AIM:To compare intraluminal stenting and external ligation of Ahmed glaucoma valves(AGV)for refractory glaucoma management and postoperative hypotony prevention.METHODS:This randomized prospective blind study included...AIM:To compare intraluminal stenting and external ligation of Ahmed glaucoma valves(AGV)for refractory glaucoma management and postoperative hypotony prevention.METHODS:This randomized prospective blind study included 30 eyes of 25 patients(age range:44-56y)with refractory glaucoma.This study was conducted from September 2018 to January 2020.The study included two groups,AGV with intraluminal stenting group(n=15 eyes)and AGV with external ligation group(n=15 eyes).Follow-up period was one year postoperatively.The primary outcome was intraocular pressure(IOP)and its association with the number of postoperative glaucoma medications.IOP≤21 mm Hg without medications indicated complete success while IOP≤21 mm Hg with medications indicated qualified success;and IOP<6 mm Hg was defined as hypotony.RESULTS:After a year of follow-up,IOP was significantly reduced in the intraluminal stenting group than in the external ligation group(11.67±0.89 vs 14.2±4.0 mm Hg,respectively,P=0.024).Postoperative hypotony was more common in the external ligation group(2 cases,13.33%)than in the intraluminal stenting group(1 case,6.67%).CONCLUSION:Application of intraluminal stenting or external ligation during AGV surgery usually prevents postoperative hypotony(transient and persistent)that occurs in conventional AGV surgery.展开更多
Aim: This paper discusses the design and Finite Element Analysis (FEA) of a Percutaneous Aor-tic Valve Stent. The aim of this study was to model a percutaneous aortic valve stent and subject it to finite element analy...Aim: This paper discusses the design and Finite Element Analysis (FEA) of a Percutaneous Aor-tic Valve Stent. The aim of this study was to model a percutaneous aortic valve stent and subject it to finite element analysis. The design process was carried out to meet the functional and surgical requirements. Methods and Results: Analysis was done with different materials with loads ranging from 50 kgf/mm&amp;#178;to 73 kgf/mm&amp;#178;. These forces were selected because these val-ues are far greater than the normal human blood pressure which ranges from 10kPa to 16kPa. It was also to understand the mechanical behavior of different stent materials under such high pressures. A stent model was generated and its physical, mechanical and behavioral properties were studied. Finite element analysis and simulation of the model enhanced the designer to optimize the geometry suitable for perform-ance during and after implantation. The design objective for the stent is to have long term du-rability, low thrombogenicity, resistance to mi-gration and paravalvular leak. Conclusion: The analysis performed in this paper may aid in understanding the stent’s tolerable pressures ranges in comparison with the physiological pressures exerted by the heart and cardiac blood flow during abnormal cardiovascular conditions.展开更多
Aortic stenosis (AS) is the most common type of valvular heart disease in the elderly. Surgical aortic valve replacement (SAVR) has been the standard practice for treating severe, symptomatic AS, but recently new ...Aortic stenosis (AS) is the most common type of valvular heart disease in the elderly. Surgical aortic valve replacement (SAVR) has been the standard practice for treating severe, symptomatic AS, but recently new treatment options have emerged, Transcatheter aortic valve replacement (TAVR) is now an established treatment option in patients at high surgical risk. In this review, we focus on recent developments and compare the two treatment methods in specific populations in terms of efficacy and safety (e.g., in patients with history of prior thoracic surgery, type of anesthesia employed, access site used or need for permanent pacing). The impact of comorbidities (pulmonary hypertension, arterial hypertension and obesity paradox), the cost-effectiveness of TAVR vs. SAVR and advances in transcatheter valve technology as well as issues that merit further investigation are further discussed. Moreover, outcomes and complications of TAVR in patients of different risk category (extremely high, high, intermediate and low risk) are analyzed. We strongly believe that during the following years, TAVR may evolve as the treatment of choice in a broader group of patients with symptomatic AS and beyond those with intermediate and high-risk features.展开更多
