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Xu Y, Wang YF, Zhao MY, You W, Xu T, Meng PN, Wu XQ, Wu ZM, Kong XH, Yin DL, Zhan ME, Jia HB, Liu B, Ye F. Study on the potential clinical significance of subclinical stent edge effects after drug-eluting stent implantation. Sci Rep 2025; 15:8258. [PMID: 40064903 PMCID: PMC11893891 DOI: 10.1038/s41598-024-81329-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/19/2024] [Accepted: 11/26/2024] [Indexed: 03/14/2025] Open
Abstract
The edge effect (EE) of isolated restenosis at one or both ends of a stent is not reduced by drug-eluting stent (DES). The purpose of the study was to investigate the long-term outcome of 1-year subclinical DES-EE (sDES-EE), which was defined as any reduction in the minimal lumen area (MLA) at stent edge without any evidence of clinical ischemia. A total of 252 patients were enrolled from one of our previous randomized controlled studies, who were detected by optical coherence tomography (OCT) immediately after DES implantation and 1 year later. The primary endpoint was EE-related target lesion failure (EE-TLF) at 5 years. Secondary endpoints were the changes of morphologies and composition of stent edge plaque, and each component of EE-TLF. sDES-EE at 1 year was significantly correlated with EE-TLF at 5 years by binary logistic regression analysis after propensity scoring. The most valuable cutoff value of sDES-EE at 1 year was a 25% MLA reduction at the stent edge, according to receiver operating characteristic analysis, which showed a major increase in lipid normalized total volume (0.99 ± 0.25 mm3 vs. -0.21 ± 0.06 mm3, p = 0.025) and lipid percent atheroma volume (3.92 ± 1.34% vs. -1.22 ± 0.78%, p = 0.029). EE-TLF at 5 years was significantly higher in the sDES-EE group than in the non-sDES-EE group (15.6% vs. 4.1%, p = 0.001). sDES-EE with MLA reduction ≥ 25% at the stent edge at 1 year after PCI was an independent predictor of EE-TLF at 5 years, which was mainly caused by the progression of lipid components measured by OCT. TRIAL REGISTRATION ClinicalTrials.gov. Number NCT02140801. STUDY REGISTRATION http://www. CLINICALTRIALS gov . identifier: NCT02140801.
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Affiliation(s)
- Yi Xu
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - Yi-Fei Wang
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - Meng-Yao Zhao
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - Wei You
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - Tian Xu
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - Pei-Na Meng
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - Xiang-Qi Wu
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - Zhi-Ming Wu
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - Xiao-Han Kong
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China
| | - De-Lu Yin
- Department of Cardiology, The First Hospital of Lianyungang, Xuzhou Medical University, No. 6 East Zhenhua Road, Haizhou District, Lianyungang, Jiangsu Province, 222061, China
| | - Mei-En Zhan
- Department of Cardiology, Tianchang city people's Hospital, Bengbu Medical University, 137 East Jianshe Road, Tianchang city, 239300, Anhui Province, China
| | - Hai-Bo Jia
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China.
| | - Bin Liu
- Department of Cardiology, The second norman Bethune hospital of jilin university, No. 218, Ziqiang Street, Nanguan District, Changchun City, 130041, Jilin Province, China.
| | - Fei Ye
- Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Nanjing, Jiangsu Province, 210006, China.
