Ajit S. Puri

BACKGROUND AND OBJECTIVES: The Woven Endobridge (WEB) and the Contour Neurovascular System (Contour) are both intrasaccular devices used to treat cerebral aneurysms. We compared outcomes of these 2 devices using data from 2 large registries. METHODS: Data were sourced from the WorldWideWEB Consortium, which included 1363 cases treated with WEB from 2017, and a registry of 277 Contour cases from 10 European centers starting the same year. Patient demographics, aneurysm characteristics, procedural specifics, and outcomes were analyzed. Propensity score matching was applied for comparison. RESULTS: Before matching, the Contour group had more men (37.9% vs 30.8%), more asymptomatic cases (83.4% vs 70.3%), and fewer acute subarachnoid hemorrhage cases (10.8% vs 26.2%). After matching, no significant differences were found in demographics or aneurysm characteristics between groups. The median age was 60 years, and median aneurysm dimensions were comparable. Logistic regression showed no significant differences between WEB and Contour in achieving complete occlusion (odds ratio [OR] = 1.01, 95% CI, 0.67-1.52, P = .971), adequate occlusion (OR = 0.85, 95% CI, 0.41-1.76, P = .665), or achieving modified Rankin Scale 0 to 2 at last follow-up (OR = 0.48, 95% CI, 0.21-1.02, P = .064). Retreatment (OR = 2.23, P = .086), thromboembolic complications (OR = 0.75, P = .452), and adjunctive treatment use (OR = 1.93, P = .141) were also similar. CONCLUSION: The WEB and Contour demonstrated comparable clinical and angiographic outcomes in this large multicenter study comprised majority small, asymptomatic cerebral aneurysms.

BACKGROUND AND OBJECTIVES: The prospective single-arm nonrandomized SCENT (Surpass Intracranial Aneurysm Embolization System Pivotal) trial on flow diverter treatment of large and giant intracranial aneurysms (IA) was analyzed for patients' age and IA characteristics affecting stroke and occlusion rates over 5 years (Trial registration NCT01716117). METHODS: Impact on major ipsilateral stroke and IA occlusion was studied by stratifying age as 65 years and younger vs older than 65. Kaplan–Meier estimates of time to both endpoints, stratified by age, were created. Univariate predictors of time-to-stroke were analyzed using univariable proportional hazards regression models. Limited bivariable modeling was also attempted. RESULTS: Of 180 patients with large or giant IA enrolled, 119 were 65 years and younger, whereas 61 were older than 65 years. The 3-year risk of stroke for the older than 65 years group (19.7%) was more than double that of the 65 years and younger group (9.2%), P = .047. No new strokes were reported between 3 and 5 years. Four patients (2.2%) experienced aneurysm rupture within the first week post-treatment, 3 being 65 years and younger and the fourth older than 65 (>.99). Complete IA occlusion within age strata at 1 year was: older than 65 60% (33/55), 65 years and younger 79.1% (87/110), P = .009, 3 years: older than 65 67.6% (25/37), 65 years and younger 82.5% (66/80), P = .071, and 5 years: older than 65 85.7% (18/21), 65 years and younger 91.8% (56/61), P = .417. CONCLUSION: Age older than 65 was associated with an increased risk of stroke and predictive of incomplete healing and increased time to healing.

Background Sex-related differences in outcomes after mechanical thrombectomy (MT) for distal medium vessel occlusion (DMVO) stroke remain uncertain. While unadjusted differences have been reported in stroke populations, it is unclear whether biological sex independently influences outcomes after accounting for major prognostic factors. Methods We performed a retrospective, multicenter analysis of the MAD-MT registry. Patients with acute DMVO who underwent MT were included. Propensity score matching (PSM) was employed. The primary outcome was functional independence (modified Rankin Scale [mRS] score 0–2) at 90 days. Secondary outcomes included excellent outcome (mRS 0–1), day 1 NIHSS shift, and reperfusion success. Safety outcomes included mortality and symptomatic intracerebral hemorrhage. Results Before matching, 1147 females and 1062 males were included. After 1:1 PSM (748 patients in each group), the groups were balanced in baseline characteristics. The median age was 75 years in both groups. At 90 days, 51% of females and 54% of males achieved mRS 0–2 (P = 0.38). NIHSS shift from baseline to day 1 was similar (median −2 in both groups), and successful reperfusion (Thrombolysis in Cerebral Infarction 2b–3) was achieved in 86% of females and 89% of males (P = 0.18). Mortality was 18.4% in females and 15.5% in males (P = 0.11). Symptomatic intracerebral hemorrhage occurred in 8.3% of females and 7.7% of males (P = 0.67). Conclusions After adjustment for age, baseline disability, and vascular risk factors, biological sex was not independently associated with functional or safety outcomes following mechanical thrombectomy for DMVO stroke.