BACKGROUND Endoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction(MBO). However, the main problem with stent placement is the relativ...BACKGROUND Endoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction(MBO). However, the main problem with stent placement is the relatively short duration of stent patency.Although self-expanding metal stents(SEMSs) have a longer patency period than plastic stents(PSs), the higher costs limit the wide use of SEMSs. A PS with an antireflux valve is an attractive idea to prolong stent patency, but no ideal design for an antireflux PS(ARPS) has been proposed. We developed a new ARPS with a "duckbilled" valve attached to the duodenal end of the stent.AIM To compare the patency of ARPSs with that of traditional PSs(TPSs) in patients with unresectable distal MBO.METHODS We conducted a single-center, prospective, randomized, controlled, double-blind study. This study was conducted at the West China Hospital of Sichuan University. Consecutive patients with extrahepatic MBO were enrolled prospectively. Eligible patients were randomly assigned to receive either an ARPS or a TPS. Patients were followed by clinic visits or telephone interviews every 1-2 mo until stent exchange, death, or the final study follow-up in October 2018. The primary outcome was the duration of stent patency. Secondary outcomes included the rate of technical success, the rate of clinical success,adverse events, and patient survival.RESULTS Between February 2016 and December 2017, 38 patients were randomly assigned to two groups, with 19 patients in each group, to receive ARPSs or TPSs. Stent insertion was technically successful in all patients. There were no significant differences between the two groups in the rates of clinical success or the rates of early or late adverse events(P = 0.660, 1.000, and 1.000, respectively). The median duration of stent patency in the ARPS group was 285 d [interquartile range(IQR),170], which was significantly longer than that in the TPS group(median, 130 d;IQR, 90, P = 0.005). No significant difference in patient survival was noted between the two groups(P = 0.900).CONCLUSION The new ARPS is safe and effective for the palliation of unresectable distal MBO,and has a significantly longer stent patency than a TPS.展开更多
目的:总结Chimney支架技术联合All in One技术在经导管主动脉瓣置换术(TAVR)中应用的初步经验。方法:收集2021年7月至2022年7月首都医科大学附属北京安贞医院心脏瓣膜病介入中心在TAVR术中联合应用Chimney支架技术和All in One技术的10...目的:总结Chimney支架技术联合All in One技术在经导管主动脉瓣置换术(TAVR)中应用的初步经验。方法:收集2021年7月至2022年7月首都医科大学附属北京安贞医院心脏瓣膜病介入中心在TAVR术中联合应用Chimney支架技术和All in One技术的10例患者进行回顾性分析,总结临床资料、影像学资料、手术操作、住院和出院随访期间主要不良心脑血管事件的发生情况。结果:10例患者中男性4例,女性6例,平均年龄(76.2±3.9)岁,三叶式主动脉瓣7例,二叶式主动脉瓣3例,术前CT评估均有冠状动脉阻塞危险因素,并且术中球囊预扩张提示冠状动脉阻塞。所有患者均使用一枚药物洗脱支架完成Chimney支架技术,冠状动脉支架置入有8例位于左主干,2例位于右冠状动脉,支架平均直径(3.7±0.3)mm,平均长度(20.6±2.4)mm,在住院及平均随访(7.8±3.7)个月期间,无死亡、心肌梗死、脑卒中等主要不良心脑血管事件发生。结论:TAVR术中Chimney支架技术联合All in One技术安全可行。展开更多
Background Percutaneous aortic valve replacement is a promising strategy in the treatment of patients with aortic valve stenosis. And many kinds of valved stents have been implanted in selected patients worldwide. How...Background Percutaneous aortic valve replacement is a promising strategy in the treatment of patients with aortic valve stenosis. And many kinds of valved stents have been implanted in selected patients worldwide. However, the clinical experience is still limited. We developed a W-model valved stent and evaluated the feasibility and safety of percutaneous implantation of the device in the native aortic valve position.Methods A self expanding nitinol stent with W-model, containing porcine pericardium valves in its proximal part, was implanted in six sheep by means of a 14 French catheter through the right common iliac artery under guidance of fluoroscopy. During stent deployment the original aortic valve was pushed against the aortic wall by the self expanding force of the stent while the new valve was expanded. These sheep were followed up shortly after procedure with supra-aortic angiogram and left ventriculography. Additionally, one sheep was sacrificed after the procedure for anatomic evaluation.Results It was possible to replace the aortic valve in the beating heart in four sheep. The procedure failed in two sheep due to coronary orifice occlusion in one case and severe aortic valve regurgitation in the other case. One sheep was killed one hour after percutaneous aortic valve replacement for anatomic evaluation. There were no signs of damage of the aortic JntJma, or of obstruction of the coronary orifice,Conclusions Percutaneous aortic valve replacement with a W-model valved stent in the beating heart is possible. Further studies are mandatory to assess safety and efficacy of this kind of valved stent in larger sample size and by longer follow-up period.展开更多
