Objective The aim of this study was to determine the effect of successful coronary revascularisation on left ventricular diastolic function.Methods We consecutively studied the diastolic function by Doppler echocardio...Objective The aim of this study was to determine the effect of successful coronary revascularisation on left ventricular diastolic function.Methods We consecutively studied the diastolic function by Doppler echocardiography in 125 patients with one vessel disease before and 48 hours after selective coronary angioplasty. The following parameters of left ventricular diastolic function were evaluated: peak early (VE, m/s) and peak late diastolic (VA, m/s) flow velocity, E/A ratio, acceleration time (AT, ms), deceleration time (DT, ms) and isovolumetric relaxation time (IVRT, ms). Ejection fraction (EF; %) was determined and used to characterise systolic left ventricular function. Results All of the patients were initially successful treated with coronary angioplasty (residual stenosis <40% ). In 98 patients( 78.4% ) stents were used to improve an inadequate result after coronary angioplasty. Both patient groups (27 patients with coronary angioplasty and 98 patients with combined coronary angioplasty and stent implantation) showed no relevant differences concerning sex, age, atherosclerotic risk factors, exercise capacity and results of exercise electrocardiography. All patients who underwent stent implantation showed an early improvement of left ventricular diastolic function 48 hours after revascularisation. Surprisingly there was no significant short term improvement (48 hours) of diastolic function in patients with initially successful angioplasty.Conclusions We suppose that stent implantation might normalize coronary blood flow faster than that of coronary balloon angioplasty.展开更多
Background Coronary artery stenting is commonly used for the treatment of coronary atherosclerosis,but it causes serious clinical complications,such as the in-stent restenosis(ISR).The main reason leading to ISR is th...Background Coronary artery stenting is commonly used for the treatment of coronary atherosclerosis,but it causes serious clinical complications,such as the in-stent restenosis(ISR).The main reason leading to ISR is the neointimal hyperplasia(NH),which is related to the stresses of plaque and artery,and to the altered local hemodynamic environment due to the presence of stents.Different stent structures indeed have various impacts on the stresses of plaque and artery,and the local hemodynamic environment,such as the wall shear stress(WSS),average WSS(AWSS),and WSS gradient(WSSG).Thus,it is important to evaluate the performance of stents with different structures by the mechanical factors after coronary stenting.Methods Six stents implanted into a stenotic curved coronary artery were treated separately,and they included three typical commercial stents(Palmaz-Schatz,Xience,and Cypher)and three author-developed stents,which were constructed by reducing the numbers of link(C-Rlink)and crown(C-Rcrown),and aligning the strut(C-Astrut)of the commercial Cypher Solid mechanical analyses of the balloon-stent-plaque-artery system in Abaqus were first performed to assess the performance of different stent structures and provide the deformed boundary of lumen for the subsequent hemodynamic analysis.With the deformed boundary,then hemodynamic analyses in Ansys were conducted to quanti-fy the hemodynamic parameters induced by different stent structures.Combining the solid mechanical and hemodynamic analyses,the performance of the six stents was evaluated.Results The results show that among the three commercial stents,the Palmaz-Schatz stent has the least stent dogboning and recoiling,which corresponds to the greatest maximum plastic strain as well as the largest diameter.However,it induces the greatest maximum stress of plaque,intima,and media.From the viewpoint of hemodynamics,the Palmaz-Schatz stent also performs better and it has smaller areas of adverse low WSS(<0.5 Pa),high WSS(>15 Pa),low AWSS(<0.5 Pa),and high WSSG(>5 000 Pa/m).Compared to the commercial Cypher stent,the author-developed Cypher-based C-Rcrown and C-Astrut stents have smaller recoiling,greater maximum plastic stain and larger diameter,which indicates the improved mechanical performance of the Cypher stent.Moreover,both C-Rcrown and C-Astrut have smaller areas of adverse low WSS,high WSS,and low AWSS,but only C-Rcrown has smaller area of adverse high WSSG.Nevertheless,the C-Rlink stent is inferior to the commercial Cypher stent.In both senses of the solid mechanical and local hemodynamic analyses,the C-Rcrown stent is superior to the commercial Cypher stent and other Cypher-based stents.Conclusions In this study,solid mechanical and hemodynamic analyses were carried out to study the effects of six stents with different structures on their performances after stenting.It was found that the Palmaz-Schatz stent performed better than other two commercial stents,and the performance of the Cypher stent could be improved by reducing the number of crowns of its strut.The present study comparatively evaluates the performance of different stents inside a curved artery,and could be used as a guide to select a suitable commercial stent for clinical application,and provide a way to improve the performance of the existing commercial stents.展开更多
