Chromosome analysis of 303 pregnancy losses in Mexico.

BACKGROUND: Chromosomal abnormalities are present in 50 to 60% of miscarriages and in 6 to 19% of stillbirths. Although microarrays are preferred for studying chromosomal abnormalities, many hospitals cannot offer this methodology. OBJECTIVE: To present the results of the cytogenetic analysis of 303 products of conception (POC), which included 184 miscarriages, 49 stillbirths and 17 cases of undefined age. MATERIAL AND METHODS: Karyotyping, fluorescence in situ hybridization, short tandem repeats and microarrays were used, depending on the type of loss and available sample. RESULTS: In 29 POCs we found maternal tissue and were eliminated from the analyses. Informative results were obtained in 250 (91.2 %)/274 cases; the karyotyping success rate was 80.7%; that of single nucleotide polymorphism microarrays, 94.5%; and that of fluorescence in situ hybridization and short tandem repeat, 100%. Cytogenetic abnormalities were observed in 57.6% of miscarriages and in 24.5% of stillbirths; 94% of total anomalies were numerical and 6% were submicroscopic. CONCLUSIONS: Karyotyping with simultaneous short tandem repeat study to rule out contamination of maternal cells is effective for studying miscarriages; in stillbirths, microarrays are recommended.

ANTECEDENTES: Las alteraciones cromosómicas están presentes en 50 a 60 % de los abortos espontáneos y en 6 a 19 % de los mortinatos. Aunque se prefieren los microarreglos para estudiarlos, numerosos hospitales no pueden ofrecerlos. OBJETIVO: Presentar los resultados del estudio citogenético de 303 productos de la concepción (POC), 184 se obtuvieron de abortos espontáneos, 49 fueron mortinatos y en 17 no se identificó la de edad gestacional. MATERIAL Y MÉTODOS: Se empleó cariotipo, hibridación in situ con fluorescencia, secuencias cortas repetidas en tándem y microarreglos, según el tipo de pérdida y la muestra disponible. RESULTADOS: En 29 POC se encontró tejido materno, por lo que fueron eliminados de los análisis. En 250 (91.2 %)/274 casos se obtuvieron resultados informativos; la tasa de éxito del cariotipo fue de 80.7 %; la de los microarreglos de SNP, de 94.5 %; y la de la hibridación fluorescente in situ y la repetición corta en tándem, de 100 %. Se observaron anomalías citogenéticas en 57.6 % de los abortos espontáneos y en 24.5 % de los mortinatos; 94 % de las anomalías fueron numéricas y 6 %, submicroscópicas. CONCLUSIONES: El cariotipo en conjunto con el estudio de secuencias cortas repetidas en tándem para descartar contaminación de células maternas es efectivo para estudiar abortos espontáneos; los microarreglos se recomiendan en los mortinatos.

Potential Role of Protein Kinase FAM20C on the Brain in Raine Syndrome, an In Silico Analysis.

FAM20C (family with sequence similarity 20, member C) is a serine/threonine-specific protein kinase that is ubiquitously expressed and mainly associated with biomineralization and phosphatemia regulation. It is mostly known due to pathogenic variants causing its deficiency, which results in Raine syndrome (RNS), a sclerosing bone dysplasia with hypophosphatemia. The phenotype is recognized by the skeletal features, which are related to hypophosphorylation of different FAM20C bone-target proteins. However, FAM20C has many targets, including brain proteins and the cerebrospinal fluid phosphoproteome. Individuals with RNS can have developmental delay, intellectual disability, seizures, and structural brain defects, but little is known about FAM20C brain-target-protein dysregulation or about a potential pathogenesis associated with neurologic features. In order to identify the potential FAM20C actions on the brain, an in silico analysis was conducted. Structural and functional defects reported in RNS were described; FAM20C targets and interactors were identified, including their brain expression. Gene ontology of molecular processes, function, and components was completed for these targets, as well as for potential involved signaling pathways and diseases. The BioGRID and Human Protein Atlas databases, the Gorilla tool, and the PANTHER and DisGeNET databases were used. Results show that genes with high expression in the brain are involved in cholesterol and lipoprotein processes, plus axo-dendritic transport and the neuron part. These results could highlight some proteins involved in the neurologic pathogenesis of RNS.