Background Pulmonary regurgitation leads to progressive right ventricular dysfunction, susceptibility to arrhythmias,and sudden cardiac death. Percutaneous valve replacement has been developed in recent years, providi...Background Pulmonary regurgitation leads to progressive right ventricular dysfunction, susceptibility to arrhythmias,and sudden cardiac death. Percutaneous valve replacement has been developed in recent years, providing patients with an alternative option. Percutaneous pulmonary valve replacement has been recently introduced into clinical practice. The goal of this study was to evaluate the feasibility of percutaneous valve stent insertion to correct the pulmonary regurgitation in sheep using a cup-shaped valve stent.Methods Pulmonary regurgitation was created by percutaneous cylindrical stent insertion in native pulmonary annulus of 8 sheep. One month after the initial procedure, the sheep with previous cylindrical stent implanted underwent the same implantation procedure of pulmonary valve stent. The valve stent consisted of a cup-shaped stent and pericardial valves.Hemodynamic assessments of the bioprosthetic pulmonary valve were obtained by echocardiography at immediately post-implant and at 2 months follow up.Results Successful transcatheter cylindrical stent insertion was performed in 7 sheep but failed in 1 sheep because the cylindrical stent was released to right ventricle outflow tract. After one month the 7 sheep with pulmonary regurgitation underwent valve stent implantation successfully. Echocardiography confirmed the stents were in desired position during the follow-up. No evidence of pulmonary valve insufficiency occurred in any animals. Echocardiography showed all heart function markers were normal.Conclusions Percutaneous cylindrical stent insertion to induce significant pulmonary regurgitation in sheep was feasible, simple and reproducible. Percutaneous pulmonary valve stent implantation can reduce pulmonary regurgitation in a sheep model. Further development of animal model and clinical trials are warranted.展开更多
Objective: To evaluate the feasibility and satefy of transcatheter aortic valve implantation in animals by using a new balloon-expanding valved stent. Methods: The balloon-expandable stent is made from cobalt-based a...Objective: To evaluate the feasibility and satefy of transcatheter aortic valve implantation in animals by using a new balloon-expanding valved stent. Methods: The balloon-expandable stent is made from cobalt-based alloy material and designed with a tubular, slotted structure. Fresh bovine pericardium was treated, sutured and fixed on the balloon-expandable stent. Ten healthy sheep (five males and five females), weighing an average of (25.16 ± 1.83) kg, were selected to undergo transcatheter implantation of the valve stents. The function of the valve stent was evaluated by angiography, echocardiography, and histology six months after the procedure. Results: Of the ten experimental sheep, two sheep died during the operation because the higher position of the artificial valve affected the opening of the coronary artery. We successfully implanted the aortic valve stent in other eight sheep;however, one sheep died of heart failure two weeks after the operation due to the lower position of the valve stent. The valve stents were implanted in the desired position in seven sheep. Ascending aortic angiographic and autoptic findings immediately after the operation confirmed the satisfactory location and function of the valved stent. Echocardiography, angiography, and histology at six post-operative months confirmed the satisfactory location and function of the valve stent. Conclusion: We successfully implanted our new valve stent as a replacement of native aortic valve via the transcatheter route with satisfactory outcome. Copyright ? 2015, Chinese Medical Association Production. Production and hosting by Elsevier B.V. on behalf of KeAi Communications Co., Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).展开更多
文摘AIM:To compare intraluminal stenting and external ligation of Ahmed glaucoma valves(AGV)for refractory glaucoma management and postoperative hypotony prevention.METHODS:This randomized prospective blind study included 30 eyes of 25 patients(age range:44-56y)with refractory glaucoma.This study was conducted from September 2018 to January 2020.The study included two groups,AGV with intraluminal stenting group(n=15 eyes)and AGV with external ligation group(n=15 eyes).Follow-up period was one year postoperatively.The primary outcome was intraocular pressure(IOP)and its association with the number of postoperative glaucoma medications.IOP≤21 mm Hg without medications indicated complete success while IOP≤21 mm Hg with medications indicated qualified success;and IOP<6 mm Hg was defined as hypotony.RESULTS:After a year of follow-up,IOP was significantly reduced in the intraluminal stenting group than in the external ligation group(11.67±0.89 vs 14.2±4.0 mm Hg,respectively,P=0.024).Postoperative hypotony was more common in the external ligation group(2 cases,13.33%)than in the intraluminal stenting group(1 case,6.67%).CONCLUSION:Application of intraluminal stenting or external ligation during AGV surgery usually prevents postoperative hypotony(transient and persistent)that occurs in conventional AGV surgery.
