Regression of cardiac amyloid deposits with novel therapeutics: reaching new frontiers in cardiac ATTR amyloidosis

Abstract Background Cardiac involvement is the main driver of outcome in ATTR amyloidosis. Advances in therapeutics hold potential in transforming the course of the disease but the impact on cardiac amyloid load is unknown. The aim of this study was to evaluate the impact of patisiran, a new double stranded RNA based gene silencing therapy and a stabilizer, diflunisal, on cardiac amyloid load as measured by CMR and T1 mapping, in patients with ATTR amyloidosis. Methods and results Thirty-two patients with hereditary cardiac amyloidosis were studied. Sixteen patients received treatment with patisiran, and sixteen control subjects did not receive any disease modifying treatment. Patients were assessed with echocardiogram, CMR, NT-proBNP and six-minute walk time measurements at baseline and at 1 year (Mean interval 11.45±3.08 months in treatment group, mean interval 12.82±5.06 months in the control group). CMR analysis comprised LV volumes, T1 mapping to measure the extracellular volume (ECV) occupied by amyloid, T2 mapping and late gadolinium enhancement imaging. At 1-year follow-up, there was a substantial reduction in cardiac amyloid burden, in keeping with cardiac amyloid regression in 45% of patients on treatment. Overall the treatment group showed a reduction in ECV at 1 year follow up compared to an increase in ECV at 1 year in the control group (−1.37%, 95% CI: −3.43 to 0.68% versus 5.02%, 95% CI: 2.86% to 7.18% respectively, p<0.001). The treatment group also showed an improvement in change in 6MWT at 1 year follow up compared to 6MWT at 1 year in the control group (−8.12 meters, 95% CI: −50.8 to 34.6 meters in the treatment group versus −132.27 meters, 95% CI: −216 to −48.6 meters in the control group, p=0.002). The treatment group showed a reduction in BNP at 1 year follow up compared to an increase in the control group (−567.87, 95% CI: −1288.90 to 153.15 in the treatment group versus 2004, 95% CI: 12.82 to 3995.45 in the control group, p<0.001). There was no significant difference from baseline and 1-year data between the control and treatment groups for the difference in echocardiographic parameters, native T1, T2. There was a significant reduction in the percentage of injected dose by 99Tc-DPD scintigraphy in treated patients at 1 year compared to baseline. Conclusions These findings provide the first compelling evidence of substantial cardiac amyloid regression in ATTR amyloidosis, as well as the potential for CMR to be used to track response in treated patients with ATTR cardiac amyloidosis. Combination therapy with transthyretin knock down and stabilizing agents may well be synergistic given enhanced stoichiometry of stabilizers in the face of much reduced plasma transthyretin concentration. Funding Acknowledgement Type of funding source: None

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A Newspaper’s Effect on the Strength of Automatic Associations in Memory

Journal of Media Psychology Theories Methods and Applications ◽

10.1027/1864-1105/a000057 ◽

2012 ◽

Vol 24 (1) ◽

pp. 1-8 ◽

Cited By ~ 12

Author(s):

Florian Arendt

Keyword(s):

