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1.
Lancet ; 403(10428): 731-740, 2024 Feb 24.
Article in English | MEDLINE | ID: mdl-38346442

ABSTRACT

BACKGROUND: Multiple randomised trials have shown efficacy and safety of endovascular thrombectomy in patients with large ischaemic stroke. The aim of this study was to evaluate long-term (ie, at 1 year) evidence of benefit of thrombectomy for these patients. METHODS: SELECT2 was a phase 3, open-label, international, randomised controlled trial with blinded endpoint assessment, conducted at 31 hospitals in the USA, Canada, Spain, Switzerland, Australia, and New Zealand. Patients aged 18-85 years with ischaemic stroke due to proximal occlusion of the internal carotid artery or of the first segment of the middle cerebral artery, showing large ischaemic core on non-contrast CT (Alberta Stroke Program Early Computed Tomographic Score of 3-5 [range 0-10, with lower values indicating larger infarctions]) or measuring 50 mL or more on CT perfusion and MRI, were randomly assigned, within 24 h of ischaemic stroke onset, to thrombectomy plus medical care or to medical care alone. The primary outcome for this analysis was the ordinal modified Rankin Scale (range 0-6, with higher scores indicating greater disability) at 1-year follow-up in an intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT03876457) and is completed. FINDINGS: The trial was terminated early for efficacy at the 90-day follow-up after 352 patients had been randomly assigned (178 to thrombectomy and 174 to medical care only) between Oct 11, 2019, and Sept 9, 2022. Thrombectomy significantly improved the 1-year modified Rankin Scale score distribution versus medical care alone (Wilcoxon-Mann-Whitney probability of superiority 0·59 [95% CI 0·53-0·64]; p=0·0019; generalised odds ratio 1·43 [95% CI 1·14-1·78]). At the 1-year follow-up, 77 (45%) of 170 patients receiving thrombectomy had died, compared with 83 (52%) of 159 patients receiving medical care only (1-year mortality relative risk 0·89 [95% CI 0·71-1·11]). INTERPRETATION: In patients with ischaemic stroke due to a proximal occlusion and large core, thrombectomy plus medical care provided a significant functional outcome benefit compared with medical care alone at 1-year follow-up. FUNDING: Stryker Neurovascular.


Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Humans , Stroke/diagnostic imaging , Stroke/surgery , Brain Ischemia/therapy , Brain Ischemia/drug therapy , Treatment Outcome , Endovascular Procedures/methods , Thrombectomy/methods , Ischemic Stroke/diagnostic imaging , Ischemic Stroke/surgery , Alberta , Fibrinolytic Agents/therapeutic use
2.
JAMA ; 331(9): 750-763, 2024 03 05.
Article in English | MEDLINE | ID: mdl-38324414

ABSTRACT

Importance: Whether endovascular thrombectomy (EVT) efficacy for patients with acute ischemic stroke and large cores varies depending on the extent of ischemic injury is uncertain. Objective: To describe the relationship between imaging estimates of irreversibly injured brain (core) and at-risk regions (mismatch) and clinical outcomes and EVT treatment effect. Design, Setting, and Participants: An exploratory analysis of the SELECT2 trial, which randomized 352 adults (18-85 years) with acute ischemic stroke due to occlusion of the internal carotid or middle cerebral artery (M1 segment) and large ischemic core to EVT vs medical management (MM), across 31 global centers between October 2019 and September 2022. Intervention: EVT vs MM. Main Outcomes and Measures: Primary outcome was functional outcome-90-day mRS score (0, no symptoms, to 6, death) assessed by adjusted generalized OR (aGenOR; values >1 represent more favorable outcomes). Benefit of EVT vs MM was assessed across levels of ischemic injury defined by noncontrast CT using ASPECTS score and by the volume of brain with severely reduced blood flow on CT perfusion or restricted diffusion on MRI. Results: Among 352 patients randomized, 336 were analyzed (median age, 67 years; 139 [41.4%] female); of these, 168 (50%) were randomized to EVT, and 2 additional crossover MM patients received EVT. In an ordinal analysis of mRS at 90 days, EVT improved functional outcomes compared with MM within ASPECTS categories of 3 (aGenOR, 1.71 [95% CI, 1.04-2.81]), 4 (aGenOR, 2.01 [95% CI, 1.19-3.40]), and 5 (aGenOR, 1.85 [95% CI, 1.22-2.79]). Across strata for CT perfusion/MRI ischemic core volumes, aGenOR for EVT vs MM was 1.63 (95% CI, 1.23-2.16) for volumes ≥70 mL, 1.41 (95% CI, 0.99-2.02) for ≥100 mL, and 1.47 (95% CI, 0.84-2.56) for ≥150 mL. In the EVT group, outcomes worsened as ASPECTS decreased (aGenOR, 0.91 [95% CI, 0.82-1.00] per 1-point decrease) and as CT perfusion/MRI ischemic core volume increased (aGenOR, 0.92 [95% CI, 0.89-0.95] per 10-mL increase). No heterogeneity of EVT treatment effect was observed with or without mismatch, although few patients without mismatch were enrolled. Conclusion and Relevance: In this exploratory analysis of a randomized clinical trial of patients with extensive ischemic stroke, EVT improved clinical outcomes across a wide spectrum of infarct volumes, although enrollment of patients with minimal penumbra volume was low. In EVT-treated patients, clinical outcomes worsened as presenting ischemic injury estimates increased. Trial Registration: ClinicalTrials.gov Identifier: NCT03876457.


