Assessing the Efficacy and Safety of the Allurion® Gastric Balloon in Latin American Patients: A Multicenter Case Series

Assessing the Efficacy and Safety of the Allurion® Gastric Balloon in Latin American Patients: A Multicenter Case Series | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Assessing the Efficacy and Safety of the Allurion® Gastric Balloon in Latin American Patients: A Multicenter Case Series María Emilia Muriel, Manuel García, Fernando Martinez Lascano, and 15 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5775111/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction Allurion® gastric balloon (AGB) is an innovative option for treating overweight and grade I obesity or as a bridging treatment for bariatric surgery or because the patient does not desire a surgical intervention. This study aimed to evaluate the efficacy and safety of the AGB in a multicentric cohort. Materials and methods A retrospective analysis of consecutive cases treated with AGB (≥18 years old with BMI ≥27) was performed in eight centers in 3 countries in Latin America (Argentina, Chile, and Peru), between September 2021 to September 2022, with a 12-month follow-up. Results 402 patients were included (median BMI of 32.81 kg/m 2 ). Mean TWL% was 8.3%, 11.6%, and 14.9% at 3, 6, and 12 months respectively, with a follow-up of 93.03%, 75.37% and 40.54%. The adverse event rate was 1.24% (n=5). During the first 7 days, 34.58% (n=139) experienced concomitant symptoms, and 1.99% (n=8) asked for endoscopic balloon extraction because of intolerance. The complication rate was 6.46% (n=26). Readmission index was 4.97% (n=20) and reintervention was 2.23% (n=9). Balloon elimination was experienced by 5.7% of patients in the first 14 days, 29.10% (n=117) before the 3rd month, and 62.68% (n=252) after the 16th week. Early deflation rate was 2.73% (n=11). Digestive track elimination was perceived by 26.61%. Conclusions AGB is a safe and effective option for the treatment of overweight and obesity in Latin America. Lifestyle changes and continuous support with a multidisciplinary team are essential to achieving good mid- to long-term outcomes. Gastric balloon Obesity Overweight Swallowable Allurion®. Figures Figure 1 Figure 2 Figure 3 INTRODUCTION Obesity is one of the main challenges for public health at present times. Over 1900 million adults suffer from being overweight, 650 million are obese and 2.8 million die consequently every year [ 1 ]. Bariatric surgery is the most effective treatment for weight loss and remission of associated metabolic diseases, with sustainable long-term results [ 2 ], even though its indication is circumscribed to a reduced group of patients (mild obesity associated with type II diabetes or moderate/severe obesity) [ 3 ]. That is why alternatives are continuously explored to achieve weight loss in patients who are not eligible under these international guidelines or those who do not desire a surgical intervention. An option developed in recent years is Allurion® gastric balloon (Allurion Technologies, Natick, MA, USA), the first device designed for ambulatory placement under radioscopic control, without anesthesia or endoscopy. This swallowable balloon remains in the stomach for 16 to 20 weeks, inducing weight loss through improved satiety, delay of gastric emptying, and reduced ingestion volumes; to be spontaneously eliminated through the digestive tract without additional medical interventions. Good results were found in patients suffering from overweight and mild obesity [ 4 – 6 ]. It has been proposed as an alternative for moderate and severe obesity of difficult management, as a bridging treatment for bariatric surgery, or because the patient does not desire a surgical intervention. In Latin America, AGB was first used in 2017 and there is scarce published evidence about its results in the region. This study aimed to evaluate the efficacy and safety of the AGB in a multicentric cohort of Latin America. MATERIALS AND METHODS A retrospective analysis of consecutive cases treated with AGB was performed, in eight centers specializing in bariatric and metabolic surgery in 3 countries in Latin America (Argentina, Chile, and Peru). All patients between 18 and 65 years old with a BMI ≥ 27 treated with AGB between September 2021 and September 2022 were included, with a 12-month follow-up. The following exclusion criteria were defined: history of abdominal or gynecologic surgery related to peritonitis, bariatric, gastric or esophageal surgery, acute or chronic pancreatitis, esophagogastric pathologies like motility diseases (achalasia, scleroderma, diffuse esophageal spasm), structural anomalies of digestive tract (diverticulitis, hiatal or diaphragmatic hernias, stenosis), variceal disease, ulcers, gastroparesis, gastroesophageal reflux disease, noncontrolled endocrinologic diseases, severe coagulopathy, active oncologic pathology, renal or hepatic insufficiency, cirrhosis, noncontrolled anemia (Hb lower than 11g/dl in women and 12 g/dl in men), symptomatic congestive cardiac insufficiency, cardiac arrhythmia, unstable arterial coronary disease, psychiatric diseases, use of drugs and alcohol, non treated alimentary diseases, smoking, intestinal inflammatory disease, current fertility treatments, pregnancy or lactation, and patients who underwent placement of a second sequential balloon or decided to combine it with pharmacologic treatment. Patient optimization before intervention All patients were evaluated by a multidisciplinary team (bariatric surgeon, nutritionist, and psychologist), who performed anthropometric measures, pathologic background evaluation, nutritional behavior, sedentarism, and psychological profile. Body weight was measured with light clothes and no shoes, using a calibrated digital scale, and height was measured in a standing position with a stadiometer mounted on the scale. Complementary studies were performed in cases where undiagnosed pathologies were suspected. All patients were treated with proton pump inhibitors (dexlansoprazole 60mg/day) 15 days before the procedure, and antiemetic oral treatment (aprepitant 125 mg the previous night and 80 mg the morning of the procedure). A liquid diet and total fasting were indicated 24 and 3 hours before the procedure respectively. NSAIDs were contraindicated from 14 days before to 14 days after the procedure. Intervention All procedures were performed as stated in standard practice by bariatric surgeons, assisted by radiology technicians, in a radioscopy room during an ambulatory visit. A median length of 20 minutes was recorded. Initially, the patient swallowed the vegetal capsule containing the balloon. If the patient experienced difficulties, a guide wire was introduced through the catheter guiding the capsule. The correct placement of the capsule was radioscopically confirmed with a radio-opaque marker. Then, the balloon was filled with 550 ml of the provided liquid (distilled water with potassium sorbate), and a second radioscopic control was performed, checking the correct filling and placement in the gastric fundus. The catheter was then disconnected from the balloon with a traction maneuver. After the procedure, patients received written indications to continue with daily doses of proton pump inhibitor (dexlansoprazole or equivalent) during the whole treatment, and 80 mg aprepitant 24 hours after the procedure. The following were prescribed only when needed: 400 mg/day celecoxib for continuous abdominal pain during the first 72 hours, 30 mg/day butilhioscine for abdominal spasms or colic pain, and a 16 mg/day ondansetron for nausea or vomiting. A liquid diet was prescribed during the first 48 hours, and a gradual progression to a semisolid diet was recommended. The diet program consists of a hypocaloric-hiper proteic diet, and correct hydration (at least 1.5 liters of water daily) was highly recommended. All patients were authorized to perform regular physical activities starting from 48 hours of complete tolerance to solids. Alarm signs were established (liquid intolerance for more than 24 hours, orthostatic hypotension, tachycardia over 100, sweating, abdominal distension), and patients were thoroughly instructed about the importance of contacting the medical team to inform the symptoms. Follow-up Every patient was provided with a bioimpedance scale and a smartwatch. Both devices work through a mobile phone app (cost-free), that simplifies the medical following and communication with the patient. Every patient was recommended to take weekly psychological therapy as part of the behavioral treatment and supervised physical activity was recommended. Control visits with the bariatric surgeon were performed in person or through phone calls 48 hs and 7 days after the procedure, and every 30 days with the nutritionist for 6 months. Patients were phoned 12 months after the procedure; in case the patient did not attend the programmed