scholarly journals Higher-Quality Data Collection Is Critical to Establish the Safety and Efficacy of Pediatric Mechanical Thrombectomy

Stroke ◽  
2021 ◽  
Author(s):  
Megan Barry ◽  
Dwight Barry ◽  
Akash P. Kansagra ◽  
Danial Hallam ◽  
Michael Abraham ◽  
...  
Keyword(s):  
Data Collection ◽  
Mechanical Thrombectomy ◽  
Treatment Guidelines ◽  
Case Reports ◽  
National Institutes Of Health ◽  
Quality Data ◽  
Published Data ◽  
Childhood Stroke ◽  
Safety And Efficacy ◽  
Study Sites

Background and Purpose: Because children often have lifelong morbidity after stroke, there is considerable enthusiasm to pursue mechanical thrombectomy in childhood stroke based on literature reports. However, current published data may reflect inconsistent reporting and publication bias, which limit the ability to assess safety and efficacy of mechanical thrombectomy in childhood stroke. Methods: This retrospective cohort study compared reporting quality and clinical outcomes for mechanical thrombectomy between a trial-derived cohort of 42 children treated with mechanical thrombectomy for acute stroke at study sites and 133 patients reported in the literature. National Institutes of Health Stroke Scale at baseline, 24 hours after mechanical thrombectomy, and at discharge were compared between study site patients and literature patients. Odds ratios (ORs) were used to compare reporting frequencies. Proportional odds logistic regression was used to compare outcomes. Results: Premechanical thrombectomy National Institutes of Health Stroke Scale was available in 93% of study patients compared with 74% of patients in the literature (OR, 4.42 [95% CI, 1.47–19.89]). Postmechanical thrombectomy National Institutes of Health Stroke Scale was available in 69% of study patients compared with 29% of literature cases at 24 hours (OR, 5.48 [95% CI, 2.62–12.06]), and 64% of study patients compared with 32% of cases at discharge (OR, 3.85 [95% CI, 1.87–8.19]). For study sites, median scores were 12 at baseline, 9 at 24 hours, and 5 at discharge. Median scores in case reports were 15 at baseline, 4 at 24 hours, and 3 at discharge. ORs for differences in outcomes between groups were 5.97 (95% CI, 2.28–15.59) at 24 hours and 3.68 (95% CI, 1.45–9.34) at discharge. Conclusions: Study site patients had higher rates of National Institutes of Health Stroke Scale reporting and worse short-term outcomes compared with literature reports. Rigorous data collection is needed before treatment guidelines for pediatric mechanical thrombectomy can be developed.

Abstract WP53: Safety and Efficacy of Mechanical Thrombectomy in Acute Stroke Patients on New Oral Anticoagulants

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Nurose Karim ◽  
Alicia C Castonguay ◽  
Hisham Salahuddin ◽  
Julie Shawver ◽  
Syed Zaidi ◽  
...  
Keyword(s):  
Mechanical Thrombectomy ◽  
Oral Anticoagulants ◽  
National Institutes Of Health ◽  
New Oral Anticoagulants ◽  
Limited Data ◽  
Stroke Patients ◽  
Safety And Efficacy ◽  
Nihss Score ◽  
Symptomatic Intracerebral Hemorrhage ◽  
Symptomatic Intracranial Hemorrhage

Background: Limited data exists on the benefits of mechanical thrombectomy (MT) in acute ischemic stroke patients on new oral anticoagulants (NOAC). The aim of our study is to examine the safety and efficacy of MT in NOAC patients at our center. Methods: A retrospective review of our prospective MT database was performed for this study. Baseline characteristics, National Institutes of Health Stroke Scale (NIHSS) score, revascularization rate, symptomatic intracranial hemorrhage rate (sICH), and 90-day mortality and favorable outcomes were compared in MT patients on NOAC (MT-NOAC) versus those who were not on NOAC (MT). Results: From July 2012 to December 2018, 553 AIS patients underwent treatment with MT, with 36 patients on NOAC (6.5%). Median age was similar (73 versus 74), with 52.8% and 52.0% (p=0.8) female in the MT-NOAC and MT groups, respectively. Median baseline NIHSS score (17 IQR10-21 versus 17 IQR 12-21, p=0.75) and ASPECTS (9 IQR 8-9, p=0.80) were similar between the groups. Atrial fibrillation was more prevalent in the MT-NOAC group (80.6% versus 37.7%, p=<0.0001). No difference was seen in occlusion site between the group, with M1 occlusions the most common site (44.4% versus 43.3%, p=0.9). Median onset to revascularization times did not differ between the cohorts (146 minutes versus 206, p=0.61). Successful revascularization (mTICI≥2b) was 87.5% and 81.8% in the MT NOAC and MT groups, respectively. Rates of symptomatic intracerebral hemorrhage per ECASS III criteria were similar between the two groups (5.5% versus 4.6%, p=0.68). No difference was seen in 90-day favorable outcomes (mRS 0-2) (48.3% versus 41.1%, p=0.44) or mortality (27.6% versus 27.1%, 0.95). Conclusion: MT in patients on NOAC appears to be safe and efficacious. As our study is limited by sample size, larger prospective studies are needed to understand the safety and efficacy of MT in AIS patients on NOAC.

