Midterm follow-up after embolization of intracranial aneurysms proximal to the circle of Willis with the Silk Vista flow diverter: the I-MAMA registry.

PURPOSE: The aim of this registry was to assess technical success, procedural safety and mid- to long-term follow-up results of the Silk Vista "Mama" (SVM) flow diverter (BALT, Montmorency, France) for the treatment of proximal intracranial aneurysms. METHODS: Between August 2020 and March 2022, data from nine Italian neurovascular centres were collected. Data included patients' clinical presentation, aneurysms' size, location and status, technical details, overall complications and mid- to long-term angiographic follow-up. RESULTS: Forty-eight aneurysms in 48 patients were treated using the SVM. Most aneurysms were small (≤ 10 mm: no. 29, 60%) and unruptured (no. 31, 65%); 13 aneurysms were recurrent after coiling or clipping. 37/48 aneurysms involved the internal carotid artery (77%). Optimal opening and complete wall apposition of the device were achieved in 46 out of 48 cases (96%). Four intra- or periprocedural complications occurred (two thrombotic complications successfully resolved, one cerebellar ischemia, one perirenal hematoma), without new neurological deficit. No significant intra-stent stenosis or stent displacement was observed during follow-up. No FD-related morbidity nor mortality was reported. At midterm (6-12 months) to long-term (> 12 months) follow-up, complete aneurysm occlusion (OKM D) was achieved in 76% of cases. Eighty-eight percent of patients had complete aneurysm occlusion or entry remnant (OKM D + C). CONCLUSIONS: Our experience suggests that the new generation of low-profile SVM flow diverter for the treatment of proximal intracranial aneurysms is safe and effective, with low rates of intraprocedural complications and acceptable mid- to long-term occlusion rate.

Stress hyperglycemia is associated with futile recanalization in patients with anterior large vessel occlusion undergoing mechanical thrombectomy.

INTRODUCTION: Mechanical thrombectomy (MT) is the standard treatment for acute ischemic stroke (AIS) due to anterior large vessel occlusion (LVO). Despite successful recanalization, some patients remain disabled after 3 months. Mechanisms that can cause futile recanalization (FR) are still largely unknown. We investigated if stress hyperglycemia might be associated with FR. PATIENTS AND METHODS: This is a retrospective analysis of consecutive patients with successful recanalization treated in four participating centers between January 2021 and December 2022. According to the modified Rankin scale (mRS) status at 3 months, patients were divided into two groups: FR, if mRS score >2, and useful recanalization (UR), if mRS score ⩽2. Stress hyperglycemia was estimated by the glucose-to-glycated hemoglobin ratio (GAR) index. RESULTS: A total of 691 subjects were included. At 3 months, 403 patients (58.3%) were included in the FR group, while the remaining 288 patients (41.7%) were included in the UR group. At the multivariate analysis, variables independently associated with FR were the following: age (OR 1.04, 95% CI 1.02-1.06, p < 0.001), GAR index (OR 1.08, 95% CI 1.03-1.14, p = 0.003), NIHSS at admission (OR 1.16, 95% CI 1.11-1.22; p < 0.001), and procedure length (OR 1.01, 95% CI 1.00-1.02; p = 0.009). We observed that the model combining age, GAR index, NIHSS at admission, and procedure length had good predictive accuracy (AUC 0.78, 95% CI 0.74-0.81). CONCLUSIONS: Stress hyperglycemia predicts FR in patients with successful recanalization after MT. Further studies should explore if managing stress hyperglycemia may reduce futile recanalization. Additionally, we recommend paying close attention to AIS patients with a GAR index greater than 24.8 who exhibit a high risk of FR.

Stress hyperglycemia as a modifiable predictor of futile recanalization in patients undergoing mechanical thrombectomy for acute ischemic stroke.

