Search

Introduction: To evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of ZRC-3277 (pertuzumab biosimilar) with Perjeta® (pertuzumab) in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC)., Patients and Methods: This phase III, multicenter, double-blind study across 38 sites in India randomized (1:1) patients with HER2-positive MBC in either the ZRC-3277 or Perjeta® group. Both groups also received trastuzumab and docetaxel. Of 268 enrolled patients, mITT population had 243 patients (119 and 124 in the ZRC-3277 and Perjeta® groups, respectively). The primary objective was to compare the between-group objective response rate (ORR) after 6 cycles of treatment. ORR was determined by evaluating scans of computed tomography or magnetic resonance imaging following Response Evaluation Criteria in Solid Tumor (RECIST 1.1). Two-sided 95% confidence interval (95% CI) for the difference in ORR was determined to evaluate the noninferiority of ZRC-3277 to Perjeta®. The secondary outcomes included the assessment of PK, immunogenicity, and safety between the 2 groups., Results: In the mITT population, 104 (87.39%) and 114 (91.94%) participants achieved the ORR in the ZRC-3277 and Perjeta® groups, respectively. For predefined -15% noninferiority margin, obtained 2-sided 95% CIs (-12.19%, 3.11%) for the difference in ORR (-4.55%) between the 2 groups demonstrated the noninferiority of ZRC-3277 to Perjeta®. PK, immunogenicity, and safety were not significantly different between the 2 groups., Conclusion: Efficacy, PK, immunogenicity, and safety profiles of ZRC-3277 was found to be similar to those of Perjeta®., Competing Interests: Disclosure Deven Parmar is an employee of Zydus Therapeutics Inc, USA, whereas Maulik Doshi and Rahul Shrivastava are employees of Zydus Lifesciences Ltd. All other authors declare no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To assess the prevalence and predictors of splenic dysfunction in children with sickle cell disease (SCD)., Methods: A cross-sectional study was conducted between June 2019 and December 2020 where children aged 1 to 15 years of age with SCD were screened for splenic dysfunction. Children who were splenectomised, those with other diseases known to affect splenic function like congenital malformations, immunodeficiencies, and chronic diseases like tuberculosis, nephrotic syndrome, diabetes mellitus, chronic liver disease, celiac disease or malignancy were excluded. Splenic size was assessed by clinical examination and ultrasonography. Splenic dysfunction was assessed by Technetium-99m (99mTc) labeled autologous RBCs and by the presence of Howell Jolly bodies in the peripheral smear. Laboratory and clinical predictors of splenic dysfunction were assessed by multiple logistic regression., Results: We evaluated 66 children with SCD with a mean (SD) age of 7.41 (3.3) years. Impaired and absent splenic function as assessed by 99mTc scintigraphy was found in 13 (19.7%), and 3 (4.6%) children, respectively. Howell Jolly bodies in peripheral smear were found in 5 (7.5%) children; 3 of them had abnormal uptake on scintigraphy; all five had splenomegaly. Age > 5 years, > 4 episodes of vaso-occlusive crisis (VOC), > 3 hospitalization events in the past, > 5 blood transfusions, children not receiving hydroxyurea, reticulocyte count > 4%, and HbS > 70% were independent predictors of splenic dysfunction., Conclusion: The prevalence of splenic dysfunction in children with SCD in Central India is lower than that reported from the West. The decision to start antibiotic prophylaxis can be individualized in these children.

