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1.
Saudi Med J ; 45(7): 685-693, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38955440

ABSTRACT

OBJECTIVES: To compare carotid endarterectomy patch angioplasty (p-CEA) with eversion carotid endarterectomy (e-CEA) and associated risks of early cardio-cerebrovascular complications. METHODS: The study was a prospective randomized single-blind trial, monocentric, clinically applicable, descriptive analytical and comparative. From June 2021 to June 2023, 62 consecutive patients with symptomatic and asymptomatic stenosis of the internal carotid artery, admitted to our department and randomized into two groups: carotid endarterectomy with patch angioplasty and eversion carotid endarterectomy. Follow-up for 30 days after surgery. RESULTS: During surgery e-CEA, 70% patients had an arrhythmia, and 24 hours after 66.7%, seven days after 46.7% and month after 13.3%. During surgery p-CEA, 33.3% patients had an arrhythmia, 24 hours later 33.3%, 7 days after 13.3% and 30 days after 13.3% patients. Statistically significant difference observed during surgery (Fishers p=0.004). One day after the surgery rate of patients with arrhythmia that were treated e-CEA has decreased, but it was still higher than after p-CEA (Fishers p=0.010). CONCLUSION: The frequency and categorization of postoperative cardiac arrhythmias after eversion carotid endarterectomy, the clinical implications of various postoperative heart rhythm disturbances and their long-term effects on patients need to be further investigate through sufficiently powered randomized controlled studies.


Subject(s)
Angioplasty , Carotid Stenosis , Endarterectomy, Carotid , Postoperative Complications , Humans , Endarterectomy, Carotid/methods , Endarterectomy, Carotid/adverse effects , Male , Female , Carotid Stenosis/surgery , Prospective Studies , Aged , Angioplasty/methods , Middle Aged , Single-Blind Method , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Arrhythmias, Cardiac/etiology
2.
Sci Rep ; 14(1): 14290, 2024 06 21.
Article in English | MEDLINE | ID: mdl-38906992

ABSTRACT

To investigate the effect and safety of percutaneous endovascular angioplasty (PEA) with optional stenting for the treatment of severe stenosis or occlusion of subclavian artery, patients with severe stenosis ≥ 70% or occlusion of subclavian artery treated with PEA were retrospectively enrolled. The clinical data were analyzed. A total of 222 patients were retrospectively enrolled, including 151 males (68.0%) and 71 females (32.0%) aged 48-86 (mean 63.9 ± 9.0) years. Forty-seven (21.2%) patients had comorbidities. Subclavian artery stenosis ≥ 70% was present in 201 (90.5%) patients and complete subclavian occlusion in 21 (9.5%) cases. Angioplasty was successfully performed in all (100%) patients. Balloon-expandable stents were used in 190 (85.6%) cases, and self-expandable stents in 20 (9.0%) cases. Only 12 (5.4%) cases were treated with balloon dilation only. Among 210 patients treated with stent angioplasty, 71 (33.8% or 71/210) cases underwent balloon pre-dilation, 139 (66.2% or 139/210) had direct deployment of balloon-expandable stents, and 2 (1.0% or 2/210) experienced balloon post-dilation. Distal embolization protection devices were used in 5 (2.3% or 5/222) cases. Periprocedural complications occurred in 3 (1.4%) patients, including aortic dissection in 2 (0.9%) cases and right middle cerebral artery embolism in 1 (0.5%). No hemorrhage occurred. Among 182 (82.0%) patients with 6-month follow-up, restenosis > 70% occurred in 1 (0.5%) patient, and among 68 (30.6%) patients with 12-month follow-up, restenosis > 70% took place in 11 (16.2%) patients. Percutaneous endovascular angioplasty can be safely and efficiently performed for the treatment of severe stenosis ≥ 70% or occlusion of subclavian artery.


Subject(s)
Stents , Subclavian Artery , Humans , Male , Female , Aged , Middle Aged , Aged, 80 and over , Subclavian Artery/surgery , Retrospective Studies , Stents/adverse effects , Treatment Outcome , Subclavian Steal Syndrome/therapy , Subclavian Steal Syndrome/surgery , Endovascular Procedures/methods , Endovascular Procedures/adverse effects , Angioplasty/methods , Angioplasty/adverse effects , Constriction, Pathologic/therapy , Angioplasty, Balloon/methods , Angioplasty, Balloon/adverse effects , Arterial Occlusive Diseases/therapy , Arterial Occlusive Diseases/surgery
3.
Lancet Neurol ; 23(8): 797-806, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38914085

