Abstract In-stent stenosis has a reported prevalence of 14% to 19% at 1-yr follow-up after carotid stenting and is associated with an increased risk of acute ischemic stroke. 1,2 Risk factors include female sex, diabetes, and dyslipidemia. Cutting balloon angioplasty is a safe and effective treatment modality for the treatment of carotid in-stent stenosis, and alternative treatment options include observation with medical management and placement of another stent. 3,4 The authors present the case of a 61-yr-old man with carotid in-stent restenosis and progressive worsening on serial imaging with ultrasound. The patient had a history of carotid stenting for symptomatic stenosis 6 mo prior and was maintained on aspirin and clopidogrel. In light of the progressive worsening, the in-stent stenosis was confirmed on computed tomography (CT) angiogram. The options were discussed with the patient and he consented for treatment with cutting balloon angioplasty. Final angiogram showed improvement of the luminal diameter with a residual stenosis of 15%. The patient tolerated the procedure well and was discharged home on postoperative day 1. Follow-up ultrasound demonstrated moderate improvement in peak systolic velocities, and the plan is to continue observation with a clinical follow-up and repeat carotid Dopplers at 3 mo.
Object The use of flow-diverting stents has gained momentum as a curative approach in the treatment of complex proximal anterior circulation intracranial aneurysms. There have been some reported attempts of treating formidable lesions in the posterior circulation. Posterior circulation giant fusiform aneurysms have a particularly aggressive natural history. To date, no one approach has been shown to be comprehensively effective or low risk. The authors report the initial results, including the significant morbidity and mortality encountered, with flow diversion in the treatment of large or giant fusiform vertebrobasilar aneurysms at Millard Fillmore Gates Circle Hospital. Methods The authors retrospectively reviewed their prospectively collected endovascular database to identify patients with intracranial aneurysms who underwent treatment with flow-diverting devices and determined that 7 patients had presented with symptomatic large or giant fusiform vertebrobasilar aneurysms. The outcomes of these patients, based on the modified Rankin Scale (mRS), were tabulated, as were the complications experienced. Results Among the 7 patients, Pipeline devices were placed in 6 patients and Silk devices in 1 patient. At the last follow-up evaluation, 4 patients had died (mRS score of 6), all of whom were treated with the Pipeline device. The other 3 patients had mRS scores of 5 (severe disability), 1, and 0. The deaths included posttreatment aneurysm ruptures in 2 patients and lack of improvement in neurological status related to presenting brainstem infarcts and subsequent withdrawal of care in the other 2 patients. Conclusions Whether flow diversion will be an effective strategy for treatment of large or giant fusiform vertebrobasilar aneurysms remains to be seen. The authors' initial experience suggests substantial morbidity and mortality associated with the treatment and with the natural history. As outcomes data slowly become available for patients receiving these devices for fusiform posterior circulation aneurysms, practitioners should use these devices judiciously.
INTRODUCTION: Poor outcomes for glioblastoma (GBM) are partly due to the inability to deliver therapeutic agents to the tumor because of the blood brain barrier (BBB) as well as ineffective agents. We have evaluated bone marrow-derived mesenchymal stem cells (MSCs) as transport vehicles of biological therapeutics, particularly Delta-24-RGD (D24), an engineered tumor-selective oncolytic adenovirus that replicates and lyses only in human tumor cells. In mice, we have shown that MSCs loaded with D24 (MSCs-D24) home to GBMs after intra-arterial (IA) carotid infusion, resulting in widespread distribution in the tumor and oncolysis. Intravenous infusion is ineffective, rendering IA delivery the only effective systemic option. To understand the applicability of IA infusions of MSCs-D24 requires a large animal, human brain tumor model recapitulating the challenges of clinical use. METHODS: Rabbits underwent stereotactic xenoimplantation of human GBM cell lines. Tumor creation was confirmed on magnetic resonance imaging (MRI), histologic and immunohistochemistry analysis. Selective internal carotid artery MSCs-D24 infusion ipsilateral to the tumor was performed assess efficacy and safety. RESULTS: We report on successful xenoimplantation of human glioblastoma cell lines (U87, GSC17, and GSC8-11) in 28 immunosuppressed rabbits using Mycophenolate Mofetil, Dexamethasone, and Tacrolimus. The implanted rabbits were followed for 35 days prior to tumor assessment with MRI, angiography, and histological analysis. On MRI, the tumors were hyperintense on T2-weighted image and enhanced (evidence of BBB breakdown). On histological analysis, tumors showed phenotypic traits of human GBM and display varying levels of vascularity, an important feature for testing IA therapy. Selective internal carotid artery MSCs-D24 infusion was safe in the model, and MSCs-D24 homed to the implanted tumor at 24 hours. CONCLUSIONS: The intracranial immunosuppressed rabbit human GBM model allows testing of ESIA infusion of novel therapeutics (eg. MSCs-D24) in a clinically relevant fashion.