visit. In every consult weight loss, associated disease control, and potential complications were evaluated. Demographic variables and obesity-related conditions were analyzed. Intervention-related variables were registered: need for guide wire assisted placement, initial balloon placement (correct/incorrect), adverse events (airway accidental placement, vomiting with balloon expulsion, esophageal injury, stress-related fainting). Balloon placement tolerance was evaluated by associated symptoms in the first 7 days (nausea, vomiting, colic abdominal pain, diarrhea, constipation, and headache). Complications during the first 30 days were also registered (any deviation from the usual that required a nonplanned action and caused an adverse effect to the patient and is not considered a treatment failure) according to Clavien–Dindo, and any other complication during the 4 months following the procedure. The elimination of the balloon was also registered as well as its perception, associated symptoms, and time after placement. Elimination was defined as “premature” within the first 14 days for any cause, “early” within the first 3 months, and “on time” when it happened after 4 months. Deflation was defined as balloon elimination due to spontaneous degradation, before the 12th week, independent from the elimination way. The evolution of body weight was studied through the following variables: -Lost weight: Initial weight (kg) – Weight (kg) at the 3rd, 6th, and 12th months after the procedure. -BMI loss: Initial BMI – BMI at the 3rd, 6th, and 12th months after the procedure. -Lost Weight Percentage: [(Weight at 3rd, 6th and 12th months – Initial weight)/(Initial weight)] × 100. Statistical Analysis Absolute and relative frequencies were reported for the categorical variables; average and standard deviation or median and interquartile range 25–75 for continuous variables on behalf of the population distribution. Shapiro–Wilk test was used to determine the distribution of continuous variables. Categorical variables were compared using X 2 test. Changes in weight or BMI were compared using the T test for related data or Wilcoxon sign rank test, according to distribution. Sample Size With a fixed sample size (402 participants), a statistical power of 99% was estimated to detect a difference in BMI of 3 kg/m 2 , with a standard deviation of 4 and a two-tailed confidence interval of 95%. Statistical significance was established in 0.05. STATA v18 (StataCorp, Texas, USA) was used for analysis. DATA SURVEYING Base Data Sociodemographic and clinical data were extracted from the clinical history systems of each health institution. Data was stored in an online spreadsheet designed for data collection, using REDCap. The responsible team was identified, and patients were assigned a unique identification number. The spreadsheet had five sections: 1) Sociodemographic data, 2) Medical information related to overweight or obesity diagnosis, 3) Intervention information, 4) Follow-up data, and 5) Body weight evolution information. Ethical aspects The Investigation Committee of each institution approved the investigational protocol, and any later modification was revised. The study was conducted following the Helsinki Declaration. All data was digitally and anonymously collected, with access restricted only to authorized staff involved in the study, or regulatory authorities, maintaining and assuring information confidentiality according to law 25.326. As this was a retrospective study and minimal risk research, a dispensation of informed consent was obtained from the Ethics Committee. Informed consent signature exemption was based on the 4th version of the Council for International Organization of Medical Sciences (CIOMS) 2016. RESULTS The total sample was 402 patients (Table 1). Follow-up at 3, 6, and 12 months was completed by 374 (93.03%), 303 (75.37%) and 163 (40.54%) participants respectively. Table 1. Demographic characteristics of patients. Characteristics N= 402 Range Sex (female/male) 275 (68.40%) / 126 (31.34%) Mean age (years) 43.19 16-75 Mean initial weight (kg) 92.68 62-177 Mean initial BMI (kg/mts2) 32.81 27-52 BMI levels (kg/mts2) Overweight (27 - 29.99) Obesity G-I (30 - 34.99) Obesity G-II (35 – 39.99) Obesity G-III (≥40) 98 (24.37%) 210 (52.23%) 69 (17.16%) 25 (6.21%) Follow-up time (months) 3 6 12 374 (93,03%) 303 (75,37%) 163 (40,54%) BMI, body mass index; GI, grade 1; GII, grade 2; GIII, grade 3. Data are expressed as median or % (number). Intervention Initial placement failed in 9 cases (2.24%), in which necessary maneuvers were performed to achieve a correct placement, before filling and new radioscopic control. A guide wire guided the swallowing in 78 (19.40%) patients. During the procedure, 5 (1.24%) patients experienced adverse effects: 4 (0.99%) presented stress-related fainting, and in 1 (0.24%) the capsule was accidentally placed in the airway. In all cases, correct placement was achieved eventually. Tolerance During the first 7 days, 139 patients (34.58%) experienced symptoms. Most frequent were nausea (19.7%), vomiting (11.4%), and colic abdominal pain (8%). After placement, 77% of patients resolved every symptom in the first 4 days. Also, 8 patients (1.99%) demanded endoscopic balloon extraction, because of intolerance without any medical complication. Safety During the period of balloon permanence inside the stomach, 24 patients (5.97%) experienced a complication: 14 (3.5%) experienced mild dehydration (Clavien I), 1 (0.2%) had gastroesophageal reflux (Clavien II), 7 (1.74%) presented pyloric syndrome (Figure 1), 1 (0.2%) presented bowel obstruction (Clavien IIIb) and 1 (0.2%) experienced necrosis related gastric perforation (Clavien IIIb). The readmission ratio was 4.97% (n=20) and the complication-related re-intervention ratio was 2.23% (n=9). From these, 7 patients (1.74%) needed an endoscopic procedure and 2 (0.49%) required surgical interventions (Table 2). Table 2. Complications, readmission and re-intervention ratio of Allurion® gastric ballon Complications Clavien N=24 (5.97%) Mild dehydration I 14 (3.5%) Gastroesophageal reflux II 1 (0.2%) Pyloric syndrome IIIa 7 (1.74%) Bowel obstruction IIIb 1 (0.2%) Gastric perforation IIIb 1 (0.2%) Readmission ratio 20 (4.97%) Re-intervention ratio 9 (2.23%) Elimination Elimination or premature extraction of the balloon was registered in 23 patients (5.7%). Out of these, 11 (2.73%) eliminated it spontaneously via the digestive tract, 10 (2.48%) required endoscopy (4 cases of intolerance and 6 cases of complication) and 2 (0.49%) required surgical intervention. Elimination or early extraction occurred in 117 patients (29.10%), spontaneously in 113 cases: 6 cases by vomiting (1.49%) and 107 (26.61%) via the digestive tract. The other 4 (0.99%) required endoscopic intervention, 3 of them (0.74%) because of intolerance, and 1 (0.24%) because of complication. No surgical interventions were registered. The other 252 cases (62.68%) eliminated the device on time. We registered 251 cases with spontaneous elimination, 14 (3.48%) by vomiting, and 237 (58.95%) via the digestive tract. Only 1 (0.24%) patient required endoscopy for intolerance. No surgical interventions were registered. The early deflation rate was 2.73% (n=11). The balloon was eliminated via the digestive tract without complications in every patient except for one report of small bowel obstruction, laparoscopically solved without bowel resection (Figure 2). Weight evolution Initial average weight was 92.68 kg (62 – 177) and average weight lost was 9 kg (3 months), 12 kg (6 months), and 15.04 kg (12 months). The median initial BMI was 32.81 kg/m 2 (27 – 52), and the average BMI at 3 months was 29.6 kg/m 2 , at 6 months was 28.4 kg/m 2 , and at 12 months was 26.6 kg/m 2 . Mean Total Weight Loss percentage (%TWL) was 8.3%, 11.6%, and 14.9% at 3, 6 and 12 months respectively (Figure DISCUSSION A skyrocketing demand for new, less invasive, options for the medical care of overweight and obesity supported the implementation of AGB in Latin America. Although there is scarce evidence in the region, available data suggests solid efficacy in weight loss and a superior safety profile compared to similar methods, aligned with global standards. Our investigation included reference institutions of Argentina, Chile, and Peru which presented clinically significant weight loss values at 3, 6, and 12 months, with an average %TWL of 8.3%, 11.6%, and 14.9% respectively. Complications index was 6.46%, with a readmission rate of 4.97% and reintervention of 2.23% (1.74% endoscopically and 0.49% surgically). The placement of the AGB is technically simple, non-invasive, and associated with a low complication rate (less than 5%) compared to other gastric balloons requiring endoscopic intervention [8-10]. In our study, 9 cases (2.24%) required additional maneuvers for adequate balloon placement and new radioscopic control before filling. Also, a