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Yang Y, Zhang Z, Wang J, Fu K, Li D, He H, Shu C. Progress in research and development of biodegradable metallic vascular stents. ZHONG NAN DA XUE XUE BAO. YI XUE BAN = JOURNAL OF CENTRAL SOUTH UNIVERSITY. MEDICAL SCIENCES 2024; 49:1861-1868. [PMID: 40177769 PMCID: PMC11964820 DOI: 10.11817/j.issn.1672-7347.2024.230514] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Download PDF] [Subscribe] [Scholar Register] [Received: 11/15/2023] [Indexed: 04/05/2025]
Abstract
Vascular stents are an essential tool in cardiovascular interventional therapy, and their demand is growing with the increasing incidence of cardiovascular diseases. Compared with permanent stents, which are prone to in-stent restenosis, and drug-eluting stents, which may cause late stent thrombosis, biodegradable stents offer advantages. After providing early radial support to prevent elastic recoil, biodegradable stents gradually degrade, allowing the vessel to regain its natural physiological contractility and undergo positive remodeling. A review of the current mainstream biodegradable metal stents, magnesium-based, iron-based, and zinc-based alloys, shows promising findings in both preclinical and clinical research. Magnesium-based stents exhibit good operability and low thrombosis rates, but their limitations include rapid degradation, hydrogen evolution, and significant pH changes in the microenvironment. Iron-based stents demonstrate excellent mechanical strength, formability, biocompatibility, and hemocompatibility, but their slow corrosion rate hampers broader clinical application; accelerating degradation remains key. Zinc-based alloys have a moderate degradation rate but relatively low mechanical strength; enhancing stent strength by alloying with other elements is the main improvement direction for zinc-based stents.
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Affiliation(s)
- Yan Yang
- Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha 410011.
- Vascular Disease Institute, Central South University, Changsha 410011.
| | - Zhenfeng Zhang
- Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha 410011
- Vascular Disease Institute, Central South University, Changsha 410011
| | - Junwei Wang
- Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha 410011
- Vascular Disease Institute, Central South University, Changsha 410011
| | - Keyun Fu
- Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha 410011
- Vascular Disease Institute, Central South University, Changsha 410011
| | - Dongyang Li
- Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha 410011
- Vascular Disease Institute, Central South University, Changsha 410011
| | - Hao He
- Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha 410011.
- Vascular Disease Institute, Central South University, Changsha 410011.
| | - Chang Shu
- Department of Vascular Surgery, Second Xiangya Hospital, Central South University, Changsha 410011
- Vascular Disease Institute, Central South University, Changsha 410011
- Department of Vascular Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China
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Song L, Guan C, Yu M, Sun Z, Fu G, He Y, Jia S, Chen J, Qi F, Bai J, Li W, Ge J, Han Y, Gao R. Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: Rationale and design of the IRONMAN-II trial. Am Heart J 2024; 275:53-61. [PMID: 38838969 DOI: 10.1016/j.ahj.2024.05.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/04/2024] [Revised: 05/30/2024] [Accepted: 05/31/2024] [Indexed: 06/07/2024]
Abstract
BACKGROUND The previous first-in-human study established the preliminary safety and effectiveness of the novel thin-strut iron bioresorbable scaffold (IBS). The current study aims to directly compare the imaging and physiological efficacy, and clinical outcomes of IBS with contemporary metallic drug-eluting stents (DES). METHODS A total of 518 patients were randomly allocated to treatment with IBS (257 patients) or metallic DES (261 patients) from 36 centers in China. The study is powered to test noninferiority of the IBS compared with the metallic everolimus-eluting stent in terms of the primary endpoint of in-segment late lumen loss at 2 years, and major secondary endpoints including 2-year quantitative flow ratio and cross-sectional mean flow area measured by optical coherence tomography (OCT) (limited to the OCT subgroup, 25 patients in each group). CONCLUSION This will be the first powered randomized trial investigating the safety and efficacy of the novel thin-strut IBS compared to a contemporary metallic DES. The findings will provide valuable evidence for future research of this kind and the application of metallic bioresorbable scaffolds.
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Affiliation(s)
- Lei Song
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China; Catheterization Laboratories, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Changdong Guan
- Catheterization Laboratories, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Mengyue Yu
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiology, Fuwai Yunan hospital, Chinese Academy of Medical Sciences, Kunming, China
| | - Zhongwei Sun
- Catheterization Laboratories, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Guosheng Fu
- Department of Cardiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China
| | - Yong He
- Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China
| | - Shaobin Jia
- Department of Cardiology, General Hospital of Ningxia Medical University, Yinchuan, China
| | - Jiyan Chen
- Department of Cardiology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China
| | - Feng Qi
- Department of Cardiology, Fuwai Yunan hospital, Chinese Academy of Medical Sciences, Kunming, China
| | - Jie Bai
- Department of Cardiology, Fuwai Yunan hospital, Chinese Academy of Medical Sciences, Kunming, China
| | - Wei Li
- Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China
| | - Junbo Ge
- Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Disease, Shanghai, China
| | - Yaling Han
- Cardiovascular Research Institute and Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China
| | - Runlin Gao
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiology, Fuwai Yunan hospital, Chinese Academy of Medical Sciences, Kunming, China.
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Somogyi Škoc M, Meštrović E, Mouthuy PA, Rezić I. Synthesis, Characterization and Application of Advanced Antimicrobial Electrospun Polymers. Polymers (Basel) 2024; 16:2443. [PMID: 39274076 PMCID: PMC11398097 DOI: 10.3390/polym16172443] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2024] [Revised: 08/22/2024] [Accepted: 08/23/2024] [Indexed: 09/16/2024] Open
Abstract
The aim of this work was to synthesize, characterize and apply advanced antimicrobial biocompatible electrospun polymers suitable for medical implants for surgical repairs. Injuries to the musculoskeletal system often necessitate surgical repair, but current treatments can still lead to high failure rates, such as 40% for the repair of rotator cuff tears. Therefore, there is an urgent need for the development of new biocompatible materials that can effectively support the repair of damaged tissues. Additionally, infections acquired during hospitalization, particularly those caused by antibiotic-resistant bacteria, result in more fatalities than AIDS, tuberculosis, and viral hepatitis combined. This underscores the critical necessity for the advancement of antimicrobial implants with specialized coatings capable of combating Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus (MSSA), two strains notoriously known for their antibiotic resistance. Therefore, we developed an antimicrobial coating incorporating nanoparticle mixtures using the sol-gel process and applied it to electrospun polycaprolactone (PCL) filaments, followed by thorough characterization by using spectroscopic (FTIR, Raman, NMR) microscopic (SEM and SEM-EDX), and tensile test. The results have shown that the integration of electro-spinning technology for yarn production, coupled with surface modification techniques, holds significant potential for creating antimicrobial materials suitable for medical implants for surgical repairs.
