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On the Cutting Edge of Robotic Surgery

With its first training program for robot-assisted surgeons, the Air Force leads DOD and VA physicians into the future of medicine.

 

 

A couple of years ago, when Air Force Maj. (Dr.) Joshua Tyler discovered a surplus in the research budget of his unit – the 81st Surgical Operations Squadron at Keesler Air Force Base, Mississippi – he asked his superiors if he could buy a robot. And not just any robot: a da Vinci Xi® surgical system, the most sophisticated of its kind, the fourth-generation version of the first and only robotic system approved by the Food and Drug Administration (FDA) for general laparoscopic surgery.

Tyler, a colorectal surgeon at Keesler Medical Center, saw an opportunity to train Air Force surgeons – and surgeons throughout the Departments of Defense (DOD) and Veterans Affairs (VA) – in robot-assisted surgery, which he thought was important for two reasons: first, the growing significance of robotic surgery in performing certain procedures. “I would argue that robotics is the standard of care for urology, especially for prostate surgery,” said Tyler. “Laparoscopic prostatectomy never really took off in the United States, or really worldwide.” He also estimated that more than 80 percent of gynecological cancer surgeries are performed today using robotic systems. “For those two specialties, it’s ubiquitous.”

Robotic surgical systems, first developed in the 1980s, are today used primarily to overcome the limitations of minimally invasive surgical techniques – which, by definition, limit the size of incisions and rely on precise placement and manipulation of an endoscope and surgical instruments. They’re also used to sharpen the capabilities of surgeons performing open procedures, such as a kidney removal or transplant.

It’s reasonable to expect that today’s surgeons have been exposed to robotics in their residencies or fellowship programs, because urology and gynecology embraced the technology early in the 21st century. It wasn’t until 2010 or later that other types of procedures, such as hernia repair or colorectal procedures, were adopted for robot assistance. This is partly due to the fact that the Xi, which allows access to multiple quadrants of the abdomen, didn’t hit the market until 2014. “General surgery has been later to the party,” Tyler said. “Most of our surgeons have not had exposure to robotics in their training programs.”

The costs and complexities of training on the da Vinci system comprised Tyler’s second reason for wanting the Air Force to have its own surgical robot. Becoming credentialed in robotic surgery begins with a computer-based orientation course, followed by a hands-on orientation, and finally surgeon-to-surgeon training in basic single-site or multi-port surgical skills. It’s a rigidly defined curriculum, and out of necessity, military and VA surgeons who’ve sought certification have traveled to training sites operated by the da Vinci’s manufacturer, Intuitive Surgical® Inc., to receive their instruction.

The federal government has invested hundreds of millions of dollars in the acquisition of surgical robots, but has been slow to establish its own training and credentialing programs. Intuitive offers its credentialing course for a $3,000 training fee, and offers to cover candidates’ travel and accommodation costs – which VA and military physicians, as federal employees, can’t accept. “So suddenly that $3,000 training becomes a $4,500 or $5,000 [cost] for a federal servant,” said Tyler, “and in the current fiscal environment, that’s not really a sustainable model.”

Within Keesler’s Clinical Research Laboratory, Tyler and his colleagues established their training facility, the Institute for Defense Robotic Surgical Education (InDoRSE), for military and VA surgeons to become credentialed operators of the da Vinci system. It’s the first, and so far only, DOD medical facility to offer training with the da Vinci Xi, the latest and most advanced system. The InDoRSE is essentially a federal satellite of Intuitive’s Atlanta training facility, saving taxpayers about $3,000 per trained surgeon. So far, at a rate of about four per month, the facility has trained 41 surgeons from 21 different facilities across the DOD and VA, from among five different surgical specialties. “And those surgeons have gone back to their home hospitals and performed more than 200 robotic cases,” said Tyler. Last spring, a Keesler team performed the Air Force’s first robotic surgery, a ventral hernia repair conducted by members of the 81st Surgical Operations Squadron.