(-)-Epicatechin Inhibits Metastatic-Associated Proliferation, Migration, and Invasion of Murine Breast Cancer Cells In Vitro.

Breast cancer, due to its high incidence and mortality, is a public health problem worldwide. Current chemotherapy uses non-specific cytotoxic drugs, which inhibit tumor growth but cause significant adverse effects. (-)-Epicatechin (EC) is part of a large family of biomolecules called flavonoids. It is widely distributed in the plant kingdom; it can be found in green tea, grapes, and cocoa. Several studies in animals and humans have shown that EC induces beneficial effects in the skeletal muscle and the cardiovascular system, reducing risk factors such as arterial hypertension, endothelial dysfunction, damage to skeletal muscle structure, and mitochondrial malfunction by promoting mitochondrial biogenesis, with no adverse effects reported. Recently, we reported that EC had an antitumor effect in a murine triple-negative mammary gland tumor model, decreasing tumoral size and volume and increasing survival by 44%. This work aimed to characterize the effects of flavanol EC on proliferation, migration, and metastasis markers of triple-negative murine breast (4T1) cancer cells in culture. We found proliferation diminished and Bax/Bcl2 ratio increased. When the migration of culture cells was evaluated, we observed a significant reduction in migration. Also, the relative expression of the genes associated with metastasis, Cdh1, Mtss1, Pten, Bmrs, Fat1, and Smad4, was increased. In conclusion, these results contribute to understanding molecular mechanisms activated by EC that can inhibit metastatic-associated proliferation, migration, and invasion of murine breast cancer cells.

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.

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.

Testosterone activates glucose metabolism through AMPK and androgen signaling in cardiomyocyte hypertrophy.

BACKGROUND: Testosterone regulates nutrient and energy balance to maintain protein synthesis and metabolism in cardiomyocytes, but supraphysiological concentrations induce cardiac hypertrophy. Previously, we determined that testosterone increased glucose uptake-via AMP-activated protein kinase (AMPK)-after acute treatment in cardiomyocytes. However, whether elevated glucose uptake is involved in long-term changes of glucose metabolism or is required during cardiomyocyte growth remained unknown. In this study, we hypothesized that glucose uptake and glycolysis increase in testosterone-treated cardiomyocytes through AMPK and androgen receptor (AR). METHODS: Cultured cardiomyocytes were stimulated with 100 nM testosterone for 24 h, and hypertrophy was verified by increased cell size and mRNA levels of ß-myosin heavy chain (ß-mhc). Glucose uptake was assessed by 2-NBDG. Glycolysis and glycolytic capacity were determined by measuring extracellular acidification rate (ECAR). RESULTS: Testosterone induced cardiomyocyte hypertrophy that was accompanied by increased glucose uptake, glycolysis enhancement and upregulated mRNA expression of hexokinase 2. In addition, testosterone increased AMPK phosphorylation (Thr172), while inhibition of both AMPK and AR blocked glycolysis and cardiomyocyte hypertrophy induced by testosterone. Moreover, testosterone supplementation in adult male rats by 5 weeks induced cardiac hypertrophy and upregulated ß-mhc, Hk2 and Pfk2 mRNA levels. CONCLUSION: These results indicate that testosterone stimulates glucose metabolism by activation of AMPK and AR signaling which are critical to induce cardiomyocyte hypertrophy.

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.

Clinical and genetic description of patients with prenatally identified cardiac tumors.

OBJECTIVE: Rhabdomyomas are the most common type of prenatal cardiac tumors. When isolated, 50% to 70% are related to the tuberous sclerosis complex (TSC). The aim of this study was to reinforce the importance of additional clinical data in patients with prenatal heart tumors. METHODS: From 2010 to 2017, 10 prenatally detected cardiac tumors were referred to the Genetics Department, and a complete family history was taken. Postnatal echocardiographic and full clinical evaluation were completed. Next generation sequencing (NGS) of the TSC1 and TSC2 genes was performed. RESULTS: The 10 cases were postnatally confirmed as rhabdomyomas. Four de novo and four family cases were detected, and only one patient was previously aware of the TSC diagnosis. Molecular analysis by NGS was performed in four patients with three TSC2 mutations, two of which were previously reported and one not. DISCUSSION: Prenatal cardiac tumors are associated with TSC in 60% of cases. Prenatal diagnosis of cardiac tumors permits a further analysis of family members using the fetus as a clue for familial disease diagnosis.

