Clinical and hemodynamic outcomes and mortality risk factors in patients undergoing pulmonary thromboendarterectomy / Resultados clínicos y hemodinámicos y factores de riesgo de mortalidad en pacientes sometidos a tromboendarterectomía pulmonar

Abstract Background: Pulmonary thromboendarterectomy is the current treatment of choice in patients with chronic thromboembolic pulmonary hypertension. The objective of the present study was to analyze the clinical and hemodynamic outcomes and the risk factors for mortality in a cardiovascular center in Colombia. Methods: Cohort study, conducted between 2001 and 2019. All operated patients were included in the study. Risk factors associated with mortality were established by means of a multivariate regression using the COX method and survival was established using the Kaplan-Meier method. p < 0.05 was considered statistically significant. Results: Seventy-three patients were operated. Median age was 51 years, 55% of females, 79% had functional Class III and IV. The mean pulmonary arterial pressure was 50 mmHg and 640 dyn.s.cm−5 for pulmonary vascular resistance (PVR). After the intervention, there was a decrease in mean pulmonary artery pressure (p ≤ 0.001) and in PVR (p = 0.357); 21% had evidence of residual pulmonary hypertension. Only 8% and 6% continued with functional Class III and IV at 6 and 12 months, respectively. There were 15 deaths (19.1%; 12% at 30 days). The factors associated with mortality were the diastolic diameter of the right ventricle measured postoperatively (hazard ratio [HR] 10.88 95% confidence interval [CI] 1.97-62, p = 0.007), time of invasive mechanical ventilation (HR 1.06 95% CI 1.02-1.09 p = 0.004), and the presence of complications during the surgical procedure (HR 5.62 95% CI 1.94-16.22 p = 0.001). Conclusions: Pulmonary thromboendarterectomy is associated with excellent clinical and hemodynamic outcomes. The mortality risk factors found are not those usually described in the literature.

Resumen Antecedentes: La tromboendarterectomía pulmonar es el tratamiento de elección actual en pacientes con hipertensión pulmonar tromboembólica crónica. El objetivo del presente estudio fue analizar los resultados clínicos y hemodinámicos y los factores de riesgo de mortalidad en un centro cardiovascular de Colombia. Métodos: Estudio de cohorte entre 2001 y 2019. Se incluyeron todos los pacientes operados. Los factores de riesgo asociados a la mortalidad se establecieron mediante una regresión multivariante mediante el método COX y la supervivencia se estableció mediante el método de Kaplan-Meier. Los valores de p < 0.05 se consideraron estadísticamente significativos. Resultados: se operaron 73 pacientes. La mediana de edad fue de 51 años, 55% mujeres, 79% tenían clase funcional III y IV. La presión arterial pulmonar media fue de 50 mmHg y 640 dyn.s.cm−5 para la resistencia vascular pulmonar. Después de la intervención, hubo una disminución en la presión arterial pulmonar media (p ≤ 0.001) y en la resistencia vascular pulmonar (p = 0.357). El 21% tenía evidencia de hipertensión pulmonar residual. Solo el 8% y el 6% continuaron con clase funcional III y IV a los 6 y 12 meses respectivamente. Hubo 15 muertes (19.1%; 12% a los 30 días). Los factores asociados con la mortalidad fueron el diámetro diastólico del ventrículo derecho medido en el postoperatorio (HR 10.88 IC 95% 1.97-62, p = 0.007), el tiempo de ventilación mecánica invasiva (HR 1.06 IC 95% 1.02-1.09 p = 0.004) y el presencia de complicaciones durante el procedimiento quirúrgico (HR 5.62 IC 95% 1.94-16.22 p = 0.001). Conclusiones: La tromboendartectomía pulmonar se asocia con excelentes resultados clínicos y hemodinámicos. Los factores de riesgo de mortalidad encontrados no son los habitualmente descritos en la literatura.

Tratamiento farmacológico del paciente que vive con diabetes mellitus tipo 2 / Pharmacological treatment of the patient living with type 2 diabetes mellitus

