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One-year results following PASCAL-based or MitraClip-based mitral valve transcatheter edge-to-edge repair

ESC Heart Fail. 2022 Feb 15. doi: 10.1002/ehf2.13849. Online ahead of print.

ABSTRACT

AIMS: Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a suitable alternative to mitral valve surgery in patients with severe mitral regurgitation (MR) and high surgical risk. The PASCAL system represents a novel device, potentially augmenting the toolkit for TEER. The aim of this study was to assess and compare short and 1 year safety and efficacy of the PASCAL and MitraClip systems for TEER.

METHODS AND RESULTS: Procedural, short, and 1 year outcomes of a 1:2 propensity-matched cohort including 41 PASCAL and 82 MitraClip cases were investigated. Matching was based on clinical, laboratory, echocardiographic, and functional characteristics. The primary endpoints assessed were procedural success [as defined by the Mitral Valve Academy Research Consortium (MVARC)], residual MR, functional class, and a composite endpoint comprising death, heart failure hospitalization, and mitral valve re-intervention. We found for the PASCAL and the matched MitraClip cohort no significant differences in MVARC defined technical (90.2% vs. 95.1%, P = 0.44), device (90.2% vs. 89.0%, P = 1.0), or procedural (87.8% vs. 80.5%, P = 0.45) success rates. Accordingly, the overall MR reduction and improvement in New York Heart Association (NYHA) class were comparable (1 year follow-up: MR ≤ 2 95% vs. 93.6%, P = 1.0; NYHA ≤ 2 57.1% vs. 66.7%, P = 0.59). The composite outcome revealed no statistically significant difference between both devices (1 year follow-up: 31.7% vs. 37.8%, P = 0.55). Interestingly, we found at both short and 1 year follow-up a significantly higher rate of patients with none or trace MR in the PASCAL-treated cohort (short follow-up: 17.9% vs. 0%, P = 0.0081; 1 year follow-up: 25% vs. 0%, P = 0.0016). Conversely, the rate of aborted device implantations due to an elevated transmitral gradient was higher in PASCAL interventions (9.8% vs. 1.2%, P = 0.04).

CONCLUSIONS: Transcatheter edge-to-edge repair using the PASCAL or MitraClip device results in favourable and comparable outcomes regarding safety, efficacy, and clinical improvement after 1 year.

PMID:35170230 | DOI:10.1002/ehf2.13849

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Effectiveness of sodium bicarbonate and zinc chloride mouthwashes in the treatment of oral mucositis and quality of life in patients with cancer under chemotherapy

Nurs Open. 2022 Feb 16. doi: 10.1002/nop2.1168. Online ahead of print.

ABSTRACT

AIM: The purpose of the study is to evaluate the effectiveness of sodium bicarbonate and zinc chloride mouthwashes on oral mucositis and quality of life in patients undergoing chemotherapy.

DESIGN: The present study was a randomized controlled trial study.

METHODS: One hundred forty-four patients with a cancer diagnosis were randomly assigned into three groups: sodium bicarbonate mouthwash (n = 48), zinc chloride mouthwash (n = 48) and placebo group (n = 48). The severity of mucositis and quality of life were examined blindly at the baseline and 3-week follow-up.

RESULTS: The grade of oral mucositis decreased at the end of the third weeks in the sodium bicarbonate and zinc chloride groups rather than the placebo group (p < .001). The severity of oral mucositis in the sodium bicarbonate and zinc chloride groups decreased from end of the first week until third week (p < .001). In addition, there was significant difference in the severity of oral mucositis among the groups at the end of the second (p = .014) and the third weeks (p < .001). Also, there was a statistically significant difference in quality of life scores between the sodium bicarbonate and zinc chloride mouthwash with the placebo group (p < .001).

CONCLUSION: Zinc chloride and sodium bicarbonate mouthwashes were effective in treating and reducing the severity of oral mucositis, and subsequently improving quality of life in patients with cancer under chemotherapy. Therefore, we can recommend zinc chloride and sodium bicarbonate at the beginning of chemotherapy to improve oral health and promoting quality of life in these patients.

PMID:35170247 | DOI:10.1002/nop2.1168

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Effect of food on capsule and granule formulations of selumetinib

Clin Transl Sci. 2022 Feb 15. doi: 10.1111/cts.13209. Online ahead of print.

