Pattern of Medical Device Adverse Events in a Tertiary Care Hospital in Northern India: An Ambispective Study.

BACKGROUND: Knowledge about the pattern of adverse events caused by medical devices (MDs) is limited in India. We aimed to assess the pattern of MD adverse events (MDAEs) in a tertiary hospital in Northern India. MATERIALS AND METHODS: This descriptive study was conducted ambispectively at various clinical departments of PGIMER, Chandigarh. We followed the guidelines edged by the Materiovigilance Program of India (MvPI) to conduct this study. The prospective study (PS) was done from January to December 2020, with a concurrent retrospective study (RS) proceeding to 3 years to learn more about the reporting culture, demographics, notification status, risk class of defective devices, and the type of adverse events. RESULTS: We received 224 MDAE in the PS and identified 413 MDAE in the RS. Reporting of adverse events to the national MvPI was negligible in the RS. In the PS, nurses reported the majority of MDAEs (65%), followed by doctors (30%). The occurrence of MDAE was higher in males (PS; 52%, RS; 57%) and age groups between 21 and 30 years (PS; 19.1%, RS; 23.2%) in both studies. MDAEs were frequent in low- to moderate-risk devices (class B: 66%) in the PS, while it was documented only for high-risk devices (class C: 51% and class D: 49%) in the RS. Most of the serious adverse events (SAEs) were reported among moderate to high-risk devices, and an increased frequency of SAE (60.4%) was observed among nonnotified MDs. The overall incidence of near-miss events was 14%. CONCLUSION: Knowledge of MDAEs and reporting of defective devices to regulatory authorities is essential to prevent further incidence. Adverse events caused by MDs are ubiquitous irrespective of their risk classification, notification status, and patient demographic factors. Accelerated reporting of MDAE by all cadre of healthcare professionals is urgently required to safeguard the health of Indians.

Postoperative outcome of neonatal emergency surgeries in a tertiary care institute-A prospective observational study.

AIMS: Neonatal surgical mortality continues to be high in developing countries. A better understanding of perioperative events and optimization of causative factors can help in achieving a favorable outcome. The present study was designed to evaluate the perioperative course of surgical neonates and find out potential factors contributing to postoperative mortality. METHODS: This prospective observational study enrolled neonates, undergoing emergency surgical procedures in a tertiary care institute. Primary outcome was 6 weeks postsurgical mortality. The babies were observed till discharge and subsequently followed up telephonically for 6 weeks after surgery. Multivariable logistic regression analysis of various parameters was performed. RESULTS: Out of the 324 neonates who met inclusion criteria, 278 could be enrolled. The median age was 4 days. Sixty-two (27.7%) neonates were born before 37 weeks period of gestation (POG), and 94 (41.8%) neonates weighed below 2.5 kg. The most common diagnoses was trachea-esophageal fistula (29.9%) and anorectal malformation (14.3%). The median duration of hospital stay for survivors was 14 days. The in-hospital mortality was 34.8%. Mortality at 6 weeks following surgery was 36.2%. Five independent risk factors identified were POG < 34 weeks, preoperative oxygen therapy, postoperative inotropic support postoperative mechanical ventilation, and postoperative leukopenia. In neonates where invasive ventilation was followed by non-invasive positive pressure ventilation in the postoperative period, risk of postoperative surgical mortality was significantly reduced. CONCLUSION: Present study identified preterm birth, preoperative oxygen therapy, postoperative positive pressure ventilation, requirement of inotropes, and postoperative leukopenia as independent predictors of 6-week mortality. The possibility of early switch to noninvasive positive pressure ventilation was associated with a reduction in neonatal mortality.

Tracheoesophageal Fistula with Bilateral Facial Cleft: A Rare Occurrence.

Commissural or lateral facial cleft (macrosomia), classified at Tessier number 7 craniofacial clefts, is a rare congenital anomaly usually associated with deformities of other structures developed from the first and second branchial arches. It affects the esthetics and functional aspect of the oral cavity. Bilateral transverse cleft occurring alone is uncommon and it's with tracheoesophageal fistula (TEF) has not been reported to the best of our knowledge. We report a case of esophageal atresia (EA) and TEF with macrosomia. EA was repaired, and the patient was discharged on full feeds. He is awaiting cleft repair.

