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  • 1
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    Safety and Efficacy of Mechanical Embolectomy in Acute Ischemic Stroke : Results of the MERCI Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2005
    In:  Stroke Vol. 36, No. 7 ( 2005-07), p. 1432-1438
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 36, No. 7 ( 2005-07), p. 1432-1438
    Abstract: Background and Purpose— The only Food and Drug Administration (FDA)-approved treatment for acute ischemic stroke is tissue plasminogen activator (tPA) given intravenously within 3 hours of symptom onset. An alternative strategy for opening intracranial vessels during stroke is mechanical embolectomy, especially for patients ineligible for intravenous tPA. Methods— We investigated the safety and efficacy of a novel embolectomy device (Merci Retriever) to open occluded intracranial large vessels within 8 hours of the onset of stroke symptoms in a prospective, nonrandomized, multicenter trial. All patients were ineligible for intravenous tPA. Primary outcomes were recanalization and safety, and secondary outcomes were neurological outcome at 90 days in recanalized versus nonrecanalized patients. Results— Recanalization was achieved in 46% (69/151) of patients on intention to treat analysis, and in 48% (68/141) of patients in whom the device was deployed. This rate is significantly higher than that expected using an historical control of 18% ( P 〈 0.0001). Clinically significant procedural complications occurred in 10 of 141 (7.1%) patients. Symptomatic intracranial hemorrhages was observed in 11 of 141 (7.8%) patients. Good neurological outcomes (modified Rankin score ≤2) were more frequent at 90 days in patients with successful recanalization compared with patients with unsuccessful recanalization (46% versus 10%; relative risk [RR], 4.4; 95% CI, 2.1 to 9.3; P 〈 0.0001), and mortality was less (32% versus 54%; RR, 0.59; 95% CI, 0.39 to 0.89; P =0.01). Conclusions— A novel endovascular embolectomy device can significantly restore vascular patency during acute ischemic stroke within 8 hours of stroke symptom onset and provides an alternative intervention for patients who are otherwise ineligible for thrombolytics.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/01.STR.0000171066.25248.1d
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2005
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  • 2
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    Outpatient Low-Molecular Weight Heparin for Conversion to Warfarin in Non-Valvular Atrial Fibrillation
    Ovid Technologies (Wolters Kluwer Health) ; 2001
    In:  Stroke Vol. 32, No. suppl_1 ( 2001-01), p. 377-377
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 32, No. suppl_1 ( 2001-01), p. 377-377
    Abstract: P206 Background: Patients with non-valvular atrial fibrillation (NVAF) are often hospitalized on IV heparin until target INRs are achieved. SQ LMWH has been shown to be safe and effective for OP treatment of DVT, but has not been widely used in NVAF. We discharged 35 patients with NVAF on SQ LMWH and analyzed safety, cost and satisfaction. Methods: Patients with NVAF who were being held in the hospital only for conversion of heparin to warfarin and who met other entry criteria were enrolled. Baseline CBC, coagulation profile, neurologic exam and demographic data were obtained. Patients were instructed in the use of LMWH and warfarin and then discharged on dalteparin 100 units/kgm BID. Ten patients also chose to monitor their own INRs with a point of care testing device (Coagucheck). Eight patients elected to have a home health nurse administer the dalteparin. When two consecutive INRs were therapeutic, dalteparin was discontinued. Actual cost of outpatient care was calculated. Inpatient costs were projected based on the number of days it took to reach the therapeutic INR values. Ten days after enrollment patients responded to a phone survey regarding thrombotic and/or bleeding complications, readmission to ED or hospital and satisfaction. Results: 31 patients completed the entire process. 51%(18/35) were 〉 70 years old. There were no significant thrombotic or bleeding complications, no readmissions and one ED visit for minor bleeding at a venupuncture site (INR=2.5). 71%(22/31) reported minor bruising. Patients using Coagucheck monitored INRs 2x as frequently as patients using the lab. Outpatient costs including the cost of dalteparin, INR testing, home health visits, coagucheck supplies and 1 ED visit totaled $20,324 or $616 per patient. Projected inpatient costs including the cost of room, IV heparin, PTT and INR testing totaled $123,261 or $3,735 per patient. This represented a cost saving of $3,119 per patient. 91%(28/31) were satisfied or very satisfied with the OP treatment and 87%(27/31)reported they would use it again. Conclusions: Outpatient SQ LMWH is a safe, cost-effective and attractive alternative to inpatient IV heparin in patients with NVAF.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.32.suppl_1.377
