Multicenter Study Research Articles

Endoscopic injection vs anti-reflux surgery for moderate- and high-grade vesicoureteral reflux in children: a cost-effectiveness international study

Even if vesicoureteral reflux is a common condition in children, there are no guidelines about the best therapeutic approach. This study aims to compare the results of endoscopic injection and ureteral reimplantation in children with grade III, IV and V VUR. A multicenter retrospective study included children with grade III, IV and V VUR treated from 2003 to 2018 at three Departments of Pediatric Surgery. Patients were divided into Group A (endoscopic injections) and Group B (anti-reflux surgery), B1 (open, OUR), B2 (laparoscopic, LUR) and B3 (robot-assisted laparoscopic RALUR). Follow-up was at least 5 years. 400 patients were included, 232 (58%) in group A and 168 (42%) in group B. Mean age at surgery was 38.6 months [3.1–218.7]. Mean follow-up was 177.8 months [60–240]. Group A had shorter operative time than group B (P < 0.01); lower analgesic requirement (p < 0.05), shorter hospital stay (P < 0.05) and lower overall costs (p < 0.05), but higher postoperative PNPs (p < 0.01), lower success rate (p < 0.01) and higher redo-surgery percentage (p < 0.01). No differences in terms of postoperative complications, success rate and mean radiation exposure between the two groups. Endoscopy is associated with shorter operative time, shorter hospitalization and lower cost, also in case of multiple injections. Recurrence rate after surgery is lower meaning lower rate of re-hospitalization and radiation exposure for children.

Burden of congenital and hereditary anomalies and their epidemiological attributes in the pediatric and adult population of Peshawar valley, Pakistan

Objectives: To elucidate the burden and clinico-epidemiological attributes of congenital and hereditary anomalies (CA) in the extended Peshawar Valley of Pakistan. Method: This is a multicenter cross sectional study carried out in Buner, Charsadda, Mardan, Nowshera, Peshawar and Swabi districts, during 2017-2021. The pediatric and adult patients with CA were recruited from hospitals, public places and through door-to-door surveys. The anomalies were classified with the help of specialized clinicians. Descriptive statistics was employed. Results: In this study, 1065 independent subjects with certain types of CA from independent households were included. The index males were 71%; the majority of subjects originated from rural areas (72%), and spoke Pashto (96%). The CA were categorized into 10 major and at least 104 minor categories. There was highest representation of neurological disorders, n=375 (proportion.: 0.352; 95% CI: 0.323-0.381), followed by limb defects (n=281; prop.: 0.264), sensorineural defects (n=128; prop.: 0.120), musculoskeletal defects (n=84; prop.: 0.079), visual impairments (n=67; prop.: 0.063), hemoglobinopathies (n=40; prop.: 0.038), ectodermal disorders (n=34; prop.: 0.032), cardiovascular anomalies (n=19; prop.: 0.018), and orofacial anomalies (n=19; prop). Among the neurological disorder, intellectual disabilities and cerebral palsy were highly prevalent. The majority of the cases had a sporadic presentation (68%), and isolated occurrence (72%), whereas parental consanguinity was witnessed in 58% of cases. Conclusion: A wide range of CA were witnessed in this cohort with a preponderance of neurological disorders. The majority of the anomalies are of severe nature rendering a high morbidity burden in the population and requiring early detection, intervention and management. doi: https://doi.org/10.12669/pjms.40.10.9234 How to cite this: Naqvi SF, Ameena U, Qazi W, Ahmad S, Iqbal A, Malik S. Burden of congenital and hereditary anomalies and their epidemiological attributes in the pediatric and adult population of Peshawar valley, Pakistan. Pak J Med Sci. 2024;40(10):2181-2189. doi: https://doi.org/10.12669/pjms.40.10.9234 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Pharmacoepidemiology of combination pulmonary vasodilator therapy in critically ill infants.