Antifungal prescription practices and consumption in a tertiary care hospital of a developing country.

BACKGROUND: Antifungal stewardship is a less explored component of antimicrobial stewardship programmes, especially in developing countries. OBJECTIVE: We aimed to determine antifungal prescription practices in a tertiary centre of a developing country to identify the challenges for antifungal stewardship programmes. METHODS: Four single-day point prevalent surveys were performed in inpatient units and data were collected from medical records. Antifungal use was recorded in terms of consumption, therapeutic strategies and appropriateness. RESULTS: We found a 2.42%-point prevalence of antifungal prescriptions. Antifungal use was higher in children than adults (4.1% vs. 2.03%), medical than surgical units (3.7% vs. 1.24%) and ICUs than general wards (5.8% vs. 1.9%). The highest antifungal use was observed in the haematology-oncology units (29.3%) followed by emergency (16.2%) and gastroenterology units (11.6%). Among 215 prescriptions, amphotericin B was the most commonly prescribed (50.2%) followed by fluconazole (31.6%). The targeted antifungal therapy was practised more commonly (31.5%) than empiric (29.1%), pre-emptive (22.6%) and prophylactic (16.8%) therapy. Amphotericin B was commonly used for pre-emptive (p = .001) and targeted (p = .049) therapy, while fluconazole (p = .001) and voriconazole (p = .011) for prophylaxis. The prescriptions were inappropriate in 25.1% due to the wrong choice of antifungal (44.4%), indication (27.7%) and dosage (24%). The overall mean antifungal consumption was 2.71 DDD/1000 PD and 8.96 DOT/1000 PD. CONCLUSIONS: We report here the low prevalence of antifungal use at a tertiary care centre in a developing country. Though training for antifungal use would be important for antifungal stewardship, the challenge would remain with the affordability of antifungals.

Duodenal and Pyloric Web in Children: Clinical Presentation and Management.

Background: Duodenal and pyloric web (DW/PW) can present at any age, symptoms depend upon the location of the web along with the presence and size of the opening in the web. The surgical management is not straightforward always. Here, in this study, we aim to assess clinical characteristics, management, and outcome of children with DW/PW. Materials and Methodology: This was a retrospective study from 2005 to 2019, and data were collected from record registers. All children of DW/PW presented between this duration were included in this study. Results: A total of 45 patients (age range = 1 day to 11 years) included in the study, 40 had DW while 5 had PW. Seven patients were diagnosed antenatally and 20 patients had associated congenital anomalies. Most patients presented with vomiting either bilious or nonbilious. Plain X-ray was sufficient for the diagnosis in 60% of patients, the rest diagnosed on contrast study. The web excision and pyloroplasty were done for PW. The web excision and Heineke-Mikulicz type enteroplasty was the preferred surgery for DW but some patients were required Kimura's duodeno-duodenostomy. For postoperative nutrition, enteral feeding was established through the placement of a feeding tube beyond anastomosis. Ten patients died due to septicemia and associated anomalies. Four patients had a minor leak which was managed by conservative means. Four patients required redo surgery, adhesive obstruction was the most common indication. During follow-up, all 35 patients were doing well with no major complaints. Conclusion: DW/PW has different presentations as compared to other intestinal atresia and can present at any age. A contrast study confirms the diagnosis when plain X-ray is inconclusive. Associated anomalies and septicemia are the poor prognostic indicators. Postoperative enteral feeding helps in maintaining adequate nutrition and improves the outcome even in children with a minor anastomotic leak.

Pediatric PseudoTumoral Hepatic Tuberculosis. A Great Mimicker!!

Pediatric liver masses are rare and difficult to treat. Common liver masses in children include hepatoblastoma, hemangiomas, liver abscesses, and hydatid disease. Isolated liver tuberculosis (TB) is rare in children and can have variable clinical presentations. We report a child with isolated liver TB masquerading as a liver tumor.

Correlation of Urinary Biomarkers (Interleukin-6, Transforming growth factor-ß, E-Cadherin, and MCP-1) with Conventional Parameters of Disease Progression in Patients of Posterior Urethral Valves: A Comparative Analysis.

