Passing Extracranial Artery Occlusion by Intermediate Catheter With Expanding Microballoon (PEACE): A Novel Endovascular Therapy in Acute Tandem Occlusion Stroke

Purpose: Endovascular treatment of atherosclerotic tandem occlusions in acute ischemic stroke (AIS) is a matter of debate. This article reports a single-center experience using an intermediate catheter with microballoon for treatment of tandem occlusions. Methods: A total of 151 AIS patients with large vessel occlusion received endovascular therapy and a consecutive series of patients (n = 26) who suffered from tandem cervical intracranial occlusions were treated using the Passing Extracranial Artery Occlusion by Intermediate Catheter with Expanding Microballoon (PEACE) technique. Intracranial recanalization was achieved by aspiration or stent retriever and then emergency stenting was performed for extracranial internal carotid artery (ICA) lesion. Demographic, clinical characteristics, procedural details of endovascular therapy, and prognosis outcome were assessed. The outcomes of tandem occlusion group were compared with isolated intracranial occlusion group (n = 122) and previous studies. Results: As compared to isolated intracranial occlusion groups, only a few patients suffered from atrial fibrillation (7.7% vs 38.5%, p<0.01) in tandem occlusions group. A larger proportion of patients (61.5% vs 29.5%) had tandem occlusions in which extracranial ICA occlusion was combined with intracranial terminus occlusion in ICA (p<0.01). 46.2% of tandem occlusions patients achieved intracranial recanalization by aspiration alone versus 15.6% in patients with isolated intracranial occlusion (p<0.01). In tandem occlusion patients treated with PEACE, 92.3% achieved successful reperfusion (thrombolysis in cerebral infarct [TICI] ≥2b). The median time from puncture to recanalization was 51 minutes (interquartile range [IQR], 41–66). 67.6% favorable functional prognosis (modified Rankin score [mRS], 0–2) was seen, with 11.5% mortality and 3.8% of symptomatic intracerebral hemorrhage (sICH) at 90 days. These outcomes are all consistent or better than previously reported studies performed for tandem occlusion. Conclusions: Endovascular therapy using the PEACE technique with intermediate catheter and lined expanding microballoon is safe, efficient, and fast in the treatment of atherosclerotic tandem occlusion patients.

Brain atrophy in acute ischaemic stroke patients treated with reperfusion therapy: a systematic review

Background Brain atrophy (BA) may have a role in acute ischemic stroke (AIS) in mediating outcomes after reperfusion therapy. The extent of this association is not well understood. Purpose : To examine the impact of pre-existing BA on functional outcome, survival, symptomatic intracerebral hemorrhage (sICH), and early neurological change in patients with AIS treated with intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT). Material and Methods PubMed, EMBASE, and the Cochrane library were searched for studies on BA in AIS receiving reperfusion therapy. Studies were included if: (i) patients were aged ≥18 years; (ii) patients had been diagnosed with AIS; (iii) patients received IVT and/or EVT; (iv) studies reported on BA; (v) studies reported on post-reperfusion outcomes; and (vi) studies had a sample size of >25 patients. Results A total of 4444 patients from eight studies were included. Four out of seven studies reporting on 90-day functional outcome found pre-existing BA to be significantly associated with poor functional outcome. Moreover, two out of four studies found BA to be a significant predictor of 90-day mortality. None of the included studies reported a significant association of BA with sICH or early neurological deterioration. Conclusion This systematic review indicates a potential prognostic role of BA in AIS. Quantitative analysis of association of BA with outcomes in AIS is not possible given the heterogeneity in BA assessment and reporting across studies. Future studies using standardized BA assessment are warranted to clarify its association with clinical and safety outcomes in AIS.

