Esophageal disease is a common disorder of the digestive system that can severely affect the quality of life andprognosis of patients. Esophageal stenting is an effective treatment that has been widely used in clinica...Esophageal disease is a common disorder of the digestive system that can severely affect the quality of life andprognosis of patients. Esophageal stenting is an effective treatment that has been widely used in clinical practice.However, esophageal stents of different types and parameters have varying adaptability and effectiveness forpatients, and they need to be individually selected according to the patient’s specific situation. The purposeof this study was to provide a reference for clinical doctors to choose suitable esophageal stents. We used 3Dprinting technology to fabricate esophageal stents with different ratios of thermoplastic polyurethane (TPU)/(Poly-ε-caprolactone) PCL polymer, and established an artificial neural network model that could predict the radial forceof esophageal stents based on the content of TPU, PCL and print parameter. We selected three optimal ratios formechanical performance tests and evaluated the biomechanical effects of different ratios of stents on esophagealimplantation, swallowing, and stent migration processes through finite element numerical simulation and in vitrosimulation tests. The results showed that different ratios of polymer stents had different mechanical properties,affecting the effectiveness of stent expansion treatment and the possibility of postoperative complications of stentimplantation.展开更多
The so-called fourth-generation biodegradable vascular stent has become a research hotspot in thefield of bioengineering because of its good degradation ability and drug-loading characteristics.However,the preparationo...The so-called fourth-generation biodegradable vascular stent has become a research hotspot in thefield of bioengineering because of its good degradation ability and drug-loading characteristics.However,the preparationof polymer-degraded vascular stents is affected by known problem such as poor processflexibility,low formingaccuracy,large diameter wall thickness,limited complex pore structure,weak mechanical properties of radial support and high process cost.In this study,a deposition technique based on a high-voltage electric-field-driven continuous rotating jet is proposed to fabricate fully degraded polymer vascular stents.The experimental results showthat,due to the rotation of the deposition axis,the deposition direction of PCL(polycaprolactone)micro-jet isalways tangent to the surface of the deposition axis.The direction of the viscous drag force is also consistent withthe deposition direction of the jet.It is shown that by setting different rotation speeds of deposition axisωandlinear motion speeds of the nozzle V,the direction of rotation,pitch and angle of the individual printed spiralcurve can be precisely tuned.In the process of multiple spiral curves matching the deposition forming thin walltube mesh,the mesh shape and size of the thin wall tube can be accurately controlled by changing the number ofmatching spiral curves and the size of the matching position bias distance.Finally,the characteristics of a PCLtubular stent sample(with uniform-size microfibers and mesh shape),fabricated under the appropriate processparameters are described in detail.展开更多
It has been well established that use of drug-eluting stents has resulted in marked reduction in neointimal proliferation following stenting and that this is reflected clinically in a very significant decrease in ... It has been well established that use of drug-eluting stents has resulted in marked reduction in neointimal proliferation following stenting and that this is reflected clinically in a very significant decrease in late lumen loss, instent restenosis, and target lesion revascularization. This benefit occurs, however, in the setting of delayed endothelial and vascular wall healing with its potential for continuing thrombogenicity requiring more prolonged use of dual antiplatelet therapy to prevent stent thrombosis.……展开更多
Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-elutin...Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-eluting stents(DP-DES).The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.Methods:Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence.CPCI included at least one of the following features:unprotected left main lesion,≥2 lesions treated,≥2 stents implanted,total stent length>40 mm,moderate-to-severe calcified lesion,chronic total occlusion,or bifurcated target lesion.The primary endpoint was major adverse cardiac events(MACE)including all-cause death,recurrent myocardial infarction,and total coronary revascularization(target lesion revascularization,target vessel revascularization[TVR],and non-TVR)during the 5-year follow-up.The secondary endpoint was total coronary revascularization.Results:Among the 7712 patients included,4882(63.3%)underwent CPCI.Compared with non-CPCI patients,CPCI patients had higher 2-and 5-year incidences of MACE and total coronary revascularization.Following multivariable adjustment including stent type,CPCI was an independent predictor of MACE(adjusted hazard ratio[aHR]:1.151;95%confidence interval[CI]:1.017–1.303,P=0.026)and total coronary revascularization(aHR:1.199;95%CI:1.037–1.388,P=0.014)at 5 years.The results were consistent at the 2-year endpoints.In patients with CPCI,BP-DES use was associated with significantly higher MACE rates at 5 years(aHR:1.256;95%CI:1.078–1.462,P=0.003)and total coronary revascularization(aHR:1.257;95%CI:1.052–1.502,P=0.012)compared with that of DP-DES,but there was a similar risk at 2 years.However,BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.Conclusions:Patients underwent CPCI remained at a higher risk of mid-to long-term adverse events regardless of the stent type.The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.展开更多
