Bioprosthetic heart valves(BHVs)are important for transcatheter valve replacement.Current commercial BHVs on the market are basically porcine or bovine pericardium(BP)crosslinked with glutaraldehyde(GA).Simply applyin...Bioprosthetic heart valves(BHVs)are important for transcatheter valve replacement.Current commercial BHVs on the market are basically porcine or bovine pericardium(BP)crosslinked with glutaraldehyde(GA).Simply applying GA to BHVs can enhance mechanical stability,but cannot alleviate in vivo calcification.In this work,we developed a two-step decellularization(TSD)strategy to modify this biomacromolecular network,in which BP was post-treated,as the second step of decellularization,with a mild biosurfactant n-dodecyl-β-D-maltoside in a mixture of isopropanol and phosphate-buffered saline after the first step of traditional decellularization and GA cross-linking.The TSD-treated BP exhibited not only low cytotoxicity and excellent mechanical properties in vitro,but also low immune responses and significant anticalcification in vivo.After 60 days of subcutaneous implantation in the back of Wistar rats,the calcium content was,as quantified with an inductively coupled plasma optical emission spectrometer,only 1.1µg/mg compared to 138.6µg/mg in the control group without the post-treatment.In addition,collagen fibrils were observed with field emitting scanning electron microscopy(SEM),and the morphology and composition of the calcified sites resulting from in vivo biomineralization were studied with SEM with energy dispersive spectroscopy and also X-ray diffraction.This study proposes a facile yet effective anticalcification strategy for the modification of the bovine pericardial bioprosthetic heart valve,a natural biomacromolecular network.展开更多
Introduction:Parallel stent-stent grafting is a major endovascular technique used to preserve the supra-aortic branches during thoracic endovascular aortic repair(TEVAR)of aortic pathologies involving the aortic arch....Introduction:Parallel stent-stent grafting is a major endovascular technique used to preserve the supra-aortic branches during thoracic endovascular aortic repair(TEVAR)of aortic pathologies involving the aortic arch.The short-and mid-term results of this technique are satisfactory;however,endoleak remains a major concern.Thus,here we designed a new chimney stent-graft to decrease the endoleak rate.Aim:To testify the feasibility and safety of the new chimney stent-graft system in a canine model.Material and methods:Six Labrador retrievers were used.Pre-operative data were collected and all operations were performed under general anesthesia.The main and chimney stent-grafts were implanted through the abdominal aorta and left subclavian artery approaches,respectively.Completion digital subtraction angiography(DSA)was performed to confirm the immediate outcomes.All dogs were fed separately for 6 months and sacrificed after aortic angiography.The thoracic aorta and the main and chimney stent-grafts were harvested for histopathologic examination.Results:No complications were found in follow-up DSA.All branch arteries were patent.In?ammatory responses were observed around the stent-grafts in 3 experimental animals,and slight hyperplasia was observed in the surrounding tissues compared with the normal vessels.There was no mural thrombus in the stent,endothelial cells were noted on the inner surface of the stent,and thrombus was formed in the outer skirt and gutter area.The histopathologic examinations revealed similar results to those of gross necropsy observations.Conclusions:This study demonstrated the feasibility and safety of the Longuette stent-graft and the first to report a revised stent-graft specific for chimney technique.展开更多