ABSTRACT

BACKGROUND: Unsuccessful recanalisation or reocclusion after thrombectomy is associated with poor outcomes in patients with large vessel occlusion (LVO) acute ischaemic stroke (LVO-AIS). Bailout angioplasty or stenting (BAOS) could represent a promising treatment for these patients. We conducted a randomised controlled trial with the aim to investigate the safety and efficacy of BAOS following thrombectomy in patients with LVO. METHODS: ANGEL-REBOOT was an investigator-initiated, multicentre, prospective, randomised, controlled, open-label, blinded-endpoint clinical trial conducted at 36 tertiary hospitals in 19 provinces in China. Participants with LVO-AIS 24 h after symptom onset were eligible if they had unsuccessful recanalisation (expanded Thrombolysis In Cerebral Infarction score of 0-2a) or risk of reocclusion (residual stenosis >70%) after thrombectomy. Eligible patients were randomly assigned by the minimisation method in a 1:1 ratio to undergo BAOS as the intervention treatment, or to receive standard therapy (continue or terminate the thrombectomy procedure) as a control group, both open-label. In both treatment groups, tirofiban could be recommended for use during and after the procedure. The primary outcome was the change in modified Rankin Scale score at 90 days, assessed in the intention-to-treat population. Safety outcomes were compared between groups. This trial was completed and registered at ClinicalTrials.gov (NCT05122286). FINDINGS: From Dec 19, 2021, to March 17, 2023, 706 patients were screened, and 348 were enrolled, with 176 assigned to the intervention group and 172 to the control group. No patients withdrew from the trial or were lost to follow-up for the primary outcome. The median age of patients was 63 years (IQR 55-69), 258 patients (74%) were male, and 90 patients (26%) were female; all participants were Chinese. After random allocation, tirofiban was administered either intra-arterially, intravenously, or both in 334 [96%] of 348 participants. No between-group differences were observed in the primary outcome (common odds ratio 0·86 [95% CI 0·59-1·24], p=0·41). Mortality was similar between the two groups (19 [11%] of 176 vs 17 [10%] of 172), but the intervention group showed a higher risk of symptomatic intracranial haemorrhage (eight [5%] of 175 vs one [1%] of 169), parenchymal haemorrhage type 2 (six [3%] of 175 vs none in the control group), and procedure-related arterial dissection (24 [14%] of 176 vs five [3%] of 172). INTERPRETATION: Among Chinese patients with unsuccessful recanalisation or who are at risk of reocclusion after thrombectomy, BAOS did not improve clinical outcome at 90 days, and incurred more complications compared with standard therapy. The off-label use of tirofiban might have affected our results and their generalisability, but our findings do not support the addition of BAOS for such patients with LVO-AIS. FUNDING: Beijing Natural Science Foundation, National Natural Science Foundation of China, National Key R&D Program Beijing Municipal Administration of Hospitals Incubating Program, Shanghai HeartCare Medical Technology, HeMo (China) Bioengineering, Sino Medical Sciences Technology.


Subject(s)
Angioplasty , Ischemic Stroke , Stents , Thrombectomy , Humans , Male , Female , Aged , Middle Aged , Thrombectomy/methods , China , Ischemic Stroke/surgery , Ischemic Stroke/therapy , Angioplasty/methods , Treatment Outcome , Prospective Studies
5.
Ren Fail ; 46(1): 2353351, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38757707

ABSTRACT

OBJECTIVE: To investigate the feasibility and efficacy of combining ultrasound-guided sharp needle technique with percutaneous transluminal angioplasty (PTA) for treating outflow stenosis or dysfunction in arteriovenous fistula (AVF) among hemodialysis patients. METHODS: From October 2021 to March 2023, patients with occluded or malfunctional fistula veins not amenable to regularly angioplasty were retrospectively enrolled in the study. They underwent ultrasound-guided sharp needle intervention followed by PTA. Data on the location and length between the two veins, technical success, clinical outcomes, and complications were collected. Patency rates post-angioplasty were calculated through Kaplan-Meier analysis. RESULTS: A total of 23 patients were included. The mean length of the reconstructed extraluminal segment was 3.18 cm. The sharp needle opening was performed on the basilic vein (60.9%), brachial vein (26.1%), or upper arm cephalic vein (13%) to create outflow channels. Postoperatively, all cases presented with mild subcutaneous hematomas around the tunneling site and minor diffuse bleeding. The immediate patency rate for the internal fistulas was 100%, with 3-month, 6-month, and 12-month patency rates at 91.3%, 78.3%, and 43.5%, respectively. CONCLUSION: Sharp needle technology merged with PTA presents an effective and secure minimally invasive method for reconstructing the outflow tract, offering a new solution for recanalizing high-pressure or occluded fistulas.


Subject(s)
Arteriovenous Shunt, Surgical , Renal Dialysis , Ultrasonography, Interventional , Vascular Patency , Humans , Female , Male , Arteriovenous Shunt, Surgical/adverse effects , Arteriovenous Shunt, Surgical/methods , Middle Aged , Renal Dialysis/methods , Retrospective Studies , Aged , Adult , Needles , Angioplasty/methods , Graft Occlusion, Vascular/etiology , Feasibility Studies , Treatment Outcome
6.
Am Heart J ; 273: 121-129, 2024 07.
Article in English | MEDLINE | ID: mdl-38608997

