Concordance between LDL-C estimated by various formulas and directly measured LDL-C.

BACKGROUND: Although direct measurement of LDL cholesterol (LDL-C) in blood is possible, there are several formulas for its estimation. The performance and concordance of these formulas have not been evaluated in Colombia. OBJECTIVE: To determine the concordance between LDL-C directly measured using the enzymatic technique and existing methods to calculate it. METHODS: Study of diagnostic tests, and concordance. We analyzed complete lipid profile samples, which included direct measurement of LDL-C, from 2014 to 2022 at Hospital Universitario San Ignacio (Bogotá, Colombia). The direct LDL-C measurements were compared with estimations using the DeLong, Sampson, Friedewald, extended Martin/Hopkins, Anandaraja, and Cordova methods. Lin's concordance correlation coefficient (CCC) and Bland-Altman plots were employed, conducting subgroup analyses based on triglycerides (TG), and LDL-C levels. Kappa coefficients assessed agreement in LDL-C risk categories according to dyslipidemia guidelines. RESULTS: A total of 2144 samples were evaluated. The formulas with the best CCC were DeLong (0.971) and Sampson (0.969), with no relevant differences. The extended Martin/Hopkins formula (0.964) and the Friedewald formula (0.964) also performed well. The Anandaraja (0.921) and Cordova (0.881) equations exhibited inferior performance. For all formulas, a decrease in concordance was observed when triglycerides were ≥400 mg/dL or when LDL-C was <100 mg/dL. Most formulas demonstrated optimal agreement when assessed using risk categories according to dyslipidemia guidelines, except for Anandaraja and Cordova. CONCLUSIONS: The DeLong, Sampson, extended Martin/Hopkins, and Friedewald formulas show the best concordance with directly measured LDL-C, so in most cases the results can be considered interchangeable. However, the Anandaraja and Cordova formulas are not recommended.

External validation and comparison of six cardiovascular risk prediction models in the Prospective Urban Rural Epidemiology (PURE)-Colombia study.

AIMS: To external validate the SCORE2, AHA/ACC Pooled Cohort Equation (PCE), Framingham Risk Score (FRS), Non-Laboratory INTERHEART Risk Score (NL-IHRS), Globorisk-LAC, and WHO prediction models and compare their discrimination and calibration capacity. METHODS: Validation in individuals aged 40-69 years with at least 10 years follow-up and without baseline use of statins or cardiovascular diseases from the Prospective Urban Rural Epidemiology prospective cohort study (PURE)-Colombia. For discrimination, the C-statistic, and Receiver Operating Characteristic curves with the integrated area under the curve (AUCi) were used and compared. For calibration, the smoothed time-to-event method was used, choosing a recalibration factor based on the integrated calibration index (ICI). In the NL-IHRS, linear regressions were used. RESULTS: In 3,802 participants (59.1% women), baseline risk ranged from 4.8% (SCORE2 women) to 55.7% (NL-IHRS). After a mean follow-up of 13.2 years, 234 events were reported (4.8 cases per 1000 person-years). The C-statistic ranged between 0.637 (0.601-0.672) in NL-IHRS and 0.767 (0.657-0.877) in AHA/ACC PCE. Discrimination was similar between AUCi. In women, higher overprediction was observed in the Globorisk-LAC (61%) and WHO (59%). In men, higher overprediction was observed in FRS (72%) and AHA/ACC PCE (71%). Overestimations were corrected after multiplying by a factor derived from the ICI. CONCLUSIONS: Six prediction models had a similar discrimination capacity, supporting their use after multiplying by a correction factor. If blood tests are unavailable, NL-IHRS is a reasonable option. Our results suggest that these models could be used in other countries of Latin America after correcting the overestimations with a multiplying factor.

Detecting people at high risk of cardiovascular disease and implementing preventive interventions in this population is a key strategy in primary prevention. Recently, new risk calculation tools have been developed, but before their application and routine use in populations different from those where it was developed, it's necessary to validate them. The recommendations for predicting cardiovascular risk in Colombia's guidelines are based on studies with noteworthy limitations. This study involving 3,802 healthy individuals in Colombia supports the recommendation of using these prediction models. The estimation result should be multiplied by a correction factor, because most of the prediction models overestimate cardiovascular risk. For example, the correction factors suggested in women for AHA/ACC PCE and SCORE2 are 0.54 and 0.75, respectively. In men, the correction factors suggested in AHA/ACC PCE and SCORE2 are 0.28 and 0.61, respectively. Therefore, the present study with a contemporary population provides additional evidence to update these recommendations in Colombia and perhaps in Latin America.

Use of portable single-lead electrocardiogram device as an alternative for QTc monitoring in critically ill patients.

PURPOSE: Acquired QT prolongation is frequent and leads to a higher mortality rate in critically ill patients. KardiaMobile 1L® (KM1L) is a portable, user-friendly single lead, mobile alternative to conventional 12-lead electrocardiogram (12-L ECG) that could be more readily available, potentially facilitating more frequent QTc assessments in intensive care units (ICU); however, there is currently no evidence to validate this potential use. METHODS: We conducted a prospective diagnostic test study comparing QT interval measurement using KM1L with conventional 12-L ECG ordered for any reason in patients admitted to an ICU. We compared the mean difference using a paired t-test, agreement using Bland-Altman analysis, and Lin's concordance coefficient, numerical precision (proportion of QT measurements with <10 ms difference between KM1L and conventional 12-L ECG), and clinical precision (concordance for adequate discrimination of prolonged QTc). RESULTS: We included 114 patients (61.4% men, 60% cardiovascular etiology of hospitalization) with 131 12-L ECG traces. We found no statistical difference between corrected QT measurements (427 ms vs. 428 ms, p = .308). Lin's concordance coefficient was 0.848 (95% CI 0.801-0.894, p = .001). Clinical precision was excellent in males and substantial in females (Kappa 0.837 and 0.781, respectively). Numerical precision was lower in patients with vasoactive drugs (-13.99 ms), QT-prolonging drugs (13.84 ms), antiarrhythmic drugs (-12.87 ms), and a heart rate (HR) difference of ≥5 beats per minute (bpm) between devices (-11.26 ms). CONCLUSION: Our study validates the clinical viability of KM1L, a single-lead mobile ECG device, for identifying prolonged QT intervals in ICU patients. Caution is warranted in patients with certain medical conditions that may affect numerical precision.

