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Endoscopic Bariatric Therapy

A Guide to the Intragastric Balloon

Bazerbachi, Fateh MD1; Vargas, Eric J. MD1; Abu Dayyeh, Barham K. MD, MPH, FASGE1

American Journal of Gastroenterology: September 2019 - Volume 114 - Issue 9 - p 1421–1431
doi: 10.14309/ajg.0000000000000239
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Intragastric balloons (IGBs) are the most widely available endoscopic bariatric therapy for class I and II obesity in the United States. Although simple in application and reversible by nature, these devices may help patients initiate the important first steps in weight loss maintenance, provided that parallel efforts are in motion to prevent weight recidivism. Too often, therapeutic nihilism stems from unrealistic expectations of a given therapy. In the case of IGBs, this sentiment may occur when these interventions are applied in a vacuum and not within the purview of a multidisciplinary program that actively involves dieticians, endocrinologists, gastroenterologists, and surgeons. There is a clear and present need to apply different tactics in the remissive strategy to control the obesity pandemic, more so in a struggling landscape of an ever-widening gap in bridging interventions. With such demand, the IGB is an available tool that could be helpful when correctly implemented. In this exposition, we summarize the current state of IGBs available worldwide, discuss their mechanism of action, relay evidence for their short- and long-term efficacy, address safety profile concerns, and suggest procedural considerations in the real-world quotidian application.

1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.

Correspondence: Barham K. Abu Dayyeh, MD, MPH, FASGE. E-mail: AbuDayyeh.Barham@mayo.edu.

Received October 12, 2018

Accepted March 07, 2019

Online date: May 9, 2019

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BACKGROUND

It is now accepted that obesity as a chronic disease has reached pandemic heights, with close to 40% of US adults afflicted and more than a fifth of healthcare expenses consumed by related comorbidities (1). Mild to moderate weight loss of 5%–10% of initial body weight improves the substantial proportion of these comorbidities, but restoring normal body weight in adults with obesity with lifestyle interventions alone remains a challenge (2,3). In general, bariatric surgery continues to be the most effective means to achieve durable weight loss and comorbidity resolution and improve mortality and quality of life (4); however, despite the plethora of benefits obtained from surgery, the overwhelming majority of eligible patients do not receive it due to fear of complications, limited access, and costs associated with these interventions. Indeed, it is estimated that only 216,000 patients received a bariatric intervention in 2016 (5), a striking disparity when viewed juxtaposed with more than 15 million patients with class III obesity in the United States (6). Similarly, patients with class I and II obesity who do not qualify for bariatric surgery are left with largely ineffective means to achieve the weight loss thresholds for comorbidity improvement. Importantly, these patients contribute significantly more to the comorbid disease burden and mortality than those with class III obesity alone, creating a gap in obesity management (1). Currently, both government agencies (the Agency for Healthcare Research and Quality) and national societies, such as the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the American Society for Metabolic and Bariatric Surgery, have recognized this management gap calling for improved treatment options (8–10). As a result, less-invasive weight loss therapies, such as intragastric balloons (IGBs), were introduced as an attempt to bridge this gap in obesity, facilitating access and application to the larger segment of the population with class I and II obesity and to those who benefit from preoperative weight loss before traditional bariatric surgery or organ transplantation. In this exposition, we discuss the available IGBs, outlining their mechanisms of action, efficacy, safety, and their clinical applications.

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INTRAGASTRIC BALLOONS: MECHANISMS OF ACTION AND DESIGNS

It was observed that large ingested bezoars could lodge in the stomach for prolonged periods of time without being associated with any symptom other than insidious weight loss (11). This clinical observation has led to the early application of IGB for weight loss in the 1980s (12). Currently, there are 8 IGBs in the world market, with 3 of them currently approved by the United States Food and Drug Administration (FDA): (i) the Orbera intragastric balloon (OIB) (Apollo Endosurgery, Austin, TX), previously known as the BioEnterics Intragastric Balloon (Allergan, Irvine, CA); (ii) the ReShape Duo (Duo) (ReShape Medical, San Clemente, CA); and (iii) the Obalon IGB (Obalon Therapeutics, Carlsbad, CA). Characteristics of available IGBs in the world market are summarized in Table 1.

