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1. Comparison of multilayer and single-layer coronary plaque models on stress/strain calculations based on optical coherence tomography images

Author

Mengde Huang, Akiko Maehara, Dalin Tang, Jian Zhu, Liang Wang, Rui Lv, Yanwen Zhu, Xiaoguo Zhang, Mitsuaki Matsumura, Lijuan Chen, Genshan Ma, and Gary S. Mintz

Subjects
coronary plaque, vulnerable plaque, multilayer artery model, plaque stress, imagebased plaque models, Physiology, QP1-981
Abstract

Mechanical stress and strain conditions are closely related to atherosclerotic plaque progression and rupture and have been under intensive investigations in recent years. It is well known that arteries have a three-layer structure: intima, media and adventitia. However, in vivo image-based multilayer plaque models are not available in the current literature due to lack of multilayer image segmentation data. A multilayer segmentation and repairing technique was introduced to segment coronary plaque optical coherence tomography (OCT) image to obtain its three-layer vessel structure. A total of 200 OCT slices from 20 patients (13 male; 7 female) were used to construct multilayer and single-layer 3D thin-slice models to calculate plaque stress and strain and compare model differences. Our results indicated that the average maximum plaque stress values of 20 patients from multilayer and single-layer models were 385.13 ± 110.09 kPa and 270.91 ± 95.86 kPa, respectively. The relative difference was 42.2%, with single-layer stress serving as the base value. The average mean plaque stress values from multilayer and single-layer models were 129.59 ± 32.77 kPa and 93.27 ± 18.20 kPa, respectively, with a relative difference of 38.9%. The maximum and mean plaque strain values obtained from the multilayer models were 11.6% and 19.0% higher than those from the single-layer models. Similarly, the maximum and mean cap strains showed increases of 9.6% and 12.9% over those from the single-layer models. These findings suggest that use of multilayer models could improve plaque stress and strain calculation accuracy and may have large impact on plaque progression and vulnerability investigation and potential clinical applications. Further large-scale studies are needed to validate our findings.

Published
2023
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2. Relationship Between Optical Coherence Tomography–Derived In‐Stent Neoatherosclerosis and the Extent of Lipid‐Rich Neointima by Near‐Infrared Spectroscopy and Intravascular Ultrasound: A Multimodal Imaging Study

Author

Mitsuhiro Takeuchi, Tomotaka Dohi, Mitsuaki Matsumura, Tatsuya Fukase, Ryota Nishio, Norihito Takahashi, Hirohisa Endo, Hiroki Nishiyama, Shinichiro Doi, Iwao Okai, Hiroshi Iwata, Shinya Okazaki, Katsumi Miyauchi, Hiroyuki Daida, and Tohru Minamino

Subjects
in‐stent restenosis, near‐infrared spectroscopy, neoatherosclerosis, optical coherence tomography, optical frequency domain imaging, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background In‐stent restenosis, especially for neoatherosclerosis, is a major concern following percutaneous coronary intervention. This study aimed to elucidate the association of features of in‐stent restenosis lesions revealed by optical coherence tomography (OCT)/optical frequency domain imaging (OFDI) and the extent of lipid‐rich neointima (LRN) assessed by near‐infrared spectroscopy (NIRS) and intravascular ultrasound, especially for neoatherosclerosis. Methods and Results We analyzed patients undergoing percutaneous coronary intervention for in‐stent restenosis lesions using both OCT/OFDI and NIRS–intravascular ultrasound. OCT/OFDI‐derived neoatherosclerosis was defined as lipid neointima. The existence of large LRN (defined as a long segment with 4‐mm maximum lipid core burden index ≥400) was evaluated by NIRS. In 59 patients with 64 lesions, neoatherosclerosis and large LRN were observed in 17 (26.6%) and 21 lesions (32.8%), respectively. Naturally, large LRN showed higher 4‐mm maximum lipid core burden index (median [interquartile range], 623 [518–805] versus 176 [0–524]; P

Published
2022
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3. Predicting plaque vulnerability change using intravascular ultrasound + optical coherence tomography image-based fluid–structure interaction models and machine learning methods with patient follow-up data: a feasibility study

Author

Xiaoya Guo, Akiko Maehara, Mitsuaki Matsumura, Liang Wang, Jie Zheng, Habib Samady, Gary S. Mintz, Don P. Giddens, and Dalin Tang

Subjects
Vulnerable plaque, OCT, IVUS, Morphological index, Patient-specific model, FSI, Medical technology, R855-855.5
Abstract

Abstract Background Coronary plaque vulnerability prediction is difficult because plaque vulnerability is non-trivial to quantify, clinically available medical image modality is not enough to quantify thin cap thickness, prediction methods with high accuracies still need to be developed, and gold-standard data to validate vulnerability prediction are often not available. Patient follow-up intravascular ultrasound (IVUS), optical coherence tomography (OCT) and angiography data were acquired to construct 3D fluid–structure interaction (FSI) coronary models and four machine-learning methods were compared to identify optimal method to predict future plaque vulnerability. Methods Baseline and 10-month follow-up in vivo IVUS and OCT coronary plaque data were acquired from two arteries of one patient using IRB approved protocols with informed consent obtained. IVUS and OCT-based FSI models were constructed to obtain plaque wall stress/strain and wall shear stress. Forty-five slices were selected as machine learning sample database for vulnerability prediction study. Thirteen key morphological factors from IVUS and OCT images and biomechanical factors from FSI model were extracted from 45 slices at baseline for analysis. Lipid percentage index (LPI), cap thickness index (CTI) and morphological plaque vulnerability index (MPVI) were quantified to measure plaque vulnerability. Four machine learning methods (least square support vector machine, discriminant analysis, random forest and ensemble learning) were employed to predict the changes of three indices using all combinations of 13 factors. A standard fivefold cross-validation procedure was used to evaluate prediction results. Results For LPI change prediction using support vector machine, wall thickness was the optimal single-factor predictor with area under curve (AUC) 0.883 and the AUC of optimal combinational-factor predictor achieved 0.963. For CTI change prediction using discriminant analysis, minimum cap thickness was the optimal single-factor predictor with AUC 0.818 while optimal combinational-factor predictor achieved an AUC 0.836. Using random forest for predicting MPVI change, minimum cap thickness was the optimal single-factor predictor with AUC 0.785 and the AUC of optimal combinational-factor predictor achieved 0.847. Conclusion This feasibility study demonstrated that machine learning methods could be used to accurately predict plaque vulnerability change based on morphological and biomechanical factors from multi-modality image-based FSI models. Large-scale studies are needed to verify our findings.

Published
2021
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4. Using optical coherence tomography and intravascular ultrasound imaging to quantify coronary plaque cap thickness and vulnerability: a pilot study

Author

Rui Lv, Akiko Maehara, Mitsuaki Matsumura, Liang Wang, Qingyu Wang, Caining Zhang, Xiaoya Guo, Habib Samady, Don P. Giddens, Jie Zheng, Gary S. Mintz, and Dalin Tang

Subjects
OCT, IVUS, Fibrous cap, Vulnerable plaque, Cap thickness, Medical technology, R855-855.5
Abstract

Abstract Background Detecting coronary vulnerable plaques in vivo and assessing their vulnerability have been great challenges for clinicians and the research community. Intravascular ultrasound (IVUS) is commonly used in clinical practice for diagnosis and treatment decisions. However, due to IVUS limited resolution (about 150–200 µm), it is not sufficient to detect vulnerable plaques with a threshold cap thickness of 65 µm. Optical Coherence Tomography (OCT) has a resolution of 15–20 µm and can measure fibrous cap thickness more accurately. The aim of this study was to use OCT as the benchmark to obtain patient-specific coronary plaque cap thickness and evaluate the differences between OCT and IVUS fibrous cap quantifications. A cap index with integer values 0–4 was also introduced as a quantitative measure of plaque vulnerability to study plaque vulnerability. Methods Data from 10 patients (mean age: 70.4; m: 6; f: 4) with coronary heart disease who underwent IVUS, OCT, and angiography were collected at Cardiovascular Research Foundation (CRF) using approved protocol with informed consent obtained. 348 slices with lipid core and fibrous caps were selected for study. Convolutional Neural Network (CNN)-based and expert-based data segmentation were performed using established methods previously published. Cap thickness data were extracted to quantify differences between IVUS and OCT measurements. Results For the 348 slices analyzed, the mean value difference between OCT and IVUS cap thickness measurements was 1.83% (p = 0.031). However, mean value of point-to-point differences was 35.76%. Comparing minimum cap thickness for each plaque, the mean value of the 20 plaque IVUS-OCT differences was 44.46%, ranging from 2.36% to 91.15%. For cap index values assigned to the 348 slices, the disagreement between OCT and IVUS assignments was 25%. However, for the OCT cap index = 2 and 3 groups, the disagreement rates were 91% and 80%, respectively. Furthermore, the observation of cap index changes from baseline to follow-up indicated that IVUS results differed from OCT by 80%. Conclusions These preliminary results demonstrated that there were significant differences between IVUS and OCT plaque cap thickness measurements. Large-scale patient studies are needed to confirm our findings.

Published
2020
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5. Combining IVUS + OCT Data, Biomechanical Models and Machine Learning Method for Accurate Coronary Plaque Morphology Quantification and Cap Thickness and Stress/Strain Index Predictions

Author

Rui Lv, Liang Wang, Akiko Maehara, Mitsuaki Matsumura, Xiaoya Guo, Habib Samady, Don P. Giddens, Jie Zheng, Gary S. Mintz, and Dalin Tang

Subjects
coronary vulnerable plaque, plaque models, fibrous cap thickness, vulnerable plaque model, plaque vulnerability prediction, Biotechnology, TP248.13-248.65, Medicine (General), R5-920
Abstract

Assessment and prediction of vulnerable plaque progression and rupture risk are of utmost importance for diagnosis, management and treatment of cardiovascular diseases and possible prevention of acute cardiovascular events such as heart attack and stroke. However, accurate assessment of plaque vulnerability assessment and prediction of its future changes require accurate plaque cap thickness, tissue component and structure quantifications and mechanical stress/strain calculations. Multi-modality intravascular ultrasound (IVUS), optical coherence tomography (OCT) and angiography image data with follow-up were acquired from ten patients to obtain accurate and reliable plaque morphology for model construction. Three-dimensional thin-slice finite element models were constructed for 228 matched IVUS + OCT slices to obtain plaque stress/strain data for analysis. Quantitative plaque cap thickness and stress/strain indices were introduced as substitute quantitative plaque vulnerability indices (PVIs) and a machine learning method (random forest) was employed to predict PVI changes with actual patient IVUS + OCT follow-up data as the gold standard. Our prediction results showed that optimal prediction accuracies for changes in cap-PVI (C-PVI), mean cap stress PVI (meanS-PVI) and mean cap strain PVI (meanSn-PVI) were 90.3% (AUC = 0.877), 85.6% (AUC = 0.867) and 83.3% (AUC = 0.809), respectively. The improvements in prediction accuracy by the best combination predictor over the best single predictor were 6.6% for C-PVI, 10.0% for mean S-PVI and 8.0% for mean Sn-PVI. Our results demonstrated the potential using multi-modality IVUS + OCT image to accurately and efficiently predict plaque cap thickness and stress/strain index changes. Combining mechanical and morphological predictors may lead to better prediction accuracies.

