Publications by authors named "David Wright"

1,222 Publications

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Infections associated with cardiac electronic implantable devices: economic perspectives and impact of the TYRX™ antibacterial envelope.

Europace 2021 Jun;23(Supplement_4):iv33-iv44

Department of Cardiovascular Medicine and Heart, Vascular and Thoracic Institute, Cleveland Clinic, OH, USA.

The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2-3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems.
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http://dx.doi.org/10.1093/europace/euab126DOI Listing
June 2021

In vivo operating lengths of the gastrocnemius muscle during gait in children who idiopathically toe-walk.

Exp Physiol 2021 Jun 22. Epub 2021 Jun 22.

Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.

New Findings: What is the central question of this study? What are the in vivo operating lengths of the gastrocnemius muscle in children who idiopathically toe-walk? What is the main finding and its importance? We show, for the first time, that children who idiopathically toe-walk operate at more plantarflexed positions but at longer fascicle lengths than typically developing children during gait. However, these ranges utilised during gait correspond to where children who idiopathically toe-walk are optimally strong. This should be considered when prescribing clinical treatments to restore typical gait.

Abstract: Children who idiopathically toe-walk (ITW) habitually operate at greater plantarflexion angles than typically developing (TD) children, which might result in shorter, sub-optimal, gastrocnemius fascicle lengths. However, currently no experimental evidence exists to substantiate this notion. Five children who ITW and 14 TD children completed a gait analysis, whilst gastrocnemius fascicle behaviour was simultaneously quantified using ultrasound. The moment-angle (hip, knee and ankle) and -length (gastrocnemius) relationships were determined from isometric maximum voluntary contractions (MVC) on an isokinetic dynamometer combined with ultrasound. During gait, children who ITW operated at more plantarflexed angles (Δ = 20°; p = 0.013) and longer muscle fascicle lengths (Δ = 12mm; p = 0.008) than TD children. During MVC, no differences in the peak moment of any joint were found. However, peak plantarflexor moment occurred at significantly more plantarflexed angles (-16 vs. 1°; p = 0.010) and at longer muscle fascicle lengths (44 vs. 37mm; p = 0.001) in children who ITW than TD children. Observed alterations in the moment-angle and -length relationships of children who ITW coincided with the ranges used during gait. Therefore, the gastrocnemius muscle in children who ITW operates close to the peak of the force-length relationship, similarly to TD children. Thus, this study indicates that children who ITW present with substantial alterations in the gastrocnemius muscle functional properties, which appear well adapted to the characteristic demands of equinus gait. The absence of proximal joint weakness also supports the notion that idiopathic toe-walking is truly an ankle joint pathology. These findings should be considered when prescribing clinical treatments to restore typical gait. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1113/EP089658DOI Listing
June 2021

Exercise-based cardiac rehabilitation for cardiac implantable electronic device recipients.

Eur J Prev Cardiol 2021 Jun 21. Epub 2021 Jun 21.

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.

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http://dx.doi.org/10.1093/eurjpc/zwab103DOI Listing
June 2021

White and Gray Matter Abnormalities in Australian Footballers With a History of Sports-Related Concussion: An MRI Study.

Cereb Cortex 2021 Jun 19. Epub 2021 Jun 19.

Department of Neuroscience, Monash University, Melbourne, VIC 3004, Australia.

Sports-related concussion (SRC) is a form of mild traumatic brain injury that has been linked to long-term neurological abnormalities. Australian rules football is a collision sport with wide national participation and is growing in popularity worldwide. However, the chronic neurological consequences of SRC in Australian footballers remain poorly understood. This study investigated the presence of brain abnormalities in Australian footballers with a history of sports-related concussion (HoC) using multimodal MRI. Male Australian footballers with HoC (n = 26), as well as noncollision sport athletes with no HoC (n = 27), were recruited to the study. None of the footballers had sustained a concussion in the preceding 6 months, and all players were asymptomatic. Data were acquired using a 3T MRI scanner. White matter integrity was assessed using diffusion tensor imaging. Cortical thickness, subcortical volumes, and cavum septum pellucidum (CSP) were analyzed using structural MRI. Australian footballers had evidence of widespread microstructural white matter damage and cortical thinning. No significant differences were found regarding subcortical volumes or CSP. These novel findings provide evidence of persisting white and gray matter abnormalities in Australian footballers with HoC, and raise concerns related to the long-term neurological health of these athletes.
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http://dx.doi.org/10.1093/cercor/bhab161DOI Listing
June 2021

Evaluation of the RCOG guideline in the prediction of small for gestational age neonates and comparison with the competing risks model.

BJOG 2021 Jun 17. Epub 2021 Jun 17.

Fetal Medicine Research Institute, King's College Hospital, London, UK.

Objectives: To examine the predictive performance for small for gestational age (SGA) neonates of the relevant guideline by the Royal College of Obstetricians and Gynecologists (RCOG), and to compare the performance of the RCOG guideline with that of our competing risks model for SGA.

Design: Prospective observational study.

Setting: Obstetric ultrasound departments in two UK maternity hospitals.

Population: 96,678 women with singleton pregnancies attending for routine ultrasound examination at 19-24 weeks' gestation.

Methods: Risks for SGA for different thresholds were computed, according to the competing risks model using maternal history and second trimester estimated fetal weight, uterine artery pulsatility index and mean arterial pressure. Detection rates by the RCOG guideline scoring system and the competing risks model for SGA were compared, at the screen positive rate (SPR) derived from the RCOG guideline.

Main Outcome Measures: SGA <10 or <3 percentile for different gestational age thresholds.

Results: At a 22.5% SPR, as defined by the RCOG guideline, the competing risks model predicted 56%, 72% and 81% of cases of SGA neonates with birth weight <10 percentile delivered at ≥37, <37 and <32 weeks' gestation, respectively, which were significantly higher than the respective figures of 36%, 44% and 45% achieved by the application of the RCOG guideline. The respective figures for SGA neonates with birth weight <3 percentile were 66%, 79%, 85% and 41%, 45%, 44%.