Table 1-a

Table 1-a

Table 1-b

Table 1-b

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Gastric emptying and accommodation

The effect of IGBs on gastric emptying is one of the many processes by which they modulate hunger and satiation (7,13). Adapted from the gastric restriction component of multiple bariatric procedures to date, IGBs were designed to elicit a gastric restriction process through their space-occupying design and produce perturbations in physiologic parameters, such as gastric emptying, accommodation, and gastrointestinal neurohormonal release that alter satiety and satiation, all synergistically leading to weight loss. These findings have mostly been elucidated from studies using the single, fluid-filled IGB, the OIB (Apollo Endosurgery). The first mechanistic study was a prospective, randomized clinical trial that demonstrated that the OIB produced significant delays in gastric emptying compared with lifestyle interventions alone. The study also revealed an association between delays in gastric emptying and positive weight loss outcomes (7). A similar effect of the OIB on gastric emptying was also demonstrated in 2 additional smaller studies (13,14). These effects are yet to be demonstrated when applying the dual, fluid-filled balloons (Duo) or the more recent gas-filled balloons. Thus, based on the available literature, it is not clear whether IGBs with different contents (fluid vs gas) or shape (single vs double balloon) share similar or different mechanisms of action. However, a recent meta-analysis of 44 studies and 5,549 patients examined the relation between balloon-filling volume and % total body weight loss (%TBWL) achieved, and found no significant correlation on meta-regression (15). Moreover, another recent meta-analysis suggests that gas-filled balloons do not significantly delay gastric emptying, as opposed to fluid-filled balloons (16).

Despite the lack of association between balloon-filling volume and %TBWL, our group has recently shown that increasing the balloon-filling volume, in a study examining the adjustable Spatz3 balloon, was associated with a further delay in gastric emptying and a further decrease in post-adjustment patient weight (17). One hypothesis is that the change in filling volume after homeostasis is established, rather than a fixed, unchanging filling volume, is the impetus behind overcoming the gastric-emptying steady state. This may suggest that a dual, fluid-filled balloon may not have the same augmented delay in gastric emptying, at least from a dual filling volume perspective, because the volume is predetermined at balloon insertion.

Other aspects of gastric physiology, such as gastric accommodation, may also be altered when IGBs are placed. Samsom et al. (18) have demonstrated that the placement of an IGB modifies the distribution of food, leading to distention of the antrum and potentially invoking exaggerated fundic relaxation. The placement of an IGB in the proximal stomach may instigate this reflex and interrupt certain neurohormonal pathways, which may account for the mechanism of action of certain IGBs currently unavailable in the United States (19,20).

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Neurohormones: ghrelin

Following diet-induced weight loss, ghrelin levels typically rise in response to a state of negative energy balance, whereas in sleeve gastrectomy, ghrelin levels fall due to the surgical removal of ghrelin-producing cells (21,22). Changes in gut neurohormones such as ghrelin that are implicated in satiety and metabolic control after IGBs have been conflicting. In a prospective, sham-controlled study by Mathus-Vliegen and Eichenberger (23), no increase in ghrelin concentrations was observed with the OIB after 13 and 26 weeks of implantation, despite significant weight loss. A study by Mion et al. (14) also demonstrated that plasma ghrelin levels remained lower with the OIB, with a positive correlation with weight reduction (r = 0.668). At least one other study, however, showed a transient increase in plasma ghrelin levels during OIB treatment which has historically been expected with negative energy balance (24,25). Differences in ghrelin assays (active ghrelin vs total ghrelin) and the timing of acquisition could potentially explain the differences across these studies. However, stimulation of mechanoreceptors in the body and fundus could be responsible for the lower ghrelin levels after IGB-induced weight loss. More investigations with IGBs are needed to confirm this vagal hypothesis.

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EFFICACY OF IGBs

Short-term efficacy (up to 12 months)

IGBs are effective in producing anywhere from 6% to 15% TBWL compared with the 1%–5% produced through lifestyle interventions alone. In the United States, there have been 3 pivotal trials with the FDA-approved IGBs. The REDUCE multicenter, blinded, sham-controlled clinical trial compared 187 patients with the ReShape Duo IGB with 139 patients receiving lifestyle interventions alone. The %TBWL at 6 months among completers in the ReShape Duo group (n = 167) was 7.6% ± 5.5% compared with 3.6% ± 6.3% in the control group (n = 126) (26). The OIB underwent a similar trial, where 125 patients obtained the balloon and 130 patients received lifestyle interventions alone. The %TBWL among completers at 6 months in the OIB group (n = 116) was 10.7% ± 6.8% compared with 4.7% ± 5% in the control group (n = 99) (27).