Treatment Group ◽

Term Effect ◽

Control Group ◽

Implicit Measure ◽

Short Term ◽

Short Term Treatment ◽

Short Term Effect ◽

Automatic Associations ◽

Foreign Nationality ◽

The Impact

A test was done to see if reading a newspaper which consistently overrepresents foreigners as criminals strengthens the automatic association between foreign country and criminal in memory (i.e., implicit cultivation). Further, an investigation was done to find out if reading articles from the same newspaper produces a short-term effect on the same measure and if (1) emotionalization of the newspaper texts, (2) emotional reactions of the reader (indicated by arousal), and (3) attributed text credibility moderate the short-term treatment effect. Eighty-five participants were assigned to one of three experimental conditions. Participants in the control group received short factual crime texts, where the nationality of the offender was not mentioned. Participants in the factual treatment group received the same texts, but the foreign nationality was mentioned. Participants in the emotionalized treatment group received emotionalized articles (i.e., texts which are high in vividness and frequency) covering the same crimes, with the foreign nationality mentioned. Supporting empirical evidence for implicit cultivation and a short-term effect was found. However, only emotionalized articles produced a short-term effect on the strength of the automatic association, indicating that newspaper texts must have a minimum of stimulus intensity to overcome an effect threshold. There were no moderating effects of arousal or credibility pertaining to the impact on the implicit measure. However, credibility moderated the short-term effect on a first-order judgment (i.e., estimated frequency of foreigners of all criminals). This indicates that a newspaper’s effect on the strength of automatic associations is relatively independent from processes of propositional reasoning.

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The Effect of Javanese Language Videos with a Community Based Interactive Approach Method as an Educational Instrument for Knowledge, Perception, and Adherence amongst Tuberculosis Patients

Pharmacy ◽

10.3390/pharmacy9020086 ◽

2021 ◽

Vol 9 (2) ◽

pp. 86

Author(s):

Fauna Herawati ◽

Yuni Megawati ◽

Aslichah ◽

Retnosari Andrajati ◽

Rika Yulia

Keyword(s):

Intervention Group ◽

Personal Control ◽

Control Group ◽

P Value ◽

Interactive Approach ◽

Community Based ◽

Tuberculosis Patients ◽

Level Of Knowledge ◽

The Impact

The long period of tuberculosis treatment causes patients to have a high risk of forgetting or stopping the medication altogether, which increases the risk of oral anti-tuberculosis drug resistance. The patient’s knowledge and perception of the disease affect the patient’s adherence to treatment. This research objective was to determine the impact of educational videos in the local language on the level of knowledge, perception, and adherence of tuberculosis patients in the Regional General Hospital (RSUD) Bangil. This quasi-experimental study design with a one-month follow-up allocated 62 respondents in the intervention group and 60 in the control group. The pre- and post-experiment levels of knowledge and perception were measured with a validated set of questions. Adherence was measured by pill counts. The results showed that the intervention increases the level of knowledge of the intervention group higher than that of the control group (p-value < 0.05) and remained high after one month of follow-up. The perceptions domains that changed after education using Javanese (Ngoko) language videos with the Community Based Interactive Approach (CBIA) method were the timeline, personal control, illness coherence, and emotional representations (p-value < 0.05). More than 95% of respondents in the intervention group take 95% of their pill compared to 58% of respondents in the control group (p-value < 0.05). Utilization of the local languages for design a community-based interactive approach to educate and communicate is important and effective.

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Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05228-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xin Ye ◽

Dawei Zhu ◽

Siyuan Chen ◽

Xuefeng Shi ◽

Rui Gong ◽

...

Keyword(s):

Quality Of Life ◽

Hearing Loss ◽

Cost Effectiveness ◽

Treatment Group ◽

Hearing Aids ◽

Control Group ◽

Chinese Adults ◽

Community Based ◽

The Impact

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.

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Positive and Negative Affect Changes during Gender-Affirming Hormonal Treatment: Results from the European Network for the Investigation of Gender Incongruence (ENIGI)

Journal of Clinical Medicine ◽

10.3390/jcm10020296 ◽

2021 ◽

Vol 10 (2) ◽

pp. 296

Author(s):

Imke Matthys ◽

Justine Defreyne ◽

Els Elaut ◽

Alessandra Daphne Fisher ◽

Baudewijntje P. C. Kreukels ◽

...

