Nevin Manimala

J Cardiovasc Electrophysiol. 2021 Mar 16. doi: 10.1111/jce.15006. Online ahead of print.

ABSTRACT

BACKGROUND: Powered transvenous lead extraction (TLE) tools are commonly required to remove the leads with long implant duration due to fibrotic adhesions. However, comparative data are lacking among different types of TLE tools.

AIM: To compare the efficacy and safety of two different rotational mechanical dilator sheaths in retrospectively analyzed patients who underwent TLE.

METHODS AND RESULTS: A total of 566 lead extractions from 302 patients using TightRail^TM (333 lead extractions from 169 patients) and Evolution® (233 lead extractions from 133 patients) mechanical dilator sheaths were performed between July 2009 and June 2018. Acute and long term outcomes of study groups were compared. There is no statistically significant difference between Evolution® and TightRail^TM groups in procedural success (93.9% vs. 94%), clinical success (99.2% vs. 98%) and major complications (3.8% vs. 1.2%), respectively (p>0.05). In multivariate regression analysis, lead dwell time, the number of extracted leads, and baseline leukocyte count was found as independent predictors of procedural success (p<0.05). During the median follow-up of 36.6 (0.2-118) months, all-cause mortality was observed in 73 patients (25.6% in the Evolution® vs. 23.1 in the TightRail^TM group, p>0.05). Chronic renal disease, heart failure, and coagulopathy were shown as independent predictors of all-cause mortality in multivariate regression analysis (p<0.05).

CONCLUSIONS: TLE using TightRail^TM or Evoluation® mechanical dilator sheaths was a safe and effective therapeutic option. Both mechanical dilator sheaths showed similar efficacy, safety, and all-cause mortality at acute and long-term follow-up of patients who underwent TLE. This article is protected by copyright. All rights reserved.

PMID:33724617 | DOI:10.1111/jce.15006

Colorectal Dis. 2021 Mar 16. doi: 10.1111/codi.15631. Online ahead of print.

ABSTRACT

AIM: Treatment of early rectal cancer (ERC) is undergoing a revolution towards rectum preservation. Adjuvant and neoadjuvant therapy alongside local excision (LE) means that organ preservation is a real possibility for most patients and a viable alternative for frailer patients. This study presents our 12-year experience as a specialist regional early rectal cancer unit, evolving towards organ preservation.

METHOD: Data was collected prospectively between 2006 – 2018 for all patients referred to the regional ERC multidisciplinary team (MDT) with suspected or confirmed ERC. Patients considered suitable for LE, or those declining radical surgery, were offered LE or neoadjuvant short course radiotherapy (SCRT), delay and LE with subsequent rescue surgery or contact brachytherapy for unfavourable histopathology.

RESULTS: 102 patients underwent LE. 10 patients were excluded (N=92). 45 patients underwent LE directly and 47 patients received SCRT and LE. After SCRT & LE, a pathological complete response was achieved in 44.7%. This approach also resulted in a lower rate of lymphovascular invasion (22.2% vs. 6.4%), fewer distant recurrences (4.4% vs 0%) and a better disease-specific mortality (11.1% vs 0%) (p<0.05). Although statistically insignificant, fewer patients required rescue surgery after SCRT(15.6% vs 4.3%).

CONCLUSION: Organ preservation with a good oncological outcome is better achieved by neoadjuvant radiotherapy, delay and LE. To achieve this, careful patient selection, thorough preoperative investigation, experienced surgical technique and a deep appreciation of tumour biology, managed via a dedicated early rectal cancer network is paramount.

PMID:33724612 | DOI:10.1111/codi.15631

Hum Brain Mapp. 2021 Mar 16. doi: 10.1002/hbm.25399. Online ahead of print.

ABSTRACT

Because of the high dimensionality of neuroimaging data, identifying a statistical test that is both valid and maximally sensitive is an important challenge. Here, we present a combination of two approaches for functional magnetic resonance imaging (fMRI) data analysis that together result in substantial improvements of the sensitivity of cluster-based statistics. The first approach is to create novel cluster definitions that optimize sensitivity to plausible effect patterns. The second is to adopt a new approach to combine test statistics with different sensitivity profiles, which we call the min(p) method. These innovations are made possible by using the randomization inference framework. In this article, we report on a set of simulations and analyses of real task fMRI data that demonstrate (a) that the proposed methods control the false-alarm rate, (b) that the sensitivity profiles of cluster-based test statistics vary depending on the cluster defining thresholds and cluster definitions, and (c) that the min(p) method for combining these test statistics results in a drastic increase of sensitivity (up to fivefold), compared to existing fMRI analysis methods. This increase in sensitivity is not at the expense of the spatial specificity of the inference.

