Imbalance in the vWF - ADAMTS13 axis exists early in acute pancreatitis and predicts persistent organ failure and pancreatic necrosis-a prospective study.

BACKGROUND: The pathophysiology of Acute Pancreatitis (AP) may be complicated by endothelial activation. von Willebrand Factor (vWF)- ADAMTS13 axis is a marker of endothelial activation. The study aimed to investigate the axis in AP, comparing it in patients with and without persistent organ failure (OF), with and without pancreatic necrosis, and correlating it with the standard severity scores (CRP, APACHE II, BISAP, SOFA, and qSOFA) METHODS: vWF-Antigen (vWF:Ag), vWF-Collagen-Binding-Assay (vWF:CBA), and ADAMTS13 activity (ADAMTS13:act) levels were measured within 5 days of symptom onset in consecutive patients (n = 98), who were admitted with a first episode of AP (Dec 2021-May 2023). RESULTS: Of the 98 patients admitted with AP, 78(79.6 %) had no or transient OF; 20(20.4 %) had persistent OF. Age was comparable (43.73 ± 15.36 vs 38.65 ± 13.69) [mean ± SD](years), and males were predominant in both groups (70.5 % vs 80 %). Patientswith persistent OF had higher vWF:CBA(%)[323(279-486.5) vs 199.5(159.1-295.75)] and lower ADAMTS13:act(%)[35.4(23.8-56.85) vs 56.35(44.1-71.9)][median (25th - 75th percentile)](P = 0.001) than those with no or transient OF. Patients with pancreatic necrosis (n = 19) had lower ADAMTS13:act(%)[42.79 ± 18.69] than those without pancreatic necrosis (n = 18) [62.49 ± 22.64] (P < 0.01). ADAMTS13:act had a negative correlation(r = -0.2), whereas vWF:Ag and vWF:CBA had a positive correlation (r = 0.2) with the standard severity scores (P < 0.05). ADAMTS13:act could predict pancreatic necrosis [AUROC-0.737, P < 0.05] and persistent OF [AUROC-0.746, P < 0.001], while vWF:CBA could predict persistent OF [AUROC- 0.73, P < 0.001]. CONCLUSION: vWF-ADAMTS13 axis helps to predict severe disease and is associated with poor outcomes in acute pancreatitis.

A longitudinal study of sexual health and quality of life in endometrial carcinoma survivors.

OBJECTIVES: This study aimed to assess sexual health and quality of life (QoL) in endometrial cancer survivors and the factors influencing these variables. METHODS: A mixed method design comprising quantitative (cohort design) and qualitative (face-to-face interviews) aspects was chosen. A total of 132 patients who underwent surgery alone, surgery followed by adjuvant vaginal brachytherapy, or surgery followed by chemotherapy and radiation were included. Female Sexual Function Index (FSFI) and Functional Assessment of Cancer Therapy General (FACT-G) questionnaires were used to assess the participants' sexual health and QoL at 6 months and 1 year post-treatment. Multivariate logistic regression models were used to analyze the factors associated with general and sexual well-being. RESULTS: At 1 year, 89% of the participants still had low sexual function scores. Survivors over 50 years (OR 284.7, 95% CI 13 to 364, p<0.001) and educated below graduate level (OR 26.8, 95% CI 2 to 370, p=0.014) had low sexual function scores. Patients who had surgery alone had better QoL than those who received adjuvant radiation. Women who had surgery, chemotherapy, and radiation had the lowest QoL scores (OR 6.4, 95% CI 2.1 to 19.5, p=0.001). All scores improved with time. CONCLUSIONS: This study demonstrated the high prevalence of low sexual function and poor QoL in endometrial cancer survivors. There was a communication gap between the women and their partners as well as their healthcare providers. This study highlights the need for discussion about the survivors' sexual well-being and QoL.

Bacterial infection-related glomerulonephritis in patients with diabetes.