Aims: Posterior urethral valves (PUV) are the leading cause of end-stage renal disease in boys. The study aimed to look at the ongoing renal damage and profibrotic activity by measuring the levels of Interleukin-6 (IL-6), Transforming growth factor-ß (TGF-ß), E-cadherin, and Monocyte Chemoattractant Protein-1 (MCP-1) and observing trends in subsequent follow-ups and at the same time correlating them with the established parameters of disease progression. Materials and Methods: This prospective study included 36 consecutive patients of PUV, managed over a period of 18 months. IL-6, TGF-ß, E-cadherin, and MCP-1 were measured in urine samples at the time of admission, pre-fulguration and 3 months' and 9 months' post fulguration. The observed values were correlated with the conventional parameters used in clinical practice. Results: All the biomarkers showed statistically significant trends when these values were compared on admission, postoptimization and 3 months' and 9 months' postfulguration. None of the biomarkers showed a significant correlation with renal function tests. E-Cadherin and TGF-ß showed a positive and a negative correlation with ultrasonography (USG) kidney, ureter, and bladder (KUB) respectively. E-Cadherin showed a positive correlation, whereas IL-6 and TGFß showed negative correlation respectively with micturating cystourethrogram (MCUG). IL-6 showed statistically a significant negative correlation with dimercapto succinic acid (DMSA). MCP-1 did not show any significant correlation with USG KUB, MCUG and DMSA. Conclusion: This study concludes that E-Cadherin, IL-6, TGF-ß can be promising urinary biomarkers for early detection of the ongoing renal damage in patients of PUV following valve fulguration. MCP-1 may have more complex interactions, with inflammatory markers; which warrants further research.

Unusual manifestations of Peutz-Jegher's syndrome in children.

PeutzJegher's syndrome (PJS) is a rare, autosomal dominant disease, characterized by gastrointestinal (GI) polyps and perioral hyperpigmentation along with the increased risk of certain malignancies. In children, the most common presentation is recurrent intussusception due to polyps. These polyps can involve any part of the GI tract and can present with a variety of clinical presentations. Usually, these polyps can be removed endoscopically but often require surgical excision also. In this report, we discuss two children of PJS with uncommon presentations, one presented with retrograde intussusception and another with gastric outlet obstruction. The first child underwent laparoscopy and another required open surgery with intraoperative enteroscopy.

Primary Repair of Pediatric Posttraumatic Complete Bladder Neck Horizontal Transection: Our Experience.

Complete transverse transection just below the bladder neck is extremely rare. We present two such cases with associated pelvic fracture following trauma. Both underwent early primary vesicourethral anastomosis with no postoperative complications and are continent in the follow-up.

Reverse Gastric Tube Esophagoplasty with and without Lower Esophageal Stump Wrap - Comparison of Outcome.

Aim and Objectives: The aim of the study is to compare the outcome in children born with long-gap esophageal atresia following reverse gastric tube esophagoplasty (RGTE) with or without the lower esophageal stump as a "fundoplication" wrap. Materials and Methods: All children who underwent RGTE between 2008 and 2018 were retrospectively analyzed. Patients in whom the lower esophagus (LE) had been excised as is done routinely in RGTE (Group 1) were compared with those where the LE was wrapped partially or completely around the intraabdominal neo-esophagus (Group 2). Both vagal nerves were preserved to the extent possible. Complications and final outcome, including weight and height centiles were assessed. Follow-up upper gastrointestinal contrast study and reflux scans were studied. Results: Nineteen patients (mean age: 15.78 ± 5.02 months [range 10-30 months] at RGTE) were studied; nine in Group 1 and ten in Group 2. Both groups had similar early postoperative complications as well as the requirement of dilatation for anastomotic stricture. Dysphagia for solids was noticed in two patients with complete lower esophageal wrap (n = 4), one requiring removal. More patients in Group 2 had absent reflux (n = 7) compared to Group 1 (n = 3) (P = 0.118). At a mean follow-up period of 45.75 ± 18.77 months (14-84 months), Group 2 children reached better height and weight percentiles compared to Group 1. Conclusion: We have described a novel method of using the LE as a "fundoplication" wrap following RGTE. Vagi should be preserved. Those with complete esophageal wrap may develop dysphagia to solids and this is, therefore, not recommended. Lower esophageal wrap patients appeared to have a better outcome in terms of growth and less reflux.

A Fix for a Scalp Varix! A Rare Case of Cirsoid Aneurysm in a Child.