Characteristics Associated With Elevated Time Below Range in Elderly Patients With Type 1 Diabetes Using an Automated Insulin Delivery System.

BACKGROUND: This study investigated the characteristics associated with an increased risk of hypoglycemia, in elderly patients with type 1 diabetes mellitus (T1D) using automated insulin delivery (AID) systems. METHODS: Cross-sectional observational study including patients >60 years, using sensor-augmented insulin pump therapy with predictive low-glucose management (SAPT-PLGM), hybrid closed-loop (HCL), and advanced hybrid closed-loop (AHCL), for more than three months. A geriatric assessment was performed, and body composition was determined to investigate its association with achieving time below range (TBR) <70 mg/dL goals. RESULTS: The study included 59 patients (47.5% of men, mean age of 67.6 years, glycated hemoglobin [HbA1c] of 7.5 ± 0.6%, time in range (TIR) 77.8 ± 9.9%). Time below range <70 and <54 mg/dL were 2.2 ± 2.3% and 0.4 ± 0.81%, respectively. Patients with elevated TBR <70 mg/dL (>1%) had higher HbA1c levels, lower TIR, elevated time above range (TAR), and high glycemic variability. Regarding body composition, greater muscle mass, grip strength, and visceral fat were associated with a lower TBR <70 mg/dL. These factors were independent of the type of technology used, but TIR was higher when using AHCL systems compared with SAPT-PLGM and HCL systems. CONCLUSIONS: In elderly patients treated with AID systems with good functional status, lower lean mass, lower grip strength, and lower visceral fat percentage were associated with TBR greater than 1%, regardless of the device used. A similar finding along was found with CGM indicators such as higher HbA1c levels, lower TIR, higher TAR, and higher CV. Geriatric assessment is crucial for personalizing patient management.

Short-term versus usual-term antibiotic treatment for uncomplicated Staphylococcus aureus bacteremia: a systematic review and meta-analysis.

Introduction: Uncomplicated Staphylococcus aureus bacteremia remains a leading cause of morbidity and mortality in hospitalized patients. Current guidelines recommend a minimum of 14 days of treatment. Objective: To evaluate the efficacy and safety of short versus usual antibiotic therapy in adults with uncomplicated S. aureus bacteremia (SAB). Methods: We developed a search strategy to identify systematic review and meta-analysis of non-randomized studies (NRS), comparing short versus usual or long antibiotic regimens for uncomplicated SAB in MEDLINE, Embase, and the Cochrane Register up to June 2023. The risk of bias was assessed using the ROBINS I tool. The meta-analysis was performed using Review Manager software with a random effect model. Results: Six NRS with a total of 1700 patients were included. No significant differences were found when comparing short versus prolonged antibiotic therapy as defined by the authors for 90-day mortality [odds ratio (OR): 1.09; 95% confidence interval (CI): 0.82-1.46, p: 0.55; I2 = 0%] or 90-day recurrence or relapse of bacteremia [OR: 0.72; 95% CI: 0.31-1.68, p: 0.45; I2 = 26%]. Sensitivity analysis showed similar results when comparing a predefined duration of <14 days versus ⩾14 days and when excluding the only study with a high risk of bias. Conclusion: Shorter-duration regimens could be considered as an alternative option for uncomplicated SAB in low-risk cases. However, based on a small number of studies with significant methodological limitations and risk of bias, the benefits and harms of shorter regimens should be analyzed with caution. Randomized clinical trials are needed to determine the best approach regarding the optimal duration of therapy.

Comparing short and regular antibiotic treatment duration, for a type of blood infection caused by S. aureus We investigated the optimal duration of antibiotic treatment for adults with a specific type of blood infection (uncomplicated Staphylococcus aureus), a condition with a significant global impact on mortality and costs. After a thorough search, only six trials involving 1700 patients were identified. We therefore decided to perform a meta-analysis (a type of statistical analysis). The results showed that the duration of antibiotics, whether short or long (less or more than 14 days), did not significantly affect mortality or recurrence of infection within 90 days. Consequently, we suggested that shorter courses of antibiotics might be appropriate for less severe cases. However, we emphasized caution because of the limitations of the studies. We recommended further research with improved methods to determine the optimal approach to treating this type of infection.

Concordance between nice classification and histopathology in colonic polyps: a tertiary center experience.

