The association of novel inflammatory marker GlycA and incident atrial fibrillation in the Multi-Ethnic Study of Atherosclerosis (MESA)

Background Emerging evidence has implicated that inflammation contributes to the pathogenesis of atrial fibrillation (AF). GlycA is a novel marker of systemic inflammation with low intra-individual variability and high analytic precision. GlycA has been associated with incident cardiovascular disease (CVD) independent of other inflammatory markers. However, whether GlycA is associated with AF, specifically, has yet to be established. We examined the association between GlycA and AF in a multi-ethnic cohort. Methods We studied 6,602 MESA participants aged 45–85, with no clinical CVD at baseline, with data on GlycA and incident AF. We used multivariable-adjusted Cox models to evaluate the association between GlycA and incident AF. We also examined other inflammatory markers [high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL6) and fibrinogen] and incident AF for comparison. Results The mean (SD) age was 62 (10) years, 53% women. The mean plasma GlycA was 381 (62) μmol/L. Over median follow-up of 12.9 years, 869 participants experienced AF. There was no statistically significant association between GlycA and incident AF after adjusting for sociodemographics, CVD risk factors, and other inflammatory markers [Hazard Ratio (95% CI) per 1 SD increment in GlycA: 0.97 (0.88–1.06)]. Neither hsCRP nor fibrinogen was associated with incident AF in same model. In contrast, IL-6 was independently associated with incident AF [HR 1.12 per 1 SD increment (1.05–1.19)]. Conclusions Although GlycA has been associated with other CVD types, we found that GlycA was not associated with AF. More research will be required to understand why IL-6 was associated with AF but not GlycA. Clinical trial registration MESA is not a clinical trial. However, the cohort is registered at: URL: https://clinicaltrials.gov/ct2/show/NCT00005487 Unique identifier: NCT00005487.

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Accuracy of a smartwatch based single-lead electrocardiogram device in detection of atrial fibrillation

Heart ◽

10.1136/heartjnl-2019-316004 ◽

2020 ◽

Vol 106 (9) ◽

pp. 665-670 ◽

Cited By ~ 8

Author(s):

Kevin Rajakariar ◽

Anoop N Koshy ◽

Jithin K Sajeev ◽

Sachin Nair ◽

Louise Roberts ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Predictive Value ◽

Cardiac Rhythm ◽

Hospital Setting ◽

Automated Diagnosis ◽

Unique Identifier ◽

Clinical Trial Registration ◽

Automated Algorithms ◽

Improved Accuracy

ObjectiveThe AliveCor KardiaBand (KB) is an Food and Drug Administration-approved smartwatch-based cardiac rhythm monitor that records a lead-Intelligent ECG (iECG). Despite the appeal of wearable integrated ECG devices, there is a paucity of data evaluating their accuracy in diagnosing atrial fibrillation (AF). We evaluated whether a smartwatch-based device for AF detection is an accurate tool for diagnosing AF when compared with 12-lead ECG.MethodsA prospective, multi-centre, validation study was conducted in an inpatient hospital setting. The KB paired with a smartwatch, generated an automated diagnosis of AF or sinus rhythm (SR). This was compared with a 12-lead ECG performed immediately after iECG tracing. Where an unclassified or no-analysis tracing was generated, repeat iECG was performed.Results439 ECGs (iECGs (n=239) and 12-lead ECG (n=200)) were recorded in 200 patients (AF: n=38; SR: n=162) from three tertiary centres. Sensitivity and specificity using KB was 94.4% and 81.9% respectively, with a positive predictive value of 54.8% and negative predictive value of 98.4%. Agreement between 12-lead ECG and KB diagnosis was moderate when unclassified tracings were included (κ=0.60, 95% CI 0.47 to 0.72). Combining the automated device diagnosis with blinded electrophysiologists (EP) interpretation of unclassified tracings improved overall agreement (EP1: κ=0.76, 95% CI 0.65 to 0.87; EP2: κ=0.74, 95% CI 0.63 to 0.86).ConclusionThe KB demonstrated moderate diagnostic accuracy when compared with a 12-lead ECG. Combining the automated device diagnosis with EP interpretation of unclassified tracings yielded improved accuracy. However, even with future improvements in automated algorithms, physician involvement will likely remain an essential component when exploring the utility of these devices for arrhythmia screening.Clinical trial registrationURL: https://www.anzctr.org.au/ Unique identifier: ACTRN12616001374459.