PMID:33724597 | DOI:10.1002/hbm.25399

Phytother Res. 2021 Mar 16. doi: 10.1002/ptr.7074. Online ahead of print.

ABSTRACT

Gastrointestinal discomfort (GD), which often includes gastroesophageal reflux disease (GERD), is a common disorder in healthy adults affecting 40% of the worldwide population. The symptoms related to GD can have a negative impact on the quality of life (QoL). Current treatments for GERD are associated with side effects. We conducted a randomized double-blind placebo-controlled trial to assess the effect of a standardized extract of Opuntia ficus-indica L. cladodes and Olea europaea L. leaves on the symptoms and QoL of healthy adults with GD. One hundred healthy participants with GD were enrolled in the study and divided into two groups: 60 participants taking verum (400 mg/day) and 40 taking the placebo for 8 weeks. The Gastrointestinal Quality of Life index (GIQLI) and GERD Symptom Assessment Scale (GSAS) questionnaires were administered at the beginning of the study and after 4 and 8 weeks. The group treated with verum experienced a statistically significant improvement of GIQLI and GSAS scores (p < .001). Moreover, the effect size measured revealed a clinical significance. A day-dependent improvement of symptoms was also observed. The standardized extract represents a fast, effective, and well-tolerated treatment for improving symptoms related to GD and GERD.

PMID:33724592 | DOI:10.1002/ptr.7074

Phytother Res. 2021 Mar 16. doi: 10.1002/ptr.7079. Online ahead of print.

ABSTRACT

Phytonutrients exert several pharmacological effects on humans. In this study, we performed an umbrella review of the association of phytonutrient supplements (PNSs) with biomarkers of cardiovascular disease. Relevant published systematic reviews and meta-analyses of clinical trials were identified by searching PubMed, Embase, and Cochrane Library until July 4, 2020. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) for summarized effects and I² statistics of heterogeneity were extracted from individual studies or reanalyzed using a random-effects model. Of the 50 included studies, pooled effects of PNSs on blood pressure, lipid profiles, and glycemic control were reported in 16, 25, and 14 articles, respectively. The findings appeared to be highly heterogeneous among individual trials of included systematic reviews and meta-analyses. Ginger (WMD = -6.36 mmHg, 95% CI = -11.27, -1.46) and Hibiscus sabdariffa (WMD = -7.58 mmHg, 95% CI = -9.69, -5.46) were associated with lowered systolic blood pressure, whereas Aloe vera, Nigella sativa, and spirulina were associated with beneficial effects on both lipid profiles and glycemic control. In summary, this umbrella review has provided up-to-date evidence for the effect of PNSs on biomarkers related to hypertension, dyslipidemia, and diabetes. The results must be interpreted with caution due to potential heterogeneity.

PMID:33724587 | DOI:10.1002/ptr.7079

Ultrasound Obstet Gynecol. 2021 Mar 16. doi: 10.1002/uog.23629. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study was to explore the risk of levator ani avulsion and levator hiatus enlargement following vaginal birth after cesarean section (VBAC) in comparison to primiparous women after their first vaginal delivery.

METHODS: In this multicenter observational cohort study we identified all women who had a term VBAC for their second delivery at the Departments of Gynecology and Obstetrics, Faculty of Medicine in Pilsen and the 1st Faculty of Medicine , Prague, Charles University, Czech Republic between 2012 and 2016. Women having a repeat VBAC, preterm birth or stillbirth were excluded from the study. As a control group, we enrolled a cohort of primiparous women who had their first vaginal birth during the studied period. To increase our control sample we also invited all primiparous women who delivered vaginally between May and June 2019 . All participants were invited for a 4D pelvic floor ultrasound to assess levator trauma. Levator avulsion and the levator hiatus area at rest and on maximal Valsalva were assessed off-line from the stored pelvic floor volumes during contraction and Valsalva. The laterality of the avulsion was additionally noted. The cohorts were then compared using Chi-square test and Wilcoxon two-sample test according to the distribution of normality, p-value <0.05 was considered statistically significant. Multivariate regression controlling for age and BMI was additionally performed.