ABSTRACT

RATIONALE: Antiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high. In coronary artery and cerebrovascular disease, dual APT (DAPT)compared to acetylsalicylic acid alone has been proven to reduce MACE without increasing the risk of major bleeding when applied for a restricted number of weeks. However, within the PAD population, insufficient data are available to understand the potential attributable effect of DAPT over single APT (SAPT). Therefore, prospective randomized studies in targeted study populations are warranted. TRIAL DESIGN: CLEAR-PATH is a Dutch multicenter, double-blind, placebo-controlled, randomized trial comparing SAPT (clopidogrel 75 mg plus placebo) with DAPT (clopidogrel 75 mg plus acetylsalicylic acid 80 mg) in patients with PAD undergoing EVR. CLEAR-PATH includes a time-to-event analysis with a follow-up of one year. The primary composite efficacy endpoint consists of all-cause mortality, nonfatal stroke, nonfatal myocardial infarction, severe limb ischemia, (indication for) re-intervention due to any symptomatic restenosis, re-occlusion, or due to acute limb ischemia, and major amputation. The primary safety endpoint contains major bleeding following the Thrombolysis in Myocardial Infarction classification. The enrolment started in August 2022. In total 450 primary efficacy outcome events are required which expectedly amounts to 1696 subjects. Recruitment will take approximately 36 months. CONCLUSION: CLEAR-PATH will assess the efficacy and safety of DAPT compared to SAPT following EVR in PAD patients. TRIAL REGISTRATION NUMBER: NL80009.041.21.


Subject(s)
Aspirin , Clopidogrel , Dual Anti-Platelet Therapy , Lower Extremity , Peripheral Arterial Disease , Platelet Aggregation Inhibitors , Humans , Aspirin/administration & dosage , Aspirin/therapeutic use , Double-Blind Method , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/administration & dosage , Peripheral Arterial Disease/therapy , Clopidogrel/therapeutic use , Clopidogrel/administration & dosage , Lower Extremity/blood supply , Dual Anti-Platelet Therapy/methods , Male , Angioplasty/methods , Thrombosis/prevention & control , Thrombosis/etiology , Thrombosis/epidemiology , Female , Netherlands/epidemiology , Prospective Studies , Hemorrhage/chemically induced , Hemorrhage/epidemiology
7.
BMC Neurol ; 24(1): 99, 2024 Mar 18.
Article in English | MEDLINE | ID: mdl-38500074

ABSTRACT

BACKGROUND: Acute stroke treatment with intracranial thrombectomy and treatment of ipsilateral carotid artery stenosis/occlusion ("tandem lesion", TL) in one session is considered safe. However, the risk of stent restenosis after TL treatment is high, and antiplatelet therapy (APT) preventing restenosis must be well balanced to avoid intracranial hemorrhage. We investigated the safety and 90-day outcome of patients receiving TL treatment under triple-APT, focused on stent-patency and possible disadvantageous comorbidities. METHODS: Patients receiving TL treatment in the setting of acute stroke between 2013 and 2022 were analyzed regarding peri-/postprocedural safety and stent patency after 90 days. All patients received intravenous eptifibatide and acetylsalicylic acid and one of the three drugs prasugrel, clopidogrel, or ticagrelor. Duplex imaging was performed 24 h after treatment, at discharge and 90 days, and digital subtraction angiography was performed if restenosis was suspected. RESULTS: 176 patients were included. Periprocedural complications occurred in 2.3% of the patients at no periprocedural death, and in-hospital death in 13.6%. Discharge mRS score was maintained or improved at the 90-day follow-up in 86%, 4.54% had an in-stent restenosis requiring treatment at 90 days. No recorded comorbidity considered disadvantageous for stent patency showed statistical significance, the duration of the endovascular procedure had no significant effect on outcome. CONCLUSION: In our data, TL treatment with triple APT resulted in a low restenosis rate, low rates of sICH and a comparably high number of patients with favorable outcome. Aggressive APT in the initial phase may therefore have the potential to prevent recurrent stroke better than restrained platelet inhibition. Comorbidities did not influence stent patency.


Subject(s)
Carotid Stenosis , Endovascular Procedures , Stroke , Thrombosis , Humans , Retrospective Studies , Hospital Mortality , Treatment Outcome , Angioplasty/methods , Stroke/diagnostic imaging , Stroke/surgery , Stroke/etiology , Endovascular Procedures/methods , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/surgery , Stents/adverse effects , Thrombectomy/adverse effects , Thrombosis/etiology , Constriction, Pathologic/etiology
9.
PLoS One ; 19(2): e0297800, 2024.
Article in English | MEDLINE | ID: mdl-38330071

ABSTRACT

PURPOSE: The aim of this study was to evaluate the usability of a recently developed extracorporeally-perfused cadaver model for training the angiographic management of acute arterial diseases and periprocedural complications that may occur during endovascular therapy of the lower extremity arterial runoff. MATERIALS AND METHODS: Continuous extracorporeal perfusion was established in three fresh-frozen body donors via inguinal and infragenicular access. Using digital subtraction angiography for guidance, both arterial embolization (e.g., embolization using coils, vascular plugs, particles, and liquid embolic agents) and endovascular recanalization procedures (e.g., manual aspiration or balloon-assisted embolectomy) as well as various embolism protection devices were tested. Furthermore, the management of complications during percutaneous transluminal angioplasty, such as vessel dissection and rupture, were exercised by implantation of endovascular dissection repair system or covered stents. Interventions were performed by two board-certified interventional radiologists and one resident with only limited angiographic experience. RESULTS: Stable extracorporeal perfusion was successfully established on both thighs of all three body donors. Digital subtraction angiography could be performed reliably and resulted in realistic artery depiction. The model allowed for repeatable training of endovascular recanalization and arterial embolization procedures with typical tactile feedback in a controlled environment. Furthermore, the handling of more complex angiographic devices could be exercised. Whereas procedural success was be ascertained for most endovascular interventions, thrombectomies procedures were not feasible in some cases due to the lack of inherent coagulation. CONCLUSION: The presented perfusion model is suitable for practicing time-critical endovascular interventions in the lower extremity runoff under realistic but controlled conditions.