Background: Anterior-posterior electrode placement is preferred in electrical cardioversion of atrial fibrillation. However, the optimal anterior-posterior electrode position in relation to the heart is not studied., Methods and Results: We performed a prospective observational study on patients presenting for cardioversion of atrial fibrillation. Electrodes were placed in the anterior-posterior position and shock was delivered in a step-up approach (100 J→200 J→360 J). Fluoroscopic images were obtained, and distances were measured from points A, midanterior electrode; and B, midposterior electrode, to midpoint of the cardiac silhouette. Patients requiring one 100 J shock for cardioversion success (group I) were compared with those requiring >1 shock/100 J (group II). Logistic regression was used to determine the impact of electrode distance on low energy (100 J) cardioversion success. Computed tomography scans from this cohort were analyzed for anatomic landmark correlation to the cardiac silhouette. Of the 87 patients included, 54 (62%) comprised group I and 33 (38%) group II. Group I had significantly lower distances from the mid-cardiac silhouette to points A (5.0±2.4 versus 7.4±3.3 cm; P <0.001) and B (7.3±3.0 versus 10.0±3.8 cm; P =0.002) compared with group II. On multivariate analysis, higher distances from the mid-cardiac silhouette to point A (odds ratio, 1.33 [95% CI, 1.07-1.70]; P =0.01) and B (odds rsatio, 1.24 [95% CI, 1.05-1.50]; P =0.01) were independent predictors of low energy (100 J) cardioversion failure. Based on review of computed tomography scans, we suggest that the xiphoid process may be an easy landmark to guide proximity to the myocardium., Conclusions: In anterior-posterior electrode placement, closer proximity to the cardiac silhouette predicts successful 100 J cardioversion irrespective of clinical factors.

Background and Objectives: Acute kidney injury (AKI) is a menace in the pediatric intensive care unit (PICU) and is responsible for significant morbidity and mortality all over the world. There are limited data available on pediatric AKI in central India. Our primary objective is to determine the clinical, etiological, and outcome profile of AKI in the pediatric age group of 3 months to 15 years admitted to the All India Institute of Medical Sciences (AIIMS), Raipur. The secondary objective(s) is to predict the association of mortality in children diagnosed with AKI and to estimate the number of patients developing chronic kidney disease (CKD) at three-month follow-up., Materials and Methods: This observational study was conducted in the Department of Pediatrics at AIIMS Raipur, Chhattisgarh, from September 2021 to February 2023. All patients aged 3 months to 15 years of age satisfying the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for AKI and presenting to the hospital were included, and those refusing consent or having CKD stage ≥3 were excluded. A total of 66 children were assessed for eligibility. Out of these 66 patients, 2 were excluded as they had AKI on CKD, and a total of 64 patients were included. For all included patients, details of their demography, clinical features, etiology workup, and hospital stay were collected. Their outcome was observed and categorized into complete response, partial response, no response, left against medical advice (LAMA), or death. Patients who were discharged were followed up for three months and observed for the recovery or development of CKD., Results: The incidence of AKI in the PICU was 15.48% (64/413). Ventricular septal defect with pneumonia and pneumonia (12.5%, 8/64 each) were the most common diagnoses at presentation, resulting in AKI. The most common clinical presentations were fever (54.7%, 35/64) and respiratory distress (43.8%, 28/64). Out of them, 73.4% (47/64) had sepsis, and 62.5% (40/64) had shock. About 56.2% (36/64) of children had non-oliguric AKI as compared to 43.8% (28/64) who had oliguric AKI. Among total children with AKI, 54.7% (35/64) of patients had prerenal AKI, 43.8% (28/64) had renal AKI, and 1.6% (1/64) had postrenal AKI. Of all the children included, 32.8% (21/64) experienced complete resolution of AKI, while 18.8% (12/64) showed partial resolution, and 1.6% (1/64) remained unresolved. Among them, 3.1% (2/64) LAMA, and 43.8% (28/64) died. The median duration of the hospital stay in our study was 16.5 days. Out of them, 59.4% (38/64) of patients required renal replacement therapy (60.5% required peritoneal dialysis (PD), 36.8% required hemodialysis (HD), and 2.6% required both). Among survivors, 19.35% (6/31) developed CKD on a three-month follow-up., Conclusion: The incidence of AKI was seen in critically ill children in the PICU, and it was associated with high mortality., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Kapil et al.)