scholarly journals Initial Experience Performing Mechanical Thrombectomy With the CatchView Mini Device for Distal M2 Segment Middle Cerebral Artery Occlusions

2021 ◽  
Vol 12 ◽  
Author(s):  
Pedro Vega ◽  
Eduardo Murias ◽  
Jose María Jimenez ◽  
Juan Chaviano ◽  
Lorena Benavente ◽  
...  
Keyword(s):  
Middle Cerebral Artery ◽  
Cerebral Artery ◽  
Mechanical Thrombectomy ◽  
Standard Of Care ◽  
Functional Independence ◽  
National Institutes Of Health ◽  
Vessel Occlusion ◽  
Safety And Efficacy ◽  
Hemorrhagic Complications ◽  
Mean Time

Background: Mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke due to large vessel occlusion; however, its safety and efficacy in patients with distal strokes remains unclear. In this study, we investigated the safety and efficacy of MT for distal middle cerebral artery (MCA) occlusions using the CatchView Mini (CVM; Balt, Montmorency, France).Methods: This was a prospective single-center analysis of patients with a single MCA-M2 occlusion treated with the CVM device. Consecutive patients were prospectively enrolled from October 2018 to March 2020. Efficacy outcomes included successful recanalization [modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3], procedure times, and number of device passes. Clinical outcomes included National Institutes of Health Stroke Scale Score (NIHSS) at discharge, 90-day functional independence (modified Rankin Scale 0–2) and safety outcomes included hemorrhagic complications, and 90-day mortality.Results: A total of 45 patients (mean age: 74.0 ± 12.6; 53.3% [24/45] female) were included in the study. Upon admission, 33.3% (15/45) of patients were mRS 3–5; and mean NIHSS was 13.2 ± 4.2 Mean time from symptom onset to final angiography was 250.0 ± 83.4 min with a mean intervention duration of 34.0 ± 12.6 min. The mean number of device passes was 1.8 ± 1.5 final mTICI 2b/3 was achieved in 91.1% (41/45) of patients. Eight hemorrhagic complications (17.8%, 8/34) occurred, none of which were symptomatic. At 90-days, 57.8% (26/45) patients were functionally independent and the rate of mortality was 15.6% (7/45).Conclusions: The present analysis demonstrates a low risk profile and high recanalization success for patients with distal M2 occlusions treated with the CVM device.

Measuring the Masses: Mass-Gathering Medical Case Reporting, Conceptual Modeling – The DREAM Model (Paper 5)

2021 ◽  
pp. 1-7
Author(s):  
Adam Lund ◽  
Sheila Turris ◽  
Haddon Rabb ◽  
Matthew Brendan Munn ◽  
Elizabeth Chasmar ◽  
...  
Keyword(s):  
Data Collection ◽  
Health Outcomes ◽  
Case Reports ◽  
Conceptual Modeling ◽  
Evidence Base ◽  
Medical Services ◽  
Published Data ◽  
Mass Gathering ◽  
Medical Case ◽  
Levels Of Care

Abstract Introduction: Without a robust evidence base to support recommendations for first aid, health, and medical services at mass gatherings (MGs), levels of care will continue to vary. Streamlining and standardizing post-event reporting for MG medical services could improve inter-event comparability, and prospectively influence event safety and planning through the application of a research template, thereby supporting and promoting growth of the evidence base and the operational safety of this discipline. Understanding the relationships between categories of variables is key. The present paper is focused on theory building, providing an evolving conceptual model, laying the groundwork for exploring the relationships between categories of variables pertaining the health outcomes of MGs. Methods: A content analysis of 54 published post-event medical case reports, including a comparison of the features of published data models for MG health outcomes. Findings: A layered model of essential conceptual components for post-event medical reporting is presented as the Data Reporting, Evaluation, & Analysis for Mass-Gathering Medicine (DREAM) model. This model is relational and embeds data domains, organized operationally, into “inputs,” “modifiers,” “actuals,” and “outputs” and organized temporally into pre-, during, post-event, and reporting phases. Discussion: Situating the DREAM model in relation to existing models for data collection vis a vis health outcomes, the authors provide a detailed discussion on similarities and points of difference. Conclusion: Currently, data collection and analysis related to understanding health outcomes arising from MGs is not informed by robust conceptual models. This paper is part of a series of nested papers focused on the future state of post-event medical reporting.