Subject(s)
Endovascular Procedures , Vascular Diseases , Humans , Endovascular Procedures/methods , Arteries , Angioplasty/methods , Stents , Cadaver , Treatment Outcome , Retrospective Studies
10.
J Neuroradiol ; 51(1): 82-88, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37364744

ABSTRACT

Percutaneous transluminal angioplasty (PTA) and stenting have been used for the treatment of internal carotid artery (ICA) stenosis over the past two decades. A systematic review was performed to understand the efficacy of PTA and/or stenting for petrous and cavernous ICA stenosis. In total, 151 patients (mean age 64.9) met criteria for analysis, 117 (77.5%%) were male and 34 (22.5%) were female. Of the 151 patients, 35 of them (23.2%) had PTA, and 116 (76.8%) had endovascular stenting. Twenty-two patients had periprocedural complications. There was no significant difference in the complication rates between the PTA (14.3%) and stent (14.7%) groups. Distal embolism was the most common periprocedural complication. Average clinical follow up for 146 patients was 27.3 months. Eleven patients (7.5%) out of 146 had retreatment. The treatment of petrous and cavernous ICA with PTA and stenting has relatively significant procedure related complication rates and adequate long-term patency.


Subject(s)
Angioplasty, Balloon , Carotid Stenosis , Humans , Male , Female , Middle Aged , Aged , Carotid Stenosis/therapy , Carotid Stenosis/surgery , Constriction, Pathologic , Treatment Outcome , Angioplasty/methods , Stents , Carotid Artery, Internal/diagnostic imaging
11.
J Neuroradiol ; 51(1): 66-73, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37364746

ABSTRACT

BACKGROUND: Although radiotherapy is common for head/neck and chest cancers (HNCC), it can result in post-irradiation stenosis of the subclavian artery (PISSA). The efficacy of percutaneous transluminal angioplasty and stenting (PTAS) to treat severe PISSA is not well-clarified. AIMS: To compare the technical safety and outcomes of PTAS between patients with severe PISSA (RT group) and radiation-naïve counterparts (non-RT group). METHODS: During 2000 and 2021, we retrospectively enrolled patients with severe symptomatic stenosis (>60%) of the subclavian artery who underwent PTAS. The rate of new recent vertebrobasilar ischaemic lesions (NRVBIL), diagnosed on diffusion-weight imaging (DWI) within 24 h of postprocedural brain MRI; symptom relief; and long-term stent patency were compared between the two groups. RESULTS: Technical success was achieved in all 61 patients in the two groups. Compared with the non-RT group (44 cases, 44 lesions), the RT group (17 cases, 18 lesions) had longer stenoses (22.1 vs 11.1 mm, P = 0.003), more ulcerative plaques (38.9% vs 9.1%, P = 0.010), and more medial- or distal-segment stenoses (44.4% vs 9.1%, P<0.001). The technical safety and outcome between the non-RT group and the RT group were NRVBIL on DWI of periprocedural brain MRI 30.0% vs 23.1%, P = 0.727; symptom recurrence rate (mean follow-up 67.1 ± 50.0 months) 2.3% vs 11.8%, P = 0.185; and significant in-stent restenosis rate (>50%) 2.3% vs 11.1%, P = 0.200. CONCLUSION: The technical safety and outcome of PTAS for PISSA were not inferior to those of radiation-naïve counterparts. PTAS for PISSA is an effective treatment for medically refractory ischaemic symptoms of HNCC patients with PISSA.


Subject(s)
Angioplasty, Balloon , Subclavian Artery , Humans , Constriction, Pathologic , Subclavian Artery/diagnostic imaging , Case-Control Studies , Retrospective Studies , Angioplasty/methods , Treatment Outcome , Stents
12.
Eur Radiol ; 34(4): 2352-2363, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37723287