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.

GDF11 Modulates Ca2+-Dependent Smad2/3 Signaling to Prevent Cardiomyocyte Hypertrophy.

Growth differentiation factor 11 (GDF11), a member of the transforming growth factor-ß family, has been shown to act as a negative regulator in cardiac hypertrophy. Ca2+ signaling modulates cardiomyocyte growth; however, the role of Ca2+-dependent mechanisms in mediating the effects of GDF11 remains elusive. Here, we found that GDF11 induced intracellular Ca2+ increases in neonatal rat cardiomyocytes and that this response was blocked by chelating the intracellular Ca2+ with BAPTA-AM or by pretreatment with inhibitors of the inositol 1,4,5-trisphosphate (IP3) pathway. Moreover, GDF11 increased the phosphorylation levels and luciferase activity of Smad2/3 in a concentration-dependent manner, and the inhibition of IP3-dependent Ca2+ release abolished GDF11-induced Smad2/3 activity. To assess whether GDF11 exerted antihypertrophic effects by modulating Ca2+ signaling, cardiomyocytes were exposed to hypertrophic agents (100 nM testosterone or 50 µM phenylephrine) for 24 h. Both treatments increased cardiomyocyte size and [³H]-leucine incorporation, and these responses were significantly blunted by pretreatment with GDF11 over 24 h. Moreover, downregulation of Smad2 and Smad3 with siRNA was accompanied by inhibition of the antihypertrophic effects of GDF11. These results suggest that GDF11 modulates Ca2+ signaling and the Smad2/3 pathway to prevent cardiomyocyte hypertrophy.

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.

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.

Non-invasive Positive Airway Pressure in Obesity Hypoventilation Syndrome and Chronic Obstructive Pulmonary Disease: Present and Future Perspectives.

Obesity hypoventilation syndrome (OHS) is a sleep disorder that has acquired great importance worldwide because of its prevalence and association with obesity leading to increased morbidity and mortality with reduced quality of life. The primary feature is insufficient sleep-related ventilation, resulting in abnormally elevated arterial carbon dioxide pressure (PaCO2) during sleep and demonstration of daytime hypoventilation. There are three main mechanisms that can generate diurnal hypoventilation in obese patients: alteration of the respiratory mechanics secondary to obesity; central hypoventilation secondary to leptin resistance and sleep disorder with sleep hypoventilation and obstructive apnoeas, which can be potentially solved with the use of positive airway pressure: non-invasive ventilation (NIV) and continuous positive airway pressure (CPAP). There are no established guidelines for the treatment of OHS, and only a few randomised controlled trials have been published. In this review, we have gone over the role of positive airway pressure, in particular the mechanisms that produce improvement, ventilatory modes available, clinical applications, technical considerations and future research. In addition, we added a review on NIV efficacy in chronic obstructive pulmonary disease (COPD), both in acute respiratory failure due to exacerbation and mainly in stable setting where more controversy and scientific contributions are coming.

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.

The high frequency of genetic diseases in hypotonic infants referred by neuropediatrics.

Neonatal hypotonia is a relatively common cause of consultation in daily pediatric practice. It is part of the clinical presentation of a large group of heterogeneous diseases, many of which have an important and classifiable genetic background. Identification of the specific disorder can help optimize the management and treatment of the patient and inform genetic counseling for the family, and therefore input from clinical geneticists is critical at the earliest stages of medical management. Here we present 30 patients with hypotonia of unknown etiology referred by a neuropediatrician to clinical genetics. Clinical, genetic, and molecular evaluation of each patient was performed. Sixty-nine percent of the patients included in the study had a genetic disease, including eight with Prader-Willi syndrome, three with spinal muscular atrophy, one with Rett syndrome, and one with Sotos syndrome harboring a previously undescribed mutation. Our data demonstrate that a multidisciplinary approach used from the outset that includes molecular analysis can help improve diagnosis and management of hypotonic infants.

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.