 

Robotic Surgery: The Basics

Robotic surgical systems, first developed in the 1980s, are today used primarily to overcome the limitations of minimally invasive surgical techniques – which, by definition, limit the size of incisions and rely on precise placement and manipulation of an endoscope and surgical instruments. They’re also used to sharpen the capabilities of surgeons performing open procedures, such as a kidney removal or transplant.

da-vinci-xi-surgical-arms

The da Vinci Xi robotic surgical system demonstrates its four arms. ©2018 Intuitive Surgical

The DOD medical establishment, including the InDoRSE, now uses 24 robotic systems at 16 different facilities, all of them either third- (Si) or fourth-generation (Xi) versions of the da Vinci system. The Xi, a versatile multi-port system capable of accessing multiple abdominal quadrants, is composed of three core elements:

  • A moveable cart with four mounted overhead arms. One arm is equipped with an endoscopic camera that’s been inserted into the patient through a small opening, while others are equipped with articulated or “wristed” instruments that can bend and rotate beyond the capability of the human hand.
  • A vision system consisting of the endoscope, cameras, and a display offering a magnified, high-definition, three-dimensional view of the surgical site.
  • A surgeon console, where the primary surgeon is seated and looking at a magnified view of the surgical site while operating the robotic arms. The system translates the surgeon’s hand movements electronically into scaled-down manipulations of the instruments, and is capable of filtering out any shaking or tremors for natural, steady movements.

The da Vinci system has been approved by the FDA for use in urological surgeries, general laparoscopic procedures, non-cardiovascular thorascopic surgeries, and thorascopically assisted cardiotomy. The obvious advantage associated with the robotic system is that it can access hard-to-reach places. “Laparascopic instruments are rigid, and they give you kind of awkward linear motions,” Tyler said. In the narrow confines of the pelvis, that’s a severe limiting factor, which is why more than 90 percent of prostatectomies are now performed robotically. “It’s the same for rectal cancer surgery,” said Tyler. “There are times when I’ve got a margin of error of a couple of millimeters in a cancer operation with a big tumor, so the precision of having your wrists coupled with extra visualization is incredible.”

The ultimate measure of robotic surgery, of course, is not the surgeon’s ease of use, but outcomes for both the patient and provider. Robotic surgery is a young field, and the developing research picture is unsettled and sometimes contradictory – but misinterpretations often aren’t the fault of researchers themselves. For example, a recent retrospective Stanford University study comparing robotically assisted kidney removal surgeries to those performed by human surgeons found that the robotic procedures tended to take longer and cost more, but that there was no statistical difference in patient outcomes or length of hospital stay. The article reporting on these results, in the British daily The Telegraph, was decidedly less nuanced: “Humans still make better surgeons than robots, study shows.”

Make no mistake: Surgical robots are expensive. A single da Vinci system costs between $1.5 and $2.2 million, and its operation involves an annual service contract that’s usually in the low six figures. Many of the surgical attachments fitted to its arms are disposable, ranging in cost from $600 to $1,000 each – and a single procedure can use between three and eight separate instruments. The Stanford study calculated that robotic nephrectomies cost, on average, $2,600 more than conventional surgery.

3-D-imaging-system

A surgeon’s view through a 3-D imaging system displays articulating instrumentation during an operation using the latest state-of-the-art robotic surgical system at William Beaumont Army Medical Center (WBAMC) in El Paso, Texas, May 2, 2016. WBAMC performed the first robotic surgery in the Department of Defense using the robotic system. The surgeon-manipulated system allows surgeons to operate with articulating instruments that bend and rotate with far greater freedom than the human wrist through an incision smaller than a centimeter. Photo by Marcy Sanchez

But Tyler, a published outcomes researcher, rejects the idea that robotic procedures take longer and cost more – and he’s not alone in his thinking. Studies making those assertions, he said, tend to rely on limited data and variables, such as a single procedure or time frame. The time it takes to perform a given procedure can vary widely based on the institution and where the surgeon is in his or her learning curve.

When weighing the benefits of robotic surgery, Tyler said, it’s important to look at the individual procedure. Kidney removal, studied by the Stanford team, isn’t a particularly tricky operation for a qualified surgeon, and therefore probably not the most appropriate application for robotics. “If we talk about hernia surgery, I think the benefit is less pain than laparoscopy,” said Tyler. “For colon procedures, the benefits are smaller incisions, quicker recovery, and quicker discharge. And we all know those are benefits, but we rarely put a dollar amount on them. A single hospital day costs about $1,500. So, if you can save one single event of surgical site infection, it’s a savings of about $21,000.”