Published
2023
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6. Human Coronary Plaque Optical Coherence Tomography Image Repairing, Multilayer Segmentation and Impact on Plaque Stress/Strain Calculations

Author

Mengde Huang, Akiko Maehara, Dalin Tang, Jian Zhu, Liang Wang, Rui Lv, Yanwen Zhu, Xiaoguo Zhang, Mitsuaki Matsumura, Lijuan Chen, Genshan Ma, and Gary S. Mintz

Subjects
coronary, vulnerable plaque, coronary plaque models, multilayer vessel geometry, Biotechnology, TP248.13-248.65, Medicine (General), R5-920
Abstract

Coronary vessel layer structure may have a considerable impact on plaque stress/strain calculations. Most current plaque models use single-layer vessel structures due to the lack of available multilayer segmentation techniques. In this paper, an automatic multilayer segmentation and repair method was developed to segment coronary optical coherence tomography (OCT) images to obtain multilayer vessel geometries for biomechanical model construction. Intravascular OCT data were acquired from six patients (one male; mean age: 70.0) using a protocol approved by the local institutional review board with informed consent obtained. A total of 436 OCT slices were selected in this study. Manually segmented data were used as the gold standard for method development and validation. The edge detection method and cubic spline surface fitting were applied to detect and repair the internal elastic membrane (IEM), external elastic membrane (EEM) and adventitia–periadventitia interface (ADV). The mean errors of automatic contours compared to manually segmented contours were 1.40%, 4.34% and 6.97%, respectively. The single-layer mean plaque stress value from lumen was 117.91 kPa, 10.79% lower than that from three-layer models (132.33 kPa). On the adventitia, the single-layer mean plaque stress value was 50.46 kPa, 156.28% higher than that from three-layer models (19.74 kPa). The proposed segmentation technique may have wide applications in vulnerable plaque research.

Published
2022
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7. Using Optical Coherence Tomography and Intravascular Ultrasound Imaging to Quantify Coronary Plaque Cap Stress/Strain and Progression: A Follow-Up Study Using 3D Thin-Layer Models

Author

Rui Lv, Akiko Maehara, Mitsuaki Matsumura, Liang Wang, Caining Zhang, Mengde Huang, Xiaoya Guo, Habib Samady, Don. P. Giddens, Jie Zheng, Gary S. Mintz, and Dalin Tang

Subjects
coronary plaque, plaque progression prediction, patient-specific coronary plaque models, vulnerable plaque, optical coherence tomography-based coronary models, Biotechnology, TP248.13-248.65
Abstract

Accurate plaque cap thickness quantification and cap stress/strain calculations are of fundamental importance for vulnerable plaque research. To overcome uncertainties due to intravascular ultrasound (IVUS) resolution limitation, IVUS and optical coherence tomography (OCT) coronary plaque image data were combined together to obtain accurate and reliable cap thickness data, stress/strain calculations, and reliable plaque progression predictions. IVUS, OCT, and angiography baseline and follow-up data were collected from nine patients (mean age: 69; m: 5) at Cardiovascular Research Foundation with informed consent obtained. IVUS and OCT slices were coregistered and merged to form IVUS + OCT (IO) slices. A total of 114 matched slices (IVUS and OCT, baseline and follow-up) were obtained, and 3D thin-layer models were constructed to obtain stress and strain values. A generalized linear mixed model (GLMM) and least squares support vector machine (LSSVM) method were used to predict cap thickness change using nine morphological and mechanical risk factors. Prediction accuracies by all combinations (511) of those predictors with both IVUS and IO data were compared to identify optimal predictor(s) with their best accuracies. For the nine patients, the average of minimum cap thickness from IVUS was 0.17 mm, which was 26.08% lower than that from IO data (average = 0.23 mm). Patient variations of the individual errors ranged from ‒58.11 to 20.37%. For maximum cap stress between IO and IVUS, patient variations of the individual errors ranged from ‒30.40 to 46.17%. Patient variations of the individual errors of maximum cap strain values ranged from ‒19.90 to 17.65%. For the GLMM method, the optimal combination predictor using IO data had AUC (area under the ROC curve) = 0.926 and highest accuracy = 90.8%, vs. AUC = 0.783 and accuracy = 74.6% using IVUS data. For the LSSVM method, the best combination predictor using IO data had AUC = 0.838 and accuracy = 75.7%, vs. AUC = 0.780 and accuracy = 69.6% using IVUS data. This preliminary study demonstrated improved plaque cap progression prediction accuracy using accurate cap thickness data from IO slices and the differences in cap thickness, stress/strain values, and prediction results between IVUS and IO data. Large-scale studies are needed to verify our findings.

Published
2021
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8. Predictors and Long‐Term Clinical Impact of Acute Stent Malapposition: An Assessment of Dual Antiplatelet Therapy With Drug‐Eluting Stents (ADAPT‐DES) Intravascular Ultrasound Substudy

Author

Bin Wang, Gary S. Mintz, Bernhard Witzenbichler, Cristiano F. Souza, D. Christopher Metzger, Michael J. Rinaldi, Peter L. Duffy, Giora Weisz, Thomas D. Stuckey, Bruce R. Brodie, Mitsuaki Matsumura, Myong‐Hwa Yamamoto, Rupa Parvataneni, Ajay J. Kirtane, Gregg W. Stone, and Akiko Maehara

Subjects
coronary artery disease, intravascular imaging, malapposition, stent, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

BackgroundThe impact of acute stent malapposition (ASM) on long‐term clinical outcomes in patients undergoing percutaneous coronary intervention is still controversial. We sought to evaluate predictors and long‐term clinical outcomes of ASM. Methods and ResultsADAPT‐DES (Assessment of Dual Antiplatelet Therapy With Drug‐Eluting Stents) was a prospective multicenter study of 8663 patients undergoing percutaneous coronary intervention using drug‐eluting stents. In a prespecified intravascular ultrasound–guided substudy, 2072 patients with 2446 culprit lesions had post–percutaneous coronary intervention intravascular ultrasound and were classified according to the presence or absence of ASM. After intravascular ultrasound–guided percutaneous coronary intervention, the overall prevalence of ASM after successful drug‐eluting stents implantation was 14.4% per patient and 12.6% per lesion. Compared to lesions without ASM, lesions with ASM had larger in‐stent lumen areas, larger stent areas, and larger in‐stent vessel areas. A larger mean plaque area along with more attenuated plaque was observed in lesions with ASM versus lesions without ASM. Lesions with ASM had greater proximal and distal reference lumen areas and more distal, but not proximal, reference calcium compared to lesions without ASM. At 2‐year follow‐up, there was no significant difference in the incidence of cardiac death; myocardial infarction; early, late, or very late stent thrombosis; or clinically driven target lesion revascularization in patients with ASM versus those without ASM. Furthermore, ASM was not an independent predictor of 2‐year major adverse cardiac events or target lesion revascularization even when forced into the multivariate model. ConclusionsIn patients treated with intravascular ultrasound–guided drug‐eluting stents implantation, ASM was not associated with adverse clinical events during long‐term follow‐up including, but not limited to, stent thrombosis. Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT00638794.

Published
2016
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9. Mannosylated Polyrotaxanes for Increasing Cellular Uptake Efficiency in Macrophages through Receptor-Mediated Endocytosis

Author

Kai Shibaguchi, Atsushi Tamura, Masahiko Terauchi, Mitsuaki Matsumura, Hiroyuki Miura, and Nobuhiko Yui

Subjects
polyrotaxane, cyclodextrin, macrophage, mannose, macrophage mannose receptor, Organic chemistry, QD241-441
Abstract

Macrophages play an important role in the regulation of inflammation and immune response as well as the pathogenesis of chronic inflammatory diseases and cancer. Therefore, targeted delivery of therapeutic reagents to macrophages is an effective method for treatment and diagnosis. We previously examined the therapeutic applications of polyrotaxanes (PRXs) comprised of multiple cyclodextrins (CDs) threaded on a polymer chain and capped with bulky stopper molecules. In the present study, we designed an α-d-mannose-modified α-CD/poly(ethylene glycol)-based PRX (Man-PRX). The intracellular uptake of Man-PRX through the interaction with macrophage mannose receptor (MMR) in macrophage-like RAW264.7 cells was examined. Intracellular Man-PRX uptake was observed in MMR-positive RAW264.7 cells but was negligible in MMR-negative NIH/3T3 cells. In addition, the intracellular Man-PRX uptake in RAW264.7 cells was significantly inhibited in the presence of free α-d-mannose and an anti-MMR antibody, which suggests that MMR is involved in the intracellular uptake of Man-PRX. Moreover, the polarization of RAW264.7 cells affected the Man-PRX internalization efficiency. These results indicate that Man-PRX is an effective candidate for selective targeting of macrophages through a specific interaction with the MMR.

Published
2019
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10. Sensitization potential of dental resins: 2-hydroxyethyl methacrylate and its water-soluble oligomers have immunostimulatory effects.

Author

Izumi Fukumoto, Atsushi Tamura, Mitsuaki Matsumura, Hiroyuki Miura, and Nobuhiko Yui

Subjects
Medicine, Science
Abstract

The immunostimulatory effects of the representative dental resin monomer 2-hydroxyethyl methacrylate (HEMA), a HEMA derivative that does not contain a double bond (2-hydroxyethyl isobutyrate, HEIB), and polymerized water-soluble oligomers of HEMA (PHEMA) were investigated. It is known that expression levels of either or both of CD54 and CD86 in THP-1 cells are increased by exposure to sensitizing substances. In this study, the expression levels of CD54 and CD86, the production of reactive oxygen species (ROS), and the viability of the cells were measured after 24 h of incubation with these materials at different concentrations. The concentrations of the materials that induced the expression of both CD54 and CD86 were low in the following order: NiSO4, HEMA, and methyl methacrylate (MMA). These results indicate that these dental resin monomers have lower sensitizing potentials than NiSO4. Although HEIB, which lacks a double bond, resulted in negligible ROS production and reduced cytotoxicity than HEMA, it induced the expression of CD54 and CD86. Comparison of the results for HEMA and HEIB indicates that dental resin monomer-induced sensitization may be related not only to the oxidative stress related to the methacryloyl group but also to the structures of these compounds. Of particular interest is the result that a water-soluble PHEMA oligomer with a relatively high-molecular weight also exhibited negligible cytotoxicity, whereas the expression level of CD54 increased after exposure to PHEMA at a high concentration. This result serves as a warning that polymerized substances also have the potential to induce sensitization. This study provides insight into the nature of allergic responses to dental resin materials in clinical use and may facilitate the development of more biocompatible restorative materials in the future.

