Browsing by keyword "stent"
Now showing items 1-7 of 7
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Acutely Symptomatic Hypoperfusion Through an Occluded Subclavian to Internal Carotid Artery Bypass Graft: Salvage Mechanical Thrombectomy and Graft RevascularizationThis middle-aged patient had undergone surgical placement of a left subclavian to internal carotid artery bypass graft five years ago for treatment of symptomatic, chronic, bilateral carotid occlusions. The patient was neurologically intact after the procedure and until the day of presentation with symptoms of an acute left anterior circulation stroke. Initial workup confirmed acute occlusion of the graft as the cause of the patient's symptoms. Endovascular recanalization of the bypass graft in the setting of chronic bilateral carotid occlusions was a technical and conceptual challenge. Simultaneous radial and femoral vascular access allowed for direct recanalization of the graft (through thrombectomy, angioplasty, and stent placement) with intraoperative patency surveillance of the circle of Willis via the posterior circulation. Most of the neurological deficits improved, and the patient was discharged to rehabilitation close to neurologic baseline.
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Early postmarket results with PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experienceOBJECTIVE: Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device. METHODS: This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed ( > 30 days after the procedure) complications. RESULTS: A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A1 segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a device-related intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2. CONCLUSIONS: PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist's armamentarium, especially with regard to its off-label use.
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Flow-diverter stents for endovascular management of non-fetal posterior communicating artery aneurysms-analysis on aneurysm occlusion, vessel patency, and patient outcomeBackground Use of flow-diversion technology in the treatment of incidental and recanalized posterior communicating artery (PComA) aneurysms. Methods Patients treated with the Pipeline embolization device (PED) for PComA aneurysms were identified and included in our retrospective analysis. We evaluated aneurysm characteristics, modified Rankin Scale score (mRS) on admission, angiography follow-up, and patient clinical outcome at discharge, at three to nine months, and at 12-18 months. Results We included 56 patients with a mean age of 56 years. Median mRS on admission was 0. All aneurysms involved the PComA and were either new findings or found to have shown recanalization at angiography follow-up from previous coil embolization or surgical clipping. Intraprocedural device foreshortening was observed in one case requiring additional placement of a self-expanding stent. One intraprocedural aneurysm rupture occurred because of a broken distal wire. This patient had an mRS of 4 after the procedure. Three- to nine-month and 12- to 18-month follow-up angiography showed near complete or complete aneurysm occlusion in most cases. Minimal to mild intimal hyperplasia was seen in five cases at three to nine months. PComA patency over time showed 29 of 46 initially patent vessels still patent at six months. Thirteen and seven PComAs showed progressive decrease in flow at three to nine months and 12-18 months, respectively. Median mRS remained 0 for all patients at three- to nine-month and 12- to 18-month follow-up. Conclusions Our preliminary results show that flow-diversion technology is an effective and safe treatment option. Larger studies with long-term follow-up are needed to validate our promising results.
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Intravascular lithotripsy for severely calcified carotid artery stenosis - A new frontier in carotid artery stentingCarotid stenosis due to severely calcified plaque can pose a significant therapeutic challenge. Extremely calcified scars/stenosis plaques can be challenging from an endovascular treatment perspective as severely calcified lesions are prone to technical failure, stent re-coil and restenosis. Intravascular lithotripsy, approved for treatment of severely calcified coronary lesions, can be used for breaking up the calcium build up in the intimal and medial layers of the vessel wall prior to stenting. This was designated as a breakthrough device innovation by the Food and Drug Administration. This new technique addresses the challenge of the disease without compromising patient safety during the procedure. We here report procedural set-up, execution and early patient follow up from our first use of this emerging technology in a neurointerventional practice setting.
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Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomesBACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis > 50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2+/-10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.
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Shear-Activated Nanoparticle Aggregates Combined With Temporary Endovascular Bypass to Treat Large Vessel OcclusionBACKGROUND AND PURPOSE: The goal of this study is to combine temporary endovascular bypass (TEB) with a novel shear-activated nanotherapeutic (SA-NT) that releases recombinant tissue-type plasminogen activator (r-tPA) when exposed to high levels of hemodynamic stress and to determine if this approach can be used to concentrate r-tPA at occlusion sites based on high shear stresses created by stent placement. METHODS: A rabbit model of carotid vessel occlusion was used to test the hypothesis that SA-NT treatment coupled with TEB provides high recanalization rates while reducing vascular injury. We evaluated angiographic recanalization with TEB alone, intra-arterial delivery of soluble r-tPA alone, or TEB combined with 2 doses of intra-arterial infusion of either the SA-NT or soluble r-tPA. Vascular injury was compared against stent-retriever thrombectomy. RESULTS: Shear-targeted delivery of r-tPA using the SA-NT resulted in the highest rate of complete recanalization when compared with controls (P=0.0011). SA-NT (20 mg) had a higher likelihood of obtaining complete recanalization as compared with TEB alone (odds ratio 65.019, 95% confidence interval 1.77, >1000; P=0.0231), intra-arterial r-tPA alone (odds ratio 65.019, 95% confidence interval 1.77, >1000; P=0.0231), or TEB with soluble r-tPA (2 mg; odds ratio 18.78, 95% confidence interval 1.28, 275.05; P=0.0322). Histological analysis showed circumferential loss of endothelium restricted to the area where the TEB was deployed; however, there was significantly less vascular injury using a TEB as compared with stent-retriever procedure (odds ratio 12.97, 95% confidence interval 8.01, 21.02; P<0.0001). CONCLUSIONS: A novel intra-arterial, nanoparticle-based thrombolytic therapy combined with TEB achieves high rates of complete recanalization. Moreover, this approach reduces vascular trauma as compared with stent-retriever thrombectomy.
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Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS RegistryBACKGROUND AND PURPOSE: Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials. METHODS: STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis. RESULTS: A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab-adjudicated modified Thrombolysis in Cerebral Infarction > /=2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2. CONCLUSIONS: This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.