To the Editor: COVID-19 syndrome, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, most commonly presents with upper respiratory infectious symptoms and may lead to hypoxemic failure, the most common cause of ventilation support.1-5 There may be a hypercoagulable state during SARS-CoV-2 infections that could lead to an increased vascular thrombotic phenomenon and a potential need for neurointerventional procedures.6-8 We aim to outline practices to be considered when managing COVID-19 patients requiring neurointerventional care. GENERAL PLANNING Given the number of SARS-CoV-2 infections within the community, patients presenting with neurological emergencies needing immediate interventional therapy will not be able to be tested in time, and thus such patients should be considered as persons under investigation (PUIs) for SARS-CoV-2 viral infection.4 Care of such patients should be performed with maximal personal protective equipment (PPE), including N95 masks.9,10 All patients needing emergent neurointerventional procedures should be considered PUIs. Maximal PPE should be employed when performing emergent neurointerventional procedures on COVID-19 or PUI patients. Personnel It is ideal to minimize the number of neurointerventional radiology (NIR) attendings, fellows, nurses, and technologists who are in-house at any one time to minimize personnel exposure to SARS-CoV-2.11 This is feasible with a general trend towards canceling elective procedures during the pandemic. Members of the NIR team need to be appropriately fitted with the N95 mask and be aware as to how to obtain all appropriate PPE as N95s may be stored in secure environments. Those who have facial hair or cannot tolerate an N95 must be trained to use a powered air purifying respirator (PAPR) or follow alternative institutional protocols. One can reuse the N95 for up to 8 h without an outer cover; however, when a face mask is worn over the N95 to prevent gross contamination, its reuse can be extended. During cases it is imperative that team members within the NIR suite restrict their movement and not enter clean areas until the procedure is completed and they have doffed their PPEs appropriately. This will necessitate that a member of the team be placed in the clean control room to obtain the equipment necessary during the procedure. The number of NIR personnel within the hospital setting should be minimal. All team members must be fitted appropriately with N95 masks. An outer standard surgical mask should be worn over the N95 to prolong the shelf life of the N95. NIR personnel should be divided as such to prevent the movement of NIR suite personnel to clean areas. NIR Suite and Control Room NIR suites are typically positive-pressure areas to minimize outside infectious contaminants and prevent procedure-related infections; however, this also increases the risk of spreading aerosolized respiratory secretions from COVID-19 patients. Reports from Singapore and New York University share the idea of converting COVID-designated NIR suites into negative-pressure areas with high efficiency particulate air (HEPA) filters, thus reducing the risk of contaminating air flow systems and minimizing the exposure of clean areas to infectious particulate matter. While there may be a theoretical risk of increasing surgical site infections (SSIs) in a negative-pressure environment, this may be outweighed by the benefits of minimizing the exposure of clean areas to infectious matter.12 If a facility has 2 NIR suites, one should become the designated suite for COVID+/PUI patients and the other for documented COVID-19-negative patients. The inventory in the COVID-19-designated suite should remain in closed storage closets at all times, or a barrier such as plastic sheets could be secured to cover the inventory. Infrequently used inventory should be removed from the suite and could be stored in the control room or an adjacent anteroom. In addition, you must determine if the control room attached to the COVID NIR suite can be maintained as a clean environment. This can be done if the pressure of the control room can be changed to be higher than that of the NIR suite. If this can be achieved, then portable material within the NIR suite can be moved to the control room. If the control room cannot be maintained as a clean environment, then it is ideal to move nonessential portable equipment from the control room, as it also may require a terminal clean. All COVID-contaminated areas (NIR suite and possibly the control room) will need terminal cleaning from ceiling to floor, including the lights and air ducts. Designate one NIR suite as COVID NIR and remove all portable equipment that may get contaminated. Predetermine supplies needed for the NIR case and take those to COVID NIR. Keep the clean control room entrance to the COVID NIR room closed at all times during the procedure. Maintain 1 team member in the NIR control room to seek needed supplies. Anteroom An anteroom serves as a gateway from the COVID-designated NIR suite to the halls, preventing infectious particulate matter from reaching the halls.13 The anteroom is a small area outside of the NIR suite under negative pressure and fitted with a HEPA filter allowing for personnel to remove their PPE and wash hands before entering a clean area. The negative pressure within the anteroom prevents contaminated particulate matter from traveling to other parts of the hospital. Most NIR suites may not have an attached anteroom, thus engineering staff should be contacted to build a portable anteroom for the COVID NIR suite. Build an anteroom attached to the COVID-NIR suite to prevent contamination of adjacent clean areas. PREOPERATIVE, OPERATIVE, AND POSTOPERATIVE BEST PRACTICES Transfer from emergency department (ED) to NIR Room All nonintubated patients being transported should have a face mask in place. For an intubated patient, it is safest to maintain a closed circuit until after the procedure is concluded. If that is not possible, extreme caution must be taken while clamping the tube when transferring from bagging to ventilator, or ideally the patient may remain