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Coronary Artery Disease: HELP
Articles by Michael Joner
Based on 42 articles published since 2010
(Why 42 articles?)
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Between 2010 and 2020, M. Joner wrote the following 42 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. 2018

Byrne, Robert A / Stefanini, Giulio G / Capodanno, Davide / Onuma, Yoshinobu / Baumbach, Andreas / Escaned, Javier / Haude, Michael / James, Stefan / Joner, Michael / Jüni, Peter / Kastrati, Adnan / Oktay, Semih / Wijns, William / Serruys, Patrick W / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Germany. ·EuroIntervention · Pubmed #28948934.

ABSTRACT: A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

2 Editorial The Mystery of Spotty Calcification: Can We Solve It by Optical Coherence Tomography? 2016

Yahagi, Kazuyuki / Joner, Michael / Virmani, Renu. ·From CVPath Institute Inc, Gaithersburg, MD. · From CVPath Institute Inc, Gaithersburg, MD. rvirmani@cvpath.org. ·Circ Cardiovasc Imaging · Pubmed #26743464.

ABSTRACT: -- No abstract --

3 Editorial Should CMR Become the New Darling of Noninvasive Imaging for the Monitoring of Progression and Regression of Coronary Heart Disease? 2015

Yahagi, Kazuyuki / Joner, Michael / Virmani, Renu. ·CVPath Institute, Inc., Gaithersburg, Maryland. · CVPath Institute, Inc., Gaithersburg, Maryland. Electronic address: rvirmani@cvpath.org. ·J Am Coll Cardiol · Pubmed #26184619.

ABSTRACT: -- No abstract --

4 Editorial Does neointimal characterization following DES implantation predict long-term outcomes? 2014

Sakakura, Kenichi / Joner, Michael / Virmani, Renu. ·CVPath Institute, Inc., Gaithersburg, Maryland. · CVPath Institute, Inc., Gaithersburg, Maryland. Electronic address: rvirmani@cvpath.org. ·JACC Cardiovasc Imaging · Pubmed #25124010.

ABSTRACT: -- No abstract --

5 Editorial Glagov's phenomenon: has our understanding of vascular remodeling changed? 2014

Joner, Michael / Virmani, Renu. ·CVPath Institute Inc., Gaithersburg, Maryland, USA. ·Coron Artery Dis · Pubmed #24492456.

ABSTRACT: -- No abstract --

6 Review Drug-Coated Balloons: Technologies and Clinical Applications. 2018

Ang, Huiying / Lin, Jinjie / Huang, Ying Ying / Chong, Tze Tec / Cassese, Salvatore / Joner, Michael / Foin, Nicolas. ·National Heart Centre Singapore, 5 Hospital Drive, Singapore 169609, Singapore. · School of Materials Science and Engineering, Nanyang Technological University, Nanyang Avenue, Singapore 639798, Singapore. · Department of Vascular Surgery, Singapore General Hospital, 169608 Singapore, Singapore. · Deutsches Herzzentrum Munchen, Technische Universitat Munchen, Munich 80636, Germany. · Duke-NUS Medical School, 8 College Road, Singapore 169857, Singapore. ·Curr Pharm Des · Pubmed #29283056.

ABSTRACT: The progress and development of drug-coated balloons (DCBs) represents an emerging alternative treatment in peripheral and coronary artery diseases, particularly when a non-stent approach is necessary. Several studies and meta-analyses have evaluated the clinical outcomes of DCBs in different lesions and this review aims to compile the progress and updated clinical data of DCB strategy in both peripheral artery diseases (PAD) and coronary artery diseases (CAD). The review highlights that clinical data has encouraged the use of DCB for applications in PAD and in the treatment of coronary in-stent restenosis (ISR). The employment of DCB in side branch treatment of bifurcation lesions has been reported to be feasible and safe, with good angiographic and clinical outcome. The use of DCB for arteriovenous fistula and grafts stenoses is a promising strategy, but more clinical data is required to draw reliable conclusions. The limitations and impact of the current generation of DCBs will be discussed and the clinical development of newer generation of the device is also covered in this review.

7 Review Mechanical behavior of polymer-based 2017

Ang, Hui Ying / Huang, Ying Ying / Lim, Soo Teik / Wong, Philip / Joner, Michael / Foin, Nicolas. ·National Heart Centre Singapore, Singapore, Singapore. · School of Materials Science and Engineering, Nanyang Technological University, Singapore, Singapore. · Duke-NUS Medical School, Singapore, Singapore. · Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. ·J Thorac Dis · Pubmed #28894598.

