Neurocritical care complications and interventions influence the outcome in aneurysmal subarachnoid hemorrhage.

BACKGROUND: This observational study was performed to show the impact of complications and interventions during neurocritical care on the outcome after aneurysmal subarachnoid hemorrhage (SAH). METHODS: We analyzed 203 cases treated for ruptured intracranial aneurysms, which were classified regarding clinical outcome after one year according to the modified Rankin Scale (mRS). We reviewed the data with reference to the occurrence of typical complications and interventions in neurocritical care units. RESULTS: Decompressive craniectomy (odds ratio 21.77 / 6.17 ; p < 0.0001 / p = 0.013), sepsis (odds ratio 14.67 / 6.08 ; p = 0.037 / 0.033) and hydrocephalus (odds ratio 3.71 / 6.46 ; p = 0.010 / 0.00095) were significant predictors for poor outcome and death after one year beside "World Federation of Neurosurgical Societies" (WFNS) grade (odds ratio 3.86 / 4.67 ; p < 0.0001 / p < 0.0001) and age (odds ratio 1.06 / 1.10 ; p = 0.0030 / p < 0.0001) in our multivariate analysis (binary logistic regression model). CONCLUSIONS: In summary, decompressive craniectomy, sepsis and hydrocephalus significantly influence the outcome and occurrence of death after aneurysmal SAH.

Impact of Antiplatelet Therapy During Endovascular Therapy for Tandem Occlusions: A Collaborative Pooled Analysis.

Background and Purpose- Antiplatelet agents could be used in the setting of endovascular therapy for tandem occlusions to reduce the risk of de novo intracranial embolic migration, reocclusion of the extracranial internal carotid artery lesion, or in-stent thrombosis in case of carotid stent placement but have to be balanced with the intracerebral hemorrhagic transformation risk. In this study, we aim to investigate the impact of acute antiplatelet therapy administration on outcomes during endovascular therapy for anterior circulation tandem occlusions. Methods- This is a retrospective analysis of a collaborative pooled analysis of 11 prospective databases from the multicenter observational TITAN registry (Thrombectomy in Tandem Lesions). Patients were divided into groups based on the number of antiplatelet administered during endovascular therapy. The primary outcome was favorable outcome, defined as a modified Rankin Scale score of 0 to 2 at 90 days. Results- This study included a total of 369 patients; 145 (39.3%) did not receive any antiplatelet agent and 224 (60.7%) received at least 1 antiplatelet agent during the procedure. Rate of favorable outcome was nonsignificantly higher in patients treated with antiplatelet therapy (58.3%) compared with those treated without antiplatelet (46.0%; adjusted odds ratio, 1.38 [95% CI, 0.78-2.43]; P=0.26). Rate of 90-day mortality was significantly lower in patients treated with antiplatelet therapy (11.2% versus 18.7%; adjusted odds ratio, 0.47 [95% CI, 0.22-0.98]; P=0.042), without increasing the risk of any intracerebral hemorrhage. Successful reperfusion (modified Thrombolysis in Cerebral Ischemia score 2b-3) rate was significantly better in the antiplatelet therapy group (83.9% versus 71.0%; adjusted odds ratio, 1.89 [95% CI, 1.01-3.64]; P=0.045). Conclusions- Administration of antiplatelet therapy during endovascular therapy for anterior circulation tandem occlusions was safe and was associated with a lower 90-day mortality. Optimal antiplatelet therapy remains to be assessed, especially when emergent carotid artery stenting is performed. Further randomized controlled trials are needed.

Follow-up after carotid stenting with the CASPER stent system: A duplex ultrasound evaluation.