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Affiliation(s)
- Maja Somogyi Škoc
- Faculty of Textile Technology, University of Zagreb, 10000 Zagreb, Croatia
| | - Ernest Meštrović
- Faculty of Chemical Engineering and Technology, University of Zagreb, 10000 Zagreb, Croatia
| | - Pierre-Alexis Mouthuy
- Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences Medical Science Division, University of Oxford, Oxford OX3 7LD, UK
| | - Iva Rezić
- Faculty of Textile Technology, University of Zagreb, 10000 Zagreb, Croatia
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Deng Y, Huang J, Chen C, Wen Y, Qiu D. Fe 3O 4 coated stent prevent artery neointimal hyperplasia by inhibiting vascular smooth muscle cell proliferation. Mater Today Bio 2024; 27:101133. [PMID: 39027680 PMCID: PMC11254736 DOI: 10.1016/j.mtbio.2024.101133] [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: 03/17/2024] [Revised: 05/27/2024] [Accepted: 06/19/2024] [Indexed: 07/20/2024] Open
Abstract
In-stent restenosis (ISR), caused by aggressive vascular smooth muscle cell (VSMC) proliferation, is a serious complication of stenting. Therefore, developing therapeutic approaches that target VSMC inhibition is imperative. Our previous study showed that VSMC hyperplasia was attenuated after iron stent degradation, and VSMC proliferation around the stented section was arrested. The corrosion products of the iron stents were primarily Fe3O4 particles. Therefore, we hypothesized that Fe3O4 particles generated by iron stents would prevent neointimal hyperplasia by inhibiting VSMC proliferation. To test this hypothesis, culture assays and flow cytometry were performed to investigate the proliferation of VSMC. Global gene sequencing and Kyoto Encyclopedia of Genes and Genomes enrichment analyses were performed to investigate the underlying mechanisms. Fe3O4-coated stents were implanted into rabbit carotid arteries to evaluate the inhibitory effects of Fe3O4 on neointimal hyperplasia. The major findings of the study were as follows: 1) Fe3O4 attenuated neointimal hyperplasia by preventing VSMC proliferation after stenting; 2) Fe3O4 exerted inhibitory effects on VSMCs by downregulating proliferative genes such as SOX9, EGR4, and TGFB1, but upregulated inhibitory genes such as DNMT1, TIMP3, and PCNA; 3) Fe3O4 inhibited VSMCs by preventing phenotypic transformation from the contractile to the synthetic phase; and 4) Fe3O4-coated stents achieved satisfactory hemocompatibility in a rabbit model. Our study highlights the additional benefits of Fe3O4 particles in inhibiting VSMC proliferation, indicating that Fe3O4 coated stent potentially served as an attractive therapeutic approach for ISR prevention.
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Affiliation(s)
- Yalan Deng
- Department of Ultrasonic Imaging, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China
- NHC Key Laboratory of Cancer Proteomics & Laboratory of Structural Biology, Xiangya Hospital, Central South University, Changsha, Hunan, PR China
| | - Jiabing Huang
- Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Jiangxi, Nanchang, PR China
| | - Changqing Chen
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
| | - Yanbing Wen
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
| | - Dongxu Qiu
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
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Sondore D, Briede I, Linde M, Trusinskis K, Narbute I, Jegere S, Lismanis A, Kumsars I, Grikis K, Strazdins U, Erglis A. Bioresorbable Scaffold Use in Coronary Chronic Total Occlusions: A Long-Term, Single-Center Follow-Up Study. MEDICINA (KAUNAS, LITHUANIA) 2024; 60:1233. [PMID: 39202514 PMCID: PMC11356204 DOI: 10.3390/medicina60081233] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/06/2024] [Revised: 07/26/2024] [Accepted: 07/28/2024] [Indexed: 09/03/2024]
Abstract
Background and Objectives: Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) is often associated with longer total stent length. Our aim was to evaluate the long-term safety and effectiveness of bioresorbable scaffold (BRS) implantation in CTO to avoid using a full metal jacket. Materials and Methods: We conducted a single-center prospective longitudinal case study including 34 patients who underwent PCI of CTO with at least one BRS and drug-eluting stent (DES) implantation (n = 27) or BRS-only at the Latvian Centre of Cardiology between 2016 and 2018. Quantitative coronary angiography (QCA) and intravascular ultrasound were performed during the index procedure and long-term follow-up. Results: Of 34 patients with a mean age of 60.6 ± 9.5 years, 76.5% were male. The most common CTO artery was the right coronary artery (73.5%, n = 25). The median length of occlusion was 23.0 mm (interquartile range (IQR) = 13.9-32.7), with a total mean BRS/DES length of 49.6 ± 20.4 mm. During the median follow-up of 5.6 years (IQR = 5.0-5.9), the primary endpoint of target vessel re-occlusion occurred in 5.9% (n = 2) of patients. Target lesion revascularization (TLR) was performed in 35.3% (n = 12) of patients, with a mean time to TLR of 62.5 (95% confidence interval (CI), 53.9-71.2) months. Through QCA, there was a statistically significant increase in median residual diameter stenosis (20.1-31.4%, p < 0.01) and residual length of stenosis (5.2-7.1%, p = 0.04) compared with the index procedure. Conclusions: Our study demonstrates that BRS is a safe and feasible option for PCI of CTO, allowing for the avoidance of long segment stenting and ensuring long-term patency of the coronary artery.
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Affiliation(s)
- Dace Sondore
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Ieva Briede
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Matiss Linde
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Karlis Trusinskis
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Inga Narbute
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Sanda Jegere
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Aigars Lismanis
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
| | - Indulis Kumsars
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Karlis Grikis
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Uldis Strazdins
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
| | - Andrejs Erglis
- Pauls Stradins Clinical University Hospital, LV-1002 Riga, Latvia; (D.S.); (U.S.)