Subject(s)
Brain Ischemia , Ischemic Stroke , Stroke , Adult , Humans , Female , Aged , Male , Stroke/diagnostic imaging , Stroke/surgery , Ischemic Stroke/diagnostic imaging , Ischemic Stroke/surgery , Brain Ischemia/diagnostic imaging , Brain Ischemia/surgery , Thrombectomy/adverse effects , Thrombectomy/methods , Brain/diagnostic imaging
3.
Int J Stroke ; : 17474930241237120, 2024 Mar 16.
Article in English | MEDLINE | ID: mdl-38395748

ABSTRACT

BACKGROUND: Following transient ischemic attack (TIA) and minor stroke, the risk of recurrent stroke can be significantly reduced with short-duration dual antiplatelet therapy (DAPT). We wish to investigate whether 10 days of DAPT is as effective as 21 days' treatment. STUDY DESIGN: This is an open-label, randomized, parallel-group study comparing whether 10 days of DAPT treatment (ASA + clopidogrel) is non-inferior to 21 days of DAPT in patients with acute ischemic stroke (AIS) or high-risk TIA. In both groups, DAPT is started within 24 hours of symptom onset. This study is being conducted in approximately 15 study sites in the Kingdom of Saudi Arabia. The planned sample size is 1932. OUTCOMES: Non-inferiority of 10 days compared to 21 days of DAPT in the prevention of the composite endpoint of stroke and death at 90 days in AIS/TIA patients. The primary safety outcome is major intra-cranial and systemic hemorrhage. STUDY PERIOD: Enrolment started in the second quarter of 2023, and the completion of the study is expected in the fourth quarter of 2025. DISCUSSION: The trial is expected to show that 10 days of DAPT is non-inferior for the prevention of early recurrence of vascular events in patients with high-risk TIAs and minor strokes.