Introduction: Mechanical thrombectomy (MT) is the first line treatment in acute ischemic stroke (AIS) due to large vessel occlusion (LVO). Approximately half of patients treated with MT does not have a favorable outcome 3 months after stroke. The aim of this study was to identify predictors of futile recanalization (FR) in patients with LVO treated with MT. Methods: A retrospective analysis of consecutive patients with acute ischemic stroke due to anterior circulation LVO who underwent MT. Patients with a TICI score of 2b or 3 were included. We distinguished two groups, FR and meaningful recanalization (MR), according to patients' disability three months after stroke (FR: mRS score > 2; MR: mRS score < 2). Results: We enrolled 238 patients (FR, n = 129, 54.2%; MR, n = 109, 45.8%). Age (OR 1.05, 95% CI 1.01-1.09, p = 0.012), female sex (OR 2.43, 95% CI 1.12-5.30, p = 0.025), stress hyperglycemia, as measured by the GAR index, (OR 1.17, 95% CI 1.06-1.29, p = 0.002), NIHSS at admission (OR 1.15, 95% CI 1.07-1.25, p = 0.001) and time from symptoms onset to MT (OR 1.01, 95% CI 1.00-1.01, p = 0.020) were independent predictors of FR. The AUC for the model combining age, female sex, GAR index, NIHSS at admission and time from symptoms onset to MT was 0.81 (95% CI 0.76-0.87; p < 0.001). The optimal GAR index cut-off score to predict FR was 17.9. Discussion: FR is common after MT. We recognized older age, female sex and baseline NIHSS as non-modifiable predictors of FR. On the other hand, time from symptoms onset to MT and stress hyperglycemia were modifiable pre- and post-MT factors, respectively. Any effort should be encouraged to reduce the impact of these modifiable predictors.

Hyperdense middle cerebral artery sign predicts favorable outcome in patients undergoing mechanical thrombectomy.

Non-contrast computer tomography detects the presence of hyperdense middle cerebral artery sign (HMCAS). Studies on the prognostic value of HMCAS among patients undergoing mechanical thrombectomy (MT) are conflicting. A retrospective analysis of consecutive patients with acute ischemic stroke due to middle cerebral artery occlusion, presenting with or without HMCAS, who underwent MT, was performed. We enrolled 191 patients (HMCAS +, n = 140; HMCAS -, n = 51). Prevalence of successful recanalization was significantly higher in patients with HMCAS than in those without HMCAS (92.1% versus 74.5%, p = 0.001). Patients with HMCAS had a better clinical outcome than those HMCAS - (54.3% versus 37.3%, p = 0.037, for three-month favorable outcome; 62.9% versus 39.3%, p = 0.004, for major neurological improvement at discharge; 8.6% versus 19.6%, p = 0.035, for in-hospital mortality; 14.3% versus 27.5%, p = 0.035, for intracranial hemorrhage; 2.9% versus 17.6%, p = 0.001, for symptomatic intracranial hemorrhage). Multivariate analyses confirmed that HMCAS represents an independent predictor of three-month favorable outcome (OR 2.48, 95% CI 1.10-5.58, p = 0.028), major neurological improvement at discharge (OR 2.40, 95% CI 1.09-5.20, p = 0.030), in-hospital mortality (OR 0.29, 95% CI 0.010-0.81, p = 0.018), presence of ICH (OR 0.49, 95% CI 0.25-0.97, p = 0.042) and presence of SICH (OR 0.16, 95% CI 0.04-0.63, p = 0.009). HMCAS presence predicts favorable outcome in patients undergoing MT. This result may indicate that hyperdense clots are more likely to respond to MT than isodense ones. This effect is mediated by reduction in hemorrhagic transformation.

Silk Vista Baby flow diverter stent for ruptured intracranial aneurysms: a retrospective observational study.

PURPOSE: Flow diversion changed the approach to complex intracranial aneurysms, leading to a widespread use and a rapid technological evolution. Indeed, indications continued to expand, including ruptured intracranial aneurysms in selected cases. Recently, new devices have been designed specifically to target smaller vessels. Therefore, we conducted a multicenter study to evaluate clinical outcome, complications, and occlusion rate of patients with ruptured aneurysms treated with new generation low profile Silk Vista Baby (SVB) flow diverter stent (FD). METHODS: We performed a retrospective observational study on consecutive patients who underwent treatment with SVB for ruptured aneurysms at 12 Italian centers. Primary end point was favorable clinical outcome rate, defined as modified ranking score (mRS) of 0-2 at the 3 months. Secondary outcomes were complication rate, aneurysm re-rupture, and complete aneurysm occlusion at last radiological follow-up. RESULTS: Twenty-five patients were included; at 3 months' follow-up, 19 patients (79.1%) had favorable clinical outcome (mRS 0-2). Three patients (12.5%) died during follow-up. In-stent thrombosis occurred in two cases (8.3%), managed with glycoprotein IIb/IIIA and intra-stent angioplasty, without clinical consequences. In 18 (85.7%) patients, complete occlusion at 3 months was demonstrated. No rebleeding occurred during follow-up. Presentation with unfavorable World Federation of Neurosurgical Societies grading system (WFNS) and posterior circulation location were both significantly correlated with unfavorable clinical outcome (p = 0.005 and p = 0.02). CONCLUSIONS: Our data suggests that low profile FD treatment of ruptured intracranial aneurysms located distally of the circle of Willis is feasible. New generation low profile FD may represent an alternative option in carefully selected cases.