- Faculty of Medicine and Life Sciences, University of Latvia, LV-1004 Riga, Latvia
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Lele M, Kapur S, Hargett S, Sureshbabu NM, Gaharwar AK. Global trends in clinical trials involving engineered biomaterials. SCIENCE ADVANCES 2024; 10:eabq0997. [PMID: 39018412 PMCID: PMC466960 DOI: 10.1126/sciadv.abq0997] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/17/2024] [Accepted: 06/11/2024] [Indexed: 07/19/2024]
Abstract
Engineered biomaterials are materials specifically designed to interact with biological systems for biomedical applications. This paper offers the comprehensive analysis of global clinical trial trends involving such materials. We surveyed 834 studies in the ClinicalTrials.gov database and explored biomaterial types, their initiation points, and durations in clinical trials. Predominantly, synthetic and natural polymers, particularly silicone and collagen, are used. Trials, focusing on ophthalmology, dentistry, and vascular medicine, are primarily conducted in the United States, Canada, and Italy. These trials encompass a broad demographic, and trials enrolled fewer than 100 participants. The study duration varied ranging from 0.5 to 4.5 years. These biomaterials are mainly bioresorbable or bioinert, with the integration of cells in biomaterials remaining an underexplored area. Our findings shed light on current practices and future potentials of engineered biomaterials in clinical research, offering insights for advancing this dynamic field globally.
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Affiliation(s)
- Mahim Lele
- Bridgeland High School, 10707 Mason Rd., Cypress, TX 77433, USA
| | - Shaunak Kapur
- Seven Lakes High School, 9251 S Fry Rd., Katy, TX 77494, USA
| | - Sarah Hargett
- Department of Biomedical Engineering, College of Engineering, Texas A&M University, College Station, TX 77843, USA
| | - Nivedhitha Malli Sureshbabu
- Department of Biomedical Engineering, College of Engineering, Texas A&M University, College Station, TX 77843, USA
| | - Akhilesh K. Gaharwar
- Department of Biomedical Engineering, College of Engineering, Texas A&M University, College Station, TX 77843, USA
- Interdisciplinary Program in Genetics, Texas A&M University, College Station, TX 77843, USA
- Center for Remote Health Technologies and Systems, Texas A&M University, College Station, TX 77843, USA
- Department of Material Science and Engineering, College of Engineering, Texas A&M University, College Station, TX 77843, USA
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Rai V, Iglesias JF, Bossard M, Dahal K, Chang CC, Tomaniak M. Editorial: Reviews in bioresorbable scaffold. Front Cardiovasc Med 2024; 11:1437555. [PMID: 38903963 PMCID: PMC11188400 DOI: 10.3389/fcvm.2024.1437555] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2024] [Accepted: 05/27/2024] [Indexed: 06/22/2024] Open
Affiliation(s)
- Vikrant Rai
- Department of Translational Research, Western University of Health Sciences, Pomona, CA, United States
| | - Juan F. Iglesias
- Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland
| | - Matthias Bossard
- Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland
| | - Khagendra Dahal
- School of Medicine, Creighton University, Omaha, NE, United States
| | - Chun Chin Chang
- Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
| | - Mariusz Tomaniak
- 1 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland
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Forkmann C, Pritsch M, Baumann-Zumstein P, Lootz D, Joner M. In vivo chronic scaffolding force of a resorbable magnesium scaffold. J Biomech 2024; 164:111988. [PMID: 38364489 DOI: 10.1016/j.jbiomech.2024.111988] [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: 10/19/2023] [Revised: 01/31/2024] [Accepted: 02/05/2024] [Indexed: 02/18/2024]
Abstract
The aim of this study is to qualitatively characterize the in vivo chronic scaffolding force of the Magmaris® Resorbable Magnesium Scaffold (RMS). This important parameter of scaffolds must be balanced between sufficient radial support during the healing period of the vessel and avoidance of long-term vessel caging. A finite element model was established using preclinical animal data and used to predict the device diameter and scaffolding force up to 90 days after implantation. To account for scaffold resorption, it included backbone degradation as well as formation of discontinuities as observed in vivo. The predictions of the model regarding acute recoil and chronic development of the device diameter were in good agreement with the preclinical data, supporting the validity of the model. It was found that after 28 and 90 days, the Magmaris® RMS retained 90 % and 47 % of its initial scaffolding force, respectively. The reduction in scaffolding force was mainly driven by discontinuities in the meandering segments. Finite element analysis combined with preclinical data is a reliable method to characterize the chronic scaffolding force.
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Affiliation(s)
| | | | | | - Daniel Lootz
- Biotronik AG, Ackerstraße 6, 8180 Bülach, Switzerland.
| | - Michael Joner
- German Heart Center Munich, Lazarettstraße 36, 80636 München, Germany.
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Carbonaro D, Lucchetti A, Audenino AL, Gries T, Vaughan TJ, Chiastra C. Multi-objective design optimization of bioresorbable braided stents. COMPUTER METHODS AND PROGRAMS IN BIOMEDICINE 2023; 242:107781. [PMID: 37683458 DOI: 10.1016/j.cmpb.2023.107781] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/20/2023] [Revised: 08/18/2023] [Accepted: 08/25/2023] [Indexed: 09/10/2023]
Abstract
BACKGROUND AND OBJECTIVES Bioresorbable braided stents, typically made of bioresorbable polymers such as poly-l-lactide (PLLA), have great potential in the treatment of critical limb ischemia, particularly in cases of long-segment occlusions and lesions with high angulation. However, the successful adoption of these devices is limited by their low radial stiffness and reduced elastic modulus of bioresorbable polymers. This study proposes a computational optimization procedure to enhance the mechanical performance of bioresorbable braided stents and consequently improve the treatment of critical limb ischemia. METHODS Finite element analyses were performed to replicate the radial crimping test and investigate the implantation procedure of PLLA braided stents. The stent geometry was characterized by four design parameters: number of wires, wire diameter, initial stent diameter, and braiding angle. Manufacturing constraints were considered to establish the design space. The mechanical performance of the stent was evaluated by defining the radial force, foreshortening, and peak maximum principal stress of the stent as objectives and constraint functions in the optimization problem. An approximate relationship between the objectives, constraint, and the design parameters was defined using design of experiment coupled with surrogate modelling. Surrogate models were then interrogated within the design space, and a multi-objective design optimization was conducted. RESULTS The simulation of radial crimping was successfully validated against experimental data. The radial force was found to be primarily influenced by the number of wires, wire diameter, and braiding angle, with the wire diameter having the most significant impact. Foreshortening was predominantly affected by the braiding angle. The peak maximum principal stress exhibited contrasting behaviour compared to the radial force for all parameters, with the exception of the number of wires. Among the Pareto-optimal design candidates, feasible peak maximum principal stress values were observed, with the braiding angle identified as the differentiating factor among these candidates. CONCLUSIONS The exploration of the design space enabled both the understanding of the impact of design parameters on the mechanical performance of bioresorbable braided stents and the successful identification of optimal design candidates. The optimization framework contributes to the advancement of innovative bioresorbable braided stents for the effective treatment of critical limb ischemia.