OBJECTIVE: To report results of duplex ultrasound evaluation of consecutive patients after carotid stenting with the double layer Carotid Artery Stent designed to Prevent Embolic Release (CASPER) stent system. METHODS: Between January 2014 and June 2017, a single-center, retrospective study of 101 consecutive patients (21.8% female; median age, 72.1 years) was performed. Patients with internal carotid artery stenosis treated with the CASPER stent were included. Eligibility criteria for stenting included stenosis of ≥70% of the vessel diameter (or ≥50% diameter with ulceration) in symptomatic carotid artery stenosis or ≥80% stenosis in asymptomatic patients at the carotid artery bifurcation or the proximal cervical internal carotid artery. Duplex ultrasound examination was performed before and within 24 hours of implantation as well as at 14 days, and 3, 6, and 12 months. RESULTS: At the 12-month follow-up visit, moderate in-stent restenosis (ISR) (≥50% and <70%) was detected in three stents (2.8%) and severe (≥70%) ISR in two (1.9%; including one case of stent occlusion). All but the two latter patients remained asymptomatic during the follow-up period. One patient required retreatment for ISR after a minor stroke and another patient with stent occlusion also re-presented with a minor stroke. Multivariable logistic regression was unable to detect any significant factors associated with ISR. CONCLUSIONS: Duplex ultrasound examination after carotid stenting is a useful tool for patient follow-up and determination of ISR. We found a low incidence of ISR assessed by duplex ultrasound examination at 12 months after CASPER stenting, but further studies are warranted.

Severe Leukoaraiosis Is Associated with Poor Outcome after Successful Recanalization of M1 Middle Cerebral Artery Occlusion Strokes.

BACKGROUND: Severe leukoaraiosis (LA) is an established risk factor for poor outcome after mechanical thrombectomy (MT) for large vessel occlusion stroke. There is uncertainty whether this association also applies to successfully recanalized patients with M1 segment middle cerebral artery (MCA) occlusions. METHODS: A retrospective single-centre study of patients with successful reperfusion (thrombolysis in cerebral infarction, TICI 2b or 3) after MT for an M1 MCA occlusion was performed over a 7-year period. LA score (LAS) was assessed using the age-related white matter change scale on pre-interventional brain imaging. RESULTS: A total of 209 patients (median age 75.0 years) were included. LAS was assessed on pre-interventional imaging by computed tomography in 177 (84.7%) patients and magnetic resonance imaging in 32 (15.3%) patients. The median LAS was 1 (IQR 0-8), and severe LA consisted of the top 25 percentile, ranging from 9 to 24. Multivariable analysis demonstrated an association of severe LA (OR 0.32, 95% CI 0.12-0.88, p = 0.023), higher NIHSS on admission (OR 0.89, 95% CI 0.84-0.94, p < 0.001), advanced age (OR 0.97, 95% CI 0.95-1.00, p = 0.039), good leptomeningeal collaterals (OR 3.65, 95% CI 1.46-8.15, p = 0.001), and TICI 3 score (OR 3.26, 95% CI 10.52-7.01) with good clinical outcome after 3 months as measured with the modified Rankin scale. CONCLUSION: Severe LA is associated with poor clinical outcome at 3 months in acute stroke patients undergoing MT due to emergent M1 MCA occlusion.

Carotid Calcium Volume and Stenosis after Stent Implantation.

INTRODUCTION: Internal carotid artery (ICA) stenosis could be treated with stent placement. It was hypothesized that calcium amount could be predictive of vessel stenosis after stent placement. We utilised computed tomography (CT) angiography to quantify volume of calcium material in bulbar ICA. MATERIALS AND METHODS: 28 patients with 31 treated ICA stenosis were collected and analysed using CT angiography-based calcium volume measurement. The Casper stent system (CSS) was used exclusively. Prospective data on emergent carotid stenosis were collected using serial ultrasound controls over a 12-month period. RESULTS: Median age was 76 years (interquartile range (IQR) 67.5-77.8) and the majority were men (71.4%). Plaque median calcium volume was 0.142 cm3 (IQR 0.030 - 0.227) and median average Hounsfield Units (HU) were 561.0 (414.5-675.0). We detected positive linear relationship between average HU and ICA calcium volume. Furthermore, weak positive correlation was observed between calcium volume and residual stenosis as seen on post-interventional angiography, (correlation coefficient R = 0.38, p=0.035). Stronger positive correlation emerged between plaques' average HU and residual stenosis (R = 0.42, p=0.018). Angiographic stenosis showed univariate association with late stenosis as detected 12 months after CAS. CONCLUSION: Calcium burden could be associated with residual stenosis after CSS placement. Larger studies are needed to confirm our preliminary data.

Neutrophil to lymphocyte ratio predicts intracranial hemorrhage after endovascular thrombectomy in acute ischemic stroke.

