Medical Device Daily 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.

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.

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.”