Data on large vessel strokes are important for resource allocation and infrastructure development.
To determine an annual incidence of large vessel occlusions (LVOs) and a thrombectomy eligible ...patient population.
All patients with acute ischemic stroke discharged over 3 years from a tertiary-level hospital serving a large geographic area were evaluated for an LVO (M1, internal carotid artery terminus, basilar artery). The incidence of LVO was determined for the hospital's 4-county primary service area (PSA, population 210 000) based on each county's discharges and extrapolated to the US population. 'Thrombectomy eligibility' for anterior circulation LVOs was based on time (onset <6 hours) and imaging (Alberta Stroke Program Early CT Score (ASPECTS) ≥6). The number of annual thrombectomy procedures was calculated for Medicare and private payer patients using federally available databases.
1157 patients were discharged from the hospital's PSA, of whom 129 (11.1%, 95% CI 9.5% to 13.1%) had an LVO. This translated into an LVO incidence of 24 per 100 000 people per year (95% CI 20 to 28). 20 per 100 000 people per year had anterior circulation LVOs (95% CI 19 to 22), of whom 10/100 000/year (95% CI 8 to 11) were 'thrombectomy eligible'. An additional 5/100 000/year (95% CI 3 to 6) presented with favorable ASPECTS after 6 hours of symptom onset. Basilar occlusion incidence was estimated at 4/100 000/year (95% CI 2 to 5). These rates yield 77 569 (95% CI 65 835 to 91 091) new LVOs per year in the USA. An estimated 10 284 mechanical thrombectomy procedures were performed in 2015.
This study estimates an LVO incidence of 24 per 100 000 person-years (95% CI 20 to 28). A current estimated annual thrombectomy rate of three procedures per 100 000 people indicates significant potential increase in the volume of endovascular procedures and the need to develop systems of care.
Stent retriever thrombectomy of large-vessel occlusion results in better outcomes than medical therapy alone. Alternative thrombectomy strategies, particularly a direct aspiration as first pass ...technique, while promising, have not been rigorously assessed for clinical efficacy in randomised trials. We designed COMPASS to assess whether patients treated with aspiration as first pass have non-inferior functional outcomes to those treated with a stent retriever as first line.
We did a multicentre, randomised, open label, blinded outcome, core lab adjudicated non-inferiority trial at 15 sites (ten hospitals and four specialty clinics in the USA and one hospital in Canada). Eligible participants were patients presenting with acute ischaemic stroke from anterior circulation large-vessel occlusion within 6 h of onset and an Alberta Stroke Program Early CT Score of greater than 6. We randomly assigned participants (1:1) via a central web-based system without stratification to either direct aspiration first pass or stent retriever first line thrombectomy. Those assessing primary outcomes via clinical examinations were masked to group assignment as they were not involved in the procedures. Physicians were allowed to use adjunctive technology as was consistent with their standard of care. The null hypothesis for this study was that patients treated with aspiration as first pass achieve inferior outcomes compared with those treated with a stent retriever first line approach. The primary outcome was non-inferiority of clinical functional outcome at 90 days as measured by the percentage of patients achieving a modified Rankin Scale score of 0–2, analysed by intent to treat; non-inferiority was established with a margin of 0·15. All randomly assigned patients were included in the safety analyses. This trial is registered at ClinicalTrials.gov, number: NCT02466893.
Between June 1, 2015, and July 5, 2017, we assigned 270 patients to treatment: 134 to aspiration first pass and 136 to stent retriever first line. A modified Rankin score of 0–2 at 90 days was achieved by 69 patients (52%; 95% CI 43·8–60·3) in the aspiration group and 67 patients (50%; 41·6–57·4) in the stent retriever group, showing that aspiration as first pass was non-inferior to stent retriever first line (pnon-inferiority=0·0014). Intracranial haemorrhage occurred in 48 (36%) of 134 in the aspiration first pass group, and 46 (34%) of 135 in the stent retriever first line group. All-cause mortality at 3 months occurred in 30 patients (22%) in both groups.