Published
2013
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13. Coronary Artery Lesion Lipid Content and Plaque Burden in Diabetic and Nondiabetic Patients: PROSPECT II

Author

Christine Gyldenkerne, Michael Maeng, Lars Kjøller-Hansen, Akiko Maehara, Zhipeng Zhou, Ori Ben-Yehuda, Hans Erik Bøtker, Thomas Engstrøm, Mitsuaki Matsumura, Gary S. Mintz, Ole Fröbert, Jonas Persson, Rune Wiseth, Alf I. Larsen, Lisette O. Jensen, Jan E. Nordrehaug, Øyvind Bleie, Elmir Omerovic, Claes Held, Stefan K. James, Ziad A. Ali, Hans C. Rosen, Gregg W. Stone, and David Erlinge

Subjects
myocardial infarction, Physiology (medical), diabetes mellitus, spectroscopy, near-infrared, Cardiology and Cardiovascular Medicine, coronary artery disease
Abstract

Background: Patients with diabetes have increased rates of major adverse cardiac events (MACEs). We hypothesized that this is explained by diabetes-associated differences in coronary plaque morphology and lipid content. Methods: In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), 898 patients with acute myocardial infarction with or without ST-segment elevation underwent 3-vessel quantitative coronary angiography and coregistered near-infrared spectroscopy and intravascular ultrasound imaging after successful percutaneous coronary intervention. Subsequent MACEs were adjudicated to either treated culprit lesions or untreated nonculprit lesions. This substudy stratified patients by diabetes status and assessed baseline culprit and nonculprit prevalence of high-risk plaque characteristics defined as maximum plaque burden ≥70% and maximum lipid core burden index ≥324.7. Separate covariate-adjusted multivariable models were performed to identify whether diabetes was associated with nonculprit lesion–related MACEs and high-risk plaque characteristics. Results: Diabetes was present in 109 of 898 patients (12.1%). During a median 3.7-year follow-up, MACEs occurred more frequently in patients with versus without diabetes (20.1% versus 13.5% [odds ratio (OR), 1.94 (95% CI, 1.14–3.30)]), primarily attributable to increased risk of myocardial infarction related to culprit lesion restenosis (4.3% versus 1.1% [OR, 3.78 (95% CI, 1.12–12.77)]) and nonculprit lesion–related spontaneous myocardial infarction (9.3% versus 3.8% [OR, 2.74 (95% CI, 1.25–6.04)]). However, baseline prevalence of high-risk plaque characteristics was similar for patients with versus without diabetes concerning culprit (maximum plaque burden ≥70%: 90% versus 93%, P =0.34; maximum lipid core burden index ≥324.7: 66% versus 70%, P =0.49) and nonculprit lesions (maximum plaque burden ≥70%: 23% versus 22%, P =0.37; maximum lipid core burden index ≥324.7: 26% versus 24%, P =0.47). In multivariable models, diabetes was associated with MACEs in nonculprit lesions (adjusted OR, 2.47 [95% CI, 1.21–5.04]) but not with prevalence of high-risk plaque characteristics (adjusted OR, 1.21 [95% CI, 0.86–1.69]). Conclusions: Among patients with recent myocardial infarction, both treated and untreated lesions contributed to the diabetes-associated ≈2-fold increased MACE rate during the 3.7-year follow-up. Diabetes-related plaque characteristics that might underlie this increased risk were not identified by multimodality imaging. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02171065.

Published
2023

15. Impact of Intravascular Ultrasound–Derived Lesion-Specific Virtual Fractional Flow Reserve Predicts 3-Year Outcomes of Untreated Nonculprit Lesions: The PROSPECT Study

Author

Fumiyasu Seike, Gary S. Mintz, Mitsuaki Matsumura, Ziad A. Ali, Mengdan Liu, Allen Jeremias, Ori Ben-Yehuda, Bernard De Bruyne, Patrick W. Serruys, Kazunori Yasuda, Gregg W. Stone, and Akiko Maehara

Subjects
Fractional Flow Reserve, Myocardial, Time Factors, Treatment Outcome, Predictive Value of Tests, Risk Factors, Myocardial Infarction, Humans, Coronary Artery Disease, Coronary Angiography, Cardiology and Cardiovascular Medicine, Severity of Illness Index, Plaque, Atherosclerotic, Ultrasonography, Interventional
Abstract

Background: Hemodynamic assessment of untreated nonculprit lesions was not studied in the PROSPECT study (Providing Regional Observations to Study Predictors of Events in the Coronary Tree). We developed a virtual intravascular ultrasound–derived lesion-specific fractional flow reserve (lesion-specific IVUS-FFR) algorithm to assess individual lesion-level FFR. We sought to investigate the relation between lesion-specific IVUS-FFR and major adverse cardiovascular events (MACE) arising from untreated nonculprit lesions in the PROSPECT study. Methods: In PROSPECT, 697 patients with acute coronary syndromes underwent 3-vessel grayscale and virtual histology–IVUS to correlate untreated nonculprit plaque morphology with 3-year nonculprit related MACE (composite of cardiac death, cardiac arrest, myocardial infarction, or rehospitalization due to unstable or progressive angina). Lesion-specific IVUS-FFR was calculated from volumetric IVUS lumen area measurements at 0.4 mm intervals by applying a mathematical circulation model using basic fluid dynamics equations. Results: Lesion-specific IVUS-FFR was analyzable in 3227 nonculprit lesions in 660 patients among whom 54 nonculprit MACE events (3 myocardial infarctions) occurred at median 3.4-year follow-up. By receiver-operating characteristic analysis, the best cutoff value of lesion-specific IVUS-FFR to predict nonculprit MACE was ≤0.95. After adjusting for patient and lesion characteristics, lesion-specific IVUS-FFR (hazard ratio, 4.83 [95% CI, 2.20–10.61]; P 2 , plaque burden ≥70%, and virtual histology thin-cap fibroatheroma. Conclusions: Minor reductions in lesion-specific IVUS-FFR were independently associated with future nonculprit MACE arising from untreated angiographically mild stenoses along with previously established high-risk lesion morphological characteristics. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00180466.

Published
2022

16. Clinical Utility of Intravascular Imaging

Author

Gary S. Mintz, Mitsuaki Matsumura, Ziad Ali, and Akiko Maehara

Subjects
Radiology, Nuclear Medicine and imaging, Cardiology and Cardiovascular Medicine
Published
2022

17. Reasons for lesion uncrossability as assessed by intravascular ultrasound

Author

Hanan Salem, Gary S. Mintz, Mitsuaki Matsumura, Mingyou Zhang, Eisuke Usui, Fumiyasu Seike, Tatsuhiro Fujimura, Masahiko Noguchi, Xun Hu, Ge Jin, Chenguang Li, Khady N. Fall, Ziad A. Ali, Ajay J. Kirtane, Michael B. Collins, Susheel K. Kodali, Tamim M. Nazif, Martin B. Leon, Jeffrey W. Moses, Dimitri Karmpaliotis, and Akiko Maehara

Subjects
Atherectomy, Coronary, Treatment Outcome, Humans, Calcium, Radiology, Nuclear Medicine and imaging, Coronary Artery Disease, General Medicine, Coronary Angiography, Vascular Calcification, Cardiology and Cardiovascular Medicine, Ultrasonography, Interventional
Abstract

The purpose of the current study was to use intravascular ultrasound (IVUS) to clarify anatomical and morphological lesion characteristics of uncrossable lesions.Uncrossable lesions are not always severely calcified. The prevalence of uncrossable lesions that are nonseverely calcified as well as other mechanisms for uncrossability has not been well clarified.A total of 252 de novo uncrossable lesions in native coronary arteries that underwent either rotational or orbital atherectomy due to inability of any balloon to cross the lesion and 38 lesions with severe calcium in which IVUS crossed preatherectomy were included. Severe calcium is defined as maximum arc of calcium ≥270°.Severe calcification was absent in 16% of uncrossable lesions, 83% of which had a significant vessel bend. Compared with crossable lesions with severe calcium, uncrossable lesions with severe calcium more often had a bend in the vessel (71% vs. 21%, p 0.001) and a longer length of continuous severe calcium (median length of calcium ≥270° 3.8 mm vs. 1.9 mm, p = 0.001). Other than severe calcium (especially long continuous calcium) or a bend in the vessel, anatomical factors associated with uncrossabilty were aorto-ostial lesion location and small vessels.Uncrossable lesions are not always severely calcified. The interaction of lesion morphology (continuous long and large arcs of calcium) and vessel geometry (bend in the vessel or ostial lesion location) affect lesion crossability.

Published
2022

18. Impact of Calcium Eccentricity on the Safety and Effectiveness of Coronary Intravascular Lithotripsy: Pooled Analysis From the Disrupt CAD Studies.

Author

Ali, Ziad A., Kereiakes, Dean J., Hill, Jonathan M., Shigeru Saito, Di Mario, Carlo, Honton, Benjamin, Gonzalo, Nieves, Riley, Robert F., Akiko Maehara, Mitsuaki Matsumura, Shin, Doosup, Stone, Gregg W., and Shlofmitz, Richard A.

Abstract

BACKGROUND: Coronary intravascular lithotripsy (IVL) safely facilitates successful stent implantation in severely calcified lesions. This analysis sought to determine the relative impact of lesion calcium eccentricity on the safety and effectiveness of IVL using high-resolution optical coherence tomography imaging. METHODS: Individual patient-level data (n=262) were pooled from 4 distinct international prospective studies (Disrupt CAD I, II, III, and IV) and analyzed by an independent optical coherence tomography core laboratory. IVL performance in eccentric versus concentric calcification was analyzed by dividing calcified lesions into quartiles (=180° [most eccentric], 181°-270°, 271°-359°, and 360° [concentric]) by maximum continuous calcium arc. RESULTS: In the 230 patients with clear imaging field on optical coherence tomography, there were no differences in preprocedure minimum lumen area, diameter stenosis, or maximum calcium thickness. The calcium length and volume index increased progressively with increasing mean and maximum continuous calcium arc (ie, concentricity). Conversely, the minimum calcium thickness decreased progressively with increasing concentricity. Post-procedure, the number of calcium fractures, fracture depth, and fracture width increased with increasing concentricity, with a 4-fold increase in the number of fractures in lesions with 360° of calcium arc compared with =180°. This increase in IVL-induced calcium fracture with increasing calcium burden and concentricity facilitated stent expansion and luminal gain such that there were no significant differences across quartiles. CONCLUSIONS: IVL induced calcium fractures proportional to the magnitude of coronary artery calcium, including in eccentric calcium, leading to consistent improvements in stent expansion and luminal gain in both eccentric and concentric calcified coronary lesions. [ABSTRACT FROM AUTHOR]

Published
2023
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20. Outcomes of retrograde approach for chronic total occlusions by guidewire location

Author

Gary S. Mintz, Myong Hwa Yamamoto, Jeffrey W. Moses, Juan J Russo, Mitsuaki Matsumura, Emad Hakemi, Martin B. Leon, Yongzhen Fan, Gregg W. Stone, Megha Prasad, Khady Fall, He Huang, Masahiko Ochiai, Yousif Ahmad, Akiko Maehara, Ajay J. Kirtane, Ziad A. Ali, Fotis Gargoulas, and Dimitrios Karmpaliotis

