BB&T Contributing Writer

SAN DIEGO — About 20 million Americans would qualify for insurance coverage for bariatric surgery, but fewer than 200,000, or about 1%, have it done. Many patients fear available bariatric surgery options because the operation dramatically and permanently alters the alimentary tract anatomy and can be associated with potential risks and side effects following the surgery that potential patients do not want to experience.

In an effort to reach the remaining 98% of obese patients who are not receiving the life-saving surgery, companies are scrambling to help these patients by enticing them with less invasive, albeit not quite as effective, procedures — a trade-off that appears to be gaining popularity if the Lap-Band from Allergan (Irvine, California) is any indication. In addition to the less-invasive, reversible, gastric bands, other novel approaches were presented or discussed here at last month’s annual meeting of the American Society for Bariatric Surgery (Gainesville, Florida).

Historically, bariatric surgery consisted of three main types: the Roux-en-Y procedure, also called the gastric bypass, which is both restrictive and malabsorptive; the duodenal switch (mostly malabsorptive); and the Lap-Band (restrictive only). Although the first two types permanently alter the alimentary anatomy, bands only restrict the gastric pouch and can be removed or adjusted, leaving the anatomy intact.

U.S. skepticism

The Lap-Band has garnered the majority of market share in Europe, but “U.S. surgeons were skeptical when it was first cleared by the FDA in 2001, citing poor weight loss and band slippage as the most common reasons,” according to David Provost, MD, of Southwestern Medical Center (Dallas) in a presentation, “Laparoscopic Adjustable Gastric Banding for Morbid Obesity: The U.S. Experience.” However, “now it has garnered over 20% of all bariatric surgeries performed in the U.S., due to improved outcomes and a marked reduction in complications.”

In a meta analysis he performed that included 4,937 patients, he found that “excess weight loss using the Lap-Band ranged from 32% to 62% at one year; 35% to 61% at two years; 39% to 66% at three years, and remained around 55% from four years on.”

He concluded that “the Lap-Band provides excellent weight loss, co-morbidity improvement, and 55% excess weight loss out to four years — the same as is seen with gastric bypass.” Because the long-term success rate of the band is similar to that of gastric bypass but without the permanency, market shares have shifted, with about 70% (down from 85%) of the surgeries being Roux-en-Y, 25% Lap Band and the remaining 5% consisting of the duodenal switch, gastrectomy sleeve and other procedures.

All of these procedures require varying degrees of surgery and each bears its own set of morbidities, or side effects coupled with its individual benefit profile. With the exception of totally non-compliant patients, each procedure will produce some amount of weight loss; and in tandem with lifestyle changes, the amount can be dramatic.

“Obesity carries with it a two to three times mortality rate over a normal-weight individual,” said Luca Busetto, MD, of Terapia Medica e Chirurgic Obesita (Padova, Italy) in a presentation titled “Reduction of 5 Years Total Mortality in Morbid Obese Patients Treated with Laparoscopic Adjustable Gastric Banding.”

He accumulated data on 4,732 patients with BMI of more than 40 and divided them into two matched groups: one receiving medical management and one group receiving the Lap-Band — and then looked at each group’s long-term mortality in order to compare medical management with the least invasive surgical procedure. “The Lap-Band patients peaked at two years with an excess weight loss of 42%, but had a reduction of 60% in total mortality compared to those who were medically managed,” he said.

Improving longevity

This study, along with numerous others presented during the conference, validated that surgical weight loss improves longevity and reduces co-morbidities over the alternative of medical management in obese patients. In addition, there is evidence that bariatric surgery also improves their mental outlook on life.

A poster presentation, “Quality of Life After Gastric Banding in a Multidisciplinary Institution” by Tony T. Brancatisano, of the Institute of Weight Control (Sydney, Australia), studied 945 obese patients pre- and post-Lap-Band and found that “pre-operatively the patients indicated that they had severe disabilities with moderate depression. Even a moderate weight loss provided a dramatic improvement in quality of life.”

If the least-invasive surgical procedure, gastric banding, produces enough weight loss for improvement mentally and physically, then why aren’t more patients having bariatric surgery?