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Wu X, Renkens MPL, Kerkmeijer L, Lunardi M, Huang J, Ding D, O'Leary N, de Winter RJ, Onuma Y, Serruys PW, Wykrzykowska J, Tu S, Wijns W. Angiography-Based Superficial Wall Strain of De Novo Stenotic Coronary Arteries: Serial Assessment of Vessels Treated with Bioresorbable Scaffold or Drug-Eluting Stent. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2023; 53:51-60. [PMID: 37005105 DOI: 10.1016/j.carrev.2023.03.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2023] [Accepted: 03/14/2023] [Indexed: 03/29/2023]
Abstract
OBJECTIVES This study sought to present an angiography-based computational model for serial assessment of superficial wall strain (SWS, dimensionless) of de-novo coronary stenoses treated with either bioresorbable scaffold (BRS) or drug-eluting stent (DES). BACKGROUND A novel method for SWS allows the assessment of the mechanical status of arteries in-vivo, which may help for predicting cardiovascular outcomes. METHODS Patients with arterial stenosis treated with BRS (n = 21) or DES (n = 21) were included from ABSORB Cohort B1 and AIDA trials. The SWS analyses were performed along with quantitative coronary angiography (QCA) at pre-PCI, post-PCI, and 5-year follow-up. Measurements of QCA and SWS parameters were quantified at the treated segment and adjacent 5-mm proximal and distal edges. RESULTS Before PCI, the peak SWS on the 'to be treated' segment (0.79 ± 0.36) was significantly higher than at both virtual edges (0.44 ± 0.14 and 0.45 ± 0.21; both p < 0.001). The peak SWS in the treated segment significantly decreased by 0.44 ± 0.13 (p < 0.001). The surface area of high SWS decreased from 69.97mm2 to 40.08mm2 (p = 0.002). The peak SWS in BRS group decreased to a similar extent (p = 0.775) from 0.81 ± 0.36 to 0.41 ± 0.14 (p < 0.001), compared with DES group from 0.77 ± 0.39 to 0.47 ± 0.13 (p = 0.001). Relocation of high SWS to device edges was often observed in both groups after PCI (35 of 82 cases, 41.7 %). At follow-up of BRS, the peak SWS remained unchanged compared to post-PCI (0.40 ± 0.12 versus 0.36 ± 0.09, p = 0.319). CONCLUSION Angiography-based SWS provided valuable information about the mechanical status of coronary arteries. Device implantation led to a significant decrease of SWS to a similar extent with either polymer-based scaffolds or permanent metallic stents.
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Affiliation(s)
- Xinlei Wu
- The Lambe Institute for Translational Medicine, Smart Sensors Laboratory, Corrib Core Laboratory and Curam, University of Galway, Ireland
| | - Mick P L Renkens
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
| | | | - Mattia Lunardi
- The Lambe Institute for Translational Medicine, Smart Sensors Laboratory, Corrib Core Laboratory and Curam, University of Galway, Ireland
| | - Jiayue Huang
- The Lambe Institute for Translational Medicine, Smart Sensors Laboratory, Corrib Core Laboratory and Curam, University of Galway, Ireland
| | - Daixin Ding
- The Lambe Institute for Translational Medicine, Smart Sensors Laboratory, Corrib Core Laboratory and Curam, University of Galway, Ireland
| | - Neil O'Leary
- The Lambe Institute for Translational Medicine, Smart Sensors Laboratory, Corrib Core Laboratory and Curam, University of Galway, Ireland
| | - Robbert J de Winter
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands
| | - Yoshinobu Onuma
- The Lambe Institute for Translational Medicine, Smart Sensors Laboratory, Corrib Core Laboratory and Curam, University of Galway, Ireland
| | - Patrick W Serruys
- The Lambe Institute for Translational Medicine, Smart Sensors Laboratory, Corrib Core Laboratory and Curam, University of Galway, Ireland
| | - Joanna Wykrzykowska
- Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands; UMC Groningen, Thorax Center, University of Groningen, Groningen, the Netherlands
| | - Shengxian Tu
- Med-X Research Institute, Shanghai Jiao Tong University, China
| | - William Wijns
- The Lambe Institute for Translational Medicine, Smart Sensors Laboratory, Corrib Core Laboratory and Curam, University of Galway, Ireland.
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Liao ZY, Liou JY, Lin SC, Hung HF, Chang CM, Chen LC, Chua SK, Lo HM, Hung CF. Successful bailout stenting strategy against rare spontaneous retrograde dissection of partially absorbed magnesium-based resorbable scaffold: A case report. World J Clin Cases 2021; 9:1148-1155. [PMID: 33644179 PMCID: PMC7896648 DOI: 10.12998/wjcc.v9.i5.1148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/18/2020] [Revised: 12/19/2020] [Accepted: 01/05/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND In the development of coronary stent technology, bioresorbable scaffolds are promising milestones in improving the clinical treatment of coronary artery disease. The “leave nothing behind” motto is the premise of the fourth revolution in percutaneous coronary intervention (PCI). Studies proving the safety and efficacy of the magnesium-based resorbable scaffolds (MgBRSs) include the BIOSOLVE-I and BIOSOLVE-II trials and the latest BIOSOLVE-IV registry. However, spontaneous retrograde dissection of a partially absorbed MgBRS may still occur, albeit rarely.
