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Nevin Manimala Statistics

Aortic Valve ReplAcemenT versus Conservative Treatment in Asymptomatic SeveRe Aortic Stenosis: The AVATAR Trial

Circulation. 2021 Nov 13. doi: 10.1161/CIRCULATIONAHA.121.057639. Online ahead of print.

ABSTRACT

Background: Surgical aortic valve replacement (SAVR) represents a class I indication in symptomatic patients with severe aortic stenosis (AS). However, indications for early SAVR in asymptomatic patients with severe AS and normal left ventricular function remain debated. Methods: The Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis (AVATAR) trial is an investigator-initiated international prospective randomized controlled trial that evaluated the safety and efficacy of early SAVR in the treatment of asymptomatic patients with severe AS, according to common criteria (valve area ≤1 cm2 with aortic jet velocity >4 m/s or a mean trans-aortic gradient ≥40 mm Hg), and with normal LV function. Negative exercise testing was mandatory for inclusion. The primary hypothesis was that early SAVR would reduce the primary composite endpoint of all-cause death, acute myocardial infarction, stroke or unplanned hospitalization for heart failure, as compared to a conservative strategy according to guidelines. The trial was designed as event-driven to reach a minimum of 35 prespecified events. The study was performed in 9 centers in 7 European countries. Results: Between June 2015 and September 2020, 157 patients (mean age 67 years, 57 % men) were randomly allocated to early surgery (n=78) or conservative treatment (n=79). Follow-up was completed in May 2021. Overall median follow-up was 32 months: 28 months in the early surgery group and 35 months in the conservative treatment group. There was a total of 39 events, 13 in early surgery and 26 in conservative treatment group. In the early surgery group, 72 patients (92.3 %) underwent SAVR with operative mortality of 1.4 %. In an intention-to-treat analysis, patients randomized to early surgery had a significantly lower incidence of primary composite endpoint than those in the conservative arm (HR 0.46, 95 % CI 0.23-0.90, p=0.02). There was no statistical difference in secondary endpoints, including all-cause mortality, first heart failure hospitalizations, major bleeding or thromboembolic complications, but trends were consistent with the primary outcome. Conclusions: In asymptomatic patients with severe AS, early surgery reduced a primary composite of all-cause death, acute myocardial infarction, stroke or unplanned hospitalization for heart failure compared with conservative treatment. This randomized trial provides preliminary support for early SAVR once AS becomes severe, regardless of symptoms.

PMID:34779220 | DOI:10.1161/CIRCULATIONAHA.121.057639

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Intravenous Thrombolysis Before Mechanical Thrombectomy for Acute Ischemic Stroke: A Meta-Analysis

J Am Heart Assoc. 2021 Nov 15:e022303. doi: 10.1161/JAHA.121.022303. Online ahead of print.

ABSTRACT

Background Whether intravenous thrombolysis before mechanical thrombectomy provides additional benefit for functional outcome in acute ischemic stroke remains uncertain. We performed a meta-analysis to compare the outcomes of direct mechanical thrombectomy (dMT) to mechanical thrombectomy with bridging using intravenous thrombolysis (bridging therapy [BT]) in patients with acute ischemic stroke. Methods and Results We performed a literature search in the PubMed, Excerpta Medica database, and Cochrane Central Register of Controlled Trials from January 1, 2003, to April 26, 2021. We included randomized clinical trials and observational studies that reported the 90-day functional outcome in patients with acute ischemic stroke undergoing dMT compared with BT. The 12 included studies (3 randomized controlled trials and 9 observational studies) yielded 3924 participants (mean age, 68.0 years [SD, 13.1 years]; women, 44.2%; 1887 participants who received dMT and 2037 participants who received BT). A meta-analysis of randomized controlled trial and observational data revealed similar 90-day functional independence (odds ratio [OR], 1.04; 95% CI, 0.90-1.19), mortality (OR, 1.03; 95% CI, 0.78-1.36), and successful recanalization (OR, 0.93; 95% CI, 0.76-1.14) for patients treated with dMT or BT. Compared with those in the BT group, patients in the dMT group were less likely to experience symptomatic intracranial hemorrhage (OR, 0.68; 95% CI, 0.51-0.91; P=0.008) or any intracranial hemorrhage (OR, 0.71; 95% CI, 0.61-0.84; P<0.001). Conclusions In this meta-analysis of patients with acute ischemic stroke, we found no significant differences in 90-day functional outcome or mortality between dMT and BT, but a lower rate of symptomatic intracranial hemorrhage for dMT. These findings support the use of dMT without intravenous thrombolysis bridging therapy. Registration URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: 42021234664.

