58 research outputs found
Timing of vessel imaging for suspected large vessel occlusions does not affect groin puncture time in transfer patients with stroke.
BACKGROUND: Access to endovascular therapy (ET) in cases of acute ischemic stroke may be limited, and rapid transfer of eligible patients to hospitals with endovascular capability is needed.
OBJECTIVE: To determine the optimal timing of diagnostic CT angiography to confirm large vessel occlusion (LVO).
METHODS: Of 57 emergency department transfers to Mount Sinai Hospital (MSH) for possible ET from January 2015 through March 2016, 39 (68%) underwent ET, among whom 22 (56%) had CT angiography before transfer and 17 (44%) had CT angiography on arrival. We compared mean outside hospital arrival to groin puncture (OTG) time between the two groups using t-tests and Wilcoxon rank sum tests. OTG was defined as the difference between groin puncture and outside hospital arrival time minus ambulance travel time.
RESULTS: Average age was 73±13 years and average National Institute of Health Stroke Scale score was 19±5. There was no difference in average OTG time between the two groups (191 min for CT angiography at outside hospital vs 190 min for CT angiography at MSH (p=0.99 for t-test and 0.69 for rank sum test)). Among the 18 patients who were transferred but did not receive ET, 10 had no LVO, 5 had large established infarcts on arrival and 3 had post-tissue plasminogen activator hemorrhage. In 9/10 patients without LVO, CT angiography was not performed before transfer.
CONCLUSIONS: CT angiography timing in the transfer process does not affect OTG time, but 90% of patients without LVO had not had CT angiography before transfer. Hence, it might be beneficial to obtain a CT angiogram at the outside hospital, if it can be acquired and read rapidly, to avoid the cost and potential clinical deterioration associated with unnecessary transfers
Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry
Background: The purpose of this study was to report the safety and performance of aspiration thrombectomy with the Penumbra System for patients with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO) and late onset to treatment.
Methods: This is a retrospective subset analysis of a global prospective multicenter registry (COMPLETE) that enrolled adults with AIS due to LVO and a pre-stroke modified Rankin Scale score (mRS) of 0 or 1 who were treated first-line with aspiration thrombectomy either alone (A Direct Aspiration First Pass Technique [ADAPT]) or in combination with the 3D Revascularization Device (ADAPT + 3D). This subset analysis included all patients in the registry who had anterior circulation LVO, an Alberta Stroke Program Early CT Score of at least 6, and late onset to treatment (\u3e6 h from stroke onset to puncture).
Results: Of the 650 patients in the COMPLETE registry, 167 were included in this subset analysis. The rate of successful revascularization (modified thrombolysis in cerebral infarction score 2b-3 achieved) at the end of the procedure was 83.2%, the rate of good functional outcome (mRS 0-2) at 90 days was 55.4%, and the all-cause mortality rate at 90 days was 14.4%. No device-related serious adverse events (SAEs) occurred. Procedure-related SAEs occurred in 9 patients (5.4%) within 24 h and in 12 patients (7.2%) overall. The rate of successful revascularization was higher for patients treated first-line with ADAPT (88.0%) than for patients treated first-line with ADAPT + 3D (75.0%; p = 0.035); no significant difference was observed between the ADAPT and ADAPT + 3D groups for any other primary or secondary outcome.
Conclusion: For patients with AIS due to anterior circulation LVO and with late onset to treatment, aspiration thrombectomy with the Penumbra System appears to be safe and effective. The rates of good functional outcome and all-cause mortality from this study compared favorably with those rates from the medical management arms of the DAWN and DEFUSE-3 studies.
