Weight regain after intragastric balloon for pre-surgical weight loss

Abstract

BACKGROUND

Over one-third of Americans carry the diagnosis of obesity, many also with obesity-related comorbidities. This can place patients at increased risk of operative and postoperative complications. The intragastric balloon has been shown to aid in minor weight loss, however its weight recidivism in patients requiring short interval weight loss has not been well studied.

AIM

To evaluate weight loss, ability to undergo successful elective surgery after intragastric balloon placement, and weight management after balloon removal.

METHODS

This study is a retrospective review of patients in a single academic institution undergoing intragastric balloon placement from 2019-2023 to aid in weight loss prior to undergoing elective surgery. Clinical outcomes including weight loss, duration of balloon placement, successful elective surgery, weight regain post-balloon and post-procedure complications were assessed. Exclusion criteria included those with balloon in place at time of study.

RESULTS

Thirty-three patients completed intragastric balloon therapy from 2019-2023 as a bridge to elective surgery. All patients were required to participate in a 12-month weight management program to be eligible for balloon therapy. Elective surgeries included incisional hernia repair, umbilical hernia repair, inguinal hernia repair, and knee and hip replacements. The average age at placement was 53 years ± 11 years, majority (91%) were male. The average duration of intragastric balloon therapy was 186 days ± 41 days. The average weight loss was 14.0 kg ± 7.4 kg and with an average percent excess body weight loss of 30.0% (7.9%-73.6%). Over half of the patients (52.0%) achieved the goal of 30-50 lbs (14-22 kg) weight loss. Twenty-one patients (64%) underwent their intended elective surgery, 2 patients (6%) deferred surgery due to symptom relief with weight loss alone. Twenty-one of the patients (64%) have documented weights in 3 months after balloon removal, in these patients the majority (76%) gained weight after balloon removed. In patients with weight regain at 3 months, they averaged 5.8 kg after balloon removal in the first 3 months, this averaged 58.4% weight regain of the initial weight lost.

CONCLUSION

Intragastric balloon placement is an option for short-term weight management, as a bridge to elective surgery in patients with body mass index (BMI) > 35. Patients lost an average of 14 kg with the balloon, allowing two-thirds of patients to undergo elective surgery at a healthy BMI. However, most patients regained an average of 58% of the original weight lost after balloon removal. The intragastric balloon successfully serves as a tool for rapid weight loss, though patients must be educated on the risks including weight regain.

Key Words: Intragastric balloon; Weight loss; Obesity; Bariatric; Body mass index

Core Tip: Obesity places patients at increased risk of postoperative complications. The intragastric balloon is an endoscopic tool which is lower risk and temporary and offers good initial weight loss in the preoperative setting for patient’s undergoing elective surgery in order to reduced perioperative risk, however the majority of patient will experience some degree of weight regain following removal of the balloon.

INTRODUCTION

The prevalence of obesity worldwide has tripled since 1975, as of 2021, 650 million (13%) adults are obese [body mass index (BMI) > 30 kg/m²] and 1.9 billion (39%) adults are overweight (BMI > 25 kg/m²) worldwide[1]. In the United States, the numbers are even higher, with over 40% of Americans carrying the diagnosis of obesity[2]. Increased weight is a major risk factor for numerous diseases such as cardiovascular disease, diabetes, osteoarthritis, and many cancers including colon, breast, liver, endometrial, and kidney. Obesity is also a risk factor for postoperative complications including increased risk of surgical site infections, wound complications, and thromboembolic events. Due to its high prevalence and obesity-related conditions, the Global Obesity Observatory has reported that overweight and obesity to have cost 1.96 trillion annually in 2020 and is estimated to increase to a substantial 4.32 trillion annually by 2035[3].

