Intragastric Balloon

Anatomy and Physiology

Anatomy

The stomach is an intraperitoneal digestive organ lying between the esophagus and the first portion of the small intestine, called the duodenum.[8] The stomach primarily lies within the epigastric and umbilical regions of the abdomen. There are four main anatomical divisions within the stomach. The first is the cardia, which surrounds the superior opening of the stomach at the thoracic level 11.

The next division is the fundus, a rounded and often gas-filled portion of the stomach that is both superior and left of the cardia. The large, central portion of the stomach inferior to the fundus is known as the body. The fourth division is the pylorus. The pylorus connects the stomach to the duodenum, with subdivisions into the antrum, canal, and pyloric sphincter. The pyloric sphincter serves as a demarcation of the transpyloric plane at lumbar vertebrae level one.

The stomach has a greater and lesser curvature. The greater curvature is the long and convex curvature on the lateral border of the stomach. It curves towards the right as it courses mediately to the antrum. It is vascularly supplied by the short gastric arteries and the right and left gastro-omental arteries. The right gastro-omental artery is a terminal branch of the gastroduodenal artery that arises off the common hepatic artery. The left gastro-omental artery is a branch of the splenic artery derived from the celiac trunk. The lesser curvature of the stomach is shorter and concave and located on the medial surface of the stomach. The angular notch indicates the junction of the body and the pyloric region of the stomach and is the most inferior part of the lesser curvature. The lesser curvature provides attachments to the hepatogastric ligament. The vascular supply to the lesser curvature is the left gastric artery and right gastric branch of the hepatic artery. The right gastric artery comes off the common hepatic artery, derived from the celiac trunk. The left gastric artery directly comes off of the celiac trunk.[9] 

There are two sphincters of importance when relating to gastric emptying located at each orifice of the stomach, the inferior esophageal sphincter, and the pyloric sphincter.

Pathophysiology

The insertion of an intragastric balloon promotes the feeling of satiation and uses restriction as a mechanism for weight loss. The balloon reduces the stomach's capacity to accommodate food, resulting in a reduced caloric intake. The intragastric balloon typically occupies up to a third of the stomach cavity.[10] Since the intragastric balloon mechanism relies on a restrictive process, the efficacy is dependent on patient adherence to both diet and exercise modifications. A complex neuro-humoral axis that regulates the feeling of satiation and body weight exists, represented within the gut-brain axis.[5] 

There are nervous and humoral afferent cells from the gastrointestinal tract and adipose tissue integrated within brain stem circuitry. Signals for hunger, saturation, and satiation are provided within complex brainstem circuits. Mechanical stimuli like stomach distention feed the system but are modulated via hormonal and psychological factors like the reward system. After ingestion of food, the stomach undergoes distention and signals saturation via the parasympathetic afferent fibers. By contrast, the brainstem nuclei control the pre-prandial tone and relaxation post-meal. Neuroimaging studies have demonstrated a difference between physiological distention via nutrients versus intragastric balloon distention of the stomach. The mechanic distention by the inflated balloon addresses the region of the brain in which pain processing occurs. This pain processing is part of a visceral pain neuromatrix that is downregulated with the infusion of nutrients. This processing may be part of a physiological process for the body to ensure an adequate intake of food despite experiencing gastric distention.[11] 

The processing likely explains the side effects in the first days following the placement of an intragastric balloon and satiety after food ingestion. Functional MRI studies have demonstrated that sweet liquid beverages did not lead to any significant effect on the cortical brain circuits associated with a food craving, meaning that a patient who has an increased intake of liquid calories may not have many benefits from the placement of an intragastric balloon system.[10]

Regarding the hormonal effects on satiation and hunger, ghrelin is a hormone of discussion. Ghrelin is a 28 amino acid sequence peptide, primarily expressed in the gastric fundus and key in weight regulation. Ghrelin stimulates appetite and feeding behavior, energy homeostasis, and carbohydrate metabolism. This hormone does stimulate the release of growth hormone from the pituitary gland. The orexigenic effects of ghrelin are secondary to the binding of the hormone to the growth hormone secretagogue receptors. Ghrelin promotes both adipose depositions as well as lipogenesis.[12] It stimulates appetite and food intake by acting upon the hypothalamic gland at the arcuate nucleus. It inhibits insulin secretion and causes an increase in plasma glucose levels. It also stimulates both gastric as well as intestinal motility. The role of the intragastric balloon with ghrelin is unclear. Research has shown that calorie intake may be a required signal for the secretion of ghrelin, and the mechanical effects of the balloon's inflation alone did not show a reduction in the plasma levels of ghrelin.

