Magnetic sphincter augmentation: a viable rescue therapy for symptomatic reflux following bariatric surgery.

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are commonly performed bariatric procedures in obesity management. Gastroesophageal reflux disease (GERD) in this population has reported rates of 23-100%. GERD after LSG has been noted with recent studies demonstrating de novo reflux or symptom exacerbation despite weight loss. Fundoplication is not an option, and medically refractory GERD after LSG is usually treated with conversion to RYGB. GERD post-RYGB is a unique entity, and management poses a clinical and technical challenge. We evaluate safety and effectiveness of magnetic sphincter augmentation after bariatric surgery. MATERIALS AND METHODS: A retrospective review of a prospectively maintained database was performed identifying patients that underwent LINX placement for refractory GERD after LSG, LRYGB, or duodenal switch across three institutions. Outcomes included complications, length of stay, PPI use, GERD-HRQL scores, and patient overall satisfaction. RESULTS: From March 2014 through June 2018, 13 identified patients underwent LINX placement after bariatric surgery: 8 LSG, 4 LRYGB, and 1 duodenal switch. The patients were 77% female, with mean age 43 and average BMI 30.1. Average pre-operative DeMeester score was 24.8. Pre-operatively, 5 patients were on daily PPI, 6 on BID PPI, and 1 on PPI + H2 blocker. We noted decreased medication usage post-operatively, with 4 patients taking daily PPI, and 9 off medication completely. A GERD-HRQL score was obtained pre- and post-operatively in 6 patients with average reduction from 25 to 8.5 (p value 0.002). Two patients experienced complications requiring endoscopic dilation after LINX placement. 100% of patients reported overall satisfaction post procedure. CONCLUSION: LINX placement is a safe, effective treatment option for surgical management of refractory GERD after bariatric surgery. It can relieve symptoms and obviate the requirement of high-dose medical management. Magnetic lower esophageal sphincter augmentation should be another tool in the surgeon's toolbox for managing reflux after bariatric surgery in select patients.

Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314.

BACKGROUND: Single-incision minimally invasive surgery has previously been associated with incisions 2.0-3.0 cm in length. We present a novel single-incision surgical platform compatible for insertion through a standard 15-mm trocar we previously described in six patients with short-term follow-up data. The objective of this phase II study was to evaluate the safety and feasibility of the platform in a larger collective and to evaluate 1-year follow-up data of the phase I trial. METHODS: The technology features a multiple-use introducer, accommodating the articulating instruments, and is inserted through a 15-mm laparoscopic trocar. Cholecystectomy is performed through an umbilical incision. A prospective feasibility study was performed at a single center. Inclusion criteria were age of 18-75 years and biliary colic, exclusion criteria were acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI > 40 kg/m(2), or choledocholithiasis. Endpoints included complications, length of stay, pain medication, cosmetic results, and the presence of hernia. RESULTS: Twenty-seven patients (23 females; phase I: 6 patients, phase II: 21 patients) with an average age of 41.7 years and BMI 26.6 kg/m(2) were recruited for the study. Umbilical incision length did not exceed 15 mm. There were no intraoperative complications. Average OR time decreased from 91 min for the first six cases to 56 min for the last six cases. Average length of stay was 7.8 h. Pain control was achieved with diclofenac for no more than 7 days. All patients had no adverse events at 5-month follow-up, and all phase I patients had no adverse events nor evidence of umbilical hernia at 1 year. CONCLUSION: This study demonstrates that single-incision cholecystectomy with the platform is feasible, safe, and reproducible in a larger patient population. Long-term follow-up showed no hernias or other adverse events. Further studies will be needed to evaluate longer-term hernia rates.

