According to the epidemiological survey on obesity in Turkey (OBEBI 2012), 14% of Turkish people, more than 6 million adults, are obese. Obesity leads to metabolic, cardiovascular, digestive, respiratory, and rheumatic complications. It increases the risk of cancer [1] and decreases life expectancy. The socio-economic consequences are essential.
Nutritional management alone is not effective: 14% of patients have “effective” weight loss (greater than or equal to 10% body weight), and 31 to 37% of patients have a weight loss of 5% regardless of the type of diet and after two years [2]. Bariatric surgical techniques are effective [2] and are indicated for patients with a BMI of 40 or 35 with comorbidities. The morbidity of these techniques is not negligible, and their mortality varies from 0.1% for restrictive methods to 0.5% for bypass and 1.11% for biliopancreatic diversions [3].
There is a group of patients who do not respond to the dietary management of overweight and who are not yet candidates for bariatric surgery.
The gastric balloon is an endoscopic technique for managing overweight and obesity.
Historical
Various polyurethane balloons used in the 1980s have not been demonstrated [4], and the occurrence of severe and frequent complications has led to their withdrawal from the market [5]. In 1987, the Tarpon Springs conference defined a quality standard for intragastric balloons: they must be smooth, radiopaque, resistant, easy to put on and drop off, and have proven effectiveness in weight loss.
Some balloons have an adjustable volume; others can be ingested.
Mode of action
Ballooning is associated with a reduced feeling of hunger, increased satiety, and decreased daily energy intake [6]. The balloon induces non-univocal variations of some peptides involved in regulating appetites, such as ghrelin, leptin, and adiponectin, and a decrease in the secretion of cholecystokinin and peptide P [7, 8, 9, 10]. The balloon induces an increase in the volume of the proximal stomach, an increase in gastric compliance, and a slowing of gastric emptying [9, 11]. The importance of reducing gastric emptying would be associated with increased weight loss. These changes are related to an increase in vagal tone. These effects seem to wear out over time.
Pose
The balloons can be filled either with a sterile saline solution containing methylene blue, which will color the urine in the event of a leak (Orbera®, Spatz®), or by air (Heliosphere Bag and Bag pre-op®, Newtech® EasyLife Balloon®), or a mixture of saline and air (Endalis®).
A high endoscopy precedes the pose to check the absence of pre-existing pathology that may contraindicate the establishment of the device. A contraindication is a history of obesogastroduodenal surgery, hiatal hernia greater than 5 cm, untreated peptic ulcer, or severe esophagitis. The lubricated balloon is introduced under digital control at the upper aero-digestive junction and then slowly descended to the fundus under endoscopic control. The balloon should not be bent or repositioned to prevent premature disconnection of the filling catheter. The filling balloon will always be performed under endoscopic supervision, and The sub-cardinal position of the inflated balloon will be controlled. The duration of the gesture varies from 10 minutes to 30 minutes.
The laying technique varies with the type of balloon.
The Orbera® balloon is the most used. The filling tube is removed by actuating the self-sealing flap of the balloon, thus releasing the latter, which floats freely in the stomach.
The Heliosphere Bag® and Pre-op® Bag balloons are packaged in a cover that opens after the release of a safety loop. The complete release of the flask must be checked before filling with 600 to 720 ml of air. Once the balloon is filled, the needle is retracted inside the catheter, and the balloon is released by traction. The pose of this balloon could be more delicate [8].
Other balloons are available, but the decline in use is not essential.
The End Ball® balloon has an introducer system that can be placed the same way as the Orbera® balloon or the endoscope. The balloon is inflated with a mixture of air and physiological saline. During the release of the balloon, the needle of the introduction system must be disconnected and reassembled therein. Then we must go back together with the introduction system and the endoscope.
The Heliosphere Bag balloons are gradually being replaced by the Newtech® Balloons 600 and 720 with a triple-layered polymer pocket. The laying technique is identical.
The Spatz® balloon can be introduced as the Orbera® balloon and with a cap to secure it to the endoscope.
The Easy Life® balloon is introduced by attaching it to the endoscope using a polypectomy loop.
The balloon volume could alter the importance of weight loss: an increased weight loss was observed with a volume of 600 ml versus 500 ml [12], but the correlation between the volume of filling and weight loss has not been constantly observed.
It must be ensured that there are no gastroduodenal lesions associated with balloon placement by renewing gastroscopy at the end of the procedure.
There is no support for health insurance devices, endoscopy, and the installation of the gastric balloon.
Adjustment
Spatz® and Easy Life® balloons can be left in place for up to 12 months and can be adjusted using a catheter connected to the balloon, which is recovered by a diathermic loop during a gastroscopy. Their volume can be reduced in the event of intolerance to the balloon or, on the contrary, increased to 700 ml for the Spatz® balloon and 800 ml for the Easy Life® balloon when the loss of weight stagnates.