Besides the restrictive process of the balloon and the hormonal factors, another mechanism for weight-loss post intragastric balloon insertion is gastric emptying. Scintigraphic gastric emptying time post-balloon placement at the three-month mark demonstrated a significant slowing of both solids and liquids in terms of gastric emptying time, positively correlated with weight loss. There is the question of whether the initial effects of the intragastric balloon persist during the entire time of treatment period. Subjective rating of food desires and hunger decreases shortly after the balloon's initial placement, but these alterations have demonstrated to disappear at the two-month mark post-placement.[13] 

The proposed slowing of gastric emptying is likely seen with saline or fluid-filled balloons. Once filled with fluid, the balloon sinks to the bottom, distal portion of the stomach, resulting in a longer period of both food and liquids to empty within the stomach. An increased length of gastric emptying leads to an increase in the length of satiation.[14] 

Overall, the proposed mechanisms for weight loss during the intragastric balloon treatment timeframe are likely secondary to gastric distention via the restrictive process, hormonal signaling via ghrelin, and the slowed gastric emptying time.

Indications

The first-line treatment and initial management for a patient with obesity are lifestyle interventions. This would include counseling the patient on nutrition, exercise, sleep, stress, and developing health goals. When considering a patient for an intragastric balloon, the BMI guidelines differ between Europe and the US. However, in both circumstances, patients must have attempted previous weight loss and management with diet and exercise. In Europe, a patient with a BMI of 27 kg/m^2 is the threshold, but in the US, it is a BMI of 30 kg/m^2.[15] 

In Europe, a patient with a BMI of 27 to 35 kg/m^2 or in the US with a BMI of 30 to 35 kg/m^2, an intragastric balloon can be considered an early intervention therapy to induce weight loss. These patients do not meet the eligibility criteria to undergo bariatric operations, but early intervention would benefit from preventing or even treating obesity-related illnesses. If a patient has a BMI of 35 kg/m^2 with one or more of the aforementioned obesity-related medical conditions or a BMI greater than 40 kg/m^2, bariatric surgical intervention would be the treatment of choice. Approximately 1 to 2% of these patients who meet these criteria undergo surgical intervention given risks associated with surgery.[16] 

In this circumstance, although the patients are eligible for bariatric surgery, alternative interventions to help induce weight loss, like intragastric balloon therapy, can be used. Suppose a patient has a measured BMI that is greater than 50 kg/m^2. In that case, a patient can be considered high risk for either an anesthesia-related complication or a technical complication during surgical intervention. This is secondary to the large amounts of intra-abdominal fat and hepatomegaly.[17] 

These patients can be considered for an intragastric balloon as a bridging intervention before undergoing a bariatric operation. Having notable preoperative weight loss can decrease the complexity of the surgery and the associated risks with the surgery at hand. Out of the noted criteria for intragastric balloon placement, it is used primarily for those not meeting the BMI criteria for bariatric surgery. When counseling a patient who qualifies for bariatric surgery, this should be encouraged as it has superior weight-loss efficacy and durability compared to lifestyle changes alone. Further research is needed to evaluate the intragastric balloon as a bridging therapy to bariatric operations.

Contraindications

A complete history and physical examination should be completed for all patients to screen for contraindications of intragastric balloon placement. The patient's history should focus on any gastrointestinal disorders. Absolute contraindications to an intragastric balloon include any prior gastric surgeries, coagulopathies, severe liver disease, upper gastrointestinal bleeding lesions, pregnancy as well as the desire to become pregnant, alcoholism, drug addiction, and any contraindication for the patient to undergo esophagogastroduodenoscopy (EGD). 