Background and Objective Previous reports from PANDA III trial had proven that BuMA biodegradable polymer(BP)sirolimus-elutingstents(SES),with faster drug eluting rate and polymer absorption kinetics,was non-inferior ...Background and Objective Previous reports from PANDA III trial had proven that BuMA biodegradable polymer(BP)sirolimus-elutingstents(SES),with faster drug eluting rate and polymer absorption kinetics,was non-inferior to the Excel SES in an all-comers population for 1-year target lesion failure(TLF),with a lower incidence of stent thrombosis(ST).The aim of the present study was to perform a safety evaluation of BuMA SES in the complex patient and lesion subgroup.展开更多
Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis on best medical therapy. Angioplasty with stent for symptomatic intracranial stenosis trial ...Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis on best medical therapy. Angioplasty with stent for symptomatic intracranial stenosis trial Ⅰ (ASSIST-Ⅰ) was a prospective and nonrandomized feasibility and safety study to evaluate the APOLLO Stent System for treatment of symptomatic intracranial artery stenosis, and prepare for ASSIST Ⅱ-a prospective, multicenter,and randomized controlled-study. The APOLLO stent delivery system (MicroPort Medical [Shanghai] Limited Co.), specifically designed for intracranial artery stenosis, consists of a stent and a balloon and a rapid-exchange delivery catheter. The stent is made of 316L stainless steel, with diameters of 2.0 to 4.0 mm and length of 8 mm or 13 mm. Only two links connect the rings of 1 mm in length, rendering the stent a good flexibility enough to navigate tortuous intracranial vessels. The nominated pressure of the stent is designed at 6 atm to reduce the risk of occlusion to side branches and perforators and rupture and dissection of target vessel. The crimping technique is applied in this system, insuring a compact ability of stent so wonderful that the struts of stent do not lift when the stent negotiates a turn, which lessen the likelihood of vessel wall injury and stent migrating. Materials and methods Thirty-four patients with 35 symptomatic intracranial stenoses of ≥50%, which resulted in transient ischemic attacks (TIAs [23 lesions /22 patients]) and minor stroke (7 lesions/7 patents), and both TIAs and stroke (5 lesions/ 5 patients), and with 1 asymptomatic severe stenosis, were enrolled in ASSIST-Ⅰ from December 10, 2003 to August 12, 2004. Their age was 54.3 years±SD of 9.49, three patients were male, and all had ≥1 risk factors of atherosclerosis. Patients received the evaluation of National Institutes of Health Stroke Scale (NIHSS), modified Rankin scale (mRS )and Barthel idex (BI) before and one-, three-, six-, and 12-month after the procedure. Results Stent success, defined as stent-assisted angioplasty successfully, resulting in ≤20% residual stenosis, was obtained in 35 lesions ( 97.2%, 35/36) and 33 patients ( 97.1%, 33/34). The stenosis rate of pre- and post -procedure was 80.5%± SD of 12.65 and 7.4%±SD 15.74, respectively. The Procedure-related complications were 8.3% for lesion (3/36) and 8.8% for patient (3/34), included 1 acute thrombosis, which obtained complete patency by means of intrathrombus thombolysis at once without sequelae, and 2 ischemic perforator strokes (1 irreversible stroke and 1 reversible). The disable stroke, defined as one that led to mRS score of ≥2, 30 days after the stroke, occurred in one patient ( 2.9%, 1/34; mRS of 2). Procedure success, defined as stent success without disable stroke or death at discharge by means of the endovascular therapy, was achieved in 33 lesions ( 91.7%, 33/36) and in 31 patients ( 91.2%, 31/34). Treatment success, defined as stent success without disable stroke and death at the 30th day, by means of the endovascular and medical therapy, was obtained in 34 lesions ( 94.4%, 34/36) and 32 patients ( 94.1%, 32/34). Clinical Follow-up, median 170 days (ranged from 30 days to 273 days; ≥1 month, n=34; ≥3 months, n=23; ≥6 months, n=13), was performed in 34 patients. There were no ischemic neurological events and death occurred. Cumulated disable stroke occurred in 1 patient ( 2.9%, 1/34). NIHSS was 1.09±SD of 1.694 and 0.47±SD of 1.051, before procedure and at the 30th day (n=34), respectively, and 0.57±SD of 0.992 at 3 months (n=23), 0.15±SD of 0.376 at 6 months (n=13), respectively; mRS was 0.65±SD of 0.812 and 0.47±SD of 0.563, before procedure and at 30 days, respectively, and 0.61±SD of 0.583 at 3 months, 0.38±SD of 0.506 at 6 months, respectively; and BI was 97.54±SD of 5.918 and 99.26±SD of 2.179, before procedure and at 30 days, respectively, and 99.35±SD of 2.288 at 3 months, 100.00±SD展开更多
Background and objective Airway stent placement is the effective regimen for central airway obstruction(CAO),while its application scenarios varied.This study aimed to make clinical comparison of airway stent placemen...Background and objective Airway stent placement is the effective regimen for central airway obstruction(CAO),while its application scenarios varied.This study aimed to make clinical comparison of airway stent placement in the intervention room and operating room.Methods Patients underwent airway stent placement between 2014 and 2018 were included in this retrospective case-control study.Clinical performance of airway stent placement in intervention room and operating room were compared.Results 82 patients were included in this study,including 39 in the intervention room and 43 in the operating room.Patients treated in the intervention room had lower Charlson comorbidity index(CCI)(P=0.018)and received less Y-shaped stents(P<0.001).Better clinical response(P=0.026),more stents placed(P<0.001)and longer length of stent(P<0.001)were observed in operating room,while there was no significantly statistical difference of stent-related complications and post-stent survival rate between the two groups.Extracorporeal membrane oxygenation(ECMO)supported airway stent placement procedures were performed in the operating room,which provided definitive safety support for high-risk intervention.Conclusion Patients with CAO could benefit from the operating room scenario,and airway stent placement in the operating room is more suitable for patients with higher CCI scores and receiving more complicated procedures.展开更多
