Multicenter early United States feasibility study and periprocedural safety of LVIS EVO for the treatment of unruptured intracranial aneurysms.

BACKGROUND: Stent development has focused recently on low-profile, self-expandable stents compatible with 0.0165 inch microcatheters. The LVIS EVO is the second-generation version of the Low-Profile Visualized Intraluminal Support (LVIS) with improved visibility and resheathability. The LVIS EVO underwent a limited premarket release (PMR) in December 2023. This study aims to report the early safety and feasibility experience with the LVIS EVO stent for the treatment of intracranial aneurysms in the United States (US). METHODS: This was a multicenter, retrospective, observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. All physicians who had placed an LVIS EVO stent were asked to input their cases after institutional review board approval was obtained. The data were then sent to a single center for analysis. Any patient aged 18 years or older who underwent treatment of an intracranial aneurysm with a LVIS EVO stent in the US was included from the initial PMR in December 2023 until April 2024. Patient age (or ≤90 years old), sex, preoperative modified Rankin Scale (mRS), aneurysm location, aneurysm measurements, and information about preoperative antiplatelet management were all collected. Data on periprocedural complications, 30-day mortality, discharge mRS, and length of stay were also collected. RESULTS: Some 53 patients with 55 aneurysms underwent treatment with the LVIS EVO stent at 15 institutions. All aneurysms were unruptured. The most common location was the anterior communicating artery (35%) followed by the middle cerebral artery bifurcation (31%). All patients were on dual antiplatelet therapy. The average aneurysm size was 5.2 mm with a neck size of 3.7 mm. The smallest distal parent vessel size was 1.2 mm and 36% of stents were deployed in distal parent vessels <2 mm. All (100%) cases had successful deployment and the stent was repositioned in 10% of cases. A single stent was utilized in 91% of cases. Coils were placed in 48 cases (87.2%) and a microcatheter was jailed in 98% of those cases. Immediate Raymond Roy (RR) Class I occlusion was obtained in 33%, Class II in 22%, Class IIIa in 37%, and Class IIIb in 8% of cases. There were no delayed thromboembolic or hemorrhagic complications. CONCLUSIONS: The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The drawn filled tube (DFT) technology results in improved visibility of the stent, allowing for more controlled stent positioning and visualization of vessel wall apposition. All cases in our series had complete neck coverage and good wall apposition. There were no thromboembolic or hemorrhagic complications.

Primary results from the CLEAR study of a novel stent retriever with drop zone technology.

BACKGROUND: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. OBJECTIVE: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. METHODS: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). RESULTS: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). CONCLUSIONS: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. TRIAL REGISTRATION NUMBER: NCT04514562.

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology.

BACKGROUND: Most conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation. METHODS: This is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement. RESULTS: Each study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0-2%, and 10.26% were deceased. CONCLUSIONS: Tracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

Walrus large bore guide catheter impact on recanalization first pass effect and outcomes: the WICkED study.

BACKGROUND: The use of a balloon-guide catheter (BGC) in acute stroke treatment has been widely adopted after demonstrating optimized procedure metrics and outcomes. Initial technical constraints of previous devices included catheter stiffness and smaller inner diameters. We aim to evaluate the performance and safety of the Walrus BGC, a variable stiffness catheter with a large bore 0.087 inch inner diameter (ID), via the the WICkED study (Walrus Large Bore guide Catheter Impact on reCanalization first pass Effect anD outcomes). METHODS: This is a retrospective, site adjudicated, multicenter study on consecutive patients with large vessel occlusion treated with the Walrus BGC. Baseline characteristics, procedural outcomes and functional outcomes were analyzed. RESULTS: A total of 338 patients met the inclusion criteria. The Walrus was successfully tracked into distal vasculature and allowed therapeutic device delivery in all but 3 cases (0.9%). Large aspiration catheters ≥0.070 inch ID were used in 71.9% of cases. Stent retriever thrombectomy was used as the first-line modality in 59.2% and thromboaspiration in 40.8% of cases. The successful recanalization rate (modified treatment in cerebral ischemia (mTICI) 2b/3) was 94.4%, with 64.8% of the patients achieving mTICI 2b/3 after the first pass. The Walrus-related adverse event rate was 0.6%, corresponding to two vessel dissections. Functional independence was 50% (126/252) and mortality 25% (63/252). Unfavorable outcomes were more likely in older patients, who had unsuccessful reperfusion, longer procedure times, and a higher mean number of passes. CONCLUSION: In acute ischemic stroke patients presenting with large vessel occlusion, the Walrus BGC demonstrated excellent navigability and safety profile, allowed the accommodation of leading large bore aspiration catheters, and demonstrated high vessel recanalization rates.