CASE SUMMARY We describe an unusual case of coronary artery disease in a patient who had undergone a successful PCI 8 mo earlier, where an MgBRS was implanted into the left anterior descending artery (LAD) and left circumflex artery with drug-coated balloons for a ramus intermedius branch stenosis to achieve the “leave nothing behind” therapeutic intention and was currently presenting with a gradual worsening of chest tightness. The distal edge vascular response, during subsequent attempts with balloon angioplasty was performed smoothly. However, spontaneous retrograde dissection of a partially absorbed MgBRS in the LAD ensued. Successful bailout stenting was performed with revascularization of the entry and exit sites created by spontaneous dissection and complete sealing of the intramural hematoma. The patient recovered well and was discharged after 2 d of intervention. When followed up in August 2020 (7 mo later), the patient showed uneventful recovery.
CONCLUSION Spontaneous retrograde dissection of a partially absorbed MgBRS was successfully treated using bailout sirolimus-eluting coronary stent strategy.
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Affiliation(s)
- Zhen-Yu Liao
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei 11101, Taiwan
- Ph.D. Program in Nutrition and Food Science, Fu Jen Catholic University , New Taipei 24205, Taiwan
| | - Jer-Young Liou
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei 11101, Taiwan
| | - Shen-Chang Lin
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei 11101, Taiwan
| | - Huei-Fong Hung
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei 11101, Taiwan
| | - Che-Ming Chang
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei 11101, Taiwan
| | - Lung-Ching Chen
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei 11101, Taiwan
| | - Su-Kiat Chua
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei 11101, Taiwan
| | - Huey-Ming Lo
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei 11101, Taiwan
- School of Medicine, Fu Jen Catholic University, New Taipei 24205, Taiwan
| | - Chi-Feng Hung
- School of Medicine, Fu Jen Catholic University, New Taipei 24205, Taiwan
- MS Program Transdisciplinary Long-Term Care, Fu Jen Catholic University, New Taipei 24205, Taiwan
- Ph.D. Program in Pharmaceutical Biotechnology, Fu Jen Catholic University, New Taipei 24205, Taiwan
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Stent edge vascular response and in-stent geometry after aerobic exercise. Cardiovasc Interv Ther 2020; 36:111-120. [PMID: 32152930 PMCID: PMC7829229 DOI: 10.1007/s12928-020-00655-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2019] [Accepted: 02/24/2020] [Indexed: 11/29/2022]
Abstract
The purpose of the present study was to investigate the edge vascular response in patients treated with second-generation drug-eluting stents (DES) after 3 months of aerobic exercise intervention. Thirty-two patients with significant coronary artery disease underwent percutaneous coronary intervention with DES implantation prior to randomization to aerobic interval training (AIT, 14 patients) versus moderate continuous training (MCT, 18 patients). Plaque changes were assessed using grayscale and radiofrequency intravascular ultrasound at baseline and follow-up. The main endpoints were changes in plaque burden and necrotic core content in the 5-mm proximal and distal stent edges. Plaque burden in the distal stent edges decreased significantly in both groups (AIT: − 3.3%; MCT: − 0.4%, p = 0.01 for both), and more in the AIT group (p = 0.048). Necrotic core content decreased significantly in the distal stent edges in both groups (− 2.1 mm3 in AIT, − 0.3 mm3 in MCT, p = 0.01 for both), and more in the AIT group (p = 0.03). There were no significant changes in proximal stent edges or in in-stent geometry at follow-up. In this small study of patients treated with DES implantation, 3 months of aerobic exercise training demonstrated decreased plaque burden and necrotic core content in the distal stent edges, with larger reductions in the AIT group.
