Magnetic device in reduced port and single port bariatric surgery: First 170 cases experience / Dispositivo magnético en cirugía bariátrica por puerto reducidos y puerto único: Primera experiencia de 170 casos

Introduction: Magnetic devices have been successfully used in bariatric surgery. To the date, the only reported use of the magnet was for liver retraction. Our purpose in this study is to demonstrate the safety and viability of using a magnetic system in different steps in single port and reduced port bariatric surgery.MethodsProspective and observational study was performed. Patients older than 18 years, undergoing primary laparoscopic sleeve gastrectomy (SG), one-anastomosis gastric bypass (OAGB), and Roux-en-Y gastric bypass (RYGB) or revisional surgery by single-port or reduced-port approach between July 2020 and June 2021 were included.ResultsA total of 170 patients (mean BMI, 41.47kg/m2; mean age 36.92 yrs) completed laparoscopic bariatric surgery (54 single-port sleeve gastrectomy [SPSG], 16 reduced-port SG, 83 RYGB, 4 OAGB and 14 revision surgeries), using the magnetic surgical system in different steps of the surgery. Mean surgical time for SPSG and reduced-port SG was 65.52min and 59.36min respectively; and for RYGB 74.19min, OAGB 70.98min, and revisional surgeries 88.38min. As for intraoperative complications, 2.94% mild liver laceration without significant bleeding was reported. There were no 30-day mortalities and no major complications.ConclusionMagnetic assistance in single-port and reduced-port bariatric surgery is an innovative technique. With this prospective study we attempt to demonstrate the safety profile and potential uses that may improve the implementation of new surgical approaches in bariatric surgery (AU)

Introducción: Los dispositivos magnéticos se han usado satisfactoriamente en cirugía bariátrica. Hasta la fecha, el único uso reportado de los imanes ha sido para la retracción hepática. Nuestro propósito con este estudio es demostrar la seguridad y viabilidad de usar dispositivos magnéticos en diferentes pasos de la cirugía bariátrica por puerto único y por puerto reducido.MétodosSe realizó un estudio prospectivo y observacional. Se incluyeron pacientes mayores de 18 años que fueron sometidos a cirugía laparoscópica primaria de manga gástrica (MG), bypass gástrico de una sola anastomosis (BAGUA), bypass gástrico en Y de Roux (BGYR) y cirugía de revisión por abordaje de puerto único o puerto reducido entre los meses de julio de 2020 y junio de 2021.ResultadosA un total de 170 pacientes (media IMC, 41,47 kg/m2; media edad 36,92 años) se les realizó una cirugía bariátrica laparoscópica (54 MG por puerto único, 16 MG por puerto reducido, 4 BAGUA y 14 cirugías de revisión) utilizando el dispositivo magnético en diferentes pasos del proceso quirúrgico. El tiempo promedio de la MG por puerto único y MG por puerto reducido fueron 65,52 min y 59,36 min, respectivamente; mientras que para BGYR 74,19 min, BAGUA 70,98 min y cirugías de revisión 88,38 min. Entre las complicaciones intraoperatorias se reportaron 2,94% de laceraciones hepáticas leves sin sangrado significante. No hubo ningún porcentaje de mortalidad ni de complicaciones mayores a los 30 días.ConclusionesLa asistencia magnética en cirugía bariátrica por puerto único y por puerto reducido es una técnica innovadora. Con este estudio prospectivo intentamos demostrar el perfil de seguridad y los usos potenciales que pueden mejorar la implementación de nuevos abordajes quirúrgicos en cirugía bariátrica (AU)

Promising effects of 33 to 36 Fr. bougie calibration for laparoscopic sleeve gastrectomy: a systematic review and network meta-analysis.

