Central DuPage Hospital in suburban Chicago recruited Barbara Buttin, M.D., a gynecologic oncologist, earlier this year. What made her a catch worth having is her robotic surgery skills. CDH plans to develop a center of excellence for gynecologic oncology, and included in that vision is the ability to offer procedures on its da Vinci surgical robot.

"Lots of women were traveling two or three hours to see the doctors downtown [in Chicago] to have minimally invasive surgery because it isn't frequently offered out in the suburbs," Buttin says. Now those women can get the same procedures at CDH, and the 313-bed hospital could capture more business.

But traditional minimally invasive approaches to gynecological cancers already exist. Compared with regular laparoscopy, robot-assisted laparoscopy typically costs the hospital more per case and consumes more operating room time.

So, many hospitals are asking: Is there a justification for da Vinci-assisted laparoscopy over straight laparoscopy?

For Buttin, the answer is yes, and the biggest reason is that it makes minimally invasive surgery an option for more women. For example, regular laparoscopic hysterectomy is too complicated for many surgeons to perform for certain patients, including obese uterine cancer patients. The da Vinci gives these patients a minimally invasive alternative to open surgery.

Hospitals consider many factors in deciding whether to offer robotic surgery — patient benefit, hospital competition and hospital costs. The trend toward robotic surgery also brings up such issues as overall health care spending, the comparative effectiveness of treatment options and the pace of technology adoption.

A debate over value

Intuitive Surgical Inc. in Sunnyvale, Calif., introduced the da Vinci Surgical System in 1999. A year later, it became the first robotic surgical system cleared by the Food and Drug Administration for general laparoscopic surgery. It is the only surgical robot on the market and has been installed in more than 1,200 U.S. hospitals.

Da Vinci use took off quickly in urologic oncology because regular laparoscopic radical prostatectomy was too technically difficult for many surgeons. The robot offers an alternative to open prostatectomy. Now it's used in many surgical realms, including general surgery, thoracics, colorectal cancer, bariatrics, cardiology, gynecology, pediatrics and otolaryngology.

As with regular laparoscopy, robot-assisted laparoscopy generally offers patients many benefits when compared with open surgery — lower risk of infection because there is no large incision, shorter lengths of stay, less pain and a quicker recovery. It's cosmetically appealing because it leaves no large scar.

However, the physician community is conflicted about whether outcomes are better with the robot, particularly when it's compared with traditional laparoscopy, and whether the machines are worth the added cost. "There is a reasonable amount of debate about whether there are really well-established benefits to robotic versus the regular laparoscopic approach," says Christopher Brandt, M.D., chair of the department of surgery at MetroHealth System, Cleveland.

More than 4,600 peer-reviewed clinical papers have been published involving the da Vinci System, notes Intuitive Surgical spokesman Christopher Simmonds. What's lacking, many experts say, are well-constructed studies comparing the effectiveness and cost of robotic surgery with open surgery and regular laparoscopy.

"The robot has been rapidly applied into clinical practice, really with a minimal amount of data looking at its effectiveness," says Jason D. Wright, M.D., assistant professor of women's health at Columbia University College of Physicians and Surgeons. "This is an expensive, new and unproven technology, so it is an ideal situation for doing comparative effectiveness studies."

Wright is lead author of a research paper that calls into question the comparative effectiveness of robotic versus regular laparoscopic hysterectomy for endometrial cancer patients. "When robotics is compared with open surgery, there are certainly going to be benefits," he says. "But when you start comparing robotic surgery with laparoscopy, then finding a benefit is increasingly difficult."

More research likely will be done, but it is unclear whether it will have a big influence because the robots already are widely used. "The question ultimately is: Will this just be part of the routine armamentarium?" Brandt says.

The horse and the cart

Many physicians say the da Vinci was accepted rapidly into practice because Intuitive did a great job marketing the robot to doctors and patients. "People believe through marketing that it's faster, easier, better," says Geri Amori, vice president of the Risk Management & Patient Safety Institute. "And the doctors put pressure on the hospitals to buy them."