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Affiliation(s)
- Dario Carbonaro
- PoliTo(BIO)Med Lab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Turin, Italy
| | - Agnese Lucchetti
- Institut für Textiltechnik of RWTH Aachen University, Aachen, Germany
| | - Alberto L Audenino
- PoliTo(BIO)Med Lab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Turin, Italy
| | - Thomas Gries
- Institut für Textiltechnik of RWTH Aachen University, Aachen, Germany
| | - Ted J Vaughan
- Biomechanics Research Centre (BioMEC), School of Engineering, College of Science and Engineering, University of Galway, Ireland
| | - Claudio Chiastra
- PoliTo(BIO)Med Lab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Turin, Italy.
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Blázquez-Carmona P, Mora-Macías J, Martínez-Vázquez FJ, Morgaz J, Domínguez J, Reina-Romo E. Mechanics Predicts Effective Critical-Size Bone Regeneration Using 3D-Printed Bioceramic Scaffolds. Tissue Eng Regen Med 2023; 20:893-904. [PMID: 37606809 PMCID: PMC10519928 DOI: 10.1007/s13770-023-00577-2] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2023] [Revised: 06/25/2023] [Accepted: 07/11/2023] [Indexed: 08/23/2023] Open
Abstract
BACKGROUND 3D-printed bioceramic scaffolds have gained popularity due to their controlled microarchitecture and their proven biocompatibility. However, their high brittleness makes their surgical implementation complex for weight-bearing bone treatments. Thus, they would require difficult-to-instrument rigid internal fixations that limit a rigorous evaluation of the regeneration progress through the analysis of mechanic-structural parameters. METHODS We investigated the compatibility of flexible fixations with fragile ceramic implants, and if mechanical monitoring techniques are applicable to bone tissue engineering applications. Tissue engineering experiments were performed on 8 ovine metatarsi. A 15 mm bone segment was directly replaced with a hydroxyapatite scaffold and stabilized by an instrumented Ilizarov-type external fixator. Several in vivo monitoring techniques were employed to assess the mechanical and structural progress of the tissue. RESULTS The applied surgical protocol succeeded in combining external fixators and subject-specific bioceramic scaffolds without causing fatal fractures of the implant due to stress concentrator. The bearing capacity of the treated limb was initially altered, quantifying a 28-56% reduction of the ground reaction force, which gradually normalized during the consolidation phase. A faster recovery was reported in the bearing capacity, stiffening and bone mineral density of the callus. It acquired a predominant mechanical role over the fixator in the distribution of internal forces after one post-surgical month. CONCLUSION The bioceramic scaffold significantly accelerated in vivo the bone formation compared to other traditional alternatives in the literature (e.g., distraction osteogenesis). In addition, the implemented assessment techniques allowed an accurate quantitative evaluation of the bone regeneration through mechanical and imaging parameters.
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Affiliation(s)
- Pablo Blázquez-Carmona
- Escuela Técnica Superior de Ingeniería, Universidad de Sevilla, Avenida Camino de los Descubrimientos s/n, 41092, Seville, Spain.
- Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Seville, Spain.
| | - Juan Mora-Macías
- Escuela Técnica Superior de Ingeniería, Universidad de Huelva, Huelva, Spain
- Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Seville, Spain
| | - Francisco J Martínez-Vázquez
- Escuela Técnica Superior de Ingeniería, Universidad de Sevilla, Avenida Camino de los Descubrimientos s/n, 41092, Seville, Spain
| | - Juan Morgaz
- Departamento Medicina y Cirugía Animal, Universidad de Córdoba, Campus Universitario de Rabanales, Córdoba, Spain
| | - Jaime Domínguez
- Escuela Técnica Superior de Ingeniería, Universidad de Sevilla, Avenida Camino de los Descubrimientos s/n, 41092, Seville, Spain
- Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Seville, Spain
| | - Esther Reina-Romo
- Escuela Técnica Superior de Ingeniería, Universidad de Sevilla, Avenida Camino de los Descubrimientos s/n, 41092, Seville, Spain
- Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Seville, Spain
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11
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Plocon C, Evanghelidis A, Enculescu M, Isopencu G, Oprea O, Bacalum M, Raileanu M, Jinga S, Busuioc C. Development and Characterization of Electrospun Composites Built on Polycaprolactone and Cerium-Containing Phases. Int J Mol Sci 2023; 24:14201. [PMID: 37762504 PMCID: PMC10532413 DOI: 10.3390/ijms241814201] [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: 08/31/2023] [Revised: 09/13/2023] [Accepted: 09/15/2023] [Indexed: 09/29/2023] Open
Abstract
The current study reports on the fabrication of composite scaffolds based on polycaprolactone (PCL) and cerium (Ce)-containing powders, followed by their characterization from compositional, structural, morphological, optical and biological points of view. First, CeO2, Ce-doped calcium phosphates and Ce-substituted bioglass were synthesized by wet-chemistry methods (precipitation/coprecipitation and sol-gel) and subsequently loaded on PCL fibres processed by electrospinning. The powders were proven to be nanometric or micrometric, while the investigation of their phase composition showed that Ce was present as a dopant within the crystal lattice of the obtained calcium phosphates or as crystalline domains inside the glassy matrix. The best bioactivity was attained in the case of Ce-containing bioglass, while the most pronounced antibacterial effect was visible for Ce-doped calcium phosphates calcined at a lower temperature. The scaffolds were composed of either dimensionally homogeneous fibres or mixtures of fibres with a wide size distribution and beads of different shapes. In most cases, the increase in polymer concentration in the precursor solution ensured the achievement of more ordered fibre mats. The immersion in SBF for 28 days triggered an incipient degradation of PCL, evidenced mostly through cracks and gaps. In terms of biological properties, the composite scaffolds displayed a very good biocompatibility when tested with human osteoblast cells, with a superior response for the samples consisting of the polymer and Ce-doped calcium phosphates.