New drugs to target different pathways in pulmonary hypertension has resulted in increased combination therapy, but details of this use in infants are not well described. In this large multicenter database study, we describe the pharmacoepidemiology of combination pulmonary vasodilator therapy in critically ill infants. We identified inborn infants discharged home from a Pediatrix neonatal ICU from 1997 to 2020 exposed to inhaled nitric oxide, sildenafil, epoprostenol, or bosentan for greater than two consecutive days. We compared clinical variables and drug utilisation between infants receiving simultaneous combination and monotherapy. We reported each combination's frequency, timing, and duration and graphically represented drug use over time. Of the 7681 infants that met inclusion criteria, 664 (9%) received combination therapy. These infants had a lower median gestational age and birth weight, were more likely to have cardiac and pulmonary anomalies, receive cardiorespiratory support, and had higher in-hospital mortality than those receiving monotherapy. Inhaled nitric oxide and sildenafil were most frequently used, and utilisation of combination and monotherapy for all drugs increased over time. Inhaled nitric oxide and epoprostenol were used in infants with a higher gestational age, earlier postnatal age, and shorter duration than sildenafil and bosentan. Dual therapy with inhaled nitric oxide and sildenafil was the most common combination therapy. Our study revealed an increased use of combination pulmonary vasodilator therapy, favouring inhaled nitric oxide and sildenafil, yet with considerable practice variation. Further research is needed to determine the optimal combination, sequence, dosing, and disease-specific indications for combination therapy.

Comparison of early outcomes in patients who underwent common femoral thromboendarterectomy with vein versus bovine pericardial patches

The treatment outcomesof vein and bovine pericardial patches in thromboendarterectomy (TEA) for common femoral artery (CFA) lesions in patients with peripheral arterial disease (PAD) remain unclear. The purpose of this study was to evaluate the efficacy and safety of the bovine pericardial patch by comparing it with vein patch angioplasty. This was a multicenter retrospective study. We reviewed the data of patients who underwent TEA with patch angioplasty (vein versus bovine pericardial patch angioplasty) for PAD between January 2018 and December 2022. Indication for revascularization is PAD patients with claudication symptoms to rest pain and foot ulcers that interfere with daily life, with lesions in the CFA region. The primary endpoint was 2-year patency. The secondary endpoints were postoperative wound complications, including patch rupture, and safety of remote-phase puncture of the patch area after patch angioplasty. Within the observation period, TEA was performed on 157 limbs in 136 patients using vein patches, and on 86 limbs in 79 patients using bovine pericardial patches. The number of claudication/rest pain/tissue loss was 110/13/34 cases in the vein patch group and 57/14/15 cases in the bovine pericardial patch group, respectively. No significant differences were observed in patient characteristics. No significant between group differences were observed in operative time, blood loss, or percentage of patients who underwent concomitant revascularization during the procedure. The 2-year primary patency rates of the vein and bovine pericardial patch were 95.6% and 92.8%, respectively (P= .49). The rate of surgical site infection (SSI) in this study was 2.5% in the vein patch group and 5.8% in the bovine pericardial patch group, respectively (P=.29). Rupture of the patch occurred in 4 (2.5%) and 4 (4.7%) patients in the vein and bovine pericardial patch groups, respectively (P= .46), and the percentage of cases requiring revision of the patch site was 7 (4.5%) and 5 (5.8%) in the vein and bovine pericardial patch groups, respectively (P= .76). Postoperatively, 23 patients in the vein and 13 patients in the bovine pericardial patch groups underwent patch puncture during the remote period. The median follow-up duration from the date of the surgery to the date of the puncture was 544 days and 374 days in the vein and bovine pericardial patch groups, respectively. No patch-related complications were observed during remote stage puncture. Compared with vein patches, TEA with bovine pericardial patches had acceptable outcomes in terms of patency and postoperative complications.

Objectively measured levels of moderate to vigorous intensity physical activity are associated with cognitive impairment in diabetic hemodialysis patients: a cross-sectional study