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2001
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  • 3
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    Abstract 96: CTP-Mismatch Maps Improve Interobserver Agreement
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Stroke Vol. 43, No. suppl_1 ( 2012-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. suppl_1 ( 2012-02)
    Abstract: Introduction: The use of mismatch between the ischemic core and penumbra to select patients who are likely to benefit from acute stroke therapy has gained popularity. Interpretation of the ischemic core and penumbra on standard CT-perfusion (CTP) maps is subjective. This may lead to variability among physicians in the decision if a patient is a good candidate for acute stroke therapy. A CTP-Mismatch map with outlines of the ischemic core and penumbra could limit this variability. The goal of this study was to determine if inter-observer agreement regarding a patient’s suitability for acute stroke therapy improves with the use of a CTP-Mismatch map. The figure shows a typical CTP-Mismatch map. Methods: Ninety-six consecutive patients evaluated with CTP prior to intra-arterial therapy at St. Lukes Hospital in 2008-09 were included. 79 patients had adequate quality CTP for this analysis. Standard CTP maps (CBV, CBF, MTT, and Tmax) and a CTP-Mismatch map were generated with a fully automated program for processing of CTP source images (RAPID). RAPID assessed the ischemic core using a CBF threshold 〈 30% of the contralateral hemisphere (rCBF 〈 30%). The ischemic penumbra was defined by a Tmax threshold of 〉 6 sec (Tmax 〉 6s). The standard CTP maps and the CTP-Mismatch map were independently analyzed by two vascular neurologists in a blinded fashion. The raters assessed a patient's suitability for intra-arterial therapy based on the following mismatch criteria: (1) a ratio between (Tmax 〉 6s) and (rCBF 〈 30%) volumes 〉 1.8 and (2) an absolute difference between (Tmax 〉 6s) and (CBF 〈 30%) volumes 〉 15ml. Interobserver reliability was assessed with Cohen’s kappa. Results: When assessment of suitability for intra-arterial therapy was based on interpretation of standard CTP maps, the two raters agreed in 58 of 79 patients (kappa=0.46; 95% CI=0.24-0.60). The agreement between observers improved when suitability was determined using CTP-Mismatch maps (agreement in 76 of 79 cases; kappa=0.92; 95% CI=0.75-0.92; p 〈 0.001 for difference between kappa values). The 3 cases with inter-observer disagreement had artifact on the CTP-Mismatch map. Following concensus adjudication of these 3 cases, 40 of the 79 patients (51%) were deemed suitable candidates for acute stroke therapy. Conclusion: CTP-Mismatch maps with estimates of ischemic core and penumbra volumes markedly improve inter-observer agreement regarding assessment of suitability for acute stroke therapy. Such maps, which can be generated automatically, may help standardize decision making algorithms for evaluation of potential intra-arterial therapy candidates.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.43.suppl_1.A96
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
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  • 4
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    Abstract TP234: What Stroke Survivors and Families Need to Know For Decision-making During Acute Ischemic Stroke Care - A Qualitative Research Study