Predictive Factors for the Need of Tracheostomy in Patients With Large Vessel Occlusion Stroke Being Treated With Mechanical Thrombectomy

Background: Patients with large vessel occlusion stroke (LVOS) eligible for mechanical thrombectomy (MT) are at risk for stroke- and non-stroke-related complications resulting in the need for tracheostomy (TS). Risk factors for TS have not yet been systematically investigated in this subgroup of stroke patients.Methods: Prospectively derived data from patients with LVOS and MT being treated in a large, academic neurological ICU (neuro-ICU) between 2014 and 2019 were analyzed in this single-center study. Predictive value of peri- and post-interventional factors, stroke imaging, and pre-stroke medical history were investigated for their potential to predict tracheostomy during ICU stay using logistic regression models.Results: From 635 LVOS-patients treated with MT, 40 (6.3%) underwent tracheostomy during their neuro-ICU stay. Patients receiving tracheostomy were younger [71 (62–75) vs. 77 (66–83), p &lt; 0.001], had a higher National Institute of Health Stroke Scale (NIHSS) at baseline [18 (15–20) vs. 15 (10–19), p = 0.009] as well as higher rates of hospital acquired pneumonia (HAP) [39 (97.5%) vs. 224 (37.6%), p &lt; 0.001], failed extubation [15 (37.5%) vs. 19 (3.2%), p &lt; 0.001], sepsis [11 (27.5%) vs. 16 (2.7%), p &lt; 0.001], symptomatic intracerebral hemorrhage [5 (12.5%) vs. 22 (3.9%), p = 0.026] and decompressive hemicraniectomy (DH) [19 (51.4%) vs. 21 (3.8%), p &lt; 0.001]. In multivariate logistic regression analysis, HAP (OR 21.26 (CI 2.76–163.56), p = 0.003], Sepsis [OR 5.39 (1.71–16.91), p = 0.004], failed extubation [OR 8.41 (3.09–22.93), p &lt; 0.001] and DH [OR 9.94 (3.92–25.21), p &lt; 0.001] remained as strongest predictors for TS. Patients with longer periods from admission to TS had longer ICU length of stay (r = 0.384, p = 0.03). There was no association between the time from admission to TS and clinical outcome (NIHSS at discharge: r = 0.125, p = 0.461; mRS at 90 days: r = −0.179, p = 0.403).Conclusions: Patients with LVOS undergoing MT are at high risk to require TS if extubation after the intervention fails, DH is needed, and severe infectious complications occur in the acute phase after ischemic stroke. These factors are likely to be useful for the indication and timing of TS to reduce overall sedation and shorten ICU length of stay.

Multi-Center Randomized Phase II Clinical Trial on Remote Ischemic Conditioning in Acute Ischemic Stroke Within 9 Hours of Onset in Patients Ineligible to Recanalization Therapies (TRICS-9): Study Design and Protocol

Aim: To assess the efficacy of remote ischemic conditioning (RIC) in patients with ischemic stroke within 9 h of onset, that are not candidates for recanalization therapies.Sample Size Estimates: A sample size of 80 patients (40 in each arm) should yield 80% power to detect a 20% difference in early neurological improvement at 72 h at p = 0.05, two sided.Methods and Design: TRICS-9 is a phase II, multicenter, controlled, block randomized, open-label, interventional clinical trial. Patients recruited in Italian academic hospitals will be randomized 1:1 to either RIC plus standard medical therapy or standard medical therapy alone. After randomization, RIC will be applied manually by four alternating cycles of inflation/deflation 5 min each, using a blood pressure cuff around the non-paretic arm.Study Outcomes: The primary efficacy outcome is early neurological improvement, defined as the percent change in the National Institute of Health Stroke Scale (NIHSS) at 72 h in each arm. Secondary outcomes include early neurologic improvement at 24 and 48 h, disability at 3 months, rate of symptomatic intracerebral hemorrhage, feasibility (proportion of patients completing RIC), tolerability after RIC and at 72 h, blood levels of HIF-1α, and HSP27 at 24 h and 72 h.Discussion/Conclusion: RIC in combination with recanalization therapies appears to add no clinical benefit to patients, but whether it is beneficial to those that are not candidates for recanalization therapies is still to be demonstrated. TRICS-9 has been developed to elucidate this issue.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT04400981.

