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Nevin Manimala Statistics

Rotational Thromboelastometry Derivative Fibrinogen-Platelet Ratio Predicts Thrombosis in Microsurgery

J Reconstr Microsurg. 2021 May 19. doi: 10.1055/s-0041-1727190. Online ahead of print.

ABSTRACT

BACKGROUND: Early detection of thrombotic events is of paramount importance for microsurgical procedures. Here, we present findings that underscore the value of rotational thromboelastometry (ROTEM) to aid in decision-making for pre- and postoperative anticoagulation, as well for patients with suspected hypercoagulability.

METHODS: We prospectively collected pre- and postoperative ROTEM values on all free flap cases at the University of California, San Francisco, from 2015 to 2016. Patient age, body mass index, comorbidities, operative reports, risk factors, thrombotic complications, and outcomes were collected from electronic medical records. Two-sample t-tests were used to compare ROTEM values between cohorts. Modeling for sensitivity, specificity, and accuracy was done for threshold fibrinogen-to-platelet ratio (FPR).

RESULTS: Of 52 patients who underwent free-tissue transfer, 15 had a thrombotic event either intraoperatively or postoperatively that required revision of the vascular anastomosis. Eight patients were clinically hypercoagulable preoperatively, seven of which had a thrombotic event. Several pre- and postoperative ROTEM values differed significantly between thrombotic and nonthrombotic cases. Preoperative (p = 0.027) and postoperative (p = 0.013) FPR were statistically significant when comparing the thrombotic to the nonthrombotic cohort. Threshold FPR ≥ 30 was the most sensitive and FPR ≥ 40 was the most specific.

CONCLUSION: Our study affirms other studies that established ROTEM as an effective predictive tool for thrombotic events during free-tissue transfer. However, a lower threshold for FPR improves catchment of thrombotic events and flap failure with acceptable sensitivity. Our results support the routine use of ROTEM for detecting hypercoagulability in patients who would potentially benefit from intervention to prevent thrombotic complications.

PMID:34010965 | DOI:10.1055/s-0041-1727190

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Integrative genomic analysis of blood pressure and related phenotypes in rats

Dis Model Mech. 2021 May 1;14(5):dmm048090. doi: 10.1242/dmm.048090. Epub 2021 May 19.

ABSTRACT

Despite remarkable progress made in human genome-wide association studies, there remains a substantial gap between statistical evidence for genetic associations and functional comprehension of the underlying mechanisms governing these associations. As a means of bridging this gap, we performed genomic analysis of blood pressure (BP) and related phenotypes in spontaneously hypertensive rats (SHR) and their substrain, stroke-prone SHR (SHRSP), both of which are unique genetic models of severe hypertension and cardiovascular complications. By integrating whole-genome sequencing, transcriptome profiling, genome-wide linkage scans (maximum n=1415), fine congenic mapping (maximum n=8704), pharmacological intervention and comparative analysis with transcriptome-wide association study (TWAS) datasets, we searched causal genes and causal pathways for the tested traits. The overall results validated the polygenic architecture of elevated BP compared with a non-hypertensive control strain, Wistar Kyoto rats (WKY); e.g. inter-strain BP differences between SHRSP and WKY could be largely explained by an aggregate of BP changes in seven SHRSP-derived consomic strains. We identified 26 potential target genes, including rat homologs of human TWAS loci, for the tested traits. In this study, we re-discovered 18 genes that had previously been determined to contribute to hypertension or cardiovascular phenotypes. Notably, five of these genes belong to the kallikrein-kinin/renin-angiotensin systems (KKS/RAS), in which the most prominent differential expression between hypertensive and non-hypertensive alleles could be detected in rat Klk1 paralogs. In combination with a pharmacological intervention, we provide in vivo experimental evidence supporting the presence of key disease pathways, such as KKS/RAS, in a rat polygenic hypertension model.