Consenso Argentino de Cirugía Metabólica / ARGENTINE CONSENSUS ON METABOLIC SURGERY

Introducción: la creciente pandemia de obesidad y diabetes tipo 2 (DM2) demanda opciones terapéuticas más efectivas para lograr un adecuado control metabólico y disminuir la morbimortalidad cardiovascular en este grupo de pacientes. En este contexto, la cirugía metabólica (CM) constituye una herramienta innovadora, segura y eficaz que complementa pero no reemplaza a los cambios necesarios del estilo de vida y tratamiento médico. Objetivos: el objetivo del Consenso es la fundamentación y acuerdo de utilización de una técnica quirúrgica, específicamente el Bypass Gástrico en Y de Roux (BPGYR), en el tratamiento de pacientes con DM2 que presentan un índice de masa corporal (IMC) entre 30-35 kg/m2 e inadecuado control metabólico. Conclusiones: el Consenso Argentino de Cirugía Metabólica elaborado por la Sociedad Argentina de Diabetes (SAD), la Sociedad Argentina de Nutrición (SAN) y la Sociedad Argentina de Cirugía de la Obesidad (SACO) expresa la opinión de expertos sobre la evidencia científica disponible y propone considerar a la CM en el algoritmo terapéutico de pacientes con DM2 e IMC 30-35 kg/m2 que no logran adecuado control metabólico con tratamiento médico convencional. Se describen los criterios a tener en cuenta en la selección de pacientes para CM, y se destaca el rol del equipo multidisciplinario liderado por médicos especialistas en enfermedades endocrino-metabólicas en la selección, evaluación, preparación y seguimiento de estos pacientes.

Consenso Argentino de Cirugía Metabólica / Argentine Consensus on Metabolic Surgery

Introducción: la creciente pandemia de obesidad y diabetes tipo 2 (DM2) demanda opciones terapéuticas más efectivas para lograr un adecuado control metabólico y disminuir la morbimortalidad cardiovascular en este grupo de pacientes. En este contexto, la cirugía metabólica (CM) constituye una herramienta innovadora, segura y eficaz que complementa pero no reemplaza a los cambios necesarios del estilo de vida y tratamiento médico. Objetivos: el objetivo del Consenso es la fundamentación y acuerdo de utilización de una técnica quirúrgica, específicamente el Bypass Gástrico en Y de Roux (BPGYR), en el tratamiento de pacientes con DM2 que presentan un índice de masa corporal (IMC) entre 30-35 kg/m2 e inadecuado control metabólico. Conclusiones: el Consenso Argentino de Cirugía Metabólica elaborado por la Sociedad Argentina de Diabetes (SAD), la Sociedad Argentina de Nutrición (SAN) y la Sociedad Argentina de Cirugía de la Obesidad (SACO) expresa la opinión de expertos sobre la evidencia científica disponible y propone considerar a la CM en el algoritmo terapéutico de pacientes con DM2 e IMC 30-35 kg/m2 que no logran adecuado control metabólico con tratamiento médico convencional. Se describen los criterios a tener en cuenta en la selección de pacientes para CM, y se destaca el rol del equipo multidisciplinario liderado por médicos especialistas en enfermedades endocrino-metabólicas en la selección, evaluación, preparación y seguimiento de estos pacientes

[PRE-OPERATIVE IRON DEFICIENCY IN BARIATRIC SURGERY: DIAGNOSIS AND TREATMENT]. / DEFICIENCIA DE HIERRO EN EL PREOPERATORIO DE CIRUGÍA BARIÁTRICA: DIAGNÓSTICO Y TRATAMIENTO.

