Abstract
Background:
The Spatz3® Intragastric Adjustable Balloon (SAB) offers a novel approach to weight loss in super obese patients [body mass index (BMI) ≥50 kg/m2]. This study evaluates the safety, effectiveness, and predictors of success of SAB in this population.
Methods:
A retrospective study was conducted at King Abdullah Medical City, Makkah, Saudi Arabia, involving 94 patients with SAB implantation. Weight loss metrics (%EWL, %TBWL), complications, and predictors of adverse events were analyzed.
Results:
Eleven patients required early SAB removal due to severe symptoms. Complications included gastrointestinal bleeding (3.2%), gastric ulcer/erosion (27.7%), and deflation (5.3%). Significant weight loss was observed at 6 and 12 months. The mean absolute weight loss was 22.03 kg at 12 months, with %EWL of 19.27%. Early weight loss at 3 months predicted long-term success. SAB adjustments did not significantly impact outcomes. Post SAB, 57% of patients proceeded to laparoscopic sleeve gastrectomy (LSG) with rare postoperative complications (2.9%).
Conclusion:
SAB is safe and effective for patients with BMI ≥50 kg/m2, achieving significant weight loss at 12 months. Early weight loss predicts long-term success, and subsequent LSG can be performed without significant complications. Further research should explore long-term outcomes and comparative analyses.
Keywords: Spatz adjustable balloon, intragastric balloon, obesity, excess weight loss, total body weight loss
INTRODUCTION
Super obesity, characterized by a body mass index (BMI) of 50 kg/m2 or higher, is a severe form of obesity with rapidly increasing prevalence.[1] This condition is associated with chronic diseases and reduced life expectancy and a significant burden on healthcare systems.[2] While modest weight reduction (5–10%) yields health benefits and is recommended as the initial goal, lifestyle modifications and pharmacotherapy often yield short-lived effects and are poorly tolerated.[3,4] Bariatric surgery has revolutionized obesity treatment, leading to substantial weight loss and improved comorbidities.[5,6] However, surgical management of patients with super obesity poses technical challenges and carries high morbidity and mortality risks.[7]
Preoperative weight loss plays a crucial role in mitigating surgical risks, with a 5% reduction in weight, associated with a significant decrease in postoperative mortality.[8] Consequently, a staged approach to weight loss has gained prominence before bariatric surgery, particularly in patients with super obesity. Various weight loss programs have undergone scrutiny, including lifestyle changes, medications, botox gastric injections, and two-stage surgical interventions, yielding varying effects.[9,10,11] Among these approaches, endoscopic insertion of an intragastric balloon (IGB) has emerged as an effective strategy. The IGB serves as a bridge to definitive bariatric surgery for patients with super obesity. Weiner et al.[12] were pioneers in demonstrating the feasibility of weight reduction using IGB immediately prior to bariatric surgery. Subsequent studies achieved more than 10% preoperative weight loss in 90% of patients following IGB placement. Notably, some studies reported significant improvement in associated comorbidities and better surgical outcomes.[13,14,15,16,17] A recent meta-analysis further affirmed the efficacy and the safety of IGB in reducing weight prior to bariatric surgery.[18]
The Spatz Adjustable Balloon System® (Spatz FGIA, Inc., NY, USA) (SAB), developed by Spatz FGIA, Inc. (New York, USA), distinguishes itself from other IGBs used in previous studies. Its unique feature lies in the ability to adjust its volume – either increasing or decreasing it – based on patient tolerability and need for additional weight reduction. Recently approved by FDA, SAB targets individuals with a BMI between 30 and 40 kg/m2.[19] However, its application in patients with BMI exceeding 50 kg/m2 remains undocumented. Therefore, the aim of this study is to retrospectively evaluate the effectiveness of the SAB in patients with super obesity and report any associated complications.
PATIENTS AND METHODS
This was a retrospective single-center study carried out in the Digestive Liver Health and Advanced Endoscopy unit in King Abdullah Medical City (KAMC), a tertiary center in Makkah, Kingdom of Saudi Arabia (KSA).
