A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional
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16 Emerging Technologies Bariatric Times • March 2016 were high. 8 In addition, of the patients who completed treatment, two-thirds reported that they would u ndergo it again, and 77 percent said they would recommend it to a friend. Adverse events included post- implantation accommodative symptoms of nausea, vomiting, and abdominal pain. Out of 264 patients that had the dual balloon implanted, 87 percent had nausea or vomiting. These symptoms were reported as mostly mild in severity and typically subsided within 3 to 7 days. Symptoms were reported by patients using the Rhodes Index of Nausea, Vomiting, and Retching form (Rhodes Index) and an abdominal pain visual analog scale (VAS) at baseline, Day 3, and Weeks 1, 4, 12, and 24 during the REDUCE study (Figures 8 and 9). 8 CLINICAL BENEFITS OF INTRAGASTRIC BALLOON SYSTEMS In both randomized, clinical studies, the intragastric balloon resulted in better weight loss compared to diet and exercise alone. In addition to positive patient results, surgeons may find that the system offers other clinical benefits. Personally, I find that endoscopic placement of the balloon is not complicated. The stomach should be inspected and known to be normal prior to implantation, and the device can be placed and removed under conscious sedation in an outpatient procedure. I also find that since the procedure is not a traditional weight loss surgery, such as laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy, and therefore does not alter the anatomy, patient acceptability is high. Patients with BMIs between 30 and 40kg/m 2 may also find the intragastric balloon procedure attractive if they are not ready or do not qualify for surgery. Lastly, unlike pharmaceuticals, there is no daily decision for the patient to make about whether to follow the program, thus adherence may be improved, compared to t hose individuals who use lifestyle modifications alone or in combination with pharmaceuticals. LIMITATIONS/ADVERSE EVENTS It is important for patients and practices to understand the following about intragastric balloon procedures: 1) some patients will not respond well to the device, 2) weight loss might not be significant, and 3) it needs to be used in association with a good supportive diet and lifestyle changes. Several risks and limitations should be discussed with patients when offering the balloon procedure, including the following: 1. Contraindications. Inability to place the balloon secondary to incidental findings in the stomach (i.e., ulcers, tumors, large hiatal hernia, achalasia or any other severe motility disorder). 2. Adverse events. The majority of patients will experience nausea, vomiting, and abdominal discomfort during the first few days, and some patients may require early balloon removal for intolerance. The range can be as low as two percent in some experienced practices to as high as 18 percent as was seen in the US pivotal study. 11 Experience and patient management of expectations, education, reassurance, and medications may lower the percentage of early balloon removal. We also learned from the REDUCE trial that shorter stature patients (<5'4") require less fluid (750cc instead of 900cc) to have lower rate of intolerance. 8 For Orbera, smaller balloons (400cc to 500cc) may be warranted in patients with motor dyspepsia or gastroparesis. 12 3. Balloon deflation. Balloon deflation has become a rare PARTICIPANTS IN INTRAGASTRIC BALLOON RESEARCH ALFREDO GENCO, MD U niversity of Roma, Italy Involved in large Italian multicenter i ntragastric balloon data 3 JOSE AFONSO SALLET, MD Sao Paulo, Brazil. Involved in a large case series of intragastric balloon 4 GONTRAND LOPEZ-NAVA, MD Bariatric Endoscopy Unit, Madrid Sanchinarro University Hospital, Madrid, Spain Involved in a large case series and sequential use of intragastric balloon 5 MANOEL GALVAO-NETO Sao Paulo, Brazil Has extensive experience with different endoluminal techniques, including intragastric balloon procedures BARHAM ABU DAYYEH, MD Mayo Clinic, Rochester, Minnesota Principal investigator for the Orbera Intragastric Balloon system FDA clinical trial, 11 and placed the first Orbera balloon in the United States after FDA approval JAIME PONCE, MD, FACS, FASMBS Chattanooga Bariatrics, Chattanooga, Tennessee Principal investigator for the ReShape Integrated Dual Balloon System clinical trial, 8 and placed the first ReShape balloon in the United States after FDA approval F IGURE 10. Dr. Ponce and staff from the Parkway Surgery Center, Ringgold, Georgia, during placement of the first ReShape Integrated Dual Balloon in the United States after FDA approval.