Several Obalon balloons can be ingested (one balloon every month for three months) depending on the effectiveness of the sensation of gastric fullness and weight loss.
Withdrawal
The date of extraction of the balloon varies according to the duration of use of the balloons (Table I).
Extraction of the balloon is performed by endoscopy in the 3rd month for the Obalon® balloon, in the 6th month for the Orbera®, End Ball®, Heliosphère®, and Newtech® balloons, and at one year for the Spatz® and EasyLifeballoon® balloons. A residue-free diet of a few days and a liquid diet associated with taking prokinetics 48 hours before withdrawal are necessary.
Removal of the balloon requires intubation.
Ablation is performed endoscopically using a needle and bipod forceps kit. The entire contents of single-layer balloons (silicone or polyurethane) are aspirated using the catheter connected to the puncture needle. The bipod clamp is used to extract the balloon. A polypectomy loop or foreign body forceps can also be used. The average withdrawal time varies from 15 to 35 minutes. The use of a dual-channel gastroscope can reduce the withdrawal time. It depends on the experience of the operator.
Bagi Heliosphere balloons consisting of two layers should be stitched near the valve on one or more occasions. The air is sucked in for about 5 minutes using the suction probe. When removing with the bipod handle, it is necessary to catch the silicone and polyurethane layers. The withdrawal of this type of balloon has been inconsistently reported as more complex [13]. It depends on the experience of the operator [14].
Newtech® balloons are easier to extract because they have only one polymer layer.
It must be ensured the absence of gastroduodenal lesions related to the balloon removal maneuvers by renewing the gastroscopy at the end of the procedure.
Like the installation, there is no support for the removal of the balloon by compulsory health insurance.
We must ensure the absence of gastroduodenal lesions related to the maneuvers pose and removal of the balloon by performing a control endoscopy at the end of the procedure.
Following
Ballooning is often performed on an outpatient basis, but hospitalization may be necessary in case of poor tolerance. Treatment with a proton pump inhibitor is prescribed until the balloon is removed. An anti-emetic treatment with ondan-sétron may be prescribed during the 72 hours following placement [15]. Antispasmodics and analgesics, as well as scopolamine, may also be provided. A liquid diet, or even short fasting, is proposed in the immediate aftermath of the balloon placement [16, 17]. If the procedure is performed on an outpatient basis, the patient must have telephone contact and consultation the following days. A biological assessment (ionogram, creatinine) is recommended. Nutritional and behavioral management by a multidisciplinary team is necessary [18]. Resumption of physical activity is essential [18]. Psychotherapeutic follow-up is helpful if it has been indicated during the prior psychiatric consultation [18]. Multidisciplinary monitoring should be continued after the removal of the balloon to avoid weight gain [19].
The installation of the balloon is only possible in the context of multidisciplinary care.
Side effects occurring in the days following the balloon placement may require hospitalization.
Indications and contraindications
The balloon indications are not the subject of any expert consensus, and the HAS in 2009 did not conclude that the gastric balloon is effective in the management of non-morbid obesity or in reducing the anesthetic risk. Or surgical in case of morbid obesity.
The gastric balloon is approved (simple CE marking):
in overweight or non-morbidly obese patients (BMI> 27 kg / m2 depending on the type of balloon) who could not achieve sustained weight loss despite nutritional management by a doctor or nutritionist;
in patients with morbid obesity (BMI> 40 or> 35 kg / m2 with comorbidities) who refuse bariatric surgery;
in super-obese patients (BMI> 50 kg / m2) before bariatric surgery.
Gastric balloons with a duration of 3 or 6 months could be recommended for patients with a BMI <35, while adjustable balloons could be reserved for patients with a higher BMI.
The recognized contraindications are numerous:
- severe liver disease,
- Crohn’s disease,
- severe cognitive or mental disorders,
- alcoholism or drug addiction not weaned,
- pregnancy, desire for pregnancy, breastfeeding,
- refusal of medical follow-up and dietary instructions,
- Bulimia-type eating disorder,
- antecedent gastric or anti-reflux surgery, or gastric band,
- giant hiatal hernia (> 5 cm), progressive peptic ulcer, severe grade III or IV esophagitis,
- anti-inflammatory treatment, abnormal coagulation, anticoagulant, or antiaggregant treatment.
The practice of scuba diving and air transport by non-pressurized aircraft contraindicate balloons to the air.
Balloon indications are not consensual. The contraindications are numerous. Health Insurance does not support device installation and removal.
