BBI Contributing Editor

SAN FRANCISCO – By far the most forward-thinking presentations by a panel of renowned surgeons during the 91^st clinical congress of the American College of Surgeons (ACS; Chicago), held here in mid-October, was that of re-positioning surgeons as “interventionalists of the future.” Over the past several years, with the movement of minimally invasive and interventional procedures that have cannibalized surgical procedures, surgeons have lost the volume of both open and minimally invasive procedures to other specialists; namely interventional radiologists, interventional cardiologists, and even interventional oncologists. This shift in patient care has made the future direction of surgeons uncertain.

Panelists selected by the ACS Committee on Emerging Surgical Technology and Education presented a multidisciplinary perspective on how new interventional therapies will affect patient care and how they foresee the “new” surgeons role in that scenario. Currently, when a patient is referred to an interventional radiologist, the radiologist most likely suggests a procedure that he can perform, usually not surgery. On the other hand, if that same patient is referred to a surgeon, then most likely surgery will be the recommended course of action. Many times the best interest of the patient is overlooked because today’s hospital system is currently not designed around the patient, but rather around the specialty. Thus, a complete re-vamping of practice patterns, hospital design, and training of future specialists is required in order to best serve the patient. Members of the ACS are driving forces in initiating this necessary move in hospitals throughout the U.S.

Lawrence Cohn, MD, senior surgeon at Harvard Medical School (Boston), reminded the audience of what happened to open-heart surgery once angioplasty became a popular alternative. He noted that surgeons were “too busy performing coronary artery bypass grafts [CABG] and gave up other procedures to do CABGs and valves.” The volume of open-heart surgical procedures once was so great that it almost became necessary to allow other specialists to perform these other procedures, but as percutaneous coronary interventions (PCI) ate into the volume of CABG procedures, the cardiac surgeons found their caseload diminishing, while other procedures they formerly performed had been farmed out to other specialists.

Along with this, those surgeons discovered that during their heyday, they had trained too many cardiac surgeons and now there were not enough procedures to support a minimum number for each surgeon to maintain critical competence. “Will cardiac surgeons rise to the challenge?” Cohn asked. Yes, he said, “with a re-direction of training and organization within the hospital, which is critical to the survival of surgery, and by far best for the patient.”

He added that the residency program at Harvard “has already developed a cross-training where the cardiac resident spends 50% of his time in a cath lab and 50% of his time in surgery. They are integrating cardiothoracic training with interventional and electrophysiology, exposing residents to aortic stent grafting, percutaneous valve technology and stenting of peripheral arteries.” Cohn said the development of a hybrid service line allows the patient to be offered the best diagnosis and treatments available regardless of specialist providing the care (i.e., interventionalist, interventional radiologist, surgeon). With this model, a patient who may have several disease entities requiring different procedures could all be treated in one hybrid service center.

Under conventional hospital organization, a patient is shuffled between diagnostic (often imaging) departments, cath lab, surgical suites, etc. and often on various floors of the hospital. “With a hybrid department,” Cohn said, “the entire disease state continuum – diagnostic, interventional procedures, surgery – is encompassed in one specific location; embracing all of the specialties, in order to provide better patient care.” He added: “They are already performing hybrid cardiovascular care at Harvard by performing a PCI in the morning, and then a minimally invasive aortic valve repair in the afternoon.”

Noting that Vanderbilt Medical Center (Nashville) already has built an integrated facility and is operating a total cardiac care hybrid center, Cohn said other institutions that also have a hybrid cardiovascular service system in place are the University of Pennsylvania (Philadelphia) and the Cleveland Clinic. The key to the success of cardiovascular hybrid service centers, he said, will be that the outcomes must be as good as what are already being delivered in minimally invasive procedures. In other words, providing new technologies all in one place is good for the patient, but not if it sacrifices current standards of care. Only new technologies that can provide the same level of care should be incorporated into the new hybrid service systems, Cohn said.

Outside of cardiac care, Mahmood Razavi, MD, clinical trial director at St. Joseph’s Medical Center (Orange, California), explained how manufacturers realized the opportunity for minimally invasive surgery and alternatives to surgery and developed techniques that interventional radiologists and oncologists could use to treat surgical patients. As image-guided therapies were developed, the radiologist became even more involved in the treatment of the surgical patient. Razavi described each specialty as being “the four arms of cancer treatment: surgery, radiation and medical oncology, interventional radiology and image-guided therapies.” He said that with each specialist vying for the same patient, the best interest of the patient was not always in the forefront.