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 The purpose of this study was to evaluate the effects of percutaneous transluminal renalr stenting (PTRS) on hypertension and renal function in patients with atherosclerotic renovascular disease.Methods A t...Background The purpose of this study was to evaluate the effects of percutaneous transluminal renalr stenting (PTRS) on hypertension and renal function in patients with atherosclerotic renovascular disease.Methods A total of 147 stents were deployed in 147 lesions of 135 consecutive patients for poorly controlled hypertension or preservation of renal function. Clinical follow-up of the effect of the procedure on renal function, blood pressure control, number of antihypertensive medications, and survival was performed in 128 (95%) patients after 22±14 months. Angiographic follow-up were performed in 70% of the patients at 7.24-5.6 months after PTRS. Results The immediate technical success was 100%. At 22±14 months, systolic and diastolic blood pressures significantly decreased (from 172±23 to 159±20 mm Hg and from 93±16 to 85±13 mm Hg, respectively; P<0.05). The number of antihypertensive medications was reduced on average by 0.74 (from 2.6±1.8 to 1.9±1.7, P<0.01). Among the 49 patients whose renal function was impaired initially (Serum creatinine concentration (SCC) >130 μmol/L), SCC was improved in 25%, became stabilized in 48% and continued to deteriorate in 27%. When SCC was <130 μtmol/L, 97% of the patients remained stabilized, while only 2 patients, SCC deteriorated by 22 months. The cumulative probability of survival was 96% (129/135) at 22 months, with 3 deaths related to end-stage renal disease. The in-stentrestenosis rate was 7.4% (7/95) at a mean follow up of 7.2±5.6 months.Conclusions In patients with atherosclerotic renal-artery stenosis, PTRS could beneficially affect blood pressure control and may improve or prevent further deterioration of renal function.展开更多
Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis in spite of best medical therapy. This was a single center, nonrandomized prospective study ...Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis in spite of best medical therapy. This was a single center, nonrandomized prospective study to evaluate the safety, feasibility and clinical efficacy of stenting for patients with symptomatic intracranial stenosis. Methods One hundred and fifty-five consecutive patients with 170 symptomatic intracranial stenoses of ≥50%, resulted in transient ischemic attacks or minor stroke, were enrolled from September 5, 2001 to August 12, 2004. Their age was 50.9 years±SD of 12.98, 132 patients were male and 150 had ≥1 risk factors of atherosclerosis. The “offending” lesions were situated at middle cerebral (n=93), intracranial internal carotid (n=19), basilar (n=29), intracranial vertebral (n=28) and posterior inferior cerebellar (n=1). Patients received neurological evaluation with National Institutes of Health Stroke Scale (NIHSS) score before and immediately after procedure, and one-, three-, six-, and 12-month after the procedure. Disable stroke was defined as one that led to a modified Rankin scale (mRS) score of ≥2. 1. Results of the Periprocedural Period: Total of 177 balloon-expandable stents was used. Stent Success, defined as stent-assisted angioplasty successfully, resulting in ≤20% residual stenosis, was obtained in 157 lesions ( 92.4%, 157/170) and 142 patients ( 91.2%, 142/155). The stenosis rate of pre- and post -procedure for all patients was 78.2%±SD of 13.93 and 10.8%±SD 20.77, respectively The Procedure-related Complications were 11.8% for lesion (20/170) and 12.9% for patients (20/155), including 6 acute / subacute occlusions and 1 asymptomatic dissection, which all obtained complete patency by means of endovascular therapy at once without sequelae; 6 intracranial hemorrhage, 3 of them recovered (NIHSS at 30-day ≤pre-procedure’s) and one remained hemiparesis with 2 points on NIHSS score at the discharging time, and two died; 1 TIA , disappeared after 3 days; 1 reversible and 4 irreversible ischemic penetrator strokes, and1 irreversible embolic stroke . The rate of complications in stent success group (G1) was 13.4% (19/142) compared with 7.7% (1/13) in stent failure group (G2). The rates of disable stroke (n=5) and death (n=2) within 30 days were 4.5% (7/155) for total patients, 4.9% in G1 (7/142), and 0 in G 2(0/13), respectively. Endovascular Procedure Success was achieved in 144 lesions ( 84.7%, 144/170) and in 129 patients ( 83.2%, 129/155). Procedure success was defined as stent success without disable stroke or death at discharge by means of endovascular therapy, in spite of complications, such as acute / subacute occlusion or dissection. Treatment Success, defined as stent success without inability stroke and death at the 30 th day, by means of endovascular and medical therapy, was obtained in 150 lesions ( 88.2%, 150/170) and in 135 patients ( 87.1%, 135/155). 