Conclusion: The detection rate for SGA neonates by the competing risk approach is almost double than that achieved by the RCOG guideline.
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http://dx.doi.org/10.1111/1471-0528.16815DOI Listing
June 2021

A multi-representation approach to the contextual interference effect: effects of sequence length and practice.

Psychol Res 2021 Jun 16. Epub 2021 Jun 16.

Sport, Health, Activity, Performance and Exercise Research Centre Flinders University, Adelaide, Australia.

The present study investigated the long-term benefit of Random-Practice (RP) over Blocked-Practice (BP) within the contextual interference (CI) effect for motor learning. We addressed the extent to which motor sequence length and practice amount factors moderate the CI effect given that previous reports, often in applied research, have reported no long-term advantage from RP. Based on predictions arising from the Cognitive framework of Sequential Motor Behavior (C-SMB) and using the Discrete Sequence Production (DSP) task, two experiments were conducted to compare limited and extended practice amounts of 4- and 7-key sequences under RP and BP schedules. Twenty-four-hour delayed retention performance confirmed the C-SMB prediction that the CI-effect occurs only with short sequences that receive little practice. The benefit of RP with limited practice was associated with overnight motor memory consolidation. Further testing with single-stimulus as well as novel and unstructured (i.e., random) sequences indicated that limited practice under RP schedules enhances both reaction and chunking modes of sequence execution with the latter mode benefitting from the development of implicit and explicit forms of sequence representation. In the case of 7-key sequences, extended practice with RP and BP schedules provided for equivalent development of sequence representations. Higher explicit awareness of sequence structures was associated with faster completion of practiced but also of novel and unstructured sequences.
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http://dx.doi.org/10.1007/s00426-021-01543-0DOI Listing
June 2021

Integrating pharmacists into aged care facilities to improve the quality use of medicine (PiRACF Study): protocol for a cluster randomised controlled trial.

Trials 2021 Jun 11;22(1):390. Epub 2021 Jun 11.

Health Research Institute, Faculty of Health, University of Canberra, Bruce, ACT, Australia.

Background: Medication management in residential aged care facilities is an ongoing concern. Numerous studies have reported high rates of inappropriate prescribing and medication use in aged care facilities, which contribute to residents' adverse health outcomes. There is a need for new models of care that enhance inter-disciplinary collaboration between residential aged care facility staff and healthcare professionals, to improve medication management. Pilot research has demonstrated the feasibility and benefits of integrating a pharmacist into the aged care facility team to improve the quality use of medicines. This protocol describes the design and methods for a cluster randomised controlled trial to evaluate the outcomes and conduct economic evaluation of a service model where on-site pharmacists are integrated into residential aged care facility healthcare teams to improve medication management.

Methods: Intervention aged care facilities will employ on-site pharmacists to work as part of their healthcare teams 2 to 2.5 days per week for 12 months. On-site pharmacists, in collaboration with facility nurses, prescribers, community pharmacists, residents and families will conduct medication management activities to improve the quality use of medicines. Aged care facilities in the control group will continue usual care. The target sample size is 1188 residents from a minimum of 13 aged care facilities. The primary outcome is the appropriateness of prescribing, measured by the proportion of residents who are prescribed at least one potentially inappropriate medicine according to the 2019 Beers Criteria. Secondary outcomes include hospital and emergency department presentations, fall rates, prevalence and dose of antipsychotics and benzodiazepines, Anticholinergic Cognitive Burden Score, staff influenza vaccination rate, time spent on medication rounds, appropriateness of dose form modification and completeness of resident's allergy and adverse drug reaction documentation. A cost-consequence and cost-effectiveness analysis will be embedded in the trial.

Discussion: The results of this study will provide information on clinical and economic outcomes of a model that integrates on-site pharmacists into Australian residential aged care facilities. The results will provide policymakers with recommendations relevant to further implementation of this model.

Trial Registration: ACTRN12620000430932 . Registered on 1 April 2020 with ANZCTR.
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http://dx.doi.org/10.1186/s13063-021-05335-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8193166PMC
June 2021

Use of U.S. Blood Donors for National Serosurveillance of SARS-CoV-2 Antibodies: Basis for an Expanded National Donor Serosurveillance Program.

Clin Infect Dis 2021 Jun 10. Epub 2021 Jun 10.

Vitalant Research Institute, San Francisco, CA, USA.

Introduction: The REDS-IV-P Epidemiology, Surveillance and Preparedness of the Novel SARS-CoV-2 Epidemic (RESPONSE) seroprevalence study conducted monthly cross-sectional testing for SARS-CoV-2 antibodies on blood donors in six U.S. metropolitan regions to estimate the extent of SARS-COV-2 infections over time.

Study Design/methods: During March-August 2020, approximately ≥1,000 serum specimens were collected monthly from each region and tested for SARS-CoV-2 antibodies using a well-validated algorithm. Regional seroprevalence estimates were weighted based on demographic differences with the general population. Seroprevalence was compared with reported COVID-19 case rates over time.

Results/findings: For all regions, seroprevalence was <1.0% in March 2020. New York experienced the biggest increase (peak seroprevalence, 15.8 % in May). All other regions experienced modest increases in seroprevalence(1-2% in May-June to 2-4% in July-August). Seroprevalence was higher in younger, non-Hispanic Black, and Hispanic donors. Temporal increases in donor seroprevalence correlated with reported case rates in each region. In August, 1.3-5.6 estimated cumulative infections (based on seroprevalence data) per COVID-19 case reported to CDC.

Conclusion: Increases in seroprevalence were found in all regions, with the largest increase in New York. Seroprevalence was higher in non-Hispanic Black and Hispanic blood donors than in non-Hispanic White blood donors. SARS-CoV-2 antibody testing of blood donor samples can be used to estimate the seroprevalence in the general population by region and demographic group. The methods derived from the RESPONSE seroprevalence study served as the basis for expanding SARS-CoV-2 seroprevalence surveillance to all 50 states and Puerto Rico.
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http://dx.doi.org/10.1093/cid/ciab537DOI Listing
June 2021

Muscle architecture and passive lengthening properties of the gastrocnemius medialis and Achilles tendon in children who idiopathically toe-walk.