Some of the balloons are placed via EGD or swallowing. In circumstances in which a balloon retrieval is necessary due to complications, an EGD can be required for this retrieval process. The relative contraindications to intragastric balloon therapy include a large hiatal hernia measuring 3 cm or greater in size, inflammatory bowel disease including ulcerative colitis and Crohn disease, previous abdominal surgeries, esophagitis, chronic nonsteroidal anti-inflammatory drug usage, and any prior uncontrolled psychiatric disorders.[18] 

Of note, a hiatal hernia larger than 5 cm in size is considered an absolute contraindication for the Orbera intragastric balloon. Psychiatric disorders should be addressed before balloon placement, as this could equate to problems with compliance.

Equipment

Types of Intragastric Balloons

Intragastric balloons vary in terms of the material, duration of therapy, balloon volume, adjustability, and the methodology of insertion and removal. The intragastric balloon placement is typically done within an endoscopy unit as an outpatient procedure. The procedure typically takes roughly 30 minutes, and the patient may be discharged 1 to 2 hours post placement of the balloon. Currently, the three FDA-approved balloons include the Obalon, Orbera, and ReShape balloons. These three balloons are also approved in Europe and the Elipse, End-Ball, Heliosphere BAG, Lexbal, MedSil, and Spatz3.[5] 

The Orbera balloon was approved for usage in 1997 in Europe and later by the FDA in the US in 2015. This is the balloon system in which most of the data on both safety and efficacy are available. The Orbera balloon is composed of silicone, filled with 400 to 700 mL of saline, and is placed endoscopically into the stomach for up to 6-months. The total body weight loss is measured at approximately 10.2%, with excess weight-loss measuring at 26.5%.[5] 

Since 2015, the ReShape system, a dual balloon system, and the Obalon, the first swallowable balloon that allows up to three balloons to be inserted without endoscopy, have been introduced. The Obalon system consists of three separate balloons. These are inserted by swallowing and then filled with gas nitrogen to approximately 250 mL each by an attached catheter. Typically, one balloon is inserted per month with up to three balloons. At the six-month mark post insertion of the initial balloon, all balloons are retrieved endoscopically. The estimated total body weight loss is measured at 7.1%.[5] While the Obalon System can be placed without endoscopy, retrieval of the balloon requires endoscopy, which is important to discuss with the patient.

The ReShape balloon is placed in an endoscopic fashion for up to six months and filled with saline of approximately 750 to 900 mL. It is then retrieved at the six-month mark endoscopically. The estimated total bodyweight-loss percentage is 6.8%, with an estimated weight loss of 25.1%. 

The Spatz3 balloon is unique in that it is adjustable and can be in place for up to 12 months. This balloon system can reside in the stomach for up to one year. It is placed endoscopically and retrieved in an endoscopic fashion. It is adjustable and filled with saline. The balloon itself is made of a silicone material. The total body weight loss is measured at 20.1%, with an estimated weight loss of 45.8%. 

The Elipse is the only intragastric balloon that is removed via natural excretion. This does not require any endoscopic procedure. This balloon is noted to be procedure-less and made from polyurethane. It is filled with approximately 550 mL of saline via a catheter. The balloon is left in situ for up to four months. Given the resorbable material inside the balloon, it degrades, which allows a natural release valve to open and empties the balloon. This is then naturally excreted.[19] This balloon may be favorable for patients who would like to avoid having an endoscopic procedure or undergo anesthesia. After the procedure, the patient may be allowed to have a clear liquid diet approximately six hours post-procedure. A liquid diet is typically adhered to until the beginning of the second week, after which a patient can begin a soft food diet. The patient can expect to start consuming a regular diet approximately three weeks after insertion of the balloon if he can tolerate such.

Personnel

Before placing an intragastric balloon, a patient should be under the care of a multidisciplinary team, including a nutritionist. The nutritionist will help develop a plan for the patient before placement of the balloon, in the periprocedural timeframe, and post balloon removal. Typically, the gastroenterology team sees the patient for 12 months in totality, which includes the six months with the balloon in place and six months post balloon removal.[20] 

The patient should have a planned exercise and diet regimen before placement of the balloon and during and after its removal. A key for the placement of the balloon itself is an experienced endoscopist and staff. The patient should be seen by a multidisciplinary team, including a nutritionist, gastroenterologist, primary care clinician, and psychologist/psychiatrist.