There are several tools or solutions for weight management: Lifestyles modification, pharmacologic management, and bariatric surgery. Lifestyle modification through comprehensive weight management programs has been reported to be successful to individuals losing 5%-10% of their excess weight[4,5]. New medications have promising data on weight management but are not yet widely available and many come with serious adverse effects. Bariatric surgery offers the most durable weight loss with long term data reporting a sustained 21% weight loss at 10 years after gastric bypass[6]. However, few qualifying patients undergo bariatric surgery, and these procedures carry not insignificant morbidity and mortality[7]. Endoscopic solutions, such as the intragastric balloon, has gained recognition has a lower risk procedure that does not permanently alter patient anatomy and offers good initial weight loss[8].

We utilize the intragastric balloon as a bridge to elective surgery in patients requiring preoperative weight loss to minimize the known postoperative complications associated obesity. Long-term weight loss durability remains difficult to achieve after intragastric balloon therapy with many patients regaining weight after ballon removal[9,10]. Due to this difficulty for weight maintenance, we require all patients planning for intragastric balloon therapy to participate in MOVE!, which is a national Veteran Affairs weight management program developed by the National Center for Health Promotion and Disease Prevention. This is supported by improved weight loss outcomes with combined lifestyle modifications[11]. We sought to evaluate weight recidivism after completion of therapy and removal of the intragastric balloon with patients enrolled in a comprehensive weight management program. We hypothesized that patients would have similar weight loss and there would be weight regain after removal.

MATERIALS AND METHODS

Patients with a BMI > 35 kg/m² who required weight loss prior to elective surgery at the Rocky Mountain Regional Veterans Affairs Medical Center, part of Eastern Colorado Health System, from January 2019 to December 2023 were eligible for the study. In order to qualify for intragastric balloon placement patients needed to meet three criteria. First, the patient required a BMI > 35 kg/m². Second, patients’ participate in MOVE! for 12 months. MOVE! is a national, comprehensive multidisciplinary weight loss program which includes dietary and physical activity changes, in additional for medical and surgical weight management. And third, patient could not have any contraindications to placement. Contraindications to intragastric balloon include prior gastric surgery, hiatal hernia greater than 5 cm or hiatal hernia greater than 2 cm combined with gastroesophageal reflux disease.

The intragastric balloon (Orbera, Apollo Endosurgery, Austin, TX, United States) was placed endoscopically and filled to 550 mL with methylene blue and saline solution. The balloon was left in place for up to 6 months with a goal of removal at the time of the indication elective surgery[12].

Our outcomes measures were weight loss with balloon in place and weight change following balloon removal up to one year after balloon placement. Weights measures utilized were from hospital and clinic encounters, self-reported weights were not counted. Patient comorbidities, post procedure complications and balloon duration were also evaluated. The study was approved by the Colorado Multi-institutional Review Board (COMIRB), protocol number #221659.

Comparison of patient and procedural categorical variables was completed with Chi-squared tests (Fisher’s exact tests when applicable). Continuous variables (weight, weight change, etc.) were evaluated for normality using D’Agostino-Pearson test; age, procedure length, duration of therapy, weight was normally distributed. Continuous variables were evaluated using t-tests. All statistical analyses were performed within GraphPad Prism software.

RESULTS

Thirty-seven patients had intragastric balloon placed for weight loss prior to elective surgery during the study period. Four (11%) patients were excluded due to balloon still in place. The average patient age was 53 years ± 11 years. The majority of patients, 30 (91%) were male. Demographics listed in Table 1. The most prevalent comorbidity was hypertension in 23 (70%) of the patients, additional comorbidities are listed in Table 1. All patients were American Society of Anesthesiology class of II or III. Charlson Comorbidity Index scores listed in Table 1. Procedure length was on average 15 minutes ± 6 minutes. The average duration of balloon therapy was 186 days ± 41 days. No patients required early balloon removal due to intolerance. Patients that underwent hernia repair post removal did not suffer any weight-related complications or hernia recurrences. Nearly half of the patients (42%) reported nausea and/or emesis in the first month, followed by heartburn symptoms (29%). Thirteen (43%) patients had an ED visit in the first 30 days after IGB placement, of which 5 (15%) were for symptoms of the IGB or post-procedure complications. Five (15%) had a 30-day readmission, of these 3 were for dehydration, 1 for aspiration pneumonia and 1 for management of chronic medical disease (Cushing’s disease). The majority of patients had planned hernia repair (25 patients, 76%), followed by knee replacement surgery (21 patients, 21%) as indication surgery for intragastric balloon placement.