With the proposal of disease state management systems (or hybrid service systems, as Cohn referred to them), all the specialists would come together to treat the patient with the best available technology suited to that patient. For instance, the cancer floor would now entail an imaging center, image guided therapies, interventional therapies, and surgery – all for cancer patients only. The same would be true for digestive diseases, gynecological diseases, neurological diseases, etc. – a hospital specialty center would be dedicated to all technologies for the treatment of a specific disease group; disregarding the type of specialist responsible for delivering a specific technology. Razavi said, “Some of the newer technologies will replace surgery, while other technologies will increase the number of surgeries.” The patient benefits no matter which procedure is selected, as all the specialists are united toward the best interest of the patient.

Training of interventionalists seen critical

In order to reach these goals of integrated disease management systems, training interventionalists of the future is critical, as addressed by Michael Silva, MD, of the Cleveland Clinic. He offered an historical overview of how surgery has evolved over the years. Initially, when less-invasive alternatives were presented, surgeons and patients reminded themselves that open surgery had been proven over years to be safe and effective. As emerging less-invasive technologies entered the mainstream, thoughts trended toward the fact that such new procedures might be better because of faster recovery and the ability to serve those patients not able to undergo surgery. Today, open surgery often is viewed as the last option.

Silva noted: “Today’s surgical fellow needs to have endovascular, minimally invasive and open surgery skills – a training challenge, since open surgical skills and endoscopic skills are not necessarily translational.” He suggested that at the general surgery resident level, there be an exposure and some experience with basic surgical and interventional procedures, while at the fellow level, there is the need to develop expertise in both endovascular and open procedures. In order to accomplish this, a standardized high-volume, intense cross-training program must be in place, which he is developing along with other centers throughout the U.S.

The biggest training challenge facing practicing surgeons today is how to get credentialed in order to perform new procedures that were not taught in their residency program. To address this issue, an intense three-month program has been approved by the ACS for extended training at five medical centers: the Cleveland Clinic, Texas Tech University Health Sciences Center (Lubbock, Texas), Northwestern University Medical Center (Chicago), Kaiser-Permanente Medical Center (Oahu, Hawaii), and Baylor College of Medicine (Houston). At these centers, a practicing surgeon can take a Senior Emerging Technology Fellowship and learn the basics of catheter based procedures, the physical skills required to perform these procedures, and apply this training on patients; thereby gaining the necessary credentials to return to his home hospital and perform these procedures.

The final panel member to speak was Julie Ann Freischlag, MD, chair of the department of surgery at the Johns Hopkins University School of Medicine (Baltimore), who described the changes in training that her institution already has adopted and incorporated into its training programs. She said that those training programs “have changed to be disease-based, incorporating the total care of the patient, which may include imaging, cancer therapy, embolic surgery, etc. Their goal is to become experts in the disease, not in a procedure.” Since Johns Hopkins has implemented this program into vascular surgery, the volume has increased 40% in the past six months. Her feeling is that a surgeon with the proper training can and should do everything, including imaging, biopsy, surgery and alternative procedures (with the exception of chemotherapy). When asked how this might work in a rural setting, she responded: ”Does rural surgery exist anymore? Airplanes can get patients to the right place for better outcomes in a matter of hours.”

The panel was convincing in its re-positioning of surgeons as interventionists of the future and in demonstrating effectiveness of disease-based patient management. The concept should also help device manufacturers introduce new products more quickly, as the politics and turf battles should be diminished. A company should, in theory, no longer concern itself with which subspecialty to align, rather just with which disease its products most effectively treats.

New technologies highlighted

NiTi Medical Technologies (Netanya, Israel) launched its first series of products that use nitinol technology in devices designed to perform gastrointestinal anastomoses. Following the excision of bowel segment, the severed colon ends need to be approximated together without contamination of the peritoneal cavity by bowel contents and the two ends then joined with an effective leak-proof seal until the anastomosis has healed. It is widely accepted among surgeons that an ideal colon anastomosis would have 1) good blood supply, 2) accurate serosal opposition with no tension, and 3) no leakage.

The current gold standard for closing anastomoses is staples, such as those manufactured by Ethicon EndoSurgical (Cincinnati) and Tyco Healthcare (Mansfield, Massachusetts), although they have been criticized by some for leaving a foreign body behind within the abdominal cavity.