BACKGROUND: The development of intracranial hemorrhage (ICH) in acute ischemic stroke is associated with a higher neutrophil to lymphocyte ratio (NLR) in peripheral blood. Here, we studied whether the predictive value of NLR at admission also translates into the occurrence of hemorrhagic complications and poor functional outcome after endovascular treatment (EVT). METHODS: We performed a retrospective analysis of consecutive patients with anterior circulation ischemic stroke who underwent EVT at a tertiary care center from 2012 to 2016. Follow-up scans were examined for non-procedural ICH and scored according to the Heidelberg Bleeding Classification. Demographic, clinical, and laboratory data were correlated with the occurrence of non-procedural ICH. RESULTS: We identified 187 patients with a median age of 74 years (interquartile range [IQR] 60-81) and a median baseline National Institutes of Health Stroke scale (NIHSS) score of 18 (IQR 13-22). A bridging therapy with recombinant tissue-plasminogen activator (rt-PA) was performed in 133 (71%). Of the 31 patients with non-procedural ICH (16.6%), 13 (41.9%) were symptomatic. Patients with ICH more commonly had a worse outcome at 3 months (p = 0.049), and were characterized by a lower body mass index, more frequent presence of tandem occlusions, higher NLR, larger intracranial thrombus, and prolonged rt-PA and groin puncture times. In a multivariate analysis, higher admission NLR was independently associated with ICH (OR 1.09 per unit increase, 95% CI (1.00-1.20, p = 0.040). The optimal cutoff value of NLR that best distinguished the development of ICH was 3.89. CONCLUSIONS: NLR is an independent predictor for the development of ICH after EVT. Further studies are needed to investigate the role of the immune system in hemorrhagic complications following EVT, and confirm the value of NLR as a potential biomarker.

Thrombectomy in Acute Stroke With Tandem Occlusions From Dissection Versus Atherosclerotic Cause.

BACKGROUND AND PURPOSE: Tandem steno-occlusive lesions were poorly represented in randomized trials and represent a major challenge for endovascular thrombectomy in acute anterior circulation strokes. The impact of the cervical carotid lesion cause (ie, atherosclerotic versus dissection) on outcome of tandem patients endovascularly treated remains to be assessed. METHODS: We retrospectively analyzed individual data of prospectively collected consecutive tandem patients treated with endovascular thrombectomy. The primary outcome was favorable outcome at 90 days (modified Rankin Scale score of 0-2). Secondary efficacy outcomes included successful reperfusion (modified Thrombolysis in Cerebrovascular Infarction scores of 2b-3), time to reperfusion, and safety outcomes encompassed procedural complications, symptomatic intracerebral hemorrhage, and 90-day mortality. RESULTS: Among the 295 included patients, 65 had cervical carotid dissection and 230 had cervical carotid atherosclerotic cause. The rate of favorable outcome was 56.3% in the dissection group versus 47.6% in the atherosclerotic arm (center-, age-, and admission National Institutes of Health Stroke Scale-adjusted odds ratio, 1.08; 95% confidence interval, 0.50-2.30; P=0.85). No significant differences were observed in secondary outcomes. The rates of successful reperfusion, symptomatic intracerebral hemorrhage, and 90-day mortality were 78.5% versus 74.5% (P=0.13), 4.6% versus 5.2% (P=1.0), and 7.8% versus 15.3% (P=0.94) in the dissection versus atherosclerotic groups, respectively. The median procedural time was 76 minutes (interquartile range, 52-95 minutes) in the dissection group and 67 minutes (interquartile range, 45-98 minutes) in the atherosclerotic group (P=0.24). CONCLUSIONS: We found no differences in the outcomes of patients with anterior circulation tandem atherosclerotic and dissection lesions treated with endovascular thrombectomy. Further studies are warranted.

Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial.