ABSTRACT: Bioresorbable scaffolds (BRS) were developed to overcome the drawbacks of current metallic drug-eluting stents (DES), such as late in-stent restenosis and caging of the vessel permanently. The concept of the BRS is to provide transient support to the vessel during healing before being degraded and resorbed by the body, freeing the vessel and restoring vasomotion. The mechanical properties of the BRS are influenced by the choice of the material and processing methods. Due to insufficient radial strength of the bioresorbable material, BRS often required large strut profile as compared to conventional metallic DES. Having thick struts will in turn affect the deliverability of the device and may cause flow disturbance, thereby increasing the incidence of acute thrombotic events. Currently, the bioresorbable poly-l-lactic acid (PLLA) polymer and magnesium (Mg) alloys are being investigated as materials in BRS technologies. The bioresorption process, mechanical properties,

8 Review Pathophysiology of native coronary, vein graft, and in-stent atherosclerosis. 2016

Yahagi, Kazuyuki / Kolodgie, Frank D / Otsuka, Fumiyuki / Finn, Aloke V / Davis, Harry R / Joner, Michael / Virmani, Renu. ·CVPath Institute, Inc., 19 Firstfield Road, Gaithersburg, MD 20878, USA. · Department of Medicine, Emory University Hospital, 550 Peachtree Street, Nebraska, Atlanta, GA 30308, USA. ·Nat Rev Cardiol · Pubmed #26503410.

ABSTRACT: Plaque rupture, usually of a precursor lesion known as a 'vulnerable plaque' or 'thin-cap fibroatheroma', is the leading cause of thrombosis. Less-frequent aetiologies of coronary thrombosis are erosion, observed with greatest incidence in women aged <50 years, and eruptive calcified nodules, which are occasionally identified in older individuals. Various treatments for patients with coronary artery disease, such as CABG surgery and interventional therapies, have led to accelerated atherosclerosis. These processes occur within months to years, compared with the decades that it generally takes for native disease to develop. Morphological identifiers of accelerated atherosclerosis include macrophage-derived foam cells, intraplaque haemorrhage, and thin fibrous cap. Foam-cell infiltration can be observed within 1 year of a saphenous vein graft implantation, with subsequent necrotic core formation and rupture ensuing after 7 years in over one-third of patients. Neoatherosclerosis occurs early and with greater prevalence in drug-eluting stents than in bare-metal stents and, although rare, complications of late stent thrombosis from rupture are associated with high mortality. Comparison of lesion progression in native atherosclerotic disease, atherosclerosis in saphenous vein grafts, and in-stent neoatherosclerosis provides insight into the pathogenesis of atheroma formation in natural and iatrogenic settings.

9 Review Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Grüntzig Lecture ESC 2014. 2015

Byrne, Robert A / Joner, Michael / Kastrati, Adnan. ·Deutsches Herzzentrum München, Technische Universität München, Lazarettstr. 36, Munich, Germany. · Deutsches Herzzentrum München, Technische Universität München, Lazarettstr. 36, Munich, Germany DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany kastrati@dhm.mhn.de. ·Eur Heart J · Pubmed #26417060.

ABSTRACT: Modern-day stenting procedures leverage advances in pharmacotherapy and device innovation. Patients treated with contemporary antiplatelet agents, peri-procedural antithrombin therapy and new-generation drug-eluting stents (DES) have excellent outcomes over the short to medium term. Indeed, coupled with the reducing costs of these devices in most countries there remain very few indications where patients should be denied treatment with standard-of-care DES therapy. The two major causes of stent failure are stent thrombosis (ST) and in-stent restenosis (ISR). The incidence of both has reduced considerably in recent years. Current clinical registries and randomized trials with broad inclusion criteria show rates of ST at or <1% after 1 year and ∼0.2-0.4% per year thereafter; rates of clinical ISR are 5% respectively. Angiographic surveillance studies in large cohorts show rates of angiographic ISR of ∼10% with new-generation DES. The advent of high-resolution intracoronary imaging has shown that in many cases of late stent failure neoatherosclerotic change within the stented segment represents a final common pathway for both thrombotic and restenotic events. In future, a better understanding of the pathogenesis of this process may translate into improved late outcomes. Moreover, the predominance of non-stent-related disease as a cause of subsequent myocardial infarction during follow-up highlights the importance of lifestyle and pharmacological interventions targeted at modification of the underlying disease process. Finally, although recent developments focus on strategies which circumvent the need for chronically indwelling stents--such as drug-coated balloons or fully bioresorbable stents-more data are needed before the wider use of these therapies can be advocated.

10 Review Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary. 2015

Byrne, Robert A / Serruys, Patrick W / Baumbach, Andreas / Escaned, Javier / Fajadet, Jean / James, Stefan / Joner, Michael / Oktay, Semih / Jüni, Peter / Kastrati, Adnan / Sianos, George / Stefanini, Giulio G / Wijns, William / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. · Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands. · Bristol Heart Institute, Bristol, UK. · Interventional Cardiology, Hospital San Carlos, Madrid, Spain. · Interventional Cardiology, Clinique Pasteur, Toulouse, France. · Clinical Research Center, Uppsala University, Uppsala, Sweden. · CVPath Institute, Inc., Gaithersburg, USA. · Cardio Med Device Consultants, Baltimore, USA. · Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. · AHEPA University Hospital, Thessaloniki, Greece. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. · Cardiovascular Center O.L.V.Z., Aalst, Belgium. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland stephan.windecker@insel.ch. ·Eur Heart J · Pubmed #26071600.