Abstract 1122‐000217: Acute Isolated PCA Occlusion Treated with Mechanical Thrombectomy: A Single‐Center Experience and Literature Review

Introduction : Acute isolated posterior cerebral artery (aPCA) occlusions account for 5–10% of all ischemic strokes. Due to peculiar patient presentation, the potential benefit of mechanical thrombectomy (MT) for these patients remains controversial. Our objective is to evaluate the safety, feasibility and effectiveness of MT in these patients and compare it to literature. Methods : For this retrospective single‐center study, charts were reviewed for consecutive patients diagnosed with aPCA stroke who underwent MT from January 2013 thru July 2020. Presenting symptoms, patient demographics, procedural information, and 90‐day follow‐up details were noted. For the literature review, a systematic search of Pubmed, MEDLINE, and EMBASE databases was conducted for the keywords “posterior cerebral artery” and “thrombectomy” for articles published between January 2010 thru June 2021. Estimated rates for rate of recanalization, favorable outcomes (mRS 0–2), symptomatic intracerebral hemorrhage (sICH), and mortality were extracted. Results : Twenty‐one patients were included in the study. Mean age was 71.2 years (SD ±10.2). Median NIHSS score at presentation was 9 (IQR 5–15) with visual symptoms reported in 12 cases (57.1%). Overall, final mTICI 2b‐3 was achieved in 17 patients (80.9%) with first‐pass mTICI 2b‐3 attained in 8 (38.1%). Post‐procedure sICH occurred in 1 patients (4.7%). Fifteen patients (71.4%) had an mRS of 0–2 at 90‐days and visual symptoms resolved in 83.3%. Mortality occurred in 2 patients (9.5%). For the systematic review, 4 articles plus our cohort were included in the final analysis, totalizing 222 patients. The estimated rate of successful recanalization was 85.25% (95% CI, 73.05%‐97.45%), sICH was 3.60% (95% CI, 1.11%‐6.09%), and mortality was 10.51% (95% CI, 5.88%‐15.15%). Conclusions : Our results indicate MT as a potentially safe and efficacious treatment modality for aPCA strokes. Our results, in addition to the systematic review, indicate that patient selection and assessment may be the key in obtaining favorable long‐term clinical outcomes.

Abstract 1122‐000168: Hyperacute Stenting and Angioplasty for Isolated Non‐tandem Cervical ICA Strokes within the First 48 Hours

Introduction : Acute stroke that involves complete and isolated occlusion of extracranial cervical ICA segment with no intracranial clot burden account for a minority of stroke cases. Since endarterectomy is not recommended in the hyperacute phase (first 48 hours), management of these strokes includes administration of IV‐tPA as part of standard medical therapy. This makes endovascular intervention with acute carotid artery stenting (CAS) with or without balloon angioplasty a viable treatment option during the hyperacute phase of the disease. We aim to present our two‐decade long experience of endovascular management of complete and isolated cervical ICA occlusive strokes in the hyperacute phase, and attempt to evaluate the clinical efficacy and safety of this treatment modality. Methods : A prospectively maintained database was retrospectively searched for patients who presented from Jan 2000 – Dec 2020 with acute cervical ICA stroke confirmed on angiography. Only patients who had 100% occlusion of cervical ICA segment and who underwent acute CAS within the first 48 hours of symptom onset were included. Patients who had an intracranial or tandem lesion or those with <100% EC‐ICA stenosis were excluded. Information on demographics, co‐morbidities, procedural details, and complications was recorded. Rate of adequate revascularization and follow up were also recorded. Results : A total of 46 patients with acute cervical ICA occlusive stroke were included in the study. Mean age was 68.9 years, and 32 (69.6%) were male. Median NIH Stroke Scale at admission was 8 (IQR 7) with a perfusion deficit seen in 78.3% of cases. IV‐tPA was administered in 41.3% of cases with median time from symptom onset to puncture 14.4 hours. Stenting was performed in all patients with pre‐ and/or post‐angioplasty done in 78.3% of cases. Successful recanalization was achieved in 82.6% cases. One patient (2.2%) suffered a symptomatic intracerebral hemorrhage (sICH) post‐procedure. Outcome measures were reported as stable or improved NIHSS at discharge in 86.9% of cases, with good outcome (functional independence at 90‐day‐mRS <2) at 78.3% and a mortality rate of 6.5%. Conclusions : Emergent stenting and angioplasty for acute cervical ICA occlusive strokes within the first 48 hours (hyperacute phase) can be performed successfully with good clinical outcomes and an impressive rate of recanalization.