In compression anastomoses, following the excision of bowel segment, the severed colon ends are approximated together and the two ends then joined to form an effective seal until the anastomosis has healed naturally. Unlike previous devices in this area, the technology at the core of NiTi’s compression anastomosis clip (CAC) is nitinol, a shape memory alloy that allows the device be opened and applied at low temperature and then at body temperature returns to a closed configuration that holds the bowel tissue together under a constant compressive force regardless of the thickness of intervening tissue.

This then leads to ischemia of the entrapped bowel wall and the formation of a compression anastomosis along the outer perimeter of the device to form a continuous, virtually seamless seal, while the inner tissue and clamping element detach and pass out of the body through the digestive system within two weeks, leaving nothing behind.

For a side-to-side anastomosis, the intestinal walls internal to the clip are slit by a blade built into the applicator in order to make the opening between the two parts of bowel.

The privately held, venture-backed company, whose parent company is incorporated in the U.S., was founded in 1997 by the chief surgeon of the largest hospital in Israel and a nitinol technology scientist who immigrated to Israel from Russia.

NiTi’s devices can be used to perform side-to-side, end-to-side, and end-to-end compression anastomoses in open, laparoscopic, hand-assisted laparoscopic and endoscopic surgeries throughout the upper and lower GI tract.

The company received 510(k) clearances for four products between May 2004-May 2005, using stapling devices as the predicate for the procedure – the Valtrack device from Davis & Geck as predicate for the compression, and Medtronic’s (Minneapolis) Coalescent U-clip device as predicate for nitinol occlusion.

Over the past two years, these products have been used on about 150 patients in Israel, China and now the U.S. The company has just begun a multi-center product launch at Cornell-Presbyterian Medical Center, Columbia-Presbyterian Medical Center (both New York) and Washington University Medical Center (St. Louis).

NiTi’s current technology is targeted for the 650,000 bowel procedures performed in the U.S.; worldwide it is addressing more than 1.6 million procedures. To date, the company has seen no strictures, no leakage and a virtually seamless anastomosis.

In another ACS presentation, V. Suzanne Klimberg, MD, director of breast surgical oncology and professor of surgery at Arkansas Cancer Research Center (Little Rock), discussed a radical new form of reducing local cancer recurrence.

Typically, local radiation or whole breast radiation follows a lumpectomy, requiring the patient to make daily returns to the hospital for five to 30 days following the lumpectomy. For many patients, this is a hardship both to them and to their caretakers, especially if they live out of area, confirming the statistics that show about 30% of all lumpectomy patients do not complete their radiation treatments.

Klimberg used the RITA Medical Systems (Mountain View, California) radio frequency system that heats tissue to a high enough temperature to ablate tissue or cause cell death on the tumor bed following the lumpectomy of 48 patients. She tried to determine what percentage of patients could be spared re-excision using the RF ablation of the tumor bed as an extra margin of safety against local recurrence.

Literature has shown that local recurrence rates can be up to 35% of all lumpectomies, which is the current rationale for radiation therapy following surgery – to kill any remaining tumor cells. If RF ablation can be shown to be as effective as radiation, then the following advantages would be made available to the patients: 1) No return visits to the hospital following surgery, 2) The surgeon can perform the ablation at the same time as surgery, so no additional radiation oncologist fees and services would be required, 3) Follow-up mammograms are much easier to read after RF ablation than they are after radiation and 4) The cosmesis following ablation is better than with radiation.

Comparing RF ablation to radiation following lumpectomy will be a long study in order to gain acceptance, but Klimberg is paving the way to that end. She said she was able to demonstrate in her study that 44% of the patients who would have returned for re-excision were spared that extra trip back to the operating room.

Exhibiting for the first time at ACS was Encision (Boulder, Colorado), a company whose products address the growing attention being paid to patient safety.

With some 85% of surgeons using electrosurgical instruments in almost 4 million laparoscopic surgical procedures, the importance of reducing the risk of unintended stray energy burns to patients during minimally invasive procedures cannot be over-emphasized. Unintended tissue damage, and even death, can result from stray electrosurgical burns caused by insulation failure and capacitive coupling during laparoscopy.

To this end, Encision has developed a complete line of laparoscopic electrosurgical instruments designed with the company’s Active Electrode Monitoring system, which provides a fail-safe solution to unintended stray energy burns.

Especially with the advent of laparoscopic surgery, surgeons now work through very small incisions, manipulating instruments through long, narrow spaces that make it more difficult than ever to prevent electricity from traveling outside its intended path and accidentally burning non-targeted tissue.