Finally, in a pivotal, multicenter, randomized, sham-controlled clinical trial, investigators compared 198 patients receiving up to 3 consecutive balloon capsules (the Obalon IGB) plus lifestyle interventions with 189 patients receiving sham capsules in addition to lifestyle interventions. The %TBWL after swallowing 3 consecutive balloon capsules (n = 174) was 7.1% ± 5.0% at 6 months from the first swallowed capsule compared with 3.6% ± 5.1% in the control group (n = 176) (Figure 1) (28,29). A recent meta-analysis of 20 randomized controlled trials (RCTs) (N = 1,195 patients), including only 1 of the 3 pivotal US RCTs described previously (26), demonstrated the short-term efficacy of IGBs as a group with higher effect size favoring fluid-filled vs gas-filled IGBs (30). This observation was maintained in a network meta-analysis restricted to RCTs comparing IGBs available in the world market (31). Overall, the OIB has been the most extensively used and investigated IGB in the world, with usage dating back for more than a decade, and with a meta-analysis of 55 studies including 6,645 OIB implantations demonstrating a pooled estimate of %TBWL at 6 months of 13.2% (95% confidence interval [CI], 12.4–13.95) (32).

Figure 1

Figure 1

However, weight loss after IGB insertion usually plateaus after the first few months (33). This phenomenon may be related to increased stomach-accommodating volume, allowing larger intake of food, decreases in resting energy expenditure, hormonal adaptions, or behavioral intervention fatigue. This plateau observation has been key in the conceptualization and innovation of adjustable IGBs (Spatz3 Adjustable Balloon; Spatz FGIA), which is currently being studied in an FDA-approved trial where the IGB volume can be increased to ameliorate weight loss when a plateau occurs. Recent literature suggests that this volume-altering has important clinical and physiologic significance to augment weight loss and break through plateaus (17,33). Whether changes in the accommodation are responsible for this observed plateau remain to be investigated.

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Weight recidivism after therapy

Although IGBs are safe and effective in managing obesity for a short term, they are temporary measures, and weight regain is an expected result after their removal. This aftermath can be observed from a number of studies that evaluated patient course after balloon removal for variable periods. In a study of 500 obese patients who underwent 6 months of treatment with IGB, only half of the patients maintained >20% excess weight loss at 1 year after IGB removal and a quarter of patients kept this weight loss at 5 years (34). In a Brazilian study of 224 patients, weight regain after IGB removal was observed in 66% of patients (35), and the authors found that the lack of psychological counseling and nutrition support, in addition to a sedentary lifestyle, contributed to the long-term weight regain after IGB removal. Similarly, a Lebanese group suggested that up to 79% of patients will regain weight in the long term and more than a third will resort to other bariatric interventions after IGB treatment is concluded (36). However, patients remain at a lower weight than their preimplantation levels (37–42).

One of the strategies to combat this weight recidivism is sequential therapy with another balloon. This strategy has been highlighted in the study by Dumenceau et al., where further weight loss was achieved with a second balloon insertion sequentially after the first balloon was removed (37). Other strategies to mitigate weight regain may also include the addition of adjuvant pharmacotherapy after IGB removal, and this has been suggested for other bariatric interventions as well (43). Ultimately, it is unreasonable to expect that a reversible and temporary intervention, be it lifestyle interventions, endoscopic devices, or antiobesity medications will result in a sustained weight loss benefit if not supplanted by continuous management from a multidisciplinary team, including nutritionists, primary care providers, behavioral therapists, and gastroenterologists. Obesity is best viewed as a treatable but not a curable condition, akin to approaching other chronic health conditions such as diabetes or hypertension. Phenotype-driven individualized personalization of treatment will likely become the norm in the future so that weight loss responses are easily achieved and readily maintained.