IMPORTANCE: Intracranial stenosis is one of the most common etiologies of stroke. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis. OBJECTIVE: To evaluate the efficacy and safety of the balloon-expandable stent plus medical therapy vs medical therapy alone in patients with symptomatic intracranial stenosis (≥70%). DESIGN, SETTING, AND PATIENTS: VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial is an international, multicenter, 1:1 randomized, parallel group trial that enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013. INTERVENTIONS: Patients (N = 112) were randomized to receive balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). PRIMARY OUTCOME MEASURE: a composite of stroke in the same territory within 12 months of randomization or hard transient ischemic attack (TIA) in the same territory day 2 through month 12 postrandomization. A hard TIA was defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischemia lasting at least 10 minutes but resolving within 24 hours. Primary safety measure: a composite of any stroke, death, or intracranial hemorrhage within 30 days of randomization and any hard TIA between days 2 and 30 of randomization. Disability was measured with the modified Rankin Scale and general health status with the EuroQol-5D, both through month 12. RESULTS: Enrollment was halted by the sponsor after negative results from another trial prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled. The 30-day primary safety end point occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (5/53; 9.4% [95% CI, 3.1%-20.7%]) (P = .05). Intracranial hemorrhage within 30 days occurred in more patients in the stent group (5/58; 8.6% [95% CI, 2.9%-19.0%]) vs none in the medical group (95% CI, 0%-5.5%) (P = .06). The 1-year primary outcome of stroke or hard TIA occurred in more patients in the stent group (21/58; 36.2% [95% CI, 24.0-49.9]) vs the medical group (8/53; 15.1% [95% CI, 6.7-27.6]) (P = .02). Worsening of baseline disability score (modified Rankin Scale) occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (6/53; 11.3% [95% CI, 4.3%-23.0%]) (P = .09).The EuroQol-5D showed no difference in any of the 5 dimensions between groups at 12-month follow-up. CONCLUSIONS AND RELEVANCE: Among patients with symptomatic intracranial arterial stenosis, the use of a balloon-expandable stent compared with medical therapy resulted in an increased 12-month risk of added stroke or TIA in the same territory, and increased 30-day risk of any stroke or TIA. These findings do not support the use of a balloon-expandable stent for patients with symptomatic intracranial arterial stenosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00816166.

Predictors of functional dependence despite successful revascularization in large-vessel occlusion strokes.

BACKGROUND AND PURPOSE: High revascularization rates in large-vessel occlusion strokes treated by mechanical thrombectomy are not always associated with good clinical outcomes. We evaluated predictors of functional dependence despite successful revascularization among patients with acute ischemic stroke treated with thrombectomy. METHODS: We analyzed the pooled data from the Multi Mechanical Embolus Removal in Cerebral Ischemia (MERCI), Thrombectomy Revascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO), and TREVO 2 trials. Successful revascularization was defined as thrombolysis in cerebral infarction score 2b or 3. Functional dependence was defined as a score of 3 to 6 on the modified Rankin Scale at 3 months. We assessed relationship of demographic, clinical, angiographic characteristics, and hemorrhage with functional dependence despite successful revascularization. RESULTS: Two hundred and twenty-eight patients with successful revascularization had clinical outcome follow-up. The rates of functional dependence with endovascular success were 48.6% for Trevo thrombectomy and 58.0% for Merci thrombectomy. Age (odds ratio, 1.04; 95% confidence interval, 1.02-1.06 per 1-year increase), National Institutes of Health Stroke Scale score (odds ratio, 1.08; 95% confidence interval, 1.02-1.15 per 1-point increase), and symptom onset to endovascular treatment time (odds ratio, 1.11; 95% confidence interval, 1.01-1.22 per 30-minute delay) were predictors of functional dependence despite successful revascularization. Symptom onset to reperfusion time beyond 5 hours was associated with functional dependence. All subjects with symptomatic intracranial hemorrhage had functional dependence. CONCLUSIONS: One half of patients with successful mechanical thrombectomy do not have good outcomes. Age, severe neurological deficits, and delayed endovascular treatment were associated with functional dependence despite successful revascularization. Our data support efforts to minimize delays to endovascular therapy in patients with acute ischemic stroke to improve outcomes. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00318071, NCT01088672, and NCT01270867.

Microsurgical Clipping after Failed Contour Device Embolization of an Anterior Communicating Artery Aneurysm: Technical Note.