Silk Vista Baby Is a Safe and Technically Feasible Flow Diverting Stent for Distal Aneurysm Treatment.

Background and Purpose: Flow diverting stents are designed to divert blood flow from the aneurysm sac, allowing for eventual occlusion following endovascular therapy. This case series reports clinical experience using the Silk Vista Baby (SVB, Balt Extrusion, Montmorency, France), a flow diverter (FD) designed to treat intracranial aneurysms in small, distal vessels. Methods: All patients who underwent treatment with SVB at the University Hospital "Santa Maria della Misericordia" of Udine between July 2018 and September 2020 were retrospectively identified. Baseline patient and aneurysm characteristics, intraprocedural technical outcomes, periprocedural complications, modified Rankin Scale (mRS) at discharge, magnetic resonance imaging (MRI) results at 3-month follow-up, and angiographic results at 6-month follow-up were collected. Results: A total of 18 patients (55.6% [10/18] male; mean age 62.6 years, range: 42-77 years) were retrospectively identified, receiving treatment for 22 aneurysms. Most patients were symptomatic (14/18, 77.8%) and approximately half had subarachnoid hemorrhage (10/18, 55.6%). Sufficient aneurysm coverage was achieved in 88.9% (16/18) of patients with a single device. Mortality did not occur (0/18, 0%); adverse device-related events included side branch occlusion (1/18, 5.6%) and in-stent thrombosis (1/18, 5.6%). At discharge, 77.8% (14/18) had an mRS of 0. In most cases, patients showed complete occlusion (10/15, 66.7%) or a small aneurysmal remnant (3/15, 20.0%) upon MRI; upon angiography, most showed complete occlusion (10/13, 76.9%) or only a small aneurysmal remnant (2/13, 15.4%). Conclusion: This case series showed that the SVB FD is safe and feasible to use in patients with aneurysms in small, distal vessels. Additional randomized, prospective studies with larger cohorts are needed for the SVB.

First multicenter experience using the Silk Vista flow diverter in 60 consecutive intracranial aneurysms: technical aspects.

BACKGROUND: The aim of this study was to assess the technical success and procedural safety of the new Silk Vista device (SV) by evaluating the intraprocedural and periprocedural complication rate after its use in several institutions worldwide. METHODS: The study involved a retrospective review of multicenter data regarding a consecutive series of patients with intracranial aneurysms, treated with the SV between September 2020 and January 2021. Clinical, intra/periprocedural and angiographic data, including approach, materials used, aneurysm size and location, device/s, technical details and initial angiographic aneurysm occlusion, were analyzed. RESULTS: 60 aneurysms were treated with SV in 57 procedures. 66 devices were used, 3 removed and 63 implanted. The devices opened instantaneously in 60 out of 66 (91%) cases and complete wall apposition was achieved in 58 out of 63 (92%) devices implanted. In 4 out of 66 (6%) devices a partial opening of the distal end occurred, and in 5 (8%) devices incomplete apposition was reported. There were 3 (5%) intraprocedural thromboembolic events managed successfully with no permanent neurological morbidity, and 4 (7%) postprocedural events. There was no mortality in this study. The initial occlusion rates in the 60 aneurysms were as follows: O'Kelly-Marotta (OKM) A in 34 (57%) cases, OKM B in 15 (25%) cases, OKM C in 6 (10%) cases, and OKM D in 5 (8%) cases. CONCLUSIONS: Our study demonstrated that the use of the new flow diverter Silk Vista for the treatment of intracranial aneurysms is feasible and technically safe.

Indirect Flow Diversion for Off-Centered Bifurcation Aneurysms and Distant Small-Vessel Aneurysms, a Retrospective Proof of Concept Study From Five Neurovascular Centers.

