Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study.

BACKGROUND: Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE. METHODS: The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality. RESULTS: In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0-2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4-9.0] mm, and the median neck width was 3.6 [2.7-5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4-12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively. CONCLUSION: These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs.

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.

Safety and Efficacy of Flow Diverters for Treatment of Unruptured Anterior Communicating Artery Aneurysms: Retrospective Multicenter Study.

BACKGROUND: The anterior communicating artery (AComm) region is the most common site of intracranial aneurysms, with increased rupture risk compared with other locations. Overall, flow diverters present as a safe and efficacious treatment for intracranial aneurysms, but there is paucity of data for their use in the treatment of unruptured AComm aneurysms. We present the largest multicentric analysis evaluating the outcomes of flow diverters in AComm aneurysm treatment. METHODS: Databases from 10 centers were retrospectively reviewed for unruptured AComm aneurysms treated with flow diverters. Demographics, clinical presentation, radiographic characteristics, procedural complications, and outcomes were assessed. RESULTS: A total of 144 patients harboring 147 AComm aneurysms were treated between January 2012 and December 2021. Seventy-four were women (51.4%) and median age was 60 (IQR 50-67) years. All were unruptured AComm aneurysms. Half of the cohort had similar anterior cerebral artery sizes (51.4%). The most common morphology was saccular (94.6%), with a branch involvement in 32.7% of cases. Median vessel diameter was 2.4 mm, and the Pipeline Flex was the most prevalent device (32.7%). Median follow-up time was 17 months, with complete occlusion in 86.4% at the last follow-up. Functional independence (modified Rankin Scale score 0-2) was reported in 95.1%. Intraprocedural complications occurred in 5.6%, and postoperative complications were noted in 9.7% of cases. Combined major complication and mortality rate was 2.1%. CONCLUSIONS: Our study suggests that flow diverters are a useful treatment for AComm aneurysms. Mid-term results indicated favorable aneurysm occlusion with a good safety profile. Additional prospective studies with longer follow-up periods and independent adjudication are warranted to better assess these results.

Sonolucent Cranioplasty in Extracranial to Intracranial Bypass Surgery: Early Multicenter Experience of 44 Cases.

BACKGROUND: The new sonolucent cranioplasty implant (clear polymethyl methacrylate, PMMA) adds functionality besides surgical reconstruction. One possible application uses the transcranioplasty ultrasound (TCUS) technique after PMMA cranioplasty to assess graft patency of extracranial-intracranial (EC-IC) bypass procedures. OBJECTIVE: To report our early multicenter experience. METHODS: This is a multicenter analysis of consecutive EC-IC bypass patients from 5 US centers (2019-2022) with closure postbypass using PMMA implant. RESULTS: Forty-four patients (median age 53 years, 68.2% females) were included. The most common indication for bypass was Moyamoya disease/syndrome (77.3%), and superficial temporal artery to middle cerebral artery bypass was the most common procedure (79.5%). Pretreatment modified Rankin Scales of 0 and 1 to 2 were noted in 11.4% and 59.1% of patients, respectively. Intraoperative imaging for bypass patency involved a combination of modalities; Doppler was the most used modality (90.9%) followed by indocyanine green and catheter angiography (86.4% and 61.4%, respectively). Qualitative TCUS assessment of graft patency was feasible in all cases. Postoperative inpatient TCUS confirmation of bypass patency was recorded in 56.8% of the cases, and outpatient TCUS surveillance was recorded in 47.7%. There were no cases of bypass failure necessitating retreatment. Similarly, no implant-related complications were encountered in the cohort. Major complications requiring additional surgery occurred in 2 patients (4.6%) including epidural hematoma requiring evacuation (2.3%) and postoperative surgical site infection (2.3%) that was believed to be unrelated to the implant. CONCLUSION: This multicenter study supports safety and feasibility of using sonolucent PMMA implant in EC-IC bypass surgery with the goal of monitoring bypass patency using TCUS.