J Anat 2021 Jun 9. Epub 2021 Jun 9.

Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.

Children who idiopathically toe-walk (ITW) habitually operate at greater plantarflexion angles and thus, at shorter muscle-tendon unit (MTU) lengths than typically developing (TD) children. Therefore, it is often assumed that habitual use of the gastrocnemius muscle in this way will cause remodelling of the muscle-tendon architecture compared to TD children. However, the gastrocnemius muscle architecture of children who ITW has never been measured. It is essential that we gain a better understanding of these muscle-tendon properties, to ensure that appropriate clinical interventions can be provided for these children. Five children who ITW (age 8 ± 2 years) and 14 TD children (age 10 ± 2 years) participated in this study. Ultrasound was combined with isokinetic dynamometry and surface electromyography, to measure muscle architecture at common positions and passive lengthening properties of the gastrocnemius muscle and tendon across full range of motion. Regardless of which common condition groups were compared under, both the absolute and normalised to MTU muscle belly and fascicle lengths were always longer, and the Achilles tendon length was always shorter in children who ITW than TD children (p < 0.05; large effect sizes). The passive lengthening properties of the muscle and tendon were not different between groups (p > 0.05); however, passive joint stiffness was greater in children who ITW at maximum dorsiflexion (p = 0.001) and at a joint moment common to all participants (p = 0.029). Consequently, the findings of this pilot study indicate a remodelling of the relative MTU that does not support the concept that children who ITW commonly experience muscle shortening. Therefore, greater consideration of the muscle and tendon properties are required when prescribing clinical interventions that aim to lengthen the MTU, and treatments may be better targeted at the Achilles tendon in children who ITW.
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http://dx.doi.org/10.1111/joa.13464DOI Listing
June 2021

Evaluating and Improving Engagement in Care After High-Intensity Stays for Mental or Substance Use Disorders.

Psychiatr Serv 2021 Jun 9:appips202000287. Epub 2021 Jun 9.

Program Evaluation and Resource Center, Office of Mental Health and Suicide Prevention, Veterans Health Administration (VHA), U.S. Department of Veterans Affairs (VA), Menlo Park, California (Schmidt, Wright, Cherkasova, Trafton); Center for Innovation to Implementation, Health Services Research and Development (HSR&D), VHA, VA Palo Alto Health Care System, Menlo Park, California (Schmidt, Harris); Department of Surgery (Harris) and Department of Psychiatry and Behavioral Sciences (Trafton), School of Medicine, Stanford University, Stanford, California.

Objective: This interrupted time-series analysis examined whether activating a quality measure, supported by education and a population management tool, was associated with higher postdischarge engagement (PDE) in outpatient care after inpatient and residential stays for mental or substance use disorder care.

Methods: Discharges from October 2016 to May 2019 were identified from national Veterans Health Administration (VHA) records representing all 140 VHA health care systems. Engagement was defined as multiple mental or substance use disorder outpatient visits in the 30 days postdischarge. The number of such visits required to meet the engagement definition depended on a patient's suicide risk and acuity level of inpatient or residential treatment. Health care system-level performance was calculated as the percentage of qualifying discharges with 30-day PDE. A segmented mixed-effects linear regression model tested whether monthly health care system performance changed significantly after activation of the PDE measure (activation rollout period, October-December 2017).

Results: A total of 322,344 discharges qualified for the measure. In the regression model, average health care system performance was 65.6% at the beginning of the preactivation period (October 2016) and did not change significantly in the following 12 months. Average health care system performance increased by 5.7% (SE=0.8%, p<0.001) after PDE measure activation and did not change significantly thereafter-a difference representing 11,464 more patients engaging in care than would have without activation of the measure.

Conclusions: Results support use of this measure, along with education, technical assistance, and population management tools, to improve engagement after discharge from residential and inpatient mental and substance use disorder treatment.
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http://dx.doi.org/10.1176/appi.ps.202000287DOI Listing
June 2021

Anatomic-Functional Correlates in Lesions of Retinal Vein Occlusion.

Invest Ophthalmol Vis Sci 2021 Jun;62(7):10

Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, United Kingdom.

Purpose: To evaluate anatomic-functional associations at sites of retinal lesions in retinal vein occlusion (RVO).

Methods: This pilot, prospective, observational study was conducted at the Northern Ireland Clinical Research Facility (NICRF) of Queen's University and the Belfast Health and Social Care Trust, Northern Ireland, between August 1, 2018, and September 30, 2019. The study included 10 treatment-naïve patients with RVO (10 RVO eyes and 10 fellow eyes). There were 81 points/sites assessed for each eye at baseline; six patients were re-assessed 6 months after anti-vascular endothelial growth factor therapy at the same locations. We investigated associations between retinal sensitivity and presence of structural RVO lesions, including retinal ischemia, hemorrhages, intraretinal fluid (IRF) and subretinal fluid outside the foveal/parafoveal regions. Comparisons were made between RVO eyes and fellow eyes at baseline, and between RVO eyes at baseline and at 6 months after treatment. Regression models were used to investigate anatomic-functional associations.

Results: At baseline, strong associations were found between reduced retinal sensitivity and presence of ischemia (estimate = -2.08 dB; P < 0.001), intraretinal fluid (estimate = -7.82 dB; P < 0.001), and subretinal fluid (estimate = -8.66 dB; P < 0.001). Resolution of subretinal fluid but not intraretinal fluid was associated with improved function (estimate = 2.40 dB [P = 0.022]; estimate = 1.16 dB [P = 0.228], respectively). However, reperfusion of ischemic retina, observed in 31 of 486 points (6%) 6 months after anti-vascular endothelial growth factor therapy, was associated with a further decrease in retinal sensitivity (estimate = -2.34 dB; P = 0.035).

Conclusions: Retinal sensitivity was decreased at sites of RVO lesions. Decreased function at sites of retinal ischemia did not recover after treatment, even when reperfusion occurred.
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http://dx.doi.org/10.1167/iovs.62.7.10DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8196416PMC
June 2021

Prefrontal Cortex Activation During Motor Sequence Learning Under Interleaved and Repetitive Practice: A Two-Channel Near-Infrared Spectroscopy Study.