AIM: Diabetic patients are prone to infections, thus making them a unique cohort at risk of developing bacterial infection-related glomerulonephritis (IRGN). METHODS: In total, 1693 adult diabetic patients underwent kidney biopsy between 2005 and 2021 at our tertiary care hospital in South India. Of these, 121 consecutive cases which met criteria of bacterial IRGN were included in this study. RESULTS: The mean age of the cohort was 53.1 ± 10.1 years and 83/121 (68.5%) were males. Majority (98.3%) had type 2 diabetes for a median duration of 6 (IQR, 2-12) years. The most common sites of infection were skin (47/121, 38.8%) and urinary tract (15/121, 12.4%). Fifty percent (58/121) of patients had underlying advanced diabetic kidney disease (DKD). Isolated C3 deposits (without immunoglobulin) occurred in 66/121 (54.5%) patients predominantly in advanced DKD patients. IgA-dominant glomerulonephritis occurred in only 9/121 (7.4%) patients. Short-course oral steroid was given to 86/121 (71.1%) patients. Steroid related dysglycemia and immunosuppression related infections occurred in 9/61 (14.8%) and 16/61 (26.2%) patients respectively. Of the 90 patients with follow up details >3 months, 46 (51.1%) progressed to kidney failure over a median period of 0.5 (IQR, 0-7.2) months. Patients diagnosed in the latter half of our study period (2013-2021) were older, less commonly presented with fever, had more pronounced hypocomplementemia and severe renal histology predominantly with a 'starry sky' immunofluorescence pattern. CONCLUSION: Superimposed bacterial IRGN on underlying DKD is associated with poor renal outcomes. Use of short course steroid was associated with significant toxicity.

Impact of tubal patency test selection on the live birth rate following intrauterine insemination in couples with unexplained infertility: a retrospective cohort study.

OBJECTIVE: We planned a study to evaluate the impact of selecting hysterosalpingography (HSG) over diagnostic laparoscopy during initial fertility evaluation on IUI treatment outcomes in couples diagnosed with unexplained infertility. METHODS: The study comprised a retrospective cohort and included couples evaluated for infertility at our tertiary level hospital between January 2008 and December 2019. Couples diagnosed with unexplained infertility based on tubal patency tests (either HSG or diagnostic laparoscopy) were included. We compared outcomes following ovarian stimulation (OS) and intrauterine insemination (IUI) between women who underwent HSG versus laparoscopy for up to three treatment cycles. RESULTS: A total of 7413 women were screened, out of which 1002 women were diagnosed with unexplained infertility. We did not find a significant statistical difference in the clinical pregnancy (16.7% vs. 11.7%; OR (odds ratio) 1.51; 95% CI (confidence interval) 0.90-2.5) or live birth rate per IUI cycle (15.1% vs. 10.7%; OR 1.51, 95% CI 0.9-2.6) in women who underwent HSG for tubal evaluation as compared to laparoscopy. After adjustment for potential confounders through multivariate analysis, we found that outcomes were comparable between the HSG and laparoscopy. CONCLUSION: The current study did not find any significant difference in treatment outcomes following OS and IUI in women with unexplained infertility who underwent HSG compared to laparoscopy for the assessment of the tubal patency during the initial fertility workup. The finding suggests minimal or no impact of selecting HSG over diagnostic laparoscopy as a tubal patency test on the subsequent IUI outcomes.

The outcomes of surgical treatment for lateral Hoffa fracture nonunions.

INTRODUCTION: Lateral Hoffa nonunion are rare injuries. A significant percentage of these nonunions are due to missed acute lateral Hoffa fractures. Operative management of these injuries is difficult and complicated by the presence of bone loss, infection, and soft-tissue contractures. In this study, the aim was to assess clinical and functional outcome in our group of patients with lateral Hoffa nonunion who had undergone operative management and to determine whether variables such as fracture type, infection, and previous surgery affect nonunion/complication rates. MATERIALS AND METHODS: Data were analyzed for patients with lateral Hoffa nonunion who underwent surgical fixation from January 2008 to December 2020 at a tertiary-care referral center. Patients with lateral condyle Hoffa nonunion and having a minimal follow-up of 1 year were included in this study. Patients with medial Hoffa nonunion, pathological fractures, and children aged less than 16 years were excluded from the study. The fractures were classified by the AO/OTA and Letenneur classification systems. Clinical and functional outcomes were assessed by the Knee society score (KSS) and the lower extremity functional scale (LEFS). RESULTS: All the 12 patients had united in our series. One patient had reduction failure at 3 months who united after re-fixation. The union rate in our patients was 100%, with a loss of reduction rate of 7.7%, and post-traumatic arthrosis of 7.7%. The average follow-up period was 52.16 ± 27.7 months. The mean knee flexion obtained at the final follow-up was 104.5° (80°-130°). The average KSS clinical score was 80.6 (65-88). The average KSS functional score was 92 (70-100). The average LEFS score was 71 (47-79). There is a statistically significant improvement in the knee range of motion in our patients (p = 0.001). However, no correlation could be detected between variables like type of fracture, infection, and previous surgeries and outcomes. CONCLUSIONS: Lateral Hoffa nonunion can be managed with careful planning of surgical approaches and fixation techniques.