Cystic angiomatosis skull lesion obliteration with neuroendovascular sclerotherapy as a unique treatment: case report.

Cystic angiomatosis is a rare bone condition with complex presentation and difficult treatment. Current management strategies have poorly tolerated side effects and a low likelihood of disease eradication. The control of calvarial lesions that are symptomatic usually involves surgical excision and subsequent cranioplasty. This paradigm can present with a risk of morbidity and mortality depending on the anatomy of the lesion. Here, the authors present a novel approach to a difficult-to-treat occipital calvarial lesion directly overlying the transverse sinus, performing a small, partial-thickness craniectomy and alcohol sclerotherapy in a combined neurosurgery-neuroendovascular approach. At 3 years after treatment, the authors noted a complete, encouraging radiographic and clinical outcome.

Infectious intracranial aneurysms: a systematic review of epidemiology, management, and outcomes.

Infectious intracranial aneurysms (IIAs) are a rare cerebrovascular complication of systemic infections induced by microbial infiltration and degradation of the arterial vessel wall. Studies on the epidemiology and management of IIAs are limited to case reports and retrospective single-center studies, and report a large variability in epidemiological features, management, and outcomes due to the limited sample size. We conducted a systematic review of all published papers on IIAs in the English literature using MEDLINE and SCOPUS database from January 1950 to June 2017. A total of 288 publications describing 1191 patients with IIA (1398 aneurysms) were included and reviewed for epidemiological features, disease features, treatment and outcome. All patients were merged into a single cohort and summary data are presented. The majority of reported IIAs are distally located, relatively small (<5 mm), involve the anterior circulation, are associated with a relatively high rate of rupture, and demonstrate a propensity to multiplicity of aneurysms. Sensitive diagnosis of IIAs requires digital subtraction angiography and not CT angiography or MR angiography. Treatment of ruptured, symptomatic, or enlarging IIAs has evolved over the last 50 years. Endovascular therapy is associated with a high success rate and low morbidity compared with microsurgical and medical management. A treatment algorithm for the management of patients with IIA in various contexts is proposed and the need for prospective multicenter studies is emphasized.

Treatment of blood blister aneurysms of the internal carotid artery with flow diversion.

BACKGROUND: Blood blister aneurysms (BBA) are a rare subset of intracranial aneurysms that represent a therapeutic challenge from both a surgical and endovascular perspective. OBJECTIVE: To report multicenter experience with flow diversion exclusively for BBA, located at non-branching segments along the anteromedial wall of the supraclinoidal internal carotid artery (ICA). METHODS: Consecutive cases of BBA located at non-branching segments along the anteromedial wall of the supraclinoidal ICA treated with flow diversion were included in the final analysis. RESULTS: 49 patients with 51 BBA of the ICA treated with devices to achieve the flow diversion effect were identified. 43 patients with 45 BBA of the ICA were treated with the pipeline embolization device and were included in the final analysis. Angiographic follow-up data were available for 30 patients (32 aneurysms in total); 87.5% of aneurysms (28/32) showed complete obliteration, 9.4% (3/32) showed reduced filling, and 3.1% (1/32) persistent filling. There was no difference between the size of aneurysm (≤2 mm vs >2 mm) or the use of adjunct coiling and complete occlusion of the aneurysm on follow-up (P=0.354 and P=0.865, respectively). Clinical follow-up data were available for 38 of 43 patients. 68% of patients (26/38) had a good clinical outcome (modified Rankin scale score of 0-2) at 3 months. There were 7 (16%) immediate procedural and 2 (5%) delayed complications, with 1 case of fatal delayed re-rupture after the initial treatment. CONCLUSIONS: Our data support the use of a flow diversion technique as a safe and effective therapeutic modality for BBA of the supraclinoid ICA.