Subjects
medicine.diagnostic_test, business.industry, Vascular compartment, Intravascular ultrasound, Retrograde approach, Medicine, Cardiology and Cardiovascular Medicine, business, Nuclear medicine, Total occlusion
Abstract

BACKGROUND Connecting the antegrade wire (AW) and the retrograde wire (RW) is a goal of chronic total occlusion (CTO) treatment, but angiographic guidewire location is sometimes misleading. AIMS The aim of this study was to evaluate the association between intravascular ultrasound (IVUS)-defined AW and RW position and procedural outcomes when treating CTO lesions using the retrograde approach. METHODS Overall, 191 CTO lesions treated using an IVUS-guided retrograde approach at three centres in Japan, China, and the USA were included. RESULTS When the AW and RW angiographically overlapped, four wire positions were seen on IVUS: (i) AW within the plaque (AW-intraplaque) and RW-intraplaque in 34%; (ii) AW-intraplaque and RW in the subintimal space (RW-subintima) in 28%; (iii) AW-subintima and RW-subintima in 22%; or (iv) AW-subintima and RW-intraplaque in 16%. The procedure succeeded without repositioning the wire in 89% of AW-intraplaque/RW-intraplaque, 61% of AW-intraplaque/RW-subintima and 57% of AW-subintima/RW-subintima, but only one (3%) AW-subintima/RW-intraplaque. Lesion and procedure complexity and failure/complications were greatest in AW-subintima/RW-intraplaque. CONCLUSIONS IVUS-identified vascular compartment concordance versus IVUS-identified vascular compartment mismatch leads to higher success rates irrespective of intraplaque or subintimal passage. AW-subintima/RW-intraplaque was associated with the most complex CTO morphology and procedure, and repositioning the wire was almost always necessary. Visual summary. When the antegrade wire is in the subintimal space and the retrograde wire is in the intraplaque, re-wiring is almost always necessary.

Published
2021

21. Prevalence and Impact of Neoatherosclerosis on Clinical Outcomes After Percutaneous Treatment of Second-Generation Drug-Eluting Stent Restenosis

Author

Zhaoyang Chen, Mitsuaki Matsumura, Gary S. Mintz, Masahiko Noguchi, Tatsuhiro Fujimura, Eisuke Usui, Fumiyasu Seike, Xun Hu, Ge Jin, Chenguang Li, Hanan Salem, Khady N. Fall, Evan Shlofmitz, Ajay J. Kirtane, J. Jane Cao, Jeffrey W. Moses, Ziad A. Ali, Allen Jeremias, Richard A. Shlofmitz, and Akiko Maehara

Subjects
Coronary Restenosis, Hyperplasia, Treatment Outcome, Prevalence, Humans, Drug-Eluting Stents, Female, Constriction, Pathologic, Renal Insufficiency, Cardiology and Cardiovascular Medicine, Lipids
Abstract

Background: Clinical and morphological factors associated with lipidic versus calcified neoatherosclerosis within second-generation drug-eluting stents and the impact of lipidic versus calcified neoatherosclerosis on long-term outcomes after repeat intervention have not been well studied. Methods: A total of 512 patients undergoing optical coherence tomography before percutaneous coronary intervention for second-generation drug-eluting stents in-stent restenosis were included. Neoatherosclerosis was defined as lipidic or calcified neointimal hyperplasia in ≥3 consecutive frames or ruptured lipidic neointimal hyperplasia. The primary outcome was target lesion failure (cardiac death, target vessel myocardial infarction, definite stent thrombosis, or clinically driven target lesion revascularization). Results: The overall prevalence of neoatherosclerosis was 28.5% (146/512): 56.8% lipidic, 30.8% calcified, and 12.3% both lipidic and calcific. The prevalence increased as a function of time from stent implantation: 20% at 1 to 3 years, 30% at 3 to 7 years, and 75% >7 years. Renal insufficiency, poor lipid profile, and time from stent implantation were associated with lipidic neoatherosclerosis, whereas severe renal insufficiency, female sex, and time from stent implantation were associated with calcified neoatherosclerosis. Multivariable Cox regression revealed that female sex and lipidic neoatherosclerosis were associated with more target lesion failure, whereas stent age and final minimum lumen diameter after reintervention were related to lower target lesion failure. Calcified neoatherosclerosis was not related to adverse events after reintervention for in-stent restenosis given a large enough minimum lumen diameter was achieved. Conclusions: Lipidic but not calcified neoatherosclerosis was associated with poor subsequent outcomes after repeat revascularization if optimal stent expansion was achieved in lesions with calcified neoatherosclerosis.

Published
2022

22. Clinical determinants of coronary artery disease burden and vulnerability using optical coherence tomography co-registered with intravascular ultrasound

Author

Yang Cao, Yoshihisa Kanaji, Gary S. Mintz, Masahiro Hoshino, Tetsumin Lee, Akiko Maehara, Tadashi Murai, Mitsuaki Matsumura, Eisuke Usui, Wenbin Zhang, Taishi Yonetsu, and Tsunekazu Kakuta

Subjects
Male, medicine.medical_specialty, Patient characteristics, Coronary Artery Disease, Lesion, Coronary artery disease, Cost of Illness, Optical coherence tomography, Predictive Value of Tests, Diabetes mellitus, Internal medicine, Intravascular ultrasound, medicine, Humans, cardiovascular diseases, Thrombus, Ultrasonography, Interventional, Disease burden, Aged, medicine.diagnostic_test, business.industry, General Medicine, Middle Aged, medicine.disease, Cardiology, Female, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Tomography, Optical Coherence
Abstract

Objectives We investigated clinical determinants of disease burden and vulnerability using optical coherence tomography (OCT) co-registered with intravascular ultrasound (IVUS) in a large cohort of patients. Methods A total of 704 patients [44.5% with acute coronary syndromes (ACS)] underwent coronary intervention. IVUS plaque burden and OCT lipid, macrophage and calcium indices and the presence of thrombus, plaque rupture and thin-cap fibroatheroma (TCFA) were analyzed. Results Median patient age was 66 years with 81.8% men, 34.4% with diabetes mellitus and 15.5% with preadmission statins. Median lesion length was 25.7 mm, and 33.0% had a TCFA. Adjusted models indicated (1) older patient age was related to more calcium, but fewer macrophages; (2) men were related to more thrombus with plaque rupture while women had more thrombus without plaque rupture; (3) ACS presentation was related to morphological acute thrombotic events (more thrombus with/without rupture) and plaque vulnerability (more TCFA, more lipid and macrophages and larger plaque burden); (4) diabetes mellitus was related to a greater atherosclerotic disease burden (more lipid and calcium and larger plaque burden) and more thrombus without rupture; (5) hypertension was related to more macrophages; (6) current smoking was related to less calcium; and (7) renal insufficiency and preadmission statin therapy were not independently associated with IVUS or OCT plaque morphology. Conclusion Patient characteristics, especially diabetes mellitus and aging, affect underlying atherosclerotic burden, among which a greater lipidic burden along with sex differences influence local thrombotic morphology that affects clinical presentation.

Published
2021

23. Stent Expansion Indexes to Predict Clinical Outcomes

Author

D. Christopher Metzger, Thomas Stuckey, Gregg W. Stone, Michael Rinaldi, Mitsuaki Matsumura, Tatsuhiro Fujimura, Giora Weisz, Akiko Maehara, Peter L. Duffy, Gary S. Mintz, Zhipeng Zhou, Bernhard Witzenbichler, and Ziad A. Ali

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Hazard ratio, Stent, Percutaneous coronary intervention, equipment and supplies, Confidence interval, surgical procedures, operative, medicine.anatomical_structure, Intravascular ultrasound, Conventional PCI, medicine, cardiovascular diseases, Radiology, Cardiology and Cardiovascular Medicine, business, Target lesion revascularization, Artery
Abstract

Objectives The aim of this study was to evaluate various stent expansion indexes to determine the best predictor of clinical outcomes. Background Numerous intravascular ultrasound (IVUS) studies have shown minimum stent area (MSA) to be the most powerful predictor of future events. Methods ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. Native coronary artery lesions treated with IVUS-guided PCI with final analyzable IVUS were included. Ten stent expansion indexes (MSA, MSA/vessel area at MSA site, conventional stent expansion [MSA/average of proximal and distal reference luminal area], minimum stent expansion using Huo-Kassab or linear model accounting for vessel tapering, stent asymmetry [minimum/maximum stent diameter within the entire stent], stent eccentricity [smallest minimum/maximum stent diameter at a single slice within the stent], IVUS-XPL [Impact of intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions] criteria, and ILUMIEN IV criteria) were evaluated for their associations with lesion-specific 2-year clinically driven target lesion revascularization (TLR) or definite stent thrombosis. Results Overall, 2,140 lesions in 1,831 patients were included; final MSA measured 6.2 ± 2.4 mm2. Among the 10 stent expansion indexes, only MSA/vessel area at the MSA site was independently associated with 2-year clinically driven TLR or definite stent thrombosis (hazard ratio: 0.77; 95% confidence interval: 0.59-0.99; P = 0.04) after adjusting for morphologic and procedural parameters. Conclusions In this IVUS-guided PCI cohort with excellent final MSA overall, stent/vessel area at the MSA site, an index of relative stent expansion, was superior to absolute MSA and other expansion indexes in predicting 2-year clinically driven TLR or definite stent thrombosis.

Published
2021

24. Diagnostic performance of angiography-based fractional flow reserve by patient and lesion characteristics

Author

Abid Assali, De Bruyne B, Martin B. Leon, Stephan Achenbach, Gabriel Greenberg, Ran Kornowski, Allen Jeremias, Ajay J. Kirtane, Thomas McAndrew, Daniel M. Kolansky, Stephane Fournier, Thomas Engstrom, Mitsuaki Matsumura, Richard Shlofmitz, Ovidiu Dressler, Rami Jubeh, Yuhei Kobayashi, William F. Fearon, Carlos Collet, Ziad A. Ali, and Akiko Maehara

Subjects
medicine.medical_specialty, Acute coronary syndrome, medicine.diagnostic_test, business.industry, Fractional flow reserve, medicine.disease, Lesion, Internal medicine, Diabetes mellitus, Angiography, medicine, Cardiology, In patient, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Body mass index, Calcification
Abstract

BACKGROUND A large, prospective, multicentre trial recently showed that fractional flow reserve (FFR) derived from coronary angiography (FFRangio) has an accuracy of 92% compared with conventional guidewire-based FFR (FFRwire); however, little is known about whether specific patient/lesion characteristics affect the diagnostic performance. AIMS The primary goal of the present study was to investigate whether specific patient or lesion characteristics such as high body mass index (BMI), presentation with an acute coronary syndrome, or lesion location affect the diagnostic performance of FFRangio in patients enrolled in the FAST-FFR study. METHODS FFRangio was measured in a blinded fashion in 301 patients (319 vessels) who were undergoing FFRwire assessment. Using an FFRwire ≤0.80 as a reference, the diagnostic performance of FFRangio was compared in pre-specified subgroups. RESULTS The mean FFRwire and FFRangio were 0.81±0.13 and 0.80±0.12. Overall, FFRangio had a sensitivity of 93.5% and specificity of 91.2% for predicting FFRwire. Patient characteristics including age, sex, clinical presentation, body mass index, and diabetes did not affect sensitivity or specificity (p>0.05 for all). Similarly, lesion characteristics including calcification and tortuosity did not affect sensitivity or specificity (p>0.05 for all), nor did lesion location (proximal, middle, versus distal). Sensitivity was equally high across all target vessels, while specificity was highest in the LAD and lower (~85%) in the RCA and LCx (p