4.
Circulation ; 148(1): 20-34, 2023 07 04.
Article in English | MEDLINE | ID: mdl-37199147

ABSTRACT

BACKGROUND: Existing data and clinical trials could not determine whether faster intravenous thrombolytic therapy (IVT) translates into better long-term functional outcomes after acute ischemic stroke among those treated with endovascular thrombectomy (EVT). Patient-level national data can provide the required large population to study the associations between earlier IVT, versus later, with longitudinal functional outcomes and mortality in patients receiving IVT+EVT combined treatment. METHODS: This cohort study included older US patients (age ≥65 years) who received IVT within 4.5 hours or EVT within 7 hours after acute ischemic stroke using the linked 2015 to 2018 Get With The Guidelines-Stroke and Medicare database (38 913 treated with IVT only and 3946 with IVT+EVT). Primary outcome was home time, a patient-prioritized functional outcome. Secondary outcomes included all-cause mortality in 1 year. Multivariate logistic regression and Cox proportional hazards models were used to evaluate the associations between door-to-needle (DTN) times and outcomes. RESULTS: Among patients treated with IVT+EVT, after adjusting for patient and hospital factors, including onset-to-EVT times, each 15-minute increase in DTN times for IVT was associated with significantly higher odds of zero home time in a year (never discharged to home) (adjusted odds ratio, 1.12 [95% CI, 1.06-1.19]), less home time among those discharged to home (adjusted odds ratio, 0.93 per 1% of 365 days [95% CI, 0.89-0.98]), and higher all-cause mortality (adjusted hazard ratio, 1.07 [95% CI, 1.02-1.11]). These associations were also statistically significant among patients treated with IVT but at a modest degree (adjusted odds ratio, 1.04 for zero home time, 0.96 per 1% home time for those discharged to home, and adjusted hazard ratio 1.03 for mortality). In the secondary analysis where the IVT+EVT group was compared with 3704 patients treated with EVT only, shorter DTN times (≤60, 45, and 30 minutes) achieved incrementally more home time in a year, and more modified Rankin Scale 0 to 2 at discharge (22.3%, 23.4%, and 25.0%, respectively) versus EVT only (16.4%, P<0.001 for each). The benefit dissipated with DTN>60 minutes. CONCLUSIONS: Among older patients with stroke treated with either IVT only or IVT+EVT, shorter DTN times are associated with better long-term functional outcomes and lower mortality. These findings support further efforts to accelerate thrombolytic administration in all eligible patients, including EVT candidates.


Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Humans , Aged , United States/epidemiology , Ischemic Stroke/diagnosis , Ischemic Stroke/therapy , Cohort Studies , Brain Ischemia/drug therapy , Treatment Outcome , Medicare , Fibrinolytic Agents/therapeutic use , Thrombolytic Therapy/adverse effects , Thrombectomy/adverse effects , Endovascular Procedures/adverse effects
5.
Oper Neurosurg (Hagerstown) ; 24(5): 492-498, 2023 05 01.
Article in English | MEDLINE | ID: mdl-36715979

ABSTRACT

BACKGROUND: Mycotic aneurysms represent a rare type of intracranial aneurysm. Treatment options usually consist of coiling, clipping, or liquid embolization. Data regarding outcomes after flow diversion of mycotic aneurysms are sparse. OBJECTIVE: To present a single-center case series regarding our experience with FD as definitive treatment for ruptured mycotic aneurysms initially treated with coil embolization. METHODS: We retrospectively reviewed a prospectively maintained database of all cerebrovascular procedures performed at a single institution between 2017 and 2021 for cases that used FD for the management of intracranial mycotic aneurysms. Prospectively collected data included patient demographics, medical history, rupture status, aneurysm morphology, aneurysm location, and periprocedural complications. The main outcomes included neurological examination and radiographic occlusion rate on cerebral digital subtraction angiography. RESULTS: Three patients with 4 ruptured mycotic aneurysms that were initially treated with coil embolization were identified that required retreatment. The aneurysms were located along the middle cerebral artery bifurcation (n = 2), posterior cerebral artery P1/2 junction (n = 1), and basilar artery apex (n = 1), which all demonstrated recurrence after initial coil embolization. Successful retreatment using flow diverting stents was performed in all 3 patients. At the last angiographic follow-up, all aneurysms demonstrated complete occlusion. No patients suffered new periprocedural complications or neurological deficits after FD. CONCLUSION: Flow-diverting stents may be an effective treatment option for intracranial mycotic aneurysms that are refractory to previous endovascular coiling. Future studies are warranted to establish the associated long-term safety and clinical efficacy.


Subject(s)
Aneurysm, Infected , Intracranial Aneurysm , Humans , Retrospective Studies , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Aneurysm, Infected/diagnostic imaging , Aneurysm, Infected/surgery , Cerebral Angiography , Treatment Outcome
6.
Neurology ; 100(5): e465-e472, 2023 01 31.
Article in English | MEDLINE | ID: mdl-35680419