Cirsoid aneurysm (CA) is a rare arteriovenous fistula of the scalp. There exists scant literature on the incidence and approach to CA in children. We describe a case of CA in a 7-year-old boy which was diagnosed by angiography and managed with angiographic embolization followed by surgical excision.

Abdominal Wall Yolk Sac Tumor in a Child.

Midline vascular abdominal wall lesions are likely to be mistaken for vascular malformations in young children. We report a case of large yolk sac tumor located in the anterior abdominal wall just below xiphisternum in a 20-month-old girl diagnosed by raised serum alpha fetoprotein levels and fine-needle aspiration cytology. Preoperative chemotherapy helped in reducing its size allowing wide resection and primary wound closure. This case is reported for the unusual location and role of chemotherapy in management.

Oral Atenolol versus Propranolol in the Treatment of Infantile Hemangioma: A Systematic Review and Meta-Analysis.

Background: Infantile hemangioma (IH) is the most common benign vascular tumor of infancy. Propranolol is considered first-line therapy for IH. However, it is associated with side effects. Therefore, there was a need for alternative therapy. Atenolol, a selective b1-blocker may be free from such side effects. Hence, the present study aims to develop a more accurate estimate of the safety and efficacy of atenolol compared to propranolol in the treatment of IH. Methodology: A search of various literature databases (PubMed, Embase, Ovid, Scopus, Cochrane Central, CINAHL, Web of Science, and Google Scholar) was done to identify studies which compared propranolol versus atenolol in the treatment of IH. The combined odds ratio along with corresponding 95% confidence intervals (CIs) were evaluated using a fixed-effects model. Results: A total of 300 articles were screened of which five studies including 116 patients in atenolol arm and 138 patients in the propranolol arm were analyzed. Atenolol was comparable to propranolol in terms of efficacy as no significant difference was seen between both the treatment arms in terms of hemangioma activity score (mean difference 0.25 [95% CI;‒0.21, 0.71]) and complete response (odds ratio [OR] =0.43; 95% CI; 0.17, 1.11; P = 0.08,). Atenolol therapy was better than propranolol in terms of safety, i.e., serious/potentially serious side effect, (OR = 0.11; 95% CI; 0.02, 0.51; P = 0.005) and wheezing/bronchial hyperreactivity (OR = 0.11; 95% CI; 0.02, 0.51; P = 0.005). Conclusion: The present meta-analysis provides evidence that atenolol has got a comparable efficacy and better safety profile with propranolol.

TIMP-2 as a noninvasive urinary marker for predicting neurogenic bladder in patients under follow-up for spina bifida.

INTRODUCTION: Neurogenic bladder (NB) post-meningomyelocele (MMC) repair is a major challenge and needs lifelong follow-up. Many cytokines have been implicated in the pathogenesis of NB. To avoid repeated urodynamic studies (UDS) and renal scans, we studied urinary tissue inhibitors of metalloproteinases-2 (TIMP-2) levels and correlated with urodynamic profiles to establish their efficacy. MATERIALS AND METHODS: Prospective case-control study on children between 6 months to 12 years of age, who were at least 6 months post-MMC repair and had NB on UDS. Patients were evaluated under 4 cohorts of 20 patients each: Group A (NB on treatment), Group B (NB not on treatment), Group C (no NB), and Group D (Controls). All groups underwent radiofrequency thermocoagulation, urine culture, ultrasonography. Urine samples were stored at -800°C and analyzed using a validated Human ELISA kit for TIMP-2. RESULTS: Eighty patients with a mean age of 3.54 ± 2.1 years were studied. A common ultrasound finding was a thickened urinary bladder (33.3%). All UDS parameters showed a statistically significant differences between groups with NB (Groups A and B) and a group without NB (Group C). Analysis of TIMP-2 levels between individual groups was statistically significant. The area under the receiver operating characteristic curve between urinary TIMP-2 and cystometric parameters indicated that urinary TIMP-2 levels are highly diagnostic of NB. TIMP-2 value of 358.5 pg/ml was found to be the least value with 93.5 sensitivity and 86.2% specificity. CONCLUSION: This study highlights the potential of urinary marker TIMP-2 as noninvasive and cost-effective test to initially diagnose and predict the progression of disease in NBs with reasonable sensitivity and specificity.