RESULTS: A total of 301 women had a VBAC for their second delivery during the studied period. Of these, 152 (50.5%) attended the ultrasound examination and full data were available for 141 women for statistical analyses. The control group comprised 113 primiparous women. A significant difference between VBAC and control group in age (32.7 vs. 30.1 years, p < 0.05), BMI (28.4 vs 27.4, p < 0.05), durations of the first (293.1 vs 346.9 min, p < 0.05) and the second (27.6 vs 35.5 min, p < 0.05) stages of labor at time of the index birth was observed. The levator avulsion rate was significantly higher in the VBAC compared to the control group (32.6 vs 18.6 %, p = 0.01). The difference was observed dominantly in unilateral avulsions and remained significant after controlling for age and BMI (adjusted OR 2.061; 95% CI:1.103 – 3.852). There were no statistically significant differences in the size of levator hiatus at rest (12.0 vs. 12.6 cm² , p = 0.28) or Valsalva (18.6 vs. 18.7 cm² , p = 0.55). The incidence of levator ballooning was comparable in VBAC and Controls (17.7 % and 18.6 %, p = 0.9).

CONCLUSIONS: VBAC is associated with a significantly higher rate of levator ani avulsion compared to the first vaginal birth in nulliparous women. The difference was significant even after controlling for age and BMI. This article is protected by copyright. All rights reserved.

PMID:33724564 | DOI:10.1002/uog.23629

Reprod Domest Anim. 2021 Mar 16. doi: 10.1111/rda.13928. Online ahead of print.

ABSTRACT

This study aimed to evaluate the effect of seminal plasma on bovine sperm cryopreservation and to assess the integrity of plasma and acrosomal membranes, mitochondrial potential, remodeling of F-actin cytoskeleton and sperm chromatin fragmentation during the cooling, equilibrium and freezing/thawing stages. Six ejaculates collected from 7 Nelore bulls (n=42) were used in this study. Each ejaculate was divided into two aliquots (with seminal plasma=SP group; without seminal plasma=NSP group) and packed to a final concentration of 50 x 10⁶ sperm per straw. Statistical analyses were performed using SAS software (version 9.3) and P≤0.05 was considered significant. A time effect was observed for all sperm characteristics (P<0.05), except for chromatin fragmentation (P>0.05). The presence of seminal plasma better preserved the acrosomal integrity (SP=75.2% and NSP=71.7%; P<0.05) and also provided lower F-actin remodeling during cryopreservation process (SP=29.9% and NSP=32.4%; P<0.05). Regarding to the cryopreservation stages, it was observed that cooling step induced higher remodeling of F-actin than the equilibrium and freezing/thawing stages (56.3%, 32.2% and 23.9%, respectively; P<0.05). The equilibrium step had minor influence on overall sperm characteristics while the freezing/thawing stage was responsible for the highest percentage of damage in plasma membrane (-65.2%), acrosomal membrane (-34.0%) and mitochondrial potential (-48.1%). On the other hand, none of the cryopreservation stages affected chromatin integrity. It was concluded that the presence of seminal plasma provides increased acrosomal integrity and reduced remodeling of F-actin cytoskeleton. Higher F-actin remodeling is observed after the cooling step while the freezing/thawing step is most damaging to sperm membranes and mitochondrial potential during bovine sperm cryopreservation.

PMID:33724558 | DOI:10.1111/rda.13928

J Clin Lab Anal. 2021 Mar 16:e23705. doi: 10.1002/jcla.23705. Online ahead of print.

ABSTRACT

BACKGROUND: Conflicting results are found in the literature relating serum lipids levels and prostate cancer. Some results imply a relationship between them; others contradict this association. The purpose of this study was to investigate a possible association between serum lipids levels and prostate cancer, at time of diagnosis.

METHODS: We measured serum levels of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides in 237 patients submitted to a prostate biopsy, with PSA between 2 and 10 ng/ml. Patients without cancer at biopsy were used as controls, and the others were considered as cases. No information about lipid-lowering therapy, including statins, was available neither in cases nor in controls. Cases were divided into risk groups, according to the disease severity, based on staging. Lipids levels were compared between groups, using parametric and nonparametric tests. Logistic regression analysis and odds ratios were calculated.