on a single ventilator from ED until after treatment, when the ventilator can be changed in a negative-pressure setting. All personnel working with COVID-19 patients should have maximal PPE. A face mask should be placed on all nonintubated patients during transport. Endotracheal tubes should be clamped before transferring to ventilator. Intubation and Procedure With most NIR emergencies (subarachnoid hemorrhage, carotid blow out, epistaxis, etc), intubation becomes essential for the protection of the airway; however, with large vessel occlusion (LVO)-related ischemic stroke, there continues to be a lack of guidance for the best practice. If intubation is to be performed, it should ideally be performed in a negative-pressure environment to minimize the contamination of adjacent areas and personnel, and hypotension should be avoided in stroke patients.14 If intubation must be performed in the NIR suite, then only anesthesia staff donning appropriate PPE should be present within the room, and postintubation a barrier around the patient's face should be applied to contain aerosolization.15 Before entering the NIR suite, you should wait for a period of time (determined by your engineering team) to minimize aerosolized particulate matter within the NIR environment; however, such delays will not be ideal in cases of LVO-related stroke patients. If a negative-pressure room is available, full recirculation time is typically around 3 min, so staff may re-enter the room within 5 min. Other centers have not changed their anesthesia/intubation paradigms secondary to the COVID status. In these circumstances, patients remain on nasal cannula O2 with a face mask, and there is not a need to extubate, which is the largest producer of aerosolized matter. Thus, performing thrombectomies without intubation allows for the avoidance of intubation and extubation (highest risk of aerosolization), risk of patient continuing to be intubated and requiring ventilator and intensive care unit (ICU) room, and prolonged recovery times. Intubation and extubation lead to maximal aerosolization and contamination. Intubation and extubation should ideally be performed in negative-pressure rooms. NIR personnel should not be present for intubations/extubations. NIR should enter with appropriate PPE once airway is secure and patient face barrier is in place. Extubation and Transfer to Final Destination While it is ideal if resources allow for the transport of an intubated patient into a negative-pressure room to extubate, this may be unlikely given the rise in the COVID patient population requiring critical care services and negative-pressure rooms. Thus, if possible, extubate the patient within the NIR environment under the same conditions as described for intubation. Once the patient is extubated and has stopped coughing, it is ideal to transport to the final destination rather than an intermediary stop within the postanesthesia care unit (PACU). This will minimize contamination during transport and minimize the number of healthcare personnel exposed. For those patients not intubated, extubation is avoided; however, they should also be transported to the final destination with a face mask and without stopping in a PACU environment. Flat-panel detector computed tomography (CT) scanning capabilities of modern angiographic equipment may also reduce the need to transport to postprocedure CT. Extubate with a minimal number of surrounding personnel (must use N95s). Transfer the patient to the final destination rather than an intermediary location (PACU). Terminal clean the COVID NIR suite. CONCLUSION The COVID-19 pandemic is affecting most regions of the United States, necessitating a change in our practice patterns. We have outlined general principles to be taken into consideration as neurointerventional teams look to care for their patients while preventing the exposure of other patients as well as healthcare personnel. Disclosures The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article.
OBJECTIVE This study was conducted to investigate the impact of antiplatelet administration in the periprocedural period on the occurrence of thromboembolic complications (TECs) in patients undergoing treatment using the Woven EndoBridge (WEB) device for intracranial wide-necked bifurcation aneurysms. The primary objective was to assess whether the use of antiplatelets in the pre- and postprocedural phases reduces the likelihood of developing TECs, considering various covariates. METHODS A retrospective multicenter observational study was conducted within the WorldWideWEB Consortium and comprised 38 academic centers with endovascular treatment capabilities. Univariable and multivariable logistic regression analyses were performed to determine the association between antiplatelet use and TECs, adjusting for covariates. Missing predictor data were addressed using multiple imputation. RESULTS The study comprised two cohorts: one addressing general thromboembolic events and consisting of 1412 patients, among whom 103 experienced TECs, and another focusing on symptomatic thromboembolic events and comprising 1395 patients, of whom 50 experienced symptomatic TECs. Preprocedural antiplatelet use was associated with a reduced likelihood of overall TECs (OR 0.32, 95% CI 0.19–0.53, p < 0.001) and symptomatic TECs (OR 0.49, 95% CI 0.25–0.95, p = 0.036), whereas postprocedural antiplatelet use showed no significant association with TECs. The study also revealed additional predictors of TECs, including stent use (overall: OR 4.96, 95% CI 2.38–10.3, p < 0.001; symptomatic: OR 3.24, 95% CI 1.26–8.36, p = 0.015), WEB single-layer sphere (SLS) type (overall: OR 0.18, 95% CI 0.04–0.74, p = 0.017), and posterior circulation aneurysm location (symptomatic: OR 18.43, 95% CI 1.48–230, p = 0.024). CONCLUSIONS The findings of this study suggest that the preprocedural administration of antiplatelets is associated with a reduced likelihood of TECs in patients undergoing treatment with the WEB device for wide-necked bifurcation aneurysms. However, postprocedural antiplatelet use did not show a significant impact on TEC occurrence.