ObjectiveThe purpose of this study was to observe the relationship between objectively measured levels of physical activity and cognitive impairment (CI) in the presence or absence of diabetes in middle-aged and elderly hemodialysis patients.MethodsIn this multicenter cross-sectional study, 339 clinically stable hemodialysis patients (210 males; mean age: 67.38 ± 8.07 years) aged ≥55 years were included from 7 dialysis units in Shanghai, China. The Chinese version of the Modified Mini-Mental State Examination (MMSE) was used to assess the CI. The duration of physical activity at different intensities, including moderate to vigorous physical activity (MVPA) as well as light physical activity (LPA), was measured using a triaxial accelerometer (ActiGraph GT3X+, Pensacola, FL, USA). Logistic regression and multiple linear regression were used for analyses.ResultsThe prevalence of CI was higher in hemodialysis patients with comorbid diabetes (24.3%). In diabetic patients, MVPA (increase per 10 min/day) was negatively associated with CI after adjusting for covariates [(OR = 0.89, 95%CI = 0.79–0.99), p = 0.042]. However, no significant association between physical activity and CI was found in non-diabetic hemodialysis patients. Further analyses revealed that MVPA was positively associated with temporal orientation, attention and calculation and recall in diabetic hemodialysis patients.ConclusionPhysical activity was associated with CI in diabetic hemodialysis patients rather than the non-diabetes group. This study is important for early differential diagnosis of CI and improvement of cognitive status in hemodialysis patients.

Knowledge, attitudes, and practices on the use of local anaesthesia in the Emergency Department

Background: Local anaesthesia (LA) is frequently used in the Emergency Department (ED). Local anaesthetic systemic toxicity (LAST) is a potentially fatal complication associated with its use. It is assumed that all doctors administering LA are trained in all aspects of its use including the management of LAST.Methods: A prospective, multicentre cross-sectional study was conducted at three academic EDs in Gauteng. Doctors working in the ED completed an online questionnaire designed to assess knowledge, attitudes and practices regarding the use of LA as well as the recognition and management of LAST.Results: A total of 94 completed questionnaires were analysed. Of these, 44% of participants had graduated from medical school less than 5 years ago, and 72% had less than 5 years of experience working in the ED. The overall mean knowledge score percentage for the safe use of LA was 48.2%. The overall mean knowledge score percentage for recognition and management of LAST was 56.7%. A total of 78% of participants knew that intravenous intralipid emulsion (ILE) therapy is needed in managing LAST; however, only 25% of participants knew where to access ILE and only 33% knew how to use it.Conclusion: The overall level of knowledge on LA and the management of LAST among doctors working in the ED is low. There is also an apparent lack of awareness of the potential for toxicity despite frequent use of LA. Although the occurrence of LAST is rare, our findings highlight an obligation for continuous education on local anaesthesia and the management of LAST.Contribution: The result of this research indicates a gap in training regarding the potential for toxicity of local anaesthesia, recognition of systemic toxicity, and the management thereof. These findings suggest the possibility of misdiagnosis and under reporting of LAST.

Oral corticosteroid dosage and taper duration at onset in myelin oligodendrocyte glycoprotein antibody-associated disease influences time to first relapse

BackgroundWe sought to identify an optimal oral corticosteroid regimen at the onset of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), which would delay time to first relapse while minimising cumulative corticosteroid...

Prognostic evaluation using radiomics after stereotactic body radiotherapy in early-stage lung cancer

Non-small cell lung cancer (NSCLC), the leading cause of cancer-related deaths, is the most common subtype of lung cancer with an incidence of 85%. Stereotactic body radiotherapy (SBRT) is a curative treatment option for patients with early-stage NSCLC who cannot undergo surgery due to medical reasons or who refuse surgery. Radiomics non-invasively extracts advanced imaging features invisible to the human eye from medical images. Radiomics has prognostic value in predicting oncological outcomes after lung SBRT. Although studies on this subject are available in the literature, they are quite heterogeneous. There is a need for large-scale multicenter studies in which standard imaging techniques are used to obtain radiomic features, artificial intelligence-based segmentations are used to eliminate differences between contours, and SBRT dose schemes with appropriate therapeutic indexes are applied. This review aimed to interpret the existing studies and emphasize the clinical importance of radiomics, which can contribute to personalized treatment. A comprehensive literature search was conducted through the PubMed database using a wide range of keywords, which yielded 11 peer-reviewed articles published between 2017 and 2024. Seven articles evaluated computed tomography radiomics, and four evaluated fluorodeoxyglucose positron emission tomography-computed tomography radiomics. Oncological outcomes are not always identical in patients with a similar history receiving similar treatments at the same stage and age. Clinical, demographic, or treatment-related data are insufficient to predict prognosis and determine personalized treatment. Incorporating radiomics to these data can help establish models with higher accuracy and achieve personalized treatment.

