New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial.

[Figure: see text].

Early Experience with Comaneci, a Newly FDA-Approved Controllable Assist Device for Wide-Necked Intracranial Aneurysm Coiling.

BACKGROUND: Comaneci (Rapid Medical) is a compliant, adjustable mesh that provides temporary scaffolding during coiling of wide-necked intracranial aneurysms (WNAs) that preserves antegrade flow. We report our early multi-institutional experience with the Comaneci device in the USA. METHOD: We reviewed all patients with WNAs that were treated using the Comaneci device for coil remodeling of ruptured and unruptured aneurysms at 4 institutions between July 2019 and May 2020. Clinical characteristics, angiographic variables, and endovascular results were assessed. RESULTS: A total of 26 patients were included (18 women). The mean age was 62.7 years (range 44-81). Fifteen patients presented with ruptured aneurysms and 11 with unruptured aneurysms. The mean aneurysm neck width was 3.91 mm (range 1.9-6.5) with a mean dome-to-neck ratio of 1.57 (range 0.59-3.39). The mean maximum width was 5.80 mm (range 3.0-9.9) and the mean maximum height was 5.61 mm (range 2.0-11.8). Successful aneurysm occlusion was achieved in 25 of 26 patients. Complete occlusion was achieved in 16 patients, near-complete occlusion was observed in 9 patients, and 1 patient demonstrated residual filling. The mean time of device exposure was 24 min (range 8-76). No vasospasm was observed at the device location. Clot formation on the device was noted in 2 separate cases, but there were no clinical sequelae. There was 1 intraprocedural complication in a case that involved the simultaneous use of 2 Comaneci devices. CONCLUSIONS: Our initial experience shows that the Comaneci device is a promising and reliable tool that can safely support coil remodeling of WNAs.

Intraarterial Thrombolysis as Rescue Therapy for Large Vessel Occlusions.

Background and Purpose- Mechanical thrombectomy (MT) devices have led to improved reperfusion and clinical outcomes in acute ischemic stroke patients with emergent large vessel occlusions; however, less than one-third of patients achieve complete reperfusion. Use of intraarterial thrombolysis in the context of MT may provide an opportunity to enhance these results. Here, we evaluate the use of intraarterial rtPA (recombinant tissue-type plasminogen activator) as rescue therapy (RT) after failed MT in the North American Solitaire Stent-Retriever Acute Stroke registry. Methods- The North American Solitaire Stent-Retriever Acute Stroke registry recruited sites within North America to submit data on acute ischemic stroke patients treated with the Solitaire device. After restricting the population of 354 patients to use of RT and anterior emergent large vessel occlusions, we compared patients who were treated with and without intraarterial rtPA after failed MT. Results- A total of 37 and 44 patients was in the intraarterial rtPA RT and the no intraarterial rtPA RT groups, respectively. Revascularization success (modified Thrombolysis in Cerebral Infarction ≥2b) was achieved in more intraarterial rtPA RT patients (61.2% versus 46.6%; P=0.13) with faster times to recanalization (100±85 versus 164±235 minutes; P=0.36) but was not statistically significant. The rate of symptomatic intracranial hemorrhage (13.9% versus 6.8%; P=0.29) and mortality (42.9% versus 44.7%; P=0.87) were similar between the groups. Good functional outcome (modified Rankin Scale score of ≤2) was numerically higher in intraarterial rtPA patients (22.9% versus 18.4%; P=0.64). Further restriction of the RT population to M1 occlusions only and time of onset to groin puncture ≤8 hours, resulted in significantly higher successful revascularization rates in the intraarterial rtPA RT cohort (77.8% versus 38.9%; P=0.02). Conclusions- Intraarterial rtPA as RT demonstrated a similar safety and clinical outcome profile, with higher reperfusion rates achieved in patients with M1 occlusions. Prospective studies are needed to delineate the role of intraarterial thrombolysis in MT.

Ideal sedation for stroke thrombectomy: a prospective pilot single-center observational study.

