First-line aspiration is becoming a preferred technique for acute ischaemic stroke treatment. Recent technical advances that facilitate successful first-pass aspiration include larger bore embolectomy catheters guided by more manoeuvrable delivery catheters.
Materials
A novel tapered tip delivery catheter was specifically designed to deliver an 0.088" aspiration catheter through a specialized 8F 90 cm introducer sheath (Route 92 Medical, Inc. San Mateo, CA) to M1 and ICA/ICA-T occlusions. The unique operating system, MonoPoint®, is designed to maximize aspiration physics and improve first pass efficiency by engulfing the embolus. Utilizing a single RHV and a novel catheter-on-a-rail simplifies operator handling and control. Tenzing®, the specialized delivery catheter, replaces the traditional microcatheter and is designed to reduce the need for a microwire to facilitate catheter delivery to the face of the embolus.
Methods
SUMMIT NZ (ACTRN12619000890134p) was designed as a prospective, single-arm, open label clinical trial at two sites in New Zealand. Eligible participants were patients presenting with acute ischemic stroke from either anterior or posterior circulation large-vessel occlusion within 24 hours of onset, a National Institutes of Health Stroke Scale Score of greater than or equal to 6 and a pre-stroke modified Rankin Score of less than or equal to 2. The primary effectiveness endpoint was arterial revascularization as measured by a modified Thrombosis in Cerebrovascular Infarction (mTICI) score of 2b or greater at the end of angiography after all endovascular treatments as adjudicated by an independent core laboratory. The primary safety endpoints were device-related peri-procedural complications such as dissection or perforation, symptomatic Intracranial Cerebral Hemorrhage (SICH) at 24 hours and embolization to a previously uninvolved territory.
Results
From September 27, 2019 to January 11, 2021, 34 subjects (mean age 68.5, NIHSSS 15.9, time last known well 5.9 hours) were enrolled with a diagnosis of acute ischemic stroke. Acute occlusion was located in the middle cerebral artery (74%, 25/34) and internal carotid artery (26%, 9/34). Successful revascularization was achieved in 97% (33/34) of subjects. No serious adverse device effects have been reported.
Conclusions
Preliminary findings suggest that first-line aspiration embolectomy using a novel MonoPoint® system including an 0.088" inner diameter aspiration catheter achieves a high rate of arterial revascularization with an acceptable safety profile. A full report on enrollment and results are to be presented.
Disclosures
S. Brew: 1; C; Route 92 Medical. 2; C; Route 92 Medical, Microvention. B. McGuinness: 1; C; Route 92 Medical. 2; C; Route 92 Medical. J. Caldwell: 1; C; Route 92 Medical. 2; C; Route 92 Medical. S. Lee: 1; C; Route 92 Medical. P. Barber: None. A. Holden: 2; C; Medtronic, Gore, Boston Scientific. T. Wu: None. M. Krauss: None. A. Laing: None. W. Collecutt: None. D. Liebeskind: 2; C; Cerenovus, Genentech, Medtronic, Rapid Medical, Stryker. S. Hetts: 2; C; Stryker, Microvention, Terumo, ThrombX.
Intravenous infusion of alteplase is used for thrombolysis before endovascular thrombectomy for ischemic stroke. Tenecteplase, which is more fibrin-specific and has longer activity than alteplase, is given as a bolus and may increase the incidence of vascular reperfusion.
Background and hypothesis Intravenous thrombolysis with alteplase remains standard care prior to thrombectomy for eligible patients within 4.5 h of ischemic stroke onset. However, alteplase only succeeds in reperfusing large vessel arterial occlusion prior to thrombectomy in a minority of patients. We hypothesized that tenecteplase is non-inferior to alteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. Study design EXTEND-IA TNK is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint non-inferiority study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale≤3 (no upper age limit), large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal computed tomography and absence of contraindications to intravenous thrombolysis. Patients are randomized to either IV alteplase (0.9 mg/kg, max 90 mg) or tenecteplase (0.25 mg/kg, max 25 mg) prior to thrombectomy. Study outcomes The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified treatment in cerebral infarction 2 b/3 or the absence of retrievable thrombus. Secondary outcomes include modified Rankin Scale at day 90 and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration ClinicalTrials.gov NCT02388061
Patients with large ischemic core stroke have poor clinical outcomes and are frequently not considered for interfacility transfer for endovascular thrombectomy (EVT).
