Intragastric Balloon

Fig. 1.

BIB^® (reproduced with permission of Apollo Endosurgery, Austin, TX).

The BIB^® is made of a transparent silicone elastomer, resistant to corrosion by gastric acid. It has a self-sealing radiopaque valve to which a silicone catheter is attached to fill the balloon. The balloon has an initial cylindrical shape and final oval shape, with a variable filling from 400 to 700 ml, allowing an adequate volumetric adjustment for each patient, designed to float freely inside the stomach, increasing satiety and decreasing gastric reservoir capacity and food intake. It can be kept in the stomach for up to 6 months, after which there is an increased risk of spontaneous deflation and resultant bowel obstruction. Balloon deflation is accomplished by puncturing the balloon with a needle and simply removing it with a foreign-body grasper or a customized one.

In 2004, an air-filled balloon, the Heliosphere^® (Helioscopie, Vienne, France), was approved for use in Europe, Canada, South America, and other countries, but not in the USA [9]. It is a double-bag polymer balloon covered with a smooth external pouch of biocompatible silicone with a radiopaque marker, which must be filled with air to a final volume of 650 to 750 ml. The Heliosphere^® is a lighter balloon (30 g), a characteristic that possibly increases patient tolerability.

Indications

The balloon, an endoscopic approach to obesity, is positioned in-between clinical and surgical treatment. It overcomes the results of clinical treatment on inducing more effective and durable weight loss and cannot be compared with the much better and long-term efficacy of the bariatric surgery.

Traditionally, IGBs have been used on morbidly obese patients and as a bridge to surgical procedures. More recently, there is a trend to its use on low-BMI patients even with cosmetic purposes, for example, in Brazil, the BIB^® is approved by the FDA-like agency (ANVISA, reg# 80143600103) to be used in patients with BMI of 27 and over. Another trend is the use for specific achievements like effectively lose weight to have a more conservative treatment in orthopedic and spinal surgery or effectively lose weight to get pregnant as it improves fertility, among other benefits. Other interesting indication is on morbidly obese children and teenagers under a strict protocol.

A list of indications follows below:

Patient with BMI > 35 kg/m², unresponsive to clinical treatment who refuses surgical therapy or has contraindications
Patient with BMI < 35 kg/m², comorbidities, unresponsive to clinical treatment in a period superior to 3 years
Super-obese presurgical preparation (bridge procedure)
Anesthesia risk reduction before major surgeries
Pre-op weight loss for orthopedic patients, allowing a more conservative approach or decreasing surgical risk
Clinical risk reduction for severe chronic diseases associated, induced, or worsened by obesity

Contraindications

Relative Contraindications

Severe reflux esophagitis (higher risk for complications)
GEJ conditions or diseases
Chronic use of NSAIDs

Absolute Contraindications

Previous gastric surgery (especially Nissen fundoplication and gastrectomy)
Gastric or duodenal active ulcer
Hiatal hernia >5 cm
Collagen diseases
Hepatic cirrhosis, portal hypertension
Cancer
AIDS
Crohn’s disease
Anticoagulant chronic use
Drug and alcohol abuse
Pregnancy and lactation
Psychiatric disorder (uncontrolled)

Technique

Implant

Patient under deep sedation with anesthesiologist (can be changed to anesthesia with intubation under anesthesiologist’s discretion and patient’s clinical condition).
Endoscopic evaluation of esophagus, stomach, and duodenum for planning of the procedure, measuring the distance until the GEJ.
Aspirate gastric residues.
Removal of the endoscope.
Insertion of the deflated balloon into the stomach, in an orogastric manner until surpassing the previously measured GEJ (Fig. 2).

Fig. 2.