Preparation

Before placing an intragastric balloon, a patient should be seen in the office to review the procedure and obtain consent. The risks, benefits, and alternatives of the procedure must be explained. For a patient to be prepared for intragastric balloon placement, there are recommendations that a patient adheres to a clear liquid diet a few days before the procedure to empty the stomach.[21] 

A proton pump inhibitor should be started before insertion to reduce the amount of stomach acid secretion within the stomach. A nutritionist must evaluate a patient before and throughout the treatment process until at least six months post-balloon removal. The patient is made NPO at midnight the night before the procedure.[22]

Technique or Treatment

Intragastric balloon therapy is performed within the endoscopy suite. Light sedation using propofol is often used. If concerns of airway protection are present, general anesthesia can be utilized instead. Light sedation is provided to the patient and then prepped for endoscopy. An endoscopic evaluation of the lower, distal esophagus and the stomach is performed to ensure the absence of any ulcers or large hiatal hernias.[23] 

Next, the deflated balloon is slid down the esophagus into the stomach and followed using the endoscope. Once the balloon is in an appropriate position, the central wire from the balloon is removed. The catheter is connected to a syringe to fill the balloon. The balloon is typically filled 50 mL at a time under endoscopic supervision. The balloon is filled to 500 mL, but this is dependent on the balloon type. The filling catheter is detached with the deployment of the balloon. The balloon has a self-sealing valve to prevent leaks. 

The catheter is removed with the balloon staying within the stomach cavity. The endoscope should be slid easily around the balloon to ensure that the balloon is not too snug within the stomach or wedged with the potential to cause an outlet obstruction in the stomach. In terms of recovery, the patient spends a few hours after insertion of the intragastric balloon in the hospital, where they typically receive IV fluids and anti-emetic medications.

If the patient tolerates the balloon well, they are discharged the same day. The recommended nutritional guidelines vary, but immediately after the procedure, the patient is on a clear liquid diet which is advanced to a complete liquid diet that includes protein shakes. The following diet would be a puréed food diet and then advance to a soft diet up to a regular diet. The time frames on the advancement of diet are provider-specific, but adequate time is necessary to allow the stomach to adjust to the intragastric balloon.

When discussing the removal of the balloon, a provider can also use a clear liquid diet a couple of days before removing it to ensure emptying of the stomach is adequate. The time when balloon removal occurs is dependent on which type of balloon was used, as discussed above.[24] Again, the patient is within the endoscopy suite under light sedation. The balloon is punctured with a needle under direct vision using the endoscope. The balloon is aspirated or connected to suction to remove the saline or gas and is deflated. A grasper is used to remove the balloon out through the mouth. To ease the removal of the balloon through the esophagus, a lubricating material such as mineral oil can be used.

Complications

Given the non-invasive or minimally invasive intragastric balloon procedure, it has gained popularity as a weight-loss procedure. However, adverse events do occur. Patients were analyzed for adverse events in a retrospective analysis that included over 1000 procedures between 2016 and 2017. Approximately 7.2% of these patients had required treatment for dehydration, 2% required readmission, 1.1% needed re-operation, and 6.2% necessitated intervention within the first 30 days. A study of over 145,000 patients found that intragastric balloon therapy had a higher adverse event rate than laparoscopic bariatric surgery. Specifically, this was due to a significantly higher non-operative re-intervention rate in the intragastric balloon group versus the laparoscopic bariatric surgery group.[25]

Gastrointestinal symptoms including nausea, abdominal pain, vomiting, dyspepsia, constipation, acid reflux, and burping are typical symptoms from intragastric balloon therapy. Gastric accommodation to the intragastric balloon is why gastrointestinal symptoms occur. Up to approximately 91% of patients will have some form of the symptoms.[22] 

Patients have prescribed medications to aid in controlling these symptoms. A proton pump inhibitor is started before balloon insertion. An anti-emetic medication like ondansetron or aprepitant is often prescribed for as-needed use. During the first week of intragastric balloon therapy, an anticholinergic medication such as scopolamine can be used. Prospective studies have demonstrated that a serotonin receptor antagonist may be effective when combined with midazolam. If a patient experiences persistent symptomatology, the balloon may be removed out of necessity.[26] Approximately 4 to 7% of patients will continue to have significant gastrointestinal symptoms after the first seven days of therapy. Less than 3% of these patients will require an endoscopic re-intervention or early balloon removal.

