Prospective evaluation to characterize the real-world performance of the EMBOVAC aspiration catheter for neurothrombectomy: a post-market clinical follow-up trial.

BACKGROUND: A direct aspiration first pass technique (ADAPT) is an effective alternative to stent retriever thrombectomy for patients with large vessel occlusion (LVO). The PERFECT study evaluated direct aspiration with the EMBOVAC large bore aspiration catheter in patients with LVO strokes. METHODS: PERFECT was a prospective, post-market, single-arm, multicenter, observational study of patients enrolled across 11 European centers between October 2020 and July 2022. Three direct aspiration passes with EMBOVAC were mandated before switching strategy. The primary endpoint was core-lab assessed successful reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b) post-procedure. Other outcomes included first pass mTICI ≥2c, independent 90-day modified Rankin Scale (mRS) evaluation, and symptomatic intracerebral hemorrhage (sICH) at 24 hours by a clinical events committee. RESULTS: EMBOVAC was used in 100 patients (mean age 70.4±14.0 years, 59.0% (59/100) female). Final mTICI ≥2b was achieved in 98.0% (97/99), final mTICI ≥2b with no change in frontline therapy or thrombolytics use during the procedure was achieved in 87.9% (87/99), final mTICI ≥2c in 86.9% (86/99), and first pass mTICI ≥2c in 53.5% (53/99). sICH at 24 hours was 0%. The 90-day mRS ≤2 rate was 56.6% (56/99) and all-cause mortality was 12.9%. One device-related serious adverse event occurred within 90 days (1.0%). CONCLUSIONS: PERFECT demonstrates that EMBOVAC achieves successful reperfusion rates and favorable clinical outcomes when used in the endovascular treatment of acute ischemic stroke (AIS) using a direct aspiration technique as first line therapy in a real-world setting in patients with AIS secondary to large vessel occlusion. TRIAL REGISTRATION: www. CLINICALTRIALS: gov Unique identifier: NCT04531904.

NIMBUS geometric clot extractor for challenging clots: Real-world clinical experience and clot composition.

PURPOSE: Revascularization rates following mechanical thrombectomy (MT) for acute ischemic stroke (AIS) remain suboptimal for patients with fibrin-rich, recalcitrant clots. The NIMBUS Geometric Clot Extractor has demonstrated promising in vitro revascularization rates using fibrin-rich clot analogs. This study assessed the retrieval rate and composition of clot using NIMBUS in a clinical setting. METHODS: This retrospective study included patients who underwent MT with NIMBUS at two high-volume stroke centers between December 2019 and May 2021. NIMBUS was used for clots deemed challenging to remove at the interventionalist's discretion. At one of the centers, per pass clot was collected for histological analysis by an independent lab. RESULTS: A total of 37 patients (mean age 76.87 ± 11.73 years; 18 female; mean time from stroke onset 11.70 ± 6.41 h) were included. NIMBUS was used as first and second-line device in 5 and 32 patients, respectively. The main reason for using NIMBUS (32/37) was the failure of standard MT techniques after a mean 2.86 ± 1.48 number of passes. Substantial reperfusion (mTICI ≥2b) was achieved in 29/37 patients (78.4%) with a mean of 1.81 ± 1.00 NIMBUS passes (mean 4.68 ± 1.68 passes with all devices), and NIMBUS was the final device used in 79.3% (23/29) of those cases. Clot specimens from 18 cases underwent composition analysis. Fibrin and platelets represented 31.4 ± 13.7% and 28.8 ± 18.8% of clot components; 34.4 ± 19.5% were red blood cells. CONCLUSIONS: In this series, NIMBUS was effective in removing tough clots rich in fibrin and platelets in challenging real-world situations.

The DERIVO®2 Embolization Device in the treatment of ruptured and unruptured intracranial aneurysms: A multicenter analysis.