Biodegradable polymer vascular stents(BPVSs)have been widely used in percutaneous coronary interventions for the treatment of coronary artery diseases.The development of BPVSs is an integrated process that combines ma...Biodegradable polymer vascular stents(BPVSs)have been widely used in percutaneous coronary interventions for the treatment of coronary artery diseases.The development of BPVSs is an integrated process that combines material design/selection,manufacturing,and performance characterization.Three-dimensional(3D)printing technology is a powerful tool for polymer stent fabrication.Current review studies have focused primarily on the material and structural design of polymer stents but have failed to comprehensively discuss different 3D printing approaches and stent characterization techniques.In this paper,we address these shortcomings by discussing 3D printing methods and their application in BPVSs.First,some commonly used 3D printing methods(including material extrusion,vat polymerization,and powder bed fusion)and potential 3D printing strategies(including material jetting and binder jetting)for fabricating BPVSs are discussed;furthermore,the main post-treatments are summarized.Then,techniques to characterize the morphology,mechanical properties,and biological prop-erties of the printed BPVSs are introduced.Subsequently,representative commercial BPVSs and lab-grade BPVSs are compared.Finally,based on the limitations of stent printing and characterization processes,future perspec-tives are proposed,which may help develop new techniques to fabricate more customized stents and accurately evaluate their performance.展开更多
Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES ...Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents （PF-PES） in comparison with permanent polymer sirolimus-eluting stents （PP-SES） in patients with acute ST-segment elevation myocardial infarction （STEMI）. Methods Patients with STEMI were randomly assigned to receive PP-SES （n=55）, and PF-PES （n=50）. The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure （TLF） was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction （Re-MI）, or target lesion revascularization （TLR）. Results Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group （P=0.757）. The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure （10.9% PP-SES vs. 12.0% PF-PES, P=0.861） and definite or probable stent thrombosis （1.8% PP-SES vs. 2.0% PF-PES, P=1.000） at one year. Conclusions The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with laraer study DODUlations are needed to net definite conclusions.展开更多
基金Nanning Technology and Innovation Special Program(20204122)and Research Grant for 100 Talents of Guangxi Plan.
文摘Esophageal disease is a common disorder of the digestive system that can severely affect the quality of life andprognosis of patients. Esophageal stenting is an effective treatment that has been widely used in clinical practice.However, esophageal stents of different types and parameters have varying adaptability and effectiveness forpatients, and they need to be individually selected according to the patient’s specific situation. The purposeof this study was to provide a reference for clinical doctors to choose suitable esophageal stents. We used 3Dprinting technology to fabricate esophageal stents with different ratios of thermoplastic polyurethane (TPU)/(Poly-ε-caprolactone) PCL polymer, and established an artificial neural network model that could predict the radial forceof esophageal stents based on the content of TPU, PCL and print parameter. We selected three optimal ratios formechanical performance tests and evaluated the biomechanical effects of different ratios of stents on esophagealimplantation, swallowing, and stent migration processes through finite element numerical simulation and in vitrosimulation tests. The results showed that different ratios of polymer stents had different mechanical properties,affecting the effectiveness of stent expansion treatment and the possibility of postoperative complications of stentimplantation.
基金supported by the National Natural Science Foundation of China(Grant Nos.51305128 and 52005059)The Key Scientific and Technological Project of Henan Province(Grant Nos.242102231054 and 242102220073)The Provincial Graduate Quality Engineering Project(Grant No.YJS2024JD38)。
文摘The so-called fourth-generation biodegradable vascular stent has become a research hotspot in thefield of bioengineering because of its good degradation ability and drug-loading characteristics.However,the preparationof polymer-degraded vascular stents is affected by known problem such as poor processflexibility,low formingaccuracy,large diameter wall thickness,limited complex pore structure,weak mechanical properties of radial support and high process cost.In this study,a deposition technique based on a high-voltage electric-field-driven continuous rotating jet is proposed to fabricate fully degraded polymer vascular stents.The experimental results showthat,due to the rotation of the deposition axis,the deposition direction of PCL(polycaprolactone)micro-jet isalways tangent to the surface of the deposition axis.The direction of the viscous drag force is also consistent withthe deposition direction of the jet.It is shown that by setting different rotation speeds of deposition axisωandlinear motion speeds of the nozzle V,the direction of rotation,pitch and angle of the individual printed spiralcurve can be precisely tuned.In the process of multiple spiral curves matching the deposition forming thin walltube mesh,the mesh shape and size of the thin wall tube can be accurately controlled by changing the number ofmatching spiral curves and the size of the matching position bias distance.Finally,the characteristics of a PCLtubular stent sample(with uniform-size microfibers and mesh shape),fabricated under the appropriate processparameters are described in detail.