guide wire was used to guide the placement in 78 patients (19.4%) who presented difficulties with swallowing. International evidence suggests that in up to 46% of cases, this instrument was used to simplify the process [4, 11-13]. During the procedure, 5 (1.24%) adverse events were registered, 4 (0.99%) stress-related fainting, and 1 (0.24%) accidental placement of the capsule in the airway. In every case, the correct placement of the balloon was achieved, and no further complications were registered. In other published series [14], other adverse events were reported. Machytka et al. informed the detachment of the capsule in the lower esophageal sphincter before its filling. An empty balloon was eliminated the next day without complications with the stools. It is important to stress that adequate evaluation and preparation of patients before the procedure, and precise procedure execution by a suitable professional, are fundamental to minimize risks and ensure a successful experience. Device tolerance is also an important variable to assess efficacy and tolerance. Nausea and vomiting are the most common secondary effects during the first weeks, but they are usually temporary and disappear with adequate pharmacologic treatment [15]. In our study population, 139 cases (34.58%) experienced symptoms during the first week, the most frequent were nausea (19.7%), vomiting (11.4%), and abdominal pain (8%). After placement, 77% improved their symptoms during the first 4 days, and 8 patients (1.99%) demanded endoscopic extraction, without any complication. Jense et al. reported 80% of symptoms during the first week following placement, with excellent response to medical treatment. Endoscopic extraction was required in 1.4% of the cases [4]. In another experience, Jamal et al. reported 71.7% of nausea and vomiting after placement, in addition to 46.2% of abdominal pain [5]. The differences with our results might be related to antiemetic and antispasmodic drugs used during the preparation in our program that were not used in the previously mentioned series. Luckily, associated symptoms are mild, temporary, and easily managed. One of the advantages of the Allurion device is the low risk of complications, especially when compared to traditional balloons because of the noninvasive nature of the method and the shorter time of permanence of the device in the stomach, resulting in a lower risk of pressure ulcers in the gastric wall [8-10, 16-17]. In our analysis, the complication rate was 6.46%. Most of the cases were mild dehydration (3.5%) and resolved with IV hydration without the need for additional intervention. Also, 7 patients (1.74%) suffered from pyloric obstruction, solved by endoscopic procedures, one of them (0.2%) with small bowel obstruction after balloon deflation and another (0.2%) with gastric perforation after necrosis. Both required urgent surgical intervention and were treated with a laparoscopic approach. Gastroesophageal reflux symptoms (0.2%) were scarce, and resolved with proton pump inhibitors for 30 days. The readmission rate was 4.97% and the reintervention rate was 2.23%. Similar results were reported in a meta-analysis by Vantanasiri et al., reporting bowel obstruction incidence of 0.2% and gastric perforation of 0.06%, 3 patients required surgery, and one case was solved by colonoscopy [18]. Regarding the device period of permanence in the stomach, the early deflation rate was 2.73%, meaning that in 11 cases the balloons disintegrated before the 16th week. Out of those, 1 patient (0.2%) presented bowel obstruction successfully treated with surgery and the rest eliminated the balloon via the digestive tract without complications. In every case, cost-free sequential placement was offered, and 4 patients agreed to start the treatment again. According to the Dutch group publication, 2.38% of patients experienced early deflation [4]. In one patient the balloon required endoscopic extraction after a partial early deflation, which caused symptoms suggesting a bowel obstruction. It is important to stress that to optimize safety outcomes it is fundamental to consider a collaborative focus integrating adequate patient selection, early complications detection, and their management by a specialized bariatric team. In our experience, 107 patients (26.61%) perceived the digestive elimination of the balloon. Of those, 19.15% presented concomitant symptoms, 58.95% via the digestive tract and 3.48% orally. In the study by Jamal et al; from the 106 patients, 49 (46%) noticed the absence of the balloon after degradation, and out of those, 61.2% did it between 3 and 4 months [5]; results matching our study population (62.68%). It was also informed that 70.7% eliminated the device without associated symptoms, 12% reported oral elimination, 9% associated diarrhea, and 2% to mild abdominal pain [5]. Similar results are shown in our investigation, with 10.19% of colic abdominal pain, 3.48% of vomiting, 3.73% of diarrhea and 0.24% of anal pain at evacuation. The current bibliography shows a similar %TWL to our experience. Jense et al. reported a %TWL of 9.94%, 11.83%, and 10.97% at 3, 6, and 12 months of follow-up [4]. Jamal et al. stratified their sample into two groups according to their initial BMI. The BMI group between 27.5 and 34.9 kg/m 2 showed a %TWL of 10.2%, 10.6%, and 8.8%, meanwhile, the BMI group between 35 and 49 kg/m 2 reported a TWL% of 11.5%, 11.2% and 6.6% at 3, 6 and 12 months follow up respectively [5]. Also, Vantanasiri et al. included 6 studies with 1446 patients, establishing an average %TWL of 12.8% between 4 to 6 months and 10.9% at 12 months [16]. Even though our %TWL curve shows a significative ascent close to the end of the follow-up period, it is important to consider that only 40% of patients consulted after 1 year of the procedure, potentially representing a bias in this subgroup. AGB represents a significant advance in the treatment of overweight and obesity with an average loss of 7 – 15% of the initial body weight during the period of use [18]. Long-term weight loss also depends greatly on the capacity of the patient to maintain lifestyle changes once the balloon is eliminated and the adherence to follow-up with a specialized multidisciplinary team. Unfortunately, most evidence about intragastric balloons does not include this approach. This study does have limitations, the analyzed sample had to pay for the Allurion ® gastric balloon treatment, which might represent a bias because when patients are required to pay for a treatment, they tend to be more closely committed. This might produce an artificially high following rate, even though current research observed a rate of follow-up loss from 6.97% to 59.46%. Another limitation is the retrospective character of the current analysis where initial symptoms might be underestimated. Nevertheless, it is an interesting experience for the current bibliography and the first report in Latin America. Finally, we consider that it is essential for patients to understand that weight loss with an AGB must be accompanied by lifestyle changes to achieve and maintain optimal results. Besides, it is necessary to personalize the treatment based on individual needs and maintain continuous follow-up with healthcare providers to increase the long-term success rate. CONCLUSIONS AGB is a safe and effective option for the treatment of overweight and obesity in Latin America. Lifestyle changes and continuous support with a multidisciplinary team are essential to achieving good mid- to long-term outcomes. Long-term prospective studies might reveal more data to define the exact indications. Declarations Conflicts of interest The authors declare no conflicts of interest. Funding declaration The authors declare no financial support or funding for this research. Author Contribution A.B.C and D wrote the main manuscript text. E.F. prepared figures 1-3. G. H. and I prepared tables 1-2. All authors reviewed the manuscript. References World Health Organization (WHO) Obesity and Overweight. Available online https://www.who.int/en/news-room/fact-sheets/detail/obesity-and-overweight (accessed on 02 June 2023). Jakobsen G, Småstuen M, Sandbu R, et al. Association of bariatric surgery vs medical obesity treatment with long-term medical complications and obesity-related comorbidities. JAMA. 2018; 319(3):291–301. Eisenberg D, Shikora SA, Aarts E et al. American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery. Surg Obes Relat Dis. 2022 Dec;18(12):1345-1356. Jense MTF, Palm-Meinders IH, Sanders B, et al. The Swallowable Intragastric Balloon Combined with Lifestyle Coaching: Short-Term Results of a Safe and Effective Weight Loss Treatment for People Living with Overweight and Obesity. Obes Surg. 2023 Jun;33(6):1668-1675. Jamal MH, Almutairi R, Elabd R, et al. The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal. Obes Surg. 2019 Apr;29(4):1236-1241. Ienca R, Al Jarallah M, Caballero A, et al. The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients. Obes Surg. 2020 Sep;30(9):3354-3362. Editorial, E. (2008). Declaración de Helsinki de la Asociación Médica Mundial. Arbor, 184(730), 349–352. Recuperado a partir de https://arbor.revistas.csic.es/index.php/arbor/article/view/183. Imaz I, Martínez-Cervell C, García-Álvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis.Obes Surg. 2008;18(7):841–6 Alsabah S, al Haddad E, Ekrouf S, et al. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018;14(3):311–7. Genco A, Bruni T, Doldi SB, et al. BioEnterics intragastric balloon: the Italian experience with 2,515 patients. Obes Surg. 2005;15(8):1161–4 Taha O, Abdelaal M, Asklany A, et al. Outcomes of a Swallowable Intragastric Balloon (Elipse™) on 96 Overweight and Obese Patients. Obes Surg. 2021;31(3):965-969. Machytka E, Gaur S, Chuttani R, et al. Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study. Endoscopy. 2017;49(2):154-160. Raftopoulos I, Giannakou A. The Elipse balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017;13(7):1174–82 Genco A, Ernesti I, Ienca R, et al. Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience. Obes Surg. 2018;28(2):405-409. Trang J, Lee SS, Miller A, et al. Incidence of nausea and vomiting after intragastric balloon placement in bariatric patients - A systematic review and meta-analysis. Int J Surg. 2018;57:22-29. Ponce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11(4):874–81. Alhashemi M, Alkhamis A, Jamal M, et al. Safety and Effectiveness of Two Different Fluid-Filled Intragastric Balloons: A Single Center Experience. Obes Surg. Published online October 2, 2024. doi:10.1007/s11695-024-07524-7 Vantanasiri K, Matar R, Beran A, Jaruvongvanich V. The Efficacy and Safety of a Procedureless Gastric Balloon for Weight Loss: a Systematic Review and Meta-Analysis. Obes Surg. 2020 Sep;30(9):3341-3346. Additional Declarations No competing interests reported. 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sobrepeso","correspondingAuthor":false,"prefix":"","firstName":"Matias","middleName":"Facundo","lastName":"Sosa","suffix":""},{"id":399558098,"identity":"956850b6-4334-4ca6-b5d1-8bf7cbeb3b21","order_by":5,"name":"Pablo Javier Castellaro","email":"","orcid":"","institution":"Centro Integral para el tratamiento de la obesidad y sobrepeso","correspondingAuthor":false,"prefix":"","firstName":"Pablo","middleName":"Javier","lastName":"Castellaro","suffix":""},{"id":399558100,"identity":"c701059c-16bc-4e37-82c8-5cc8a0febe18","order_by":6,"name":"Matias Sepulveda","email":"","orcid":"","institution":"Centro medico NOVAMED","correspondingAuthor":false,"prefix":"","firstName":"Matias","middleName":"","lastName":"Sepulveda","suffix":""},{"id":399558101,"identity":"33c1e8be-eff3-43ea-adc2-b3f013139ec9","order_by":7,"name":"Mariano Palermo","email":"","orcid":"","institution":"DIAGNOMED","correspondingAuthor":false,"prefix":"","firstName":"Mariano","middleName":"","lastName":"Palermo","suffix":""},{"id":399558102,"identity":"0d98a93d-958c-4e1a-8863-91900c6e6b12","order_by":8,"name":"Maria de la Paz Piatanesi","email":"","orcid":"","institution":"DIAGNOMED","correspondingAuthor":false,"prefix":"","firstName":"Maria","middleName":"de la Paz","lastName":"Piatanesi","suffix":""},{"id":399558104,"identity":"ea02cfd0-7c67-4346-b425-8e2d97828522","order_by":9,"name":"Julio Ernesto Argonz","email":"","orcid":"","institution":"Sanatorio Las Lomas","correspondingAuthor":false,"prefix":"","firstName":"Julio","middleName":"Ernesto","lastName":"Argonz","suffix":""},{"id":399558106,"identity":"cfe05fb2-408a-4301-ba4d-c6cead801972","order_by":10,"name":"Maria Eleonora Puentes","email":"","orcid":"","institution":"Sanatorio Las Lomas","correspondingAuthor":false,"prefix":"","firstName":"Maria","middleName":"Eleonora","lastName":"Puentes","suffix":""},{"id":399558107,"identity":"b0849974-6cf6-420b-b61e-459ccfb811e0","order_by":11,"name":"Diego Awruch","email":"","orcid":"","institution":"Sanatorio Británico","correspondingAuthor":false,"prefix":"","firstName":"Diego","middleName":"","lastName":"Awruch","suffix":""},{"id":399558108,"identity":"8edfbe11-0f43-4067-ab9a-6c887d39cf02","order_by":12,"name":"Rogelio Tioni","email":"","orcid":"","institution":"Sanatorio Británico","correspondingAuthor":false,"prefix":"","firstName":"Rogelio","middleName":"","lastName":"Tioni","suffix":""},{"id":399558109,"identity":"fe95c9ca-9383-4379-bcbe-624b1e6cfae3","order_by":13,"name":"María Clotilde Gancedo","email":"","orcid":"","institution":"Obesity Care","correspondingAuthor":false,"prefix":"","firstName":"María","middleName":"Clotilde","lastName":"Gancedo","suffix":""},{"id":399558110,"identity":"c9e27269-c168-4e33-8337-09c5a041064d","order_by":14,"name":"Ariel Ferraro","email":"","orcid":"","institution":"Obesity Care","correspondingAuthor":false,"prefix":"","firstName":"Ariel","middleName":"","lastName":"Ferraro","suffix":""},{"id":399558111,"identity":"a1766e90-44c9-4ef2-85dc-b85ffca3c8cd","order_by":15,"name":"Arianna Sibila Portmann Baracco","email":"","orcid":"","institution":"Clínica Anglo-Americana","correspondingAuthor":false,"prefix":"","firstName":"Arianna","middleName":"Sibila Portmann","lastName":"Baracco","suffix":""},{"id":399558112,"identity":"b4abcf7e-8443-4092-9684-873d50f93723","order_by":16,"name":"Luciano Poggi Garland","email":"","orcid":"","institution":"Clínica Anglo-Americana","correspondingAuthor":false,"prefix":"","firstName":"Luciano","middleName":"Poggi","lastName":"Garland","suffix":""},{"id":399558113,"identity":"0d796788-eb6d-414a-a0b0-8df0fd22bf8b","order_by":17,"name":"Carlos Esquivel","email":"","orcid":"","institution":"Sanatorio Allende","correspondingAuthor":false,"prefix":"","firstName":"Carlos","middleName":"","lastName":"Esquivel","suffix":""}],"badges":[],"createdAt":"2025-01-06 15:53:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5775111/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5775111/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":73674796,"identity":"e1b846d0-d258-4a78-af0d-229b7806ab27","added_by":"auto","created_at":"2025-01-13 12:59:07","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":450101,"visible":true,"origin":"","legend":"\u003cp\u003eBallon pyloric syndrome.\u003c/p\u003e\n\u003cp\u003eA. CT scan coronal, B. CT scan axial, C. Upper endoscopy, D. Deflated and extracted ballon.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5775111/v1/abdb6c81d3d95706cb17d8c1.png"},{"id":73674795,"identity":"18dfa12e-a13b-4b19-b4c7-d4da110e74b0","added_by":"auto","created_at":"2025-01-13 12:59:07","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":43972,"visible":true,"origin":"","legend":"\u003cp\u003eBallon excretion time and route\u003c/p\u003e\n\u003cp\u003ePerception of elimination via digestive tract was reported in 107 patients (26.61%), out of which 41 (10.19%) referred colic abdominal pain before elimination, 20 (4.97%) reported vomiting, 15 (3.73%) diarrhea, 15 (3.73%) anal sensation of elimination and 1 (0.24%) anal pain during evacuation.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5775111/v1/ddbdb601e499277af6f0ed09.png"},{"id":73674807,"identity":"01c8d308-01a1-4582-8a14-9218b0570442","added_by":"auto","created_at":"2025-01-13 12:59:07","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":17874,"visible":true,"origin":"","legend":"\u003cp\u003eWeight outcomes in patients treated with Allurion\u003csup\u003e®\u003c/sup\u003e gastric ballon.\u003c/p\u003e\n\u003cp\u003eAverage body mass index (A) and percentage of total weight loss (B) of patients at different time intervals. [BMI, body mass index (kg/m\u003csup\u003e2\u003c/sup\u003e); [%TWL, Percentage of total weight loss].\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-5775111/v1/968a2212ea8745e3f6e72ba1.png"},{"id":84494035,"identity":"0a7dfe04-c898-49a7-81aa-e77fce7de130","added_by":"auto","created_at":"2025-06-12 15:09:36","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1155490,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5775111/v1/090e7687-af0f-4caa-a0e2-4e08e66c9031.pdf"},{"id":73674799,"identity":"1db9eca6-927a-40ff-a0d2-7a5732d4868e","added_by":"auto","created_at":"2025-01-13 12:59:07","extension":"pptx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":225027,"visible":true,"origin":"","legend":"","description":"","filename":"GRAPHICALABSTRACTTEMPLATE.pptx","url":"https://assets-eu.researchsquare.com/files/rs-5775111/v1/010141121dac05161337c301.pptx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eAssessing the Efficacy and Safety of the Allurion® Gastric Balloon in Latin American Patients: A Multicenter Case Series\u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eObesity is one of the main challenges for public health at present times. Over 1900\u0026nbsp;million adults suffer from being overweight, 650\u0026nbsp;million are obese and 2.8\u0026nbsp;million die consequently every year [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eBariatric surgery is the most effective treatment for weight loss and remission of associated metabolic diseases, with sustainable long-term results [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], even though its indication is circumscribed to a reduced group of patients (mild obesity associated with type II diabetes or moderate/severe obesity) [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. That is why alternatives are continuously explored to achieve weight loss in patients who are not eligible under these international guidelines or those who do not desire a surgical intervention.