ABSTRACT: The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

11 Review Neoatherosclerosis: overview of histopathologic findings and implications for intravascular imaging assessment. 2015

Otsuka, Fumiyuki / Byrne, Robert A / Yahagi, Kazuyuki / Mori, Hiroyoshi / Ladich, Elena / Fowler, David R / Kutys, Robert / Xhepa, Erion / Kastrati, Adnan / Virmani, Renu / Joner, Michael. ·CVPath Institute, Inc., 19 Firstfield Road, Gaithersburg, MD 20878, USA. · Deutsches Herzzentrum München, Technische Universitat München, Munich, Germany. · Office of the Chief Medical Examiner, Baltimore, MD, USA. · CVPath Institute, Inc., 19 Firstfield Road, Gaithersburg, MD 20878, USA mjoner@cvpath.org michaeljoner@me.com. ·Eur Heart J · Pubmed #25994755.

ABSTRACT: Despite the reduction in late thrombotic events with newer-generation drug-eluting stents (DES), late stent failure remains a concern following stent placement. In-stent neoatherosclerosis has emerged as an important contributing factor to late vascular complications including very late stent thrombosis and late in-stent restenosis. Histologically, neoatherosclerosis is characterized by accumulation of lipid-laden foamy macrophages within the neointima with or without necrotic core formation and/or calcification. The development of neoatherosclerosis may occur in months to years following stent placement, whereas atherosclerosis in native coronary arteries develops over decades. Pathologic and clinical imaging studies have demonstrated that neoatherosclerosis occurs more frequently and at an earlier time point in DES when compared with bare metal stents, and increases with time in both types of implant. Early development of neoatherosclerosis has been identified not only in first-generation DES but also in second-generation DES. The mechanisms underlying the rapid development of neoatherosclerosis remain unknown; however, either absence or abnormal endothelial functional integrity following stent implantation may contribute to this process. In-stent plaque rupture likely accounts for most thrombotic events associated with neoatherosclerosis, while it may also be a substrate of in-stent restenosis as thrombosis may occur either symptomatically or asymptomatically. Intravascular optical coherence tomography is capable of detecting neoatherosclerosis; however, the shortcomings of this modality must be recognized. Future studies should assess the impact of iterations in stent technology and risk factor modification on disease progression. Similarly, refinements in imaging techniques are also warranted that will permit more reliable detection of neoatherosclerosis.

12 Review Impact of local flow haemodynamics on atherosclerosis in coronary artery bifurcations. 2015

Antoniadis, Antonios P / Giannopoulos, Andreas A / Wentzel, Jolanda J / Joner, Michael / Giannoglou, George D / Virmani, Renu / Chatzizisis, Yiannis S. ·Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. ·EuroIntervention · Pubmed #25983161.

ABSTRACT: Coronary artery bifurcations are susceptible to atherosclerosis as a result of the unique local flow patterns and the subsequent endothelial shear stress (ESS) environment that are conducive to the development of plaques. Along the lateral walls of the main vessel and side branches, a distinct flow pattern is observed with local low and oscillatory ESS, while high ESS develops at the flow divider (carina). Histopathologic studies have shown that the distribution of plaque at bifurcation regions is related to the local ESS patterns. The local ESS profile also influences the outcome of percutaneous coronary interventions in bifurcation lesions. A variety of invasive and non-invasive imaging modalities have enabled 3D reconstruction of coronary bifurcations and thereby detailed local ESS assessment by computational fluid dynamics. Highly effective strategies for treatment and ultimately prevention of atherosclerosis in coronary bifurcations are anticipated with the use of advanced imaging and computational fluid dynamic techniques.

13 Review Pathological aspects of bioresorbable stent implantation. 2015

Sanchez, Oscar D / Yahagi, Kazuyuki / Byrne, Robert A / Mori, Hiroyoshi / Zarpak, Roya / Wittchow, Eric / Foin, Nicolas / Virmani, Renu / Joner, Michael. ·CVPath Institute, Inc., Gaithersburg, MD, USA. ·EuroIntervention · Pubmed #25983157.

ABSTRACT: The treatment of obstructive coronary artery disease has been revolutionised by the advent of drug-eluting stent therapy. However, concerns remain about complications late after stent implantation including late stent thrombosis, hypersensitivity reactions and neoatherosclerosis. In this respect, the introduction of fully bioresorbable stents (BRS)--which resorb over time and leave the arterial wall free of any metal constraints--represents a potentially important disruptive technology. However, although the concept is intuitively attractive, a thorough understanding of the histopathological changes seen after BRS implantation and an appreciation of comparative changes versus existing metal stent technologies are vital to guide BRS clinical usage. In this respect, translational investigation of polymer chemistry, biomedical engineering, as well as in vitro and in vivo testing in animal models is an important undertaking. This article will review the pathological aspects of BRS implantation with a focus on acute and chronic vascular reactions derived from preclinical animal studies, including insights from in vivo imaging. Finally, potential future directions of this novel therapeutic approach will be discussed.