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Affiliation(s)
- Cristiana Plocon
- University Politehnica of Bucharest, RO-060042 Bucharest, Romania; (C.P.); (G.I.); (O.O.); (S.J.)
| | | | - Monica Enculescu
- National Institute for Materials Physics, RO-077125 Magurele, Romania; (A.E.); (M.E.)
| | - Gabriela Isopencu
- University Politehnica of Bucharest, RO-060042 Bucharest, Romania; (C.P.); (G.I.); (O.O.); (S.J.)
| | - Ovidiu Oprea
- University Politehnica of Bucharest, RO-060042 Bucharest, Romania; (C.P.); (G.I.); (O.O.); (S.J.)
| | - Mihaela Bacalum
- National Institute of Physics and Nuclear Engineering, RO-077125 Magurele, Romania; (M.B.); (M.R.)
| | - Mina Raileanu
- National Institute of Physics and Nuclear Engineering, RO-077125 Magurele, Romania; (M.B.); (M.R.)
| | - Sorin Jinga
- University Politehnica of Bucharest, RO-060042 Bucharest, Romania; (C.P.); (G.I.); (O.O.); (S.J.)
| | - Cristina Busuioc
- University Politehnica of Bucharest, RO-060042 Bucharest, Romania; (C.P.); (G.I.); (O.O.); (S.J.)
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12
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Abubakar M, Javed I, Rasool HF, Raza S, Basavaraju D, Abdullah RM, Ahmed F, Salim SS, Faraz MA, Hassan KM, Hajjaj M. Advancements in Percutaneous Coronary Intervention Techniques: A Comprehensive Literature Review of Mixed Studies and Practice Guidelines. Cureus 2023; 15:e41311. [PMID: 37539426 PMCID: PMC10395399 DOI: 10.7759/cureus.41311] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/03/2023] [Indexed: 08/05/2023] Open
Abstract
Percutaneous coronary intervention (PCI) is a widely used therapy for coronary artery disease (CAD), but it carries risks and complications. Adhering to evidence-based practice guidelines is crucial for optimal outcomes. This review compares the recommendations of the 2021 American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) and 2018 European Society of Cardiology (ESC) guidelines for coronary artery revascularization and discusses emerging trends and novel devices in PCI. A comprehensive literature review of mixed studies, clinical trials, and guidelines was conducted. Intravascular imaging, including intravascular ultrasound and optical coherence tomography, for stent optimization, is also recommended when feasible. However, differences reflecting variations in evidence quality interpretation and applicability were identified. Furthermore, novel devices and technologies with the potential for improving outcomes were highlighted, but their safety and efficacy compared to standard-of-care techniques require further evaluation through extensive randomized trials. Clinicians should stay updated on advancements and personalize treatment decisions based on individual patient factors. Future research should address evidence gaps and barriers to adopting innovative devices and techniques. This review provides recommendations for clinical practice, emphasizing the need to remain current with the evolving landscape of PCI to optimize patient outcomes. The discoveries provide valuable counsel for the deliberation of clinical interventions and prospective inquiries within the realm of interventional cardiology. Overall, the review underscores the importance of evidence-based practice and ongoing advancements in PCI for CAD management.
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Affiliation(s)
- Muhammad Abubakar
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
- Department of Internal Medicine, Siddique Sadiq Memorial Trust Hospital, Gujranwala, PAK
| | - Izzah Javed
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
| | - Hafiz Fahad Rasool
- Department of Public Health, School of Public Health, Nanjing Medical University, Nanjing, CHN
| | - Saud Raza
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
| | - Deepak Basavaraju
- Department of Internal Medicine, Mysore Medical College and Research Institute, Mysore, IND
| | | | - Faizan Ahmed
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
| | - Siffat S Salim
- Department of Surgery, Holy Family Red Crescent Medical College Hospital, Dhaka, BGD
| | - Muhammad Ahmad Faraz
- Department of Forensic Medicine, Post Graduate Medical Institute, Lahore General Hospital, Lahore, PAK
| | - Khawaja Mushammar Hassan
- Department of Internal Medicine, Ameer-ud-Din Medical College/Lahore General Hospital, Lahore, PAK
| | - Mohsin Hajjaj
- Department of Internal Medicine, Jinnah Hospital, Lahore, PAK
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13
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Moulias A, Koros R, Papageorgiou A, Patrinos P, Spyropoulou P, Vakka A, Bozika M, Vasilagkos G, Apostolos A, Nastouli KM, Tsigkas G, Davlouros P. OCT Guidance in Bifurcation Percutaneous Coronary Intervention. Rev Cardiovasc Med 2023; 24:88. [PMID: 39077489 PMCID: PMC11264033 DOI: 10.31083/j.rcm2403088] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2022] [Revised: 02/14/2023] [Accepted: 02/22/2023] [Indexed: 07/31/2024] Open
Abstract
Coronary bifurcation is defined by the European Bifurcation Consensus as a coronary artery stenosis adjacent to the origin of a significant side branch. Its anatomy is composed of 3 different segments: proximal main vessel, distal main vessel and side branch. Coronary artery bifurcation lesions are encountered in approximately 15-20% of all percutaneous coronary interventions and constitute a complex subgroup of lesions characterized by lower procedural success rates and higher rates of adverse outcomes. In recent years, a growing focus in the European and Japanese bifurcation club meetings has been the emerging role of intravascular imaging, in guiding successful bifurcation percutaneous coronary interventions (PCI). In this review we will present the main ways optical coherence tomography (OCT) can be used to improve outcomes during bifurcation PCI.