Functional principal component analysis for identifying the child growth pattern using longitudinal birth cohort data.

BACKGROUND: Longitudinal studies are important to understand patterns of growth in children and limited in India. It is important to identify an approach for characterising growth trajectories to distinguish between children who have healthy growth and those growth is poor. Many statistical approaches are available to assess the longitudinal growth data and which are difficult to recognize the pattern. In this research study, we employed functional principal component analysis (FPCA) as a statistical method to find the pattern of growth data. The purpose of this study is to describe the longitudinal child growth trajectory pattern under 3 years of age using functional principal component method. METHODS: Children born between March 2002 and August 2003 (n = 290) were followed until their third birthday in three neighbouring slums in Vellore, South India. Field workers visited homes to collect details of morbidity twice a week. Height and weight were measured monthly from 1 month of age in a study-run clinic. Longitudinal child growth trajectory pattern were extracted using Functional Principal Component analysis using B-spline basis functions with smoothing parameters. Functional linear model was used to assess the factors association with the growth functions. RESULTS: We have obtained four FPCs explained by 86.5, 3.9, 3.1 and 2.2% of the variation respectively for the height functions. For height, 38% of the children's had poor growth trajectories. Similarly, three FPCs explained 76.2, 8.8, and 4.7% respectively for the weight functions and 44% of the children's had poor growth in their weight trajectories. Results show that gender, socio-economic status, parent's education, breast feeding, and gravida are associated and, influence the growth pattern in children. CONCLUSIONS: The FPC approach deals with subjects' dynamics of growth and not with specific values at given times. FPC could be a better alternate approach for both dimension reduction and pattern detection. FPC may be used to offer greater insight for classification.

Prognostic significance of MR identified EMVI, tumour deposits, mesorectal nodes and pelvic side wall disease in locally advanced rectal cancer.

AIM: To study the prognostic significance of MRI identified tumour deposits (TD), extramural vascular invasion (EMVI), lymph node metastases (LNM) and pelvic sidewall (PSW) disease in rectal cancer. METHODS: This IRB approved study was conducted on patients with stage IIA-IIIC rectal adenocarcinoma treated with neoadjuvant long course chemoradiotherapy (LCCRT) and total mesorectal excision (TME) type of surgery between 2012-2018. A radiologist blinded to outcome reviewed staging and restaging magnetic resonance imaging (MRI) for TD, EMVI, LNM and PSW. The agreement between four radiologists was studied and we obtained outcome data from a prospectively maintained database. The prognostic significance of imaging findings was assessed. RESULTS: A total of 297 (186 males) patients with a mean age of 47.3 (SD14.4) years were included in the study. The majority had T3 (n = 206) or T4 (n = 59) stage disease. The mean duration of follow-up was 49.3 ± 25 months (6.6-101 months). 5-year overall (OS) and disease-free survival (DFS) was 84% and 74%, respectively. Staging and restaging MRI had EMVI in 49.5% and 31.3%; TD in 47.5% and 31.6%; LNM in 61.1% and 38.1% and PSW in 11.4% and 6.1%. OS was adversely affected by EMVI, TD and PSW with the adjusted HR (aHR) of 3.32, 3.31, 3.27 for staging MRI and 2.99, 3.1, 2.81 for restaging MRI, respectively, p < 0.05. DFS was affected by EMVI (aHR = 1.85, 2.33) and TD (aHR = 1.83, 2.19), p < 0.05. Persistence of these findings after LCCRT led to worst outcome. Intra- and interobserver agreement for EMVI, TD and LN was 0.789, 0.734, 0.406 and 0.449, 0.354, 0.376, respectively, p < 0.001. CONCLUSIONS: MRI identified that TD, EMVI and PSW disease are independent poor prognostic indicators in rectal cancer patients. Interobserver agreement for these findings was moderate to fair.

Bedside lung ultrasonography: comparison with chest radiography (BLUR), a diagnostic study in a developing country.

