Introduction EXCELLENT (NCT03685578; Cerenovus) is a large, prospective, international, real‐world registry of endovascular clot removal in acute ischemic stroke (AIS) with EmboTrap as the first line mechanical thrombectomy (MT) device, which included collection and analysis of the retrieved thrombus material. Methods Between September 2018 and March 2021, 1000 “all‐comer” patients were enrolled at 34 global sites (27 US, 5 EU, 1 UK, 1 Israel) and treated according to standard of care at each center (with Embrotrap as first line). The study employed blind endpoint evaluation, including a core imaging lab and an independent 90‐day mRS assessment. Retrieved clot was collected per each MT maneuver from 538 subjects across 26 sites and clot analysis was performed by independent central labs blinded to clinical data. Results mITT population included 998 subjects. Mean age was 69.9±14.18 years (range 18–102), 51.8% (517/998) subjects were female and 9.9% (97/997) had a pre‐stroke mRS 3–5. Baseline NIHSS was 15.6±6.87 (range 0–36); 10.1% (82/815) subjects had a large core (ASPECTS 0–5); 5.8% (57/990) had posterior stroke; 56.3% (523/929) underwent MT ≤ 6hrs of onset and 38.1% (380/998) received IV‐tPA prior to MT. First pass eTICI 2c‐3 was achieved in 38.3% (377/984) and final 2b‐3 in 94.5 % (930/984; median number of passes = 1) of subjects. 90‐day mRS≤2 or ≤pre‐stroke was 46.9% (429/915) and 90‐day all‐cause mortality was 19.0% (175/921). The univariate analysis of clot components showed high red blood cell and low platelet content were significant predictors of good mRS outcome (p < 0.001 and 0.009) and negative predictors of 90‐day mortality (p < 0.001 and 0.017, respectively). Conclusions This large multi‐center, all‐comer cohort reflects the population undergoing thrombectomy today in a real world‐setting. Final angiographic, clinical and thrombus composition results, along with multivariate analysis of predictors of clinical outcomes, will be presented at the time of the conference.
Abstract 28: First Pass Outcomes And Associated Clot Characteristics: Secondary Analysis Of The Excellent Registry
Introduction: EXCELLENT (NCT03685578) is a global prospective, multicenter, real-world registry of mechanical thrombectomy for stroke with the EmboTrap device as first line treatment which includes clot collection and analysis. Aim of the study: To report the rates of clinical outcomes and clot characteristics associated with first pass reperfusion in EXCELLENT. Methods: Per pass angiographic outcomes assessed by an independent core lab were available in 984 subjects Analysis of clot from 538 cases was performed by independent central labs blinded to clinical data. 90-day mRS assessment was blinded to subject data. Results: First pass reperfusion of mTICI 2b-3 (63.2%) and 2c-3 (38.3%) was significantly predictive of mRS 0-2 or ≤pre-stroke (p=0.011 and p=0.016) but not all-cause mortality at 90 days (p=0.080 and p=0.123, respectively). Further, mTICI 2c-3 in one pass was associated with a higher rate of mRS 0-2 or ≤pre-stroke vs. mTICI 2c-3 reperfusion in >1 pass, (55.5% and 45.1%, respectively, p=0.013) and a rate of all-cause mortality at 90 days of 14.6% vs. 19.8% (p=0.097). Full patient characteristics and clinical outcomes are shown in Table 1. Notable clot composition findings included: RBC (%, mean±SD): mTICI 2c-3, 1 pass 47.69±22.25, mTICI 2c-3, >1 pass 43.86±19.05, (p=0.088); fibrin: mTICI 2c-3, 1 pass 23.20±13.80, mTICI 2c-3 >1 pass 25.40 ± 13.52 (p=0.131); von Willebrand factor (VWF): mTICI2c-3, 1 pass 16.09±14.62, mTICI 2c-3, >1 pass 19.42±17.15 (p=0.038). Conclusions: First pass reperfusion in the EXCELLENT registry was associated with better clinical outcomes at 90 days. Clots retrieved with first pass reperfusion had higher RBC and lower fibrin and VWF content compared to those who achieved reperfusion at greater than one pass.