PMID:34779235 | DOI:10.1161/JAHA.121.022303

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Metabolic Factors Mediate the Association Between Serum Uric Acid to Serum Creatinine Ratio and Cardiovascular Disease

J Am Heart Assoc. 2021 Nov 15:e023054. doi: 10.1161/JAHA.121.023054. Online ahead of print.

ABSTRACT

Background The serum uric acid/serum creatinine ratio (SUA/SCr), which represents renal function-normalized SUA, is associated with diverse adverse outcomes. The aim of this study was to investigate the association between SUA/SCr and cardiovascular disease (CVD), and determine whether and to what extent this association is mediated by cardiometabolic factors. Methods and Results This prospective study enrolled 96 378 participants from the Kailuan study without stroke and myocardial infarction at baseline (2006). Cox proportional hazard models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). Mediation analyses were conducted to separately explore the mediating effects of cardiometabolic factors on the association between SUA/SCr and CVD. During median follow up of 11.01 years, 6315 (6.55%) individuals developed incident CVD. After adjustment for potential confounders, the highest quartile of SUA/SCr was associated with the highest risk of CVD (HR, 1.15; 95% CI, 1.07-1.23), stroke (HR, 1.16; 95% CI, 1.07-1.26), ischemic stroke (HR, 1.12; 95% CI, 1.02-1.22), and hemorrhagic stroke (HR, 1.36; 95% CI, 1.11-1.65), but not with myocardial infarction (HR, 1.07; 95% CI, 0.92-1.25). The association was consistent across different degrees of kidney function and glucose tolerance statuses. Additionally, the association between high SUA/SCr and CVD was partially mediated by triglycerides (30.74%), body mass index (BMI) (19.52%), total cholesterol (15.06%), hs-CRP (high-sensitivity C-reactive protein) (13.06%), diastolic blood pressure (11.75%), and blood glucose (-16.38%). Conclusions SUA/SCr and CVD were positively associated. Furthermore, this association was partially mediated through blood lipids, BMI, blood pressure, hs-CRP, and blood glucose.

PMID:34779219 | DOI:10.1161/JAHA.121.023054

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Regulation of the Enzymatic Activities of Lysozyme by the Surface Ligands of Ultrasmall Gold Nanoclusters: The Role of Hydrophobic Interactions

Langmuir. 2021 Nov 15. doi: 10.1021/acs.langmuir.1c02719. Online ahead of print.

ABSTRACT

Nanomaterials for biological applications would inevitably encounter and interact with biomolecules, which have a profound impact on the properties, functions, and even fates of both nanomaterials and biomolecules. Among the biomolecules, lysozyme (Lys) is of great importance in defending the bacterial intruder and maintaining health. Here, the interactions between fluorescent gold nanoclusters (AuNCs) (∼2 nm) capped with different surface ligands and Lys were thoroughly investigated. Fluorescence spectroscopic studies showed that dihydrolipoic acid (DHLA)-capped and glutathione (GSH)-capped AuNCs both quenched the intrinsic fluorescence of Lys by different quenching mechanisms. Agarose gel electrophoresis and zeta-potential assays showed that statistically one DHLA-AuNC could bind one Lys, while one GSH-AuNC could bind 3-4 Lys, providing new examples for the concept of a “protein complex”. Activity assays indicated that DHLA-AuNCs heavily inhibited the enzymatic activity of Lys, while GSH-AuNCs had little effect. By synchronous fluorescence and circular dichroism spectroscopic studies, it was deduced that both AuNCs would interact with Lys by electrostatic attractions due to the distinct surface charges, and then DHLA-AuNCs would further interact with Lys by hydrophobic interactions, probably due to the hydrophobic carbon chain of DHLA and the hydrophobic side chains of amino acid residues in Lys, which was proved by the significant secondary structure changes caused by DHLA-AuNCs. Meanwhile, conformational changes induced by GSH-AuNCs with zwitterionic ligands were neglectable. Therefore, this work provided a comprehensive study of the consequences and mechanisms of the interactions between Lys and AuNCs, which was essential for the design and better use of nanomaterials as biological agents.