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

BACKGROUND: The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. METHODS: PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. RESULTS: As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. CONCLUSIONS: The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture. TRIAL REGISTRATION: NCT02186561.

Evaluation of time-resolved whole brain flat panel detector perfusion imaging using RAPID ANGIO in patients with acute stroke: comparison with CT perfusion imaging.

BACKGROUND: In contrast to conventional CT perfusion (CTP) imaging, flat panel detector CT perfusion (FD-CTP) imaging can be acquired directly in the angiosuite. OBJECTIVE: To evaluate time-resolved whole brain FD-CTP imaging and assess clinically important qualitative and quantitative perfusion parameters in correlation with previously acquired conventional CTP using the new RAPID for ANGIO software. METHODS: We included patients with internal carotid artery occlusions and M1 or M2 occlusions from six centers. All patients underwent mechanical thrombectomy (MT) with preinterventional conventional CTP and FD-CTP imaging. Quantitative performance was determined by comparing volumes of infarct core, penumbral tissue, and mismatch. Eligibility for MT according to the perfusion imaging criteria of DEFUSE 3 was determined for each case from both conventional CTP and FD-CTP imaging. RESULTS: A total of 20 patients were included in the final analysis. Conventional relative cerebral blood flow (rCBF) <30% and FD-CTP rCBF <45% showed good correlation (R2=0.84). Comparisons of conventional CTP Tmax >6 s versus FD-CTP Tmax >6 s and CTP mismatch versus FD-CTP mismatch showed more variability (R2=0.57, and R2=0.33, respectively). Based on FD-CTP, 16/20 (80%) patients met the inclusion criteria for MT according to the DEFUSE 3 perfusion criteria, in contrast to 18/20 (90%) patients based on conventional CTP. The vessel occlusion could be correctly extrapolated from the hypoperfusion in 18/20 cases (90%). CONCLUSIONS: In our multicenter study, time-resolved whole brain FD-CTP was technically feasible, and qualitative and quantitative perfusion results correlated with those obtained with conventional CTP.

Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes.

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.

Predictors of incomplete aneurysm occlusion after treatment with the Pipeline Embolization Device: PREMIER trial 1 year analysis.

BACKGROUND: Flow diverters have revolutionized the treatment of intracranial aneurysms. Nevertheless, some aneurysms fail to occlude with flow diversion. The Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device (PREMIER) was a prospective, multicenter and single-arm trial of small and medium wide-necked unruptured aneurysms. In the current study, we evaluate the predictors of treatment failure in the PREMIER cohort. METHODS: We analyzed PREMIER patients who had incomplete occlusion (Raymond-Roy >1) at 1 year angiographic follow-up and compared them with those who achieved Raymond-Roy 1, aiming to identify predictors of treatment failure. RESULTS: 25 aneurysms demonstrated incomplete occlusion at 1 year. There was a median reduction of 0.9 mm (IQR 0.41-2.43) in maximum diameter between pre-procedure and 1 year measurements, with no aneurysmal hemorrhage. Patients with incomplete occlusion were significantly older than those with complete occlusion (p=0.011). Smoking (p=0.045) and C6 segment location (p=0.005) were significantly associated with complete occlusion, while location at V4 (p=0.01) and C7 (p=0.007) and involvement of a side branch (p<0.001) were significantly associated with incomplete occlusion. In multivariable logistic regression, significant predictors of incomplete occlusion were non-smoker status (adjusted OR 4.49, 95% CI 1.11 to 18.09; p=0.03) and side branch involvement (adjusted OR 11.68, 95% CI 3.84 to 35.50; p<0.0001), while C6 location had reduced odds of incomplete occlusion (adjusted OR 0.29, 95% CI 0.10 to 0.84; p=0.02). CONCLUSIONS: The results of our study are consistent with previous retrospective series and warrant consideration for technique adaptations to achieve higher occlusion rates. Further follow-up is needed to assess progression of aneurysm occlusion and clinical behavior in these cases.