BACKGROUND: It remains unclear whether outcomes of patients treated with endovascular thrombectomy with large-vessel occlusion and unwitnessed onset of stroke differ from those with witnessed onset in the extended time window. METHODS: We enrolled patients with anterior circulation large-vessel occlusion (internal carotid artery, M1, or M2 segment of the middle cerebral artery) undergoing endovascular thrombectomy within 6 to 24 hours from the time last seen well, from 2014 to 2022, at 66 sites in Europe, North America, and Asia. Patients with a prestroke modified Rankin Scale score of >3 or age P =0.022). Mortality was 21.6% among unwitnessed and 22.0% among witnessed ( P =0.847), and symptomatic intracranial hemorrhage rates were 6.6% and 5.8%, respectively ( P =0.623). The primary outcome (modified Rankin Scale shift) showed no difference comparing unwitnessed to witnessed patients (odds ratio, 1.35 [95% CI, 0.82–2.20]; P =0.235) in the inverse probability of treatment weighting. Unwitnessed patients were more likely to achieve functional independence or return of Rankin (1.53 [1.01–2.33]; P =0.045). Other secondary outcomes did not differ between the witnessed and unwitnessed patients. CONCLUSIONS: In the extended time window, unwitnessed patients with large-vessel occlusion undergoing endovascular thrombectomy have at least the same likelihood of favorable outcomes as witnessed patients. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04096248.

We propose a deterministic and time-efficient contact-aware path planner for neurovascular navigation. The algorithm leverages information from pre- and intra-operative images of the vessels to navigate pre-bent passive tools, by intelligently predicting and exploiting interactions with the anatomy. A kinematic model is derived and employed by the sampling-based planner for tree expansion that utilizes simplified motion primitives. This approach enables fast computation of the feasible path, with negligible loss in accuracy, as demonstrated in diverse and representative anatomies of the vessels. In these anatomical demonstrators, the algorithm shows a 100% convergence rate within 22.8s in the worst case, with sub-millimeter tracking errors (less than 0.64 mm), and is found effective on anatomical phantoms representative of around 94% of patients.

Tay-Sachs disease (TSD) and Sandhoff disease are fatal neurodegenerative diseases without an effective therapy that are caused by mutations in the HEXA and HEXB genes, respectively. Together they encode the heterodimeric isozyme of hexosaminidase, hexosaminidase A (HexA), that degrades GM2 ganglioside. This report describes a 5-year-long study using a bidirectional adeno-associated virus 9 (AAV9) vector (AAV9-Bic_HexA/HexB) encoding both HEXA and HEXB in the TSD sheep model. Bidirectional AAV9 was delivered i.v. or through various cerebrospinal fluid (CSF) delivery routes: intracerebroventricular (ICV), cisterna magna (CM), and lumbar intrathecal space (LIT). The longest survival and best distribution were achieved by multipoint CSF delivery (combined CM, ICV, and LIT) with treated animals that survived up to 5 years of age (untreated animals with TSD die after ~9 months). Extension in survival was accompanied by lasting improvement in neurological examination and maze testing. Improvement in biomarkers of efficacy, including MRI, magnetic resonance spectroscopy, diffusion tensor imaging, and CSF levels of GM2 ganglioside and HexA activity, was evident. Postmortem assessments showed broad HexA distribution, GM2 ganglioside clearance, and vector genome distribution, especially in deep brain structures. Therapeutic efficacy documented in this study supports translation of bidirectional vector and multipoint CSF delivery to a clinical trial in patients with TSD and Sandhoff disease.

Purpose Treating small-caliber vessel aneurysms with flow diverters poses challenges due to narrow luminal diameters and tortuous vasculature, which complicate the navigation and deployment of conventional devices using standard microcatheters. The Silk Vista Baby (SVB, Balt, Montmorency, France) flow diverter was developed to treat intracranial aneurysms located in smaller vessels or more distal segments and is compatible with 0.017″ microcatheters. We present the largest multicenter analysis to date evaluating the outcomes of SVB use in unruptured distal anterior cerebral artery (DACA) aneurysms. Methods Retrospective data from 20 centers were reviewed for patients with unruptured DACA aneurysms treated with the SVB. Demographic information, clinical presentation, radiographic characteristics, complications, and outcomes were recorded. Results Seventy-nine patients (79 DACA aneurysms) were treated between January 2018 and December 2022; 59 were female (74.7%), and the median age was 61 years (IQR 53–67). Most aneurysms were saccular (89.9%), and 65.8% involved a branch. The median parent vessel diameter was 1.9 mm (IQR 1.7–2.1). A single stent was implanted in 97.5% of cases; 2.5% required two stents. The median imaging follow-up duration was 12 months (IQR 9.5–24). At the last follow-up, 76% of aneurysms showed complete or near-complete occlusion (O’Kelly–Marotta scale C or D, Raymond-Roy 1 or 2). Overall, thromboembolic or hemorrhagic complications occurred in 14% of patients, with two cases being symptomatic. The mortality rate was 0%, and the retreatment rate was 1.3%. Conclusion In this multicenter series, the SVB flow diverter represented a valuable treatment option for distal anterior cerebral artery (DACA) aneurysms.