INTRODUCTION: chronic inflammation induced by obesity alters iron homeostasis leading to mild /moderate iron deficiency and anaemia. Between 14% and 43% of patients may suffer from iron deficiency without anaemia before surgery. The management of peri-operative iron deficiency improves patient outcome and quality of life. Under certain circumstances intravenous (IV) iron must be considered. IV iron (which may avoid iron blockage in enterocytes and macrophages) has turned out to be a safe and efficient alternative. Objetives: 1) To assess the prevalence of iron deficiency in morbidly obese patients candidates for bariatric surgery. 2) Assess whether supplementation of parenteral iron in iron-deficient patients is effective in preventing the decrease in hematocrit after surgery. MATERIALS AND METHODS: prospective, observational study which included 89 morbidly obese patients who underwent bariatric surgery. The population was divided according to whether or not patients had pre-op iron deficiency, and post-op evolution was analyzed. Iron-deficient patients were supplemented with 500 mg of intravenous (IV) carboximaltose and were evaluated post-op. RESULTS: twenty-three patients (25.8%) presented preop iron deficiency pre-operatively while six (6.74%) had anemia. 74.2% (66 patients) had no iron deficiency. The group without iron deficiency at one month of surgery had the following laboratory values: Hematocrit: 41.30% ± 3.77; hemoglobin: 13.64 g/l ± 1.25 and transferrin saturation: 30.55 %. The patients with pre-op iron deficiency had the following values: Hematocrit: 40.40% ± 3.03; hemoglobin: 13.40 g/l ± 1.07; transferrin saturation: 15.50% ± 4.18, and ferritin: 87.10 ng/ml ± 81.23. Post-op hematocrit reduction was 38.40% ± 3.17 (p: 0.034). In iron-deficient patients without IV iron supplementation (n=15), hematocrit and hemoglobin were 41.2% ± 2.5 and 13.7 g/l ± 0.9 respectively with post-op reduction (37.5% ± 3.4 and 12.3 g/l p < 0.05). IV iron supplementation in iron-deficient patients (n = 9) increased hemoglobin (13.5 g/l ± 0.7), compared with the pre-op (12.8 g/l ± 1.2; p: 0.05), as well as transferrin saturation and ferritin. One month after surgery there were no significant changes in hematocrit (pre-op: 39%, post-op: 40% p: > 0.05). DISCUSSION: 1) Almost 26% of patients present pre-op iron deficiency. 2) Treatment with IV iron seems to be efficient to prevent hematocrit reduction and to improve iron metabolism in pre-op iron-deficient patients. In patients without iron deficiency, hematocrit and iron metabolism remain normal one month after surgery without the need for iron supplementation.

Introducción: la inflamación crónica inducida por la obesidad produce alteración de la homeostasis del hierro, llevando a deficiencia de hierro y a anemia de leve a moderada. Entre el 14 y el 43% de los pacientes pueden presentar déficit de hierro sin anemia antes de la cirugía. El tratamiento del déficit de hierro en el perioperatorio mejora el pronóstico y la calidad de vida de los pacientes. En ciertas situaciones, puede el hierro enovenoso (el cual evita el bloqueo del hierro en enterocitos y macrófagos), ser una alternativa segura y efectiva. Objetivos: 1) Valorar la prevalencia de ferropenia en pacientes obesos mórbidos candidatos a cirugía bariátrica. 2) Evaluar si la suplementación de hierro parenteral en pacientes ferropénicos es eficaz a la hora de prevenir el descenso de hematocritos tras la cirugía. Material y métodos: estudio prospectivo, observacional, que incluyó 89 pacientes obesos mórbidos sometidos a cirugía bariátrica. Se dividió la población en el preoperatorio (pre OP) según la condición de ferropenia o ausencia de ferropenia, y se analizó la evolución postoperatoria (post OP). Los pacientes ferropénicos fueron suplementados con 500 mg de hierro carboximaltosa endovenoso (EV) y evaluados en el post OP. Resultados: veintitrés pacientes (25,8%) presentaron ferropenia en el pre OP y 6 (6,74%) anemia. El 74,2% (66 pacientes) no tuvieron ferropenia. El grupo sin ferropenia al mes de la cirugía presentó: hematocrito: 41,30% ± 3,77; hemoglobina: 13,64 g/l ± 1,25 y saturación de transferrina 30,55 %. Los pacientes con ferropenia en el pre OP presentaron: hematocrito: 40,40% ± 3,03; hemoglobina: 13,40 g/l ± 1,07; saturación de transferrina: 15,50% ± 4,18 y ferritina: 87,10 ng/ ml ± 81,23 . En el post OP se observó descenso de hematocrito: 38,40% ± 3,17 (p:0,034). En pacientes ferropénicos, sin aporte de hierro EV (n = 15), el hematocrito y hemoglobina fueron de 41,2% ± 2,5 y 13,7 g/l ± 0,9, respectivamente, con descenso en el post OP (37,5% ± 3,4 y 12,3 g/l p < 0,05). La suplementación con hierro EV en pacientes ferropénicos (n = 9) aumentó la hemoglobina (13,5 g/l ± 0,7) con respecto al pre OP (12,8 g/l ± 1,2; p:0,05), así como la saturación de transferrina y ferritina. Al mes de la cirugía el Hematocrito no tuvo cambios significativos (Hematocrito pre OP: 39%; Hematocrito post OP: 40% p: > 0,05). Discusion:1) Casi el 26% de los pacientes presentan ferropenia en el pre OP. 2) El tratamiento con hierro EV parece ser eficaz para prevenir un descenso de hematocritos y mejorar el metabolismo del hierro en pacientes ferropénicos previos a la cirugía. Los pacientes sin ferropenia al mes de la cirugía mantienen valores normales de hematocritos y metabolismo del hierro sin necesidad de suplementación de hierro.