Abstract 1122‐000133: ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke Trial (SOLONDA)

Introduction : The ANA™ (Anaconda Biomed) thrombectomy system is a novel stroke thrombectomy device comprising a self‐expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, ANA allows distal aspiration in combination with a stentretriever (SR) to mobilize the clot into the funnel where it remains copped during extraction. We investigate safety and efficacy of ANA™ in a first‐in‐man study. Methods : The SOLONDA study was prospective, multicenter (9 centers in Spain) with blinded assessment of the primary outcome by an independent core lab. Patients with an acute occlusion of terminal internal carotid artery (TICA), M1 or M2 segments of the middle cerebral artery (MCA) admitted within 8 hours from symptom onset were eligible. The primary endpoint was successful reperfusion, defined as mTICI≥2b in the target vessel with ≤3 passes of the ANA device in combination with a SR, without the use of rescue therapy in the intention to treat population. Primary predefined analysis was non‐inferiority as compared to performance endpoint observed in HERMES (71.1%). Secondary outcome measures included per‐pass reperfusion scores, symptomatic intracerebral hemorrhage (sICH), NIHSS at day 5, and mRS at 90 days. After enrollment of 74 patients, an interim analysis was conducted. The trial Steering Committee decided to terminate recruitment due to overwhelming evidence that safety and performance objectives were reached. Results : Mean age was 71.6 (SD 8.9) years, 46.6% women and median NIHSS on admission 14 (IQR 10–19). Sites of primary occlusion were: TICA 10 (13.7%), M1‐MCA 37 (50.7%) and M2‐MCA in 26 (35.6%) patients. The independent imaging corelab determined that successful reperfusion within 3 passes without rescue therapy was achieved in 60/72 (83.3%) with a rate of complete reperfusion (TICI 2c‐3) of 60% (43/72 patients). After non‐inferiority was confirmed (p<0.01), the ANA device also showed superiority in the primary outcome analysis (p = 0.02). Median procedural time from first angiogram to recanalization or final angiogram was 38(±28) minutes. First pass successful recanalization rate was 56% with a rate of first pass complete recanalization of 39%. Rescue therapy to obtain a mTICI≥2b was needed in 12/72 (17%) patients. At 90 days, the rate of favorable functional outcome was 57.5% and the rate of excellent functional outcome (mRS 0–1) 45.2%. The rate of severe adverse device‐related effects as adjudicated by the data safety monitoring board was 1.4% (one patient suffered an arterial dissection). Conclusions : In this first‐in‐man clinical experience, the ANA device achieved a high rate of complete recanalization with a good safety profile and favourable 90 days clinical outcomes. ClinicalTrials.gov Identifier: NCT04095767

Abstract 1122‐000126: Mobile Stroke Unit Process Metrics in Large Vessel Occlusion Stroke Patients: BEST‐MSU Substudy