BACKGROUND: Flow diverters are an increasingly used treatment option for intracranial aneurysms. A recent addition to the European market is the DERIVO®2 Embolization Device (DED2), promising improved radiopacity. We aimed to assess the safety and efficacy of the DED2 regarding angiographic and clinical outcomes in ruptured and unruptured cerebral aneurysms. METHODS: We performed a multicenter trial at six interventional centers. Data were prospectively collected and all patients treated with the DED2 were included. The primary endpoint was angiographic aneurysm occlusion at 6 months as assessed by the O'Kelly Marotta (OKM) grading scale with a favorable outcome definition of OKM C + D. Clinical outcome was evaluated according to the modified Rankin scale (mRS). RESULTS: Between August 2020 and July 2021, 37 patients were treated with the DED2 and were included in our analysis. Five patients presented with ruptured aneurysms. Median age was 60 years, 27 patients were female, and 10 male. Median mRS was 0 (range 0-4). Mean aneurysm size was 8.9 ± 7.1 mm with a mean neck size of 6.5 ± 6.1. The DED2 fully opened at deployment in all cases. Clinical follow-up was available for 30 patients (81%). Twenty-five (83%) had an mRS of 0 or 1. Three patients with ruptured aneurysms died during the follow-up period. No treatment-related major morbidity was observed. Follow-up imaging was available in 27 (90%) patients, with 23 patients (85%) showing satisfactory aneurysm occlusion OKM grade C-D. CONCLUSION: In this small cohort, the DED2 provided safe and effective treatment of ruptured and unruptured intracranial aneurysms.

When Can an Emergency CTA Be Dispensed with for TIA Patients?

BACKGROUND: Transient ischemic attacks (TIAs) and minor strokes are often precursors of a major stroke. Therefore, diagnostic work-up of the TIA is essential to reduce the patient's risk of further ischemic events. PURPOSE: With the help of this retrospective study, we aim to determine for which TIA patients a CT angiography (CTA) is not immediately necessary in order to reduce radiation exposure and nephrotoxicity. MATERIAL AND METHODS: Clinical and imaging data from patients who presented as an emergency case with a suspected diagnosis of TIA at a teaching hospital between January 2016 and December 2021 were evaluated. The included 1526 patients were divided into two groups-group 1, with major pathologic vascular findings in the CTA, and group 2, with minor vascular pathologies. RESULTS: Out of 1821 patients with suspected TIA on admission, 1526 met the inclusion criteria. In total, 336 (22%) had major vascular pathologies on CTA, and 1190 (78%) were unremarkable. The majority of patients with major vascular pathologies were male and had a history of arterial hypertension, coronary heart disease, myocardial infarction, ischemic stroke, TIA, atherosclerotic peripheral vascular disease, smoking, antiplatelet medication, had a lower duration of TIA symptoms, and had lower ABCD2 scores. CONCLUSIONS: We were able to demonstrate a direct correlation between major CTA pathologies and a history of smoking, age, hyperlipidemia, history of peripheral arterial disease, and a history of stroke and TIA. We were able to prove that the ABCD2 score is even reciprocal to CTA pathology. This means that TIA patients without described risk factors do not immediately require a CTA and could be clarified in the course of treatment with ultrasound or MRI.

CT and DSA for evaluation of spontaneous intracerebral lobar bleedings.

Purpose: This study retrospectively examined the extent to which computed tomography angiography (CTA) and digital subtraction angiography (DSA) can help identify the cause of lobar intracerebral bleeding. Materials and methods: In the period from 2002 to 2020, data from patients who were >18 years at a university and an academic teaching hospital with lobar intracerebral bleeding were evaluated retrospectively. The CTA DSA data were reviewed separately by two neuroradiologists, and differences in opinion were resolved by consensus after discussion. A positive finding was defined as an underlying vascular etiology of lobar bleeding. Results: The data of 412 patients were retrospectively investigated. DSA detected a macrovascular cause of bleeding in 125/412 patients (33%). In total, sixty patients had AVMs (15%), 30 patients with aneurysms (7%), 12 patients with vasculitis (3%), and 23 patients with dural fistulas (6%). The sensitivity, specificity, positive and negative predictive values, and accuracy of CTA compared with DSA were 93, 97, 100, and 97%. There were false-negative CTA readings for two AVMs and one dural fistula. Conclusion: The DSA is still the gold standard diagnostic modality for detecting macrovascular causes of ICH; however, most patients with lobar ICH can be investigated first with CTA, and the cause of bleeding can be found. Our results showed higher sensitivity and specificity than those of other CTA studies.