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MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03227-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mohamad Hadi El Charif ◽

Samer Doughan ◽

Rawya Kredly ◽

Sara Kassas ◽

Rayan Azab ◽

...

Keyword(s):

Clinical Trial ◽

Wound Healing ◽

Anal Fissure ◽

Topical Therapy ◽

Trial Registration ◽

Clinical Trial Registration ◽

Anal Fissures ◽

Link Type ◽

Anorectal Region ◽

Registration Date

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

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Incidence and Predictors of Hospitalization in Patients with Atrial Fibrillation: Results from the Chinese Atrial Fibrillation Registry Study

10.21203/rs.3.rs-123416/v1 ◽

2020 ◽

Author(s):

Zhaojie Dong ◽

Xin Du ◽

Shangxin Lu ◽

Chao Jiang ◽

Shijun Xia ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cardiovascular Diseases ◽

Proportional Hazards Model ◽

Cox Model ◽

Cox Proportional Hazards ◽

Cox Proportional Hazards Model ◽

Chronic Obstructive ◽

Unique Identifier ◽

Clinical Trial Registration

Abstract Background: Patients with atrial fibrillation (AF) underwent a high risk of hospitalization, which, however, has not been paid much attention in clinic. Therefore, we aimed to assess the incidence, causes and predictors of hospitalization in AF patients.Methods: From August 2011 to December 2017, 20,172 AF patients from the Chinese Atrial Fibrillation Registry (China-AF) Study were enrolled in this study. We described the incidence, causes of hospitalization according to age and gender categories. The Cox proportional hazards model was employed to identify predictors of first all-cause and first cause-specific hospitalization. Results: After a mean follow-up of 37.3 ± 20.4 months, 7,512 (37.2%) AF patients experienced one or more hospitalizations. The overall incidence of all-cause hospitalization was 24.0 per 100 patient-years. Patients aged < 65 years were predominantly hospitalized for AF (42.1% of the total frequency of hospitalizations); while patients aged 65-74 and ≥ 75 years were mainly hospitalized for non-cardiovascular diseases (43.6% and 49.3%, respectively). Multivariate Cox model analysis verified the higher risk of hospitalization in patients complicated with heart failure (HF)[hazard ratio (HR) 1.15, 95% confidence interval (CI) 1.08-1.24], established coronary artery disease (CAD) (HR 1.26, 95%CI 1.19-1.34), ischemic stroke/transient ischemic attack (TIA) (HR 1.26, 95%CI 1.18-1.33), diabetes (HR 1.16, 95%CI 1.10-1.22), chronic obstructive pulmonary disease (COPD) (HR 1.41, 95%CI 1.13-1.76), gastrointestinal disorder (HR 1.39, 95%CI 1.23-1.58), and renal dysfunction (HR 1.31, 95%CI 1.16-1.48). Conclusions: More than one-third of AF patients included in this study were hospitalized at least once during almost 3 years of follow-up. The main cause for hospitalization among elderly patients (≥65 years) is non-cardiovascular diseases rather than AF. Multidisciplinary management of comorbidities should be advocated as strategies to reduce hospitalization in AF patients.Clinical Trial Registration: URL: http://www.chictr.org.cn/showproj.aspx?proj=5831. Unique identifier: ChiCTR-OCH-13003729.

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Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis

Circulation ◽

10.1161/circulationaha.119.041949 ◽

2019 ◽

Vol 140 (18) ◽

pp. 1451-1459 ◽

Cited By ~ 10

Author(s):

John W. Eikelboom ◽

Stuart J. Connolly ◽

Jacqueline Bosch ◽

Olga Shestakovska ◽

Victor Aboyans ◽

...

