Advances in Endoscopic Bariatrics at Penn Interventional and Advanced Endoscopy

Advances in GI Endoscopy GI Practice and Care

Drs. Octavia Pickett-Blakely, Monica Saumoy and Gregory Ginsberg have introduced a series of recent advances in bariatric endoscopy at Penn Gastroenterology for select patients with obesity.

The Weight Management and Obesity Program at Penn Interventional and Advanced Endoscopy is currently performing intragastric balloon implantation, endoscopic sleeve gastroplasty and transoral outlet reduction (TORe) for patients at every point of the bariatric surgery continuum.

Drs. Octavia Pickett-Blakely, MD, MHS and Monica Saumoy, MD, MS, are leading a series of advances in bariatric endoscopy for select patients with obesity. These procedures supplement a long history of forward-thinking strategies to incorporate innovation into interventional and advanced endoscopic practice at Penn GI, including per oral endoscopic procedures and duodenal mucosal resurfacing (see articles, this issue).

Bariatric surgery is the mainstay therapy for individuals with 1) a BMI >40; 2) patients with a BMI >35 with one or more obesity-related comorbidities (e.g., type II diabetes, non-alcoholic fatty liver disease); and 3) patients unable to achieve a healthy sustained weight loss with lifestyle interventions and pharmacological therapy. However, CDC reports now suggest that more than 103 million individuals in the United States are obese, of which only 1,343,000 had bariatric surgery between 2011 – 2017, according to the American Society of Metabolic & Bariatric Surgery.

Without elaborating on the many obstacles to bariatric surgery, it’s clear that increasing the options and availability of bariatric surgery would be beneficial to the wider population of affected persons. With the advent of endoscopic bariatric surgery, this option now appears to be on the horizon.

“What we’re seeing now is a natural evolution in endoscopy toward bariatrics,” says Gregory Ginsberg, MD, Director of Interventional and Advanced Endoscopy at Penn Medicine.

The chief advantages of bariatric endoscopy are those of any minimally invasive procedure – reductions in operative time, complications and recovery. But bariatric endoscopy offers other prominent benefits, according to Octavia Pickett-Blakely, MD, MS, Director of the GI Nutrition, Obesity and Celiac Sprue Program at Penn GI.

Bariatric endoscopic surgeries are incisionless, many are temporary, and many can be reversed when necessary. In addition, these procedures do not preclude future bariatric surgery if it becomes necessary or desirable to do so.

Another principal benefit of bariatric endoscopy is the capacity to bring about rapid weight loss, which has numerous positive implications for patients struggling with obesity.

Rapid weight loss in obese patients leads to greater loss of weight, and greater success at weight loss over the long term, and is identified with improvement in hypertension and other physical benefits. [1]

The Weight Management and Obesity program is currently performing three FDA-approved procedures, intragastric balloon implantation, endoscopic sleeve gastroplasty and an investigational procedure, transoral outlet reduction (TORe). The approved procedures are designed to produce rapid weight loss as precedent to further medical weight loss under the care of weight loss specialists or as a bridge to bariatric or non-bariatric surgery. TORe is a novel endoscopic suturing procedure used to tighten the gastrojejunal anastomosis created during Roux-en-Y gastric bypass (RYGB) surgery in patients who have regained weight after bariatric surgery.

Intragastrical Balloon System

The intragastric balloon is intended to be used as an adjunct to a moderate intensity diet and behavior modification program.

Intragastric balloon implantation involves the endoscopic placement of a deflated balloon into the stomach. Composed of silicone, the deflated balloon is then filled with saline fluid to about the size of a grapefruit. The balloon is indicated for temporary use to facilitate weight loss in adults with obesity (BMI between 30 – 40 kg/m2) who were unable to lose weight or sustain weight loss through supervised diet and exercise. The balloon is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. Patients continue to receive counseling and guidance while the balloon is in place.