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SAFETY OF IGBs

Despite the recent reports, IGBs remain one of the safest temporary endoscopic bariatric treatments available. A recent systematic review (31) of 15 RCTs including 886 IGB implantations showed 0% mortality and low rates of severe serious adverse events (SAEs) (24,26–28,40,44–54) (Table 2). The rates of non-SAEs associated with IGBs in RCTs are also summarized in Table 3, with most being accommodative symptoms, such as abdominal pain and nausea, which are usually self-limited and expected (55). Early removal rates are the major predictor of decreased efficacy with IGBs, with a recent meta-analysis of 68 studies of the OIB (32) revealing a pooled 7.5% early removal rate for intolerance. Similar intolerance data are not completely available for the other IGBs, but severe SAEs in this meta-analysis were rare, with an incidence of migration, gastric perforation, and mortality of 1.4%, 0.1%, 0.08%, respectively. Fifty percent of gastric perforations (4 of 8) occurred in patients who had undergone previous gastric or esophageal surgeries. Similarly, among 41,863 implantations of different IGBs in Brazil, only 3 balloon-related mortalities were reported (gastric perforation, pulmonary aspiration, and pulmonary embolism) (56). As a result, previous gastric or esophageal surgery is a contraindication for IGB placement in the United States.

Table 2

Table 2

Table 3

Table 3

Through medical device reporting, the FDA has recently issued 3 alerts between February 2017 and June 2018 to educate providers on the potential risks of acute pancreatitis and spontaneous balloon hyperinflation and 12 reports of unanticipated deaths worldwide that occurred in patients with the OIB System and the ReShape Integrated Dual Balloon System (57,58). Seven of these 12 deaths occurred in the United States (4 with the Orbera system and 3 with the ReShape system), with mortality rate, per the manufacturer, of 0.036% (<4 deaths per 10,000 patients) for the Orbera system and 0.06% (3 deaths per 5,000 patients) for the ReShape system. As relayed previously in recent systematic reviews and meta-analyses, the incidence of these SAEs was exceedingly rare, and thus highlighting a few important points. First, when patients are appropriately selected and followed in a multidisciplinary program, IGBs are safe interventions. Second, most of these reports were related to gastric perforations, in which most of them typically occur in patients with previous gastrointestinal surgery, underscoring the importance of a proper evaluation before the placement, in addition to baseline endoscopic assessment. Third, and more importantly, inadequate periprocedural management of retching, nausea, and vomiting leads to gastric perforation, re-enforcing the need for close follow-up after IGB placement. A recent Canadian study (59) suggested that IGBs offer lower safety profile than invasive bariatric procedures, demonstrated by a propensity-matched analysis showing higher nonoperative reintervention rate and a higher overall adverse events profile (5% in IGB group vs 2.6% in bariatric surgery group; P = 0.2). However, nonoperative reinterventions, secondary to accommodative symptoms (e.g., nausea, vomiting, abdominal pain), contributed to this adverse events profile. In this limited experience, the occurrence of any of these expected symptoms was deemed an SAE, although cumulative knowledge about periprocedural management of IGB implantation mitigates many, if not most, of these events (26,60).

More recently, 2 large post–FDA approval US studies involving 523 patients with IGB showed no incidence of death, with a favorable safety profile comparable with routine diagnostic endoscopy, highlighting both the safety and efficacy of these interventions when administered as part of a multidisciplinary and comprehensive program (61,62). The Canadian study also reviewed 781 IGB placements in 2016, and none were associated with death, myocardial infarction, cerebrovascular event, or venous thromboembolism. Only 2.8% of these cases required an early removal of the balloon due to adverse events/intolerance (59). This is in contrast to 6.4%–16.6% early removal rates in the US postregulatory approval studies (61,62). Thus, overall, IGBs remain one of the safest bariatric interventions available in the market in the appropriate clinical settings, with the inherent risks similar to any routine endoscopy (Table 4).

Table 4

Table 4

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BALLOON CHARACTERISTICS, FILLING VOLUMES, AND DWELLING TIME

As described in Table 1, there are multiple IGBs in the market with different shapes, filling volumes, content (fluid vs gas), materials, indwelling times (4–12 months), and placement/retrieval mechanisms. Limited data compare these IGBs with each other. However, a synthesis of the available literature demonstrated that fluid-filled IGBs are more effective than gas-filled IGBs for weight loss, but gas-filled IGBs remain better tolerated (30,31). These differences in outcomes and tolerance may partially be explained by the differing effects on gastric emptying (16). Small increments in weight loss were observed when increasing the balloon volume beyond 500 mL (Figure 2) (15). On the other hand, literature from adjustable IGBs suggests that the ability to volume-alter balloons improves tolerance and overall weight loss outcomes, although these adjustable IGBs are only currently available in clinical trials (63). Finally, although the weight loss with IGBs is most steep within the first 3 months, balloons with longer dwelling times (12 months) are associated with better long-term weight maintenance (64).