Introduction:  Triage is crucial in patient screening within emergency departments (EDs) worldwide. It is one of the essential and standard medical practices in many developed countries. However, in India, there is a need for improvement in triage utilization, as it is predominantly performed by resident doctors or medical officers, leading to an uneven distribution of clinical skills among healthcare providers (HCPs). A comprehensive analysis incorporating literature review and data collection revealed that while mandatory screening is conducted in most Indian EDs, the formal implementation of standardized triage protocols remains limited. Like in developed countries, registered nurses or nursing officers (NOs) can be effectively trained and directed to play the role of dedicated triage personnel in EDs of most of the healthcare facilities in India., Method and Materials:  This study aimed to examine the current state of triage utilization and its impact on the distribution of responsibilities among HCPs in Indian EDs. Through this online survey, the investigators assessed the knowledge and practical understanding of clinical triaging among NOs, working at various hospitals nationwide., Results:  The participants included 5,029 NOs working in various parts of India, predominantly nursing graduates (82.52%), the majority being employed in government healthcare settings (84.01%) and most having over five years of cumulative working experience in the ED (70.77%). Nurses showed inadequate knowledge and awareness about the Pediatric Assessment Triangle (PAT) used for quick initial evaluation (62.18% among all participants). Concerning the complete triage process applicable, especially in pediatric ED settings, they had even less satisfactory knowledge and understanding, e.g., identifying primary (28.27%) and secondary (22.69%) survey components via focused history and examination, properly using temperature assessment (23.32%) and instant blood glucose level assessment (22.95%) in triage, and knowing various types of internationally accepted triage systems for ED-based health facilities such as the Emergency Severity Index (ESI), Canadian Triage and Acuity Scale (CTAS), and Australasian Triage Scale (ATS) (15.87%). ANOVA and post hoc analysis revealed that the intergroup performance of the study participants with maximum correct responses to the knowledge-determining specified subset of the questionnaire depicts the significantly higher role of graduate nursing degree over diploma such as General Nursing and Midwifery (GNM)/Auxiliary Nursing and Midwifery (ANM) qualification, working in government hospital versus private setup, and ED working experience of >5 years over that of <5 years., Conclusions:  Of the participants in the study, 50% were not evaluated for cognitive or psychomotor domains during their assessment examinations. The research illuminated a significant disparity in knowledge and proficiency levels among Indian nurses concerning pediatric triage, especially with the ability to effectively apply the PAT for initial patient evaluations, discern components of primary and secondary surveys, and comprehend various triage systems. This study underscores the importance of comprehensive reform in the Indian healthcare system and teaching curriculum by emphasizing clinical triage training and interprofessional collaboration, and establishing guidelines and regulations to ensure consistent and standardized triage practices across all EDs., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Anand et al.)

Introduction: Childhood obesity in India is on the rise and is rarely raised as a concern. In the central Indian states, focus is largely on undernutrition. Thus, studies related to risk factors for being overweight and obese and the impact of obesity on the psychology of children are lacking. Hence, a hospital-based study with objectives to identify social and demographic factors associated with obesity and the estimation of the prevalence of depression among these children was conducted., Methods: This observational study was conducted in a tertiary care institute in the state of Chhattisgarh from July 2020 to October 2021. Children with obesity as per the WHO (> 95 th percentile for the BMI) in the age group of 6-12 years were included after due consent. A proforma was administered targeting the objectives of the study and the Childhood Depression Rating Scale (CDR-S) and clinical evaluation identified the depressed., Results: Among the 5,019 children screened during the study period, 54 met the inclusion criteria (1.07%). Fifty percent of children were from the upper middle class as per the Kuppuswamy scale. Seventy percent consumed junk food more than three times a week. Twenty-three children (42.6%) engaged in physical activity of > 1 hour and 49(90.7%) had a screen time of > 2 hours. The prevalence of depression among these children stood at 5.6% with the mean age being 11.67 years. Multiple logistic regression showed an inverse association of depression with physical activity., Conclusion: Obesity is prevalent in higher socioeconomic groups. Many risk factors like screen time, junk food consumption, and physical activity are modifiable. The prevalence of depression increased with age. Physical activity showed an inverse relation to depression in obese children., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Mathew et al.)