文摘Aim: This paper discusses the design and Finite Element Analysis (FEA) of a Percutaneous Aor-tic Valve Stent. The aim of this study was to model a percutaneous aortic valve stent and subject it to finite element analysis. The design process was carried out to meet the functional and surgical requirements. Methods and Results: Analysis was done with different materials with loads ranging from 50 kgf/mm&amp;#178;to 73 kgf/mm&amp;#178;. These forces were selected because these val-ues are far greater than the normal human blood pressure which ranges from 10kPa to 16kPa. It was also to understand the mechanical behavior of different stent materials under such high pressures. A stent model was generated and its physical, mechanical and behavioral properties were studied. Finite element analysis and simulation of the model enhanced the designer to optimize the geometry suitable for perform-ance during and after implantation. The design objective for the stent is to have long term du-rability, low thrombogenicity, resistance to mi-gration and paravalvular leak. Conclusion: The analysis performed in this paper may aid in understanding the stent’s tolerable pressures ranges in comparison with the physiological pressures exerted by the heart and cardiac blood flow during abnormal cardiovascular conditions.
文摘Aortic stenosis (AS) is the most common type of valvular heart disease in the elderly. Surgical aortic valve replacement (SAVR) has been the standard practice for treating severe, symptomatic AS, but recently new treatment options have emerged, Transcatheter aortic valve replacement (TAVR) is now an established treatment option in patients at high surgical risk. In this review, we focus on recent developments and compare the two treatment methods in specific populations in terms of efficacy and safety (e.g., in patients with history of prior thoracic surgery, type of anesthesia employed, access site used or need for permanent pacing). The impact of comorbidities (pulmonary hypertension, arterial hypertension and obesity paradox), the cost-effectiveness of TAVR vs. SAVR and advances in transcatheter valve technology as well as issues that merit further investigation are further discussed. Moreover, outcomes and complications of TAVR in patients of different risk category (extremely high, high, intermediate and low risk) are analyzed. We strongly believe that during the following years, TAVR may evolve as the treatment of choice in a broader group of patients with symptomatic AS and beyond those with intermediate and high-risk features.
基金Supported by the Sichuan Province Science and Technology Department,China,No.2017SZ0009
文摘BACKGROUND Endoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction(MBO). However, the main problem with stent placement is the relatively short duration of stent patency.Although self-expanding metal stents(SEMSs) have a longer patency period than plastic stents(PSs), the higher costs limit the wide use of SEMSs. A PS with an antireflux valve is an attractive idea to prolong stent patency, but no ideal design for an antireflux PS(ARPS) has been proposed. We developed a new ARPS with a "duckbilled" valve attached to the duodenal end of the stent.AIM To compare the patency of ARPSs with that of traditional PSs(TPSs) in patients with unresectable distal MBO.METHODS We conducted a single-center, prospective, randomized, controlled, double-blind study. This study was conducted at the West China Hospital of Sichuan University. Consecutive patients with extrahepatic MBO were enrolled prospectively. Eligible patients were randomly assigned to receive either an ARPS or a TPS. Patients were followed by clinic visits or telephone interviews every 1-2 mo until stent exchange, death, or the final study follow-up in October 2018. The primary outcome was the duration of stent patency. Secondary outcomes included the rate of technical success, the rate of clinical success,adverse events, and patient survival.RESULTS Between February 2016 and December 2017, 38 patients were randomly assigned to two groups, with 19 patients in each group, to receive ARPSs or TPSs. Stent insertion was technically successful in all patients. There were no significant differences between the two groups in the rates of clinical success or the rates of early or late adverse events(P = 0.660, 1.000, and 1.000, respectively). The median duration of stent patency in the ARPS group was 285 d [interquartile range(IQR),170], which was significantly longer than that in the TPS group(median, 130 d;IQR, 90, P = 0.005). No significant difference in patient survival was noted between the two groups(P = 0.900).CONCLUSION The new ARPS is safe and effective for the palliation of unresectable distal MBO,and has a significantly longer stent patency than a TPS.
