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.
The Spatz balloon is an effective procedure without mortality; however, it carries a risk of catheter impaction necessitating surgical extraction (4.1%). The failure rate--4.1%; intolerance without ability to adjust balloon--5.5%; major complications occurred in 3 (4.1%); minor (balloon deflations) in 3 (4.1%), and 2 asymptomatic gastric ulcers at extraction (2.7%). The longer implantation period and adjustment option combine to produce greater weight loss, albeit <10% weight loss beyond the pre-adjustment weight loss.
(1) Within the limitations of a retrospective review, the Spatz3 balloon appears to be an effective wt loss balloon with better response rates in BMI < 40. (2) Up adjustments yielded a mean 5.7 kg extra wt loss. (3) Down adjustments alleviated early intolerance in 80% of patients. (4) These two adjustment functions may be instrumental in yielding a responder rate of 88.5%.
Discuss this article AbstractThe Spatz3 Adjustable balloon system is approved for 1 year Background: implantation and allows multiple changes in the balloon volume during the course of implantation. Other intragastric balloons are currently approved for 6 months and their balloon volumes cannot be adjusted after implantation.To determine the efficacy and safety of the Spatz3 adjustable balloon Aim: system.Seventy seven consecutive patients (66 females and 11 males) in Methods: two medical centers were implanted with the Spatz3 adjustable balloon device and were followed prospectively. The patients' mean BMI was 37.2; the mean weight was 108.7 kg; the mean age was 41 (16-68); the mean balloon volume was 469 ml (450-500 ml). Adjustments were made for intolerance or weight loss plateau.The mean weight loss at 1 year was 17.2 kg with 15.9 % weight loss Results: and 42.9 % Excess Weight Loss (%EWL). Eighteen patients underwent balloon volume adjustments: three downward adjustments of 100 -150 cc which alleviated early intolerance; 15 upward adjustments (mean 320 ml; range 200-500) at a mean 4.1 months (range 2-5 months) yielded additional mean wt loss of 8.2 kg (range 0-25 kg) after the adjustment. Three balloons were removed before the 1 year completion date due to intolerance and three others were removed for other reasons (pregnancy, gall bladder surgery, and alcoholism). There was one episode of gastric ulceration which required endoscopic therapy and balloon removal. There were no deflations or perforations.The Spatz3 adjustable balloon is a safe and effective treatment Conclusions: for weight loss. The adjustability function can yield greater weight loss for those who show weight loss plateau and can mitigate intolerance.
Round (helical) atelectasis is a little-known form of pulmonary collapse. It is thought to occur secondary to lung compression from pleural effusion or following therapeutic pneumothorax. Its occurrence is favoured in patients with exudative pleural effusions and extensive pleural thickening. It presents radiographically as a pulmonary pseudotumour, and experience with this entity and its pathogenesis are discussed.
INTRODUCTION: Intragastric balloons (IGBs) are a safe and effective treatment for obesity. However, limited knowledge exists on the underlying biological changes with IGB placement. METHODS: This single-institution study was part of an adjustable IGB randomized controlled trial. Subjects with obesity were randomized in a 2 is to 1 ratio to 32 weeks of IGB with diet/exercise counseling (n = 8) vs counseling alone (controls, n = 4). Diet/exercise counseling was continued for 24 weeks post-IGB removal to assess weight maintenance. We used mass spectrometry for nontargeted plasma lipidomics analysis and 16S rRNA sequencing to profile the fecal microbiome. RESULTS: Subjects with IGBs lost 15.5% of their body weight at 32 weeks vs 2.59% for controls (P < 0.05). Maintenance of a 10.5% weight loss occurred post-IGB explant. IGB placement, followed by weight maintenance, led to a −378.9 μM/L reduction in serum free fatty acids compared with pre-IGB (95% confidence interval: 612.9, −145.0). This reduction was mainly in saturated, mono, and omega-6 fatty acids when compared with pre-IGB. Polyunsaturated phosphatidylcholines also increased after IGB placement (difference of 27 μM/L; 95% confidence interval: 1.1, 52.8). Compared with controls, saturated and omega-6 free fatty acids (linoleic and arachidonic acids) were reduced after IGB placement. The fecal microbiota changed post-IGB placement and weight maintenance vs pre-IGB (P < 0.05). Further analysis showed a possible trend toward reduced Firmicutes and increased Bacteroidetes post-IGB and counseling, a change that was not conclusively different from counseling alone. DISCUSSION: IGB treatment is associated with an altered fecal microbiome profile and may have a better effect on obesity-related lipidome than counseling alone.
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