Figure 2

Figure 2

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OPERATIVE AND PERIOPERATIVE MANAGEMENT

Balloon placement

The largest body of data comes from the Brazilian Intragastric Balloon Consensus Statement and clarifies important management details (56). For endoscopically placed IGBs, it is recommended that the procedure be performed in at least an outpatient endoscopy center with advanced life support and the ability to administer conscious sedation. Deeper forms of sedation for balloon placement can be used but will require anesthesia support. In our experience, IGB placement can be safely provided without airway protection, which is not the case for IGB removal. The adult-size gastroscope with high-definition, white light examination is the preferred instrument to evaluate the esophagus, stomach, and duodenum before balloon placement and monitor the location of the balloon with inflation and after release. A good quality preplacement EGD is mandatory and may alter therapeutic plans. In the postregulatory US study (61), 1% of procedures were aborted because of pathology on endoscopy or previous undisclosed GI surgery. Prophylactic use of antifungal or antimicrobial drugs is not recommended. Triple antiemetic therapy that includes the use of corticosteroids (intraoperatively) is recommended. It is not clear at this point whether the use of more potent and expensive antiemetic agents such as aprepitant (Emend) is associated with an incremental benefit over lower-cost alternatives to justify its routine use. Proton pump inhibitor therapy and the avoidance of nonsteroidal anti-inflammatory drugs are recommended during IGB therapy.

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Postoperative management

After IGB placement, patients should be consuming a transitional diet that includes an initial period of full liquids to prevent dehydration. Aggressive management of accommodative symptoms (nausea, vomiting, abdominal cramps) during the first week after IGB placement is critical to prevent dehydration or esophageal injury from retching. Therefore, antiemetics are to be scheduled and not prescribed on as needed basis, at least during the first 3 days. An anxiolytic at bedtime as needed is helpful to avoid anticipatory symptoms of cramping, which are vigorous and pronounced in the first couple of days. Aggressive management with antispasmodics (such as hyoscyamine) is also important during this acclimating period. Patients should be followed within 1 week after IGB placement to monitor for complications and manage accommodative symptoms. Monthly contact with the patient while the IGB is in the stomach is recommended. Persistent vomiting beyond 10–14 days after IGB placement is uncommon and warrants a clinical investigation for electrolyte imbalance, dehydration, gastric outlet obstruction, dietary indiscretion, or balloon intolerance with consideration for initiating prokinetic pharmacotherapy or early balloon removal. In addition, constipation is a common culprit when GI symptoms, such as nausea or bloating, occur >10–14 days after placement, and a rigorous bowel regimen with scheduled osmotic laxative and a rescue suppository should also be discussed with the patient.

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Balloon removal

For balloon removal, it is recommended that patients be on at least 2 days of liquid diet, followed by a 12-hour fasting period due to the expected IGB-induced gastric-emptying delay, and that the procedure is performed in an outpatient endoscopy center with advanced life support and the ability to administer monitored anesthesia care. Aspiration precautions during IGB removal should be observed (left decubitus positioning of the patient with elevation of the head of the bed). Anesthesia support for IGB removal with endotracheal intubation to prevent aspiration should be used in select patients with clinical suspicion of dietary noncompliance, with continued symptoms of delayed gastric emptying or gastric outlet obstruction, or when moderate to large amount of food is found in the stomach during the removal procedure. Administration of antibiotics or prokinetic agents before IGB removal is not recommended. For patients who were not on proton pump inhibitor therapy before balloon placement, these medications should be titrated off over 4 weeks after balloon removal to mitigate any possible rebound acid hypersecretion (65). The specific endoscopic tools and techniques for IGBs removal vary with the specific device, and we recommend that operators carefully follow the instructions for use provided with each device.