Safety and Efficacy of the Novel Low-Profile APERIO Hybrid17 for a Treatment of Proximal and Distal Vessel Occlusion in Acute Ischemic Stroke: A Multi-Center Experience.

OBJECTIVE: To report our initial experience with the novel low-profile APERIO Hybrid17 Thrombectomy Device (AP17) for proximal and distal vessel occlusions in acute ischemic stroke. METHODS: A multicentric retrospective analysis of patients treated with the AP17 was performed. The primary effectiveness endpoint was first-pass TICI ≥2b (Thrombolysis in cerebral infarction scale). The primary safety endpoint was the occurrence of hemorrhagic complications. Further outcome measures were number of passes, device-related complications, and 3-month functional outcome. RESULTS: The AP17 was used in 71 patients (mean age: 73 years) with a median baseline National Institutes of Health Stroke Scale score of 9. Treated vessels were the carotid-T in 8 cases (11%), the M1-segment in 16 (23%), the M2-segment in 29 (41%), the anterior cerebral artery in 3 (4%), and basilar/posterior cerebral arteries in 15 (21%). The rates of first-pass and final TICI ≥2b were 75.6% and 92.7%, retrospectively, with a mean number of passes of 3 ± 2. Final TICI ≥2b rates were comparable between large and medium vessel occlusions. Symptomatic intracranial hemorrhages were recorded in 2 cases (2.8%). At 3-month clinical follow-up, a modified Rankin scale score ≤2 was achieved in 69.0% (29/42). The all-cause mortality at discharge was 17.4%. CONCLUSIONS: The AP17 was associated with a reasonable safety and efficacy profile for both proximal and distal vessel occlusions. These results may contribute to establish mechanical thrombectomy for distal occlusions.

The Tigertriever 13 for mechanical thrombectomy in distal and medium intracranial vessel occlusions.

PURPOSE: To report our two-center initial experience using the Tigertriever 13 in the treatment of acute stroke of distal, medium vessel occlusions (DMVO). METHODS: We performed a retrospective analysis of all patients treated by mechanical thrombectomy using the Tigertriever 13 device (a manually expandable low profile stent retriever) due to an acute DMVO. Locations included the anterior, middle, and posterior cerebral artery in the A2 and A3, the M3 and M4, and the P2 or P3 segment and the superior cerebellar artery. RESULTS: Forty-three patients with 45 DMVOs underwent MTE using the Tigertriever 13 with the intention-to-treat approach between May 2019 and December 2020. After a median of two thrombectomy maneuvers, the successful recanalization rate (mTICI 2b-3) was 84.4% (38/45) with a first pass effect of 26.7% (12/45). The rate of symptomatic intracranial hemorrhages (sICH) and subarachnoid hemorrhages (SAH) was 7.0% (3/43) and 14.0% (6/43), respectively. At discharge, 53.5% (23/43) of the patients had a favorable clinical outcome (mRS 0-2). CONCLUSION: Mechanical thrombectomy in DMVOs using the Tigertriever 13 leads to high recanalization rates. The incidence of mostly asymptomatic hemorrhagic events appears higher compared to MTE procedures in LVOs. Further studies will help to identify anatomic and clinical criteria to define a guideline for MTE in DMVOs.

Mechanical Thrombectomy in Acute Terminal Internal Carotid Artery Occlusions Using a Large Manually Expandable Stentretriever (Tiger XL Device): Multicenter Initial Experience.