Published
2021

25. Coronary morphological features in women with non-ST-segment elevation MINOCA and MI-CAD as assessed by optical coherence tomography

Author

Eisuke Usui, Mitsuaki Matsumura, Nathaniel R Smilowitz, Gary S Mintz, Jacqueline Saw, Raymond Y Kwong, Masahiro Hada, Ehtisham Mahmud, Caitlin Giesler, Binita Shah, Sripal Bangalore, Louai Razzouk, Masahiro Hoshino, Kevin Marzo, Ziad A Ali, C Noel Bairey Merz, Tomoyo Sugiyama, Bryan Har, Tsunekazu Kakuta, Judith S Hochman, Harmony R Reynolds, and Akiko Maehara

Abstract

Aims We aimed to use optical coherence tomography (OCT) to identify differences in atherosclerotic culprit lesion morphology in women with myocardial infarction (MI) with non-obstructive coronary arteries (MINOCA) compared with MI with obstructive coronary artery disease (MI-CAD). Methods and results Women with an OCT-determined atherosclerotic aetiology of non-ST segment elevation (NSTE)-MINOCA (angiographic diameter stenosis We analysed 58 women with NSTE-MINOCA and 52 women with NSTE-MI-CAD. Optical coherence tomography features of underlying vulnerable plaque (thin-cap fibroatheroma) were less common in MINOCA (3 vs. 35%) than in MI-CAD. Intraplaque haemorrhage (47 vs. 2%) and layered plaque (31 vs. 12%) were more common in MINOCA than MI-CAD, whereas plaque rupture (14 vs. 67%), plaque erosion (8 vs. 14%), and calcified nodule (0 vs. 6%) were less common in MINOCA. The angle of ruptured cavity was smaller and thrombus burden was lower in MINOCA. Conclusion The prevalence of atherothrombotic culprit lesion subtype varied substantially between MINOCA and MI-CAD. A majority of culprit lesions in MINOCA had the appearance of IPH or layered plaque. Clinical Trial Registration Information Clinical Trial Name: Heart Attack Research Program- Imaging Study (HARP); ClinicalTrial.gov Identifier: NCT02905357; URL: https://clinicaltrials.gov/ct2/show/NCT02905357

Published
2022

26. Artificial intelligence and optical coherence tomography for the automatic characterisation of human atherosclerotic plaques

Author

Akiko Maehara, Bo Xu, Gary S. Mintz, Bo Yu, Ziad A. Ali, Juan Luis Gutiérrez-Chico, Ming Zeng, Peng Wu, Niels Ramsing Holm, William Wijns, Luping He, Xiaoling Zeng, Lianglong Chen, Chen Zhao, Shengxian Tu, Haibo Jia, Mitsuaki Matsumura, Miao Chu, and Takashi Kubo

Subjects
medicine.diagnostic_test, business.industry, Plaque composition, External validation, Diagnostic accuracy, 030204 cardiovascular system & hematology, Plaque, Atherosclerotic, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Sørensen–Dice coefficient, Optical coherence tomography, Artificial Intelligence, Clinical Research, Median time, Fibrous plaque, Humans, Medicine, 030212 general & internal medicine, Artificial intelligence, Tomography, Cardiology and Cardiovascular Medicine, business, Tomography, Optical Coherence
Abstract

BACKGROUND: Intravascular optical coherence tomography (IVOCT) enables detailed plaque characterisation in-vivo, but visual assessment is time-consuming and subjective.AIMS: This study aims to develop and validate an automatic framework for IVOCT plaque characterisation using artificial intelligence (AI).METHODS: IVOCT pullbacks from 5 international centres were analysed in a corelab, annotating basic plaque components, inflammatory markers and other structures. A deep convolutional network with encoding-decoding architecture and pseudo-3D input was developed and trained using hybrid loss. The proposed network was integrated into commercial software to be externally validated on additional IVOCT pullbacks from three international corelabs, taking the consensus among corelabs as reference.RESULTS: Annotated images from 509 pullbacks (391 patients) were divided into 10,517 and 1,156 cross-sections for the training and testing datasets, respectively. Dice coefficient of the model was 0.906 for fibrous plaque, 0.848 for calcium and 0.772 for lipid in the testing dataset. Excellent agreement in plaque burden quantification was observed between the model and manual measurements (R2=0.98). In the external validation, the software correctly identified 518 out of 598 plaque regions from 300 IVOCT cross-sections, with a diagnostic accuracy of 97.6%[95%CI:93.4%-99.3%] in fibrous plaque, 90.5%[95%CI:85.2%-94.1%] in lipid and 88.5%[95%CI:82.4%-92.7%] in calcium. The median time required for analysis was 21.4 (18.6-25.0) seconds per pullback.CONCLUSIONS: A novel AI framework for automatic plaque characterisation in IVOCT was developed, providing excellent diagnostic accuracy in both internal and external validation. This model might reduce subjectivity in image interpretation and facilitate IVOCT quantification of plaque composition, with potential applications in research and IVOCT-guided PCI.

Published
2021

27. Cardiac Computed Tomography Angiography Anatomical Characterization of Patients Screened for a Dedicated Transfemoral Transcatheter Valve System for Primary Aortic Regurgitation

Author

Shawnbir Gogia, Torsten P. Vahl, Vinod H. Thourani, Pradeep K. Yadav, Isaac George, Susheel K. Kodali, Nadira Hamid, Lauren Ranard, Tiffany Chen, Mitsuaki Matsumura, Akiko Maehara, Hendrik Treede, Stephan Baldus, David Daniels, Brett C. Sheridan, Firas Zahr, Mark J. Russo, James M. McCabe, Stanley J. Chetcuti, Martin B. Leon, Raj R. Makkar, and Omar K. Khalique

Subjects
Cardiology and Cardiovascular Medicine
Published
2023

31. Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial

Author

Franco Fabbiocchi, Zhen Zhang, Fernando Alfonso, Nick E.J. West, Giulio Guagliumi, Takashi Akasaka, Richard Shlofmitz, Ori Ben-Yehuda, Keyvan Karimi Galougahi, Gregg W. Stone, Richard R Rapoza, Mitsuaki Matsumura, Akiko Maehara, Ziad A. Ali, and Gary S. Mintz

Subjects
medicine.medical_specialty, medicine.medical_treatment, Coronary Artery Disease, 030204 cardiovascular system & hematology, Coronary Angiography, law.invention, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Randomized controlled trial, Clinical Research, law, Intravascular ultrasound, Coronary stent, medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, Ultrasonography, Interventional, medicine.diagnostic_test, business.industry, Percutaneous coronary intervention, Stent, Treatment Outcome, surgical procedures, operative, Conventional PCI, Angiography, Stents, Radiology, Cardiology and Cardiovascular Medicine, business, Tomography, Optical Coherence, Mace
Abstract

Aims In the ILUMIEN III trial, among 450 randomised patients with non-complex lesions undergoing percutaneous coronary intervention (PCI), optical coherence tomography (OCT) guidance led to greater stent expansion than angiography guidance, similar minimal stent area compared to both intravascular ultrasound (IVUS) guidance and angiography guidance, and lower rates of uncorrected dissection and malapposition than both IVUS guidance and angiography guidance. Whether these differences impact on clinical outcomes is unknown. The aim of the present study was to report the 12-month clinical follow-up data from the ILUMIEN III study. Methods and results OCT-guided PCI, using an external elastic lamina-based protocol, was compared to operator-directed IVUS-guided or angiography-guided PCI. Target lesion failure (TLF) and major adverse cardiovascular events (MACE) at 12 months were adjudicated by a blinded clinical events committee. There were no significant differences in the rates of TLF (2.0% OCT, 3.7% IVUS, 1.4% angiography), MACE (9.8% OCT, 9.1% IVUS, 7.9% angiography), or any of the individual components of these outcomes among the groups. No independent predictors of 12-month stent-related clinical events were identified from final OCT. Conclusions In this underpowered study, OCT-guided PCI of non-complex lesions did not show a statistical difference in clinical outcomes at 12 months compared with IVUS or angiography guidance. An appropriately powered trial, including only complex patients and lesions, is underway to substantiate the potential clinical benefit of OCT-guided PCI. Trial registration NCT02471586.

Published
2021

32. Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI – design and rationale of ILUMIEN IV: OPTIMAL PCI

Author

Robert McGreevy, Keyvan Karimi Galougahi, Akiko Maehara, Mitsuaki Matsumura, Jonathan Hill, Zhen Zhang, Takashi Akasaka, Gary S. Mintz, Nick E.J. West, Ori Ben-Yehuda, Francesco Prati, Richard Shlofmitz, Ziad A. Ali, Matthew J. Price, Hiram G. Bezerra, William Wijns, Gregg W. Stone, Giulio Guagliumi, Richard R. Rapoza, and Ulf Landmesser

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Percutaneous coronary intervention, Lumen (anatomy), Stent, 030204 cardiovascular system & hematology, medicine.disease, law.invention, 03 medical and health sciences, surgical procedures, operative, 0302 clinical medicine, Randomized controlled trial, law, Intravascular ultrasound, Coronary stent, Conventional PCI, medicine, cardiovascular diseases, 030212 general & internal medicine, Myocardial infarction, Radiology, Cardiology and Cardiovascular Medicine, business
Abstract

Aims Randomised trials have demonstrated improvement in clinical outcomes with intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI. The ILUMIEN III trial demonstrated non-inferiority of an optical coherence tomography (OCT)- versus IVUS-guided PCI strategy in achieving similar post-PCI lumen dimensions. ILUMIEN IV is a large-scale, multicentre, randomised trial designed to demonstrate the superiority of OCT- versus angiography-guided stent implantation in patients with high-risk clinical characteristics (diabetes) and/or complex angiographic lesions in achieving larger post-PCI lumen dimensions and improving clinical outcomes. Methods and results ILUMIEN IV is a prospective, single-blind clinical investigation that will randomise between 2,490 and 3,656 patients using an adaptive design to OCT-guided versus angiography-guided coronary stent implantation in a 1:1 ratio. The primary endpoints are: (1) post-PCI minimal stent area assessed by OCT in each randomised arm, and (2) target vessel failure, the composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target vessel revascularisation. Clinical follow-up will continue for up to two years. The trial is currently enrolling, and the principal results are expected in 2022. Conclusions The large-scale ILUMIEN IV randomised controlled trial will evaluate the effectiveness of OCT-guided versus angiography-guided PCI in improving post-PCI lumen dimensions and clinical outcomes in patients with diabetes and/or with complex coronary lesions. Trial registration NCT03507777.