The standard size of bougie for laparoscopic sleeve gastrectomy (LSG) is not yet established. Therefore, a systematic review and network meta-analysis were conducted to assess the weight loss effects and associated complications of LSG for patients with morbid obesity, based on different bougie sizes. A total of 15 studies were reviewed in this systemic review and network meta-analysis (2,848 participants), including RCTs and retrospective studies in PubMed, and Embase until September 1, 2020. The effectiveness of different bougie calibration sizes was assessed based on excess weight loss (EWL), total complications, and staple line leak. Within this network meta-analysis, S-sized (≤ 32 Fr.) and M-sized (33-36 Fr.) bougies had similar effects and were associated with the highest EWL improvement among all different bougie sizes (S-sized: standardized mean difference [SMD], 10.52; 95% confidence interval [CI] - 5.59 to - 26.63, surface under the cumulative ranking curve [SUCRA], 0.78; and M-sized: SMD, 10.16; 95% CI - 3.04-23.37; SUCRA, 0.75). M-sized bougie was associated with the lowest incidence of total complications (M-sized: odds ratio, 0.43; 95% CI, 0.16-1.11; SUCRA, 0.92). Based on our network meta-analysis, using M-sized bougie (33-36 Fr.) is an optimal choice to balance the effectiveness and perioperative safety of LSG in the clinical practice.

Port-sharing techniques for laparoscopic cholecystectomy and sleeve gastrectomy.

In Japan, the number of bariatric surgeries performed has remained low. Thus, concomitant laparoscopic cholecystectomy (LC) with laparoscopic sleeve gastrectomy (LSG) is still relatively uncommon, but is increasing. We developed new port-sharing techniques for LC and LSG, which we performed on 26 obese Japanese patients with gall bladder (GB) diseases, using the LSG trocar arrangement and one additional trocar. We performed LC first, and after exchanging a port for a liver retractor in the epigastrium, we then completed LSG. One patient with an anomalous extrahepatic bile duct required one additional port. The mean LC time was 55 min, and the transition to LSG just after LC was smooth in all the patients. One patient suffered postoperative intraperitoneal hemorrhage, which was managed conservatively. Concomitant LC with LSG using port-sharing techniques is feasible and safe for obese Japanese patients with GB diseases.

EndoBarrier™ Implantation Rapidly Improves Insulin Sensitivity in Obese Individuals with Type 2 Diabetes Mellitus.

The EndoBarrier™ medical device is a duodenal-jejunal bypass liner designed to mimic the effects of gastric bypass surgery to induce weight loss and glycaemic improvement. In this study, 10 participants with type 2 diabetes mellitus (T2DM), a mean body mass index (BMI) of 43.3 ± 5.0 (kg/m2) and a mean glycated haemoglobin A1c (HbA1c) of 60.6 ± 8.6 mmol/mol were examined at baseline (before implantation of EndoBarrier™), 4 weeks after implantation, at 36 weeks (right before explantation) and 24 weeks after the removal of the device to explore the short and long-term effects on glucose metabolism. Besides a significant reduction in body weight and fat mass, EndoBarrier™ treatment significantly improved insulin sensitivity during Botnia clamp investigations after four weeks of implantation. The beneficial effects decreased over time but remained significant 24 weeks after removal of the device.

Magnetic Liver Retraction Decreases Postoperative Pain and Length of Stay in Bariatric Surgery Compared to Nathanson Device.