\u003c/p\u003e \u003cp\u003eAn option developed in recent years is Allurion\u0026reg; gastric balloon (Allurion Technologies, Natick, MA, USA), the first device designed for ambulatory placement under radioscopic control, without anesthesia or endoscopy. This swallowable balloon remains in the stomach for 16 to 20 weeks, inducing weight loss through improved satiety, delay of gastric emptying, and reduced ingestion volumes; to be spontaneously eliminated through the digestive tract without additional medical interventions. Good results were found in patients suffering from overweight and mild obesity [\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. It has been proposed as an alternative for moderate and severe obesity of difficult management, as a bridging treatment for bariatric surgery, or because the patient does not desire a surgical intervention.\u003c/p\u003e \u003cp\u003eIn Latin America, AGB was first used in 2017 and there is scarce published evidence about its results in the region. This study aimed to evaluate the efficacy and safety of the AGB in a multicentric cohort of Latin America.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cp\u003eA retrospective analysis of consecutive cases treated with AGB was performed, in eight centers specializing in bariatric and metabolic surgery in 3 countries in Latin America (Argentina, Chile, and Peru).\u003c/p\u003e\n\u003cp\u003eAll patients between 18 and 65 years old with a BMI ≥ 27 treated with AGB between September 2021 and September 2022 were included, with a 12-month follow-up.\u003c/p\u003e\n\u003cp\u003eThe following exclusion criteria were defined: history of abdominal or gynecologic surgery related to peritonitis, bariatric, gastric or esophageal surgery, acute or chronic pancreatitis, esophagogastric pathologies like motility diseases (achalasia, scleroderma, diffuse esophageal spasm), structural anomalies of digestive tract (diverticulitis, hiatal or diaphragmatic hernias, stenosis), variceal disease, ulcers, gastroparesis, gastroesophageal reflux disease, noncontrolled endocrinologic diseases, severe coagulopathy, active oncologic pathology, renal or hepatic insufficiency, cirrhosis, noncontrolled anemia (Hb lower than 11g/dl in women and 12 g/dl in men), symptomatic congestive cardiac insufficiency, cardiac arrhythmia, unstable arterial coronary disease, psychiatric diseases, use of drugs and alcohol, non treated alimentary diseases, smoking, intestinal inflammatory disease, current fertility treatments, pregnancy or lactation, and patients who underwent placement of a second sequential balloon or decided to combine it with pharmacologic treatment.\u003c/p\u003e\n\u003cp\u003ePatient optimization before intervention\u003c/p\u003e\n\u003cp\u003eAll patients were evaluated by a multidisciplinary team (bariatric surgeon, nutritionist, and psychologist), who performed anthropometric measures, pathologic background evaluation, nutritional behavior, sedentarism, and psychological profile.\u003c/p\u003e\n\u003cp\u003eBody weight was measured with light clothes and no shoes, using a calibrated digital scale, and height was measured in a standing position with a stadiometer mounted on the scale. Complementary studies were performed in cases where undiagnosed pathologies were suspected.\u003c/p\u003e\n\u003cp\u003eAll patients were treated with proton pump inhibitors (dexlansoprazole 60mg/day) 15 days before the procedure, and antiemetic oral treatment (aprepitant 125 mg the previous night and 80 mg the morning of the procedure). A liquid diet and total fasting were indicated 24 and 3 hours before the procedure respectively. NSAIDs were contraindicated from 14 days before to 14 days after the procedure.\u003c/p\u003e\n\u003cp\u003eIntervention\u003c/p\u003e\n\u003cp\u003eAll procedures were performed as stated in standard practice by bariatric surgeons, assisted by radiology technicians, in a radioscopy room during an ambulatory visit. A median length of 20 minutes was recorded.\u003c/p\u003e\n\u003cp\u003eInitially, the patient swallowed the vegetal capsule containing the balloon. If the patient experienced difficulties, a guide wire was introduced through the catheter guiding the capsule. The correct placement of the capsule was radioscopically confirmed with a radio-opaque marker. Then, the balloon was filled with 550 ml of the provided liquid (distilled water with potassium sorbate), and a second radioscopic control was performed, checking the correct filling and placement in the gastric fundus. The catheter was then disconnected from the balloon with a traction maneuver.\u003c/p\u003e\n\u003cp\u003eAfter the procedure, patients received written indications to continue with daily doses of proton pump inhibitor (dexlansoprazole or equivalent) during the whole treatment, and 80 mg aprepitant 24 hours after the procedure. The following were prescribed only when needed: 400 mg/day celecoxib for continuous abdominal pain during the first 72 hours, 30 mg/day butilhioscine for abdominal spasms or colic pain, and a 16 mg/day ondansetron for nausea or vomiting.\u003c/p\u003e\n\u003cp\u003eA liquid diet was prescribed during the first 48 hours, and a gradual progression to a semisolid diet was recommended. The diet program consists of a hypocaloric-hiper proteic diet, and correct hydration (at least 1.5 liters of water daily) was highly recommended.\u003c/p\u003e\n\u003cp\u003eAll patients were authorized to perform regular physical activities starting from 48 hours of complete tolerance to solids.\u003c/p\u003e\n\u003cp\u003eAlarm signs were established (liquid intolerance for more than 24 hours, orthostatic hypotension, tachycardia over 100, sweating, abdominal distension), and patients were thoroughly instructed about the importance of contacting the medical team to inform the symptoms.\u003c/p\u003e\n\u003cp\u003eFollow-up\u003c/p\u003e\n\u003cp\u003eEvery patient was provided with a bioimpedance scale and a smartwatch. Both devices work through a mobile phone app (cost-free), that simplifies the medical following and communication with the patient.\u003c/p\u003e\n\u003cp\u003eEvery patient was recommended to take weekly psychological therapy as part of the behavioral treatment and supervised physical activity was recommended.\u003c/p\u003e\n\u003cp\u003eControl visits with the bariatric surgeon were performed in person or through phone calls 48 hs and 7 days after the procedure, and every 30 days with the nutritionist for 6 months. Patients were phoned 12 months after the procedure; in case the patient did not attend the programmed visit. In every consult weight loss, associated disease control, and potential complications were evaluated.\u003c/p\u003e\n\u003cp\u003eDemographic variables and obesity-related conditions were analyzed.\u003c/p\u003e\n\u003cp\u003eIntervention-related variables were registered: need for guide wire assisted placement, initial balloon placement (correct/incorrect), adverse events (airway accidental placement, vomiting with balloon expulsion, esophageal injury, stress-related fainting).\u003c/p\u003e\n\u003cp\u003eBalloon placement tolerance was evaluated by associated symptoms in the first 7 days (nausea, vomiting, colic abdominal pain, diarrhea, constipation, and headache). Complications during the first 30 days were also registered (any deviation from the usual that required a nonplanned action and caused an adverse effect to the patient and is not considered a treatment failure) according to Clavien–Dindo, and any other complication during the 4 months following the procedure.\u003c/p\u003e\n\u003cp\u003eThe elimination of the balloon was also registered as well as its perception, associated symptoms, and time after placement. Elimination was defined as “premature” within the first 14 days for any cause, “early” within the first 3 months, and “on time” when it happened after 4 months. Deflation was defined as balloon elimination due to spontaneous degradation, before the 12th week, independent from the elimination way.\u003c/p\u003e\n\u003cp\u003eThe evolution of body weight was studied through the following variables:\u003c/p\u003e\n\u003cp\u003e-Lost weight: Initial weight (kg) – Weight (kg) at the 3rd, 6th, and 12th months after the procedure.