BACKGROUND: Endovascular therapy has revolutionized the treatment of cerebral aneurysms in recent years and decades. So-called intrasaccular devices (i.e., Woven EndoBridge [WEB], MicroVention, Aliso Viejo, California, United States; or Contour, Cerus Neurovascular, Fremont, California, United States) are a promising endovascular technology, especially for wide-based aneurysms. However, long-term outcome data are currently particularly scarce for Contour and strategies for failed Contour cases are lacking. Here, we report the feasibility of microsurgical clipping after failed Contour device embolization. METHODS: Feasibility of microsurgical clipping after failed aneurysm embolization with a Contour intrasaccular device was assessed in a patient. RESULTS: We present the case of a 36-year-old male patient diagnosed with Hunt and Hess grade 1 subarachnoid hemorrhage from an anterior communicating artery aneurysm. The ruptured aneurysm was initially treated with the Contour device. After 3 months, angiographic imaging showed a clear aneurysm residual deemed not endovascularly accessible. The patient was then successfully clipped using microsurgical techniques. The patient was discharged with no neurologic abnormalities. CONCLUSION: After thorough bibliographical research, this presents the first published case report of microsurgical clipping after failed embolization with Contour. The main insights gained after clipping were that the Contour does not significantly disturb or hinder clipping. In contrast to coils in aneurysms to be clipped, the Contour can be easily compressed by the clip blades and does not have to be removed. In addition, the Contour had not migrated into the subarachnoid space and there was no abnormal scarring. Clipping appears to be a reasonable treatment strategy for failure of embolization with Contour if endovascular means are not suitable.

Effect of concomitant usage of alteplase and mechanical thrombectomy for M1 middle cerebral artery occlusion on clinical outcome: a retrospective analysis of 457 patients from two centers.

Introduction: Endovascular thrombectomy (EVT) and concomitant usage of intravenous alteplase (alteplase) in large vessel occlusion stroke may produce unwanted excess intracerebral hemorrhage (ICH). Whether this applies specifically to isolated occlusion of the M1 segment of the middle cerebral artery (MCA) is unknown. Methods: A retrospective study from two tertiary thrombectomy centers. ICH was determined according to Heidelberg Bleeding Classification (HBC). Factors associated with the occurrence of ICH in EVT alone vs. EVT with alteplase were evaluated using logistic regression analysis. Factors related to the clinical outcome as determined with a modified Rankin scale (mRS) were investigated with univariate and adjusted multivariate logistic regression analysis. The interaction between clinical variables and the usage of alteplase on the occurrence of ICH was evaluated. Results: Any ICH occurred in 156/457 (34.1%) patients Class 1a bleeding in 37 (8.1%), type 2 in 45 (9.8%) Class 1c in 22 (4.8%), Class 2 in 25 (5.5%), and Class 3 (extraparenchymal) in 27 (5.9%). ICH occurred in similar frequency between alteplase-treated patients vs. EVT alone (85/262 [32%] vs. 71/195 [36%]; OR 1.19 (95% CI 0.81-1.76). After adjustment, odds for clinical outcome were lower in ICH patients (OR 0.44 [95% CI 0.25-0.74]), p = 0.002). Higher ICH rate was associated with more EVT steps (p for interaction -0.005), and usage of only stent-retriever (p for interaction =0.005). Conclusion: Utilization of alteplase alongside EVT for MCA M1 occlusion did not result in excessive ICH occurrences or clinical deterioration.

Thrombus migration in emergent M1 middle cerebral artery occlusion.

BACKGROUND AND PURPOSE: Thrombus migration (TM) is a well-established phenomenon in patients with intracranial vessel occlusion, particularly in those who receive alteplase. However, the relationship between TM, reperfusion success, and clinic-radiological outcomes is still being determined. This study aimed to describe the various outcomes in the event of TM in patients with M1 middle cerebral artery (M1 MCA) occlusion. MATERIALS AND METHODS: The study involved a retrospective analysis of patients undergoing endovascular thrombectomy (EVT) due to M1 MCA occlusion from two tertiary centers between January 2015 and December 2020. The proximal positions of thrombi were measured using a curve tool on CT or MR angiography before EVT. Subsequently, measurements were taken on angiographic imaging. Patients were grouped based on the amount of difference between the two measurements: growth (≤ - 10 mm), stability (> -10 mm and ≤ 10 mm), migration (> 10 mm), and resolution. RESULTS: A total of 463 patients (266 [57%] females, median 76 [interquartile range IQR: 65-83] years) were analyzed. Of them, 106 (22.8%) expressed any degree of TM. In multivariate ordinal regression analysis, the alteplase was significantly associated with TM (t = 2.192, p = 0.028), as was the greater interval from first imaging to angiography (t = 2.574, p = 0.010). In multivariate logistical regression analysis, the good clinical outcome measured by the modified Rankin scale (0-2) was not associated with TM status. CONCLUSIONS: Thrombus migration within the M1 MCA segment occurs in almost a quarter of patients, is associated with alteplase administration, and is mainly irrelevant to radiological and clinical outcome.