All patients who had Spatz3 Adjustable Balloon System® (Spatz FGIA, Inc., NY, USA) inserted for weight loss at our institute with BMI ≥50 kg/m2 were included in the study. The hospital information system (Mediplus®), patient medical record, and the endoscopy database (Endobase®) were searched for information on patient symptoms, comorbidities, medication used, and lab results, including details on SAB insertion, adjustments and its complications along with the weight loss achieved. The absolute weight loss, mean percent excess weight loss (%EWL), and the % total body weight loss (%TBWL) at 3, 6, and 12 months were recorded.
SAB insertion
All procedures were done by a certified and experienced endoscopist. Under conscious sedation, upper gastrointestinal (GI) endoscopy was performed till the second part of the duodenum. After confirming the absence of upper GI tract pathology precluding SAG insertion, the SAB was inserted following the manufacturer’s instructions. Briefly, the SAB was loaded onto the tip of the endoscope and introduced into the stomach. Once the balloon position was confirmed within the stomach, it was inflated with 450–500 ml of saline mixed with methylene blue solution. Post procedure, patients received prescription for antiemetic proton pump inhibitor and were advised to follow a liquid diet for subsequent 2 weeks. Regular follow-up occurred at 3, 6, and 12 months in the clinic. Adjustments to the SAB were made at the discretion of the endoscopist, primarily for inadequate weight reduction at around 6 months. During adjustments, an endoscopy was performed, ensuring balloon integrity, and the balloon valve was brought out with the help of a snare. The necessary volume of the above solution was added to the balloon, not exceeding a total of 700 ml.
Statistics
All data were analyzed using a statistical package for social sciences (SPSS) Version 20. Results were presented as percentages, mean (standard deviation, SD), and 95% confidence interval (CI) where appropriate. For comparisons within similar samples (6 months and 12 months post SAB implantation), paired sample two-tailed t-tests were employed for continuous variables. One sample t-test was used to compare the means between baseline and 6 months post IGB insertion. Independent sample t-test was utilized for comparisons between different samples (patients with and without balloon adjustment). Baseline variables were examined using univariate and multivariate models to identify predictors of IGB efficacy. Stepwise logistic was employed for multivariate analysis, with statistical significance set at P < 0.05. Variance inflation factors (VIFs) were used to assess the degree of collinearity among the independent variables. Variables with a VIF greater than 10 were flagged for potential collinearity.
BMI was defined as a person’s weight in kilograms (kg) divided by his/her height in meters squared. Ideal weight was determined by using MDcalc (MD Aware, LLC, NY, USA). Excess body weight (EWL) was defined as baseline weight minus ideal body weight. Percent EWL (%EWL) was calculated as the weight loss (baseline weight minus follow-up month) divided by excess weight multiplied by 100. Percent total body weight loss (%TBWL) was calculated as the weight loss (baseline weight minus follow-up month weight) divided by baseline weight multiplied by 100.
Ethical considerations
The study was approval from KAMC IRB, registered with the National BioMedical Ethics Committee at King Abdulaziz City for Science and Technology, on 14-07-1433 (Registration No. H-02-K-001).
RESULTS
Patient characteristics
A total of 97 patients underwent SAB insertion, but three did not receive the implantation due to findings of previous surgery that were not revealed prior to endoscopy. Consequently, 94 patients had successful implantation of SAB with no immediate complication at the time of insertion, and were included in the study. The mean age of the included patients was 40 [standard deviation (SD) ±12] years. Among them, 50 were male (53.2%). The mean initial weight was 172.47 (SD ± 50.12) kilograms (kg), and the mean BMI at the time of insertion was 64.03 (SD ± 17.68) kg/m2. The mean excess body weight was 117 (SD ± 41). The most common comorbidities at the time of presentation were sleeping disorder (44.7%), diabetes mellitus (33%), and asthma (11.7%) [Table 1].
Table 1.
