Amin Aghaebrahim

Background: The Millipede AspiRation for Revascularization in Stroke (MARRS) pivotal study was a prospective, multicenter, single arm trial evaluating the safety and efficacy of the corrugated Millipede catheter system in patients with acute ischemic stroke due to large vessel occlusion. Methods: Patients aged 18–85 years with internal carotid artery, M1, M2, or basilar artery occlusions treatable within 8 hours were eligible. Catheter selection was based on target vessel diameter (Millipede88 >2.7 mm; Millipede70 >2.2 mm). The primary efficacy endpoint was modified Thrombolysis in Cerebral Infarction (mTICI) ≥2b within ≤3 passes without rescue therapy. Imaging and clinical outcomes were independently adjudicated. Secondary endpoints included first pass effect (mTICI ≥2c). Results: 180 patients were treated (57% US, 43% EU). Median age was 69 years, mean baseline National Institutes of Health Stroke Scale score was 17, and median Alberta Stroke Program Early CT Score was 9. M1 occlusion was the most common target lesion (62%). The primary endpoint was achieved in 160/180 patients (88.9%; 95% CI lower bound 84.3%) in the intention-to-treat cohort. Direct first pass aspiration was performed with Millipede88 and Millipede70 in 64% and 36% of patients, respectively. Navigation success was 96% with Millipede88 and 99% with Millipede70. Among Millipede88 patients, first pass mTICI ≥2c was achieved in 60%, increasing to 75% in the M1 subgroup. Final mTICI ≥2c was achieved in 85% of primary Millipede88 cases. Symptomatic intracranial hemorrhage occurred in 2.3%, intracranial dissection in 1.1%, no perforations occurred, and 90 day all cause mortality was 13.9%. Conclusions: The Millipede aspiration system demonstrated excellent deliverability and high rates of first pass and final mTICI ≥2c, particularly in M1 occlusions, with low rates of adverse events. Trial registration number: ClinicalTrials.gov NCT05714501 .

Background: Delayed aneurysm rupture (DAR) is a potentially devastating complication after flow-diverters (FD) deployment and their exact mechanisms are still unclear. The purpose of this meta-analysis is to synthesize the latest evidence on DAR after FD treatment and identify predictive factors. Methods: A systematic review and meta-analysis were conducted according to established protocols. Searches were conducted in PubMed, Scopus, Web of Science, and Embase databases up to June 2024 using variations of “aneurysm “and “delayed aneurysm rupture” terms. Original studies reporting DAR and including more than five patients were included. All analyses were conducted in R software (version 4.4.2), employing the “meta” and “tableone” packages. Results: 64 studies with 9820 patients were included, large aneurysm size (OR=1.08, 95% CI (1.02, 1.14), P value=0.008), intra-aneurysmal thrombus (OR=1.05, 95% CI (1.01, 1.09), P value=0.010) and posterior circulation location (OR=1.02, 95% CI (1.00, 1.04), P value=0.014) were significant risk factors for DAR. The pooled prevalence of DAR was 1.40%, with a rate of 1.18% after removing outliers. DAR occurred within 30 days in 66.7% of cases, with a mortality rate of 73.3% at discharge. Conclusion: DAR following flow diversion treatment is an uncommon but devastating complication and remains a limitation of the technique. It is influenced by factors such as large aneurysm size, intra-aneurysmal thrombosis, and posterior circulation involvement. The first 30 days post-procedure represent a particularly high-risk period. Despite advancements in FD technology, significant gaps remain, highlighting the need for further research to improve risk assessment and treatment strategies.