Background: Treatment of cerebral aneurysms using hemodynamic implants such as endosaccular flow disruptors and endoluminal flow diverters has gained significant momentum during recent years. The intended target zone of those devices is the immediate interface between aneurysm and parent vessel. The therapeutic success is based on the reduction of aneurysmal perfusion and the subsequent formation of a neointima along the surface of the implant. However, a subset of aneurysms-off-centered bifurcation aneurysms involving the origin of efferent branches and aneurysms arising from peripheral segments of small cerebral vessels-oftentimes cannot be treated via coiling or implanting a hemodynamic implant at the neck level for technical reasons. In those cases, indirect flow diversion-a flow diverter deployed in the main artery proximal to the parent vessel of the aneurysm-can be a viable treatment strategy, but clinical evidence is lacking in this regard. Materials and Methods: Five neurovascular centers contributed to this retrospective analysis of patients who were treated with indirect flow diversion. Clinical data, aneurysm characteristics, anti-platelet medication, and follow-up results, including procedural and post-procedural complications, were recorded. Results: Seventeen patients (mean age: 60.5 years, range: 35-77 years) with 17 target aneurysms (vertebrobasilar: n = 9) were treated with indirect flow diversion. The average distance between the flow-diverting stent and the aneurysm was 1.65 mm (range: 0.4-2.4 mm). In 15/17 patients (88.2%), perfusion of the aneurysm was reduced immediately after implantation. Follow-ups were available for 12 cases. Delayed opacification (OKM A3: 11.8%), reduction in size (OKM B1-3: 29.4%) and occlusion (D1: 47.1%) were observable at the latest investigation. Clinically relevant procedural complications and adverse events in the early phase and in the late subacute phase were not observed in any case. Conclusion: Our preliminary data suggest that indirect flow diversion is a safe, feasible, and effective approach to off-centered bifurcation aneurysms and distant small-vessel aneurysms. However, validation with larger studies, including long-term outcomes and optimized imaging, is warranted.

Dynamic Hyperglycemic Patterns Predict Adverse Outcomes in Patients with Acute Ischemic Stroke Undergoing Mechanical Thrombectomy.

BACKGROUND: Admission hyperglycemia impairs outcome in acute ischemic stroke (AIS) patients undergoing mechanical thrombectomy (MT). Since hyperglycemia in AIS represents a dynamic condition, we tested whether the dynamic patterns of hyperglycemia, defined as blood glucose levels > 140 mg/dl, affect outcomes in these patients. METHODS: We retrospectively analyzed data of 200 consecutive patients with prospective follow-up. Based on blood glucose level, patients were distinguished into 4 groups: (1) persistent normoglycemia; (2) hyperglycemia at baseline only; (3) hyperglycemia at 24-h only; and (4) persistent (at baseline plus at 24-h following MT) hyperglycemia. RESULTS: AIS patients with persistent hyperglycemia have a significantly increased risk of poor functional outcome (OR 6.89, 95% CI 1.98-23.94, p = 0.002, for three-month poor outcome; OR 11.15, 95% CI 2.99-41.52, p = 0.001, for no major neurological improvement), mortality (OR 5.37, 95% CI 1.61-17.96, p = 0.006, for in-hospital mortality; OR 4.43, 95% CI 1.40-13.97, p = 0.01, for three-month mortality), and hemorrhagic transformation (OR 6.89, 95% CI 2.35-20.21, p = 0.001, for intracranial hemorrhage; OR 5.42, 95% CI 1.54-19.15, p = 0.009, for symptomatic intracranial hemorrhage) after endovascular treatment. These detrimental effects were partially confirmed after also excluding diabetic patients. The AUC-ROC showed a very good performance for predicting three-month poor outcome (0.76) in-hospital mortality (0.79) and three-month mortality (0.79). CONCLUSIONS: Our study suggests that it is useful to perform the prolonged monitoring of glucose levels lasting 24-h after MT.

Prior Use of Antiplatelet Therapy and Outcomes after Endovascular Therapy in Acute Ischemic Stroke Due to Large Vessel Occlusion: A Single-Center Experience.

Endovascular therapy (EVT) represents the gold standard treatment in patients affected by acute ischemic stroke (AIS) due to large vessel occlusion (LVO). Prior antiplatelet (APT) therapy might increase the risk of bleeding and modify the clinical outcome of AIS patients treated with EVT. Thus, we compared effectiveness and safety of EVT in Caucasian patients with and without previous use of APT agents. We recruited consecutive patients admitted to Udine University Hospital with AIS undergoing EVT from January 2015 to December 2017. The following outcomes were documented: successful recanalization, 3-month favorable outcome, symptomatic intracranial hemorrhage (sICH), parenchymal hematoma (PH), and 3-month mortality. The study population included 100 patients (mean age 70.1 ± 11.2 years, 58% males). At time of admission, 34 patients were taking APT agents. Patients on APT pretreatment were older, had more vascular risk factors, and showed higher levels of serum creatinine than APT naïve patients. Moreover, prior APT therapy was associated with a higher rate of pre-stroke disability and a more severe stroke at admission. Patients pretreated with APT had higher rates of successful recanalization (91.2% vs. 74.2%, p = 0.04). Prevalence of 3-month unfavorable outcome and 3-month mortality was significantly higher in APT-pretreated patients than in those without APT pretreatment. However, these associations were not confirmed on multivariable analyses. Prevalence of sICH and PH did not differ in the two groups. APT pretreatment is associated to successful recanalization rate, without increasing the risk of intracranial bleeding in patients with LVO undergoing EVT.

