BB&T contributing writer

WASHINGTON – Like other healthcare issues in Washington, over the past few years there has been a heated debate on whether surgery would go the direction of NOTES (natural orifice trans-endoluminal surgery) or single port surgery; and at this year's annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) (Los Angeles) both sides (unlike the Republicans and Democrats) have come to the conclusion that it will be both. To keep the information gained from this 2nd largest surgical association in perspective, it is important to note that only about 30% of all surgeries in the U.S. are performed laparoscopically; albeit the attendees here perform the majority of their surgeries using laparoscopy, of which about 5%-10% are single port.

High on the list of enthusiasm at the exhibits, were new products that support all of the advanced procedures: NOTES, single port, robotics, microlaparoscopy, and a myriad of other innovative approaches designed to treat in a more minimally invasive way the variety of procedures that fall under the heading of general surgery.

Since single port surgery instruments are available and used today, they took the headline spot at most of the exhibits. Although NOTES maintains a strong following, it remains in the background of most exhibit booths since there are yet any FDA-cleared, NOTES-specific products that can produce revenues.

The stand out in the crowd of single port exhibitors was Covidien (Norwalk, Connecticut) whose SILS (single incision laparoscopic surgery) platform includes the broadest offering (see Table 5). One of the 14 new products launched at this meeting was their SILS Stitch, the only automatic endoscopic suturing device with articulating features and rotating tip that should save valuable time in the OR. Covidien's endomechanical & energy products contribute about 35% of sales and even more in operating profit. To expand even further in these areas, they added more “SILS“ single port instruments (shears, dissectors, clinch, suturing device), a new stapling technology (Tristaple), and a new Ligasure line.

Ethicon Endo-Surgery (EES; Cincinnati), a Johnson & Johnson (New Brunswick, New Jersey) company, had 7 new products, which will be officially available within the next few months. EES developed a novel percutaneous instrument platform that utilizes a full sized instrument head on a 3 mm shaft that can be introduced percutaneously thus offering “the best of both worlds: performance and cosmesis.“ These new products represent the company's commitment to transforming patient care by enabling innovation through collaboration across the continuum of surgical techniques—from advanced minimally-invasive to open procedures. This blending of product mixes to meet the needs of specific surgeons and procedures appeared to be the theme throughout the meeting.

“To achieve the best possible patient outcomes, surgeons need technology solutions that are as diverse as the procedures they perform and the techniques they use,“ said Kevin Lobo, worldwide president, Ethicon Endo-Surgery.

Although an early strong proponent in NOTES research and product development, EES has now opted to present a blended approach to serving the NOTES, single port, microlaparoscopy and robotic markets. Brian Dunkin, MD, of the Methodist Institute of Technology Innovation and Education (Houston) presented a pre-clinical study that used a percutaneous retraction device and a magnetic anchoring and guidance system (MAGS) that consists of an internal surgical device coupled across the abdominal wall and manipulated using an external handheld magnet. MAGS is being co-developed by EES with the University of Texas Southwestern Medical Center (Dallas) for application in all types of next generation surgery including NOTES, single and reduced port. In his presentation, Dunkin demonstrated how the integration of the percutaneous instrument platform and MAGS may help overcome some critical limitations of single port laparoscopic surgery by improving the surgeons' dexterity. He concluded “devices that enable surgeons to perform single site surgery more like traditional laparoscopy may improve adoption of this type of surgery.“

To get started in this patient-driven market, the shout-out to surgeons that have yet to start training in any of the advanced techniques was to begin by using “reduced“ port operations. This can mean either reduce the number of ports that would normally be used in a procedure, or reduce the size of each port, or both. Interestingly, when the size of the port is reduced from 5-10 mm down to 2-3 mm, it is referred to as microlaparoscopy, whereas 20 years ago when 2 mm ports were first introduced, it was called needleoscopic surgery. Call it what you want, the reduction in size not only means a virtually scarless outcome, but also the potential to eliminate a port for each needleoscopic instrument used, resulting in cost savings. Original needleoscopic instruments fell out of favor largely due to their lack of rigidity that led to inefficiencies in surgery. The newer micro instruments that employ advanced technology materials are strong enough to get the job done sufficiently. Stryker Endoscopy's (San Jose, California) microlaparoscopy instruments have a trocar like tip, eliminating the time and cost of making a small incision using a trocar prior to insertion. In addition to Stryker, Karl Storz (El Segundo, California), also has microendoscopy, or minilaparoscopy, instruments available. As yet, there are no 3 mm stapling devices or energy devices and only 2 cameras at that size.

In a plenary session on NOTES, Jeffrey Marks, MD Associate Professor Case Medical Center, Director of Surgical Endoscopy, University Hospital (Cleveland) remarked, “Has the air gone out of the balloon with NOTES? Two years ago this huge ballroom would have had people spilling out into the halls. Today, we have some empty seats.“ Adding to that comment, another panel member, Paul Curcillo, MD Director, Robotics and Minimally Invasive Surgery Drexel University (Philadelphia) said that the seemingly lower interest in NOTES was because the early market and product development was exciting. “Although we have hit milestones with NOTES, we are now entering clinical trials which are long and hard.“

Marks discussed similarities and differences between endolumenal and translumenal (NOTES) procedures, while Curcillo shared his feelings that there will eventually be a blended mix between NOTES and Single Port surgery.

