Bariatric and metabolic endoscopy in the handling of fatty liver disease. A new emerging approach?

BACKGROUND: non-alcoholic fatty liver disease (NAFLD) is the most frequent cause of chronic hepatopathy in our environment. However, the benefits of the bariatric endoscopy in this disease are barely documented. OBJECTIVES: to evaluate changes in NAFLD, via non-invasive methods in obese patients who underwent bariatric restrictive endoscopy. Weight, metabolic changes and the level of technical safety were also analyzed as secondary objectives. METHODS: thirty patients with NAFLD and obesity (mean BMI 38.22 ± 6.55 kg/m2) underwent bariatric restrictive endoscopy; this included 15 one-year intragastric balloons and 15 sutured gastroplasties (ESG-Apollo®). A non-invasive prospective analysis was performed via analytical (hepatic function, insulin-resistance and hepatic steatosis/fibrosis scores) and ultrasonographic parameters. In addition, anthropometric features and the evolution of the main obesity-related comorbidities were evaluated. The follow-up period was one year in all cases. RESULTS: thirty patients were included; 63% were female with a mean age of 46 ± 13.8 years. There was a decrease in FLI, HSI, NAFLD-Fibrosis Score, hepatic ultrasonographic steatosis, subcutaneous fat (p < 0.001), HOMA-IR, insulin and triglycerides (p < 0.05) after 12 months. An average EWL of 44.02% (16.34% TBWL) was obtained after one year, with EWL > 25% in 27/30 patients (TBWL > 10% in 25/30 patients) (p < 0.001). Obesity-related comorbidities were resolved in 17/30 (57%) of cases, 5/8 (62.5%) HTA, 5/12 (41.7%) DLP, 2/4 (50%) T2DM, 2/3 (66.7%) SOAS and 3/3 (100%) arthropathy. An improvement in HbA1c in the ESG-Apollo group (p = 0.017) was the only difference. One migrated and spontaneously expelled balloon was the only technical incidence. CONCLUSIONS: bariatric endoscopy could be proposed during short-term follow-up as an effective and safe alternative in patients with obesity and NAFLD. It stimulates weight loss and improves analytical and ultrasound parameters from hepatic fat, insulin-resistance and hypertriglyceridemia. It also improves associated major comorbidities.

Feasibility, results and endoscopic requirements of the Elipse® swallowable intragastric balloon: initial experience.

BACKGROUND: the Elipse® intragastric balloon (EIGB) is a swallowable capsule that is filled under x-ray control. After 16 weeks, its self-releasing valve is degraded and the balloon is deflated and excreted naturally, without endoscopy. The aim of this study was to assess the feasibility of EIGB and its efficacy, duration, safety and endoscopic requirements. METHODS: this is a prospective, descriptive, non-randomized study of the first patients enrolled for EIGB. An x-ray was systematically performed after placement to ensure the correct filling of the balloon. The balloon duration was determined according to its excreted visualization or by x-ray/ultrasound. The efficacy, tolerance, adverse events and their resolution outcome (endoscopic requirements), as well as the final satisfaction degree at 16 weeks, were analyzed. RESULTS: the study included 30 patients with a basal mean weight and body mass index (BMI) of 83.3 ± 10.7 kg and 30.6 ± 2.7 kg/m². All subjects swallowed the capsule with correct x-ray control. The mean weight loss was 11.2 ± 5.5 kg (12.1 ± 5.8% of total weight loss [TWL], 64.7 ± 25% of excess weight loss [EWL]), with a weight loss > 10% in 80% of patients (p < 0.05) after four months. Early elimination of the balloon with an insufficient duration (< 12 weeks) was observed in 2/24 patients (8.3%). There was an acceptable tolerance in 80%. With regard to adverse effects, one balloon was vomited up, there was one intolerance and the balloon was removed by gastroscopy and one small bowel ileal obstruction, which was removed by ileoscopy. The final satisfaction degree was good in 60% of cases. CONCLUSIONS: EIGB placement by x-ray seems feasible and safe. Although some devices have a shorter duration than expected, such as < 16 weeks in 29% patients and < 12 weeks in 8.3% of patients, an acceptable weight loss at four months was obtained. There were some adverse effects that required endoscopy, thus we advise that the procedure be supervised by a bariatric endoscopist.

HIV-infection, atherosclerosis and the inflammatory pathway: candidate gene study in a Spanish HIV-infected population.