Objective: Retrospective case-matched comparison of magnetic liver retraction to a bedrail-mounted liver retractor in bariatric surgery specifically targeting short-term postoperative outcomes, including pain and resource utilization. Background: Retraction of the liver is essential to ensure appropriate visualization of the hiatus in bariatric surgery. Externally mounted retractors require a dedicated port or an additional incision. Magnetic devices provide effective liver retraction without the need of an incision. Methods: The sample consisted of primary and revisional bariatric surgery patients, including Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and biliopancreatic diversion with duodenal switch (BPD-DS) operations. Propensity score analysis was used to match patients with magnetic retraction to patients with a bedrail-mounted retractor with a 1:2 ratio using preoperative characteristics. Baseline characteristics and postprocedure outcomes were compared using two-sample t-tests or Wilcoxon rank sum tests and chi-square or Fisher's exact test as appropriate. Results: One hundred patients met inclusion criteria for the use of magnetic liver retraction (45 RYGB, 35 SG, 20 BPD-DS) with 196 suitable matched external retractor patients identified. Patients were matched and comparable for all preoperative characteristics except for transversus abdominus plane block (27% versus 47%). Patients in the magnet cohort had significantly decreased mean 12-hour postoperative pain scores (2.9 versus 4.2, P = .004) and decreased hospital length of stay (LOS) (1.5 versus 1.9 days, P = .005) while operating room supply were higher in the magnet cohort ($4600 versus $4213, P = .0001). Conclusions: Magnetic liver retraction in bariatric surgery is associated with decreased postoperative pain scores, decreased hospital LOS, and increased operating supply costs.

A Preclinical Animal Study of Combined Intragastric Balloon and Duodenal-Jejunal Bypass Liner for Obesity and Metabolic Disease.

INTRODUCTION: Endoscopic bariatric and metabolic therapies can potentially reproduce similar gastric and small intestinal anatomic and physiologic manipulations as Roux-en-Y gastric bypass. This proof of concept animal study was aimed to assess the feasibility, safety, efficacy, and impact on gastrointestinal physiology of combined intragastric balloons (IGB) and duodenal-jejunal bypass liner (DJBL) for the treatment of obesity. METHODS: Five Ossabaw pigs were fed a high-calorie diet to develop obesity and were randomly assigned to receive IGB or DJBL in sequence. The weight gain rate was calculated. Fasting and postprandial blood samples were drawn before any intervention (serving as the baseline group) and 1 month after second device insertion (serving as the combination group) to measure gut neurohormonal changes and metabolic parameters. RESULTS: Four pigs successfully received a sequential device insertion. One pig developed duodenal sleeve prolapse that was spontaneously resolved. One pig was early terminated because of developing a central line infection. The rate of weight gain in the combination group (0.63 ± 1.3 kg/wk) was significantly lower than the baseline group (1.96 ± 2.17 kg/wk) and numerically lower than after insertion of the IGB (1.00 ± 1.40 kg/wk) or the DJBL (0.75 ± 2.27 kg/wk) alone. A trend of higher postprandial glucagon-like peptide-1 was observed in the combination group compared with the baseline group. DISCUSSION: A combination of IGB and DJBL is feasible and well tolerated. A strategy of sequential use of these devices might offer a synergistic approach that can enhance weight loss and metabolic outcomes.

Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).

OBJECTIVE: The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS). SUMMARY BACKGROUND DATA: DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study. METHODS: We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed. RESULTS: A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%. CONCLUSIONS: The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.

Computational Tools for the Reliability Assessment and the Engineering Design of Procedures and Devices in Bariatric Surgery.

Obesity is one of the main health concerns worldwide. Bariatric Surgery (BS) is the gold standard treatment for severe obesity. Nevertheless, unsatisfactory weight loss and complications can occur. The efficacy of BS is mainly defined on experiential bases; therefore, a more rational approach is required. The here reported activities aim to show the strength of experimental and computational biomechanics in evaluating stomach functionality depending on bariatric procedure. The experimental activities consisted in insufflation tests on samples of swine stomach to assess the pressure-volume behaviour both in pre- and post-surgical configurations. The investigation pertained to two main bariatric procedures: adjustable gastric banding (AGB) and laparoscopic sleeve gastrectomy (LSG). Subsequently, a computational model of the stomach was exploited to validate and to integrate results from experimental activities, as well as to broad the investigation to a wider scenario of surgical procedures and techniques. Furthermore, the computational approach allowed analysing stress and strain fields within stomach tissues because of food ingestion. Such fields elicit mechanical stimulation of gastric receptors, contributing to release satiety signals. Pressure-volume curves assessed stomach capacity and stiffness according to the surgical procedure. Both AGB and LSG proved to reduce stomach capacity and to increase stiffness, with markedly greater effect for LSG. At an internal pressure of 5 kPa, outcomes showed that in pre-surgical configuration the inflated volume was about 1000 mL, after AGB the inflated volume was slightly lower, while after LSG it fell significantly, reaching 100 mL. Computational modelling techniques showed the influence of bariatric intervention on mechanical stimulation of gastric receptors due to food ingestion. AGB markedly enhanced the mechanical stimulation within the fundus region, while LSG significantly reduced stress and strain intensities. Further computational investigations revealed the potentialities of hybrid endoscopic procedures to induce both reduction of stomach capacity and enhancement of gastric receptors mechanical stimulation. In conclusion, biomechanics proved to be useful for the investigation of BS effects. Future exploitations of the biomechanical methods may largely improve BS reliability, efficacy and penetration rate.

