Fibrinógeno humano liofilizado para solución inyectable / Lyophilized human fibrinogen for solution for injection

INTRODUCCIÓN: Algunas consideraciones quirúrgicas en pacientes con enfermedades oncológicas se asocian con hemorragias graves. Aunque la causa suele ser multifactorial, la hipofibrinogenemia (nivel de fibrinógeno plasmático <150 a 200 mg/dl) es común. El fibrinógeno es el principal componente estructural en la formación de coágulos y es esencial para una hemostasia eficaz, pero el fibrinógeno es el primer factor que cae a y sangrado quirúrgico2 . Las causas de hipofibrinogenemia incluyen el consumo de factores de coagulación, exacerbado por niveles críticamente bajos en situaciones como hemorragia importante durante cirugías, así como la hemodilución y la hiperfibrinólisis3, 4 Existe una estrecha asociación entre los niveles bajos de fibrinógeno y el sangrado posoperatorio grave5 . Además, la transfusión de componentes sanguíneos después de una cirugía cardíaca se asocia fuertemente con una mayor morbilidad, mortalidad y costos hospitalarios6 . El manejo eficaz de la coagulación es esencial para ayudar a lograr resultados exitosos. La principal coagulopatía observada durante esta cirugía abdominal extensa es la rápida caída de la concentración de fibrinógeno plasmático y, en consecuencia, la disminución de la calidad del coágulo7 . Las directrices recientes de la Asociación Europea de Cirugía Cardiotorácica y la Asociación Europea de Anestesiología Cardiotorácica recomiendan el uso de crioprecipitado o concentrado de fibrinógeno (FC) para el tratamiento de la hipofibrinogenemia adquirida durante la cirugía cardíaca. ACERCA DE LA TECNOLOGÍA SANITARIA: Hay varias fuentes de fibrinógeno disponibles, siendo el crioprecipitado y el concentrado de fibrinógeno humano (HFC) las opciones preferidas en términos de concentración de fibrinógeno. Ambos tipos de productos han demostrado capacidad para aumentar los niveles de fibrinógeno plasmático en pacientes hemorrágicos10,11. El crioprecipitado tiene un contenido variable de fibrinógeno, requiere compatibilidad con el tipo de sangre, tiempo para descongelarse y conlleva riesgos de lesión pulmonar aguda relacionada con transfusiones y transmisión de patógenos, y se ha retirado en algunos países europeos12,13 . El HFC es una preparación altamente purificada que contiene una concentración definida de fibrinógeno, no requiere coincidencia del tipo de sangre y ofrece una mayor seguridad contra patógenos debido a los pasos de inactivación del virus utilizados en la producción. El crioprecipitado se precipita descongelando plasma fresco congelado de donantes, desprovisto de leucocitos, que se centrifuga y se re-suspende en plasma; mientras que FC es una preparación inactivada por virus, altamente purificada y derivada de plasma. Existe un alto grado de variabilidad en la concentración de fibrinógeno en el crioprecipitado, que según se informa contiene entre 3 y 30 g/l de unidades de fibrinógeno. Un estudio encontró que 2 unidades de crioprecipitado por cada 10 kg de peso corporal aumentaban la concentración de fibrinógeno plasmático en 1 g/l18; sin embargo, el contenido de fibrinógeno del crioprecipitado no está estandarizado. Por el contrario, el FC reconstituido contiene un contenido estandarizado de 200 mg/dL de fibrinógeno. METODOLOGÍA: Primero se realizó una revisión de los documentos que fueron enviados a la unidad y se conversó con la Unidad funcional de Banco de Sangre y Medicina Transfusional (Unidad solicitante) del Instituto Nacional de Enfermedades Neoplásicas (INEN). La segunda parte estuvo enfocada en un análisis de la revisión de la literatura para respaldar la decisión basada en evidencia científica. Se priorizaron estudios por ensayos clínicos aleatorizados (ECA) o revisiones sistemáticas (RS), en caso de haber nuevos estudios observacionales que no fueron incluidos en RS se evaluaron su inclusión. ANALISIS DE EVIDENCIA: En Astana, Kazajstán24 se realizó un estudio prospectivo y aleatorizado realizado en pacientes que se sometieron a cirugía cardíaca y desarrollaron hemorragia e hipofibrinogenemia clínicamente significativas después de la cirugía cardiaca con circulación extracorpórea; el crioprecipitado y el fibrinógeno concentrado (FC) eran el estándar de atención en la institución. El estudio incluyó a todos los pacientes adultos de ≥18 años sometidos a cirugía cardíaca con hemorragia significativa e hipofibrinogenemia, definida como un nivel plasmático de fibrinógeno <200 mg/dL confirmado por el método Clauss. Después de la inscripción se aleatorizó en dos grupos, FC calculado como: [nivel de fibrinógeno objetivo (mg/dL) ­ nivel de fibrinógeno medido (mg/dL)] / 1,8 (mg/dL por mg/kg de peso corporal); y crioprecipitado 1 unidad/5-10kg. Además, estimaron costos directos. Ochenta y ocho pacientes adultos con hipofibrinogenemia adquirida (<2,0 g/l) distribuido en crioprecipitado (N = 40) o FC (N = 48), con datos demográficos y laboratoriales similares entre los grupos. En general, se administró una media 9,33±0,94 unidades (rango, 8-10) de crioprecipitado y 1,40±0,49 g (rango 1-2) de FC. Cabe mencionar que antes de la cirugía, los niveles de fibrinógeno plasmático eran ligeramente más bajos en el grupo FC. Después de la administración de crioprecipitado o FC, los niveles medios de fibrinógeno aumentaron en ambos grupos. Desde antes de la administración hasta 24 horas después de la administración, el nivel medio de fibrinógeno plasmático aumentó en una media de 125 ± 65 mg/dL en el grupo de crioprecipitado y 96 ± 65 mg/dL en el grupo de FC (entre grupos, p = 0,4409 para varianzas iguales. 48 horas después de la administración del fármaco del estudio, los niveles de fibrinógeno habían aumentado aún más en ambos grupos y no hubo diferencias significativas en los niveles de fibrinógeno entre los pacientes de los grupos de crioprecipitado y FC. Los autores concluyen que en el estudio mostraron que tanto el FC como el crioprecipitado fueron eficaces para aumentar los niveles de fibrinógeno plasmático en pacientes que requirieron cirugía cardíaca, que sufrieron hemorragia significativa e hipofibrinogenemia. No se informaron problemas de seguridad para ninguno de los medicamentos. Se describió que el concentrado de fibrinógeno era significativamente más barato que el crioprecipitado y ventajoso debido a la velocidad y facilidad de preparación. Debido a la necesidad de cumplir con los protocolos establecidos en el centro hospitalario, las dosis no fueron equivalentes de fibrinógeno. CONCLUSIONES: INFORME N° 000098-2024-UFBSMT- DP-DISAD/INEN remitido por la Dra. Evelyn Norabuena Mautino, Coordinador de la Unidad Funcional de Banco de Sangre y Medicina Transfusional(e) del INEN al Jefe de la Unidad Funcional de Evaluación de Tecnologías Sanitarias del INEN. Existe una estrecha asociación entre los niveles bajos de fibrinógeno y el sangrado posoperatorio grave5. Además, la transfusión de componentes sanguíneos después de una cirugía cardíaca se asocia fuertemente con una mayor morbilidad, mortalidad y costos hospitalarios6. El fibrinógeno se puede complementar mediante la administración de plasma fresco congelado (PFC), crioprecipitado o concentrado de fibrinógeno. El PFC y el crioprecipitado son productos sanguíneos alogénicos que requieren pruebas cruzadas y descongelación antes de su administración y también están relacionados con un mayor riesgo de transmisión de patógenos y reacciones inmunológicas17,18. Alternativamente, el concentrado de fibrinógeno es un derivado del plasma sometido a pasteurización que minimiza el riesgo de reacciones inmunológicas y alérgicas18,19. Se realizó una estrategia de búsqueda en PubMed encontrando un total, de 102 artículos, donde finalmente se seleccionaron 4 estudios. La evidencia científica indica que el análisis de la concentración de fibrinógeno plasmático mostró que el crioprecipitado y el FC tenían una eficacia comparable. Sin embargo, el FC tiene ventajas sobre el crioprecipitado debido a su facilidad de manipulación, menor reacción cruzada y alta pureza. Se puede considerar el uso de concentrado de fibrinógeno para el tratamiento de hemorragias en pacientes con hipofibrinogenemia adquirida en cirugías. El beneficio económico del FC es incierto, teniendo evidencias contradictorias, pero un estudio indica que puede ser competitivo con la crioterapia, si el costo del FC disminuye en un 44% o demostrar que ahorra entre 025 y 066 días de UCI, mientras que otro estudio indica el beneficio neto incremental del concentrado de fibrinógeno frente al crioprecipitado fue positivo (probabilidad de ser rentable 86% y 97% a $0 y USD $1489 disposición a pagar, respectivamente. El beneficio neto fue muy incierto para los pacientes no selectivos y con enfermedades críticas del estudio FIBERS.

