in the ongoing prospective, randomized, multicenter ILUMIEN III study, to demonstrate that OCT-guided stent placement is superior to angiography-guided and non-inferior to IVUS-guided stent implantation. (Circ J 2016; 80: 2063-2072).

The efficacy of an IVUS-guided stent implantation strategy to improve acute results and clinical outcome has been described previously. OCT is another technique which allows high-resolution intracoronary imaging. However, the use of invasive imaging modalities to guide PCI has, as yet, played a limited role in current clinical practice. This may be partly explained by the expertise required for interpretation and clinical decision making. We present a novel technology which enables real-time co-registration of OCT images with angiography. This will simplify matching cross-sectional images to their geographic position on the angiogram, thereby facilitating imaging-guided PCI.

Objectives: This study sought to explore the association between the Framingham Risk Score (FRS) and coronary plaque characteristics assessed by optical coherence tomography (OCT) imaging., Background: Clinical prediction models are useful for identifying high-risk patients. However, coronary events often occur in individuals estimated to be at low risk., Methods: A total of 254 patients with coronary artery disease who underwent three-vessel OCT were divided into tertiles according to FRS. Nonculprit plaque characteristics were compared among the three groups., Results: A total of 663 plaques were analyzed. FRS was significantly associated with calcification [37% (low FRS) vs. 46% (intermediate FRS) vs. 70% (high FRS); P<0.001] and neovascularization [39% (low FRS) vs. 41% (intermediate FRS) vs. 56% (high FRS); P<0.001], but not with lipid-rich plaques or thin-cap fibroatheroma (TCFA). On multivariate analysis, FRS was an independent predictor of the presence of both calcification and neovascularization. There were no deaths, two acute myocardial infarctions, and 15 nontarget lesion revascularizations at the 1-year follow-up. The event rate increased progressively across FRS tertiles [2.4% (low FRS) vs. 7.1% (intermediate FRS) vs. 8.6% (high FRS); P=0.186]. The c-statistic for FRS to predict future clinical events was 0.628 (95% confidence interval, 0.500-0.757). The addition of both calcification and TCFA to FRS provided incremental prognostic value [c-statistics: 0.761 (95% confidence interval, 0.631-0.890)]., Conclusion: The present study showed significant associations between FRS and the presence of coronary calcification and neovascularization in nonculprit plaques. The combination of FRS and OCT-detected calcifications and TCFA provides improved prognostic ability in identifying patients with known coronary artery disease who are at risk of recurrent events.

Despite remarkable advances in the interventional landscape, device delivery during percutaneous coronary intervention (PCI) can still present technical challenges especially when performed in complex anatomical settings and through radial approach. To overcome difficult coronary stent delivery, several strategies have been developed. A niche option in such complex cases is the anchoring balloon technique, which involves inflation of a balloon non-coaxially in a side branch or distally to the target lesion in a coaxial fashion, to facilitate stent delivery. However, the main limitation of this technique is the requirement of a large guide catheter (≥7French) which may preclude the use of radial approach. We describe, step-by-step, the distal anchoring ballooning technique performed by a 6Fr radial approach to overcome the stent delivery failure in complex anatomical scenarios and to safely and successfully carry out the PCI procedures., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Stent thrombosis (ST) is a rare but serious complication following percutaneous coronary intervention. Analysis of thrombus composition from patients undergoing catheter thrombectomy may provide important insights into the pathological processes leading to thrombus formation. We performed a large-scale multicentre study to evaluate thrombus specimens in patients with ST across Europe., Methods: Patients presenting with ST and undergoing thrombus aspiration were eligible for inclusion. Thrombus collection was performed according to a standardized protocol and specimens were analysed histologically at a core laboratory. Serial tissue cross sections were stained with haematoxylin-eosin (H&E), Carstairs and Luna. Immunohistochemistry was performed to identify leukocyte subsets, prothrombotic neutrophil extracellular traps (NETs), erythrocytes, platelets, and fibrinogen., Results: Overall 253 thrombus specimens were analysed; 79 (31.2%) from patients presenting with early ST, 174 (68.8%) from late ST; 79 (31.2%) were from bare metal stents, 166 (65.6%) from drug-eluting stents, 8 (3.2%) were from stents of unknown type. Thrombus specimens displayed heterogeneous morphology with platelet-rich thrombus and fibrin/fibrinogen fragments most abundant; mean platelet coverage was 57% of thrombus area. Leukocyte infiltrations were hallmarks of both early and late ST (early: 2260 ± 1550 per mm(2) vs. late: 2485 ± 1778 per mm(2); P = 0.44); neutrophils represented the most prominent subset (early: 1364 ± 923 per mm(2) vs. late: 1428 ± 1023 per mm(2); P = 0.81). Leukocyte counts were significantly higher compared with a control group of patients with thrombus aspiration in spontaneous myocardial infarction. Neutrophil extracellular traps were observed in 23% of samples. Eosinophils were present in all stent types, with higher numbers in patients with late ST in sirolimus-and everolimus-eluting stents., Conclusion: In a large-scale study of histological thrombus analysis from patients presenting with ST, thrombus specimens displayed heterogeneous morphology. Recruitment of leukocytes, particularly neutrophils, appears to be a hallmark of ST. The presence of NETs supports their pathophysiological relevance. Eosinophil recruitment suggests an allergic component to the process of ST., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Orthopedic strain and radiation exposure are recognized risk factors in personnel staff performing fluoroscopically guided cardiovascular procedures. However, the potential occupational health effects are still unclear. The purpose of this study was to examine the prevalence of health problems among personnel staff working in interventional cardiology/cardiac electrophysiology and correlate them with the length of occupational radiation exposure., Methods and Results: We used a self-administered questionnaire to collect demographic information, work-related information, lifestyle-confounding factors, all current medications, and health status. A total number of 746 questionnaires were properly filled comprising 466 exposed staff (281 males; 44±9 years) and 280 unexposed subjects (179 males; 43±7years). Exposed personnel included 218 interventional cardiologists and electrophysiologists (168 males; 46±9 years); 191 nurses (76 males; 42±7 years), and 57 technicians (37 males; 40±12 years) working for a median of 10 years (quartiles: 5-24 years). Skin lesions (P=0.002), orthopedic illness (P<0.001), cataract (P=0.003), hypertension (P=0.02), and hypercholesterolemia (P<0.001) were all significantly higher in exposed versus nonexposed group, with a clear gradient unfavorable for physicians over technicians and nurses and for longer history of work (>16 years). In highly exposed physicians, adjusted odds ratio ranged from 1.7 for hypertension (95% confidence interval: 1-3; P=0.05), 2.9 for hypercholesterolemia (95% confidence interval: 1-5; P=0.004), 4.5 for cancer (95% confidence interval: 0.9-25; P=0.06), to 9 for cataract (95% confidence interval: 2-41; P=0.004)., Conclusions: Health problems are more frequently observed in workers performing fluoroscopically guided cardiovascular procedures than in unexposed controls, raising the need to spread the culture of safety in the cath laboratory., (© 2016 American Heart Association, Inc.)