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Affiliation(s)
- Athanasios Moulias
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Rafail Koros
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Angeliki Papageorgiou
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Panagiotis Patrinos
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Panagiota Spyropoulou
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Angeliki Vakka
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Maria Bozika
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Georgios Vasilagkos
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Anastasios Apostolos
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | | | - Grigorios Tsigkas
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
| | - Periklis Davlouros
- Department of Cardiology, General University Hospital of Patras, 26504 Patras, Greece
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14
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Qiu D, Deng Y, Wen Y, Yin J, Feng J, Huang J, Song M, Zhang G, Chen C, Xia J. Iron corroded granules inhibiting vascular smooth muscle cell proliferation. Mater Today Bio 2022; 16:100420. [PMID: 36110422 PMCID: PMC9468459 DOI: 10.1016/j.mtbio.2022.100420] [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: 07/02/2022] [Revised: 09/01/2022] [Accepted: 09/03/2022] [Indexed: 11/17/2022]
Abstract
In-stent restenosis after interventional therapy remains a severe clinical complication. Current evidence indicates that neointimal hyperplasia induced by vascular smooth muscle cell (VSMC) proliferation is a major cause of restenosis. Thus, inhibiting VSMC proliferation is critical for preventing in-stent restenosis. The incidence of restenosis was reduced in nitrided iron-based stents (hereafter referred to as iron stents). We hypothesized that the corroded granules produced by the iron stent would prevent in-stent restenosis by inhibiting VSMC proliferation. To verify this hypothesis, we introduced a dynamic circulation device to analyze the components of corroded granules. To investigate the effects of corroded granules on VSMC proliferation, we implanted the corroded iron stent into the artery of the atherosclerotic artery stenosis model. Moreover, we explored the mechanism underlying the inhibition of VSMC proliferation by iron corroded granules. The results indicated that iron stent produced the corroded granules after implantation, and the main component of the corrosion granules was iron oxide. Remarkably, the corroded granules reduced the neointimal hyperplasia in an atherosclerotic artery stenosis model, and iron corroded granules decreased the neointimal hyperplasia by inhibiting VSMC proliferation. In addition, we revealed that corroded granules reduced VSMC proliferation by activating autophagy through the AMPK/mTOR signaling pathway. Importantly, safety of iron corroded granules was evaluated and proved to be satisfactory hemocompatibility in rabbit model. Overall, the role of corroded granules in restenosis prevention was described for the first time. This finding highlighted the implication of corroded granules produced by iron stent in inhibiting VSMC proliferation, pointing to a new direction to prevent in-stent restenosis.
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Affiliation(s)
- Dongxu Qiu
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
| | - Yalan Deng
- NHC Key Laboratory of Cancer Proteomics & Laboratory of Structural Biology, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, PR China
| | - Yanbin Wen
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
| | - Jun Yin
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
| | - Jie Feng
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
| | - Jiabing Huang
- Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Jiangxi, Nanchang, PR China
| | - Mingyu Song
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
| | - Gui Zhang
- R&D Center, Lifetech Scientific (Shenzhen) Co Ltd, Shenzhen, 518057, PR China
| | - Changqing Chen
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
- Corresponding author.
| | - Jian Xia
- Department of Neurology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, PR China
- Corresponding author.
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Oh S, Jeong MH, Park DS, Kim M, Kim JH, Hyun DY, Cho KH, Kim MC, Sim DS, Hong YJ, Kim JH, Ahn Y. Successful implantation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film with good patency on follow-up angiography: A case report. Medicine (Baltimore) 2022; 101:e29666. [PMID: 35866823 PMCID: PMC9302256 DOI: 10.1097/md.0000000000029666] [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] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/04/2023] Open
Abstract
RATIONALE Despite technological advances in interventional cardiology during the last decades, many concerns remain regarding the narrowing and occlusion of the in-stent area. Particularly, polymer materials pose several problems, including chronic arterial inflammation, impaired arterial healing, and stent thrombosis. To avoid these complications, we invented the TIGEREVOLUTION stent with a cobalt-chromium alloy-based stent platform deposited with N-TiO2 film, which has demonstrated good biocompatibility. As this stent is not coated with polymer, it is expected to have decreased risk of stent thrombosis. PATIENT CONCERNS A 62-year-old Korean man visited our department because of angina. We commenced coronary angiography (CAG). DIAGNOSIS CAG revealed critical stenosis in the mid-portion of the right coronary artery, with a minimum lumen area of 1.08mm2 on optical coherence tomography (OCT). INTERVENTION Percutaneous coronary intervention was performed with implantation of a novel 3.5 × 26-mm polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film (TIGEREVOLUTION® stent). Post-percutaneous coronary intervention OCT showed good stent expansion and apposition, and the patient was discharged successfully and uneventfully. OUTCOMES Eight months later, follow-up coronary angiography demonstrated good stent patency with no definitive evidence of in-stent restenosis, with thin stent strut coverage demonstrated on OCT. LESSONS We report the first case of TIGEREVOLUTION stent implantation with follow-up OCT at 8 months.
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Affiliation(s)
- Seok Oh
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
| | - Myung Ho Jeong
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Gwangju, Korea
- *Correspondence: Myung Ho Jeong, Department of Cardiology, Chonnam National University Hospital; Department of Cardiology, Chonnam National University Medical School, 42, Jebong-ro, Dong-gu, Gwangju 61469, Korea (e-mail: )
| | - Dae Sung Park
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Munki Kim
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Jung Ha Kim
- Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea
| | - Dae Young Hyun
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
| | - Kyung Hoon Cho
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
| | - Min Chul Kim
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Gwangju, Korea
| | - Doo Sun Sim
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Gwangju, Korea
| | - Young Joon Hong
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Gwangju, Korea
| | - Ju Han Kim
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Gwangju, Korea
| | - Youngkeun Ahn
- Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea
- Department of Cardiology, Chonnam National University Medical School, Gwangju, Korea
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16
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Bossard M, Madanchi M, Avdijaj D, Attinger-Toller A, Cioffi GM, Seiler T, Tersalvi G, Kobza R, Schüpfer G, Cuculi F. Long-Term Outcomes After Implantation of Magnesium-Based Bioresorbable Scaffolds—Insights From an All-Comer Registry. Front Cardiovasc Med 2022; 9:856930. [PMID: 35498044 PMCID: PMC9046914 DOI: 10.3389/fcvm.2022.856930] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2022] [Accepted: 03/08/2022] [Indexed: 12/18/2022] Open
Abstract
BackgroundThe magnesium-based sirolimus-eluting bioresorbable scaffold (Mg-BRS) Magmaris™ showed promising clinical outcomes, including low rates of both the target lesion failure (TLF) and scaffold thrombosis (ScT), in selected study patients. However, insights regarding long-term outcomes (>2 years) in all-comer populations remain scarce.MethodsWe analyzed data from a single-center registry, including patients with acute coronary syndrome (ACS) and chronic coronary syndrome (CCS), who had undergone percutaneous coronary intervention (PCI) using the Mg-BRS. The primary outcome comprised the device-oriented composite endpoint (DoCE) representing a hierarchical composite of cardiac death, ScT, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) up to 5 years.ResultsIn total, 84 patients [mean age 62 ± 11 years and 63 (75%) men] were treated with the Mg-BRS devices between June 2016 and March 2017. Overall, 101 lesions had successfully been treated with the Mg-BRS devices using 1.2 ± 0.4 devices per lesion. Pre- and postdilatation using dedicated devices had been performed in 101 (100%) and 98 (97%) of all the cases, respectively. After a median follow-up time of 62 (61–64) months, 14 (18%) patients had experienced DoCEs, whereas ScT was encountered in 4 (4.9%) patients [early ScTs (<30 days) in three cases and two fatal cases]. In 4 (29%) of DoCE cases, optical coherence tomography confirmed the Mg-BRS collapse and uncontrolled dismantling.ConclusionIn contradiction to earlier studies, we encountered a relatively high rate of DoCEs in an all-comer cohort treated with the Mg-BRS. We even observed scaffold collapse and uncontrolled dismantling. This implicates that this metal-based BRS requires further investigation and may only be used in highly selected cases.