Transvenous Onyx Embolization of Carotid-Cavernous Fistulas: Mid- and Long-Term Outcomes.

Objective Endovascular treatment of carotid-cavernous fistulas (CCFs) has been consistently shown to give excellent results and is currently the mainstay of treatment of these complex vascular pathologies. Onyx is currently the most widely used agent, but there has been concern over high rates of cranial nerve (CN) deficits seen in patients with CCF treated with Onyx and paucity of data on long-term outcomes. Methods This is a retrospective analysis of patients who underwent transvenous Onyx embolization between 2011 and 2018. The data collected included demographics, comorbidities, presenting symptoms, CCF morphology, degree of obliteration, procedure-related complications, clinical outcomes, and follow-up. Results A total of seven patients (five females) were included. The median age was 66 years (range: 15-79 years). Median duration of symptoms before treatment was 4 weeks (range: 1-24 weeks). There were three direct and four indirect CCFs. Barrow classification is as follows: A-3; B-3; C-0; and D-1. Immediate complete occlusion was achieved in all cases. There was also one case of immediate postoperative change in CN function (new partial CN VI deficit) that resolved completely at 1-month follow-up. The mean length of stay was 3 days (±2). The preoperative extraocular movement CN deficits had the following outcomes: three resolved; two improved; and one persisted. Proptosis, chemosis, conjunctival injection, and tinnitus were resolved in all patients. The median follow-up was 34 months (range: 10-91 months). Conclusion Transvenous Onyx embolization is a safe and effective treatment of CCFs when technical aspects to reduce complications are performed diligently. Our technique demonstrates safety of the Onyx as a stand-alone embolization for the treatment of CCF.

Impact and prevention of errors in endovascular treatment of unruptured intracranial aneurysms.

BACKGROUND: Preventing errors and complications in neurointervention is crucial, particularly in the treatment of unruptured intracranial aneurysms (UIAs), where the natural history is generally benign, and the margin of treatment benefit small. We aimed to investigate how neurointerventionalists perceive the importance and frequency of errors and the resulting complications in endovascular UIA treatment, and which steps could be taken to prevent them. METHODS: An international multidisciplinary survey was conducted among neurointerventionalists. Participants provided their demographic characteristics and neurointerventional treatment volume. They were asked about their perceptions on the importance and frequency of different errors in endovascular UIA treatment, and which solutions they thought to be most effective in preventing these errors. RESULTS: Two-hundred-thirty-three neurointerventionalists from 38 countries participated in the survey. Participants identified errors in technical execution as the most common source of complications in endovascular UIA treatment (40.4% thought these errors constituted a relatively or very large proportion of all complication sources), closely followed by errors in decision-making/indication (32.2%) and errors related to management of unexpected events (28.4%). Simulation training was thought to be most effective in reducing technical errors, while cognitive errors were believed to be best minimized by abandoning challenging procedures, more honest discussion of complications and better standardization of procedure steps. CONCLUSION: Neurointerventionalists perceived both technical and cognitive errors to be important sources of complications in endovascular UIA treatment. Simulation training, a cultural change, higher acceptance of bail-out strategies and better standardization of procedures were perceived to be most effective in preventing these.

Combined Transarterial and Transvenous Onyx Embolization of Jugular Foramen Paragangliomas.