14 Review Optical coherence tomography surveillance following drug-eluting stent implantation. 2015

Koppara, T / Virmani, R / Joner, M. ·CVPath Institute Inc., Gaithersburg, MD, USA - mjoner@cvpath.org. ·Minerva Cardioangiol · Pubmed #25566936.

ABSTRACT: Drug-eluting stents are currently used in the majority of percutaneous coronary interventions. Preclinical investigations and human autopsy studies have shown that the high efficacy of drug-eluting stents (DES) in preventing restenosis is achieved at the expense of a delay in healing. Optical coherence tomography (OCT) represents a novel intracoronary imaging tool to evaluate vascular healing response after stent implantation. Owing to its outstanding resolution in the catheter near-field, quantitative morphometric measures were complemented by more qualitative description of neointimal tissue characterization. Clinical imaging studies employing these methodologies gained valuable insights into vascular healing responses after DES implantation and are reported in this review. However, an important limitation of OCT imaging analysis, despite its high resolution, remains the inability to assess the precise cellular composition and functional capability of the neointimal tissue, especially of the endothelium. Future long-term clinical studies are warranted to determine the clinical relevance of surrogate parameters derived from preliminary OCT surveillance studies.

15 Review Clinical classification of plaque morphology in coronary disease. 2014

Otsuka, Fumiyuki / Joner, Michael / Prati, Francesco / Virmani, Renu / Narula, Jagat. ·Cardiovascular Pathology Inc., 19 Firstfield Road, Gaithersburg, MD 20878, USA. · San Giovanni Addolorata Hospital and CLI Foundation, Via Amba Aradam, 8, Rome 00184, Italy. · Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, USA. ·Nat Rev Cardiol · Pubmed #24776706.

ABSTRACT: In published post-mortem pathological studies, more than two-thirds of acute coronary events are associated with the rupture of lipid-rich, voluminous, and outwardly remodelled plaques covered by attenuated and inflamed fibrous caps in the proximal part of coronary arteries. Superficial erosion of the plaques is responsible for most of the remaining events; the eroded plaques usually do not demonstrate much lipid burden, do not have thin fibrous caps, are not positively remodelled, and are not critically occlusive. Both noninvasive and invasive imaging studies have been performed to clinically define the plaque characteristics in acute coronary syndromes in an attempt to identify the high-risk plaque substrate susceptible to development of an acute coronary event. Optical coherence tomography (OCT)--an intravascular imaging modality with high resolution--can be used to define various stages of plaque morphology, which might allow its use for the identification of high-risk plaques vulnerable to rupture, and their amenability to pre-emptive interventional treatment. OCT might also be employed to characterize plaque pathology at the time of intervention, to provide a priori knowledge of the mechanism of the acute coronary syndrome and, therefore, to enable improved management of the condition.

16 Review Has our understanding of calcification in human coronary atherosclerosis progressed? 2014

Otsuka, Fumiyuki / Sakakura, Kenichi / Yahagi, Kazuyuki / Joner, Michael / Virmani, Renu. ·From CVPath Institute Inc, Gaithersburg, MD. ·Arterioscler Thromb Vasc Biol · Pubmed #24558104.

ABSTRACT: Coronary artery calcification is a well-established predictor of future cardiac events; however, it is not a predictor of unstable plaque. The intimal calcification of the atherosclerotic plaques may begin with smooth muscle cell apoptosis and release of matrix vesicles and is almost always seen microscopically in pathological intimal thickening, which appears as microcalcification (≥0.5 μm, typically <15 μm in diameter). Calcification increases with macrophage infiltration into the lipid pool in early fibroatheroma where they undergo apoptosis and release matrix vesicles. The confluence of calcified areas involves extracellular matrix and the necrotic core, which can be identified by radiography as speckled (≤2 mm) or fragmented (>2, <5 mm) calcification. The calcification in thin-cap fibroatheromas and plaque rupture is generally less than what is observed in stable plaques and is usually speckled or fragmented. Fragmented calcification spreads into the surrounding collagen-rich matrix forming calcified sheets, the hallmarks of fibrocalcific plaques. The calcified sheets may break into nodules with fibrin deposition, and when accompanied by luminal protrusion, it is associated with thrombosis. Calcification is highest in fibrocalcific plaques followed by healed plaque rupture and is the least in erosion and pathological intimal thickening. The extent of calcification is greater in men than in women especially in the premenopausal period and is also greater in whites compared with blacks. The mechanisms of intimal calcification remain poorly understood in humans. Calcification often occurs in the presence of apoptosis of smooth muscle cells and macrophages with matrix vesicles accompanied by expression of osteogenic markers within the vessel wall.