Endovascular Coil Embolization of a Posterior Communicating Artery Aneurysm: 2-Dimensional Operative Video
Abstract Since the International Subarachnoid Aneurysm Trial, 1 endovascular treatment has been the favored treatment for appropriate ruptured intracranial aneurysms. While our endovascular technology has advanced to allow us to treat the majority of intracranial aneurysms, simple coil embolization is still the most common modality. This video demonstrates the fundamentals of aneurysm catheterization and coiling for safe treatment. In addition, the set-up and devices are detailed. This video is to add to the library of basic techniques that will aid a large number of practitioners. This patient consented to endovascular treatment. The video demonstrates endovascular coil embolization of a posterior communicating artery aneurysm in a 76-yr-old female who presented with a subarachnoid hemorrhage. Image of biplane suite in video used courtesy of Siemens Medical Solutions USA, Inc. Illustration at 5:12 reprinted from Yasargil MG, et al, Microneurosurgery IV B , p. 9, Thieme, New York, 1995.
Mechanical Thrombectomy of Carotid Terminus Occlusion Using Direct Aspiration Technique—Video Illustration: 2-Dimensional Operative Video
Abstract Acute carotid terminus occlusion (CTO) is responsible for up to 5% of acute ischemic strokes secondary to emergent large vessel occlusion (ELVO) and up to 20% of acute internal carotid artery (ICA) occlusions. 1 The term “CTO” has also been used to describe occlusions in the supra-clinoid segment or at the bifurcation of the ICA. Compared to other ELVOs, patients with CTO present with higher stroke severity and larger infarct volume, likely to be a result of disruption of direct Circle of Willis collaterals across the anterior communicating artery (AComA) and posterior communicating artery (PComA). 2,3 Similary, CTO is usually associated with worse prognosis compared to other ELVOs in general. With regard to response to treatment, previous studies have reported significantly lower recanalization rates with intravenous alteplase with CTO compared to M1 segment occlusion. With regard to the safety and efficacy of mechanical thrombectomy, prior reports provide conflicting results with some reporting lower successful recanalization rates with CTO compared to M1 occlusion, and others reporting similar results. In our experience, we have found that successful recanalization of CTO can be achieved with a similar approach to M1 occlusions utilizing a direct aspiration first pass technique (ADAPT). 3,4 Herein, we present a case of CTO for which we performed mechanical thrombectomy using ADAPT. This procedure was an emergent standard of care procedure for which a consent was not required and so not obtained.
Abstract TP9: Solitaire FR Thrombectomy For Acute Stroke: Real-world Experience After FDA Approval
Background and Purpose: Based on promising results of the Solitaire FR With the Intention for Thrombectomy (SWIFT) trial, Solitaire FR stent retriever device recently received the Food and Drug Administration (FDA) approval for recanalization of cerebral vessels in patients with acute ischemic stroke. Real world experience with this device since its FDA approval in the United States has not been previously described. Methods: We conducted retrospective analysis of consecutive acute ischemic strokes cases from March 2012 to July 2012 in 10 centers within the United States, where Solitaire FR was used as a single device or in conjunction with other intra-arterial endovascular approaches. Results: A total of 107 patients were identified (mean age, 64 years; male gender, 51%; mean admission NIHSS score 17). Mean time from symptom onset to angiogram (groin puncture) was 4 hrs 47 min. Intravenous thrombolysis with tissue plasminogen activator (tPA) was administered in 37% of cases. Other endovascular techniques utilized in conjunction with Solitaire FR included intra-arterial thrombolysis with tPA (12% of patients), aspiration thrombectomy with Penumbra system (29%) and stenting (17%). Complete recanalization (TIMI 2-3) was achieved in 88% of patients. The rate of sICH within the first 24 hours was 15%. In-hospital mortality was 24%. 30-day clinical follow up data was available on 82 (77%) patients. Of those, 28 patients (34%) had favorable functional outcome (defined as modified Ranking Scale,mRS≤2) and 22 patients (27%) had excellent functional outcome (mRS≤1) at 30 days. Three or more passes with the Solitaire device was associated with a higher incidence of mortality compared with patients requiring 1 or 2 passes only (43% and 18% respectively, p = 0.011). No statistically significant correlation between clot location or length and outcome was evident. Use of other devices with the Solitaire FR was correlated with worsened outcome (p=0.037). Conclusions: This is the first study describing real-world experience with Solitaire FR device outside the SWIFT trial in the United States. Out study shows that variety of other endovascular approaches are used in conjunction with Solitaire FR.
