The growing number of medical options available to patients looking to shed weight reflects the nation’s mounting obesity problem. A good example is taking shape at University of Colorado Hospital, where balloons are joining bypass as weapons in the battle.
Shelby Sullivan, MD, a specialist in endoscopic bariatric weight-loss procedures, recently joined the University of Colorado School of Medicine’s Division of Gastroenterology. Sullivan, who arrives from Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, will expand the choices available to patients looking to lose weight without gastric bypass and other surgical procedures already offered at UCH.
The aim is not to supplant surgery but rather to supplement it, said Dianna Webb, program director for the Digestive Health Center, which is the hospital’s home for endoscopic procedures. “We’re looking to combine forces, resources, knowledge and past experience to make both programs successful,” she said.
The number of bariatric surgery cases at UCH increased 12 percent between 2013 and 2015, said Tonie Moore, clinical operations manager for the Multispecialty Surgery Practice, Plastic and Reconstructive Surgery and Wound and Ostomy Care. But building a nationally recognized program that offers a wider range of services could spur even greater growth, she added. “We want to provide exposure of our services on both sides.”
“Our goal is to make CU a national leader in endoscopic bariatric therapy,” Sullivan said. “As we increase the options that we are offering, we believe we will also increase the total number of patients who come here.”
Battle of the balloons
The new options include two balloon systems recently approved by the FDA for non-surgical weight loss. The ReShape Integrated Dual Balloon System, approved in July 2015, consists of two silicone balloons inserted endoscopically in the stomach and then filled via catheter with saline and blue dye to detect a leak. The balloons take up stomach space for six months, helping the patient lose weight, after which they are removed.
The Obalon Balloon System gained the FDA go-ahead in September. Patients simply swallow a capsule containing the balloon that is attached to a tube. The clinician then inflates the balloon with a nitrogen-mix gas that Sullivan says remains stable over time. For the clinical trial of the device, patients swallowed a second balloon at the three-week mark, and a third at either nine of 12 weeks, depending on weight loss, Sullivan said. Clinicians remove the balloons in six to 12 months.
ReShape and Obalon are alternatives to the Orbera system, already available at UCH, which uses a single fluid-filled balloon to take up stomach space. Sullivan said the Obalon device helps patients avoid nausea and vomiting, the primary negative side effects of the two fluid-filled balloon systems.
New aspirations
Sullivan also brings to UCH expertise in the recently FDA-approved – and in some circles controversial – AspireAssist procedure. Unlike the balloons and surgical procedures which by various methods reduce the size of the stomach and therefore the amount of food a patient can consume during meal, the AspireAssist approach routes a large portion of a meal directly out of the body.
The idea of gastric bypass is to route food to a much smaller stomach. AspireAssist gives a meal a direct exit ramp. During the roughly 20-minute procedure, the clinician endoscopically inserts a tube in the stomach via a catheter and guidewire. After the gastric tract heals, the clinician connects the tube to a port placed outside the body near the lower navel in a separate procedure. With the port in place, the patient waits 20 to 30 minutes after eating, then connects a pump to the port and drains the stomach contents.
The aspiration removes about 30 percent of the calories of each meal, Sullivan said. Coupled with lifestyle changes and nutritional support, the system generally produced weight loss of 15 percent to 20 percent after one year, she added.
Sullivan, who has performed 28 AspireAssist procedures during two trials of the device, demonstrated it Nov. 4 in a live procedure at UCH that was broadcast live to several hundred attendees at a conference in New Orleans during Obesity Week.
The balloon procedures generally aim at people with BMIs of 30 to 40. Aspire, by contrast, is approved for patients with a body mass index (BMI) of 35 to 55 who haven’t lost weight non-surgically. It’s drawn criticism by some clinicians who say the procedure increases the risk of infection, doesn’t match weight loss generally achieved by surgical procedures like sleeve gastrectomies that remove a large portion of the stomach, and doesn’t encourage people to eat less.
Food for thought
During a spirited discussion between Sullivan and conference attendees that followed the Nov. 4 procedure, the broadcast moderator acknowledged, “It’s a polarizing operation, to say the least.”
But Sullivan emphasizes that Aspire is just one of many weight-loss options available to patients. She notes that the idea that patients can eat anything they want and then simply get rid of it is false. In fact, to get food through the thin tube, an individual must chew it for a long time.
“The food has to disintegrate in the mouth,” as Sullivan put it to one of conference questioners. The patient also has to mix the thoroughly chewed food with liquid to create a “slurry” that can pass through to the stomach. She said that patients in the trial of the system did not resort to “compensatory eating” after aspirating food and that they generally ate less.
“There was evidence that patients improved their eating behaviors,” Sullivan said. She added that at UCH, patients who choose Aspire or any other endoscopic weight loss procedure will also receive care from a nurse coordinator, Jennifer DeSanto, RN; and a dietitian, Elizabeth Daeninck, RD. Sullivan said she also plans to work closely with clinicians at the Anschutz Health and Wellness Center to bolster patients’ commitment to lifestyle changes, regardless of the weight-loss procedure they choose.
Broadening options
In this, the endoscopic program will mirror the integrated approach of the hospital’s longstanding, nationally accredited Bariatric Surgery program, led by Jonathan Schoen, MD. Both Schoen and Sullivan emphasized that the programs aim to collaborate rather than compete.
“We’re both tackling the same disease,” Schoen said. “Ideally we will be working together on the same problem.”
The question of what kind of weight-loss procedure a patient chooses depends on several factors, Schoen said. One of them is cost. Endoscopic procedures nearly always require out-of-pocket payment; the Orbera system, for example, costs nearly $7,000, while AspireAssist costs $9,000, including a full year of therapy, Sullivan said. By contrast, insurance plans – including CU Exclusive for UCHealth employees – generally cover bariatric surgery. In 2017, Schoen added, the state of Colorado added it as an “essential health benefit” for coverage of state employees under the Affordable Care Act.
Bariatric surgery is considered most appropriate for individuals with BMIs of 40 or greater or those with a BMI of 35 and two or more comorbidities related to their weight, such as obstructive sleep apnea. Endoscopic procedures offer an alternative for those with a lower BMI, and they avoid the risk of surgical complications. The American Society for Metabolic and Bariatric Surgery acknowledges as much, noting that “there is a need for less invasive weight loss interventions to potentially reduce morbidity and improve access.”
Schoen and Sullivan also emphasize that any weight-loss procedure is simply one part of a process that requires individuals to make lifestyle changes in areas like diet, exercise and social relationships. With all of these factors taken into account, the key for UCH is to address the needs of as many patients as possible, said Moore, who noted she meets regularly with Webb of the Digestive Health Center to talk about program collaboration and sharing resources.
“With the increasing awareness of the problems of obesity, it’s best that we provide many weight-loss options at University for different populations of patients,” she said.