ABSTRACT

BACKGROUND AND OBJECTIVES: To assess American Academy of Neurology (AAN)-recommended Practice Guidelines (PGs) for equity in gender representation among physician authors. METHODS: This cross-sectional study included AAN-recommended PG publications from January 1, 2015, to December 31, 2020. Author degrees and gender were identified by 2 reviewers using the publication and/or online searches. Gender was determined from pronouns or photographs. Gender representation was compared with Association of American Medical Colleges (AAMC) data on academic neurologists. Data were analyzed using Z tests of 2 proportions and descriptive statistics. RESULTS: AAMC benchmarks report academic women neurologists represented 35% of the specialty in 2015, 38% in 2018, and 39% in 2020. We identified 68 unique PG publications with 709 physician authors, 31% (223) women, 68% (484) men, and 0.3% (2) gender could not be identified. Representation of women physicians was low among PG authors across all benchmarks, significantly so for 2018 and 2020 (p < 0.01). Among physician first authors, women were significantly underrepresented across all benchmarks (18% [12/65], p < 0.01). Representation of women physicians was lower when men physicians were first authors vs women physicians (31% [161/524] vs 43% [50/118], p = 0.02). Among subspecialties with 10+ PGs, women physician authorship was highest in child neurology (48% [57/120]) and lowest in stroke and vascular neurology (16% [18/113]). DISCUSSION: We found that women physicians were underrepresented as authors of AAN-recommended PGs. This suggests a missed opportunity for neurology because PGs that include expertise from women physicians may improve care and translation into practice. In addition, women physicians lose out on professional development from authorship. Further research is needed to understand causality and address gaps.


Subject(s)
Neurology , Physicians, Women , Male , Child , Humans , Female , United States , Cross-Sectional Studies , Neurologists , Academies and Institutes , Authorship
7.
Neurology ; 100(3): e336-e347, 2023 01 17.
Article in English | MEDLINE | ID: mdl-36289001

ABSTRACT

BACKGROUND AND OBJECTIVES: The effect of anesthesia choice on endovascular thrombectomy (EVT) outcomes is unclear. Collateral status on perfusion imaging may help identify the optimal anesthesia choice. METHODS: In a pooled patient-level analysis of EXTEND-IA, EXTEND-IA TNK, EXTEND-IA TNK part II, and SELECT, EVT functional outcomes (modified Rankin Scale score distribution) were compared between general anesthesia (GA) vs non-GA in a propensity-matched sample. Furthermore, we evaluated the association of collateral flow on perfusion imaging, assessed by hypoperfusion intensity ratio (HIR) - Tmax > 10 seconds/Tmax > 6 seconds (good collaterals - HIR < 0.4, poor collaterals - HIR ≥ 0.4) on the association between anesthesia type and EVT outcomes. RESULTS: Of 725 treated with EVT, 299 (41%) received GA and 426 (59%) non-GA. The baseline characteristics differed in presentation National Institutes of Health Stroke Scale score (median [interquartile range] GA: 18 [13-22], non-GA: 16 [11-20], p < 0.001) and ischemic core volume (GA: 15.0 mL [3.2-38.0] vs non-GA: 9.0 mL [0.0-31.0], p < 0.001). In addition, GA was associated with longer last known well to arterial access (203 minutes [157-267] vs 186 minutes [138-252], p = 0.002), but similar procedural time (35.5 minutes [23-59] vs 34 minutes [22-54], p = 0.51). Of 182 matched pairs using propensity scores, baseline characteristics were similar. In the propensity score-matched pairs, GA was independently associated with worse functional outcomes (adjusted common odds ratio [adj. cOR]: 0.64, 95% CI: 0.44-0.93, p = 0.021) and higher neurologic worsening (GA: 14.9% vs non-GA: 8.9%, aOR: 2.10, 95% CI: 1.02-4.33, p = 0.045). Patients with poor collaterals had worse functional outcomes with GA (adj. cOR: 0.47, 95% CI: 0.29-0.76, p = 0.002), whereas no difference was observed in those with good collaterals (adj. cOR: 0.93, 95% CI: 0.50-1.74, p = 0.82), p interaction: 0.07. No difference was observed in infarct growth overall and in patients with good collaterals, whereas patients with poor collaterals demonstrated larger infarct growth with GA with a significant interaction between collaterals and anesthesia type on infarct growth rate (p interaction: 0.020). DISCUSSION: GA was associated with worse functional outcomes after EVT, particularly in patients with poor collaterals in a propensity score-matched analysis from a pooled patient-level cohort from 3 randomized trials and 1 prospective cohort study. The confounding by indication may persist despite the doubly robust nature of the analysis. These findings have implications for randomized trials of GA vs non-GA and may be of utility for clinicians when making anesthesia type choice. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that use of GA is associated with worse functional outcome in patients undergoing EVT. TRIAL REGISTRATION INFORMATION: EXTEND-IA: ClinicalTrials.gov (NCT01492725); EXTEND-IA TNK: ClinicalTrials.gov (NCT02388061); EXTEND-IA TNK part II: ClinicalTrials.gov (NCT03340493); and SELECT: ClinicalTrials.gov (NCT02446587).