Contour Neurovascular System for endovascular embolization of cerebral aneurysms: a multicenter cohort study of 10 European neurovascular centers.

BACKGROUND: Intrasaccular devices have become increasingly popular in the treatment of cerebral aneurysms, particularly at the bifurcation. Here we evaluate the Contour Neurovascular System, an intrasaccular device for the endovascular treatment of cerebral aneurysms, in a multicenter cohort study, the largest to the best of our knowledge. METHODS: Consecutive patients with intracranial aneurysms treated with the Contour Neurovascular System between February 2017 and October 2022 at 10 European neurovascular centers were prospectively collected and retrospectively reviewed. Patient and aneurysm characteristics, procedural details, and angiographic and clinical outcomes were evaluated. RESULTS: During the study period, 279 aneurysms (median age of patients 60 years, IQR 52-68) were treated with Contour. In 83.2% of patients the device was placed electively, whereas the remaining patients were treated in the setting of acute subarachnoid hemorrhage. The most common locations were the middle cerebral artery (26.5%) followed by the anterior communicating region (26.2%). Median aneurysm dome and neck size were 5.2 mm (IQR 4.2-7) and 3.9 mm (IQR 3-5). Contour size 7 (39%) and 9 (25%) were most used. Thromboembolic and hemorrhagic complications occurred in 6.8% and 0.4% of aneurysms, respectively. Raymond-Roy 1 and 2 occlusions at last follow-up were achieved in 63.2% and 28.3%, respectively, resulting in adequate occlusion of 91.5% of aneurysms. CONCLUSION: This is the largest multicenter study reporting the outcome on the Contour Neurovascular System. At 1 year, the self-evaluated data on safety and efficacy are comparable to data of existing intrasaccular devices. Contour is a promising technology in the treatment of cerebral aneurysms.

Distance to thrombus, ischemic lesion volume and clinical outcome after thrombectomy for M1 middle cerebral artery occlusion.

BACKGROUND: Stroke resulting from occlusion of the middle cerebral artery (MCA) can have devastating consequences, potentially leading to a loss of independence. This study aimed to investigate the relationship between the distance to the thrombus (DT) and both ischemic lesion volume (ILV) and clinical outcomes. METHODS: We retrospectively evaluated patients with thromboembolic MCA M1 segment occlusion who underwent neurovascular imaging followed by endovascular thrombectomy (EVT) at two comprehensive stroke centers over a 3-year period (2018-2020). Preinterventional computed tomography (CT) or magnetic resonance (MR) angiography was used to measure DT, defined as the distance from the carotid­T bifurcation to the proximal surface of the M1 occlusion. Postinterventional CT or MR imaging was employed to determine the ILV and clinical outcomes were assessed using the modified Rankin scale (mRS) at 3 months. RESULTS: There were 346 patients evaluated. The median DT was 9.4 mm (interquartile range, IQR 6.0-13.7 mm) and the median ILV was 13.9 ml (IQR 2.2-53.1 ml). After adjustment, an increase in DT was associated with a decrease in odds for a larger ILV (odds ratio, OR 0.96, 95% confidence interval, CI 0.92-0.99, p = 0.041). Through this association, more distal thrombi were associated with good clinical outcome (mRS 0-2; clinical outcome available in 282 patients, p = 0.018). The ILV was inversely associated with better clinical outcome OR 0.52 (95% CI 0.40-0.67). CONCLUSION: Based on the findings, DT was identified as an independent albeit weak predictor for ILV and clinical outcomes in patients with MCA M1 occlusion who underwent EVT.

Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms.