Results
The effect of the Orbera® balloon on weight loss was evaluated in the short term by many open series but also by a randomized trial “ballooning and dietary monitoring versus dietary monitoring alone,” by two randomized balloon trials versus “ghost,” by a randomized balloon trial versus sibutramine [19] and by a repeated balloon trial for two periods of six months each versus one balloon and dietary follow-up alone for the next six months [20]. The loss of weight with the Heliosphere® ball seems similar to that observed with the Orbera® balloon [9, 17]. The results of these tests all suggest balloon efficiency. There is a possible bias linked to the impossibility of having double-blind randomization. Nutritional or behavioral management associated with balloon placement improves its effectiveness [18, 19].
Nutritional or behavioral management associated with ballooning is necessary to improve the effectiveness of weight loss.
The available series covered several thousand patients with BMIs ranging from 25 to over 50 kg / m2 and frequent comorbidities that were often multiple and varied in profile. The average weight loss observed at balloon removal at six months is 15 kg (range: 0-25 kg), or 12% of body weight. Excess weight loss is 32%, and the BMI falls by five points [22]. The loss of weight is rapid and achieved mainly at the expense of body fat [18]. Insulin resistance and hepatic steatosis decrease as well as hepatic volume in super-obese patients [22]. Type II diabetes, elevated LDL-cholesterol, hypertriglyceridemia and hypertension are corrected or improved in more than 80% of patients, and this Effecteffect persists one year after balloon removal [20, 23, 24]. A recent multicentre study has confirmed the efficacy of improving comorbidities in overweight patients [23]. A significant improvement in sleep apnea and infertility syndrome has also been reported. The quality of life of patients is improved [9, 20]. The effect of the balloon has been said to be more frequent in subjects with a BMI less than 35 kg / m2 [24], but the weight loss is more significant when the BMI is high [25]. The Effecteffect is less in cases of bulimia [26]. The potential benefit of gastric ballooning in super-obese patients before performing gastric bypass to reduce anesthetic risks, technical difficulties, conversion rate, and complications [27, 28] was not found in a prospective randomized study [28].
The Effecteffect of the ball may increase after its withdrawal. This effect appears to be maintained 12 months after withdrawal in 40 to 60% of patients [19], although it has also been described as nil at a distance from withdrawal. This Effecteffect would persist for 24 months after withdrawal in 50% of patients [29] and even three years for overweight patients [23]. The placement of a second balloon immediately after or away from the withdrawal further improves weight loss, but the Effecteffect is quantitatively more minor than that observed with the first balloon [20]. The loss of weight seems more critical with the adjustable ball, but the series is limited [30].
The remote Effecteffect of the withdrawal is still better to describe because of the numerically limited number of available series and the sometimes large number of lost to follow-up.
The gastric balloon causes weight loss and improved comorbidities. The Effecteffect of the balloon decreases at a distance from the withdrawal but persists in at least one-third of the patients. Nutritional and behavioral management after the removal of the balloon is imperative for medium-term effectiveness.
Morbidity
Common side effects are observed immediately after the balloon is placed [22, 31]. Nausea, vomiting, and abdominal pain are controlled by a systematic treatment and become standard in a few days. Dehydration (1.6%) and hypokalemia (0.4%) may be observed if these symptoms persist; early removal of the balloon must then be discussed. Reflux symptomatology is sometimes observed despite antisecretory treatment (0.5 to 1.8%). Erosions or gastric or even oesophageal ulcerations have been reported more rarely. The balloon may deflate spontaneously, especially when it is removed beyond the time specified by the manufacturer. There is a risk of bowel obstruction, especially in patients who have had abdominal surgery.
Severe complications are rarer (0.1 to 0.2%), mainly gastric perforation type, or exceptional such as oesophageal rupture during the installation or removal of the balloon and acute pancreatitis. The gestational mortality would be 0.06 to 0.1%, most often related to the complications of gastric perforation [17, 31].
Immediate side effects are common and are most often prevented by medical treatment. Complications are rare but can be severe.
What does the gastric balloon really bring in the management of obesity?
The gastric balloon causes short-term significant weight loss in a majority of patients. This weight loss is associated with an improvement in comorbidities related to obesity at the cost of specific but controlled morbidity. This Effecteffect is eroded over time but persists in the medium term in at least one-third of patients initially responders. The weight loss induced by the balloon seems to reinforce the motivation of the patients who must follow a multidisciplinary follow-up aiming at the modification of the alimentary and behavioral habits. This demonstration of efficiency in the short and medium-term raises the question of the “real” benefit of the balloon in the long term. This profit remains to be established. The place of the balloon compared to that of the bariatric surgery and the interest in the repetition of the gesture must also be specified.
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Les Cinq points forts
Le ballon gastrique peut être proposé aux patients en surcharge pondérale avec un indice de masse corporelle (IMC) > 27, chez les patients en obésité non morbide (30 < IMC < 40) et .