2. Results of Clinical and Angiographic Follow-up: Clinical Follow-up, median 344 days (ranged from 30 days to 1057 days, 378 days ± SD of 270.2), was performed in 150 patients (140 in G1 and 10 in G2). Ischemic neurological events in the distribution of the target lesion occurred in 5 patients ( 3.3%, 5/150), including 2 strokes and 1 death ( 2.0%, 3/150), and 2 TIAs ( 1.3%, 2/150) during the follow-up. Death and stroke ( 20.0%, 2/10), and TIAs ( 10.0%, 1 /10) in G2 were higher than that in G1 ( 0.7%, 1/140 and 0.7%, 1/140, respectively) after one month. Cumulated neurological events occurred in 15.5% (24/155) of total patients, included TIAs in 3( 1.9%, 3/155), and symptomatic and asymptomatic stroke in 21( 13.5%, 21/155), which resulted in 3 deaths ( 1.9%, 3/155). Cumulated disable stroke and death occurred in 9 patients ( 5.8%, 9/155). Cumulated neurological events, stroke, and disable stroke and death were 14.1% (20/142), 12.7%(18/142) and 4.9%, (7/142), respectively, in G1, compared with 30.8%( 4/13), 23.1%(3/13) and 15.展开更多
Objective It remains undetermined whether biodegradable polymer drug-eluting stents(BP-DES)are superior to second generation drugeluting stents(G2-DES)in patients with and without diabetes mellitus(DM).The study aims ...Objective It remains undetermined whether biodegradable polymer drug-eluting stents(BP-DES)are superior to second generation drugeluting stents(G2-DES)in patients with and without diabetes mellitus(DM).The study aims to evaluate the efficacy and safety of G2-DES and BP-DES in patients with and without DM in a high-volume cardiovascular center in China.展开更多
Background and Purpose Symptomatic intracranial artery stenosis is a high-risk factor of ipsilateral ischemic stroke. Angioplasty with stent has been introduced to treat patients with transient ischemic attack (TIA) a...Background and Purpose Symptomatic intracranial artery stenosis is a high-risk factor of ipsilateral ischemic stroke. Angioplasty with stent has been introduced to treat patients with transient ischemic attack (TIA) and minor stroke attributed to intracranial stenosis since 1996. However, procedure-related neurological complications, either ischemic or hemorrhagic, could result in stroke and death, and benefits of stenting might be offset by higher disable stroke and death. So, the neurovascular angioplasty team should make great efforts to control procedural complications below an acceptable level, such as 10%, because it is impossible to avoid complication absolutely. The team should also be able to recognize, analyze and manage various procedure-related complications, to reduce the risk of disable stroke and death. The purposes of this article were to report our experiences of 20 complications, which occurred during the period of periprocedure.Methods Between September 5, 2001 and August 12, 2004, a total of 155 patients with 170 symptomatic intracranial stenoses of ≥ 50% received intracranial stenting. The management strategies for complication were as follow: ① intra-thrombus urokinase thrombolysis through micro-catheter for acute or subacute occlusion. ② another stenting for dissection. ③ antiplatelet and anticoagulation therapy for penetrator events. ④ continuing nimodipine intravenously for vasospasm. ⑤ to control blood pressure below 110 / 70 mm Hg, to neutralize heparin with protamine sulfate and to discontinue antithrombotic agents, etc, for intracranial hemorrhage. Disable stroke was defined as one that led to a modified Rankin scale (mRS) score of ≥2, 30 days after stroke. Results Procedure -related neurological complications occurred in 20 patients (12.9%, 20/ 155) and 20 lesions (11.7%, 20/ 170), including 6 intracranial hemorrhage (symptomatic, n=4; asymptomatic, n=2), 13 ischemic cerebral events (stroke, n=12; transient ischemic attacks, n=1) and 1 asymptomatic dissection. The probable causes, managements and outcomes of 20 complications are shown in table. Finally, by the means of aggressive endovascular and medical therapies, disable stroke and death within 30 days was 3.2% (5/155) and 1.3% (2/155), respectively. Conclusions Higher risk of procedure-related neurological complications may occur in stenting of intracranial stenosis. To reduce the possibility of disable stroke and death within 30 days, it is mandatory to develop strict procedural and periprocedural management strategies.展开更多
Objective To evaluate the preliminaily clinical efficacy and retrievability of a retrievable hinged covered metallic stent in the treatment of the bronchial stump fistula(BSF).Methods Between April 2003 and March 2005...Objective To evaluate the preliminaily clinical efficacy and retrievability of a retrievable hinged covered metallic stent in the treatment of the bronchial stump fistula(BSF).Methods Between April 2003 and March 2005,8 patients with bronchial stump fistula after pneumonectomy or lobectomy were treated with two types(A and B) of retrievable hinged covered metallic stents.Type A stent was placed in 6 patients and type B in 2 under fluoroscopic guidance.The stent was removed with a retrieval set when BSF was healed or complications occurred.Results Stent placement in the bronchial tree was technically successful in all patients,without procedure-related complications.Immediate closure of the BSF was achieved in all patients after the procedure.Stents were removed from all patients but one.Removal of the stents was difficult in two patients due to tissue hyperplasia.Patients were followed up for 6-21 months.Placement of the stents remained stable in all patients except one due to severe cough.Permanent closure of BSF was achieved in 7(87.5%) of 8 patients.Conclusion Use of a retrievable hinged covered expandable metallic stent is a simple,safe,and effective procedure for closure of the BSF.Retrieval of the stent seems to be feasible.(J Intervent Radiol,2007,16:253-257)展开更多