BACKGROUND: Robotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases. OBJECTIVE: To evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms. METHODS: This prospective, international, multicenter study enrolled patients with brain aneurysms that required endovascular coiling and/or stent-assisted coiling. The primary effectiveness endpoint was defined as successful completion of the robotic-assisted endovascular procedure without any unplanned conversion to manual treatment with guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. The primary safety endpoint included intraprocedural and periprocedural events. RESULTS: The study enrolled 117 patients (74.4% female) with mean age of 56.6 years from 10 international sites,. Headache was the most common presenting symptom in 40/117 (34.2%) subjects. Internal carotid artery was the most common location (34/122, 27.9%), and the mean aneurysm height and neck width were 5.7±2.6 mm and 3.5±1.4 mm, respectively. The overall procedure time was 117.3±47.3 min with 59.4±32.6 min robotic procedure time. Primary effectiveness was achieved in 110/117 (94%) subjects with seven subjects requiring conversion to manual for procedure completion. Only four primary safety events were recorded with two intraprocedural aneurysm ruptures and two strokes. A Raymond-Roy Classification Scale score of 1 was achieved in 71/110 (64.5%) subjects, and all subjects were discharged with a modified Rankin Scale score of ≤2. CONCLUSIONS: This first-of-its-kind robotic-assisted neurovascular trial demonstrates the effectiveness and safety of the CorPath GRX System for endovascular embolization of cerebral aneurysm procedures. TRIAL REGISTRATION NUMBER: NCT04236856.

Management of failed flow diversion for intracranial aneurysm beyond the first 6 months of follow-up: an international Delphi consensus.

OBJECTIVE: The placement of flow-diverting devices has become a common method of treating unruptured intracranial aneurysms of the internal carotid artery. The progressive improvement of aneurysm occlusion after treatment-with low complication and rupture rates-has led to a dilemma regarding the management of aneurysms in which occlusion has not occurred within 6-24 months. The authors aimed to identify clinical consensus regarding management of intracranial aneurysms displaying persistent filling 6-24 months after flow diversion and to ascertain questions that may drive future investigation. METHODS: An international panel of 67 experts was invited to participate in a multistep Delphi consensus process on the treatment of intracranial aneurysms after failed flow diversion. RESULTS: Of the 67 experts invited, 23 (34%) participated. Qualitative analysis of an initial survey with open-ended questions resulted in 51 statements regarding management of aneurysms showing persistent filling after flow diversion. The statements were grouped into 8 categories, and in the second round, respondents rated the degree of their agreement with each statement on a 5-point Likert scale. Flow diverters with surface modifiers did not influence administration of dual-antiplatelet therapy according to 83%. Consensus was also reached regarding the definition of treatment failure at specific time points, including at 6 months if there is aneurysm growth or persistent rapid flow through the entirety of the aneurysm (96%), at 12 months if there is aneurysm growth or symptom onset (78%), and at 24 months if there is persistent filling regardless of size and filling characteristics (74%). Although experts agreed that the degree of intimal hyperplasia or in-device stenosis could not be ascertained by noninvasive imaging alone (83%), only 65% chose digital subtraction angiography as the preferred modality. At 6 and 12 months, retreatment is preferred if there is persistent filling with aneurysm growth (96%, 96%), device malposition (48%, 87%), or a history of subarachnoid hemorrhage (65%, 70%), respectively, and at 24 months if there is persistent filling without reduction in aneurysm size (74%). Experts favored treatment with an additional flow diverter (87%) over aneurysm clipping, applying the same principles for follow-up (83%) and treatment failure (91%) as for the first flow diverter. CONCLUSIONS: The authors present the consensus practices of experts in the management of intracranial aneurysms without occlusion 6-24 months after treatment with a flow-diverting device.

Neurothrombectomy for the treatment of acute ischemic stroke: results from the TREVO study.

BACKGROUND: Fast recanalization has been shown to be one of the most important factors for good clinical outcome in stroke patients with acute large vessel occlusion. While intravenous thrombolysis has been shown to be of limited effect in patients with large clot burden, intra-arterial neurothrombectomy offers a new and promising possibility to achieve high recanalization rates within a short time. The Trevo device is a stent-like retriever and was primarily designed to remove thrombus in patients experiencing an acute ischemic stroke. We report on the results of the TREVO Study, which was a prospective, multicenter study in acute stroke patients treated with the Trevo device. METHODS: Patients were recruited in seven European centers under the control of an external monitor. Centers were selected because of their long experience with interventional stroke therapy especially with neurothrombectomy. We included adults aged 18-85 years with angiographically confirmed large vessel occlusion strokes and NIHSS scores of 8-30 and treatable within 8 h of symptom onset. The primary endpoint was revascularization, defined as at least TICI (thrombolysis in cerebral infarction) 2a. The revascularization scores were assessed by an independent core lab. Secondary endpoints were clinical outcome at 90 days (mRS 90), any device-related serious adverse events and the rate of symptomatic intracerebral hemorrhages. RESULTS: 60 patients were enrolled. The overall recanalization rate (≥TICI 2a) was 91.7% and TICI 2b and 3 was achieved in 78.3%. At 90 days, 55% of the patients had a favorable neurological outcome (mRS 0-2) and 20% had died. Patients with successful recanalization (TICI 2a,b/3) had a good 90-day neurological outcome (mRS 0-2) in 60%, whereas no patient without recanalization had a mRS 90 <3. The overall rate of symptomatic intracerebral hemorrhage according to the SITS-MOST criteria was 5% (3/60). CONCLUSIONS: The study suggest that the Trevo Stentriever™ is a safe and effective device, which may offer the possibility of a high reperfusion rate and a high rate of patients with good clinical outcome after acute ischemic stroke due to proximal arterial occlusion. Randomized trials comparing intravenous thrombolysis with neurothrombectomy are now urgently needed to evaluate this new approach of interventional stroke therapy.