Front Hum Neurosci 2021 14;15:644968. Epub 2021 May 14.

School of Exercise Science, Sport & Health, Charles Sturt University, Bathurst, NSW, Australia.

Training under high interference conditions through interleaved practice (IP) results in performance suppression during training but enhances long-term performance relative to repetitive practice (RP) involving low interference. Previous neuroimaging work addressing this contextual interference effect of motor learning has relied heavily on the blood-oxygen-level-dependent (BOLD) response using functional magnetic resonance imaging (fMRI) methodology resulting in mixed reports of prefrontal cortex (PFC) recruitment under IP and RP conditions. We sought to clarify these equivocal findings by imaging bilateral PFC recruitment using functional near-infrared spectroscopy (fNIRS) while discrete key pressing sequences were trained under IP and RP schedules and subsequently tested following a 24-h delay. An advantage of fNIRS over the fMRI BOLD response is that the former measures oxygenated and deoxygenated hemoglobin changes independently allowing for assessment of cortical hemodynamics even when there is neurovascular decoupling. Despite slower sequence performance durations under IP, bilateral PFC oxygenated and deoxygenated hemoglobin values did not differ between practice conditions. During test, however, slower performance from those previously trained under RP coincided with hemispheric asymmetry in PFC recruitment. Specifically, following RP, test deoxygenated hemoglobin values were significantly lower in the right PFC. The present findings contrast with previous behavioral demonstrations of increased cognitive demand under IP to illustrate a more complex involvement of the PFC in the contextual interference effect. IP and RP incur similar levels of bilateral PFC recruitment, but the processes underlying the recruitment are dissimilar. PFC recruitment during IP supports action reconstruction and memory elaboration while RP relies on PFC recruitment to maintain task variation information in working memory from trial to trial. While PFC recruitment under RP serves to enhance immediate performance, it does not support long-term performance.
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http://dx.doi.org/10.3389/fnhum.2021.644968DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160091PMC
May 2021

mHAT app for automated malaria rapid test result analysis and aggregation: a pilot study.

Malar J 2021 May 26;20(1):237. Epub 2021 May 26.

Department of Chemistry, Vanderbilt University, 1234 Stevenson Center Lane, Nashville, TN, 37212, USA.

Background: There are a variety of approaches being used for malaria surveillance. While active and reactive case detection have been successful in localized areas of low transmission, concerns over scalability and sustainability keep the approaches from being widely accepted. Mobile health interventions are poised to address these shortcomings by automating and standardizing portions of the surveillance process. In this study, common challenges associated with current data aggregation methods have been quantified, and a web-based mobile phone application is presented to reduce the burden of reporting rapid diagnostic test (RDT) results in low-resource settings.

Methods: De-identified completed RDTs were collected at 14 rural health clinics as part of a malaria epidemiology study at Macha Research Trust, Macha, Zambia. Tests were imaged using the mHAT web application. Signal intensity was measured and a binary result was provided. App performance was validated by: (1) comparative limits of detection, investigated against currently used laboratory lateral flow assay readers; and, (2) receiver operating characteristic analysis comparing the application against visual inspection of RDTs by an expert. Secondary investigations included analysis of time-to-aggregation and data consistency within the existing surveillance structures established by Macha Research Trust.

Results: When compared to visual analysis, the mHAT app performed with 91.9% sensitivity (CI 78.7, 97.2) and specificity was 91.4% (CI 77.6, 97.0) regardless of device operating system. Additionally, an analysis of surveillance data from January 2017 through mid-February 2019 showed that while the majority of the data packets from satellite clinics contained correct data, 36% of data points required correction by verification teams. Between November 2018 and mid-February 2019, it was also found that 44.8% of data was received after the expected submission date, although most (65.1%) reports were received within 2 days.

Conclusions: Overall, the mHAT mobile app was observed to be sensitive and specific when compared to both currently available benchtop lateral flow readers and visual inspection. The additional benefit of automating and standardizing LFA data collection and aggregation poses a vital improvement for low-resource health facilities and could increase the accuracy and speed of data reporting in surveillance campaigns.
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http://dx.doi.org/10.1186/s12936-021-03772-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8153521PMC
May 2021

Combined action observation and motor imagery: An intervention to combat the neural and behavioural deficits associated with developmental coordination disorder.

Neurosci Biobehav Rev 2021 May 19;127:638-646. Epub 2021 May 19.

Research Centre for Health, Psychology and Communities, Department of Psychology, Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, UK.

Action observation (AO) and motor imagery (MI) have been used separately across different populations to alleviate movement impairment. Recently these two forms of covert motor simulation have been combined (combined action observation and motor imagery; AOMI), resulting in greater neurophysiological activity in the motor system, and more favourable behavioural outcomes when compared to independent AO and MI. This review aims to outline how some of the neural deficits associated with developmental coordination disorder (DCD) are evident during AO and MI, and highlight how these motor simulation techniques have been used independently to improve motor skill learning in children in this population. The growing body of evidence indicating that AOMI is superior to the independent use of either AO and MI is then synthesised and discussed in the context of children with DCD. To conclude, recommendations to optimise the delivery of AOMI for children with DCD are provided and future avenues for research are highlighted.
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http://dx.doi.org/10.1016/j.neubiorev.2021.05.015DOI Listing
May 2021

Development and feasibility testing of an evidence-based training programme for pharmacist independent prescribers responsible for the medicines-related activities within care homes.

Int J Pharm Pract 2021 May 21. Epub 2021 May 21.

Leicester Medical School, University of Leicester, Leicester, UK.

Introduction: The UK pharmacists with independent prescribing rights (pharmacist independent prescribers [PIPs]) are authorised to prescribe within their areas of competence. To enable PIPs to provide pharmaceutical care to residents in care homes and assume responsibility for medicines management, a process for development and assessment of competence is required. The aim of this research was to develop a training and accreditation process (training programme) to enable PIPs to operate safely and effectively within care homes.