Background We describe the first-in-human experience using the Route 92 Medical Aspiration System to perform thrombectomy in the initial 45 consecutive stroke patients enrolled in the SUMMIT NZ trial. This aspiration system includes a specifically designed delivery catheter which enables delivery of 0.070 inch and 0.088 inch aspiration catheters. Methods The SUMMIT NZ trial is a prospective, multicenter, single-arm study with core lab imaging adjudication. Patients presenting with acute ischemic stroke from large vessel occlusion are eligible to enrol. The study has had three phases which transitioned from use of the 0.070 inch to the 0.088 inch catheter. Results Vessel occlusions were located in the internal carotid artery (27%), M1 (60%) and M2 (13%). Median baseline National Institutes of Health Stroke Scale (NIHSS) was 16 (IQR 10). Across the three phases, the first-pass reperfusion rate of modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b was 62% using the Route 92 Medical system; this rate was 29% in phase 1, 56% in phase 2, and 80% in phase 3. The first-pass reperfusion rate of mTICI ≥2c was 42% overall, 29% in phase 1, 33% in phase 2, and 55% in phase 3. A final reperfusion rate of mTICI ≥2b was achieved in 96% of cases, with 36% of cases using adjunctive devices. Patients had an average improvement of 6.7 points in NIHSS from baseline at 24 hours, and at 90 days 48% were functionally independent (modified Rankin Scale 0–2). Conclusions In this early experience, the Route 92 Medical Aspiration System has been effective and safe. The system has design features that improve catheter deliverability and have the potential to increase first-pass reperfusion rates in aspiration thrombectomy.
Stroke endovascular clot retrieval (ECR) in patients with large proximal vessel occlusion improves clinical outcomes. We present the New Zealand ECR experience.All New Zealand patients treated with ECR since 2011 were included. Patients were considered eligible if they were independent prior to stroke and had proximal intracranial arterial occlusion.Three hundred and twelve patients [136 women, mean (SD) age of 64 (17) years] from 11 district health boards have been treated between March 2011 and April 2018. There were 260 (83%) patients with anterior and 52 (17%) with posterior circulation arterial occlusion. One hundred and ninety-three (62%) patients were pre-treated with intravenous alteplase. The median time from symptom onset to groin puncture was 210 (range 65-985) minutes. Complete or near-complete recanalisation (Thrombolysis in Cerebral Infarction scores of 3 or 2b) was achieved in 260 of 300 (87%) and the National Institutes of Health Stroke Scale score improved from a median of 18 at baseline to 7 at 24 hours. By day 90, 55% of the anterior circulation patients and 40% of the posterior circulation patients were living independently at home. Mortality rates were 20% for anterior circulation patients and 30% for the posterior circulation patients.This study has shown that stroke endovascular clot retrieval is being provided safely and effectively in New Zealand. However, there remain discrepancies in service provision, and ongoing regional, inter-regional and inter-sector collaboration is essential to implement comprehensive and equitable ECR services across the country.
Purpose: Decompressive craniectomy remains controversial because of uncertainty regarding its benefit to patients; this study aimed to explore current practice following the RESCUEicp Trial, an important study in the evolving literature on decompressive craniectomies.Methodology: Fifty-eight neurosurgeons in New Zealand, Australia, Nepal and the USA completed a survey consisting of two case scenarios and several multi-choice questions exploring their surgical management and prognostication of traumatic brain injuries following the RESCUEicp Trial.Results: One in ten neurosurgeons (n = 6, 10.3%) were no longer performing decompressive craniectomies for TBI following the RES-CUEicp Trial and two fifths (n = 23, 39.7%) were less enthusiastic.Most neurosurgeons would not operate in the face of severe disability (n = 46, 79.3%) or vegetative state/death (n = 57, 98.3%).There was significant variability in the neurosurgeons' prognostic estimates, which were generally more optimistic than the CRASH prognostic model.Those with more pessimistic prognostic estimates and those who use decision support tools were more likely to decline decompressive surgery to the two case scenarios.Conclusions: RESCUEicp had a notable impact on neurosurgeons and their management of TBI.Although there remains no clear clinical consensus on the contraindications for decompressive craniectomy, most neurosurgeons would not operate if severe disability or vegetative state (the rates of which are increased by such surgery) seemed likely.Whilst unreliable, prognostic estimates still have an impact on clinical decision making and neurosurgical management.Wider use of decision support tools should be considered.
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