Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive u...Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive use of a CE-marked filter embolic protection device.Methods This study was a prospective multi-center, single-arm trial. Between June and October 2003, 77 patients were enrolled in 8 investigational centers throughout Europe. The primary endpoint was the incidence of Major Neurological Events (MANE) through one month. Other endpoints were the ability to properly place the stent, and primary patency and MANE after six months. Eligible for the study were patients with a de novo or restenotic target lesion located in the common and/or internal carotid artery (>70% stenosis for asymptomatic and >50% stenosis for symptomatic patients). The ev3 Spider (Embolic Protection Filter was used in 75 of 77 cases. Results In 76 out of the 77 patients (99%), the stent could be successfully implanted with a residual stenosis ≤30% as criterion. Of the 74 patients that had a carotid ultrasound at one month follow-up, none had a re-stenosis of the target lesion. There were three MANEs during or immediately after the procedure (3.9%), two were major and one was a minor stroke. There were eight severe complications (9.1%); six of these happened during or immediately after the procedure and were related to the procedure, none was related to the device. They are resolved without sequelae. No deaths have occurred.Conclusions The Protégé stent is safe and performs well in the treatment of carotid artery stenosis. The technical success rate for placement of the Protégé stent as assessed by the residual stenosis post implant was very high and all stents were successfully deployed. The incidence of MANE was comparable with that in other recent carotid stent studies and still lower than standard CEA.展开更多
Background:Although transcatheter closure of atrial septal defect(ASD)is safe and effective for patients with sufficient rim,ASD patients with absent and/or malaligned aortic and/or superior rim have higher risks of d...Background:Although transcatheter closure of atrial septal defect(ASD)is safe and effective for patients with sufficient rim,ASD patients with absent and/or malaligned aortic and/or superior rim have higher risks of device embolization and cardiac erosion.We have treated such high-risk patients using a Figulla Flex II(FFII)device shaped flared and straddling behind the aorta because this method would avoid such serious complications.However,its long-term efficacy and safety remain unclear.Therefore,the midterm efficacy and safety of this method were studied.Methods:We retrospectively evaluated the outcome of 47 consecutive patients with such rim(age 6–73 years,weight 17–75 kg,31 females)treated with this method at our hospital between February 2016 and September 2019.To make the flared and straddling shape,we selected a FFII 4–6 mm larger than the balloon sizing diameter by stop-flow technique.We also studied the device shape,the disc pressure to the Valsalva wall and their changes over 6 months by transesophageal echocardiography.Results:All procedures were successful,and leakage disappeared within 1 year.During a mean follow up of 37±12 months,complications included a transient sinus node dysfunction and one I°atrioventricular block within 3 months.Whole device shape changed from bulky to thin:the device waist and thickness significantly decreased by around 1.5 mm and 3.5 mm,respectively(p<0.05),but the two discs remained flared and straddling behind the aorta over 6 months;therefore,the disc edges seldom pressed the Valsalva wall perpendicularly,even though the inner plane of either disc often slightly pressed the wall.Conclusions:ASD closure using a FFII shaped flared and straddling behind the aorta is probably effective and safe for patients with absent and/or malaligned aortic and/or superior rim although requiring care for conduction disorders.展开更多
Blood blister-like aneurysms(BBAs)are fragile and difficult to treat.However,the optimal treatment has yet to be determined.Pipeline embolization devices and Willis covered stent implementation are still controversial...Blood blister-like aneurysms(BBAs)are fragile and difficult to treat.However,the optimal treatment has yet to be determined.Pipeline embolization devices and Willis covered stent implementation are still controversial strategies for treating BBA.Herein,we report a case of recurrent BBA successfully treated with a Willis covered stent.A long-term follow-up angiography after the procedure indicated complete occlusion of the aneurysm.This case demonstrates the safety and efficacy of applying the Wills cover stent in the treatment of recurrent BBA after Pipeline implantation.展开更多