The golden 35†min of stroke intervention with ADAPT: effect of thrombectomy procedural time in acute ischemic stroke on outcome.

INTRODUCTION: In acute ischemic stroke (AIS), extending mechanical thrombectomy procedural times beyond 60 min has previously been associated with an increased complication rate and poorer outcomes. OBJECTIVE: After improvements in thrombectomy methods, to reassess whether this relationship holds true with a more contemporary thrombectomy approach: a direct aspiration first pass technique (ADAPT). METHODS: We retrospectively studied a database of patients with AIS who underwent ADAPT thrombectomy for large vessel occlusions. Patients were dichotomized into two groups: 'early recan', in which recanalization (recan) was achieved in ≤35 min, and 'late recan', in which procedures extended beyond 35 min. RESULTS: 197 patients (47.7% women, mean age 66.3 years) were identified. We determined that after 35 min, a poor outcome was more likely than a good (modified Rankin Scale (mRS) score 0-2) outcome. The baseline National Institutes of Health Stroke Scale (NIHSS) score was similar between 'early recan' (n=122) (14.7±6.9) and 'late recan' patients (n=75) (15.9±7.2). Among 'early recan' patients, recanalization was achieved in 17.8±8.8 min compared with 70±39.8 min in 'late recan' patients. The likelihood of achieving a good outcome was higher in the 'early recan' group (65.2%) than in the 'late recan' group (38.2%; p<0.001). Patients in the 'late recan' group had a higher likelihood of postprocedural hemorrhage, specifically parenchymal hematoma type 2, than those in the 'early recan' group. Logistic regression analysis showed that baseline NIHSS, recanalization time, and atrial fibrillation had a significant impact on 90-day outcomes. CONCLUSIONS: Our findings suggest that extending ADAPT thrombectomy procedure times beyond 35 min increases the likelihood of complications such as intracerebral hemorrhage while reducing the likelihood of a good outcome.

Equivalent favorable outcomes possible after thrombectomy for posterior circulation large vessel occlusion compared with the anterior circulation: the MUSC experience.

INTRODUCTION: In acute ischemic stroke (AIS), posterior circulation large vessel occlusions (LVOs) have been associated with poorer outcomes compared with anterior circulation LVOs. The outcomes of anterior versus posterior circulation thrombectomy for LVOs were compared at a high volume center employing a direct aspiration first pass technique (ADAPT). METHODS: We retrospectively studied a database of AIS cases that underwent ADAPT thrombectomy for LVOs. Cases were grouped by anatomical location of thrombectomy (posterior vs anterior circulation), and analysis was performed on both entire sample size. RESULTS: A total of 436 AIS patients (50.2% women, mean age 67.3 years) underwent ADAPT thrombectomy for LVO during the study period, of whom 13% of had posterior circulation thrombectomy. Patients with posterior circulation thrombectomy did not show a significant difference in preprocedural variables, including age, baseline National Institutes of Health Stroke Scale (NIHSS), and onset to groin time, compared with anterior circulation (P>0.05). There were also no differences in procedural variables between the two groups. Patients in the posterior group were found to have a similar likelihood of good outcome (modified Rankin Scale score 0-2) at 90 days compared with the anterior group (42.9% vs 43.2%, respectively), and a small but not significant increase in mortality at 90 days. Multilogistic regression analysis showed that the anatomical location (anterior vs posterior) was not an independent predictor of good outcome or mortality after thrombectomy. Prominent predictors of outcome/mortality included age, female gender, procedure time, and baseline NIHSS. CONCLUSIONS: Our findings demonstrate that when patients are carefully selected for thrombectomy, those with posterior circulation LVOs can achieve similar outcomes compared with anterior circulation thrombectomy, indicating comparable safety and efficacy profiles.