OBJECTIVESeveral retrospective studies have supported the use of conscious sedation (CS) over general anesthesia (GA) as the preferred methods of sedation for stroke thrombectomy, but a recent randomized controlled trial showed no difference in outcomes after CS or GA. The purpose of the Ideal Sedation for Stroke Thrombectomy (ISST) study was to evaluate the difference in time and outcomes in the reperfusion of anterior circulation in ischemic stroke using GA and monitored anesthesia care (MAC).METHODSThe ISST study was a prospective, open-label registry. A total of 40 patients who underwent mechanical thrombectomy for anterior circulation ischemic stroke were enrolled. Informed consent was obtained from each patient before enrollment. The primary endpoint included the interval between the patient's arrival to the interventional radiology room and reperfusion time. Secondary endpoints were evaluated to estimate the effects on the outcome of patients between the 2 sedation methods.RESULTSOf the 40 patients, 32 received thrombectomy under MAC and 8 patients under GA. The male-to-female ratio was 18:14 in the MAC group and 4:4 in the GA group. The mean time from interventional radiology room arrival to reperfusion in the GA group was 2 times higher than that in the MAC group. Complete reperfusion (TICI grade 3) was achieved in more than 50% of patients in both groups. The mean modified Rankin Scale score at 3 months was < 2 in the MAC group and > 3 in the GA group (p = 0.021).CONCLUSIONSThe findings from the pilot study showed a significantly shorter time interval between IR arrival and reperfusion and better outcomes in patients undergoing reperfusion for ischemic stroke in the anterior circulation using MAC compared with GA.Clinical trial registration no.: NCT03036631 (clinicaltrials.gov).

Interhospital Transfer Before Thrombectomy Is Associated With Delayed Treatment and Worse Outcome in the STRATIS Registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke).

BACKGROUND: Endovascular treatment with mechanical thrombectomy (MT) is beneficial for patients with acute stroke suffering a large-vessel occlusion, although treatment efficacy is highly time-dependent. We hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared with direct presentation. METHODS: STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke because of anterior-circulation large-vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without intravenous tissue plasminogen activator and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0-2) at 90 days. We assessed (1) real-world time metrics of stroke care delivery, (2) outcome differences between direct and transfer patients undergoing MT, and (3) the potential impact of local hospital bypass. RESULTS: A total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct versus 311.5 minutes for transfer patients (P<0.001). Clinical outcomes were better in the direct group, with 60.0% (299/498) achieving functional independence compared with 52.2% (213/408) in the transfer group (odds ratio, 1.38; 95% confidence interval, 1.06-1.79; P=0.02). Likewise, excellent outcome (modified Rankin Score 0-1) was achieved in 47.4% (236/498) of direct patients versus 38.0% (155/408) of transfer patients (odds ratio, 1.47; 95% confidence interval, 1.13-1.92; P=0.005). Mortality did not differ between the 2 groups (15.1% for direct, 13.7% for transfer; P=0.55). Intravenous tissue plasminogen activator did not impact outcomes. Hypothetical bypass modeling for all transferred patients suggested that intravenous tissue plasminogen activator would be delayed by 12 minutes, but MT would be performed 91 minutes sooner if patients were routed directly to endovascular-capable centers. If bypass is limited to a 20-mile radius from onset, then intravenous tissue plasminogen activator would be delayed by 7 minutes and MT performed 94 minutes earlier. CONCLUSIONS: In this large, real-world study, interhospital transfer was associated with significant treatment delays and lower chance of good outcome. Strategies to facilitate more rapid identification of large-vessel occlusion and direct routing to endovascular-capable centers for patients with severe stroke may improve outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02239640.

First Pass Effect: A New Measure for Stroke Thrombectomy Devices.