Methods: Located in England, Scotland and Northern Ireland across four sites and based on a systematic review, it consisted of four phases: (1) initial stakeholder engagement, (2) uni-professional focus groups and interviews, (3) expert panel consensus and (4) feasibility testing. Four PIPs were trained each to provide pharmaceutical care to 10 care home residents. An expert panel synthesised the evidence at each stage to develop each iteration of the training programme. Content analysis was used throughout.

Results: Differences in baseline knowledge of PIPs required inclusion of a Personal Development Framework and the provision of a mentor. Face-to-face training focussed on managing medicines for a complex older person, minimising prescribing costs and supporting people without capacity. Provision of time to understand local context and develop relationships with care homes and general practitioners was identified as a central requirement. PIPs were assessed for competency via viva. Feasibility testing demonstrated that the derived training programme was acceptable, practical and effective.

Discussion: The model seemed to work, but due to small numbers, larger-scale testing of the training programme is now required.
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http://dx.doi.org/10.1093/ijpp/riab025DOI Listing
May 2021

Muscular forces responsible for proximal humeral deformity following fracture.

J Orthop Trauma 2021 May 14. Epub 2021 May 14.

University of California Irvine School of Medicine University of California Irvine, Department of Orthopedic Surgery Cornell University Orthopaedic Biomechanics Laboratory, Congress Medical Foundation.

Objectives: To evaluate the contribution of each of the rotator cuff muscles and deltoid to fracture deformity in a two-part proximal humerus fracture model. Our hypothesis was that superior cuff muscles would have the greatest contribution to coronal plane deformity while muscles with anterior and posterior attachments would have the greatest contribution to axial and sagittal plane deformity.

Methods: A medial wedge osteotomy was created in eight cadaveric shoulder specimens. A custom shoulder testing system was used load to each rotator cuff muscle and deltoid under increasing loading conditions. Fracture displacement was measured using a Microscribe digitizing system. The primary outcome was the contribution of each muscle to varus collapse. Secondary outcomes included contributions of each muscle to apex anterior/posterior deformity and humeral head anteversion/retroversion.

Results: Unbalanced loading of the supraspinatus resulted in the greatest varus deformity (34.5±2.3°) followed by the infraspinatus (22.3±3.6°) and subscapularis (21.7±3.1°) (p<0.05). Unbalanced loading of the subscapularis induced the greatest apex posterior (27.5±4.8°, p<0.05) and retroversion (39.0±5.6°, p<0.05) deformity while the infraspinatus induced the greatest apex anterior (8.7±3.4°, p>0.05) and anteversion (17.7±5.7°, p>0.05) deformity.

Conclusions: In this proximal humerus fracture model, the supraspinatus was the primary driver of varus deformity while the subscapularis and infraspinatus contributed to apex posterior/retroversion and apex anterior/anteversion, respectively. The subscapularis and infraspinatus are also important secondary drivers of varus deformity. This study establishes a physiologically relevant fracture model that mimics in vivo conditions for future biomechanical testing.
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http://dx.doi.org/10.1097/BOT.0000000000002142DOI Listing
May 2021

Longitudinal hippocampal volumetric changes in mice following brain infarction.

Sci Rep 2021 May 13;11(1):10269. Epub 2021 May 13.

The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, VIC, Australia.

Hippocampal atrophy is increasingly described in many neurodegenerative syndromes in humans, including stroke and vascular cognitive impairment. However, the progression of brain volume changes after stroke in rodent models is poorly characterized. We aimed to monitor hippocampal atrophy occurring in mice up to 48-weeks post-stroke. Male C57BL/6J mice were subjected to an intraluminal filament-induced middle cerebral artery occlusion (MCAO). At baseline, 3-days, and 1-, 4-, 12-, 24-, 36- and 48-weeks post-surgery, we measured sensorimotor behavior and hippocampal volumes from T-weighted MRI scans. Hippocampal volume-both ipsilateral and contralateral-increased over the life-span of sham-operated mice. In MCAO-subjected mice, different trajectories of ipsilateral hippocampal volume change were observed dependent on whether the hippocampus contained direct infarction, with a decrease in directly infarcted tissue and an increase in non-infarcted tissue. To further investigate these volume changes, neuronal and glial cell densities were assessed in histological brain sections from the subset of MCAO mice lacking hippocampal infarction. Our findings demonstrate previously uncharacterized changes in hippocampal volume and potentially brain parenchymal cell density up to 48-weeks in both sham- and MCAO-operated mice.
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http://dx.doi.org/10.1038/s41598-021-88284-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119705PMC
May 2021

New Horizon: Exercise and a Focus on Tissue-Brain Cross Talk.

J Clin Endocrinol Metab 2021 May 13. Epub 2021 May 13.

Department of Human Health and Nutritional Science, University of Guelph, Guelph, Canada.

The worlds' population is aging leading to increased rates of neurodegenerative disorders. Exercise has countless health benefits and has consistently been shown to improve brain health and cognitive function. The purpose of this review is to provide an overview of exercise-induced adaptations in the brain with a focus on crosstalk between peripheral tissues and the brain. We highlight recent studies into exercise-induced circulating factors, or exerkines, including irisin, cathepsin B, GPLD1, ketones, and the mechanisms mediating their effects in the brain.
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http://dx.doi.org/10.1210/clinem/dgab333DOI Listing
May 2021

Study protocol for a phase II randomised, double-blind, placebo-controlled trial of perampanel as an antiepileptogenic treatment following acute stroke.

BMJ Open 2021 05 10;11(5):e043488. Epub 2021 May 10.

Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia.

Introduction: Stroke is a common cause of epilepsy that may be mediated via glutamate dysregulation. There is currently no evidence to support the use of antiseizure medications as primary prevention against poststroke epilepsy. Perampanel has a unique antiglutamatergic mechanism of action and may have antiepileptogenic properties. This study aims to evaluate the efficacy and safety of perampanel as an antiepileptogenic treatment in patients at high risk of poststroke epilepsy.