Mechanical thrombectomy using a Solitaire stent retriever in the treatment of pediatric acute ischemic stroke

2019 ◽  
Vol 23 (3) ◽  
pp. 363-368 ◽  
Author(s):  
Bing Zhou ◽  
Xiao-Chuan Wang ◽  
Jun-Yi Xiang ◽  
Ming-Zhao Zhang ◽  
Bo Li ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Balloon Dilation ◽  
Stent Retriever ◽  
National Institutes Of Health ◽  
Clinical Prognosis ◽  
Nihss Score ◽  
Grade 3

OBJECTIVEMechanical thrombectomy using a Solitaire stent retriever has been widely applied as a safe and effective method in adult acute ischemic stroke (AIS). However, due to the lack of data, the safety and effectiveness of mechanical thrombectomy using a Solitaire stent in pediatric AIS has not yet been verified. The purpose of this study was to explore the safety and effectiveness of mechanical thrombectomy using a Solitaire stent retriever for pediatric AIS.METHODSBetween January 2012 and December 2017, 7 cases of pediatric AIS were treated via mechanical thrombectomy using a Solitaire stent retriever. The clinical practice, imaging, and follow-up results were reviewed, and the data were summarized and analyzed.RESULTSThe ages of the 7 patients ranged from 7 to 14 years with an average age of 11.1 years. The preoperative National Institutes of Health Stroke Scale (NIHSS) scores ranged from 9 to 22 with an average of 15.4 points. A Solitaire stent retriever was used in all patients, averaging 1.7 applications of thrombectomy and combined balloon dilation in 2 cases. Grade 3 on the modified Thrombolysis In Cerebral Infarction scale of recanalization was achieved in 5 cases and grade 2b in 2 cases. Six patients improved and 1 patient died after thrombectomy. The average NIHSS score of the 6 cases was 3.67 at discharge. The average modified Rankin Scale score was 1 at the 3-month follow-up. Subarachnoid hemorrhage after thrombectomy occurred in 1 case and that patient died 3 days postoperatively.CONCLUSIONSThis study shows that mechanical thrombectomy using a Solitaire stent retriever has a high recanalization rate and excellent clinical prognosis in pediatric AIS. The safety of mechanical thrombectomy in pediatric AIS requires more clinical trials for confirmation.

Mechanical thrombectomy in pediatric stroke: systematic review, individual patient data meta-analysis, and case series

2019 ◽  
Vol 24 (5) ◽  
pp. 558-571 ◽  
Author(s):  
Kartik Bhatia ◽  
Hans Kortman ◽  
Christopher Blair ◽  
Geoffrey Parker ◽  
David Brunacci ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Neurological Outcomes

OBJECTIVEThe role of mechanical thrombectomy in pediatric acute ischemic stroke is uncertain, despite extensive evidence of benefit in adults. The existing literature consists of several recent small single-arm cohort studies, as well as multiple prior small case series and case reports. Published reports of pediatric cases have increased markedly since 2015, after the publication of the positive trials in adults. The recent AHA/ASA Scientific Statement on this issue was informed predominantly by pre-2015 case reports and identified several knowledge gaps, including how young a child may undergo thrombectomy. A repeat systematic review and meta-analysis is warranted to help guide therapeutic decisions and address gaps in knowledge.METHODSUsing PRISMA-IPD guidelines, the authors performed a systematic review of the literature from 1999 to April 2019 and individual patient data meta-analysis, with 2 independent reviewers. An additional series of 3 cases in adolescent males from one of the authors’ centers was also included. The primary outcomes were the rate of good long-term (mRS score 0–2 at final follow-up) and short-term (reduction in NIHSS score by ≥ 8 points or NIHSS score 0–1 at up to 24 hours post-thrombectomy) neurological outcomes following mechanical thrombectomy for acute ischemic stroke in patients < 18 years of age. The secondary outcome was the rate of successful angiographic recanalization (mTICI score 2b/3).RESULTSThe authors’ review yielded 113 cases of mechanical thrombectomy in 110 pediatric patients. Although complete follow-up data are not available for all patients, 87 of 96 (90.6%) had good long-term neurological outcomes (mRS score 0–2), 55 of 79 (69.6%) had good short-term neurological outcomes, and 86 of 98 (87.8%) had successful angiographic recanalization (mTICI score 2b/3). Death occurred in 2 patients and symptomatic intracranial hemorrhage in 1 patient. Sixteen published thrombectomy cases were identified in children < 5 years of age.CONCLUSIONSMechanical thrombectomy may be considered for acute ischemic stroke due to large vessel occlusion (ICA terminus, M1, basilar artery) in patients aged 1–18 years (Level C evidence; Class IIb recommendation). The existing evidence base is likely affected by selection and publication bias. A prospective multinational registry is recommended as the next investigative step.