Background: Narrow-Band imaging International Colorectal Endoscopic (NICE) could reduce histopathology study requirements in colorectal polyp evaluation. Local and regional studies are required to validate its utility. Objectives: To evaluate concordance between NICE classification and histopathology. Design: Prospective analytic study performed in the Hospital Universitario San Ignacio, Bogotá (Colombia) between 2021 and 2022. Methods: Concordance between NICE I, II and III classification and histopathology [Hyperplastic Polyp (HP), adenoma and deep submucosal invasive cancer (DSIC)] was evaluated using weighted kappa. Diagnostic performance was evaluated for NICE I-II versus NICE III for DSIC versus adenoma/HP. A subgroup analysis was performed for polyps ⩾10 mm and those located in the rectum, sigmoid, and left colon. Results: A total of 238 polyps from 135 patients were evaluated. Median age 67 years (IQR 58.5-74.5), 54.4% males. 23 (17.1%) had ⩾3 polyps. Of polyps, 52.1% were located on rectum, sigmoid and left colon. A total of 182 (76.5%) were <10 mm. NICE and histopathology evidenced a fair-moderate concordance (quadratic weighted kappa 0.36, linear weighted kappa 0.43). NICE classification (NICE I-II versus III) compared to histopathology (DSIC versus adenoma/HP) evidenced a sensitivity of 90.9% and specificity of 99.1%. For DSIC diagnosis specificity was ⩾95% on polyps ⩾10 mm and those left sided located. Conclusion: NICE and histopathology concordance is suboptimal. However, NICE III for DSIC diagnosis evidence good specificity. Therefore, NICE III polyps require a prompt histopathological evaluation and follow-up. Good operative characteristics stand in polyps ⩾10 mm and left sided located. NBI formal training is recommended in gastroenterology units in Latin America.

Concordance between colonoscopy polyp evaluation with NBI optical technology and histopathology evaluation Most colorectal cancer are developed from polyps. A proper polyp evaluation is required to orientate which polyp could be a potential neoplasia. However, a definitive diagnosis is made according to histopathology evaluation. On the other hand, Narrow-Band imaging International Colorectal Endoscopic (NICE) classification based on colonoscopy could predict neoplastic polyps and drive therapeutic decisions. Our tertiary center study in Colombia evidence that NICE classification predicts adequately neoplastic polyps but is suboptimal to categorize low risk polyps. Therefore, histopathology polyp evaluation should be still recommended and NBI formal training is recommended in gastroenterology units in Latin -America.

Frecuencia y distribución geográfica del uso de sacubitril/valsartán en Colombia entre los años 2019 y 2020 / Frequency and geographical distribution of the use of sacubitril/valsartan in Colombia between 2019 and 2020

Resumen Introducción: La adherencia al tratamiento de la falla cardiaca en la vida real es subóptima. Se desconoce la adherencia a las recomendaciones del uso de sacubitril/valsartán en Colombia. Objetivo: Evaluar la frecuencia de uso, la distribución geográfica y las características demográficas de los pacientes a quienes se les formuló sacubitril/valsartán en 2019-2020, utilizando los datos del Sistema Integrado de Información de Protección Social (SISPRO). Materiales y método: Estudio descriptivo de corte transversal, en el que se extrajo la información relativa a la distribución de la prescripción del medicamento por departamento, género, quinquenio de edad y los códigos CIE-10 con los cuales se indicó. Resultados: Entre los años 2019 y 2020, se prescribieron 23.026 pacientes con sacubitril/valsartán en Colombia, de los cuales el 63.86% fueron hombres. El 92% de las prescripciones se hicieron a pacientes mayores de 50 años. Las regiones del país con mayor frecuencia de prescripción fueron Bogotá, Sucre y Santander. Conclusiones: Con base en la prevalencia estimada de falla cardiaca (2 a 3%), la frecuencia de formulación de sacubitril/valsartán en Colombia es menor a la esperada. Las regiones rurales del país son las que presentan el menor uso, lo que sugiere barreras de acceso que deben ser exploradas.

Abstract Introduction: Real-life adherence to the management of heart failure is suboptimal. Adherence to the recommendations for the use of sacubitril/valsartan in Colombia is unknown. Objective: To assess the frequency of use, geographic distribution, and demographic characteristics of patients who were prescribed sacubitril/valsartan in 2019-2020, using data from the "Sistema Integrado de Información de Protección Social" (SISPRO). Materials and method: This is a descriptive cross-sectional study. Information was extracted on the prescription distribution by department, gender, five-year age groups and the ICD-10 codes with which the medication was prescribed. Results: Between 2019 and 2020, 23,026 patients in Colombia were prescribed sacubitril/valsartan; 63.86% of the patients were men. Ninety-two percent of the prescriptions were for patients over the age of 50. The regions of the country with the highest prescription frequency were Bogotá, Sucre and Santander. Conclusions: Taking into account the estimated prevalence of heart failure (2-3%), the frequency with which sacubitril/valsartan is prescribed in Colombia is lower than expected. The rural regions of the country have the lowest use, which suggests access barriers that should be explored.

Cut-off points of neck and waist circumference as predictors of obstructive sleep apnea in the Colombian population: a comparison with polysomnography

ABSTRACT BACKGROUND: Neck circumference (NC) is a useful anthropometric measure for predicting obstructive sleep apnea (OSA). Ethnicity and sex also influence obesity phenotypes. NC cut-offs for defining OSA have not been established for the Latin American population. OBJECTIVES: To evaluate NC, waist circumference (WC), and body mass index (BMI) as predictors of OSA in the Colombian population and to determine optimal cut-off points. DESIGN AND SETTING: Diagnostic tests were conducted at the Javeriana University, Bogota. METHODS: Adults from three cities in Colombia were included. NC, WC, and BMI were measured, and a polysomnogram provided the reference standard. The discrimination capacity and best cut-off points for diagnosing OSA were calculated. RESULTS: 964 patients were included (57.7% men; median age, 58 years) and 43.4% had OSA. The discrimination capacity of NC was similar for men and women (area under curve, AUC 0.63 versus 0.66, P = 0.39) but better for women under 60 years old (AUC 0.69 versus 0.57, P < 0.05). WC had better discrimination capacity for women (AUC 0.69 versus 0.57, P < 0.001). There were no significant differences in BMI. Optimal NC cut-off points were 36.5 cm for women (sensitivity [S]: 71.7%, specificity [E]: 55.3%) and 41 cm for men (S: 56%, E: 62%); and for WC, 97 cm for women (S: 65%, E: 69%) and 99 cm for men (S: 53%, E: 58%). CONCLUSIONS: NC and WC have moderate discrimination capacities for diagnosing OSA. The cut-off values suggest differences between Latin- and North American as well as Asian populations.