A direct aspiration as first pass thrombectomy conferred non-inferior functional outcome at 90 days compared with stent retriever first line thrombectomy. This study supports the use of direct aspiration as an alternative to stent retriever as first-line therapy for stroke thrombectomy.
Penumbra.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
BACKGROUND AND PURPOSE—In acute ischemic stroke, fast and complete recanalization of the occluded vessel is associated with improved outcomes. We describe a novel measure for newer generation ...devicesthe first pass effect (FPE). FPE is defined as achieving a complete recanalization with a single thrombectomy device pass.
METHODS—The North American Solitaire Acute Stroke Registry database was used to identify a FPE subgroup. Their baseline features and clinical outcomes were compared with non-FPE patients. Clinical outcome measures included 90-days modified Rankin Scale score, National Institutes of Health Stroke Scale score, mortality, and symptomatic intracranial hemorrhage. Multivariate analyses were performed to determine whether FPE independently resulted in improved outcomes and to identify predictors of FPE.
RESULTS—A total of 354 acute ischemic stroke patients underwent thrombectomy in the North American Solitaire Acute Stroke registry. FPE was achieved in 89 out of 354 (25.1%). More middle cerebral artery occlusions (64% versus 52.5%) and fewer internal carotid artery occlusions (10.1% versus 27.7%) were present in the FPE group. Balloon guide catheters were used more frequently with FPE (64.0% versus 34.7%). Median time to revascularization was significantly faster in the FPE group (median 34 versus 60 minutes; P=0.0003). FPE was an independent predictor of good clinical outcome (modified Rankin Scale score ≤2 was seen in 61.3% in FPE versus 35.3% in non-FPE cohort; P=0.013; odds ratio, 1.7; 95% confidence interval, 1.1–2.7). The independent predictors of achieving FPE were use of balloon guide catheters and non-internal carotid artery terminus occlusion.
CONCLUSIONS—The achievement of complete revascularization from a single Solitaire thrombectomy device pass (FPE) is associated with significantly higher rates of good clinical outcome. The FPE is more frequently associated with the use of balloon guide catheters and less likely to be achieved with internal carotid artery terminus occlusion.
OBJECT Pessimism exists regarding flow diversion for posterior circulation aneurysms because of reports of perforator territory infarcts and delayed ruptures. The authors report the results of ...patients who underwent Pipeline Embolization Device (PED) flow diversion using novel strategies for treatment of fusiform posterior circulation aneurysms, and compare these results with those from previously reported series. METHODS The authors conducted a retrospective review of data from consecutive patients with fusiform vertebrobasilar artery aneurysms treated with the PED. RESULTS This review resulted in the identification of 12 such patients (mean ± SD age 55.1 ± 14.1 years). Eleven patients had symptoms; 1 had a dissecting aneurysm identified on imaging for neck pain. The average aneurysm size was 13.25 ± 4.5 mm. None of the aneurysms were ruptured or previously treated. The average clinical follow-up duration was 22.1 ± 10.7 months and radiological follow-up was 14.5 ± 11.1 months from the index PED treatment. One patient suffered a perforator stroke and had a modified Rankin Scale (mRS) score of 4 at last follow-up. Another patient had a retained stent pusher requiring retrieval via surgical cut-down but recovered to an mRS score of 0 at last follow-up. Eleven (91.7%) of 12 patients recovered to an mRS score of 0 or 1. Two patients had aneurysmal remnants at 7 and 10 months, respectively, after the index PED, which were retreated with PEDs. At last follow-up, all 12 aneurysms were occluded and PEDs were patent. The minimum follow-up duration was 12 months from the index PED treatment; no patient experienced delayed hemorrhage, stroke, or in-stent stenosis. CONCLUSIONS Flow diversion with selective adjunctive techniques is evolving to become a safer treatment option for posterior circulation aneurysms. This is the longest clinical follow-up duration reported for a single-center experience of flow-diversion treatment of these aneurysms.