[Evaluation of factors associated with major hemorrhage in patients undergoing primary total hip arthroplasty]. / Evaluación de factores asociados a hemorragia mayor en pacientes sometidos a artroplastía total de cadera primaria.

INTRODUCTION: the use of blood transfusions leads to increased hospital costs and an increased risk of medical complications and death. Therefore, it is necessary to study the incidence of major bleeding events and the factors associated with these outcomes in patients undergoing primary total hip arthroplasty (THA). MATERIAL AND METHODS: observational, longitudinal and prospective study, carried out at the High Specialty Medical Unit of Traumatology and Orthopedics of Lomas Verdes of the Mexican Institute of Social Security, in the Joint Replacement Service, in the period from March 1, 2020 to July 1, 2020. RESULTS: the incidence of major bleeding in patients undergoing primary THA was 84.8%, when considering two criteria: a decrease in hemoglobin 2 g/dl and the need for transfusion 2 units of red blood cells. This figure increased to 87.1% when also including trans-surgical bleeding at its 75th percentile, equivalent to 500 ml. Transfusion of at least one unit of red blood cells during surgery was performed in 68% of patients. Trans-surgical bleeding reached a maximum of 1,900 ml, with a 75th percentile of 500 ml. Unlike other studies, in our institution, female gender did not prove to be a significant risk factor for major bleeding. CONCLUSION: it is advisable to analyze the procedures and particularities of THA surgery that may be associated with a lower risk of bleeding in older patients.