\u003c/p\u003e\n\u003cp\u003e-BMI loss: Initial BMI – BMI at the 3rd, 6th, and 12th months after the procedure.\u003c/p\u003e\n\u003cp\u003e-Lost Weight Percentage: [(Weight at 3rd, 6th and 12th months – Initial weight)/(Initial weight)] × 100.\u003c/p\u003e\n\u003cdiv id=\"Sec3\"\u003e\n \u003ch2\u003eStatistical Analysis\u003c/h2\u003e\n \u003cp\u003eAbsolute and relative frequencies were reported for the categorical variables; average and standard deviation or median and interquartile range 25–75 for continuous variables on behalf of the population distribution. Shapiro–Wilk test was used to determine the distribution of continuous variables.\u003c/p\u003e\n \u003cp\u003eCategorical variables were compared using X\u003csup\u003e2\u003c/sup\u003e test. Changes in weight or BMI were compared using the T test for related data or Wilcoxon sign rank test, according to distribution.\u003c/p\u003e\n \u003cp\u003eSample Size\u003c/p\u003e\n \u003cp\u003eWith a fixed sample size (402 participants), a statistical power of 99% was estimated to detect a difference in BMI of 3 kg/m\u003csup\u003e2\u003c/sup\u003e, with a standard deviation of 4 and a two-tailed confidence interval of 95%.\u003c/p\u003e\n \u003cp\u003eStatistical significance was established in 0.05.\u003c/p\u003e\n \u003cp\u003eSTATA v18 (StataCorp, Texas, USA) was used for analysis.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eDATA SURVEYING\u003c/h3\u003e\n\u003cp\u003eBase Data\u003c/p\u003e \u003cp\u003eSociodemographic and clinical data were extracted from the clinical history systems of each health institution. Data was stored in an online spreadsheet designed for data collection, using REDCap. The responsible team was identified, and patients were assigned a unique identification number.\u003c/p\u003e \u003cp\u003eThe spreadsheet had five sections: 1) Sociodemographic data, 2) Medical information related to overweight or obesity diagnosis, 3) Intervention information, 4) Follow-up data, and 5) Body weight evolution information.\u003c/p\u003e \u003cp\u003eEthical aspects\u003c/p\u003e \u003cp\u003e The Investigation Committee of each institution approved the investigational protocol, and any later modification was revised. The study was conducted following the Helsinki Declaration.\u003c/p\u003e \u003cp\u003eAll data was digitally and anonymously collected, with access restricted only to authorized staff involved in the study, or regulatory authorities, maintaining and assuring information confidentiality according to law 25.326.\u003c/p\u003e \u003cp\u003e As this was a retrospective study and minimal risk research, a dispensation of informed consent was obtained from the Ethics Committee. Informed consent signature exemption was based on the 4th version of the Council for International Organization of Medical Sciences (CIOMS) 2016.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eThe total sample was 402 patients (Table 1). Follow-up at 3, 6, and 12 months was completed by 374 (93.03%), 303 (75.37%) and 163 (40.54%) participants respectively.\u003c/p\u003e\n\u003cp\u003eTable 1. Demographic characteristics of patients.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"633\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 208px;\"\u003e\n \u003cp\u003eCharacteristics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eN= 402\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eRange\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 208px;\"\u003e\n \u003cp\u003eSex (female/male)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003e275 (68.40%) / 126 (31.34%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 208px;\"\u003e\n \u003cp\u003eMean age (years)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003e43.19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e16-75\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 208px;\"\u003e\n \u003cp\u003eMean initial weight (kg)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003e92.68\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e62-177\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 208px;\"\u003e\n \u003cp\u003eMean initial BMI (kg/mts2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003e32.81\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e27-52\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 208px;\"\u003e\n \u003cp\u003eBMI levels (kg/mts2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 208px;\"\u003e\n \u003cp\u003eOverweight (27 - 29.99)\u003c/p\u003e\n \u003cp\u003eObesity G-I (30 - 34.99)\u003c/p\u003e\n \u003cp\u003eObesity G-II (35 \u0026ndash; 39.99)\u003c/p\u003e\n \u003cp\u003eObesity G-III (\u0026ge;40)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003e98 (24.37%)\u003c/p\u003e\n \u003cp\u003e210 (52.23%)\u003c/p\u003e\n \u003cp\u003e69 (17.16%)\u003c/p\u003e\n \u003cp\u003e25 (6.21%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 208px;\"\u003e\n \u003cp\u003eFollow-up time (months)\u003c/p\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e374 (93,03%)\u003c/p\u003e\n \u003cp\u003e303 (75,37%)\u003c/p\u003e\n \u003cp\u003e163 (40,54%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eBMI, body mass index; GI, grade 1; GII, grade 2; GIII, grade 3.\u003c/p\u003e\n\u003cp\u003eData are expressed as median or % (number).\u003c/p\u003e\n\u003cp\u003eIntervention\u003c/p\u003e\n\u003cp\u003eInitial placement failed in 9 cases (2.24%), in which necessary maneuvers were performed to achieve a correct placement, before filling and new radioscopic control.\u003c/p\u003e\n\u003cp\u003eA guide wire guided the swallowing in 78 (19.40%) patients.\u003c/p\u003e\n\u003cp\u003eDuring the procedure, 5 (1.24%) patients experienced adverse effects: 4 (0.99%) presented stress-related fainting, and in 1 (0.24%) the capsule was accidentally placed in the airway. In all cases, correct placement was achieved eventually.\u003c/p\u003e\n\u003cp\u003eTolerance\u003c/p\u003e\n\u003cp\u003eDuring the first 7 days, 139 patients (34.58%) experienced symptoms. Most frequent were nausea (19.7%), vomiting (11.4%), and colic abdominal pain (8%). After placement, 77% of patients resolved every symptom in the first 4 days.\u003c/p\u003e\n\u003cp\u003eAlso, 8 patients (1.99%) demanded endoscopic balloon extraction, because of intolerance without any medical complication.\u003c/p\u003e\n\u003cp\u003eSafety\u003c/p\u003e\n\u003cp\u003eDuring the period of balloon permanence inside the stomach, 24 patients (5.97%) experienced a complication: 14 (3.5%) experienced mild dehydration (Clavien I), 1 (0.2%) had gastroesophageal reflux (Clavien II), 7 (1.74%) presented pyloric syndrome (Figure 1), 1 (0.2%) presented bowel obstruction (Clavien IIIb) and 1 (0.2%) experienced necrosis related gastric perforation (Clavien IIIb).\u003c/p\u003e\n\u003cp\u003eThe readmission ratio was 4.97% (n=20) and the complication-related re-intervention ratio was 2.23% (n=9). From these, 7 patients (1.74%) needed an endoscopic procedure and 2 (0.49%) required surgical interventions (Table 2).\u003c/p\u003e\n\u003cp\u003eTable 2. Complications, readmission and re-intervention ratio of Allurion\u0026reg; gastric ballon\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"624\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eComplications\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eClavien\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 220px;\"\u003e\n \u003cp\u003eN=24 (5.97%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eMild dehydration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 220px;\"\u003e\n \u003cp\u003e14 (3.5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eGastroesophageal reflux\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 220px;\"\u003e\n \u003cp\u003e1 (0.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003ePyloric syndrome\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eIIIa\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 220px;\"\u003e\n \u003cp\u003e7 (1.74%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eBowel obstruction\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eIIIb\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 220px;\"\u003e\n \u003cp\u003e1 (0.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eGastric perforation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003eIIIb\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 220px;\"\u003e\n \u003cp\u003e1 (0.2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eReadmission ratio\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 220px;\"\u003e\n \u003cp\u003e20 (4.97%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eRe-intervention ratio\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 177px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 220px;\"\u003e\n \u003cp\u003e9 (2.23%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eElimination\u003c/p\u003e\n\u003cp\u003eElimination or premature extraction of the balloon was registered in 23 patients (5.7%). Out of these, 11 (2.73%) eliminated it spontaneously via the digestive tract, 10 (2.48%) required endoscopy (4 cases of intolerance and 6 cases of complication) and 2 (0.49%) required surgical intervention.