BACKGROUND: The recently introduced Tigertriever XL Device for treatment of cerebral vessel occlusions combines manual adjustability and maximum length in one device. In this study, we report our initial experience with the Tigertriever XL in terminal ICA occlusions. METHODS: Retrospective multicenter analysis of acute terminal ICA occlusions treated by mechanical thrombectomy using the Tigertriever XL Device. RESULTS: 23 patients were treated using the Tigetriever XL due to an acute occlusion of the terminal ICA. The overall successful reperfusion rate after a median of two maneuvers using the Tigertriever XL Device was 78.3% (mTICI 2b-3). In 43.5% (10/23) additional smaller devices were applied to treat remaining occlusions in downstream territories, which resulted in a final successful reperfusion rate of 95.7%. Device related complications did not occur. Two symptomatic intracerebral hemorrhages (sICH) were observed. CONCLUSIONS: The Tigertriever XL Device might be a helpful tool in the treatment of ICA terminus occlusions with large clot burden resulting in high reperfusion rates. This is mainly related to the manual adjustability of the device combined with the maximum length.

The transvenous retrograde pressure cooker technique for the curative embolization of high-grade brain arteriovenous malformations.

BACKGROUND: Transvenous embolization of brain arteriovenous malformations (AVMs) can be curative. We aimed to evaluate the cure rate and safety of the transvenous retrograde pressure cooker technique (RPCT) using coils and n-butyl-2-cyanoacrylate as a venous plug. METHODS: All AVM patients treated via transvenous embolization between December 2004 and February 2017 in a single center were extracted from our database. Inclusion criteria were: inability to achieve transarterial cure alone; AVM < 3 cm; and single main draining vein. Outcome measures were immediate and 90 days' angiographic AVM occlusion rate, and morbidity and mortality at 30 days and 12 months, according to the modified Rankin Scale (mRS) score. RESULTS: Fifty-one patients (20 women; median age 47 years) were included. A majority (71%) were high grade (3 to 5 in the Spetzler-Martin classification). AVMs were deeply seated in 30 (59%) and cortical in 21 patients (41%). Thirty-three patients were previously embolized transarterially (65%). All patients but one were cured within a single session with the RPCT (96%). Cure was confirmed on follow-up digital subtraction angiography at 3 months in 82% of patients. Three patients experienced intracranial hemorrhage (6%), one requiring surgical evacuation. There were no deaths. One treatment-related major permanent deficit was observed (2.0%). Mean mRS before treatment, at 30 days, and 12 months after RPCT was 1.5, 1.5, and 1.3, respectively. CONCLUSIONS: The retrograde pressure cooker technique can be curative in carefully selected high-grade AVMs. Long-term follow-up and prospective studies are needed to confirm our results.

Incidence of Acute Kidney Injury After Computed Tomography Angiography±Computed Tomography Perfusion Followed by Thrombectomy in Patients With Stroke Using a Postprocedural Hydration Protocol.

Background The risk of contrast-induced acute kidney injury (AKI) in patients with stroke receiving both computed tomography (CT) angiography and mechanical thrombectomy has been investigated only in small case series. No studies have investigated whether additional CT perfusion or chronic kidney disease (CKD) are associated with higher rates of AKI. Methods and Results Retrospective analysis of the AKI incidence in 1089 consecutive patients receiving CT angiography and mechanical thrombectomy from 2015 to 2017 and in subgroups with CKD (n=99) and CT perfusion (n=104) was performed. Patients received a standardized hydration protocol. Data on kidney function after mechanical thrombectomy were available in 1017 patients. A total of 59 (5.8%) patients developed AKI, and only 4 (6.8%) patients needed hemodialysis, all with known CKD. Patients with AKI significantly more often had known CKD (20.3% versus 8.4%, P=0.002), diabetes mellitus (33.9% versus 20.9%, P=0.018), and tandem occlusion (32.2% versus 16.2%, P=0.003) and a significantly higher in-hospital mortality (20.3% versus 7.0%, P<0.001) compared with patients without AKI. However, there were no significant independent predictors for AKI in multivariable logistic regression analysis. Sex (odds ratio [OR], 2.03; 95% CI, 1.17-3.52 [P=0.012]), higher National Institutes of Health Stroke Scale (OR, 1.10; 95% CI, 1.05-1.14 [P<0.001]), AKI (OR, 3.52; 95% CI, 1.63-7.64 [P=0.001]), diuretic use (OR, 1.80; 95% CI, 1.02-3.19), futile or incomplete recanalization (OR, 0.19; 95% CI, 0.09-0.40 [P<0.001]), and total volume of contrast agent volume (OR, 1.007; 95% CI, 1.002-1.011 [P=0.004]) were independently associated with in-hospital death. Two thirds of the patients with AKI died of severe brain damage and not AKI itself. Conclusions Post-contrast AKI rarely occurs in patients with stroke receiving a contrast agent for CT angiography/CT perfusion and subsequent mechanical thrombectomy. Patients with known CKD had higher rates of AKI and only these patients needed hemodialysis, but CKD was not independently associated with AKI or in-hospital mortality.