Background: The role of culprit plaque and related atherothrombotic components on incomplete stent apposition (ISA) occurrence after primary percutaneous coronary intervention (p-PCI) is unknown., Methods and results: ST-segment elevation myocardial infarction (STEMI) patients undergoing p-PCI with an everolimus-eluting stent were prospectively investigated with optical coherence tomography (OCT) of the infarct-related artery before, after stenting and at 9 months. OCT data, aspirated thrombus and serum inflammatory biomarkers were analyzed. 114 patients with 114 lesions were evaluated. Acute ISA occurred in 82 lesions (71.9%), preferentially in larger vessels with a median area of 0.2 mm(2). The presence of thrombus before stent implantation (odds ratio (OR) 5.5, 95% confidence interval (CI) [1.1-26.9], P=0.04) and the lipid content in the target segment (OR 1.3, 95% CI [1.0-1.5], P=0.04) independently predicted acute ISA. At 9-month follow-up, ISA persisted in 46 lesions (56.1%). The volume of acute ISA significantly predicted persistent ISA (OR 1.3, 95% CI [1.1-1.5], P=0.01). Late-acquired ISA occurred in 39 lesions (34.2%) with a median area of 0.3 mm(2). Red/mixed thrombus before stent implantation (OR 3.7, 95% CI [1.0-13.3], P=0.05) and length of the underlying ruptured plaque (OR 1.7, 95% CI [1.1-2.8] P=0.02) were independently associated with late-acquired ISA., Conclusions: In STEMI patients, culprit plaque and atherothrombotic components of the infarct-related artery significantly contribute to the onset of acute and late ISA. ISA persistence at follow-up depends on the initial volume of acute ISA.

Background: Acute kidney injury (AKI) is a well-recognized predictor of morbidity and mortality after percutaneous coronary intervention. However, the impact of AKI on the outcome of patients with acute coronary syndromes (ACS) in relation to coronary artery bypass grafting (CABG) has not been established., Methods: Of the 17,421 patients who presented with non-ST-segment elevation ACS or ST-segment elevation myocardial infarction enrolled in the ACUITY and HORIZONS-AMI trials, 1,406 (8.0%) underwent CABG as principal treatment after coronary angiography. End points were measured at 1 month and 1 year and included death, myocardial infarction, and ischemia-driven target vessel revascularization. Acute kidney injury was defined as a rise in creatinine of ≥ 0.5 mg/dL, or > 25%, from baseline at initial angiography., Results: Acute kidney injury occurred during hospital admission in 449 (31.9%) of the 1,406 patients treated with CABG. One-month and 1-year mortality was 6.7% vs 2.2% (P < .0001) and 10.4% vs 4.3% (P < .0001) for patients with vs without AKI, respectively. Analogously, the 1-month and 1-year incidence of composite major adverse cardiac events (MACEs; death, MI, or target vessel revascularization) was 17.6% vs 12.4% (P = .003) and 22.0% vs 15.3% (P = .002) for patients with vs without AKI, respectively. After adjustment for age, sex, race, diabetes, hypertension, and baseline creatinine clearance, AKI was an independent predictor of mortality (overall and cardiac-related) and MACE at both 1 month and 1 year in patients treated with CABG., Conclusions: Acute kidney injury occurred in approximately 1 of every 3 patients with ACS treated with CABG and is a powerful independent predictor of death and MACE. These data highlight the need for AKI prevention strategies in patients undergoing CABG., (Copyright © 2015. Published by Elsevier Inc.)