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PATIENT SELECTION AND FOLLOW-UP

Patient selection

In general, IGBs should be considered in patients with class I and II obesity (body mass index [BMI] between 30 and 40 kg/m2), who are unsuccessful in losing or maintaining weight loss with lifestyle interventions alone. Clinicians should initially screen all potential candidates with a comprehensive evaluation for medical conditions, comorbidities, and psychosocial or behavioral patterns that contribute to their obesity before enrolling patients in a weight loss program that includes IGBs. Thus, an evaluation by an obesity medicine physician is recommended. Contraindications to placement are multiple, including large hiatal hernias (>5 cm), active peptic ulcer disease in the stomach, previous gastric or esophageal surgery, upper gastrointestinal inflammatory bowel disease, gastric neoplasms, esophageal dysphagia, dysmotility, and eosinophilic esophagitis. Other contraindications include known gastroparesis, coagulation disorders, variceal disease, substance abuse, uncontrolled psychiatric disease, pregnancy, chronic use of nonsteroidal anti-inflammatory drugs, and prohibitive medical comorbidities that increase the risk of endoscopy or anesthesia (for endoscopically managed IGBs) (66).

Outside the above-mentioned parameters, IGBs can be used in select patients with class III obesity (BMI > 40 kg/m2) as a bridge to traditional bariatric surgery or to facilitate nonbariatric interventions that could not be performed safely due to weight limits (i.e., orthopedic surgery, organ transplantation) (32,60,67–72).

If IGBs are applied before a surgical procedure that involves gastric manipulation or resection, a waiting period of at least 30 days is recommended before undertaking the operative intervention and at least 6 months before endoscopic suturing. This recommendation stems from the fact that IGBs (at least those that are fluid filled) have been shown to transiently increase gastric wall thickness (73). In the literature, IGBs have been shown to produce significant weight loss in patients with wide range of BMIs (32,60). The use of IGBs in overweight individuals (BMI = 27–29 kg/m2) (52), adolescents (74), sequential balloon therapy (75), and in combination with obesity pharmacotherapy (76) is encouraging, and further investigation is warranted.

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Patient follow-up

Once placed, IGBs should be accompanied by moderate- to high-intensity lifestyle interventions, which include dietary interventions, exercise therapy, and behavior modification. Active patient participation in these structured weight loss programs during both initial weight loss phase and long-term maintenance phase is highly recommended if not required. All patients should be followed prospectively to capture changes in weight and weight-related comorbidities, and also all related adverse outcomes. Poor responders, such as those who fail to achieve at least 5% TBWL by 3 months, should be identified and offered a detailed evaluation and alternative therapy that includes an intensified behavioral and lifestyle program and pharmacotherapy (9). Acknowledging the limited data, it is recommended that patients are initiated on obesity pharmacotherapy with continuation of the behavioral and lifestyle program after IGB removal by a team experienced in administering these therapies to maximize weight maintenance (76,77). A minimum of 6 (12 recommended) visits or contacts with patients is recommended within the 12 months after IGB implantation. However, if clinicians do not have access to psychology or nutrition support within their practice, early observational data suggest that electronic off-site contracted services that offer these services to patients are acceptable alternatives for highly motivated patients (78).

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IMPACT OF Igbs ON OBESITY COMORBIDITIES AND QUALITY OF LIFE

After removal, IGBs improve obesity-related comorbidities and markers of metabolic health in association with their weight loss, although long-term amelioration in metabolic health cannot yet be judged from the current body of literature.

Furthermore, the unique and sole application of the IGB is unlikely, by itself, to result in meaningful and sustained improvements in comorbidities and maintenance of weight loss. It is important to note that a clinically significant and durable improvement in metabolic parameters will generally be translated in long-term follow-up. To date, such dedicated, robust studies are lacking; however, the absence of evidence should not be construed as evidence of absence. Ten RCTs and 30 observational studies including more than 5,600 subjects were analyzed in a recent meta-analysis to investigate the impact of IGBs on obesity comorbidities. Most studies evaluated the impact on comorbidities in the short term with a paucity of long-term data. There was moderate-quality evidence for improvement in most metabolic parameters in patients assigned to IGB therapy compared with those receiving lifestyle interventions alone: fasting glucose improved by 12.7 mg/dL (95% CI: −21.5, −4), triglycerides by 19 mg/dL (95% CI: −42, −3.5), waist circumference by 4.1 cm (95% CI: −6.9, −1.4), and diastolic blood pressure by 2.9 mm Hg (95% CI: −4.1, −1.8) over lifestyle intervention alone. The odds ratio for diabetes resolution after IGB therapy was 1.4 (95% CI: 1.3, 1.6) (79,80).