Cut-off points of neck and waist circumference as predictors of obstructive sleep apnea in the Colombian population: a comparison with polysomnography.

BACKGROUND: Neck circumference (NC) is a useful anthropometric measure for predicting obstructive sleep apnea (OSA). Ethnicity and sex also influence obesity phenotypes. NC cut-offs for defining OSA have not been established for the Latin American population. OBJECTIVES: To evaluate NC, waist circumference (WC), and body mass index (BMI) as predictors of OSA in the Colombian population and to determine optimal cut-off points. DESIGN AND SETTING: Diagnostic tests were conducted at the Javeriana University, Bogota. METHODS: Adults from three cities in Colombia were included. NC, WC, and BMI were measured, and a polysomnogram provided the reference standard. The discrimination capacity and best cut-off points for diagnosing OSA were calculated. RESULTS: 964 patients were included (57.7% men; median age, 58 years) and 43.4% had OSA. The discrimination capacity of NC was similar for men and women (area under curve, AUC 0.63 versus 0.66, P = 0.39) but better for women under 60 years old (AUC 0.69 versus 0.57, P < 0.05). WC had better discrimination capacity for women (AUC 0.69 versus 0.57, P < 0.001). There were no significant differences in BMI. Optimal NC cut-off points were 36.5 cm for women (sensitivity [S]: 71.7%, specificity [E]: 55.3%) and 41 cm for men (S: 56%, E: 62%); and for WC, 97 cm for women (S: 65%, E: 69%) and 99 cm for men (S: 53%, E: 58%). CONCLUSIONS: NC and WC have moderate discrimination capacities for diagnosing OSA. The cut-off values suggest differences between Latin- and North American as well as Asian populations.

Esophagogastric Junction Contractile Integral (EGJ-CI) in Various Phenotypes of Gastroesophageal Reflux Disease (GERD)

Introduction: Two parameters of high-resolution esophageal manometry are used to observe the function of the esophagogastric junction (EGJ): the anatomical morphology of the EGJ and contractile vigor, which is evaluated with the esophagogastric junction contractile integral (EGJ-CI). To date, how these parameters behave in different gastroesophageal reflux disease (GERD) phenotypes has not been evaluated. Materials and methods: An analytical observational study evaluated patients with GERD confirmed by pH-impedance testing and endoscopy undergoing high-resolution esophageal manometry. The anatomical morphology of the EGJ and EGJ-CI was assessed and compared between reflux phenotypes: acid, non-acid, erosive, and non-erosive. Results: 72 patients were included (63% women, mean age: 54.9 years), 81.9% with acid reflux and 25% with erosive esophagitis. In the latter, a decrease in EGJ-CI (median: 15.1 vs. 23, p = 0.04) and a more significant proportion of patients with type IIIa and IIIb EGJ (83.3% vs 37.1%, p < 0.01) were found. No significant differences existed in the manometric parameters of patients with and without acid and non-acid reflux. Conclusion: In our population, EGJ-CI significantly decreased in patients with erosive GERD, suggesting that it could be used to predict this condition in patients with GERD. This finding is also related to a higher proportion of type III EGJ and lower pressure at end-inspiration of the lower esophageal sphincter in this reflux type.

Introducción: Para observar la función de la unión esofagogástrica (UEG) se utilizan dos parámetros de la manometría esofágica de alta resolución: la morfología anatómica de la UEG y el vigor contráctil, el cual se evalúa con la integral de contractilidad distal de la unión esofagogástrica (IC-UEG). Hasta el momento, no se ha evaluado cómo se comportan estos parámetros en los diferentes fenotipos de enfermedad por reflujo gastroesofágico (ERGE). Metodología: Estudio observacional analítico en el que se evaluaron pacientes con ERGE confirmado por pH-impedanciometría y endoscopia, llevados a manometría esofágica de alta resolución. Se evaluó la morfología anatómica de la UEG y la IC-UEG, y se comparó entre los diferentes fenotipos de reflujo: ácido, no ácido, erosivo y no erosivo. Resultados: Se incluyó a 72 pacientes (63% mujeres, edad media: 54,9 años), 81,9% con reflujo ácido y 25% con esofagitis erosiva. En este último grupo se encontró una disminución de la IC-UEG (mediana: 15,1 frente a 23, p = 0,04) y una mayor proporción de pacientes con UEG tipo IIIa y IIIb (83,3% frente a 37,1%, p < 0,01). No se encontraron diferencias significativas en los parámetros manométricos de los pacientes con y sin reflujo ácido y no ácido. Conclusión: En nuestra población, la IC-UEG estuvo significativamente disminuida en los pacientes con ERGE erosivo, lo que sugiere que podría ser utilizada como un predictor de esta condición en pacientes con ERGE. Este hallazgo también se relaciona con mayor proporción de UGE tipo III y menor presión al final de la inspiración del esfínter esofágico inferior en este tipo de reflujo.

Results From a Virtual Clinic for the Follow-up of Patients Using the Advanced Hybrid Closed-Loop System.