文摘Objective The aim of this study was to determine the effect of successful coronary revascularisation on left ventricular diastolic function.Methods We consecutively studied the diastolic function by Doppler echocardiography in 125 patients with one vessel disease before and 48 hours after selective coronary angioplasty. The following parameters of left ventricular diastolic function were evaluated: peak early (VE, m/s) and peak late diastolic (VA, m/s) flow velocity, E/A ratio, acceleration time (AT, ms), deceleration time (DT, ms) and isovolumetric relaxation time (IVRT, ms). Ejection fraction (EF; %) was determined and used to characterise systolic left ventricular function. Results All of the patients were initially successful treated with coronary angioplasty (residual stenosis <40% ). In 98 patients( 78.4% ) stents were used to improve an inadequate result after coronary angioplasty. Both patient groups (27 patients with coronary angioplasty and 98 patients with combined coronary angioplasty and stent implantation) showed no relevant differences concerning sex, age, atherosclerotic risk factors, exercise capacity and results of exercise electrocardiography. All patients who underwent stent implantation showed an early improvement of left ventricular diastolic function 48 hours after revascularisation. Surprisingly there was no significant short term improvement (48 hours) of diastolic function in patients with initially successful angioplasty.Conclusions We suppose that stent implantation might normalize coronary blood flow faster than that of coronary balloon angioplasty.
基金supported by the Natural Science Foundation of China ( NSFC) ( 31300780,11272091, 11422222,31470043)supported by the National 973 Basic Research Program of China ( 2013CB733800)China scholarship Council ( 201706090121) ,and ARC ( FT140101152)
文摘Background Coronary artery stenting is commonly used for the treatment of coronary atherosclerosis,but it causes serious clinical complications,such as the in-stent restenosis(ISR).The main reason leading to ISR is the neointimal hyperplasia(NH),which is related to the stresses of plaque and artery,and to the altered local hemodynamic environment due to the presence of stents.Different stent structures indeed have various impacts on the stresses of plaque and artery,and the local hemodynamic environment,such as the wall shear stress(WSS),average WSS(AWSS),and WSS gradient(WSSG).Thus,it is important to evaluate the performance of stents with different structures by the mechanical factors after coronary stenting.Methods Six stents implanted into a stenotic curved coronary artery were treated separately,and they included three typical commercial stents(Palmaz-Schatz,Xience,and Cypher)and three author-developed stents,which were constructed by reducing the numbers of link(C-Rlink)and crown(C-Rcrown),and aligning the strut(C-Astrut)of the commercial Cypher Solid mechanical analyses of the balloon-stent-plaque-artery system in Abaqus were first performed to assess the performance of different stent structures and provide the deformed boundary of lumen for the subsequent hemodynamic analysis.With the deformed boundary,then hemodynamic analyses in Ansys were conducted to quanti-fy the hemodynamic parameters induced by different stent structures.Combining the solid mechanical and hemodynamic analyses,the performance of the six stents was evaluated.Results The results show that among the three commercial stents,the Palmaz-Schatz stent has the least stent dogboning and recoiling,which corresponds to the greatest maximum plastic strain as well as the largest diameter.However,it induces the greatest maximum stress of plaque,intima,and media.From the viewpoint of hemodynamics,the Palmaz-Schatz stent also performs better and it has smaller areas of adverse low WSS(<0.5 Pa),high WSS(>15 Pa),low AWSS(<0.5 Pa),and high WSSG(>5 000 Pa/m).Compared to the commercial Cypher stent,the author-developed Cypher-based C-Rcrown and C-Astrut stents have smaller recoiling,greater maximum plastic stain and larger diameter,which indicates the improved mechanical performance of the Cypher stent.Moreover,both C-Rcrown and C-Astrut have smaller areas of adverse low WSS,high WSS,and low AWSS,but only C-Rcrown has smaller area of adverse high WSSG.Nevertheless,the C-Rlink stent is inferior to the commercial Cypher stent.In both senses of the solid mechanical and local hemodynamic analyses,the C-Rcrown stent is superior to the commercial Cypher stent and other Cypher-based stents.Conclusions In this study,solid mechanical and hemodynamic analyses were carried out to study the effects of six stents with different structures on their performances after stenting.It was found that the Palmaz-Schatz stent performed better than other two commercial stents,and the performance of the Cypher stent could be improved by reducing the number of crowns of its strut.The present study comparatively evaluates the performance of different stents inside a curved artery,and could be used as a guide to select a suitable commercial stent for clinical application,and provide a way to improve the performance of the existing commercial stents.