Objective： Porcine liver extract has been shown to be effective in the clinical treatment of severe hepatitis. The aim of the present study was to study its antifibrotic as well as immune regulatory effect in vitro. ...Objective： Porcine liver extract has been shown to be effective in the clinical treatment of severe hepatitis. The aim of the present study was to study its antifibrotic as well as immune regulatory effect in vitro. Methods： Hepat＇ocytes, hepatic stellate cells （HSCs）, hepatoma cell line （HepG2） and human peripheral blood mononuclear cells （PMNCs） were studied with respect to proliferation, extracellular matrix production and apoptotic activities by proliferation assay, radioimmunoassay, gene transfection, reporter gene analysis and flow cytometry, respectively. Results： A strong stimulatory proliferation effect was observed in hepatocytes, and an inhibitory effect was found in HSCs. Hyaluronic acid （HA） production and reporter gene activities driven by various etl（I） procollagen gene promoters in HSC-T6 were significantly decreased after treatment with the extract. Fluo-Anexin V binding apoptotic HepG2 cells were more prominent in the presence of 60ug/ml extract. More CD4^＋/CD69^＋ positive T lymphocytes existed in the presence of the extract. Conclusion： Porcine liver extract is effective for antifibrogenesis via hepatocyte regeneration, HSC and hepatoma cell inhibition in vitro. The elevation of active T lymphocytes is helpful for immune surveillance. Fine mapping of the extract is necessary in order to get definite molecules which are essential in all described functions.展开更多
Objective: Influenza is a highly infectious viral disease, which occurs epidemically almost every winter in Japan. Rapid screening of patients with suspected influenza in places of mass gathering is important to delay...Objective: Influenza is a highly infectious viral disease, which occurs epidemically almost every winter in Japan. Rapid screening of patients with suspected influenza in places of mass gathering is important to delay or prevent transmission of the infection. The aim of this study was to assess the effectiveness of our newly developed infection screening system that employed vital signs and percutaneous oxygen saturation (SpO2) as parameters in a clinical setting. Methods: Since SpO2 accurately reflects respiratory status during influenza virus infection, we upgraded our previous system by adding SpO2 as a new parameter to improve the screening accuracy. This system instantly measures SpO2 and vital signs (i.e., heart rate, respiration rate, and facial temperature), which automatically detects infected individuals via a neural network-based nonlinear discriminant function using these derived parameters. We tested the system on 45 patients with seasonal influenza (35.8℃ < body temperature < 40.0℃, 18-35 years) and 64 normal control subjects (35.0℃ < body temperature < 37.5℃, 18-30 years) at Japan Self-Defense Central Hospital in 2012. Results: The system identified 40/45 patients with influenza and 60/64 normal control subjects, and provided sensitivity, specificity, and positive and negative predictive value (PPV, NPV) of 88.8%, 93.8%, 90.9%, and 92.3%, respectively. By including SpO2 as a screening parameter, we achieved superior sensitivity and NPV compared to that reported in our previous paper (sensitivity = 88%;NPV = 82%). Conclusions: Our results suggest that SpO2 is a good screening parameter that improves the accuracy of infection screening. The proposed system has the potential to efficiently identify infected individuals, thereby delaying or preventing the spread of infection during epidemic seasons.展开更多
This study aimed to investigate the long-term biocompatibility, safety, and degradation of the ultrathin nitrided iron bioresorbable scaffold (BRS) in vivo, encompassing the whole process of bioresorption in porcine c...This study aimed to investigate the long-term biocompatibility, safety, and degradation of the ultrathin nitrided iron bioresorbable scaffold (BRS) in vivo, encompassing the whole process of bioresorption in porcine coronary arteries. Fifty-two nitrided iron scaffolds (strut thickness of 70 μm) and 28 Vision Co–Cr stents were randomly implanted into coronary arteries of healthy mini-swine. The efficacy and safety of the nitrided iron scaffold were comparable with those of the Vision stentwithin 52 weeks after implantation. In addition, the long-term biocompatibility, safety, and bioresorption of the nitrided iron scaffold were evaluated by coronary angiog-raphy, optical coherence tomography, micro-computed tomography, scanning electron microscopy, energy dispersive spectrometry and histopathological evaluations at 4, 12, 26, 52 weeks and even at 7 years after im-plantation. In particular, a large number of struts were almost completely absorbed in situ at 7 years follow-up, which were first illustrated in this study. The lymphatic drainage pathway might serve as the potential clearance way of iron and its corrosion products.展开更多
