Periprocedural safety of saccular aneurysm embolization with the Penumbra SMART Coil System: a SMART registry subset analysis

Background Using data from the SMART registry, we report on periprocedural safety of the Penumbra SMART Coil System for endovascular coil embolization of saccular intracranial aneurysms. Methods The SMART registry was a prospective, multi-center registry of site standard of care endovascular coiling procedures performed using at least 75% Penumbra SMART Coil, PC400, and/or POD coils. This subset analysis reports on the periprocedural safety outcomes of the saccular intracranial aneurysm cohort. Predictors of rupture/re-rupture or perforation (RRP), thromboembolic complications, and device- or procedure-related adverse events (AEs) were determined in univariate and multivariate analysis. Results Between June 2016 and August 2018, 851 saccular aneurysm patients (31.0%, 264/851 ruptured) were enrolled across 66 North American centers. Clinically significant (ie, a serious adverse event) RRP occurred in 2.0% (17/851) of cases – 1.9% (5/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Clinically significant thromboembolic events occurred in 3.1% (26/851) of cases – 5.3% (14/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Multivariate predictors of periprocedural RRP were increased packing density and adjunctive treatment with a balloon. For periprocedural thromboembolic events, multivariate predictors were bifurcation location and ruptured status. For device- or procedure-related AEs, multivariate predictors were bifurcation location and adjunctive treatment with stent or balloon. Conclusion The low rates of thromboembolic complications and RRP events demonstrate the adequate safety profile of the SMART Coil System to treat cerebral aneurysms in routine clinical practice

Bridging thrombolysis in atrial fibrillation stroke is associated with increased hemorrhagic complications without improved outcomes

BACKGROUND: Atrial fibrillation (AF) associated ischemic stroke is associated with worse functional outcomes, less effective recanalization, and increased rates of hemorrhagic complications after intravenous thrombolysis (IVT). Conversely, AF is not associated with hemorrhagic complications or functional outcomes in patients undergoing mechanical thrombectomy (MT). This differential effect of MT and IVT in AF associated stroke raises the question of whether bridging thrombolysis increases hemorrhagic complications in AF patients undergoing MT. METHODS: This international cohort study of 22 comprehensive stroke centers analyzed patients with large vessel occlusion (LVO) undergoing MT between June 1, 2015 and December 31, 2020. Patients were divided into four groups based on comorbid AF and IVT exposure. Baseline patient characteristics, complications, and outcomes were reported and compared. RESULTS: 6461 patients underwent MT for LVO. 2311 (35.8%) patients had comorbid AF. In non-AF patients, bridging therapy improved the odds of good 90 day functional outcomes (adjusted OR (aOR) 1.29, 95% CI 1.03 to 1.60, p=0.025) and did not increase hemorrhagic complications. In AF patients, bridging therapy led to significant increases in symptomatic intracranial hemorrhage and parenchymal hematoma type 2 (aOR 1.66, 1.07 to 2.57, p=0.024) without any benefit in 90 day functional outcomes. Similar findings were noted in a separate propensity score analysis. CONCLUSION: In this large thrombectomy registry, AF patients exposed to IVT before MT had increased hemorrhagic complications without improved functional outcomes, in contrast with non-AF patients. Prospective trials are warranted to assess whether AF patients represent a subgroup of LVO patients who may benefit from a direct to thrombectomy approach at thrombectomy capable centers

Outcomes of Mechanical Thrombectomy for Patients With Stroke Presenting With Low Alberta Stroke Program Early Computed Tomography Score in the Early and Extended Window