Deficiencia de hierro en el preoperatorio de cirugía bariátrica: diagnóstico y tratamiento / Pre-operative iron deficiency in bariatric surgery: diagnosis and treatment

Introducción: la inflamación crónica inducida por la obesidad produce alteración de la homeostasis del hierro, llevando a deficiencia de hierro y a anemia de leve a moderada. Entre el 14 y el 43% de los pacientes pueden presentar déficit de hierro sin anemia antes de la cirugía. El tratamiento del déficit de hierro en el perioperatorio mejora el pronóstico y la calidad de vida de los pacientes. En ciertas situaciones, puede el hierro enovenoso (el cual evita el bloqueo del hierro en enterocitos y macrófagos), ser una alternativa segura y efectiva. Objetivos: 1) Valorar la prevalencia de ferropenia en pacientes obesos mórbidos candidatos a cirugía bariátrica. 2) Evaluar si la suplementación de hierro parenteral en pacientes ferropénicos es eficaz a la hora de prevenir el descenso de hematocritos tras la cirugía. Material y métodos: estudio prospectivo, observacional, que incluyó 89 pacientes obesos mórbidos sometidos a cirugía bariátrica. Se dividió la población en el preoperatorio (pre OP) según la condición de ferropenia o ausencia de ferropenia, y se analizó la evolución postoperatoria (post OP). Los pacientes ferropénicos fueron suplementados con 500 mg de hierro carboximaltosa endovenoso (EV) y evaluados en el post OP. Resultados: veintitrés pacientes (25,8%) presentaron ferropenia en el pre OP y 6 (6,74%) anemia. El 74,2% (66 pacientes) no tuvieron ferropenia. El grupo sin ferropenia al mes de la cirugía presentó: hematocrito: 41,30% ± 3,77; hemoglobina: 13,64 g/l ± 1,25 y saturación de transferrina 30,55 %. Los pacientes con ferropenia en el pre OP presentaron: hematocrito: 40,40% ± 3,03; hemoglobina: 13,40 g/l ± 1,07; saturación de transferrina: 15,50% ± 4,18 y ferritina: 87,10 ng/ ml ± 81,23 . En el post OP se observó descenso de hematocrito: 38,40% ± 3,17 (p:0,034). En pacientes ferropé- nicos, sin aporte de hierro EV (n=15), el hematocrito y hemoglobina fueron de 41,2% ± 2,5 y 13,7 g/l ± 0,9, respectivamente, con descenso en el post OP (37,5% ± 3,4 y 12,3 g/l p<0,05). La suplementación con hierro EV. en pacientes ferropénicos (n=9) aumentó la hemoglobina (13,5 g/l ± 0,7) con respecto al pre OP (12,8 g/l ± 1,2; p:0,05), así como la saturación de transferrina y ferritina. Al mes de la cirugía el Hematocrito no tuvo cambios significativos (Hematocrito pre OP: 39%; Hematocrito post OP: 40% p:>0,05). Discusion:1) Casi el 26% de los pacientes presentan ferropenia en el pre OP. 2) El tratamiento con hierro EV parece ser eficaz para prevenir un descenso de hematocritos y mejorar el metabolismo del hierro en pacientes ferropénicos previos a la cirugía. Los pacientes sin ferropenia al mes de la cirugía mantienen valores normales de hematocritos y metabolismo del hierro sin necesidad de suplementación de hierro (AU)