Dural venous sinus stenting for medically and surgically refractory idiopathic intracranial hypertension.

Background Idiopathic intracranial hypertension (IIH) is a syndrome defined by elevated intracranial hypertension without radiographic evidence of a mass lesion in the brain. Dural venous sinus stenosis has been increasingly recognized as a treatable cause, and dural venous sinus stenting (DVSS) is increasingly performed. Methods A 5 year single-center retrospective analysis of consecutive patients undergoing DVSS for medically refractory IIH. Results There were 43 patients with a mean imaging follow-up of 6.5 months and a mean clinical follow-up period of 13.5 months. DVSS was performed as the first procedure for medically refractory IIH in 81.4% of patients, whereas 18.6% of patients included had previously had a surgical procedure (ventriculoperitoneal (VP) shunt or optic nerve sheath fenestration (ONSF)). Headache was present in all patients and after DVSS improved or remained stable in 69.2% and 30.8%, respectively. Visual acuity changes and visual field changes were present in 88.4% and 37.2% of patients, respectively. Visual field improved or remained unchanged in 92%, but worsened in 8% after stenting. There was a stent patency rate of 81.8%, with an 18.2% re-stenosis rate. Of the 43 procedures performed, there was a 100% technical success rate with zero major or minor complications. Conclusion Based on this single-center retrospective analysis, DVSS can be performed with high technical success and low complication rates. A majority of patients presented primarily with headache, and these patients had excellent symptom relief with DVSS alone. Patients presenting with visual symptoms had lower success rates, and this population, if stented, should be carefully followed for progression of symptoms.

Impact of ASPECT scores and infarct distribution on outcomes among patients undergoing thrombectomy for acute ischemic stroke with the ADAPT technique.

OBJECTIVE: To investigate the associations between Alberta Stroke Program Early CT Score (ASPECTS) or distribution and sidedness of acute infarction and clinical outcomes following intervention with a direct aspiration first pass technique (ADAPT). METHODS: A review was performed of patients who had undergone thrombectomy with ADAPT for emergent large vessel occlusions of the middle cerebral artery (MCA) between December 2012 and May 2015. Preintervention CT scans were reviewed by a blinded radiologist to calculate ASPECTS and determine the distribution of infarction. Clinical outcomes were compared for subsets of patients depending upon ASPECTS and regional infarction distribution (cortical, subcortical, or both). RESULTS: One hundred and fifty-four patients (50% female, mean age 67) underwent thrombectomy using ADAPT for MCA emergent large vessel occlusion. The median presenting National Institute of Health Stroke Scale score was 15. Fifty-five per cent of patients had left-side occlusions. Similar good outcomes were achieved for patients with perfect and non-perfect ASPECTS (modified Rankin Scale (mRS) 0-2: 63% vs 51%, respectively; p=0.20). Similar outcomes were also achieved for patients with 'poor' ASPECTS (≤6) compared with those with ASPECTS >6 (mRS 0-2: 52% vs 53%, respectively; p=0.91). Regional distribution and sidedness of core infarction on preintervention CT also did not correlate with worse outcomes. CONCLUSIONS: Patients with moderate-sized core infarcts involving various distributions in either hemisphere can potentially achieve similar good outcomes compared with those with no core infarction at presentation. A treatment algorithm for acute ischemic stroke, which employs hardline ASPECTS thresholds or excludes patients with basal ganglia infarcts, might preclude patients who would potentially benefit from mechanical thrombectomy with ADAPT.

Safety, immediate and mid-term results of the newer generation of hydrogel coils in the treatment of ruptured aneurysms: a multicenter study.