The balloon is approved for placement for up to six months,” Dr Ginsberg says, during which time, he adds, patients can lose as much as 25% of their total body weight. Once the weight-loss threshold or other objectives have been achieved, the balloon is deflated and removed. In clinical trials, patients who combined balloon implantation with lifestyle interventions lost three times more weight than patients using lifestyle intervention alone. Subsequent reports suggest that patients experience improved control of hypertension, diabetes and obstructive sleep apnea during treatment, and that mean cholesterol and triglyceride levels were significantly improved at six months.

All patients having endoscopic intragastric balloon implantation are required to make a commitment to a healthier lifestyle, including permanent healthy changes to diet, regular exercise and weight loss counseling to help ensure an optimal response to the procedure.

The FDA has issued two communications to health care providers about the potential risks of fluid-filled intragastric balloons, and intolerance may be an issue. Subsequent reports suggest that the balloon is generally safe, and that potential risks and the likelihood of intolerance can be greatly diminished by careful screening and endoscopic examination prior to implantation, both standard procedures at Penn Gastroenterology.

Endoscopic Sleeve Gastroplasty

Endoscopic sleeve gastroplasty (ESG), a reportedly safe and efficacious endoscopic therapy that does not require an implanted device, has generated much interest and potentially represents a major advance in obesity therapy. At Penn Interventional and Advanced Endoscopy, Monica Saumoy, MD, is partnering with Dr. Pickett-Blakely to offer endoscopic sleeve gastroplasty (ESG) to patients seeking longer-term endoscopic bariatric weight-loss management.

An incisionless, transoral, minimally invasive alternative to open or laparoscopic bariatric sleeve gastrectomy, ESG uses a suturing platform mounted on the endoscope to place about a dozen full-thickness running transmural sutures (or cinched plications) in the stomach to essentially replicate the restrictive luminal sleeve by closing off the greater portion of the gastric volume. Whereas traditional sleeve gastrectomy removes 75% to 80% of the gastric volume by resection, ESG leaves the stomach intact.

“The potential advantage is that the procedure provides a more permanent solution than the intragastric balloon, and can be refined as needed, based on the patient’s performance,” says Dr. Saumoy.

Sutures are applied along the greater curvature of the stomach, shortening the stomach by about 30%, and resulting in a ~70% reduction in functional volume. The procedure can be performed in about 90 minutes, and most patients go home the same day. The final configuration of the sleeve is confirmed following the procedure by endoscopy, and oral contrast studies are performed at 24 hours, and at three and six months’ post procedure.

“Following the procedure, the average patient can expect to lose 20% of their body weight within two years,” says Dr. Pickett-Blakely.

As with endoscopic intragastric balloon implantation, patients opting for ESG receive weight-management counseling to ensure their personal commitment and preparedness for the lifestyle interventions, nutritional counseling, behavioral modification and weekly or biweekly communication with the weight loss team at Penn Medicine in the months and years following ESG.

Transoral Outlet Reduction (TORe)

Weight regain occurs in about half of individuals within five years of Roux-en-Y gastric bypass (RYGB) surgery. For most, the weight gain is limited and controllable. A minority of patients, however, will recapture a substantial portion of their original weight loss.

Studies in this population have suggested that over time, dilation of the gastrojejunal anastomosis (GJA) created between the stomach pouch and small intestine during RYGB is a precipitant of weight regain. Expansion of the GJA is thought to lead to decreased distension of the pouch with a solid meal and diminished satiety response.

Open surgical revision of the GJA has been faulted for lack of efficacy, increases in perioperative morbidity and mortality, and numerous complications. Laparoscopic reoperative bariatric surgery is somewhat safer, but complication rates remain an issue.

Transoral outlet reduction (TORe) of dilated gastrojejunal anastomosis after bariatric surgery is being performed as an investigational procedure at Penn Medicine to treat bariatric patients with dilation of the GJA.

TORe has been found to be a safer, less invasive, more effective and durable alternative to surgical or laparoscopic GJA revision. The procedure involves the endoscopic placement of sutures at the aperture of the anastomosis to reduce the dilation. In the largest series of TORe to date, the procedure resulted in weight loss at six months.


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