BACKGROUND AND PURPOSE: In acute ischemic stroke, fast and complete recanalization of the occluded vessel is associated with improved outcomes. We describe a novel measure for newer generation devices: the first pass effect (FPE). FPE is defined as achieving a complete recanalization with a single thrombectomy device pass. METHODS: The North American Solitaire Acute Stroke Registry database was used to identify a FPE subgroup. Their baseline features and clinical outcomes were compared with non-FPE patients. Clinical outcome measures included 90-days modified Rankin Scale score, National Institutes of Health Stroke Scale score, mortality, and symptomatic intracranial hemorrhage. Multivariate analyses were performed to determine whether FPE independently resulted in improved outcomes and to identify predictors of FPE. RESULTS: A total of 354 acute ischemic stroke patients underwent thrombectomy in the North American Solitaire Acute Stroke registry. FPE was achieved in 89 out of 354 (25.1%). More middle cerebral artery occlusions (64% versus 52.5%) and fewer internal carotid artery occlusions (10.1% versus 27.7%) were present in the FPE group. Balloon guide catheters were used more frequently with FPE (64.0% versus 34.7%). Median time to revascularization was significantly faster in the FPE group (median 34 versus 60 minutes; P=0.0003). FPE was an independent predictor of good clinical outcome (modified Rankin Scale score ≤2 was seen in 61.3% in FPE versus 35.3% in non-FPE cohort; P=0.013; odds ratio, 1.7; 95% confidence interval, 1.1-2.7). The independent predictors of achieving FPE were use of balloon guide catheters and non-internal carotid artery terminus occlusion. CONCLUSIONS: The achievement of complete revascularization from a single Solitaire thrombectomy device pass (FPE) is associated with significantly higher rates of good clinical outcome. The FPE is more frequently associated with the use of balloon guide catheters and less likely to be achieved with internal carotid artery terminus occlusion.

Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry.

BACKGROUND AND PURPOSE: Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials. METHODS: STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis. RESULTS: A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab-adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2. CONCLUSIONS: This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Predictors of Mortality in Acute Ischemic Stroke Intervention: Analysis of the North American Solitaire Acute Stroke Registry.

BACKGROUND AND PURPOSE: Failure to recanalize predicts mortality in acute ischemic stroke. In the North American Solitaire Acute Stroke registry, we investigated parameters associated with mortality in successfully recanalized patients. METHODS: Logistic regression was used to evaluate baseline characteristics and recanalization parameters for association with 90-day mortality. A multivariable model was developed based on backward selection with retention criteria of P<0.05 from factors with at least marginal significance (P≤0.10), then refit to minimize the number of excluded cases (missing data). RESULTS: Successfully recanalized patients had lower mortality (25.2% [59/234] versus 46.9% [38/81] P<0.001). There was no difference in symptomatic intracranial hemorrhage between patients with successful versus failed recanalization (9% [21/234] versus 14% [11/79]; P=0.205). However, mortality was significantly higher in patients with symptomatic intracranial hemorrhage (72% [23/32] versus 26% [73/281]; P<0.001). Proximal occlusion (internal carotid artery or vertebrobasilar), initial National Institutes of Health Stroke Scale≥18, use of rescue therapy (P<0.05), and 3+ passes (P<0.10) were associated with mortality in recanalized patients. In the multivariate model with good predictive power (c index=0.72), proximal occlusion, initial National Institutes of Health Stroke Scale≥18, and use of rescue therapy remained significant independent predictors of 90-day mortality. CONCLUSIONS: Failure to recanalize and presence of symptomatic intracranial hemorrhage resulted in increased mortality. Despite successful recanalization, proximal occlusion, high National Institutes of Health Stroke Scale, and need for rescue therapy were predictors of mortality.

Influence of age on clinical and revascularization outcomes in the North American Solitaire Stent-Retriever Acute Stroke Registry.