Objective: The aim of this study was to evaluate the post-marketing safety, tolerability, immunogenicity and efficacy of Bevacizumab (manufactured by Hetero Biopharma) in a broader population of patients with solid tumors., Patients and Methods: This phase IV, prospective, multi-centric clinical study was carried out in Indian patients with solid malignancies (metastatic colorectal cancer, non-squamous non-small-cell lung cancer, metastatic renal cell carcinoma) treated with Bevacizumab between April 2018 and July 2019. This study included 203 patients from 16 tertiary care oncology centers across India for safety assessment, of which a subset of 115 patients who have consented were also evaluated for efficacy and immunogenicity. This study was prospectively registered in the Clinical Trial Registry of India (CTRI), and was commenced only after receiving approval from the competent authority (Central Drugs Standard Control Organization, CDSCO)., Results: Out of the 203 enrolled patients, 121 (59.6%) patients reported 338 adverse events (AEs) during this study. Of 338 reported AEs, 14 serious adverse events (SAEs) were reported by 13 patients including 6 fatal SAEs, assessed as unrelated to the study medication and 7 non-fatal SAEs, 5 assessed as related, and 3 unrelated to Bevacizumab. Most AEs reported in this study (33.9%) were general disorders and administration site conditions, followed by gastrointestinal disorders (29.1%). The most frequently reported AEs were diarrhea (11.3%), asthenia (10.3%), headache (8.9%), pain (7.4%), vomiting (7.9%), and neutropenia (5.9%). At the end of the study, 2 (1.75%) of 69 patients reported antibodies to Bevacizumab without affecting safety and efficacy. However, at the end of 12 months, no patient had reported antibodies to Bevacizumab. Complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) were reported in 18.3%, 22.6%, 9.6%, and 8.7% of patients, respectively. The overall response rate (CR + PR) was reported in 40.9% of patients at the end of the study. Disease control rate (DCR), also known as the clinical benefit rate (CBR) was reported in 50.4% of patients., Conclusions: Bevacizumab (Cizumab, Hetero Biopharma) was observed to be safe, well tolerated, lacking immunogenicity, and efficacious in the treatment of solid tumors. The findings of this phase IV study of Bevacizumab, primarily as a combination therapy regimen suggest its suitability and rationality for usage in multiple solid malignancies., Clinical Trial Registry Number: CTRI/2018/4/13371 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/advsearch.php : 19/04/2018]; Trial Registered Prospectively., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)

Fluid bolus in critically ill children is always a matter of concern and has to be balanced between benefits and harms. While optimizing pre-load is important in the golden hour period, fluid overload is a concern in ICU stay. Various dynamic parameters both clinical and device-guided assessment can help in optimizing fluid therapy., How to Cite This Article: Venkatesan DK, Goel AK. Fluid Bolus: How Much More? Indian J Crit Care Med 2023;27(4):296., Competing Interests: Source of support: Nil Conflict of interest: None, (Copyright © 2023; The Author(s).)

How to cite this article: Venkatesan DK, Goel AK, Pratyusha, K. FOCUS more on POCUS. Indian J Crit Care Med 2023;27(3):225., Competing Interests: Source of support: Nil Conflict of interest: None, (Copyright © 2023; The Author(s).)

High burden of acute malnutrition among children less than 5 years is a major public health problem in India. A "Two-days National Consultation on Addressing Acute Malnutrition" was organized to gather experiences and evidence from 13 states of India on prevention and management of acute malnutrition among children and documenting viewpoints from experts and government counterparts on the same. The consultation centered around five key themes of addressing acute malnutrition; 1) capacity building, 2) strengthening screening, 3) nutritional care of wasting, 4) tracking progress, and 5) scale-up. The paper highlights the experiences and key recommendations around the above key themes. It emerged that there is a need to further accelerate the efforts toward strengthening existing platforms and services to address acute malnutrition among children. Regular trainings of the frontline workers, increased convergence, regular monitoring, and continued service delivery during the pandemic should be undertaken for better outcomes., Competing Interests: There are no conflicts of interest., (Copyright: © 2023 Indian Journal of Community Medicine.)

A multicentric study is being conducted in which children with severe acute malnutrition (SAM) aged 6-59 months are identified with only weight-for-height z-score (WHZ) < - 3 criteria. The present study aimed to assess associations of anthropometric parameters and body composition parameters, to improve treatment of SAM. We conducted a cross-section assessment using the enrolment data of children who participated in a multi-centric longitudinal controlled study from five Indian states. Fat-free mass (FFM) and fat mass (FM) were determined by bio-electrical impedance analysis (BIA). Six hundred fifty-nine children were enrolled in the study using WHZ < -3 criteria. Available data shows that WHZ, WAZ and BMIZ were significantly associated with FFMI while MUACZ was significantly associated with both FMI and FFMI. Children with both severe wasting and severe stunting had significantly lower FFMI compared to those who were only severely wasted. All forms of anthropometric deficits appear to adversely impact FFM and FM.Trial registrationThe study is registered with Clinical Trial Registration of India (Registration No.: CTRI/2020/09/028013 dated 24/09/2020)., (© 2022. The Author(s).)

