A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional
Issue link: https://bariatrictimes.epubxp.com/i/651228
17 Emerging Technologies Bariatric Times • March 2016 e vent as the manufactures have improved the design of the devices, but patients and providers should remain aware of this possibility and the need for i mmediate removal if balloon deflates to avoid its migration . ReShape Integrated Dual Balloon System. In the REDUCE pivotal trial, balloon deflation o ccurred in six percent of patients without migrations usually late in the treatment phase. Deflation in the ReShape Integrated Dual Balloon System c an be detected by instructing patients to look for a change in urine color to blue-green and a decrease in the sensation of fullness after eating. O rbera Intragastric Balloon System. In the US Pivotal Study of the Orbera Intragastric Balloon System, there were no spontaneous deflations. A ccording to Directions for Use (DFU) for the Orbera Intragastric Balloon System, 12 balloon deflation may be detected when patients report loss of satiety, increased hunger and/or weight gain. In these cases, patients should be examined endoscopically. 4. Ulcers. Ulcers can occur in 2 10 to 10 8 percent of patients. These are usually small and superficial, but patients should be aware of the need to take proton-pump inhibitors (PPI) during the six- month balloon therapy. PERSONAL EXPERIENCE I became interested in the intragastric balloon as I witnessed it being used internationally. I had the opportunity to visit Dr. Manoel Galvao-Neto in Sao Paulo, Brazil, and discuss the procedure in length with him and others. Less than one percent of the individuals with obesity and morbid obesity are having bariatric surgery. 13 Many patients that are struggling with obesity and have BMIs between 30 and 40kg/m 2 are not seeking treatment via bariatric surgery. Some reasons for not seeking treatment may include not being ready or being afraid. Many patients have maximized different diet plans and pharmacotherapy, and we didn't have anything else to offer them. The endoluminal therapies, like the intragastric balloon, helps to fill the gap between lifestyle/diet and pharmacoptherapy and surgery, especially for the patient population with BMIs 30 to 40kg/m 2 . These therapies may attract patients to our practices and allow them to undergo effective treatment for their obesity. My endoscopic skills were sufficient, and I was offered the opportunity to participate and be the principal investigator for the R EDUCE pivotal trial. After FDA approval, we have seen significant enthusiasm by the bariatric surgery community, and patients that followed the news s egments in the media asked for this therapy. We decided to develop all the necessary clinical care pathways, structured a one-year comprehensive program, and placed t he first ReShape Integrated Dual Balloon after FDA approval on September 1, 2015. (Figure 10). My colleague, Dr. Abu Dayyeh from M ayo Clinic, Rochester, Minnesota, placed the first Orbera balloon after FDA endorsement on August 14, 2015. During the clinical trials and e xposure to international experience with the balloon, I have learned that intolerance is very variable among centers and very dependent on expertise. Early r emovals in international publications are 7.5 percent, 9 and some centers have early removal rates as low as two percent. 10 Even i n the US clinical trials, the range of early removals varied significantly among all the centers. Many centers around the world have abandoned the intragastric balloon as it has not o ffered adequate results for their patients. The most important thing I have learned is that the balloon is not "magic." It is only a supportive instrument for a well-structured c omprehensive diet and exercise program. The majority of patients that follow the comprehensive program with a balloon will lose