Background The ESCAPE-MeVO (Endovascular Treatment to Improve Outcomes for Medium Vessel Occlusions) and DISTAL (Endovascular Therapy plus Best Medical Treatment vs Best Medical Treatment Alone for Medium Vessel Occlusion Stroke) trials failed to demonstrate the superiority of endovascular thrombectomy over best medical management for medium and small vessel occlusions. Potential limitations of these trials include older patient populations, lower presenting National Institutes of Health Stroke Scale (NIHSS) scores, higher rates of premorbid disability, delayed revascularization times, inclusion of both medium and small vessel occlusions, and widespread use of stent retrievers. Here we present M2 occlusion data from the Imperative Trial, evaluating aspiration thrombectomy with the Zoom System. Methods The Imperative Trial is a prospective, multicenter, single-arm trial with independent core lab and safety board adjudication, evaluating aspiration thrombectomy with the Zoom System (Imperative Care, Campbell, CA, USA) for large vessel, including M2, occlusions. This subanalysis includes patients with primary M2 occlusions. Angiographic outcomes were defined as modified Treatment in Cerebral Infarction (mTICI) score ≥2b (good) and ≥2c (excellent). Clinical outcomes were defined as modified Rankin Scale score (mRS) 0–2 (good) and 0–1 (excellent) at 90 days. Safety was assessed by all-cause mortality, symptomatic intracranial hemorrhage (sICH), and all hemorrhage. Results Of 260 enrolled patients, 25% (65/260) had primary M2 occlusions. Median age was 69 years; median NIHSS was 13. Good and excellent reperfusion were achieved in 88% (57/65) and 66% (43/65), respectively. At 90 days, good and excellent clinical outcomes occurred in 62% (39/63) and 56% (35/63), respectively. Mortality, sICH, and any hemorrhage were 4.6% (3/65), 1.5% (1/65), and 18% (12/65), respectively. Conclusions The Zoom System demonstrated excellent safety and efficacy in M2 occlusions. These findings support aspiration thrombectomy for M2 occlusions as a viable treatment in well-selected patients.

BACKGROUND: Rapid and complete recanalization is a primary goal in the endovascular treatment of large vessel occlusion stroke. The effectiveness and safety of super large bore aspiration catheters (0.088″ inner diameter) for the treatment of large vessel occlusion stroke have not been demonstrated in a randomized trial. METHODS: SUMMIT MAX (A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients) was a prospective, randomized, controlled, open-label clinical trial of patients with internal carotid artery and middle cerebral artery M1 occlusions, comparing the super large bore HiPoint Reperfusion system (Route 92 Medical) to the Vecta Aspiration system (Stryker Neurovascular). We hypothesized that the effectiveness and safety of the HiPoint reperfusion system were noninferior (12.5% noninferiority margin) to the Vecta Aspiration system. The primary effectiveness end point was successful reperfusion, defined as modified Treatment in Cerebral Infarction≥2b as adjudicated by an independent core lab, using only the assigned study device, with any use of a nonstudy device before or after the use of study device defined as failure. The primary safety end point was symptomatic intracranial hemorrhage within 24 hours (−8/+24) post-procedure. RESULTS: There were 250 patients enrolled of whom 166 met the criteria for the modified intent-to-treat population: 89 in HiPoint and 77 in Vecta. The median age was 69 years; 54.2% were female. Successful reperfusion with any adjunctive therapy counted as a failure was 77.5% (69/89) in the HiPoint group versus 50.6% (39/77) in the Vecta group ( P P =0.75). CONCLUSIONS: In this randomized trial of patients with anterior large vessel occlusion, the super large bore HiPoint system was noninferior to the Vecta system in achieving successful reperfusion, with a similar safety profile. This study supports the super large bore HiPoint system for mechanical thrombectomy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05018650.

