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
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
No comments:
Post a Comment