文摘Background and Objective Previous reports from PANDA III trial had proven that BuMA biodegradable polymer(BP)sirolimus-elutingstents(SES),with faster drug eluting rate and polymer absorption kinetics,was non-inferior to the Excel SES in an all-comers population for 1-year target lesion failure(TLF),with a lower incidence of stent thrombosis(ST).The aim of the present study was to perform a safety evaluation of BuMA SES in the complex patient and lesion subgroup.
文摘Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis on best medical therapy. Angioplasty with stent for symptomatic intracranial stenosis trial Ⅰ (ASSIST-Ⅰ) was a prospective and nonrandomized feasibility and safety study to evaluate the APOLLO Stent System for treatment of symptomatic intracranial artery stenosis, and prepare for ASSIST Ⅱ-a prospective, multicenter,and randomized controlled-study. The APOLLO stent delivery system (MicroPort Medical [Shanghai] Limited Co.), specifically designed for intracranial artery stenosis, consists of a stent and a balloon and a rapid-exchange delivery catheter. The stent is made of 316L stainless steel, with diameters of 2.0 to 4.0 mm and length of 8 mm or 13 mm. Only two links connect the rings of 1 mm in length, rendering the stent a good flexibility enough to navigate tortuous intracranial vessels. The nominated pressure of the stent is designed at 6 atm to reduce the risk of occlusion to side branches and perforators and rupture and dissection of target vessel. The crimping technique is applied in this system, insuring a compact ability of stent so wonderful that the struts of stent do not lift when the stent negotiates a turn, which lessen the likelihood of vessel wall injury and stent migrating. Materials and methods Thirty-four patients with 35 symptomatic intracranial stenoses of ≥50%, which resulted in transient ischemic attacks (TIAs [23 lesions /22 patients]) and minor stroke (7 lesions/7 patents), and both TIAs and stroke (5 lesions/ 5 patients), and with 1 asymptomatic severe stenosis, were enrolled in ASSIST-Ⅰ from December 10, 2003 to August 12, 2004. Their age was 54.3 years±SD of 9.49, three patients were male, and all had ≥1 risk factors of atherosclerosis. Patients received the evaluation of National Institutes of Health Stroke Scale (NIHSS), modified Rankin scale (mRS )and Barthel idex (BI) before and one-, three-, six-, and 12-month after the procedure. Results Stent success, defined as stent-assisted angioplasty successfully, resulting in ≤20% residual stenosis, was obtained in 35 lesions ( 97.2%, 35/36) and 33 patients ( 97.1%, 33/34). The stenosis rate of pre- and post -procedure was 80.5%± SD of 12.65 and 7.4%±SD 15.74, respectively. The Procedure-related complications were 8.3% for lesion (3/36) and 8.8% for patient (3/34), included 1 acute thrombosis, which obtained complete patency by means of intrathrombus thombolysis at once without sequelae, and 2 ischemic perforator strokes (1 irreversible stroke and 1 reversible). The disable stroke, defined as one that led to mRS score of ≥2, 30 days after the stroke, occurred in one patient ( 2.9%, 1/34; mRS of 2). Procedure success, defined as stent success without disable stroke or death at discharge by means of the endovascular therapy, was achieved in 33 lesions ( 91.7%, 33/36) and in 31 patients ( 91.2%, 31/34). Treatment success, defined as stent success without disable stroke and death at the 30th day, by means of the endovascular and medical therapy, was obtained in 34 lesions ( 94.4%, 34/36) and 32 patients ( 94.1%, 32/34). Clinical Follow-up, median 170 days (ranged from 30 days to 273 days; ≥1 month, n=34; ≥3 months, n=23; ≥6 months, n=13), was performed in 34 patients. There were no ischemic neurological events and death occurred. Cumulated disable stroke occurred in 1 patient ( 2.9%, 1/34). NIHSS was 1.09±SD of 1.694 and 0.47±SD of 1.051, before procedure and at the 30th day (n=34), respectively, and 0.57±SD of 0.992 at 3 months (n=23), 0.15±SD of 0.376 at 6 months (n=13), respectively; mRS was 0.65±SD of 0.812 and 0.47±SD of 0.563, before procedure and at 30 days, respectively, and 0.61±SD of 0.583 at 3 months, 0.38±SD of 0.506 at 6 months, respectively; and BI was 97.54±SD of 5.918 and 99.26±SD of 2.179, before procedure and at 30 days, respectively, and 99.35±SD of 2.288 at 3 months, 100.00±SD
文摘Background and objective Airway stent placement is the effective regimen for central airway obstruction(CAO),while its application scenarios varied.This study aimed to make clinical comparison of airway stent placement in the intervention room and operating room.Methods Patients underwent airway stent placement between 2014 and 2018 were included in this retrospective case-control study.Clinical performance of airway stent placement in intervention room and operating room were compared.Results 82 patients were included in this study,including 39 in the intervention room and 43 in the operating room.Patients treated in the intervention room had lower Charlson comorbidity index(CCI)(P=0.018)and received less Y-shaped stents(P<0.001).Better clinical response(P=0.026),more stents placed(P<0.001)and longer length of stent(P<0.001)were observed in operating room,while there was no significantly statistical difference of stent-related complications and post-stent survival rate between the two groups.Extracorporeal membrane oxygenation(ECMO)supported airway stent placement procedures were performed in the operating room,which provided definitive safety support for high-risk intervention.Conclusion Patients with CAO could benefit from the operating room scenario,and airway stent placement in the operating room is more suitable for patients with higher CCI scores and receiving more complicated procedures.