The safety profile of intragastric balloons is of importance. Serious adverse events from the balloon, including gastric perforation, balloon migration, and mortality, are rare. A meta-analysis of intragastric balloon risks determined that gastric perforation rate is approximately 0.1%, balloon migration 1.4%, and mortality 0.08%.[27] 

Adverse events can be associated with the procedure or the balloon itself. Regarding balloon-related adverse events, serious events include gastric or esophageal perforation, gastric ulceration, and balloon migration can occur. These adverse events are primarily unique to the saline, liquid-filled balloons.[28] These include acute pancreatitis as well as spontaneous hyperinflation. The risk for balloon migration or rupture is likely secondary to the balloon being in the stomach for an extended period than intended. If the balloon is left in the stomach longer than recommended, this poses a risk for rupture and migration into the small intestine. While most ruptures are excreted successfully, some may cause an intestinal obstruction. These patients should be closely monitored to ensure that the balloon is removed in a timely fashion to reduce the risk of both migrations and intestinal obstruction.[29] 

A safety precaution to detect rupture is by dyeing the saline balloons with a blue dye. The patient may notice their urine turning blue or green as the ruptured dye is absorbed and then excreted renally. The dye serves as a warning mechanism so that the patient is aware of a rupture and can help retrieve it before the balloon migrates and causes a subsequent small bowel obstruction. A multi-balloon therapy can be advantageous over one with a single balloon. If one balloon ruptures, the second balloon may prevent the migration or subsequent obstruction.[30][31]

Another adverse event of concern includes spontaneous hyperinflation. The FDA has received approximately 200 reports worldwide since 2015.[32] Greater than 99% of these cases involve the Orbera balloon therapy. Hyperinflation involves filling these balloons with an additional amount of either air or liquid once placed in the stomach, which will typically necessitate early removal of the device itself.

Another area of concern is that of acute pancreatitis. Acute pancreatitis can develop secondary to any type of intragastric balloon but has clinically been observed mainly with liquid-filled balloons. The FDA has received almost 30 adverse reports worldwide since 2015, with approximately 2/3 of these events involving the Orbera balloon system.[33] 

The mechanism for acute pancreatitis can be secondary to either direct injury from the balloon or the distended stomach, which exerts pressure on the pancreatic parenchyma. Acute pancreatitis can also develop via an indirect mechanism where a pancreatic injury is secondary through a duodenal obstruction. Compression of the balloon onto the stomach may compromise blood flow to that region, leading to localized ischemia, ulceration, and eventual perforation. An aid to diagnose this condition or for clinical recognition of the complication, a provider should look for the recent placement of a gastric balloon, symptoms consistent with the diagnosis of pancreatitis, and either biochemical or radiological evidence supporting pancreatitis. Laboratory work can consist of a lipase level, amylase, complete blood count, renal function test, and liver function tests. An abdominal CT or ultrasound can be used for radiological diagnosis.[20] 

Adverse events can be secondary to the procedure itself, which primarily occur during balloon removal. Adverse effects include gastrointestinal bleeding, esophageal tears, esophageal perforation, and pneumonia. Most balloons discussed require endoscopic retrieval and a needle to deflate the ballooning mechanism, sturdy grasper, or snare to remove the balloon.

In terms of mortality, the FDA has received reports of 18 deaths worldwide from 2016 to the present in patients with a liquid-filled balloon system used to treat obesity.[34] Only eight of these deaths involved patients in the US, three of which used the ReShape balloon and five with the Orbera balloon. Of these deaths, one occurred due to esophageal perforation, two from pulmonary embolism, three from gastric perforation, and the remaining two from unknown causes.[34] 

To accurately determine mortality, better studies are needed. These 18 deaths reported since 2016 are noted, but the incidence rate of death in those who underwent intragastric balloon therapy is unknown. A systematic review published in 2016 did demonstrate a mortality rate of 0.05%.[35] More research is necessary for the incidence of death, but the FDA recommends that patients are both instructed and closely monitored for symptoms of life-threatening complications mentioned above. Balloon removal should be performed promptly if needed by a highly trained endoscopist performing the procedure.