BACKGROUND: This study determines the diagnostic utility of lung ultrasonography (LUS) in a medical ward in a developing country. In a low resource country like India, we hope that use of lung ultrasound in primary and secondary hospitals will assist in earlier and better bedside diagnosis. METHODS: This prospective diagnostic study was done to test the diagnostic accuracy of LUS against a composite reference standard, which included clinical history and examination, basic laboratory investigations, imaging and the diagnosis at discharge. We evaluated 321 consecutive patients, admitted in our medical wards with an LUS within 24 hours of the chest radiograph being done. FINDINGS: Between August 2016 and August 2017, we enrolled 321 patients. The sensitivity and specificity of the LUS for all pathologies were found to be 82.5% (76.50 to 87.20) and 78.2% (69.09 to 85.26) respectively. A subgroup analysis including the patients in whom CT was part of the composite reference standard showed sensitivity and specificity of 87.9% and 92.9% for all lung pathologies. It was found that there was superior sensitivity and specificity of LUS compared with chest radiograph in a subgroup analysis of pulmonary oedema and acute respiratory distress syndrome (ARDS). INTERPRETATION: We found that the LUS was better than chest radiograph and as good as CT in most pathologies, especially pulmonary oedema and ARDS. We believe that training in the basics of bedside LUS must be part of the medical curriculum and a low-cost ultrasound machine must be made available in medical wards, so that clinical diagnosis can be supplemented with this tool. In a low resource setting like India, where access to chest radiograph and CT may be difficult particularly in a rural setup, expertise in LUS would be helpful in easy bedside diagnosis and saving cost on a CT scan.

Customized cost-effective polymethylmethacrylate cranioplasty: a cosmetic comparison with other low-cost methods of cranioplasty.

BACKGROUND: Intraoperative hand-moulded cranioplasty and polymethylmethacrylate (PMMA) prostheses made from bone impressions are economical but the cosmetic results are less than satisfactory. Commercially available customized prostheses perform better but are prohibitively expensive. We evaluate the performance of a locally developed, low-cost customized PMMA cranioplasty prosthesis. OBJECTIVE: To compare the cosmetic outcome of 3 types of PMMA cranioplasty as well as with objective measurements on postoperative CT scans METHODS: This study includes 70 patients who underwent cranioplasty between March 2016 and June 2020. In this period, patients had their cranioplasty prostheses made by intra-operative hand moulding (HM), by using the removed bone as a template and making a bone impression (BI) or by 3D printing the prosthesis based on a CT scan. Cosmetic outcomes were assessed by the patient and the operating surgeon on an 8-point scale. The degree of measured anthropometric asymmetry was measured on a postoperative CT scan and correlated with the cosmetic outcome. RESULTS: Our locally produced 3D-printed cranioplasty prostheses showed a statistically better performance in cosmetic scores when compared to the HM and BI (p value < 0.001). CT anthropometric measurements significantly correlated with cosmetic outcome (p value 0.01) CONCLUSION: Our 3D cranioplasty prostheses had better cosmetic outcomes than HM and BI prostheses, and our technique is able to produce them at 10% of the cost of the currently available commercial customized prostheses.

Long-Term Outcomes and Prognostic Factors Affecting Survival after Pulmonary Metastasectomy in Solid Tumors of Childhood: A Single Center Experience.

Introduction: This study assessed the long-term survival and the prognostic variables affecting survival following pulmonary metastasectomy (PM) secondary to childhood solid tumors. Materials and Methods: A retrospective analysis was done on 22 children who underwent PM for solid tumors between January 2007 and February 2020. The overall survival (OS) and event-free survival (EFS) at the end of the study period were noted. Tumor histology, completeness of resection, disease-free interval, laterality, location, number, and size of lung nodules were assessed for their significance in contributing to survival. Results: High-grade osteosarcoma (54.5%), followed by Wilms' tumor (18.2%), was the most common histological types. Unilateral nodules (59.1%) situated in a peripheral, sub-pleural location (91%) were the most common presentation. Pleural extension was noted in 12 (54.5%) patients. Synchronous pulmonary metastases were noted in 12 (54.5%) patients. Two developed metastases while undergoing chemotherapy and eight after the completion of therapy. The EFS and OS were both 31.8% at a median follow-up of 15.5 months (range 3-129 months). The median time required for an event to occur was 4 months (95% confidence interval [CI]: 1.4, 6.6 months) and median post-PM survival interval was 17 months (95% CI: 6.6, 27.4 months). Significant association was noted between preoperative tumor response to chemotherapy (P = 0.002) and survival. Conclusion: PM can improve survival in a select group of children with metastatic solid tumors. Favorable tumor response to chemotherapy was found to be a significant prognostic factors influencing survival.

Patient Characteristics and Outcomes in Necrotizing Soft-tissue Infections: Results from a Prospective Cohort Study in a Tertiary Care Center Intensive Care Unit in South India.

