Evaluating the Safety of the Intragastric Balloon: Spanish Multicenter Experience in 20,680 Cases and with 12 Different Balloon Models.

INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.

Bariatric endoscopy, care-curative medicine and legal conflicts. Spanish Bariatric Endoscopy Group (Gettemo-SEED) Positioning.

Bariatric endoscopy treats obesity as a disease, in addition to its multiple associated comorbidities, so it should be considered in the "care-curative" field and not as "satisfying, voluntary or outcoming" medicine. Insufficient weight loss cases, or complications may occur. This, in parallel with the greater diffusion of these techniques, results an increase in the risk of complaints and judicial claims, which will presumably grow during next years. In this sense, we consider that all Bariatric Endoscopic Units working with medical-scientific rigor, must be able to be accredited and have legal support by the Scientific Societies. We propose to create a Medical-Legal Advisory Committee, composed of a medical team and a specialized law firm, which allows advising and guiding the endoscopist when incurring in a conflict.

Spanish Intragastric Balloon Consensus Statement (SIBC): practical guidelines based on experience of over 20 000 cases.

BACKGROUND: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.

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.

Endoscopic sleeve gastroplasty, laparoscopic sleeve gastrectomy, and laparoscopic greater curve plication: do they differ at 2 years?

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an effective treatment option for obesity. However, data comparing its efficacy to bariatric surgery are scarce. We aimed to compare the effectiveness and safety of ESG with laparoscopic sleeve gastrectomy (LSG) and laparoscopic greater curve plication (LGCP) at 2 years. METHODS : We reviewed 353 patient records and identified 296 patients who underwent ESG (n = 199), LSG (n = 61), and LGCP (n = 36) at four centers in Spain between 2014 and 2016. We compared their total body weight loss (%TBWL) and safety over 2 years. A linear mixed model (LMM) was used to analyze repeated measures of weight loss outcomes at 6, 12, 18, and 24 months to compare the three procedures. RESULTS : Among the 296 patients, 210 (ESG 135, LSG 43, LGCP 32) completed 1 year of follow-up and 102 (ESG 46, LSG 34, LGCP 22) reached 2 years. Their mean (standard deviation [SD]) body mass index (BMI) was 39.6 (4.8) kg/m2. There were no differences in age, sex, or BMI between the groups. In LMM analysis, adjusting for age, sex, and initial BMI, we found ESG had a significantly lower TBWL, %TBWL, and BMI decline compared with LSG and LGCP at all time points (P = 0.001). The adjusted mean %TBWL at 2 years for ESG, LSG, and LGCP were 18.5 %, 28.3 %, and 26.9 %, respectively. However, ESG, when compared with LSG and LGCP, had a shorter inpatient stay (1 vs. 3 vs. 3 days; P < 0.001) and lower complication rate (0.5 % vs. 4.9 % vs. 8.3 %; P = 0.006). CONCLUSION : All three procedures induced significant weight loss in obese patients. Although the weight loss was lower with ESG compared with other techniques, it displayed a better safety profile and shorter hospital stay.

Main prophylactic measures in bariatric endoscopy. Spanish Expert Recommendations Guideline.

Bariatric endoscopy (BE) encompasses a number of techniques -some consolidated, some under development- aiming to contribute to the management of obese patients and their associated metabolic diseases as a complement to dietary and lifestyle changes. To date different intragastric balloon models, suture systems, aspiration methods, substance injections and both gastric and duodenal malabsorptive devices have been developed, as well as endoscopic procedures for the revision of bariatric surgery. Their ongoing evolution conditions a gradual increase in the quantity and quality of scientific evidence about their effectiveness and safety. Despite this, scientific evidence remains inadequate to establish strong grades of recommendation allowing a unified perspective on prophylaxis in BE. This dearth of data conditions leads, in daily practice, to frequently extrapolate the measures that are used in bariatric surgery (BS) and/or in general therapeutic endoscopy. In this respect, this special article is intended to reach a consensus on the most common prophylactic measures we should apply in BE. The methodological design of this document was developed while attempting to comply with the following 5 phases: Phase 1: delimitation and scope of objectives, according to the GRADE Clinical Guidelines. Phase 2: setup of the Clinical Guide-developing Group: national experts, members of the Grupo Español de Endoscopia Bariátrica (GETTEMO, SEED), SEPD, and SECO, selecting 2 authors for each section. Phase 3: clinical question form (PICO): patients, intervention, comparison, outcomes. Phase 4: literature assessment and synthesis. Search for evidence and elaboration of recommendations. Based on the Oxford Centre for Evidence-Based Medicine classification, most evidence in this article will correspond to level 5 (expert opinions without explicit critical appraisal) and grade of recommendation C (favorable yet inconclusive recommendation) or D (inconclusive or inconsistent studies). Phase 5: External review by experts. We hope that these basic preventive measures will be of interest for daily practice, and may help prevent medical and/or legal conflicts for the benefit of patients, physicians, and BE in general.

Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments.

During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available.

Spanish Consensus Document on Bariatric Endoscopy. Part 1. General considerations.