Studies comparing the costs of robot-assisted and laparoscopic or open procedures often focus on operating room costs, and don’t factor costs over the continuum of the patient’s surgical stay. Tyler’s records of his own surgeries over the past few years, more than 200 open, laparoscopic, and robotic cases, reveal that his robotic procedures are associated with lower rates of surgical site infection and shorter hospital stays. Dr. Amir Bastawrous, a Seattle colorectal surgeon, has published data suggesting robotic surgery is actually faster and more cost-effective when the costs of the center’s overall care, and not just the operating room costs, are captured by the study.

Over the longer term, significant differences in outcomes are more difficult to determine. A study of robotic and open prostate cancer surgeries, published in the journal The Lancet in the summer of 2016, found that patients who underwent the robotic procedure generally spend less time in the hospital – but there was no difference in urinary or sexual function among patients in a three-month follow-up. The key question – whether there’s a difference in cancer recurrence – may soon be answered in a two-year follow-up, but at least one comparison of open and robot-assisted prostatectomy, an investigation reported in European Urology in 2014, has suggested that the microscopic precision of robot-assisted cancer surgery may produce better longer-term outcomes. “Robot-assisted surgeries,” the authors wrote, “have fewer instances of cancer cells at the edge of their surgical specimen,” reducing the likelihood that those patients would need additional treatments.

 

Beyond the Hospital

It may be that the wariness of robotic surgery’s critics is in part due to the fact that there isn’t yet an FDA-approved competitor for the da Vinci system – it’s hard for some experts to view a proprietary monopoly as cost-effective. Tyler admits that Keesler’s acquisition of its da Vinci systems was a combination of luck and grassroots advocacy. “This certainly wasn’t a top-down program, where the Surgeon General determined that we develop the program,” he said. “That would have been a lot more costly.”

DARPA sponsored another investigation into medical battlefield robotics in 2005, an unmanned “trauma pod” designed to perform full scalpel-and-stitch surgeries on wounded service members in forward locations, but the project wasn’t completed, and many challenges remain for such an application.

Up-front costs and limited mobility are the chief barriers to expanding the horizons of robot-assisted surgery within the military medical system. Interestingly, the da Vinci was born from a joint DARPA/NASA project in the 1980s, an effort to develop a “telesurgical” robot capable of performing surgery remotely on the battlefield or in other remote environments. One of the chief stumbling blocks for this application was latency – the delay between the surgeon’s actions and the robot’s responses – but information technology has since largely bridged this gap. In the famous “Lindbergh Operation” of 2001, a team of surgeons in New York, using high-speed telecommunications, performed a successful cholecystectomy on a patient in Strasbourg, France, with the use of a ZEUSTM surgical robot.

DARPA sponsored another investigation into medical battlefield robotics in 2005, an unmanned “trauma pod” designed to perform full scalpel-and-stitch surgeries on wounded service members in forward locations, but the project wasn’t completed, and many challenges remain for such an application.

It was the Army that initially sponsored, in 2002, the investigation of a less-expensive open-source surgical robot, now known as RAVEN, aimed at providing a more practical alternative to an expensive proprietary system. Based on freely available hardware designs and software, a more fully evolved RAVEN, or an open-source system like it, may someday result in a smaller, cheaper, more durable surgical robot that can be used in more extreme environments.

In the meantime, the military’s surgical robots are on the move – not at forward locations, but at least far beyond the continental confines of the DOD’s medical establishment. According to Tyler, there are plans to introduce da Vinci systems in military medical facilities in Baghdad, Iraq, and Kandahar, Afghanistan. In March 2018, the USNS Mercy, the world’s largest floating hospital, departed Pearl Harbor for its 13th annual Pacific Partnership voyage with a da Vinci robot on board. The days of the trauma pod may be far off – but maybe not as far as we think. “In my opinion, there’s very little role for robotics in the damage-control/trauma setting, where a recently injured patient is in danger of bleeding to death,” Tyler said. “But once those patients are stabilized and resuscitated and back to an appropriate level of care … there are reconstructive options that may be better served with robotics. There’s a lot we don’t know yet, but I think getting robots to some of these facilities is a step in the right direction for us to start answering that question.”

This article was first published in the Veterans Affairs & Military Medicine Outlook Spring 2018 edition publication.

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Craig Collins is a veteran freelance writer and a regular Faircount Media Group contributor who...


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