Friday, October 31, 2014

Adjustable Intragastric Balloons: A 12 Month Pilot Trial in Endoscopic Weight Loss Management

Objectives Intragastric balloons(IGBs) are associated with, 1) intolerances in the early period, 2) diminished weight loss after the third month, 3) risk of bowel obstruction mandating removal at six months, and 4) the need for a dedicated extraction tool.The introduction of an adjustable balloon could improve comfort and offer greater efficacy. A migration prevention function, safely enabling prolonged implantation, could improve efficacy and weight maintenance post extraction. Polypectomy snare extraction would also be beneficial. The first implantations of an adjustable balloon with attached migration-prevention anchor is reported.

Aims & Methods The SpatzTM Adjustable Balloon is mounted on a curled non-crushable catheter that straightens overa guidewire, and passed transorally, under conscious sedation. The non-crushability of the catheter loops is mediated by an internal chain. Post-implantation, an extractable inflation tube housed in the catheter can be snared endoscopically and pulled outside the mouth for volume adjustments. 18 patients (15 female, 3 male); mean BMI 39,4(range 29,4 to 53,2); and mean wt. 114,9kg (range 73,5 to 163kg) were implanted with mean balloon volume of 406,9 cc (range 350 to 600cc) of saline.

Results Mean weight loss at 24 weeks was 15.6 kg with a 26.4% EWL (% excess weight loss), and 35.5 kg with a 67.3 %EWL at 52 weeks. Sixteen adjustments were successfully performed. Six downward adjustments alleviated intolerance, yielding an additional mean weight loss of 4.6 kg. Ten upward adjustments for weight loss plateau yielded a mean additional weight loss of 8.1 kg. There were no major complications, however, seven of the 18 balloons were removed.

Conclusion The Spatz ABS has been successfully implanted in eighteen patients. 1) Upward adjustments yielded additional weight loss. 2) Downward adjustments alleviated intolerance, with continued weight loss. 3) Eight extractions were performed with a polypectomy snare. 4) Preliminary one year results are encouraging.

Jeffrey Brooks et al

Symptomatic bacterial contamination of an intragastric balloon

A 45-year-old woman had an intragastric balloon placed endoscopically for metabolic syndrome and obesity (body mass index = 37.42 kg/m2). She was being maintained on omeprazole daily. Under endoscopic view, the balloon was positioned in the stomach and inflated with 650 mL of 0.9% NaCl mixed with 20 mL of methylene blue solution. After 4 months, the patient had lost 22 kg but began to report intense nausea, vomiting, abdominal distention, and abdominal pain. An abdominal plain film showed a radiolucent and elongated structure in the upper abdomen (A). Endoscopy revealed an enlarged balloon, and the solution inside the balloon was collected during its removal by puncture. Inspection of the balloon after withdrawal showed its surface to be irregular with microbubbles and what appeared to be extensive fungal colonization (B). No samples were taken from the balloon surface, but culture and examination of the solution inside the balloon revealed Klebsiella pneumoniae (a gas-producing bacterium) and Candida spp. The patient was discharged without any symptoms and remained asymptomatic during the next 3 months. Disclosure All authors disclosed no financial relationships relevant to this publication. Commentary Patients with intragastric bezoars lose weight, an observation that prompted Mary and Lloyd Garren to develop the first intragastric balloon to function as an artificial bezoar, ostensibly by inducing a feeling of satiety and thereby helping to curb appetite. In 1985, the U.S. Food and Drug Administration approved the use of a 200-mL air-filled cylindrical, but sharp-edged, plastic bubble, ie, the Garren-Edwards Gastric Bubble, for use in morbidly obese patients, as an adjunct to dietary and behavior modification therapy. Other intragastric balloons have been developed and tried since then and have indeed resulted in weight loss, which sometimes was quite significant, although several randomized, controlled studies failed to show a significant advantage of the balloon over a sham procedure. Reported complications of intragastric balloons have included gastric ulceration, bubble intolerance, and, perhaps most important, spontaneous deflation of the bubble with resultant intestinal obstruction, the risk of which is significantly higher when balloons are left in place longer than 6 months. Here the authors report another adverse effect, namely, abdominal distention and pain, attributed to gas production by Klebsiella. The observation of Klebsiella in the balloon raises many questions: Why was the inner balloon not sterile? What happened to balloon permeability over the time that the balloon resided in the stomach? Was inner colonization a local phenomenon facilitated by the clumps of microorgansims on the external surface of the balloon? One would imagine that were gastric acid to have been normal, there probably would not have been a proliferation of “fungal-appearing” forms nor of bacteria other than Helicobacter pylori. How does the presence of an intragastric balloon affect gastric acid secretion? So many questions. Winnie the Pooh said, “No one can be uncheered with a balloon.” Although this balloon probably led to some cheering at first, it then, I am sure, lead to uncheering as reality set in: obesity is a major health problem that involves lifelong attention to diet, behavior modification, and perhaps the help of a skilled surgeon. I wish this patient good fortune.