Brazil Study: Gastric Balloon Valid Option, but Outcomes Not Durable

Marlene Busko

November 17, 2015

LOS ANGELES — A multicenter study of more than 3000 overweight and obese patients in Brazil who had intragastric-balloon procedures indicates that this is "a valid endoscopic therapeutic option for weight loss," says the lead author, but unfortunately, the weight loss wasn't maintained long term in the majority of people.

Detailing the experience in his country at the recent Obesity Week 2015, Bruno Sander, MD, a bariatric surgeon in Belo Horizonte, Brazil, acknowledged that "beach culture" is important there and body image is highly valued. As a result, "most of our patients [undergo] the intragastric-balloon procedure due to esthetics," he summarized, with participants typically having a body mass index (BMI) between 27 and 35 and being less than 16 kg above a normal weight.

Overall, the patients, who had an average age of 36 and were mostly women (68%), had a mean BMI of 34.8 when the intragastric balloon was endoscopically inserted into the stomach, which fell to 28.6 when the balloon was removed up to 8 months later.

But although the patients received advice about diet, behavior modification, and physical activity from a dietician, psychiatrist, and fitness trainer, 30% regained their lost weight within 6 months of balloon removal, and 70% regained their lost weight by 3 years.

Niche Between Diet/Exercise Alone and Bariatric Surgery?

The intragastric-balloon procedure is an endoscopic, outpatient procedure done to increase satiety and train people to eat less, in conjunction with diet and exercise, and it is approved in more than 80 countries.

In Brazil, the gastric-balloon procedure — where the balloon stays in the stomach for 6 or 12 months — has been used for more than 10 years, and the procedure can be repeated. There, it is approved for use in people with a BMI of 27 or more, Dr Sander noted.

In contrast, the US Food and Drug Administration (FDA) only approved the ReShape integrated dual balloon system (ReShape Medical) and Orbera intragastric-balloon system (Apollo Endosurgery) this past summer, for patients with a BMI of 30 to 40.

US patients have, however, been traveling over the border to Canada for self-funded balloon procedures.

The assigned discussant at Obesity Week, George M Eid, MD, a bariatric surgeon in Pittsburgh, Pennsylvania, noted that there is "a lot of interest" in gastric-balloon systems in the United States, with the two recent FDA approvals.

But session cochair Michel Gagner, MD, a bariatric surgeon from Hôpital du Sacre Coeur, Montreal, Quebec, told Medscape Medical News: "I think the hype that we see right now in the United States [may be short-lived]. We might have this interview 3 or 4 years from now, and we'll see that people are [no longer] interested" in this procedure.

On the other hand, perhaps there will be "better balloons [that] may be inserted for longer periods," up to 3 or 4 years, which may result in better, long-lasting outcomes, Dr Gagner speculated.

Most Weight Lost Around 4 Months After Balloon Procedure

The current study looked at data from 3545 overweight and obese patients who had intragastric-balloon procedures in three private clinics in Brazil from 2009 to 2014.

Most patients had a BMI of 27 to <30 (overweight) or 30 to <35 (class 1 obesity), and the rest had a BMI of 35 to <40 (class 2 obesity) or >40 (class 3 obesity).

About 200 patients had the balloon procedure as a bridge to bariatric surgery; these were extremely obese people (BMI >40) who needed to lose weight to be able to qualify for bariatric surgery.

Nausea and vomiting were common in the first 7 days, and one patient had gastric perforation. The maximum period implant of the intragastric balloon was 8 months

Of the 3545 patients, 110 patients (3.1%) had the balloon removed early; 39 patients (1.1%) gained or failed to lose weight; and 59 patients (2.2%) had incomplete data.

In the remaining 3340 patients, the patients who were overweight or had class 1 obesity lost the highest percentage of excess body weight: 142.7% and 78.7%, respectively.

Patients with class 2 and class 3 obesity lost 61.5% and 47.1% of their excess body weight, respectively.

Most weight was lost around the 4-month mark.

Twelve patients (0.34%) had spontaneous balloon hyperinflation, and 22 patients (0.62%) had spontaneous balloon deflation or leakage.

When the balloon deflates, the filling solution containing methylene blue leaks into the urine, causing the urine to turn green, so the patient quickly returns to the clinic to have the balloon removed, Dr Sander said.

Not a Benign Procedure?

About 5% of patients had complications that did not lead to balloon removal: 161 patients (4.54%) had fungal contamination; two patients (0.05%) had Wernicke-Korsakoff syndrome (a brain disorder due to thiamine [vitamin B1] deficiency); and 14 patients (0.39%) became pregnant during the implant period.

Only one patient (0.028%) had a complication that led to removal of the balloon; the patient had gastric perforation and upper digestive bleeding.

Dr Eid asked if the volume of filling solution (which ranged from 620 to 700 mL) affected outcomes or side effects, but Dr Sander said it did not.

With regard to balloon removal, patients have to return to the clinic for this, and if they fail to do so, they have to pay an extra fee, so they do all return, Dr Sander explained.

However one audience member cautioned that the procedure is not benign, noting that there have been three or four reported cases of pancreatitis; there has been a case report of hepatitis in Australia; and there have been cases where air enters the balloon and it hyperinflates.

Obesity Week 2015: Los Angeles, California. Abstract 105, presented November 4, 2015.

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