Keyword(s):

Clinical Trial ◽

Gastrointestinal Bleeding ◽

Cancer Diagnosis ◽

Minor Bleeding ◽

Antithrombotic Drugs ◽

Unique Identifier ◽

Clinical Trial Registration ◽

Risk Of Bleeding ◽

Genitourinary Cancer

Background: Patients treated with antithrombotic drugs are at risk of bleeding. Bleeding may be the first manifestation of underlying cancer. Methods: We examined new cancers diagnosed in relation to gastrointestinal or genitourinary bleeding among patients enrolled in the COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies) and determined the hazard of new cancer diagnosis after bleeding at these sites. Results: Of 27 395 patients enrolled (mean age, 68 years; women, 21%), 2678 (9.8%) experienced any (major or minor) bleeding, 713 (2.6%) experienced major bleeding, and 1084 (4.0%) were diagnosed with cancer during a mean follow-up of 23 months. Among 2678 who experienced bleeding, 257 (9.9%) were subsequently diagnosed with cancer. Gastrointestinal bleeding was associated with a 20-fold higher hazard of new gastrointestinal cancer diagnosis (7.4% versus 0.5%; hazard ratio [HR], 20.6 [95% CI, 15.2–27.8]) and 1.7-fold higher hazard of new nongastrointestinal cancer diagnosis (3.8% versus 3.1%; HR, 1.70 [95% CI, 1.20–2.40]). Genitourinary bleeding was associated with a 32-fold higher hazard of new genitourinary cancer diagnosis (15.8% versus 0.8%; HR, 32.5 [95% CI, 24.7–42.9]), and urinary bleeding was associated with a 98-fold higher hazard of new urinary cancer diagnosis (14.2% versus 0.2%; HR, 98.5; 95% CI, 68.0–142.7). Nongastrointestinal, nongenitourinary bleeding was associated with a 3-fold higher hazard of nongastrointestinal, nongenitourinary cancers (4.4% versus 1.9%; HR, 3.02 [95% CI, 2.32–3.91]). Conclusions: In patients with atherosclerosis treated with antithrombotic drugs, any gastrointestinal or genitourinary bleeding was associated with higher rates of new cancer diagnosis. Any gastrointestinal or genitourinary bleeding should prompt investigation for cancers at these sites. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01776424.

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Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2020-015943 ◽

2020 ◽

Vol 12 (11) ◽

pp. 1107-1112 ◽

Cited By ~ 1

Author(s):

Hal Rice ◽

Mario Martínez Galdámez ◽

Markus Holtmannspötter ◽

Laurent Spelle ◽

Konstantinos Lagios ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Neurological Complications ◽

Parent Artery ◽

Unique Identifier ◽

Clinical Trial Registration ◽

Pipeline Embolization Device ◽

Link Type ◽

Post Market ◽

Safety Endpoint ◽

Primary Safety Endpoint

BackgroundThe first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.MethodsThe SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.ResultsOf 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.ConclusionsThe findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population.Clinical trial registration-URLhttp://www.clinicaltrials.gov. Unique identifier: NCT02719522.

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Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients

Stroke ◽

10.1161/strokeaha.118.020232 ◽

2018 ◽

Vol 49 (12) ◽

pp. 2933-2944 ◽

Cited By ~ 76

Author(s):

Gregory Y.H. Lip ◽

Allison Keshishian ◽

Xiaoyan Li ◽

Melissa Hamilton ◽

Cristina Masseria ◽

...

Keyword(s):

Atrial Fibrillation ◽

Observational Study ◽

Oral Anticoagulants ◽

Healthcare Providers ◽

Pooled Analysis ◽

Nonvalvular Atrial Fibrillation ◽

Unique Identifier ◽

Clinical Trial Registration ◽

Cox Models ◽

Multiple Data

Background and Purpose— This ARISTOPHANES study (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) used multiple data sources to compare stroke/systemic embolism (SE) and major bleeding (MB) among a large number of nonvalvular atrial fibrillation patients on non–vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods— A retrospective observational study of nonvalvular atrial fibrillation patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015, was conducted pooling Centers for Medicare and Medicaid Services Medicare data and 4 US commercial claims databases. After 1:1 NOAC-warfarin and NOAC-NOAC propensity score matching in each database, the resulting patient records were pooled. Cox models were used to evaluate the risk of stroke/SE and MB across matched cohorts. Results— A total of 434 046 patients were included in the 6 matched cohorts: 100 977 apixaban-warfarin, 36 990 dabigatran-warfarin, 125 068 rivaroxaban-warfarin, 37 314 apixaban-dabigatran, 107 236 apixaban-rivaroxaban, and 37 693 dabigatran-rivaroxaban patient pairs. Apixaban (hazard ratio [HR], 0.64; 95% CI, 0.58–0.70), dabigatran (HR, 0.82; 95% CI, 0.71–0.95), and rivaroxaban (HR, 0.79; 95% CI, 0.73–0.85) were associated with lower rates of stroke/SE compared with warfarin. Apixaban (HR, 0.60; 95% CI, 0.56–0.63) and dabigatran (HR, 0.71; 95% CI, 0.65–0.78) had lower rates of MB, and rivaroxaban (HR, 1.06; 95% CI, 1.02–1.10) had a higher rate of MB compared with warfarin. Differences exist in rates of stroke/SE and MB across NOACs. Conclusions— In this largest observational study to date on NOACs and warfarin, the NOACs had lower rates of stroke/SE and variable comparative rates of MB versus warfarin. The findings from this study may help inform the discussion on benefit and risk in the shared decision-making process for stroke prevention between healthcare providers and nonvalvular atrial fibrillation patients. Clinical Trial Registration— URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT03087487.

