ABSTRACT
BackgroundCross-study heterogeneity has limited the evidence-based evaluation of middle meningeal artery embolization (MMAE) as a treatment for chronic subdural hematoma (CSDH). Ongoing trials and prospective studies suggest that heterogeneity in upcoming publications may detract from subsequent meta-analyses and systemic reviews. This study aims to describe this data heterogeneity in order to promote harmonization with common data elements (CDEs) in publications.MethodsClinicalTrialsgov and PubMed were searched for published or ongoing prospective trials of MMAE. The Nested Knowledge AutoLit living review platform was utilized to classify endpoints from randomized control trials (RCT) and prospective cohort studies comparing MMAE to other treatments. The Qualitative Synthesis feature was used to determine cross-study overlap of outcome-related data elements.ResultsEighteen studies were includedtwelve RCTs, two non-randomized controlled studies, two prospective single-arm trials, one combined prospective and retrospective controlled study, and one prospective cohort study. The most commonly reported data element was recurrence (15/18), but seven heterogenous (non-comparable) definitions were employed for ‘recurrence.’ Mortality was reported in 10/18 studies, but no common timepoint was reported in more than four studies. Re-intervention and CSDH volume were reported in eight studies, CSDH width in seven, and no other outcome was common across more than five studies.ConclusionsThere was significant heterogeneity in data element collection even among prospective, registered trials of MMAE. Even among CDEs, variation in definition and timepoints prevented harmonization. A standardized approach based on CDEs may be necessary to facilitate future meta-analyses and evidence-driven evaluation of MMAE treatment of CSDH.DisclosuresG. Adusumilli: None. S. Ghozy: None. K. Kallmes: 4;C;Nested Knowledge, Inc, Superior Medical Experts, Inc. 5;C;Nested Knowledge, Inc, Conway Medical LLC. N. Hardy: 4;C;Nested Knowledge, Inc. 5;C;Nested Knowledge, Inc. R. Tarchand: None. C. Zinn: None. D. Lamar: None. E. Singeltary: 5;C;Nested Knowledge, Inc. L. Siegel: 5;C;Nested Knowledge, Inc. D. Kallmes: 1;C;Microvention, Balt USA, Medtronic. 4;C;Nested Knowledge, Inc, Superior Medical Experts, Inc, Conway Medical LLC. A. Arthur: 1;C;STEM Trial. S. Gellißen: None. J. Fiehler: 1;C;Imaging Core Lab for EMBOLISE, German Ministry of Science and Education, German Ministry of Economy and Innovation, German Research Foundation, European Union, Hamburgische Investition- und Förderbank, Medtronic, Microvention, Route92, Stryker. 2;C;Acandis, Bayer, Boehringer Ingelheim, Cerenovus, Covidien, Medtronic, Medina, Microvention, Penumbra, Phenox, Stryker, Transverse Medical. 4;C;Tegus Medical. J. Heit: 1;C;iSchemaView.. 2;C;Medtronic, Microvention.
ABSTRACT
IntroductionHigh blood glucose was shown to be associated with worse clinical outcome and increased edema formation in patient with acute stroke undergoing mechanical thrombectomy.1 A better understanding of the pathophysiological pathways and a quantification of their effects might support targeted therapeutic approaches.Aim of the StudyTo quantify the amount of outcome deterioration explained by edema formation due to high blood glucose.Methods124 patients with acute ischemic stroke who underwent mechanical thrombectomy were included. Mediation analysis was performed to quantify the amount of outcome deterioration (probability for mRS>2) explained by edema formation in patients with high blood glucose. In addition, the moderating effects of good and poor collaterals were investigated.ResultsProbability for poor outcome increased with increasing blood glucose levels (OR 1.23/10 mg/dl), edema formation (OR 1.13/% net water uptake) and poor collaterals (OR 1.64). Edema formation was also associated with higher blood glucose levels (regression coefficient 0.033). An increase of blood glucose levels from 100mg/dl to 200mg/dl resulted in a 47 percentage-points decrease of the probability of good outcome in patients with good collaterals and a 26 percentage points decrease in patients with poor collaterals. Edema formation explained 15% of the outcome deterioration caused by higher blood glucose levels.ConclusionEdema formation explains 15% of the total adverse effects of high blood glucose levels. Major pathways might include other direct effects of high blood glucose, such as altered vessel wall and thrombus characteristics and higher thrombogenicity of the cerebral blood flow.ReferencesThorén, M., et al. “Predictors for Cerebral Edema in Acute Ischemic Stroke Treated with Intravenous Thrombolysis.” Stroke 2017;48(9): 2464–2471.Do you have any conflict of interest to declare?: YesHelge Kniep is a consultant for Eppdata.Jens Fiehler received research support from: German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Route92, Stryker. He is consultant for: Acandis, Bayer, Cerenovus, Covidien, Medtronic, Microvention, Penumbra, Phenox, Stryker and stock holder of Tegus Medical.