Clinical Significance

The initial weight loss for a patient undergoing an intragastric balloon system can produce a total body weight loss of anywhere from 6 to 15%, compared to the 1 to 5% through lifestyle modifications alone.[36] In patients of which intragastric balloon therapy was the primary weight-loss agent, with no prior bariatric surgeries noted, the short-term weight reduction at the six-month mark post-treatment averaged roughly 11.5 kg, but this was more pronounced in those patients who had a higher BMI.[34] 

The American Society For Gastrointestinal Endoscopy (ASGE) and Bariatric Endoscopy Task Force performed a meta-analysis regarding weight loss via intragastric balloon therapy. The degree of weight-loss achieved was dependent upon the balloon system utilized. Two meta-analyses support more significant weight reduction with a liquid-filled balloon than an air-filled balloon.[27] A meta-analysis of 55 studies, including 6645 Orbera implantations, performed by the ASGE demonstrated an estimated total body weight loss of 12.3%, 13.16%, and 11.27% at the three months, six months, and twelve-month post-implantation mark, respectively. Three randomized controlled studies demonstrated that the excess weight-loss percentage over the controls was 26.9%, thus meeting the standard for preserving and incorporating valuable endoscopic innovations. The standards are set to approximately 5% of total body weight loss with 15% excess weight loss over the control subjects.[27]

Intragastric balloons are practical and safe for managing obesity in the short term, but these are temporary measures. Weight regain is expected to occur after removing the balloon, so it is not a mechanism for sustained weight loss. In a study of 500 patients who had six months of treatment with balloon therapy, only 50% of these patients had maintained 20% excess weight loss at the one-year mark post balloon removal, and only 25% of these patients maintained this weight loss at the five-year mark.[37] 

Notably, there is no difference between lifestyle changes versus balloon therapy at ten years, so many patients may require additional treatments. It is important to note that intensive lifestyle intervention programs have a weight loss of approximately 7 to 10 kg after six months. Behavioral therapy appears to have long-term weight loss of around 5 kg.[38] 

Long-term follow-up after intragastric balloon placement therapy is heterogenic. Some patients undergo repeated usage of this therapy, others undergo pharmacotherapy, and others may decide on undergoing bariatric surgery. A review of controlled studies of the three mentioned FDA balloon systems concluded that all these systems have comparable efficacy on weight loss. The effects of the balloon were greater than the control subjects but less than that of bariatric surgery and the weight-loss combination drug phentermine-topiramate. Studies of metabolic parameters with intragastric balloon placement demonstrated improvement in diabetes and hypertension in patients with a  BMI classification of overweight but not obese. Long-term data evaluating patient outcomes of cardiovascular disease and mortality are not available. Still, it is thought that balloon therapies will not achieve meaningful and sustained improvements in obesity-related comorbidities if used as monotherapy.

Intragastric Balloon Therapy versus Other Weight-loss Therapies

Overall, intragastric balloon therapy can expect to achieve anywhere from an 8 to 15% total body weight loss in the short term.[39] This number is dependent on the type of balloon used. Pharmacotherapy and lifestyle interventions tend to have similar weight-loss results ranging from 2 to 9% of total body weight.[40] 

In comparison, bariatric surgery can achieve an estimated total body weight loss of 13 to 30%, dependent on the procedure performed.[41] The lower estimate is associated with laparoscopic adjustable bands and the sleeve gastrectomy procedure on the higher end. Multiple trials have demonstrated that intragastric balloons induce effective weight loss compared to lifestyle intervention alone, which served as a basis for the approval by the FDA for intragastric balloons.

Currently, no trials directly compare pharmacotherapy methods of weight loss to the intragastric balloon. A meta-analysis of the individual therapies supports short-term weight loss achieved via the balloon compares favorably with pharmacological therapy.[40] One pharmacologic study has reported that the intragastric balloon typically produces a 6-month total body weight loss of 5.6%. This total bodyweight-loss is less than the FDA-approved weight-loss drug, Qsymia, composed of phentermine and topiramate. The drug has a placebo-subtracted total bodyweight-loss percent measured at 6.6% at the six-month mark. Direct comparative studies are required to determine intragastric balloon therapy efficacies compared to weight-loss drugs. Other medications approved for the treatment of obesity can be used in conjunction with intragastric balloon therapy to aid in weight loss, including semaglutide, liraglutide, phentermine, topiramate, bupropion-naltrexone.