Endoscopic Treatments for Obesity: The Good, the Bad, and the Ugly.

In the current setting of an obesity pandemic, there is an urgent need for minimally invasive, safe, and effective interventions for weight loss. Endoscopic bariatric procedures have been developed as an alternative to more traditional medical and surgical therapies. Multiple options are undergoing evaluation or are already available for clinical use. This review aims to describe these treatments, including their mechanisms of action, efficacy, safety and the knowledge gaps regarding their use.

Novel and emerging devices and operations in the treatment of obesity in children and adolescents.

Obesity is among the most common and costly chronic disorders worldwide. Estimates suggest that in the United States obesity affects one-third of adults, accounts for up to one-third of total mortality, is concentrated among lower income groups, and increasingly affects children as well as adults. A lack of effective options for long-term weight reduction magnifies the enormity of this problem; individuals who successfully complete behavioral and dietary weight-loss programs eventually regain most of the lost weight. We included evidence from basic science, clinical, and epidemiological literature to assess current knowledge regarding mechanisms underlying excess body-fat accumulation, the biological defense of excess fat mass, and the tendency for lost weight to be regained. A major area of emphasis is the science of energy homeostasis, the biological process that maintains weight stability by actively matching energy intake to energy expenditure over time. Growing evidence suggests that obesity is a disorder of the energy homeostasis system, rather than simply arising from the passive accumulation of excess weight. We need to elucidate the mechanisms underlying this "upward setting" or "resetting" of the defended level of body-fat mass, whether inherited or acquired. The ongoing study of how genetic, developmental, and environmental forces affect the energy homeostasis system will help us better understand these mechanisms and are therefore a major focus of this statement. The scientific goal is to elucidate obesity pathogenesis so as to better inform treatment, public policy, advocacy, and awareness of obesity in ways that ultimately diminish its public health and economic consequences.

Technical review: Vertical sleeve gastrectomy in adolescents.

Sleeve gastrectomy is an effective tool for inducing sustainable weight loss in adolescents with obesity. It is a seemingly straight-forward procedure, and yet deceptive in technical nuances. This review highlights the technical preparation (equipment, patient positioning, pre-operative management), and conduct (anatomy, instruments, methodology, pitfalls) of the operation, and concludes with essentials for anticipating and managing complications of the operation. Throughout the discussion, we emphasize practical techniques to maintain patient safety while achieving maximum weight loss benefits.

Current and Future Endoscopic Weight Loss Solutions.

Obesity poses a significant health care concern in the United States, with 39.8% of adults being classified as obese. Several different methods have been introduced to combat obesity, from medical therapy to surgical options. Bariatric surgery has been demonstrated to be superior to medical therapy alone for weight loss in obese patients. Despite this information, only about 1% of eligible patients undergo bariatric surgery per year. The reason for this treatment gap is multifactorial, but patient apprehension to undergo surgery is a major driving force. Many patients perceive bariatric surgery as dangerous, and believe that living with their current weight is safer than undergoing surgery. To combat this treatment gap, endoscopic therapies have been developed to reach more patients in a less invasive way. This article will review endoscopic treatment options currently available and approved by the Food and Drug Administration, as well as other treatment modalities that are currently in development.