Clinical trial registration: https://www.clinicaltrials.gov, NCT03464565
Aspiration thrombectomy of M2 middle cerebral artery occlusion to treat acute ischemic stroke: A core lab–adjudicated subset analysis from the COMPLETE registry and literature review
Background
Although the benefits of aspiration thrombectomy for treating acute ischemic stroke caused by proximal large vessel occlusion have been established, fewer data are available for evaluating aspiration thrombectomy of distal occlusion. The objective of this study was to evaluate, by means of prospectively collected data, the safety and efficacy of aspiration thrombectomy in patients with M2 middle cerebral artery (MCA) occlusion. Methods
This study is a subset analysis of a global prospective multicenter observational registry that included patients who presented with either anterior or posterior large vessel occlusion and were eligible for mechanical thrombectomy using the Penumbra System including the Penumbra 3D Revascularization Device. For this analysis, all patients in the registry with M2 MCA occlusion were included. Results
Of the 650 patients in the registry, 113 (17.4%) had M2 MCA occlusion. The rate of a modified treatment in cerebral infarction score of 2b to 3 after the procedure was 79.6% (90/113), the rate of a modified Rankin Scale score of 0–2 at 90 days was 72.5% (79/109), and the all-cause mortality rate at 90 days was 8.8% (10/113). Device-related serious adverse events occurred in one patient (0.9%) within 24 h and in two patients (1.8%) overall. Procedure-related serious adverse events occurred in four patients (3.5%) within 24 h and in six patients (5.3%) overall (nine events). Conclusion
For appropriately selected patients, aspiration thrombectomy for acute ischemic stroke due to M2 MCA occlusion was safe and effective, with high rates of technical success and good functional outcome
Impact of interhospital transfer vs. direct admission on acute ischemic stroke patients: A subset analysis of the COMPLETE registry
Background: Efficacy of thrombectomy treatment in acute ischemic stroke large vessel occlusion (AIS-LVO) patients is time dependent. Direct admission to thrombectomy centers (vs. interhospital transfer) may reduce time to treatment and improve outcomes. In this subset analysis of the COMPLETE registry, we compared outcomes between direct to thrombectomy center (Direct) vs. transfer from another hospital to thrombectomy center (Transfer) in AIS-LVO patients treated with aspiration thrombectomy.
Methods: COMPLETE was a prospective, international registry that enrolled patients from July 2018 to October 2019, with a 90-day follow-up period that was completed in January 2020. Imaging findings and safety events were adjudicated by core lab and independent medical reviewers, respectively. Pre-defined primary endpoints included post-procedure angiographic revascularization (mTICI ≥2b), 90-day functional outcome (mRS 0-2), and 90-day all-cause mortality. Planned collections of procedural time metrics and outcomes were used in the present post-hoc analysis to compare outcomes between transfer and direct patient cohorts.
Results: Of 650 patients enrolled, 343 were transfer [52.8% female; mean (SD) age, 68.2 (13.9) years], and 307 were direct [55.4% female; 68.5 (14.5) years] admit. Median onset-to-puncture time took longer in the transfer vs. direct cohort (5.65 vs. 3.18 h: 2.33 h difference, respectively; p \u3c 0.001). There was no significant difference in successful revascularization rate, mTICI ≥2b (88.3 and 87.3%), sICH at 24 h (3.8 and 3.9%), median length of hospital stay (7 and 6 days), and 90-day mortality (16.9 and 14.0%) between transfer vs. direct patients, respectively. However, achieving 90-day functional independence was less likely in transfer compared with direct patients (mRS 0-2 was 50.3 vs. 61.7%, p = 0.0056).
Conclusions: In the COMPLETE registry, direct to thrombectomy center was associated with significantly shorter onset-to-puncture times, and higher rates of good clinical outcome across different geographies. Additional research should focus on AIS-LVO detection to facilitate direct routing of patients to appropriate treatment centers.
Clinical trial registration: https://clinicaltrials.gov (Unique identifier: NCT03464565)
Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results
Background and Purpose:
The purpose of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry was to evaluate the generalizability of the safety and efficacy of the Penumbra System (Penumbra, Inc, Alameda) in a real-world setting. Methods:
COMPLETE was a global, prospective, postmarket, multicenter registry. Patients with large vessel occlusion–acute ischemic stroke who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device as frontline approach were enrolled at 42 centers (29 United States, 13 Europe) from July 2018 to October 2019. Primary efficacy end points were successful postprocedure angiographic revascularization (modified Thrombolysis in Cerebral Infarction ≥2b) and 90-day functional outcome (modified Rankin Scale score 0–2). The primary safety end point was 90-day all-cause mortality. An imaging core lab determined modified Thrombolysis in Cerebral Infarction scores, Alberta Stroke Program Early CT Scores, clot location, and occurrence of intracranial hemorrhage at 24 hours. Independent medical reviewers adjudicated safety end points. Results:
Six hundred fifty patients were enrolled (median age 70 years, 54.0% female, 49.2% given intravenous recombinant tissue plasminogen activator before thrombectomy). Rate of modified Thrombolysis in Cerebral Infarction 2b to 3 postprocedure was 87.8% (95% CI, 85.3%–90.4%). First pass and postprocedure rates of modified Thrombolysis in Cerebral Infarction 2c to 3 were 41.5% and 66.2%, respectively. At 90 days, 55.8% (95% CI, 51.9%–59.7%) had modified Rankin Scale score 0 to 2, and all-cause mortality was 15.5% (95% CI, 12.8%–18.3%). Conclusions:
Using Penumbra System for frontline mechanical thrombectomy treatment of patients with large vessel occlusion–acute ischemic stroke in a real-world setting was associated with angiographic, clinical, and safety outcomes that were comparable to prior randomized clinical trials with stringent site and operator selection criteria. REGISTRATION:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT0346456
Decline in subarachnoid haemorrhage volumes associated with the first wave of the COVID-19 pandemic
BACKGROUND: During the COVID-19 pandemic, decreased volumes of stroke admissions and mechanical thrombectomy were reported. The study\u27s objective was to examine whether subarachnoid haemorrhage (SAH) hospitalisations and ruptured aneurysm coiling interventions demonstrated similar declines.