17 Review Drug-coated balloon therapy in coronary and peripheral artery disease. 2014

Byrne, Robert A / Joner, Michael / Alfonso, Fernando / Kastrati, Adnan. ·Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, D-80636 Munich, Germany. · Cardiac Department, Hospital Universitario de La Princesa, IIS-IP, Universidad Autónoma de Madrid, c/ Diego de León 62, Madrid 28006, Spain. ·Nat Rev Cardiol · Pubmed #24189405.

ABSTRACT: Nonstent-based local drug delivery during percutaneous intervention offers potential for sustained antirestenotic efficacy without the limitations of permanent vascular implants. Preclinical studies have shown that effective local tissue concentrations of drugs can be achieved using drug-coated balloon (DCB) catheters. Matrix coatings consisting of a mixture of lipophilic paclitaxel and hydrophilic spacer (excipient) are most effective. Clinical applications most suited to DCB therapy are those for which stent implantation is not desirable or less effective, such as in-stent restenosis, bifurcation lesions, or peripheral artery stenoses. Randomized trials have shown superiority of DCBs over plain-balloon angioplasty for both bare-metal and drug-eluting coronary in-stent restenosis, and similar efficacy as repeat stenting with a drug-eluting stent (DES). Bycontrast, randomized trials of DCBs in de novo coronary stenosis have, to date, not shown similar efficacy to standard-of-care DES therapy. In peripheral artery disease, DCB therapy has proven superior to plain-balloon angioplasty for treatment of de novo femoropoliteal and below-the-knee disease, and shown promising results for in-stent restenosis. Overall, however, despite many years of clinical experience with DCBs, the number of large, high-quality, randomized clinical trials is low, and further data are urgently needed across the spectrum of clinical indications.

18 Article Are we curing one evil with another? A translational approach targeting the role of neoatherosclerosis in late stent failure. 2020

Lenz, Tobias / Nicol, Philipp / Castellanos, Maria Isabel / Abdelgalil, Ayat Aboutaleb Abdellah / Hoppmann, Petra / Kempf, Wolfgang / Koppara, Tobias / Lahmann, Anna Lena / Rüscher, Alena / Kessler, Horst / Joner, Michael. ·Deutsches Herzzentrum München (German Heart Centre Munich), Klinik fβ Herz- und Kreislauferkrankungen, Technische Universität München, Lazarettstraße 36, 80363 Munich, Germany. · DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Biedersteiner Straße 29, 80802 Munich, Germany. · Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675 Munich, Germany. · Department of Chemistry and Center for Integrated Protein Science, Institute for Advanced Study, Technische Universität München, Lichtenbergstr. 4, 85747 Garching, Germany. ·Eur Heart J Suppl · Pubmed #32368195.

ABSTRACT: Neoatherosclerosis is defined as foamy macrophage infiltration into the peri-strut or neointimal area after stent implantation, potentially leading to late stent failure through progressive atherosclerotic changes including calcification, fibroatheroma, thin-cap fibroatheroma, and rupture with stent thrombosis (ST) in advanced stages. Human autopsy as well as intravascular imaging studies have led to the understanding of neoatherosclerosis formation as a similar but significantly accelerated pathophysiology as compared to native atherosclerosis. This acceleration is mainly based on disrupted endothelial integrity with insufficient barrier function and augmented transmigration of lipids following vascular injury after coronary intervention and especially after implantation of drug-eluting stents. In this review, we summarize translational insights into disease pathophysiology and discuss therapeutic approaches to tackle this novel disease entity. We introduce a novel animal model of neoatherosclerosis alongside accompanying

19 Article Qualitative and quantitative neointimal characterization by optical coherence tomography in patients presenting with in-stent restenosis. 2019

Xhepa, Erion / Byrne, Robert A / Rivero, Fernando / Rroku, Andi / Cuesta, Javier / Ndrepepa, Gjin / Kufner, Sebastian / Valiente, Teresa Bastante / Cassese, Salvatore / Garcia-Guimaraes, Marcos / Lahmann, Anna Lena / Rai, Himanshu / Schunkert, Heribert / Joner, Michael / Pérez-Vizcayno, María José / Gonzalo, Nieves / Alfonso, Fernando / Kastrati, Adnan. ·Deutsches Herzzentrum München, Klinik an der Technischen Universität München, Munich, Germany. xhepa@dhm.mhn.de. · Deutsches Herzzentrum München, Klinik an der Technischen Universität München, Munich, Germany. · Hospital Universitario de La Princesa, Madrid, Spain. · DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. · Hospital Universitario Clínico San Carlos, Madrid, Spain. ·Clin Res Cardiol · Pubmed #30783752.