BACKGROUND AND PURPOSE: The Solitaire With the Intention for Thrombectomy (SWIFT) and thrombectomy revascularization of large vessel occlusions in acute ischemic stroke (TREVO 2) trial results demonstrated improved recanalization rates with mechanical thrombectomy; however, outcomes in the elderly population remain poorly understood. Here, we report the effect of age on clinical and angiographic outcome within the North American Solitaire-FR Stent-Retriever Acute Stroke (NASA) Registry. METHODS: The NASA Registry recruited sites to submit data on consecutive patients treated with Solitaire-FR. Influence of age on clinical and angiographic outcomes was assessed by dichotomizing the cohort into ≤80 and >80 years of age. RESULTS: Three hundred fifty-four patients underwent treatment in 24 centers; 276 patients were ≤80 years and 78 were >80 years of age. Mean age in the ≤80 and >80 cohorts was 62.2±13.2 and 85.2±3.8 years, respectively. Of patients >80 years, 27.3% had a 90-day modified Rankin Score ≤2 versus 45.4% ≤80 years (P=0.02). Mortality was 43.9% and 27.3% in the >80 and ≤80 years cohorts, respectively (P=0.01). There was no significant difference in time to revascularization, revascularization success, or symptomatic intracranial hemorrhage between the groups. Multivariate analysis showed age >80 years as an independent predictor of poor clinical outcome and mortality. Within the >80 cohort, National Institutes of Health Stroke Scale (NIHSS), revascularization rate, rescue therapy use, and symptomatic intracranial hemorrhage were independent predictors of mortality. CONCLUSION: Greater than 80 years of age is predictive of poor clinical outcome and increased mortality compared with younger patients in the NASA registry. However, intravenous tissue-type plasminogen activator use, lower NIHSS, and shorter revascularization time are associated with better outcomes. Further studies are needed to understand the endovascular therapy role in this cohort compared with medical therapy.

Effect of balloon guide catheter on clinical outcomes and reperfusion in Trevo thrombectomy.

INTRODUCTION: The Solitaire stent retriever registry showed improved reperfusion, faster procedure times, and better outcome in acute stroke patients with large vessel occlusion treated with a balloon guide catheter (BGC) and Solitaire stent retriever compared with a conventional guide catheter. The goal of this study was to evaluate whether use of a BGC with the Trevo stent retriever improves outcomes compared with a conventional guide catheter. METHODS: The TRACK registry recruited 23 sites to submit demographic, clinical, and site adjudicated angiographic and outcome data on consecutive patients treated with the Trevo stent retriever. BGC use was at the discretion of the physician. RESULTS: 536 anterior circulation patients (of whom 279 (52.1%) had BGC placement) were included in this analysis. Baseline characteristics were notable for younger patients in the BGC group (65.4±15.3 vs 68.1±13.6, P=0.03) and lower rate of hypertension (72% vs 79%, P=0.06). Mean time from symptom onset to groin puncture was longer in the BGC group (357 vs 319 min, P=0.06).Thrombolysis in Cerebral Infarction 2b/3 scores were higher in the BGC cohort (84% vs 75.5%, P=0.01). There was no difference in reperfusion time, first pass effect, number of passes, or rescue therapy. Good clinical outcome at 3 months was superior in patients with BGC (57% vs 40%; P=0.0004) with a lower mortality rate (13% vs 23%, P=0.008). Multivariate analysis demonstrated that BGC use was an independent predictor of good clinical outcome (OR 2; 95% CI 1.3 to 3.1, P=0.001). CONCLUSIONS: In acute stroke patients presenting with anterior circulation large vessel occlusion, use of a BGC with the Trevo stent retriever resulted in improved reperfusion, improved clinical outcome, and lower mortality.

Falxuplication, a Novel Method for Wrap-Clipping a Fusiform Aneurysm: Technical Note.

BACKGROUND: Various techniques have been used for wrap-clipping a ruptured, fusiform intracranial aneurysm; however, there is no available literature on use of the falx cerebri for wrap-clipping. We present a review of the literature, with an illustrative case, of a ruptured fusiform pericallosal artery aneurysm firmly attached to the lower edge of the falx cerebri and not amenable to endovascular intervention. METHODS: Although the firm attachment between the inferior falx and the fusiform aneurysm was maintained, a section of the lower thinner part of the falx cerebri firmly attached to the aneurysm was dissected and wrapped around the fusiform aneurysm, and then stabilized with a fenestrated clip. We chose a segment slightly longer than the length of the fusiform aneurysm to avoid pre- and post-wrap-clipping stenosis. RESULTS: Postprocedure, except for a small area of numbness on the left distal anterolateral left leg, the patient was neurologically intact and remained neurologically intact at a 12-month follow-up. CONCLUSIONS: An inferior thin segment of the falx cerebri can be used for wrap-clipping of ruptured fusiform anterior cerebral artery aneurysms. Furthermore, the inferior falx can be wrapped around the attached fusiform anterior cerebral artery aneurysm without compromising flow, offering a safe solution in these unusually complex cases.