Endovascular Treatment of Intracranial Atherosclerotic Stenosis. / Endovaskuläre Behandlung intrakranieller arteriosklerotischer Stenosen.

BACKGROUND: Intracranial atherosclerotic stenosis (ICAS) causes 5 - 10 % of all ischemic strokes in the European population. Indication for endovascular treatment is a special challenge and the selection of material as well as interventional techniques essentially differs from the treatment of extracranial stenoses. According to recent studies patient selection became evidence based; however the method should not be abandoned. New technical approaches can contribute to avoid complications. METHOD: We performed a review of the literature with regard to conservative as well as endovascular treatment of ICAS. Different technical approaches are discussed and strategies to avoid complications are stressed. Based on the treatment indication, the positions of the authorities and the professional societies are taken into account. RESULTS AND CONCLUSION: A single self-expanding stent is approved for the treatment of ICAS. Balloon mounted and other self-expanding Stents are available for off-label use. Anatomical conditions and features of the stenosis determine the choice of material. Distal wire perforations causing intracranial bleedings may occur during exchange manoeuvres and constitute one of the technical complications in the treatment of ICAS. In contrast, there is hardly any efficient way to eliminate the risk of ischemia in the territory of perforating arteries arising from the intracranial posterior circulation and the middle cerebral artery. The results of the randomized prospective trials strengthen the conservative treatment of ICAS. Endovascular treatment should not be withheld from patients with either hemodynamic stenosis, recurrent ischemic events under best medical treatment in the territory of the stenosed vessel or acute occlusions of a stenosis. KEY POINTS: · Medical therapy and risk reduction constitute the primary treatment of intracranial stenosis.. · Recurrence under best medical treatment and acute occlusions of intracranial stenosis are indications for endovascular treatment.. · Acute occlusions due to intracranial stenosis often are treated by stenting and angioplasty after mechanical thrombectomy.. · Exchange manoeuvres with distal wire perforation can cause intracranial hemorrhage.. · Basal ganglia and brain stem ischemia constitute a specific risk in treatment of vessel segments bearing perforators.. CITATION FORMAT: · Nordmeyer H, Chapot R, Haage P. Endovascular Treatment of Intracranial Atherosclerotic Stenosis. Fortschr Röntgenstr 2019; 191: 643 - 652.

Treatment Methods and Early Neurologic Improvement After Endovascular Treatment of Tandem Occlusions in Acute Ischemic Stroke.