Objectives: This study sought to investigate the effect of treatment delay on microvascular reperfusion in ST-segment elevation myocardial infarction (STEMI) patients from the large, multicenter, prospective HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial., Background: Despite restoration of epicardial blood flow during primary percutaneous coronary intervention (PCI), one-third of patients do not obtain myocardial perfusion due to impairment in the microvascular circulation., Methods: We examined the effect of symptom onset-to-balloon time (SBT) and door-to-balloon time (DBT) on myocardial reperfusion during primary PCI in STEMI, utilizing resolution of ST-segment elevation (STR) and the myocardial blush grade (MBG). The primary analysis was the relationships between SBT ≤2, >2 to 4, and >4 h and DBT ≤1, >1 to 1.5, >1.5 to 2, and >2 h with MBG and STR. Clinical risk was assessed using a modified version of the Thrombolysis In Myocardial Infarction risk score for STEMI., Results: In 2,056 patients, absent microvascular perfusion (MBG 0/1) and STR (STR <30%) after primary PCI was significantly more common in patients with longer SBT, in patients with both low and high clinical risk profiles. By multivariable analysis, SBT (p < 0.0001), anterior infarction (p < 0.0001), reference vessel diameter (p = 0.005), lesion minimum lumen diameter (p < 0.0001), hyperlipidemia (p = 0.03), and current smoking (p = 0.001) were independent predictors of MBG 0/1, whereas SBT (p = 0.007), anterior infarction (p < 0.0001), and history of renal insufficiency (p = 0.0002) were independent predictors of absent STR. DBT (p < 0.0001) was an independent predictor of MBG 0/1. MBG 0/1 and STR<30% identified patients with increased 3-year mortality., Conclusions: The present study suggests that delay in mechanical reperfusion therapy during STEMI is associated with greater injury to the microcirculation., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The association between anatomic features of the left anterior descending artery (LAD) and outcomes in patients with anterior ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. We sought to clarify the impact of an LAD coronary artery wrapping around the left ventricular (LV) apex on clinical outcomes in patients with anterior STEMI. Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction enrolled patients with STEMI presenting <12 hours after symptom onset who underwent primary percutaneous coronary intervention. Patients with a culprit lesion in the LAD were categorized as (1) LAD wrapping around the LV apex (wrap-around LAD, n = 871) versus (2) LAD not wrapping around the LV apex (non-wrap-around LAD, n = 224). Killip class ≥II, dysrhythmia, and LV mural thrombi were more frequently observed in the wrap-around LAD group; LV ejection fraction was worse in the wrap-around LAD group (54.5% vs 58.7%, p = 0.006). At 3 years of follow-up, major adverse cardiac events (death, stroke, or stent thrombosis, 12.7% vs 5.4%, p = 0.002), death (6.6% vs 3.2%, p = 0.052), stroke (1.9% vs 0.5%, p = 0.12), stent thrombosis (5.6% vs 2.3%, p = 0.047), and severe heart failure (4.5% vs 1.4%, p = 0.03) were more common in patients with a wrap-around LAD versus those with a non-wrap-around LAD. Multivariate analysis indicated that a wrap-around LAD independently and significantly predicted major adverse cardiac events (hazard ratio 2.18, p = 0.02) and severe heart failure (odds ratio 3.31, p = 0.049) in patients with an anterior STEMI. In conclusion, a wrap-around LAD predicted adverse clinical outcomes at 3 years in patients with anterior STEMI who underwent primary percutaneous coronary intervention., (Copyright © 2015 Elsevier Inc. All rights reserved.)

This study aimed at comparing neuropsychological test scores in 83 cardiologists and nurses (exposed group, EG) working in the cardiac catheterization laboratory, and 83 control participants (non exposed group, nEG), to explore possible cognitive impairments. The neuropsychological assessment was carried out by means of a battery called "Esame Neuropsicologico Breve." EG participants showed significantly lower scores on the delayed recall, visual short-term memory, and semantic lexical access ability than the nEG ones. No dose response could be detected. EG participants showed lower memory and verbal fluency performances, as compared with nEG. These reduced skills suggest alterations of some left hemisphere structures that are more exposed to IR in interventional cardiology staff. On the basis of these findings, therefore, head protection would be a mandatory good practice to reduce effects of head exposure to ionizing radiation among invasive cardiology personnel (and among other exposed professionals).

Objectives: Plaque ruptures and attenuated plaques are considered to be unstable and have been identified in both culprit and nonculprit lesions of patients with ST-segment elevation myocardial infarction (STEMI). However, there are limited data available on the natural evolution of these plaques and their long-term clinical outcome. We investigated the natural evolution and long-term impact of plaque ruptures and attenuated plaques in untreated segments of infarct-related arteries in patients with STEMI., Methods: In the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial, 389 patients with 429 lesions underwent intravascular ultrasound (IVUS) at baseline. Follow-up IVUS at 13 months was conducted in 245 patients. Three-year follow-up data were available for all patients., Results: Segments not treated between baseline and follow-up were compared. Baseline IVUS identified 29 plaque ruptures in 27 patients (7%). Of 11 plaque ruptures with follow-up IVUS, four healed and seven persisted. Conversely, through follow-up IVUS, nine new plaque ruptures in nine patients (4%) were identified. Attenuated plaques were identified in 31 of 38 plaque ruptures (81.5%), of which 24 were in the same circumferential segment as the ruptured cavity and seven were within 5 mm proximal or distal to the plaque rupture. Morphologic changes during follow-up, including new plaque ruptures and changes in the attenuated plaque frequency and distribution, were not accompanied by either serious lumen compromise or clinical events., Conclusion: Serial IVUS analysis demonstrated that the morphology of unstable plaques within untreated segments in STEMI patients treated with optimal systemic therapies markedly changed during the 13-month follow-up period, without lumen compromise or clinical events at the 3-year follow-up.