Methods And Analysis: Up to 328 patients with cortical ischaemic stroke or lobar haemorrhage will be enrolled, and receive their first treatment within 7 days of stroke onset. Patients will be randomised (1:1) to receive perampanel (titrated to 6 mg daily over 4 weeks) or matching placebo, stratified by stroke subtype (ischaemic or haemorrhagic). Treatment will be continued for 12 weeks after titration. 7T MRI will be performed at baseline for quantification of cerebral glutamate by magnetic resonance spectroscopy and glutamate chemical exchange saturation transfer imaging. Blood will be collected for measurement of plasma glutamate levels. Participants will be followed up for 52 weeks after randomisation.The primary study outcome will be the proportion of participants in each group free of late (more than 7 days after stroke onset) poststroke seizures by the end of the 12-month study period, analysed by Fisher's exact test. Secondary outcomes will include time to first seizure, time to treatment withdrawal and 3-month modified Rankin Scale score. Quality of life, cognitive function, mood and adverse events will be assessed by standardised questionnaires. Exploratory outcomes will include correlation between cerebral and plasma glutamate concentration and stroke and seizure outcomes.

Ethics And Dissemination: This study was approved by the Alfred Health Human Research Ethics Committee (HREC No 44366, Reference 287/18).

Trial Registration Number: ACTRN12618001984280; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-043488DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112439PMC
May 2021

Targeting the Cerebrovascular System: Next-Generation Biomarkers and Treatment for Mild Traumatic Brain Injury.

Neuroscientist 2021 May 8:10738584211012264. Epub 2021 May 8.

Department of Neuroscience, Monash University, Melbourne, Victoria, Australia.

The diagnosis, prognosis, and treatment of mild traumatic brain injuries (mTBIs), such as concussions, are significant unmet medical issues. The kinetic forces that occur in mTBI adversely affect the cerebral vasculature, making cerebrovascular injury (CVI) a pathophysiological hallmark of mTBI. Given the importance of a healthy cerebrovascular system in overall brain function, CVI is likely to contribute to neurological dysfunction after mTBI. As such, CVI and related pathomechanisms may provide objective biomarkers and therapeutic targets to improve the clinical management and outcomes of mTBI. Despite this potential, until recently, few studies have focused on the cerebral vasculature in this context. This article will begin by providing a brief overview of the cerebrovascular system followed by a review of the literature regarding how mTBI can affect the integrity and function of the cerebrovascular system, and how this may ultimately contribute to neurological dysfunction and neurodegenerative conditions. We then discuss promising avenues of research related to mTBI biomarkers and interventions that target CVI, and conclude that a clinical approach that takes CVI into account could result in substantial improvements in the care and outcomes of patients with mTBI.
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http://dx.doi.org/10.1177/10738584211012264DOI Listing
May 2021

Early human impacts and ecosystem reorganization in southern-central Africa.

Sci Adv 2021 May 5;7(19). Epub 2021 May 5.

Ministry of Civic Education and National Unity, Lilongwe, Malawi.

Modern engage in substantial ecosystem modification, but it is difficult to detect the origins or early consequences of these behaviors. Archaeological, geochronological, geomorphological, and paleoenvironmental data from northern Malawi document a changing relationship between forager presence, ecosystem organization, and alluvial fan formation in the Late Pleistocene. Dense concentrations of Middle Stone Age artifacts and alluvial fan systems formed after ca. 92 thousand years ago, within a paleoecological context with no analog in the preceding half-million-year record. Archaeological data and principal coordinates analysis indicate that early anthropogenic fire relaxed seasonal constraints on ignitions, influencing vegetation composition and erosion. This operated in tandem with climate-driven changes in precipitation to culminate in an ecological transition to an early, pre-agricultural anthropogenic landscape.
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http://dx.doi.org/10.1126/sciadv.abf9776DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099189PMC
May 2021

Testing the performance of risk prediction models to determine progression to referable diabetic retinopathy in an Irish type 2 diabetes cohort.

Br J Ophthalmol 2021 Apr 26. Epub 2021 Apr 26.

Ophthalmology, Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, Northern Ireland, UK

Background /aims: To evaluate the performance of existing prediction models to determine risk of progression to referable diabetic retinopathy (RDR) using data from a prospective Irish cohort of people with type 2 diabetes (T2D).

Methods: A cohort of 939 people with T2D followed prospectively was used to test the performance of risk prediction models developed in Gloucester, UK, and Iceland. Observed risk of progression to RDR in the Irish cohort was compared with that derived from each of the prediction models evaluated. Receiver operating characteristic curves assessed models' performance.

Results: The cohort was followed for a total of 2929 person years during which 2906 screening episodes occurred. Among 939 individuals followed, there were 40 referrals (4%) for diabetic maculopathy, pre-proliferative DR and proliferative DR. The original Gloucester model, which includes results of two consecutive retinal screenings; a model incorporating, in addition, systemic biomarkers (HbA1c and serum cholesterol); and a model including results of one retinopathy screening, HbA1c, total cholesterol and duration of diabetes, had acceptable discriminatory power (area under the curve (AUC) of 0.69, 0.76 and 0.77, respectively). The Icelandic model, which combined retinopathy grading, duration and type of diabetes, HbA1c and systolic blood pressure, performed very similarly (AUC of 0.74).

Conclusion: In an Irish cohort of people with T2D, the prediction models tested had an acceptable performance identifying those at risk of progression to RDR. These risk models would be useful in establishing more personalised screening intervals for people with T2D.
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http://dx.doi.org/10.1136/bjophthalmol-2020-318570DOI Listing
April 2021

Competing risks model for prediction of small-for-gestational-age neonates from biophysical markers at 19 to 24 weeks' gestation.

Am J Obstet Gynecol 2021 Apr 24. Epub 2021 Apr 24.

Fetal Medicine Research Institute, King's College Hospital, London, United Kingdom. Electronic address:

Background: Antenatal identification of women at high risk to deliver small-for-gestational-age neonates may improve the management of the condition. The traditional but ineffective methods for small-for-gestational-age screening are the use of risk scoring systems based on maternal demographic characteristics and medical history and the measurement of the symphysial-fundal height. Another approach is to use logistic regression models that have higher performance and provide patient-specific risks for different prespecified cutoffs of birthweight percentile and gestational age at delivery. However, such models have led to an arbitrary dichotomization of the condition; different models for different small-for-gestational-age definitions are required and adding new biomarkers or examining other cutoffs requires refitting of the whole model. An alternative approach for the prediction of small-for-gestational-age neonates is to consider small for gestational age as a spectrum disorder whose severity is continuously reflected in both the gestational age at delivery and z score in birthweight for gestational age.

