Endoscopic bariatric procedures are gaining traction as possible minimally invasive treatment modalities for obesity. This article focuses on the various endoscopic devices and procedures that pertain to primary and revisional treatments. Additionally, the article discusses the potential for applying these various devices and procedures to other points of intervention, including early intervention, bridge to surgery, and primary metabolic treatment (eg, diabetes management). Devices that are currently in human use are preferentially discussed, followed by references to devices that may see clinical use in the near future.
Endoscopic bariatric procedures are gaining traction as possible treatment modalities for obesity. A major reason for its intuitive appeal is that endoluminal obesity therapy represents a much-needed minimally invasive treatment option that is currently lacking in the management strategy of this worsening epidemic. For example, treatment of coronary artery disease spans a continuum, with cardiac stenting representing a point of intervention between medications/lifestyle changes and cardiac surgery. Similarly, for treatment of degenerative joint disease, arthroscopic surgery has an important role between medication/lifestyle changes and joint replacement surgery. By comparison, in the treatment of obesity, there is currently a glaring absence of minimally invasive options between medications/lifestyle changes, which have limited efficacy, and conventional bariatric surgery, which exhibits a not insignificant morbidity and mortality profile that causes many to avoid seeking treatment.
Endoscopic bariatric procedures can potentially satisfy the need for a minimally invasive option in one or more different capacities. For example, they may be used as (1) an early intervention to provide weight loss or weight stabilization in early-stage obese patients who do not yet qualify for traditional bariatric surgery. Alternatively, they could be used as (2) a bridge to surgery to reduce operative risk for various bariatric and nonbariatric surgeries. Endoscopic bariatric procedures could also be used as (3) a primary metabolic treatment to address comorbid illnesses such as diabetes. Furthermore, they could be used as (4) a primary bariatric treatment in the traditional surgical population, with the efficacy matching the specific device risk profile. Finally, they could be used as (5) revisional treatment for patients requiring repair following traditional bariatric surgery ( Table 1 ).
| Procedure Category | Procedure Aim |
|---|---|
| Early intervention | Providing weight loss or stabilization in early-stage obese patients who do not yet qualify for traditional surgery |
| Bridge to surgery | Reducing the obesity-related operative risk for various bariatric and nonbariatric surgeries |
| Metabolic | Primarily addressing comorbid illness (eg, diabetes) |
| Primary | Endoscopic option for the traditional surgical population, with outcomes and risk profiles similar to those of current surgeries |
| Revision | Repairing failed bariatric surgical procedures |
This article focuses its discussion on the various endoscopic devices and procedures that pertain to the last 2 points of intervention—primary and revisional treatments. However, it is important to keep in mind that many of these devices may also be applicable to 1 or more of the other 3 categories. This aspect depends on various device-specific attributes such as safety, removability or reversibility, and effect on comorbid illness. For example, intragastric balloons may be best applied as a bridge therapy because they require removal after 6 months, whereas endoscopic suturing may have more wide-ranging applications as a primary treatment, revisional treatment, early intervention, or bridge to surgery depending on how the suturing instrument is used. Another example may include endoscopic sleeves that could be applied as both primary metabolic therapy and bridge to surgery, given that they currently require removal and achieve significant metabolic end points. This review largely focuses on the primary and revisional applications for specific devices, as the current literature is concentrated on these areas. Study results pertaining to applications in (1) early intervention, (2) bridge to surgery, and (3) primary metabolic categories are highlighted where available. Devices that are currently in human use are preferentially discussed, followed by references to devices that may see clinical use in the near future ( Table 2 ).
| Procedure Category | Procedures/Devices |
|---|---|
| Primary | Intragastric balloons (Allergan, Spatz-FGIA Inc, Helioscopie) RESTORe Suturing System (C.R. Bard Inc) TOGa Stapler (Satiety Inc) TERIS (Barosense) Bypass Liners (GI Dynamics, ValenTx) Incisionless Operating Platform (USGI Medical Inc) |
| Revision | Sclerotherapy Bard EndoCinch Suturing System (C.R. Bard Inc) Incisionless Operating Platform (USGI Medical Inc) StomaphyX (Endogastric Solutions) OverStitch (Apollo) OTSC-Clip (Ovesco AG) |
| Future directions | Neuromodulation Transoral anastomosis devices Devices targeting neurohormonal pathways |
Primary treatment
Intragastric Balloons
Intragastric balloons have been in use since 1982 as a space-occupying device to induce a sense of satiety, and they represent the most frequently placed endoscopic device to date. The BioEnterics Intragastric Balloon (BIB; Allergan, Irvine, CA, USA) has been the most extensively studied of the intragastric balloons ( Fig. 1 ). The BIB is designed as a sphere to hold 400 to 800 mL of saline, and requires removal after 6 months. BIBs are currently in use worldwide, although they are not yet available in the United States; this is in part due to several complications and premature balloon deflation associated mainly with the predecessor, the Garren-Edwards Gastric Bubble (GEGB).