Patterns of Brain Maturation in Autism and Their Molecular Associations

In the neurotypical brain, regions develop in coordinated patterns, providing a fundamental scaffold for brain function and behavior. Whether altered patterns contribute to clinical profiles in neurodevelopmental conditions, including autism, remains unclear. To examine if, in autism, brain regions develop differently in relation to each other and how these differences are associated with molecular/genomic mechanisms and symptomatology. This study was an analysis of one the largest deep-phenotyped, case-control, longitudinal (2 assessments separated by approximately 12-24 months) structural magnetic resonance imaging and cognitive-behavioral autism datasets (EU-AIMS Longitudinal European Autism Project [LEAP]; study dates, February 2014-November 2017) and an out-of-sample validation in the Brain Development Imaging Study (BrainMapASD) independent cohort. Analyses were performed during the 2022 to 2023 period. This multicenter study included autistic and neurotypical children, adolescents, and adults. Autistic participants were included if they had an existing autism diagnosis (DSM-IV/International Statistical Classification of Diseases and Related Health Problems, Tenth Revision or DSM-5 criteria). Autistic participants with co-occurring psychiatric conditions (except psychosis/bipolar disorder) and those taking regular medications were included. Neuroanatomy of neurotypical and autistic participants. Intraindividual changes in surface area and cortical thickness over time, analyzed via surface-based morphometrics. A total of 386 individuals in the LEAP cohort (6-31 years at first visit; 214 autistic individuals, mean [SD] age, 17.3 [5.4] years; 154 male [72.0%] and 172 neurotypical individuals, mean [SD] age, 16.35 [5.7] years; 108 male [62.8%]) and 146 individuals in the BrainMapASD cohort (11-18 years at first visit; 49 autistic individuals, mean [SD] age, 14.31 [2.4] years; 42 male [85.7%] and 97 neurotypical individuals, mean [SD] age, 14.10 [2.5] years; 58 male [59.8%]). Maturational between-group differences in cortical thickness and surface area were established that were mostly driven by sensorimotor regions (eg, across features, absolute loadings for early visual cortex ranged from 0.07 to 0.11, whereas absolute loadings for dorsolateral prefrontal cortex ranged from 0.005 to 0.06). Neurodevelopmental differences were transcriptomically enriched for genes expressed in several cell types and during various neurodevelopmental stages, and autism candidate genes (eg, downregulated genes in autism, including those regulating synaptic transmission; enrichment odds ratio =3.7; P =2.6 × -10). A more neurotypical, less autismlike maturational profile was associated with fewer social difficulties and more typical sensory processing (false discovery rate P <.05; Pearson r ≥0.17). Results were replicated in the independently collected BrainMapASD cohort. Results of this case-control study suggest that the coordinated development of brain regions was altered in autism, involved a complex interplay of temporally sensitive molecular mechanisms, and may be associated with both lower-order (eg, sensory) and higher-order (eg, social) clinical features of autism. Thus, examining maturational patterns may provide an analytic framework to study the neurobiological origins of clinical profiles in neurodevelopmental/mental health conditions.

Chronic kidney disease in Kuwait: a multicenter study of two cohorts with different levels of access to public healthcare

IntroductionKuwait has a large expatriate community who experience both restricted access to public health services and lower income than Kuwaiti citizens. Given these conditions, we examined differences in characteristics and management of chronic kidney disease (CKD) between Kuwaitis and expatriates.MethodsClinical and laboratory data for adult CKD Stages 3–5 not on dialysis (CKD 3–5 ND) patients with native kidneys attending nephrology clinics in all Ministry of Health hospitals collected from January 1, 2022, to December 31, 2022. Cohort was then divided into Kuwaiti patients and expatriates patients for comparison.ResultsWe collected data from 2,610 patients (eGFR: 30.8 ml/min/1.73m2; age: 62.6 years; males: 56.7%; Kuwaitis: 62.1%). Kuwaitis were older (63.94 vs. 60.3 years, p < 0.001), with lower mean eGFR (30.4 vs. 31.5 ml/min/1.73m2, p = 0.052) than non-Kuwaitis, however, Kuwaitis had lower mean blood pressure (137.2/76.5 vs. 139.1/78.9 mmHg, p = 0.006), lower HbA1c in diabetics (7.59 vs. 7.82%, p = 0.010), and better lipid profile despite higher body mass indexes (29.6 vs. 28.9 kg/m2, p = 0.002). Both groups had high diabetes mellitus and hypertension rates. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) were used in only 22.6% and renin-angiotensin-aldosterone system inhibitors (RAASi) in only 46.2%.ConclusionCKD 3–5 ND is caused by diabetes mellitus in 56.6% of cases, and the majority have hypertension. In our study, non-Kuwaitis had higher eGFR; however, restricted public healthcare access and lower income can lead to an unhealthy diet and suboptimal care, which may cause higher blood pressure, higher HbA1c, and a higher dyslipidemia rate. RAASi and SGLT2i utilization must increase to combat CKD, and antihypertensive selection must improve.