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Kozuma K, Shinozaki T, Kozuma K, Kashiwabara K, Oba K, Aoki J, Awata M, Nanasato M, Shiode N, Tanabe K, Yamaguchi J, Kimura T, Matsuyama Y. Impact of Residual Stenosis on the Angiographic Edge Restenosis of a Second-Generation Drug-Eluting Stent. Int Heart J 2019; 60:1050-1060. [DOI: 10.1536/ihj.18-717] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Affiliation(s)
- Kayoko Kozuma
- Department of Biostatistics, Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo
| | - Tomohiro Shinozaki
- Department of Biostatistics, Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo
| | - Ken Kozuma
- Division of Cardiology, Teikyo University School of Medicine
| | - Kosuke Kashiwabara
- Department of Biostatistics, Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo
| | - Koji Oba
- Department of Biostatistics, Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo
| | - Jiro Aoki
- Division of Cardiology, Mitsui Memorial Hospital
| | - Masaki Awata
- Division of Cardiology, National Hospital Organization Osaka National Hospital
| | | | - Nobuo Shiode
- Division of Cardiology, Hiroshima City Hiroshima Citizens Hospital
| | - Kengo Tanabe
- Division of Cardiology, Mitsui Memorial Hospital
| | | | - Takeshi Kimura
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
| | - Yutaka Matsuyama
- Department of Biostatistics, Division of Health Sciences and Nursing, Graduate School of Medicine, The University of Tokyo
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Pernigotti A, Moscarella E, Spitaleri G, Scardino C, Ishida K, Brugaletta S. Methods to assess bioresorbable vascular scaffold devices behaviour after implantation. J Thorac Dis 2017; 9:S959-S968. [PMID: 28894602 DOI: 10.21037/jtd.2017.06.110] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
Bioresorbable vascular scaffolds (BRS) represent a novel approach for coronary revascularization offering several advantages as compared to current generation DES, potentially reducing rate of late adverse events and avoiding permanent vessel caging. Nevertheless, safety concerns have been raised for an increased risk of scaffold thrombosis (ScT) in both early and late phases, probably related to a suboptimal scaffold implantation. In this context, the use of different imaging methodologies has been strongly suggested in order to guarantee an optimal implantation. We herein analyze the different imaging methodologies available to assess BRS after implantation and at follow-up.
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Affiliation(s)
- Alberto Pernigotti
- Hospital Clinic, Institut Clinic Cardiovascular, IDIBAPS, Barcelona, Spain
| | | | - Giosafat Spitaleri
- Hospital Clinic, Institut Clinic Cardiovascular, IDIBAPS, Barcelona, Spain
| | - Claudia Scardino
- Hospital Clinic, Institut Clinic Cardiovascular, IDIBAPS, Barcelona, Spain
| | - Kohki Ishida
- Hospital Clinic, Institut Clinic Cardiovascular, IDIBAPS, Barcelona, Spain
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Bioresorbable vascular scaffolds for the treatment of coronary artery disease: Clinical outcomes from randomized controlled trials. Catheter Cardiovasc Interv 2016; 88:21-30. [DOI: 10.1002/ccd.26810] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/05/2016] [Accepted: 09/14/2016] [Indexed: 11/07/2022]
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8
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Gogas BD, Benham JJ, Hsu S, Sheehy A, Lefer DJ, Goodchild TT, Polhemus DJ, Bouchi YH, Hung OY, Yoo SY, Joshi U, Giddens DP, Veneziani A, Quyyumi A, Rapoza R, King SB, Samady H. Vasomotor Function Comparative Assessment at 1 and 2 Years Following Implantation of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold and the Xience V Everolimus-Eluting Metallic Stent in Porcine Coronary Arteries. JACC Cardiovasc Interv 2016; 9:728-41. [DOI: 10.1016/j.jcin.2015.12.018] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/21/2015] [Revised: 12/01/2015] [Accepted: 12/11/2015] [Indexed: 10/22/2022]
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Tateishi H, Suwannasom P, Sotomi Y, Nakatani S, Ishibashi Y, Tenekecioglu E, Abdelghani M, Cavalcante R, Zeng Y, Grundeken MJ, Albuquerque FN, Veldhof S, Onuma Y, Serruys PW. Edge Vascular Response After Resorption of the Everolimus-Eluting Bioresorbable Vascular Scaffold - A 5-Year Serial Optical Coherence Tomography Study. Circ J 2016; 80:1131-41. [PMID: 26936236 DOI: 10.1253/circj.cj-15-1325] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