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. suppl_1 ( 2013-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Background: Explaining the benefits and risks of tissue plasminogen activator (tPA) is typically done through hurried verbal explanations in the emergency department, but it may not be understood by patients and caregivers. However, spending more time to explain the risks and benefits may delay the administration of tPA. We sought to develop a decision aid tool to facilitate this communication. Methods: A multidisciplinary research team searched available materials of stroke descriptions intended for a lay audience. The research team and medical illustrator also developed different formats of presenting results from the NINDS tPA trial. We conducted focus groups of stroke survivors and their caregivers at two medical centers to provide feedback on what information should be communicated and how it should be presented. Results: To date, we have convened three focus groups. We have enrolled 12 stroke survivors with a mean age of 54. Two had received tPA. We also enrolled three caregivers with a mean age of 68. Survivors typically did not recall being educated about acute stroke or its treatment during the hospitalization. Participants preferred broadening the definition of a “good” outcome to functional independence (i.e. modified Rankin score of 0-2) over a narrower one of being symptom-free. They also preferred viewing information about the increased chance of a good outcome rather than the decreased chance of a bad outcome such as death. Participants’ opinions sometimes differed from researchers’, such as the choice of colors to depict good outcome or death and the preference of simple bar graphs over pictographs. Conclusions: The different opinions between researchers and patients and caregivers highlight the need to obtain input from all stakeholders in designing effective decision aid tools. Further focus groups are planned to refine the decision-aid tool. We also plan to pilot-test the implementation of this tool in the workflow of managing patients with stroke in the emergency department.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.44.suppl_1.ATP234
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 5
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    Analysis of the Costs and Payments of a Coordinated Stroke Center and Regional Stroke Network
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. 8 ( 2013-08), p. 2254-2259
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. 8 ( 2013-08), p. 2254-2259
    Abstract: An earlier study demonstrated significantly improved access, treatment, and outcomes after the implementation of a progressive, comprehensive stroke program at a tertiary care community hospital, Saint Luke’s Neuroscience Institute (SLNI). This study evaluated the costs associated with implementing such a program. Methods— Retrospective analysis of total hospital costs and payments for treating patients with ischemic stroke at SLNI (n=1570) as program enhancement evolved over time (2005, 2007, and 2010) and compared with published national estimates. Analyses were stratified by patient demographic characteristics, patient outcomes, treatments, time, and comorbidities. Results— Controlling for inflation, there was no difference in SLNI total costs between 2005 and either 2007 or 2010, suggesting that while SLNI provided an increased level of services, any additional expenditures were offset by efficiencies. SLNI total costs were slightly lower than published benchmarks. Consistent with previous stroke care cost estimates, the median overall differential between total hospital costs and payments for all ischemic stroke cases was negative. Conclusions— SLNI total costs remained consistent over time and were slightly lower than previously published estimates, suggesting that a focused, streamlined stroke program can be implemented without a significant economic impact. This finding further demonstrates that providing comprehensive stroke care with improved access and treatment may be financially feasible for other hospitals.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.113.001370
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 6
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    Sphenopalatine Ganglion Stimulation to Augment Cerebral Blood Flow : A Randomized, Sham-Controlled Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Stroke Vol. 50, No. 8 ( 2019-08), p. 2108-2117
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 50, No. 8 ( 2019-08), p. 2108-2117