Cranial Osteomyelitis: A Comprehensive Review of Modern Therapies.

BACKGROUND: Cranial osteomyelitis is a rare but potentially life-threatening condition that requires early diagnosis with prompt and appropriate management by neurosurgeons to prevent further central nervous system complications. METHODS: The literature in the Medline database was comprehensively reviewed with the keywords "cranial osteomyelitis," "skull base osteomyelitis (SBO)," "central skull base osteomyelitis," and "temporal bone osteomyelitis." Items in the reference list of each article relevant to the objective of this study were reviewed. RESULTS: This review produced 183 articles: 13 book chapters, 24 case reports, 17 case series, 98 original articles, 30 review articles, and 1 meta-analysis. We classified cranial osteomyelitis as sinorhino-otogenic, including anterior, middle, and posterior skull base osteomyelitis; and non-sinorhino-otogenic, including iatrogenic, posttraumatic, hematologic, and osteomyelitis with other causes. CONCLUSIONS: New diagnostic modalities, the introduction of broad-spectrum antibiotics, and recent advances in neurosurgical procedures have led to a decrease in the rate of treatment failure in cranial osteomyelitis. Early recognition of initial nonspecific symptoms is key to diagnosing and managing this treatable but life-threatening condition. Early identification of the causative pathogen, appropriate broad-spectrum antibiotic therapy over a period of 8-20 weeks, and aggressive surgical debridement are essential for managing cranial osteomyelitis. On the other hand, inadequate treatment is responsible for refractory cases and poses a great diagnostic challenge. A new classification dividing cranial osteomyelitis into sinorhino-otogenic versus nonsinorhino-otogenic groups could prove valuable for clinical communication and treatment.

Subarachnoid Trabeculae: A Comprehensive Review of Their Embryology, Histology, Morphology, and Surgical Significance.

INTRODUCTION: Brain is suspended in cerebrospinal fluid (CSF)-filled subarachnoid space by subarachnoid trabeculae (SAT), which are collagen-reinforced columns stretching between the arachnoid and pia maters. Much neuroanatomic research has been focused on the subarachnoid cisterns and arachnoid matter but reported data on the SAT are limited. This study provides a comprehensive review of subarachnoid trabeculae, including their embryology, histology, morphologic variations, and surgical significance. METHODS: A literature search was conducted with no date restrictions in PubMed, Medline, EMBASE, Wiley Online Library, Cochrane, and Research Gate. Terms for the search included but were not limited to subarachnoid trabeculae, subarachnoid trabecular membrane, arachnoid mater, subarachnoid trabeculae embryology, subarachnoid trabeculae histology, and morphology. Articles with a high likelihood of bias, any study published in nonpopular journals (not indexed in PubMed or MEDLINE), and studies with conflicting data were excluded. RESULTS: A total of 1113 articles were retrieved. Of these, 110 articles including 19 book chapters, 58 original articles, 31 review articles, and 2 case reports met our inclusion criteria. CONCLUSIONS: SAT provide mechanical support to neurovascular structures through cell-to-cell interconnections and specific junctions between the pia and arachnoid maters. They vary widely in appearance and configuration among different parts of the brain. The complex network of SAT is inhomogeneous and mainly located in the vicinity of blood vessels. Microsurgical procedures should be performed with great care, and sharp rather than blunt trabecular dissection is recommended because of the close relationship to neurovascular structures. The significance of SAT for cerebrospinal fluid flow and hydrocephalus is to be determined.

A Prospective Multicenter Trial of the TransForm Occlusion Balloon Catheter: Trial Design and Results.

BACKGROUND AND PURPOSE: Adjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm™ Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC. METHOD AND STUDY DESIGN: The TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients. RESULTS: The performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use. CONCLUSION: BACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results.

North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results.

BACKGROUND: Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials. METHODS: The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage. RESULTS: 354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. Clinical outcome: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2). CONCLUSIONS: The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.

Clinical and Angiographic Outcomes with the Combined Local Aspiration and Retriever in the North American Solitaire Stent-Retriever Acute Stroke (NASA) Registry.