Surgical interventions for weight loss are more efficacious for the patient, but as noted, certain circumstances or patient factors may limit the patient from undergoing such procedures. A retrospective study performed by the National Patient-Centered Clinical Research Network examined over 65,000 patients and discovered the total body weight loss at the one-year and five-year postoperative time frames. At the one-year mark, the average total body weight loss for the gastric bypass was 31.2%, sleeve gastrectomy was 25.2%, and the adjustable gastric band was 13.7%. At the five-year postoperative mark, the average total body weight loss for the gastric bypass was 25.5%, the sleeve gastrectomy measured at 18.8%, and the adjustable gastric band at 11.7%.[41] 

With the large differences in weight-loss durability and efficacy, intragastric balloons should not be used instead of a bariatric operation when the latter is both feasible and appropriate for the patient.[22]

Additional Treatments

Additional measures may be needed for a patient to sustain or even augment weight loss after intragastric balloon therapy. These treatments can include pharmacologic, bariatric surgery, or repeat balloon therapy. It is estimated that with the continuation of an exercise regimen and diet, approximately 50% of weight loss achieved during the intragastric balloon therapy can be maintained at least one-year post balloon removal. For a patient to undergo repeat balloon therapy, they must undergo a mandatory one-month balloon holiday, meaning four weeks without a balloon in place. Studies demonstrate that these subsequent repeat therapies are just as effective as the initial treatment.[42] To be considered for repeat therapy, patients should be evaluated individually. If the patient was compliant with exercise and diet during the initial treatment, they are likely a good candidate for subsequent treatment.[43] 

Consideration for an adjustable balloon system can be determined if a patient would like to undergo repeat balloon therapy. Studies have shown that approximately 80 to 90% of the weight loss achieved using intragastric balloon therapy is during the first 3 to 4 months.[29] After this timeframe, the stomach accommodates, and the restricted mechanism is partially lost. Therefore, in an adjustable balloon system, the balloon volume may be increased to induce a higher level of weight loss. The adjustable Spatz balloon allows the adjustment of the balloon's volume. An adjustable system can be beneficial for patients intolerant of the balloon. They may benefit from a downward balloon volume adjustment, permitting patients to continue the treatment.

Intragastric balloon therapy can be used in conjunction with bariatric operations for effective and safe weight loss in individuals with severe obesity. A study demonstrated that satisfactory results using the Orbera intragastric balloon were a predictor of a favorable outcome with subsequent lap band surgery. Weight-loss achieved with the intragastric balloon in the pre-operative stage aided in decreasing the risk and complexity of bariatric surgery in patients with a BMI greater than 50 kg/m^2.[44] 

Intragastric balloons can be used as a bridge to bariatric surgery, but the benefit of such may not be as dramatic as once thought. Trials that compared the balloon therapy versus control before a bariatric operation demonstrated that the balloon did not prevent postoperative complications. It was associated with a 34% failure rate and a higher cost.[45][46] The weight loss was greater in the patients who underwent the balloon therapy prior, which necessitates future studies to better evaluate these balloons as a bridging therapy mechanism for another procedure.

Conclusion

Currently, intragastric balloons serve as valuable adjuncts to bariatric patient therapy. Their usage is on the rise, given their minimally invasive and temporary nature. Currently, bariatric surgery provides higher efficacy of weight loss but has its risks, complications, and benefits compared to intragastric balloons. Minimally invasive treatments like the intragastric balloon in conjunction with lifestyle modifications and pharmacotherapy treatments are promising. Intragastric balloons may also serve as a bridging therapy for patients who do not meet the qualifications to undergo bariatric surgery or would like to avoid surgery. Intragastric balloons are worth consideration for these patients and should be discussed in a comprehensive, thorough fashion with patients.

Enhancing Healthcare Team Outcomes

The evaluation of the intragastric balloon and a multidisciplinary team approach was analyzed by a retrospective review of 119 balloons placed in 116 patients endoscopically from May 2001 to August 2006. In this review, 49 patients were followed by a multidisciplinary team every 15 days during six months compared to 67 patients followed by individual providers. The patients who were followed by the multidisciplinary team had the most significant decrease in excess body weight and BMI. Conclusions from this analysis demonstrate that intragastric balloon therapy effectively achieves short-term weight loss in obese patients and that a multidisciplinary team approach combined with lifestyle augmentation markedly enhances weight loss. Before, during, and after intragastric balloon placement, a multidisciplinary team is recommended.[47]