PMID:34779209 | DOI:10.1021/acs.langmuir.1c02719

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Association between diet of the vegan population and self-perception of periodontal state in Metropolitan Lima

Nutr Hosp. 2021 Nov 15. doi: 10.20960/nh.03757. Online ahead of print.

ABSTRACT

OBJECTIVE: to determine the association between vegan diet and self-perceived periodontal status in a vegan population of Metropolitan Lima, Peru.

MATERIALS AND METHODS: a total of 240 people (120 vegans and 120 non-vegans) were surveyed in this study during the months of August to December 2020 in a virtual way. To evaluate self-perception of periodontal status and oral hygiene habits, the self-report of periodontal disease was used, which is validated with a Cronbach’s alpha of 0.77. In addition, other variables such as age, sex, socioeconomic level, educational level, and tobacco consumption were registered. A Poisson regression with robust variance estimator was used both for the association of variables, and prevalence ratios were reported in a crude and adjusted model. The confidence level was 95 % and the significance level was p < 0.05.

RESULT: a statistically significant association was found between the appearance of reddish and/or swollen gums (PR = 0.67; 95 % CI: 0.25-0.54) and poor perception of the state of the gums (PR = 0.43; 95 % CI: 0.33-0.56) with the vegan diet. Finally, for the gum bleeding dimension during brushing, no statistically significant differences were observed between vegans and non-vegans.

PMID:34779213 | DOI:10.20960/nh.03757

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A supportive donor nerve for long-term facial paralysis: Anatomical analysis of the posterior auricular nerve and micro-anatomical comparison with zygomatic nerve

J Plast Reconstr Aesthet Surg. 2021 Oct 22:S1748-6815(21)00490-3. doi: 10.1016/j.bjps.2021.09.049. Online ahead of print.

ABSTRACT

BACKGROUND: The posterior auricular nerve (PAN) is an inspiring candidate for the additional axonal source in long-term facial paralysis to improve the functional results of the cross-facial nerve (FN) graft technique. However, no studies have analyzed the PAN’s axonal load and its microscopic anatomy to assess its utilization in facial reanimation. The present study aims to examine the anatomical and microscopic features of the PAN to analyze its feasibility as a donor nerve.

METHODS: The bilateral facial side of 14 fresh frozen adult human cadavers was examined for the study. The PAN’s anatomical course was recorded, and nerve specimens from the PAN and zygomatic nerve (ZN) were obtained to compare their microscopic anatomy and axon counts using a light microscope and transmission electron microscope.

RESULTS: The PAN’s average branching distance and its course length were 5.8 ± 2.69 mm and 59.2 ± 5.85, respectively. The mean number of myelinated axons was 600.28 ± 69.97 in the PAN and 728.85 ± 166.31 in the ZN. This difference between the two nerves was statistically significant (p = 0.002). However, considering the gender variable, the mean axon counts of PAN and ZN were statistically similar for face sides and their average. Furthermore, the ultrastructural anatomy of both nerves was similar in electron microscopic evaluation.

CONCLUSIONS: The present study confirms that the PAN is a proper candidate to be a supportive donor nerve due to its isolated site, consistent anatomical course, convenient ultrastructural anatomy as well as axonal load.

PMID:34776387 | DOI:10.1016/j.bjps.2021.09.049

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Development of a new tool for predicting the behavior of individuals with intellectual disability in the dental office: A pilot study

Disabil Health J. 2021 Nov 9:101229. doi: 10.1016/j.dhjo.2021.101229. Online ahead of print.