RESULTS: LDL and total cholesterol levels were lower in patients with cancer, with the difference being statistically significant for LDL cholesterol (p = 0.010) and borderline for total cholesterol (p = 0.050). No significant differences were found between the several risk groups. Odds ratios for low LDL cholesterol (<130 mg/dl) and low total cholesterol (<200 mg/dl), with prostate cancer as the outcome, were 1.983 and 1.703, respectively. There were no significant differences between cases and controls for the other lipids.

CONCLUSION: Lower LDL cholesterol (<130 mg/dl) and lower total cholesterol (<200 mg/dl) serum levels seem to associate with prostate cancer, at time of diagnosis.

PMID:33724557 | DOI:10.1002/jcla.23705

Magn Reson Med. 2021 Mar 16. doi: 10.1002/mrm.28696. Online ahead of print.

ABSTRACT

PURPOSE: To explore if R₂ ‘ mapping can assess renal hypoxia in rabbits with ischemia reperfusion injury (IRI).

METHODS: Forty rabbits were randomly divided into 4 groups according to the clipping time: the sham group and 45 min, 60 min, and 75 min for the mild, moderate, and severe groups (with n = 10 each group), respectively. Intravenous furosemide (FU) was administered 24 h after IRI. All rabbits were performed 5 times (IRI_pre , IRI_24h , FU_5min , FU_12min , and FU_24min ) with a 3.0 Tesla MR. The R₂ ‘ values and the hypoxic scores were then recorded. The repeated measurement analysis of variance and Spearman correlation analysis was used for statistical analysis.

RESULTS: Compared to the baseline, the medullary R₂ ‘ values increased significantly 24 h after the IRI (baseline 19.31 ± 1.21 s^-1 , mild group 20.05 ± 1.26 s^-1 , moderate group 25.38 ± 1.38 s^-1 , and severe group 25.79 ± 1.10 s^-1 ; each P < .001). FU led to a significant decrease in the medullary R₂ ‘ value (sham group 11.17 ± 4.33 s^-1 , mild group 7.80 ± 0.74 s^-1 , moderate group 3.92 ± 0.28 s^-1 , and severe group 3.82 ± 0.23 s^-1 ; each P < .05). Quantitative hypoxic scores revealed significant differences among the 4 groups in the outer medulla (P < .001 each). The medullary R₂ ‘ differences (before and after intravenous FU) were significantly correlated with the hypoxic scores, respectively (P < .001).

CONCLUSION: R₂ ‘ mapping can evaluate the renal hypoxia in the procession of IRI in rabbits and might serve as a quantitative biomarker for IRI.

PMID:33724527 | DOI:10.1002/mrm.28696

J Clin Lab Anal. 2021 Mar 16:e23760. doi: 10.1002/jcla.23760. Online ahead of print.

ABSTRACT

BACKGROUND: Identifying new molecular diagnostic markers for Mycoplasma Pneumoniae Pneumonia (MPP) has always been an essential topic since MPP cases have increased every year, especially among children. Here, we examined the correlation between serum level of Purinergic receptor P2X7, vitamin A, and 25-hydroxy vitamin D (25(OH)D) and the severity of MPP, aiming to identify molecules that have the potential to become diagnostic markers.

METHODS: This study was conducted on 186 cases aged 1-14 (136 MPP and 50 non-MPP patients). Serum levels of Purinergic receptor P2X7, vitamin A, 25(OH)D, and multiple inflammatory and immune factors were measured, compared, and tested for statistical significance.

RESULTS: Serum P2X7, tumor necrosis factor-α (TNF-α), and interleukin-1β (IL-1β) levels were significantly increased in severe MPP patients, while serum vitamin A, 25(OH)D, IgA, and IgG levels were significantly decreased.

CONCLUSION: Our results demonstrated a positive correlation between serum P2X7 level and the severity of MPP, and negative correlations between serum levels of vitamin A and 25(OH)D and the severity of MPP, suggesting that high serum levels of P2X7 and low serum levels of vitamin A and 25(OH)D may indicate relatively severer MPP.

PMID:33724522 | DOI:10.1002/jcla.23760