BACKGROUND: Various techniques are used to enhance the results of mechanical thrombectomy with stent-retrievers, including proximal arrest with balloon guide catheter (BGC), conventional large bore proximal catheter (CGC), or in combination with local aspiration through a large-bore catheter positioned at the clot interface (Aspiration-Retriever Technique for Stroke [ARTS]). We evaluated the impact of ARTS in the North American Solitaire Acute Stroke (NASA) registry. SUMMARY: Data on the use of the aspiration technique were available for 285 anterior circulation patients, of which 29 underwent ARTS technique, 131 CGC, and 125 BGC. Baseline demographics were comparable, except that ARTS patients are less likely to have hypertension or atrial fibrillation. The ARTS group had more ICA occlusions (41.4 vs. 22% in the BGC, p = 0.04 and 26% in CGC, p = 0.1) and less MCA/M1 occlusions (44.8 vs. 68% in BGC and 62% in CGC). Time from arterial puncture to reperfusion or end of procedure with ARTS was shorter than with CGC (54 vs. 91 min, p = 0.001) and was comparable to the BGC time (54 vs. 67, p = 0.11). Final degree of reperfusion was comparable among the groups (TICI [modified Thrombolysis in Cerebral Infarction] score 2b or higher was 72 vs. 70% for CGC vs. 78% for BGC). Procedural complications, mortality, and good clinical outcome at 90 days were similar between the groups. KEY MESSAGES: The ARTS mechanical thrombectomy in acute ischemic stroke patients appears to yield better results as compared to the use of CGCs with no significant difference when compared to BGC. This early ARTS technique NASA registry data are limited by the earlier generation distal large bore catheters and small sample size. Future studies should focus on the comparison of ARTS and BGC techniques.

Predictors of poor outcome despite recanalization: a multiple regression analysis of the NASA registry.

BACKGROUND: Mechanical thrombectomy with stent-retrievers results in higher recanalization rates compared with previous devices. Despite successful recanalization rates (Thrombolysis in Cerebral Infarction (TICI) score ≥2b) of 70-83%, good outcomes by 90-day modified Rankin Scale (mRS) score ≤2 are achieved in only 40-55% of patients. We evaluated predictors of poor outcomes (mRS >2) despite successful recanalization (TICI ≥2b) in the North American Solitaire Stent Retriever Acute Stroke (NASA) registry. METHODS: Logistic regression was used to evaluate baseline characteristics and recanalization outcomes for association with 90-day mRS score of 0-2 (good outcome) vs 3-6 (poor outcome). Univariate tests were carried out for all factors. A multivariable model was developed based on backwards selection from the factors with at least marginal significance (p≤0.10) on univariate analysis with the retention criterion set at p≤0.05. The model was refit to minimize the number of cases excluded because of missing covariate values; the c-statistic was a measure of predictive power. RESULTS: Of 354 patients, 256 (72.3%) were recanalized successfully. Based on 234 recanalized patients evaluated for 90-day mRS score, 116 (49.6%) had poor outcomes. Univariate analysis identified an increased risk of poor outcome for age ≥80 years, occlusion site of internal carotid artery (ICA)/basilar artery, National Institute of Health Stroke Scale (NIHSS) score ≥18, history of diabetes mellitus, TICI 2b, use of rescue therapy, not using a balloon-guided catheter or intravenous tissue plasminogen activator (IV t-PA), and >30 min to recanalization (p≤0.05). In multivariable analysis, age ≥80 years, occlusion site ICA/basilar, initial NIHSS score ≥18, diabetes, absence of IV t-PA, ≥3 passes, and use of rescue therapy were significant independent predictors of poor 90-day outcome in a model with good predictive power (c-index=0.80). CONCLUSIONS: Age, occlusion site, high NIHSS, diabetes, no IV t-PA, ≥3 passes, and use of rescue therapy are associated with poor 90-day outcome despite successful recanalization.

Rescue Thrombectomy in Large Vessel Occlusion Strokes Leads to Better Outcomes than Intravenous Thrombolysis Alone: A 'Real World' Applicability of the Recent Trials.