SCN8A gene encodes sodium channel alpha subunit Nav1.6, and its mutation is associated with Early Infantile Epileptic Encephalopathy-13 (EIEE-13). The mean age of onset is 4-5 months. The phenotype of SCN8A mutation varies from benign epilepsy syndromes, movement disorder, intellectual disability to severe epileptic syndromes with different types of seizures. We hereby report a case of a one-year old female who had an onset of infantile spasms on the seventeenth day of life, which gradually progressed to focal, multifocal, GTCS, and epileptic encephalopathy by one year of age associated with global developmental delay and hypotonia. All metabolic workup, TMS, GCMS, and MRI brain were normal. EEG at 2.5 months was suggestive of epileptic discharge arising from the left frontal region, evolving into generalized discharges. Whole exome sequencing revealed a heterozygous mutation in the SCN8A gene at exon 16 (p.Val892Ala) suggestive of Early Infantile Epileptic Encephalopathy-13 (EIEE-13). This is a novel mutation in the SCN8A gene which has not been reported previously in the literature.

Background: Severe acute malnutrition (SAM) is a major underlying cause of mortality among children. Around one third of the world's acutely malnourished children live in India. The WHO recommends community-based management of acute malnutrition (CMAM) for managing children with SAM. In India, different states are implementing community-based SAM treatment programme, hereinafter called CSAM, using varieties of locally produced nutrient dense food items with different nutrient compositions. The study will assess the effectiveness of these state specific CSAM interventions., Methods: The longitudinal quasi-experimental study will be undertaken in two purposively selected blocks of one district each in the four intervention states and one comparison state. From each state, 200 SAM children identified using weight-for-length/height z-score (WHZ) < - 3 criteria will be enrolled in the study. Their anthropometric data and skinfold thickness will be taken on admission, at sixth week and at discharge by trained field investigators. Other child details, incidence of morbidity and socio-economic details will be collected on admission. To assess food consumption pattern including consumption of locally produced nutrient dense food supplements, dietary assessment, using 24-h dietary recall will be conducted on admission, at sixth week and at discharge. In addition, body composition parameters will be assessed for a sub-set of children using bio-electrical impedance analysis on admission and at discharge to analyse changes in total body water, fat-free mass, and fat mass. Post discharge, all study participants will be followed up monthly until 6 months. Atleast 10% of the sample will be checked for quality assessment. The study's primary outcome is cure rate defined as children attaining WHZ ≥ -2. Secondary outcomes include mean weight gain, mean length of stay, body composition parameters, relapse and mortality rates. Additionally, process evaluation and cost effectiveness analysis will be conducted., Discussion: There is a shortage of robust evidence regarding the effectiveness of locally produced nutrient dense food supplements provided as part of the CSAM intervention in India. This study will contribute to evidence on effective strategies to manage children with uncomplicated SAM in India. The study protocol has all necessary ethical approvals. Written informed consent will be obtained from caregivers of the children., Trial Registration: The study is registered with Clinical Trial Registration of India (Registration No.: CTRI/2020/09/028013 ) Date of registration 24/09/2020., (© 2021. The Author(s).)

Objective: To estimate the burden of undernutrition and its association with rotavirus positivity among under-five children admitted with diarrhea., Methods: This prospective observational study was carried out in hospital-setting from February 2016 to January 2020. For all cases who met the eligibility criteria, an informed written consent was obtained from parents/caregivers. A case report form was used to collect sociodemographic, anthropometric and clinical data. The anthropometric measurements of children were performed according to World Health Organization (WHO) guidelines., Results: Nutritional assessment revealed that 74.1% study subjects were underweight [Weight-for-Age (WAZ) < -2], 59% were stunted [Height-for-Age (HAZ), < -2] and 52.3% were wasted Body Mass Index (BMIZ) < -2]. Stunting was found to be significantly higher among boys as compared to girls and rotavirus positive diarrhea was significantly less prevalent among stunted children., Conclusion: There exists a very high prevalence of underweight, stunting, and wasting among hospitalized children with diarrhea. As the better nutrition has not been shown to guard against rotavirus diarrhea, coverage scale-up of rotavirus vaccination, improved hygiene and sanitation, and focussed nutrition programmes are the need of the hour in India.