Obesity is a chronic multifactorial, incurable, recurrent, and progressive disease associated with significant physical and psychological complications, and considerable morbidity and mortality. For this reason, the assessment, management, and follow-up of obese patients should take place in the setting of a multidisciplinary unit equipped with adequate human and structural resources. Medical treatment using hygienic-dietary measures, while indispensable, may be insufficient, and surgery, which is reserved for severe or morbid obesity, is not exempt from complications neither is to the liking of many patients. In this context three situations may be considered where endoscopic treatment, used as a supplementary strategy with few complications, contributes to benefit obese patients: first, in a subgroup of patients with grade-II overweight or non-morbid obesity where medical therapy alone failed or needs supplementation. Second, in patients with morbid obesity when surgery is rejected, is contraindicated, or entails excessive risk. Finally, in patients with superobesity who need to lose weight before bariatric surgery in order to reduce surgery-related morbidity and mortality. In this regard, the Spanish Task Force on Bariatric Endoscopy (Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad, GETTEMO) have developed this Consensus Document to serve as practical guidance for all professionals involved in the endoscopic management of obesity, and to facilitate establishing a minimum set of requirements for the proper functioning of a bariatric endoscopy unit.

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.

A new swallowable intragastric balloon (Elipse®). Coffee for everybody? The position of GETTEMO.

Recently, the Elipse® swallow balloon with spontaneous evacuation has been incorporated. GETTEMO wants to position defending innovations in endoscopic treatment of bariatric patients, including this new gastric balloon. Any bariatric endoscopic procedure must always be done within a suitable protocol and in a Multidisciplinary Unit. In order to ensure maximum safety and to be able to effectively solve potential complications, in most of the cases a prior endoscopy should be required to rule out complications, the balloon must be implanted (or supervised) by a bariatric endoscopist and it is necessary to have an Endoscopic Emergency Department.

GETTEMO position statement on bariatric endoscopic techniques as a voluntary medicine.

Dear Editor, We would like to clarify certain points in the article by C. Dolz et al. entitled "Informed consent in digestive endoscopy - Patient information, endoscopist protection", more specifically regarding the section "Obesity treatments". First, we want to congratulate the authors for their highly relevant yearlong research of the medico-legal aspects of Spanish endoscopy and for sharing their knowledge with endoscopists on a national level. With regard to the endoscopic management of obesity, we consider that the informed consent process should be even more comprehensive than that with other endoscopic techniques. As the author highlighted, there is less experience in some of these techniques.

Multicenter study on the safety of bariatric endoscopy.

INTRODUCTION: Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy. METHODS: A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise. RESULTS: In all, 6,771 bariatric endoscopic procedures were collected, wherein 57 serious complications (0.84%) were identified. Balloons: Orbera®-Medsil®, 5/5,589; Spatz2® (older model): 44/225; Heliosphere®: 1/70; Obalon®: 0/107. Sutures: POSE®, 5/679; sleeve gastroplasty with Apollo® system: 0/55. Prostheses: Endobarrier®: 2/46. All complications were resolved with medical/endoscopic management except for five cases (0.07%) that required surgery. A single lawsuit occurred (esophageal perforation with Spatz2® balloon), which had a favorable outcome. There was no mortality, and apparently no differences were found according to endoscopist expertise level. CONCLUSIONS: In our multicenter experience, bariatric endoscopy may be considered as a safe procedure (0.84% of serious complications in all). However, some devices may induce a higher proportion of complications, such as 19.55% for Spatz2® balloons (already replaced) or 4.34% for Endobarrier® sleeves (at the upper limit of accepted safety), although our experience with the latter is limited. All complications were resolved with conservative medical management, and only exceptionally required surgery (0.07%). No technique-related mortality was seen, and only one lawsuit occurred. Further evolutionary studies are required on the novel endoscopic techniques presently emerging to authenticate our results.

Current endoscopic techniques in the treatment of obesity.

BACKGROUND: in recent years new endoscopic strategies and techniques for the treatment of obesity have emerged and developed. AIM OF THE STUDY: in this article we will review and analyze the current state of the following techniques and the basic differential characteristics between each of them: balloons and prosthesis, injection of substances, systems of sutures, malabsorptives techniques and others currently in research. METHODS: we will evaluate the endoscopic technique and their main indications, results, tolerances, complications and adverse effects observed, reporting our personal experience and in relation with an extensive literature review. RESULTS: comparatively with the most widespread technique of the Bioenterics balloon, the Spatz balloon can provide greater weight loss but with worse tolerance and more complications and the Heliosphere Bag gets a similar weight loss but with greater technical difficulty. Other balloons and prosthesis (Ullorex, Semistationary, Silimed, Endogast) still require technical improvements and higher studies. The injection of botulinum toxin, although secure, seems to offer a smaller and more transient efficacy. Suture systems (TOGa, endoluminal vertical gastroplasty and POSE) appear to be effective but are technically more laborious. Malabsorptives procedures (Endobarrier, ValenTX) are somewhat laborious but effective, particularly indicated in obese patients with type 2 diabetes mellitus. CONCLUSIONS: the development of new endoscopic techniques and improvement in existing designs, suggest an increasingly important role of the endoscopist in the treatment of obesity. We consider it important to individually select and use the endoscopic technique, depending on the desirable outcomes (efficacy, tolerance, safety, adverse effects and risks) and the experience of each hospital. We believe that these techniques should be applied by specifically trained endoscopists in specialized hospitals.