\u003c/p\u003e\n\u003cp\u003eElimination or early extraction occurred in 117 patients (29.10%), spontaneously in 113 cases: 6 cases by vomiting (1.49%) and 107 (26.61%) via the digestive tract. The other 4 (0.99%) required endoscopic intervention, 3 of them (0.74%) because of intolerance, and 1 (0.24%) because of complication. No surgical interventions were registered.\u003c/p\u003e\n\u003cp\u003eThe other 252 cases (62.68%) eliminated the device on time. We registered 251 cases with spontaneous elimination, 14 (3.48%) by vomiting, and 237 (58.95%) via the digestive tract. Only 1 (0.24%) patient required endoscopy for intolerance.\u0026nbsp;No surgical interventions were registered.\u003c/p\u003e\n\u003cp\u003eThe early deflation rate was 2.73% (n=11). The balloon was eliminated via the digestive tract without complications in every patient except for one report of small bowel obstruction, laparoscopically solved without bowel resection (Figure 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWeight evolution\u003c/p\u003e\n\u003cp\u003eInitial average weight was 92.68 kg (62 \u0026ndash; 177) and average weight lost was 9 kg (3 months), 12 kg (6 months), and 15.04 kg (12 months).\u003c/p\u003e\n\u003cp\u003eThe median initial BMI was 32.81 kg/m\u003csup\u003e2\u003c/sup\u003e (27 \u0026ndash; 52), and the average BMI at 3 months was 29.6 kg/m\u003csup\u003e2\u003c/sup\u003e, at 6 months was 28.4 kg/m\u003csup\u003e2\u003c/sup\u003e, and at 12 months was 26.6 kg/m\u003csup\u003e2\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eMean Total Weight Loss percentage (%TWL) was 8.3%, 11.6%, and 14.9% at 3, 6 and 12 months respectively (Figure\u0026nbsp;\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eA skyrocketing demand for new, less invasive, options for the medical care of overweight and obesity supported the implementation of AGB in Latin America. Although there is scarce evidence in the region, available data suggests solid efficacy in weight loss and a superior safety profile compared to similar methods, aligned with global standards.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOur investigation included reference institutions of Argentina, Chile, and Peru which presented clinically significant weight loss values at 3, 6, and 12 months, with an average %TWL of 8.3%, 11.6%, and 14.9% respectively. Complications index was 6.46%, with a readmission rate of 4.97% and reintervention of 2.23% (1.74% endoscopically and 0.49% surgically).\u003c/p\u003e\n\u003cp\u003eThe placement of the AGB is technically simple, non-invasive, and associated with a low complication rate (less than 5%) compared to other gastric balloons requiring endoscopic intervention [8-10]. In our study, 9 cases (2.24%) required additional maneuvers for adequate balloon placement and new radioscopic control before filling. Also, a guide wire was used to guide the placement in 78 patients (19.4%) who presented difficulties with swallowing. International evidence suggests that in up to 46% of cases, this instrument was used to simplify the process [4, 11-13]. During the procedure, 5 (1.24%) adverse events were registered, 4 (0.99%) stress-related fainting, and 1 (0.24%) accidental placement of the capsule in the airway. In every case, the correct placement of the balloon was achieved, and no further complications were registered. In other published series [14], other adverse events were reported. Machytka et al. informed the detachment of the capsule in the lower esophageal sphincter before its filling. An empty balloon was eliminated the next day without complications with the stools. It is important to stress that adequate evaluation and preparation of patients before the procedure, and precise procedure execution by a suitable professional, are fundamental to minimize risks and ensure a successful experience.\u003c/p\u003e\n\u003cp\u003eDevice tolerance is also an important variable to assess efficacy and tolerance. Nausea and vomiting are the most common secondary effects during the first weeks, but they are usually temporary and disappear with adequate pharmacologic treatment [15]. In our study population, 139 cases (34.58%) experienced symptoms during the first week, the most frequent were nausea (19.7%), vomiting (11.4%), and abdominal pain (8%). After placement, 77% improved their symptoms during the first 4 days, and 8 patients (1.99%) demanded endoscopic extraction, without any complication. Jense et al. reported 80% of symptoms during the first week following placement, with excellent response to medical treatment. Endoscopic extraction was required in 1.4% of the cases [4]. In another experience, Jamal et al. reported 71.7% of nausea and vomiting after placement, in addition to 46.2% of abdominal pain [5]. The differences with our results might be related to antiemetic and antispasmodic drugs used during the preparation in our program that were not used in the previously mentioned series. Luckily, associated symptoms are mild, temporary, and easily managed.\u003c/p\u003e\n\u003cp\u003eOne of the advantages of the Allurion device is the low risk of complications, especially when compared to traditional balloons because of the noninvasive nature of the method and the shorter time of permanence of the device in the stomach, resulting in a lower risk of pressure ulcers in the gastric wall [8-10, 16-17]. In our analysis, the complication rate was 6.46%. Most of the cases were mild dehydration (3.5%) and resolved with IV hydration without the need for additional intervention. Also, 7 patients (1.74%) suffered from pyloric obstruction, solved by endoscopic procedures, one of them (0.2%) with small bowel obstruction after balloon deflation and another (0.2%) with gastric perforation after necrosis. Both required urgent surgical intervention and were treated with a laparoscopic approach. Gastroesophageal reflux symptoms (0.2%) were scarce, and resolved with proton pump inhibitors for 30 days. The readmission rate was 4.97% and the reintervention rate was 2.23%. Similar results were reported in a meta-analysis by Vantanasiri et al., reporting bowel obstruction incidence of 0.2% and gastric perforation of 0.06%, 3 patients required surgery, and one case was solved by colonoscopy [18].\u003c/p\u003e\n\u003cp\u003eRegarding the device period of permanence in the stomach, the early deflation rate was 2.73%, meaning that in 11 cases the balloons disintegrated before the 16th week. Out of those, 1 patient (0.2%) presented bowel obstruction successfully treated with surgery and the rest eliminated the balloon via the digestive tract without complications. In every case, cost-free sequential placement was offered, and 4 patients agreed to start the treatment again. According to the Dutch group publication, 2.38% of patients experienced early deflation [4]. In one patient the balloon required endoscopic extraction after a partial early deflation, which caused symptoms suggesting a bowel obstruction. It is important to stress that to optimize safety outcomes it is fundamental to consider a collaborative focus integrating adequate patient selection, early complications detection, and their management by a specialized bariatric team.\u003c/p\u003e\n\u003cp\u003eIn our experience, 107 patients (26.61%) perceived the digestive elimination of the balloon. Of those, 19.15% presented concomitant symptoms, 58.95% via the digestive tract and 3.48% orally. In the study by Jamal et al; from the 106 patients, 49 (46%) noticed the absence of the balloon after degradation, and out of those, 61.2% did it between 3 and 4 months [5]; results matching our study population (62.68%). It was also informed that 70.7% eliminated the device without associated symptoms, 12% reported oral elimination, 9% associated diarrhea, and 2% to mild abdominal pain [5]. Similar results are shown in our investigation, with 10.19% of colic abdominal pain, 3.48% of vomiting, 3.73% of diarrhea and 0.24% of anal pain at evacuation.\u003c/p\u003e\n\u003cp\u003eThe current bibliography shows a similar %TWL to our experience. Jense et al. reported a %TWL of 9.94%, 11.83%, and 10.97% at 3, 6, and 12 months of follow-up [4]. Jamal et al. stratified their sample into two groups according to their initial BMI. The BMI group between 27.5 and 34.9 kg/m\u003csup\u003e2\u003c/sup\u003e showed a %TWL of 10.2%, 10.6%, and 8.8%, meanwhile, the BMI group between 35 and 49 kg/m\u003csup\u003e2\u003c/sup\u003e reported a TWL% of 11.5%, 11.2% and 6.6% at 3, 6 and 12 months follow up respectively [5]. Also, Vantanasiri et al. included 6 studies with 1446 patients, establishing an average %TWL of 12.8% between 4 to 6 months and 10.9% at 12 months [16]. Even though our %TWL curve shows a significative ascent close to the end of the follow-up period, it is important to consider that only 40% of patients consulted after 1 year of the procedure, potentially representing a bias in this subgroup.