When patients with coronary stents undergo non-cardiac surgery, bridging therapy with low-molecular-weight heparin (LMWH) is not infrequent in clinical practice. However, the efficacy and safety of this approach is poorly understood. This was a retrospective analysis of patients with coronary stent(s) on any antiplatelet therapy undergoing non-cardiac surgery between March 2003 and February 2012. The primary efficacy endpoint was the 30-day incidence of major adverse cardiac or cerebrovascular events (MACCE), defined as the composite of cardiac death, myocardial infarction, acute coronary syndrome leading to hospitalisation, or stroke. The primary safety endpoint was the 30-day composite of Bleeding Academic Research Consortium (BARC) bleedings ≥ 2. Among 515 patients qualifying for the analysis, LMWH bridging was used in 251 (49 %). At 30 days, MACCE occurred more frequently in patients who received LMWH (7.2 % vs 1.1 %, p=0.001), driven by a higher rate of myocardial infarction (4.8 % vs 0 %, p< 0.001). This finding was consistent across several instances of statistical adjustment and after the propensity matching of 179 pairs. Patients bridged with LMWH also experienced a significantly higher risk of BARC bleedings ≥ 2 (21.9 % vs 11.7 %, p=0.002) compared to those who were not, which remained significant across different methods of statistical adjustment and propensity matching. In conclusion, LMWH bridging in patients with coronary stents undergoing surgery is a common and possibly harmful practice, resulting in worse ischaemic outcomes at 30 days, and a significant risk of bleeding.