According to Marks, “Some of the tools that were developed for NOTES will work well with endoluminal approaches as well; no procedure is always going to be done one way or the other“ While American surgeons have approached NOTES as a research-based science, Marks cited a study done in Germany with 125 patients that underwent a NOTES laparoscopic cholecystectomy. They had a 1% major complication rate and a 6% morbidity rate, which is considered unacceptable in the U.S. He noted that two probable causes for this was that they did not use a platform for anchoring and stability, nor did they use flexible instruments but rather off-the-shelf standard laparoscopic instruments. “If studies like this continue, NOTES will die,“ he said. “It is up to us to determine the best products and procedures that make the risk-benefit ratio acceptable.“

Marks concluded by noting that surgery is in a state of evolution with many approaches available and although one might argue that NOTES might not survive in the robust way it was once believed it would, we would not have the single port approaches we have today if NOTES never existed. Or, “Was NOTES a means to an end?“

Low Adoption Due to Lack of Training

Embedded in many of the presentations at this meeting was the question “why are 70% of all surgical procedures still performed as an open procedure?“ Originally, when laparoscopy was a nascent entity, a key barrier for adoption was the possibility of cancer recurrence. Since then many studies have proven that there is no difference in cancer recurrence. So why, with a proven shorter length of stay, less pain, better wound management, improved cosmesis, would there still be a resistance to laparoscopy? Of the roughly 500,000 cholecystectomies performed in the U.S. annually, only 40% are done laparoscopically. Many of the more advanced surgeons attending this meeting feel that the hurdle to adoption is that the operation is much more difficult to perform, thus requiring additional training.

This is also true with the conversion from multiple port to single port surgery. And although potential cancer recurrence was often cited as the reason not to perform laparoscopic surgery, oftentimes, benign surgeries are more difficult to perform than cancer surgeries. Many feel that such a low level of adoption after 20 years is due to lack of training. In an effort to train more surgeons on advanced laparoscopic procedures, notably single port, Covidien has taken their show on the road. Literally. They have fully equipped a semi-truck with all their SILS equipment and are offering mobile training services at local Medical Centers. “Delivered Tour“ features a state-of-the-art operating room-style facility housed in an 85-foot, nearly 80,000-pound tractor-trailer that will travel around the country to bring these advanced laparoscopic surgery tools directly to surgeons and hospitals. When parked, the truck expands to a 1,200-square-foot facility with a conference room, clinical training area with advanced audio-visual tools and five operating room stations that will accommodate 10 surgeons simultaneously. The truck's inaugural route is scheduled to commence this week beginning in Raleigh, North Carolina, traveling through parts of Florida, then to Atlanta and finally returning to Raleigh. This test route will help determine the feasibility of such an undertaking. Surgeons sign up in advance of the arrival of the mobile center and then partake in an hour of didactic training, followed by another hour of hands on lab using tissue blocks. Talk about “taking it to the road.“ Now that's a road show!

Search for cost savings in addition to cosmesis

The initial objective of reducing the number and size of ports was to improve upon laparoscopic surgery in terms of less pain, quicker recovery, and with a more cosmetically appealing result; but recently it is also to be able to decrease cost by reducing ports, trocars, disposables, and even eliminating an extra body in the OR.

Patient demand for scarless surgery is the key driving force for adoption regardless of the approximate incremental cost of performing the same procedure using standard laparoscopic technique of about $425 for single port and $2000 for robotic. The Holy Grail is to be able to decrease the total cost of care, regardless of the price of individual instruments.

But with Obama healthcare at our doorstep, should the incremental cost of developing advanced technologies with modest incremental patient benefit be better spent at finding a lower cost to perform the same tasks? To this point, at one of the plenary sessions, a speaker pointed out that in India (it was later corrected that it was in Germany) mosquito netting has been used to replace the very costly mesh that is used in hernia repair. With the change in economy and healthcare delivery, there could very well follow a movement towards cost savings rather than technology advancement if in fact the advancement is only cosmetic. To that end, it is expected that the next round of product developments and clinical trials may center on forms of cost savings. Besides trending away from costly disposables, another form of cost savings will be found in eliminating additional personnel in the OR. Several products have been designed to be anchored to a fixed platform, eliminating the need for another hand to hold the instrument or camera. Stryker offers the Wingman camera clamp, ProSurgics (Cupertino, California) offers FreeHand robotic camera holder, Virtual Ports (Richmond, Virginia) offers a self-retractor, and Dennis Fowler, MD Professor of Clinical Surgery, Columbia University (New York) demonstrated a new technology being developed called Insertable Robotic Effecter Platform (IREP) that eliminates the need of an extra hand. It is anticipated that more products that reduce the amount of time or people in the OR will enter the market.