PMID:34010951 | DOI:10.1242/dmm.048090

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Identifying Factors Affecting Outcomes in Scalp Replantation: A Systematic Review of the Literature

J Reconstr Microsurg. 2021 May 19. doi: 10.1055/s-0041-1729876. Online ahead of print.

ABSTRACT

INTRODUCTION: Replantation is the ideal treatment in traumatic scalp defects to provide immediate coverage with restoration of hair-bearing skin. However, data are limited to case reports and small case series. Comprehensive analysis of techniques and outcomes is not available. Our aim was to systematically analyze the available literature to better understand management and postoperative outcomes of patients undergoing scalp replantation.

METHODS: A systematic review of the PubMed, Cochrane, and EBSCO databases was performed in October 2019. Search terms included “replantation,” “replant,” “revascularized,” “revascularization,” “avulsion,” and “scalp.” Only papers reporting microvascular replantation of completely avulsed scalps, including case reports, were included. Review articles, non-English language articles, articles discussing nonreplant coverage, incomplete scalp avulsions, and articles discussing delayed scalp replantation were excluded. Data extracted included demographics, percent of scalp affected, mechanism, operative technique, and postoperative outcomes. Statistical analysis was performed using Mann-Whitney U tests, Kruskal-Wallis, and chi-squared tests.

RESULTS: From a total of 704 initial results, 61 studies were included for analysis comprising 149 scalps. Complete survival was achieved in 54.7%, partial survival in 38.9%, and failure in 6.7%. Total ischemia time greater than 12 hours was associated with complete replant failure. Arterial anastomoses appeared to protect against complete loss. The number of venous repairs, proportion of venous-to-arterial repairs, use of vein grafts, thromboprophylaxis, or intraoperative complications did not affect outcomes. Patients required significant volumes of blood products, which was associated with partial success. Salvage rate after unplanned return to the operating room was 60.0%. Normal hair growth was achieved in all surviving native scalp tissue.

CONCLUSION: Scalp replantations, while technically challenging, are the ideal treatment for scalp avulsions. Fortunately, these have high rates of success. And as a focal point of a patient’s appearance, this is invaluable in restoration of a sense of normalcy.

PMID:34010964 | DOI:10.1055/s-0041-1729876

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Longitudinal Milestone Assessment Extending Through Subspecialty Training: The Relationship Between ACGME Internal Medicine Residency Milestones and Subsequent Pulmonary and Critical Care Fellowship Milestones

Acad Med. 2021 May 18. doi: 10.1097/ACM.0000000000004165. Online ahead of print.

ABSTRACT

PURPOSE: The Accreditation Council for Graduate Medical Education (ACGME) milestones were implemented across medical subspecialties in 2015. Although milestones were proposed as a longitudinal assessment tool potentially providing opportunities for early implementation of individualized learning plans in fellowship, the association of subspecialty fellowship ratings with prior residency ratings remains unclear. This study aimed to assess the relationship between internal medicine (IM) residency milestones and pulmonary-critical care medicine (PCCM) fellowship milestones.

METHOD: A multicenter retrospective cohort analysis was conducted for all PCCM trainees enrolled in ACGME-accredited PCCM fellowship programs in 2017-2018 who had complete prior IM milestone ratings from 2014-2017. Only professionalism and interpersonal and communication skills (ICS) were included based on shared anchors between IM and PCCM milestones. Using a generalized estimating equations model, the association of PCCM milestones ≤ 2.5 during the first year of fellowship with corresponding IM subcompetencies was assessed at each time-point, nested by program. Statistical significance was determined using logistic regression.

RESULTS: The study included 354 unique PCCM fellows. For both ICS and professionalism subcompetencies, fellows with higher IM ratings were less likely to obtain PCCM ratings ≤ 2.5 during the first fellowship year. Each ICS subcompetency was significantly associated with future lapses in fellowship (ICS01: β = -0.67, P = 0.003; ICS02: β = -0.70, P = 0.001; ICS03: β = -0.60, P = 0.004) at various residency timepoints. Similar associations were noted for PROF03 (β = -0.57, P = 0.007).