Giant vertebral aneurysm: A case report detailing successful treatment with combined stenting and surgery.

BACKGROUND: Giant aneurysms (>25 mm) arising from the vertebral artery (VA) often present with slow progression of symptoms and signs because of gradual brainstem and cranial nerve compression. The underlying pathophysiology is not well understood, and treatment, wherever possible, is tailored to each singular case. Endovascular management does not usually solve the problem of mass compression, whereas surgical treatment involves several complications. CASE DESCRIPTION: A 58-year-old woman presented with a continuously growing giant right VA aneurysm, partially thrombosed, even after endovascular treatment (placement of two diversion flow stents). Operative partial aneurysmectomy and intraoperative placement of an endovascular balloon allowed removal from circulation without significant bleeding with a good neurological outcome. CONCLUSIONS: The variability of VA thrombosed giant aneurysms implies a customized therapeutic strategy. Combined endovascular techniques and surgical clipping allow safe and successful trapping and aneurysmectomy. This case highlights the benefits of treating similar pathologies with a combination of both techniques.

Short and long-term outcomes after combined intravenous thrombolysis and mechanical thrombectomy versus direct mechanical thrombectomy: a prospective single-center study.

Recent clinical trials demonstrated that mechanical thrombectomy (MT) using second-generation endovascular devices has beneficial effects in acute ischemic stroke (AIS) due to large vessel occlusion (LVO). However, it remains controversial if intravenous thrombolysis (IVT) prior to MT is superior compared to direct mechanical thrombectomy (DMT). The aims of this study were to compare short and long-term outcomes between IVT + MT and DMT patients. We prospectively recruited AIS patients with LVO in the anterior or posterior circulation eligible for MT with and without prior IVT. Modified Rankin Scale (mRS) and mortality were assessed at baseline, at discharge, 90-days and 1-year after stroke. Favorable outcome was defined as a mRS score ≤2. Of the 66 patients included, 33 (50%) were in IVT + MT group and 33 (50%) were in DMT group. Except for a higher prevalence of patients using anticoagulants at admission in DMT group, baseline characteristics did not differ in the two groups. Procedural characteristics were similar in IVT + MT and DMT group. Rate of favorable outcome was significantly higher in IVT + MT patients than DMT ones both 90-days (51.5 vs. 18.2%; p = 0.004) and 1-year (51.5 vs. 15.2%; p = 0.002) after stroke. DMT patients were six times more likely to die during the 1-year follow-up compared to IVT + MT patients. This study suggests that bridging therapy may improve short and long-term outcomes in patients eligible for endovascular treatment. Further studies with larger patient numbers and randomized design are needed to confirm our findings.

Drug-coated balloon dilation before carotid artery stenting of post-carotid endarterectomy restenosis.

PURPOSE: To investigate if drug-coated balloon (DCB) predilation may improve the efficacy of carotid artery stenting (CAS) for restenosis after carotid endarterectomy (CEA). METHODS: Eighteen consecutive patients (11 men; median age 75 years) with significant restenosis within 24 months of CEA were treated with a paclitaxel-coated DCB prior to CAS. Clinical outcomes and stent patency were systematically appraised. RESULTS: All patients were successfully treated according to this clinical protocol. The only complication occurred in a patient who had a transient ischemic attack during prolonged DCB inflation. At a median follow-up of 18 months, no >50% restenosis was observed on duplex ultrasound scans; however, moderate hyperplasia at the proximal stent edge was found in 4 patients. One patient died at 9 months from a myocardial infarction. CONCLUSION: Despite the small sample size and in keeping with the historically high risk of recurrent restenosis after CAS for CEA restenosis, this case series suggests that DCB dilation followed by CAS for postsurgical restenosis is feasible, safe, and may be associated with favorable clinical outcomes at midterm follow-up.