We present a case report about percutaneous closure of a congenital Gerbode defect using Nit-Occlud~? Lê VSD coil. The patient was referred to our hospital with a diagnosis of ventricular septal defect(VSD) and s...We present a case report about percutaneous closure of a congenital Gerbode defect using Nit-Occlud~? Lê VSD coil. The patient was referred to our hospital with a diagnosis of ventricular septal defect(VSD) and severe pulmonary arterial hypertension. But transthoracic echocardiography revealed a communication between the left ventricle(LV) and the right atrial(RA), called Gerbode defect. Catheterization confirmed the shunt from the LV to the RA. We successfully closed the defect with a VSD coil. After uneventful 6 mo follow-up, the patient was out of dyspnea, the symptom urged him to have medical attention. This case report is to discuss the diagnosis and percutaneous treatment approach for this rare congenital heart disease.展开更多
Objective To explore the efficacy of transcatheter closure of patent ductus arteriosus (PDA) with detachable coil and Amplatzer duct occluder (ADO). Methods Transcatheter colsure of PDA was performed in 160 case...Objective To explore the efficacy of transcatheter closure of patent ductus arteriosus (PDA) with detachable coil and Amplatzer duct occluder (ADO). Methods Transcatheter colsure of PDA was performed in 160 cases, aged 4.56±2.67 years, of whom 3 had residual shunt after surgical ligation, 2 had pulmomary stenosis (PS), 1 had coarctation of aorta (COA), 1 had right aortic arch, and 2 had atrial septal defect (ASD). Results Detachable coils (Duct Occlude pfm or Cook Inc) were successfully used in 51 patients with a smallest PDA diameter of 1.86±0.78mm. Amplatzer duct occluders were also successfully performed in other 109 with a moderate to large PDA diameter of 3.89±1.32mm, of whom 3 with PS or COA were performed balloon dilation firstly, and 2 with ASD were performed PDA occlusion firstly; 1 month to 4.8 years follow-up coil or Amplatzer device closure of PDA showed that neither residual shunt nor any complication. Conclusion It is suggested that the detachable coil and Amplatzer duct occluder are simple and safe for the catheter closure from small to large sized PDA.展开更多
Background To compare the safety and efficacy of pipeline embolization device(PED)and Tubridge flow diverter(TFD)for unruptured posterior circulation aneurysms.Methods Posterior aneurysm patients treated with PED or T...Background To compare the safety and efficacy of pipeline embolization device(PED)and Tubridge flow diverter(TFD)for unruptured posterior circulation aneurysms.Methods Posterior aneurysm patients treated with PED or TFD between January,2019,and December,2021,were retrospectively reviewed.Patients’demographics,aneurysm characteristics,treatment details,complications,and follow-up information were collected.The procedural-related complications and angiographic and clinical outcome were compared.Results A total of 107 patients were involved;PED was applied for 55 patients and TFD for 52 patients.A total of 9(8.4%)procedural-related complications occurred,including 4(7.3%)in PED group and 5(9.6%)in TFD group.During a mean of 10.3-month angiographic follow-up for 81 patients,complete occlusion was achieved in 35(85.4%)patients in PED group and 30(75.0%)in TFD group.The occlusion rate of PED group is slightly higher than that of TFD group.A mean of 25.0-month clinical follow-up for 107 patients showed that favorable clinical outcome was achieved in 53(96.4%)patients in PED group and 50(96.2%)patients in TFD group,respectively.No statistical difference was found in terms of procedural-related complications(p=0.737),occlusion rate(p=0.241),and favorable clinical outcome(0.954)between groups.Conclusions The current study found no difference in complication,occlusion,and clinical outcome between PED and TFD for unruptured PCAs.展开更多
文摘Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive use of a CE-marked filter embolic protection device.Methods This study was a prospective multi-center, single-arm trial. Between June and October 2003, 77 patients were enrolled in 8 investigational centers throughout Europe. The primary endpoint was the incidence of Major Neurological Events (MANE) through one month. Other endpoints were the ability to properly place the stent, and primary patency and MANE after six months. Eligible for the study were patients with a de novo or restenotic target lesion located in the common and/or internal carotid artery (>70% stenosis for asymptomatic and >50% stenosis for symptomatic patients). The ev3 Spider (Embolic Protection Filter was used in 75 of 77 cases. Results In 76 out of the 77 patients (99%), the stent could be successfully implanted with a residual stenosis ≤30% as criterion. Of the 74 patients that had a carotid ultrasound at one month follow-up, none had a re-stenosis of the target lesion. There were three MANEs during or immediately after the procedure (3.9%), two were major and one was a minor stroke. There were eight severe complications (9.1%); six of these happened during or immediately after the procedure and were related to the procedure, none was related to the device. They are resolved without sequelae. No deaths have occurred.Conclusions The Protégé stent is safe and performs well in the treatment of carotid artery stenosis. The technical success rate for placement of the Protégé stent as assessed by the residual stenosis post implant was very high and all stents were successfully deployed. The incidence of MANE was comparable with that in other recent carotid stent studies and still lower than standard CEA.
