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).
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.
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.
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.
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.
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).
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.
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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