BACKGROUND The edge vascular response (EVR) has been linked to important prognostic implications in patients treated with permanent metallic stents. We aimed to investigate the relationship of EVR with the geometric changes in the everolimus-eluting bioresorbable scaffold using serial optical coherence tomography (OCT) analysis. METHODS AND RESULTS In the first-in-man ABSORB trial, 28 patients (29 lesions) underwent serial OCT at 4 different time points (Cohort B1: post-procedure, 6, 24, and 60 months [n=13]; Cohort B2: post-procedure, 12, 36, and 60 months [n=15]) following implantation of the scaffold. In Cohort B1, there was no significant luminal change at the distal or proximal edge segment throughout the entire follow-up. In contrast, there was a significant reduction of the lumen flow area (LFA) of the scaffold between post-procedure and 6 months (-1.03±0.49 mm(2)[P<0.001]), whereas between 6 and 60 months the LFA remained stable (+0.31±1.00 mm(2)[P=0.293]). In Cohort B2, there was a significant luminal reduction of the proximal edge between post-procedure and 12 months (-0.57±0.74 mm(2)[P=0.017]), whereas the lumen area remained stable (-0.26±1.22 mm(2)[P=0.462]) between 12 and 60 months. The scaffold LFA showed a change similar to that observed in Cohort B1. CONCLUSIONS Our study demonstrated a reduction in the scaffold luminal area in the absence of major EVR, suggesting that the physiological continuity of the lumen contour is restored long term. (Circ J 2016; 80: 1131-1141).
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Tanaka A. Bioresorbable Scaffold – Taking the Edge Off? –. Circ J 2016; 80:1100-1101. [DOI: 10.1253/circj.cj-16-0277] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/30/2023]
Affiliation(s)
- Atsushi Tanaka
- Department of Cardiovascular Medicine, Wakayama Medical University
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On Studying the Interaction Between Different Stent Models and Rabbit Tracheal Tissue: Numerical, Endoscopic and Histological Comparison. Ann Biomed Eng 2015; 44:368-81. [DOI: 10.1007/s10439-015-1504-3] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2015] [Accepted: 11/05/2015] [Indexed: 12/14/2022]
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Gogas BD, Yang B, Passerini T, Veneziani A, Piccinelli M, Esposito G, Rasoul-Arzrumly E, Awad M, Mekonnen G, Hung OY, Holloway B, McDaniel M, Giddens D, King SB, Samady H. Computational fluid dynamics applied to virtually deployed drug-eluting coronary bioresorbable scaffolds: Clinical translations derived from a proof-of-concept. Glob Cardiol Sci Pract 2014; 2014:428-36. [PMID: 25780796 PMCID: PMC4355516 DOI: 10.5339/gcsp.2014.56] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/07/2014] [Accepted: 12/11/2014] [Indexed: 11/23/2022] Open
Abstract
Background: Three-dimensional design simulations of coronary metallic stents utilizing mathematical and computational algorithms have emerged as important tools for understanding biomechanical stent properties, predicting the interaction of the implanted platform with the adjacent tissue, and informing stent design enhancements. Herein, we demonstrate the hemodynamic implications following virtual implantation of bioresorbable scaffolds using finite element methods and advanced computational fluid dynamics (CFD) simulations to visualize the device-flow interaction immediately after implantation and following scaffold resorption over time. Methods and Results: CFD simulations with time averaged wall shear stress (WSS) quantification following virtual bioresorbable scaffold deployment in idealized straight and curved geometries were performed. WSS was calculated at the inflow, endoluminal surface (top surface of the strut), and outflow of each strut surface post-procedure (stage I) and at a time point when 33% of scaffold resorption has occurred (stage II). The average WSS at stage I over the inflow and outflow surfaces was 3.2 and 3.1 dynes/cm2 respectively and 87.5 dynes/cm2 over endoluminal strut surface in the straight vessel. From stage I to stage II, WSS increased by 100% and 142% over the inflow and outflow surfaces, respectively, and decreased by 27% over the endoluminal strut surface. In a curved vessel, WSS change became more evident in the inner curvature with an increase of 63% over the inflow and 66% over the outflow strut surfaces. Similar analysis at the proximal and distal edges demonstrated a large increase of 486% at the lateral outflow surface of the proximal scaffold edge. Conclusions: The implementation of CFD simulations over virtually deployed bioresorbable scaffolds demonstrates the transient nature of device/flow interactions as the bioresorption process progresses over time. Such hemodynamic device modeling is expected to guide future bioresorbable scaffold design.