ABSTRACT
IntroductionRemote attendance of trainees via videostreaming (tele-observership, e-fellowship) emerges as an additional method to acquire knowledge in endovascular interventions.1–3 The ESMINT/EYMINT e-fellowship was launched in 2020 with a 6-month fellowship for 6 remote trainees with individual assignment to a neurointerventional specialist (mentor). The program is currently enrolling fellows for the third consecutive season.Aim of study1) Assessment of situational awareness during remote attendance. 2) Assessment of learning progress. 3) Identification of technical and organizational limitations of tele-observerships.MethodsProspective evaluation of telestreamed cases from 2020 to 2022 via questionnaires for trainees and mentors.ResultsFrom 06/2020 to 05/2022 a total of 311 cases were telestreamed by 11 high volume neurointerventional centers in Europe. While in the initial season 6 fellows were enrolled in a 1:1 assignment to a mentor, the second season included 22 fellows which were assigned as pairs to one mentor. A subset of 102 cases was prospectively and anonymously evaluated. A high level of situational awareness was reported in 75.5% of all cases. After finishing the program, the general improvement of neurointerventional knowledge was evaluated to be extensive (17%), substantial (50%), and moderate (33%). Procedural and technical knowledge were identified as fields of pronounced improvement. Limited access to telestreaming during regular duty hours at their hospital was stated by fellows as main hindrance to remote attendance.ConclusionsTele-observerships may facilitate location-independent training of complex neurointerventional procedures through high levels of situational awareness. Future programs will have to incorporate individual training schedules to enable fellows to better attend complex elective procedures.ReferencesBechstein M, Elsheikh S, Wodarg F, et al. Republished: Interhospital Teleproctoring of Endovascular Intracranial Aneurysm Treatment Using a Dedicated Live-streaming Technology: First Experiences during the Covid-19 Pandemic. J Neurointerv Surg 2021;13(2):E1.Bechstein M, Buhk JH, Frolich AM, et al. Training and Supervision of Thrombectomy by Remote Live Streaming Support (RESS): Randomized Comparison Using Simulated Stroke Interventions. Clin Neuroradiol 2021;31(1):181–7.Lim DZ, Mitreski G, Maingard J, et al. The Smart Angiography Suite. J Neurointerv Surg 2021.Do you have any conflict of interest to declare?: No
ABSTRACT
IntroductionMechanical thrombectomy (MT) has been shown to improve functional outcome in patients with anterior circulation stroke. However, previous works suggest only limited explanatory effect of infarct volume reduction on outcome in patients undergoing MT vs. standard medical care1.Aim of the studyThe amount of improvement of functional outcome explained by follow-up infarct volume reduction after successful recanalization has not been investigated in detail. Results might allow quantification of pathophysiological effects and could improve the understanding of the value of follow-up infarct volume as imaging endpoint in clinical trials.MethodsAll patients from our institution enrolled in the German Stroke Registry from 05/2015 to 12/2019 with anterior circulation stroke, availability of the relevant clinical data and follow-up CT (12h-2 weeks) were analyzed. A mediation analysis was conducted to investigate the effect of successful recanalization (Tici≥2b) on good functional outcome (90d mRS≤2) with mediation through follow-up infarct volume.Results429 patients were included. Multivariate regression confirms significant association of successful recanalization with lower follow-up infarct volume and better functional outcome. Results of the mediation analysis suggest a 23 percentage points (pp) increase of probability of good function outcome (95%CI: 16pp-29pp) in patients with successful recanalization. 57% (95%CI: 38%-79%) of the treatment effect was explained by follow-up volume reduction.Conclusions57% of the improvement of functional outcome after successful recanalization is explained by follow-up infarct volume reduction. Results reflect established pathophysiological assumptions and confirm the value of infarct volume as imaging endpoint in clinical trials.ReferencesBoers AMM, Jansen IGH, Brown S, et al. Mediation of the relationship between endovascular therapy and functional outcome by follow-up infarct volume in patients with acute ischemic stroke. Jama Neurology 2019;76:194–202. DOI: 10.1001/Jamaneurol.2018.3661Do you have any conflict of interest to declare?: YesHelge Kniep, Fabian Flottmann and Friederike Austein are consultants for Eppdata.Milani Deb-Chatterji has received research grants from the Werner Otto Stiftung.Gabriel Broocks received grants from Balt USA, LLC.Götz Thomalla received fees as consultant from Acandis, Bayer, and Portola, and fees as lecturer from Acandis, Alexion, Amarin, Bayer, Boehringer-Ingelheim, BristolMyersSquibb, Daiichii Sankyo, Portola, and Stryker.Jens Fiehler received research support from: German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Route92, Stryker. He is consultant for: Acandis, Bayer, Cerenovus, Covidien, Medtronic, Microvention, Penumbra, Phenox, Stryker and stock holder of Tegus Medical.