Baseline demographics and comorbidities
| Variable | n=94 (%) |
|---|---|
| Age in years (mean±SD) | 40±12 |
| Gender | |
| Male | 50 (53.2) |
| Female | 44 (46.8) |
| Height (mean±SD) | 163.93±9.42 |
| Weight (mean±SD) | 172.47±50.12 |
| BMI (mean±SD) | 64.03±17.68 |
| Excess Body Weight | 117±41 |
| DM | 31 (33) |
| IHD | 6 (6.4) |
| COPD | 2 (2.1) |
| Asthma | 11 (11.7) |
| Sleeping Disorder | 42 (44.7) |
| Cerebrovascular Disease | 8 (8.5) |
Safety and complications
Out of the 94 patients, two were lost to follow-up, and 11 had an early SAB removal due to intolerance. The complications associated with SAB were GI bleeding in 3.2% (n = 3) (presented with hematemesis, one had a gastric ulcer, one intestinal obstruction, and one Mallory–Weiss tear), gastric ulcer/erosion in 27.7% (n = 26), deflation in 5.3% (n = 5), migration in 2.1% (n = 2) (one in addition had an obstruction and the other had gastric ulcer), and intestinal obstruction in 1.1% (n = 1) (partial obstruction: The patient was admitted for 2 days for observation, and the balloon passed spontaneously per rectum). Other symptoms included abdominal pain in 21.3% (n = 20) that was severe enough in 8 patients for unplanned SAB removal, nausea in 13.8% (n = 13), vomiting in 17% (n = 16), gastroesophageal reflux disease (GERD) in 12.8% (n = 12), and diarrhea in 3.2% (n = 3) [Table 2A].
Table 2A.
Complication of gastric balloon insertion
| Variable | n=94 (%) |
|---|---|
| Endoscopic-related | |
| Perforation | 0 (0.0) |
| Bleeding | 3 (3.2) |
| Aspiration | 0 (0.0) |
| Anesthesia-related | |
| Hypoxia | 0 (0.0) |
| Hypotension | 0 (0.0) |
| IGB*-related | |
| Gastric Outlet Obstruction | 0 (0.0) |
| Intestinal Obstruction | 1 (1.1) |
| Migration | 2 (2.1) |
| Deflation | 5 (5.3) |
| Gastric Ulcer Erosion | 26 (27.7) |
| Other | |
| Abdominal Pain | 20 (21.3) |
| Nausea | 13 (13.8) |
| Vomiting | 16 (17) |
| GERD | 12 (12.8) |
| Diarrhea | 3 (3.2) |
*IGB: Intragastric balloon
Weight loss outcomes and IGB adjustments
The median duration of balloon implantation in the stomach was 47 weeks (interquartile range: 40–60). Eighty-one patients had documented weight at 3 months and 6 months, while 55 patients were assessed at 12 months. The BMI reduced by 4.28 kg/m2 at 3 months, 5.69 kg/m2 at 6 months, and 9.23 kg/m2 at 12 months. Mean %EWL was 10.57% (SD ± 9.20), 12.33% (SD ± 10.28), and 19.27% (SD ± 18.45) at 3, 6, and 12 months, respectively. Patients achieving %EWL greater than 25% were 9.9% (n = 8), 8.6% (n = 7), and 33% (n = 18) at 3, 6, and 12 months, respectively. Additionally, patients achieving %EWL greater that 40% were 16% (n = 9) at 12 months (with 0% at 3 and 6 months). %EWL at 6 months showed a significant difference compared to 12 months (P = 0.002). The mean absolute weight loss in 3, 6, and 12 months was 11.89 kgs (SD ± 10.76), 14.39 kgs (SD ± 13.43), and 22.03 kgs (SD ± 22.07), respectively. The mean absolute weight loss at 12 months was significantly higher than 6 months (P < 0.002). Mean %TBWL at 3, 6, and 12 months was 6.60% (SD ± 5.37), 7.89% (SD ± 6.52), and 11.99% (SD ± 11.60), respectively. Patients achieving more than 10% TBWL were 17.3% (n = 14), 32.5% (n = 27), and 52.7% (n = 29) at 3, 6, and 12 months, respectively. The mean %TBWL at 6 months has a significant difference compared to 12 months (P < 0.002). The mean absolute weight loss, %TBWL, and %EWL demonstrated a significant difference compared to baseline measurements (P < 0.000) [Table 3]. Regarding IGB adjustment, the mean fluid inserted in the SAB was approximately 490 ml (SD ± 110). Thirty-six (38.3%) patients underwent SAB adjustment by increasing the balloon fluid; the mean inserted fluid was 329 ml (SD ± 206). Patients with SAB adjustment showed no significant difference in %EWL, %TBWL, or BMI decrease at 3, 6, and 12 months, respectively [Table 4].
