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

Interhospital Transfer Before Thrombectomy Is Associated With Delayed Treatment and Worse Outcome in the STRATIS Registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke).

BACKGROUND: Endovascular treatment with mechanical thrombectomy (MT) is beneficial for patients with acute stroke suffering a large-vessel occlusion, although treatment efficacy is highly time-dependent. We hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared with direct presentation. METHODS: STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke because of anterior-circulation large-vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without intravenous tissue plasminogen activator and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0-2) at 90 days. We assessed (1) real-world time metrics of stroke care delivery, (2) outcome differences between direct and transfer patients undergoing MT, and (3) the potential impact of local hospital bypass. RESULTS: A total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct versus 311.5 minutes for transfer patients ( CONCLUSIONS: In this large, real-world study, interhospital transfer was associated with significant treatment delays and lower chance of good outcome. Strategies to facilitate more rapid identification of large-vessel occlusion and direct routing to endovascular-capable centers for patients with severe stroke may improve outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02239640

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

A performance evaluation study of nano-biochar as a potential slow-release nano-fertilizer from wheat straw residue for sustainable agriculture

Agro-Wastes are identified as to manufacture potential valuable organic biochar fertilizer product economically while also managing the waste. Biochar (BC) produced from agriculture waste is helps to improve the soil because of its neutral pH, addition of organic carbon to the soil and lower salt index values. This study focused on the development of nano-biochar into a more enhanced biochar product where it was checked whether the biochar derived from wheat straw can absorb nutrients and then act as support matter for releasing micronutrients and macro-nutrients for the plants on slow liberation basis. Wheat biochar (WBC) and wheat nanobiochar (WBNC) were synthesized by pyrolysis at two different temperatures and nutrients were fused into the WBC via impregnation technique. Physical parameters such as Proximate, Ultimate analysis & other were also studied and inspected by standard control procedures. Studies were also carried out on water retention (WR), water absorbance (WA), swelling ratio (SR) and equilibrium water content (EWC) for all samples; data was collected and compared for the better sample. Slow-release studies performed portrayed the release pattern of nutrients for prolonged periods, which are very important for the plant growth, yield and productivity. Overall, the experimental results displayed that BNC produced at 350 degrees C showed promising features of (SI:0.05, SR: 3.67, WA:64%, EWC:78.6%, FC:53.05% and pH:7.22), is a good substance however the nano-biochar has improved results; environmental friendly & could be utilized as a potential fertilizer on slow release for sustainable and green agriculture application

Investigation of slow pyrolysis mechanism and kinetic modeling of Scenedesmus quadricauda biomass

Bioenergy potential of microalage Scednedesmus quadricuda through pyrolysis was investigated using kinetic and thermodynamic analyses. From model-free isoconversional methods, the estimated average activation energies were 152.37 (+/- 20.93), 174.98 (+/- 22.38), and 153.00 (+/- 21.23) kJ/mol, using Friedman, OFW and advance Vyazovkin methods, respectively. Avrami-Erofeev's A1/4 reaction model was the most probable single-step re-action mechanism determined from the combined kinetic analysis. The activation energy profile, however, indicated a complex degradation process in the active pyrolysis zone. Two independent parallel reactions were considered in the active pyrolysis zone. Average activation energy for low temperature conversion was 77.95 (+/- 3.12) kJ/mol, pre-exponential coefficient 4.86E4 (+/- 2.24E4) s(-1), and n = 1.51 (+/- 0.10), whereas for high temperature conversion, the activation energy was 73.26 (+/- 17.93) kJ/mol, pre-exponential coefficient 1.32E3 (+/- 2.61E3) s(-1), and n = 1.21 (+/- 0.16). Thermodynamic analysis of pyrolysis in terms of enthalpy, Gibbs free energy, and entropy indicated the feasibility of conversion

A Prospective Multicenter Trial of the TransForm Occlusion Balloon Catheter: Trial Design and Results

Background and Purpose: Adjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC. Method and Study Design: The TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients. Results: The performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use. Conclusion: BACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results

TARGET® Intracranial Aneurysm Coiling Prospective Multicenter Registry: Final Analysis of Peri-Procedural and Long-Term Safety and Efficacy Results

Background and Purpose: To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils. Methods: The TARGET Registry is a prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with de novo intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100% 360-complex coils on clinical and angiographic outcomes. Results: 148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2%) patients with ruptured and 90 (61.8%) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1–67.4), 73% female, and 71.6% were Caucasian. Median follow-up time was 5.9 (IQR 4.0–6.9) months. The majority were treated with TARGET 360-coils (63.7%), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7% of patients. A good outcome at discharge (mRS 0–2) was seen in 89.9% of the full cohort, and in 84.5 and 93.3% in the ruptured and unruptured patients, respectively. The median packing density was 28.8% (IQR 20.3–41.1). Long-term complete and near complete occlusion rate was seen in 90.4% of aneurysms and complete obliteration was seen in 66.2% of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8%) patients and all-cause mortality was seen in 3/148 (2%) patients. Conclusion: In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0% achieved complete or near complete occlusion with excellent independent functional outcome. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT0174890

Effect of balloon guide catheter on clinical outcomes and reperfusion in Trevo thrombectomy.

INTRODUCTION: The Solitaire stent retriever registry showed improved reperfusion, faster procedure times, and better outcome in acute stroke patients with large vessel occlusion treated with a balloon guide catheter (BGC) and Solitaire stent retriever compared with a conventional guide catheter. The goal of this study was to evaluate whether use of a BGC with the Trevo stent retriever improves outcomes compared with a conventional guide catheter. METHODS: The TRACK registry recruited 23 sites to submit demographic, clinical, and site adjudicated angiographic and outcome data on consecutive patients treated with the Trevo stent retriever. BGC use was at the discretion of the physician. RESULTS: 536 anterior circulation patients (of whom 279 (52.1%) had BGC placement) were included in this analysis. Baseline characteristics were notable for younger patients in the BGC group (65.4±15.3 vs 68.1±13.6, P=0.03) and lower rate of hypertension (72% vs 79%, P=0.06). Mean time from symptom onset to groin puncture was longer in the BGC group (357 vs 319 min, P=0.06).Thrombolysis in Cerebral Infarction 2b/3 scores were higher in the BGC cohort (84% vs 75.5%, P=0.01). There was no difference in reperfusion time, first pass effect, number of passes, or rescue therapy. Good clinical outcome at 3 months was superior in patients with BGC (57% vs 40%; P=0.0004) with a lower mortality rate (13% vs 23%, P=0.008). Multivariate analysis demonstrated that BGC use was an independent predictor of good clinical outcome (OR 2; 95% CI 1.3 to 3.1, P=0.001). CONCLUSIONS: In acute stroke patients presenting with anterior circulation large vessel occlusion, use of a BGC with the Trevo stent retriever resulted in improved reperfusion, improved clinical outcome, and lower mortality

New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke Primary Results of the Multicenter TIGER Trial

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