Studies have demonstrated weight loss in the short-term and mid-term ranges, but long-term weight loss, especially following balloon removal, has been equivocal. Genco and colleagues retrospectively reviewed 2515 Italian patients and showed a 6 month excess weight loss of 33.9% ± 18.7%. However, in a randomized controlled trial comparing balloon treatment versus sham over a 3-month period in 43 patients (mean body mass index [BMI; calculated as the weight in kilograms divided by height in meters squared, ie, kg/m 2 ] of 43.3 kg/m 2 ), Mathus-Vliegen and Tytgat found no statistical difference. Of note, after excluding 8 patients who either had not met the 3-month weight loss goal (n = 5) or did not tolerate the balloon (n = 3), the remaining balloon patients (n = 12) exhibited a mean weight loss of 21.3 kg (excess weight loss [EWL] of 17.1%) after 12 months. Following balloon removal at 12 months, these patients had still maintained weight loss of 12.6 kg (9.9%) at the end of the second, balloon-free year (with nutrition and physician counseling). In summary, this data suggests that in patients who tolerate therapy, balloon treatment could result in substantial 1-year weight loss, and the greater part of that weight loss could be maintained during a second, balloon-free year.
In another prospective study examining long-term outcomes after BIB placement, 100 consecutive morbidly obese patients were enrolled to 6 months of BIB therapy with no structured weight maintenance program following balloon removal. Ninety-seven percent of patients completed a mean final follow-up of 4.8 years. After 6 months, 63% of patients had 10% or more baseline weight loss. At final follow-up, only 28% were able to maintain this. At that time, 35 patients had undergone bariatric surgery and 34 patients had no significant weight change from baseline. These findings suggested that balloon implantation may be helpful in a minority of patients for long-term weight loss without a structured weight maintenance program.
Intragastric balloons have also been used in the super-morbidly obese population as a bridge to conventional bariatric surgery. In one study, a BIB was placed in 26 high-risk superobese patients with a mean BMI of 65.3 ± 9.8 kg/m 2 and mean 4.33 ± 1.12 severe comorbidities. Endoscopic placement was uneventful in all patients. However, one patient died of cardiac arrest following aspiration on the first postinsertion day. The mean weight loss was 28.5 ± 19.6 kg after the balloon was removed at 6 months. The mean reduction in comorbidity status was 4.33 to 2.23. Twenty patients underwent primary bariatric surgery the day after BIB removal, and 2 patients were rejected because of inadequate weight loss.
Intragastric balloons are designed for 6-month deployment, but recent studies suggest that repeated treatment may sustain weight loss at least to 1 year. In a prospective, nonrandomized multicenter study, patients with repeat treatment had greater weight loss than single-treatment patients at 1 year (12.0 kg vs 6.0 kg; 40.9% vs 20.8% EWL; P = .008) but this difference became dampened by the 3-year mark (less than 2 kg difference).
In summary, intragastric balloons may represent a potential option for patients unwilling to undergo bariatric surgery, or as a potential bridge to bariatric surgery with an eye toward reducing perioperative risk.
Transoral Gastric Volume Reduction (TRIM Procedure) Using the Bard Suturing System
The EndoCinch device (C.R. Bard Inc, Murray Hill, NJ, USA) was the first endoscopic suturing platform used for the treatment of obesity. It was originally designed for the treatment of gastroesophageal reflux disease and then revisions of failed gastric bypass (discussed in the section on revisional treatment), and more recently for the primary treatment of obesity. The device features a hollow capsule that fits on to the endoscope tip and uses suction for tissue acquisition. A hollow needle is delivered through the acquired tissue to pass suture material back and forth. The most recent iteration of this device (the Restore Suturing System) allows for the creation of deeper, full-thickness plications and eliminates the need for device withdrawal for suture reloading as was required by its predecessor ( Fig. 2 ).
In 2008 Fogel and colleagues published a single-center, non–United States study using the EndoCinch system to perform transoral gastric volume reduction in 64 patients with a mean BMI of 39.9 ± 5.1 kg/m 2 . A running suture pattern was used to approximate a vertical gastroplasty ( Fig. 3 ). The mean procedure time was 45 minutes, and no adverse events were reported. The mean %EWL at 12 months was 58.1 ± 19.9%. The mean BMI at 12 months was 30.6 ± 4.7 kg/m 2 . When stratifying by original BMI groups, the patients with lowest BMI appeared to lose the most weight: BMI of 40 kg/m 2 or more had a %EWL at 12 months of 48.9 ± 10.7%. For BMI of 35 to 40 kg/m 2 , the %EWL at 12 months was 56.5 ± 13.9%. For BMI less than 35 kg/m 2 , the %EWL at 12 months was 85.1 ± 24.0%. These results raised the possibility of a role for transoral gastric volume reduction in early intervention of obesity.
A recent United States pilot study in 18 patients with a BMI of 30 to 56 kg/m 2 was published by Brethauer and colleagues. Gastric plications were created to approximate the anterior and posterior gastric walls to achieve functional volume reduction in the gastric body and fundus ( Fig. 4 ). The procedure was successfully performed in all patients. The average number of plications was 6 (range 4–8). The average procedure time was 125 ± 23 minutes. There were no serious or significant procedure-related complications. The first 10 patients were kept overnight per study protocol, and the remaining 8 were discharged on the day of the procedure. Data regarding weight loss, comorbidity improvement, and durability are currently under assessment.
Related posts:
Obesity Overview: Epidemiology, Health and Financial Impact, and Guidelines for Qualification for Surgical Therapy
Medical Therapy for Obesity
Presurgical Evaluation and Postoperative Care for the Bariatric Patient
Endoscopic Management of Common Bariatric Surgical Complications
Management of Acute Postoperative Hemorrhage in the Bariatric Patient
Accessing the Pancreatobiliary Limb and ERCP in the Bariatric Patient
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