INTRODUCCIÓN: el uso de transfusiones sanguíneas conlleva aumentos en los costos hospitalarios y un mayor riesgo de complicaciones médicas y fallecimientos; por lo que es necesario el estudio de la incidencia de eventos de hemorragia mayor y de los factores que se asocien a estos desenlaces en los pacientes que se someten a una artroplastía total de cadera (ATC) primaria. MATERIAL Y MÉTODOS: estudio observacional, longitudinal y prospectivo, llevado a cabo en la Unidad Médica de Alta Especialidad de Traumatología y Ortopedia de Lomas Verdes del Instituto Mexicano del Seguro Social, en el Servicio de Reemplazo Articular, en el período comprendido entre el 01 Marzo 2020 al 01 Julio 2020. RESULTADOS: la incidencia de hemorragia mayor en pacientes sometidos a ATC primaria fue de 84.8%, al considerarse dos criterios: una disminución de hemoglobina 2 g/dl y la necesidad de transfusión 2 unidades de glóbulos rojos. Esta cifra aumentó a 87.1% al incluir también el sangrado transquirúrgico en su percentil 75, equivalente a 500 ml. La transfusión de al menos una unidad de glóbulos rojos durante la cirugía se realizó en 68% de los pacientes. El sangrado transquirúrgico alcanzó un máximo de 1,900 ml, con un percentil 75 de 500 ml. A diferencia de otros estudios, en nuestra institución, el género femenino no demostró ser un factor de riesgo significativo para la hemorragia mayor. CONCLUSIÓN: es aconsejable analizar los procedimientos y las particularidades de la cirugía de ATC que puedan estar asociados con un menor riesgo de hemorragia en los pacientes mayores.

Serie de casos de sangrado intraluminal postoperatorio en colectomía izquierda / Case series of postoperative intraluminal bleeding in left colectomy

Introducción: El sangrado digestivo intraluminal postoperatorio es una entidad poco frecuente y su manifestación clínica no difiere de la hemorragia digestiva baja de otra etiología. A pesar de que su presentación más habitual es la hematoquecia autolimitada en la primera deposición, en un discreto porcentaje puede requerir transfusiones, tratamiento endoscópico, hemodinámico, o incluso cirugía. Objetivo: Analizar los pacientes con sangrado digestivo intraluminal postoperatorio tratados en un centro de alta complejidad y realizar una revisión bibliográfica del tema. Diseño: Estudio retrospectivo, descriptivo. Material y métodos: Pacientes con sangrado anastomótico durante el post operatorio inmediato de una colectomía izquierda, operados en el Servicio de Cirugía General y Coloproctología desde enero del 2017 a diciembre del 2021. Las variables estudiadas fueron edad, sexo, anticoagulación y su causa, descenso de hemoglobina, cirugía realizada y su indicación, vía de abordaje, configuración de la anastomosis, electividad de la cirugía, complicaciones, días de internación y manejo terapéutico. Resultados: Se incluyeron 4 pacientes con una edad media de 72 (rango 54-87) años y una distribución por sexo de 1:1. En todos la colectomía izquierda fue programada y en 3 el abordaje fue laparoscópico. La anastomosis fue termino-terminal con sutura mecánica circular. Todos los pacientes presentaron sangrado en las primeras 24 horas postoperatorias. El tratamiento fue decidido de acuerdo a la condición hemodinámica: en los 2 pacientes con estabilidad hemodinámica fue suficiente el tratamiento conservador con reanimación y transfusiones. Los otros 2 que presentaron inestabilidad hemodinámica requirieron manejo intervencionista con endoscopía rígida, videocolonoscopía y cirugía. Conclusión: El sangrado intraluminal es una complicación poco frecuente de la anastomosis colorrectal que requiere manejo intervencionista solo en los pacientes que presentan inestabilidad hemodinámica. (AU)

Introduction: Postoperative intraluminal gastrointestinal bleeding is a rare entity and its clinical manifestation does not differ from lower gastro-intestinal bleeding of another etiology. Despite the fact that its most common presentation is self-limited hematochezia at the first stool, in a small percentage it may require transfusions, endoscopic or hemodynamic management, or even surgery. Aim: To analyze the patients with postoperative intraluminal gastrointestinal bleeding treated in a tertiary center and to carry out a bibliographic review of the subject. Design: Retrospective descriptive study. Material and methods: Patients with immediate postoperative anastomotic bleeding from a left colectomy, operated on at the General Surgery and Coloproctology Service from January 2017 to December 2021 were included. The variables recorded were age, sex, anticoagulation and its cause, decrease in hemoglobin, procedure performed and its indication, surgical approach, type of anastomosis, electiveness of surgery, complications, hospital stay and management. Results: Four patients with a mean age of 72 (range 54-87) years and a 1:1 gender distribution were included. All procedures were elective and 3 laparoscopic. All anastomoses were performed end-to-end with a circular stapler. All patients presented bleeding in the first 24 postoperative hours. The treatment was decided according to the hemodynamic condition; patients with hemodynamic stability (2) received medical treatment while those with hemodynamic instability (2) required interventional management with rigid endoscopy, colonoscopy and surgery. Conclusion: Intraluminal bleeding is a rare complication of colorectal anastomosis that requires interventional management only in patients with hemodynamic instability. (AU)

Risk of bleeding in anticoagulated patients undergoing dental extraction treated with topical tranexamic acid compared to collagen-gelatin sponge: Randomized clinical trial.

This two-arm, parallel-group, double-blind, randomized clinical trial design evaluated the risk of postoperative bleeding in anticoagulated patients undergoing dental extraction treated with topical TXA in comparison to collagen-gelatin sponge. Forty patients were randomly included in one of the study groups: (1) topical use of 4.8% TXA solution; and (2) resorbable hydrolyzed collagen-gelatin sponge applied to the surgical alveolus. Primary outcomes were postoperative bleeding episodes and secondary outcomes were thromboembolic events and postoperative INR values. The relative risk (RR), the absolute risk reduction (RAR) and the number needed to treat (NNT) were used as effect estimates and calculated from the counting of bleeding episodes observed during the first postoperative week. The bleeding rate under the TXA treatment was 22.2%, while in the collagen-gelatin sponge group it was 45.7%, resulting in a RR of 0.49 (95% CI 0.24-099; p = 0.046), RAR 23.5% and NNT 4.3. TXA was more effective in reducing bleeding in surgical sites located in the mandible (RR = 0.10; 95% CI 0.01-0.71; p = 0.021) and the posterior region (RR = 0.39; 95% CI 0.18-0.84; p = 0.016). Within the limitations of the study it seems that topical TXA is more effective in controlling bleeding after tooth extractions in anticoagulated patients than collagen-gelatin sponge. CLINICAL TRIAL REGISTRATION: RBR-83qw93.