Background: Necrotizing soft tissue infections (NSTIs) are life-threatening infections characterized by progressive destruction of muscle, fascia, and overlying subcutaneous tissue. Prospective studies in the field are few, and data from the Indian subcontinent are bleak. Prompt diagnosis and timely treatment are critical for optimal outcomes. The aims of this study are to provide detailed information on the clinical profile of patients with NSTIs and to identify predictors of mortality in order to pick up reversible factors that may improve outcomes. Materials and methods: This study was a prospective cohort study of adult patients with NSTIs in a tertiary center in South India. All patients who were admitted to the surgical intensive care unit (ICU) of the institute with a diagnosis of NSTI were screened and enrolled. All patients were managed according to the local protocol for treatment of NSTIs and intensive care support. Results: In our cohort of patients, simple and multiple logistic regression analysis showed that four factors, namely, AKIN stage 3, shock, need for mechanical ventilation for more than 3 days, and low serum albumin values were found to be significantly associated with higher mortality. Conclusion: The successful management of these patients calls for early diagnosis, resuscitation, surgical debridement, appropriate and timely antibiotics, and early ventilatory weaning before multi-organ failure associated with shock and AKI occurs. How to cite this article: Kurian GP, Korula PJ, Jacob JM, Desha AMK, Karuppusami R, Kandasamy S. Patient Characteristics and Outcomes in Necrotizing Soft-tissue Infections: Results from a Prospective Cohort Study in a Tertiary Care Center Intensive Care Unit in South India. Indian J Crit Care Med 2022;26(4):452-456.

Risk Factors for Candida Infection among Children Admitted to a Pediatric Intensive Care Unit in a Tertiary Care Centre in Southern India.

Background: To describe the clinical profile, risk factors, and outcomes that are associated with candida infection among critically ill children. Patients and methods: A retrospective case-control study wherein 109 children admitted to the pediatric intensive care unit (PICU) in the years between 2015 and 2017 with the growth of candida from blood, urine, endotracheal (ET) aspirate, and pus swabs were included and compared to 97 age and sex-matched controls chosen from the same time period. Results: Of the 124 candida isolates from 109 children, 37% were from blood, 24% from urine, and 14% in pus; 40% of the isolates were from ET aspirate. Candida non-albicans types (70%) predominated with Candida tropicalis causing 50% of the infections. Risk factors for candida infection were neutropenia [OR 20.01, 95% CI (0.94-422.32)], mechanical ventilation [OR 5.97, 95% CI (2.44-14.62)], peritoneal dialysis [OR 5.81, 95% CI (1.27-26.50)], institution of amino acids [OR 5.41, 95% CI (0.85-34.13)], presence of central venous catheter [OR 3.83, 95% CI (1.59-9.19)], antibiotic use >5 days [OR 3.58, 95% CI (1.38-9.29)]. Candida Cases (95.4%) had a septic shock with acute kidney injury in 34% and had significantly lower survival than controls [72 (66%) of 109 vs. 74 (80%) of 92] (p = 0.023). Conclusions: The rate of candida infection in our PICU was 4.2% of PICU admissions. The most common species was C. tropicalis. The independent risk factors for candida infection were neutropenia, antibiotic duration >5 days, peritoneal dialysis, amino acid administration, mechanical ventilation, and presence of a central venous catheter (CVC). How to cite this article: Rajeshwari R, Vyasam S, Chandran J, Porwal S, Ebenezer K, Thokchom M, et al. Risk Factors for Candida Infection among Children Admitted to a Pediatric Intensive Care Unit in a Tertiary Care Centre in Southern India. Indian J Crit Care Med 2022;26(6):717-722.

Intraoperative administration of systemic/epidural/intrathecal morphine on the quality of recovery following substitutional urethroplasty with buccal mucosal graft: A randomized control trial.