ABSTRACT: AIMS: To describe optical coherence tomography (OCT) findings in patients with in-stent restenosis (ISR) and determine predictors of neointimal patterns and neoatherosclerosis. METHODS AND RESULTS: Patients undergoing OCT prior to PCI for ISR in three European centres were included. Analyses were performed in a core laboratory. Qualitative and quantitative [gray-scale signal intensity (GSI)] neointima analyses were performed on a per quadrant basis. A total of 107 patients were included. Predominantly homogeneous lesions included 4.5% (0.0-14.3) non-homogeneous quadrants, while predominantly non-homogeneous ones included 28.1% (20.3-37.5) homogeneous quadrants. Mean GSI values differed significantly between homogeneous [108.4 (92.5-123.6)], non-homogeneous [79.9 (61.2-95.9)], and neoatherosclerosis [88.3 (72.8-104.9)] quadrants (p < 0.001 for all comparisons). Stent underexpansion was observed in 48.5% and 61.1% of lesions, respectively (p = 0.225). Female sex and maximal neointimal thickness independently correlate with a non-homogeneous pattern, while angiographic pattern and diabetes mellitus inversely correlate with such pattern. Time from index stenting procedure was the only independent predictor of neoatherosclerosis. CONCLUSIONS: Different neointimal patterns coexist in a significant proportion of ISR lesions. GSI values differ significantly between neointimal categories. Neoatherosclerosis is a time-dependent phenomenon, displaying different time courses in DES compared to BMS, with earlier appearance in the former group. Stent underexpansion is a frequent finding in patients with ISR.

20 Article Ten-Year Clinical Outcomes From a Trial of Three Limus-Eluting Stents With Different Polymer Coatings in Patients With Coronary Artery Disease. 2019

Kufner, Sebastian / Joner, Michael / Thannheimer, Anna / Hoppmann, Petra / Ibrahim, Tareq / Mayer, Katharina / Cassese, Salvatore / Laugwitz, Karl-Ludwig / Schunkert, Heribert / Kastrati, Adnan / Byrne, Robert A / Anonymous7720973. ·Deutsches Herzzentrum München, Technische Universität München, Munich (S.K., M.J., A.T., K.M., S.C., H.S., A.K., R.A.B.). · German Centre for Cardiovascular Research, Partner Site Munich Heart Alliance (M.J., K.-L.L., H.S., A.K., R.A.B.). · 1. medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich (P.H., T.I., K.-L.L.). ·Circulation · Pubmed #30586724.

ABSTRACT: BACKGROUND: New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up. METHODS: Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients. RESULTS: The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES. CONCLUSIONS: In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676.

21 Article Neoatherosclerosis in Patients With Coronary Stent Thrombosis: Findings From Optical Coherence Tomography Imaging (A Report of the PRESTIGE Consortium). 2018

Joner, Michael / Koppara, Tobias / Byrne, Robert A / Castellanos, Maria Isabel / Lewerich, Jonas / Novotny, Julia / Guagliumi, Giulio / Xhepa, Erion / Adriaenssens, Tom / Godschalk, Thea C / Malik, Nikesh / Alfonso, Fernando / Tada, Tomohisa / Neumann, Franz-Josef / Desmet, Walter / Ten Berg, Jurrien M / Gershlick, Anthony H / Feldman, Laurent J / Massberg, Steffen / Kastrati, Adnan / Anonymous3800955. ·Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany. Electronic address: joner@dhm.mhn.de. · Klinik und Poliklinik für Innere Medizin I, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany. · Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany. · Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. · Medizinische Klinik und Poliklinik I, Ludwig-Maximilians-Universität, Munich, Germany. · Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy. · Department of Cardiology, University Hospitals Leuven, and Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. · Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands. · Department of Cardiovascular Sciences, University of Leicester & Leicester NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, United Kingdom. · Hospital Universitario de La Princesa, Madrid, Spain. · Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. · Département de Cardiologie, AP-HP, DHU FIRE, U-1148 INSERM, Hôpital Bichat, Paris, France. · Medizinische Klinik und Poliklinik I, Ludwig-Maximilians-Universität, Munich, Germany; German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany. ·JACC Cardiovasc Interv · Pubmed #30025727.

ABSTRACT: 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.

22 Article Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. 2018

Räber, Lorenz / Mintz, Gary S / Koskinas, Konstantinos C / Johnson, Thomas W / Holm, Niels Ramsing / Onuma, Yoshinobu / Radu, Maria D / Joner, Michael / Yu, Bo / Jia, Haibo / Meneveau, Nicolas / de la Torre Hernandez, Jose Maria / Escaned, Javier / Hill, Jonathan / Prati, Francesco / Colombo, Antonio / Di Mario, Carlo / Regar, Evelyn / Capodanno, Davide / Wijns, William / Byrne, Robert A / Guagliumi, Giulio. ·Department of Cardiology, Bern University Hospital, Bern, Switzerland. ·EuroIntervention · Pubmed #29939149.