Background and Purpose: A tandem occlusion of the intracranial circulation and the extracranial carotid artery (ICA) occurs in 10-20% of all strokes based on large vessel occlusion (LVO). The optimal treatment strategy for those patients is unknown. We report our management strategy and the outcome in these patients in a large single-center cohort. Materials and Methods: We retrospectively identified and analyzed all patients treated by Mechanical Thrombectomy (MT) for an intracranial LVO associated with an occlusion of the extracranial ICA between April 2009 and May 2016 (163/1,645, 9.9%). The following data was collected: Recanalization rate, occurrence of symptomatic intracranial hemorrhage (sICH), clinical result according to the early neurological improvement (ENI, NIHSS score improvement of ≥8 points after 24 h or NIHSS score of 0 or 1 after 3 days) and functional outcome and mortality during long term follow up. Secondary endpoints were the patency of the internal carotid artery at 24 h. Patient demographics and anti-aggregation regimen were recorded as co-variables. Results: 163/1,645 (9.9%) MT patients had a tandem occlusion. All thrombectomy procedures were performed with stent retrievers. PTA with or without additional placement of a stent was performed in 149 vs. 14 patients. The overall rate of TICI IIB/III recanalization was 91.4%. An early neurological improvement was found in 79 of 163 patients (48.4%), 51% (76/149) in the stent group and 21% (3/14) in the non stent group. 120/163 patients (73.6%) had a long term favorable outcome (mRS 0-2). The ICA re-occlusion rate at 24 h was 5.4% (8/149) in the stent group and 42% (6/14) in the non stent group. The rate of symptomatic hemorrhage was 4.9%. The regression analysis showed that only younger age (p = 0.002) and shorter recanalization times (p = 0.017) were associated with good outcome. Conclusion: Stent-PTA of the ICA in addition to MT with a stent retriever was safe and effective in tandem occlusion of the anterior brain circulation. PTA and MT without stenting in tandem lesions showed a higher early re-occlusion rate and lower rate of early neurological improvement. The technical approach should aim for the fastest possible recanalization of the intracranial vessels, either with stenting first or last.

Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up.

PURPOSE: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year. RESULTS: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment. CONCLUSIONS: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. TRIAL REGISTRATION NUMBER: NCT02390037.

Angioplasty and Stenting of Intracranial Arterial Stenosis in Perforator-Bearing Segments: A Comparison Between the Anterior and the Posterior Circulation.

Background and Purpose: Subgroup analysis of the SAMMPRIS trial showed a higher rate of periprocedural perforator strokes with the Wingspan stent in the basilar artery in patients with symptomatic intracranial atherosclerotic stenosis (ICAS). It remains unclear whether angioplasty (PTA) alone or in combination with other stent types (PTAS) will yield similar results in perforator-bearing segments of the anterior and posterior circulation. Methods: We retrospectively analyzed the periprocedural complication rate, long term outcome and stroke etiology in 59 consecutive patients with ICAS of the middle cerebral artery (79 treatments) and 67 patients with ICAS of the intracranial vertebral and basilar artery (76 treatments) treated with PTA or PTAS from 2007 to 2015 in a high-volume neuro-interventional center. Results: Periprocedural symptomatic ischemic strokes occurred significantly more often in patients with posterior vs. anterior ICAS treatment (14.5 vs. 5.1%, p = 0.048). During a mean follow-up period of 19 (±23.7) months, 5 recurrent ischemic and 2 hemorrhagic strokes (10.4%) occurred in the territory of the treated artery in posterior circulation compared to 2 ischemic strokes in the anterior circulation (3.4%, p = 0.549). Overall, significantly more patients treated for a posterior ICAS suffered a periprocedural or follow-up stroke [25% vs. 11.4%, p = 0.024]. Periprocedural ischemic strokes were predominantly perforator strokes (73.3%), while all ischemic strokes during follow-up were caused by distal embolization (57.1%) or delayed stent occlusion (42.9%). There was no difference between PTA alone and PTAS. Conclusion: The periprocedural and long-term symptomatic stroke rate was significantly higher in the treatment of perforator-bearing arteries in the posterior circulation. There was no difference between PTA alone or PTAS.

Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap).

