Primary results from the CLEAR study of a novel stent retriever with drop zone technology.

BACKGROUND: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. OBJECTIVE: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. METHODS: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). RESULTS: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). CONCLUSIONS: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. TRIAL REGISTRATION NUMBER: NCT04514562.

Circle of Willis Configuration and Thrombus Localization Impact on Ischemic Stroke Patient Outcomes: A Systematic Review.

Background and Objectives: The published literature highlights the fact that the integrity of the Circle of Willis has a direct impact on stroke outcome, especially in cases of distal internal carotid T occlusion. The aim of this study was to review the available data on the Circle of Willis configuration and thrombus location impact on patient outcome in cases of ischemic stroke. Materials and Methods: A systematic search according to PRISMA guidelines was performed in PubMed, Cochrane, and EMBASE databases to identify studies investigating the influence of Circle of Willis variants on ischemic stroke outcomes published up to March 2023. The manuscripts were reviewed by three researchers separately and scored on the quality of the research using the MINORS criteria. Results: After screening 157 manuscripts, 11 studies (n = 4643) were included. Circle of Willis integrity plays a vital role in stroke outcome, especially when T-form occlusions are present. Despite this, in the event of M1 occlusion Circle of Willis configuration does not play an important role. In cases of distal internal carotid artery occlusion, the presence of a fully developed contralateral A1 segment and anterior communicating artery is essential for a favorable stroke outcome. Conclusions: The preserved integrity of the Circle of Willis has great significance for collateral flow in the event of ischemic stroke and helps patients to achieve more favorable outcomes, as it determines the affected brain territory. The clinical outcome of the ischemic stroke appears to be significantly better if only one artery territory is affected, compared to two or more.

Transcatheter arterial embolization for upper gastrointestinal tract bleeding.

INTRODUCTION: Transcatheter arterial embolization is a possible treatment for patients with recurrent bleeding from the upper gastrointestinal tract after failed endoscopic management and is also an alternative to surgical treatment. AIM: To analyze the outcomes of transcatheter arterial embolization and identify the clinical and technical factors that influenced the rates of morbidity and mortality. MATERIAL AND METHODS: A retrospective analysis was carried out, based on the data of 36 patients who underwent transcatheter arterial embolization for acute nonvariceal upper gastrointestinal bleeding in 2013 to 2015 in our center. An analysis was performed between early rebleeding rates, mortality and the following factors: patient sex, age, number of units of packed red blood cells and packed plasma administered to the patients, length of hospital stay, therapeutic or prophylactic embolization. RESULTS: The technical success rate of the embolization procedure was 100%. There were 15 (41.70%) therapeutic embolizations and 21 (58.3%) prophylactic embolizations. There was a 77.8% clinical success rate. Following embolization, 10 (27.80%) patients had repeated bleeding and 9 (25.0%) patients died. Significant associations were found between rebleeding and prophylactic embolization (OR = 10.53; p = 0.04) and between mortality and prophylactic embolization (OR = 10.53; p = 0.04) and units of packed red blood cells (OR = 1.25; p < 0.01). CONCLUSIONS: In our experience, transcatheter arterial embolization is a safe treatment method for acute nonvariceal upper gastrointestinal bleeding and a possible alternative to surgery for high-risk patients.