OBJECTIVE: Jugular foramen paragangliomas are highly vascular tumors known to have significant venous hemorrhage during resection even after conventional transarterial embolization. The authors report a novel technique to the endovascular embolization of jugular foramen paragangliomas using a combined transarterial and transvenous access for better intraoperative control of blood loss and visualization. METHODS: This is a retrospective data collection of 2 patients diagnosed with jugular foramen paragangliomas with novel embolization technique and surgical resection. RESULTS: Two patients underwent embolization of jugular foramen paragangliomas through combined transarterial and transvenous routes using 2 double-lumen balloon microcatheters. In both cases, single arterial vessel embolization was performed through the occipital artery in Case 1 and the tympanic branch of the ascending pharyngeal artery in Case 2. Simultaneously, balloon microcatheter occlusion in the sigmoid sinus and single venous outflow vessel embolization was performed. Near-complete occlusion was established, with angiographic disappearance of tumor blush. Surgical resection was performed in both cases. Estimated blood loss BL was 600 mL in Case 1 and 200 mL in Case 2. No blood transfusions were required, intraoperatively or postoperatively. There were no cranial nerve deficits post embolization. One patient had a persistent House Brackman 2 facial nerve palsy after resection. CONCLUSIONS: The initial experience with simultaneous transvenous and transarterial paraganglioma embolization demonstrated the safety of the technique and superior embolic agent penetration. This was supported by our observations during embolization and intraoperatively during tumor resection. Additional patients need to be treated with this technique for better assessment of long-term efficacy and incidence of embolization-related cranial neuropathies.

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.

BACKGROUND: Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. OBJECTIVE: To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. METHODS: PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. RESULTS: A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). CONCLUSIONS: Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. TRIAL REGISTRATION: NCT02186561.

Transvenous arteriovenous malformation embolization.

Transvenous embolization of arteriovenous malformations has emerged as a safe and effective intervention. In carefully selected patients the transvenous approach has shown efficacy similar to that of conventional transarterial routes. The optimal lesions amenable to the transvenous approach have not been robustly delineated; however, the approach is reserved for small, deep seeded, single venous drainage lesions with poorly amenable arterial vascular supply. In this video we demonstrate a case of transvernous Onyx embolization of a Spetzler-Martin grade 3 (SM3) left hemispheric, ruptured arteriovenous malformation. The patient underwent successful, single session, complete embolization of the arteriovenous malformation through a venous route without further complications or repeat treatment.

Preliminary outcomes of single antiplatelet therapy for surface-modified flow diverters in an animal model: analysis of neointimal development and thrombus formation using OCT.

OBJECTIVE: To evaluate the rate of neointimal development and thrombus formation of surface-modified flow diverters in single antiplatelet therapy (SAPT) using optical coherence tomography (OCT) in a porcine model. METHODS: We divided 10 experimental pigs into two groups. One group (n=6) received dual antiplatelet therapy (DAPT) and the other group (n=4) received SAPT. Four stents (two per carotid artery) were implanted in both groups. The stents used were the Pipeline Flex embolization device (PED Flex), Pipeline Flex with Shield technology (PED Shield), and the Solitaire AB stent. All animals underwent weekly angiography and OCT. The OCT data were analyzed using the following measurements: neointimal ratio ((stent - lumen area)/stent area), stent-coverage ratio (number of stent struts covered by neointima/total stent struts), and the presence or absence of thrombus formation per 1 mm cross-section. RESULTS: PED Flex and Shield in the SAPT group had higher neointimal ratios than in the DAPT group (P<0.001, respectively). In the DAPT group, the speed of endothelial growth on day 7 in the PED Shield group was higher than that in the PED Flex group (P<0.001). In the SAPT group, PED Flex demonstrated significantly more thrombus formation on day 7 than PED Shield (P<0.001). CONCLUSIONS: The PED Shield stent showed faster endothelial growth than the other devices and comparable neointimal volume. There was significantly less thrombus formation on PED Shield than PED Flex when using SAPT in a porcine model.

Endovascular Recanalization of Symptomatic Intracranial Arterial Stenosis Despite Aggressive Medical Management.