Importance: Limited data are available about the outcomes of mechanical thrombectomy (MT) for real-world patients with stroke presenting with a large core infarct. Objective: To investigate the safety and effectiveness of MT for patients with large vessel occlusion and an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of 2 to 5. Design, setting, and participants: This retrospective cohort study used data from the Stroke Thrombectomy and Aneurysm Registry (STAR), which combines the prospectively maintained databases of 28 thrombectomy-capable stroke centers in the US, Europe, and Asia. The study included 2345 patients presenting with an occlusion in the internal carotid artery or M1 segment of the middle cerebral artery from January 1, 2016, to December 31, 2020. Patients were followed up for 90 days after intervention. The ASPECTS is a 10-point scoring system based on the extent of early ischemic changes on the baseline noncontrasted computed tomography scan, with a score of 10 indicating normal and a score of 0 indicating ischemic changes in all of the regions included in the score. Exposure: All patients underwent MT in one of the included centers. Main outcomes and measures: A multivariable regression model was used to assess factors associated with a favorable 90-day outcome (modified Rankin Scale score of 0-2), including interaction terms between an ASPECTS of 2 to 5 and receiving MT in the extended window (6-24 hours from symptom onset). Results: A total of 2345 patients who underwent MT were included (1175 women [50.1%]; median age, 72 years [IQR, 60-80 years]; 2132 patients [90.9%] had an ASPECTS of ≥6, and 213 patients [9.1%] had an ASPECTS of 2-5). At 90 days, 47 of the 213 patients (22.1%) with an ASPECTS of 2 to 5 had a modified Rankin Scale score of 0 to 2 (25.6% [45 of 176] of patients who underwent successful recanalization [modified Thrombolysis in Cerebral Ischemia score ≥2B] vs 5.4% [2 of 37] of patients who underwent unsuccessful recanalization; P = .007). Having a low ASPECTS (odds ratio, 0.60; 95% CI, 0.38-0.85; P = .002) and presenting in the extended window (odds ratio, 0.69; 95% CI, 0.55-0.88; P = .001) were associated with worse 90-day outcome after controlling for potential confounders, without significant interaction between these 2 factors (P = .64). Conclusions and relevance: In this cohort study, more than 1 in 5 patients presenting with an ASPECTS of 2 to 5 achieved 90-day functional independence after MT. A favorable outcome was nearly 5 times more likely for patients with low ASPECTS who had successful recanalization. The association of a low ASPECTS with 90-day outcomes did not differ for patients presenting in the early vs extended MT window

Abstract Number: LBA4 Platelet Function Testing and Acute Thrombotic Events in Intracranial Aneurysm Patients Undergoing Flow Diversion

Introduction Introduction The role of platelet function testing in patients with intracranial aneurysms undergoing flow diversion remains controversial with limited evidence of its influence on thrombotic outcomes. We report an observational cohort analysis evaluating the association of P2Y12 assay testing with thrombotic events in patients undergoing flow diversion. Methods We performed a retrospective review of our prospectively maintained procedural database to identify patients who underwent flow diversion between January 2020 and July 2022. One physician within our practice never performs P2Y12 assay testing. All other physicians utilize P2Y12 assay testing as part of routine practice. These two different patient cohorts were compared. Acute thrombotic events were our primary outcome. Secondary outcomes included delayed intracerebral hemorrhage, intimal hyperplasia without clinical sequalae, and transient neurologic deficits. Results We identified 150 patients who underwent flow diversion at our institution between January 2020 and July 2022. Median age was 59 years old (Interquartile range (IQR) 49–67), with 113 females (82.5%) and 24 males (17.5%). Out of 150 patients, 93 (62.0%) patients were treated by physicians who performed routine pre and postoperative testing of aspirin and Plavix assays, with subsequent adjustment of antithrombotic dosing accordingly, while 57 patients (38.0%) were treated by the single physician who prescribes aspirin and clopidogrel pre‐operatively without testing. In all, seven out of 150 patients (4.7%) had an acute thrombotic event requiring intraarterial anti‐thrombotic infusion or urgent thrombectomy, or both. Of these, six where from the 93 patient testing cohort (6.5%), and one in 57 patients non‐testing cohort (1.8%) (p = 0.2). Patients who had a thrombotic event were more likely to have underlying atrial fibrillation (28.6% vs 4.9%, p = 0.01) but otherwise had similar demographics, vascular risk factors, maximal aneurysmal diameter, and parent vessel diameter (Table 1). In a multivariable analysis adjusting for age, maximal aneurysm diameter, ruptured aneurysms, and atrial fibrillation, P2Y12 sensitivity assay testing was not significantly associated with acute thrombotic events in aneurysm patients undergoing flow diversion (Odds Ratio (OR) = 0.15, 95% Confidence Interval (CI) = 0.01‐2.67), p = 0.2). Secondary outcomes were also comparable between both groups; transient neurologic deficits were noted in 4/93 in the testing group (4.3%), and 6/57 in the non‐testing group (10%) (p = 0.14), intracranial hemorrhage occurred in only 2 patients, both in the testing group (p = 0.3), and mild intimal hyperplasia was observed in 18.3% in the testing group versus 12.3% in the non‐testing group (p = 0.33). Conclusions Platelet function testing showed no significant correlation with thrombotic events or outcomes in our cohort. The role of platelet function testing remains controversial, albeit widely used in patients undergoing flow diversion of intracranial aneurysms