Objective: To estimate the prevalence of rotavirus diarrhea and its demographic, social, and clinical characteristics among children less than five years of age admitted in a rural tertiary care institute., Methods: This prospective hospital-based observational study was carried out during February 2016 to June 2019. Diarrheal admissions of children aged 0-59 mo were screened and those who met the inclusion criteria were included in the study. Sociodemographic and clinical information was collected using a case report form. Stool samples were collected within 48 h of admission and transported in cold chain every month to the referral laboratory situated at Christian Medical College for testing., Results: Among the children admitted with acute diarrhea, 148 (11.02%) were positive for rotavirus in the study. As per Vesikari scoring system, around three fourth (76.2%) of children were having severe or very severe diarrhea. Severity of diarrhea was more among rotavirus positive cases as assessed by the Vesikari scoring system. The rotavirus diarrhea showed a peak during November to February., Conclusion: Rotavirus diarrhea is an issue of public health importance, particularly due to its association with the severe diarrhea. As evidenced from similar settings in the world, rotavirus vaccine introduction and increased coverage is the most important strategy towards prevention and control of rotavirus diarrhea.

Introduction: Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro-D-glucose integrated with computed tomography (18F-FDG PET-CT) is clinically useful and extensively used in initial staging and follow-up of patients with head and neck squamous cell carcinoma (HNSCC). We studied the potential prognostic significance of primary tumor maximum standard uptake value (SUVmax) by 18F-FDG PET-CT in oropharyngeal cancer., Methods: Sixty patients with early and locally advanced histopathologically proven oropharyngeal squamous cell cancer were staged using FDG PET-CT at diagnosis. All patient received radiation therapy and concurrent chemotherapy (in stage III and IVA disease) and were assessed prospectively for treatment outcome. Groups were created based on stage and cut off for SUVmax. The association of SUVmax of primary tumour and stage with disease-free survival and overall survival was analyzed by univariate and multivariate statistics., Results: In univariate analysis, a primary tumour SUVmax of greater than 13.0 and advanced stage (IVA) predicted inferior disease-free survival (P=0.0241 and 0.0005, respectively) and overall survival (P=0.0510, toward significance and 0.0003, respectively). In proportional hazards analysis, stage was significant only when adjusted for primary SUVmax., Conclusion: SUVmax failed to demonstrate predictive significance in oropharyngeal cancer, and an increase in primary tumor uptake is possibly a direct effect of advanced disease and consequently increased metabolic activity and aggressiveness., (Copyright © 2021. Published by Elsevier Ltd.)

Objective: To develop and assess Pediatric Appropriateness Evaluation Protocol for India (PAEP-India) for inter-rater reliability and appropriateness of hospitalization., Design: Cross-sectional study., Setting: The available PAEP tools were reviewed and adapted for Indian context by ten experienced pediatricians following semi-Delphi process. Two PAEP-India tools; newborn (≤28 days) and children (>28 days-18 years) were developed. These PAEP-India tools were applied to cases to assess appropriateness of admission and inter-rater reliability between assessors., Participants: Two sets of case records were used: (i) 274 cases from five medical colleges in Delhi-NCR [≤28 days (n=51); >28 days to 18 years (n=223)]; (ii) 622 infants who were hospitalized in 146 health facilities and were part of a cohort (n= 30688) from two southern Indian states., Interventions: Each case-record was evaluated by two pediatricians in a blinded manner using the appropriate PAEP-India tools, and 'admission criteria' were categorized as appropriate, inappropriate or indeterminate., Outcome Measures: The proportion of appropriate hospitalizations and inter-rater reliability between assessors (using kappa statistic) were estimated for the cases., Results: 97.8% hospitalized cases from medical colleges were labelled as appropriate by both reviewers with inter-rater agreement of 98.9% (k=0.66). In the southerm Indian set of infants, both reviewers labelled 80.5% admissions as appropriate with inter-rater agreement of 96.1% (k= 0.89)., Conclusions: PAEP-India (newborn and child) tools are simple, objective and applicable in diverse settings and highly reliable. These tools can potentially be used for deciding admission appropriateness and hospital stay and may be evaluated later for usefulness for cost reimbursements for insurance proposes.