Incidence of Inborn Errors of Metabolism and Endocrine Disorders Among 40965 Newborn Infants at Riyadh Second Health Cluster of the Ministry of Health Saudi Arabia

Inborn errors of metabolism (IEM) and endocrine disorders are common genetic conditions in the Saudi population with the incidence rate often underestimated. Newborn screening (NBS) using various disease panels provides the first line in the early detection and intervention among infants with a high risk of IEM. Here we aim to assess the incidence of screening disorders and provide an overview of the NBS program at the Ministry of Health Tertiary Care King Fahad Medical City. Dried blood spots (DBS) from 40,965 newborn infants collected on the second day after birth were analyzed for 20 disorders. The total number of positive screen (“repeat”) samples over 10 years was about 1% (n = 382/40,965). The true positive result rate was 15.3% (n = 46/301) with the recall rates of individual disorders ranging from 0.26% (95% CI, 0.17–0.69) to 2.6% (95% CI, 2.19–3.05). The false positive result rate was 84.7% (n = 255/301) with biotinidase activity found to be the most common cause of the second sample repeat. The overall incidence of the screened diseases was 1:891 (95% CI, 11.61–12.47). CH and CAH are the most prevalent among endocrine disorders with an incidence of 1:4097 (95% CI, 2.19–3.05), and PA and ASA among the IEM with an incidence of 1:10,241 (95% CI, 0.09–0.95). In summary, we provide updated data and our experience on the incidence of various IEM and endocrine disorders among the Saudi population, highlight the role of false positive results of biotinidase activity that can increase the recall rate and lead to overestimation of the incidence data, and recommend multicenter studies to achieve a successful national NBS program.

Efficacy of vedolizumab and ustekinumab in pediatric-onset inflammatory bowel disease: A real-world multicenter study.

Vedolizumab and ustekinumab are effective in inducing and maintaining corticosteroid-free clinical remission (CFR) in adult patients with inflammatory bowel disease (IBD). This study describes the efficacy and safety of vedolizumab and ustekinumab in pediatric IBD. All patients ≤18 years of age with Crohn's disease (CD) or ulcerative colitis (UC) treated with vedolizumab or ustekinumab in three centers in Northern France were followed retrospectively. The primary outcome was CFR at Week 14 (W14). Twenty-five patients (9 CD, 16 UC) and 33 patients (28 CD, 5 UC) were started on vedolizumab and ustekinumab respectively between 2016 and 2021. All were previously treated with antitumor necrosis factor (TNF). The median time from diagnosis to treatment initiation was 21.0 (12.0-44.0) and 42.0 (22.0-73.5) months for vedolizumab and ustekinumab respectively. Among vedolizumab-treated patients, 36% were in CFR at W14, including 22% in CD and 44% in UC. At W52, 56% were in CFR, including 33% in CD and 69% in UC. Among ustekinumab-treated patients, 49% were in CFR at W14, including 54% in CD and 20% in UC. At W52, 55% were in CFR, including 57% in CD and 40% in UC. There was a significant increase in median growth velocity between W0 and W52 of +2 SD in vedolizumab-treated patients (p = 0.0002). Four adverse events were reported during vedolizumab treatment, none for ustekinumab-treated patients. Vedolizumab and ustekinumab appear to be effective in inducing and maintaining CFR in pediatric-onset IBD. Randomized controlled trials are needed to confirm these results.