Enrollment in time-sensitive endovascular stroke trials can be challenging because of an inability to consent a debilitated patient. Often the legally authorized representative is not on site. Remote ...consent procedures in the US are inconsistent with the majority of sites shunning these approaches. The current pandemic with visitor restrictions highlights the need for enhancing these options.
Remote electronic and phone consent procedures specifically for endovascular stroke trials from two comprehensive stroke centers (CSC) are presented. An overview of the genesis of informed consent procedures in the US is also included.
The two CSCs identified as Institution-1 and Institution-2 are large tertiary systems. Institution-1 is a non-profit university-affiliated academic medical center in rural geography. Institution-2 is an HCA hospital in an urban environment. Both serve patients through a spoke-and-hub network, have participated in multiple randomized endovascular stroke trials, and have successfully used these remote options for enrollment. A tiered approach is employed at both institutions with an emphasis on obtaining informed consent in person and resorting to alternatives methods when efforts to that are unsuccessful. A rationale for electronic and phone consent is included, followed by step-by-step illustration of the process at each institution.
Two examples of remote electronic or phone consent procedures from institutions in different geographic environments and organization structures demonstrate that these options can be successfully used for enrollment in stroke trials. The current pandemic highlights the need to enhance these approaches while maintaining appropriate adherence to ethical and legal frameworks.
Endovascular thrombectomy (ET) for acute ischemic stroke is the current standard of care. Although successful ET has high efficacy in improving functional outcomes, the decision to abort a long ...procedure remains a challenge. Longer procedure time (PT) has been associated with lower rates of functional independence.
The objective of this study was to evaluate the impact of PT on outcomes and complications after ET using different techniques at a multicenter level and to define the risk of procedure extension in different patient cohorts.
Patients undergoing ET with a stent retriever (SR) or a direct aspiration at first pass technique at 7 U.S. centers between June 2013 and February 2018 were reviewed from prospectively maintained databases that include baseline variables and technical and clinical outcomes. Multivariate analyses were used to assess impact of PT on 90-day modified Rankin scores, successful recanalization, post-procedural symptomatic hemorrhage (sICH), and complications.
The study included 1,359 patients and demonstrated a decreased likelihood of good functional outcomes (modified Rankin score 0 to 2) when PT extended beyond 30 min (p < 0.01). Rates of sICH and complications increased exponentially with PT (doubling rates of 26 and 50 min, respectively). The cumulative rate of successful recanalization and good outcomes plateaued after 60 min of PT. In patients with PT >30 min, fewer attempts predicted the success of ET and good outcomes (p < 0.01). Successful recanalization was achieved faster with the direct aspiration at first pass technique than in SR. The direct aspiration technique was more sensitive to PT than SR, and posterior stroke was more sensitive to PT than anterior stroke.
Longer ET procedures lead to lower rates of functional independence and higher rates of sICH and complications. Exceeding 60 min or 3 attempts should trigger careful assessment of futility and risks of continuing the procedure.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
BACKGROUND AND PURPOSE—The purpose of this study was to evaluate trends in length of stay, discharge status, and costs among patients with acute ischemic stroke who underwent endovascular therapy ...(ET) between 2011 and 2017.
METHODS—Using a retrospective observational study design, acute ischemic stroke patients undergoing ET from 2011 to 2017 were identified in the Premier Healthcare Database. The Mann-Kendall trend test was performed to examine clinical and economic outcomes trends.
RESULTS—Among the 505 824 acute ischemic stroke patients, 11 811(2.3%) were treated with ET. Patients receiving ET had a significant increase in home discharge and a significant decrease in mortality (17.7% to 29.6%, P<0.01; 21.6% to 12.8%, P<0.01). There was a significant decline in length of stay from 11.7 days to 8.7 days (P<0.01). Total index admission costs declined ≈17% from 2011 to 2017 ($50 516.5–$42 026.9, P<0.01).
