BB&T Contributing Writer

LAS VEGAS — More than two decades ago a group of pioneering surgeons formed a new surgical society to address the need for education, guidelines, and research in endoscopy in order to advance emerging technology and new techniques on behalf of their patients. That group of 50 surgeons known as the Society of American Gastrointestinal Endoscopic Surgeons (SAGES; Los Angeles) held its first meeting in Williamsburg, Virginia, in 1986 with 110 attendees.

Today, SAGES boasts more than 5,400 members, with 2,400 of them in attendance at this meeting, making it the largest minimal-access surgery meeting in the U.S. SAGES is now the pre-eminent association for the advancement of minimally invasive surgery, endoscopy, laparoscopy and emerging technologies in these sectors, often bridging the two different skill sets between endoscopists and surgeons and pioneering a fusion of technologies.

So advanced not approved

“Nothing I am going to discuss today is FDA-approved” were the opening remarks of William Richards, MD, director of laparoendoscopic surgery at Vanderbilt Medical Center (Nashville, Tennessee) in his presentation “Endolumenal Treatment for Obesity,” suggesting the advanced and frequently breakthrough nature of these procedures. He continued: “I believe in five years there will be a standard of treatment for obesity that is translumenal. There will be several devices or procedures that will fill the void between diet/medical management and bariatric surgery as we know it today.”

He described two new intragastric balloons: one developed by Heliosphere of France, that is air-filled and left in the stomach for six months, and the BIBB by Ethicon Endo-Surgery (Cincinnati), a business of Johnson and Johnson (New Brunswick, New Jersey), that is water-filled, its volume able to be varied. Both of these products are designed for those patients who are either only moderately obese or are not candidates for gastric bypass surgery or who are super obese and need to lose enough weight before bariatric surgery so as to not pose a greater surgical risk than necessary.

Discussing other endolumenal procedures for obesity management, J. Stephen Scott, MD, associate professor of clinical surgery at the University of Missouri-Columbia, presented his research on “Safety, Feasibility and Weight Loss after Transoral Gastroplasty (TOGA),” in which two centers studied the safety and feasibility of a new trans-oral restrictive procedure for treatment of obesity.

The TOGA system developed by Satiety (Palo Alto, California) is comprised of a set of transoral, endoscopically-guided staplers used to create a restrictive pouch along the lesser curve of the stomach to restrict outflow and thus create the feeling of fullness, satiety. According to Scott, “Insertion was easy, laparoscopic assistance was unnecessary, and the patients achieved an excess weight loss at six months that paralleled that of Lap-Band.”

He concluded by saying that there is great interest “in new procedures to treat obesity that offer lower morbidity than current options.”

Also presenting at the conference in the endolumenal bariatric space was EndoVx (Napa, California) which, in collaboration with the University of San Francisco Medical Center, demonstrated the feasibility of a laparoscopic surgical vagotomy for weight loss. In a study in collaboration with the Moses Cone Health System (Greensboro, North Carolina) researchers found “that the addition of truncal vagotomy to Lap-Band may enhance weight loss.”

NOTES a late afternoon magnet

Even after 5 pm on a Friday afternoon in “sin city,” the huge main ballroom was standing-room-only for the NOTES (Natural Orifice Translumental Endoscopic Surgery) plenary session, demonstrating the eagerness on behalf of this audience to learn about the latest new trend in minimally invasive procedures.

NOTES is an emerging platform that allows abdominal surgeries using flexible endoscopes passed through a natural orifice such as the mouth. The obvious advantages are that there are no wound infections, no adhesions, and potential full range articulation and visualization within the abdomen.

Jeffrey Marks, MD, Case Western Medical Center (Cleveland, Ohio) headed a panel discussion on NOTES and described the procedure as follows: “. . . a completely incisionless surgery performed though any body orifice that allows access to the area of interest. The objective of NOTES is to allow for a quicker recovery, less immune suppression, better cosmesis —and possibly move the procedure to an outpatient setting using conscious sedation.”

Some have referred to NOTES as the technology in search of an application, but there is continued interest — albeit of the cautious sort — in going forward with the research.