Coronary angiography confirms or excludes coronary artery disease, assesses lesions severity, and helps to decide percutaneous coronary interventions (PCI). Coronary angiography has clear limitations. Intravascular imaging guides PCI. Frequency domain optical coherence tomography (OCT) gained attention for accurate planning and guidance of complex PCI. High-speed OCT image acquisition enables prompt vessel assessment in stable and unstable patients. The high-resolution images provide precise tissue characterization and a reliable quantitative assessment of the coronary pathology. Immediately after stent implantation, OCT allows accurate evaluation of stent expansion and symmetry. Real-time angio-OCT co-registration integrates OCT into the PCI workflow for accurate decision making., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the pathophysiological features and response to primary percutaneous coronary intervention (PCI) of nonruptured/eroded plaque versus ruptured plaque as a cause of ST-segment elevation myocardial infarction (STEMI)., Background: Autopsy series identified nonruptured/eroded plaque and ruptured plaque as the principal pathological substrates underlying coronary thrombosis in STEMI. The real incidence of different plaque morphologies, associated biological factors, superimposed thrombus, and their interaction with primary PCI remain largely unknown., Methods: In a prospective study, 140 patients with STEMI underwent optical coherence tomography of the infarct-related artery (IRA) before PCI, after everolimus-eluting stent implantation and at 9-month follow-up. Histopathology and immunohistochemistry of thrombus aspirates and serum biomarkers were assessed at baseline., Results: Culprit plaque morphology was adjudicated in 97 patients: 32 plaques (33.0%) with an intact fibrous cap (IFC), 63 (64.9%) plaques with a ruptured fibrous cap (RFC), and 2 (2.1%) spontaneous dissections. Patients with an IFC and RFC had similar clinical characteristics, and serum inflammatory and platelets biomarkers. An IFC presented more frequently with a patent IRA (56.2% vs. 34.9%; p = 0.047), and had fewer lipid areas (lipid-rich areas: 75.0% vs. 100.0%; p < 0.001) and less residual thrombus before stenting (white thrombus: 0.41 mm(3) vs. 1.52 mm(3); p = 0.001; red thrombus: 0 mm(3) vs. 0.29 mm(3); p = 0.001) with a lower peak of creatine kinase-myocardial band (66.6 IU/l vs. 149.8 IU/l; p = 0.025). At the 9-month optical coherence tomography, IFC and RFC had similar high rates of stent strut coverage (92.5% vs. 91.2%; p = 0.15) and similar percentage of volume obstruction (12.6% vs. 10.2%; p = 0.27). No significant differences in clinical outcomes were observed up to 2 years., Conclusions: In the present study, an IFC was observed at the culprit lesion site of one-third of STEMIs. IFC, compared with RFC, was associated with higher rates of patent IRA at first angiography, fewer lipid areas, and residual endoluminal thrombus. However, no difference in vascular response to everolimus-eluting stent was observed. (Optical Coherence Tomography Assessment of Gender Diversity in Primary Angioplasty [OCTAVIA]; NCT01377207)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the association between long-term radiation exposure in the catheterization laboratory (cath lab) and early signs of subclinical atherosclerosis., Background: There is growing evidence of an excess risk of cardiovascular disease at low-dose levels of ionizing radiation exposure., Methods: Left and right carotid intima-media thickness (CIMT) was measured in 223 cath lab personnel (141 male; age, 45 ± 8 years) and 222 unexposed subjects (113 male; age, 44±10 years). Leukocyte telomere length (LTL) was evaluated by quantitative reverse transcriptase polymerase chain reaction. The DNA repair gene XRCC3 Thr241Met polymorphism was also analyzed to explore the possible interaction with radiation exposure. The occupational radiological risk score (ORRS) was computed for each subject on the basis of the length of employment, individual caseload, and proximity to the radiation source. A complete lifetime effective dose (mSv) was recorded for 57 workers., Results: Left, right, and averaged CIMTs were significantly increased in high-exposure workers compared with both control subjects and low-exposure workers (all p values<0.04). On the left side, but not on the right, there was a significant correlation between CIMT and ORRS (p=0.001) as well as lifetime dose (p=0.006). LTL was significantly reduced in exposed workers compared with control subjects (p=0.008). There was a significant correlation between LTL and both ORRS (p=0.002) and lifetime dose (p=0.03). The XRCC3 Met241 allele presented a significant interaction with high exposure for right side (pinteraction=0.002), left side (pinteraction<0.0001), and averaged (pinteraction<0.0001) CIMTs., Conclusions: Long-term radiation exposure in a cath lab may be associated with increased subclinical CIMT and telomere length shortening, suggesting evidence of accelerated vascular aging and early atherosclerosis., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Patients with ST-segment-elevation myocardial infarction are at increased risk of cerebrovascular events. We assessed the incidence, predictors, and implications of cerebrovascular events in patients with ST-segment-elevation myocardial infarction managed with a primary percutaneous coronary intervention strategy., Methods and Results: In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, 72 of 3602 patients (2.0%) experienced at least 1 cerebrovascular event (stroke: 63 patients; transient ischemic attack: 12 patients) during the 3-year follow-up (40.3% within 30 days, 20.8% between 30 days and 1 year, and 38.9% between 1 and 3 years). Stroke was ischemic in 58 (92.1%) patients and hemorrhagic in 5 (7.9%) patients. More than half of all strokes (52.3%) were disabling. By principal management strategy, cerebrovascular events developed in 2.0%, 14.9%, and 1.9% of patients triaged to primary percutaneous coronary intervention, coronary artery bypass grafting, and medical therapy, respectively (P<0.0001). Cerebrovascular events were independently predicted by older age, creatinine clearance <60 mL/min, treatment with coronary artery bypass grafting, anemia, and diabetes mellitus. Cerebrovascular events were associated with significantly increased rates of 3-year mortality (20.5% versus 6.5%; P<0.0001), as well as reinfarction (14.3% versus 3.8%; P=0.0007), ischemia-driven target vessel revascularization (22.8% versus 13.0%; P=0.006), and major bleeding (23.5% versus 8.4%; P<0.0001)., Conclusions: In HORIZONS-AMI, cerebrovascular events within 3 years after ST-segment-elevation myocardial infarction in patients undergoing a primary percutaneous coronary intervention management strategy occurred in 2.0% of patients and were most frequent after coronary artery bypass grafting. Cerebrovascular events were often disabling and were strongly associated with high rates of death, reinfarction, recurrent ischemia, and major bleeding., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966., (© 2015 American Heart Association, Inc.)

Objectives: Contrast-induced acute kidney injury (CI-AKI) may occur after percutaneous coronary intervention (PCI)., Methods: We evaluated patients with ST-elevation myocardial infarction (STEMI) undergoing emergency PCI with serial biomarkers., Results: Of the 390 patients enrolled in the HORIZONS-AMI biomarker substudy, 56 (14.3%) developed AKI. In the AKI group, the levels of B-type natriuretic peptide were consistently higher than in the no-AKI group at baseline (P = 0.0327), hospital discharge (P = 0.0002), 30-day follow-up (P = 0.0193), and 1-year follow-up (P = 0.031). At hospital discharge, the AKI group had elevated biomarkers compared to the no-AKI group: D-dimer (P = 0.0066), C-reactive protein (P = 0.0468), endothelial cell-selective adhesion molecule (P = 0.0169), adiponectin (P = 0.0346), and von Willebrand factor (P = 0.0168); there was also a trend toward higher cystatin C (P = 0.0585) in the AKI group. Similar correlations between biomarker panel increase and the development of CI-AKI were consistent at baseline, 30-day, and 1-year follow-up. Chemokine (C-C motif) ligand 23 showed an opposite pattern with an increase at all time points in the no-AKI compared to the AKI group., Conclusions: The risk of CI-AKI after primary PCI for STEMI may be associated with hemostatic imbalances, activation of procoagulants, decreased endogenous anticoagulants, enhanced inflammation, platelet activation, or decreased fibrinolytic activity., (© 2014 Wiley Periodicals, Inc.)