CONCLUSIONS: Findings demonstrated an association between IM milestone ratings and low milestone ratings during PCCM fellowship. IM trainees with low ratings in several professionalism and ICS subcompetencies were more likely to be rated ≤ 2.5 during their first year in PCCM fellowship. This highlights a potential use of longitudinal milestones to target educational gaps at the beginning of PCCM fellowship.

PMID:34010863 | DOI:10.1097/ACM.0000000000004165

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Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors

J Pediatr Hematol Oncol. 2021 May 19. doi: 10.1097/MPH.0000000000002206. Online ahead of print.

ABSTRACT

PURPOSE: Pegteograstim (Neulapeg) is a recombinant human granulocyte colony-stimulating factor conjugated with methoxy-maleimide-polyethylene glycol. We conducted a single-arm study investigating its safety and noninferiority to conventional filgrastim in children and adolescents.

MATERIALS AND METHODS: Patients younger than 21 years with solid tumors were eligible for the study. Pegteograstim was administered on day 7 of the fourth chemotherapy cycle. Toxicities were monitored, and the change in absolute neutrophil count was compared with that of the historic control (conventional filgrastim). This trial was registered at ClinicalTrials.gov as NCT02787876.

RESULTS: Thirty-two patients were enrolled. Adverse events possibly related to pegteograstim were musculoskeletal pain (n=3), skin nodule (n=1), paroxysmal cough (n=1), urticaria (n=2), rash (n=1), and itching (n=1). These adverse events were all grade 1 or 2. Duration of neutropenia (ANC<500/µL) was shorter in the pegteograstim group compared with the historic control (median 6.5 vs. 10 d, P=0.004). The time from day 0 to neutrophil recovery (ANC>500/µL) was shorter in the pegteograstim group (median 15 vs. 18 d, P=0.003).

CONCLUSIONS: Pegteograstim is safe and shows comparable efficacy to conventional filgrastim in children and adolescents. Randomized controlled trials are needed to confirm its safety and efficacy.

PMID:34010932 | DOI:10.1097/MPH.0000000000002206

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Influence of Pediatric Endoscopic Endonasal Skull Base Resections on Midface and Skull Base Development

Pediatr Neurosurg. 2021 May 19:1-12. doi: 10.1159/000516236. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this study is to use imaging data to determine if endoscopic endonasal surgery (EES) for skull base tumor resection interrupts skull base growth and development, resulting in an atrophic midface skeletal structure, compared to matched normal controls.

METHODS: Data were collected by a retrospective chart review done on children aged 16 years and below who underwent endoscopic tumor resection and had pre- and postoperative magnetic resonance imaging with relevant midface anatomy. 121 normal controls were matched to 20 EES patients by age and gender. Three measurements related to midface anatomy were taken from 1 sagittal T1 slice and 1 axial T2 slice of each scan. Statistical analysis was used to compare growth measures between cases and controls.

RESULTS: Twenty patients who underwent EES between November 2015 and April 2018 met our inclusion criteria. The mean age of the patients, 11 males and 9 females, was 10 years, and 8 patients (38%) were aged 7 years or younger. Six patients who had a high-flow CSF leak obtained a nasoseptal flap. A student T test and multivariate regression analysis found that EES did not affect midface and skull base growth. Among the variables assessed, age appears to be the only driver of growth.

CONCLUSION: There were no identified differences in craniofacial growth in pediatric patients undergoing EES for skull base tumor resection as compared to the control group. EES does not appear to significantly interfere with midface/skull base development and is a good surgical option for pediatric patients.