The association of anesthesia approach during endovascular thrombectomy (EVT) with clinical outcomes in large strokes is unexplored. We aimed to evaluate whether general anesthesia (GA), compared with non-GA, was associated with better functional outcomes in the SELECT2 trial. In a prespecified secondary analysis of the SELECT2 trial that enrolled patients with large strokes on noncontrast CT (Alberta Stroke Program Early CT Score [ASPECTS] 3-5), CT perfusion/MRI (core volume ≥50 mL), or both, functional outcomes were compared in EVT-treated patients who received GA or non-GA and whether this association was modified by stroke severity (NIH Stroke Scale score), ischemic injury estimates, and collateral status was evaluated. The primary outcome was 90-day functional status (ordinal modified Rankin Scale [mRS]). Secondary outcomes were functional independence (mRS scores 0-2), independent ambulation (mRS scores 0-3), complete dependence or death (mRS scores 5-6), and mortality. Of 178 EVT patients (median [interquartile range] age 66 [58-75] years, stroke severity 19 [15-23], CT-ASPECTS 4 [3-5], and core volume 101.5 [70-138] mL, 71 women [39.9%]), 104 (58%) received GA. Time from randomization to arterial puncture was longer with GA (40 [23-59] minutes) vs non-GA (27 [18-47] minutes), but procedural duration (GA: 57 [31.5-77] minutes vs non-GA: 49.5 [30-71] minutes) was similar. Successful reperfusion (modified treatment in cerebral infarction [mTICI] score 2b-3) rates were similar (GA 81 (78%) vs non-GA 62 (84%), adjusted relative risk [aRR] 0.91, 95% CI 0.79-1.06). In addition, mRS distribution did not differ between GA and non-GA groups (adjusted generalized odds ratio 1.21, 95% CI 0.86-1.70), as well as independent ambulation (GA: 41% vs non-GA: 34%, aRR 1.22, 95% CI 0.86-1.74) and functional independence (GA: 22% vs non-GA: 18%, aRR 1.32, 95% CI 0.75-2.35). Stroke severity, ASPECTS, ischemic core volume, or collaterals did not modify the association between anesthesia and functional outcome (all p-interaction >0.05). Patients experienced systolic blood pressure (SBP) variability ≥40 mm Hg and minimum intraprocedural SBP (p-interaction = 0.77 and 0.89, respectively). In patients with large core strokes randomized in SELECT2, EVT outcomes did not differ significantly based on anesthesia approach (GA or non-GA) without heterogeneity across stroke severity and size. While GA was associated with higher SBP variability and lower minimum SBP, this did not modify GA association with functional outcomes. While allocation to anesthesia approach was nonrandomized, our findings suggest that optimizing institutional protocols for preferred anesthesia technique, whether GA or non-GA, may enhance EVT procedural outcomes. ClinicalTrials.gov ID: NCT03876457. This study provides Class II evidence that in patients presenting within 24 hours with large vessel occlusion strokes undergoing EVT, the 90-day mRS score is comparable in those with or without GA.

BACKGROUND AND OBJECTIVES: The Silk Vista Baby (SVB) flow diverter (FD) stent (Balt SAS) is the first device designed for treating distally located brain aneurysms. It can be delivered through a 0.017-inch ID microcatheter, enabling access to small, distal vessels. The aim of this study was to evaluate the effectiveness, safety, technical success, occlusion rate, and clinical outcomes of the SVB device. METHODS: This retrospective, multicenter study included data from 18 centers from November 2023 to September 2024. Procedures were performed by experienced neurointerventionalists following institutional standards of care. Outcomes analyzed included effectiveness, safety, and aneurysm occlusion rates. Descriptive analyses and Pearson χ ² or Independent t -Test were used for statistical evaluation. RESULTS: A total of 95 patients, mean age 55.4 years, were included. A total of 31% of aneurysms were ruptured at admission. Most (58.3%) were located in the anterior circulation, and 45% had previous treatment, mainly coiling (69.4%). Complication rates were higher for ruptured aneurysms (24.1%) compared with unruptured ones (9.2%). Two deaths occurred, 1 (1.1%) related to the procedure. At discharge, 87% of patients had modified Rankin Scale ≤2. The latest follow-up showed overall complete/near-complete occlusion rates of 76.1%, with 81.14% for ruptured and 73.43% for unruptured aneurysms. Technical success was higher in unruptured cases (100% vs 93.1%). CONCLUSION: Our case series demonstrated the efficacy of the SVB with a high rate of technical success. The occlusion rates for ruptured cases are comparable with those of other FDs. However, the rates are lower for unruptured cases. This discrepancy is likely due to the characteristics of the aneurysms, particularly in the presence of side branches in bifurcation lesions. The SVB safety profile is similar to other FDs in unruptured cases, while the ruptured group presented more complications.