Now patients are demanding it, says John C. Evanko, M.D., division chief for gynecology and OR director at Columbia University Medical Center. "There are a lot of patients who come to your office and say, 'I want to have my surgery robotically,' even if they're not a candidate for it."

While some physicians criticize the da Vinci's rapid expansion into practice, others argue that putting the new technology "cart" before the comparative effectiveness research "horse" sometimes is the only way technology advances.

Technology companies drive innovation by developing products they think are good ideas and will sell, says Marc Bessler, director of minimally invasive surgery at New York–Presbyterian Hospital/Columbia University Medical Center. "Who is going to develop the technology unless they can sell it, and how can you prove the technology is better until you have it developed? When you have something that is logically and intuitively better, then it has to come before the proof. Ultimately the proof either comes or the technology gets abandoned."

The idea that da Vinci-assisted laparoscopy is more intuitive than traditional laparoscopy is what sold many doctors and hospitals on the technology. The da Vinci eliminates the counterintuitive motion of traditional laparoscopy, in which the surgical tool endpoints move in the opposite direction of the surgeon's hands. The robotic instruments are more flexible because they have "wrists," and the da Vinci offers a three-dimensional view, as opposed to regular laparoscopy's two-dimensional view. The robot gives the surgeon "the same view as you would have in open surgery, except even more detailed," Buttin says. "You can zoom in so much more. You can visualize every little blood vessel, every little nerve."

The robot appeals to physicians who don't like traditional laparoscopy because of its technical difficulty. Buttin says that in her field of gynecology, about 70 percent of hysterectomies are being done open. "So there is a lot of improvement to be achieved by recruiting some of those surgeons who just don't like laparoscopy for its quirks and special skill set, but who could embrace robotic surgery with their current skill set."

The technology doesn't offer as much to surgeons who already are skilled at traditional laparoscopy, Evanko says. "What it's done is made mediocre laparoscopists into great laparoscopists, but it hasn't made the great laparoscopist into an exceptional one." But some skilled laparoscopy surgeons use the da Vinci anyway because it makes them more marketable to patients and because operating while sitting at the robot's console is more comfortable than standing over a patient for hours.

Assessing ROI

Although little comparative effectiveness data is out there, the da Vinci gets positive reviews from many hospitals using it.

Conversations with patients convinced Mark Robinson, chief operating officer of Trident Medical Center in Charleston, S.C., that the surgical robot offers better outcomes than open surgery and regular laparoscopy. Patients leave the hospital sooner and in less pain and are able to get back to work more quickly, he says.

The 296-bed hospital bought its first da Vinci for $1.8 million at the end of 2008. Now, the hospital has two robots, and Trident Health plans to buy a third, for the system's 94-bed Summerville (S.C.) Medical Center. Trident Medical Center physicians performed robotic surgery on 662 patients last year, and volume likely will reach 750 patients this year, Robinson says.

Da Vinci procedures cost the hospital more per case, but reimbursements still exceed costs, Robinson says. Although the hospital was last in its market to buy a robot, it quickly became a leader, performing twice as many robotic surgeries as other area hospitals and boasting the second-highest volume in the state, he says.

Robinson attributes success to the medical center's approach to robotics. Its South Carolina Institute for Robotic Surgery has a clinical coordinator for robotic surgery, treats robotics as a subsection of the surgery department, and features multispecialty collaboration among the surgeons using the da Vinci.

Capturing market share can be the biggest advantage of investing in the robot, several physicians say. "Some hospitals, if they can market this and can be first in their area to do it, they can make their money back in a couple of years because, one, they're getting the patients, and, two, they're getting recognition for being cutting edge," Bessler says.

The investment is a big one. The robot alone costs $1 million to $2 million, the maintenance contract runs around $150,000 annually, and the surgical equipment is more expensive per case. So once the initial investment is made, it makes sense to spread it over several service lines.

