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Nevin Manimala Statistics

Percutaneous mitral valve repair in severe secondary mitral regurgitation: Analysis of index hospitalization and economic evaluation based on the MITRA-FR trial

Arch Cardiovasc Dis. 2021 Nov 18:S1875-2136(21)00174-1. doi: 10.1016/j.acvd.2021.10.005. Online ahead of print.

ABSTRACT

BACKGROUND: Percutaneous mitral valve repair (pMVR) is reimbursed in France for severe secondary mitral regurgitation (SMR), but French data regarding the hospitalization index stay are lacking.

AIMS: Our objectives were to describe the index hospitalization stay and to evaluate the cost of hospital stay for pMVR used in SMR.

METHODS: A secondary evaluation based on patients who were randomized to the intervention group of the MITRA-FR study was undertaken. The economic evaluation was conducted according to the French hospital perspective. Medical resource use was estimated using specific data collected from patients enrolled in the MITRA-FR study and non-specific data from national statistics.

RESULTS: The population was represented by 144 patients who underwent pMVR at 33 French centres. There was a mean±standard deviation of 7.9±1.5 hospital staff during procedures. The mean procedure duration was 154±68 minutes and increased with the number of implanted clips. Median total length of stay was 8 days. The occurrence of a serious adverse event was not associated with an increased risk of admission to the critical care unit, but was associated with an increased length of stay. The mean total cost was 28,025±3424€, which includes 21,547€ for the cost of medical devices used during pMVR and 6478±3424€ for other costs.

CONCLUSION: The cost of pMVR is substantial for patients with SMR, which advocates for further efforts to identify the patients with SMR who are likely to derive a clear clinical benefit from the procedure.

PMID:34802961 | DOI:10.1016/j.acvd.2021.10.005

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Nevin Manimala Statistics

Effects of allyl isothiocyanate on the expression, function, and its mechanism of ABCA1 and ABCG1 in pulmonary of COPD rats

Int Immunopharmacol. 2021 Nov 18:108373. doi: 10.1016/j.intimp.2021.108373. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Allyl isothiocyanate(AITC) has been shown to play an important role in the improved symptoms of chronic obstructive pulmonary disease(COPD) and the inhibition of inflammation, but the role in COPD lipid metabolism disorder and the molecular mechanism remains unclear. We aimed to explore whether and how AITC affects COPD by regulating lipid metabolism and inflammatory response.

METHODS: The COPD rat model was established by cigarette smoke exposure. Cigarette smoke extract stimulated 16HBE cells to induce a cell model. The effect of AITC treatment was detected by lung function test, H&E staining, Oil red O staining, immunohistochemistry, ELISA, CCK-8, HPLC, fluorescence efflux test, siRNA, RT-PCR, and Western blotting. Biological analysis was performed to analyze the results. Graphpad Prism 8.0 software was used for statistical analysis.

RESULTS: AITC can improve lung function and pathological injury in COPD rats. The levels of IL-1 β and TNF- α in the AITC treatment group were significantly lower than those in the model group(P < 0.05), and the lipid metabolism was also improved (P < 0.05). AITC reverses CSE-induced down-regulation of LXR α, ABCA1, and ABCG1 expression and function in a time-and concentration-dependent manner (P < 0.05). AITC regulates the cholesterol metabolism disorder induced by CSE in NR8383 cells and attenuates macrophage inflammation (P < 0.05). In addition, after silencing LXR α with siRNA, the effect of AITC was also inhibited.

CONCLUSION: These results suggest that AITC improves COPD by promoting RCT process and reducing inflammatory response via activating LXR pathways.

PMID:34802946 | DOI:10.1016/j.intimp.2021.108373

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Nevin Manimala Statistics

Effects of meditation compared to music listening on biomarkers in breast cancer survivors with cognitive complaints: secondary outcomes of a pilot randomized control trial

Explore (NY). 2021 Nov 10:S1550-8307(21)00230-5. doi: 10.1016/j.explore.2021.10.011. Online ahead of print.

ABSTRACT

CONTEXT: We previously reported positive behavioral effects of both daily mantra meditation and classical music listening interventions in breast cancer survivors with cancer related cognitive complaints.

OBJECTIVE: The objective of this pilot study was to compare the effects of the meditation intervention to a music listening intervention on biomarkers of inflammation and cellular aging (secondary outcomes) in breast cancer survivors.

DESIGN: Randomized control trial, baseline data collection (time 1), post intervention data collection (time 2) SETTING: Community-based, Central Texas PARTICIPANTS: 25 breast cancer survivors (BCS) who were 3 months to 6 years post chemotherapy completion and reported cognitive changes.

