Tag: nevin manimala

Minerva Surg. 2021 Aug 2. doi: 10.23736/S2724-5691.21.08902-4. Online ahead of print.

ABSTRACT

BACKGROUND: The prognostic role of the extension of lymphadenectomy in Non-small-cell lung cancer is still a debated and intriguing issue. The aim of this study is to validate a prognostic score including the number of resected lymph-nodes previously reported using a large multicentre dataset.

METHODS: From 01/2002 to 12/2012, data on 4858 NSCLC patients undergoing curative-intent surgery in six Institutions were retrospectively reviewed. To test the discriminative ability of the model, composed of a panel of high-risk,pathologic stage, nodal status, age, number of Resected Nodes and intermediate risk factors (gender, grading, histology), was determined. The Kaplan-Meier method was used to estimate Overall(OS), Cancer-Specific(CSS) and Disease-free Survival(DFS) curves, and the log rank test was adopted to evaluate the differences between groups.

RESULTS: Pathological stages were: I in 46,5%, II in 24,1%, III in 27,8% and IV in 1,6% of cases. Overall, 5-years OS, CSS and DFS were 54,6%, 76,7% and 44,8%, respectively. Stratifying the sample of 3948 patients with complete data into Low-risk (LR, #107), Intermediate-risk (IR, #1268) and High-Risk (HR, #2573) groups, the optimal prognostic discrimination power of this score was confirmed (C-statistics: 0.71, 95%CI 69-73). Specifically in LR, IR and HR, 5-years OS was 83,5%, 66,4% and 46,2% (p<0.0001), 5y-CSS was 95,8%, 89% and 69% (p<0.0001), and 5y-DFS was 74,7%, 59.1% and 35,5% (p<0.0001), respectively CONCLUSIONS: Our study confirms the optimal prognostic discrimination power of the previous prognostic model including the number of harvested nodes.

PMID:34338459 | DOI:10.23736/S2724-5691.21.08902-4

Dermatol Ther. 2021 Aug 2:e15074. doi: 10.1111/dth.15074. Online ahead of print.

ABSTRACT

vascular malformations (VM) are congenital, benign, relatively frequent lesions. Scant data have been published about the epidemiology, clinical presentation and treatment of VM from a dermatologist’s perspective. The substantial differences between subtypes, broad range of specialists consulted and confusing nomenclature used over previous years may hamper a correct diagnosis. The main objective of this study is to describe VM epidemiology. As a secondary endpoint we evaluate clinical characteristics, clinical-radiological correlation and treatment approaches. we carried out an observational, descriptive, retrospective study. Cases presented to the multidisciplinary committee of our hospital from 2009 to 2019 were retrieved. Electronic medical records, monthly committee reports and the iconographic archive were reviewed and statistically analyzed. Overall, venous malformations are the most frequent VM, followed by capillary malformations, arteriovenous malformations and lymphatic malformations. Considering only patients under 16, capillary malformations are the most frequent ones. Capillary and lymphatic malformations are larger than venous or arteriovenous. While capillary malformations are usually asymptomatic, symptomatic cases are threefold more frequent in the other subtypes. Decisions on active or conservative management depend on VM size but not location or patient age. Capillary malformations are mainly treated with laser therapy; venous with sclerotherapy or surgery; arteriovenous with surgery and lymphatic with surgery or sirolimus. Dermatologists play an important role in VM diagnosis and management. Our 10-year multidisciplinary experience should contribute to the literature and represent a practical resource for clinicians and researchers. This article is protected by copyright. All rights reserved.

PMID:34338412 | DOI:10.1111/dth.15074

Int J Clin Pract. 2021 Aug 2:e14696. doi: 10.1111/ijcp.14696. Online ahead of print.

ABSTRACT

BACKGROUND: Effects of abdominal obesity on outcomes of atrial fibrillation (AF) ablation remains ill-defined. Here, we evaluated the impact of abdominal obesity on the long-term efficacy and safety of catheter AF ablation among Korean patients.

METHODS: We utilized the Korean National Health Insurance Service database to identify patients who underwent AF ablation. Abdominal obesity was defined as waist circumference ≥90cm (males) and ≥85cm (females). The primary endpoint was AF recurrence and secondary endpoints were ischemic stroke, intracranial hemorrhage and death. Additionally, safety endpoints of peri-procedural complications were studied.