The effectiveness and cost-effectiveness of attachment-based family therapy for young adults with high suicidal ideation: protocol of a randomized controlled trial

BackgroundYoung adult suicidality is worldwide a prevalent mental health problem and the number one cause of death, with devastating consequences for individuals and their families, and substantial economic costs. However, psychological and pharmacological treatments currently recommended in guidelines for treatment of high-risk youth for fatal suicide have limited effect. In line with the World Health Organization’s (WHO) recommendation to involve the family in treatment of these youth, attachment-based family therapy (ABFT) was developed, a 16-week attachment and emotion-focused treatment, implemented in mental health care settings across various European countries in the past years, and becoming increasingly popular among therapists. However, the (cost-)effectiveness of ABFT has not been studied in emerging adults. In the proposed pragmatic randomized controlled trial (RCT), we aim to evaluate the effectiveness and cost-effectiveness of ABFT compared to treatment as usual (TAU) on suicidality, as delivered in daily practice.MethodsThis pragmatic multicenter study in the Netherlands and Belgium includes 13 participating sites. Participants are suicidal young adults (≥ 31 SIQ-JR score) between 16 and 30 years old who seek mental health treatment (n = 142) and their caregivers. The primary outcome is suicidality (SIQ-JR), with assessments at baseline, post-intervention (5 months after baseline), 3, 6, and 12 months after intervention. We predict that, compared to TAU, ABFT will lead to a stronger reduction in suicidality and will be more cost-effective, over the course of all time points. We also expect stronger decreases in depressive symptoms, given that suicidality is very common in individuals with depressive disorder, as well as more improvement in family functioning, autonomy, entrapment, and young adult attachment, in the ABFT condition.DiscussionThis study can contribute to improving the care for suicidal youngsters with high mortality risk. Treatment of suicidal emerging adults is understudied. The results will inform clinical guidelines and policy makers and improve treatment of suicidal emerging adults.Trial registrationThis trial is registered on ClinicalTrials.gov (NCT05965622, first posted on July 28, 2023).

Cerebral vasculitis as clinical manifestation of neuroborreliosis: Pattern of vascular pathology and prognostic factors of outcome.

Neuroborreliosis is a tick-borne condition that affects the central and/or peripheral nervous system. Cerebral infarction associated with neuroborreliosis-related vasculitis has been reported in only a handful of cases. Therefore, specific patterns of vascular pathology and prognostic outcome factors are still incompletely understood. To determine the pattern of vascular pathology and prognostic outcome factors in patients with neuroborreliosis-related vasculitis. We performed a longitudinal multicenter study between 1997 and 2022 in five academic study sites in Germany with a cumulative reference area of 1,620,000 inhabitants. All patients diagnosed with neuroborreliosis-associated cerebral vasculitis were included. The evaluation of clinical parameters, including NIH Stroke Scale (NIHSS), disability ranking (modified Rankin Scale, mRS), and neuroimaging, was performed at admission as well as after 3 and 12 months. Linear regression analysis was used to identify the independent predictors of recurrent strokes, involvement of posterior circulation, or multiple vessels. Patients with neuroborreliosis-related vasculitis (n = 51) were relatively young (mean age: 62 years) and displayed a predominance of vascular events within the posterior circulation (60.8%). A history of smoking was linked to recurrent strokes/TIA (64.7% vs. 23.5%; p = 0.006), strokes in multiple territories (100% vs. 35.9%; p < 0.0001), and posterior circulation events (64.5% vs. 30.0%, p = 0.017), whereas other cardiovascular risk factors showed no significant differences. Linear regression analysis corroborated smoking's association with recurrent strokes/ transient ischemic attacks (B: 0.412; p = 0.002), multiple territory strokes/TIA (B: 0.467; p = 0.033), and posterior circulation events (B: 0.317; p = 0.033). A thorough CSF examination for neuroborreliosis is crucial, especially in younger stroke patients, particularly those experiencing posterior circulation ischemic events. Smoking cessation should be prompted in patients with neuroborreliosis-associated cerebral vasculitis.

