Medical Device Daily Contributing Writer
SAN DIEGO — No gastrointestinal meeting would be complete without a session on NOTES, or Natural Orifice Translumenal Endoscopic Surgery, a marriage between flexible endoscopy and laparoscopic surgery that was designed to be scarless, and now is found to also be almost painless, and with shorter recovery times than laparoscopic surgery.
So Digestive Disease Week 2008, held here in mid-May, featured Anthony Kalloo, MD, professor of medicine and gastroenterology at Johns Hopkins University School of Medicine (Baltimore) and a pioneer of NOTES in the U.S.
Discussing "Breakthroughs in Endoscopic Techniques and NOTES," Kalloo had the attitude of "If you can imagine it, it can happen."
Expounding on the very experiments that have been done using NOTES procedure, he pointed out that the initial goals of NOTES were to be able to practice fundamental surgical principles, such as those listed in Table 1, while operating through a flexible endoscope.
Kalloo described early glimpses into research that have the opportunity to change the way medicine is practiced today.
1. The opportunity to perform surgery outside of the operating room. Early studies have shown that a sterile environment such as the OR may not be required for NOTES procedures nor anesthesia in many procedures, alleviating the need for the costly OR.
2. Acute trauma may be able to start treatment onsite. Paramedics may be able to begin treatment of an acute trauma at the site of the injury using NOTES techniques, such as applying cellulose to stop intra-peritoneal hemorrhage.
3. Previously non-accessible areas of the spine could be treated. There has never been access to the anterior spinal column, but with NOTES, this could present a big opportunity for spinal repairs such as disc replacements, and other interventions that have been considered inaccessible.
4. Mobile robots may be able to treat from a distance. Mobile robots may be able to be passed down the scope, make incisions, and have a surgeon perform the actual surgery from a remote place. These are all possibilities for this new technology and are being investigated worldwide.
5. Intrauterine fetal procedures. Another new frontier that is being tested is the use of NOTES in pregnancy. Kalloo cited research presented here by Samuel Giday, MD, of the department of medicine and gastroenterology at Johns Hopkins, titled "Successful Diagnostic and Therapeutic Intrauterine Fetal Interventions by NOTES."
"An intrauterine fetal intervention is an area where morbidity and mortality using standard laparoscopic techniques is substantial," said Kalloo. Current transabdominal laparoscopic fetoscopy is less invasive, but limited by rigid instruments that only allow anterior access to fetal parts.
Giday introduced transgastric and/or transvaginal flexible endoscopes fitted with high-resolution ultrasound into the peritoneal cavity and allowed for full viewing of the fetus with visualization that was equivalent or superior to transabdominal ultrasound. He also was able to perform transuterine intracardiac injections with no immediate complications or evidence of induction of preterm labor following the procedures.
"Although far away from clinical applications, NOTES has potential for intrauterine diagnostic and therapeutic fetal procedures," Kalloo said.
After mentioning that several new products were developed quickly by industry in order to enable the physician to practice these fundamentals, he stated that even further futuristic research is continuing in NOTES, as listed in Table 2.
New Roles for Endoscopists
Endoscopic procedures were first introduced as a diagnostic tool that allowed the physician visualization of the alimentary tract and resulted in well over 2 million scope procedures being performed in the U.S. annually.
The next step — to be able to treat through the endoscope — required advanced enabling technology, an example of which are polypectomies, which occur in 20% of all colonoscopies, where the polyps are removed with the same scope and at the same time as the screening procedure.
Advanced technologies allow for new clinical applications to rapidly spring up. Such is the case with flexible therapeutic endoscopy which now also includes NOTES procedures, as well as new methods to treat Barrett's disease, GERD and obesity, to name a few.
Endoscopists, initially thought of as diagnosticians, are assuming more treatments, using the latest advances in their primary tool: the endoscope. Now there are a myriad of procedures — from treatment for GERD and Barrett's esophagus to novel bariatric procedures — that can be performed through a flexible endoscope, with the numbers of new advances and applications for these new technologies growing almost daily.
"Bariatric surgery is one of the most common surgical procedures in the U.S., with more than 240,000 surgeries performed annually and the prediction of laparoscopic gastric bypass becoming the most commonly performed surgical procedure in the US during this decade," said Adam Slivka, MD, associate chief of gastroenterology, hepatology and nutrition at the University of Pittsburgh Medical Center.
"A new role for endoscopists is that of managing the complications of bariatric surgery where the endoscopist is playing an increasing role in post-op care," said Lawrence Friedman, MD, professor of medicine at Harvard University and Tufts University School of Medicine (Boston). Bariatric surgery patients are, by definition, a high-risk population and as they age will continue to present with late stage surgery-specific issues, most of which can be handled endoscopically.
In addition to endoscopic repairs for bariatric procedures post-op, several new technologies are addressing other novel approaches to performing once-surgical procedures through an endoscope.
Charles Filipi, MD, of Creighton University School of Medicine (Omaha, Nebraska), presented a new transoral gastroplasty device for GERD and obesity, which is expected to be available for human trials later this year.
The noninvasive gastroplasty device can treat two separate disorders: GERD and morbid obesity, both of which "are particularly serious health issues in the western hemisphere and major contributors to the escalating cost of health care in the U.S.," Filipi said.
He added, "We believe that this device will result in much more effective treatments for both conditions, fewer complications and less patient expense, while permitting each procedure to be performed on an outpatient basis."
Conventional treatments for GERD and obesity are performed surgically, requiring hospitalization and the potential for complications. GERD is the third-most-prevalent disease in the U.S., with more than 19 million people suffering from it weekly and 61 million Americans reporting heartburn monthly.
The device, a flexible tube with a metal capsule at the tip, is introduced through the mouth and esophagus, suctions two sides of the specified juncture in position for suturing, removes the mucosal lining, then stitches the two sides back together. The theory being that by suturing mucosa-to-mucosa, a stronger bond is formed and the resulting durability allows it to last longer, distinguishing this procedure from other noninvasive methods that have been developed.
Safestitch Medical (Miami) has developed the device with licensed intellectual property from Creighton University.
Also competing in this space is Endogastric Solutions (Redmond, Washington), which recently reported that 85% of patients remain symptom-free and off daily GERD medication at one year after transoral incisionless fundoplication surgery using the company's EsophyX device.
The EsophyX device also enables surgeons and advanced interventional gastroenterologists to offer their patients substantive anatomical repair without incisions for gastroesophageal reflux disease (GERD).
Earlier entries in the area of endoluminal procedures for GERD were C.R. Bard's (Murray Hill, New Jersey) Endostitch and NDO Surgical's (Mansfield, Massachusetts) Plicator.
As the technologies progress, so do the clinical applications that are enabled by these advances. One can only marvel at what will be next.
DDW is jointly sponsored by the American Association for the Study of Liver Diseases (Alexandria, Virginia), the American Gastroenterological Association (Bethesda, Maryland), the American Society for Gastrointestinal Endoscopy (Oak Brook, Illinois) and the Society for Surgery of the Alimentary Tract (Beverly, Massachusetts).