Insertion of the deflated balloon into the stomach in an orogastric manner until surpassing the previously measured GEJ with the patient under deep sedation with anesthesiologist.
Confirm that the balloon is well positioned and if not, reposition it under endoscopic view in an optimal location (between gastric fundus and body).
Removal of guidewire from insufflation catheter.
Connect unidirectional valve to the 0.9 % saline + methylene blue solution.
Inject of 400–700 ml of the solution with “luer-lock” syringes (60 ml syringes, inject each syringe in a 10 s period) (Fig. 3).

Fig. 3.

Injection of 400–700 ml of methylene blue solution keeping visual inspection during balloon filling.
Keep visual inspection during balloon filling.
After insufflated, the balloon should touch gastric walls.
After completing the desired volume, close the unidirectional valve and apply gentle negative pressure in the catheter with the syringe (optional).
Retrieve endoscope to esophagus.
Pull the balloon against the GEJ, keeping constant pressure until disconnection of the valve.
Remove insufflation catheter.
Advance the endoscope to the stomach for inspection of balloon and valve looking for leaks (Fig. 4).

Fig. 4.

Balloon at the end of the procedure well positioned on the gastric fundus with no signs of leak observed in a “U-turn” maneuver.
Aspirate stomach and remove the endoscope.

* Air–filled balloon has a security system with a prolene thread that must be sectioned before insufflation. Afterward, the white nylon thread is pulled, opening the safety layer. The balloon is then filled with 650 to 750 ml of air by means of a unidirectional valve system, having the insufflation catheter removed at the end.

Prescription and Post-Implant Recommendations (By the Authors)

Steroids—continue for 3 days.
Prokinetics (start during procedure)—continue for 7 days.
Ondansetron and steroids—continue for 7 days.
Scopolamine (patch or oral)—continue for 7 days.
PPI on double dose—continue as long as the patient has the balloon.
Weekly follow-up during the first 2 weeks with endoscopy team.
Monthly visits—until explant—multidisciplinary team.
Remind the patient that he will have mild to severe nausea/vomiting during the first days, and in case of dehydration or uncontrollable pain, he should contact the team.
Patient must comply with follow-up plan, doing regular physical activities.

Continuous use of PPI is mandatory, not only for protection of the gastric mucosa and to ameliorate gastroesophageal reflux but also to protect the balloon itself from the deleterious action of hydrochloridric acid [10].

Explant Recommendations (By the Authors)

Patient under general anesthesia, intubated.
Endoscopy for evaluation of stomach and planning of the procedure.
Aspirate residues as much as possible (mandatory intubation in the presence of residues).
It is recommended to have two suction sources (one for the endoscope and another for the suction catheter in order to be precise with amount of liquid aspirated from the balloon).
Balloon puncture with an appropriate customized needle catheter (Fig. 5) always under direct view, anterograde (preferable) (Fig. 6), or in U-turn (alternative), according to endoscopist’s choice and stomach conditions.

Fig. 5.

Customized needle catheter and double-hook grasper (Apollo Endosurgery, Austin, TX).

Fig. 6.

Balloon puncture with customized needle catheter under direct view, anterograde.
After puncture, remove the needle and connect to the suction tube with a separate container for measuring the aspirated content.
Intermittent aspiration avoiding collapse/bending of the catheter.
Keep constant visual inspection until complete suction of the liquid, observing the thin edges of the balloon collapsing (Fig. 7).

Fig. 7.

Visual inspection until complete suction of the liquid, observing the thin edges of the balloon collapsing.
Keep track of the amount of liquid aspirated.
For balloon retrieval, adequate material will be needed: double-hook grasper (Fig. 5), polypectomy snare, foreign-body graspers, based on endoscopist’s preference.
The balloon capture point must be planned in a way that there is a good contact area, avoiding the valve and being sure there is an adequate hold (Fig. 8).

Fig. 8.