Published
2021

35. Directional versus orbital atherectomy of femoropopliteal artery lesions: Angiographic and intravascular ultrasound outcomes

Author

Anvar Babaev, Michael Halista, Zulfiya Bakirova, Valeryia Avtushka, Mitsuaki Matsumura, and Akiko Maehara

Subjects
4-Acetamido-4'-isothiocyanatostilbene-2,2'-disulfonic Acid, Atherectomy, Angiography, General Medicine, Plaque, Atherosclerotic, Femoral Artery, Peripheral Arterial Disease, Treatment Outcome, Coated Materials, Biocompatible, Humans, Radiology, Nuclear Medicine and imaging, Popliteal Artery, Prospective Studies, Cardiology and Cardiovascular Medicine, Angioplasty, Balloon, Ultrasonography, Interventional, Vascular Patency
Abstract

The aim of this study was to compare the ability of two different atherectomy modalities, the directional atherectomy system (DAS) and the orbital atherectomy system (OAS), to modify plaque and augment luminal gain as evaluated by angiography and intravascular ultrasound (IVUS) in patients with symptomatic femoro-popliteal peripheral arterial disease (PAD).Atherectomy is frequently utilized in the treatment of complex PAD. To date, there are no head-to-head comparisons of existing devices and their selection is based mostly on operator preference rather than on supportive data.This was a single-center, prospective, randomized trial designed to assess the impact of DAS in comparison to OAS on atherosclerotic plaque. Pre- and postatherectomy lesion characterization was performed by angiography and IVUS. Drug-coated balloon (DCB) angioplasty was performed after atherectomy with similar analysis repeated.Sixty patients were randomized to undergo either DAS or OAS. Pretreatment angiographic and IVUS characteristics were similar in the DAS and OAS groups. DAS led to a greater reduction in plaque volume throughout the entire lesion (5.9% vs. 1.1%, p = 0.003). This corresponded to a greater increase in total vessel and lumen volume by IVUS (161.5 mmCompared to OAS, DAS demonstrated a greater plaque volume reduction and luminal gain with significantly fewer stents needed post-DCB.

Published
2022

36. Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque

Author

Akiko Maehara, Ovidiu Dressler, Ori Ben-Yehuda, Ziad A. Ali, Mitsuaki Matsumura, Ulf Jensen, Thor Trovik, Gary S. Mintz, Thomas Engstrøm, Prospect Absorb Investigators, Jonas Persson, Stefan James, Claes Held, Hans Erik Bøtker, Rune Wiseth, Aaron Crowley, Michael Maeng, Lars Kjøller-Hansen, David Erlinge, and Gregg W. Stone

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Pilot Projects, Coronary Artery Disease, 030204 cardiovascular system & hematology, medicine.disease_cause, Coronary artery disease, Blood Vessel Prosthesis Implantation, 03 medical and health sciences, Percutaneous Coronary Intervention, 0302 clinical medicine, Internal medicine, Absorbable Implants, medicine, Humans, 030212 general & internal medicine, Ultrasonography, Interventional, Aged, business.industry, Dual Anti-Platelet Therapy, Coronary Stenosis, Stent, Percutaneous coronary intervention, Middle Aged, medicine.disease, Vulnerable plaque, Thrombosis, Plaque, Atherosclerotic, Large plaque, Cardiology, Female, Stents, lipids (amino acids, peptides, and proteins), Cardiology and Cardiovascular Medicine, business, Bioresorbable scaffold
Abstract

BACKGROUND: Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild.OBJECTIVES: We sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques.METHODS: Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically non-obstructive stenosis not intended for PCI but with IVUS plaque burden ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) vs. GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (non-powered) safety endpoint was randomized target lesion failure (TLF; cardiac death, target vessel-related MI or clinically-driven target lesion revascularization) at 24 months. The secondary (non-powered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (MACE; cardiac death, MI, unstable angina, or progressive angina) at latest follow-up.RESULTS: A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by NIRS-IVUS median plaque burden was 73.7%, median MLA was 2.9 mm2, and median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9±2.6 mm2 compared with 3.0±1.0 mm2 in GDMT alone-treated lesions (least square means difference 3.9 mm2, 95% CI 3.3-4.5, PCONCLUSIONS: PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial.

Published
2020

37. Prognostic impact of healed coronary plaque in non-culprit lesions assessed by optical coherence tomography

Author

Gary S. Mintz, Eisuke Usui, Akiko Maehara, Tetsumin Lee, Mitsuaki Matsumura, Tomoyo Sugiyama, Taishi Yonetsu, Masao Yamaguchi, Masahiro Hada, Yiran Zhang, Tsunekazu Kakuta, Tadashi Murai, Yoshihisa Kanaji, and Masahiro Hoshino

Subjects
0301 basic medicine, medicine.medical_specialty, medicine.medical_treatment, Myocardial Infarction, Coronary Artery Disease, 030204 cardiovascular system & hematology, Coronary Angiography, Revascularization, Culprit, Lesion, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, Internal medicine, medicine, Humans, Myocardial infarction, business.industry, Hazard ratio, Stent, Percutaneous coronary intervention, Prognosis, medicine.disease, Coronary Vessels, Plaque, Atherosclerotic, 030104 developmental biology, Cardiology, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Tomography, Optical Coherence, Mace
Abstract

We sought to investigate the characteristics and prognostic impact of healed plaque (HP) detected by optical coherence tomography (OCT) in non-culprit segments in treated vessels.OCT analysis included HP having a different optical intensity with clear demarcation from underlying plaque, thin-cap fibroatheroma (TCFA), and minimal lumen area. Non-culprit lesion (NCL) was defined as a plaque with90° arc of disease (≥0.5 mm intimal thickness), length ≥2 mm, and location5 mm from the stent edges. Major adverse cardiac event (MACE) included cardiac death, myocardial infarction (MI), or ischemia-driven revascularization (IDR).We studied a total of 726 NCLs in 538 patients who underwent percutaneous coronary intervention with evaluable non-culprit segments by OCT. The prevalence of an HP was 17.8% (129/726) per lesion and 21.9% (118/538) per patient. At median follow-up of 2.2 years, there were 65 NCL-related MACE events, including 6 MIs and 65 IDRs of which 87.7% had a stable presentation. The presence of untreated HP was positively correlated with subsequent NCL-related MACE (hazard ratio [HR] 2.01, 95% confidence interval [CI], 1.20-3.37, p 0.01). There were 16 IDRs with stable angina occurring at a specific OCT-imaged NCL where an untreated HP was positively associated with subsequent NCL-related MACE (HR 3.72, 95% CI 1.35-10.30, p = 0.01) along with TCFA (HR 10.0, 95% CI 3.20-31.40, p 0.01) and minimal lumen area3.5 mmAn OCT-detected HP in an NCL is a marker for future (mostly) stable non-culprit-related MACE at both a patient- and lesion-level.

Published
2020

38. Using intravascular ultrasound image-based fluid-structure interaction models and machine learning methods to predict human coronary plaque vulnerability change

Author

David Muccigrosso, Liang Wang, Dalin Tang, Akiko Maehara, Richard G. Bach, Zheyang Wu, Kristen L. Billiar, Gregg W. Stone, Chun Yang, Gary S. Mintz, Mitsuaki Matsumura, and Jie Zheng

Subjects
Male, medicine.medical_specialty, Support Vector Machine, 0206 medical engineering, Cardiovascular research, Biomedical Engineering, Vulnerability, Bioengineering, 02 engineering and technology, Coronary Angiography, Machine Learning, Coronary artery disease, 03 medical and health sciences, Imaging, Three-Dimensional, 0302 clinical medicine, Risk Factors, Coronary plaque, Internal medicine, Intravascular ultrasound, medicine, Vulnerability prediction, Humans, Ultrasonography, Interventional, Ultrasonography, medicine.diagnostic_test, business.industry, Models, Cardiovascular, 030229 sport sciences, General Medicine, Middle Aged, medicine.disease, Coronary Vessels, 020601 biomedical engineering, Plaque, Atherosclerotic, Biomechanical Phenomena, Computer Science Applications, Human-Computer Interaction, ROC Curve, Area Under Curve, Linear Models, Cardiology, Female, business, Image based
Abstract

Plaque vulnerability prediction is of great importance in cardiovascular research. In vivo follow-up intravascular ultrasound (IVUS) coronary plaque data were acquired from nine patients to construct fluid-structure interaction models to obtain plaque biomechanical conditions. Morphological plaque vulnerability index (MPVI) was defined to measure plaque vulnerability. The generalized linear mixed regression model (GLMM), support vector machine (SVM) and random forest (RF) were introduced to predict MPVI change (ΔMPVI = MPVI

Published
2020

39. Visualizing Inside Conduits-Intraoperative Screening of Grafts by Optical Coherence Tomography

Author

Edward F. Lundy, Keyvan Karimi Galougahi, Dylan Dominguez-Sulca, Elma Chowdhury, Susan V. Thomas, Craig R. Porter, Gary S. Mintz, Mitsuaki Matsumura, Akiko Maehara, David J. Cohen, Jeffrey W. Moses, Evan S. Shlofmitz, Allen Jeremias, Nick E.J. West, Newell B. Robinson, Richard A. Shlofmitz, and Ziad A. Ali

Subjects
Pulmonary and Respiratory Medicine, Treatment Outcome, Humans, Surgery, Stents, Saphenous Vein, Coronary Artery Bypass, Cardiology and Cardiovascular Medicine, Coronary Angiography, Tomography, Optical Coherence, Plaque, Atherosclerotic, Vascular Patency
Abstract

Saphenous vein graft (SVG) failure is a complex phenomenon, with technical, biologic, and local factors contributing to early and medium- and long-term failure after coronary artery bypass graft. Both technical and conduit factors may have significant impact on early SVG failure.We review the complex factors that play a pathogenic role in SVG failure, followed by review of the existing literature on potential utility of high-definition optical coherence tomography (OCT) in comprehensive intraoperative assessment of SVGs.We describe a new technique for intraoperative acquisition of OCT images in the harvested SVGs and introduce a classification system for pathologic processes that can be detected in the harvested SVG conduits by OCT.The potential impact on early graft failure of the exclusion of segments of SVGs that are less than optimal (ie, containing fibroatheroma, retained thrombus, sclerotic valves, or procurement injury) will be examined in the randomized controlled OCTOCAB (Intraoperative Optical Coherence Tomography of the Saphenous Vein Conduit in Patients Undergoing Coronary Artery Bypass Surgery) trial.