    Abstract: Many patients with acute ischemic stroke are not eligible for thrombolysis or mechanical reperfusion therapies due to contraindications, inaccessible vascular occlusions, late presentation, or large infarct core. Sphenopalatine ganglion (SPG) stimulation to enhance collateral flow and stabilize the blood-brain barrier offers an alternative, potentially more widely deliverable, therapy. Methods— In a randomized, sham-controlled, double-masked trial at 41 centers in 7 countries, patients with anterior circulation ischemic stroke not treated with reperfusion therapies within 24 hours of onset were randomly allocated to active SPG stimulation or sham control. The primary efficacy outcome was improvement beyond expectations on the modified Rankin Scale of global disability at 90 days (sliding dichotomy), assessed in the modified intention-to-treat population. The initial planned sample size was 660 patients, but the trial was stopped early when technical improvements in device placement occurred, so that analysis of accumulated experience could be conducted to inform a successor trial. Results— Among 303 enrolled patients, 253 received at least one active SPG or sham stimulation, constituting the modified intention-to-treat population (153 SPG stimulation and 100 sham control). Age was median 73 years (interquartile range, 64–79), 52.6% were female, deficit severity on the National Institutes of Health Stroke Scale was median 11 (interquartile range, 9–15), and time from last known well median 18.6 hours (interquartile range, 14.5–22.5). For the primary outcome, improved 3-month disability beyond expectations, rates in the SPG versus sham treatment groups were 49.7% versus 40.0%; odds ratio, 1.48 (95% CI, 0.89–2.47); P =0.13. A significant treatment interaction with stroke location (cortical versus noncortical) was noted, P =0.04. In the 87 patients with confirmed cortical involvement, rates of improvement beyond expectations were 50.0% versus 27.0%; odds ratio, 2.70 (95% CI, 1.08–6.73); P =0.03. Similar response patterns were observed for all prespecified secondary efficacy outcomes. No differences in mortality or serious adverse event safety end points were observed. Conclusions— SPG stimulation within 24 hours of onset is safe in acute ischemic stroke. SPG stimulation was not shown to statistically significantly improve 3-month disability above expectations, though favorable outcomes were nominally higher with SPG stimulation. Beneficial effects may distinctively be conferred in patients with confirmed cortical involvement. The results of this study need to be confirmed in a larger pivotal study. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT03767192.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.118.024582
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
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  • 7
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    Predictors of Functional Dependence Despite Successful Revascularization in Large-Vessel Occlusion Strokes
    Ovid Technologies (Wolters Kluwer Health) ; 2014
    In:  Stroke Vol. 45, No. 7 ( 2014-07), p. 1977-1984
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 7 ( 2014-07), p. 1977-1984
    Abstract: High revascularization rates in large-vessel occlusion strokes treated by mechanical thrombectomy are not always associated with good clinical outcomes. We evaluated predictors of functional dependence despite successful revascularization among patients with acute ischemic stroke treated with thrombectomy. Methods— We analyzed the pooled data from the Multi Mechanical Embolus Removal in Cerebral Ischemia (MERCI), Thrombectomy Revascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO), and TREVO 2 trials. Successful revascularization was defined as thrombolysis in cerebral infarction score 2b or 3. Functional dependence was defined as a score of 3 to 6 on the modified Rankin Scale at 3 months. We assessed relationship of demographic, clinical, angiographic characteristics, and hemorrhage with functional dependence despite successful revascularization. Results— Two hundred and twenty-eight patients with successful revascularization had clinical outcome follow-up. The rates of functional dependence with endovascular success were 48.6% for Trevo thrombectomy and 58.0% for Merci thrombectomy. Age (odds ratio, 1.04; 95% confidence interval, 1.02–1.06 per 1-year increase), National Institutes of Health Stroke Scale score (odds ratio, 1.08; 95% confidence interval, 1.02–1.15 per 1-point increase), and symptom onset to endovascular treatment time (odds ratio, 1.11; 95% confidence interval, 1.01–1.22 per 30-minute delay) were predictors of functional dependence despite successful revascularization. Symptom onset to reperfusion time beyond 5 hours was associated with functional dependence. All subjects with symptomatic intracranial hemorrhage had functional dependence. Conclusions— One half of patients with successful mechanical thrombectomy do not have good outcomes. Age, severe neurological deficits, and delayed endovascular treatment were associated with functional dependence despite successful revascularization. Our data support efforts to minimize delays to endovascular therapy in patients with acute ischemic stroke to improve outcomes. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00318071, NCT01088672, and NCT01270867.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.114.005603