ABSTRACT
IntroductionTreatment effects of successful recanalization after mechanical thrombectomy (MT) have been evaluated for acute ischemic strokes with large vessel occlusion. However, for medium-vessel occlusions (MeVO) treatment effects of successful recanalization have not been investigated in detail.Aim of the studyTo quantify treatment effects of different degrees of recanalization after MT in MeVO on long term function outcome.MethodsAll patients enrolled in the German Stroke Registry from 05/2015 to 12/2019 with MeVO of the middle cerebral artery and availability of the relevant data points were included. The treatment effect of different degrees of recanalization (TICI scores) was analyzed using established binarized outcome metrics (good outcome: 90d mRS≤2) and linearized outcome metrics defined as the mRS increase pre-stroke to 90d. Treatment effects were assessed using double robust inverse-probability-weighted regression-adjustment estimators for multivalued treatments.Results597 patients fulfilled the inclusion criteria. 97 (16%) patients had TICI<2b with good outcome in 19%. 194 (33%) patients had TICI 2b and 296 (50%) had TICI 3. For both cohorts, percentage of good outcome was 55%. Covariate-controlled treatment effect estimation suggests that TICI 2b recanalization increases probability of good long-term functional outcome from 27% to 58% (31 pp). Pre-stroke to 90d mRS increase was reduced by 1.0 mRS points. Full recanalization with TICI 3 did not further increase probability of good outcome and did not further reduce stroke-related mRS increase.ConclusionTICI 2b recanalization in MeVO increased probability of good outcome from 27% to 58%, TICI 3 recanalization did not further improve prognosis.Do you have any conflict of interest to declare?: YesConflict of Interest StatementHelge Kniep and Fabian Flottmann are consultants for Eppdata.Milani Deb-Chatterji has received research grants from the Werner Otto Stiftung.Götz Thomalla received fees as consultant from Acandis, Bayer, and Portola, and fees as lecturer from Acandis, Alexion, Amarin, Bayer, Boehringer-Ingelheim, BristolMyersSquibb, Daiichii Sankyo, Portola, and Stryker.Jens Fiehler received research support from: German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Route92, Stryker. He is consultant for: Acandis, Bayer, Cerenovus, Covidien, Medtronic, Microvention, Penumbra, Phenox, Stryker and stock holder of Tegus Medical.
ABSTRACT
Introduction: Red blood cell (RBC) rich vs fibrin rich clots have different mechanical properties and greater knowledge about clot composition in the context of clinical, imaging, and procedural factors in mechanical thrombectomy (MT) may help with procedural optimization. The EXCELLENT Registry (NCT03685578) is a prospective, global, multi-center, observational registry of EmboTrap as the first line MT device for large vessel occlusion (LVO). We present an interim analysis of clot collected per pass in the registry. Methods: Five hundred thirty-three clot specimens from 376 subjects were collected by 20 sites and sent for analysis by independent Central Labs under standardized protocol. Analysis was interrupted by COVID-19, but the labs were fully operational as of June 2020 and on track to deliver results for 300 subjects in Q4. At the time of abstract submission, composition data for 234 clots from 163 subjects was available. All available data will be presented at the time of the conference. Results: Cardioembolic etiology (n=100) was associated with lower RBC (40.2 vs 47.2%) and higher fibrin content (31.7 vs 26.7%) compared to large artery disease (n=12). Hyperdense/vessel susceptibility sign (78+, 24-, per independent imaging core lab) corresponded to higher mean RBC content (44.4 vs 34.9%). Treatment with IV tPA (60+, 91-) had no clear impact on clot composition (42.3 vs 40.6% RBC;30.4 vs 30.0% fibrin). Notably, clots retrieved with the first 2 passes of were more RBC rich (42.1 vs 28.0%) and clots retrieved in higher passes had a higher average fibrin content (35.5 vs 29.6%) suggesting that higher fibrin content leads to greater refractoriness. Conclusions: Clot density/susceptibility on baseline imaging, stroke etiology and number ofthrombectomy passes were associated with differential clot composition. These findings may havepotential implications for the development of better MT strategies.