Fungaemia due to rare yeasts in paediatric intensive care units: A prospective study.

BACKGROUND: Considering the emergence of fungaemia due to rare yeasts at our centre, we performed a systematic epidemiologic study on fungaemia due to rare yeast. OBJECTIVES: We undertook the present prospective observational study to explore the epidemiological features and clinical characteristics of fungaemia due to rare yeasts in paediatric ICUs at our centre. METHODS: The successive yeasts isolated from blood at our PICUs during December 2017 through March 2019 were identified by molecular methods. Fungaemia due to yeasts other than C. albicans, C. tropicalis, C. glabrata, C. krusei and C. parapsilosis was categorised as rare yeasts. Antifungal susceptibility testing of the yeast isolates was performed as per clinical and laboratory standards institute (CLSI) guidelines. We also compared different clinical parameters of fungaemia due to common versus rare yeasts, and rare yeasts in neonates versus non-neonates. RESULTS: During the study period, 212 yeast isolates were obtained from 159 patients at PICUs of our hospital, and 127 isolates from 98 patients (61.6%) were categorised as rare yeasts. Neonates acquired fungaemia significantly earlier after ICU admission than non-neonates (median:4 vs 6 days; p = .005). Regarding epidemiology study of rare yeast fungaemia, Wickerhamomyces anomalus (43.8%) and Candida utilis (40.8%) were common isolates; surgical intervention and gastrointestinal disease were significantly associated; overall, azole, echinocandin and amphotericin B resistance was at 9.1%, 1.02% and 1.02%, respectively; overall mortality was 65.3%. CONCLUSIONS: The emergence of rare yeasts especially W. anomalus and C. utilis causing fungaemia in our children demands urgent attention to control the spread.

Role of urodynamics in male patients of high-anorectal malformations: a prospective study.

PURPOSE: Association of spinal or vertebral anomalies and the iatrogenic denervation during surgical correction of anorectal malformation patients especially in boys can lead to neurogenic bladder inthese subset of patients. The paucity of literature with regard to urodynamic studies focusing exclusively in male children with high-anorectal malformations (HARM) lead us to analyze the urodynamic changes. The objective was to study urodynamic profile in male patients who have undergone surgery for anorectal malformation. METHODS: Male high-anorectal malformation patients who had completed all the stages of repair were prospective studied. Following the basic work up, all patients based on the urodynamics were categorized into 2 groups as safe or unsafe bladders. Unsafe bladder was defined as detrusor pressure > 40 cm (high detrusor pressure) or pressure variability of 15 cm of water (detrusor overactivity) or significant post-void residue. MRI was limited to patients with only abnormal urodynamics to rule out spinal causes of neurogenic bladder and due to financial constraints, it could not be offered to all patients. RESULTS: 41 HARM meet the exclusion criteria. All patients were asymptomatic with none having history of urinary tract infections. Ultrasound showed bladder wall thickening in 31.7% patients. UDS revealed reduction in bladder capacity and compliance was noted in 31.7% and 30% patients, respectively. Elevated detrusor pressures (> 40 cm of water) were noted in 10% (4/41), detrusor overactivity with concomitant elevated detrusor pressures in 19.5% (8/41) and normal UDS in 70% (29/41). 13 patients (31.7%) had abnormal cystometric parameters with 12(30%) having unsafe bladders. MRI confirmed sacral agenesis in 1 patient with unsafe bladder. CONCLUSION: Urodynamics can demonstrate occult neurovesical dysfunction in patients with HARM. This would help in early renal protective therapy and prevent the burden of long-term sequelae of neurovesical dysfunction in HARM patients.

Survival in patients with high-risk neuroblastoma treated without autologous stem cell transplant or dinutuximab beta.