OBJECTIVE: To assess the 'real-world' performance of the newer generation of hydrogel coils in ruptured aneurysms. METHODS: A multicenter retrospective study was carried out of angiographic and clinical outcome data on consecutive patients with ruptured aneurysms treated with at least 70% of the newer generation of hydrogel coils. Demographics and data on clinical grade, smoking, use of statins, aneurysm size, location, technique used, packing density, immediate angiographic result, angiographic follow-up, rebleeding and clinical outcome were obtained and analyzed. RESULTS: Eighty patients (54F; 26M) with an average age of 55.1 years were entered in the study. Forty-four presented good clinical grade (Hunt and Hess 1 or 2). Forty-two (52.5%) aneurysms were ≤5 mm. 56.7% of the aneurysms were treated with simple coil embolization and 39.6% with balloon-assisted coil. The packing density ranged from 9.3% to 92.6% (mean 48.5%). Immediate occlusion rates (Raymond-Roy Scale) were: complete occlusion (class I) in 57.5%, residual neck (class II) in 32.5% and residual aneurysm (class III) in 10%. Intraoperative rupture occurred in 3 cases (3.75%). Clinical follow-up, available in 73 patients, showed a good outcome (modified Rankin Scale 0-2) in 76.3%. Preliminary data on imaging follow-up were available in 54 patients (average 6.8 months) with complete occlusion in 77.8%, residual neck in 20.3% and residual aneurysm in 1.9%. There was no re-hemorrhage. CONCLUSIONS: Our data show that the use of the newer-generation hydrogel coils in the treatment of ruptured aneurysms is feasible, safe and effective with high immediate and mid-term occlusion rates and low morbidity.

Endovascular treatment for AIS with underlying ICAD.

BACKGROUND: Acute large vessel occlusion (LVO) can result from thromboemboli or underlying intracranial atherosclerotic disease (ICAD). Although the technique for revascularization differs significantly for these two lesions (simple thrombectomy for thromboemboli and balloon angioplasty and stenting for ICAD), the underlying etiology is often unknown in acute ischemic stroke (AIS). OBJECTIVE: To evaluate whether procedural complications, revascularization rates, and functional outcomes differ among patients with LVO from ICAD or thromboembolism. METHODS: A retrospective review of thrombectomy cases from 2008 to 2015 was carried out for cases of AIS due to underlying ICAD. Thirty-six patients were identified. A chart and imaging review was performed to determine revascularization rates, periprocedural complications, and functional outcomes. Patients with ICAD and acute LVO were compared with those with underlying thromboemboli. RESULTS: Among patients with ICAD and LVO, mean National Institutes of Health Stroke Scale (NIHSS) score on admission was 12.9±8.5, revascularization (Thrombolysis In Cerebral Infarction, TICI ≥2b) was achieved in 22/34 (64.7%) patients, 11% had postprocedural intracerebral hemorrhage (PH2), and 14/33 (42.4%) had achieved a modified Rankin Scale (mRS) score of 0-2 at the 3-month follow-up. Compared with patients without underlying ICAD, there was no difference in NIHSS on presentation, or in the postprocedural complication rate. However, procedure times for ICAD were longer (98.5±59.8 vs 37.1±34.2 min), there was significant difference in successful revascularization rate between the groups (p=0.001), and a trend towards difference in functional outcome at 3 months (p=0.07). CONCLUSIONS: Despite AIS with underlying ICAD requiring a more complex, technically demanding recanalization strategy than traditional thromboembolic AIS, it appears safe, and good outcomes are obtainable.

Initial experience with the PulseRider for the treatment of bifurcation aneurysms: report of first three cases in the USA.

INTRODUCTION: The PulseRider is a novel device intended for use in the treatment of aneurysms arising at bifurcations. We present the initial results of the first three cases in the USA employing the PulseRider device. METHODS: Aneurysms intended to be treated with the PulseRider device at a single institution were identified prospectively. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad-necked were considered candidates for treatment with the novel device. RESULTS: Patients were pretreated with dual antiplatelet therapy. All cases were performed under general endotracheal anesthesia. An appropriately sized PulseRider device was deployed across the neck of the aneurysm. A microcatheter was then navigated over a 0.014 inch microwire through the device into the aneurysm. Complete occlusion of the aneurysm was achieved in all cases without intraprocedural complications. CONCLUSIONS: We have found in our early experience with the Pulse Rider device that its use is safe and effective as an adjunct in the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.