BACKGROUND AND PURPOSE: EmboTrap is a novel stent retriever designed to achieve rapid and substantial flow restoration in acute ischemic stroke secondary to large-vessel occlusions. Here, we evaluated EmboTrap's safety and efficacy compared with established stent retrievers. METHODS: ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) was a single-arm, prospective, multicenter study, comparing the EmboTrap device to a composite performance goal criterion derived using a Bayesian meta-analysis from the pivotal SWIFT (Solitaire device) and TREVO 2 (Trevo device) trials. Patients at 11 US and 8 European sites were eligible for inclusion if they had large-vessel occlusions and moderate-to-severe neurological deficits within 8 hours of symptom onset. The primary efficacy end point was achievement of modified Thrombolysis in Cerebral Ischemia (mTICI) reperfusion scores of ≥2b within 3 EmboTrap passes as adjudicated by the core laboratory. The primary safety end point was a composite of symptomatic intracerebral hemorrhage and serious adverse device effects. Secondary end points included functional independence (modified Rankin Scale, 0-2) and all-cause mortality at 90 days. RESULTS: Between October 2015 and February 2017, 227 patients were enrolled and treated with the EmboTrap device. The primary efficacy end point (mTICI ≥2b within 3 passes) was achieved in 80.2% (95% confidence interval, 74%-85% versus 56% performance goal criterion; P value, <0.0001), and mTICI 2c/3 was 65%. After all interventions, mTICI 2c/3 was achieved in 76%, and mTICI ≥2b was 92.5%. The rate of first pass (mTICI ≥2b following a single pass) was 51.5%. The primary safety end point composite rate of symptomatic intracerebral hemorrhage or serious adverse device effects was 5.3%. Functional independence and all-cause mortality at 90 days were 67% and 9%, respectively. CONCLUSIONS: The EmboTrap stent-retriever mechanical thrombectomy device demonstrated high rates of substantial reperfusion and functional independence in patients with acute ischemic stroke secondary to large-vessel occlusions. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02488915.

Direct Mechanical Intervention Versus Bridging Therapy in Stroke Patients Eligible for Intravenous Thrombolysis: A Pooled Analysis of 2 Registries.

BACKGROUND AND PURPOSE: Randomized controlled trials have shown that mechanical thrombectomy (MT) plus best medical treatment improves outcome in stroke patients with large-vessel occlusion in the anterior circulation. Whether direct MT is equally effective as bridging thrombolysis (intravenous thrombolysis plus MT) in intravenous thrombolysis eligible patients remains unclear. METHODS: We compared clinical and radiological outcomes at 3 months in 249 bridging patients with 111 patients receiving direct MT for large-vessel occlusion anterior circulation stroke from 2 prospective registries (study period Essen: June 2012 to August 2013, Bern February 2009 to August 2014). We matched all patients from the direct MT group who would have qualified for intravenous thrombolysis with controls from the bridging group, using multivariate and propensity score methods. Subgroup analyses for internal carotid artery occlusions were performed. RESULTS: Baseline characteristics did not differ between the direct MT group and bridging cohort, except for higher rates of coronary heart disease (P=0.029) and shorter intervals from onset to endovascular therapy (P<0.001) in the MT group. Functional outcome, mortality, and intracerebral hemorrhage did not differ, neither in univariate nor after multivariate and propensity score matching. However, in patients with internal carotid artery occlusion, mortality in the direct cohort was significantly lower. CONCLUSIONS: In this matched-pair analysis, there was no difference in outcome in patients with large-vessel occlusion anterior circulation stroke treated with direct MT compared with those treated with bridging thrombolysis; however, mortality in patients with internal carotid artery occlusion treated with direct MT was significantly lower than after bridging thrombolysis. Randomized trials comparing direct MT with bridging therapy are needed.

The association between collateral status, recanalization and long term outcome in stroke patients treated with stent retrievers - Are there indications not to perform thrombectomy based on CT angiography?