Keyword(s):

Negative Affect ◽

Sex Steroids ◽

Hormonal Treatment ◽

Control Group ◽

First Year ◽

Positive And Negative Affect ◽

European Network ◽

Psychological Burden ◽

The Impact

Improving transgender people’s quality of life (QoL) is the most important goal of gender-affirming care. Prospective changes in affect can influence QoL. We aim to assess the impact of initiating gender-affirming hormonal treatment (HT) on affect. In the European Network for the Investigation of Gender Incongruence (ENIGI) study, we prospectively collected data of 873 participants (451 transwomen (TW) and 422 transmen (TM)). At baseline, psychological questionnaires including the Positive and Negative Affect Schedule (PANAS) were administered. The PANAS, levels of sex steroids and physical changes were registered at each follow-up visit during a 3-year follow-up period, starting at the initiation of hormonal therapy. Data were analyzed cross-sectionally and prospectively. Over the first three months, we observed a decline in positive affect (PA) in both TM and TW. Thereafter, PA reached a steady state in TW, whereas in TM there was also a second decline at 18 months. In both TM and TW there was no persisting difference comparing baseline to the 36-months results. Concerning negative affect (NA), we observed a decline during the first year in TM, which sustained during the second year and was not different anymore at 36 months compared to baseline. In TW though, we did not find any change of NA during the entire follow-up. Even if some of these results show significant differences, they should be considered with caution, since there was no control group and the absolute differences are small. No association between affect and the level of sex steroids was observed. Baseline QoL and psychological burden are related to affect independently from gender but are not necessarily good predictors of the evolution of one’s affect during the gender-affirming process. Further research is necessary to investigate these preliminary results.

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Impact of pharmacist-conducted anticoagulation patient education and telephone follow-up on transitions of care: a randomized controlled trial

BMC Health Services Research ◽

10.1186/s12913-021-06156-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Lamis R. Karaoui ◽

Elsy Ramia ◽

Hanine Mansour ◽

Nisrine Haddad ◽

Nibal Chamoun

Keyword(s):

Tertiary Care ◽

Intervention Group ◽

Bleeding Event ◽

Transitions Of Care ◽

Control Group ◽

Published Data ◽

Post Discharge ◽

Readmission Rates ◽

The Impact

Abstract Background There is limited published data in Lebanon evaluating the impact of supplemental education for anticoagulants use, especially DOACs, on clinical outcomes such as bleeding. The study aims to assess the impact of pharmacist-conducted anticoagulation education and follow-up on bleeding and readmission rates. Methods This study was a randomized, non-blinded interventional study conducted between August 2017 and July 2019 in a tertiary care teaching Lebanese hospital. Participants were inpatients ≥18 years discharged on an oral anticoagulant for treatment. Block randomization was used. The control group received the standard nursing counseling while the intervention group additionally received pharmacy counseling. Phone call follow-ups were done on day 3 and 30 post-discharge. Primary outcomes included readmission rates and any bleeding event at day 3 and 30 post-discharge. Secondary outcomes included documented elements of education in the medical records and reported mortality upon day 30 post-discharge. Results Two hundred patients were recruited in the study (100 patients in each study arm) with a mean age of 73.9 years. In the pharmacist-counseled group, more patients contacted their physician within 3 days (14% versus 4%; p = 0.010), received explicit elements of education (p < 0.001) and documentation in the chart was better (p < 0.05). In the standard of care group, patients were more aware of their next physician appointment date (52% versus 31%, p < 0.001). No difference in bleeding rates at day 3 and 30 post-discharge was observed between the groups. Conclusions Although pharmacist-conducted anticoagulation education did not appear to reduce bleeding or readmission rates at day 30, pharmacist education significantly increased patient communication with their providers in the early days post-discharge. Trial registration Lebanon Clinical Trial Registry LBCTR2020033424. Retrospectively registered. Date of registration: 06/03/2020.

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Impact of failed ab-interno trabeculectomy (trabectome) on subsequent XEN45 gel stent implantation in pseudophakic eyes

International Ophthalmology ◽

10.1007/s10792-021-01977-w ◽

2021 ◽

Author(s):

D. Kiessling ◽

C. Rennings ◽

M. Hild ◽

A. Lappas ◽

T. S. Dietlein ◽

...