Collecting High-Quality Data

2018 ◽  
Author(s):  
Mary Kay Gugerty ◽  
Dean Karlan
Keyword(s):  
Data Collection ◽  
Social Desirability ◽  
Measurement Errors ◽  
Monitoring And Evaluation ◽  
Quality Data ◽  
Social Desirability Bias ◽  
High Quality ◽  
High Quality Data ◽  
Evaluation Systems ◽  
Demand Effect

Without high-quality data, even the best-designed monitoring and evaluation systems will collapse. Chapter 7 introduces some the basics of collecting high-quality data and discusses how to address challenges that frequently arise. High-quality data must be clearly defined and have an indicator that validly and reliably measures the intended concept. The chapter then explains how to avoid common biases and measurement errors like anchoring, social desirability bias, the experimenter demand effect, unclear wording, long recall periods, and translation context. It then guides organizations on how to find indicators, test data collection instruments, manage surveys, and train staff appropriately for data collection and entry.

P084 DEEP REMISSION WITH DOUBLE BIOLOGIC THERAPY: A SUCCESSFUL CASE OF COMBINATION USTEKINUMAB AND VEDOLIZUMAB FOR SEVERE REFRACTORY CROHN’S DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S72-S72
Author(s):  
Ahmed Elmoursi ◽  
Courtney Perry ◽  
Terrence Barrett
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Combination Therapy ◽  
Clinical Remission ◽  
Biologic Therapy ◽  
Case Reports ◽  
Sigmoid Resection ◽  
Safety And Efficacy ◽  
Ileal Stricture

Abstract Background Stricturing Crohn’s disease (CD) constitutes a severe phenotype often associated with a high degree of morbidity (3). Surgical resection is first-line therapy for symptomatic strictures, but most patients relapse without subsequent medical therapy (4–5). Biologics are the mainstay for inducing and maintaining remission, but some cases are refractory despite maximum dosage of therapy. Reports of dual biological therapy (DBT) in refractory, stricturing CD are sparse, and prior case reports document only clinical remission (1). To contribute further knowledge regarding the use of DBT in stricturing CD, we present the case of a refractory CD patient who achieved deep remission with ustekinumab and vedolizumab. Case Presentation A 35 year old non-smoking, Caucasian male was referred to our clinic in 2014 for refractory CD complicated by multiple strictures. Prior to establishing care with us, he received two jejunal resections and a sigmoid resection. Previously failed therapies included azathioprine with infliximab, adalimumab, and certolizumab. He continued to progress under our care despite combination methotrexate/certolizumab, as well as methotrexate/golimumab. He underwent proctocolectomy with end ileostomy in 2015 and initiated vedolizumab q8weeks post-operatively. He reoccurred in 2018, when he presented with an ulcerated ileal stricture. He was switched from vedolizumab to ustekinumab q8weeks and placed on prednisone, but continued to progress, developing significant hematochezia requiring hospitalization and blood transfusions. Ileoscopy performed during hospital admission confirmed severe, ulcerating disease in the ileum with stricture. Ustekinumab dosing was increased to q4weeks, azathioprine was initiated, and he underwent stricturoplasty. Follow-up ileoscopy three months later revealed two ulcers in the neo- TI (Figure 1). Vedolizumab q8weeks was initiated in addition to ustekinumab q4weeks and azathioprine 125mg. After four months on this regimen the patient felt better, but follow-up ileoscopy showed two persistent ulcers in the neo-TI. Vedolizumab dosing interval was increased to q4weeks. After four months, subsequent ileoscopy demonstrated normal neo-TI (Figure 2). Histologic evaluation of biopsies confirmed deep remission of crohn’s disease. No adverse side effects have occurred with maximum doses of both ustekinumab and vedolizumab combination therapy. Discussion This case supports both the safety and efficacy of ustekinumab and vedolizumab dual biologic therapy for treatment of severe, refractory Crohn’s disease. While there are reports of DBT inducing clinical remission, this case supports efficacy for vedolizumab and ustekinumab combination therapy to induce deep histologic remission. Large practical clinical trials are needed to better investigate the safety and efficacy of DBT with vedolizumab and ustekinumab, but our case suggests this combination may be a safe and efficacious therapy for refractory CD patients.