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 The purpose of this study was to evaluate the effects of percutaneous transluminal renalr stenting (PTRS) on hypertension and renal function in patients with atherosclerotic renovascular disease.Methods A total of 147 stents were deployed in 147 lesions of 135 consecutive patients for poorly controlled hypertension or preservation of renal function. Clinical follow-up of the effect of the procedure on renal function, blood pressure control, number of antihypertensive medications, and survival was performed in 128 (95%) patients after 22±14 months. Angiographic follow-up were performed in 70% of the patients at 7.24-5.6 months after PTRS. Results The immediate technical success was 100%. At 22±14 months, systolic and diastolic blood pressures significantly decreased (from 172±23 to 159±20 mm Hg and from 93±16 to 85±13 mm Hg, respectively; P<0.05). The number of antihypertensive medications was reduced on average by 0.74 (from 2.6±1.8 to 1.9±1.7, P<0.01). Among the 49 patients whose renal function was impaired initially (Serum creatinine concentration (SCC) >130 μmol/L), SCC was improved in 25%, became stabilized in 48% and continued to deteriorate in 27%. When SCC was <130 μtmol/L, 97% of the patients remained stabilized, while only 2 patients, SCC deteriorated by 22 months. The cumulative probability of survival was 96% (129/135) at 22 months, with 3 deaths related to end-stage renal disease. The in-stentrestenosis rate was 7.4% (7/95) at a mean follow up of 7.2±5.6 months.Conclusions In patients with atherosclerotic renal-artery stenosis, PTRS could beneficially affect blood pressure control and may improve or prevent further deterioration of renal function.
文摘Background and Purpose Annual stroke rates might be as high as 10% to 24% in patients with symptomatic intracranial stenosis in spite of best medical therapy. This was a single center, nonrandomized prospective study to evaluate the safety, feasibility and clinical efficacy of stenting for patients with symptomatic intracranial stenosis. Methods One hundred and fifty-five consecutive patients with 170 symptomatic intracranial stenoses of ≥50%, resulted in transient ischemic attacks or minor stroke, were enrolled from September 5, 2001 to August 12, 2004. Their age was 50.9 years±SD of 12.98, 132 patients were male and 150 had ≥1 risk factors of atherosclerosis. The “offending” lesions were situated at middle cerebral (n=93), intracranial internal carotid (n=19), basilar (n=29), intracranial vertebral (n=28) and posterior inferior cerebellar (n=1). Patients received neurological evaluation with National Institutes of Health Stroke Scale (NIHSS) score before and immediately after procedure, and one-, three-, six-, and 12-month after the procedure. Disable stroke was defined as one that led to a modified Rankin scale (mRS) score of ≥2. 1. Results of the Periprocedural Period: Total of 177 balloon-expandable stents was used. Stent Success, defined as stent-assisted angioplasty successfully, resulting in ≤20% residual stenosis, was obtained in 157 lesions ( 92.4%, 157/170) and 142 patients ( 91.2%, 142/155). The stenosis rate of pre- and post -procedure for all patients was 78.2%±SD of 13.93 and 10.8%±SD 20.77, respectively The Procedure-related Complications were 11.8% for lesion (20/170) and 12.9% for patients (20/155), including 6 acute / subacute occlusions and 1 asymptomatic dissection, which all obtained complete patency by means of endovascular therapy at once without sequelae; 6 intracranial hemorrhage, 3 of them recovered (NIHSS at 30-day ≤pre-procedure’s) and one remained hemiparesis with 2 points on NIHSS score at the discharging time, and two died; 1 TIA , disappeared after 3 days; 1 reversible and 4 irreversible ischemic penetrator strokes, and1 irreversible embolic stroke . The rate of complications in stent success group (G1) was 13.4% (19/142) compared with 7.7% (1/13) in stent failure group (G2). The rates of disable stroke (n=5) and death (n=2) within 30 days were 4.5% (7/155) for total patients, 4.9% in G1 (7/142), and 0 in G 2(0/13), respectively. Endovascular Procedure Success was achieved in 144 lesions ( 84.7%, 144/170) and in 129 patients ( 83.2%, 129/155). Procedure success was defined as stent success without disable stroke or death at discharge by means of endovascular therapy, in spite of complications, such as acute / subacute occlusion or dissection. Treatment Success, defined as stent success without inability stroke and death at the 30 th day, by means of endovascular and medical therapy, was obtained in 150 lesions ( 88.2%, 150/170) and in 135 patients ( 87.1%, 135/155). 2. Results of Clinical and Angiographic Follow-up: Clinical Follow-up, median 344 days (ranged from 30 days to 1057 days, 378 days ± SD of 270.2), was performed in 150 patients (140 in G1 and 10 in G2). Ischemic neurological events in the distribution of the target lesion occurred in 5 patients ( 3.3%, 5/150), including 2 strokes and 1 death ( 2.0%, 3/150), and 2 TIAs ( 1.3%, 2/150) during the follow-up. Death and stroke ( 20.0%, 2/10), and TIAs ( 10.0%, 1 /10) in G2 were higher than that in G1 ( 0.7%, 1/140 and 0.7%, 1/140, respectively) after one month. Cumulated neurological events occurred in 15.5% (24/155) of total patients, included TIAs in 3( 1.9%, 3/155), and symptomatic and asymptomatic stroke in 21( 13.5%, 21/155), which resulted in 3 deaths ( 1.9%, 3/155). Cumulated disable stroke and death occurred in 9 patients ( 5.8%, 9/155). Cumulated neurological events, stroke, and disable stroke and death were 14.1% (20/142), 12.7%(18/142) and 4.9%, (7/142), respectively, in G1, compared with 30.8%( 4/13), 23.1%(3/13) and 15.