Background and Aims: Substitutional urethroplasty with buccal mucosal grafting for urethral stricture is associated with significant pain, and thus inappropriate perioperative pain management could delay postoperative recovery. The objective of our research was to determine the effects of analgesia with systemic or epidural or intrathecal morphine on quality of recovery (QoR) in patients undergoing substitutional urethroplasty with buccal mucosal grafting. Material and Methods: This prospective, double-blinded, randomized control trial was conducted over 2 years in ASA I and II patients who underwent substitutional urethroplasty with buccal mucosal graft. Patients were randomized into three groups, and Group A received systemic morphine (0.1 mg/kg), Group B received epidural morphine (3 mg), and Group C received intrathecal morphine (150 µg). The QoR between the groups were compared postoperatively using the 40-item QoR questionnaire, and the hemodynamic variations, time taken for ambulation, resumption of oral intake, and incidence of complications were also compared. Results: Out of the recruited 93 patients, 88 patients were analyzed. The QoR score for each domain was comparable between the three groups. The total QoR score for systemic, epidural, and intrathecal morphine groups were 189 (185-191), 189 (187-191), and 185 (183-189), respectively. Additionally, the hemodynamic variations, time taken for ambulation, and resumption of oral intake were comparable between all three groups except the incidence of postoperative nausea and vomiting (PONV) and pruritis, which were higher in the intrathecal group. Conclusion: All three modalities, namely systemic morphine (0.1 mg/kg), epidural morphine (3 mg), and intrathecal morphine (150 µg), offer similar QoR after substitutional urethroplasty. However, the incidence of PONV and pruritis was higher with the administration of intrathecal morphine.

An observational study on the practice of noninvasive ventilation at a tertiary level Australian intensive care unit.

BACKGROUND: Failure of Non-Invasive Ventilation (NIV) is associated with increased morbidity and mortality among critically ill patients. Although there is evidence of association between disease related factors and NIV failure, it is unclear whether factors related to NIV application contribute to NIV failure. OBJECTIVES: To evaluate NIV failure rate and factors associated with NIV failure. DESIGN, SETTINGS AND OUTCOMES: Prospective, observational, pilot study conducted in a 23-bed, tertiary care Intensive Care Unit (ICU). NIV failure was defined as application of NIV resulting in intubation or death in ICU. RESULTS: Amongst 238 patients admitted with respiratory failure, NIV was administered to 60 patients (34 males, 26 females) for a total of 70 application episodes. The etiology of respiratory failure included acute pulmonary edema (28.6%), acute lung injury (22.9%) and pneumonia (15.7%). The mean (SD) age was 62 (17.6) years, BMI 32.0 (8.5) kg/m2 and median APACHE-II score 17.5 (14.0-23.8). NIV failure occurred in 22 out of 70 applications (31.4% [95%CI 20.0-43.0]). NIV failure assessed by simple logistic regression analysis, was associated with admission diagnosis (OR 6.0, 95%CI: 1.3-28.7, p = 0.03), use of bi-level NIV-PS (OR 5.00, 95%CI: 1.04-24.1, p = 0.04), presence of nasogastric tube (OR 6.20, 95%CI: 1.9-19.8, p < 0.01) and with short NIV breaks in the 2nd 24-hours (OR 0.96, 95%CI: 0.91-0.99, p = 0.04). CONCLUSION: NIV failure was observed in 31.4%. Factors associated with NIV failure were etiology of respiratory illness, type of NIV support and short NIV breaks, presumably reflecting illness severity or progress of disease. The presence of a nasogastric tube during application of NIV may adversely impact NIV application.

Cardiovascular implantable electronic device lead removal in a resource-constrained setting: A single-center experience from India.

BACKGROUND: Data from large-volume centers in developed countries, using dedicated tools, show a high success rate with a good safety record for the percutaneous lead removal procedure. However, there are constraints to replicate the results in a resource-poor setting and there is limited data from India. METHODS: We retrospectively analyzed lead removal procedures performed in our institution from 2008 to 2019. RESULTS: Seventy-five patients underwent percutaneous removal of 138 leads. Of these, 44 procedures and 80 leads qualified as extraction with a median dwell time of 52.1 (IQR 28.2-117.2) months. Overall, 33/44 (75.0%) procedures were successful and 65/80 (81.2%) leads were successfully extracted. Manual traction was successful in the extraction of 44/57 (77.2%) leads. All leads implanted less than 2.7 years could be removed with manual traction alone. Specialized tools were used in 23 leads and 21 (91.3%) of those could be successfully extracted. Inability to use dedicated tools was an independent predictor of procedural failure (adjusted OR 14.0; 95% CI 1.8-110.2; p-value 0.012). Right-sided implant (adjusted OR 12.6; 95% CI 1.3-119.5; p-value 0.027) was also independently associated with failure. There was 1 death (1.3%) and minor complications occurred in 6 (8.0%) patients. CONCLUSIONS: In a resource-limited setting, percutaneous lead extraction of predominantly pacemaker leads by manual traction methods achieved success in extracting about three-fourths of the leads. Inability to use specialized tools was the main factor limiting success. The complication rate was low.