ABSTRACT

Selumetinib is an oral, potent, and highly selective allosteric MEK1/2 inhibitor approved for the treatment of pediatric patients (aged ≤2 years) with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. A granule formulation of selumetinib is under development to improve dosing precision for younger pediatric patients who may be unable to swallow capsules. This phase I crossover study investigated the effect of food on the pharmacokinetic (PK) properties of selumetinib capsule and granule formulations. Healthy male volunteers were randomized to receive selumetinib granules (25 mg) or capsules (50 mg [2 × 25 mg]) under fasted or fed conditions (a low-fat meal). Plasma concentrations and PK parameters were determined less than or equal to 48 h postdose. Safety and tolerability were assessed. Across 24 volunteers, selumetinib was absorbed quickly, with a time to maximum concentration (Tmax ) ranging from ~1-3 h. Geometric mean ratios (90% confidence interval [CI]) for maximum plasma concentration (Cmax ) in the fed versus fasted state were 0.61 (90% CI 0.51-0.72) and 0.40 (90% CI 0.33-0.48) for the granule and capsule formulations, respectively, whereas geometric mean ratios (90% CI) for area under the plasma drug concentration-time curve in the fed versus fasted state were 0.97 (90% CI 0.91-1.02) and 0.62 (90% CI 0.55-0.70), respectively. Levels of less than 10% conversion to the N-desmethyl selumetinib metabolite were observed. Selumetinib was well-tolerated, with only a few adverse events of mild intensity reported. Selumetinib administration with a low-fat meal resulted in lower Cmax and longer Tmax for both formulations versus fasted conditions. However, area under the curve for selumetinib granules was similar under fasted and fed conditions. Overall, these findings support further development of this formulation for pediatric patients.

PMID:35170228 | DOI:10.1111/cts.13209

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Prevalence and risk factors for uveitis in spondyloarthritis

Int J Rheum Dis. 2022 Feb 15. doi: 10.1111/1756-185X.14303. Online ahead of print.

ABSTRACT

AIM: To determine the prevalence and risk factors for uveitis in spondyloarthritis (SpA) patients.

METHODS: A total of 225 patients who fulfilled Assessment of Spondyloarthritis International Society classification criteria for axial and peripheral SpA were enrolled. The diagnosis of uveitis was confirmed by an ophthalmologist. From medical records and from clinical evaluation associated information like disease duration, and human leukocyte antigen B27 was collected. Relevant laboratory tests were done and disease severity was assessed using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score – erythrocyte sedimentation rate and C-reactive protein. Characteristics of uveitis positive and uveitis negative groups were compared. Multivariate logistic regression analysis was done for the risk factors, and P values <.05 were considered significant.

RESULTS: Prevalence of uveitis was 18.7%. The disease duration was 9.3 ± 7 years and 5.4 ± 4.5 years in uveitis and no uveitis groups respectively (P ≤ .001). Family history of SpA was positive in 45.2% in the uveitis group (P ≤ .001). The frequency of axial SpA was 92.9% and 73.8% in the uveitis and no uveitis groups respectively (P ≤ .008). The mean BASDAI was 2.4 ± 1.9 and 3.3 ± 2.8 in uveitis and no uveitis groups respectively (P = .050). In multivariate logistic regression analysis, among the selected variables, family history of SpA (odds ratio [OR] =3.697; 95% CI =1.616-8.457; P = .002) and duration of disease (OR =1.089; 95% CI =1.004-1.181; P = .039) were independently associated with the occurrence of uveitis.

CONCLUSIONS: The prevalence of uveitis was 18.7%. The family history and the disease duration of SpA were independently associated with uveitis.

PMID:35170215 | DOI:10.1111/1756-185X.14303

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Comparison of postoperative laparoscopic and open total mesorectal excision on lower urinary tract function in men with rectal cancer

Low Urin Tract Symptoms. 2022 Feb 15. doi: 10.1111/luts.12429. Online ahead of print.

ABSTRACT

OBJECTIVES: This study investigated male voiding dysfunction (VD) or lower urinary tract function in rectal cancer (RC) patients after laparoscopic or open total mesorectal excision with pelvic autonomic nerve preservation (PANP).

METHODS: One hundred and eighty-seven male RC patients admitted between January 2016 and May 2019 were enrolled in this study, 112 of whom underwent laparoscopic total mesorectal excision (LTME) and 75 underwent open total mesorectal excision (OTME). The International Prostatic Symptom Score (IPSS) was compared between the two groups.

RESULTS: The postoperative IPSS in patients with RC was elevated on day 7 and gradually decreased during the first month after surgery. Compared with the OTME group, the IPSS scores decreased less in the LTME group at week 1, and months 1 and 3 postoperatively (6.82 ± 2.13 vs 10.15 ± 3.86, 5.70 ± 2.45 vs 7.21 ± 2.0, and 5.01 ± 2.09 vs 5.75 ± 2.55, respectively; P < 0.05). The VD rate was significantly lower in the LTME group than the OTME group at 1, 2, and 3 weeks postoperatively (21.4% vs 26.8%,13.4% vs 25.3%, and 9.8% vs18.6%, respectively; P < 0.05); however, there was no major difference in the incidence of VD 6 months postoperatively between the two groups (P > 0.05). VD was more frequent in the OTME group than the LTME group 6 months postoperatively, but the difference was not statistically significant (odds ratio = 1.857, 95% CI, 0.964-3.645, P = 0.064).