ABSTRACT

BACKGROUND: The dental treatment of individuals with intellectual disability can represent a considerable professional challenge.

OBJECTIVE: To develop a model for predicting the behavior of patients with intellectual disability in the dental office.

METHODS: The study group comprised 250 patients with Down syndrome (DS), autism spectrum disorder (ASD), cerebral palsy (CP), idiopathic cognitive impairment or rare disorders. We collected their demographic, medical, social and behavioral information and identified potential predictors (chi-squared test). We developed stratified models (Akaike information criterion) to anticipate the patients’behavior during intraoral examinations and to discern whether the dental treatment should be performed under general anesthesia. These models were validated in a new study group consisting of 80 patients. Goodness of fit was quantified with sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and area under the receiver operating characteristic curve (AUC). We developed a mathematical algorithm for executing the models and developed software for its practical implementation (PREdictors of BEhavior in Dentistry, “PREBED”).

RESULTS: For patients with DS, ASD and CP, the model predicting the need for physical restraint during examination achieved a PPV of 0.90, 0.85 and 1.00, respectively, and an NPV of 0.66, 0.76 and 1.00, respectively. The model predicting the need for performing treatment under general anesthesia achieved a PPV of 0.63, 1.00 and 1.00, respectively, and an NPV of 1.00, 1.00 and 0.73, respectively. However, when validating the stratified models, the percentage of poorly classified individuals (false negatives + false positives) ranged from 24% to 46.6%.

CONCLUSIONS: The results of the PREBED tool open the door to establishing new models implementing other potentially predictive variables.

PMID:34776386 | DOI:10.1016/j.dhjo.2021.101229

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Geriatric assessment with management for older patients with cancer receiving radiotherapy. Protocol of a Norwegian cluster-randomised controlled pilot study

J Geriatr Oncol. 2021 Nov 11:S1879-4068(21)00247-2. doi: 10.1016/j.jgo.2021.11.001. Online ahead of print.

ABSTRACT

About 50% of patients with cancer are expected to need radiotherapy (RT), and the majority of these are older. To improve outcomes for older patients with cancer, geriatric assessment (GA) with management (GAM) is highly recommended. Evidence for its benefits is still scarce, in particular for patients receiving RT. We report the protocol of a cluster-randomised pilot study designed to test the effect, feasibility and health economic impact of a GAM intervention for patients ≥65 years, referred for palliative or curative RT. The randomising units are municipalities and city districts. The intervention is municipality-based and carried out in collaboration between hospital and municipal health services from the start of RT to eight weeks after the end of RT. Its main constituents are an initial GA followed by measures adapted to individual patients’ impairments and needs, systematic symptom assessments and regular follow-up by municipal cancer nurses, appointed to coordinate the patient’s care. Follow-up includes at least one weekly phone call, and a house call four weeks after the end of RT. All patients receive an individually adapted physical exercise program and nutritional counselling. Detailed guidelines for management of patients’ impairments are provided. Patients allocated to the intervention group will be compared to controls receiving standard care. The primary outcome is physical function assessed by the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire C-30. Secondary outcomes are global quality of life, objectively tested physical performance and use of health care services. Economic evaluation will be based on a comparison of costs and effects (measured by the main outcome measures). Feasibility will be assessed with mixed methodology, based on log notes and questionnaires filled in by the municipal nurses and interviews with patients and nurses. The study is carried out at two Norwegian RT centres. It was opened in May 2019. Follow-up will proceed until June 2022. Statistical analyses will start by the end of 2021. We expect the trial to provide important new knowledge about the effect, feasibility and costs of a GAM intervention for older patients receiving RT. Trial registration: ClinTrials.gov, ID NCT03881137, initial release 13th of March 2019.

PMID:34776384 | DOI:10.1016/j.jgo.2021.11.001

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Surgical under-treatment of older adult patients with cancer: A systematic review and meta-analysis

J Geriatr Oncol. 2021 Nov 11:S1879-4068(21)00250-2. doi: 10.1016/j.jgo.2021.11.004. Online ahead of print.