Resumen Introducción: el abordaje del paciente con diabetes mellitus tipo 2 ha cambiado a lo largo del tiempo. Años anteriores el enfoque terapéutico giraba en torno al nivel de hemoglobina glicada (HbA1c); ahora, con el advenimiento de nuevas moléculas, y luego de entender que la meta terapéutica no es sólo un punto de corte de HbA1c, se ha modificado el objetivo, para estar centrado en el paciente, en sus comorbilidades macro y microvasculares, riesgo cardiovascular y falla cardíaca. En esta revisión de la literatura se exponen las preguntas que se deben resolver al momento de definir una estrategia terapéutica en el paciente con diabetes mellitus tipo 2. Métodos: valoración de guías locales e internacionales de tratamiento de diabetes mellitus tipo 2. Resultados: se valoraron las guías del tratamiento de la diabetes mellitus tipo 2 realizadas por la Asociación Colombiana de Endocrinología, Asociación Colombiana de Medicina Interna, Asociación Colombiana de Nefrología, Sociedad Colombiana de Cardiología y Cirugía Cardiovascular, American Diabetes Association, American Association of Clinical Endocrinology, European Association for the Study of Diabetes y European Society of Cardiology. Además, se revisaron los ensayos clínicos que respaldan el uso de los diferentes grupos farmacológicos disponibles para el tratamiento de los pacientes con diabetes mellitus tipo 2. Conclusión: es menester del clínico realizar el abordaje terapéutico de los pacientes con diabetes mellitus tipo 2 de forma individualizada, centrado en el riesgo cardiovascular, comorbilidades asociadas, riesgo de hipoglucemia y costos de la intervención brindada.

Abstract Introduction: the approach to the patient with diabetes has changed over the past decade. Some years ago, the primary goal of treatment was to achieve a certain level of A1c as a marker of glucose control. Now, with new molecules in the market that can modify the disease and its complications the treatment is focused on the individual patient, his micro and macrovascular complications and the risk of cardiovascular, heart failure and renal complications. In this review of the literature, we expose some questions that need to be solved when approaching the treatment of a patient with type 2 diabetes. Methods: we reviewed local and international guidelines on the treatment of type 2 diabetes. Results: we reviewed guidelines in the treatment of diabetes, local guidelines; Asociación Colombiana de Endocrinología, Asociación Colombiana de Medicina Interna, Asociación Colombiana de Nefrología, Sociedad Colombiana de Cardiología y Cirugía Cardiovascular. International guidelines; American Diabetes Association, American Association of Clinical Endocrinology, European Association for the Study of Diabetes y European Society of Cardiology Additionally, we revised clinical trial that support the use of the different drugs that are recommended by the guidelines as first, second- or third-line treatment. Conclusion: as clinicians we are expected to give the patient an individualized approach, based on their own comorbidities, risk of cardiovascular and renal disease and risk of hypoglycemia guided by national and international guidelines and latest clinical trial that support our approach.

El índice de fragilidad y sus características en ensayos clínicos aleatorizados de diabetes mellitus / The Fragility Index and its characteristics in randomized clinical trials of diabetes mellitus

Resumen Introducción: para valorar la robustez de los resultados se ha propuesto una herramienta llamada el Índice de Fragilidad (IF), esta se define como el mínimo número de pacientes que se tienen que cambiar de "No eventos" a "Eventos" en el grupo de intervención para que un resultado estadísticamente significativo pase a no significativo, evidenciando que entre menor sea el IF, los resultados serán más frágiles. Diferentes autores han encontrado que la significancia de los resultados de muchos Ensayos Clínicos Controlados (ECA) dependen de pocos eventos. El objetivo del estudio fue evaluar el IF de los ECA en diabetes mellitus de cinco de las revistas médicas de mayor impacto a nivel mundial. Metodología: se realizó búsqueda electrónica en PubMed, para identificar ECA en Annals of Internal Medicine, BMJ, The Lancet, The New England Journal of Medicine y JAMA. Se revisaron los ECA en pacientes con diabetes mellitus o prediabetes y se calculó el IF para cada desenlace según el método descrito por Walsh et al, usando tablas de contingencia 2x2. Se planeó usar el coeficiente de correlación de Spearman para evaluar la correlación entre el IF y el tamaño de la muestra, el número de eventos, el valor de p y el tiempo de seguimiento. Se evaluó la significancia de todos los resultados con un valor de p<0,05. Resultados: la mediana del IF fue 11, y en tres estudios (7,3%) se encontró que el resultado no era estadísticamente significativo después de recalcular la p con el test exacto de Fisher. Se encontró relación directa leve entre el número de eventos y el IF (Rho= 0,343, p= 0,02) y correlación moderada inversa entre el valor de p y el IF (Rho= -0,632, p= 0,000). No se encontró correlación estadísticamente significativa entre el tamaño de muestra, tiempo de seguimiento y pérdidas con el IF. Conclusiones: en los ECA sobre diabetes, los resultados estadísticamente significativos dependen de pocos eventos, evidenciado por un bajo valor en el IF, los valores de esta medición están relacionados de forma directa con el número de eventos, e inversa con el valor de p.