ABSTRACT

OBJECTIVES: To assess the predictive value of hemodynamic features for stroke relapse in patients with intracranial vertebrobasilar atherosclerotic stenosis treated with percutaneous transluminal angioplasty and stenting (PTAS) using quantitative digital subtraction angiography (q-DSA). METHODS: In this retrospective longitudinal study, patients with intracranial vertebrobasilar atherosclerotic stenosis and who underwent PTAS treatment between January 2012 and May 2020 were enrolled. The q-DSA assessment was performed before and after PTAS. ROIs 1-4 were placed along the vertebral artery, proximal and distal basilar artery, and posterior cerebral artery; ROIs 5-8 were in 5 mm and 10 mm proximal and distal to the lesion, respectively. Relative time to peak (rTTP) was defined as the difference in TTP between ROIs. Cox regression analyses were performed to determine risk factors for recurrent stroke. RESULTS: A total of 137 patients (mean age, 62 years ± 10 [standard deviation], 83.2% males) were included, and 26 (19.0%) patients had stroke relapse during follow-up (median time of 42.6 months [interquartile range, 19.7-60.7]). Preprocedural rTTP4-1 (adjusted hazard ratio (HR) = 2.270; 95% CI 1.371-3.758; p = 0.001) and preprocedural rTTP8-5 (adjusted HR = 0.240; 95% CI 0.088-0.658; p = 0.006) were independently associated with the recurrent stroke. These hemodynamic parameters provided an incremental prognostic value for stroke relapse (AUC, 0.817 [0.704-0.931]; the net reclassification index, 0.431 [0.057-0.625]; and the integrated discrimination index, 0.140 [0.035-0.292]). CONCLUSIONS: In patients with intracranial vertebrobasilar atherosclerosis treated with PTAS, preprocedural prolonged TTP of the target vessel and shortened trans-stenotic TTP difference were associated with stroke relapse. Q-DSA-defined hemodynamic parameters provided incremental predictive value over conventional parameters for stroke recurrence. CLINICAL RELEVANCE STATEMENT: Quantitative DSA analysis enables intuitive observation and semi-quantitative evaluation of peri-therapeutic cerebral blood flow. More importantly, quantitative DSA-defined hemodynamic parameters have the potential for risk stratification of patients with intracranial atherosclerotic stenosis. KEY POINTS: Semi-quantitative angiography-based parameters can reflect pre- and postprocedural subtle changes in blood flow in patients with intracranial atherosclerotic stenosis. Although angioplasty procedures can significantly improve blood flow status, patients with more restricted baseline blood flow still show a higher risk of stroke recurrence. Angiography-based hemodynamic features possess prognostic value and can serve as clinical markers to assess stroke risk of patients with intracranial atherosclerotic stenosis.


Subject(s)
Atherosclerosis , Intracranial Arteriosclerosis , Stroke , Vertebrobasilar Insufficiency , Male , Humans , Middle Aged , Female , Constriction, Pathologic , Retrospective Studies , Longitudinal Studies , Vertebrobasilar Insufficiency/diagnostic imaging , Vertebrobasilar Insufficiency/therapy , Stroke/complications , Atherosclerosis/complications , Atherosclerosis/diagnostic imaging , Atherosclerosis/therapy , Angioplasty/methods , Hemodynamics , Angiography, Digital Subtraction/methods , Intracranial Arteriosclerosis/complications , Intracranial Arteriosclerosis/diagnostic imaging , Intracranial Arteriosclerosis/therapy , Recurrence , Stents/adverse effects
13.
N Engl J Med ; 390(1): 9-19, 2024 Jan 04.
Article in English | MEDLINE | ID: mdl-37888915

ABSTRACT

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).


Subject(s)
Angioplasty , Blood Vessel Prosthesis Implantation , Chronic Limb-Threatening Ischemia , Drug-Eluting Stents , Peripheral Arterial Disease , Popliteal Artery , Humans , Absorbable Implants , Angioplasty/adverse effects , Angioplasty/methods , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/methods , Blood Vessel Prosthesis Implantation/methods , Chronic Disease , Chronic Limb-Threatening Ischemia/etiology , Chronic Limb-Threatening Ischemia/surgery , Everolimus/administration & dosage , Everolimus/adverse effects , Everolimus/therapeutic use , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/therapeutic use , Ischemia/drug therapy , Ischemia/etiology , Ischemia/surgery , Peripheral Arterial Disease/complications , Peripheral Arterial Disease/drug therapy , Peripheral Arterial Disease/surgery , Popliteal Artery/surgery , Tissue Scaffolds , Treatment Outcome
15.
Article in English | MEDLINE | ID: mdl-38082865

ABSTRACT

This study focuses on the robustness of a generic Finite Element Model (FEM) of Percutaneous Transluminal Angioplasty (PTA) procedure with permanent set. The influence of three different parameters on simulation robustness were investigated: the stenosis percent, the stenosis offset and the arterial caliber. Five arterial calibers are modeled by adapting the ratio between the inner diameter and the wall thickness. Overall, forty configurations were tested with the same simulation settings and boundary conditions. Results shows convergence issues caused by excessive deformations of elements for stenosis above 65% blockage. Moreover, an increasing stenosis offset tends to decrease convergence. Simulation of PTA on small calibers and large calibers are less robust than intermediate e.g., iliac calibers.Clinical Relevance- PTA can benefit from numerical tools to improve the procedure outcomes. A FEM simulation of PTA without stent deployment can predict the permanent strain induced by this surgery for various configurations. However, robustness of the simulation is required to consider its transfer to clinics. This work aims to determine the robustness boundaries of an implicit solver for PTA simulation. It shows that an implicit solver is robust for all artery calibers with a stenosis below 50% blockage. Moreover medium-caliber arteries exhibit better robustness with converging solutions for stenosis reaching 60% blockage.


