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The endovascular occlusion system for safe and immediate peripheral vessel occlusion during vascular interventions.

ABSTRACT: Endovascular occlusion of blood vessels is an important part of interventional therapy concepts. Here, we evaluate the feasibility, procedural safety and efficacy of the novel endovascular occlusion system (EOS) in the arterial system in a porcine model. Thirteen devices were deployed in the iliac and femoral arteries (diameter: 4-5 mm) of five adult swine. Post-deployment angiography was performed at 1, 5 and 10 min and 6 h. All devices (n = 13) could be successfully delivered without any complications, such as dissection, perforation or rupture. The devices could be easily advanced to the target vessel segment, deployed at the intended target location and produced immediate and complete vessel occlusion which was confirmed to be maintained after 6 h. No leaks, recanalization or device migration was observed. In this pilot study, we demonstrate the feasibility, safety and efficacy of immediate vessel occlusion with the EOS device in the peripheral arterial system in a porcine animal model. Our data indicate that this novel device allows precise delivery without the occurrence of cardiovascular complications. Owing to its long-term safety and efficacy the EOS may represent a promising and effective alternative to currently available devices for vessel occlusion during vascular interventions.

SUBMITTER: Emmert MY

PROVIDER: S-EPMC3805205 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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The endovascular occlusion system for safe and immediate peripheral vessel occlusion during vascular interventions.

Emmert Maximilian Y MY Venbrux Anthony A Rudakov Leon L Cesarovic Nikola N Radvany Martin G MG Gailloud Philippe P Falk Volkmar V Plass Andre A

Interactive cardiovascular and thoracic surgery 20130717 5

Endovascular occlusion of blood vessels is an important part of interventional therapy concepts. Here, we evaluate the feasibility, procedural safety and efficacy of the novel endovascular occlusion system (EOS) in the arterial system in a porcine model. Thirteen devices were deployed in the iliac and femoral arteries (diameter: 4-5 mm) of five adult swine. Post-deployment angiography was performed at 1, 5 and 10 min and 6 h. All devices (n = 13) could be successfully delivered without any compl ...[more]

PMID: 23868605

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Project description:BackgroundThe long-term outcomes of acute large vessel occlusion (LVO) in anterior circulation treated by endovascular treatment (EVT) remains to be determined. The aim of this study was to assess the 5-year outcomes of patients with LVO who underwent EVT.MethodsThis study was an observational, nationwide registry of consecutive patients with acute LVO who received EVT in 28 comprehensive stroke centers in China. The primary outcome was the proportion of favorable outcome [modified Rankin Scale score (mRS) 0-2] at 5 years. Secondary outcomes included proportions of patients with excellent outcome (mRS 0-1), all-cause mortality and risk of stroke recurrence at 5 years.ResultsA total of 807 patients were included into the study and had 90-day follow-up data, 657 patients had 5-year follow-up data. At 90 days, 218 patients (27.0%) had an excellent outcome, 349 patients (43.2%) had a favorable functional outcome. 199 patients (24.7%) died. At 5 years, 190 patients (28.9%) had an excellent outcome, 261 patients (39.7%) had a favorable functional outcome, 317 patients (48.2%) died and 129 (28.2%) had stroke recurrence. Because of missing 5-year follow-up data, among available 269 patients who achieved functional independence at 90 days, 208 (77.3%) maintained favorable outcome, 19 (7.1%) had disability (mRS 3-5) and 42 (15.6%) died at 5 years. Furthermore, among available 189 patients with mRS 3-5 at 90 days, 53 (28.0%) patients achieved favorable functional outcome, 60 (31.7%) patients maintained unfavorable functional outcome and 76 (40.2%) patients died within 5 years. Multivariate analyses identified that younger age [odds ratio (OR): 0.96; 95% CI, 0.93-0.99; P = 0.009], lower mRS at 90 days (OR: 0.15; 95% CI, 0.10-0.23; P < 0.001) and absence of stroke recurrence (OR: 0.001; 95% CI, 0.000-0.006; P < 0.001) were significantly associated with favorable outcome at 5 years. Advanced age (OR: 1.06, 95% CI, 1.04-1.08; P < 0.001), higher mRS at 90 days (OR: 0.84; 95% CI, 0.73-0.98; P = 0.021) and atrial fibrillation (OR: 1.63; 95% CI, 1.02-2.60; P = 0.04) were independent factors for stroke recurrence.ConclusionOur results indicated that the beneficial effect of EVT in patients with acute LVO can be sustained during the course of at least 5 years. Reducing the risk of stroke recurrence by anticoagulation for atrial fibrillation may be a crucial strategy to improve long-term outcome.