\u003c/p\u003e\n\u003cp\u003eAGB represents a significant advance in the treatment of overweight and obesity with an average loss of 7 – 15% of the initial body weight during the period of use [18]. Long-term weight loss also depends greatly on the capacity of the patient to maintain lifestyle changes once the balloon is eliminated and the adherence to follow-up with a specialized multidisciplinary team. Unfortunately, most evidence about intragastric balloons does not include this approach.\u003c/p\u003e\n\u003cp\u003eThis study does have limitations, the analyzed sample had to pay for the Allurion\u003csup\u003e®\u003c/sup\u003e gastric balloon treatment, which might represent a bias because when patients are required to pay for a treatment, they tend to be more closely committed. This might produce an artificially high following rate, even though current research observed a rate of follow-up loss from 6.97% to 59.46%. Another limitation is the retrospective character of the current analysis where initial symptoms might be underestimated. Nevertheless, it is an interesting experience for the current bibliography and the first report in Latin America.\u003c/p\u003e\n\u003cp\u003eFinally, we consider that it is essential for patients to understand that weight loss with an AGB must be accompanied by lifestyle changes to achieve and maintain optimal results. Besides, it is necessary to personalize the treatment based on individual needs and maintain continuous follow-up with healthcare providers to increase the long-term success rate.\u0026nbsp;\u003c/p\u003e\n\n"},{"header":"CONCLUSIONS","content":"\u003cp\u003eAGB is a safe and effective option for the treatment of overweight and obesity in Latin America. Lifestyle changes and continuous support with a multidisciplinary team are essential to achieving good mid- to long-term outcomes. Long-term prospective studies might reveal more data to define the exact indications.\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eConflicts of interest\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflicts of interest.\u003c/p\u003e\n\u003cp\u003eFunding declaration\u003c/p\u003e\n\u003cp\u003eThe authors declare no financial support or funding for this research.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eA.B.C and D wrote the main manuscript text. E.F. prepared figures 1-3. G. H. and I prepared tables 1-2. All authors reviewed the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWorld Health Organization (WHO) Obesity and Overweight. Available online https://www.who.int/en/news-room/fact-sheets/detail/obesity-and-overweight (accessed on 02 June 2023).\u003c/li\u003e\n\u003cli\u003eJakobsen G, Sm\u0026aring;stuen M, Sandbu R, et al. Association of bariatric surgery vs medical obesity treatment with long-term medical complications and obesity-related comorbidities. JAMA. 2018; 319(3):291\u0026ndash;301.\u003c/li\u003e\n\u003cli\u003eEisenberg D, Shikora SA, Aarts E et al. American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery. Surg Obes Relat Dis. 2022 Dec;18(12):1345-1356.\u003c/li\u003e\n\u003cli\u003eJense MTF, Palm-Meinders IH, Sanders B, et al. The Swallowable Intragastric Balloon Combined with Lifestyle Coaching: Short-Term Results of a Safe and Effective Weight Loss Treatment for People Living with Overweight and Obesity. Obes Surg. 2023 Jun;33(6):1668-1675.\u003c/li\u003e\n\u003cli\u003eJamal MH, Almutairi R, Elabd R, et al. The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal. Obes Surg. 2019 Apr;29(4):1236-1241.\u003c/li\u003e\n\u003cli\u003eIenca R, Al Jarallah M, Caballero A, et al. The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients. Obes Surg. 2020 Sep;30(9):3354-3362.\u003c/li\u003e\n\u003cli\u003eEditorial, E. (2008). Declaraci\u0026oacute;n de Helsinki de la Asociaci\u0026oacute;n M\u0026eacute;dica Mundial. Arbor, 184(730), 349\u0026ndash;352. Recuperado a partir de https://arbor.revistas.csic.es/index.php/arbor/article/view/183.\u003c/li\u003e\n\u003cli\u003eImaz I, Mart\u0026iacute;nez-Cervell C, Garc\u0026iacute;a-\u0026Aacute;lvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis.Obes Surg. 2008;18(7):841\u0026ndash;6\u003c/li\u003e\n\u003cli\u003eAlsabah S, al Haddad E, Ekrouf S, et al. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018;14(3):311\u0026ndash;7.\u003c/li\u003e\n\u003cli\u003eGenco A, Bruni T, Doldi SB, et al. BioEnterics intragastric balloon: the Italian experience with 2,515 patients. Obes Surg. 2005;15(8):1161\u0026ndash;4\u003c/li\u003e\n\u003cli\u003eTaha O, Abdelaal M, Asklany A, et al. Outcomes of a Swallowable Intragastric Balloon (Elipse\u0026trade;) on 96 Overweight and Obese Patients. Obes Surg. 2021;31(3):965-969.\u003c/li\u003e\n\u003cli\u003eMachytka E, Gaur S, Chuttani R, et al. Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study. Endoscopy. 2017;49(2):154-160.\u003c/li\u003e\n\u003cli\u003eRaftopoulos I, Giannakou A. The Elipse balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017;13(7):1174\u0026ndash;82\u003c/li\u003e\n\u003cli\u003eGenco A, Ernesti I, Ienca R, et al. Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience. Obes Surg. 2018;28(2):405-409.\u003c/li\u003e\n\u003cli\u003eTrang J, Lee SS, Miller A, et al. Incidence of nausea and vomiting after intragastric balloon placement in bariatric patients - A systematic review and meta-analysis. Int J Surg. 2018;57:22-29.\u003c/li\u003e\n\u003cli\u003ePonce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11(4):874\u0026ndash;81.\u003c/li\u003e\n\u003cli\u003eAlhashemi M, Alkhamis A, Jamal M, et al. Safety and Effectiveness of Two Different Fluid-Filled Intragastric Balloons: A Single Center Experience. Obes Surg. Published online October 2, 2024. doi:10.1007/s11695-024-07524-7\u003c/li\u003e\n\u003cli\u003eVantanasiri K, Matar R, Beran A, Jaruvongvanich V. The Efficacy and Safety of a Procedureless Gastric Balloon for Weight Loss: a Systematic Review and Meta-Analysis. Obes Surg. 2020 Sep;30(9):3341-3346.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Gastric balloon, Obesity, Overweight, Swallowable, Allurion®.","lastPublishedDoi":"10.21203/rs.3.rs-5775111/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5775111/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAllurion® gastric balloon (AGB) is an innovative option for treating overweight and grade I obesity or as a bridging treatment for bariatric surgery or because the patient does not desire a surgical intervention. This study aimed to evaluate the efficacy and safety of the AGB in a multicentric cohort.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA retrospective analysis of consecutive cases treated with AGB (≥18 years old with BMI ≥27) was performed in eight centers in 3 countries in Latin America (Argentina, Chile, and Peru), between September 2021 to September 2022, with a 12-month follow-up.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e402 patients were included (median BMI of 32.81 kg/m\u003csup\u003e2\u003c/sup\u003e). Mean TWL% was 8.3%, 11.6%, and 14.9% at 3, 6, and 12 months respectively, with a follow-up of 93.03%, 75.37% and 40.54%. The adverse event rate was 1.24% (n=5). During the first 7 days, 34.58% (n=139) experienced concomitant symptoms, and 1.99% (n=8) asked for endoscopic balloon extraction because of intolerance. The complication rate was 6.46% (n=26). Readmission index was 4.97% (n=20) and reintervention was 2.23% (n=9). Balloon elimination was experienced by 5.7% of patients in the first 14 days, 29.10% (n=117) before the 3rd month, and 62.68% (n=252) after the 16th week. Early deflation rate was 2.73% (n=11). Digestive track elimination was perceived by 26.61%.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAGB is a safe and effective option for the treatment of overweight and obesity in Latin America. Lifestyle changes and continuous support with a multidisciplinary team are essential to achieving good mid- to long-term outcomes.\u003c/p\u003e","manuscriptTitle":"Assessing the Efficacy and Safety of the Allurion® Gastric Balloon in Latin American Patients: A Multicenter Case Series","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-01-13 12:59:02","doi":"10.21203/rs.3.rs-5775111/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"12b7d4d0-07c9-42c7-a6f8-727a192c5840","owner":[],"postedDate":"January 13th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-12T15:09:13+00:00","versionOfRecord":[],"versionCreatedAt":"2025-01-13 12:59:02","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5775111","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5775111","identity":"rs-5775111","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}