Table 3.
Outcomes of weight loss, %EWL, and %TBWL at 3, 6, and 12 months after balloon insertion
| Outcome | 3 Month (n=81) | 6 Month (n=81) | 12 Month (n=55) | P valuea(comparing baseline and 6 months) | P valueb(comparing 6 and 12 months) |
|---|---|---|---|---|---|
| Mean absolute weight loss (kg) | 11.89±10.76 | 14.39±13.43 | 22.03 (SD±22.07) | P=<0.000 | P=<0.002 |
| Mean %TBWL | 6.60±5.37 | 7.89±6.52 | 11.99 (SD±11.60) | P=<0.000 | P=<0.002 |
| % Patients with >10%TBWL (n) | 17.3% (14) | 33.3% (27) | 52.7% (n=29) | --- | --- |
| Mean %EWL | 10.57±9.20 | 12.33±10.28 | 19.27% (SD±18.45) | P=<0.000 | P=0.002 |
| % Patients with >25% EWL (n) | 9.9% (8) | 8.6% (7) | 33% (n=18) | --- | --- |
| % Patients with >40% EWL (n) | 0% (0) | 0% (0) | 16% (n=9) | --- | --- |
EWL: excess weight loss; TBWL: total body weight loss. aUsing one sample t-test. bUsing paired t-test
Table 4.
Outcomes of mean %EWL, %TBWL, and BMI decrease at 3, 6, and 12 months in patients with and without balloon adjustment
| Follow-up months | 3 (n=81) | 6 (n=81) | 12 (n=55) |
|---|---|---|---|
| Mean %EWL | |||
| IGB without adjustment | 10.75±10.08 | 13.17±11.25 | 22.15±25.29 |
| IGB + adjustment | 10.31±7.88 | 11.11±8.71 | 23.51±21.88 |
| P* | P=0.836 | P=0.373 | P=0.847 |
| Mean %TBWL | |||
| IGB without adjustment | 6.84±6.12 | 8.35±7.11 | 14.28±16.53 |
| IGB + adjustment | 6.24±4.10 | 7.23±5.61 | 15.94±15.22 |
| P* | P=0.624 | P=0.444 | P=0.722 |
| Mean BMI decrease | |||
| IGB without adjustment | 4.29±3.87 | 5.95±6.56 | 9.41±11.30 |
| IGB + adjustment | 4.28±2.86 | 5.39±4.59 | 11.87±11.16 |
| P* | P=0.984 | P=0.669 | P=0.450 |
IGB=intragastric balloon. %EWL=percent estimated weight loss. %TBWL=percent total body weight loss. *Using independent-samples t-test
Surgery
Fifty seven percent (46/81) patients proceeded to have definitive laparoscopic sleeve gastrectomy (LSG). The median duration between SAB removal and surgery was 14 weeks (interquartile range: 8–27). No intraoperative complications were observed in these patients. However, one patient (2.9%) experienced postoperative complications, including leak and infection [Table 2B]. Among the remaining 35 patients, 15 had not achieved the desired weight loss, five were considered high risk for LSG, one patient had severe adhesions during LSG, leading to the procedure being abandoned, and the rest were still awaiting surgery.
Table 2B.