Subject(s)
Anesthesia, General , Thrombectomy , Humans , Anesthesia, General/adverse effects , Prospective Studies , Thrombectomy/methods , Treatment Outcome , Randomized Controlled Trials as Topic
8.
Anesth Analg ; 134(2): 369-379, 2022 02 01.
Article in English | MEDLINE | ID: mdl-34609988

ABSTRACT

BACKGROUND: Monitored anesthesia care (MAC) and general anesthesia (GA) with endotracheal intubation are the 2 most used techniques for patients with acute ischemic stroke (AIS) undergoing endovascular thrombectomy. We aimed to test the hypothesis that increased arterial oxygen concentration during reperfusion period is a mechanism underlying the association between use of GA (versus MAC) and increased risk of in-hospital mortality. METHODS: In this retrospective cohort study, data were collected at the Cleveland Clinic between 2013 and 2018. To assess the potential mediation effect of time-weighted average oxygen saturation (Spo2) in first postoperative 48 hours between the association between GA versus MAC and in-hospital mortality, we assessed the association between anesthesia type and post-operative Spo2 tertiles (exposure-mediator relationship) through a cumulative logistic regression model and assessed the association between Spo2 and in-hospital mortality (mediator-outcome relationship) using logistic regression models. Confounding factors were adjusted for using propensity score methods. Both significant exposure-mediator and significant mediator-outcome relationships are needed to suggest potential mediation effect. RESULTS: Among 358 patients included in the study, 104 (29%) patients received GA and 254 (71%) received MAC, with respective hospital mortality rate of 19% and 5% (unadjusted P value <.001). GA patients were 1.6 (1.2, 2.1) (P < .001) times more likely to have a higher Spo2 tertile as compared to MAC patients. Patients with higher Spo2 tertile had 3.8 (2.1, 6.9) times higher odds of mortality than patients with middle Spo2 tertile, while patients in the lower Spo2 tertile did not have significant higher odds compared to the middle tertile odds ratio (OR) (1.8 [0.9, 3.4]; overall P < .001). The significant exposure-mediator and mediator-outcome relationships suggest that Spo2 may be a mediator of the relationship between anesthetic method and mortality. However, the estimated direct effect of GA versus MAC on mortality (ie, after adjusting for Spo2; OR [95% confidence interval {CI}] of 2.1 [0.9-4.9]) was close to the estimated association ignoring Spo2 (OR [95% CI] of 2.2 [1.0-5.1]), neither statistically significant, suggesting that Spo2 had at most a modest mediator role. CONCLUSIONS: GA was associated with a higher Spo2 compared to MAC among those treated by endovascular thrombectomy for AIS. Spo2 values that were higher than the middle tertile were associated with higher odds of mortality. However, GA was not significantly associated with higher odds of death. Spo2 at most constituted a modest mediator role in explaining the relationship between GA versus MAC and mortality.


Subject(s)
Brain Ischemia/mortality , Endovascular Procedures/mortality , Hospital Mortality/trends , Ischemic Stroke/mortality , Oxygen Saturation/physiology , Thrombectomy/mortality , Aged , Aged, 80 and over , Brain Ischemia/surgery , Cohort Studies , Endovascular Procedures/trends , Female , Humans , Ischemic Stroke/surgery , Male , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/mortality , Retrospective Studies , Thrombectomy/trends , Treatment Outcome
9.
Int J Stroke ; 17(6): 689-693, 2022 07.
Article in English | MEDLINE | ID: mdl-34282987