Adaptation And Use of the Papworth Haemostasis Checklist - Clinical Outcomes Analysis at Hospital Estadual Mário Covas.

INTRODUCTION: Postoperative bleeding is one of the main causes of complications in cardiovascular surgery, which highlights the importance of ensuring adequate intraoperative hemostasis, providing a better patient outcome. This study aimed to improve the prevention of postoperative bleeding in the Cardiovascular Surgery Department of the Hospital Estadual Mário Covas (Santo André, Brazil) using an adapted version of the Papworth Haemostasis Checklist to assess the impact of this standardization on bleeding rate, postoperative complications, reoperation, and mortality. METHODS: This is a non-randomized controlled clinical trial, whose non-probabilistic sample consisted of patients undergoing cardiac surgery in the abovementioned service within a two-year interval. The Papworth Haemostasis Checklist was adapted to the Brazilian laboratory parameters and the questions were translated into Portuguese. This checklist was used before the surgeon started the chest wall closure. Patients were followed up until 30 days after surgery. A P-value < 0.05 was considered statistically relevant. RESULTS: This study included 200 patients. After the checklist, a reduction in 24-hour drain output, postoperative complications, and reoperation was observed, although statistical significance was not reached. Finally, there was a significant reduction in the number of deaths (8 vs. 2; P=0.05). CONCLUSION: The use of the adapted checklist in our hospital proved to be an effective intervention to improve the prevention of postoperative bleeding, with a direct impact in the number of deaths in the study period. The reduction in deaths was possible thanks to the reduction in the bleeding rate, postoperative complications, and reoperations for bleeding.

Tranexamic acid effects in postoperative bleeding outcomes in laparoscopic sleeve gastrectomy: a controlled study.

PURPOSE: To demonstrate through a controlled study whether the use of tranexamic acid in bariatric surgeries is effective for bleeding control. METHODS: Prospective, comparative, and double-blind study performed with patients from 18 to 65 years old submitted to bariatric surgery. The selected patients received venous tranexamic acid (TXA) during the induction of anesthesia or not (CG). The anesthesia and thromboprophylaxis protocols were similar among the groups. For statistical analysis, the χ2 and analysis of variance tests were performed at a significance level of p < 0.05, using the statistical program SPSS 21.0®. RESULTS: Sixty-one patients were included in the study, 31 in the control group and 30 in the TXA group (GTXA). In the intraoperative period, the bleeding volume was greater in the CG than in the GTXA. In the postoperative period, the tranexamic acid group had a higher value hematocrit, absence of surgical reoperations due to bleeding complications, and shorter hospitalization time than the control group. CONCLUSIONS: The use of tranexamic acid was effective in reducing bleeding rates and of hospital stay length, in addition to demonstrating the clinical safety of its use, for not having been associated with any thromboembolic events.

Preoperative risk factors for early hemorrhagic complications in bariatric surgery: a case-control study.

BACKGROUND: Although a reliable procedure in morbid obesity treatment, bariatric surgery may be associated with serious complications such as leakage or bleeding. We aimed to analyze the preoperative factors involved in patients with early postoperative hemorrhage after any type of bariatric surgery who required conservative treatment or reoperation for this complication. METHODS: Retrospective case-controlled study (1:3) of 2 patient cohorts (postoperative bleeding/controls) matched by type of surgical intervention. RESULTS: Hypertension (Odds Ratio 5.029; 95% Confidence Interval 1.78-14.13) and history of antiplatelet medication (OR 13.263; 95% CI 1.39-125.9) were independent risk factors in the bivariate analyses, confirmed in the logistic regression model on multivariate analysis. CONCLUSIONS: With no between-group differences in Body Mass Index (BMI) and type 2 Diabetes (T2D), early hemorrhagic complications were found to be more frequent in patients with hypertension or antiplatelet drug treatment.

Experiencia en trasplante pulmonar pediátrico en Chile / Experience with pediatric lung transplantation in Chile

El trasplante de pulmón (TP) es una opción para pacientes pediátricos con enfermedades pulmonares terminales. OBJETIVO: Evaluar resultados y sobrevida de pacientes pediátricos trasplantados de pulmón. MÉTODOS: Análisis retrospectivo de registros clínicos de pacientes TP ≤ 15 años de Clínica Las Condes. Se analizaron datos demográficos, tipo de trasplante, función pulmonar basal y post trasplante, complicaciones precoces y tardías y sobrevida. RESULTADOS: Nueve pacientes < 15 años de edad se han trasplantado. La edad promedio fue 12,7 años. La principal indicación fue fibrosis quística (7 pacientes). El IMC promedio fue de 17,6 y todos estaban con oxígeno domiciliario. El 77% utilizó soporte extracorpóreo intraoperatorio. Las principales complicaciones precoces fueron hemorragia y la disfunción primaria de injerto mientras que las tardías fueron principalmente las infecciones y la disfunción crónica de injerto. Cuatro pacientes han fallecido y la sobrevida a dos años fue de 85%. El trasplante les permitió una reinserción escolar y 3 lograron completar estudios universitarios. CONCLUSIÓN: El trasplante pulmonar es una alternativa para niños con enfermedades pulmonares avanzadas mejorando su sobrevida y calidad de vida.