Intraoperative and postoperative complications of weight reduction surgery
| Complications | n (%) |
|---|---|
| Intraoperative | |
| Hypoxia | 0 (0) |
| Hypotension | 0 (0) |
| Arrhythmia | 0 (0) |
| Postoperative | |
| Leak | 1 (2.9) |
| Infection | 1 (2.9) |
| Abdominal Collection | 0 (0) |
| Prolonged Hospitalization | 0 (0) |
| Anastomotic Stricture | 0 (0) |
| Fistula | 0 (0) |
| Reoperation | 0 (0) |
| Readmission | 0 (0) |
| DVT | 0 (0) |
Predictors of SAB-related adverse events and weight loss at 6 months
Both univariable and multivariable analysis found that variables such as age, gender, baseline weight, and SAB volume insertion at the time of implantation or DM were not associated with SAB-related adverse events, that included SAB intolerance [Table 5]. When analyzing for predictors of >10% TBWL at 6 months, absolute weight loss at 3 months and SAB adjustment were associated with significant weight loss. However, only weight loss at 3 months remained significant on multivariate analysis [Table 6].
Table 5.
Predictors of SAB-related complications
| Variable | Odds ratio (P) | |
|---|---|---|
|
| ||
| Univariable | Multivariable | |
| Age | 0.628 | 0.264 |
| Gender | 0.344 | 0.942 |
| Baseline weight | 0.887 | 0.093 |
| Balloon Volume | 0.066 | 0.092 |
| DM | 0.347 | 0.594 |
Table 6.
Predictors of >10% TBWL at 6 months
| Variable | Odds ratio (P) | |
|---|---|---|
|
| ||
| Univariable | Multivariable | |
| Age | 0.670 | 0.940 |
| Gender | 0.719 | 0.280 |
| Baseline weight | 0.710 | 0.910 |
| DM | 0.450 | 0.702 |
| Weight loss at 3 months | 0.180 | 0.134 |
| Absolute weight loss at 3 months | 0.000 | 0.001 |
| Balloon Volume | 0068 | 0.122 |
| Duration of balloon (weeks of IGB inserted) | 0.390 | 0.156 |
| Amount adjustment | 0.022 | 0.989 |
DISCUSSION
IGBs have emerged as a valuable tool in the management of obesity, providing a less invasive alternative to surgery interventions. The SAB represents a paradigm shift in IGB therapy. By allowing endoscopic volume adjustments, it addresses the limitations of static balloons. SAB’s dynamic nature enables clinicians to fine-tune the intragastric environment, optimizing weight loss while minimizing adverse events. The ability to overcome weight loss plateaus through volume additions is a significant advantage. In our study, 11.7% of patients required early SAB removal due to intolerance, and abdominal pain emerged as the most frequent complication (21.3%). SAB demonstrated substantial mean absolute weight loss (22.03%), %TBWL (11.99%), and %EWL (19.27%) compared to the baseline, at 12 months. Notably, weight loss at 3 months served as a predictor of long-term success.