“NOTES procedures require an integration of endoscopic techniques into the OR,” Mark said, and producing a transition in the use of flexible endoscopy as a diagnostic tool to it use as a therapeutic tool. But, he cautioned, “Just because we can perform a procedure using NOTES technique, doesn’t mean we should. There also has to be a benefit to doing it that way.”

Several companies, including Boston Scientific (Natick, Massachusetts), U.S. Surgical (Norwalk, Connecticut), Ethicon-Endo Surgery, Karl Storz Endoscopy (Culver City, California), W.L. Gore (Flagstaff, Arizona), and Olympus (Center Valley, Pennsylvania) are either funding academic research investigating NOTES, or developing products to enable NOTES procedures. Marks said that there are many “off-the-shelf tools available that can be used for NOTES procedures, but the ideal NOTES access and closure device would be applicable to all NOTES orifices and would be 100% leak proof.”

In a presentation titled “Complete Endoscopic Closure of Gastrotomy following NOTES using the NDO Plicator,” Marks presented his own experience with the procedure.The NDO Plicator from NDO Surgical (Mansfield, Massachusetts) is a semi-flexible instrument with a scope that approximates full thickness tissue and delivers a double pre-knotted PTFE suture. It was developed for GERD but has worked well for NOTES, although there is no long-term data on it yet for this usage.

Marks concluded: “although this instrument was designed for another purpose, it has performed well so far for NOTES closure, and we should use it as an example to look for other tools that are out there that were designed for other purposes and see if they are adaptable to NOTES.”

Endolumenal approach to GERD

Five years ago it appeared that protein pump inhibitors faced the threat of market share erosion due to endolumenal approaches for treating gastroesophageal reflux disease (GERD). Today, only one device still co-exists with both medical management and surgery for the treatment of GERD.

William Richards, MD, director of laparoendoscopic surgery at Vanderbilt University, (Nashville, Tennessee) presented the “Paradigm Shift in the Treatment of Gastroesophageal Reflux Disease: The Addition of Endoscopic Techniques.” He described the digestive tract as “complicated and sophisticated, delivering over 50 different peptides that act on the brain signaling it to do something.” Thus, he said it is understandable why some previous endolumenal attempts at treating GERD have failed. The digestive tract “outsmarted” these efforts.

Currently, there are about 700,000 upper endoscopies performed annually in the U.S. for GERD evaluation, with 200,000 of them evaluated specifically for GERD surgery. Of these, 70,000 go on to have an anti-reflux surgical procedure, primarily a laparoscopic Nissen procedure.

The only still viable endolumenal approach to treating these patients is with the NDO Plicator device, developed and manufactured by privately owned and investor-backed NDO Surgical. The Plicator is retro fluxed within the stomach and then performs an automated full thickness plication including delivery of tied knots in the sutures. The procedure can be performed in an outpatient setting using conscious sedation and takes approximately 15-20 minutes. Richards concluded by sharing his “New Paradigm” for treating the refractory GERD patient: “For those with a small hiatal hernia, adequate LES pressure, and no Barrett’s esophagus, he performs the endoscopic procedure. For those patients with a large hiatal hernia, no LES pressure, and Barrett’s esophagus, he recommends the laparoscopic Nissen procedure.”

Anti-fogged laparoscopy

New Wave Surgical (Bronx, New York) made its first appearance at this meeting to demonstrate its cute little multi-functional device that eliminates laparoscope fogging, cleans, and finds a true white balance while keeping the laparoscope safe during surgery.

An estimated 4 million laparoscopic procedures are performed in the U.S. annually and fogging of the lens at the end of the scope remains a time-consuming nuisance. Since most ORs are kept cold, once the scope is introduced into the warm body, the lens fogs up, reducing visibility and requiring the continual removal, cleaning, and defogging of the scope.

Developed by two surgical interns from Weill Cornell Medical College (Manhattan, New York), a small foam stress-ball-like device heats anti-fog solution within its reservoir for up to four hours while holding the scope and preventing it from burning drapes and patients or from falling on the floor. Not quite as elaborate as some of the new endolumenal instruments shown at this meeting, but equally elegant.

In a poster presentation, the company concluded: “To our knowledge, [this] is the first device to combine heat and anti-fog solution to definitively address the fogging problem [and] is also the first device specifically intended for white-balancing, protecting or cleaning the laparoscope during the procedure and may significantly increase laparoscopic surgical efficiency.”