BACKGROUND: Evidence regarding the implementation of medium-term strategies in advanced hybrid closed-loop (AHCL) system users is limited. Therefore, this study aimed to describe the efficacy and safety of the AHCL system in patients with type 1 diabetes (T1D) on a six-month follow-up in a virtual diabetes clinic (VDC). METHOD: A prospective cohort of adult patients with T1D treated using the AHCL system (Mini Med 780G; Medtronic, Northridge, California) in a VDC follow-up. Standardized training and follow-up were conducted virtually. Clinical data and metabolic control outcomes were reported at baseline, and at three and six months. RESULTS: Sixty-four patients (mean age = 42 ± 14.6 years, 65% men, 54% with graduate education) were included. Percentage time in range (%TIR) increased significantly regardless of prior therapy with intermittently scanned continuous glucose monitoring + multiple daily injections and sensor-augmented pump therapy with predictive low-glucose management after starting AHCL and persisted during the follow-up period with no hypoglycemic events. The %TIR 70 to 180 mg/dL according to socioeconomic strata was 73.4% ± 5.3%, 78.1% ± 8.1%, and 84.2% ± 7.5% for the lower, middle, and upper strata, respectively. The sensor was used more frequently in the population with a higher education level. Adherence to sensor use and SmartGuard retention were higher in patients who underwent the VDC follow-up. CONCLUSIONS: Medium-term follow-up of users of AHCL systems in a VDC contributes to safely achieving %TIR goals. Virtual diabetes clinic follow-up favored adherence to sensor use and continuous SmartGuard use. Socioeconomic strata were associated with a better glycemic profile and education level was associated with better adherence to sensor use.

Dynamic changes in liver function tests do not correctly reclassify patients at risk of choledocholithiasis beyond ASGE 2019 criteria.

Introduction: Dynamic changes in liver function tests have been proposed to correctly reclassify the risk of choledocholithiasis; however, information is scarce and insufficient to recommend its use. Methods: Retrospective cohort of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) due to moderate and high risk of choledocholithiasis according to the 2019 American Society of Gastrointestinal Endoscopy (ASGE) guidelines. We evaluated whether significant changes in liver function tests (bilirubin, transaminases, or alkaline phosphatase), defined as an increase or a reduction ⩾30 or ⩾50% between two measurements taken with a difference of 24-72 h can correctly reclassify the risk of choledocholithiasis beyond the ASGE guidelines. The net reclassification index (NRI) was calculated for patients with and without choledocholithiasis. Results: Among 1175 patients who underwent ERCP, 170 patients were included in the analysis (59.4% women, median 59.5 years). Among patients without a diagnosis of choledocholithiasis, the number of patients correctly reclassified by transaminases was slightly higher than those incorrectly reclassified (NRI = 0.24 for aspartate amino transaminase and 0.20 for alanine amino transaminase). However, among patients with a diagnosis of choledocholithiasis, it led to incorrect reclassification in a greater number of cases (NRI = -0.21 and -0.14, respectively). The benefits of reclassification were minimal for bilirubin and alkaline phosphatase, or for value changes >50%. A subgroup analysis showed similar findings in patients without a history of cholecystectomy and in those with normal bile duct. Conclusion: Dynamic changes in liver function tests do not improve choledocholithiasis risk classification beyond the 2019 ASGE criteria. New criteria should continue to be sought to optimize risk stratification.

Factors associated with a nonresponse to prone positioning in patients with severe acute respiratory distress syndrome due to SARS-CoV-2.

OBJECTIVE: To identify risk factors for nonresponse to prone positioning in mechanically ventilated patients with COVID-19-associated severe acute respiratory distress syndrome and refractory hypoxemia in a tertiary care hospital in Colombia. METHODS: Observational study based on a retrospective cohort of mechanically ventilated patients with severe acute respiratory distress syndrome due to SARS-CoV-2 who underwent prone positioning due to refractory hypoxemia. The study considered an improvement ≥ 20% in the PaO2/FiO2 ratio after the first cycle of 16 hours in the prone position to be a 'response'. Nonresponding patients were considered cases, and responding patients were controls. We controlled for clinical, laboratory, and radiological variables. RESULTS: A total of 724 patients were included (58.67 ± 12.37 years, 67.7% males). Of those, 21.9% were nonresponders. Mortality was 54.1% for nonresponders and 31.3% for responders (p < 0.001). Variables associated with nonresponse were time from the start of mechanical ventilation to pronation (OR 1.23; 95%CI 1.10 - 1.41); preintubation PaO2/FiO2 ratio (OR 0.62; 95%CI 0.40 - 0.96); preprone PaO2/FiO2 ratio (OR 1.88. 95%CI 1.22 - 2.94); and radiologic multilobe consolidation (OR 2.12; 95%CI 1.33 - 3.33) or mixed pattern (OR 1.72; 95%CI 1.07 - 2.85) compared with a ground-glass pattern. CONCLUSION: This study identified factors associated with nonresponse to prone positioning in patients with refractory hypoxemia and acute respiratory distress syndrome due to SARS-CoV-2 receiving mechanical ventilation. Recognizing such factors helps identify candidates for other rescue strategies, including more extensive prone positioning or extracorporeal membrane oxygenation. Further studies are needed to assess the consistency of these findings in populations with acute respiratory distress syndrome of other etiologies.

Clinical characteristics, treatments, and outcomes of difficult biliary stones in a reference hospital in Colombia.