INTRODUCTION: Stroke is the leading cause of adult disability and the fifth leading cause of mortality in the United States. Despite the study of many neuroprotective agents for acute ischemic stroke, none has been shown to be effective in large randomized clinical trials. Steroid receptor coactivator (SRC) is a promising class of agents since they are involved in cellular proliferation and regeneration, immune modulation, angiogenesis, antioxidant protection and are expressed in the brain. METHODS: Twenty c57bl/6 mice were randomly assigned to control or treatment groups (n = 10 mice per group). All mice underwent middle cerebral artery occlusion for 90 minutes followed by reperfusion via the intraluminal filament method. Occlusion was confirmed by laser doppler flowmetry. Intraperitoneal injections of saline (control) or 10-1 (treatment) were given 30 minutes after reperfusion. Each animal was tested using a modified Bederson’s neurological deficit scale (mNDS) and euthanized at the conclusion of the 24-hour survival period. Brain slices were stained with 2,3,5- triphenyltetrazolium chloride (TTC) to identify ischemic brain tissue. RESULTS: When compared with the control group, 10-1 treated mice showed significantly lower mNDS scores (p = 0.000336) and incidence of circling (p = 0.00256). Calculated infarct volumes, based on TTC staining, of the 10-1 treated group were significantly lower (p = 0.0009) when compared to the control group. CONCLUSIONS: We have shown that 10-1 is a promising therapeutic agent and provides substantial neuroprotection through its many multicellular processes in a rodent study. Current studies are being conducted to investigate the mechanism of 10-1 as neuroprotectant.
Introduction: Surpass™ Flow Diverter was developed to treat large or giant wide-neck intracranial aneurysms (IA) not amenable to surgical or current standard endovascular treatment due to location, morphology, or known treatment challenges. FDA approved on July 13 2018, Surpass™ fulfills an unmet clinical need. Indications for Use allow for placement in the entire intracranial internal carotid artery (ICA). Surpass™ is available in diameters of 3 to 5 mm and lengths of 15 to 50 mm. Methods: SCENT Trial is an international, multi-center, prospective, non-randomized trial comparing the outcomes of Surpass™ Flow Diverter treatment to historical control. It is designed to evaluate the safety and efficacy of Surpass™ for treatment of wide-neck (≥4mm), large or giant IA ≥10 mm in size. The primary safety endpoint is the percent of subjects experiencing neurologic death or major ipsilateral stroke at 12 months. The primary effectiveness endpoint is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (≤50% stenosis) of the parent artery, and any retreatment of the target aneurysm at 12-month. Results: From 2012 to 2015, 180 subjects were treated at 26 sites. Mean age was 61.0 years and 91.7% (165/180) were females. Aneurysms were most frequently located in the carotid-ophthalmic segment (33.3%; 60/180), followed by the cavernous segment (28.9%; 52/180), posterior communicating artery (21.1%; 38/180), supraclinoid carotid artery (11.1%; 20/180), superior hypophyseal artery (3.3%; 6/180), and the petrous segment (2.2%; 4/180). Mean aneurysm dimension included dome height 13.4±5.7 mm. Mean neck width was 6.7 mm. Technical success occurred in 97.8% (176/180) of subjects while the mean number of Surpass™ devices used was 1.1 per procedure, with 86.7% (156/180) of aneurysms treated with a single flow diverter. The 12-month primary effectiveness rate was 62.8% [(113/180), 95% CI 55.3, 69.9] and 12-month major ipsilateral stroke or neurological death rate of 10.6% [(19/180), 95% CI 55.3, 69.9] Conclusions: Surpass™ Flow Diverter is safe and effective to treat large and giant aneurysms intracranial internal carotid aneurysms.
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