Persistence of Sutures and Gastric Reduction After Endoscopic Sleeve Gastroplasty: Radiological and Endoscopic Assessment.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an effective medium-term procedure for obesity treatment. There are no consistent studies confirming persistence of maintained gastric tubular configuration. We determined sleeve duration, gastric reduction degree, and suture persistence at 12-month follow-up. PATIENTS AND METHODS: This is a prospective, single-center study, including patients with obesity undergoing ESG with at least 1-year follow-up, who underwent the following: (1) Barium X-ray study (BS) prior and at 6 months, assessing degree of gastric reduction (severe, moderate, or mild), and (2) gastroscopy at 12 months, accounting the number of persistent sutures (tense, lax, or absent). Secondary outcomes were weight loss data and procedure safety profile. RESULTS: Thirty-eight patients (30 women), median age of 47.0 [40.0-51.0] years, and average baseline BMI of 37.6 [35.5-41.5] kg/m2 were included. Median %TWL of 17.1% [16.1-22.3%] with TWL > 10% in 94.7% of patients was obtained at 1 year. No major AEs were observed. Six months BS was performed on 30 patients: 12 (40.0%), 14 (46.7%), and 4 (13.3%) patients showed severe, moderate, and mild gastric reduction, respectively. Twelve months gastroscopy was performed on 22 patients with 83.64% of sutures persisting (92 of 110, mean 4.2 of 5.0 sutures/patient) and 70.9% with adequate tension. We found intact sutures in 12 patients (54.5%), and 10 patients (45.5%) had some suture detached (average 1.8, r = 1-3). There were no differences in %TWL according to BS reduction (p = 0.662) or number of persistent sutures (p = 0.678). CONCLUSIONS: ESG is an effective and safe weight loss strategy at 12-month follow-up with persistence of most sutures and maintenance of notable gastric reduction and remodeling.

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

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.

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

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.

Eficacia y seguridad del TORe mediante sutura endoscópica para tratar la reganancia ponderal tras bypass gástrico quirúrgico en Y-de-Roux / Efficacy and safety of transoral outlet reduction via endoscopic suturing in patients with weight regain after a surgical Roux-en-Y gastric bypass

Introducción: muchos de los pacientes sometidos a cirugía bariátrica (bypass gástrico en Y-de-Roux [RYGB]), con el tiempo, pueden recuperar parte del peso perdido. La reducción transoral del vaciamiento gástrico (TORe) con sutura endoscópica podría ser una alternativa válida en estos pacientes. Métodos: serie inicial retrospectiva que incluye a 13 pacientes consecutivos remitidos por reganancia ponderal tras RYGB y con anastomosis gastroyeyunal dilatada (> 15 mm). El TORe fue realizado mediante un dispositivo endoscópico de suturas transmurales (OverStitch-Apollo(R)), reduciendo el diámetro de la anastomosis y del reservorio gástrico. Se describen los datos iniciales de viabilidad técnica, seguridad y eficacia, con un seguimiento limitado a seis meses. Resultados: tras el RYGB, existía una pérdida media máxima de 37,69 kg y una posterior reganancia media de 21,62 kg. Se redujo el diámetro medio de la anastomosis de 36 mm (rango 20-45) a 9 mm (rango 5-12) (reducción del 75%) con una media de 2,5 suturas y el del reservorio de 7,2 cm (rango 2-10) a 4,7 cm (rango 4-5) (reducción del 34,72%) con una media de 2,7 suturas. La pérdida media de peso a los seis meses tras el TORe fue de 12,29 kg (pérdida del 56,85% del peso reganado tras RYGB). No se registraron complicaciones relacionadas con el procedimiento. Conclusiones: la reducción mediante sutura endoscópica de la anastomosis gastroyeyunal dilatada y del reservorio gástrico parece una opción viable y segura según nuestra limitada experiencia inicial. Dentro de un abordaje multidisciplinar y en un seguimiento a corto plazo, se presenta como una opción mínimamente invasiva y eficaz para controlar la reganancia ponderal tras RYGB

Introduction: many patients that undergo bariatric surgery (Roux-en-Y gastric bypass [RYGB]) may regain some of their weight lost over time. A transoral outlet reduction (TORe) with endoscopic suture could be a valid alternative in these patients. Methods: this was a retrospective initial series of 13 consecutive patients with weight regain after RYGB and a dilated gastro-jejunal anastomosis (> 15 mm). TORe was performed using an endoscopic transmural suture device (OverStitch-Apollo(R)), which was used to reduce the anastomosis aperture and also to treat the gastric pouch. The initial data of feasibility, safety and weight loss are described with a limited follow-up of six months. Results: there was a mean maximum weight loss of 37.69 kg after RYGB and a subsequent average regain of 21.62 kg. The mean anastomosis diameter was 36 mm (range 20-45) which was reduced to 9 mm (range 5-12) (75% reduction), with an average of 2.5 sutures. The mean pouch size was 7.2 cm (range 2-10), which decreased to 4.7 cm (range 4-5) (34.72% reduction), with an average of 2.7 sutures. The mean weight loss six months after TORe was 12.29 kg, a weight loss of 56.85% of the weight regained after RYGB. No complications related to the procedure were recorded. Conclusions: endoscopic suture reduction of the dilated gastro-jejunal anastomosis and the gastric pouch seems a feasible and safe option in our limited initial experience. With a multidisciplinary approach and a short term follow-up, this seems to be a minimally invasive and effective option to control weight regain after RYGB

Efficacy and safety of transoral outlet reduction via endoscopic suturing in patients with weight regain after a surgical Roux-en-Y gastric bypass.

INTRODUCTION: many patients that undergo bariatric surgery (Roux-en-Y gastric bypass [RYGB]) may regain some of their weight lost over time. A transoral outlet reduction (TORe) with endoscopic suture could be a valid alternative in these patients. METHODS: this was a retrospective initial series of 13 consecutive patients with weight regain after RYGB and a dilated gastro-jejunal anastomosis (> 15 mm). TORe was performed using an endoscopic transmural suture device (OverStitch-Apollo®), which was used to reduce the anastomosis aperture and also to treat the gastric pouch. The initial data of feasibility, safety and weight loss are described with a limited follow-up of six months. RESULTS: there was a mean maximum weight loss of 37.69 kg after RYGB and a subsequent average regain of 21.62 kg. The mean anastomosis diameter was 36 mm (range 20-45) which was reduced to 9 mm (range 5-12) (75% reduction), with an average of 2.5 sutures. The mean pouch size was 7.2 cm (range 2-10), which decreased to 4.7 cm (range 4-5) (34.72% reduction), with an average of 2.7 sutures. The mean weight loss six months after TORe was 12.29 kg, a weight loss of 56.85% of the weight regained after RYGB. No complications related to the procedure were recorded. CONCLUSIONS: endoscopic suture reduction of the dilated gastro-jejunal anastomosis and the gastric pouch seems a feasible and safe option in our limited initial experience. With a multidisciplinary approach and a short term follow-up, this seems to be a minimally invasive and effective option to control weight regain after RYGB.