文摘目的:总结Chimney支架技术联合All in One技术在经导管主动脉瓣置换术(TAVR)中应用的初步经验。方法:收集2021年7月至2022年7月首都医科大学附属北京安贞医院心脏瓣膜病介入中心在TAVR术中联合应用Chimney支架技术和All in One技术的10例患者进行回顾性分析,总结临床资料、影像学资料、手术操作、住院和出院随访期间主要不良心脑血管事件的发生情况。结果:10例患者中男性4例,女性6例,平均年龄(76.2±3.9)岁,三叶式主动脉瓣7例,二叶式主动脉瓣3例,术前CT评估均有冠状动脉阻塞危险因素,并且术中球囊预扩张提示冠状动脉阻塞。所有患者均使用一枚药物洗脱支架完成Chimney支架技术,冠状动脉支架置入有8例位于左主干,2例位于右冠状动脉,支架平均直径(3.7±0.3)mm,平均长度(20.6±2.4)mm,在住院及平均随访(7.8±3.7)个月期间,无死亡、心肌梗死、脑卒中等主要不良心脑血管事件发生。结论:TAVR术中Chimney支架技术联合All in One技术安全可行。
文摘Background Percutaneous aortic valve replacement is a promising strategy in the treatment of patients with aortic valve stenosis. And many kinds of valved stents have been implanted in selected patients worldwide. However, the clinical experience is still limited. We developed a W-model valved stent and evaluated the feasibility and safety of percutaneous implantation of the device in the native aortic valve position.Methods A self expanding nitinol stent with W-model, containing porcine pericardium valves in its proximal part, was implanted in six sheep by means of a 14 French catheter through the right common iliac artery under guidance of fluoroscopy. During stent deployment the original aortic valve was pushed against the aortic wall by the self expanding force of the stent while the new valve was expanded. These sheep were followed up shortly after procedure with supra-aortic angiogram and left ventriculography. Additionally, one sheep was sacrificed after the procedure for anatomic evaluation.Results It was possible to replace the aortic valve in the beating heart in four sheep. The procedure failed in two sheep due to coronary orifice occlusion in one case and severe aortic valve regurgitation in the other case. One sheep was killed one hour after percutaneous aortic valve replacement for anatomic evaluation. There were no signs of damage of the aortic JntJma, or of obstruction of the coronary orifice,Conclusions Percutaneous aortic valve replacement with a W-model valved stent in the beating heart is possible. Further studies are mandatory to assess safety and efficacy of this kind of valved stent in larger sample size and by longer follow-up period.
文摘Background Pulmonary regurgitation leads to progressive right ventricular dysfunction, susceptibility to arrhythmias,and sudden cardiac death. Percutaneous valve replacement has been developed in recent years, providing patients with an alternative option. Percutaneous pulmonary valve replacement has been recently introduced into clinical practice. The goal of this study was to evaluate the feasibility of percutaneous valve stent insertion to correct the pulmonary regurgitation in sheep using a cup-shaped valve stent.Methods Pulmonary regurgitation was created by percutaneous cylindrical stent insertion in native pulmonary annulus of 8 sheep. One month after the initial procedure, the sheep with previous cylindrical stent implanted underwent the same implantation procedure of pulmonary valve stent. The valve stent consisted of a cup-shaped stent and pericardial valves.Hemodynamic assessments of the bioprosthetic pulmonary valve were obtained by echocardiography at immediately post-implant and at 2 months follow up.Results Successful transcatheter cylindrical stent insertion was performed in 7 sheep but failed in 1 sheep because the cylindrical stent was released to right ventricle outflow tract. After one month the 7 sheep with pulmonary regurgitation underwent valve stent implantation successfully. Echocardiography confirmed the stents were in desired position during the follow-up. No evidence of pulmonary valve insufficiency occurred in any animals. Echocardiography showed all heart function markers were normal.Conclusions Percutaneous cylindrical stent insertion to induce significant pulmonary regurgitation in sheep was feasible, simple and reproducible. Percutaneous pulmonary valve stent implantation can reduce pulmonary regurgitation in a sheep model. Further development of animal model and clinical trials are warranted.
基金The authors are grateful to LePu (BeiJing) Medical Equipment CO., LTD. This study was sup-ported by China Postdoctoral Science Foundation
文摘Objective: To evaluate the feasibility and satefy of transcatheter aortic valve implantation in animals by using a new balloon-expanding valved stent. Methods: The balloon-expandable stent is made from cobalt-based alloy material and designed with a tubular, slotted structure. Fresh bovine pericardium was treated, sutured and fixed on the balloon-expandable stent. Ten healthy sheep (five males and five females), weighing an average of (25.16 ± 1.83) kg, were selected to undergo transcatheter implantation of the valve stents. The function of the valve stent was evaluated by angiography, echocardiography, and histology six months after the procedure. Results: Of the ten experimental sheep, two sheep died during the operation because the higher position of the artificial valve affected the opening of the coronary artery. We successfully implanted the aortic valve stent in other eight sheep;however, one sheep died of heart failure two weeks after the operation due to the lower position of the valve stent. The valve stents were implanted in the desired position in seven sheep. Ascending aortic angiographic and autoptic findings immediately after the operation confirmed the satisfactory location and function of the valved stent. Echocardiography, angiography, and histology at six post-operative months confirmed the satisfactory location and function of the valve stent. Conclusion: We successfully implanted our new valve stent as a replacement of native aortic valve via the transcatheter route with satisfactory outcome. Copyright ? 2015, Chinese Medical Association Production. Production and hosting by Elsevier B.V. on behalf of KeAi Communications Co., Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).