The local experience and the success rate of different available treatments for difficult biliary stones in Colombia are poorly described. We made an observational study reporting patients treated for difficult biliary stones, at Hospital Universitario San Ignacio in Bogotá, Colombia between January 2015, and November 2021. Clinical characteristics, endoscopic retrograde cholangiopancreatography (ERCP) findings, and outcomes are presented. Additionally, the success rates of Endoscopic Sphincterotomy Plus Large Balloon Dilation (ESLBD), Mechanical Lithotripsy (ML), temporary stenting (TS), cholangioscopy-guided laser lithotripsy (CGLL), and surgery are described. A total of 146 patients were included (median age 69 years, IQR 58.5-78.5, 33.8% men). The median stone diameter was 15 mm (IQR 10 - 18 mm). One stone was presented in 39.9%, two stones in 18.2%, and ≥3 stones in the remaining stone. A 67.6% disproportion rate was observed between the stone and distal common bile duct. Successful stone extraction was achieved in 56.2% in the first procedure, 22.6% in the second, 17.1% in the third, 3.4% in the fourth, and 0.7% in the fifth procedures. The successful extraction rates were 56.8% for ESLBD, 75% for ML, 23.4% for TS, 57.7% for CGLL, and 100% for surgery. Endoscopic management of difficult stones is usually successful, although it usually requires 2 or more ERCPs procedures. The surgical requirements were low. ESLBD is an effective technique unlike TS. Few patients required advanced techniques such as ML or CGLL. Endoscopic procedures are associated with a low rate of complications.

Evaluation of diuretic efficiency of intravenous furosemide in patients with advanced heart failure in a heart failure clinic.

INTRODUCTION: Diuretic efficiency (DE) is an independent predictor of all-cause mortality in acute heart failure (HF) at long-term follow-up. The performance of DE in advanced HF and the outpatient scenario is unclear. METHODS: Survival function analysis on a retrospective cohort of patients with advanced HF followed at the outpatient clinic of Hospital Universitario San Ignacio (Bogotá, Colombia) between 2017 and 2021. DE was calculated as the average of total diuresis in milliliters divided by the dose of IV furosemide in milligrams for each 6-h session, considering all the sessions in which the patient received levosimendan and IV furosemide. We stratified DE in high or low using the median value of the cohort as the cutoff value. The primary outcome was a composite of all-cause mortality and HF hospitalizations during a 12-month follow-up. Kaplan-Meier curves and log-rank test were used to compare patients with high and low DE. RESULTS: In all, 41 patients (66.5 ± 13.2 years old, 75.6% men) were included in the study, with a median DE of 24.5 mL/mg. In total, 20 patients were categorized as low and 21 as high DE. The composite outcome occurred more often in the high DE group (13 versus 5, log-rank test p = 0.0385); the all-cause mortality rate was 29.2% and was more frequent in the high DE group (11 versus 1, log-rank test p = 0.0026). CONCLUSION: In patients with advanced HF on intermittent inotropic therapy, a high DE efficiency is associated with a higher risk of mortality or HF hospitalization in a 12-month follow-up period.

Emerging Disease: A Case Series of post-COVID-19 Cholangiopathy

Introduction: Post-COVID-19 cholangiopathy is a novel condition characterized by biliary tract sclerosis and elevated alkaline phosphatase levels in critically ill patients. This case series aims to describe the experience of a Latin American reference hospital in managing this condition. Methods: This case series includes patients with confirmed coronavirus disease 2019 (COVID-19) who exhibited subsequent elevation of alkaline phosphatase levels exceeding three times the normal value. The patients also had documented bile duct abnormalities observed through cholangioresonance or endoscopic retrograde cholangiopancreatography (ERCP). The clinical presentation, imaging findings, complications, and treatment approaches are described. Results: Eight patients (56.5 ± 9.2 years old, 62.5% male) were included in the study. All patients had previously experienced severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pneumonia and required mechanical ventilation. Four patients (50%) received sedoanalgesia with ketamine, and all eight patients (100%) received propofol. All patients developed infections, such as cholangitis or liver abscesses, caused by gram-negative bacteria. The peak alkaline phosphatase level during follow-up averaged 1646.12 ± 611.3. Imaging findings revealed intrahepatic (100%) and extrahepatic (87.5%) bile duct dilation. In 75% of cases, bile molds with a black appearance were extracted. Seven patients experienced recurrent cholangitis, and three patients were referred for pre-liver transplant consultation. Conclusions: Post-COVID-19 cholangiopathy is characterized by severe cholestasis, intra- and extrahepatic bile duct dilation, formation of bile molds, and recurrent cholangitis. In our study, a possible association between sepsis caused by gram-negative bacteria and the use of sedative medications is hypothesized. Further studies are necessary to establish the most appropriate management strategies for these patients, as they currently face unfavorable long-term morbidity and mortality outcomes.

Introducción: la colangiopatía pos-COVID-19 es una entidad nueva caracterizada por esclerosis del tracto biliar y elevación de fosfatasa alcalina en el paciente críticamente enfermo. Esta serie de casos describe la experiencia de un hospital de referencia en Latinoamérica. Métodos: serie de casos que incluye a pacientes con enfermedad por coronavirus de 2019 (COVID-19) confirmada y elevación posterior de fosfatasa alcalina > 3 veces del valor normal, asociados a anormalidades en las vías biliares documentada por colangiorresonancia o colangiopancreatografía retrógrada endoscópica (CPRE). Se describe la presentación clínica, hallazgos imagenológicos, complicaciones y tratamiento. Resultados: se incluyeron a 8 pacientes (56,5 ± 9,2 años, 62,5% hombres). Todos presentaron neumonía por coronavirus del síndrome respiratorio agudo grave de tipo 2 (SARS-CoV-2) previo a desarrollo de colangiopatía, y requirieron ventilación mecánica. Cuatro pacientes (50%) recibieron sedoanalgesia con ketamina y ocho (100%) con propofol. Todos presentaron infecciones (colangitis/abscesos hepáticos) por bacterias gramnegativas. El nivel pico de fosfatasa alcalina durante el seguimiento fue en promedio 1646,12 ± 611,3. Los hallazgos imagenológicos incluyeron dilatación de la vía biliar intrahepática (100%) y extrahepática (87,5%). En el 75% se extrajo el molde biliar de apariencia negra. Siete pacientes presentaron recurrencia de colangitis y tres pacientes fueron referidos a consulta de pretrasplante hepático. Conclusiones: la colangiopatía pos-COVID-19 está caracterizada por colestasis grave con dilatación de la vía biliar intra- y extrahepática, formación de moldes biliares y colangitis recurrente. En nuestro estudio se plantea como hipótesis una posible relación con sepsis por bacterias gramnegativas y uso de medicamentos sedativos. Se requieren nuevos estudios para establecer el manejo más adecuado para estos pacientes, que hasta el momento presentan una morbimortalidad desfavorable a largo plazo.