ABSTRACT

Older patients with cancer often have lower surgery rates and survival than younger patients, but this may reflect surgical contraindications of advanced disease, comorbidities, and frailty – and not necessarily under-treatment. This review describes variations in surgery rates and observed or net survival among younger (<75) and older (≥75) patients with lung, breast, and colorectal cancer, while taking account of pre-existing health factors, in order to understand how under-treatment is defined and estimated in the literature. MEDLINE, Embase, Web of Science and PubMed databases were searched. Thirty relatively high-quality studies of patients with breast (230,200; 71.9%), lung (77,573; 24.2%), and colorectal (12,407; 3.9%) cancers were identified. Compared to younger patients, older patients were less likely to receive surgical treatment for 1) breast cancer after adjusting for comorbidity, performance status (PS), functional status and patient choice, 2) lung cancer after accounting for stage, comorbidity, PS, and 3) colorectal cancer after adjusting for stage, comorbidity, and gender. The pooled unadjusted analyses showed lower surgery receipt in older patients in breast (odds ratio [OR] 0.31, 95% confidence interval [CI] 0.13-0.78), lung (OR 0.54, 95% CI 0.39-0.75), and colorectal (OR 0.59, 95% CI 0.51-0.68) cancers. Lower surgery rates in older patients may contribute to their poorer survival compared to younger patients. Future research quantifying under-treatment should include necessary clinical factors, patient choice, patient’s quality of life and a statistically-robust approach, which will demonstrate how much of the survival deficit in older patients is due to their receiving lower surgery rates.

PMID:34776385 | DOI:10.1016/j.jgo.2021.11.004

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Plant-based Diets in Kidney Disease: Nephrology Professionals’ Perspective

J Ren Nutr. 2021 Nov 11:S1051-2276(21)00235-1. doi: 10.1053/j.jrn.2021.09.008. Online ahead of print.

ABSTRACT

OBJECTIVE: Plant-based diets can delay the progression of chronic kidney disease (CKD) and help manage complications and co-morbid conditions such as hypertension, acidosis, diabetes, and cardiovascular disease. However, it is unclear how often plant-based diets are recommended to patients with kidney disease. The objective of this study was to understand nephrology professionals’ familiarity, perception, and recommendation of plant-based diets to people with kidney disease.

DESIGN AND METHODS: A survey to understand perception of recommendation of plant-based diets for patients with CKD was developed. Nephrology professionals from the National Kidney Foundation’s member directory were e-mailed a link to complete the survey online. This directory includes professionals who work in a variety of nephrology settings, including both CKD and end-stage renal disease care. Survey items were evaluated with descriptive statistics. Differences across items were determined using chi-square tests and t-tests.

RESULTS: A total of 3,901 professionals were sent the survey, and 644 completed the survey. A majority were dietitians (58%) and worked in dialysis clinics (54%). Most (88%) had heard of using plant-based diets for kidney disease treatment, and a majority (88%) believed it could improve CKD management, cardiovascular disease (90%), hypertension (90%), diabetes (84%), high cholesterol (90%), and obesity (84%). Dietitians were more likely to report plant-based diets as beneficial for each health condition (P < .05). Professionals were most confident that a plant-based diet could help control hypertension (3.75 ± 0.99 on a scale of 1-5), compared with delaying progression of CKD (3.68 ± 1.15) or treating acidosis (3.68 ± 1.13). Dietitians felt more confident in their ability to plan a balanced plant-based diet compared with other specialties (3.49 vs. 2.74, P < .001).

CONCLUSION: Nephrology professionals who work in nondialysis-dependent CKD settings, and those who work with patients on dialysis, are aware of the benefits of plant-based diets in kidney disease. However, plant-based diets are not routinely being offered as a treatment option. Nephrology practices should work to increase dietitian referrals to offer patients support in transitioning to a plant-based diet.

PMID:34776341 | DOI:10.1053/j.jrn.2021.09.008