Background and objectives: Large-bore aspiration catheters have demonstrated better recanalization times and higher first-pass effects in large vessel occlusions. However, vessel tortuosity and branching vessels can hinder navigability, potentially increasing the ‘ledge effect’, procedural times, and the risk of vessel injury. Recently, a newly designed delivery catheter (Carrier Delivery Catheter (CDC), Balt, France) has been introduced to the US market. This paper aims to report our combined experience with this catheter in a real-life clinical setting. Methods: This is a retrospective, multicenter study based on a prospectively maintained database of patients with ischemic stroke who underwent mechanical thrombectomy between February 2024 and January 2025. All consecutive patients who underwent mechanical thrombectomy in which a CDC was used were included. Results: A total of 43 patients from three centers in the USA were included. The mean age was 69.74 years, and most of the patients were male (60.5%). The CDC delivered the aspiration catheter to the clot in all cases. The mean National Institutes of Health Stroke Scale (NIHSS) score was 18, and the mean time between puncture to clot access was 18.14 min. No vessel dissection or perforation was reported, and 4.6% of symptomatic hemorrhagic complications were reported. None of the complications were adjudicated to be directly related to the use of the Carrier. Conclusion: Our case series shows that the CDC is a useful and reliable tool as a delivery catheter for treating vessel occlusions in both the anterior and posterior circulation. This study serves as proof of concept and may provide a foundation for future prospective analyses of this innovative delivery system.

Background Perianeurysmal cyst (PC) formation post-aneurysm embolization is an uncommon entity that can develop post-rupture or unruptured aneurysm treatment. PCs may present with different clinical presentations depending on the initial aneurysm. Currently, there is no standardized treatment for perianeurysmal cysts. Methods We performed a systematic review of perianeurysmal cyst cases. A literature search was performed on PUBMED, Science Direct, and Web of Science using the terms: “peri aneurysm” OR “perianeurysmal” OR “peri-aneurysm” AND “cyst” OR “cysts” OR “cystic”. We also included a case from our institution. Results A total of twenty-six cases were included. Most of the patients were males with a mean age of presentation of 59.34 years. Mass effect and hydrocephalus were the most common clinical presentation with 60% of the cases presenting headaches. The majority of the patients had aneurysms larger than 10 mm (82%). Most of the aneurysms were within the anterior circulation (69.2%), six cases of twenty-six (23%) presented ruptured aneurysms. From 22 cases, the preferred treatment modality was endovascular coiling. Two patients died, one directly related to an aneurysm rupture. Conclusion Our analysis shows a possible association between aneurysm size greater than 10 mm and PC occurrence. We concluded that PC may arise as a result of abnormal fluid and vascular dynamics secondary to brain aneurysms that could lead to perivascular changes. Our findings emphasize the lack of uniformity regarding diagnosis and management modalities for this pathology and highlight the need for a standardized approach. Further research is needed for this heterogeneous pathology.

Background: Previous studies have shown that when thrombectomy has failed, rescue intracranial stenting is associated with better clinical outcomes compared with failed reperfusion. However, comparative data regarding stent type are lacking. Objective: To compare the procedural and clinical outcomes of balloon-mounted stents (BMS) with those of self-expandable stents (SES). Methods: Retrospective analysis of a prospectively collected database from the Stenting and Angioplasty in NeuroThrombectomy (SAINT) consortium. Patients were included if thrombectomy had failed and they then underwent rescue emergency stenting. Patients treated with SES or BMS were compared using inverse probability of treatment weighting. The primary outcome was the final reperfusion as measured by the modified Thrombolysis in Cerebral Infarction (mTICI) Scale. Safety measures included rates of symptomatic intracranial hemorrhage, procedural complications, and 90-day mortality. Results: A total of 328 patients were included. Baseline clinical and procedural characteristics were well balanced among both groups. The BMS group (n=127) had higher rates of successful reperfusion (94.5% vs 86.6%, aOR=4.23, 95% CI 1.57 to 11.37, P=0.004) and increased likelihood of higher degree of final reperfusion on the mTICI Scale (acOR=2.06, 95% CI 1.19 to 3.57, P=0.01) than the SES group (n=201). No difference in modified Rankin Scale shift (acOR=0.98, 95% CI 0.54 to 1.79, P=0.95), rates of mRS0–2 (26% vs 36%, aOR=0.93, 95% CI 0.46 to 1.88, P=0.83) and mRS0–3 (43% vs 50%, aOR=0.92, 95% CI 0.51 to 1.66, P=0.77) at 90 days were noted. Safety measures were comparable in both groups. Conclusion: The present study demonstrates higher reperfusion rates with BMS than with SES in failed thrombectomy procedures that involved rescue stenting. No differences in hemorrhagic complications or clinical outcomes were noted. Further larger controlled studies are warranted.