"You've got to take a $1.8 million investment and embrace it; otherwise, at the end of the day, it will sit in the corner of one of your operating rooms," Robinson says. Trident launched its da Vinci program in urology, but now the general gynecology, gynecologic oncology, general surgery and thoracic surgery service lines offer robotic surgery. This year, the hospital plans to add cardiac surgery to the list.

In some markets, it's becoming difficult to maintain a service line without owning a da Vinci because patients demand it. "If you don't have a robot and you were doing 100 open prostates last year, I guarantee you in a few years, you're doing very few prostates," Bessler says. "The guys who do open prostatectomies are doing a lot fewer, and they're picking up robotics or they're going out of business."

In addition, many new doctors don't want to go to a hospital without a robot. Cleveland's MetroHealth is considering buying a robot for these reasons, Brandt says. "The argument for it for us is, if you want those service lines and you want to recruit somebody to do it, you have to have a robot." This is particularly the case with urologic and gynecologic oncology, he says.

Learning curve

Training and credentialing for surgeons and OR staff are important aspects of a robotic surgery program, Amori says.

Intuitive offers product training. Clinical training is conducted on a peer-to-peer basis. A surgeon's first robotic operations typically are proctored by a more experienced surgeon. The hospital or surgeon purchases the proctoring service as part of training they have independently determined to be a credentialing requirement. Intuitive merely coordinates among the hospital, surgeon and proctor.

Hospitals determine their own credentialing criteria. Some surgeons are able to conduct robotic surgery on their own after a handful of cases overseen by a proctor. Intuitive recommends hospitals establish a da Vinci surgery steering committee to coordinate departments, oversee cases, establish guidelines for credentialing and proctoring, and analyze and report on operative and clinical outcomes data.

Injuries that have occurred during robotic surgery are the subject of at least two lawsuits, one of which resulted in a $7.5 million jury verdict against a Chicago doctor in February 2012.

Physicians say there is a learning curve with robotic surgery, just as there is with regular laparoscopy. Studies estimate the learning curve for regular laparoscopic and robotic radical prostatectomy at 150 or more cases, notes a 2009 Journal of the American Medical Association article.

The learning curve for a surgeon to become comfortable with robotic hysterectomy is about 20, Buttin says. "Cases start out taking a lot of time for a new surgeon, but then there is an exponential improvement," she says.

The more cases physicians do, the better they perform, research shows. One concern: Some surgeons might not handle enough cases annually to maintain their skills, Amori says.

Part of a surgeon's and OR staff's training must be to know what to do if the robot has a problem or the patient's condition suddenly crashes. The FDA's Manufacturer and User Facility Device Experience reports show hundreds of instances of equipment problems with the da Vinci. Most are minor, and the surgery continues; however, some require the physician to convert to open surgery.

The OR team must "practice moving that machine away from a patient and pretending you have to go to open surgery," Amori says. "Be sure your physicians are equally competent in both robotic and traditional forms of the surgery."

Some fear a generation of da Vinci-trained doctors will lack strong regular laparoscopy or open surgery skills. If the robot failed completely, most surgeons could convert to open surgery and complete the operation, Bessler says. "The really good robotic surgeon who's never trained with open surgery may be in trouble, may have to call in a partner to bail them out."

If enough new physicians prefer robotic laparoscopic surgery and have less training in regular laparoscopy and open surgery, demand for robots will grow. Many physicians hope a competitor will invent a system to compete with the da Vinci. "Then hospitals will have choices, and that will drive costs down," Evanko says.

Robotic surgery is still so new, there's no telling how far it will go. "Maybe the robot will fade away and it will never have gotten good enough," Evanko says. "But I predict it's going to get better and better, and eventually it's going to be the way it's done."

Geri Aston is a contributing editor to H&HN.

 

 

The belly button option

Another trend that's emerging in minimally invasive surgery is single-incision laparoscopy. Instead of making multiple incisions through which to insert instruments, the surgeon makes one incision through which several instruments are inserted. The advantage is primarily cosmetic because the incision typically is through the belly button.