BACKGROUND: The optimal management of intracranial arterial stenosis is unclear, particularly in patients who have failed medical management. We report a multicenter real-world experience of endovascular recanalization of intracranial atherosclerotic stenosis refractory to aggressive medical therapy. METHODS: Retrospective multicenter case series of consecutive endovascularly treated patients presenting with symptomatic (transient ischemic attack [TIA] or stroke) intracranial stenosis who had failed medical therapy. Patients were divided into 2 groups: patients with recurrent TIA or stroke despite medical management (group 1) versus patients presenting with a stroke and worsening symptoms (progressive or crescendo stroke) despite medical management (group 2). RESULTS: A total of 101 patients were treated in 8 stroke centers from August 2009 to May 2017. Sixty-nine presented with recurrent TIA or stroke and 32 with stroke and worsening symptoms. Successful recanalization was achieved in 84% of patients. Periprocedural stroke occurred in 3 patients and 2 had a recurrent ischemic stroke at the 90-day follow-up. Symptomatic intraparenchymal hemorrhage secondary to reperfusion injury occurred in 3 patients and 1 had a hemorrhagic stroke after discharge. There were 2 periprocedural perforations that resulted in death. At 90 days, 86% of patients (64/74) did not have a recurrence of stroke and the 90-day cumulative ischemic stroke rate was 6.7% with 90-day mortality of 11.2%. The 90-day favorable outcome (modified Rankin Scale score, ≤2) rate was 77.5%. CONCLUSIONS: Endovascular recanalization of unstable intracranial atherosclerotic stenosis in patients who have failed medical therapy is feasible. Future randomized trials need to determine if recanalization is of any value for this population.

The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial.

INTRODUCTION: The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device. METHODS: The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months. RESULTS: One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9%) were female. Fifty-seven aneurysms (57/153, 37.3%) arose from the anterior cerebral artery, 43 (43/153, 28.1%) from the internal carotid artery, 17 (17/153, 11.1%) from the middle cerebral artery, 27 (27/153, 17.6%) from the basilar artery, six (6/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110/139) demonstrated complete occlusion- 92.1% (128/139) in this population demonstrated ≥95% occlusion and 95% demonstrated ≥90% occlusion (132/139). Eight participants (5.2%, 8/153) had at least one primary safety event in the ITT population. CONCLUSION: The LVIS stent system allows safe and highly effective coil embolization of WNAs. CLINICAL REGISTRATION NUMBER: NCT01793792.

Association of follow-up infarct volume with functional outcome in acute ischemic stroke: a pooled analysis of seven randomized trials.

BACKGROUND: Follow-up infarct volume (FIV) has been recommended as an early indicator of treatment efficacy in patients with acute ischemic stroke. Questions remain about the optimal imaging approach for FIV measurement. OBJECTIVE: To examine the association of FIV with 90-day modified Rankin Scale (mRS) score and investigate its dependency on acquisition time and modality. METHODS: Data of seven trials were pooled. FIV was assessed on follow-up (12 hours to 2 weeks) CT or MRI. Infarct location was defined as laterality and involvement of the Alberta Stroke Program Early CT Score regions. Relative quality and strength of multivariable regression models of the association between FIV and functional outcome were assessed. Dependency of imaging modality and acquisition time (≤48 hours vs >48 hours) was evaluated. RESULTS: Of 1665 included patients, 83% were imaged with CT. Median FIV was 41 mL (IQR 14-120). A large FIV was associated with worse functional outcome (OR=0.88(95% CI 0.87 to 0.89) per 10 mL) in adjusted analysis. A model including FIV, location, and hemorrhage type best predicted mRS score. FIV of ≥133 mL was highly specific for unfavorable outcome. FIV was equally strongly associated with mRS score for assessment on CT and MRI, even though large differences in volume were present (48 mL (IQR 15-131) vs 22 mL (IQR 8-71), respectively). Associations of both early and late FIV assessments with outcome were similar in strength (ρ=0.60(95% CI 0.56 to 0.64) and ρ=0.55(95% CI 0.50 to 0.60), respectively). CONCLUSIONS: In patients with an acute ischemic stroke due to a proximal intracranial occlusion of the anterior circulation, FIV is a strong independent predictor of functional outcome and can be assessed before 48 hours, oneither CT or MRI.