Subject(s)
Angioplasty , Stents , Humans , Treatment Outcome , Constriction, Pathologic , Angioplasty/methods , Arteries
16.
Rev. chil. cardiol ; 42(3): 153-160, dic. 2023. tab, graf
Article in Spanish | LILACS | ID: biblio-1529982

ABSTRACT

Antecedentes: El Shock Cardiogénico (SC) y las Angioplastías de Alto Riesgo (AAR) están asociadas con altas tasas de mortalidad. El uso del dispositivo Impella CP podría reducir el riesgo de muerte en estos escenarios. En Chile no existen reportes evaluando el uso del dispositivo Impella CP. Objetivo: Analizar los desenlaces clínicos en pacientes que fueron sometidos al uso del dispositivo Impella CP por SC o por AAR. Métodos: Se realizó un estudio retrospectivo en 17 pacientes, los cuales representan el total de implantes realizados en el país, entre octubre 2021 y agosto 2023. Se describió las características, demográficas, procedimentales y después del implante. Se estimó la mortalidad general y se identificaron factores asociados. Resultados: La edad de los pacientes fue 69± 3,7 años y 88,2% fueron hombres. El 64,7% recibió el dispositivo por SC y 35,3% por AAR. Dentro de las comorbilidades estudiadas, la hipertensión arterial fue la más frecuente, 94,1%. Un 58,8% de los pacientes fueron revascularizados a través de la arteria radial. El 29,4% recibió el dispositivo previo a la angioplastía y 70,6% lo recibió después. El 47,1% de las angioplastías fue guiada por imágenes. En 11,8% de ellos se realizó litotricia intracoronaria y 5,9% por ablación intracoronaria. Los pacientes estuvieron 13 ±3,4 días con el soporte. La mortalidad global fue de 41,2%. Conclusiones: El uso del dispositivo Impella presentó pocas complicaciones vasculares. La mortalidad asociada con su colocación en Chile fue relativamente similar con la reportada en la literatura.


Background: Cardiogenic shock and high-risk Angioplasty are associated with a high mortality rate. Using the Impella CP device could reduce the risk of death in these scenarios. In Chile, there are no studies evaluating the use of the Impella CP device. Objective: To analyse the clinical outcomes in patients who have undergone placement of the Impella CP device for cardiogenic shock and high-risk angioplasties. Methods: A retrospective study was carried out on 17 patients, which represent the total number of implants performed in the country, between October 2021 and August 2023. The demographic, procedural and post-implant characteristics were described. Overall mortality and associated factors were identified. Results: The age was 69± 3.7 years, where 88.2% were men. 64.7% of patients received the device by SC and 35.3% by AAR. Among the comorbidities studied, arterial hypertension was the most frequent with 94.1%. 58.8% of patients were revascularized through the radial artery. 29.4% of patients received the device before angioplasty and 70.6% received it afterwards. 47.1% of angioplasties were image-guided, 11.8% had intracoronary lithotripsy, and 5.9% had intracoronary ablation. The patients spent 13 ±3.4 days with the support. Overall mortality was 41.2%. Conclusion: use of the Impella device was associated with few vascular complications. Mortality associated with use of the Impella device in Chile was similar to that previously reported in other studies.


Subject(s)
Humans , Male , Female , Middle Aged , Aged , Aged, 80 and over , Shock, Cardiogenic/therapy , Cardiology , Shock, Cardiogenic/mortality , Chile , Angioplasty/methods
17.
BMC Nephrol ; 24(1): 304, 2023 10 17.
Article in English | MEDLINE | ID: mdl-37848833

ABSTRACT

BACKGROUND: To access the efficacy of percutaneous transluminal angioplasty and arteriovenous fistula reconstruction for immature arteriovenous fistula, compare the long-term patency and post-operative complications between them. MATERIALS AND METHODS: The medical records and Hemodialysis record sheets from 44 patients between May 2020 and January 2022 who underwent percutaneous transluminal angioplasty or arteriovenous fistula reconstruction treatment for immature autogenous arteriovenous fistula (AVF) were retrospectively reviewed. The patients were divided into two groups according to the type of surgery they received, including 25 patients in the PTA group and 19 patients in the AVF reconstruction group. Clinical outcomes were included, such as the primary and secondary patency rates following the procedure, maturation time, peak systolic velocity (PSV) of brachial artery, maximum pump-controlled blood flow at initial dialysis, and post-operative complications rates in the two groups. RESULTS: Technical and clinical success was achieved in 100% of the 44 cases. For patients who underwent percutaneous transluminal angioplasty, the primary patency rate at 3, 6, and 9 months was 84.0%, 68.0%, 60.0%, and the secondary patency rate was 92.0%, 84.0%, 80.0%, respectively. And for patients who underwent arteriovenous fistula reconstruction, the primary patency rate at 3, 6, and 9 months was 89.5%, 73.7%, 68.4%, and the secondary patency rate was 100.0%, 94.7%, 94.7%, respectively. There were no significant differences between the two groups in terms of patency rates (p > .050). In patients whose maturation was successful, the average maturation time of fistula after the PTA procedure was 19.36 ± 13.94 days, and 58.63 ± 18.95 days for the reconstruction procedure (p < .010). The PSV of brachial artery before and after the procedure was 87.64 ± 23.87 cm/s and 153.20 ± 21.69 cm/s in PTA group, for reconstruction group, the number was 86.26 ± 20.59 cm/s and 151.26 ± 29.94 cm/s, respectively. No statistically significant differences (p > .050). The maximum pump-controlled blood flow at initial dialysis was 232.60 ± 16.72 ml/min in PTA group, which was significantly higher than 197.11 ± 10.45 ml/min in reconstruction group (p < .010). Subcutaneous hematoma, restenosis, thrombus formation, and pseudoaneurysm were major complications in PTA group. Restenosis, thrombus formation, and pseudoaneurysm were major complications in reconstruction group, with no statistically significant differences between the two groups (p > .050). CONCLUSION: When immature AVFs require reconstruction surgery, the patency outcomes are comparable to AVFs that undergo successful management by PTA. While, when AVFs are successfully managed by PTA, they have significantly less maturation times and higher maximum pump-controlled blood flow rates at initial dialysis AVF use.