CONCLUSIONS: LTME may be superior to OTME with respect to PANP of lower urinary tract function in males with RC.

PMID:35170222 | DOI:10.1111/luts.12429

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Botrytis cinerea BcSSP2 protein is a late infection phase, cytotoxic effector

Environ Microbiol. 2022 Feb 15. doi: 10.1111/1462-2920.15919. Online ahead of print.

ABSTRACT

Botrytis cinerea is a broad-host-range necrotrophic phytopathogen responsible for serious diseases in leading crops. To facilitate infection, B. cinerea secretes a large number of effectors that induce plant cell death. In screening secretome data of B. cinerea during infection stage, we identified a phytotoxic protein (BcSSP2) that can also induce immune resistance in plants. BcSSP2 is a small, cysteine-rich protein without any known domains. Transient expression of BcSSP2 in leaves caused chlorosis that intensifies with time and eventually leads to death. Point mutations in eight of 10 cysteine residues abolished phytotoxicity, but residual toxic activity remained after heating treatment, suggesting contribution of unknown epitopes to protein phytotoxicity. The expression of bcssp2 was low during the first 36 h after inoculation and increased sharply upon transition to late infection stage. Deletion of bcssp2 did not cause statistically significant changes in lesions size on bean and tobacco leaves. Further analyses indicated that the phytotoxicity of BcSSP2 is negatively regulated by the receptor-like kinases BAK1 and SOBIR1. Collectively, our findings show that BcSSP2 is an effector protein that toxifies the host cells, but is also recognized by the plant immune system.

PMID:35170184 | DOI:10.1111/1462-2920.15919

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Intralesional Bivalent Human Papilloma Virus Vaccine as a Treatment for Anogenital Warts versus Topical Podophyllin Resin 25%: A Pilot Study

Dermatol Ther. 2022 Feb 16:e15384. doi: 10.1111/dth.15384. Online ahead of print.

ABSTRACT

A role of human papilloma virus (HPV) vaccines as a therapy for genital warts was suggested, nevertheless; it has not been established in clinical trials and has yet to be determined. To evaluate a potential benefit of intralesional injection of bivalent HPV (Cervarix) vaccine as a treatment for anogenital warts versus topical podophyllin resin 25%. Forty four patients with anogenital warts were included in the study, 22 patients received intralesional Cervarix every 2 weeks until clearance of lesions or for a maximum of 5 sessions. The other 22 patients received topical podophyllin resin 25% twice weekly until complete resolution or for a maximum of four weeks. Follow up was done for 6 months. Dermatology life quality index (DLQI) was measured. Complete clearance of warts was achieved in 10 patients (45.5%) in Cervarix group vs 6 patients (27.3%) in Podophyllin group. The difference was statistically insignificant. No recurrence of warts was reported in Cervarix group while 2 patiens (33.3%) showed recurrence in Podophyllin group. Both treatments were well tolerated. All patients reported significant improvement of their DLQI. Intralesional Cervarix is a promising modality showing higher rates of complete response, high safety, and no recurrence. This article is protected by copyright. All rights reserved.

PMID:35170176 | DOI:10.1111/dth.15384

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Impact of a new young adult inflammatory bowel disease transition clinic on patient satisfaction and clinical outcomes

J Paediatr Child Health. 2022 Feb 16. doi: 10.1111/jpc.15907. Online ahead of print.

ABSTRACT

AIM: The transition from paediatric to adult care for patients with inflammatory bowel disease (IBD) is associated with an increased risk of treatment non-adherence, hospitalizations and emergency department (ED) use. We established a new young adult IBD clinic (YAC) in Melbourne to capture this at-risk population. We aimed to assess patient satisfaction as well as clinical outcomes.

METHODS: All patients who attended the YAC between its inception in November 2016 and November 2018 were recruited to our YAC group, 61 patients in total. A control group was selected from the pre-existing adult clinic (AC) at our service, 34 patients in total. IBD-related ED (IBD-ED) visits were collected for all patients. We compared IBD-ED visits in the 2 years before and after attending the clinic for the first time. Patient satisfaction was assessed using the IBD-Patient Satisfaction Questionnaire.

RESULTS: There was an overall decrease in IBD-ED visits between the pre-clinic and post-clinic periods in both the YAC (42.9% reduction) and AC (69.2% reduction) (P < 0.001). Patient satisfaction was high amongst both services with YAC patients indicating higher satisfaction with communication (P = 0.015).

CONCLUSION: There was a reduction in IBD-ED visits in both the YAC and the AC, high patient satisfaction, and statistically higher satisfaction with communication in the YAC. We speculate the importance of a YAC is to capture those patients in the peri-transitional period at risk of being lost to follow-up or not previously referred for specialist care.