RESULTS: Among 5,397 patients (median age 58 [IQR 51 – 65] years; 23.6% females), abdominal obesity was present in 1,759 (32.6%). The rate of AF recurrence was not statistically different between the groups at 1-year (10.3 vs 8.7 events/100-PYs, p=0.078), though abdominal obesity was associated with significantly higher rates of AF recurrence at 3-year (7.6 vs 6.3 events/100-PYs, p=0.008) and 6-year (6.3 vs 5.2 events/100-PYs, p=0.004) follow-ups. Kaplan-Meier survival analysis found significantly higher rates of AF recurrence in patients with obesity based on body mass index (BMI) and waist circumference (log-rank for trend p=0.006). Using multivariable regression analysis, obesity by both BMI and waist circumference was an independent predictor for AF recurrence (HR 1.21 [95% CI,1.05 – 1.40]), after accounting for other risk factors. There was a trend for increased rates of ischemic stroke at 3-year and 6-year follow-ups in patients with abdominal obesity. Furthermore, this group of patients had a greater rate of intracranial hemorrhage. All-cause death was comparable between both groups. Total peri-procedural complications were not associated with abdominal obesity.

CONCLUSION: Abdominal obesity as indicated by waist circumference was associated with a greater burden of concomitant diseases and an independent risk factor for long-term redo AF intervention following catheter ablation but had no effects on total peri-procedural complications.

PMID:34338415 | DOI:10.1111/ijcp.14696

Minerva Surg. 2021 Aug 2. doi: 10.23736/S2724-5691.21.08810-9. Online ahead of print.

ABSTRACT

BACKGROUND: Pudendal nerve block (PNB) is commonly used in pudendal neuralgia (PN) and as an anaesthesiological technique in obstetrical and urological procedures. The purpose of this retrospective study was to compare the efficacy of PNB with other anaesthesiolocal techniques in proctological surgery.

METHODS: A total of 362 patients were seen from a 22 months time interval. Surgical indication was placed after a conservative therapy. 78 patients underwent surgery: 42 with spinal anaesthesia with PNB and 36 with PNB alone according to their anatomical characteristics. All the patients underwent PNB in lithotomy position and with a perirectal approach. The success rate of PNB was evaluated in post operative pain control with the VAS score, after the first and the second evacuation. The follow up also included a third check on the seventh day after surgery.

RESULTS: In post operative period, the mean VAS score found after the first evacuation in patients undergoing PNB was 2.66, after the second evacuation was 1.55, while the VAS score on the seventh day was 0.38. The mean VAS score in the group who underwent spinal anaesthesia and PNB were respectively 3.71 and 1.80 after the first and second evacuation. The VAS score calculated on the seventh day was 0.50. There were no statistically significant differences in the VAS score between the 2 groups (P >0.05).

CONCLUSIONS: PNB may be a valid alternative to spinal anaesthesia in proctological patients. PNB has proven to be both safe and effective technique.

PMID:34338455 | DOI:10.23736/S2724-5691.21.08810-9

Laryngoscope. 2021 Aug 2. doi: 10.1002/lary.29785. Online ahead of print.

ABSTRACT

OBJECTIVES/HYPOTHESIS: Repair of large, recurrent, and complex tracheoesophageal fistulas (TEFs) is challenging and numerous different surgical approaches exist. These various techniques each carry a set of risks and possible complications such as fistula recurrence, tracheal stenosis or pouches, esophageal stenosis, and recurrent laryngeal nerve injury. Slide tracheoplasty is a reconstructive technique successfully used in many different airway pathologies, including TEF repair. This study examines the success, limits, and complications related to slide tracheoplasty for repair of complex TEFs.

STUDY DESIGN: Retrospective chart review.

METHODS: Patients undergoing TEF repair using a cervical or thoracic approach slide tracheoplasty, at a single institution, between July 2008 and December 2019 were retrospectively reviewed. Demographic data, comorbidities, TEF etiology and surgical history, slide tracheoplasty details and outcomes, and postoperative complication data were examined using descriptive statistics.