So far, outcomes data comparing single incision with regular laparoscopy are lagging, says John C. Evanko, M.D., division chief for gynecology and OR director at Columbia University Medical Center. The single-site approach requires more technical skill on the surgeon's part. The instrumentation is slightly more expensive than that for regular laparoscopy. Patient recovery times seem similar.

Single-site laparoscopy has been used for procedures including ovary and ovarian cyst removal, hysterectomy, gallbladder removal, colon surgery, appendectomy and kidney surgery.

The idea of virtually scarless surgery no doubt will appeal to patients. "It might be a nice marketing thing for a hospital to say, 'scarless operations are really here now,'" says Marc Bessler, director of minimally invasive surgery at New York–Presbyterian Hospital/Columbia University Medical Center. "We hide the scar in your belly button, and you can have your operation and be out the same day."

Intuitive Surgical Inc. is getting into the single-site laparoscopy field. In December, the Food and Drug Administration gave it clearance to market single-site instrumentation for gallbladder removal. The instruments work with the da Vinci Si Surgical System. The company plans to broaden its single-site offerings in the future.

 

 

War of the robots is brewing

The future might hold competition for Intuitive Surgical Inc.'s da Vinci robot. At least one company is developing commercial surgical robots, and a two-university collaboration has disseminated its robotic system to research labs at other academic institutions to foster innovation in the field.

Titan Medical Inc., a Canadian company, is developing two products. The Amadeus Composer is a surgical system with an external robot and flexible instruments designed for procedures in small or medium surgical spaces. The Amadeus Maestro is a four-armed system designed for procedures in large surgical spaces.

The global surgical robot market is about $1 billion and could grow to $5 billion by 2015, with potential for placement of 6,000 robotic systems, according to Titan. So far, Intuitive has installed more than 1,840 da Vinci systems worldwide.

Titan plans to enter the market initially by targeting general, thoracic and ENT surgeries, with additional applications in urology and gynecology, company documents state.

The company has signed nonbinding memos of understanding with three U.S. medical institutions, as well as institutions in Switzerland and India, under which the facilities will test the Amadeus surgical technologies and provide feedback. Titan aims to have its Amadeus Composer ready for tissue and animal feasibility studies this year, initiate human clinical trials in 2013, and apply for Food and Drug Administration clearance in 2014.

Meanwhile, University of Washington and University of California–Santa Cruz researchers have created the Raven II surgical robot. The device has two arms with mechanical wrists, a camera for viewing the operational field, and a surgeon-interface system for remote operation.

The team recently shipped five of its seven robots to medical research labs on an open-source basis so researchers can share developments and innovations to advance surgical robotics. "Each lab will start with an identical, fully operational system, but they can change the hardware and software … while retaining intellectual property rights for their own innovations," says Jacob Rosen, director of the UCSC Bionics Lab.

The Raven II is much smaller than the da Vinci, about 101 pounds vs. a half-ton, so it would be easier to set up and will take up less operating room space, says Blake Hannaford, director of the UW Biorobotics Laboratory. At about $250,000, the Raven is a fraction of the da Vinci price. Hannaford and Rosen are working with UW's Center for Commercialization, or C4C, to evaluate the feasibility of spinning Raven II into a start-up company. Expensive engineering work would be required to make the robot safe enough for FDA approval, so that step is far off, Hannaford says.

 

 

EXECUTIVE CORNER

Hospitals considering investing in a surgical robot must consider several factors including:

Cost

Do you have the funds? The da Vinci costs roughly between $1 million and $2 million. The yearly maintenance contract runs about $150,000, and its surgical tools are more expensive than their traditional counterparts.

Marketplace

Is your hospital losing market share in a particular service line to a competitor that owns a robot? Are you moving into a new service line in which robotic surgery is popular? Could you capture market share by being the first in your area to purchase a robot? In these cases, the investment might be worth the cost.

Service lines

Which service lines could benefit by having a robot? Will you have enough patient volume to warrant the investment and keep your physicians' skills up to speed?

Physician training and credentialing

What training and credentialing criteria will be established to ensure that surgeons using the robot are qualified? What maintenance of privileges standards will be used?