Project description:Background and Purpose: Endovascular treatment (EVT) for acute vertebrobasilar intracranial atherosclerosis-related large vessel occlusion (ICAS-LVO) and its outcomes are not well known. We aimed to evaluate endovascular and clinical outcomes of vertebrobasilar ICAS-LVO patients who underwent EVT. Methods: Consecutive acute stroke patients who underwent EVT for vertebrobasilar LVO were retrospectively reviewed. Patients were assigned to the ICAS (+) or the ICAS (-) group based on angiographical findings. Procedural details and clinical outcomes were compared between the ICAS (+) and ICAS (-) groups. Results: This study included 77 patients with acute vertebrobasilar LVO who underwent EVT. Among the study subjects, 24 (31.2%) had an ICAS-LVO. Recanalization was achieved in 19 patients in the ICAS (+) group (79.2%), which was comparable with the ICAS (-) group (84.9%; p = 0.529). However, recanalization using conventional endovascular modalities (stent retriever thrombectomy, contact aspiration thrombectomy, or intra-arterial urokinase infusion) was less successful in the ICAS (+) group (36.8%) than the ICAS (-) group (100.0%; p < 0.001). All the remaining patients in the ICAS (+) group required specific rescue treatments appropriate for ICAS, including balloon angioplasty, stenting, or intra-arterial glycoprotein IIb/IIIa inhibitor infusion to obtain a successful recanalization. Procedural time was not significantly longer in the ICAS (+) group. The rates of favorable outcomes (37.5% vs. 41.5%; p = 0.740), death, and symptomatic intracerebral hemorrhage were not significantly different between the groups. Conclusion: ICAS-LVO was common in patients who underwent EVT for acute vertebrobasilar LVO. Although conventional modalities were often ineffective for vertebrobasilar ICAS-LVO, a comparable recanalization rate could be obtained with ICAS-specific modalities. Recanalization rate and procedural time were comparable, and clinical outcomes did not differ between patients with or without ICAS-LVO.

Project description:BackgroundRecent randomized trials have suggested that endovascular thrombectomy (EVT) alone may provide similar functional outcomes as the current standard of care, EVT combined with intravenous alteplase treatment, for acute ischemic stroke secondary to large vessel occlusion. We conducted an economic evaluation of these 2 therapeutic options.MethodsWe constructed a decision analytic model with a hypothetical cohort of 1000 patients to assess the cost-effectiveness of EVT with intravenous alteplase treatment versus EVT alone for acute ischemic stroke secondary to large vessel occlusion from both the societal and public health care payer perspectives. We used studies and data published in 2009-2021 for model inputs, and acquired cost data for Canada and China, representing high- and middle-income countries, respectively. We calculated incremental cost-effectiveness ratios (ICERs) using a lifetime horizon and accounted for uncertainty using 1-way and probabilistic sensitivity analyses. All costs are reported in 2021 Canadian dollars.ResultsIn Canada, the difference in quality-adjusted life-years (QALYs) gained between EVT with alteplase and EVT alone was 0.10 from both the societal and health care payer perspectives. The difference in cost was $2847 from a societal perspective and $2767 from the payer perspective. In China, the difference in QALYs gained was 0.07 from both perspectives, and the difference in cost was $1550 from the societal perspective and $1607 from the payer perspective. One-way sensitivity analyses showed that the distributions of modified Rankin Scale scores at 90 days after stroke were the most influential factor on ICERs. For Canada, compared to EVT alone, the probability that EVT with alteplase would be cost-effective at a willingness-to-pay threshold of $50 000 per QALY gained was 58.7% from a societal perspective and 58.4% from a payer perspective. The corresponding values for at a willingness-to-pay threshold of $47 185 (3 times the Chinese gross domestic product per capita in 2021) were 65.2% and 67.4%.InterpretationFor patients with acute ischemic stroke due to large vessel occlusion eligible for immediate treatment with both EVT alone and EVT with intravenous alteplase treatment, it is uncertain whether EVT with alteplase is cost-effective compared to EVT alone in Canada and China.

Dataset Information

The endovascular occlusion system for safe and immediate peripheral vessel occlusion during vascular interventions.

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The endovascular occlusion system for safe and immediate peripheral vessel occlusion during vascular interventions.

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