ABSTRACT

RATIONALE: Randomized evidence for endovascular thrombectomy safety and efficacy in patients with large core strokes is lacking. AIMS: To demonstrate endovascular thrombectomy efficacy and safety in patients with large core on non-contrast CT or perfusion imaging (CT/MR) and determine if there is heterogeneity of treatment effect in large cores based on the imaging modality. DESIGN: SELECT2 is a prospective, randomized, multi-center, assessor-blinded controlled trial with adaptive enrichment design, enrolling up to 560 patients. PROCEDURE: Patients who meet the clinical criteria and have anterior circulation large vessel occlusions with large core on either NCCT (ASPECTS 3-5) or perfusion imaging (CTP [rCBF < 30%] and/or MRI [ADC < 620] ≥ 50 cc) will be randomized in a 1:1 ratio to undergo endovascular thrombectomy or medical management (MM) only up to 24 h of last known well. STUDY OUTCOMES: The distribution of 90-day mRS scores is the primary outcome. Functional independence (mRS = 0-2) rate is a secondary outcome. Other secondary outcomes include safety (symptomatic ICH, neurological worsening, mortality) and imaging outcomes. ANALYSIS: A normal approximation of the Wilcoxon-Mann-Whitney test (the generalized likelihood ratio test) to assess the primary outcome. Functional independence rates, safety and imaging outcomes will also be compared. DISCUSSION: The SELECT2 trial will evaluate endovascular thrombectomy safety and efficacy in large cores on either CT or perfusion imaging and may provide randomized evidence to extend endovascular thrombectomy eligibility to larger population.Registration: ClinicalTrials.gov-NCT03876457.


Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Brain Ischemia/complications , Brain Ischemia/surgery , Endovascular Procedures/methods , Humans , Ischemic Stroke/complications , Ischemic Stroke/surgery , Multicenter Studies as Topic , Patient Selection , Prospective Studies , Randomized Controlled Trials as Topic , Thrombectomy/methods , Treatment Outcome
11.
J Stroke Cerebrovasc Dis ; 30(3): 105556, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33360252

ABSTRACT

OBJECTIVES/BACKGROUND: Medical therapy is the first line of treatment for intracranial atherosclerotic disease (ICAD). Percutaneous transluminal angioplasty and stenting (PTAS) are mainly considered for those patients with severe stenosis and recurrent events despite aggressive medical therapy. In this review, we discuss the application of PTAS as a treatment option for ICAD and its future prospect. MATERIALS AND METHODS: We did the literature review of the key articles and guidelines to elaborate on the role of PTAS in the management of ICAD based on the current data and expert opinion. We searched PubMed, Google Scholar, and Scopus up to August 2020, and included articles published only in the English language. RESULTS: Since the publication of the results from SAMMPRIS and VISSIT trials, stenting is no longer recommended for secondary stroke prevention in patients with symptomatic ICAD. However, recent clinical studies on intracranial stenting for a subgroup of ICAD patients have shown promising results, likely due to better patient selection and continued advancement of endovascular techniques. CONCLUSION: There exists a lack of consensus regarding the best endovascular treatment approach (e.g., angioplasty alone or balloon mounted stent vs. self-expanding stent with or without prior angioplasty) or management of in-stent restenosis. Another area of clinical controversy relates to the ideal use and duration of antiplatelet therapy.


Subject(s)
Angioplasty, Balloon , Intracranial Arteriosclerosis/therapy , Ischemic Stroke/therapy , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/instrumentation , Clinical Trials as Topic , Diffusion of Innovation , Evidence-Based Medicine , Humans , Intracranial Arteriosclerosis/diagnostic imaging , Intracranial Arteriosclerosis/physiopathology , Ischemic Stroke/diagnostic imaging , Ischemic Stroke/physiopathology , Platelet Aggregation Inhibitors/therapeutic use , Prosthesis Design , Risk Factors , Stents , Treatment Outcome
12.
Stroke ; 50(3): 697-704, 2019 03.
Article in English | MEDLINE | ID: mdl-30776994