Carotid sacrifice with a single Penumbra occlusion device: a feasibility study in a swine model.

INTRODUCTION: Carotid sacrifice is a valuable tool in the treatment of select vascular lesions. Traditional coil embolization as the primary means of carotid sacrifice can be expensive, with high radiation exposure. We investigated the feasibility of a novel hybrid coil, the Penumbra occlusion device (POD), for carotid sacrifice in a swine model. METHODS: A total of eight common carotid artery sacrifices were performed in fully heparinized pigs under fluoroscopic guidance. A single POD device was deployed within each vessel, and intermittent follow-up angiography was performed to assess flow. RESULTS: Complete carotid occlusion was achieved in all cases with a single POD (time range 2-15 min) without any coil migration or intraprocedural complications. Once the anchor zone was stable, no distal migrations were observed during either proximal soft coil packing or during hand injected angiography. Complete occlusion was verified between 2 and 15 min following POD deployment. CONCLUSIONS: Carotid artery sacrifice using a novel POD device is safe and effective, allowing for reduced radiation and material costs compared with any other described endovascular technique.

The case for a milestone-based simulation curriculum in modern neuroendovascular training.

The role of simulation in formal neuroendovascular training has not been defined. This report details the general principles underlying the use of simulation in training, the critical aspects of the simulation environment which would aid it as a teaching tool specific to the field of neuroendovascular care, summarizes the available evidence to support a milestone-based curriculum, and outlines an example of what such a curriculum would entail. Building on these foundations, we articulate the rationale for the development and widespread adoption of a simulation curriculum for formal neuroendovascular training.

Initial multicenter technical experience with the Apollo device for minimally invasive intracerebral hematoma evacuation.

BACKGROUND: No conventional surgical intervention has been shown to improve outcomes for patients with spontaneous intracerebral hemorrhage (ICH) compared with medical management. OBJECTIVE: We report the initial multicenter experience with a novel technique for the minimally invasive evacuation of ICH using the Penumbra Apollo system (Penumbra Inc, Alameda, California). METHODS: Institutional databases were queried to perform a retrospective analysis of all patients who underwent ICH evacuation with the Apollo system from May 2014 to September 2014 at 4 centers (Medical University of South Carolina, Stony Brook University, University of California at San Diego, and Semmes-Murphy Clinic). Cases were performed either in the neurointerventional suite, operating room, or in a hybrid operating room/angiography suite. RESULTS: Twenty-nine patients (15 female; mean age, 62 ± 12.6 years) underwent the minimally invasive evacuation of ICH. Six of these parenchymal hemorrhages had an additional intraventricular hemorrhage component. The mean volume of ICH was 45.4 ± 30.8 mL, which decreased to 21.8 ± 23.6 mL after evacuation (mean, 54.1 ± 39.1% reduction; P < .001). Two complications directly attributed to the evacuation attempt were encountered (6.9%). The mortality rate was 13.8% (n = 4). CONCLUSION: Minimally invasive evacuation of ICH and intraventricular hemorrhage can be achieved with the Apollo system. Future work will be required to determine which subset of patients are most likely to benefit from this promising technology.

Balloon-augmented Onyx embolization of cerebral arteriovenous malformations using a dual-lumen balloon: a multicenter experience.