Is a picture-perfect thrombectomy necessary in acute ischemic stroke?

2021 ◽  
pp. neurintsurg-2020-017193
Author(s):  
Ching-Jen Chen ◽  
Reda Chalhoub ◽  
Dale Ding ◽  
Jeyan S Kumar ◽  
Natasha Ironside ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Mechanical Thrombectomy ◽  
National Institutes Of Health ◽  
Stroke Patients ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Symptomatic Intracerebral Hemorrhage ◽  
History Of ◽  
Multivariable Models ◽  
Secondary Outcomes

BackgroundThe benefit of complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 3) over near-complete reperfusion (≥90%, mTICI 2c) remains unclear. The goal of this study is to compare clinical outcomes between mechanical thrombectomy (MT)-treated stroke patients with mTICI 2c versus 3.MethodsThis is a retrospective study from the Stroke Thrombectomy and Aneurysm Registry (STAR) comprising 33 centers. Adults with anterior circulation arterial vessel occlusion who underwent MT yielding mTICI 2c or mTICI 3 reperfusion were included. Patients were categorized based on reperfusion grade achieved. Primary outcome was modified Rankin Scale (mRS) 0–2 at 90 days. Secondary outcomes were mRS scores at discharge and 90 days, National Institutes of Health Stroke Scale score at discharge, procedure-related complications, and symptomatic intracerebral hemorrhage.ResultsThe unmatched mTICI 2c and mTICI 3 cohorts comprised 519 and 1923 patients, respectively. There was no difference in primary (42.4% vs 45.1%; p=0.264) or secondary outcomes between the unmatched cohorts. Reperfusion status (mTICI 2c vs 3) was also not predictive of the primary outcome in non-imputed and imputed multivariable models. The matched cohorts each comprised 191 patients. Primary (39.8% vs 47.6%; p=0.122) and secondary outcomes were also similar between the matched cohorts, except the 90-day mRS which was lower in the matched mTICI 3 cohort (p=0.049). There were increased odds of the primary outcome with mTICI 3 in patients with baseline mRS ≥2 (36% vs 7.7%; p=0.011; pinteraction=0.014) and a history of stroke (42.3% vs 15.4%; p=0.027; pinteraction=0.041).ConclusionsComplete and near-complete reperfusion after MT appear to confer comparable outcomes in patients with acute stroke.

scholarly journals Improving Specimen Labelling and Data Collection in Bio-science Research using Mobile and Web Applications

2020 ◽  
Vol 10 (1) ◽  
pp. 1-16
Author(s):  
Isaac Nyabisa Oteyo ◽  
Mary Esther Muyoka Toili
Keyword(s):  
Data Collection ◽  
Web Applications ◽  
Data Entry ◽  
Science Research ◽  
Quality Data ◽  
Quality Of Data ◽  
Data Entry Form ◽  
Research Activities ◽  
Daunting Task

AbstractResearchers in bio-sciences are increasingly harnessing technology to improve processes that were traditionally pegged on pen-and-paper and highly manual. The pen-and-paper approach is used mainly to record and capture data from experiment sites. This method is typically slow and prone to errors. Also, bio-science research activities are often undertaken in remote and distributed locations. Timeliness and quality of data collected are essential. The manual method is slow to collect quality data and relay it in a timely manner. Capturing data manually and relaying it in real time is a daunting task. The data collected has to be associated to respective specimens (objects or plants). In this paper, we seek to improve specimen labelling and data collection guided by the following questions; (1) How can data collection in bio-science research be improved? (2) How can specimen labelling be improved in bio-science research activities? We present WebLog, an application that we prototyped to aid researchers generate specimen labels and collect data from experiment sites. We use the application to convert the object (specimen) identifiers into quick response (QR) codes and use them to label the specimens. Once a specimen label is successfully scanned, the application automatically invokes the data entry form. The collected data is immediately sent to the server in electronic form for analysis.

Sign in / Sign up

Export Citation Format

Share Document