INTERVENTION(S): Kirtan Kriya meditation (KK) or classical music listening (ML), 8 weeks, 12 min a day MAIN OUTCOME: Telomerase activity [TA], c-reactive protein [CRP], soluble IL-2 receptor alpha [sIL-2Rα], soluble IL-4 receptor [sIL-4R], soluble IL-6 receptor [sIL-6R], soluble tumor necrosis factor receptor II [sTNF-RII], VEGF receptor 2 [sVEGF-R2], and VEGF receptor 3 [sVEGF-R3] RESULTS: Repeated measures analysis of variance models were analyzed from time 1 to time 2 by group for each biomarker. A pattern of greater telomerase activity across time in both groups (F (1,15) = 3.98, p = .06, ω2 = 0.04); significant decreases in sIL-4R across time for both groups (F (1,22) = 6.28, p = .02, ω2 = .003); group*time effect was nominally different but not statistically different for sIL-4R (F(1,22) = 3.82, p = .06, ω2 = .001); and a pattern for a group*time effect with ML group showing higher levels of sVEGF-R3 at time 2 (F (1,20) = 2.59, p = .12, ω2 = .009). No significant effects were found for CRP, sIL-2Rα, sIL-6R, sTNF-RII, or sVEGF-R2.

PMID:34802955 | DOI:10.1016/j.explore.2021.10.011

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Nevin Manimala Statistics

Statistical analysis plan for the coaching for healthy AGEing trial – a cluster-randomised controlled trial to enhance physical activity and prevent falls in community-dwelling older people

Braz J Phys Ther. 2021 Nov 12:S1413-3555(21)00098-8. doi: 10.1016/j.bjpt.2021.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: This statistical analysis plan details the Coaching for Healthy AGEing (CHAnGE) trial analysis methodology.

OBJECTIVE: To investigate the effect of a combined physical activity and fall prevention program on physical activity and falls compared to a healthy eating among people aged 60 years and over.

METHODS: The CHAnGE trial is a pragmatic parallel-group cluster-randomised controlled trial with allocation concealment and blinded assessors. Clusters are allocated to either (1) a physical activity and fall prevention intervention or (2) to a healthy eating intervention. The primary outcomes are: objectively measured physical activity at 12 months post-randomisation, and self-reported falls throughout the 12-month trial period. Secondary outcomes include the proportion of participants reporting a fall, the proportion of participants meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and use of health and community services.

ANALYSIS: We will follow the intention-to-treat principle. All analysis will allow for cluster randomisation using a generalised estimating equation approach. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression models adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will take into account cluster randomisation and will be adjusted for baseline scores. A subgroup analysis will assess differential effects of the intervention by baseline physical activity levels and history of falls.

PMID:34802917 | DOI:10.1016/j.bjpt.2021.10.003

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Nevin Manimala Statistics

Improving Obstuctive Sleep Apnea Care in the Postanesthesia Care Unit

J Perianesth Nurs. 2021 Nov 18:S1089-9472(21)00286-0. doi: 10.1016/j.jopan.2021.07.007. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this quality improvement project was to improve care of obstructive sleep apnea (OSA) patients through increased staff recognition of OSA in the postanesthesia care unit (PACU).

DESIGN: Retrospective chart review with implementation of best practice guideline form to front of patient’s chart.

METHODS: Baseline data were collected during June 2020. Staff education was provided on current hospital policy of OSA patients. Implementation of a care guideline sheet was added to the front of patient charts for patients meeting inclusion criteria; it consisted of continuous pulse oximetry, 30-degree head of bed elevation, continuous positive airway pressure (CPAP) therapy, 1 hour minimum postoperative observation, nonopioid analgesics, and referral to polysomnography. A retrospective chart review was performed following the OSA guideline intervention.

FINDINGS: Both pre- (N = 413) and postintervention (N = 420) groups had statistically similar demographics. CPAP use increased from 16 to 22 (t = 0.890; P = .336). The number of patients experiencing dyspnea decreased from 10 to 8 (t = 0.263; P = .608). The number of patients experiencing acute respiratory events (AREs) decreased from 24 to 18 (t = 1.012; P = .314).

CONCLUSION: There were no significant statistical findings. However, increased recognition of OSA patients by PACU staff can lead to improved care alterations.

PMID:34802923 | DOI:10.1016/j.jopan.2021.07.007

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Nevin Manimala Statistics

Diagnostic Efficiency of Diffusion Sequences and a Clinical Nomogram for Detecting Lymph Node Metastases from Rectal Cancer

Acad Radiol. 2021 Nov 19:S1076-6332(21)00469-4. doi: 10.1016/j.acra.2021.10.009. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVES: First, to evaluate and compare three different diffusion sequences (i.e., standard DWI, IVIM, and DKI) for nodal staging. Second, to combine the DWI, and anatomic information to assess metastatic lymph node (LN).