Introduction : Mobile Stroke Units (MSUs) speed thrombolytic treatment for acute ischemic stroke and improve clinical outcomes compared to standard management by Emergency Medical Services (EMS). However, MSU process metrics in the subset of patients with large vessel occlusions (LVOs) having endovascular thrombectomy (EVT) have yet to be optimized. Methods : A pre‐specified Benefits of Stroke Treatment Using a Mobile Stroke Unit (BEST‐MSU) substudy of tPA‐eligible stroke patients with imaging evident LVOs was conducted. The primary outcome was process metrics related to treatment times from stroke onset and first medical alert. Safety outcomes included rates of symptomatic intracerebral hemorrhage and procedural complications. Groups were compared using Chi‐square or Fisher’s exact tests for categorical variables, and Wilcoxon rank‐sum tests for continuous variables. Results : A total of 295 patients were included, 169 in the MSU group and 126 in the EMS group. Baseline characteristics were comparable between the groups, with the exception of baseline NIHSS (MSU mean 19.0 [IQR 13.0,23.0] vs EMS 16.0 [11.0, 20.0], p = 0.003). 92% of MSU and 87% of EMS LVO patients received tPA, and 78% and 85% went on to have EVT. Process metrics are detailed in Table 1. MSU LVO patients had faster tPA bolus from 911‐alert (MSU 45.0 minutes [40.0, 53.5] vs EMS 76.0 [64.0, 87.8], p<0.001), however the two groups had similar alert to groin puncture (MSU 142.5 [116.8, 171.0] versus EMS 131.5 [114.0, 159.8], p = 0.15). MSU patients spent more time on‐scene, (EMS arrival to ED arrival, 53.0 [45.0, 62.0] vs 27.0 [22.0, 33.0], p<0.001) however less time prior to EVT (door to groin puncture, 76.5 [54.8, 108.5] vs 94.0 [72.0, 123.0], p<0.001) with variable use of field CTAs and direct cath lab admission with ED bypass, yielding a net neutral result. The variability among site protocols is reflected in the range of median alert to groin puncture times (minimum 107.0 minutes, maximum 152.0). In the 222 patients undergoing EVT, median alert to recanalization time was 181.5 minutes [146.8, 225.5] in the MSU group and 190.5 [157.5, 227.5] in the EMS group (p = 0.47). Recanalization (Thrombolysis In Cerebral Infarction [TICI] 2b/3) was achieved in 76% of MSU and 70% of EMS (p = 0.32) with comparable rates of EVT complications (including hemorrhage, perforation, dissection, hematoma). 54% MSU and 44% of EMS LVO patients achieved good functional outcome (modified Rankin Scale [mRS] ≤ 2) at 90 days (p = 0.11). Conclusions : In tPA‐eligible LVO stroke patients, MSU management did not increase or expedite EVT treatment times as compared to standard EMS management. Future MSU processes should include field CTA with direct admission to cath labs to maximize the early treatment advantage this technology provides.