PMID:34010830 | DOI:10.1159/000516236

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Mirabegron versus Solifenacin in Children with Overactive Bladder: Prospective Randomized Single-Blind Controlled Trial

Urol Int. 2021 May 19:1-7. doi: 10.1159/000515992. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study is to investigate the efficacy and safety of mirabegron versus solifenacin in the treatment of newly diagnosed overactive bladder (OAB) in children.

METHODS: We conducted a prospective randomized controlled study on pediatric patients with newly diagnosed OAB. Patients were randomized into 3 groups: mirabegron (50 mg once daily) in group I, solifenacin (5 mg) in group II, and placebo in group III. Before starting our treatment and at the end of the 3 months course, we obtained a 3-day voiding diary. This diary included incontinence episode per day, mean voided volume per micturition, mean number of micturition per day, and post-void residual urine. Moreover, the parents/patients were asked to rate symptom relief, and the adverse events were recorded throughout the study period.

RESULTS: A total of 190 patients aged from 5 to 14 years completed this study. At the end of this trial, both groups I and II showed significant improvement versus placebo regarding our efficacy parameters with no significant difference between group I and II. The overall success rate based on assessment of symptom relief was significantly higher in the treated groups (87.5% in I and 90.2% in II) versus placebo (55.8%). Dry mouth was reported in 2.8, 10, and 0% and constipation in 2.8, 11.4, and 1.4% in group I, II, and III, respectively, without statistically significant difference between group I and placebo. However, there was a significant difference between group II and placebo regarding these side effects.

CONCLUSION: Both mirabegron and solifenacin have comparable efficacy regarding the control of OAB symptoms in the newly diagnosed children, but mirabegrone seems to have less side effects.

PMID:34010843 | DOI:10.1159/000515992

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Complications after Functional Neck Dissection in Head and Neck Cancer Patients: An Observational, Retrospective, Single-Centre Study

ORL J Otorhinolaryngol Relat Spec. 2021 May 19:1-9. doi: 10.1159/000514459. Online ahead of print.

ABSTRACT

INTRODUCTION: Functional neck dissection (FND) represents a surgical procedure usually associated with less morbidity.

METHODS: An observational, retrospective, analysis of patients diagnosed with any type of head and neck malignancy was designed to summarize and report the incidence of postoperative complications in patients undergoing FND including just those levels described for selective neck dissections in a tertiary university hospital between June 2016 and June 2019.

RESULTS: 131 patients met the inclusion criteria. The total number of sides studied was 200. 40.5% of the patients suffer a complication in the postoperative period, being the spinal accessory nerve (SAN) injury the most common complication (10%). We did not find any statistical -correlation between the previous organ-preservation treatments and surgical complications (p = 0.207). An advanced T stage (p = 0.009) and the need of bilateral FND (p = 0.034) were significantly correlated with a higher risk of surgical complications.

CONCLUSION: FND represents a useful technique. In this study, 40.5% of the patients suffer a complication in the postoperative period, being the SAN injury the most common complication. However, these data contribute to increasing our knowledge about surgical complications related to FND.

PMID:34010845 | DOI:10.1159/000514459

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Correcting the Fundamentals of Laparoscopic Surgery (FLS) “illusion of validity” in laparoscopic vaginal cuff suturing

J Minim Invasive Gynecol. 2021 May 16:S1553-4650(21)00224-7. doi: 10.1016/j.jmig.2021.05.002. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: The “illusion of validity” is a cognitive bias in which the ability to interpret and predict surgical performance accurately is overestimated. To address this bias, we assessed participants comparing FLS and non FLS tasks to cadaveric vaginal cuff suturing in order to determine the most representative simulation task for laparoscopic vaginal cuff suturing.

DESIGN: Validity (Messick Framework) study comparing FLS and non-FLS tasks to cadaveric vaginal cuff suturing.

SETTING: Simulation center cadaver lab PARTICIPANTS: : Obstetrics and gynecology residents (n=21), minimally invasive gynecologic surgery fellows (n=3), gynecologic surgical subspecialists (n=4), general obstetrician/gynecologists (n=10).