Abstract Introduction: to evaluate the robustness of the results, a tool called the Fragility Index (FI) has been proposed, which is defined as the minimum number of patients that have to be changed from "No events" to "Events" in the intervention group to change a statistically significant to nonsignificant result. Showing that among a lower Fragility Index, the results of the trial will be less robust or more fragile. Different authors have found that the significance of the results of many controlled clinical trials (RCTs) depend on very few events. The objective of the study is to evaluate the FI of controlled clinical trials in diabetes mellitus in five of the general medical journals with the greatest impact factor worldwide. Methods: an electronic search was conducted in PubMed to identify randomized clinical trials in The Annals of Internal Medicine, BMJ, The Lancet, The New England Journal of Medicine and JAMA. Clinical trials were reviewed with diabetic or prediabetic patients and the FI was then calculated for each outcome according to the method described by Walsh et al, using 2x2 contingency tables. A priori was planned to use the Spearman correlation coefficient to evaluate the direct correlation between the Fragility Index and sample size, number of events, p-value and follow-up time. The significance of all the results was evaluated with a value of p <0.05. Results: the median Fragility Index was 11, and in three studies (7.3%) the result were not statistically significant after recalculating the p value with Fisher's exact test. A slight direct relationship between the number of events and the Fragility Index (Rho = 0.343, p = 0.02) was found and a moderate inverse correlation was observed between the p value and the FI (Rho = -0.632, p = 0.000 ). No statistically significant correlation was found between sample size, follow-up time and losses with the FI. Conclusions: in controlled clinical trials on diabetes, we found that the statistically significant results depend on a few events, evidenced by a low value in the Fragility Index. The values of this measurement are related to the number of events and negatively to the p value.

Clinical and hemodynamic outcomes and mortality risk factors in patients undergoing pulmonary thromboendarterectomy.

BACKGROUND: Pulmonary thromboendarterectomy is the current treatment of choice in patients with chronic thromboembolic pulmonary hypertension. The objective of the present study was to analyze the clinical and hemodynamic outcomes and the risk factors for mortality in a cardiovascular center in Colombia. METHODS: Cohort study, conducted between 2001 and 2019. All operated patients were included in the study. Risk factors associated with mortality were established by means of a multivariate regression using the COX method and survival was established using the Kaplan-Meier method. p < 0.05 was considered statistically significant. RESULTS: Seventy-three patients were operated. Median age was 51 years, 55% of females, 79% had functional Class III and IV. The mean pulmonary arterial pressure was 50 mmHg and 640 dyn.s.cm-5 for pulmonary vascular resistance (PVR). After the intervention, there was a decrease in mean pulmonary artery pressure (p ≤ 0.001) and in PVR (p = 0.357); 21% had evidence of residual pulmonary hypertension. Only 8% and 6% continued with functional Class III and IV at 6 and 12 months, respectively. There were 15 deaths (19.1%; 12% at 30 days). The factors associated with mortality were the diastolic diameter of the right ventricle measured postoperatively (hazard ratio [HR] 10.88 95% confidence interval [CI] 1.97-62, p = 0.007), time of invasive mechanical ventilation (HR 1.06 95% CI 1.02-1.09 p = 0.004), and the presence of complications during the surgical procedure (HR 5.62 95% CI 1.94-16.22 p = 0.001). CONCLUSIONS: Pulmonary thromboendarterectomy is associated with excellent clinical and hemodynamic outcomes. The mortality risk factors found are not those usually described in the literature.

Arterial lactate levels and their prognostic value in patients undergoing pulmonary thromboendarterectomy.

Objective: Evaluate the change of lactate levels and its prognostic role in the postoperative period of patients undergoing pulmonary thromboendarterectomy. Methods: Retrospective study between 2001 and 2019. Patients older than 18 years and who underwent pulmonary thromboendarterectomy were included. The U Mann Whitney test was performed to evaluate the change between lactate levels, and Cox regression analysis to evaluate the relationship with mortality. Areas under the curve were constructed for lactate levels. Results: Seventy-three patients were operated on during the study period. Median age was 51 years, 55% female. The median lactate on days 1 was 4.65 mml/L and on day 2 it was 1.62 mml/L with a change of 2.87 mml/L. No differences were found between the levels measured on day 1 and 2 between the people who died and those who did not on day 30. In the multivariate regression of COX, no relationship with mortality was found. The area under the curve shows regular performance on both day 1 and day 2 in predicting mortality outcomes. Conclusions: The behavior of the lactate in patients undergoing pulmonary thromboendarterectomy shows a rapid change during the first hours after the procedure. No role was found as a predictor of mortality neither in-hospital nor in follow-up.

