The Swallowable Intragastric Balloon Combined with Lifestyle Coaching: Short-Term Results of a Safe and Effective Weight Loss Treatment for People Living with Overweight and Obesity

Obesity Surgery https://doi.org/10.1007/s11695-023-06573-8 ORIGINAL CONTRIBUTIONS The Swallowable Intragastric Balloon Combined with Lifestyle Coaching: Short‑Term Results of a Safe and Effective Weight Loss Treatment for People Living with Overweight and Obesity Marijn T.F. Jense1,2,3 · Inge H. Palm‑Meinders2 · Boy Sanders2 · Evert‑Jan G. Boerma1,2 · Jan Willem M. Greve1,2,3 Received: 30 December 2022 / Revised: 23 March 2023 / Accepted: 28 March 2023 © The Author(s) 2023 Abstract Background Some patients with overweight or obesity are not eligible for surgery according to international guidelines or do not wish a surgical intervention. For these patients, different treatment options are being explored. In this study, we examined the effectiveness of the swallowable intragastric balloon (IB) combined with lifestyle coaching, in patients living with overweight and obesity. Method A retrospective data study was conducted on patients with a swallowable IB placement between December 2018 and July 2021, combined with a 12-month coaching program. Before balloon placement, patients underwent multidisciplinary screening. The IB was swallowed and filled with fluid once in the stomach and naturally excreted around 16 weeks. Results A total of 336 patients, 71.7% female, were included with a mean age of 45.7 (±11.7) years. Mean baseline weight and BMI were 107.54 (±19.16) kg and 36.1 (±5.02) kg/m2. After 1 year, the mean total weight loss was 11.0% (±8.4). The mean placement duration was 13.1 (±2.82) min, and in 43.7%, a stylet was used to facilitate placement. The most common symptoms were nausea (80.4%) and gastric pain (80.3%). In the majority of patients, complaints were resolved within a week. The early deflation of the balloon occurred in 8 patients (2.4%) of which one showed symptoms suggesting a gastric outlet obstruction. Conclusion Given the low rate of long-term complaints while providing a positive effect on weight loss, we conclude that the swallowable intragastric balloon, combined with lifestyle coaching, is a safe and effective treatment option for patients living with overweight and obesity. Keywords Intragastric balloon · Obesity treatment · Obesity · Overweight · Weight loss · Lifestyle coaching Introduction Key Points • The use of a swallowable intragastric balloon resulted in clinically meaningful weight loss • Complication rates of the swallowable intragastric balloon are low • There is a low amount of long-term physical complaints • The swallowable intragastric balloon can successfully be combined with anti-obesity medication For people living with obesity, bariatric surgery is a possible solution. In The Netherlands, bariatric surgery is currently only reimbursed for patients who comply with international guidelines stating that a patient needs to have a BMI of at least 35 kg/m2 with comorbidities or a BMI of Jan Willem M. Greve * Marijn T.F. Jense Inge H. Palm‑Meinders 1 Bariatric Surgery, Zuyderland Medical Center, Henri Dunantstraat 5, 6419 Heerlen, PC, Netherlands Boy Sanders 2 Dutch Obesity Clinic South, John F. Kennedylaan 301, 6419 Heerlen, XZ, Netherlands Evert‑Jan G. Boerma 3 Maastricht University Medical Center, Maastricht, The Netherlands 13 Vol.:(0123456789) Obesity Surgery 40 kg/m2 [1, 2]. However, some patients are not eligible for surgery according to these international guidelines or do not wish a surgical intervention. Other treatment options, such as anti-obesity medication (AOM) or the intragastric balloon (IB), are being explored. Since the beginning of 2022, certain types of AOM are available as an insured treatment option in combination with intensive lifestyle coaching in The Netherlands [3, 4]. Although multiple pharmacological agents have been proven to be effective for weight loss, they do come with side effects. In addition to the side effects, interactions with regularly used medication are common and worrisome [5–7]. The use of IBs has already been reported [8]. However, most IBs have to be placed endoscopically [8, 9]. Although endoscopy is less invasive than surgery, it remains to be invasive. The difference with the Allurion IB is that this balloon has to be swallowed by the patient. Once the capsule with the balloon is in the stomach, the balloon is filled with fluid. After 16 weeks, a filament attached to the valve of the balloon will be dissolved. Once the filament is dissolved the valve will open and the balloon will empty itself in the stomach. The fluid and the emptied balloon will be excreted via the intestinal tract. This way, no endoscopy is necessary, and therefore the treatment is less invasive, time-consuming, and costly. In the Dutch Obesity Clinic (DOC), one of the treatment options is 12 months of lifestyle coaching combined with an Allurion IB. The patients have to pay for the treatment themselves. Although multiple studies have reported on the use of the Allurion IB, not many studies have combined the use of the IB with lifestyle coaching for a longer period [10, 11]. Via the current retrospective data study, we aim to evaluate the safety and effectiveness of the Allurion IB in combination with lifestyle coaching. Method Study Design All patient data used in this study were obtained from patients who have received an IB at the DOC and have given their consent to use patient data for scientific research. In addition to the IB, patients received lifestyle coaching to be able to maintain their weight loss. For this retrospective data study, local approval was given by the ethics committee in accordance with the ethical standards as laid down in the 2013 Declaration of Helsinki. All data were collected and blinded in SPSS by a health professional of the DOC who had a treatment relationship with the patients. The researcher who worked with the data was not able to trace information back to the patients. 13 Participant and Eligibility Criteria The study population consisted of patients who received a balloon between December 2018 and July 2021. All adult patients who were interested in obesity treatment and had a BMI above 27 kg/m2 were screened by the medical doctors of the DOC. Pregnancy, previous operations in the upper gastro-intestinal region, and trouble with swallowing were the main exclusion criteria. Additional exclusion criteria are listed in Appendix 2. If the patient was considered eligible, treatment with an IB was initiated. Included in the treatment with the Allurion balloon at the DOC was a 12-month lifestyle program. Placement The IB is swallowed by the patient and filled with 550 mL fluid, after confirmation of the intragastric position via X-ray. After 16 weeks, the balloon deflates spontaneously and leaves the body through the intestinal tract. The duration of every placement and the use of a stylet (guidewire) were recorded at every placement appointment. Comorbidities Hypertension, type 2 diabetes, dyslipidemia, and obstructive sleep apnea syndrome (OSAS) were (...truncated)