BACKGROUND: The Interventional Management of Stroke III (IMS-III) trial demonstrated no benefit for intravenous recombinant tissue plasminogen activator (IV rt-PA) followed by endovascular therapy versus IV rt-PA alone. However, IMS-III mostly included earlier generation devices. The recent thrombectomy trials have incorporated the stent-retriever technology, but their generalizability remains unknown. METHODS: The North American Solitaire Acute Stroke (NASA) registry recruited patients treated with the Solitaire FR™ device between March 2012 and February 2013. The NASA-IMS-III-Like Group (NILG baseline NIHSS score ≥10 who received IV rt-PA) was compared to the IV rt-PA and IV + intra-arterial (IA)-IMS-III groups and the MR CLEAN, ESCAPE, SWIFT Prime, and REVASCAT trial controls to assess the stent-retriever treatment in the 'real-world' setting. The NILG was also compared to non-IV rt-PA NASA patients to evaluate the impact of IV rt-PA on thrombectomy. RESULTS: A total of 136 of the 354 NASA patients fulfilled criteria for the NILG. Baseline characteristics were well balanced across groups. Time from onset to puncture was higher in NILG than IV+IA-IMS-III patients (274 ± 112 vs. 208 ± 47 min, p < 0.0001). Occlusions involving the intracranial ICA, MCA-M1, or basilar arteries were more common in NILG than IV+IA-IMS-III patients (91.2 vs. 47.2%, p < 0.00001). Modified thrombolysis in cerebral infarction ≥2b reperfusion was higher in NILG than IV+IA-IMS-III patients (74.3 vs. 39.6%, p < 0.00001). A 90-day modified Rankin Scale score ≤2 was more frequent in the NILG than IV+IA-IMS-III patients (51.9 vs. 40.8%, p = 0.03) and MR CLEAN (51.9 vs. 19.1%, p < 0.00001), ESCAPE (51.9 vs. 29.3%, p = 0.0002), SWIFT Prime (51.9 vs. 35.5%, p = 0.02), and REVASCAT (51.9 vs. 28.2%, p = 0.0003) controls. Symptomatic intracranial hemorrhage definitions varied across the different studies with rates ranging from 2.7% (ESCAPE) to 11.9% (NILG). The NILG 90-day mortality (24.4%) was higher than in SWIFT Prime but comparable to all other groups. IV rt-PA was an independent predictor of good outcome in NASA (OR = 2.3, 95% CI 1.2-4.7). CONCLUSION: Our results support the 'real-world' applicability of the recent thrombectomy trials.

Early Experience with the TransForm™ Occlusion Balloon Catheter: A Single-Center Study.

BACKGROUND AND OBJECTIVE: Balloon-assisted coil embolization has become an important adjunct in the endovascular treatment of intracranial aneurysms. The management of broad-necked cerebral aneurysms is technically perplexed due to a variety of factors, which include the difficulty in defining the aneurysm-parent vessel interface angiographically and problems in achieving complete aneurysmal occlusion. This could later predispose to regrowth or recanalization. We sought to determine the safety and efficacy of the TransForm™ occlusion balloon catheter (TOBC) for the coiling of intracranial aneurysms at our institute. METHODS: A retrospective review was performed to identify TOBC cases between May 1, 2013, and April 30, 2014. RESULTS: A total of 24 TOBC cases were identified. In 23 cases, the TOBC was used for balloon-remodeled coil embolization, and in 1 case, it was used for vasospasm treatment alone. Out of the total 24 cases in which the TOBC was used, 16 (66.6%) were ruptured aneurysms. Stents were used in 6/23 (26%) cases. In all cases, the balloon could be placed as intended. The inflation and deflation times ranged from 3 to 4 s. No serious complications were noted. In the experience of the authors, the balloon performed the intended role in most cases. CONCLUSIONS: This series shows that the TOBC is feasible, safe and useful in the treatment of cerebral aneurysms. The balloon was traceable to the intended site and the preparation, inflation and deflation times were short. We believe that the TOBC has effective utility in treating broad-necked and small aneurysms.

North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results.

BACKGROUND: Limited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials. METHODS: The investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage. RESULTS: 354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2. CLINICAL OUTCOME: 42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2). CONCLUSIONS: The NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.