PMID:35170119 | DOI:10.1111/jpc.15907

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A 78 Seconds Complete Brain MRI Examination in Ischemic Stroke: A Prospective Cohort Study

J Magn Reson Imaging. 2022 Feb 16. doi: 10.1002/jmri.28107. Online ahead of print.

ABSTRACT

BACKGROUND: Fast 78-second multicontrast echo-planar MRI (EPIMix) has shown good diagnostic performance for detecting infarctions at a comprehensive stroke center, but its diagnostic performance has not been evaluated in a prospective study at a primary stroke center.

PURPOSE: To prospectively determine whether EPIMix was noninferior in detecting ischemic lesions compared to routine clinical MRI.

STUDY TYPE: Prospective cohort study.

POPULATION: A total of 118 patients with acute MRI and symptoms of ischemic stroke.

FIELD STRENGTH AND SEQUENCE: A 3 T. EPIMix (echo-planar based: T1-FLAIR, T2-weighted, T2-FLAIR, T2*, DWI) and routine clinical MRI sequences (T1-weighted fast spin echo, T2-weighted PROPELLER, T2-weighted-FLAIR fast spin echo, T2* gradient echo echo-planar, and DWI spin echo echo-planar).

ASSESSMENT: Three radiologists, blinded for clinical information, assessed signs of ischemic lesions (DWI↑, ADC↓, and T2/T2-FLAIR↑) on EPIMix and routine clinical MRI, with disagreements solved in consensus with a fourth reader to establish the reference standard.

STATISTICAL TESTS: Diagnostic performance including sensitivity and specificity against the reference standard was evaluated. EPIMix sensitivity was tested for noninferiority compared to the reference standard using Nam’s restricted maximum likelihood estimation (RMLE) Score. A P-value < 0.05 was considered statistically significant.

RESULTS: Of 118 patients (mean age 62 ± 16 years, 58% males), 25% (n = 30) had MRI signs of acute infarcts. EPIMix was noninferior with 97% (95% CI 83-100) sensitivity for reader 1, 100% (95% CI 88-100) sensitivity for reader 2, and 90% (95% CI 88-98) sensitivity for reader 3 vs. 93% (95% CI 78-99) sensitivity for readers 1 and 2 and 90% (95% CI 74-98) for reader 3 on routine clinical MRI. Specificity was 99% (95% CI 94-100) for reader 1, 100% (95% CI 96-100) for reader 2, and 98% (95% CI 92-100) for reader 3 on EPIMix vs. 100% (95% CI 96-100) for all readers on routine clinical MRI.

CONCLUSION: EPIMix was noninferior to routine clinical MRI for the diagnosis of acute ischemic stroke.

EVIDENCE LEVEL: 2 TECHNICAL EFFICACY: Stage 2.

PMID:35170134 | DOI:10.1002/jmri.28107

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Effects of mindfulness-based interventions on psychological distress and mindfulness in incarcerated populations: A systematic review and meta-analysis

Crim Behav Ment Health. 2022 Feb 15. doi: 10.1002/cbm.2230. Online ahead of print.

ABSTRACT

BACKGROUND: As incarcerated populations report significantly higher prevalence rates for psychological distress than community populations, it is important to have an evidence-based perspective on what reduces psychological distress among people in prison or jail.

AIMS: To examine effects of mindfulness-based interventions (MBIs) on psychological distress, including anxiety, depressive symptoms, stress and overall psychological distress, and on mindfulness in incarcerated populations.

METHODS: This systematic review and meta-analysis of randomised controlled trials (RCTs) involved a comprehensive search within the PubMed, CINAHL, PsycINFO, and SCOPUS databases to identify relevant RCTs. The quality of the included RCTs was assessed using the Cochrane Collaboration risk of bias tool. Depending on I2 statistic values for heterogeneity, either a random effects model or fixed effects model was used. Subgroup analyses for each outcome were conducted to see whether effects differed when compared MBIs to active control groups, provided with other comparable interventions, or passive control groups, provided with no intervention (i.e., treatment as usual [TAU] control groups or waiting list controls).

RESULTS: Thirteen RCTs met the eligibility criteria. Meta-analyses showed moderate effects of MBIs on depressive symptoms and overall psychological distress, large effects on stress, and small effects on anxiety and mindfulness. The overall risk of bias across studies was unclear. Fewer studies were conducted to compare effects of MBIs to other interventions than TAU.

CONCLUSIONS: Future high-quality studies comparing MBIs to other active interventions are needed to understand better whether the former are comparable or superior to other evidence-based treatments in decreasing distress and improving mindfulness in incarcerated populations and/or in which circumstances one may be preferable to the other.

PMID:35170107 | DOI:10.1002/cbm.2230