MATERIALS AND METHODS: We retrospectively identified 136 patients of rectal adenocarcinoma who met the inclusion criteria. Three diffusion sequences (i.e., standard DWI, IVIM, and DKI) were performed, and quantitative parameters were evaluated. Univariate and multivariate analyses were used to assess the associations between the anatomic and DWI information and LN pathology. Multivariate logistic regression was used to identify independent risk factors. A nomogram model was established, and the model performance was evaluated by the concordance index (c-index) and calibration curve.

RESULTS: There was a statistical difference in variables (LN long diameter, LN short diameter, LN boundary, LN signal, peri-LN signal intensity, ADC-1000, ADC-1400, ADC-2000, Kapp and D) between metastatic and non-metastatic LN for training and validation cohorts (p < 0.05). The ADC value derived from b = 1000 mm/s (ADC-1000) showed the relative higher AUC (AUC = 0.780) than the ADC value derived from b = 1400 mm/s (ADC-1400) (AUC = 0.703). The predictive accuracy of the nomogram measured by the c-index was 0.854 and 0.812 in the training and validation cohort, respectively.

CONCLUSION: The IVIM and DKI model’s diagnostic efficiency was not significantly improved compared to conventional DWI. The diagnostic accuracy of metastatic LN can be enhanced using the nomogram model, leading to a rational therapeutic choice.

PMID:34802905 | DOI:10.1016/j.acra.2021.10.009

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Nevin Manimala Statistics

Previous Surgery and the Temporal Evolution of Functional Outcomes and Complication Rates in Total Ankle Replacement

J Foot Ankle Surg. 2021 Oct 22:S1067-2516(21)00393-8. doi: 10.1053/j.jfas.2021.10.009. Online ahead of print.

ABSTRACT

Given that most ankle replacements are post-traumatic in origin, it is important to investigate if prior interventions affect a patient’s functional outcomes or increase the possibility of complications. Prior ankle surgeries create scar tissue and zones of impaired vascularity which could ultimately interfere with surgical healing. The purpose of this study is to assess the pain and functional temporal outcomes of patients with and without prior surgeries in the ipsilateral ankle. We retrospectively identified a consecutive series of 100 primary total ankle replacements (TARs) who were followed for a minimum of 3 years, with follow-up time points of 0, 6, 12, and 36 months. We documented prior surgical interventions and several patient-reported outcomes. Outcomes were measured using American Orthopaedic Foot and Ankle Society (AOFAS) score, Visual Analogue Scale (VAS), 12-Item Short Form Study (SF-12), and range of motion scores. The 2 groups showed no difference on the temporal evolution of outcomes. An irrigation and debridement of previous open fractures was the only presurgical intervention that showed a statistically significant difference in temporal evolution of functional and pain outcomes between intervention and nonintervention groups. No significant correlations were found between all outcomes and the time between the last intervention and ankle replacement surgery. A preoperative discussion should center on potential complications and predicted functional outcomes. The presence, type, and timing of an intervention prior to an ankle replacement do not strongly affect the temporal outcomes of pain and functional outcome scores. Furthermore, the complication rate is not affected by prior surgeries.

PMID:34802908 | DOI:10.1053/j.jfas.2021.10.009

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The burden of facial trauma on mortality in patients with multiple injuries: A single-center analysis of 1862 motorcycle accidents

J Craniomaxillofac Surg. 2021 Nov 15:S1010-5182(21)00243-2. doi: 10.1016/j.jcms.2021.11.006. Online ahead of print.

ABSTRACT

The study aims to assess the influence on mortality of motorcycle road accidents, caused by injuries to the head, chest, abdomen, face, skin, pelvis and extremities. Road motorcycle accidents consecutively admitted to Level I Trauma Center were retrospectively analyzed. Each body site involvement was classified through Abbreviated Injury Score (AIS-98), and Comprehensive Facial Injury (CFI) score; Injury Severity Score (ISS) was also calculated. The data collected were subjected to a descriptive analysis and inferential statistic, with uni- and multivariate analysis; mortality was the main outcome examined. 1862 patients were studied. Limbs (53.9%) and Head (53.8%) are the most involved body site, facial trauma regards 19.4% of the sample. Only 4.4% of Facial injuries occurred as isolated, 71.6% were associated to Head involvement. The overall mortality was 4.6% and 80.0% of dead patients were affected by Head injury. Multivariate analysis shows that head (OR=3.06, p <0.0001), thoracic (OR=1.82, p <0.0001) and abdominal trauma (OR=1.41, p =0.019) are predicting the risk of death. Facial trauma does not directly influence mortality and, however severe and distracting it may be, becomes secondary to the management of frequently associated brain injuries. Severity scores targeted to the risk of death, such as AIS and AIS-derived, are ineffective in describing the true characteristics of facial injuries. The CFI score has been shown to predict the weight of surgical treatment and the outcome of the hospital stay, therefore its use is recommended.