Unintended burns during electrosurgery due to insulation failure and capacitive coupling can be avoided using Encision’s active electrode monitoring technology that automatically shut down whenever any stray energy is detected.

CompView Medical (Beaverton, Oregon) displayed its relatively new systems, Digital Operating Control System (DOCS) and Nu-Boom. CompView Medical was spun off earlier this year from CompView (also Beaverton), a provider of presentation technology and group communication solutions. CompView Medical is focusing primarily on creating the operating room (OR) of the future – essentially converting OR analog systems to digitals.

“We wanted to focus strictly on the medical side,” Paul White, founder and president of CompView Medical, said in explaining the rationale for the spin-off. He said the company’s intent is to create systems that allow everyone in the operating suite to know what is going on in the surgical procedure, by manipulating digital archived pictures and putting them in view of the surgical team. Its systems also can be voice-activated.

The DOCS system features a digital capture and display system; integrated audio and videoconferencing system; dual X-ray and video display; centralized room control for lights, sound, paging, audio conferencing, and display control; videoconferencing for distance learning or consultation in telemedicine; PALS system monitor for viewing of MRIs, CAT scans or X-rays; and a nurse control station.

The overall goal of the system is to create a system that improves workflow efficiency and overall patient care, in addition to cost savings for the equipment. DOCS connects to a centralized hub so that it then can be accessed for patient education, healthcare provider notifications or referring physician inquiries.

An important feature of the company’s system is the NuBoom, use of a pedestal mounting as an alternative to ceiling-mounted audio-visual equipment. White said NuBoom can be installed in five days or less and at half the cost of the traditional alternatives. It allows for retrofitting into a range of OR settings.

He reports that CompView Medical spent two years developing the DOCS system and NuBoom systems.

The company says that DOCS and NuBoom systems provide “surgeons nurses and staff with optimum equipment control and communications capabilities.”

“We believe doctors [and] OR nurses will prefer this,” White said, in a succinct statement of the company’s primary selling point.

While the transition to digital operating rooms has been taking place for awhile now, White said there is an increasing demand for it, “especially as minimally invasive surgery becomes more pervasive in the marketplace.”

Besides providing faster installation than the 30 days required by other systems, DOCS and NuBoom provide clear cost efficiencies, according to White: $250,000 to $350,000 vs. competitors’ costs of $325,000 to $475,000.

CompView now has its own sales channels, with a direct sales force on the West Coast, with plans to launch another sales force east of the Rockies, White said.

White said plans are to have DOCS and NuBoom installations in several strategic locations by March 2006. These key cities will include New York, Miami, Dallas and Los Angeles.

Also at ACS:

• Privately held SuturTek (North Chelmsford, Massachusetts), specializing in safe-suturing devices, reported commercial launch of the SuturTek 360^° Fascia Closure Device, calling it “the only suturing device that protects against suture needlestick injuries. The 360^° Fascia Closure Device has been FDA-cleared with the safety claim that it “is designed to aid in the prevention of suture needlestick injuries.”

According to ACS, the most common cause of suture needlestick injury is fascia closure (closure of the underlying layer below the skin that must be closed at the conclusion of most major surgical procedures), accounting for 59% of sharps injuries in the OR. About 5 million fascia closures are performed each year in the U.S. alone.

The SuturTek device is designed to protect clinicians from suture needlestick injuries during fascia closure by ensuring that the sharp point of the suture needle is never exposed – via containment in a sterile, disposable suture cartridge.

“The critical importance of our 360^° Fascia Closure Device, that protects surgeons, nurses and OR staff against suture needlesticks, is underscored by a recent study from Johns Hopkins [Baltimore] reporting that almost 40% of urban surgery patients are infected with deadly diseases such as hepatitis or HIV/AIDS,” said Gerald Brecher, president and CEO of SuturTek. “Surgeons tell us that our device is not only safe, but it’s also fast, easy to use and delivers high-quality clinical results.”

The SuturTek 360^° Fascia Closure Device is a reusable system using disposable suture cart-ridges. The cartridges use standard taper-point fascia closure needles and all types of standard absorbable or non-absorbable sutures. The company said that SuturTek 360^° has been used in various surgical procedures in the U.S. and Europe, including many types of major abdominal surgeries, Caesarian deliveries, abdominal hysterectomies, hip and knee replacements and spinal surgery.