文摘Background:Although transcatheter closure of atrial septal defect(ASD)is safe and effective for patients with sufficient rim,ASD patients with absent and/or malaligned aortic and/or superior rim have higher risks of device embolization and cardiac erosion.We have treated such high-risk patients using a Figulla Flex II(FFII)device shaped flared and straddling behind the aorta because this method would avoid such serious complications.However,its long-term efficacy and safety remain unclear.Therefore,the midterm efficacy and safety of this method were studied.Methods:We retrospectively evaluated the outcome of 47 consecutive patients with such rim(age 6–73 years,weight 17–75 kg,31 females)treated with this method at our hospital between February 2016 and September 2019.To make the flared and straddling shape,we selected a FFII 4–6 mm larger than the balloon sizing diameter by stop-flow technique.We also studied the device shape,the disc pressure to the Valsalva wall and their changes over 6 months by transesophageal echocardiography.Results:All procedures were successful,and leakage disappeared within 1 year.During a mean follow up of 37±12 months,complications included a transient sinus node dysfunction and one I°atrioventricular block within 3 months.Whole device shape changed from bulky to thin:the device waist and thickness significantly decreased by around 1.5 mm and 3.5 mm,respectively(p<0.05),but the two discs remained flared and straddling behind the aorta over 6 months;therefore,the disc edges seldom pressed the Valsalva wall perpendicularly,even though the inner plane of either disc often slightly pressed the wall.Conclusions:ASD closure using a FFII shaped flared and straddling behind the aorta is probably effective and safe for patients with absent and/or malaligned aortic and/or superior rim although requiring care for conduction disorders.
文摘Blood blister-like aneurysms(BBAs)are fragile and difficult to treat.However,the optimal treatment has yet to be determined.Pipeline embolization devices and Willis covered stent implementation are still controversial strategies for treating BBA.Herein,we report a case of recurrent BBA successfully treated with a Willis covered stent.A long-term follow-up angiography after the procedure indicated complete occlusion of the aneurysm.This case demonstrates the safety and efficacy of applying the Wills cover stent in the treatment of recurrent BBA after Pipeline implantation.
文摘We present a case report about percutaneous closure of a congenital Gerbode defect using Nit-Occlud~? Lê VSD coil. The patient was referred to our hospital with a diagnosis of ventricular septal defect(VSD) and severe pulmonary arterial hypertension. But transthoracic echocardiography revealed a communication between the left ventricle(LV) and the right atrial(RA), called Gerbode defect. Catheterization confirmed the shunt from the LV to the RA. We successfully closed the defect with a VSD coil. After uneventful 6 mo follow-up, the patient was out of dyspnea, the symptom urged him to have medical attention. This case report is to discuss the diagnosis and percutaneous treatment approach for this rare congenital heart disease.
文摘Objective To explore the efficacy of transcatheter closure of patent ductus arteriosus (PDA) with detachable coil and Amplatzer duct occluder (ADO). Methods Transcatheter colsure of PDA was performed in 160 cases, aged 4.56±2.67 years, of whom 3 had residual shunt after surgical ligation, 2 had pulmomary stenosis (PS), 1 had coarctation of aorta (COA), 1 had right aortic arch, and 2 had atrial septal defect (ASD). Results Detachable coils (Duct Occlude pfm or Cook Inc) were successfully used in 51 patients with a smallest PDA diameter of 1.86±0.78mm. Amplatzer duct occluders were also successfully performed in other 109 with a moderate to large PDA diameter of 3.89±1.32mm, of whom 3 with PS or COA were performed balloon dilation firstly, and 2 with ASD were performed PDA occlusion firstly; 1 month to 4.8 years follow-up coil or Amplatzer device closure of PDA showed that neither residual shunt nor any complication. Conclusion It is suggested that the detachable coil and Amplatzer duct occluder are simple and safe for the catheter closure from small to large sized PDA.
基金supported by the National Natural Science Foundation of China(Grant Number 82171289)the Beijing Gold-Bridge Project(Grant number ZZ21060)
文摘Background To compare the safety and efficacy of pipeline embolization device(PED)and Tubridge flow diverter(TFD)for unruptured posterior circulation aneurysms.Methods Posterior aneurysm patients treated with PED or TFD between January,2019,and December,2021,were retrospectively reviewed.Patients’demographics,aneurysm characteristics,treatment details,complications,and follow-up information were collected.The procedural-related complications and angiographic and clinical outcome were compared.Results A total of 107 patients were involved;PED was applied for 55 patients and TFD for 52 patients.A total of 9(8.4%)procedural-related complications occurred,including 4(7.3%)in PED group and 5(9.6%)in TFD group.During a mean of 10.3-month angiographic follow-up for 81 patients,complete occlusion was achieved in 35(85.4%)patients in PED group and 30(75.0%)in TFD group.The occlusion rate of PED group is slightly higher than that of TFD group.A mean of 25.0-month clinical follow-up for 107 patients showed that favorable clinical outcome was achieved in 53(96.4%)patients in PED group and 50(96.2%)patients in TFD group,respectively.No statistical difference was found in terms of procedural-related complications(p=0.737),occlusion rate(p=0.241),and favorable clinical outcome(0.954)between groups.Conclusions The current study found no difference in complication,occlusion,and clinical outcome between PED and TFD for unruptured PCAs.