Published
2022

40. TCT-79 Changes in Coronary Lipid Composition During 2-Year Follow-Up After Acute Myocardial Infarction:Serial NIRS-IVUS Assessment From the PROSPECT ABSORB Trial

Author

David Erlinge, Stefan James, Elmir Omerovic, Zhipeng Zhou, Lisette Okkels Jensen, Gary S. Mintz, Jan Erik Nordrehaug, Ziad A. Ali, Øyvind Bleie, Jonas Persson, Mitsuaki Matsumura, Rune Wiseth, Ole Fröbert, Akiko Maehara, Michael Maeng, Claes Held, Alf Inge Larsen, Gregg W. Stone, Ori Ben-Yehuda, Thomas Engstroem, and Lars Kjøller-Hansen

Subjects
medicine.medical_specialty, business.industry, Lipid composition, Internal medicine, Cardiology, Medicine, Myocardial infarction, Cardiology and Cardiovascular Medicine, business, medicine.disease
Published
2021

41. Intravascular Ultrasound–Derived Calcium Score to Predict Stent Expansion in Severely Calcified Lesions

Author

Tatsuhiro Fujimura, Mitsuaki Matsumura, Ziad A. Ali, Martin B. Leon, LeRoy E. Rabbani, Dimitri Karmpaliotis, Akiko Maehara, Jeffrey W. Moses, Zixuan Zhang, Gary S. Mintz, Khady N. Fall, Ajay J. Kirtane, Michael B. Collins, Eisuke Usui, Tamim Nazif, Mingyou Zhang, Masahiko Noguchi, and Sahil A. Parikh

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Stent, chemistry.chemical_element, Percutaneous coronary intervention, Calcium, Atherectomy, chemistry, Intravascular ultrasound, medicine, Radiology, Cardiology and Cardiovascular Medicine, business, Calcium score
Abstract

Background: Coronary calcification inhibits stent expansion. We sought to establish an intravascular ultrasound–derived calcium score to predict stent underexpansion. Methods: This is a retrospective observational study including de novo lesions that underwent intravascular ultrasound–guided stenting and had maximum superficial calcium angle >270°. Lesions with angiographic calcium not treated with atherectomy or scoring/cutting balloon before stent implantation were randomly divided into derivation and validation cohorts. The end point was stent expansion (minimum stent area/average of reference lumen area) at the maximum calcium site, and stent expansion Results: The morphological characteristics associated with stent underexpansion in derivation cohort were (1) superficial calcium angle >270° longer than 5 mm (regression coefficient, −13.0 [95% CI, −18.1 to −7.8], P P =0.001), (3) calcified nodule (regression coefficient, −8.3 [95% CI, −14.3 to −2.2], P =0.007), and (4) vessel diameter P =0.006). The calcium score (0-4) was significantly correlated with poor stent expansion (regression coefficient, −8.1 [95% CI, −10.5 to −5.7], P P P interaction =0.02). In lesions without angiographic calcium, all calcium severity parameters were less than in the validation cohort, and stent underexpansion was observed in only 1.5% (1/67) of lesions. Conclusions: This intravascular ultrasound calcium score provides the interventionalists with a reliable tool to identify calcified stenoses at risk for stent underexpansion and requiring adjunctive calcium modification before stent implantation.

Published
2021

43. Using Optical Coherence Tomography and Intravascular Ultrasound Imaging to Quantify Coronary Plaque Cap Stress/Strain and Progression: A Follow-Up Study Using 3D Thin-Layer Models

Author

Mitsuaki Matsumura, Caining Zhang, Rui Lv, Akiko Maehara, Dalin Tang, Xiaoya Guo, Jie Zheng, Liang Wang, Habib Samady, Gary S. Mintz, Mengde Huang, and Don P. Giddens

Subjects
patient-specific coronary plaque models, Histology, Thin layer, Biomedical Engineering, Bioengineering, medicine.disease_cause, Optical coherence tomography, Coronary plaque, Intravascular ultrasound, medicine, optical coherence tomography-based coronary models, Original Research, Mathematics, medicine.diagnostic_test, business.industry, Stress–strain curve, Follow up studies, Bioengineering and Biotechnology, coronary plaque, plaque progression prediction, Vulnerable plaque, Angiography, vulnerable plaque, Nuclear medicine, business, TP248.13-248.65, Biotechnology
Abstract

Accurate plaque cap thickness quantification and cap stress/strain calculations are of fundamental importance for vulnerable plaque research. To overcome uncertainties due to intravascular ultrasound (IVUS) resolution limitation, IVUS and optical coherence tomography (OCT) coronary plaque image data were combined together to obtain accurate and reliable cap thickness data, stress/strain calculations, and reliable plaque progression predictions. IVUS, OCT, and angiography baseline and follow-up data were collected from nine patients (mean age: 69; m: 5) at Cardiovascular Research Foundation with informed consent obtained. IVUS and OCT slices were coregistered and merged to form IVUS + OCT (IO) slices. A total of 114 matched slices (IVUS and OCT, baseline and follow-up) were obtained, and 3D thin-layer models were constructed to obtain stress and strain values. A generalized linear mixed model (GLMM) and least squares support vector machine (LSSVM) method were used to predict cap thickness change using nine morphological and mechanical risk factors. Prediction accuracies by all combinations (511) of those predictors with both IVUS and IO data were compared to identify optimal predictor(s) with their best accuracies. For the nine patients, the average of minimum cap thickness from IVUS was 0.17 mm, which was 26.08% lower than that from IO data (average = 0.23 mm). Patient variations of the individual errors ranged from ‒58.11 to 20.37%. For maximum cap stress between IO and IVUS, patient variations of the individual errors ranged from ‒30.40 to 46.17%. Patient variations of the individual errors of maximum cap strain values ranged from ‒19.90 to 17.65%. For the GLMM method, the optimal combination predictor using IO data had AUC (area under the ROC curve) = 0.926 and highest accuracy = 90.8%, vs. AUC = 0.783 and accuracy = 74.6% using IVUS data. For the LSSVM method, the best combination predictor using IO data had AUC = 0.838 and accuracy = 75.7%, vs. AUC = 0.780 and accuracy = 69.6% using IVUS data. This preliminary study demonstrated improved plaque cap progression prediction accuracy using accurate cap thickness data from IO slices and the differences in cap thickness, stress/strain values, and prediction results between IVUS and IO data. Large-scale studies are needed to verify our findings.

Published
2021

44. Comparison of 6‐month vascular healing response after bioresorbable polymer versus durable polymer drug‐eluting stent implantation in patients with acute coronary syndromes: A randomized serial optical coherence tomography study

Author

Shinya Okazaki, Kikuo Isoda, Hirohisa Endo, Masahiko Noguchi, Gary S. Mintz, Hiroki Nishiyama, Hiroshi Iwata, Mitsuaki Matsumura, Mitsuhiro Takeuchi, Yoshiteru Kato, Tomotaka Dohi, Katsumi Miyauchi, Shinichiro Doi, Akiko Maehara, Fumiyasu Seike, Tohru Minamino, Tatsuhiro Fujimura, Hiroyuki Daida, Eisuke Usui, and Iwao Okai

Subjects
Acute coronary syndrome, Polymers, medicine.medical_treatment, Bioresorbable polymers, Percutaneous Coronary Intervention, Optical coherence tomography, Absorbable Implants, Clinical endpoint, Humans, Medicine, Radiology, Nuclear Medicine and imaging, Prospective Studies, Acute Coronary Syndrome, Sirolimus, Neointimal hyperplasia, medicine.diagnostic_test, business.industry, Stent, Drug-Eluting Stents, General Medicine, medicine.disease, Apposition, Treatment Outcome, Drug-eluting stent, Cardiology and Cardiovascular Medicine, business, Nuclear medicine, Tomography, Optical Coherence
Abstract

Objectives This study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES) in patients with acute coronary syndromes (ACS). Background Whether BP-EES induce better vascular healing compared to contemporary DP-EES remains controversial, especially for ACS. Methods In this prospective, randomized, non-inferiority trial, we used OCT to compare 6-month vascular healing in patients with ACS randomized to BP versus DP-EES: percent strut coverage (primary endpoint, non-inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated. Results A total of 104 patients with ACS were randomly assigned to BP-EES (n = 52) versus DP-EES (n = 52). Of these, 86 patients (40 BP-EES and 46 DP-EES) were included in the final OCT analyses. Six-month percent strut coverage of BP-EES (83.6 ± 11.4%) was not non-inferior compared to those of DP-EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval-2.6%), pnon-inferiority = 0.07. There were no differences in neointimal thickness 70.0 ± 33.9 μm versus 67.2 ± 33.9 μm, p = 0.71; and percent NIH volume 7.5 ± 4.7% versus 7.3 ± 5.3%, p = 0.85. By multivariable linear regression analysis, stent type was not associated with percent strut coverage or percent NIH volume; however, percent baseline embedded struts or stent expansion was positively associated with percent NIH volume. Greater NIH volume was observed in lipidic compared with non-lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005). Conclusions Six-month strut coverage of BP-EES was not non-inferior compared to those of DP-EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.

Published
2021

45. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention

Author

Joel E. Schneider, Akiko Maehara, Habib Samady, Mitsuaki Matsumura, Manesh R. Patel, Justin E. Davies, Arnold H. Seto, Gregg W. Stone, Allen Jeremias, Ziad A. Ali, Koen M. Marques, Kare Tang, Luis Gruberg, Gary S. Mintz, Andrew Sharp, Nicolas W. Shammas, and Suneel Talwar

Subjects
medicine.medical_specialty, education.field_of_study, business.industry, medicine.medical_treatment, Population, Ischemia, Stent, Percutaneous coronary intervention, Fractional flow reserve, 030204 cardiovascular system & hematology, medicine.disease, Angina, Coronary artery disease, 03 medical and health sciences, surgical procedures, operative, 0302 clinical medicine, Internal medicine, Conventional PCI, Cardiology, Medicine, cardiovascular diseases, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, business, education
Abstract

Objectives This study sought to evaluate the incidence and causes of an abnormal instantaneous wave-free ratio (iFR) after angiographically successful percutaneous coronary intervention (PCI). Background Impaired coronary physiology as assessed by fractional flow reserve is present in some patients after PCI and is prognostically relevant. Methods DEFINE PCI (Physiologic Assessment of Coronary Stenosis Following PCI) was a multicenter, prospective, observational study in which a blinded iFR pull back was performed after angiographically successful PCI in 562 vessels in 500 patients. Inclusion criteria were angina with either multivessel or multilesion coronary artery disease with an abnormal baseline iFR. The primary endpoint of the study was the rate of residual ischemia after operator-assessed angiographically successful PCI, defined as an iFR Results An average of 1.1 vessels per patient had abnormal baseline iFRs, with a mean value of 0.69 ± 0.22, which improved to 0.93 ± 0.07 post-PCI. Residual ischemia after angiographically successful PCI was present in 112 patients (24.0%), with a mean iFR in that population of 0.84 ± 0.06 (range 0.60 to 0.89). Among patients with impaired post-PCI iFRs, 81.6% had untreated focal stenoses that were angiographically inapparent, and 18.4% had diffuse disease. Among the focal lesions, 38.4% were located within the stent segment, while 31.5% were proximal and 30.1% were distal to the stent. Post-PCI vessel angiographic diameter stenosis was not a predictor of impaired post-procedural iFR. Conclusions Blinded post-PCI physiological assessment detected residual ischemia in nearly 1 in 4 patients after coronary stenting despite an operator-determined angiographically successful result. Most cases of residual ischemia were due to inapparent focal lesions potentially amenable to treatment with additional PCI. (Physiologic Assessment of Coronary Stenosis Following PCI [DEFINE PCI]; NCT03084367)