Lung transplantation (TP) is a treatment option in children with terminal lung diseases. OBJECTIVE: To evaluate the results and survival of pediatrics lung transplant patients. METHODS: Retrospective analysis of clinical records of lung transplantation of patients ≤ 15 years from Clínica Las Condes, Santiago, Chile. Demographic data, type of transplant, baseline and post transplant lung function, early and late complications and survival rate were analyzed. RESULTS: Nine patients ≤ 15 years-old were transplanted. The average age at transplant was 12.7 years. The main indication was cystic fibrosis (7 patients). The average BMI was 17.6 and all the patients were with home oxygen therapy. 77% used extracorporeal intraoperative support. Average baseline FEV1 was 25.2% with progressive improvement in FEV1 of 77% in the first year. The main early complications were hemorrhage and primary graft dysfunction, while late complications were infections and chronic graft dysfunction. Four patients have died and the estimated 2 years survival was 85%. They achieved school reinsertion and three managed to complete university studies. CONCLUSION: Lung transplantation is an alternative for children with advanced lung diseases improving their survival and quality of life.

Percutaneous Image-Guided Surgery in Complications After Bariatric Surgery.

Background: Although bariatric surgery is a standardized procedure, it is not without complications. Image-guided surgery allows minimally invasive resolution of complications, making it ideal for bariatric patients. The objective of this work was to analyze the image-guided surgery approach to postoperative complications of bariatric surgery. Materials and Methods: Retrospective comparative study in patients with complications after bariatric surgery. Patients were included consecutively according to selection criteria. All the patients were treated by the same surgical team. Results: n = 58 patients were recruited. The average age was 47.3 (range 16-62) years; the distribution by sex was male 52% and female 48%. Average body mass index was 42% (±1.26). The associated comorbidities were diabetes mellitus 41% (±0.49), dyslipidemia 41% (±0.49), and high blood pressure 39% (±0.48). Of the total, 39 (67.2%) underwent laparoscopic sleeve gastrectomy (LSG) and 19 (32.8%) under Roux-en-Y Gastric Bypass (RYGB) (P ≥ .05). Complications reported were leaks/fistulas (with/without abdominal collections) in 94.8% (±0.22), gallstones 3.5% (±0.18), and hemorrhage 1.7% (±0.13). There was no statistically significant difference between the type of bariatric surgery (LSG versus RYGB) and the complications found (P ≥ .005). There were no intestinal obstructions, strictures or acute gastric dilations, or deaths. The treatment of complications was approached percutaneously (56.9%), endoscopically (29.4%), reoperation laparoscopically (12%), and clinical control (1.7%). Conclusion: The image-guided surgery approach to postoperative complications of bariatric surgery is feasible and safe. Good results are obtained with a decrease in the surgical comorbidities associated with the procedure.

A Retrospective Analysis of Peroperative Risk Factors Associated with Posttonsillectomy Reactionary Hemorrhage in a Teaching Hospital

Introduction: Tonsillectomy is one of the most common otolaryngology procedures performed worldwide. It is also one of the first procedures learnt by residents during their training period. Although tonsillectomy is viewed relatively as a low-risk procedure, it can be potentially harmful because of the chance of posttonsillectomy hemorrhage. Objective: The objective of the present study is to analyze the effects of peroperative factors and experience of the surgeon on the incidence and pattern of posttonsillectomy reactionary hemorrhage. Methods: A retrospective review of medical charts was performed from 2014 to 2017 in a tertiary care hospital. A total of 1,284 patients who underwent tonsillectomy and adenoidectomy were included in the study. The parameters assessed were experience of the surgeon, operating time, intraoperative blood loss, difference in mean arterial pressure (MAP) and pulse rate. Results: A total of 23 (1.79%) out of the 1,284 patients had reactionary hemorrhage. Out of those 23, 16 (69.5%) patients had been operated on by trainees, while 7 (30.5%) had been operated on by consultants (p = 0.033, odds ratio [OR] = 0.04). Operating time, intraoperative blood loss, difference in MAP and pulse rate were significantly higher in the reactionary hemorrhage group, and showed a positive association with risk of hemorrhage (p < 0.05; OR >1). Re-exploration to control the bleeding was required in 10 (76.9%) out of the 23 cases. Conclusion: The experience of the surgeon experience and peroperative factors have an association with posttonsillectomy hemorrhage. Close surveillance and monitoring of the aforementioned peroperative factors will help in the identification of patients at risk of hemorrhage (AU)

Experience of a Colombian center in the endovascular management of lifethreatening postpartum hemorrhage / Experiencia de un centro colombiano en el tratamiento endovascular de la hemorragia posparto que amenaza la vida

Introduction: Postpartum hemorrhage is a world-leading cause of morbidity and mortality. Lacerations are the second most frequent cause. Early management with appropriate treatment is essential to obtain adequate outcomes; the endovascular occlusion of pelvic vessels is among the management options. Objective: To describe the management experience with the arterial embolization of pelvic vessels. Materials and methods: We conducted a retrospective case series study based on the institutional registry of Fundación Valle del Lili (Cali, Colombia), which included patients with postpartum hemorrhage admitted between January 1st, 2011 and October 31st, 2016. Results: Out of 430 patients diagnosed with PPH, 11 were subject to embolization of pelvic vessels. Within our group, 10 patients had a vaginal delivery with severe vaginal lacerations; most of them (9 cases, 82%) were referred from other lower-complexity institutions after 20.5 hours. Occlusion was more frequent in the superior vaginal and the internal pudendal arteries. No patients showed complications associated with the procedure and only 2 showed recurrent bleeding while 3 required a hysterectomy, but no deaths occurred. Conclusion: Percutaneous management is a safe and effective third-line method for difficult-management bleedings control in patients with postpartum hemorrhage after a severe perineal tear. These results are similar to case reports published in the worldwide literature available to date.