In patients with nonalcoholic fatty liver disease, the impact of IGB on nonalcoholic steatohepatitis activity and liver fibrosis was evaluated prospectively in 20 patients who underwent paired EUS-guided biopsies and MR elastography/spectroscopy at the time of placement and removal after 6 months. In this cohort, fibrosis resolution was seen in 10% of patients after 6 months of IGB therapy, with 80% achieving at least 2-point NASH activity score (NAS) improvement on liver biopsies, and 65% had complete resolution of steatohepatitis (80). Our group described, in a prospective trial, improvement in NAS score which was not correlated with the degree of weight loss but rather with improvement in mesenteric fat thickness (data not published). This is consistent with other recent studies that demonstrate improvement in liver stiffness after bariatric surgery, independent of the degree of weight loss (81). One explanation is that not all phenotypes of weight loss are equal, and it may be the case that visceral fat loss is the actual predictive measure of metabolic health rather than %TBWL.

Reimão et al. (82) showed that IGBs also produce favorable changes in body composition through the reduction of body fat mass and fat area. In 2 pivotal RCTs, where the quality of life was assessed, IGBs improved weight-related quality of life significantly more than lifestyle interventions alone (26,27). Last, in a recent study, Guedes et al. (83) demonstrated that IGB treatment in obese patients not only decreased central and total body fat but also improved the quality of life and physical activity. Thus, IGBs lead to favorable changes in metabolic markers of cardiovascular and liver health, and also the appearance and overall quality of life in association with the induced weight loss.

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CLINICAL APPLICATION, LONG-TERM WEIGHT LOSS, CLOSING THOUGHTS

IGBs are safe and effective weight loss tools that lead to improvements in physical and mental health. Before clinicians introduce IGBs into their clinical practice, a comprehensive knowledge of the indications, contraindications, risks, benefits, and outcomes of IGBs, and also a practical knowledge of the risks and benefits of alternative therapies for obesity such as lifestyle interventions, pharmacotherapy, and bariatric surgery should be obtained. Clinicians should also be credentialed and privileged to use the device by local regulatory or institutional guidelines to ensure that the necessary knowledge and technical skill for the particular device are achieved before performing these procedures. We also encourage gastroenterologists to work as a group with bariatric surgeons, endocrinologists, licensed dieticians, and behavioral psychologists to form a comprehensive obesity management team.

The paradigm for managing class I and II obesity has now evolved to a model of chronic disease management much like that of hypertension and diabetes, with an initial weight loss strategy including short-term devices such as IGBs, followed by an aggressive weight-maintenance phase that counteracts the physiologic changes that led to obesity using long-term pharmacotherapy and lifestyle changes. The question is no longer whether IGBs result in weight loss, but whether the combination of IGBs with pharmacotherapies or other endoscopic bariatric and metabolic therapies (EBTs) and the indispensable comprehensive lifestyle and behavioral intervention programs can manage obesity as a chronic disease in the long term. In the near future, and through the introduction of personalized medicine including prognostic and predictive biomarkers, clinicians will soon be able to personalize endoscopic bariatric management, maximizing effectiveness and minimizing intolerance rates (84). Offering such a step-up approach that has been successful in other chronic disease models, such as hypertension and diabetes, will likely minimize nonresponders and enhance the efficacy-to-risk ratio by providing an effective and durable nonsurgical weight loss option to this historically undertreated cohort. The future of obesity management encompasses the full spectrum of interventions from lifestyle changes, medications, bariatric endoscopy, and surgery in a personalized, patient-centered medical home approach to chronic disease management.

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CONFLICTS OF INTEREST

Guarantor of the article: Barham K. Abu Dayyeh, MD, MPH, FASGE.

Specific author contributions: F.B. and E.J.V.: drafting of the manuscript. B.K.A.D.: drafting and critical revision of the manuscript. All authors approved the final draft submitted to the journal.

Financial support: None.

Potential competing interests: F.B.: none. E.J.V.: none. B.K.A.D.: consultant: Apollo Endosurgery, Boston Scientific, Metamodix, BFKW; research support: Aspire Bariatrics, GI Dynamics, Apollo Endosurgery, USGI, Medtronic, Spatz, and Cairns; speaker: Johnson and Johnson and Olympus.

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