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Affiliation(s)
| | | | - Tiziano Passerini
- Department of Mathematics and Computer Science, Emory University, Atlanta, Georgia
| | | | | | | | | | - Mosaab Awad
- Andreas Gruentzig Cardiovascular Center, Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia
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Gogas BD. Bioresorbable scaffolds for percutaneous coronary interventions. Glob Cardiol Sci Pract 2014; 2014:409-27. [PMID: 25780795 PMCID: PMC4355515 DOI: 10.5339/gcsp.2014.55] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2014] [Accepted: 12/11/2014] [Indexed: 12/23/2022] Open
Abstract
Innovations in drug-eluting stents (DES) have substantially reduced rates of in-segment restenosis and early stent thrombosis, improving clinical outcomes following percutaneous coronary interventions (PCI). However a fixed metallic implant in a vessel wall with restored patency and residual disease remains a precipitating factor for sustained local inflammation, in-stent neo-atherosclerosis and impaired vasomotor function increasing the risk for late complications attributed to late or very late stent thrombosis and late target lesion revascularization (TLR) (late catch-up). The quest for optimal coronary stenting continues by further innovations in stent design and by using biocompatible materials other than cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding, local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics have been recently developed. These devices have been utilized in selected clinical applications so far providing preliminary evidence of safety showing comparable performance with current generation drug-eluting stents (DES). Herein we provide a comprehensive overview of the current status of these technologies, we elaborate on the potential benefits of transient coronary scaffolds over permanent stents in the context of vascular reparation therapy, and we further focus on the evolving challenges these devices have to overcome to compete with current generation DES. Condensed Abstract:: The quest for optimizing percutaneous coronary interventions continues by iterative innovations in device materials beyond cobalt chromium, platinum chromium or stainless steel for engineering coronary implants. Bioresorbable scaffolds made of biodegradable polymers or biocorrodible metals with properties of transient vessel scaffolding; local drug-elution and future restoration of vessel anatomy, physiology and local hemodynamics were recently developed. These devices have been utilized in selected clinical applications providing preliminary evidence of safety showing comparable intermediate term clinical outcomes with current generation drug-eluting stents.
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Affiliation(s)
- Bill D Gogas
- Andreas Gruentzig Cardiovascular Center, Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA
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Zhang YJ, Iqbal J, Nakatani S, Bourantas CV, Campos CM, Ishibashi Y, Cho YK, Veldhof S, Wang J, Onuma Y, Garcia-Garcia HM, Dudek D, van Geuns RJ, Serruys PW. Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: a 3-year serial optical coherence tomography study. JACC Cardiovasc Interv 2014; 7:1361-9. [PMID: 25457053 DOI: 10.1016/j.jcin.2014.06.025] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/03/2014] [Revised: 04/30/2014] [Accepted: 06/19/2014] [Indexed: 12/23/2022]
Abstract
OBJECTIVES This study sought to investigate the in-scaffold vascular response (SVR) and edge vascular response (EVR) after implantation of an everolimus-eluting bioresorbable scaffold (BRS) using serial optical coherence tomography (OCT) imaging. BACKGROUND Although studies using intravascular ultrasound have evaluated the EVR in metal stents and BRSs, there is a lack of OCT-based SVR and EVR assessment after BRS implantation. METHODS In the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study, 23 patients (23 lesions) in Cohort B1 and 17 patients (18 lesions) in Cohort B2 underwent truly serial OCT examinations at 3 different time points (Cohort B1: post-procedure, 6 months, and 2 years; B2: post-procedure, 1 year, and 3 years) after implantation of an 18-mm scaffold. A frame-by-frame OCT analysis was performed at the 5-mm proximal, 5-mm distal edge, and 2-mm in-scaffold margins, whereas the middle 14-mm in-scaffold segment was analyzed at 1-mm intervals. RESULTS The in-scaffold mean luminal area significantly decreased from