Keyword(s):

Stent Implantation ◽

Open Angle Glaucoma ◽

Control Group ◽

Repeat Surgery ◽

Medication Score ◽

Significant Difference ◽

Ab Interno Trabeculectomy ◽

The Impact ◽

Ab Interno

Abstract Purpose To determine the impact of failed ab-interno trabeculectomy on the postoperative outcome of subsequent XEN45 gel stent (Allergan, CA, USA) implantation in pseudophakic eyes. Methods In this retrospective single-center study, we included 60 pseudophakic eyes from 60 participants who underwent XEN45 gel stent implantation. Thirty eyes each underwent primary stent implantation (control group) or had previously undergone a failed ab-interno trabeculectomy (trabectome group). The groups were matched at a 1:1 ratio based on the following criteria: preoperative and maximum Intraocular pressure (IOP), preoperative medication score, cup/disk-ratio, follow-up time, best-corrected visual acuity at baseline, age, and the proportion of patients classified as primary open angle glaucoma or exfoliation glaucoma. We defined a successful surgery by the following three scores: an IOP reduction > 20% and IOP at the longest follow-up < 21 mmHg (Score A) or < 18 mmHg (Score B) or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). One open conjunctival revision was allowed in all scores, and a repeat surgery was considered a failure. Results Following an average follow-up period of 22 ± 12 months, we observed a mean IOP reduction of 38%, from 23.5 ± 5.2–14.5 ± 5.0 mmHg. Comparative analyses between the groups did not reveal a significant difference in the postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate, or success rate. Conclusions Trabectome is a viable first-line procedure for medically uncontrolled glaucoma before filtering ab-interno microstent surgery is considered.

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Efficacy of corticosteroid therapy in the treatment of long- lasting olfactory disorders in COVID-19 patients

Rhinology Journal ◽

10.4193/rhin20.515 ◽

2020 ◽

Vol 0 (0) ◽

pp. 0-0

Author(s):

L.A. Vaira ◽

C. Hopkins ◽

M. Petrocelli ◽

J.R. Lechien ◽

S. Cutrupi ◽

...

Keyword(s):

Treatment Group ◽

Case Control Study ◽

Spontaneous Recovery ◽

Olfactory Function ◽

Control Group ◽

Initial Control ◽

Group A ◽

Control Study

BACKGROUND: The growing number of COVID-19 patients with long-lasting olfactory disorders makes it necessary to identify effective treatments that enhance the spontaneous recovery of olfactory function. METHODS: Multicentre randomised case-control study that involved 18 patients with COVID-19 related anosmia or severe hyposmia for more than 30 days. Nine patients were prescribed systemic prednisone and nasal irrigation with betamethasone, ambroxol and rinazine for 15 days. The other 9, untreated, patients were used as controls. The olfactory function was evaluated with CCCRC test at 20 and 40 days from the first evaluation. RESULTS: In the control group, a median olfactory score of 20 (IQR 30) was detected at baseline. At the 20-day control there was no significant improvement in olfactory function. The improvement in olfactory performance became significant at the 40-day follow-up compared to baseline scores [60 (IQR 60) versus 20 (IQR 30)]. In the treatment group, patients had a mean olfactory score of 10 (IQR 15) at initial control. At the 20-day control, a significant im-provement in the olfactory scores, compared to the baseline, was detected [70 (IQR 40) versus 10 (IQR 15)]. Olfactory function further improved at 40 days [median score 90 (IQR 50)]. Patients in the treatment group reported significantly higher improvements of the olfactory scores than the controls at both the 20-day [40 (IQR 45) versus 10 (IQR 15)] and 40-day [60 (IQR 40) versus 30 (IQR 25)] evaluations. CONCLUSIONS: Based on the results of this study, the mix of drugs including steroids could represent a useful specific therapy to reduce the prevalence of this long-term morbidity.