INTRODUCTION: Conventional Onyx embolization of cerebral arteriovenous malformations (AVMs) requires lengthy procedure and fluoroscopy times to form an adequate 'proximal plug' which allows forward nidal penetration while preventing reflux and non-targeted embolization. We review our experience with balloon-augmented Onyx embolization of cerebral AVMs using a dual-lumen balloon catheter technique designed to minimize these challenges. METHODS: Retrospectively acquired data for all balloon-augmented cerebral AVM embolizations performed between 2011 and 2014 were obtained from four tertiary care centers. For each procedure, at least one Scepter C balloon catheter was advanced into the AVM arterial pedicle of interest and Onyx embolization was performed through the inner lumen after balloon inflation via the outer lumen. RESULTS: Twenty patients underwent embolization with the balloon-augmented technique over 24 discreet treatment episodes. There were 37 total arterial pedicles embolized with the balloon-augmented technique, a mean of 1.9 per patient (range 1-5). The treated AVMs were heterogeneous in their location and size (mean 3.3±1.6 cm). Mean fluoroscopy time for each procedure was 48±26 min (28 min per embolized pedicle). Two Scepter C balloon catheter-related complications (8.3% of embolization sessions, 5.4% of pedicles embolized) were observed: an intraprocedural rupture of a feeding pedicle and fracture and retention of a catheter fragment. CONCLUSIONS: This multicenter experience represents the largest reported series of balloon-augmented Onyx embolization of cerebral AVMs. The technique appears safe and effective in the treatment of AVMs, allowing more efficient and controlled injection of Onyx with a decreased risk of reflux and decreased fluoroscopy times.

Diagnostic angiography skill acquisition with a secondary curve catheter: phase 2 of a curriculum-based endovascular simulation program.

BACKGROUND: We have previously reported the efficacy of a simulator-based training paradigm for residents in neurosurgery with little or no prior experience in diagnostic cerebral angiography with straightfoward arch anatomy. This study investigates the utility of a simulation-based training curriculum for the acquisition of skills employing a secondary curve catheter to navigate more complex arch anatomy. METHODS: Residents at the Medical University of South Carolina (MUSC) with moderate exposure to diagnostic angiography enrolled into a standardized Institutional Review Board-approved training protocol using SimSuite Compass and Simbionix simulators. The task involved (in order) forming the Simmons catheter in the left subclavian artery and then selecting the brachiocephalic, left common carotid and left vertebral arteries. RESULTS: All participants improved their total time to complete the task over the course from the first to last trial. Each milestone within the overall task also demonstrated an improvement across trials for each participant. Following the hands-on experience, participants' rating of their knowledge of arch anatomy and vessel selection technique improved to that between competence and high competence (values of 3.3±0.49 (p<0.005) and 3.1±0.38 (p<0.01), respectively). Comfort with use of the Simmons catheter improved to a value of 2.9±0.38 (p<0.001), between an experienced learner and competence. Participants rated the usefulness of the training environment as very high (4.1±0.90 out of maximum 5). CONCLUSIONS: Residents became more proficient at vessel selection in a type II and bovine arch over a relatively compressed time period, with both objective and subjective data demonstrating acquisition of skill sets and increased confidence.

Proximal to distal approach in the treatment of tandem occlusions causing an acute stroke.

INTRODUCTION: A tandem occlusion is a rare presentation of acute stroke that involves an occlusion of the internal carotid artery at the bifurcation with an intracranial middle cerebral artery occlusion. This study describes the experience at our institution in treating tandem occlusions with a proximal to distal approach in the acute stroke setting. METHODS: A retrospective review of acute strokes caused by tandem occlusions requiring thrombectomy were performed. RESULTS: 16 cases were identified with a mean National Institutes of Health Stroke Scale score at presentation of 13.1 ± 3.9. The proximal occlusion was crossed initially with a microwire in all cases. All carotid occlusions were treated with stenting, and intracranial vessel thrombectomy was performed with a variety of devices. Procedure related complications occurred in two (12.5%) patients. Eight patients (50%) achieved a good outcome (modified Rankin Scale score of 0-2). CONCLUSIONS: A tandem occlusion of the carotid artery at the bifurcation with a concomitant intracranial occlusion is a relatively rare and complex presentation of acute stroke. We have found that addressing the proximal lesion first and covering it with a stent prior to performing distal thrombectomy appears to be a safe and effective option in the treatment algorithm.