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Affiliation(s)
- Matthias Bossard
- Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland
- *Correspondence: Matthias Bossard
| | - Mehdi Madanchi
- Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland
| | - Dardan Avdijaj
- Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland
- Faculty of Medicine, University of Zurich, Luzern, Switzerland
| | | | | | - Thomas Seiler
- Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland
| | - Gregorio Tersalvi
- Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland
| | - Richard Kobza
- Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland
| | - Guido Schüpfer
- Department of Anaestesiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Florim Cuculi
- Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland
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17
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Mori M, Sakamoto A, Sato Y, Kawakami R, Kawai K, Cornelissen A, Abebe B, Ghosh S, Romero ME, Kolodgie FD, Virmani R, Finn AV. Overcoming challenges in refining the current generation of coronary stents. Expert Rev Cardiovasc Ther 2021; 19:1013-1028. [PMID: 34860134 DOI: 10.1080/14779072.2021.2013810] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
INTRODUCTION Late stent thrombosis caused by delayed vascular healing and prolonged local inflammation were major drawbacks of 1st generation drug-eluting stents (DES). Strut design, biocompatibility of polymer, and drug-release profiles were improved in 2nd and 3rdgeneration DES. Accordingly, the indications for percutaneous coronary intervention with DES have been expanded to more complex patients and lesions. Despite these improvements, significant barriers such as greater flexibility in the duration of dual-antiplatelet therapy (DAPT) as well as reducing long-term stent-related events remain. To achieve ideal short- and long-term results, these existing limitations need to be overcome. AREAS COVERED We will discuss the current limitations of coronary DES and how they might be overcome from pathological and clinical viewpoints. EXPERT OPINION Optimizing DAPT duration after stent implantation and prevention of in-stent neoatherosclerosis are two major issues in current DES. Overcoming these drawbacks is a prerequisite toward achieving better short- and long-term clinical outcomes. New technologies including platform design, polymer types, and anti-proliferative agent itself might lead to further improvements. Although the initial experience with bioresorbable scaffold/stents (BRS) was disappointing, positive results of clinical studies regarding novel BRS are raising expectations. Overall, further device innovation is desired for overcoming the limitations of current DES.
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Affiliation(s)
| | | | - Yu Sato
- CVPath Institute, Inc, Gaithersburg, MD, USA
| | | | - Kenji Kawai
- CVPath Institute, Inc, Gaithersburg, MD, USA
| | | | | | | | | | | | | | - Aloke V Finn
- CVPath Institute, Inc, Gaithersburg, MD, USA.,School of Medicine, University of Maryland, Baltimore, Md, USA
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18
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Madanchi M, Cioffi GM, Attinger-Toller A, Wolfrum M, Moccetti F, Seiler T, Vercelli L, Burkart P, Toggweiler S, Kobza R, Bossard M, Cuculi F. Long-term outcomes after treatment of in-stent restenosis using the Absorb everolimus-eluting bioresorbable scaffold. Open Heart 2021; 8:openhrt-2021-001776. [PMID: 34518287 PMCID: PMC8438862 DOI: 10.1136/openhrt-2021-001776] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/09/2021] [Accepted: 08/27/2021] [Indexed: 01/28/2023] Open
Abstract
Background Early studies evaluating the performance of bioresorbable scaffold (BRS) Absorb in in-stent restenosis (ISR) lesions indicated promising short-term to mid-term outcomes. Aims To evaluate long-term outcomes (up to 5 years) of patients with ISR treated with the Absorb BRS. Methods We did an observational analysis of long-term outcomes of patients treated for ISR using the Absorb BRS (Abbott Vascular, Santa Clara, California, USA) between 2013 and 2016 at the Heart Centre Luzern. The main outcomes included a device-oriented composite endpoint (DOCE), defined as composite of cardiac death, target vessel (TV) myocardial infarction and TV revascularisation, target lesion revascularisation and scaffold thrombosis (ScT). Results Overall, 118 ISR lesions were treated using totally 131 BRS among 89 patients and 31 (35%) presented with an acute coronary syndrome. The median follow-up time was 66.3 (IQR 52.3–77) months. A DOCE had occurred in 17% at 1 year, 27% at 2 years and 40% at 5 years of all patients treated for ISR using Absorb. ScTs were observed in six (8.4%) of the cohort at 5 years. Conclusions Treatment of ISR using the everolimus-eluting BRS Absorb resulted in high rates of DOCE at 5 years. Interestingly, while event rates were low in the first year, there was a massive increase of DOCE between 1 and 5 years after scaffold implantation. With respect to its complexity, involving also a more unpredictable vascular healing process, current and future BRS should be used very restrictively for the treatment of ISR.
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Affiliation(s)
- Mehdi Madanchi
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | | | | | - Mathias Wolfrum
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Federico Moccetti
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Thomas Seiler
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Luca Vercelli
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Philipp Burkart
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Stefan Toggweiler
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Richard Kobza
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Matthias Bossard
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
| | - Florim Cuculi
- Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland
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19
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Ryu H, Seo M, Rogers JA. Bioresorbable Metals for Biomedical Applications: From Mechanical Components to Electronic Devices. Adv Healthc Mater 2021; 10:e2002236. [PMID: 33586341 DOI: 10.1002/adhm.202002236] [Citation(s) in RCA: 34] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/21/2020] [Revised: 01/29/2021] [Indexed: 01/16/2023]
Abstract
Bioresorbable metals and metal alloys are of growing interest for myriad uses in temporary biomedical implants. Examples range from structural elements as stents, screws, and scaffolds to electronic components as sensors, electrical stimulators, and programmable fluidics. The associated physical forms span mechanically machined bulk parts to lithographically patterned conductive traces, across a diversity of metals and alloys based on magnesium, zinc, iron, tungsten, and others. The result is a rich set of opportunities in healthcare materials science and engineering. This review article summarizes recent advances in this area, starting with an historical perspective followed by a discussion of materials options, considerations in biocompatibility, and device applications. Highlights are in system level bioresorbable electronic platforms that support functions as diagnostics and therapeutics in the context of specific, temporary clinical needs. A concluding section highlights challenges and emerging research directions.