Expanded polytetrafluoroethylene(ePTFE)is promising in biomedical fields such as covered stents and plastic surgery owing to its excellent biocompatibility and mechanical properties.However,ePTFE material prepared by ...Expanded polytetrafluoroethylene(ePTFE)is promising in biomedical fields such as covered stents and plastic surgery owing to its excellent biocompatibility and mechanical properties.However,ePTFE material prepared by the traditional biaxial stretching process is with thicker middle and thinner sides due to the bowing effect,which poses a major problem in industrial-scale fabrication.To solve this problem,we design an olive-shaped winding roller to provide the middle part of the ePTFE tape with a greater longitudinal stretching amplitude than the two sides,so as to make up for the excessive longitudinal retraction tendency of the middle part when it is transversely stretched.The as-fabricated ePTFE membrane has,as designed,uniform thickness and node-fibril microstructure.In addition,we examine the effects of mass ratio of lubricant to PTFE powder,biaxial stretching ratio and sintering temperature on the performance of the resultant ePTFE membranes.Particularly,the relation between the internal microstructure of the ePTFE membrane and its mechanical properties is revealed.Besides stable mechanical properties,the sintered ePTFE membrane exhibits satisfactory biological properties.We make a series of biological assessments including in vitro hemolysis,coagulation,bacterial reverse mutation and in vivo thrombosis,intracutaneous reactivity test,pyrogen test and subchronic systemic toxicity test;all of the results meet the relevant international standards.The muscle implantation of the sintered ePTFE membrane into rabbits indicates acceptable inflammatory reactions of our sintered ePTFE membrane fabricated on industrial scale.Such a medical-grade raw material with the unique physical form and condensed-state microstructure is expected to afford an inert biomaterial potentially for stent-graft membrane.展开更多
The aortic dissection(AD)is a life-threatening disease.The transcatheter endovascular aortic repair(EVAR)affords a minimally invasive technique to save the lives of these critical patients,and an appropriate stent-gra...The aortic dissection(AD)is a life-threatening disease.The transcatheter endovascular aortic repair(EVAR)affords a minimally invasive technique to save the lives of these critical patients,and an appropriate stent-graft gets to be the key medical device during an EVAR procedure.Herein,we report a trilayer stent-graft and corresponding delivery system used for the treatment of the AD disease.The stent-graft is made of nitinol stents with an asymmetric Z-wave design and two expanded polytetrafluoroethylene(ePTFE)membranes.Each of the inner and outer surfaces of the stent-graft was covered by an ePTFE membrane,and the two membranes were then sintered together.The biological studies of the sintered ePTFE membranes indicated that the stent-graft had excellent cytocompatibility and hemocompatibility in vitro.Both the stent-graft and the delivery system exhibited satisfactory mechanical properties and operability.The safety and efficacy of this stent-graft and the corresponding delivery system were demonstrated in vivo.In nine canine experiments,the blood vessels of the animals implanted with the stent-grafts were of good patency,and there were no thrombus and obvious stenosis by angiography after implantation for 6months.Furthermore,all of the nine clinical cases experienced successful implantation using the stent-graft and its postrelease delivery system,and the 1-year follow-ups indicated the preliminary safety and efficacy of the trilayer stent-graft with an asymmetric Z-wave design for interventional treatment.展开更多