Objective: This study aimed to develop a new competing risks model for the prediction of small-for-gestational-age neonates based on a combination of maternal demographic characteristics and medical history with sonographic estimated fetal weight, uterine artery pulsatility index, and mean arterial pressure at 19 to 24 weeks' gestation.

Study Design: This was a prospective observational study of 96,678 women with singleton pregnancies undergoing routine ultrasound examination at 19 to 24 weeks' gestation, which included recording of estimated fetal weight, uterine artery pulsatility index, and mean arterial pressure. The competing risks model for small for gestational age is based on a previous joint distribution of gestational age at delivery and birthweight z score, according to maternal demographic characteristics and medical history. The likelihoods of the estimated fetal weight, uterine artery pulsatility index, and mean arterial pressure were fitted conditionally to both gestational age at delivery and birthweight z score and modified the previous distribution, according to the Bayes theorem, to obtain an individualized posterior distribution for gestational age at delivery and birthweight z score and therefore patient-specific risks for any desired cutoffs for birthweight z score and gestational age at delivery. The model was internally validated by randomly dividing the data into a training data set, to obtain the parameters of the model, and a test data set, to evaluate the model. The discrimination and calibration of the model were also examined.

Results: The estimated fetal weight was described using a regression model with an interaction term between gestational age at delivery and birthweight z score. Folded plane regression models were fitted for uterine artery pulsatility index and mean arterial pressure. The prediction of small for gestational age by maternal factors was improved by adding biomarkers for increasing degree of prematurity, higher severity of smallness, and coexistence of preeclampsia. Screening by maternal factors with estimated fetal weight, uterine artery pulsatility index, and mean arterial pressure, predicted 41%, 56%, and 70% of small-for-gestational-age neonates with birthweights of <10th percentile delivered at ≥37, <37, and <32 weeks' gestation, at a 10% false-positive rate. The respective rates for a birthweight of <3rd percentile were 47%, 65%, and 77%. The rates in the presence of preeclampsia were 41%, 72%, and 91% for small-for-gestational-age neonates with birthweights of <10th percentile and 50%, 75%, and 92% for small-for-gestational-age neonates with birthweights of <3rd percentile. Overall, the model was well calibrated. The detection rates and calibration indices were similar in the training and test data sets, demonstrating the internal validity of the model.

Conclusion: The performance of screening for small-for-gestational-age neonates by a competing risks model that combines maternal factors with estimated fetal weight, uterine artery pulsatility index, and mean arterial pressure was superior to that of screening by maternal characteristics and medical history alone.
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http://dx.doi.org/10.1016/j.ajog.2021.04.247DOI Listing
April 2021

Competing risks model for prediction of preeclampsia.

Am J Obstet Gynecol 2021 Apr 21. Epub 2021 Apr 21.

Fetal Medicine Research Institute, King's College Hospital, 16-20 Windsor Walk, Denmark Hill, London SE5 8BB, United Kingdom. Electronic address:

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http://dx.doi.org/10.1016/j.ajog.2021.04.239DOI Listing
April 2021

Inductively coupled plasma optical emission spectroscopy as a tool for evaluating lateral flow assays.

Anal Methods 2021 05;13(18):2137-2146

Department of Chemistry, Vanderbilt University, Nashville, TN, USA.

Lateral flow assays (LFAs) are immunochromatographic point-of-care devices that have greatly impacted disease diagnosis through their rapid, inexpensive, and easy-to-use form factor. While LFAs have been successful as field-deployable tools, they have a relatively poor limit of detection when compared to more complex methods. Moreover, most design and manufacturing optimization is achieved through time- and resource-intensive brute-force optimization. Despite increased interests in LFA manufacturing, more quantitative tools are needed to study current manufacturing protocols and therefore, optimize and streamline development of these devices further. In this work, we focus on a critical LFA component, colloidal gold conjugated to a detection antibody, one of the most commonly used reporter elements. This study utilizes inductively coupled plasma optical emission spectroscopy (ICP-OES) in conjunction with a lateral flow reader to quantitatively analyze colloidal gold distributions at the read-out test and control lines, as well as residual gold on the conjugate pad and other flow through regions. Our goals are to develop a more rigorous understanding of current LFA designs as well as a quantitative understanding of shortcomings of operational characteristics for future improvement. To our knowledge, this is the first time that ICP-OES has been used to study the initial distribution of colloidal gold on an unused LFA and its redistribution after a test is performed. Using three different brands of commercially available malaria LFAs, gold content was measured within each section of an LFA at varying parasite test concentrations. As expected, the total mass of gold remained unchanged after LFA use; however, the total mass of initial gold and its redistribution varied among manufacturers. Importantly, there are also some inherent inefficiencies that exist in these commercial LFA designs; for example, only 30% of the total gold deposited onto Brand A LFAs binds to the test and control lines, sections of the test that contain interpretable signal. Using information gathered with this method, future devices could be more purposefully engineered to focus on improved binding efficiency, resulting in reduced costs, improved limit of detection, and diminished test-to-test and manufacturer-to-manufacturer variability.
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http://dx.doi.org/10.1039/d1ay00236hDOI Listing
May 2021

Diffusion Imaging Reveals Sex Differences in the White Matter Following Sports-Related Concussion.

Cereb Cortex 2021 Apr 15. Epub 2021 Apr 15.

Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC 3004, Australia.