Abstract 1122‐000185: Rescue Intracranial Stenting in Acute Ischemic Stroke

Introduction : Rescue treatment for failed thrombectomy in patients with acute ischemic stroke (AIS) from large vessel occlusion (LVO) remains controversial. We report our institutional experience with using intracranial stenting of occlusion refractory to aspiration and stent retriever thrombectomy. Methods : We performed a retrospective review of our prospectively maintained thrombectomy database to identify the LVO AIS patients who underwent intracranial stenting during endovascular thrombectomy at our comprehensive stroke center between January 2015 and July 2021. Modified Rankin scale (mRS) at 90 days was used as primary outcome. A good neurologic outcome was defined as mRS 0–3, and a poor neurologic outcome is defined as mRS score between 4–6. Secondary outcomes included symptomatic intracerebral hemorrhage (sICH) based on ECASS criteria, and in‐hospital mortality. Results : We identified 52 acute ischemic stroke patients who underwent intracranial stenting acutely. Thirty‐three patient (63.4%) are males. Median age was 64 years (Interquartile range (IQR 57–74), median baseline mRS was 0 (IQR 0–1), median NIHSS score was 13 (IQR 7–18), and median ASPECTS was 9 (IQR 8–10). Thirty six percent of the patients had a vertebrobasilar occlusion, 34% had a middle cerebral occlusion (M1 segment), and 14% had an M2 segment occlusion. The median number of thrombectomy passes prior to stenting was 3 (IQR 2–4). In 48% of patients, a combination of aspiration and stent retriever techniques were used prior to intracranial stenting. The Enterprise stent was the most commonly used stent (51.9%), followed by Wingspan stent (25%), and Neuroform Atlas stent (21.5%). Majority of the patients (93%) were loaded with anti‐thrombotics intraoperatively, with rectal Aspirin and intravenous Integrilin being the most commonly used agents. Successful recanalization (TICI 2 B or better) was achieved in 96% of the patients, while the remaining 2 patients were graded as TICI 2A recanalization. Fifty percent of the patients had good outcome at 90 days. A total of 4 patients (8%) developed a sICH, with a 90 day mortality of rate of 15.4% (8/52). Conclusions : Rescue intracranial stenting appears to be a safe and effective approach in patients with emergent large vessel occlusion refractory to thrombectomy. Larger studies are warranted to further establish the safety and efficacy of this approach.

Abstract 1122‐000113: Periprocedural Safety of Intracranial Aneurysm Embolization with Extra Soft Coils: Interim Analysis of SURF Study

Introduction : Coiling with extra soft coils is a widely accepted safe and durable treatment option for intracranial aneurysms but lacks prospective real‐world outcomes. Extra soft coils are specifically designed as fill and finish coils. The primary objective of the SURF study, a postmarket registry, is to assess the real‐world experience of extra soft coils as fill and finish coils to support adequate aneurysm occlusion at 1‐year follow‐up. This study is an interim analysis of periprocedural safety results and ramp‐up of a trial during the COVID‐19 pandemic. Methods : The SURF trial is a postmarket, prospective, multicenter, single‐arm, observational trial aiming to enroll about 800 patients. Patients undergoing embolization of intracranial aneurysm with an extra soft coil as the finishing coil were enrolled at 34 centers globally from November 2019 through July 20, 2021, and will be followed up for approximately 1 year. During the first wave of COVID‐19 in the US, enrollment was behind expectations but has caught up with projections as of July 2020. The primary safety endpoints for this interim analysis were serious adverse events (SAEs) within 24 hours after the procedure and device‐related SAEs up to 7 days after the procedure or to discharge. Results : This interim analysis is for 346 enrolled patients, characterized by a mean age of 60.1 years and being predominantly (73.1%) female. Medical history included 62.4% of patients with hypertension and 18.2% of patients with a previous history of stroke. The most common aneurysm locations were the internal carotid artery (35.2%) and the anterior cerebral artery (31.1%). Unassisted coiling was the modality of choice in 49.6% of procedures, followed by stent‐assisted coiling in 30.0% and balloon‐assisted coiling in 16.9%. The rate of SAEs within 24 hours after the procedure was 7.8% (27/346; 95% CI, 5.0%‐10.6%). Device‐related SAEs occurred in 1.4% (5/346; 95% CI, 0.2%‐2.7%) of patients up to 7 days after the procedure or to discharge. The rate of major ipsilateral stroke up to discharge was 0.6% (2/346; 95% CI, 0.0%‐1.4%), and the rate of symptomatic intracerebral hemorrhage was 1.4% (5/346; 95% CI, 0.2%‐2.7%), including 2 intraprocedural ruptures and 3 patients who had ruptured aneurysm at baseline and had intraventricular and intracerebral hemorrhage. Patient follow‐up is ongoing. Conclusions : We report interim outcomes from the SURF study. This postmarket registry evaluates the safety of extra soft coils as fill and finish coils in the treatment of intracranial aneurysms. Trial ramp‐up, despite temporary delay during the initial COVID‐19 wave, has been progressing along with expectations.