The purpose of this paper is to utilize the signaling pathway polymerase chain reaction(PCR)arrays to investigate the activation of two important biological signaling pathways in endothelial cell adhesion and growth m...The purpose of this paper is to utilize the signaling pathway polymerase chain reaction(PCR)arrays to investigate the activation of two important biological signaling pathways in endothelial cell adhesion and growth mediated by adsorbed serum protein on the surface of bare and titanium nitride(TiN)-coated nickel titanium(NiTi)alloys.First,the endothelial cells were cultured on the bare and TiN-coated NiTi alloys and chitosan films as control for 4 h and 24 h,respectively.Then,the total RNA of the cells was collected and the PCR arrays were performed.After that,the differentially expressed genes in the transforming growth factor beta(TGF-b)signaling pathway and the regulation of actin cytoskeleton pathway were screened out;and the further bioinformatics analyses were performed.The results showed that both TGF-b signaling pathway and regulation of actin cytoskeleton pathway were activated in the cells after 4 h and 24 h culturing on the surface of bare and TiN-coated NiTi alloys compared to the chitosan group.The activated TGF-b signaling pathway promoted cell adhesion;the activated regulation of actin cytoskeleton pathway promoted cell adhesion,spreading,growth and motility.In addition,the activation of both pathways was much stronger in the cells cultured for 24 h versus 4 h,which indicated that cell adhesion and growth became more favorable with longer time on the surface of two NiTi alloy materials.展开更多
A big diameter bioresorbable scaffold is expected to be used for treatment of vessel stenosis of children with congenital heart disease to adapt the growth characteristics of vessel of children and avoid the late adve...A big diameter bioresorbable scaffold is expected to be used for treatment of vessel stenosis of children with congenital heart disease to adapt the growth characteristics of vessel of children and avoid the late adverse events of permanent stent implanted in children.However,it is challenging to fabricate a big diameter bioresorbable scaffold that is appropriate for percutaneous implantation with enough mechanical performance and can be smoothly delivered in children’s small vessel.In this study,a novel iron big and bioresorbable Scaffold(BBS)for pulmonary artery stenosis of children with congenital cardiovascular diseases was fabricated and evaluated.The BBS was made of nitrided iron tube and processed by laser cutting and polishing.The testing results of radial strength,recoil,shortening,maximal expansion diameter and side-branch accessability illustrated the BBS has good mechanical performance.The animal study showed that the percentage of area stenosis of BBSs was 18.1±8.6%,20.2±5.9%and 20.4±6.1%at 28,90 and 180 days after implantation in 17 rabbits,and no malposition,thrombus,dissection or tissue necrosis in the rabbit model was detected by micro-CT,STEM and histological examinations.Anφ8×23 mm BBS was implanted into a 55-month-old child with left pulmonary stenosis,and multiple spiral CT was conducted.No lumen area loss appeared at 1-and 2-year follow-ups in this first-in-man study.It suggested that the BBS might be a new strategy for the therapy of pulmonary artery stenosis in children.展开更多
基金the National Natural Science Foundation of China(No.52130302).
文摘Bioprosthetic heart valves(BHVs)are important for transcatheter valve replacement.Current commercial BHVs on the market are basically porcine or bovine pericardium(BP)crosslinked with glutaraldehyde(GA).Simply applying GA to BHVs can enhance mechanical stability,but cannot alleviate in vivo calcification.In this work,we developed a two-step decellularization(TSD)strategy to modify this biomacromolecular network,in which BP was post-treated,as the second step of decellularization,with a mild biosurfactant n-dodecyl-β-D-maltoside in a mixture of isopropanol and phosphate-buffered saline after the first step of traditional decellularization and GA cross-linking.The TSD-treated BP exhibited not only low cytotoxicity and excellent mechanical properties in vitro,but also low immune responses and significant anticalcification in vivo.After 60 days of subcutaneous implantation in the back of Wistar rats,the calcium content was,as quantified with an inductively coupled plasma optical emission spectrometer,only 1.1µg/mg compared to 138.6µg/mg in the control group without the post-treatment.In addition,collagen fibrils were observed with field emitting scanning electron microscopy(SEM),and the morphology and composition of the calcified sites resulting from in vivo biomineralization were studied with SEM with energy dispersive spectroscopy and also X-ray diffraction.This study proposes a facile yet effective anticalcification strategy for the modification of the bovine pericardial bioprosthetic heart valve,a natural biomacromolecular network.