One of the main drawbacks of intragastric balloon is early removal due to intolerance. Studies involving BioEntrics IGB (BIB) reported a pooled early removal rate of 7.35% with BMI ≥50 kg/m2.[18] In contrast, SAB’s early removal rate of 17% in the landmark, randomized control trial of patients with BMI between 30 and 40 kg/m2 aligns with our results.[19] Serious complications such as GI bleeding (3%) and intestinal obstruction (1%) were less frequent in our SAB cohort (5% and 4.3%, respectively).[20,21] Our patients experienced abdominal pain (21.3%) more often, followed by vomiting (17%). These findings diverge from other studies where abdominal pain ranged from 7% to 9%, and vomiting varied from 5% to 22%.[10,12,20,21,22]
At the end of 6 months, our study demonstrated a comparable BMI reduction (5.69 kg/m2) to the pooled BIB reduction (6.60 kg/m2) in patients with BMI ≥50 kg/m2.[18] The mean absolute weight loss in our cohort aligned with the BIB studies (6 to 28.5 kg at 6 months).[12,16,23] Similarly, the %EWL approximated that seen in other BIB studies (10 to 14.4% at 6 months).[13,24] SAB’s distinct advantage lies in its volume adjustability and extended implantation duration beyond 6 months. Surprisingly, volume adjustment did not significantly impact further weight loss in our study. This finding may be attributed to the relatively small sample size, which may have limited the statistical power to detect significant effects. However, prolonged SAB implantation (beyond 6 months) yielded substantial weight reduction at 12 months (mean weight loss: 22.03 kg vs 14.39 kg at 6 months, P < 0.0002). Notably, a study exploring a second BIB implantation after 6 months achieved 17.6% EWL at 12 months, slightly lower than our recorded 19.27% EWL.[24]
Concerns regarding IGB-induced stomach wall changes of wall thickness, fibrosis, and inflammation have implications for subsequent LSG.[25,26] Studies have not confirmed increased operative complications (e.g., fistulas along staple lines).[10,15,27,28] Over 50% of our cohort underwent definitive LSG, resulting in an overall operative complication rate of approximately 2.9%. Remarkably, this rate is lower than reported rates (ranging from 5% to 19%) in other studies despite a prolonged duration of implantation. These findings underscore the safety of LSG post-IGB.[10,20,28] The difference in outcomes between studies could be related to the difference in patient population, numbers included, type of balloon, and the design of the study.
SAB offers a unique advantage with its volume adjustability and extended implantation duration. Unlike nonadjustable IGBs, which are often limited by a 6-month dwelling period and may exhibit a weight loss plateau at 2–3 months, SAB allows a more tailored approach to address this plateau. Our study highlights the substantial weight loss achievable with prolonged implantation, with patients achieving a mean weight loss of 22.03 kg at 12 months, significantly greater than at 6 months.[29] This aligns with findings from other studies suggesting that upward volume adjustments can help maintain weight loss momentum.[19,30] However, direct head-to-head comparisons with nonadjustable IGBs are lacking, and future trials are needed to definitively confirm the extent of SAB’s superiority in this context.
SAB’s adjustability offers a strategy to address intolerance as balloon volume can be reduced for patients experiencing severe symptoms, allowing them to continue therapy. Our study noted instances where this approach mitigated symptoms, enabling successful continuation of treatment. These findings align with broader reports suggesting that tailored volume adjustments improve adherence and prevent premature device removal.[19,30] The balance between optimizing volume for efficacy and managing complications remains critical.
While SAB’s endoscopic placement ensures greater safety, it requires multiple procedures. In contrast, swallowable IGBs avoid the need for endoscopy during placement or removal but do not allow for adjustments to manage symptoms or enhance efficacy.[31] Additionally, the lack of endoscopic evaluation before placement may increase the risk of complications in patients with undetected GI abnormalities.[29]
Our retrospective study design inherently limits causal references. The study included a relatively small sample size. Large cohorts would enhance statistical power and allow for subgroup analysis. Our follow-up duration was limited to 12 months. Longer-term data would elucidate sustained effects and potential complications. Some patients were lost to follow-up, impacting data completeness and potentially introducing bias. Non-adherence to dietary and lifestyle modifications could influence weight loss outcomes; monitoring this is challenging in real-world settings. Lack of a comparative group from a single center may introduce further biases. Despite these limitations, our study stands as one of the first to evaluate the efficacy of SAB in patients with BMI ≥50 kg/m2 reflecting real-world clinical practice. It provides valuable insights into short-term safety assessment of SAB and explores the impact on subsequent LSG.
In conclusion, our study demonstrates that the Spatz3 intragastric adjustable balloon is safe and effective for weight loss in patients with BMI ≥50 kg/m2. Early weight loss predicts long-term success, and subsequent LSG can be performed without significant complications. As we continue to refine patient selection criteria and optimize follow-up protocols, IGB remains a valuable tool in the management of obesity. Further research should explore extended follow-up periods and multicenter randomized studies with comparative analysis to enhance patient outcomes.
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
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