Table 1 Demographics, indication surgery, perioperative factors and postoperative complications.

Variable	n (%)
Age, mean ± SD	53 ± 11
Male	30 (91)
Diabetes	8 (24)
Hypertension	23 (70)
Gastroesophageal reflux disease	12 (36)
Obstructive sleep apnea	17 (52)
ASA class
ASA class I	0
ASA class II	5 (15)
ASA class III	28 (85)
ASA class IV	0
Charlson Comorbidity Index Score
None (Score 0)	12 (36)
Mild (Score 1-2)	12 (36)
Moderate (Score 3-4)	8 (24)
Severe (Score 5+)	1 (3)
Procedure length (minutes), mean ± SD	15 ± 6
Duration of therapy (days), mean ± SD	186 ± 41
Indication surgery
Incisional hernia	12 (36)
Inguinal hernia	3 (9)
Umbilical hernia	10 (30)
Total knee arthroplasty	7 (21)
Total hip arthroplasty	1 (3)
Postoperative symptoms, self-reported
Nausea and/or emesis	14 (42)
Heartburn	4 (29)
30-day ED utilization, total	13 (43)
30-day ED utilization, procedure-related	5 (15)
30-day readmissions	5 (15)

ASA: American Society of Anesthesiology; ED: Emergency department.

Patients averaged 120.0 kg ± 13.0 kg with a BMI of 38.4 kg/m² ± 2.8 kg/m² at time of balloon placement. Weight loss and outcomes are included in Table 2. Mean weight at balloon removal 106.0 kg ± 15.1 kg with a BMI of 33.9 kg/m² ± 3.6 kg/m². Patients had a mean weight loss of 14.0 kg ± 7.4 kg. Patients had an average percent excess body weight loss of 30.0% ± 17.8% at balloon removal. Weights measured at monthly intervals following balloon removal are included in Table 2. Twenty-one patients (64%) had documented weights after removal. On average, there was 1.5 kg ± 9.6 kg regained in the first month, 2.5 kg ± 10.7 kg regained by the end of second month, and 5.4 kg ± 14.4 kg total regained by the end of the third month following balloon removal. Of the 21 patients, 16 (76%) patients experienced weight regain in the first three months. Five (24%) patients continued to lose weight after removal. Patients who had weight regain, gained back 5.8 kg at the end of 3 months, this averaged 58.4% weight regain of the initial weight lost. Patients who continued to lose weight had an additional weight loss of 3.2 kg at the end of 3 months. Limited 1 year data in 23 (70%) patients demonstrated 3.3 kg ± 8.9 kg weight regain with 14 patients experiencing weight regain, average weight regain of 17.9 kg ± 16.1 kg, and 9 patients with continued weight loss or weight maintenance, average continued weight loss of 9.3 kg ± 11.4 kg.

Table 2 Weight loss outcomes.

Weight outcomes	mean ± SD
Initial weight (kg)	120.0 ± 13.0
Initial BMI (kg/m2)	38.4 ± 2.8
Weight at balloon removal (kg)	106.0 ± 15.1
BMI at balloon removal (kg/m2)	33.9 ± 3.6
Weight loss at removal (kg)	14.0 ± 7.4
Excess body weight loss (%)	30.0 ± 17.8
Post-balloon weight, 1 month (kg)	109.4 ± 14.9
Post-balloon weight, 2 months (kg)	106.5 ± 17.6
Post-balloon weight, 3 months (kg)	111.5 ± 12.5
Weight regain, 1 month (kg)	1.5 ± 9.6
Weight regain, 2 months (kg)	2.5 ± 10.7
Weight regain, 3 months (kg)	5.4 ± 14.4
Weight regain, 1 year after IGB placement (kg)	3.3 ± 8.9

BMI: Body mass index.