The majority of patients with high-risk neuroblastoma (HR-NB) in low- and middle-income countries (LMIC) do not have access to autologous stem cell transplant (ASCT) and dinutuximab. Consolidation with nonmyeloablative chemotherapy is not well-defined, and the outcomes are variable. We report a single-center outcome of patients with HR-NB, treated with nonmyeloablative consolidation. A tabulated compilation of similar reports is included. A retrospective chart review of patients with HR-NB was performed from January 2009 till June 2016. Patients were treated on the backbone of HR-NBL1/SIOPEN protocol. Treatment included induction with rapid-COJEC, surgery, followed by consolidation. Consolidation involved 4 cycles of topotecan, vincristine, and doxorubicin (TVD) instead of ASCT. Infusion of vincristine and doxorubicin were modified for ease and to enable administration in the clinic. Subsequent treatment included radiotherapy to the primary tumor and differentiation therapy with isotretinoin. Over 7½ years, 28 patients with HR-NB were treated. Two (7%) patients had therapy-related mortality. A relapse or disease progression occurred in 11 (39%) patients at a median duration of 17 months (IQR: 5, 18). Treatment abandonment was observed in 4 (14%) patients. The median follow-up of disease-free patients was 49 months (IQR: 45, 79). Patients with relapse were not treated further. A 4-year EFS of 29.3% was observed when 4-cycles of TVD were administered instead of ASCT in patients with HR-NB. The study and the review will aid decision-making for care of patients in LMIC while considering the options of treatment for HR-NB if access to ACST and dinutuximab is lacking.

Extrapulmonary Pleuropulmonary Blastoma in a 3-Year-Old Child: A Case Report and Review of Literature.

Pleuropulmonary blastomas (PPBs) are very rare, highly aggressive, dysembryonic neoplasms of thoracopulmonary mesenchyme. These have been reported in the pediatric population and account for only 0.5%-1% of all primary malignant lung cancers. They normally arise from lung tissue, however rarely the parietal pleura may be the tissue of origin (extra pulmonary PPB) which are extremely rare. Common age of presentation is three to 4 years. The prognosis is poor with distant metastasis to central nervous system and bone with survival rate of approximately 42.9% at 5 years. They are managed by aggressive multimodal therapies including surgery and chemotherapy. We report a case of a 3-year-old male child with Type 2 PPB of the left hemithorax, managed by surgical excision of the mass and adjuvant chemotherapy.

Growth and Development Assessment of Children (1-5 Years) Operated for Tracheoesophageal Fistula/Esophageal Atresia: A Case Control study.

INTRODUCTION: Among children, esophageal atresia (EA) with or without tracheoesophageal fistula (TEF) is one of the major and common congenital anomalies. It is a life-threatening emergency and at birth may be associated with three C's coughing, choking, and cyanosis. It requires surgical interventions in the early neonatal period. The postsurgical period is associated with poor growth which can be developmental outcomes particularly in the first 5 years of life and attributed to postsurgical complications. The aim of the study is to assess and compare the growth and development of the children (1-5 years) operated for TEF/EA attending Pediatric Surgery OPD/admitted inwards at APC, PGIMER, Chandigarh versus healthy controls. MATERIALS AND METHODS: A case-control study was conducted on age-matched 40 children aged between 1 and 5 years operated for TEF/EA and healthy controls. The sampling technique for cases was total enumeration and for controls was purposive sampling. Tools used were socio-demographic sheets of children, clinical profile of children, Trivandrum Development Screening chart, and Vineland Social Maturity Scale for Indian adaptation. RESULTS: Majority 33 (82.5%) of children had distal TEF and more than two-third 28 (70%) have undergone primary repair. More than one-third 14 (35%) had a respiratory infection, 12 (30%) anastomosis leakage and 6 (15%) had Gastroesophageal reflux (GER) as one of the early and late postoperative complications. More than one-fourth 11 (27.5%) of TEF/EA operated children had less weight, 11 (30%) had less height and 16 (40%) had less weight for height for their reference age. A significant difference was found for height for age, weight for height, and social maturity among children who had TEF repair as compared to their healthy counterparts. CONCLUSION: Growth monitoring reflected (more than one-fourth of children were underweight and stunted while more than one-third were wasted) and showed development delay in TEF/EA operated children as compared to healthy controls.

Bladder Mass Masquerading as Eosinophilic Cystitis in a Child: When to Think Beyond Malignancy?

Eosinophilic cystitis is a rare inflammatory disease in the pediatric population with varied presentations. Diagnosis requires a high index of suspicion and cystoscopy with biopsy of the bladder mass. There are no standard treatment guidelines, however, these patients usually respond with medical management, but recurrence is a possibility. We present a case of eosinophilic cystitis in a 6-year-old boy who presented with lower urinary tract symptoms, gross hematuria, and bladder mass.