文摘Introduction:Parallel stent-stent grafting is a major endovascular technique used to preserve the supra-aortic branches during thoracic endovascular aortic repair(TEVAR)of aortic pathologies involving the aortic arch.The short-and mid-term results of this technique are satisfactory;however,endoleak remains a major concern.Thus,here we designed a new chimney stent-graft to decrease the endoleak rate.Aim:To testify the feasibility and safety of the new chimney stent-graft system in a canine model.Material and methods:Six Labrador retrievers were used.Pre-operative data were collected and all operations were performed under general anesthesia.The main and chimney stent-grafts were implanted through the abdominal aorta and left subclavian artery approaches,respectively.Completion digital subtraction angiography(DSA)was performed to confirm the immediate outcomes.All dogs were fed separately for 6 months and sacrificed after aortic angiography.The thoracic aorta and the main and chimney stent-grafts were harvested for histopathologic examination.Results:No complications were found in follow-up DSA.All branch arteries were patent.In?ammatory responses were observed around the stent-grafts in 3 experimental animals,and slight hyperplasia was observed in the surrounding tissues compared with the normal vessels.There was no mural thrombus in the stent,endothelial cells were noted on the inner surface of the stent,and thrombus was formed in the outer skirt and gutter area.The histopathologic examinations revealed similar results to those of gross necropsy observations.Conclusions:This study demonstrated the feasibility and safety of the Longuette stent-graft and the first to report a revised stent-graft specific for chimney technique.
基金Supported by the National Natural Science Foundation of China (30270605)
文摘Objective： Porcine liver extract has been shown to be effective in the clinical treatment of severe hepatitis. The aim of the present study was to study its antifibrotic as well as immune regulatory effect in vitro. Methods： Hepat＇ocytes, hepatic stellate cells （HSCs）, hepatoma cell line （HepG2） and human peripheral blood mononuclear cells （PMNCs） were studied with respect to proliferation, extracellular matrix production and apoptotic activities by proliferation assay, radioimmunoassay, gene transfection, reporter gene analysis and flow cytometry, respectively. Results： A strong stimulatory proliferation effect was observed in hepatocytes, and an inhibitory effect was found in HSCs. Hyaluronic acid （HA） production and reporter gene activities driven by various etl（I） procollagen gene promoters in HSC-T6 were significantly decreased after treatment with the extract. Fluo-Anexin V binding apoptotic HepG2 cells were more prominent in the presence of 60ug/ml extract. More CD4^＋/CD69^＋ positive T lymphocytes existed in the presence of the extract. Conclusion： Porcine liver extract is effective for antifibrogenesis via hepatocyte regeneration, HSC and hepatoma cell inhibition in vitro. The elevation of active T lymphocytes is helpful for immune surveillance. Fine mapping of the extract is necessary in order to get definite molecules which are essential in all described functions.
文摘Objective: Influenza is a highly infectious viral disease, which occurs epidemically almost every winter in Japan. Rapid screening of patients with suspected influenza in places of mass gathering is important to delay or prevent transmission of the infection. The aim of this study was to assess the effectiveness of our newly developed infection screening system that employed vital signs and percutaneous oxygen saturation (SpO2) as parameters in a clinical setting. Methods: Since SpO2 accurately reflects respiratory status during influenza virus infection, we upgraded our previous system by adding SpO2 as a new parameter to improve the screening accuracy. This system instantly measures SpO2 and vital signs (i.e., heart rate, respiration rate, and facial temperature), which automatically detects infected individuals via a neural network-based nonlinear discriminant function using these derived parameters. We tested the system on 45 patients with seasonal influenza (35.8℃ < body temperature < 40.0℃, 18-35 years) and 64 normal control subjects (35.0℃ < body temperature < 37.5℃, 18-30 years) at Japan Self-Defense Central Hospital in 2012. Results: The system identified 40/45 patients with influenza and 60/64 normal control subjects, and provided sensitivity, specificity, and positive and negative predictive value (PPV, NPV) of 88.8%, 93.8%, 90.9%, and 92.3%, respectively. By including SpO2 as a screening parameter, we achieved superior sensitivity and NPV compared to that reported in our previous paper (sensitivity = 88%;NPV = 82%). Conclusions: Our results suggest that SpO2 is a good screening parameter that improves the accuracy of infection screening. The proposed system has the potential to efficiently identify infected individuals, thereby delaying or preventing the spread of infection during epidemic seasons.