CONCLUSIONS—Clinical and economic indicators significantly improved for acute ischemic stroke patients undergoing ET from 2011 to 2017.
A study was undertaken to determine the typical length, diameter and taper of vessels in the anterior cerebral circulation.
The sample size was calculated at 100 patients based on similar ...measurements in the literature and divided into cohorts based on gender and side. These patients were consecutively collected from a population that had undergone CT angiography and did not have any vascular abnormality. The arterial diameter was measured at the proximal cavernous internal carotid artery (ICA), the ICA terminus, the middle cerebral artery (MCA) origin and an M2 origin. The length between these endpoints was calculated along the center line. The vessel taper was calculated for the ICA as the change in caliber per unit length.
The mean length of the ICA from the proximal cavernous segment to the ICA terminus was 33.1 ± 6.1 mm. The mean diameter at the cavernous ICA and the ICA terminus was 5 ± 0.6 mm and 3.6 ± 0.4 mm, respectively. The mean ICA taper was 0.04 ± 0.02 mm/1 mm. For the MCA, the diameter at the MCA and M2 origins measured 3.1 ± 0.4 mm and 2.4 ± 0.4 mm, respectively. The mean MCA length was 22.5 ± 8.1 mm. There was no significant difference based on gender or between right and left sides. Patients aged >60 years had longer ICAs (p=0.02), larger cavernous ICA (p=0.003), ICA terminus (p<0.0001) and MCA origin (p=0.01) diameters than those aged 40-60 years. The ICA vessel taper did not change with age.
ICA and MCA vessel size did not change based on gender or side. Older patients had more redundant vessels based on diameter and length. The ICA has a gentle taper from its proximal cavernous segment to the ICA terminus. This information can be important in planning interventions or designing endovascular devices.
Limited efficacy of IV recombinant tissue plasminogen activator (rt-PA) for large vessel occlusions (LVO) raises doubts about its utility prior to endovascular therapy.
To compare outcomes and ...hospital costs for anterior circulation LVOs (middle cerebral artery, internal carotid artery terminus (ICA-T)) treated with either primary endovascular therapy alone (EV-Only) or bridging therapy (IV+EV)).
A single-center retrospective analysis was performed. Clinical and demographic data were collected prospectively and relevant cost data were obtained for each patient in the study.
90 consecutive patients were divided into EV-Only (n=52) and IV+EV (n=38) groups. There was no difference in demographics, stroke severity, or clot distribution. The mean (SD) time to presentation was 5:19 (4:30) hours in the EV-Only group and 1:46 (0:52) hours in the IV+EV group (p<0.0001). Recanalization: EV-Only 35 (67%) versus IV+EV 31 (81.6%) (p=0.12). Favorable outcome: EV-Only 26 (50%) versus IV+EV 22 (58%) (p=0.45). For patients presenting within 4.5 hours (n=64): Recanalization: EV-Only 21/26 (81%) versus IV+EV 31/38 (81.6%) (p=0.93). Favorable outcome: EV-Only 14/26 (54%) versus IV+EV 22/38 (58%) (p=0.75). There was no significant difference in rates of hemorrhage, mortality, home discharge, or length of stay. A stent retriever was used in 67 cases (74.4%), with similar recanalization, outcomes, and number of passes in the EV-Only and IV+EV groups. The mean (SD) total hospital cost was $33 810 (13 505) for the EV-Only group and $40 743 (17 177) for the IV+EV group (p=0.02). The direct cost was $23 034 (8786) for the EV-Only group and $28 711 (11 406) for the IV+EV group (p=0.007). These significantly higher costs persisted for the subgroup presenting in <4.5 hours and the stent retriever subgroup. IV rt-PA administration independently predicted higher hospital costs.
IV rt-PA did not improve recanalization, thrombectomy efficacy, functional outcomes, or length of stay. Combined therapy was associated with significantly higher total and direct hospital costs than endovascular therapy alone.