title: Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management.
abstract: Intragastric balloons are associated with (1) early period intolerance, (2) diminished effect within 3-4 months, and (3) bowel obstruction risk mandating removal at 6 months. 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. The first implantations of an adjustable balloon with an attached migration prevention anchor are reported. The primary endpoint was the absence of bowel perforation, obstruction, or hemorrhage. Eighteen patients with mean BMI of 37.3 were implanted with the Spatz Adjustable Balloon system (ABS) for 12 months. Balloon volumes were adjusted for intolerance or weight loss plateau. Mean weight loss at 24 weeks was 15.6 kg with 26.4% EWL (percent of excess weight loss) and 24.4 kg with 48.8% EWL at 52 weeks. Sixteen adjustments were successfully performed. Six downward adjustments alleviated intolerance, yielding additional mean weight loss of 4.6 kg. Ten upward adjustments for weight loss plateau yielded a mean additional weight loss of 7 kg. Seven balloons were removed prematurely. Complications necessitating early removal included valve malfunction (1), gastritis (1), Mallory-Weiss tear (1), NSAID (2× dose/2 weeks) perforating ulcer (1), and balloon deflation (1). Two incidents of catheter shear from the chain: one passed uneventfully and one caused an esophageal laceration without perforation during extraction. The Spatz ABS has been successfully implanted in 18 patients. (1) Upward adjustments yielded additional weight loss. (2) Downward adjustments alleviated intolerance, with continued weight loss. (3) Preliminary 1-year implantation results are encouraging.
authors.affiliation: Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic. evmac@seznam.cz
authors.forename: Evzen
authors.initials: E
authors.lastname: Machytka
authors.forename: Pavel
authors.initials: P
authors.lastname: Klvana
authors.forename: Asher
authors.initials: A
authors.lastname: Kornbluth
authors.forename: Steven
authors.initials: S
authors.lastname: Peikin
authors.forename: Lisbeth E M
authors.initials: LE
authors.lastname: Mathus-Vliegen
authors.forename: Christopher
authors.initials: C
authors.lastname: Gostout
authors.forename: Gontrand
authors.initials: G
authors.lastname: Lopez-Nava
authors.forename: Scott
authors.initials: S
authors.lastname: Shikora
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Brooks
mesh_terms: D000328:Adult; D005260:Female; D015905:Gastric Balloon; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery*; D010865:Pilot Projects; D015431:Weight Loss; D055815:Young Adult