文摘Objective It remains undetermined whether biodegradable polymer drug-eluting stents(BP-DES)are superior to second generation drugeluting stents(G2-DES)in patients with and without diabetes mellitus(DM).The study aims to evaluate the efficacy and safety of G2-DES and BP-DES in patients with and without DM in a high-volume cardiovascular center in China.
文摘Background and Purpose Symptomatic intracranial artery stenosis is a high-risk factor of ipsilateral ischemic stroke. Angioplasty with stent has been introduced to treat patients with transient ischemic attack (TIA) and minor stroke attributed to intracranial stenosis since 1996. However, procedure-related neurological complications, either ischemic or hemorrhagic, could result in stroke and death, and benefits of stenting might be offset by higher disable stroke and death. So, the neurovascular angioplasty team should make great efforts to control procedural complications below an acceptable level, such as 10%, because it is impossible to avoid complication absolutely. The team should also be able to recognize, analyze and manage various procedure-related complications, to reduce the risk of disable stroke and death. The purposes of this article were to report our experiences of 20 complications, which occurred during the period of periprocedure.Methods Between September 5, 2001 and August 12, 2004, a total of 155 patients with 170 symptomatic intracranial stenoses of ≥ 50% received intracranial stenting. The management strategies for complication were as follow: ① intra-thrombus urokinase thrombolysis through micro-catheter for acute or subacute occlusion. ② another stenting for dissection. ③ antiplatelet and anticoagulation therapy for penetrator events. ④ continuing nimodipine intravenously for vasospasm. ⑤ to control blood pressure below 110 / 70 mm Hg, to neutralize heparin with protamine sulfate and to discontinue antithrombotic agents, etc, for intracranial hemorrhage. Disable stroke was defined as one that led to a modified Rankin scale (mRS) score of ≥2, 30 days after stroke. Results Procedure -related neurological complications occurred in 20 patients (12.9%, 20/ 155) and 20 lesions (11.7%, 20/ 170), including 6 intracranial hemorrhage (symptomatic, n=4; asymptomatic, n=2), 13 ischemic cerebral events (stroke, n=12; transient ischemic attacks, n=1) and 1 asymptomatic dissection. The probable causes, managements and outcomes of 20 complications are shown in table. Finally, by the means of aggressive endovascular and medical therapies, disable stroke and death within 30 days was 3.2% (5/155) and 1.3% (2/155), respectively. Conclusions Higher risk of procedure-related neurological complications may occur in stenting of intracranial stenosis. To reduce the possibility of disable stroke and death within 30 days, it is mandatory to develop strict procedural and periprocedural management strategies.
文摘Objective To evaluate the preliminaily clinical efficacy and retrievability of a retrievable hinged covered metallic stent in the treatment of the bronchial stump fistula(BSF).Methods Between April 2003 and March 2005,8 patients with bronchial stump fistula after pneumonectomy or lobectomy were treated with two types(A and B) of retrievable hinged covered metallic stents.Type A stent was placed in 6 patients and type B in 2 under fluoroscopic guidance.The stent was removed with a retrieval set when BSF was healed or complications occurred.Results Stent placement in the bronchial tree was technically successful in all patients,without procedure-related complications.Immediate closure of the BSF was achieved in all patients after the procedure.Stents were removed from all patients but one.Removal of the stents was difficult in two patients due to tissue hyperplasia.Patients were followed up for 6-21 months.Placement of the stents remained stable in all patients except one due to severe cough.Permanent closure of BSF was achieved in 7(87.5%) of 8 patients.Conclusion Use of a retrievable hinged covered expandable metallic stent is a simple,safe,and effective procedure for closure of the BSF.Retrieval of the stent seems to be feasible.(J Intervent Radiol,2007,16:253-257)