baseline to 6 months or 1 year (7.22 ± 1.24 mm(2) vs. 6.05 ± 1.38 mm(2) and 7.64 ± 1.19 mm(2) vs. 5.72 ± 0.89 mm(2), respectively; both p < 0.01), but remained unchanged from then onward. In Cohort B1, a significant increase in mean luminal area of the distal edge was observed (5.42 ± 1.81 mm(2) vs. 5.58 ± 1.53 mm(2); p < 0.01), whereas the mean luminal area of the proximal edge remained unchanged at 6 months. In Cohort B2, the mean luminal areas of the proximal and distal edges were significantly smaller than post-procedure measurements at 3 years. The mean luminal area loss at both edges was significantly less than the mean luminal area loss of the in-scaffold segment at both 6-month and 2-year follow-up in Cohort B1 or at 1 year and 3 years in Cohort B2. CONCLUSIONS This OCT-based serial EVR and SVR evaluation of the Absorb Bioresorbable Vascular Scaffold (Abbott Vascular, Santa Clara, California) showed less luminal loss at the edges than luminal loss within the scaffold. The luminal reduction of both edges is not a nosologic entity, but an EVR in continuity with the SVR, extending from the in-scaffold margin to both edges. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).
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Affiliation(s)
- Yao-Jun Zhang
- Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Nanjing First Hospital, Nanjing Medical University, Nanjing, China
| | - Javaid Iqbal
- Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Cardiovascular Science, University of Sheffield, Sheffield, United Kingdom
| | - Shimpei Nakatani
- Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
| | | | - Carlos M Campos
- Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
| | - Yuki Ishibashi
- Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
| | - Yun-Kyeong Cho
- Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
| | | | - Jin Wang
- Abbott Vascular, Diegem, Belgium
| | - Yoshinobu Onuma
- Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
| | | | | | | | - Patrick W Serruys
- Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom.
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Abstract
The introduction of percutaneous coronary intervention (PCI) in the late 1970s revolutionized the management of stable and unstable coronary artery disease, providing an effective, quick, safe, and increasingly widely available method for coronary revascularization for many patients. Rapid development in this field led to the introduction of a number of new technologies, including intracoronary stents that have resulted in improved efficacy and long-term safety. In this manuscript we review the experience with the 2 major available classes of stents (bare metal [BMS], drug-eluting [DES]) and describe the delivery systems for these stents. An evidence review of the large trial data comparing balloon angioplasty, BMS, and DES demonstrates the incremental advances over time, with the latest generation of DES achieving the lowest rates of restenosis, stent thrombosis, and recurrent myocardial infarction. In addition, we provide an overview of the latest developments in stent technology, including the introduction of bioresorbable stents and new stent delivery systems. These latest advances are hoped to further improve outcomes while reducing costs due to a reduction in the need for future procedures and hospitalizations due to recurrent coronary disease.
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Affiliation(s)
- Sameer D Sheth
- Department of Medicine, Brigham and Women's Hospital, Boston, MA
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17
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Keller BK, Amatruda CM, Hose DR, Gunn J, Lawford PV, Dubini G, Migliavacca F, Narracott AJ. Contribution of Mechanical and Fluid Stresses to the Magnitude of In-stent Restenosis at the Level of Individual Stent Struts. Cardiovasc Eng Technol 2014. [DOI: 10.1007/s13239-014-0181-y] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
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18
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Gogas BD, Garcia-Garcia HM, Onuma Y, Muramatsu T, Farooq V, Bourantas CV, Serruys PW. Edge Vascular Response After Percutaneous Coronary Intervention. JACC Cardiovasc Interv 2013; 6:211-21. [DOI: 10.1016/j.jcin.2013.01.132] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/25/2012] [Revised: 01/24/2013] [Accepted: 01/30/2013] [Indexed: 11/30/2022]
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