Characterization of Achalasia Subtypes Based on High-Resolution Manometry in Patients at a Reference Hospital in Colombia

Introduction: Limited information is available regarding the clinical and manometric characteristics of different subtypes of achalasia. This study aims to describe these characteristics in patients treated at a prominent hospital in Colombia. Methods: This descriptive observational study included patients diagnosed with achalasia using high-resolution esophageal manometry at Hospital Universitario San Ignacio in Bogotá, Colombia, between 2016 and 2020. We documented the clinical manifestations, manometric findings, treatment approaches, and response to treatment based on the subtype of achalasia. Results: A total of 87 patients were enrolled, with a median age of 51 years, and 56.4% of them were female. The majority had type II achalasia (78.1%), followed by type I (16%) and type III (5.7%). All patients presented with dysphagia, 40.2% experienced chest pain, and 27.6% had gastroesophageal reflux. The clinical parameters, including integrated relaxation pressure value (IRP; median: 24 mmHg, interquartile range [IQR]: 19-33), upper esophageal sphincter pressure (UES; median: 63 mmHg, IQR: 46-98), and lower esophageal sphincter pressure (LES; median: 34 mm Hg, IQR: 26-45), were similar across the different subtypes. Esophageal clearance was incomplete in all patients. Among the 35 patients who received intervention, Heller's myotomy was the most commonly employed procedure (68.5%), followed by esophageal dilation (28.6%). All patients experienced symptomatic improvement, with a median pre-treatment Eckardt score of 5 (IQR: 5-6) and a post-treatment score of 1 (IQR: 1-2). Conclusions: Type II achalasia is the most prevalent subtype. The clinical and manometric findings, as well as treatment response, exhibit similarities among the different subtypes of achalasia. In Colombia, the outcomes of this condition align with those reported in other parts of the world.

Introducción: existe información limitada sobre las características clínicas y manométricas de los diferentes subtipos de acalasia. Este estudio describe dichas características en pacientes manejados en un hospital de referencia en Colombia. Método: estudio descriptivo observacional que incluye a pacientes con diagnóstico de acalasia por manometría esofágica de alta resolución manejados en el Hospital Universitario San Ignacio de Bogotá, Colombia, entre 2016 y 2020. Se describen las manifestaciones clínicas, hallazgos manométricos, tratamiento utilizado y respuesta al mismo según el subtipo de acalasia. Resultados: se incluyeron a 87 pacientes (mediana de edad: 51 años, 56,4% mujeres). La mayoría de tipo II (78,1%), seguido por tipo I (16%) y tipo III (5,7%). Todos presentaron disfagia, 40,2% dolor torácico y 27,6% reflujo gastroesofágico. La clínica y los valores del integral de presión de relajación (IRP; mediana: 24 mm Hg, rango intercuartílico [RIC]: 19-33), presión del esfínter esofágico superior (EES; mediana: 63 mm Hg, RIC: 46-98) y presión del esfínter esofágico inferior (EEI; mediana: 34 mm Hg, RIC: 26-45) fueron similares en los diferentes subtipos. El aclaramiento esofágico fue incompleto en todos los pacientes. Entre 35 pacientes que recibieron manejo intervencionista, la miotomía de Heller fue la intervención más utilizada (68,5%), seguido por la dilatación esofágica (28,6%). La totalidad de estos pacientes presentó una mejoría sintomática con la mediana de Eckardt pretratamiento de 5 (RIC: 5-6) y postratamiento de 1 (RIC: 1-2). Conclusiones: la acalasia tipo II es la más común. La clínica y los hallazgos manométricos y respuesta a tratamiento son similares entre los subtipos de acalasia. En Colombia, esta entidad se comporta de forma similar a lo reportado en otras partes del mundo.

Quality assessment of breast cancer studies conducted with the Delphi technique.

BACKGROUND: The Delphi technique is a consensus method aiming to obtain statistical estimations from a qualitative approach, through an iterative process that leads to consensus within experts. The main characteristics of the technique include iteration, anonymity, feedback, and consensus reaching. When high-quality, quantitative evidence on a particular topic is insufficient, the Delphi technique can be used for making decisions in clinical scenarios. However, the quality of studies on breast cancer conducted with this technique, has not been assessed. OBJECTIVE: We aim to evaluate the quality of studies on breast cancer which used the Delphi technique as their method. METHODS: A quality assessment tool (Quali-D) was created through consensus among experts on the Delphi technique. Then, the tool was applied to studies on breast cancer which used the Delphi technique as their method. RESULTS: Studies conducted through the Delphi technique mainly assessed for quality indicators and expressed needs in patients with breast cancer. High-quality characteristics were reported in 63.89% of the studies. 98.61% used the Delphi technique due to lack of a more adequate method to solve their research question. 98.61% summarized and presented results in a clear way. In 91.67% of the studies, at least two rounds were conducted. 86.11% described the methods for expert selection in a complete manner. Only 54.17% of the studies reported an anonymous process and 4.17% of the studies disclosed conflicts of interest thoroughly. CONCLUSIONS: A variety of topics were assessed through the Delphi technique in cases where no other technique would have been more appropriate for assessing these issues. Significant limitations are present in terms of anonymity and full disclosure of conflicts of interest. We found that the quality of studies conducted with the Delphi technique regarding breast cancer is overall good. However, the limitations of each study must be considered when applying their results to clinical practice.