RESULTS: Twenty-six patients underwent 27 slide tracheoplasties for TEF (20 cervical approaches, 7 thoracic approaches) with a mean age of 5.2 years (IQR 0.7-7.6) at time of surgery. The most common TEF etiologies included congenital (n = 13), tracheostomy tube erosion (n = 5), and button battery ingestion (n = 4). Fistulas ranged in size from <0.5 mm to 4 cm and 59% had previous endoscopic or open repairs. There were two TEF recurrences (7.4%), one of which was successfully revised and the other which was treated with stent placement. Postoperative complications included dehiscence (3.7%), unilateral vocal fold paralysis (3.7%), and mild tracheal stenosis (18.5%).

CONCLUSIONS: Slide tracheoplasty is an effective surgical technique for treating complex congenital and acquired TEFs with lower rates of complications when compared to other techniques.

LEVEL OF EVIDENCE: IV Laryngoscope, 2021.

PMID:34338338 | DOI:10.1002/lary.29785

Diabetes Obes Metab. 2021 Aug 2. doi: 10.1111/dom.14513. Online ahead of print.

ABSTRACT

AIMS: To assess the efficacy and safety of sotagliflozin, a dual inhibitor of sodium-glucose cotransporter 1 and 2, in adults with type 2 diabetes (T2D) and stage 4 chronic kidney disease (CKD4).

MATERIALS AND METHODS: This 52-week, phase 3, randomized (1:1:1), placebo-controlled trial evaluated sotagliflozin 200 and 400 mg once daily in 277 patients with T2D and estimated glomerular filtration rate (eGFR) 15-30 mL/min/1.73 m² . The primary endpoint was HbA1c reduction with sotagliflozin 400 mg vs. placebo at 26 weeks. A hierarchical statistical testing approach was used.

RESULTS: Baseline mean HbA1c was 8.3±1.0%; systolic blood pressure (SBP), 144±15 mmHg; and eGFR, 24±4 mL/min/1.73m² . Placebo-adjusted changes with sotagliflozin 400 mg were -0.3% (95% CI -0.6 to 0.05; P=0.096) and -0.69% (-1.15 to -0.23; P=0.003) in HbA1c at weeks 26 and 52, respectively; -1.5 kg (-3.0 to -0.1) in body weight at week 26; -5.4 mmHg (-9.4 to -1.3) in SBP at week 12; and -0.3 mL/min/1.73m² (-2.1 to 1.6; P=0.776) in eGFR at week 52. Over 52 weeks, 11.8%, 5.4%, and 3.3% patients receiving placebo and sotagliflozin 200 and 400 mg, respectively, required rescue therapy for hyperglycemia. Adverse events occurred in 82.8%, 86.2%, and 81.1% patients and serious cardiovascular adverse events occurred in 12.9%, 3.2%, and 4.4% patients in the placebo and sotagliflozin 200 and 400 mg groups, respectively.

CONCLUSIONS: After 26 weeks, HbA1c reductions with sotagliflozin were not statistically significant vs placebo in adults with T2D and CKD4. The 52-week safety profile was consistent with results of the SCORED outcomes trial (NCT03242018). This article is protected by copyright. All rights reserved.

PMID:34338408 | DOI:10.1111/dom.14513

Stat Med. 2021 Aug 2. doi: 10.1002/sim.9133. Online ahead of print.

ABSTRACT

Multivariable Mendelian randomization (MVMR) is a form of instrumental variable analysis which estimates the direct effect of multiple exposures on an outcome using genetic variants as instruments. Mendelian randomization and MVMR are frequently conducted using two-sample summary data where the association of the genetic variants with the exposures and outcome are obtained from separate samples. If the genetic variants are only weakly associated with the exposures either individually or conditionally, given the other exposures in the model, then standard inverse variance weighting will yield biased estimates for the effect of each exposure. Here, we develop a two-sample conditional F-statistic to test whether the genetic variants strongly predict each exposure conditional on the other exposures included in a MVMR model. We show formally that this test is equivalent to the individual level data conditional F-statistic, indicating that conventional rule-of-thumb critical values of F> 10, can be used to test for weak instruments. We then demonstrate how reliable estimates of the causal effect of each exposure on the outcome can be obtained in the presence of weak instruments and pleiotropy, by repurposing a commonly used heterogeneity Q-statistic as an estimating equation. Furthermore, the minimized value of this Q-statistic yields an exact test for heterogeneity due to pleiotropy. We illustrate our methods with an application to estimate the causal effect of blood lipid fractions on age-related macular degeneration.

