Background and Purpose: The Tigertriever is a novel, radially adjustable, fully visible, stentriever that permits the operator to align radial expansion with target vessel diameters. This multicenter trial compared the Tigertriever’s effectiveness and safety compared with established stent retrievers. Methods: Single arm, prospective, multicenter trial comparing the Tigertriever to efficacy and safety performance goals derived from outcomes in 6 recent pivotal studies evaluating the Solitaire and Trevo stent-retriever devices with a lead-in and a main-study phase. Patients were enrolled if they had acute ischemic stroke with National Institutes of Health Stroke Scale score ≥8 due to large vessel occlusion within 8 hours of onset. The primary efficacy end point was successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia score 2b-3 within 3 passes of the Tigertriever. The primary safety end point was a composite of 90-day all-cause mortality and symptomatic intracranial hemorrhage. Secondary efficacy end points included 3-month good clinical outcome (modified Rankin Scale score 0–2) and first-pass successful reperfusion. Results: Between May 2018 and March 2020, 160 patients (43 lead-in, 117 main phase) at 17 centers were enrolled and treated with the Tigertriever. The primary efficacy end point was achieved in 84.6% in the main-study phase group compared with the 63.4% performance goal and the 73.4% historical rate (noninferiority P <0.0001; superiority P <0.01). The first pass successful reperfusion rate was 57.8%. After all interventions, successful reperfusion (modified Thrombolysis in Cerebral Ischemia score ≥2b) was achieved in 95.7% and excellent reperfusion (modified Thrombolysis in Cerebral Ischemia score 2c-3) in 71.8%. The primary safety composite end point rate of mortality and symptomatic intracranial hemorrhage was 18.1% compared with the 30.4% performance goal and the 20.4% historical rate (noninferiority P =0.004; superiority P =0.57). Good clinical outcome was achieved in 58% at 90 days. Conclusions: The Tigertriever device was shown to be highly effective and safe compared with Trevo and Solitaire devices to remove thrombus in patients with large-vessel occlusive stroke eligible for mechanical thrombectomy. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03474549.
BACKGROUND: Underlying intracranial stenosis is the most common cause of failed mechanical thrombectomy in patients with acute ischemic stroke with large vessel occlusion. Adjunct emergent stenting is sometimes performed to improve or maintain reperfusion, despite limited data regarding its safety or efficacy. METHODS: We conducted a prospective multicenter observational international cohort study. Patients were enrolled between January 2022 and December 2023 at 25 thrombectomy-capable centers in North America, Europe, and Asia. Consecutive patients treated with mechanical thrombectomy were included if they were identified as having underlying intracranial stenosis, defined as 50% to 99% residual stenosis of the target vessel or intraprocedural reocclusion. The primary outcome was functional independence, defined as a modified Rankin Scale score of 0 to 2 at 90 days. After applying inverse probability of treatment weighting based on propensity scores, we compared outcomes among patients who underwent adjunct emergent intracranial stenting (stenting) versus those who received mechanical thrombectomy alone. RESULTS: A total of 417 patients were included: 218 patients treated with mechanical thrombectomy alone (168 anterior circulation) and 199 with mechanical thrombectomy plus stenting (144 anterior circulation). Patients in the stenting group were less likely to be non-Hispanic White (51.8% versus 62.4%, P =0.03) and less likely to have diabetes (33.2% versus 43.1%, P =0.037) or hyperlipidemia (43.2% versus 56%, P =0.009). In addition, there was a lower rate of IV thrombolysis use in the stenting group (18.6% versus 27.5%, P =0.03). There was a higher rate of successful reperfusion (modified Treatment in Cerebral Infarction score ≥2B) in the stenting versus mechanical thrombectomy–alone group (90.9% versus 77.9%, P <0.001) and a higher rate of a 24-hour infarct volume of <30 mL (n=260, 67.9% versus 50.3%, P =0.005). The overall complication rate was higher in the stenting group (12.6% versus 5%, P =0.006), but there was not a significant difference in the rate of symptomatic hemorrhage (9% versus 5.5%, P =0.162). Functional independence at 90 days was significantly higher in the stenting group (42.2% versus 28.4%, adjusted odds ratio, 2.67 [95% CI, 1.66–4.32]). CONCLUSIONS: In patients with underlying stenosis who achieved reperfusion with mechanical thrombectomy, adjunct emergent stenting was associated with better functional outcome without a significantly increased risk of symptomatic hemorrhage. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05403593.