Determination of time in range associated with HbA1c ≤ 6.5% in Latin American pregnant women diagnosed with type 1 diabetes mellitus using an automated insulin delivery system.

AIMS: To determine the correlation between %TIR and HbA1c in pregnant women with type 1 diabetes mellitus (DM1). METHODS: Diagnostic test study in a prospective cohort of pregnant patients with DM1 using automated insulin delivery system (AID)in Colombia and Chile. RESULTS: Fifty-two patients were included [mean age 31.8 ± 6.2 years, pregestational HbA1c 7.2% [interquartile range (IQR), 6.5-8.2]. During follow-up, we found a better metabolic control during the second (HbA1c 6.40%, IQR 5.9,7.1) and third trimesters (HbA1c 6.25%;IQR 5.9,6.8). A weak and negative correlation between %TIR and HbA1c was found for all the gestation (Spearman's rank correlation coefficient:-0.22, p:0.0329), and in the second (r:-0.13, p: 0.38) and third trimesters (r:-0.26, p = 0.08). %TIR had poor discriminating capacity for predicting HbA1c < 6% (area under the curve [AUC], 0.59; 95% confidence interval [CI],0.46-0.72) and for predicting HbA1c < 6.5% (AUC, 0.57;95% CI,0.44-0.70). The optimal cutoff points for %TIR were > 66.1% for predicting HbA1c < 6% (65% sensitivity, 62% specificity) and %TIR > 61.1% for HbA1c < 6.5% (59% sensitivity, 54% specificity). CONCLUSION: The correlation between HbA1c and %TIR during pregnancy was weak. The optimal cutoff points for identifying patients with HbA1c < 6.0% and < 6.5% were %TIR > 66.1% and > 61.1%, respectively, with moderate sensitivity and specificity.

Clinical characteristics, treatments, and outcomes of dificult biliary stones in a reference hospital in Colombia

The local experience and the success rate of different available treatments for dificult biliary stones in Colombia are poorly described. We made an observational study reporting patients treated for dificult biliary stones, at Hospital Universitario San Ignacio in Bogotá, Colombia between January 2015, and November 2021. Clinical characteristics, endoscopic retrograde cholangiopancreatography (ERCP) findings, and outcomes are presented. Additionally, the success rates of Endoscopic Sphincterotomy Plus Large Balloon Dilation (ESLBD), Mechanical Lithotripsy (ML), temporary stenting (TS), cholangioscopy-guided laser lithotripsy (CGLL), and surgery are described. A total of 146 patients were included (median age 69 years, IQR 58.5-78.5, 33.8% men). The median stone diameter was 15 mm (IQR 10 - 18 mm). One stone was presented in 39.9%, two stones in 18.2%, and ≥3 stones in the remaining stone. A 67.6% disproportion rate was observed between the stone and distal common bile duct. Successful stone extraction was achieved in 56.2% in the first procedure, 22.6% in the second, 17.1% in the third, 3.4% in the fourth, and 0.7% in the fifth procedures. The successful extraction rates were 56.8% for ESLBD, 75% for ML, 23.4% for TS, 57.7% for CGLL, and 100% for surgery. Endoscopic management of dificult stones is usually successful, although it usually requires 2 or more ERCPs procedures. The surgical requirements were low. ESLBD is an effective technique unlike TS. Few patients required advanced techniques such as ML or CGLL. Endoscopic procedures are associated with a low rate of complications.

La tasa de éxito de diferentes tratamientos de Cálculo Biliar Difícil (CBD) en Colombia no está descrita. Hemos realizado un estudio descriptivo observacional sobre el tratamiento de CBD en el Hospital Universitario San Ignacio en Bogotá, Colombia entre enero 2015 y noviembre 2021. Se presentan las características clínicas, hallazgos en la Colangiopancreatografía Retrógrada Endoscópica (CPRE) y desenlaces asociados. Adicionalmente, se describe la tasa de éxito de los pacientes tratados mediante esfinterotomía asociada a dilatación endoscópica con balón grande (EDEBG), litotripsia mecánica (LM), stent temporal (ST), litotripsia con láser guiada por colangioscopia (LLGC) y cirugía. 146 pacientes fueron incluidos (Mediana de edad 69 años, RIC 58,6-78,5). 33,8% eran hombres. La mediana del tamaño del CBD fue de 15 mm (RIC 10-18 mm). 39,9% tenían un solo cálculo, 18,2% tenían 2 y el resto ≥3 cálculos. 67,6% tenían desproporción entre el cálculo y el colédoco distal. La extracción exitosa se logró en 56,2% en el primer procedimiento, 22,6% en el segundo, 17,1% en el tercero, 3,4% en el cuarto y 0,7% en el quinto procedimiento. La tasa de extracción exitosa fue de 56,8% con EDEBG, 75% con LM, 23,4% con ST, 57,7% con LLGC y 100% con cirugía. El manejo endoscópico del CBD es usualmente exitoso. Sin embargo, requiere usualmente ≥2 CPRE. El tratamiento quirúrgico no es común. EDEBG es una técnica efectiva a diferencia del ST. Pocos pacientes requirieron técnicas avanzadas como LM o LLGC. Los métodos endoscópicos presentan una baja tasa de complicaciones.