基金This study was supported by National Key R&D Program of China(grants number 2018YFC1106600)Shenzhen Industrial and Information Technology Bureau(20180309174916657)Science,Technology and Innova-tion Commission of Shenzhen Municipality(grant number GJHZ20180418190517302).
文摘This study aimed to investigate the long-term biocompatibility, safety, and degradation of the ultrathin nitrided iron bioresorbable scaffold (BRS) in vivo, encompassing the whole process of bioresorption in porcine coronary arteries. Fifty-two nitrided iron scaffolds (strut thickness of 70 μm) and 28 Vision Co–Cr stents were randomly implanted into coronary arteries of healthy mini-swine. The efficacy and safety of the nitrided iron scaffold were comparable with those of the Vision stentwithin 52 weeks after implantation. In addition, the long-term biocompatibility, safety, and bioresorption of the nitrided iron scaffold were evaluated by coronary angiog-raphy, optical coherence tomography, micro-computed tomography, scanning electron microscopy, energy dispersive spectrometry and histopathological evaluations at 4, 12, 26, 52 weeks and even at 7 years after im-plantation. In particular, a large number of struts were almost completely absorbed in situ at 7 years follow-up, which were first illustrated in this study. The lymphatic drainage pathway might serve as the potential clearance way of iron and its corrosion products.
基金supports from National Natural Science Foundation of China(grant no.52130302)National Key R&D Program of China(grant no.2016YFC1100300)。
文摘Expanded polytetrafluoroethylene(ePTFE)is promising in biomedical fields such as covered stents and plastic surgery owing to its excellent biocompatibility and mechanical properties.However,ePTFE material prepared by the traditional biaxial stretching process is with thicker middle and thinner sides due to the bowing effect,which poses a major problem in industrial-scale fabrication.To solve this problem,we design an olive-shaped winding roller to provide the middle part of the ePTFE tape with a greater longitudinal stretching amplitude than the two sides,so as to make up for the excessive longitudinal retraction tendency of the middle part when it is transversely stretched.The as-fabricated ePTFE membrane has,as designed,uniform thickness and node-fibril microstructure.In addition,we examine the effects of mass ratio of lubricant to PTFE powder,biaxial stretching ratio and sintering temperature on the performance of the resultant ePTFE membranes.Particularly,the relation between the internal microstructure of the ePTFE membrane and its mechanical properties is revealed.Besides stable mechanical properties,the sintered ePTFE membrane exhibits satisfactory biological properties.We make a series of biological assessments including in vitro hemolysis,coagulation,bacterial reverse mutation and in vivo thrombosis,intracutaneous reactivity test,pyrogen test and subchronic systemic toxicity test;all of the results meet the relevant international standards.The muscle implantation of the sintered ePTFE membrane into rabbits indicates acceptable inflammatory reactions of our sintered ePTFE membrane fabricated on industrial scale.Such a medical-grade raw material with the unique physical form and condensed-state microstructure is expected to afford an inert biomaterial potentially for stent-graft membrane.
基金financially supported by the National Science Foundation of China(Grant Nos.52130302,21961160721)the National Key R&D Program of China(Grant No.2016YFC1100300).