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Machine Learning to Classify Intracardiac Electrical Patterns During Atrial Fibrillation

Circulation Arrhythmia and Electrophysiology ◽

10.1161/circep.119.008160 ◽

2020 ◽

Vol 13 (8) ◽

Cited By ~ 1

Author(s):

Mahmood I. Alhusseini ◽

Firas Abuzaid ◽

Albert J. Rogers ◽

Junaid A.B. Zaman ◽

Tina Baykaner ◽

...

Keyword(s):

Atrial Fibrillation ◽

Nearest Neighbor ◽

Support Vector ◽

K Nearest Neighbor ◽

Unique Identifier ◽

Multiple Systems ◽

Linear Discriminant ◽

Link Type ◽

Decision Logic ◽

The Hilbert Transform

Background: Advances in ablation for atrial fibrillation (AF) continue to be hindered by ambiguities in mapping, even between experts. We hypothesized that convolutional neural networks (CNN) may enable objective analysis of intracardiac activation in AF, which could be applied clinically if CNN classifications could also be explained. Methods: We performed panoramic recording of bi-atrial electrical signals in AF. We used the Hilbert-transform to produce 175 000 image grids in 35 patients, labeled for rotational activation by experts who showed consistency but with variability (kappa [κ]=0.79). In each patient, ablation terminated AF. A CNN was developed and trained on 100 000 AF image grids, validated on 25 000 grids, then tested on a separate 50 000 grids. Results: In the separate test cohort (50 000 grids), CNN reproducibly classified AF image grids into those with/without rotational sites with 95.0% accuracy (CI, 94.8%–95.2%). This accuracy exceeded that of support vector machines, traditional linear discriminant, and k-nearest neighbor statistical analyses. To probe the CNN, we applied gradient-weighted class activation mapping which revealed that the decision logic closely mimicked rules used by experts (C statistic 0.96). Conclusions: CNNs improved the classification of intracardiac AF maps compared with other analyses and agreed with expert evaluation. Novel explainability analyses revealed that the CNN operated using a decision logic similar to rules used by experts, even though these rules were not provided in training. We thus describe a scaleable platform for robust comparisons of complex AF data from multiple systems, which may provide immediate clinical utility to guide ablation. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02997254. Graphic Abstract: A graphic abstract is available for this article.

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Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease

Heart ◽

10.1136/heartjnl-2017-312272 ◽

2018 ◽

Vol 104 (15) ◽

pp. 1292-1299 ◽

Cited By ~ 6

Author(s):

Dragos Vinereanu ◽

Alice Wang ◽

Hillary Mulder ◽

Renato D Lopes ◽

Petr Jansky ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Major Bleeding ◽

Treatment Effect ◽

P Value ◽

Efficacy And Safety ◽

Systemic Embolism ◽

Clinical Trial Registration ◽

Safety Outcomes ◽

Anticoagulated Patients

ObjectiveTo assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial.MethodsThere were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model.ResultsPatients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory.ConclusionsIn anticoagulated patients with AF, AS is associated with a higher risk of stroke/systemic embolism, bleeding and death. The efficacy and safety benefits of apixaban compared with warfarin were consistent, regardless of presence of MR, AR or AS.Clinical trial registrationARISTOTLE clinical trial number NCT00412984.