OBJECTIVE: Penetrating cerebrovascular injury (PCVI) is a subset of traumatic brain injury (TBI) comprising a broad spectrum of cerebrovascular pathology, including traumatic pseudoaneurysms, direct arterial injury, venous sinus stenosis or occlusion, and traumatic dural arteriovenous fistulas. These can result in immediate or delayed vascular injury and consequent neurological morbidity. Current TBI guidelines recommend cerebrovascular imaging for detection, but there is no consensus on the optimum modality. The aim of this retrospective cohort study was to compare CT angiography (CTA) and digital subtraction angiography (DSA) for the diagnosis of PCVI. METHODS: The records of all patients presenting to two level I trauma centers in the United States between January 2010 and July 2016 with penetrating head or neck trauma were reviewed. Only those who had undergone both CTA and DSA were included. Clinical and neuroimaging data were collected, and PCVIs were stratified using a modified Biffl grading scheme. DSA and CTA results were then compared. RESULTS: Of 312 patients with penetrating trauma over the study period, 56 patients (91% male, mean age 32 years) with PCVI met inclusion criteria and constituted the study cohort. The mechanism of injury was a gunshot wound in 86% (48/56) of patients. Twenty-four (43%) patients had sustained an angiographically confirmed arterial or venous injury. Compared with DSA as the gold standard, CTA had a sensitivity and specificity of 72% and 63%, respectively, for identifying PCVI. CTA had a positive predictive value of 61% and negative predictive value of 70%. Seven patients (13%) required immediate endovascular treatment of PCVI; in 3 (43%) of these patients, the injury was not identified on CTA. Twenty-two patients (39%) underwent delayed DSA an average of 25 days after injury; 2 (9%) of these patients were found to harbor new pathological conditions requiring treatment. CONCLUSIONS: In this retrospective analysis of PCVI at two large trauma centers, CTA demonstrated low sensitivity, specificity, and positive and negative predictive values for the diagnosis of PCVI. These findings suggest that DSA provides better accuracy than CTA in the diagnosis of both immediate and delayed PCVI and should be considered for patients experiencing penetrating head or neck trauma.
Introduction: Chronic subdural hematoma (CSDH) is associated with high recurrence rates. Middle meningeal artery embolization (MMAE) has emerged as a promising treatment option. In this systematic review and meta-analysis, we aimed to assess the safety and efficacy of MMAE for CSDH using liquid embolic agents and compare them with particles. Methods: We systematically reviewed all studies describing MMAE for CSDH with liquid embolic agents, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Additionally, we included a cohort of patients from our institution using liquid and particle embolic agents. Data were analyzed using random-effects proportions and comparisons meta-analysis, and statistical heterogeneity was assessed. Results: A total of 18 studies with 507 cases of MMAE with liquid embolic agents (including our institutional experience) were included in the analysis. The success rate was 99% (95% confidence interval [CI]: 98–100%), all complications rate was 1% (95% CI: 0–5%), major complications rate was 0% (95% CI: 0–0%), and mortality rate was 1% (95% CI: 0–6%). The rate of hematoma size reduction was 97% (95% CI: 73–100%), complete resolution 64% (95% CI: 33–87%), radiographic recurrence 3% (95% CI: 1–7%), and reoperation 3% (95% CI: 1–7%). No significant differences in outcomes were found between liquid and particle embolic agents. Sensitivity analyses revealed that liquid embolic agents were associated with lower reoperation rates in upfront MMAE (risk ratio 0.13, 95% CI: 0.02–0.95). Conclusion: MMAE with liquid embolic agents is safe and effective for the treatment of CSDH. Outcomes are comparable to particles, but liquids were associated with a decreased risk of reoperation in upfront MMAE. However, further studies are needed to support our findings.
25 December 2022 in Journal of Thrombosis and Thrombolysis
Background We report the largest multicenter experience to date of utilizing the Comaneci device for endovascular treatment of refractory intracranial vasospasm. Methods Consecutive patients undergoing Comaneci mechanical dilatation for vasospasm were extracted from prospectively maintained registries in 11 North American centers (2020–2022). Intra-arterial vasodilators (IAV) were allowed, with the Comaneci device utilized after absence of vessel dilation post-infusion. Pre- and post-vasospasm treatment scores were recorded for each segment, with primary radiological outcome of score improvement post-treatment. Primary clinical outcome was safety/device-related complications, with secondary endpoints of functional outcomes at last follow-up. Results A total of 129 vessels in 40 patients (median age 52 years; 67.5% females) received mechanical dilation, 109 of which (84.5%) exhibited pre-treatment severe-to-critical vasospasm (ie, score 3/4). Aneurysmal subarachnoid hemorrhage was the most common etiology of vasospasm (85%), with 65% of procedures utilizing Comaneci-17 (92.5% of patients received IAV). The most treated segments were anterior cerebral artery (34.9%) and middle cerebral artery (31%). Significant vasospasm drop (pre-treatment score (3–4) to post-treatment (0–2)) was achieved in 89.9% of vessels (96.1% of vessels experienced ≥1-point drop in score post-treatment). There were no major procedural/post-procedural device-related complications. Primary failure (ie, vessel unresponsive) was encountered in one vessel (1 patient) (1/129; 0.8%) while secondary failure (ie, recurrence in previously treated segment requiring retreatment in another procedure) occurred in 16 vessels (7 patients) (16/129; 12.4%), with median time-to-retreatment of 2 days. Favorable clinical outcome (modified Rankin Scale 0–2) was noted in 51.5% of patients (median follow-up 6 months). Conclusions The Comaneci device provides a complementary strategy for treatment of refractory vasospasm with reasonable efficacy/favorable safety. Future prospective trials are warranted.