Customized double-hook grasper opened to capture the balloon.
A therapeutic endoscope might be useful in more difficult cases.
Scopolamine (with intention to relax the EGJ) should be administered after the balloon has been captured and before retrieval.
Keeping the balloon close to the endoscope tip makes removal easier.
Traction must be uniform, without bumps or stops, under visual control.
The GEJ offers certain resistance, demanding more attention.
In the esophageal body, the passage is easier.
When the balloon reaches the cervical region, the neck must be hyperextended, deflating the orotracheal tube cuff (optional), increasing sedation as needed (Fig. 9).

Fig. 9.

Balloon removal at the end with the balloon close to the endoscope tip.
After the balloon has been removed, a second-look endoscopy is mandatory, to assure that the esophagus and the gastric wall have not been harmed.
In cases of challenging removal, therapeutic scopes and overtube are helpful.

Pre- and Post-explant Prescription and Recommendations

Pre-explant
- Prolonged fasting (16–18 h), decreasing solid food residues.
- Liquid diet for 24–36 h.
- Prokinetics—start 5–7 days before.
- Patient must go through a consultation with nutritionist and psychologist to prepare for balloon removal.
Post-explant
- Prokinetics—continue for 2 or 3 days
- Ondansetron (optional)
- Scopolamine—continue for 2 or 3 days
- PPI on double dose—continue for 7 days
- Monthly follow-up with the multidisciplinary team for at least 6 months

Results

In a systematic review, 15 articles (3,608 patients) were evaluated to estimate BIB^® effectiveness. The weight loss at balloon removal were 14.7 kg, 12.2 % of initial weight, 5.7 kg/m² drop from initial BMI, and 32.1 % of EWL. However, data were scant after balloon removal. Efficacy at balloon removal was estimated with a meta-analysis of two randomized controlled trials (75 patients) comparing balloon versus placebo, indicating the balloon group lost more weight than the placebo group. Regarding BIB^® safety, the majority of complications were mild, and early removal rate was 4.2 % [9]. The 12.2 % estimated rate of total weight loss at the end of treatment is an amount considered sufficient to obtain health benefits, according to the knowledge obtained with clinical treatment that a weight loss of 10 % improves morbid conditions associated with obesity (hypertension, diabetes, hyperlipidemia, among others) and also reduces mortality [11].

A Brazilian multicenter study evaluated 483 overweight and obese patients treated with the BIB^®. Of these, 323 completed a 6-month follow-up and 85 of them completed a 1-year follow-up. At 6 months, patients showed a global weight reduction from baseline BMI of 38.2 ± 9.4 to a 6-month BMI of 32.9 ± 8.3 kg/m². Super-obese patients under preoperative preparation (n = 32) showed a mean weight loss of 26.1 kg, mean % EWL of 23.5 %. Considering surgical risk, most patients showed a significant improvement from ASA III–IV before placement of balloon to ASA II, with easier control of comorbidities, enabling safer surgical procedures. Patients with BMI < 35 kg/m² (n = 148) showed a %EWL of 63.4 ± 28.6 %, with a success rate of 94 %. At 1-year follow-up, a subset of patients had maintained a substantial weight reduction. The 1-year % EWL was 50.9 ± 28.8 [10].

Overall, 85 patients who showed up for the 1-year follow-up maintained more than 90 % of their BMI reduction observed at the 6-month follow-up. 17 patients followed at 2 years after BIB^® placement have maintained more than 89 % of their 6-month BMI reduction, but again, results in patients who did not come back remain speculative. Although this follow-up represents less than 50 % of patients, it suggests that when patients agree to multidisciplinary treatment and change their behavior, they can maintain the weight loss more than 1–2 years after BIB^® removal [10].

From 76 subjects evaluated under BAROS Qol score, more than 85 % were satisfied with the treatment. However, such results should be viewed with caution because the gratitude for a good result in these patients could render them more motivated to reply to a questionnaire than others who did not have as good an outcome. Binge eaters have a large gastric capacity, less negative feedback, and therefore lose less weight with the intragastric balloon. Identification and treatment of binge-eating disorders are essential to satisfactory results with the BIB [10].

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