Monitoring of the heparinization in the rabbit animal model during endovascular interventions.

INTRODUCTION: The purpose of this study was to monitor and to optimize heparinization during endovascular procedures in the New Zealand White Rabbit (NZWR) model. METHODS: Right common carotid artery aneurysms were surgically created in 43 NZWR, with an average weight of 4,330 g (range 3,500-5,430 g). The activated partial thromboplastin time (aPTT) was measured during different stages of the interventional procedures. Blood samples were taken before and 10 min after administration of heparin and at the end of each endovascular procedure. We compared three different experimental groups: 100 U heparin, 500 U heparin and 100 U heparin plus pretreatment with aspirin and clopidogrel. The individual aPTT values were measured using a ball coagulometer. RESULTS: The average baseline aPTT in the rabbit is 75.2 ± 18.9 s compared to a mean of 33 s (range 26-40 s) in humans. The dosages of heparin used achieved anticoagulation in all cases. Five hundred units of heparin increased the aPTT significantly more than 100 U. No difference was found between the aPTT obtained from the 100 U and the 100 U plus pretreatment group, as aspirin and clopidogrel do not affect the coagulation cascade. CONCLUSION: One hundred units of heparin can achieve anticoagulation in a similar magnitude as needed in interventional procedures in humans. This fact enhances suitability of the rabbit animal model for the testing of intravascular devices.

Design of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial in symptomatic intracranial stenosis.

BACKGROUND: Patients with high-grade symptomatic intracranial stenosis (≥ 70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. METHODS: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥ 70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. RESULTS: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. CONCLUSIONS: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.

New concept in neurovascular navigation: technical description and preclinical experience with the Bendit 17 and Bendit 21 microcatheters in a rabbit aneurysm model.

BACKGROUND: Endovascular treatment of intracranial vascular diseases, such as aneurysms, is often challenged by unfavorable vascular anatomy. The Bendit Steerable Microcatheter (Bendit Technologies, Tel Aviv, Israel) has bending and torqueing capabilities designed to improve navigation and stability during device delivery, with or without a guidewire. We describe our preclinical experience with the Bendit 17 and Bendit 21 microcatheters in a rabbit aneurysm model. METHODS: Bifurcation and side wall aneurysms were created surgically in six New Zealand rabbits. We attempted to navigate Bendit devices through the vasculature and enter the aneurysms without a guidewire. Various positions within the aneurysm were selectively explored. Angiographic imaging was used to visualize catheterization, navigation, vascular manipulations, and placement of coils, stents, and intrasaccular devices. RESULTS: We successfully navigated the Bendit microcatheters to all aneurysms without a guidewire. We successfully recanalized a nearly occluded carotid artery and navigated the Bendit through a braided stent. In contrast, we were unable to navigate a comparator device with a guidewire as effectively as the Bendit. Coils were introduced at different locations within the aneurysm and could be pushed, pulled, and repositioned with the Bendit tip. Finally, we used the Bendit to deliver intrasaccular devices designed for terminal aneurysms to treat side wall aneurysms. CONCLUSIONS: Bendit's bending and torqueing abilities, combined with its stability in the bent position, enable quick navigation and optimal deployment of devices. Clinical studies are necessary to determine whether these navigation advantages lead to more efficient treatment of intracranial and peripheral aneurysms.