Objetivo: Evaluar el cambio de los niveles de lactato y su rol pronóstico en el posoperatorio de pacientes sometidos a tromboendarterectomía pulmonar. Métodos: Estudio retrospectivo entre 2001 y 2019. Se incluyeron pacientes mayores de 18 años que fueron sometidos a tromboendarterectomía pulmonar. Para evaluar el cambio entre los niveles de lactato se realizó la prueba de U Mann Whitney. Para evaluar la relación con la mortalidad se realizó un análisis multivariado de Cox. Se construyeron áreas bajo la curva para los niveles de lactato. Resultados: . Setenta y tres pacientes fueron operados durante el período de estudio. La mediana de edad fue de 51 años, 55% mujeres. La mediana de lactato en el día 1 fue de 4,65 mmL/L y en el día 2 fue de 1,62 mmL/L con un cambio de 2,87 mmL/L. No se encontraron diferencias entre los niveles medidos el día 1 y 2 entre las personas que murieron y las que no al día 30 hospitalario. En la regresión multivariada de COX no se encontró relación con la mortalidad. El área bajo la curva muestra un desempeño regular tanto en el día 1 como en el día 2 para predecir el resultado de la mortalidad en especial intrahospitalaria. Conclusiones: El comportamiento del lactato en pacientes sometidos a tromboendarterectomía pulmonar muestra un cambio rápido durante las primeras horas posteriores al procedimiento. No se encontró que sea un predictor de mortalidad ni hospitalaria ni durante el seguimiento.

[Heart Failure With Preserved Ejection Fraction: A Problem Of Contemporary Cardiology]. / Falla Cardíaca con Fracción de Eyección Preservada: Un Problema de la Cardiología Contemporánea.

Heart failure with preserved ejection fraction (HFpEF) is a frequent and overlooked medical condition that represents a great challenge for diagnosis and treatment. Current data shows a temporal trend towards a higher prevalence of HFpEF, even above heart failure with reduced ejection fraction (HFrEF). The pathophysiology of HFpEF is heterogeneous and involves several factors such as genetics, lifestyle, and cardiac and non-cardiac comorbidities. These factors result in remodeling, maladaptation and cardiac stiffness, that later on cause dyspnea, exercise intolerance, and fatigue. Although the mortality outcome of HFpEF is as high as HFrEF, no specific therapy has demonstrated overall benefit in these patients; which is why future therapies will bet on an individualized approach according to the patients phenotype.

Cetoacidosis diabética en niños / Diabetic ketoacidosis in children

Resumen: la cetoacidosis diabética es la complicación aguda de la diabetes más frecuente, con una alta incidencia en la población pediátrica, múltiples desencadenantes y un alto costo al sistema de salud. El punto de partida fisiopatológico es el déficit absoluto o relativo de la insulina que lleva a un incremento de las hormonas contrarreguladoras para obtener el substrato energético a partir de la glucogenólisis, la gluconeogénesis, la lipólisis y la proteólisis. Lo anterior genera un aumento de los cuerpos cetónicos que produce acidosis metabólica con una importante deshidratación y trastorno electrolítico que en conjunto exacerban y perpetúan la disfunción metabólica. El tratamiento de esta entidad tiene como base la insulinoterapia por vía intravenosa o subcutánea, incluso cuando se han alcanzado niveles óptimos de glucemia, y una hidratación adecuada. La transición a insulina subcutánea al detener el goteo de insulina es importante para prevenir la recurrencia de la cetoacidosis diabética. Con este manuscrito se pretende brindar al lector una revisión actualizada de un tema de alta relevancia clínica, que sirva como herramienta al momento de ejercer un enfoque diagnóstico y terapéutico de la cetoacidosis diabética. (AU)

Abstract: Diabetic ketoacidosis is the most frequent acute complication of diabetes with a high incidence in the pediatric population, multiple triggers and a high cost to the health system. The pathophysiological starting point is the absolute or relative insulin deficit that leads to an increase in the counterregulatory hormones to obtain an energetic substrate from glycogenolysis, gluconeogenesis, lipolysis, and proteolysis. This results in an increase in ketone bodies that produce metabolic acidosis with an important dehydration and electrolyte disorder that exacerbates and perpetuates metabolic dysfunction. The treatment of this condition is based on insulin delivery through intravenous or subcutaneous route, even when optimal levels of glycaemia have been reached, and adequate hydration. Transitioning to subcutaneous insulin when the drip is stopped is important to prevent diabetic ketoacidosis recurrence. With this manuscript, it is pretended to provide to the reader an updated review of a high clinical relevance issue that serves as a tool in the moment to exert a diagnostic and therapeutic approach of diabetic ketoacidosis. (AU)