Published
2019

46. The effectiveness of excimer laser angioplasty to treat coronary in-stent restenosis with peri-stent calcium as assessed by optical coherence tomography

Author

Jeffrey W. Moses, Thomas Pappas, Theofanis Tsiamtsiouris, Lei Song, Akiko Maehara, Fernando Sosa, Antonio Madrid, Cheolmin Lee, Elizabeth Haag, Dong Yin, Gary S. Mintz, Mitsuaki Matsumura, and Richard Shlofmitz

Subjects
medicine.medical_specialty, medicine.medical_treatment, Peri, Lumen (anatomy), chemistry.chemical_element, 030204 cardiovascular system & hematology, Calcium, Coronary Angiography, Angioplasty, Laser, Coronary Restenosis, 03 medical and health sciences, 0302 clinical medicine, Optical coherence tomography, Restenosis, Angioplasty, Humans, Medicine, cardiovascular diseases, 030212 general & internal medicine, Excimer laser, medicine.diagnostic_test, business.industry, Percutaneous coronary intervention, Stent, equipment and supplies, medicine.disease, Treatment Outcome, surgical procedures, operative, chemistry, Lasers, Excimer, Stents, Radiology, In stent restenosis, Cardiology and Cardiovascular Medicine, business, Nuclear medicine, Tomography, Optical Coherence, Excimer laser angioplasty
Abstract

AIMS We aimed to evaluate the effectiveness of excimer laser coronary angioplasty (ELCA) to treat in-stent restenosis (ISR) due to peri-stent calcium-related stent underexpansion as assessed by optical coherence tomography (OCT). METHODS AND RESULTS We studied 81 patients (81 lesions with ISR, stent underexpansion, and peri-stent calcium >90°) who underwent OCT imaging both pre and post percutaneous coronary intervention and compared lesions treated with ELCA (n=23) vs. without ELCA (n=58). ELCA use was associated with more calcium fracture (ELCA: 61%, non-ELCA: 12%, p

Published
2019

47. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography

Author

Rami Jubeh, Stephane Fournier, Thomas McAndrew, Akiko Maehara, Mitsuaki Matsumura, Thomas Engstrøm, Ran Kornowski, Ajay J. Kirtane, Allen Jeremias, William F. Fearon, Abid Assali, Stephan Achenbach, Gabriel Greenberg, Ovidiu Dressler, Martin B. Leon, Richard Shlofmitz, Bernard De Bruyne, and Daniel M. Kolansky

Subjects
Male, Coronary angiography, Cardiac Catheterization, medicine.medical_specialty, Coronary Artery Disease, Fractional flow reserve, Coronary Angiography, Severity of Illness Index, Coronary artery disease, Coronary circulation, Imaging, Three-Dimensional, Predictive Value of Tests, Physiology (medical), Internal medicine, Humans, Medicine, Prospective Studies, Guide-wire placement, Israel, Aged, business.industry, Coronary Stenosis, Reproducibility of Results, Middle Aged, medicine.disease, Coronary Vessels, Pressure wire, United States, Europe, Fractional Flow Reserve, Myocardial, medicine.anatomical_structure, Cardiology, Radiographic Image Interpretation, Computer-Assisted, Female, Cardiology and Cardiovascular Medicine, business
Abstract

Background: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFR angio ) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFR angio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFR angio . Methods: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFR angio using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFR angio for predicting pressure wire–derived FFR using a cutoff value of 0.80. The study was powered to meet prespecified performance goals for sensitivity and specificity. Results: Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFR angio was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFR angio values correlated well with FFR measurements ( r =0.80, P angio was 99%. Conclusions: FFR angio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire–derived FFR. FFR angio has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262.

Published
2019

48. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): A prospective natural history study

Author

David Erlinge, Akiko Maehara, Ori Ben-Yehuda, Hans Erik Bøtker, Michael Maeng, Lars Kjøller-Hansen, Thomas Engstrøm, Mitsuaki Matsumura, Aaron Crowley, Ovidiu Dressler, Gary S Mintz, Ole Fröbert, Jonas Persson, Rune Wiseth, Alf Inge Larsen, Lisette Okkels Jensen, Jan Erik Nordrehaug, Øyvind Bleie, Elmir Omerovic, Claes Held, Stefan K James, Ziad A Ali, James E Muller, Gregg W Stone, Ole Ahlehoff, Azad Amin, Oskar Angerås, Praveen Appikonda, Saranya Balachandran, Ståle Barvik, Kristoffer Bendix, Maria Bertilsson, Ulrika Boden, Nigussie Bogale, Vernon Bonarjee, Fredrik Calais, Jörg Carlsson, Steen Carstensen, Christina Christersson, Evald Høj Christiansen, Maria Corral, Ole De Backer, Usama Dhaha, Christian Dworeck, Kai Eggers, Charlotta Elfström, Julia Ellert, Erlend Eriksen, Christian Fallesen, Margareta Forsman, Helena Fransson, Mohsen Gaballa, Marek Gacki, Matthias Götberg, Lars Hagström, Theresa Hallberg, Kristina Hambraeus, Inger Haraldsson, Jan Harnek, Ole Havndrup, Knut Hegbom, Matthias Heigert, Steffen Helqvist, Jon Herstad, Ziad Hijazi, Lene Holmvang, Dan Ioanes, Amjid Iqbal, Allan Iversen, Jaclyn Jacobson, Lars Jakobsen, Ivana Jankovic, Ulf Jensen, Karin Jensevik, Nina Johnston, Torfi Fjalar Jonasson, Erik Jørgensen, Francis Joshi, Ulf Kajermo, Frida Kåver, Henning Kelbæk, Thomas Kellerth, Mitra Kish, Wolfgang Koenig, Sasha Koul, Bo Lagerqvist, Bertil Larsson, Jens Flensted Lassen, Olav Leiren, Zhe Li, Christer Lidell, Rikard Linder, Michael Lindstaedt, Gunilla Lindström, Shen Liu, Kjetil Halvorsen Løland, Jacob Lønborg, László Márton, Habib Mir-Akbari, Shameema Mohamed, Jacob Odenstedt, Christer Ogne, Jonas Oldgren, Göran Olivecrona, Nikolas Östlund-Papadogeorgos, Michael Ottesen, Erik Packer, Åsa Michelgård Palmquist, Quratulain Paracha, Frans Pedersen, Petur Petursson, Truls Råmunddal, Svein Rotevatn, Raquel Sanchez, Giovanna Sarno, Kari I Saunamäki, Fredrik Scherstén, Patrick W Serruys, Iwar Sjögren, Rikke Sørensen, Iva Srdanovic, Zuka Subhani, Eva Svensson, Anne Thuesen, Jan Tijssen, Hans-Henrik Tilsted, Tim Tödt, Thor Trovik, Bjørn Inge Våga, Christoph Varenhorst, Karsten Veien, Emma Vestman, Sebastian Völz, Lars Wallentin, Joanna Wykrzykowska, Leszek Zagozdzon, Manuela Zamfir, Crister Zedigh, Hang Zhong, Zhipeng Zhou, Cardiology, ACS - Atherosclerosis & ischemic syndromes, and ACS - Heart failure & arrhythmias

Subjects
Male, medicine.medical_specialty, Myocardial Infarction, Lumen (anatomy), 030204 cardiovascular system & hematology, Scandinavian and Nordic Countries, Angina, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Intravascular ultrasound, Medicine, Humans, 030212 general & internal medicine, Myocardial infarction, Angina, Unstable, Prospective Studies, Prospective cohort study, Aged, Ultrasonography, Spectroscopy, Near-Infrared, medicine.diagnostic_test, business.industry, Unstable angina, General Medicine, Odds ratio, Middle Aged, medicine.disease, Lipids, Plaque, Atherosclerotic, Death, Cardiology, Female, business, Mace
Abstract

Background Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs). Methods PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065. Findings Between June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17 women, 745 [83 men; median age 63 [IQR 55-70] years). Median follow-up was 3.7 (IQR 3.0-4.4) years. Adverse events within 4 years occurred in 112 (13.2 951.0-15.6) of 898 patients, with 66 (8.0 95.2-10.0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46.9[SD 15.9]). Highly lipidic lesions (851 [24 of 3500 lesions, present in 520 [59 of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2.27, 95.25-4.13) and nonculprit lesion-specific MACEs (7.83, 4.12-14.89). Large plaque burden (787 [22 of 3629 lesions, present in 530 [59 of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7.095.0-10.0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13.295.4-17.6). Interpretation Combined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes. Copyright (C) 2021 Elsevier Ltd. All rights reserved. BackgroundNear-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs).MethodsPROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065.FindingsBetween June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17%] women, 745 [83%] men; median age 63 [IQR 55–70] years). Median follow-up was 3·7 (IQR 3·0–4·4) years. Adverse events within 4 years occurred in 112 (13·2%, 95% CI 11·0–15·6) of 898 patients, with 66 (8·0%, 95% CI 6·2–10·0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46·9% [SD 15·9]). Highly lipidic lesions (851 [24%] of 3500 lesions, present in 520 [59%] of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2·27, 95% CI 1·25–4·13) and non-culprit lesion-specific MACEs (7·83, 4·12–14·89). Large plaque burden (787 [22%] of 3629 lesions, present in 530 [59%] of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7·0% (95% CI 4·0–10·0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13·2% (95% CI 9·4–17·6).InterpretationCombined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes.FundingAbbott Vascular, Infraredx, and The Medicines Company.

Published
2021

49. TCT-84 Serial NIRS-IVUS Assessment of Changes in Coronary Lumen Area During 2-Year Follow-Up: Insights From the PROSPECT ABSORB Trial

Author

Gary S. Mintz, Ori Ben-Yehuda, Thomas Engstroem, Elmir Omerovic, Lisette Okkels Jensen, Ziad A. Ali, Jonas Persson, Michael Maeng, Mitsuaki Matsumura, Zhipeng Zhou, Akiko Maehara, David Erlinge, Ole Fröbert, Øyvind Bleie, Alf Inge Larsen, Stefan James, Jan Erik Nordrehaug, Gregg W. Stone, Rune Wiseth, Lars Kjøller-Hansen, and Claes Held

Subjects
medicine.medical_specialty, business.industry, medicine, Lumen (anatomy), Radiology, Cardiology and Cardiovascular Medicine, business
Published
2021

50. TCT-163 Optical Coherence Tomography Characterization of Eccentric Versus Concentric Calcium Treated With Shockwave Intravascular Lithotripsy: Patient-Level Pooled Analysis of the Disrupt CAD OCT Substudies

Author

Mitsuaki Matsumura, Ziad A. Ali, Nieves Gonzalo, Jonathan Hill, Carlo Di Mario, Richard Shlofmitz, Robert Riley, Benjamin Honton, Dean J. Kereiakes, Akiko Maehara, Shigeru Saito, and Gregg W. Stone

Subjects
medicine.diagnostic_test, business.industry, medicine.medical_treatment, chemistry.chemical_element, CAD, Calcium, Concentric, Lithotripsy, Pooled analysis, chemistry, Optical coherence tomography, Eccentric, Medicine, Cardiology and Cardiovascular Medicine, business, Nuclear medicine
Published
2021

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