INTERVENTIONS: Tasks included a simulated vaginal cuff (ipsilateral port placement), needle passage through a metal eyelet loop (contralateral and ipsilateral), and intracorporeal knot tying (contralateral and ipsilateral). Simulation task times were compared to the placement of the first cadaveric vaginal cuff suture time, as well as the in-person and blinded Global Operative Assessment of Laparoscopic Skills (GOALS) score (“relations to other variables” validity evidence). Statistical analyses included Spearman’s test of correlation (continuous and ordinal variables) or Wilcoxon rank sum test (categorical variables).

MEASUREMENTS AND MAIN RESULTS: There was a stronger association with cadaver cuff suturing time for simulated vaginal cuff suturing time (r: 0.73, P<0.001) compared to FLS intracorporeal contralateral suturing time (r: 0.54, P<0.001). Additional measures associated with cadaveric performance included subspecialty training (Median: 82 vs. 185 seconds, P=0.002), number of total laparoscopic hysterectomies (r: -0.53, P<0.001), number of laparoscopic cuff closures (r: -0.61, P<0.001), number of simulated laparoscopic suturing experiences (r: -0.51, P<0.001), and eyelet contralateral time (r: 0.52, P<0.001). Strong agreement between the in-person and blinded GOALS (ICC=0.80) supports response process evidence. Correlations of cadaver cuff time with in-person (Spearman’s r: -0.84, P<0.001), and blinded GOALS (r: -0.76, P<0.001) supports relations to other variables evidence CONCLUSION: : The weaker correlation between FLS suturing and cadaver cuff suturing compared to a simulated vaginal cuff model may lead to an “illusion of validity” for assessment in gynecology. Since gynecology specific validity evidence has not been well established for FLS, we recommend prioritizing the use of a simulated-vaginal cuff suturing assessment in addition to FLS.

PMID:34010696 | DOI:10.1016/j.jmig.2021.05.002

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The effect of umbilical cord blood spexin, free 25(OH) vitamin D3 and adipocytokine levels on intrauterine growth and anthropometric measurements in newborns

Cytokine. 2021 May 16;144:155578. doi: 10.1016/j.cyto.2021.155578. Online ahead of print.

ABSTRACT

Spexin is a newly described peptide and is known to reduce the uptake of long-chain fatty acids into adipocytes. The serum spexin levels of obese children between the ages of 12-18 are lower. The effect of serum spexin and free 25(OH) vitamin D3 levels on intrauterine development in newborns is unknown. Our aims is to evaluate the effects of spexin and adipocytokin levels in the cord blood of term newborn babies on the weight of the baby according to the gestation age (GA) and anthropometric measurement results. Babies who were born in our hospital and whose GA was ≥37 weeks were evaluated in three groups as appropriate for GA (AGA), small for GA (SGA) and large for GA (LGA). A total of 84 babies, including an equal number of infants in AGA, SGA and LGA groups, were included in the study. Spexin, leptin, active ghrelin, free 25(OH) vitamin D3, glucose, and insulin levels in the cord blood of infants were examined at birth. The results were compared according to GA and birth weight (BW). There was no statistically significant difference between groups in terms of mean spexin, active ghrelin, free 25(OH) vitamin D3, and insulin levels. The mean leptin level was significantly higher in LGA group than SGA and AGA groups (p 0.004). The mean spexin and leptin levels were higher in girls than in boys (respectively p value 0.029, 0.003). Although there is a significant positive correlation between BW, head circumference, height, umbilical circumference, umbilical circumference/height ratio and the mean leptin levels (p < 0.001), there was no significant correlation between mean spexin, active ghrelin, free 25 (OH) vitamin D3, insulin, and glucose levels. This study suggests that spexin may not have an effect on intrauterine development.

PMID:34010726 | DOI:10.1016/j.cyto.2021.155578