PMID:34802885 | DOI:10.1016/j.jcms.2021.11.006

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Le Fort I osteotomy and soft tissue response: A retrospective cohort study comparing three different techniques

J Craniomaxillofac Surg. 2021 Nov 14:S1010-5182(21)00246-8. doi: 10.1016/j.jcms.2021.11.009. Online ahead of print.

ABSTRACT

The aim of this study was to evaluate the nasolabial soft tissues effects in three different Le Fort I osteotomy techniques using cone beam computed tomography (CBCT) evaluation of three-dimensional (3D) volume surfaces. A retrospective study was designed, and three groups were evaluated: group 1, patients who underwent conventional Le Fort I osteotomy; group 2, patients who underwent subspinal Le Fort I osteotomy; and group 3, patients who underwent conventional Le Fort I osteotomy with ANS recontouring or removal. CBCT evaluation was performed at two time points: T0, 1 week before surgery; T1, 6 months after surgery. A total of 90 patients were enrolled in this study (group 1: 30; group 2: 30; group 3: 30). Mean maxillary advancement was 4.26 mm. For group 1, mean change in inter-alar width was 2.29 ± 1.57 mm (minimum -2mm; maximum 6.1 mm; for group 2 it was 1.20 ± 1.56 mm (minimum -1.7 mm; maximum 5.9 mm), and for group 3 was 1.84 ± 1.76 mm (minimum -2.3 mm; maximum 5.9 mm). For group 1, mean change in alar base width was 1.69 ± 2.32 mm (minimum -4.8 mm; maximum 6,1 mm); in group 2 it was 0.85 ± 2.08 mm (minimum -4mm; maximum 6 mm), and group 3 was 1.21 ± 1.83 mm (minimum -2mm; maximum 5 mm). Results showed statistically significant differences in nasolabial area (P < 0.001). Within the limitations of the study it seems that subspinal Le Fort I osteotomy should be preferred when the priority is to avoid changes to the nasolabial region.

PMID:34802886 | DOI:10.1016/j.jcms.2021.11.009

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Nevin Manimala Statistics

Magnetic Resonance Imaging in Coronavirus Disease – 2019 Associated Rhino-Orbital-Cerebral Mucormycosis (CA-ROCM) – Imaging Analysis of 50 Consecutive Patients

Curr Probl Diagn Radiol. 2021 Nov 3:S0363-0188(21)00166-3. doi: 10.1067/j.cpradiol.2021.09.004. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Rhino-orbital-cerebral mucormycosis has emerged as a major opportunistic infection in patients with COVID-19. High clinical suspicion and prompt imaging are crucial for early diagnosis and management. Our study evaluates imaging characteristics of patients with COVID-19 associated Rhino-orbital-cerebral Mucormycosis (CA-ROCM) in a tertiary care hospital in India.

MATERIALS AND METHODS: A retrospective analysis of clinical and imaging data of patients with CA-ROCM who presented between December 2020 to June 2021 was performed. All patients had microbiologically or histologically proven sino-nasal mucormycosis along with documented SARS-CoV-2 positive RT-PCR test and/or classical lung imaging features of COVID-19 infection. The extent of sinus involvement, bony erosions, extra-sinus soft tissue extension, orbital-intracranial invasion, perineural spread, and vascular complications were assessed.

RESULTS: Fifty patients were included for the final analysis. Diabetes was the most common associated comorbidity. Seven patients presented with stage I disease, 18 patients with stage II, and 25 patients with stage III disease. The stage of disease showed a positive statistical correlation with HbA1c levels using Pearson’s correlation. The common imaging features were “Black turbinate sign” and nonenhancing sino-nasal mucosa (82%), orbital involvement (76%), and diffusion restriction in the optic nerve (24%). Intracranial involvement was seen as perineural extension into the brain (42%), cerebritis (30%), and internal carotid artery involvement (16%).

CONCLUSIONS: CA-ROCM is an acute invasive fungal sinusitis with an aggressive clinical course. Black-turbinate sign and peri-antral soft tissue infiltration are early features, whereas extra-nasal tissue infarction, optic nerve diffusion restriction, and vascular invasion are seen with advanced disease.

PMID:34802841 | DOI:10.1067/j.cpradiol.2021.09.004