S. Brooks* 1, 1, E. Tsvang2, M. Ganon2, et al
Introduction: Approximately 250,000 intragastric balloons (IGB) have been utilized for weight loss since the 1980’s, with well over 5,000 patients reported in the literature. To date, balloonists have been unable to reliably choose the appropriate volume per patient. Premature extraction in the first months has been reported in 3% -10% of BIB (Orbera) balloon patients due to intolerance characterized by persistent nausea, vomiting, abdominal pain or acid reflux symptoms. The SSED for the recently approved Orbera balloon in the US has reported a 22% premature extraction rate. In addition, approximately 5% of patients experience insufficient balloon effect in the first 6 weeks. For these situations, a change in balloon volume can prevent premature extraction. Balloon volume adjustments can be performed with the Spatz3 adjustable balloon with a 15 minute outpatient endoscopy.
Aims & Methods: The adjustability function of the Spatz3 adjustable balloon was assessed for its ability to alleviate 1) early intolerance and 2) insufficient balloon effect in the first 6 weeks. Between February 2015 and November 2015, 161 patients (76% females) ; mean age 45 (19-70); mean wt 98.3 kg (70-144.6); mean BMI 35.4(29.3-75.3); were implanted with the Spatz3 Adjustable balloon (Spatz FGIA Inc., NY, USA) with a mean balloon volume of 483 ml (400-600). The dietician was in direct contact daily with patients for at least 3 days or until the symptoms abated, and thereafter twice weekly for the first month, followed by once every 3 weeks.
Intolerance: Patients with persistent symptoms of nausea, vomiting, abdominal pain, pyrosis, or bloating who were unresponsive to PPI or prokinetic drugs beyond 1 week and requested balloon extraction, were adjusted downward (13 patients). Group A (6 patients) had 50-100 ml removed regardless of balloon starting volume, and group B (7 pts) had 150 ml removed (100 ml if starting volume was 400 ml).
Unresponsive: Patients with minimal or no balloon effect from the start or lost effect prior to 6 weeks underwent upward adjustments of balloon volume.
Results: 13/161patients (8.1%) with persistent intolerance underwent downward adjustments at a mean 2.8 weeks (1-4.5 weeks) with immediate relief of symptoms. Within Group A (≤100 ml), 3/6 (50%) had sustained relief and 3/6 required balloon extraction 1 week later for recurrent intolerance. Within Group B (150 ml, or 100 ml with a 400 ml balloon), 7/7(100%) had sustained relief for at least 1 month or more.
10/161 patients (6.2%) had minimal or no balloon effect or lost balloon effect prior to 6 weeks. They underwent balloon volume addition at a mean 12.5 weeks (6-24.5 weeks) with mean addition 292 ml (200-400 ml). 8/10 (80%) experience improved balloon effect and yielded an additional mean weight loss of 5 kg (0-17 kg) after the adjustment.
Conclusion: 1) Premature extraction due to early intolerance can be prevented by reducing balloon volume by 150 ml (or 100 ml if starting balloon volume is 400 ml). 2) Early loss of balloon effect or total lack of balloon effect in the first 6 weeks can be successfully rectified in 80% of patients by adding a mean 292 ml (200-400 ml) to the balloon. Larger controlled trials will be needed for confirmation and to determine appropriate volume additions.