BACKGROUND: Higher prevalence of atherosclerosis and higher cardiovascular risk is observed in HIV-infected individuals. The biological mechanisms underlying these processes are unclear. Several studies have implicated genetic variants in the inflammatory genes in cardiovascular disease and in HIV natural course infection. METHODS & FINDINGS: In this study we have tested the possible association between genetic variants in several inflammatory genes and asymptomatic cardiovascular disease measured by carotid intima media thickness (cIMT) and atherosclerotic plaque presence as dependent variables in 213 HIV-infected individuals. A total of 101 genetic variants in 25 candidate genes have been genotyped. Results were analyzed using Plink and SPSS statistical packages. We have found several polymorphisms in the genes ALOX5 (rs2115819 p = 0.009), ALOX5AP (rs9578196 p = 0.007; rs4769873 p = 0.004 and rs9315051 p = 0.0004), CX3CL1 (rs4151117 p = 0.040 and rs614230 p = 0.015) and CCL5 (rs3817655 p = 0.018 and rs2107538 p = 0.018) associated with atherosclerotic plaque. cIMT mean has been associated with CRP (1130864 p = 0.0003 and rs1800947 p = 0.008), IL1RN (rs380092 p = 0.002) and ALOX5AP (rs3885907 p = 0.02) genetic variants. CONCLUSIONS: In this study we have found modest associations between genetic variants in several inflammatory genes and atherosclerotic plaque or cIMT. Nevertheless, our study adds evidence to the association between inflammatory pathway genetic variants and the atherosclerotic disease in HIV-infected individuals.

Balón intragástrico ingerible Elipse(R). Viabilidad, resultados y requerimientos endoscópicos. Experiencia inicial / Feasibility, results and endoscopic requirements of the Elipse(R) swallowable intragastric balloon: initial experience

Antecedentes: el balón intragástrico Elipse(R) consiste en una cápsula ingerible que se rellena bajo control radiológico. Pasadas 16 semanas, su válvula se degrada, el balón se vacía y se elimina por vía natural, sin endoscopia. El objetivo del estudio es valorar su viabilidad, eficacia, duración, seguridad y requerimientos endoscópicos. Métodos: estudio prospectivo y descriptivo, no aleatorizado, de los primeros pacientes remitidos para Elipse(R). Tras colocación, se realizaba sistemáticamente una radiografía para confirmar su correcto rellenado. Se determinaba la duración del balón en función de su visualización excretado o por radiografía/ecografía. Se recogieron datos de eficacia, tolerancia, efectos adversos y su resolución (requerimientos endoscópicos), así como el grado final de satisfacción a las 16 semanas. Resultados: participaron en el estudio 30 pacientes con peso e índice de masa corporal (IMC) medios basales de 83,3 +/- 10,7 kg y 30,6 +/- 2,7 kg/m². Todos pudieron ingerir la cápsula con correcto control radiológico. A los cuatro meses presentaban una pérdida media de 11,2 +/- 5,5 kg (12,1 +/- 5,8% de pérdida total de peso [PTP], 64,7 +/- 25% de pérdida del exceso de peso [PEP]), con pérdida de peso > 10% en el 80% de pacientes (p < 0,05). Obtuvimos una eliminación precoz del balón con duración insuficiente (< 12 semanas) en 2/24 pacientes (8,3%). La tolerancia fue aceptable en el 80%. Efectos adversos: un vómito del balón, una intolerancia (extracción por gastroscopia) y una oclusión ileal (extracción por ileoscopia). El grado final de satisfacción fue bueno en el 60%. Conclusiones: la implantación del balón Elipse(R) mediante radiología parece viable y segura. A pesar de que algunos balones presentan una duración inferior a la estimable (< 16 semanas en el 29%, incluyendo < 12 semanas en el 8,3%), se obtuvo una aceptable pérdida de peso a los cuatro meses. Existen efectos adversos que requieren endoscopia, por lo que aconsejamos que sea supervisado por un endoscopista bariátrico

Background: the Elipse(R) intragastric balloon (EIGB) is a swallowable capsule that is filled under x-ray control. After 16 weeks, its self-releasing valve is degraded and the balloon is deflated and excreted naturally, without endoscopy. The aim of this study was to assess the feasibility of EIGB and its efficacy, duration, safety and endoscopic requirements. Methods: this is a prospective, descriptive, non-randomized study of the first patients enrolled for EIGB. An x-ray was systematically performed after placement to ensure the correct filling of the balloon. The balloon duration was determined according to its excreted visualization or by x-ray/ultrasound. The efficacy, tolerance, adverse events and their resolution outcome (endoscopic requirements), as well as the final satisfaction degree at 16 weeks, were analyzed. Results: the study included 30 patients with a basal mean weight and body mass index (BMI) of 83.3 +/- 10.7 kg and 30.6 +/- 2.7 kg/m². All subjects swallowed the capsule with correct x-ray control. The mean weight loss was 11.2 +/- 5.5 kg (12.1 +/- 5.8% of total weight loss [TWL], 64.7 +/- 25% of excess weight loss [EWL]), with a weight loss > 10% in 80% of patients (p < 0.05) after four months. Early elimination of the balloon with an insufficient duration (< 12 weeks) was observed in 2/24 patients (8.3%). There was an acceptable tolerance in 80%. With regard to adverse effects, one balloon was vomited up, there was one intolerance and the balloon was removed by gastroscopy and one small bowel ileal obstruction, which was removed by ileoscopy. The final satisfaction degree was good in 60% of cases. Conclusions: EIGB placement by x-ray seems feasible and safe. Although some devices have a shorter duration than expected, such as < 16 weeks in 29% patients and < 12 weeks in 8.3% of patients, an acceptable weight loss at four months was obtained. There were some adverse effects that required endoscopy, thus we advise that the procedure be supervised by a bariatric endoscopist

Endoscopia bariátrica y metabólica en el manejo del hígado graso. ¿Una nueva vía emergente? / Bariatric and metabolic endoscopy in the handling of fatty liver disease. A new emerging approach?