Subject(s)
Aneurysm, False , Arteriovenous Fistula , Arteriovenous Shunt, Surgical , Thrombosis , Humans , Graft Occlusion, Vascular/etiology , Graft Occlusion, Vascular/therapy , Vascular Patency/physiology , Retrospective Studies , Aneurysm, False/complications , Renal Dialysis/adverse effects , Angioplasty/adverse effects , Angioplasty/methods , Arteriovenous Fistula/complications , Arteriovenous Shunt, Surgical/adverse effects , Constriction, Pathologic , Treatment Outcome
18.
Angiol. (Barcelona) ; 75(5): 326-329, Sept-Oct, 2023. ilus
Article in Spanish | IBECS | ID: ibc-226589

ABSTRACT

La isquemia crónica amenazante de miembros inferiores (iCami) es una de las principales causas de morbilidad yde mortalidad a nivel mundial y se encuentra en aumento por la creciente prevalencia de la diabetes mellitus. enlas dos últimas décadas se ha demostrado la factibilidad y la seguridad de revascularizar el arco plantar (aP) y laimportancia de un aP intacto para la cicatrización de las heridas.Reportamos dos casos de pacientes con iCami que requirieron de revascularización endovascular del aP paraobtener la cicatrización de las heridas y evitar amputaciones mayores.(AU)


Chronic limb threatening ischemia (CLti) is a major cause of morbidity and mortality worldwide, and it is on the risedue to the increasing prevalence of diabetes mellitus (dm). in the last two decades, the feasibility and safety of revas-cularization of the plantar arch (Pa) and the importance of an intact Pa for wound healing have been demonstrated.We report two cases of patients with CLti who required endovascular revascularization of the Pa to obtain woundhealing and avoid major amputations.(AU)


Subject(s)
Humans , Male , Female , Aged , Cardiovascular Surgical Procedures , Talipes Cavus , Lower Extremity , Ischemia , Angioplasty/methods , Lymphatic System , Cardiovascular System , Inpatients , Physical Examination , Symptom Assessment , Foot/diagnostic imaging , Foot/physiology , Angiography
19.
Cochrane Database Syst Rev ; 7: CD013852, 2023 07 20.
Article in English | MEDLINE | ID: mdl-37470266