METHODS: We conducted a cross-sectional, retrospective, observational study across 6 continents, 37 countries and 140 comprehensive stroke centres. Patients with the diagnosis of SAH, aneurysmal SAH, ruptured aneurysm coiling interventions and COVID-19 were identified by prospective aneurysm databases or by International Classification of Diseases, 10th Revision, codes. The 3-month cumulative volume, monthly volumes for SAH hospitalisations and ruptured aneurysm coiling procedures were compared for the period before (1 year and immediately before) and during the pandemic, defined as 1 March-31 May 2020. The prior 1-year control period (1 March-31 May 2019) was obtained to account for seasonal variation.
FINDINGS: There was a significant decline in SAH hospitalisations, with 2044 admissions in the 3 months immediately before and 1585 admissions during the pandemic, representing a relative decline of 22.5% (95% CI -24.3% to -20.7%, p\u3c0.0001). Embolisation of ruptured aneurysms declined with 1170-1035 procedures, respectively, representing an 11.5% (95%CI -13.5% to -9.8%, p=0.002) relative drop. Subgroup analysis was noted for aneurysmal SAH hospitalisation decline from 834 to 626 hospitalisations, a 24.9% relative decline (95% CI -28.0% to -22.1%, p\u3c0.0001). A relative increase in ruptured aneurysm coiling was noted in low coiling volume hospitals of 41.1% (95% CI 32.3% to 50.6%, p=0.008) despite a decrease in SAH admissions in this tertile.
INTERPRETATION: There was a relative decrease in the volume of SAH hospitalisations, aneurysmal SAH hospitalisations and ruptured aneurysm embolisations during the COVID-19 pandemic. These findings in SAH are consistent with a decrease in other emergencies, such as stroke and myocardial infarction
Abstract 1122‐000105: Does Persistence in Reperfusion Pay Off?
Introduction: Reperfusion with mechanical thrombectomy improves outcomes in patients with Large Vessel Occlusion Acute Ischemic Stroke (LVO‐AIS). The technical goal of thrombectomy is reperfusion to a modified Thrombolysis in Cerebral Infarction (mTICI) grade ≥ 2b. Here we investigate if procedures requiring multiple passes to achieve complete reperfusion (MP mTICI 3) result in better outcomes compared to procedures stopped after achieving mTICI 2b‐2c on the first pass (FP mTICI 2b‐2c). Methods: Using data from the COMPLETE registry (a global prospective study of LVO‐AIS patients who underwent mechanical thrombectomy using the Penumbra System), we grouped patients into MP mTICI 3 and FP mTICI 2b‐2c. Functional independence (mRS 0–2) at 90 days, all‐cause mortality at 90 days, device‐related serious adverse events (SAE) ≤ 24 hours, procedure‐related SAEs ≤ 24 hours, embolization to new or previously uninvolved territories (ENT), symptomatic intracranial hemorrhage (sICH) ≤ 24 hours, vessel perforation, vessel dissection, and length of stay were compared. Results: Of the 650 patients in the COMPLETE registry, 215 were included in this subgroup analysis; 111 were categorized as MP mTICI 3, and 104 as FP mTICI 2b‐2c. The MP mTICI 3 group has fewer M1 occlusions (48% vs 67%, p = 0.004) and more ICA‐T occlusions (19% vs. 9%, p = 0.032). The groups were otherwise well matched with respect to age, sex, medical history, pre‐procedure ASPECTS, NIHSS, IV tPA use, onset‐to‐puncture time, and occlusion etiology. Outcomes are shown in table 1. Conclusions: In this exploratory subgroup analysis, we found that procedures requiring multiple passes to achieve complete revascularization were not associated with improved outcomes compared to procedures stopping after achieving mTICI 2b‐2c on the first pass
Abstract 1122‐000209: Cannabis and Cerebrovascular Outcomes: A National Registry Analysis