Introducción. La hemorragia posparto es la primera causa de morbimortalidad materna en el mundo y las laceraciones son la segunda causa en frecuencia. Su tratamiento temprano y apropiado es clave para obtener buenos resultados, y la oclusión endovascular de los vasos pélvicos se cuenta entre las opciones terapéuticas. Objetivo. Describir la experiencia del tratamiento con la 'embolización' (sic) arterial de los vasos pélvicos. Materiales y métodos. Se trató de un estudio retrospectivo del tipo de serie de casos basado en el registro institucional de la Fundación Valle del Lili, Cali, Colombia, en el que se incluyeron las pacientes con hemorragia posparto atendidas entre el 1º de enero del 2011 y el 31 de octubre del 2016. Resultados. De las 430 pacientes con diagnóstico de hemorragia posparto, 11 fueron sometidas a la 'embolización' de los vasos pélvicos. De este grupo, 10 pacientes tuvieron parto vaginal con laceraciones vaginales complejas, y la mayoría (9 casos, 82 %) fue remitida por otras instituciones de menor complejidad después de 20,5 horas. Las arterias ocluidas frecuentemente fueron la vaginal superior y la pudenda interna. Ninguna paciente presentó complicaciones asociadas al procedimiento y solo dos presentaron sangrado recurrente. Tres pacientes requirieron histerectomía y ninguna murió. Conclusión. El manejo percutáneo es un método de tercera línea, seguro y efectivo para el control de los sangrados de difícil manejo en las pacientes con hemorragia pospartopor desgarros perineales complejos. Estos resultados son similares a los reportados en la literatura científica mundial disponible hasta la fecha.

Safety and Efficacy of a Novel Shunt Surgery Combined with Foam Sclerotherapy of Varices for Prehepatic Portal Hypertension: A Pilot Study.

OBJECTIVES: This pilot study investigated the safety and efficacy of a novel shunt surgery combined with foam sclerotherapy of varices in patients with prehepatic portal hypertension. METHODS: Twenty-seven patients who were diagnosed with prehepatic portal hypertension and underwent shunt surgeries were divided into three groups by surgery type: shunt surgery alone (Group A), shunt surgery and devascularization (Group B), and shunt surgery combined with foam sclerotherapy (Group C). Between-group differences in operation time, intraoperative blood loss, portal pressure decrease, postoperative complications, rebleeding rates, encephalopathy, mortality rates and remission of gastroesophageal varices were compared. RESULTS: Groups A, B and C had similar operation times, intraoperative bleeding, and portal pressure decrease. The remission rates of varices differed significantly (p<0.001): one patient in Group A and 6 patients in Group B had partial response, and all 9 patients in Group C had remission (2 complete, 7 partial). Two Group A patients and one Group B patient developed recurrent gastrointestinal bleeding postoperatively within 12 months. No postoperative recurrence or bleeding was observed in Group C, and no sclerotherapy-related complications were observed. CONCLUSIONS: Shunt surgery combined with foam sclerotherapy obliterates varices more effectively than shunt surgery alone does, decreasing the risk of postoperative rebleeding from residual gastroesophageal varices. This novel surgery is safe and effective with good short-term outcomes.

Experiencia de un centro colombiano en el tratamiento endovascular de la hemorragia posparto que amenaza la vida / Experience of a Colombian center in the endovascular management of life-threatening postpartum hemorrhage

Resumen Introducción. La hemorragia posparto es la primera causa de morbimortalidad materna en el mundo y las laceraciones son la segunda causa en frecuencia. Su tratamiento temprano y apropiado es clave para obtener buenos resultados, y la oclusión endovascular de los vasos pélvicos se cuenta entre las opciones terapéuticas. Objetivo. Describir la experiencia del tratamiento con la 'embolización' (sic) arterial de los vasos pélvicos. Materiales y métodos. Se trató de un estudio retrospectivo del tipo de serie de casos basado en el registro institucional de la Fundación Valle del Lili, Cali, Colombia, en el que se incluyeron las pacientes con hemorragia posparto atendidas entre el 1º de enero del 2011 y el 31 de octubre del 2016. Resultados. De las 430 pacientes con diagnóstico de hemorragia posparto, 11 fueron sometidas a la 'embolización' de los vasos pélvicos. De este grupo, 10 pacientes tuvieron parto vaginal con laceraciones vaginales complejas, y la mayoría (9 casos, 82 %) fue remitida por otras instituciones de menor complejidad después de 20,5 horas. Las arterias ocluidas frecuentemente fueron la vaginal superior y la pudenda interna. Ninguna paciente presentó complicaciones asociadas al procedimiento y solo dos presentaron sangrado recurrente. Tres pacientes requirieron histerectomía y ninguna murió. Conclusión. El manejo percutáneo es un método de tercera línea, seguro y efectivo para el control de los sangrados de difícil manejo en las pacientes con hemorragia posparto por desgarros perineales complejos. Estos resultados son similares a los reportados en la literatura científica mundial disponible hasta la fecha.