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Affiliation(s)
- Hanjun Ryu
- Center for Bio‐Integrated Electronics Querrey Simpson Institute for Bioelectronics Northwestern University Evanston IL 60208 USA
| | - Min‐Ho Seo
- School of Biomedical Convergence Engineering College of Information & Biomedical Engineering Pusan National University 49 Busandaehak‐ro Yangsan‐si Gyeongsangnam‐do 50612 Republic of Korea
| | - John A. Rogers
- Center for Bio‐Integrated Electronics Querrey Simpson Institute for Bioelectronics Northwestern University Evanston IL 60208 USA
- Department of Mechanical Engineering Northwestern University Evanston IL 60208 USA
- Department of Civil and Environmental Engineering Northwestern University Evanston IL 60208 USA
- Department of Materials Science and Engineering Northwestern University Evanston IL 60208 USA
- Department of Biomedical Engineering Northwestern University Evanston IL 60208 USA
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20
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Wu X, Wu S, Kawashima H, Hara H, Ono M, Gao C, Wang R, Lunardi M, Sharif F, Wijns W, Serruys PW, Onuma Y. Current perspectives on bioresorbable scaffolds in coronary intervention and other fields. Expert Rev Med Devices 2021; 18:351-365. [PMID: 33739213 DOI: 10.1080/17434440.2021.1904894] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
Introduction: The first-generation bioresorbable scaffolds (BRSs) had a large strut profile to compensate for the insufficient radial strength of bioresorbable polymer materials, resulting in higher scaffold thrombosis rates than conventional drug-eluting stents. To improve the clinical safety and efficacy, the new generation BRSs have been improved by optimal structure design, post-processing of bioresorbable polymer materials, or altering bioresorbable metallic alloys.Areas covered: This review summarizes the lessons learned from the first-generation BRS, updates the clinical outcomes of trials evaluating ABSORB bioresorbable vascular scaffold at long-term and bioresorbable metallic alloy-based devices, and examines recent outcomes of BRS treated in STEMI patients. This review also provides an overview of the current clinical data of seven BRSs manufactured in Asia, and of the BRSs extended application in other clinical arenas.Expert opinion: Drawbacks of the first-generation BRSs need to be addressed by the next generation of these stents with novel materials and technologies. Clinical research, including randomized controlled trials, are required to further evaluate BRSs application in coronary artery disease. The encouraging results of BRSs innovation applied in the peripheral arteries and gastrointestinal tracts support other potential clinical applications of BRS technology.
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Affiliation(s)
- Xinlei Wu
- Institute of Cardiovascular Development and Translational Medicine, the Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.,Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Sijing Wu
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland.,Department of Cardiology, Beijing Anzhen Hospital, Beijing, China
| | - Hideyuki Kawashima
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Hironori Hara
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Masafumi Ono
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Chao Gao
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland.,Department of Cardiology, Xijing Hospital, Xi'an, China
| | - Rutao Wang
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland.,Department of Cardiology, Xijing Hospital, Xi'an, China
| | - Mattia Lunardi
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Faisal Sharif
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - William Wijns
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
| | - Patrick W Serruys
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland.,National Heart & Lung Institute, Imperial College London, London, UK
| | - Yoshinobu Onuma
- Department of Cardiology, National University of Ireland Galway (NUIG), Galway, Ireland
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21
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Zhang B, Wang X, Wang D, Guo M, Ren C, Han W, Uyama H, Li Q. Improved Antithrombogenicity of a Poly(lactic acid) Surface Grafted with Chondroitin Sulfate. ACS APPLIED BIO MATERIALS 2021; 4:2696-2703. [DOI: 10.1021/acsabm.0c01629] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Affiliation(s)
- Bo Zhang
- School of Mechanics Science and Safety Engineering, Zhengzhou University, Zhengzhou 450002, China
- National Center for International Research of Micro-Nano Molding Technology, Key Laboratory of Henan Province for Micro Molding Technology, Zhengzhou 450002, China
| | - Xiaofeng Wang
- School of Mechanics Science and Safety Engineering, Zhengzhou University, Zhengzhou 450002, China
- National Center for International Research of Micro-Nano Molding Technology, Key Laboratory of Henan Province for Micro Molding Technology, Zhengzhou 450002, China
| | - Dongfang Wang
- School of Mechanics Science and Safety Engineering, Zhengzhou University, Zhengzhou 450002, China
- National Center for International Research of Micro-Nano Molding Technology, Key Laboratory of Henan Province for Micro Molding Technology, Zhengzhou 450002, China
| | - Meng Guo
- School of Mechanics Science and Safety Engineering, Zhengzhou University, Zhengzhou 450002, China
- National Center for International Research of Micro-Nano Molding Technology, Key Laboratory of Henan Province for Micro Molding Technology, Zhengzhou 450002, China
| | - Cuihong Ren
- School of Mechanics Science and Safety Engineering, Zhengzhou University, Zhengzhou 450002, China
- National Center for International Research of Micro-Nano Molding Technology, Key Laboratory of Henan Province for Micro Molding Technology, Zhengzhou 450002, China
| | - Wenjuan Han
- School of Materials Science and Engineering, Zhengzhou University, Zhengzhou 450002, China
| | - Hiroshi Uyama
- Department of Applied Chemistry, Graduate School of Engineering, Osaka University, Suita, Japan
| | - Qian Li
- School of Mechanics Science and Safety Engineering, Zhengzhou University, Zhengzhou 450002, China
- National Center for International Research of Micro-Nano Molding Technology, Key Laboratory of Henan Province for Micro Molding Technology, Zhengzhou 450002, China
- School of Materials Science and Engineering, Zhengzhou University, Zhengzhou 450002, China
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22
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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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