ABSTRACT: This Consensus Document is the first of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The first document appraises the role of intracoronary imaging to guide percutaneous coronary interventions (PCIs) in clinical practice. Current evidence regarding the impact of intracoronary imaging guidance on cardiovascular outcomes is summarized, and patients or lesions most likely to derive clinical benefit from an imaging-guided intervention are identified. The relevance of the use of IVUS or OCT prior to PCI for optimizing stent sizing (stent length and diameter) and planning the procedural strategy is discussed. Regarding post-implantation imaging, the consensus group recommends key parameters that characterize an optimal PCI result and provides cut-offs to guide corrective measures and optimize the stenting result. Moreover, routine performance of intracoronary imaging in patients with stent failure (restenosis or stent thrombosis) is recommended. Finally, strengths and limitations of IVUS and OCT for guiding PCI and assessing stent failures and areas that warrant further research are critically discussed.

23 Article Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. 2018

Räber, Lorenz / Mintz, Gary S / Koskinas, Konstantinos C / Johnson, Thomas W / Holm, Niels R / Onuma, Yoshinubo / Radu, Maria D / Joner, Michael / Yu, Bo / Jia, Haibo / Meneveau, Nicolas / de la Torre Hernandez, Jose M / Escaned, Javier / Hill, Jonathan / Prati, Francesco / Colombo, Antonio / di Mario, Carlo / Regar, Evelyn / Capodanno, Davide / Wijns, William / Byrne, Robert A / Guagliumi, Giulio / Anonymous501142. ·Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Cardiovascular Research Foundation, New York, NY, USA. · Bristol Heart Institute, University Hospitals Bristol NHSFT, Bristol, UK. · Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. · Department of Interventional Cardiology, Cardialysis, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. · The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. · Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. · DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany. · Department of Cardiology, 2nd Affiliated Hospital of Harbin Medical University, The Key Laboratory of Myocardial Ischemia, Chinese Ministry of Education, Harbin, China. · Department of Cardiology, University Hospital Jean Minjoz, Besancon, France. · EA3920, University of Burgundy Franche-Comté, Besancon, France. · Department of Cardiology, IDIVAL, Hospital Universitario Marques de Valdecilla, Santander, Spain. · Hospital Clinico San Carlos IDISSC and Universidad Complutense, Madrid, Spain. · Department of Cardiology, King's College Hospital, London, UK. · Department of Cardiology, San Giovanni Hospital, Rome, Italy & CLI Foundation, Rome, Italy. · Interventional Cardiology Unit, Cardio-Thoracic-Vascular Department, San Raffaele, Scientific Institute, Milan, Italy. · Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy. · Department of Cardiovacular Surgery, Zürich University Hospita, Zürich, Switzerland. · Division of Cardiology, Cardio-Thoraco-Vascular and Transplant Department, CAST, Rodolico Hospital, AOU "Policlinico-Vittorio Emanuele", University of Catania, Catania, Italy. · The Lambe Institute for Translational Medicine and Curam, National University of Ireland Galway, Saolta University Healthcare Group, Galway, Ireland. · Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy. ·Eur Heart J · Pubmed #29790954.

ABSTRACT: This Consensus Document is the first of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The first document appraises the role of intracoronary imaging to guide percutaneous coronary interventions (PCIs) in clinical practice. Current evidence regarding the impact of intracoronary imaging guidance on cardiovascular outcomes is summarized, and patients or lesions most likely to derive clinical benefit from an imaging-guided intervention are identified. The relevance of the use of IVUS or OCT prior to PCI for optimizing stent sizing (stent length and diameter) and planning the procedural strategy is discussed. Regarding post-implantation imaging, the consensus group recommends key parameters that characterize an optimal PCI result and provides cut-offs to guide corrective measures and optimize the stenting result. Moreover, routine performance of intracoronary imaging in patients with stent failure (restenosis or stent thrombosis) is recommended. Finally, strengths and limitations of IVUS and OCT for guiding PCI and assessing stent failures and areas that warrant further research are critically discussed.

24 Article Randomised comparison of vascular response to biodegradable polymer sirolimus eluting and permanent polymer everolimus eluting stents: An optical coherence tomography study. 2018

Koppara, Tobias / Tada, Tomohisa / Xhepa, Erion / Kufner, Sebastian / Byrne, Robert A / Ibrahim, Tareq / Laugwitz, Karl-Ludwig / Kastrati, Adnan / Joner, Michael. ·Deutsches Herzzentrum, Technische Universität München, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Partner site Munich Heart Alliance, Munich, Germany; Department of Internal Medicine I - Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. · Deutsches Herzzentrum, Technische Universität München, Munich, Germany. · Deutsches Herzzentrum, Technische Universität München, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Partner site Munich Heart Alliance, Munich, Germany. · Department of Internal Medicine I - Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. · DZHK (German Centre for Cardiovascular Research), Partner site Munich Heart Alliance, Munich, Germany; Department of Internal Medicine I - Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. · Deutsches Herzzentrum, Technische Universität München, Munich, Germany; DZHK (German Centre for Cardiovascular Research), Partner site Munich Heart Alliance, Munich, Germany. Electronic address: michaeljoner@me.com. ·Int J Cardiol · Pubmed #29544956.