Coronary Revascularization Guided With Fractional Flow Reserve or Instantaneous Wave-Free Ratio

The differences between the use of fractional flow reserve (FFR) or instantaneous wave-free ratio (iFR) in the long term are unknown. To compare long-term outcomes of iFR- and FFR-based strategies to guide revascularization. The DEFINE-FLAIR multicenter study randomized patients with coronary artery disease to use either iFR or FFR as a pressure index to guide revascularization. Patients from 5 continents with coronary artery disease and angiographically intermediate severity stenoses who underwent hemodynamic interrogation with pressure wires were included. These data were analyzed from March, 13, 2014, through April, 27, 2021. Five-year major adverse cardiac events (MACE) (a composite of all-cause death, nonfatal myocardial infarction, and unplanned revascularization), as well as the individual components of the combined end point. At 5 years of follow-up, no significant differences were found between the iFR (mean age [SD], 65.5 [10.8] years; 962 male [77.5%]) and FFR (mean age [SD], 65.2 [10.6] years; 929 male [74.3%]) groups in terms of MACE (21.1% vs 18.4%, respectively; hazard ratio [HR], 1.18; 95% CI, 0.99-1.42; P = .06). While all-cause death was higher among patients randomized to iFR, it was not driven by myocardial infarction (6.3% vs 6.2% in the FFR study arm; HR, 1.01; 95% CI, 0.74-1.38; P = .94) or unplanned revascularization (11.9% vs 12.2% in the FFR group; HR, 0.98; 95% CI, 0.78-1.23; P = .87). Furthermore, patients in whom revascularization was deferred on the basis of iFR or FFR had similar MACE in both study arms (17.9% in the iFR group vs 17.5% in the FFR group; HR, 1.03; 95% CI, 0.79-1.35; P = .80) with similar rates of the components of MACE, including all-cause death. On the contrary, in patients who underwent revascularization after physiologic interrogation, the incidence of MACE was higher in the iFR group (24.6%) compared with the FFR group (19.2%) (HR, 1.36; 95% CI, 1.07-1.72; P = .01). At 5-year follow up, an iFR based-strategy was not statistically different than an FFR strategy to guide revascularization in terms of MACE, nonfatal myocardial infarction, and unplanned revascularization. ClinicalTrials.gov Identifier: NCT02053038.

Laparoscopic and thoracoscopic whole-stomach esophagectomy with preoperative pyloric balloon dilatation for esophageal cancer: a prospective multicenter case-series outcome

IntroductionTo mitigate gastroparesis as well as other post-operative complications, we undertook a prospective multicenter study to assess the feasibility, safety, and efficacy in the short-term outcomes of laparoscopic and thoracoscopic whole stomach esophagectomy with preoperative pyloric balloon dilatation.MethodsA prospective descriptive study on 37 patients with laparoscopic and thoracoscopic whole stomach esophagectomy with preoperative pyloric balloon dilatation from January 2019 to March 2023. The perioperative indications, clinical data, intra-operative index, pathological postoperative specimens, postoperative complications, and follow-up results were retrospectively evaluated.ResultsIn our study, all patients were male, with dysphagia as the predominant symptom (45.9%). Esophageal cancer incidence was similar between middle and lower thirds. Nodules were the primary finding on esophagoscopy (48.6%). Preoperative pyloric dilation averaged 31.2 min without complications. Surgical duration ranged from 225 to 400 min (mean 305). Gastric tube fluid volume averaged 148.9 ± 110.66 ml per day. Among 34 post-operative cases underwent gastric transit scans, most had non-dilated stomachs with efficient pyloric drug circulation. Three cases required prolonged ventilation, precluding pyloric circulation scans. Four patients developed chylous fistula, one requiring chest tube embolization. Recurrent laryngeal nerve damage occurred in 10.8% of cases.ConclusionAfter evaluating esophageal cancer patients undergoing laparoscopic whole-stomach esophagectomy with preoperative pyloric balloon dilatation, it was found that this procedure is safe, effective, and significantly reduces postoperative gastroparesis and related complications.

Sarcomas of the Head and Neck Region

Introduction: Sarcomas are relatively rare malignant tumors of mesenchymal origin, representing only about 1% of tumors in the head and neck region. Materials and Methods: A retrospective study involved patients with sarcomas of the head and neck region who were diagnosed and treated over a 5-year period. Results: Nine patients were included, 4 men and 5 women. The mean age of the patients was 51 years. Eight patients had soft tissue sarcomas, and 1 patient had osteosarcoma. The most common histologic types were dermatofibrosarcoma protuberans and angiosarcoma. Tumors presented predominantly with local symptomatology. All patients were treated only by surgical excision. No distant or regional metastases were found in any patient. Complete surgical excision was achieved in all cases, except in patients with chondrosarcoma of the nose and sinuses, who died due to local progression in the second year of follow-up. Other patients were disease-free during the observed period; a patient with osteosarcoma died in the fourth year of follow-up without recurrence of the malignant disease. Conclusion: Large prospective and multicenter studies are necessary to provide relevant data on the distribution of different types of sarcoma in the head and neck region, their clinical behavior and response to therapeutic modalities, as well as on recurrence, presence of metastases, and survival.