文摘The aortic dissection(AD)is a life-threatening disease.The transcatheter endovascular aortic repair(EVAR)affords a minimally invasive technique to save the lives of these critical patients,and an appropriate stent-graft gets to be the key medical device during an EVAR procedure.Herein,we report a trilayer stent-graft and corresponding delivery system used for the treatment of the AD disease.The stent-graft is made of nitinol stents with an asymmetric Z-wave design and two expanded polytetrafluoroethylene(ePTFE)membranes.Each of the inner and outer surfaces of the stent-graft was covered by an ePTFE membrane,and the two membranes were then sintered together.The biological studies of the sintered ePTFE membranes indicated that the stent-graft had excellent cytocompatibility and hemocompatibility in vitro.Both the stent-graft and the delivery system exhibited satisfactory mechanical properties and operability.The safety and efficacy of this stent-graft and the corresponding delivery system were demonstrated in vivo.In nine canine experiments,the blood vessels of the animals implanted with the stent-grafts were of good patency,and there were no thrombus and obvious stenosis by angiography after implantation for 6months.Furthermore,all of the nine clinical cases experienced successful implantation using the stent-graft and its postrelease delivery system,and the 1-year follow-ups indicated the preliminary safety and efficacy of the trilayer stent-graft with an asymmetric Z-wave design for interventional treatment.
基金National Natural Science Foundation of China(31271012)973 Project(No.2009CB930000)the Natural Science Foundation of Jiangsu Province(BK20150599).
文摘The purpose of this paper is to utilize the signaling pathway polymerase chain reaction(PCR)arrays to investigate the activation of two important biological signaling pathways in endothelial cell adhesion and growth mediated by adsorbed serum protein on the surface of bare and titanium nitride(TiN)-coated nickel titanium(NiTi)alloys.First,the endothelial cells were cultured on the bare and TiN-coated NiTi alloys and chitosan films as control for 4 h and 24 h,respectively.Then,the total RNA of the cells was collected and the PCR arrays were performed.After that,the differentially expressed genes in the transforming growth factor beta(TGF-b)signaling pathway and the regulation of actin cytoskeleton pathway were screened out;and the further bioinformatics analyses were performed.The results showed that both TGF-b signaling pathway and regulation of actin cytoskeleton pathway were activated in the cells after 4 h and 24 h culturing on the surface of bare and TiN-coated NiTi alloys compared to the chitosan group.The activated TGF-b signaling pathway promoted cell adhesion;the activated regulation of actin cytoskeleton pathway promoted cell adhesion,spreading,growth and motility.In addition,the activation of both pathways was much stronger in the cells cultured for 24 h versus 4 h,which indicated that cell adhesion and growth became more favorable with longer time on the surface of two NiTi alloy materials.
基金supported by the National Key R&D Program of China(Grant No.2024YFF150380O)the Science and Technology Department of Guangdong Province(Grant No.STKJ2021016).
文摘A big diameter bioresorbable scaffold is expected to be used for treatment of vessel stenosis of children with congenital heart disease to adapt the growth characteristics of vessel of children and avoid the late adverse events of permanent stent implanted in children.However,it is challenging to fabricate a big diameter bioresorbable scaffold that is appropriate for percutaneous implantation with enough mechanical performance and can be smoothly delivered in children’s small vessel.In this study,a novel iron big and bioresorbable Scaffold(BBS)for pulmonary artery stenosis of children with congenital cardiovascular diseases was fabricated and evaluated.The BBS was made of nitrided iron tube and processed by laser cutting and polishing.The testing results of radial strength,recoil,shortening,maximal expansion diameter and side-branch accessability illustrated the BBS has good mechanical performance.The animal study showed that the percentage of area stenosis of BBSs was 18.1±8.6%,20.2±5.9%and 20.4±6.1%at 28,90 and 180 days after implantation in 17 rabbits,and no malposition,thrombus,dissection or tissue necrosis in the rabbit model was detected by micro-CT,STEM and histological examinations.Anφ8×23 mm BBS was implanted into a 55-month-old child with left pulmonary stenosis,and multiple spiral CT was conducted.No lumen area loss appeared at 1-and 2-year follow-ups in this first-in-man study.It suggested that the BBS might be a new strategy for the therapy of pulmonary artery stenosis in children.