Abstract Introduction: Postpartum hemorrhage is a world-leading cause of morbidity and mortality. Lacerations are the second most frequent cause. Early management with appropriate treatment is essential to obtain adequate outcomes; the endovascular occlusion of pelvic vessels is among the management options. Objective: To describe the management experience with the arterial embolization of pelvic vessels. Materials and methods: We conducted a retrospective case series study based on the institutional registry of Fundación Valle del Lili (Cali, Colombia), which included patients with postpartum hemorrhage admitted between January 1st, 2011 and October 31st, 2016. Results: Out of 430 patients diagnosed with PPH, 11 were subject to embolization of pelvic vessels. Within our group, 10 patients had a vaginal delivery with severe vaginal lacerations; most of them (9 cases, 82%) were referred from other lower-complexity institutions after 20.5 hours. Occlusion was more frequent in the superior vaginal and the internal pudendal arteries. No patients showed complications associated with the procedure and only 2 showed recurrent bleeding while 3 required a hysterectomy, but no deaths occurred. Conclusion: Percutaneous management is a safe and effective third-line method for difficult-management bleedings control in patients with postpartum hemorrhage after a severe perineal tear. These results are similar to case reports published in the worldwide literature available to date.

Embolization of Ruptured Renal Angiomyolipoma in Puerpera.

Angiomyolipomas (AMLs) are rare benign tumors derived from mesenchymal tissue and composed of varying degrees of adipose tissue, muscle and blood vessels. Renal AMLs (RAMLs) are the result of a sporadic event, and, in most of cases, the diagnosis is usually incidental, but hemorrhage and shock may be present. During pregnancy, the size of AMLs may increase and they may rupture, probably due to the high expression of hormone receptors, and the increase in maternal circulation and abdominal pressure. The authors present a case of a woman with ruptured RAML submitted to urgent endovascular treatment four days after giving birth by cesarean section.

Angiomiolipomas (AMLs) são tumores benignos raros derivados do tecido mesenquimal, compostos em graus variados de tecido adiposo, muscular e de vasos sanguíneos. Os AMLs renais (AMLRs) resultam de um evento esporádico e, na maioria dos casos, o diagnóstico costuma ser fortuito, mas quadros de hemorragia e choque podem estar presentes. Durante a gestação, os AMLs podem aumentar de tamanho e romper, provavelmente pela alta expressão de receptores hormonais, e pelo aumento da circulação materna e da pressão abdominal. Os autores apresentam um caso de uma paciente com AMLR roto submetida a tratamento endovascular de urgência no quarto dia pós-operatório de uma cesariana.

Hemostatic profile in patients with and without postpartum hemorrhage / Perfil hemostático en pacientes con y sin hemorragia obstétrica posparto

Background: The association between coagulation profile and postpartum hemorrhage (PH) is still debated. Objective: To determine the association between hemostatic profile and PH in women with cesarean operation (CO). Methods: We included 92 patients with PH (cases) and 184 without (controls), patients were attended during 2014, at one hospital of the Instituto Mexicano del Seguro Social in Mérida, Yucatán. Demographic, clinical and laboratory data including prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count (PLC), and fibrinogen concentration were compared among cases and controls using a binary logistic regression model (LRM), from which odd ratios (OR), and 95% confidence intervals (95% CI), were obtained. Results: According to the bivariate comparison, in the LRM categorical data such as parity, any type of hypertensive comorbidity, type of anesthesia, and categorized aPTT (< 38 vs. ≥ 38 seconds), and one continuous variable (gestational age) were included. Having some hypertensive comorbidity (OR 3.55, 95% CI: 1.95-6.47), type of anesthesia (regional anesthesia, OR 0.27, 95% CI: 0.13-0.55) and aPTT (< 38 seconds, OR 0.26, 95% CI: 0.10-0.66) were all statistically significant. Categorized PT, platelet count and fibrinogen concentration, were not statistically significant. Conclusions: In this sample, having some hypertensive comorbidity increased risk of PH more than three times, while regional anesthesia and aPTT < 38 seconds reduced risk in 73% and 74%, respectively. Neither platelet count, nor fibrinogen concentration, or the PT categories modified risk of PH.

Introducción: la asociación entre el perfil hemostático y la hemorragia obstétrica posparto (HO) es controversial. Objetivo: determinar la asociación entre el perfil hemostático y la HO en pacientes con operación cesárea (OC). Métodos: se incluyeron 92 pacientes con HO (casos) y 184 sin HO (controles), atendidas durante 2014 en un hospital del Instituto Mexicano del Seguro Social de Mérida, Yucatán. Diversas variables, incluyendo la cuenta plaquetaria, el tiempo de protrombina (TP), el tiempo de tromboplastina parcial activado (TTPa) y el fibrinógeno plasmático, fueron comparadas entre casos y controles, mediante un modelo de regresión logística del que se obtuvieron razones de momios (RM) e intervalos de confianza de 95% (IC 95%). Resultados: con base en el análisis univariado se incluyeron en el modelo la paridad, comorbilidad hipertensiva (hipertensión crónica, preeclampsia, eclampsia), tipo de anestesia y el TTPa categorizado (< 38 frente a ≥ 38 segundos) y la edad gestacional (como dato continuo), resultando significativamente diferentes la presencia de comorbilidad hipertensiva (RM 3.55, IC 95%: 1.95-6.47), el tipo de anestesia (regional, RM 0.27, IC 95%: 0.13-0.55) y el TTPa (< 38 segundos, RM 0.26, IC 95%: 0.10-0.66). Conclusiones: en esta muestra, tener comorbilidad hipertensiva incrementó más de tres veces el riesgo de HO, la anestesia regional lo redujo en 73% y el TTPa < 38 segundos lo redujo en 74%. Ni el TP, ni la cuenta plaquetaria modificaron el riesgo.