PMID:34338327 | DOI:10.1002/sim.9133

Laryngoscope. 2021 Aug 2. doi: 10.1002/lary.29793. Online ahead of print.

ABSTRACT

OBJECTIVES/HYPOTHESIS: Laryngopharyngeal reflux (LPR) has been proposed both as a trigger for recurrent respiratory papillomatosis (RRP) onset and as a factor favoring an aggressive clinical course.

STUDY DESIGN: In this prospective study, 106 participants were recruited within a period of 24 months at the Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana.

METHODS: This study compared a group of RRP patients (N = 36) with a group of LPR patients (N = 28) and a group of healthy participants (N = 42) based on Reflux Symptom Index (RSI), Reflux Finding Scores (RFS), and saliva analyses (pH, pepsin concentration, bile acid concentration, and pepsin enzymatic activity).

RESULTS: The RRP group compared to the LPR group showed a statistically significant difference only in RSI and RFS scores, while the RRP group compared to healthy controls showed significantly higher values in all tested parameters (RSI score, RFS, saliva pH, pepsin concentration, bile acids concentration, pepsin enzymatic activity).

CONCLUSIONS: LPR is common in RRP patients and significantly more prevalent compared to healthy controls. Our results show that saliva analyses are a better office-based tool than RSI questionnaires and RFS scores for diagnosing LPR in RRP patients.

LEVEL OF EVIDENCE: Level 3 Laryngoscope, 2021.

PMID:34338331 | DOI:10.1002/lary.29793

Acta Anaesthesiol Scand. 2021 Aug 2. doi: 10.1111/aas.13965. Online ahead of print.

ABSTRACT

BACKGROUND: The mini-fluid challenge (MFC) is a clinical concept of predicting fluid responsiveness by rapidly infusing a small amount of intravenous fluids, typically 100 ml, and systematically assessing its haemodynamic effect. The MFC method is meant to predict if a patient will respond to a subsequent, larger fluid challenge, typically another 400 ml, with a significant increase in stroke volume.

METHODS: We critically evaluated the general methodology of MFC studies, with statistical considerations, secondary analysis of an existing study, and simulations.

RESULTS: Secondary analysis of an existing study showed that the MFC could predict the total fluid response (MFC + 400 ml) with an area under the receiver operator characteristics curve (AUROC) of 0.92, but that the prediction was worse than random for the response to the remaining 400 ml (AUROC = 0.33). In a null simulation with no response to both the MFC and the subsequent fluid challenge, the commonly used analysis could predict fluid responsiveness with an AUROC of 0.73.

CONCLUSION: Many existing MFC studies are likely overestimating the classification accuracy of the MFC. This should be considered before adopting the MFC into clinical practice. A better study design includes a second, independent measurement of stroke volume after the MFC. This measurement serves as reference for the response to the subsequent fluid challenge.

PMID:34338314 | DOI:10.1111/aas.13965

Am J Phys Anthropol. 2021 Aug 2. doi: 10.1002/ajpa.24381. Online ahead of print.

ABSTRACT

OBJECTIVE: In this study, we analyze breastfeeding and weaning practices in pre-Columbian complex hunter-gatherers from the lower Paraná River basin (South America).

MATERIALS AND METHODS: We carried out bone isotope analyses concerning δ¹³ C in collagen and apatite, the spacing between both carbon sources and δ¹⁵ N in a sample of 23 subadult and adult individuals of both sexes recovered from Late Holocene archaeological sites, ranging from 1665 ± 45 to 680 ± 80 ¹⁴ C years BP.

RESULTS AND DISCUSSION: The results indicate that exclusive breastfeeding continued until the age of ~2 years, and weaning probably until 4 years of age. Supplementary foods included C₃ plants and probably animal fats and C₄ carbohydrates. A high fractionation of 4.9‰ in δ¹⁵ N values was recognized between breastfeeding infants and adult females, perhaps reflecting episodic hyper-protein diets in women linked to men’s food provisioning during women’s gestational/postpartum period. Additionally, male adults present a higher protein intake than females. Although this difference is not statistically significant with the current sample size, it could be a clue related to a sexual division in food procurement.

PMID:34338320 | DOI:10.1002/ajpa.24381