ABSTRACT

Background and Purpose- Mechanical thrombectomy has been shown to improve clinical outcomes in patients with acute ischemic stroke. However, the impact of balloon guide catheter (BGC) use is not well established. Methods- STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter study of patients with large vessel occlusion treated with the Solitaire stent retriever as first-line therapy. In this study, an independent core laboratory, blinded to the clinical outcomes, reviewed all procedures and angiographic data to classify procedural technique, target clot location, recanalization after each pass, and determine the number of stent retriever passes. The primary clinical end point was functional independence (modified Rankin Scale, 0-2) at 3 months as determined on-site, and the angiographic end point was first-pass effect (FPE) success rate from a single device attempt (modified Thrombolysis in Cerebral Infarction, ≥2c) as determined by a core laboratory. Achieving modified FPE (modified Thrombolysis in Cerebral Infarction, ≥2b) was also assessed. Comparisons of clinical outcomes were made between groups and adjusted for baseline and procedural characteristics. All participating centers received institutional review board approval from their respective institutions. Results- Adjunctive technique groups included BGC (n=445), distal access catheter (n=238), and conventional guide catheter (n=62). The BGC group had a higher rate of FPE following first pass (212/443 [48%]) versus conventional guide catheter (16/62 [26%]; P=0.001) and distal access catheter (83/235 [35%]; P=0.002). Similarly, the BGC group had a higher rate of modified FPE (294/443 [66%]) versus conventional guide catheter (26/62 [42%]; P<0.001) and distal access catheter (129/234 [55%]; P=0.003). The BGC group achieved the highest rate of functional independence (253/415 [61%]) versus conventional guide catheter (23/55 [42%]; P=0.007) and distal access catheter (113/218 [52%]; P=0.027). Final revascularization and mortality rates did not differ across the groups. Conclusions- BGC use was an independent predictor of FPE, modified FPE, and functional independence, suggesting that its routine use may improve the rates of early revascularization success and good clinical outcomes. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239640.


Subject(s)
Catheterization/methods , Stroke/diagnostic imaging , Stroke/surgery , Thrombectomy/statistics & numerical data , Aged , Aged, 80 and over , Brain Ischemia/diagnostic imaging , Brain Ischemia/therapy , Cerebral Angiography , Female , Humans , Male , Middle Aged , Prospective Studies , Registries , Stents , Treatment Outcome
14.
Interv Neurol ; 6(3-4): 183-190, 2017 Oct.
Article in English | MEDLINE | ID: mdl-29118795

ABSTRACT

BACKGROUND AND PURPOSE: Patient selection is important to determine the best candidates for endovascular stroke therapy. In application of a hyperacute magnetic resonance imaging (MRI) protocol for patient selection, we have shown decreased utilization with improved outcomes. A cost analysis comparing the pre- and post-MRI protocol time periods was performed to determine if the previous findings translated into cost opportunities. MATERIALS AND METHODS: We retrospectively identified individuals considered for endovascular stroke therapy from January 2008 to August 2012 who were ≤8 h from stroke symptoms onset. Patients prior to April 30, 2010 were selected based on results of the computed tomography/computed tomography angiography alone (pre-hyperacute), whereas patients after April 30, 2010 were selected based on results of MRI (post-hyperacute MRI). Demographic, outcome, and financial information was collected. Log-transformed average daily direct costs were regressed on time period. The regression model included demographic and clinical covariates as potential confounders. Multiple imputation was used to account for missing data. RESULTS: We identified 267 patients in our database (88 patients in pre-hyperacute MRI period, 179 in hyperacute MRI protocol period). Patient length of stay was not significantly different in the hyperacute MRI protocol period as compared to the pre-hyperacute MRI period (10.6 vs. 9.9 days, p < 0.42). The median of average daily direct costs was reduced by 24.5% (95% confidence interval 14.1-33.7%, p < 0.001). CONCLUSIONS: Use of the hyperacute MRI protocol translated into reduced costs, in addition to reduced utilization and better outcomes. MRI selection of patients is an effective strategy, both for patients and hospital systems.

15.
Interv Neurol ; 6(1-2): 82-89, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28611838

ABSTRACT

INTRODUCTION: Mycotic aneurysms are a serious complication of infective endocarditis with increased risk of intracranial hemorrhage. Patients undergoing open heart surgery for valve repair or replacement are exposed to anticoagulants, increasing the risk of aneurysm bleeding. These patients may require endovascular or surgical aneurysm treatment prior to heart surgery, but data on this approach are scarce. METHODS: Retrospective review of consecutive patients with infectious endocarditis and mycotic aneurysms treated endovascularly with Trufill n-butyl cyanoacrylate (n-BCA) at the Cleveland Clinic between January 2013 and December 2015. RESULTS: Nine patients underwent endovascular treatment of mycotic aneurysms with n-BCA (mean age of 39 years). On imaging, 4 patients had intracerebral hemorrhage, 2 had multiple embolic infarcts, and the rest had no imaging findings. Twelve mycotic aneurysms were detected (3 patients with 2 aneurysms). Seven aneurysms were in the M4 middle cerebral artery segment, 4 in the posterior cerebral artery distribution, and 1 in the callosomarginal branch. n-BCA was diluted in ethiodized oil (1:1 to 1:2). Embolization was achieved in a single rapid injection with immediate microcatheter removal. Complete aneurysm exclusion was achieved in all cases without complications. All patients underwent open heart surgery and endovascular embolization within a short interval, 2 with both procedures on the same day. There were no new hemorrhages after aneurysm embolization. CONCLUSIONS: Endovascular embolization of infectious intracranial aneurysms with liquid embolics can be performed successfully in critically ill patients requiring immediate open heart surgery and anticoagulation. Early embolization prior to and within a short interval from open heart surgery is feasible.