Background: Target vessel revascularization (TVR) may compromise the benefits of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction (STEMI) We set out to identify the predictors and examine the impact of TVR after STEMI in patients receiving a coronary stent., Methods: In HORIZONS-AMI, 3,602 patients with STEMI were randomized to bivalirudin versus heparin and a glycoprotein IIb/IIIa inhibitor. Stents were implanted in 3,202 patients (2,982 were randomized to bare-metal stents versus paclitaxel-eluting stents, and 220 received nonrandomized stents)., Results: Target vessel revascularization occurred in 219 patients (6.9%) at 1 year and in 437 patients (14.4%) at 3 years. Target vessel revascularization was ischemia-driven in 418 cases (95.7%). Target vessel revascularization was due to restenosis in 219 patients (50.1%), definite stent thrombosis in 124 (28.4%), and disease progression in 94 (21.5%). Independent predictors of TVR were more extensive coronary artery disease, smaller vessel size, longer lesion length and the number of stents implanted, post-percutaneous coronary intervention diameter stenosis, symptom onset to balloon time, treatment with bare-metal stents rather than paclitaxel-eluting stents, and scheduled angiographic follow-up. Target vessel revascularization was an independent predictor of subsequent myocardial infarction (hazard ratio [HR] 5.25, P < .0001), ST (HR 5.98, P < .0001), and major bleeding (HR 5.25, P < .0001) but not mortality (HR 0.88, P = .61)., Conclusions: In HORIZONS-AMI, TVR within 3 years after stent implantation was performed in ~1 of every 7 patients and was associated with more extensive coronary disease, more complex procedures, and bare metal stents. Target vessel revascularization was often due to stent thrombosis and disease progression as well as restenosis and was strongly associated with adverse outcomes but not mortality., (Copyright © 2014 Elsevier Inc. All rights reserved.)

The aim was to investigate the perioperative risk of ischaemic and bleeding events in patients with coronary stents undergoing cardiac and non-cardiac surgery and how these outcomes are affected by the perioperative use of oral antiplatelet therapy. This was a multicentre, retrospective, observational study conducted in patients with coronary stent(s) undergoing cardiac or non-cardiac surgery. The primary efficacy endpoint was the 30-day incidence of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction (MI) or stroke. The primary safety endpoint was the 30-day incidence of Bleeding Academic Research Consortium (BARC) bleeding ≥ 2. A total of 666 patients were included. Of these, 371 (55.7 %) discontinued their antiplatelet medication(s) (all or partly) before undergoing surgery. At 30 days, patients with perioperative discontinuation of antiplatelet therapy experienced a significantly higher incidence of MACE (7.5 % vs 0.3 %, p< 0.001), cardiac death (2.7 % vs 0.3 %, p=0.027), and MI (4.0 % vs 0 %, p< 0.001). After adjustment, peri-operative antiplatelet discontinuation was the strongest independent predictor of 30-day MACE (odds ratio [OR]=25.8, confidence interval [CI]=3.37-198, p=0.002). Perioperative aspirin (adjusted OR 0.27, 95 % CI 0.11-0.71, p=0.008) was significantly associated with a lower risk of MACE. The overall incidence of BARC ≥ 2 bleeding events at 30-days was significantly higher in patients who discontinued oral antiplatelet therapy (25.6 % vs 13.9 %, p< 0.001). However, after adjustment, antiplatelet discontinuation was not independently associated with BARC ≥ 2 bleeding. In conclusion antiplatelet discontinuation increases the 30-day risk of MACE, in patients with coronary stents undergoing cardiac and non-cardiac surgery, while not offering significant protection from BARC≥ 2 bleeding.

Background: In the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial, 3,602 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) treated with bivalirudin had lower bleeding and mortality rates, but higher acute stent thrombosis rates compared with heparin + a glycoprotein IIb/IIIa inhibitor (GPI). Subsequent changes in primary PCI, including the use of potent P2Y12 inhibitors, frequent radial intervention, and pre-hospital medication administration, were incorporated into the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial, which assigned 2,218 patients to bivalirudin versus heparin ± GPI before primary PCI., Objectives: The goal of this study was to examine the outcomes of procedural anticoagulation with bivalirudin versus heparin ± GPI for primary PCI, given the evolution in primary PCI., Methods: Databases from HORIZONS-AMI and EUROMAX were pooled for patient-level analysis. The Breslow-Day test evaluated heterogeneity between trials., Results: A total of 5,800 patients were randomized to bivalirudin (n = 2,889) or heparin ± GPI (n = 2,911). The radial approach was used in 21.3% of patients, prasugrel/ticagrelor was used in 18.1% of patients, and GPI was used in 84.8% of the control group. Bivalirudin compared with heparin ± GPI resulted in reduced 30-day rates of major bleeding (4.2% vs. 7.8%; relative risk [RR]: 0.53; 95% confidence interval [CI]: 0.43 to 0.66; p < 0.0001), thrombocytopenia (1.4% vs. 2.9%, RR: 0.48; 95% CI: 0.33 to 0.71; p = 0.0002), and cardiac mortality (2.0% vs. 2.9%; RR: 0.70; 95% CI: 0.50 to 0.97; p = 0.03), with nonsignificantly different rates of reinfarction, ischemia-driven revascularization, stroke, and all-cause mortality. Bivalirudin resulted in increased acute (<24 h) stent thrombosis rates (1.2% vs. 0.2%; RR: 6.04; 95% CI: 2.55 to 14.31; p < 0.0001), with nonsignificantly different rates of subacute stent thrombosis. Composite net adverse clinical events were lower with bivalirudin (8.8% vs. 11.9%; RR: 0.74; 95% CI: 0.63 to 0.86; p < 0.0001). There was no significant heterogeneity between the 2 trials for these outcomes, and results were consistent across major subgroups., Conclusions: Despite increased acute stent thrombosis, primary PCI with bivalirudin improved 30-day net clinical outcomes, with significant reductions in major bleeding, thrombocytopenia, and transfusions compared with heparin ± GPI, results that were consistent with evolution in PCI technique and pharmacotherapy. (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966) (European Ambulance Acute Coronary Syndrome Angiography [EUROMAX]; NCT01087723)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