Wide-neck aneurysms: Systematic review of the neurosurgical literature with a focus on definition and clinical implications

OBJECTIVE Wide-necked aneurysms (WNAs) are a variably defined subset of cerebral aneurysms that require more advanced endovascular and microsurgical techniques than those required for narrow-necked aneurysms. The neurosurgical literature includes many definitions of WNAs, and a systematic review has not been performed to identify the most commonly used or optimal definition. The purpose of this systematic review was to highlight the most commonly used definition of WNAs. METHODS The authors searched PubMed for the years 1998.2017, using the terms gwide neck aneurysm h and gbroad neck aneurysm h to identify relevant articles. All results were screened for having a minimum of 30 patients and for clearly stating a definition of WNA. Reference lists for all articles meeting the inclusion criteria were also screened for eligibility. RESULTS The search of the neurosurgical literature identified 809 records, of which 686 were excluded (626 with \u3c 30 patients; 60 for lack of a WNA definition), leaving 123 articles for analysis. Twenty-seven unique definitions were identified and condensed into 14 definitions. The most common definition was neck size ≥ 4 mm or dome-to-neck ratio \u3c 2, which was used in 49 articles (39.8%). The second most commonly used definition was neck size ≥ 4 mm, which was used in 26 articles (21.1%). The rest of the definitions included similar parameters with variable thresholds. There was inconsistent reporting of the precise dome measurements used to determine the dome-to-neck ratio. Digital subtraction angiography was the only imaging modality used to study the aneurysm morphology in 87 of 122 articles (71.3%). CONCLUSIONS The literature has great variability regarding the definition of a WNA. The most prevalent definition is a neck diameter of . 4 mm or a dome-to-neck ratio of \u3c 2. Whether this is the most appropriate and clinically useful definition is an area for future study

High rates of conversion of anesthesia modality in agitated thrombectomy patients

Background: Patients with large vessel occlusion acute ischemic stroke (AIS) undergoing thrombectomy can be disruptively agitated. We aimed to determine if procedural and neurological outcomes differ for agitated patients. Methods: We reviewed prospectively collected data of AIS patients undergoing thrombectomy in our tertiary center between January 2014 and July 2017. We divided patients in two cohorts based on the presence of disruptive levels of agitation. We compared the baseline characteristics, procedural details and outcomes between the two cohorts. Results: A total of 156 patients were included, 60 (38.5%) were agitated. The agitated cohort had lower mean ASPECTS (8.3 vs 8.8, p 0.04); but other characteristics were well-matched (age, gender, premorbid mRS, occlusion side, NIHSS and tPA status). There was a trend for longer room arrival-to-recanalization times (87.1 vs 72.9 mins, p 0.09) and higher use of general anesthesia (GA) (35% vs 24%, p 0.14) in the agitated cohort (table 1). In the agitated cohort, pre-planned GA patients had longer arrival to recanalization times when compared with monitored anesthesia care (MAC) only patients (100.5 ± 73.0 vs 75.3 ± 49.8 mins). None of the non-agitated MAC patients required conversion to GA, however 11.6% of the agitated patients were converted to GA intra-procedurally, with the longest arrival-to-recanalization time (125.1 ± 68.7) (p 0.04). Other technical details (method of thrombectomy, number of passes, complications and degree of recanalization) and outcome measures (postoperative NIHSS or good neurological outcome at 90 days) were not different between groups. Conclusions: Agitated patients have a high incidence of conversion from MAC to GA resulting in delay in recanalization compared to pre-planned GA. Our study was limited by a small sample size and larger studies are necessary to elucidate the impact of agitation on outcome and whether there is role for pre-planned GA in agitated thrombectomy patients