Comparing the efficacy and safety of the Skyflow device with those of the Solitaire FR stent in patients with acute ischemic stroke: a prospective, multicenter, randomized, non-inferiority clinical trial

BackgroundMechanical thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in the anterior circulation. This trial aimed to indicate whether Skyflow, a new thrombectomy device, could achieve the same safety and efficacy as Solitaire FR in the treatment of AIS.MethodsThis study was a prospective, multicenter, randomized, single blind, parallel, positive controlled, non-inferiority clinical trial. Patients with intracranial anterior circulation LVO within 8 hours from onset were included to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. The primary endpoint was the rate of successful reperfusion (modified Treatment In Cerebral Infarction (mTICI) ≥2b) after the operation. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage (SAH) at 24 hours after operation.ResultsA total of 95 and 97 patients were involved in the Skyflow group and Solitaire FR group, respectively. A successful reperfusion (mTICI ≥2b) was finally achieved in 84 (88.4%) patients in the Skyflow group and 80 (82.5%) patients in the Solitaire FR group. Skyflow was non-inferior to Solitaire FR in regard to the primary outcome, with the criterion of a non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined center effect and the National Institutes of Health Stroke Scale (NIHSS) score. The rate of periprocedural sICH and SAH did not differ significantly between the two groups.ConclusionEndovascular thrombectomy with the Skyflow stent retriever was non-inferior to Solitaire FR with regard to successful reperfusion in AIS due to LVO (with a pre-specified non-inferiority margin of 12.5%).

Single-centre experience with endovascular rotational thrombectomy for single session salvage of thrombosed arteriovenous fistulas and grafts

Objectives: This paper documents our experience and outcomes of using a relatively new endovascular rotational thrombectomy device for salvage of thrombosed vascular access. Methodology: A retrospective study reviewing patients with thrombosed native AVF or AVG who underwent endovascular declotting using a rotational thrombectomy device between November 2018 and May 2020 at a tertiary university hospital in Southeast Asia. We evaluated demographics, procedural data, technical and procedural success, patency rates and complications. Results: A total of 40 patients underwent single session endovascular declotting of thrombosed vascular access. The mean follow-up period was 21.6 months (range 13.4–31 months). The technical success was 92.5% and clinical success was 80%. About 50% of patients had concomitant thrombolysis for pharmacomechanical thrombectomy. One patient had a myocardial infarction during the post-operative period. There were no other major complications within 30 days. The primary patency was 45.5% at 6 months and 22.7% at 12 months. Assisted primary patency was 68.1% at 6 months and 61.6% at 12 months, which was maintained up to 2 years. The secondary patency was 84.1% at 6 and 12 months. Conclusion: Our study shows that rotational thrombectomy device for single session thrombectomy of thrombosed arteriovenous fistulas and grafts is safe and effective. A high technical and clinical success rate was achieved, with low complication rates and specific advantages compared to other techniques, including reduced length of hospital stay. Our reported mid-term outcomes are reasonable with an assisted primary patency of 62% at 12 and 24 months. The use of newer techniques and novel dedicated thrombectomy devices show promise.

Predictors of Functional Outcome and Mortality in Endovascular Treatment for Acute Basilar Artery Occlusion: A Single-Centre Experience

Background and Purpose: The objective of this study was to identify prognostic factors of endovascular treatment in patients with acute basilar artery occlusion and add evidence about the efficacy and safety of endovascular treatment for acute basilar artery occlusion.Materials and Methods: We reviewed the data of 101 patients with acute basilar artery occlusion receiving endovascular treatment from January 2013 to September 2019. Baseline characteristics and outcomes were evaluated. A favourable functional outcome was defined as a mRS of 0 to 2 assessed at the 3 month follow-up. The association of clinical and procedural characteristics with the functional outcome and mortality was assessed.Results: The study population consisted of 101 patients: 83 males and 18 females. Successful recanalization was achieved in 99 patients (97.1%). A favourable clinical outcome was observed in 50 patients (49.5%), and the overall mortality rate was 26.7%. A favourable outcome was significantly associated with NIHSS score at admission and lung infection. Mortality was associated with NIHSS score at admission, the number of thrombectomy device passes, the postoperative pons-midbrain index, and diabetes mellitus.Conclusions: This study suggested that NIHSS score at admission, the number of thrombectomy device passes, the postoperative pons-midbrain index, diabetes mellitus, and lung infection can predict the functional outcome and mortality. These initial results add evidence about the efficacy and safety of endovascular treatment for acute basilar artery occlusion and need to be confirmed by further prospective studies.