ABSTRACT

BACKGROUND: Lower extremity atherosclerotic disease (LEAD) - also known as peripheral arterial disease - refers to the obstruction or narrowing of the large arteries of the lower limbs, most commonly caused by atheromatous plaque. Although in many cases of less severe disease patients can be asymptomatic, the major clinical manifestations of LEAD are intermittent claudication (IC) and critical limb ischaemia, also known as chronic limb-threatening ischaemia (CLTI). Revascularisation procedures including angioplasty, stenting, and bypass grafting may be required for those in whom the disease is severe or does not improve with non-surgical interventions. Maintaining vessel patency after revascularisation remains a challenge for vascular surgeons, since approximately 30% of vein grafts may present with restenosis in the first year due to myointimal hyperplasia. Restenosis can also occur after angioplasty and stenting. Restenosis and occlusions that occur more than two years after the procedure are generally related to progression of the atherosclerosis. Surveillance programmes with duplex ultrasound (DUS) scanning as part of postoperative care may facilitate early diagnosis of restenosis and help avoid amputation in people who have undergone revascularisation. OBJECTIVES: To assess the effects of DUS versus pulse palpation, arterial pressure index, angiography, or any combination of these, for surveillance of lower limb revascularisation in people with LEAD. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and LILACS databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 February 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that compared DUS surveillance after lower limb revascularisation versus clinical surveillance characterised by medical examination with pulse palpation, with or without any other objective test, such as arterial pressure index measures (e.g. ankle-brachial index (ABI) or toe brachial index (TBI)). Our primary outcomes were limb salvage rate, vessel or graft secondary patency, and adverse events resulting from DUS surveillance. Secondary outcomes were all-cause mortality, functional walking ability assessed by walking distance, clinical severity scales, quality of life (QoL), re-intervention rates, and functional walking ability assessed by any validated walking impairment questionnaire. We presented the outcomes at two time points: two years or less after the original revascularisation (short term) and more than two years after the original revascularisation (long term). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. We used the Cochrane RoB 1 tool to assess the risk of bias for RCTs and GRADE to assess the certainty of evidence. We performed meta-analysis when appropriate. MAIN RESULTS: We included three studies (1092 participants) that compared DUS plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation and arterial pressure index (ABI or TBI) for surveillance of lower limb revascularisation with bypass. One study each was conducted in Sweden and Finland, and the third study was conducted in the UK and Europe. The studies did not report adverse events resulting from DUS surveillance, functional walking ability, or clinical severity scales. No study assessed surveillance with DUS scanning after angioplasty or stenting, or both. We downgraded the certainty of evidence for risk of bias and imprecision. Duplex ultrasound plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation plus arterial pressure index (ABI or TBI) (short-term time point) In the short term, DUS surveillance may lead to little or no difference in limb salvage rate (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.49 to 1.45; I² = 93%; 2 studies, 936 participants; low-certainty evidence) and vein graft secondary patency (RR 0.92, 95% CI 0.67 to 1.26; I² = 57%; 3 studies, 1092 participants; low-certainty evidence). DUS may lead to little or no difference in all-cause mortality (RR 1.11, 95% CI 0.70 to 1.74; 1 study, 594 participants; low-certainty evidence). There was no clear difference in QoL as assessed by the 36-item Short Form Health Survey (SF-36) physical score (mean difference (MD) 2 higher, 95% CI 2.59 lower to 6.59 higher; 1 study, 594 participants; low-certainty evidence); the SF-36 mental score (MD 3 higher, 95% CI 0.38 lower to 6.38 higher; 1 study, 594 participants; low-certainty evidence); or the EQ-5D utility score (MD 0.02 higher, 95% CI 0.03 lower to 0.07 higher; 1 study, 594 participants; low-certainty evidence). DUS may increase re-intervention rates when considered any therapeutic intervention (RR 1.38, 95% CI 1.05 to 1.81; 3 studies, 1092 participants; low-certainty evidence) or angiogram procedures (RR 1.53, 95% CI 1.12 to 2.08; 3 studies, 1092 participants; low-certainty evidence). Duplex ultrasound plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation plus arterial pressure index (ABI or TBI) (long-term time point) One study reported data after two years, but provided only vessel or graft secondary patency data. DUS may lead to little or no difference in vessel or graft secondary patency (RR 0.83, 95% CI 0.19 to 3.51; 1 study, 156 participants; low-certainty evidence). Other outcomes of interest were not reported at the long-term time point. AUTHORS' CONCLUSIONS: Based on low certainty evidence, we found no clear difference between DUS and standard surveillance in preventing limb amputation, morbidity, and mortality after lower limb revascularisation. We found no studies on DUS surveillance after angioplasty or stenting (or both), only studies on bypass grafting. High-quality RCTs should be performed to better inform the best medical surveillance of lower limb revascularisation that may reduce the burden of peripheral arterial disease.


Subject(s)
Lower Extremity , Peripheral Arterial Disease , Humans , Lower Extremity/blood supply , Angioplasty/methods , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/surgery , Intermittent Claudication/etiology , Intermittent Claudication/surgery , Stents
20.
Clin Neurol Neurosurg ; 232: 107842, 2023 09.
Article in English | MEDLINE | ID: mdl-37453284

ABSTRACT

The established effectiveness of mechanical thrombectomy using a stent retriever or aspiration catheter for emergent large-vessel occlusion caused by cardiogenic embolic stroke is widely recognized. However, in cases of acute artery occlusion resulting from atherosclerotic disease, mechanical thrombectomy often encounters challenges in achieving consistent recanalization, and aggressive percutaneous transluminal angioplasty (PTA) with a balloon and/or stenting can potentially lead to arterial dissection or additional perforator infarction. We present the case of an 88-year-old man who experienced sudden unconsciousness and tetra-paresis, diagnosed with cerebral infarction resulting from right vertebral artery occlusion. During the mechanical thrombectomy procedure, we identified atheromatous disease. Considering the circumstances, we made the decision to maintain the stent placement for 30 min following the loading of dual antiplatelet drugs. As a result, the right vertebral artery was successfully recanalized, although severe stenosis persisted. Two weeks after the initial procedure, we performed wingspan stent placement with a favorable outcome. Stent retriever angioplasty, using the deploy and re-sheath method, appears to be a viable option for managing acute atherosclerotic occlusion. This case highlights the challenges encountered in mechanical thrombectomy for atherosclerotic occlusion and demonstrates a potential approach to address this issue. By keeping the stent in place for a specific duration, combined with appropriate pharmacological intervention, recanalization was achieved, offering a promising therapeutic strategy for similar cases. Stent retriever angioplasty utilizing the deploy and re-sheath method emerges as a potential option for addressing acute atherosclerotic occlusion.


Subject(s)
Arterial Occlusive Diseases , Atherosclerosis , Endovascular Procedures , Stroke , Male , Humans , Aged, 80 and over , Vertebral Artery/diagnostic imaging , Vertebral Artery/surgery , Infarction, Middle Cerebral Artery/surgery , Endovascular Procedures/methods , Angioplasty/methods , Atherosclerosis/complications , Arterial Occlusive Diseases/complications , Stents/adverse effects , Thrombectomy/methods , Treatment Outcome , Stroke/etiology
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