Ulnar Artery Access: A Nontraditional Access Site for Diagnostic Cerebral Angiography and Neurointervention: 2-Dimensional Operative Video
Abstract Basilar artery occlusions (BAOs) are devastating ischemic strokes that account for 1% of all strokes with high morbidity and mortality; however, neuroendovascular techniques such as ADAPT have recently revolutionized the clinical outcomes of these patients. 1-3 Common underlying pathology in patients with BAO include intracranial atherosclerotic disease (ICAD) as well as thromboembolic origin. 4 Basilar artery ICAD in a setting of acute stroke portends a poor prognosis and post-thrombectomy residual critical flow limiting stenosis treatment options, including balloon angioplasty with or without stent placement. 5-7 We present a video illustration of neuroendovascular technique and challenges encountered when managing this pathology. Image at 5:42 reprinted with permission from Alawieh et al, Lessons learned over more than 500 stroke thrombectomies using ADAPT with increasing aspiration catheter size, Neurosurgery , 86(1), 2020, pp. 61-70, with permission from the Congress of Neurological Surgeons. 1
Carotid In-Stent Stenosis: Cutting Balloon Angioplasty: 2-Dimensional Operative Video
Abstract In-stent stenosis has a reported prevalence of 14% to 19% at 1-yr follow-up after carotid stenting and is associated with an increased risk of acute ischemic stroke. 1,2 Risk factors include female sex, diabetes, and dyslipidemia. Cutting balloon angioplasty is a safe and effective treatment modality for the treatment of carotid in-stent stenosis, and alternative treatment options include observation with medical management and placement of another stent. 3,4 The authors present the case of a 61-yr-old man with carotid in-stent restenosis and progressive worsening on serial imaging with ultrasound. The patient had a history of carotid stenting for symptomatic stenosis 6 mo prior and was maintained on aspirin and clopidogrel. In light of the progressive worsening, the in-stent stenosis was confirmed on computed tomography (CT) angiogram. The options were discussed with the patient and he consented for treatment with cutting balloon angioplasty. Final angiogram showed improvement of the luminal diameter with a residual stenosis of 15%. The patient tolerated the procedure well and was discharged home on postoperative day 1. Follow-up ultrasound demonstrated moderate improvement in peak systolic velocities, and the plan is to continue observation with a clinical follow-up and repeat carotid Dopplers at 3 mo.
Management of Mobile Thrombus With Distal Protection Devices During Carotid Artery Angioplasty: 2-Dimensional Operative Video
Abstract Embolic protection devices (EPDs) have become a standard of care during internal carotid artery revascularization. 1,2 This video is about a 57-yr-old-male who presented with a wake-up stroke with a left hemispheric syndrome. Head computed tomography angiography (CTA) revealed tandem occlusions of the proximal left internal carotid artery (ICA) and of the distal left middle cerebral artery (MCA) with an ASPECT (Alberta Stroke Program Early CT Score) score of 6. The patient underwent a cerebral angiogram and was treated with balloon angioplasty with a distal EPD and mechanical thrombectomy. The EPD became occluded with thrombus from the ICA and was retrieved through a 6-Fr Sofia (MicroVention) under continuous aspiration. Successful revascularization of the proximal ICA and distal MCA was achieved. No procedure-related complications occurred, and the patient's neurological exam improved. Tandem occlusions can occur in up to 15% of strokes. The optimal treatment can be controversial, but mechanical thrombectomy and ICA revascularization with a distal EPD appear to be safe and effective in selected patients. 3 Consent was obtained for the procedure and for the video production.
Intracranial Stenting: Angioplasty Basic Technique, Indications, and Sizing: 2-Dimensional Operative Video