We report the case of a 51-year-old woman, treated with radiotherapy at the age of two years, for a pulmonary sarcoma. Subsequently she developed severe aortic stenosis and bilateral ostial coronary artery disease, symptomatic for dyspnea (NYHA III functional class). Due to the prohibitive surgical risk, she underwent successful stenting in the right coronary artery and left main ostia with drug eluting stents and, afterwards, transcatheter aortic valve replacement with transfemoral implantation of a 23 mm Edwards SAPIEN XT valve. The percutaneous treatment was successful without complications and the patient is in NYHA II functional class at 2 years' follow-up, fully carrying out normal daily activities.

Objective: To investigate the difference in neointimal hyperplasia (NIH) between ST-segment elevation myocardial infarction (STEMI), stable angina pectoris (SAP), and unstable angina pectoris (UAP)., Patients and Methods: From formal core laboratory intravascular ultrasound substudies, we compared NIH after paclitaxel-eluting stents (PES) or bare metal stents (BMS) in STEMI lesions from HORIZONS-AMI trial with SAP and UAP lesions from TAXUS IV, V, and ATLAS studies., Results: At follow-up, %NIH at the minimum lumen area (MLA) site was less in STEMI (n=212) than in UAP (n=233) and SAP (n=440) lesions treated with PES (19.6 vs. 26.2 vs. 25.0%, P=0.002; all intravascular ultrasound data shown as least-square means in abstract) and less in STEMI (n=66) than in UAP (n=72) and SAP (n=143) lesions treated with BMS (34.0 vs. 26.7 vs. 45.5%, P=0.0003). As a result, MLA at follow-up was larger in STEMI than in UAP and SAP lesions treated with PES (5.9 vs. 5.2 vs. 5.0 mm, P<0.0001) or treated with BMS (5.1 vs. 4.3 vs. 4.0 mm, P=0.002). Net volume obstruction ([NIH/stent volume]×100) at follow-up was significantly less in STEMI than in UAP and SAP lesions treated with PES (7.8 vs. 13.4 vs. 13.4%, P<0.0001) or BMS (20.6 vs. 28.5 vs. 32.1%, P<0.0001). Multivariate linear regression analysis showed that STEMI was correlated independently and inversely with net volume obstruction compared with SAP (regression coefficient -6.99, P<0.0001) or UAP (regression coefficient -6.29, P<0.0001)., Conclusion: Implantation of PES or BMS in STEMI compared with UAP and SAP was associated with less NIH.

Rapid reperfusion with primary percutaneous coronary intervention improves survival in patients with ST-segment elevation myocardial infarction. Preprocedural cardiopulmonary instability and adverse events (IAE) may delay reperfusion time and worsen prognosis. The aim of this study was to evaluate the relation between preprocedural cardiopulmonary IAE, door-to-balloon time (DBT), and outcomes in the Harmonizing Outcomes With Revascularization and Stents in AMI (HORIZONS-AMI) trial. Preprocedural cardiopulmonary IAE included sustained ventricular or supraventricular tachycardia or fibrillation requiring cardioversion or defibrillation, heart block or bradycardia requiring pacemaker implantation, severe hypotension requiring vasopressors or intra-aortic balloon counterpulsation, respiratory failure requiring mechanical ventilation, and cardiopulmonary resuscitation. Three-year outcomes of patients with and without IAE according to DBT were compared. Among 3,602 patients, 159 (4.4%) had ≥1 IAE. DBT did not differ significantly in patients with and without IAE; however, patients with IAE were less likely to have Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow after percutaneous coronary intervention. Mortality at 3 years was significantly higher in patients with versus those without IAE (17.0% vs 6.3%, p<0.0001), and IAE was an independent predictor of mortality, whereas DBT was not. However, a significant interaction was present such that 3-year mortality was reduced in patients with DBT<99 minutes (the median) versus ≥99 minutes to a greater extent in patients with IAE (9.9% vs 20.7%, hazard ratio 0.43, 95% confidence interval 0.16 to 1.16) compared with those without IAE (5.0% vs 7.2%, hazard ratio 0.69, 95% confidence interval 0.50 to 0.95) (p for interaction=0.004). In conclusion, IAE before PCI is an independent predictor of death and identifies a high-risk group in whom faster reperfusion may be particularly important to improve survival., (Copyright © 2014 Elsevier Inc. All rights reserved.)