Food and Drug Administration's Perspective on Medical Devices Intended for Weight Loss: A Guide for the Interventional Radiologist.

Medical devices can help patients lose weight. The Food and Drug Administration (FDA) Center for Devices and Radiological Health is responsible for assuring the safety and effectiveness of devices used for weight loss. Interventional radiologists may conduct clinical studies of devices for weight loss, such as embolization beads to stop blood flow to gastric arteries or cryoablation systems to ablate metabolism-linked nerves. The purposes of this paper are (1) to clarify the FDA's role providing regulatory oversight of clinical studies of medical devices; (2) to explain how to engage with the FDA; and (3) to provide information on the design of clinical studies intended to support a weight loss indication. In particular, Investigational Device Exemptions (IDEs) are needed for significant risk studies for new devices, or for off-label use of legally marketed devices. The FDA is available through the Pre-Submission process to assist when determining if a study requires an IDE, and to discuss plans for submitting an IDE. The FDA works with medical device manufacturers and clinical researchers who want to bring novel weight-loss devices to market.

Aspiration Therapy.

Aspiration therapy is a novel, endoscopic bariatric therapy that allows patients to remove a portion of an ingested meal through a modified percutaneous gastrostomy tube, called an A-Tube. Weight loss results from both fewer calories consumed, and from modifications in lifestyle and mealtime behaviors that patients make as a result of having the device installed. The first commercially available device for aspiration therapy, the AspireAssist (Aspire Bariatrics, King of Prussia, PA), was approved by the Food and Drug Administration in 2016 for weight loss for greater than 6 months duration in patients with a body mass index of 35-55. Multiple studies have demonstrated the effectiveness and safety of aspiration therapy, with low rates of adverse events related to the procedure, including no reported deaths, as well as no evidence of eating disorders developed during therapy. This chapter will describe our experience with aspiration therapy. We will describe how we select appropriate candidates for aspiration therapy, how we perform the procedure including a summary of the equipment used, and how we mitigate and manage complications of the procedure. This article will highlight the effectiveness of aspiration therapy as a novel and safe approach for weight loss in patients in obesity.

Novel Trocar-Free Elastic Liver Retractor in Bariatric Surgery Patients: Comparison of a Standard Laparoscopic Retraction With the First Series Using the LiVac Sling System.

During upper gastrointestinal surgery, retraction of the liver plays an essential role in the visualization and creation of an optimal surgical field. Liver retraction may be problematic, particularly in obese patients. The use of conventional liver retractors requires additional skin incision and has the potential to cause pain as well as liver injuries. The present study is the first to evaluate the performance and safety of the LiVac Sling (Livac Pty Ltd, Melbourne, Australia) trocar-free retractor system in bariatric surgery patients. In this retrospective study, data from laparoscopic primary or revisional bariatric surgeries that were performed with the LiVac Sling system and a standard retractor between May 2017 and December 2017 were collected. Demographic data, body mass index, type of surgery, number and indication of LiVac Sling system used, surgery time, and complications were analyzed. In total, 51 procedures were included. Twenty Sling devices have been used in 17 patients (13 female; 75%). The distribution of baseline characteristics was similar between the standard retractor group and LiVac Sling retractor group. In the LiVac Sling group, the number of trocars used was significantly reduced over the study period. Within 30 days postoperatively, no complications could be identified, and no device-related adverse events were reported. In this bariatric population, the use of the LiVac Sling for liver retraction was safe. No device-related adverse events were registered, and compared with standard retraction, the number of trocars used could be reduced by one.

Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 months of duodenal-jejunal bypass liner implantation.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device designed to induce weight loss and improve glycemic control. The liner is licensed for a maximum implant duration of 12 months. It might be hypothesized that extension of the dwelling time results in added value. The goals of our study were to determine weight change, change in glycemic control, and safety in patients with an intended 24 months of DJBL dwelling time. METHODS: Patients were initially selected for a 12-month implantation period. When no physical complaints or adverse events (AEs) occurred, motivated patients who responded well were selected for extension of dwelling time to 24 months. Patients underwent a control endoscopy 12 months after implantation and visited the out-patient clinic every 3 months up to explantation. Patients agreed to remove the DJBL when complaints or AEs occurred that could not be treated conservatively. RESULTS: Implantation was extended in 44 patients, and 24 (55%) patients completed the full 24 months. Twenty patients required early removal due to AEs. During dwelling time, body weight decreased significantly (15.9 kg; TBWL 14.6%). HbA1c decreased non-significantly (4.9 mmol/mol). The number of insulin users and daily dose of insulin both decreased significantly. At 24 months after removal, glycemic control had worsened, while body weight was still significantly lower compared to baseline. In total, 68% of the patients experienced at least one AE. Two patients developed a hepatic abscess. CONCLUSIONS: DJBL treatment results in significant weight loss and improves glycemic control during implantation. The largest beneficial effects occur during the first 9-12 months after implantation. Extension of dwelling time to 24 months results only in stabilization of body weight and glycemic control. After explantation, weight improvements are maintained, but glycemic control worsens. As the cumulative risk of AEs increases with time, a maximal dwelling time of 12 months is advisable.

The Use of the Overstitch for Bariatric Weight Loss.

Obesity is a public health pandemic and leading contributor to morbidity and mortality. Endoscopic bariatric therapies have emerged as a viable minimally invasive treatment option to fill the therapeutic gap between conservative and surgical approaches. The ability to reliably place full-thickness sutures throughout the gastrointestinal tract has opened the door to novel endoscopic gastric restrictive procedures. A growing body of literature supports endoscopic sleeve gastroplasty as a safe, effective, and reproducible endoscopic treatment of obesity and metabolic syndrome. In addition, endoscopic sutured revision procedures following gastric bypass and sleeve gastrectomy are now first-line with demonstrable safety and long-term efficacy.

The effect of bougie size and distance from the pylorus on dehydration after laparoscopic sleeve gastrectomy: an analysis of the ACS-MBSAQIP database.

BACKGROUND: Dehydration is the most common cause of readmission after laparoscopic sleeve gastrectomy (SG). Bougie size and distance from the pylorus, both of which have been associated with rates of dehydration postoperatively, varies by surgeon and across institutions. OBJECTIVES: To determine if there is an association between bougie size or distance from the pylorus on the rate of dehydration after laparoscopic SG. SETTING: American College of Surgeons Metabolic and Bariatric Surgery Accreditation Quality Improvement Program database. METHODS: All patients undergoing first-time, elective laparoscopic SG from 2015-2016 were identified. The association of bougie size and distance from the pylorus on the rate of dehydration within the first 30 days postoperatively was investigated. RESULTS: The inclusion criteria were met by 170,751 patients. The most commonly used bougie size was 36 Fr and the most common distance from the pylorus at which the gastric sleeve was started was 5 cm. Patients were divided into 4 groups based on bougie size and distance from the pylorus (Group 1: bougie size <36 Fr, pylorus distance <4 cm; Group 2: bougie size ≥36 Fr, pylorus distance <4 cm; Group 3: bougie size ≥36 Fr, pylorus distance ≥4 cm; and Group 4: bougie size <36 Fr, pylorus distance ≥4 cm). Patients in Group 4 were significantly less likely than any other group to experience dehydration-related complications. CONCLUSION: Both distance from the pylorus and bougie size are significantly associated with dehydration-related complications after SG. Consideration should be made for standardizing these technical aspects of SG to help reduce the rate of postoperative dehydration and hospital readmission.