The aim of this study is to generate parthenogenetic embryos from chemically activated in vitro matured caprine oocytes and to study the in vivo developmental potency of such embryos. The parthenogenetic embryos (2-8 and 16 cells to morula stage) were surgically transferred in 26 recipients. Pregnancy in recipients following embryo transfer was monitored by ultrasonography. The recipient aborted a foetus on day 34 post transfer. Sexing of parthenogenetic foetus showed a single band of amelogenin gene indicating female cell DNA. Microsatellite analysis revealed that the recipient has not contributed genetically to the parthenogenetic foetus confirming the identity of aborted foetus of parthenogenetic origin. The authors believe that this is the first authentic report on in vivo development of parthenogenetic foetus in Capra hircus.

Pacemaker generator replacement is a simple procedure that is mostly done on outpatient basis. Electrocautery is almost universally used for bleeding control and tissue dissection. Ventricular fibrillation (VF) caused by electrocautery in these procedures is a very uncommon occurrence and an underappreciated possibility with modern day devices. We report a case of monomorphic ventricular tachycardia induced by electrocautery in a patient with normal left ventricular ejection fraction during elective pacemaker generator change.

Objective: The ability to construct a three-dimensional (3-D) surface model of the endocardium and track the location of catheters within a cardiac chamber, using only cutaneous patches, would be a useful advancement in treating arrhythmias. We tested the feasibility of such a system, Ensite NavX (Endocardial Solutions, Inc., St. Paul, MN, USA), in patients undergoing catheter ablation for SVTs., Methods: Sixteen patients with 20 arrhythmias undergoing ablation were selected. Skin electrode patches were placed on the chest to create a 3-D coordinate system. A low-amplitude, 5.7 kHz signal emitted from the patches was received by conventional catheters positioned in the heart. Catheter location was determined by measuring the field strength received by the catheters. Location points were successively acquired while catheters were moved throughout the chamber. This information was collected and processed by a workstation to create a detailed 3-D model of the endocardial surface. Anatomic landmarks were labeled on the model as the mapping catheter was navigated. 3-D cardiac chamber geometry reconstruction, landmark labeling, and real time catheter tracking were performed successfully in all patients. Up to six catheters, with a total of up to 26 intracardiac electrodes, were tracked simultaneously., Results: Constructed geometries, including major vessels and valves, correlated closely with traditional anatomic models as well as intracardiac recordings and fluoroscopic images., Conclusions: Real-time catheter tracking and 3-D cardiac chamber model construction is feasible using cutaneous patches and conventional catheters. This approach may be useful in the treatment of patients with cardiac arrhythmias where ablation therapy is primarily anatomically based.

Twenty-three patients underwent endocardial radiofrequency ablation of atrial fibrillation (AF) during mitral valve procedures with a previously described left atrial lesion pattern. A temperature-controlled 7-coil surgical probe delivered 60-second lesions at 80 degrees C. The left atrial appendage was oversewn after ablation. Ages ranged from 28 to 88 years. Nineteen patients had chronic AF that was present for over 1 year in 74%; 12 patients had rheumatic mitral stenosis. Mean left atrial diameter was 5.4 +/- 0.7 cm. There was 1 operative death unrelated to the ablation, and no strokes or ablation-related complications were observed. At mean follow-up of 32.5 weeks, 86% of the 22 survivors were in sinus rhythm. All 18 patients with left atrial diameter <6 cm are in sinus rhythm. All postoperative atrial flutter was transient, and no patients required subsequent transcatheter ablation. This lesion pattern is safe and effective when applied in the method described here. It appears to be a reasonable alternative to the complete Maze 3 lesion pattern in patients with mitral valve disease., (Copyright 2002, Elsevier Science (USA). All rights reserved.)