ABSTRACT: BACKGROUND: Drug-eluting stents with biodegradable polymer coatings have shown promising outcomes in randomised studies. METHODS: We compared neointimal healing patterns including strut coverage and assessed neointimal maturity using a novel algorithm in coronary lesions treated with sirolimus-eluting stents with biodegradable polymer coating (BP-SES) or everolimus eluting stents with permanent polymer coating (PP-EES) using optical coherence tomography after 6months. RESULTS: A total of 39 patients were randomised to BP-SES (n=19) or PP-EES (n=20) for the treatment of coronary lesions. Of those, 29 patients (14 BP-SES and 15 PP-EES) underwent optical coherence tomography (OCT) and angiography at 6-month follow-up. Tissue coverage and apposition were assessed in a total of 6162 struts (BP-SES, n=2889; PP-EES, n=3273). Neointimal maturity was assessed in 3672 neointimal regions above struts using grey scale intensity analysis. OCT analysis showed neointimal coverage of 2433 (BP-SES) vs. 2702 (PP-EES) struts (84.2% vs. 82.6%, p=0.70), whereas the remainder was uncovered after 6months. Mean neointimal thickness did not differ significantly between groups (54.3±7.8μm vs. 80±14.6μm, p=0.12). The rate of malapposed struts was comparable between groups (1.3% vs. 2.2%, p=0.27). Grey scale signal intensity analysis showed mature tissue coverage of struts in 46.2% in BP-SES vs. 31.8% in PP-EES (p=0.31) of neointimal regions. CONCLUSION: The present study showed comparable early vascular healing response characterised by neointimal coverage with mainly immature neointima in both BP-SES and PP-EES.

25 Article Transcatheter aortic valve implantation and off-pump coronary artery bypass surgery: an effective hybrid procedure in selected patients. 2018

Mayr, Benedikt / Firschke, Christian / Erlebach, Magdalena / Bleiziffer, Sabine / Krane, Markus / Joner, Michael / Herold, Ulf / Nöbauer, Christian / Lange, Rüdiger / Deutsch, Marcus-André. ·Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany. · Insure (Institute for Translational Cardiac Surgery), Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany. · Department of Cardiology, Medical Park St. Hubertus, Bad Wiessee, Germany. · DZHK (German Center for Cardiovascular Research)-partner site Munich Heart Alliance, Munich, Germany. · Department of Cardiology, German Heart Center Munich, Technische Universität München, Munich, Germany. ·Interact Cardiovasc Thorac Surg · Pubmed #29490052.

ABSTRACT: OBJECTIVES: Simultaneous surgical off-pump coronary revascularization and transcatheter aortic valve implantation (TAVI) as a hybrid procedure may be a therapeutic option for patients with a TAVI indication who are not suitable for percutaneous coronary intervention and for patients who have an indication for combined surgical aortic valve implantation and coronary artery bypass grafting but present with a porcelain aorta. Early outcomes of these patients are analysed in this study. METHODS: From February 2011 to April 2017, hybrid TAVI/off-pump coronary artery bypass (OPCAB) was performed in 12 (60%) patients, hybrid TAVI/minimally invasive direct coronary artery bypass in 6 (30%) patients and staged TAVI/OPCAB in 2 (10%) patients. Endpoints of this study were 30-day mortality, device success and postoperative adverse events as defined by the updated Valve Academic Research Consortium (VARC-2). RESULTS: The median age at the time of surgery was 77 years [interquartile range (IQR), 70-81] with a median logistic EuroSCORE and Society of Thoracic Surgeons' Predicted Risk score of 16.1% (IQR, 9.3-28.1) and 3.9% (IQR, 2.2-5.6), respectively. The median Synergy between PCI with Taxus and Cardiac Surgery score was 16.5 (IQR, 9.8-22.8). TAVI implantation routes were transaortic in 9 (45%) patients, transapical and transfemoral in 5 (25%) patients each and trans-subclavian in 1 (5%) patient. Complete myocardial revascularization was achieved in 75% of patients. Device success rate was 100%. Paravalvular aortic regurgitation did not exceed mild in any patient. Stroke/transient ischaemic attack, vascular complications and myocardial infarction were not observed. Re-exploration for bleeding was required in 1 (5%) patient. Thirty-day mortality was 0%. CONCLUSIONS: Hybrid OPCAB/MIDCAB and TAVI prove to be a safe and effective alternative treatment option in selected higher risk patients.

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