BACKGROUND AND PURPOSE: To investigate the association between baseline pial collateral status on computed tomography angiography (CTA) with recanalization and functional outcome in patients with acute anterior circulation stroke treated with stent retriever thrombectomy. MATERIAL AND METHODS: Retrospective analysis of 87 patients from a prospective thrombectomy registry. Collateral status on CTA source images was categorized into good, moderate, and poor with the Tan and Miteff scores by two-blinded readers. Association between CTA collateral status and successful recanalization was investigated with univariate regression analysis. Multivariate logistic regression was used to analyse the association between collateral score and favourable clinical outcome (mRS 0-2) and death at follow-up. RESULTS: Mean age was 72.5 years and baseline median NIHSS score was 15. Patients with poor collaterals on Tan score had a significant higher mortality compared with moderate or good collaterals during a mean follow-up period of 5.2 months (85.7% vs. 30.6% vs. 25.7%, P<0.001). Univariate logistic regression analysis did not show a significant association between Tan score (OR 1.681, 95% CI 0.683-4.140) and successful recanalization. Higher age (OR 1.067, 95% CI 1.013-1.124; P=0.015) and lower Tan score (OR 0.421, 95% CI 0.192-0.922; P=0.031) were independent predictors of death at follow-up on multivariate analysis. The Miteff collateral score could be assessed only in 65 of the 87 patients and the Tan collateral score had a higher interrater reliability. CONCLUSIONS: Poor collaterals on CTA were associated with a very high rate of fatal outcome in anterior circulation stroke patients despite a high rate of successful recanalization with stent retrievers.

Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study.

BACKGROUND AND PURPOSE: The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes. RESULTS: Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period. CONCLUSIONS: The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods. CLINICAL TRIAL REGISTRATION: NCT02390037.

Comparison of outcome and interventional complication rate in patients with acute stroke treated with mechanical thrombectomy with and without bridging thrombolysis.

BACKGROUND: No randomized trial has investigated the effect of mechanical thrombectomy (MT) alone in patients with acute stroke. There are conflicting results as to whether prior intravenous thrombolysis (IVT) facilitates subsequent MT, and data in patients treated with MT alone owing to contraindications to IVT are limited. OBJECTIVE: To compare consecutive patients treated with MT alone or with preceding IVT in a large tertiary neurointerventional center, with special emphasis on contraindications to IVT. METHODS: Retrospective analysis of 283 consecutive patients with acute ischemic stroke treated with MT in a tertiary neurovascular center over 14 months. Data on characteristics of periprocedural times, recanalization rate, complications, and long-term functional outcome were collected prospectively. RESULTS: Information on prior IVT and functional outcome was available in 250 patients. Mean (SD) follow-up period was 5.7 (5.1) months and 105 (42%) patients received both IVT and MT. No significant differences were found in successful recanalization rates (Thrombolysis in Cerebral Infarction (TICI) 2b/3, 73.8% vs 73.1, p=0.952), complication rates, and long-term favorable outcome (modified Rankin Scale 0-2, 35.2% vs 40%, p=0.444) between patients receiving MT plus IVT and those receiving MT alone. A favorable outcome in patients directly treated with MT alone who were eligible for IVT was achieved in 48.2%. Thrombectomy was safe and resulted in a favorable outcome in 32% of patients with absolute contraindications to IVT. CONCLUSIONS: Preceding use of IVT was not an independent predictor of favorable outcome in patients with acute stroke treated with MT and complication rates did not differ whether or not IVT was used. MT is safe and achieved a favorable outcome in one-third of patients with stroke ineligible for IVT.

The diagnostic challenge of Divry van Bogaert and Sneddon Syndrome: Report of three cases and literature review.

Divry van Bogaert Syndrome (DBS) is a familial juvenile-onset disorder characterized by livedo racemosa, white matter disease, dementia, epilepsy and angiographic finding of "cerebral angiomatosis". A similar syndrome including livedo racemosa and cerebrovascular disease, often associated with anticardiolipin antibodies, has been described as Sneddon Syndrome (SS) highlighting the question whether these two conditions have to be considered different entities or indeed different features of a unique syndrome. Herein, we report the clinical, neuroradiological, histopathological findings and follow up of three cases diagnosed as Divry-van Bogaert Syndrome, including an updated review of literature of both DBS and SS cases. Our findings support the assumption that DBS and SS are different disease entities. DBS is characterized by the typical angiographic feature of angiomatosis, a hereditary trait and a juvenile onset of cognitive impairment and leukoaraiosis, whereas SS has less severe manifestations of cerebrovascular disease associated with livedo racemosa but without the characteristic cerebral angiography. The report of our cases and the literature review underline the necessity of a detailed work-up and the collection of larger series to better clarify the DBS and SS phenotype and course.