文摘 It has been well established that use of drug-eluting stents has resulted in marked reduction in neointimal proliferation following stenting and that this is reflected clinically in a very significant decrease in late lumen loss, instent restenosis, and target lesion revascularization. This benefit occurs, however, in the setting of delayed endothelial and vascular wall healing with its potential for continuing thrombogenicity requiring more prolonged use of dual antiplatelet therapy to prevent stent thrombosis.……
基金supported by the National Key Research and Development Program of China(Nos.2016YFC1301300 and 2016YFC1301301)National Clinical Research Center for Cardiovascular Diseases,Fuwai Hospital,Chinese Academy of Medical Sciences(No.NCRC2020013)+1 种基金Chinese Academy of Medical Sciences(CAMS)Innovation Fund for Medical Sciences(CIFMS)(No.2020-I2M-C&T-B-049)the National Natural Science Foundation for Young Scholars of China(No.81900323).
文摘Background:There are few data comparing clinical outcomes of complex percutaneous coronary intervention(CPCI)when using biodegradable polymer drug-eluting stents(BP-DES)or second-generation durable polymer drug-eluting stents(DP-DES).The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up.Methods:Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence.CPCI included at least one of the following features:unprotected left main lesion,≥2 lesions treated,≥2 stents implanted,total stent length>40 mm,moderate-to-severe calcified lesion,chronic total occlusion,or bifurcated target lesion.The primary endpoint was major adverse cardiac events(MACE)including all-cause death,recurrent myocardial infarction,and total coronary revascularization(target lesion revascularization,target vessel revascularization[TVR],and non-TVR)during the 5-year follow-up.The secondary endpoint was total coronary revascularization.Results:Among the 7712 patients included,4882(63.3%)underwent CPCI.Compared with non-CPCI patients,CPCI patients had higher 2-and 5-year incidences of MACE and total coronary revascularization.Following multivariable adjustment including stent type,CPCI was an independent predictor of MACE(adjusted hazard ratio[aHR]:1.151;95%confidence interval[CI]:1.017–1.303,P=0.026)and total coronary revascularization(aHR:1.199;95%CI:1.037–1.388,P=0.014)at 5 years.The results were consistent at the 2-year endpoints.In patients with CPCI,BP-DES use was associated with significantly higher MACE rates at 5 years(aHR:1.256;95%CI:1.078–1.462,P=0.003)and total coronary revascularization(aHR:1.257;95%CI:1.052–1.502,P=0.012)compared with that of DP-DES,but there was a similar risk at 2 years.However,BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years.Conclusions:Patients underwent CPCI remained at a higher risk of mid-to long-term adverse events regardless of the stent type.The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.
基金supported by University of Nevada Reno,USA,Na-tional Key R&D Program of China(Grant No.2018YFA0703000)National Natural Science Foundation of China(Grant No.52175289).
文摘Biodegradable polymer vascular stents(BPVSs)have been widely used in percutaneous coronary interventions for the treatment of coronary artery diseases.The development of BPVSs is an integrated process that combines material design/selection,manufacturing,and performance characterization.Three-dimensional(3D)printing technology is a powerful tool for polymer stent fabrication.Current review studies have focused primarily on the material and structural design of polymer stents but have failed to comprehensively discuss different 3D printing approaches and stent characterization techniques.In this paper,we address these shortcomings by discussing 3D printing methods and their application in BPVSs.First,some commonly used 3D printing methods(including material extrusion,vat polymerization,and powder bed fusion)and potential 3D printing strategies(including material jetting and binder jetting)for fabricating BPVSs are discussed;furthermore,the main post-treatments are summarized.Then,techniques to characterize the morphology,mechanical properties,and biological prop-erties of the printed BPVSs are introduced.Subsequently,representative commercial BPVSs and lab-grade BPVSs are compared.Finally,based on the limitations of stent printing and characterization processes,future perspec-tives are proposed,which may help develop new techniques to fabricate more customized stents and accurately evaluate their performance.
文摘Background Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents （DES） implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents （PF-PES） in comparison with permanent polymer sirolimus-eluting stents （PP-SES） in patients with acute ST-segment elevation myocardial infarction （STEMI）. Methods Patients with STEMI were randomly assigned to receive PP-SES （n=55）, and PF-PES （n=50）. The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure （TLF） was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction （Re-MI）, or target lesion revascularization （TLR）. Results Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group （P=0.757）. The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure （10.9% PP-SES vs. 12.0% PF-PES, P=0.861） and definite or probable stent thrombosis （1.8% PP-SES vs. 2.0% PF-PES, P=1.000） at one year. Conclusions The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with laraer study DODUlations are needed to net definite conclusions.