Epidemiological characteristics of patients with juvenile dermatomyositis in China: a multicenter study.

Juvenile dermatomyositis (JDM) is a rare but chronic autoimmune disease with systemic nonsuppurative inflammation. Many studies have focused on the clinical characteristics and therapy of JDM. A few studies have reported the epidemiological characteristics and social burden of JDM patients abroad, but there has been no study in China. This study was based on the FUTang Updating medical REcords Database. Data was extracted from the registry information of inpatient medical records. The epidemiological characteristics and economic burden of Chinese JDM patients were analyzed. A total of 1164 JDM patients from 24 hospitals were enrolled from Jan 2016 to Dec 2021. The ratio of boys to girls was 1:1.23, and half were between 6 and 12 years old. Over half(n=629) were admitted to the hospital at least twice for intensive treatment. 20% of JDM patients suffered from lung involvement and 2.2% suffered from subcutaneous calcification. The median days of hospitalization were 10 (range 6 to 14), in addition, the median United States dollar (USD) of expense was 2370.5(1373.7,3541.9). Lung involvement was the major factor causing high inpatient burden, length of stay, and expense. Nearly, 17% of JDM patients were admitted to the hospital as emergencies, suggesting sever disease activity stage needing urgent treatment. No deaths occurred in our study. Our study documents the epidemiological characteristics and social burden of JDM patients in China, contributing to the enhanced comprehension and effective management of JDM in the country.

Agreement between the EWGSOP2 and SDOC consensuses for sarcopenia in patients receiving hemodialysis: Findings of a cross sectional analysis from the SARC-HD study.

Differences in definitions and operational diagnoses for sarcopenia create difficulties in understanding the epidemiology of the disease. We examined the prevalences of sarcopenia using the revised European Working Group on Sarcopenia in Older People (EWGSOP2) and the Sarcopenia Definitions and Outcomes Consortium (SDOC) consensuses and analyzed their level of agreement in patients receiving hemodialysis. Data from the SARCopenia trajectories and associations with clinical outcomes in patients receiving hemodialysis (SARC-HD) multicenter study in Brazil were analyzed. Muscle strength was assessed using handgrip strength, muscle mass by calf circumference, and physical performance by the 4-m gait speed test. Sarcopenia was diagnosed according to both the EWGSOP2 (low muscle strength plus low muscle mass) and the SDOC (low muscle strength plus low physical performance). The Cohen kappa statistic was used to determine the level of agreement between the consensuses. 838 patients (57.8 ± 15.0 years; 61% men) from 19 dialysis units were included. We found similar prevalences of sarcopenia between the consensuses (EWGSOP2, n = 128, 15.3%; SDOC, n = 105, 12.5%) but with weak agreement (50 of 233 patients, 21.5%; κ = 0.34, 95% CI 0.25-0.43). Agreement was also weak within age categories (≥60 years, κ = 0.34; <60 years, κ = 0.15; both P < 0.001). Of the 51 patients diagnosed by the EWGSOP2 criterion as having severe sarcopenia, all but 1 (98.0%) met the SDOC criterion for sarcopenia (κ = 0.61, 95% CI 0.52-0.70). Low muscle strength was more frequently diagnosed using the SDOC than with the EWGSOP2 (52.3% vs 25.9%). We found a weak agreement between the EWGSOP2 and SDOC consensuses for the diagnosis of sarcopenia in patients receiving hemodialysis. Although still weak, agreement was marginally better for older patients. These findings highlight the importance of a global and standardized conceptual diagnosis of sarcopenia.

Non-COVID Admissions to the ICU After COVID Vaccination: A Multicenter Study

Non-COVID Admissions to the ICU After COVID Vaccination: A Multicenter Study