Sports-related concussion (SRC) is a serious health concern. However, the temporal profile of neuropathophysiological changes after SRC and how these relate to biological sex are still poorly understood. This preliminary study investigated whether diffusion-weighted magnetic resonance imaging (dMRI) was sensitive to neuropathophysiological changes following SRC; whether these changes were sex-specific; and whether they persisted beyond the resolution of self-reported symptoms. Recently concussed athletes (n = 14), and age- and education-matched nonconcussed control athletes (n = 16), underwent MRI 24-48-h postinjury and again at 2-week postinjury (i.e., when cleared to return-to-play). Male athletes reported more symptoms and greater symptom severity compared with females. dMRI revealed white matter differences between athletes with SRC and their nonconcussed counterparts at 48-h postinjury. These differences were still present at 2-week postinjury, despite SRC athletes being cleared to return to play and may indicate increased cerebral vulnerability beyond the resolution of subjective symptoms. Furthermore, we identified sex-specific differences, with male SRC athletes having significantly greater white matter disruption compared with female SRC athletes. These results have important implications for the management of concussion, including guiding return-to-play decisions, and further improve our understanding regarding the role of sex in SRC outcomes.
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http://dx.doi.org/10.1093/cercor/bhab095DOI Listing
April 2021

Modern Principles in the Acute Surgical Management of Open Distal Tibial Fractures.

J Am Acad Orthop Surg 2021 Jun;29(11):e536-e547

From the Department of Orthopaedic Surgery, Johns Hopkins University School of Medicine, Baltimore, MD (Shafiq), the Department of Orthopaedic Surgery, New York University School of Medicine, New York, NY (Hacquebord), and the Department of Orthopaedic Surgery, University of California, School of Medicine, Los Angeles, CA (Wright and Gupta).

Over the past two decades, management of open distal tibial fractures has evolved such that a staged approach, with external fixation and débridement during the index procedure, followed by definitive fixation and wound closure at a later date, is often considered the standard of care. Although definitive treatment of these complex injuries is often done by a multidisciplinary team of surgeons well versed in periarticular fracture repair and soft-tissue coverage in the distal extremity, the on-call orthopaedic surgeon doing the index procedure must understand the principles and rationale of the staged treatment algorithm to avoid compromising definitive treatment options and ensure the best possible patient outcome. The mechanism of injury, neurovascular status, size and location of soft-tissue injury, fracture pattern, and concomitant injuries in the polytraumatized patient should direct the treatment plan and anticipated outcomes. This review focuses on evaluation and management of these complex injuries with an emphasis on early aggressive débridement, principles of initial fracture fixation, and modern options for soft-tissue coverage, including local and free tissue transfer.
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http://dx.doi.org/10.5435/JAAOS-D-20-00502DOI Listing
June 2021

Low-temperature electrocautery reduces adverse effects from secondary cardiac implantable electronic device procedures: Insights from the WRAP-IT trial.

Heart Rhythm 2021 Mar 27. Epub 2021 Mar 27.

Cleveland Clinic, Cleveland Ohio.

Background: Cardiac device procedures require tissue dissection to free existing device lead(s). Common techniques include blunt dissection, standard electrocautery, and low-temperature electrocautery (PlasmaBlade, Medtronic); however, data on the type of electrosurgical tool used and the development of procedure- or lead-related adverse events are limited.

Objective: The purpose of this study was to determine whether standard or low-temperature electrocautery impacts the development of an adverse event.

Methods: We evaluated patients enrolled in WRAP-IT (Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial) undergoing cardiac implantable electronic device (CIED) revision, upgrade, or replacement. All adverse events were adjudicated by an independent physician committee. Data were analyzed using Cox proportional hazard regression modeling.

Results: In total, 5641 patients underwent device revision/upgrade/replacement. Electrocautery was used in 5205 patients (92.3%) (mean age 70.6 ± 12.7 years; 28.8% female), and low-temperature electrocautery was used in 1866 patients (35.9%). Compared to standard electrocautery, low-temperature electrocautery was associated with a 23% reduction in the incidence of a procedure- or lead-related adverse event through 3 years of follow up (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.65-0.91; P = .002). After controlling for the number of active leads, degree of capsulectomy, degree of lead dissection, and renal dysfunction, low-temperature electrocautery was associated with a 32% lower risk of lead-related adverse events (HR 0.68; 95% CI 0.52-0.89; P = .004). These effects were consistent across a spectrum of lead-related adverse event types.

Conclusion: This study represents one of the largest assessments of electrocautery use in patients undergoing CIED revision, upgrade, or replacement procedures. Compared to standard electrocautery, low-temperature electrocautery significantly reduces adverse effects from these procedures.
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http://dx.doi.org/10.1016/j.hrthm.2021.03.033DOI Listing
March 2021

Evidence for Structural and Functional Damage of the Inner Retina in Diabetes With No Diabetic Retinopathy.

Invest Ophthalmol Vis Sci 2021 Mar;62(3):35

Centre for Public Health, Queen's University Belfast, Block B, Royal Hospital, Belfast, Northern Ireland.

Purpose: To provide structural and functional evidence of inner retinal loss in diabetes prior to vascular changes and interpret the structure-function relationship in the context of an established neural model.

Methods: Data from one eye of 505 participants (134 with diabetes and no clinically evident vascular alterations of the retina) were included in this analysis. The data were collected as part of a large population-based study. Functional tests included best-corrected visual acuity, Pelli-Robson contrast sensitivity, mesopic microperimetry, and frequency doubling technology perimetry (FDT). Macular optical coherence tomography volume scans were collected for all participants. To interpret the structure-function relationship in the context of a neural model, ganglion cell layer (GCL) thickness was converted to local ganglion cell (GC) counts.

Results: The GCL and inner plexiform layer were significantly thinner in participants with diabetes (P < 0.05), with no significant differences in the macular retinal nerve fiber layer or the outer retina. All functional tests except microperimetry showed a significant loss in diabetic patients (P < 0.05). Both FDT and microperimetry showed a significant relationship with the GC count (P < 0.05), consistent with predictions from a neural model for partial summation conditions. However, the FDT captured additional significant damage (P = 0.03) unexplained by the structural loss.

Conclusions: Functional and structural measurements support early neuronal loss in diabetes. The structure-function relationship follows the predictions from an established neural model. Functional tests could be improved to operate in total summation conditions in the macula, becoming more sensitive to early loss.
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http://dx.doi.org/10.1167/iovs.62.3.35DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7995918PMC
March 2021