Introduction: Recreational and medical cannabis use in the United States has been increasing in recent years in light of state and federal efforts to decriminalize and legalize its use. Its legal status has long precluded extensive research into its adverse effects, especially as it pertains to the realm of vascular and cerebrovascular outcomes. To date, minimal research has been completed on the sequelae of cannabis in inpatient admissions for stroke. Methods: A query of the 2012–2015 Nationwide Inpatient Sample searched for patients admitted with stroke ICD‐9 diagnoses. These patients were then grouped by the presence of concurrent diagnosis of cannabis use disorder, and compared with respect to various peri‐ and postoperative complications, all‐cause mortality, discharge disposition, length of stay, and hospitalization costs. Propensity score matching was utilized to control for potential baseline confounders. Results: A total of 414,340 patients met inclusion/exclusion criteria, 6794 (1.64%) of whom had cannabis use disorder. After controlling for baseline characteristics, these patients had higher rates of inpatient mortality (odds ratio [OR] 1.43; p = 0.01263), and non‐routine discharge, as well as increased lengths of stay (6.5 vs 5.7 days, p<0.001) and no significant difference in hospitalization charges ( 63328 10, p = 0.3918). Conclusions: Based on a national trends analysis, chronic cannabis use appears to be associated with increased perioperative morbidity and mortality among patients admitted for stroke diagnoses. Physicians should ensure affected patients be adequately informed of associated risks. Further research should include matching of risk factors not captured in databases
Abstract Number ‐ 178: Optimizing Skin to Device at Occlusion Time Utilizing A Non‐exchange Technique with Novel Steerable Microcatheter
Introduction Vascular tortuosity and difficult access to the target vessel during mechanical thrombectomy is one of the reasons for failed reperfusion. The 021 Bendit adjustable micro catheter is a torqueable microcatheter with an adjustable, 360 rotating, bendable tip. Its unique structure provides it with trackability and support allowing it to be used as a select catheter for the guide and to directly access the target vessel without a guidewire. This feature can result in significant reduction in groin puncture to recanalization time, with possible implications on patient outcomes. It is also designed to fit in a standard sized aspiration catheter and allow delivery of a stentriever device if needed. Herein we describe the first US experience in 021 Bendit adjustable microcatheter in vessel selection and intracranial navigation in patients with large vessel occlusions. Methods We describe our experience with three patients who presented with large vessel occlusions for mechanical thrombectomy in July 2022. The system with guide catheter loaded with aspiration catheter and Bendit adjustable microcatheter was used to directly select the target vessels starting at the arteriotomy site, off the aortic arch and its support was used to advance the guide catheter into the cervical segment. It was then delivered to the intracranial circulation where it was used to deliver the aspiration catheter. Results Patient A is a 73‐year‐old man with a left M1 occlusion. The Bendit microcatheter was advanced through a 071 intermediate catheter and through a 088 guide catheter and was used to select the left common carotid artery. Time between device entering the body to clot touch time of 18 minutes. Patient B is a 57‐year‐old man who presented with a left cavernous internal carotid artery occlusion. The Bendit microcatheter was advanced through a 071 intermediate catheter and a 088 guide catheter was used to successfully select the left common carotid artery.Time between device entering body and bendit being at first lesion is 3 minutes. Patient C is a 60‐year‐old woman with a basilar occlusion. A 088 guide catheter was advanced over 071 intermediate catheter which was advanced over the Bendit microcatheter into the aortic arch. The Bendit microcatheter was maneuvered to select the right subclavian artery and the right vertebral artery, the system was subsequently advanced over the Bendit microcatheter intracranially. Time between groin puncture to aspiration device at the clot was 5 minutes. Conclusions The Bendit steerable microcatheter can be used to maneuver through the aortic arch and successfully select the target vessel without an exchange and without a guidewire. This approach can dramatically reduce access to recanalization time and ultimately neurologic outcomes in patients undergoing mechanical thrombectomy. As more experience is obtained, best practices will be able to achieve consistently lower times
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