Lehigh Valley Health Network

BACKGROUND:Mechanical thrombectomy is the standard of care for large vessel occlusion (LVO) stroke, yet most device trials focus on individual technologies rather than complete systems. OBJECTIVE:To evaluate the safety and efficacy of the Zoom Reperfusion System compared with performance goals derived from a meta-analysis of trials using established thrombectomy technologies. METHODS:Prospective, multicenter, non-randomized, investigational device exemption trial conducted across 26 United States centers from October 2021 to March 2024. Adults with anterior circulation LVO stroke within 8 hours of onset were treated using the Zoom System, which includes aspiration catheters ranging from 0.035″ to 0.071″, and a novel 0.088″ intracranial guide/aspiration catheter. The primary efficacy endpoint was successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3) within three passes using Zoom-only components, adjudicated by an independent core laboratory. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH). Secondary outcomes included final reperfusion, first-pass success, time to reperfusion, 90-day modified Rankin Scale (mRS), and mortality. RESULTS:Among 260 patients (median age 68 years; median National Institutes of Health Stroke Scale (NIHSS) 15), successful reperfusion within three passes was achieved in 83% (216/259; 95% CI: 78% to 89%), exceeding the performance goal (p<0.001). Final reperfusion was 92%, with 5.5% requiring rescue devices. First-pass mTICI 2b-3 success was 57%. Median puncture-to-reperfusion time was 19 min. At 90 days, 55% achieved mRS 0-2. The sICH rate was 1.9%, and 90-day mortality was 12.7%. CONCLUSIONS:The Zoom Reperfusion System demonstrated a safety and efficacy profile exceeding prespecified contemporary performance metrics with potential to significantly shorten reperfusion times and reduce the need for rescue therapy. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov--Identifier:NCT04129125.

Middle meningeal artery embolization (MMAE) has emerged as a treatment for chronic subdural hematoma (cSDH), but comprehensive real-world safety data remain limited. We performed a multicenter retrospective analysis of 1781 consecutive patients undergoing MMAE for cSDH (2019–2025). The primary outcome was any procedure-related complication within 30 days. Inverse probability of treatment weighting (IPTW) assessed the association between technical success and complications, adjusting for demographic, clinical, and procedural confounders. Mean age was 72.8 ± 12.4 years; 68.1

OBJECTIVE:The objective was to evaluate the trajectories of hematoma resolution and functional improvement after middle meningeal artery embolization (MMAE) for chronic subdural hematoma (cSDH), model the temporal pattern of cSDH resolution, and identify factors associated with favorable outcomes. METHODS:This real-world multicenter retrospective study included cSDH patients treated with MMAE at 24 centers between 2019 and 2024. Hematoma thickness was measured at baseline and at follow-up intervals (1-4 weeks, 1-3 months, 3-6 months, 6-12 months, and > 12 months after embolization). Resolution patterns were modeled using exponential decay functions. Modified Rankin Scale (mRS) scores assessed functional outcomes. Good functional outcome was defined as mRS score ≤ 2. Resolution patterns were modeled using exponential decay functions to estimate time to 50% and 80% reduction. Patients were categorized as complete resolution (≥ 99%) or by quartile of the remaining distribution (substantial [73%-98%], moderate [53%-73%], partial [27%-53%], minimal [< 27%]). The primary outcome was good functional status (mRS score ≤ 2). RESULTS:The authors analyzed a total of 1781 patients with 2295 cSDHs who underwent MMAE. The mean ± SD age was 72.8 ± 12.4 years and 68.1% of patients were male. The initial mean hematoma thickness was 15.31 ± 6.53 mm, decreasing to 5.24 ± 5.91 mm at final follow-up (mean reduction 64.3% ± 42.1%). Resolution followed an exponential decay pattern, with an estimated time to 50% reduction of 1.8 months and to 80% reduction of 8.9 months. Complete resolution occurred in 1031 of 2224 patients (46.4%) with complete follow-up. The median (IQR) mRS score improved from 1 (0-3) at baseline to 0 (0-2) at > 12 months. Good functional outcomes were more common in patients with complete versus minimal resolution (68.9% vs 35.0%, p < 0.001). Achieving ≥ 73% resolution within 90 days was associated with better outcomes (good outcome in 76.9% of those with ≥ 73% resolution vs 67.3% in those without, p < 0.001). Neurological deterioration was the strongest predictor of lack of good outcome (23.7% in patients with neurological deterioration vs 82.4% without, p < 0.001). CONCLUSIONS:After MMAE for cSDH, reduction in hematoma thickness follows a predictable exponential decay pattern. Greater extent (≥ 80%) and faster timing (within 90 days) of resolution are valuable prognostic indicators. Functional outcomes improve progressively through 6-12 months after the procedure. The relationship between resolution extent and functional outcomes provides quantitative benchmarks for evaluating treatment response.

BACKGROUND:The impact of intravenous (IV) thrombolysis on the outcomes of aspiration thrombectomy as the primary endovascular approach to stroke in patients with large vessel occlusion is unknown. METHODS:The Imperative Trial was a prospective, investigational device exemption, multicenter trial of first-line aspiration thrombectomy that assessed the safety and efficacy of the Zoom System, including a novel 0.088 inch aspiration catheter in patients with stroke within 8 hours of onset. We compared procedural, technical, and clinical outcomes of aspiration thrombectomy based on whether patients had received IV thrombolytics prior to the intervention. RESULTS:Among the 260 patients treated with front-line aspiration thrombectomy using the Zoom System, 125 (48%) received IV thrombolysis prior to aspiration. Rates of modified Thrombolysis in Cerebral Infarction (mTICI) ≥2b achieved with the Zoom System were higher in the aspiration-only group than in the combined group (92% vs 81%, P=0.016). Rates of mTICI ≥2c and first pass effect were similar. The use of rescue devices to achieve mTICI ≥2b was less frequent in the aspiration-only group than in the combined group (2% vs 10%, P=0.008). The rates of functional independence (modified Rankin Scale (mRS) score 0-2) in the aspiration-only group and the combined group were 50% and 59%, respectively (P=0.16). Univariate (P=0.30) and multivariate (P=0.47) ordinal regression analyses showed no significant correlation of mRS 0-2 with IV thrombolysis. Both groups had similar safety outcomes including rates of symptomatic intracranial hemorrhage and 90-day mortality. CONCLUSIONS:Aspiration thrombectomy alone may result in higher rates of successful reperfusion and reduce the need for rescue devices compared with the combined approach with IV thrombolysis.