17.
JAMA Neurol ; 73(11): 1291-1296, 2016 Nov 01.
Article in English | MEDLINE | ID: mdl-27617425

ABSTRACT

IMPORTANCE: Randomized clinical trials have shown the superiority of endovascular therapy (EVT) compared with best medical management for acute ischemic strokes with large vessel occlusion (LVO) in the anterior circulation. However, of 1287 patients enrolled in 5 trials, 94 with isolated second (M2) segment occlusions were randomized and 51 of these received EVT, thereby limiting evidence for treating isolated M2 segment occlusions as reflected in American Heart Association guidelines. OBJECTIVE: To evaluate EVT safety and effectiveness in M2 occlusions in a cohort of patients with acute ischemic stroke. DESIGN, SETTING, AND PARTICIPANTS: This multicenter retrospective cohort study pooled patients with acute ischemic strokes and LVO isolated to M2 segments from 10 US centers. Patients with acute ischemic strokes and LVO in M2 segments presenting within 8 hours from their last known normal clinical status (LKN) from January 1, 2012, to April 30, 2015, were divided based on their treatment into EVT and medical management groups. Logistic regression was used to compare the 2 groups. Univariate and multivariate analyses evaluated associations with good outcome in the EVT group. MAIN OUTCOMES AND MEASURES: The primary outcome was the 90-day modified Rankin Scale score (range, 0-6; scores of 0-2 indicate a good outcome); the secondary outcome was symptomatic intracerebral hemorrhage. RESULTS: A total of 522 patients (256 men [49%]; 266 women [51%]; mean [SD] age, 68 [14.3] years) were identified, of whom 288 received EVT and 234 received best medical management. Patients in the medical management group were older (median [interquartile range] age, 73 [60-81] vs 68 [56-78] years) and had higher rates of intravenous tissue plasminogen activator treatment (174 [74.4%] vs 172 [59.7%]); otherwise the 2 groups were balanced. The rate of good outcomes was higher for EVT (181 [62.8%]) than for medical management (83 [35.4%]). The EVT group had 3 times the odds of a good outcome as the medical management group (odds ratio [OR], 3.1; 95% CI, 2.1-4.4; P < .001) even after adjustment for age, National Institute of Health Stroke Scale (NIHSS) score, Alberta Stroke Program Early Computed Tomographic Score (ASPECTS), intravenous tissue plasminogen activator treatment, and time from LKN to arrival in the emergency department (OR, 3.2; 95% CI, 2-5.2; P < .001). No statistical difference in symptomatic intracerebral hemorrhage was found (5.6% vs 2.1% for the EVT group vs the medical management group; P = .10). The treatment effect did not change after adjusting for center (OR, 3.3; 95% CI, 1.9-5.8; P < .001). Age, NIHSS score, ASPECTS, time from LKN to reperfusion, and successful reperfusion score of at least 2b (range, 0 [no perfusion] to 3 [full perfusion with filling of all distal branches]) were independently associated with good outcome of EVT. A linear association was found between good outcome and time from LKN to reperfusion. CONCLUSIONS AND RELEVANCE: Although a randomized clinical trial is needed to confirm these findings, available data suggest that EVT is reasonable, safe, and effective for LVO of the M2 segment relative to best medical management.


Subject(s)
Brain Ischemia/therapy , Endovascular Procedures/methods , Outcome Assessment, Health Care , Stroke/therapy , Aged , Aged, 80 and over , Brain Ischemia/diagnostic imaging , Endovascular Procedures/adverse effects , Female , Humans , Infarction, Middle Cerebral Artery/diagnostic imaging , Infarction, Middle Cerebral Artery/therapy , Male , Middle Aged , Retrospective Studies , Stroke/diagnostic imaging
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