Mustard Seed Pillow for Prevention of Deformational Plagiocephaly in ≤ 32 Weeks' Gestational Age Infants: An Open Label Randomized.

OBJECTIVES: To assess the effectiveness of using mustard seed filled pillows in preventing deformational plagiocephaly (DP) in premature infants. METHODS: A prospective open label randomized trial was conducted in a tertiary care hospital in South India. Eligible preterm infants born at ≤32 weeks and <1500 g admitted in the neonatal intensive care unit (NICU) were randomly allocated to the intervention and control groups. In addition to standard nesting, the intervention group was positioned using a mustard pillow, while the control group was positioned using nesting alone. Plagiocephaly was assessed using the Cranial Index (CI), Cranial Vault Asymmetry Index (CVAI) and Argenta classification within the first week and at 4 weeks postnatal age. RESULTS: Twenty-eight infants, each in the control and intervention groups, were included for analysis. At 4 weeks postnatal age, the intervention group had lower mean (SD) CVAI scores when compared to the control group [3.16 (1.89 vs 7.85 (2.63)] with adjusted odds ratio, aOR (95% CI) of 28.2 (3.8, 210.01), P < 0.01. More number of infants in the control group had plagiocephaly measured using Argenta classification [aOR (95% CI) 25.70 (2.80, 235.67), P < 0.01]. There were no differences in the Cranial Index scores in the intervention and control groups [aOR (95% CI) 0.41 (0.11, 1.52), P = 0.184]. CONCLUSION: A mustard seed pillow is an easily available and a cost-effective intervention for preventing plagiocephaly in hospitalized preterm infants.

Late-Preterm Antenatal Steroids for Reduction of Neonatal Respiratory Complications: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of antenatal corticosteroids in reducing neonatal respiratory complications when administered to those at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. METHODS: This was a single-center, triple-blind, randomized, placebo-controlled trial in southern India enrolling pregnant participants at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. Computer-generated block randomization was used with participants randomized to either one course of intramuscular betamethasone or placebo. The primary outcome was a composite of treatment for respiratory distress in the neonate, defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life. Neonatal secondary outcomes were transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, hypoglycemia, stillbirth, and early neonatal death; maternal secondary outcomes were chorioamnionitis, postpartum hemorrhage, puerperal fever, and length of hospitalization. All analyses were based on intention to treat. A sample size of 1,200 was planned with 80% power to detect a 30% reduction in rates of respiratory distress. After a planned interim analysis, enrollment was stopped for futility. RESULTS: From March 2020 to August 2022, 847 participants were recruited, with 423 participants randomized to betamethasone and 424 participants randomized to placebo. There were 22 individuals lost to follow-up. There was no statistically significant difference in the primary outcome (betamethasone 4.9% vs placebo 4.8%, relative risk 1.03, 95% CI, 0.57-1.84, number needed to treat 786). There were no statistically significant differences in secondary neonatal or maternal outcomes. CONCLUSION: Betamethasone administered in the late-preterm period to those at risk for preterm delivery did not reduce the need for treatment of neonatal respiratory distress. CLINICAL TRIAL REGISTRATION: Clinical Trials Registry of India, CTRI/2019/09/021321.

Myofibroblast and pro-fibrotic cytokines in fibrosis of IgG4-related disease (IgG4-RD) patients from South Asia: preliminary data.

INTRODUCTION: Fibrosis is a typical pathological characteristic in IgG4-RD patients and often irreversible. There exists a lack of suitable markers for detection of earlier onset of fibrosis in various organs in IgG4-RD patients. Hence, this study aims at analysing ambispectively the myofibroblasts and the pro-fibrotic cytokines, IFN gamma and IL-33 involved in IgG4-RD associated fibrosis in South Asian patients. METHOD: Archived biopsy samples of definite/probable/possible cases of IgG4-RD, classified according to diagnostic criteria, taken from patients who attended the OPD and IPD of our tertiary care centre during January 2015-January 2020 were chosen for this study. The paraffin sections were examined qualitatively for fibrosis and the excessive collagen deposition by Hematoxylin & Eosin and Masson's Trichrome staining. Also, the presence of alpha-Smooth muscle actin (α-SMA) expressing myofibroblasts and the involvement of pro-fibrotic cytokines (IFN-gamma, IL-33) were assessed by Immunohistochemistry and scored semi-quantitatively (+mild, ++moderate, +++ severe). Serum IL-33 levels were analysed by indirect Elisa (R & D Systems). RESULTS: Myofibroblasts were present in 10/12 biopsy samples, in moderate levels in 4 (33%) and very high levels (+++) in 3 (25%) of the patients. IFN-gamma was expressed at low levels in 6 (50%) and absent in 6 (50%). All patients showed IL-33 expression with very high levels in tissue (6, 50%), as well as in serum samples. CONCLUSION: The findings of this study reinforce the role of myofibroblasts and profibrotic cytokines like IL-33 in fibrosis of Ig4-RD patients, pointing to their potential as earlier predictive markers of onset and extent of fibrosis.