Study of correlations between CT properties of retrieved cerebral thrombi with treatment outcome of stroke patients

Background All the patients with suspected stroke are directed to whole-brain CT scan. The purpose of this scan is to look for early features of ischemia and to rule out alternative diagnoses than stroke. In case of ischemic stroke, CT diagnostics (including CT angiography) is used mainly to locate the occlusion and its size, while the Hounsfield Units (HU) values of the thrombus causing the stroke are usually overlooked on CT scan or considered not important. The aim of this study was to demonstrate that the HU value is relevant and can help in better treatment planning. Patients and methods There were 25 patients included in the study, diagnosed with ischemic stroke in the middle cerebral artery (MCA) territory. In all patients, systemic thrombolysis was not successful and the mechanical recanalization was needed. The retrieved thrombi were also analyzed histologically for the determination of red blood cells (RBC) proportion. CT of the proximal MCA (M1) segment was analyzed for average HU value and its variability both in the occluded section and the symmetrical normal site. These CT parameters were then statistically studied for the possible correlations with different clinical, histological and procedure parameters using the Linear Regression and the Pearson correlation coefficient. Results Relevant positive correlations were found between average HU value of thrombus and outcome modified Rankin Scale (mRS), initial mRS, number of passes with thrombectomy device as well as RBC proportion. Conclusions Results of the present study suggest that measured HU values in CT images of the cerebral thrombi may help in the assessment of thrombus compaction and therefore better treatment planning.

Endovascular Treatment With and Without Intravenous Thrombolysis in Large Vessel Occlusions Stroke: A Systematic Review and Meta-Analysis

Background: Previous studies have shown conflicting results about the benefits of pretreatment with intravenous thrombolysis before endovascular treatment (EVT) in patients with acute ischemic stroke (AIS) with large vessel occlusions (LVOs). This study aimed to investigate the clinical efficacy and safety of EVT alone vs. bridging therapy (BT) in patients with AIS with LVOs.Methods: A systematic review with meta-analysis of all available studies comparing clinical outcomes between BT and EVT alone was conducted by searching the National Center for Biotechnology Information/National Library of Medicine PubMed and Web of Science databases for relevant literature from database inception to October 20, 2020.Results: A total of 93 studies enrolling 45,190 patients were included in the present analysis. In both unadjusted and adjusted analyses, BT was associated with a higher likelihood of 90-day good outcome (crude odds ratio [cOR] 1.361, 95% confidence interval [CI] 1.234–1.502 and adjusted OR [aOR] 1.369, 95% CI 1.217–1.540) and successful reperfusion (cOR 1.271, 95% CI 1.149–1.406 and aOR 1.267, 95% CI 1.095–1.465) and lower odds of 90-day mortality (cOR 0.619, 95% CI 0.560–0.684 and aOR 0.718, 95% CI 0.594–0.868) than EVT alone. The two groups did not differ in the occurrence of symptomatic intracranial hemorrhage (sICH) (cOR 1.062, 95% CI 0.915–1.232 and aOR 1.20, 95% CI 0.95–1.47), 24-h early recovery (cOR 1.306, 95% CI 0.906–1.881 and aOR 1.46, 95% CI 0.46–2.19), and number of thrombectomy device passes ≤ 2 (aOR 1.466, 95% CI 0.983–2.185) after sensitivity analyses and adjustment for publication bias.Conclusions: BT provides more benefits than EVT alone in terms of clinical functional outcomes without compromising safety in AIS patients with LVOs.