Embolization of ruptured renal angiomyolipoma in puerpera / Embolização de angiomiolipoma renal roto em puérpera

Abstract Angiomyolipomas (AMLs) are rare benign tumors derived from mesenchymal tissue and composed of varying degrees of adipose tissue, muscle and blood vessels. Renal AMLs (RAMLs) are the result of a sporadic event, and, in most of cases, the diagnosis is usually incidental, but hemorrhage and shock may be present. During pregnancy, the size of AMLs may increase and they may rupture, probably due to the high expression of hormone receptors, and the increase in maternal circulation and abdominal pressure. The authors present a case of a woman with ruptured RAML submitted to urgent endovascular treatment four days after giving birth by cesarean section.

Resumo Angiomiolipomas (AMLs) são tumores benignos raros derivados do tecido mesenquimal, compostos em graus variados de tecido adiposo, muscular e de vasos sanguíneos. Os AMLs renais (AMLRs) resultam de um evento esporádico e, na maioria dos casos, o diagnóstico costuma ser fortuito, mas quadros de hemorragia e choque podem estar presentes. Durante a gestação, os AMLs podem aumentar de tamanho e romper, provavelmente pela altaexpressãodereceptoreshormonais,epeloaumentodacirculaçãomaternaedapressão abdominal. Os autores apresentam um caso de uma paciente com AMLR roto submetida a tratamento endovascular de urgência no quarto dia pós-operatório de uma cesariana.

Factors associated with the increased bleeding in the postoperative period of cardiac surgery: A cohort study.

AIMS AND OBJECTIVES: To identify factors associated with the increased bleeding in patients during the postoperative period after cardiac surgery. BACKGROUND: Bleeding is among the most frequent complications that occur in the postoperative period after cardiac surgery, representing one of the major factors in morbidity and mortality. Understanding the factors associated with the increased bleeding may allow nurses to anticipate and prioritise care, thus reducing the mortality associated with this complication. DESIGN: Prospective cohort study. METHODS: Adult patients in a cardiac hospital who were in the postoperative period following cardiac surgery were included. Factors associated with the increased bleeding were investigated by means of linear regression, considering time intervals of 6 and 12 hr. RESULTS: The sample comprised 391 participants. The factors associated with the increased bleeding in the first 6 hr were male sex, body mass index, cardiopulmonary bypass duration, anoxia duration, metabolic acidosis, higher heart rate, platelets and the activated partial thromboplastin time in the postoperative period. Predictors in the first 12 hr were body mass index, cardiopulmonary bypass duration, metabolic acidosis, higher heart rate, platelets and the activated partial thromboplastin time in the postoperative. CONCLUSIONS: This study identified factors associated with the increased postoperative bleeding from cardiac surgery that have not been reported in previous studies. The nurse is important in the vigilance, evaluation and registry of chest tube drainage and modifiable factors associated with the increased bleeding, such as metabolic acidosis and postoperative heart rate, and in discussions with the multiprofessional team. RELEVANCE TO CLINICAL PRACTICE: Knowledge of the factors associated with the increased bleeding is critical for nurses so they can provide prophylactic interventions and early postoperative treatment when needed.

Safety and efficacy of a novel shunt surgery combined with foam sclerotherapy of varices for prehepatic portal hypertension: a pilot study

OBJECTIVES: This pilot study investigated the safety and efficacy of a novel shunt surgery combined with foam sclerotherapy of varices in patients with prehepatic portal hypertension. METHODS: Twenty-seven patients who were diagnosed with prehepatic portal hypertension and underwent shunt surgeries were divided into three groups by surgery type: shunt surgery alone (Group A), shunt surgery and devascularization (Group B), and shunt surgery combined with foam sclerotherapy (Group C). Between-group differences in operation time, intraoperative blood loss, portal pressure decrease, postoperative complications, rebleeding rates, encephalopathy, mortality rates and remission of gastroesophageal varices were compared. RESULTS: Groups A, B and C had similar operation times, intraoperative bleeding, and portal pressure decrease. The remission rates of varices differed significantly (p<0.001): one patient in Group A and 6 patients in Group B had partial response, and all 9 patients in Group C had remission (2 complete, 7 partial). Two Group A patients and one Group B patient developed recurrent gastrointestinal bleeding postoperatively within 12 months. No postoperative recurrence or bleeding was observed in Group C, and no sclerotherapy-related complications were observed. CONCLUSIONS: Shunt surgery combined with foam sclerotherapy obliterates varices more effectively than shunt surgery alone does, decreasing the risk of postoperative rebleeding from residual gastroesophageal varices. This novel surgery is safe and effective with good short-term outcomes.

Diagnostic evaluation of risk for bleeding in cardiac surgery with extracorporeal circulation.

OBJECTIVE: to identify the risk factors associated with cases of excessive bleeding in patients submitted to cardiac surgery with extracorporeal circulation. METHOD: case-control study on the factors of risk for bleeding based on the analysis of data from the medical charts of 216 patients submitted to cardiac surgery with elective extracorporeal circulation during a three-year period. RESULTS: variables that are commonly associated with excessive bleeding in studies in the field were analyzed, and the following were considered as risk factors for the nursing diagnosis "risk for bleeding" (00206) in cardiac surgery with extracorporeal circulation: Body mass index lower than 26.35kg/m² (Odds ratio = 3.64); Extracorporeal circulation longer than 90 minutes (Odds ratio = 3.57); Hypothermia lower than 32°C (Odds ratio = 2.86); Metabolic acidosis (Odds ratio = 3.50) and Activated partial thromboplastin time longer than 40 seconds (Odds ratio= 2.55). CONCLUSION: such variables may be clinical indicators of an operational nature for a better characterization of the risk factor "treatment regimen" and a refinement of knowledge related to coagulopathy induced by extracorporeal circulation, which is currently presumably incorporated into the "treatment regimen" category of the nursing diagnostic classification by NANDA International, Inc.