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
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  • 8
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    Final Results of the RHAPSODY Trial: A Multi‐Center, Phase 2 Trial Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A‐APC, A Recombinant Variant of Human Activated Protein C, in Combination with Tissue Plasminogen Activator, Mechanical Thrombectomy or both in Moderate to Severe Acute Ischemic Stroke
    Wiley ; 2019
    In:  Annals of Neurology Vol. 85, No. 1 ( 2019-01), p. 125-136
    Details
    In: Annals of Neurology, Wiley, Vol. 85, No. 1 ( 2019-01), p. 125-136
    Abstract: Agonism of protease‐activated receptor (PAR) 1 by activated protein C (APC) provides neuro‐ and vasculoprotection in experimental neuroinjury models. The pleiotropic PAR1 agonist, 3K3A‐APC, reduces neurological injury and promotes vascular integrity; 3K3A‐APC proved safe in human volunteers. We performed a randomized, controlled, blinded trial to determine the maximally tolerated dose (MTD) of 3K3A‐APC in ischemic stroke patients. Methods The NeuroNEXT trial, RHAPSODY, used a novel continual reassessment method to determine the MTD using tiers of 120, 240, 360, and 540 μg/kg of 3K3A‐APC. After intravenous tissue plasminogen activator, intra‐arterial mechanical thrombectomy, or both, patients were randomized to 1 of the 4 doses or placebo. Vasculoprotection was assessed as microbleed and intracranial hemorrhage (ICH) rates. Results Between January 2015 and July 2017, we treated 110 patients. Demographics resembled a typical stroke population. The MTD was the highest‐dose 3K3A‐APC tested, 540 μg/kg, with an estimated toxicity rate of 7%. There was no difference in prespecified ICH rates. In exploratory analyses, 3K3A‐APC reduced ICH rates compared to placebo from 86.5% to 67.4% in the combined treatment arms ( p = 0.046) and total hemorrhage volume from an average of 2.1 ± 5.8 ml in placebo to 0.8 ± 2.1 ml in the combined treatment arms ( p = 0.066). Interpretation RHAPSODY is the first trial of a neuroprotectant for acute ischemic stroke in a trial design allowing thrombectomy, thrombolysis, or both. The MTD was 540 μg/kg for the PAR1 active cytoprotectant, 3K3A‐APC. A trend toward lower hemorrhage rate in an exploratory analysis requires confirmation. Clinical Trial Registration Clinical Trial Registration‐URL: http://www.clinicaltrials.gov . Unique identifier: NCT02222714. ANN NEUROL 2019;85:125–136.
    Type of Medium: Online Resource
    ISSN: 0364-5134 , 1531-8249
    URL: Issue
    URL: Article
    DOI: 10.1002/ana.v85.1
    DOI: 10.1002/ana.25383
    Language: English
    Publisher: Wiley
    Publication Date: 2019
    detail.hit.zdb_id: 2037912-2
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  • 9
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    Intra-arterial Thrombolysis or Stent Placement During Endovascular Treatment for Acute Ischemic Stroke Leads to the Highest Recanalization Rate: Results of a Multicenter Retrospective Study
    Ovid Technologies (Wolters Kluwer Health) ; 2011
    In:  Neurosurgery Vol. 68, No. 6 ( 2011-06), p. 1618-1623
    Details
    In: Neurosurgery, Ovid Technologies (Wolters Kluwer Health), Vol. 68, No. 6 ( 2011-06), p. 1618-1623
    Type of Medium: Online Resource
    ISSN: 0148-396X
    URL: Article
    DOI: 10.1227/NEU.0b013e31820f156c
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2011
    detail.hit.zdb_id: 1491894-8
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  • 10
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    Organizing regional networks to increase acute stroke intervention
    Informa UK Limited ; 2005
    In:  Neurological Research Vol. 27, No. sup1 ( 2005-10), p. 9-16
    Details
    In: Neurological Research, Informa UK Limited, Vol. 27, No. sup1 ( 2005-10), p. 9-16
    Type of Medium: Online Resource
    ISSN: 0161-6412 , 1743-1328
    URL: Article
    DOI: 10.1179/016164105X25315
    RVK:
    XA 10000
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2005
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