DISCUSSION

Patients had an average weight loss of 14.0 kg, with a range of 0-27.7 kg, and had an excess body weight reduction of 30.0% with intragastric balloon therapy. This is higher than the standard 15% excess weight loss reported by the American Society for Gastrointestinal Endoscopy Bariatric Endoscopy Task Force[13]. Ultimately, 70% of the patients were successful with intragastric balloon therapy, either undergoing their intended indication surgery or no longer requiring surgery with weight reduction. Two patients deferred surgery due to resolution of hernia symptoms with weight loss. After balloon removal, 76% of patients experienced weight regain of 5.8 kg in three months, 58% of their initial weight loss. And in limited data in patients with 1 year follow-up (70%), 60% had weight regain of 81% of their initial weight loss.

Excess weight (BMI ≥ 25-30 kg/m²) is a known risk factor for complications in both hernia and joint surgery. These complications include increased risk of hernia recurrence, wound complications, surgical site infections, postoperative thromboembolic events, pressure-related injuries, and a longer hospitalization with higher rates of discharge to facility or need for home health[14-20]. Preoperative weight management is a key part of surgical evaluations in order to optimize patients prior to surgery and decrease the risks of complication.

When devising a plan for preoperative weight loss, there are several options to be evaluated. Medical weight management, which includes calorie deficits, have been reported to yield less than 10% weight reduction with 4-6 months of dieting[21]. There have been significant improvements recently with pharmacologic weight loss, with 10% + weight loss reported, however there are serious side effects to be considered and these remain difficult to obtain and maintain[22]. Additionally, less than a quarter of our patients were diabetic and so unable to qualify for many of the newer pharmacologic agents. Unsurprisingly, weight loss with the intragastric balloon is less than those seen with bariatric surgery[23]. However, the goals with bariatric surgery and the intragastric balloon are different and should not be used to treat the same concerns. Whereas the intragastric balloon is a reversible, non-permanent endoscopic procedure with minimal risks that targets short term weight loss, bariatric surgery is a definite solution which alters the gastrointestinal tract and has serious risk to consider and lifetime dietary changes. At our institution, weight management starts with enrollment in the MOVE! Program (multidisciplinary 12-month program) which offers access to medical and surgical weight loss options. The MOVE! Program consists of physicians, dietitians, physical and recreational therapists, psychologists, and coordinators, to combine healthy eating and physical activity with medical weight management and surgical option, is applicable. This has been proven to reduce weight recidivism and is recommended for all patients undergoing intragastric balloon placement[24].

Weight re-gain is a concern with all forms of weight management. The intragastric balloon has demonstrated weight regain in 37%-79%[25,26]. This heterogenous data is in line with our 76% of patients experienced weight regain after balloon removal; and supports intragastric balloon therapy as an adjunct, and not a primary therapy - in a comprehensive weight management program. Additional study is needed to determine the optimal comprehensive program to reduce weight recidivism.

There are three main limitations in this study. First, our study is limited by the low number of total patients. Second, our study included a majority of male patients, which consistent with the Veteran population, does limit generalizability. Third, long-term data is limited, this will improve with continued study and evaluation of these patients’ weight outcomes. Further studies aim to identify factors promoting continued weight loss in patients following intragastric balloon removal when used in a comprehensive weight management program.

CONCLUSION

In conclusion, the intragastric balloon can be an advantageous tool for preoperative weight optimization in patients undergoing elective surgery, however the majority of patients will experience some degree of weight regain following removal of the balloon.