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A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial

BMC Geriatrics ◽

10.1186/s12877-021-02397-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Nancy A. Hodgson ◽

Nalaka Gooneratne ◽

Adriana Perez ◽

Sonia Talwar ◽

Liming Huang

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Trial Registration ◽

Phase Iii ◽

Poor Sleep ◽

Sleep Wake Disorders ◽

Clinical Trial Registration ◽

Link Type ◽

Home Based

Abstract Background Sleep-wake disorders occur in most persons living with dementia and include late afternoon or evening agitation, irregular sleep-wake rhythms such as daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. Sleep-wake disorders pose a great burden to family caregivers, and are the principal causes of distress, poor quality of life, and institutionalization. Regulating the sleep-wake cycle through the use of light and activity has been shown to alter core clock processes and suggests that a combination of cognitive, physical, and sensory-based activities, delivered at strategic times, may be an effective mechanism through which to reduce sleep-wake disorders. Methods A definitive Phase III efficacy trial of the Healthy Patterns intervention, a home-based activity intervention designed to improve sleep-wake disorders and quality of life, is being conducted using a randomized two-group parallel design of 200 people living with dementia and their caregivers (dyads). Specific components of this one-month, home-based intervention involve 4 in-home visits and includes: 1) assessing individuals’ functional status and interests; 2) educating caregivers on environmental cues to promote activity and sleep; and 3) training caregivers in using timed morning, afternoon, and evening activities based on circadian needs across the day. The patient focused outcomes of interest are quality of life, measures of sleep assessed by objective and subjective indicators including actigraphy, subjective sleep quality, and the presence of neuropsychiatric symptoms. Caregiver outcomes of interest are quality of life, burden, confidence using activities, and sleep disruption. Salivary measures of cortisol and melatonin are collected to assess potential intervention mechanisms. Discussion The results from the ongoing study will provide fundamental new knowledge regarding the effects of timing activity participation based on diurnal needs and the mechanisms underlying timed interventions which can lead to a structured, replicable treatment protocol for use with this growing population of persons living with dementia. Clinical trial registration Clinicaltrials.gov # NCT03682185 at https://clinicaltrials.gov/; Date of clinical trial registration: 24 September 2018.

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Embolus Retriever with Interlinked Cages (ERIC) versus conventional stent retrievers for thrombectomy: a propensity score-based analysis

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2020-016289 ◽

2020 ◽

pp. neurintsurg-2020-016289

Author(s):

Célina Ducroux ◽

Nicolas Renaud ◽

Romain Bourcier ◽

Gaultier Marnat ◽

Igor Sibon ◽

...

Keyword(s):

Propensity Score ◽

Rescue Therapy ◽

Clinical Results ◽

Unique Identifier ◽

Clinical Trial Registration ◽

Link Type ◽

Radiological Data ◽

Stent Retrievers ◽

Procedural Outcomes ◽

Multicenter Registry

BackgroundThe Embolus Retriever with Interlinked Cages (ERIC) is one of the latest devices for thrombectomies. It has several architectural features that are supposed to enhance its ability to remove clots and prevent distal emboli. We aimed to compare ERIC with standard stent retrievers (SRs) using propensity score (PS) matching.MethodsThe clinical and radiological data of all consecutive patients treated with ERIC or standard FDA-approved stent retrievers were collected from a prospective multicenter registry. We compared procedural outcomes (recanalization rates according to the modified Thrombolysis In Cerebral Infarction (mTICI) score and procedural complications) and clinical outcomes (modified Rankin Scale (mRS) and mortality at 3 months). Matching of the populations with PS was performed to account for differences in baseline characteristics.ResultsA total of 1230 patients were included. In both the PS-matched cohort (195 ERIC patients, 630 SR patients) and the inverse probability of treatment weighting PS-adjusted cohort (206 ERIC patients, 1024 SR patients) there was no difference in terms of successful recanalization (modified TICI score ≥2b), good clinical outcome (mRS=0–2 or equal to pre-stroke mRS), or mortality at 3 months. Patients treated with first-line ERIC had a higher rate of complete recanalization (mTICI 3); however, they also required more passes and more frequent rescue therapy than the SR patient group.ConclusionIn a large multicenter registry with PS matching, the ERIC device provided equivalent angiographic and clinical results to conventional SRs.Clinical trial registrationURL: http://www.clinicaltrials.gov Unique identifier: NCT03776877.

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