Centrifugal technique of plasma exchange and low-dose steroid to treat very severe alcoholic hepatitis patients: A retrospective analysis.

BACKGROUND: Low-volume plasma exchange (PLEX) and low-dose steroid improve survival in severe alcoholic hepatitis. We aimed to compare one-year survival of very severe alcoholic hepatitis (VSAH) patients treated with centrifugal PLEX (cPLEX), membrane PLEX (mPLEX) or standard medical treatment (SMT). METHODS: We retrospectively analyzed survival in consecutive VSAH patients treated at our department from November 2017 to September 2021. PLEX patients received low-volume PLEX along with low-dose steroid (tab. prednisolone 10 mg or 20 mg daily). To adjust for baseline differences between the three treatment (cPLEX, mPLEX or SMT) groups, propensity score (PS) matching was done. Acute-on-chronic liver failure (ACLF) was defined as per European Association for the Study of the Liver (EASL). The primary study outcome was one-year transplant-free survival of PS-matched VSAH patients treated with cPLEX compared to SMT. RESULTS: Of 101 PLEX-eligible VSAH patients, 30 patients were treated with cPLEX, 21 with mPLEX and 50 with SMT. On comparing 30 PS-matched patients each in the cPLEX group vs. the SMT group, transplant-free survival in the cPLEX group was 86.7% at one month, 70% at three months and 52.4% at one year and in the SMT group was 33.3% at one month, 23.3% at three months and 16.7% at one year with hazard ratio (HR [95% CI]) in favor of the cPLEX group (0.29 [0.15-0.56], p < 0.001). Total 21 patients each (PS-matched) in cPLEX and mPLEX groups were compared and one-year survival was better with cPLEX (0.33 [0.16-0.69], p = 0.001). The sub-group analysis of VSAH (PS-matched cohort) patients with ACLF also showed better survival with cPLEX compared to SMT (0.38 [0.17-0.83], p = 0.003) and compared to mPLEX (0.43 [0.17-0.95], p = 0.03). CONCLUSION: Better one-year transplant-free survival was noted among PS-matched VSAH patients treated with cPLEX (and low-dose steroid) compared to SMT (without steroid).

Biomarkers of coagulation, endothelial, platelet function, and fibrinolysis in patients with COVID-19: a prospective study.

Prospective and sequential evaluation of homeostatic changes leading to thrombosis across COVID 19 disease severity spectrum are limited. In this prospective observational study, haemostasis was evaluated in patients with mild, moderate-severe, and critical COVID-19 infection. Markers of endothelial activation [Soluble thrombomodulin (sTM), von Willebrand Factor (VWF)], platelet activation [Soluble P-selectin, beta-thromboglobulin (BTG)] and global haemostasis [Rotational thromboelastometry (ROTEM)] were evaluated on days 1 and 5 after admission. The study cohort comprised of 100 adult patients (mild = 20, moderate-severe = 22, critical = 58). Sixty-five patients received anticoagulation for 10 (7-14) days. Thrombotic events were seen in 9 patients. In-hospital mortality was 21%. Endothelial activation markers were elevated at baseline in all subgroups, with levels in moderate-severe (sTM = 4.92 ng/ml, VWF = 295 U/dl) [reference-ranges: sTM = 2.26-4.55 ng/ml; Soluble P-selectin = 13.5-31.5 ng/ml; BTG = 0.034-1.99 ng/ml] and critical patients (sTM = 6.07 ng/ml, VWF = 294 U/dl) being significantly higher than in the mild group (sTM = 4.18 ng/ml, VWF = 206 U/dl). In contrast, platelet activation markers were elevated only in critically ill patients at baseline (Soluble P-selectin = 37.3 ng/ml, BTG = 2.51 ng/ml). The critical group had significantly lower fibrinolysis on days 1 and 5 when compared with the moderate-severe arm. COVID-19 infection was associated with graded endothelial activation and lower fibrinolysis that correlated with illness severity.