Marc Bessler, MD, surgical director at Columbia University (New York), said he feels that “many of them are afraid of the surgery.” In the “Emerging Endolumenal Technologies in the Treatment of Obesity” workshop that he moderated at last month’s annual meeting of the American Society for Bariatric Surgery (ASBS; Gainesville, Florida) here, several new approaches were presented that address patients’ fears of going under the knife.

One new group of procedures is that of endolumenal suturing, in which the suturing instrument is introduced through the esophagus — avoiding an abdominal incision — and is used primarily for stomach remodeling or gastrectomy.

These include Ethicon Endosurgery’s (Cincinnati) Bariatric Edge Spiderman, which has a curved needle for stomach reduction. USGI’s (San Clemente, California) G-Prox reduces the size of both the stoma and the gastric pouch. C.R. Bard’s (Murray Hill, New Jersey) Endocinch can reduce the size of the stomach and the company also is developing a “quilt-like” approach to reducing stomach size.

Other than the latter approach, all of these are revisional surgeries designed for correcting a failed surgery as opposed to a primary procedure.

Endoluminal placement

The next category of new procedures uses the endolumenal placement of a device. ValenTx (Wilson, Wyoming) uses “T” fasteners to attach a sleeve in the esophagus that then runs into the small bowel in order to avoid hormonal feedback that sends hunger signals back to the brain.

Satiety (Palo Alto, California) uses endoscopic staples to produce a sleeve gastrectomy and has early results in humans showing a 20% to 25% excess weight loss at six months.

GI Dynamics (Newton, Massachusetts) has placed its implanted sleeve endoscopically in both animals and humans and has found no migration and no complications so far.

Asked to predict what will become a winning strategy for these new products, Bessler said, “Durability and data will drive usage of new products. Durability will be an issue. Will staples outlast an artificial sleeve inside the gut? Data will drive the usage of anything new.”

Everything “a trade-off’

Asked how good the data will have to be, he replied, “Everything is a trade-off. Thirty percent excess weight loss is good at two years out, but will some of these products still be inside the patient at the two-year mark? Durability, weight loss and tolerable side effects are all variables — it is all a matter of risk vs. benefit and the patient determines much of that equation. Patients have more and more input into their healthcare decisions, which is why so many of them choose not to have the life-saving surgery.”

Bessler prophesized that patients in the future may have repeat less-invasive procedures performed serially; or that many of these newer procedures could be used in tandem with each other, or with current devices such as the Lap-Band which is made by Allergan (Irvine, California). “There will be many choices for many patients, and it will be up to them to decide which fits best with their profile,” he said.

Barriers to entry into the bariatric surgery space are low, since even a modest weight loss results in resolution, even partially, in the associated co-morbidities. Patient expectations are satisfied with a modicum of success because it improves their quality of life.

The numbers of treatable patients exceeds most other medical markets in terms of size, and even with a modest market share, a company should be able to enjoy profitable returns. There is enough of this giant pie to go around. For these reasons, as well as humanitarian ones, many new companies are developing non-surgical approaches to treat obesity.

Feeding our ‘lifestyle’

Although the ASBS focuses on healthcare and medical necessity — not cosmetics — the real opportunity may lie in the consumer market, often referred to as “Lifestyle Medicine.” Not to be overlooked is the fact that Americans spend $30 billion annually on weight loss programs, pills and nutritional supplements in order to manage their weight.

With this as a backdrop, one wonders how much would an overweight person spend to lose weight if he or she could get a minimally invasive, reversible or temporary procedure done in an office or outpatient setting? It is not inconceivable that with some of the newer devices that avoid major surgery and can be performed in an office or outpatient setting, patients could self-pay and have a weight loss procedure by choice before they become obese.

Lifestyle medicine is one of patient demand over medical necessity, and is predicted to be one of the fastest-growing areas of healthcare investment today, primarily due to the large group of baby boomers who have discretionary income.

And these boomers could expand this already huge market to include the overweight and not just the obese.

In just a few years, it may be possible for a moderately overweight mother to elect to have an intragastric balloon placed in her stomach six months before her daughter’s wedding, as insurance that she looks her best — and thinnest — on that most important day.