Introducción: la enfermedad hepática grasa no alcohólica (EHGNA) es la causa más frecuente de hepatopatía crónica en nuestro medio. Los beneficios de la endoscopia bariátrica en esta enfermedad están escasamente documentados. Objetivo: evaluar los cambios de EHGNA, mediante métodos no invasivos, en pacientes obesos sometidos a endoscopia bariátrica restrictiva. Secundariamente, analizamos los cambios ponderales y metabólicos y el grado de seguridad técnica. Métodos: treinta pacientes con EHGNA y obesidad (índice de masa corporal [IMC] medio de 38,22 +/- 6,55 kg/m²) sometidos a endoscopia bariátrica restrictiva: 15 balones de un año y 15 gastroplastias mediante suturas (ESG-Apollo(R)). Se realiza un análisis prospectivo no invasivo mediante parámetros analíticos (función hepática, insulinorresistencia, scores de esteatosis y fibrosis hepática) y ecográficos. Además, se evalúa la evolución antropométrica y de las principales comorbilidades mayores asociadas, todo ello con seguimiento a un año. Resultados: treinta pacientes (63% mujeres, edad media 46 +/- 13,8 años). A los 12 meses presentaron disminución en FLI, HSI, NAFLD-Fibrosis Score, esteatosis hepática ecográfica y grasa subcutánea (p < 0,001) y en HOMA-IR, insulina y triglicéridos (p < 0,05). Al año, se obtuvo una pérdida del exceso de peso (PEP) del 44,02% (16,34% pérdida total de peso [PTP]), con PEP > 25% en 27/30 pacientes (PP > 10% en 25/30 pacientes) (p < 0,001). Se objetivó resolución en 17/30 (57%) de las comorbilidades asociadas: 5/8 (62,5%) hipertensión arterial (HTA), 5/12 (41,7%) dislipemia (DLP), 2/4 (50%) diabetes mellitus tipo 2 (DM2), 2/3 (66,7%) síndrome de apnea obstructiva del sueño (SAOS) y 3/3 (100%) artropatía. Comparando ambos procedimientos, la mejoría en HbA1c en el grupo de ESG-Apollo (p = 0,017) fue la única diferencia. Un balón migrado y expulsado espontáneamente fue la única incidencia técnica. Conclusiones: la endoscopia bariátrica puede postularse, en un seguimiento a corto plazo, como una alternativa eficaz y segura en aquellos pacientes obesos con EHGNA. Favorece la pérdida de peso y mejora los biomarcadores analíticos y ecográficos de grasa hepática, la insulinorresistencia, la hipertrigliceridemia y las comorbilidades mayores asociadas

Background: non-alcoholic fatty liver disease (NAFLD) is the most frequent cause of chronic hepatopathy in our environment. However, the benefits of the bariatric endoscopy in this disease are barely documented. Objectives: to evaluate changes in NAFLD, via non-invasive methods in obese patients who underwent bariatric restrictive endoscopy. Weight, metabolic changes and the level of technical safety were also analyzed as secondary objectives. Methods: thirty patients with NAFLD and obesity (mean BMI 38.22 +/- 6.55 kg/m2) underwent bariatric restrictive endoscopy; this included 15 one-year intragastric balloons and 15 sutured gastroplasties (ESG-Apollo(R)). A non-invasive prospective analysis was performed via analytical (hepatic function, insulin-resistance and hepatic steatosis/fibrosis scores) and ultrasonographic parameters. In addition, anthropometric features and the evolution of the main obesity-related comorbidities were evaluated. The follow-up period was one year in all cases. Results: thirty patients were included; 63% were female with a mean age of 46 +/- 13.8 years. There was a decrease in FLI, HSI, NAFLD-Fibrosis Score, hepatic ultrasonographic steatosis, subcutaneous fat (p < 0.001), HOMA-IR, insulin and triglycerides (p < 0.05) after 12 months. An average EWL of 44.02% (16.34% TBWL) was obtained after one year, with EWL > 25% in 27/30 patients (TBWL > 10% in 25/30 patients) (p < 0.001). Obesity-related comorbidities were resolved in 17/30 (57%) of cases, 5/8 (62.5%) HTA, 5/12 (41.7%) DLP, 2/4 (50%) T2DM, 2/3 (66.7%) SOAS and 3/3 (100%) arthropathy. An improvement in HbA1c in the ESG-Apollo group (p = 0.017) was the only difference. One migrated and spontaneously expelled balloon was the only technical incidence. Conclusions: bariatric endoscopy could be proposed during short-term follow-up as an effective and safe alternative in patients with obesity and NAFLD. It stimulates weight loss and improves analytical and ultrasound parameters from hepatic fat, insulin-resistance and hypertriglyceridemia. It also improves associated major comorbidities