Introduction: chronic inflammation induced by obesity alters iron homeostasis leading to mild /moderate iron deficiency and anaemia. Between 14% and 43% of patients may suffer from iron deficiency without anaemia before surgery. The management of peri-operative iron deficiency improves patient outcome and quality of life. Under certain circumstances intravenous (IV) iron must be considered. IV iron (which may avoid iron blockage in enterocytes and macrophages) has turned out to be a safe and efficient alternative. Objetives: 1) To assess the prevalence of iron deficiency in morbidly obese patients candidates for bariatric surgery. 2) Assess whether supplementation of parenteral iron in iron-deficient patients is effective in preventing the decrease in hematocrit after surgery. Materials and methods: prospective, observational study which included 89 morbidly obese patients who underwent bariatric surgery. The population was divided according to whether or not patients had pre-op iron deficiency, and post-op evolution was analyzed. Iron-deficient patients were supplemented with 500 mg of intravenous (IV) carboximaltose and were evaluated post-op. Results: twenty-three patients (25.8%) presented preop iron deficiency pre-operatively while six (6.74%) had anemia. 74.2% (66 patients) had no iron deficiency. The group without iron deficiency at one month of surgery had the following laboratory values: Hematocrit: 41.30% ± 3.77; hemoglobin: 13.64 g/l ± 1.25 and transferrin saturation: 30.55 %. The patients with pre-op iron deficiency had the following values: Hematocrit: 40.40% ± 3.03; hemoglobin: 13.40 g/l ± 1.07; transferrin saturation: 15.50% ± 4.18, and ferritin: 87.10 ng/ml ± 81.23. Post-op hematocrit reduction was 38.40% ± 3.17 (p: 0.034). In iron-deficient patients without IV iron supplementation (n=15), hematocrit and hemoglobin were 41.2% ± 2.5 and 13.7 g/l ± 0.9 respectively with post-op reduction (37.5% ± 3.4 and 12.3 g/l p<0.05). IV iron supplementation in iron-deficient patients (n=9) increased hemoglobin (13.5 g/l ± 0.7), compared with the pre-op (12.8 g/l ± 1.2; p: 0.05), as well as transferrin saturation and ferritin. One month after surgery there were no significant changes in hematocrit (pre-op: 39%, post-op: 40% p:>0.05). Discussion: 1) Almost 26% of patients present pre-op iron deficiency. 2) Treatment with IV iron seems to be efficient to prevent hematocrit reduction and to improve iron metabolism in pre-op iron-deficient patients. In patients without iron deficiency, hematocrit and iron metabolism remain normal one month after surgery without the need for iron supplementation (AU)

Laparoscopic cholecystectomy using a novel single-incision surgical platform through a standard 15 mm trocar: initial experience and technical details.

OBJECTIVE: Single-incision minimally invasive surgery has previously been associated with incisions 2.0-3.0 cm in length. We present a novel single-incision surgical platform compatible for insertion through a standard 15-mm trocar. The objective of this study is to evaluate the safety and feasibility of the platform. METHODS: The technology is currently a Phase I investigational device. It features articulating surgical instruments and is inserted through a multiple-use introducer. The platform's introducer requires a standard 15-mm laparoscopic trocar. Cholecystectomy is performed through a 15-mm umbilical incision utilizing an additional epigastric 2-mm needle-port grasper for gallbladder retraction. A prospective feasibility study was performed at a single-center. Inclusion criteria were age 18-75 years and biliary colic. Patients were excluded if they had acute cholecystitis, dilation of the biliary tree, severe coagulopathy, BMI > 40 kg/m(2), or choledocholithiasis. Endpoints included the success rate of the platform, hospital length of stay, post-operative pain medication usage, cosmetic results, and presence of hernia. RESULTS: Six patients (5 female) with an average age of 41 years and BMI 28 kg/m(2) underwent cholecystectomy with the platform. Average OR time was 91 min and umbilical incision length did not exceed 15 mm. One case was converted to standard laparoscopy due to mechanical failure of the clip applier instrument. There were no intraoperative complications. Post-operatively, two patients developed self-resolving umbilical ecchymoses. Average length of stay was 13 h. Pain control was achieved with diclofenac for less than 7 days. At 1 month follow-up there were no complications and no umbilical hernias. CONCLUSIONS: This phase I study demonstrates that single-incision cholecystectomy through a 15-mm trocar with the Fortimedix Surgical B.V. single-incision surgical platform is feasible, safe, and reproducible. Additional benefits include excellent triangulation and range of motion as well as exceptional cosmetic results. Further studies will be needed to evaluate long-term hernia rates.