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Positive Airway Pressure Therapy Adherence with Mask Resupply: A Propensity-Matched Analysis

Journal of Clinical Medicine ◽

10.3390/jcm10040720 ◽

2021 ◽

Vol 10 (4) ◽

pp. 720

Author(s):

Adam Benjafield ◽

Liesl Oldstone ◽

Leslee Willes ◽

Colleen Kelly ◽

Carlos Nunez ◽

...

Keyword(s):

Airway Pressure ◽

Positive Airway Pressure ◽

Group Versus ◽

Control Group ◽

Billing Data ◽

Pressure Therapy ◽

Therapy Termination ◽

Few Data ◽

And Control ◽

The Impact

There are currently few data on the impact of mask resupply on longer-term adherence to positive airway pressure (PAP) therapy. This retrospective analysis investigated the effects of mask/mask cushion resupply on the adherence to PAP versus no resupply. Deidentified patient billing data for PAP supply items were merged with telemonitoring data from Cloud-connected AirSense 10/AirCurve 10 devices via AirViewTM (ResMed). Eligible patients started PAP between 1 July 2014 and 17 June 2016, had ≥360 days of PAP device data, and achieved initial U.S. Medicare adherence criteria. Patients who received a resupply of mask systems/cushions (resupply group) were propensity-score-matched with those not receiving any mask/cushion resupply (control group). A total of 100,370 patients were included. From days 91 to 360, the mean device usage was 5.6 and 4.5 h/night in the resupply and control groups, respectively (p < 0.0001). The proportion of patients with a mean device usage ≥4 h/night was significantly higher in the resupply group versus the control group (77% vs. 59%; p < 0.0001). The therapy termination rate was significantly lower in the resupply group versus the control group (14.7% vs. 31.9%; p < 0.0001); there was a trend toward lower therapy termination rates as the number of resupplies increased. The replacement of mask interface components was associated with better longer-term adherence to PAP therapy versus no resupply.

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Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽

10.1161/circ.125.suppl_10.ap186 ◽

2012 ◽

Vol 125 (suppl_10) ◽

Author(s):

Jaime Céspedes ◽

German Briceño ◽

Michael Farkouh ◽

Rajesh Vedanthan ◽

Martha Leal ◽

...

Keyword(s):

Educational Intervention ◽

Cardiovascular Health ◽

Controlled Trial ◽

Intervention Group ◽

Educational Programs ◽

Control Group ◽

Active Lifestyle ◽

And Control ◽

The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

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Comparison of Early Implant Failure Rates Between Subjects With and Without Orthodontic Treatment Before Dental Implantation

Journal of Oral Implantology ◽

10.1563/aaid-joi-d-17-00222 ◽

2019 ◽

Vol 45 (1) ◽

pp. 29-34

Author(s):

Li-ching Chang ◽

I-ming Tsai

Keyword(s):

Treatment Group ◽

Failure Rate ◽

Orthodontic Treatment ◽

Implant Failure ◽

Control Group ◽

Failure Rates ◽

Implant Surgery ◽

Dental Implantation ◽

And Control

The present study compared early dental implant failure rates between patients with and without orthodontic treatment before dental implantation. The data of adults who had undergone dental implantation between January 2007 and December 2016 were analyzed retrospectively. A total of 124 subjects with 255 implants were divided into a treatment group (46 subjects, 85 teeth) consisting of patients who had undergone implant surgery after orthodontic treatment and a control group of patients who had not undergone preimplant orthodontic treatment. Implants that failed before permanent crown fabrication were defined as failures. No significant differences in gender or age were found between the treatment group and controls. No significant differences were found in implant failure rates in either jaw between the treatment and control groups. However, the failure rate was still higher in the treatment group (14.81%) than in the control group (3.28%) for the maxilla. Results of this study demonstrate an increased implant failure rate only in the maxilla of patients who underwent orthodontic treatment before dental implantation, especially implant surgery combined with a sinus lift procedure. Further study with a larger sample size and longer follow-up period is necessary to confirm results of the present study and identify other confounding factors.

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