The benefits of cardiac imaging are immense, and modern cardiac electrophysiology (EP) requires the extensive and versatile use of a variety of cardiac imaging and radiology-based techniques. In the cardiac electrophysiology lab, doses can range around a reference effective dose (ED) of 15 milliSievert corresponding to 750 chest x-rays for a cardiac radiofrequency ablation, ranging from less than 2 to > 60 mSv. The reference dose for a regular pacemaker or ICD implant is 4 mSv (range 1.4-17) and for a CRT implant is 22 mSv (range 2.2-95). Doses on the order of magnitude of 10-100 milliSievert (mSv) correspond to a low (albeit definite, not negligible) additional lifetime risk of fatal and non-fatal cancer from between 1 in 1000 (10 mSv) to 1 in 100 (100 mSv). The increasing use and complexity of cardiac electrophysiology techniques have not been matched by increasing awareness and knowledge by prescribers and practitioners. The protection of doctors is just as important as protection of patients. Most experienced (and most exposed) interventional cardiologists and electrophysiologists have an exposure per annum of around 5 mSv, two to three times higher than diagnostic radiologists, with a typical cumulative lifetime attributable risk on the order of magnitude of 1 cancer (fatal and non-fatal) per 100 exposed subjects. Operator dose per procedure correlates somewhat with the patient dose, but may be typically 1000 times lower depending upon the shielding employed (one unit of incidence scatter dose for the operator when 1000 units of incident dose are given to the patient). However, adequate radiation protection training and diligent protection can reduce this radiation exposure by 90%. The priority given to radioprotection in every cardiology department is an effective strategy for primary prevention of cancer, a strong indicator of the quality of the cardiology division, and the most effective shielding for enhancing the safety of patients, doctors, and staff.

Background: Reinfarction after primary percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction has negative consequences. Little is known about reinfarction after drug-eluting stents and bivalirudin anticoagulation. We, therefore, sought to determine the incidence, predictors, and implications of reinfarction after primary percutaneous coronary intervention in the contemporary era., Methods and Results: Outcomes were assessed in 3202 patients undergoing stent implantation for ST-segment-elevation myocardial infarction in the Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. Independent predictors of reinfarction and mortality were identified by Cox proportional hazards modeling. The cumulative incidence of reinfarction was 1.8% at 30 days, 4.0% at 1 year, and 6.9% at 3 years. Definite stent thrombosis was responsible for 76.3% of reinfarctions occurring within 30 days and 52.0% of all reinfarctions within 3 years. Independent predictors of reinfarction were current smoking, Killip class ≥2, baseline thrombocytosis, multivessel disease, symptom onset-to-balloon time, and total stent length. Randomization to bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor and use of drug-eluting versus bare metal stents were not significant predictors of reinfarction. Reinfarction was a powerful independent predictor of subsequent cardiac mortality (hazard ratio [95% confidence interval]=7.65 [4.47-13.09]; P<0.0001) and all-cause mortality (hazard ratio [95% confidence interval]=2.88 [1.74-4.78]; P<0.0001)., Conclusions: Despite advances in pharmacotherapy and stents, reinfarction after primary percutaneous coronary intervention is not infrequent, in the contemporary era is most often attributable to stent thrombosis, and is strongly associated with subsequent cardiac and all-cause mortality. Further enhancements in drugs and devices to prevent reinfarction are needed to improve outcomes in high-risk patients with ST-segment-elevation myocardial infarction., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT00433966., (© 2014 American Heart Association, Inc.)

Aims: Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries., Methods and Results: A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries., Conclusion: Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

The clinical outcome of acute cardiovascular events may be more favorable in patients with a high body mass index (BMI), although obesity increases the risk for cardiovascular diseases. The authors sought to define the association between BMI and acute and long-term outcome of patients presenting within 12 hours of ST-segment myocardial infarction (STEMI) in a large multinational cohort. A total of 3,579 patients enrolled in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial were stratified according to BMI quartiles: <24.5, 24.5 to <27.1, 27.1 to 30.1, and >30.1 kg/m(2) (quartiles 1, 2, 3, and 4, respectively). Death, myocardial reinfarction, ischemia-driven target vessel revascularization, stroke, and noncoronary artery bypass grafting-related major bleeding events were centrally adjudicated for the acute, 30 days, and yearly follow-up. Patients with a BMI in the highest quartile were younger than patients in the lower BMI quartiles and more frequently had hypertension, hyperlipidemia, and diabetes mellitus. Complete occlusions and noncalcified lesions were more common in patients with a high BMI. In-hospital mortality decreased with increasing BMI due to lower cardiac mortality (2.9%, 2.3%, 1.2%, and 1.0% for quartiles 1, 2, 3, and 4, respectively, p <0.05). Out-of-hospital 3-year mortality was also lower in higher-weight patients due to lower noncardiac mortality (4.2%, 2.6%, 2.3%, and 1.7% for quartiles 1 to 4, respectively, p = 0.01). After adjustment for covariates, BMI was no longer predictive of acute or long-term mortality after STEMI. In conclusion, as BMI increases, patients have a more extensive adjusted cardiovascular risk profile and disease burden and premature STEMI onset but similar adjusted acute and long-term outcomes., (Copyright © 2014 Elsevier Inc. All rights reserved.)