There is uncertainty about whether patients with an anterior circulation large vessel occlusion (LVO) and a low NIH Stroke Scale (NIHSS) score (≤5) benefit from endovascular therapy (EVT) in the late time window (6-24 hours). We compared the clinical outcomes of these patients receiving EVT with those receiving medical management (MM). The CT for Late Endovascular Reperfusion multinational cohort study was conducted at 66 sites across 10 countries from January 2014 to May 2022. This subanalysis included consecutive patients with late-window stroke due to an anterior circulation LVO, defined as occlusion of the internal carotid artery or proximal middle cerebral artery (M1/M2 segments), and a baseline NIHSS score ≤5 who received EVT or MM alone. The primary end point was a 90-day ordinal shift in the modified Rankin Scale (mRS) score. Secondary outcomes were 90-day excellent outcome (defined as mRS scores 0-1 or return to baseline mRS score in patients with a prestroke mRS score >1) and favorable outcome (defined as mRS scores 0-2 or return to baseline mRS score in patients with prestroke mRS score >2). Safety outcomes were symptomatic intracranial hemorrhage and 90-day mortality. We used ordinal and binary logistic regression models to test for outcome differences. Among 5,098 patients, 318 patients were included (median [interquartile range] age 67 [56-76] years; 149 [46.9%] were female; baseline NIHSS score was 4 [2-5]). A total of 202 patients (63.5%) received EVT and 116 MM (36.5%). There was no difference in favorable 90-day ordinal mRS score shift (adjusted common odds ratio [OR] 0.77, 95% CI 0.45-1.32), excellent outcome (adjusted OR 0.86, 95% CI 0.49-1.50), or favorable outcome (adjusted OR 0.72, 95% CI 0.35-1.50) in the EVT group compared with MM. Symptomatic intracranial hemorrhage risk (adjusted OR 3.40, 95% CI 0.84-13.73) and mortality at 90 days (adjusted OR 2.44, 95% CI 0.60-10.02) were not statistically different between treatment groups. In patients with an anterior LVO and low NIHSS score in the 6-24-hour time window, there was no statistical difference in disability outcomes or intracranial bleeding risk between patients treated with EVT compared with MM. The retrospective and observational design limits our findings. Ongoing randomized controlled trials will provide further insight. This study provides Class III evidence that in adult patients with anterior circulation LVO and low NIHSS score (≤5) presenting in the late time window (6-24 hours), EVT does not improve clinical outcome vs MM. This study was registered at clinicaltrials.gov under NCT04096248.

Purpose Teleoperated Interventional Robotic systems (TIRs) are developed to reduce radiation exposure and physical stress of the physicians and enhance device manipulation accuracy and stability. Nevertheless, TIRs are not widely adopted, partly due to the lack of intuitive control interfaces. Current TIR interfaces like joysticks, keyboards, and touchscreens differ significantly from traditional manual techniques, resulting in a shallow, longer learning curve. To this end, this research introduces a novel control mechanism for intuitive operation and seamless adoption of TIRs. Methods An off-the-shelf medical torque device augmented with a micro-electromagnetic tracker was proposed as the control interface to preserve the tactile sensation and muscle memory integral to interventionalists’ proficiency. The control inputs to drive the TIR were extracted via real-time motion mapping of the interface. To verify the efficacy of the proposed control mechanism to accurately operate the TIR, evaluation experiments using industrial grade encoders were conducted. Results A mean tracking error of 0.32 ± 0.12 mm in linear and 0.54 ± 0.07° in angular direction were achieved. The time lag in tracking was found to be 125 ms on average using pade approximation. Ergonomically, the developed control interface is 3.5 mm diametrically larger, and 4.5 g. heavier compared to traditional torque devices. Conclusion With uncanny resemblance to traditional torque devices while maintaining results comparable to state-of-the-art commercially available TIRs, this research successfully provides an intuitive control interface for potential wider clinical adoption of robot-assisted interventions.