Quite possibly, not since President Lyndon Johnson showed off his scar to a roomful of captive reporters in the late 1960s had gallbladder surgery commanded so much attention.
In early February, a bevy of nurses, surgeons, photographers, reporters and sales representatives from Intuitive Surgical, Mountain View, Calif., crowded into one of 14 operating rooms at 445-bed Robert Wood Johnson University Hospital in New Brunswick, N.J. Their attention was focused not so much on the 31-year-old mother of six who was having her gallbladder removed, but on the large robot swathed in plastic as if making a gaudy fashion statement. Hanging over the linen-draped patient, the da Vinci Surgical System was ready to go to work. The device had embarked on its first procedure at Robert Wood Johnson earlier that morning, also a gallbladder surgery.
With the audience gathered and the patient prepped, the starring surgeon, Andrew Boyarsky, associate professor of surgery at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, stepped into the room. He offered a handshake--without gloves--to the visitors before proceeding to cut into the patient.
There was no need to scrub. Da Vinci took care of that. The sterile plastic sheath serves that clinical purpose.
"After being a surgeon for 20 years, operating on someone without my hands on them is really a strange phenomenon," Boyarsky said. He was speaking from a console in the corner of the operating room where he was comfortably seated as he peered into a video screen offering a magnified, three-dimensional image.
Things got even stranger for the next hour or so. Working two hand levers and five foot pedals, Boyarsky sectioned, dissected and cauterized his patient's gallbladder area from 20 feet away. The video image was so good, he said, that he instinctively flinched when he commanded the device to deliver a squirt of water to flush the surgical site. The procedure was a success, and the patient went home to her family the next day.
At least with this first generation of surgical robots, there's no need to worry that surgeons will find themselves plaintively begging their digital workhorses to "open the pod door." For all its bells and whistles, da Vinci simply represents the next evolution in laparoscopic, minimally invasive surgery, Boyarsky says. Surgeons are still in control.
"It's not a robot, it's a tele-manipulator," says Eugene Grossi, M.D., referring specifically to da Vinci's head-to-head competitor, Zeus, developed by Computer Motion, Santa Barbara, Calif. "It's more like a master-slave relationship," says Grossi, who is director of the cardiac surgical research laboratory at 879-bed NYU Medical Center in New York.
What about the cost?
Regardless of who is in charge, robotic surgery in recent months has captured the imagination of headline writers and the attention of hospital administrators searching for ways to get a leg up in a crowded market. But for all the excitement and the expectation that robotics would finally make its way into the operating room after years of success on factory floors, no one can really say whether these high-priced surgical assistants make a good business case for themselves.
"That's the big trick: trying to find a cost benefit," says Charlie Whelan, a medical-device industry analyst for Frost & Sullivan, a San Jose, Calif.-based market consulting firm. "Technology outpaces the business aspect across the board in many aspects of medical devices. There are things that will blow your mind over how efficacious and how technologically good they are, but if they don't save money or make money, they probably won't be adopted no matter how interesting they might be."
Whelan cites three-dimensional ultrasound as an example of an eye-popping technology that has failed to take off largely because it is generally an out-of-pocket expense for patients.
As Boyarsky and other surgeons become proficient in the technology, da Vinci probably won't be wasted on gallbladder surgery, which has reached near-perfection without the help of robotics, Boyarsky says. Surgeons like him are banking that robotic instruments will give them a peek into places that they cannot see with the naked eye and help them perform highly complex procedures with tremor-free, exacting hands. Also, it just feels better to sit at an ergonomically correct console than to hunch over a patient, some say.
Cost benefits are likely to materialize in faster patient recovery and, consequently, reduced average lengths of stay, saving money for hospitals, proponents believe.
That remains to be seen.
Surgical help or hype?
"I think (surgical robotics) has been vastly overplayed and overmarketed from both the hospitals' and the companies' perspective," says Aubrey Galloway, M.D., director of cardiac surgical research at NYU Medical Center. "It's a very, very early experimental tool in a strategy."
Galloway, who heads the NYU research team investigating the role robotics could play in minimally invasive heart surgery, says the technology at this point compares to walking across a street on stilts: You can do it, but using your own two feet is still the better way to go, he says.
Nevertheless, the untested benefit of robotic surgery doesn't seem to have dampened sales or interest. As of December 2000, Intuitive Surgical had installed 40 da Vinci systems worldwide--19 of them in the U.S. The devices list for a cool $1 million. The company won Food and Drug Administration approval for noncardiac chest surgeries just last month and before that, for laparoscopic surgery in July 2000. This year, Intuitive is expected to sell 55 more of the da Vinci devices, and about another 100 by the end of 2002, with the company becoming profitable in the summer of 2002, predicts Roseanne Ott, a research analyst at New York-based Lehman Brothers. The firm assisted Intuitive when it went public in June 2000.
Meanwhile, Computer Motion has taken more of a modular approach, developing one-armed, two-armed and three-armed versions of its robotic product Zeus, which costs from $100,000 to $800,000. The company reports that it has sold 600 robotic systems in 24 countries, says Robert Duggan, chairman and chief executive officer. Although only the one-armed Zeus has been FDA-approved for all types of procedures in this country, Duggan says that to date more than 150,000 procedures--everything from urological surgery to heart bypass--have been performed worldwide using all of Computer Motion's robotic devices. The company has promised its shareholders that it will turn a profit by the fourth quarter of this year.
Earlier this month, surgeons at the University of Pittsburgh using the Zeus III performed beating-heart coronary bypass surgery--a procedure that doesn't require a heart-lung machine--as part of a multicenter trial. This summer, Duggan says, a surgeon sitting at a console in New York will operate on a patient lying on an operating table in France using Computer Motion's technology.
"It's like a Lindbergh project for surgery," Duggan says.
Meanwhile, the two companies have been facing off in a patent infringement dispute since 1999, which Ott calls "the cost of doing business in the medical technology world." Each company claims it held key patents before the other did. Duggan believes his company will prevail, but it will "ultimately work out in a cross-licensing opportunity with Intuitive," he says. "That's ultimately how these things get resolved."
Officials at Intuitive Surgical say they agree that such disputes are almost inevitable in their industry and this one will eventually get resolved, although they don't agree with Computer Motion on much. "Unfortunately, litigation seems to be a way of life, and it usually comes to an end by both parties agreeing to end it and stop paying their lawyers," says Ben Gong, Intuitive's treasurer and corporate controller.
The robotic age
Despite the trials and tribulations entangled in developing a new technology, Duggan believes the surgical robotics market is here to stay.
"The market is not going to turn back to straight surgical tools and instruments," he says. "It would be like going back from word processors to pencils and paper."
Robert Wood Johnson officials say they purchased da Vinci early this year strictly for the technology, not the promise of big profits. Boyarsky says he believes that a few years down the line the robot will "enhance my ability to fix things" with the help of pristine sutures in hard-to-reach places.
He also confesses that he played virtually no role in the system's arrival in the Robert Wood Johnson operating room. Last October, he was directed to go check out the system at the American College of Surgeons meeting in Chicago, he says. The next thing he knew, the hospital administration had decided to buy it. He subsequently spent two days training at 556-bed Hackensack (N.J.) University Medical Center, operating on pigs.
Hackensack purchased two da Vincis late last year, one for the operating room and one for training surgeons as part of Intuitive's East Coast regional training center, says Garth Ballantyne, M.D., director of minimally invasive surgery at Hackensack. Through course fees that Intuitive paid to Hackensack, the da Vinci used for training is expected to pay for itself over the next several years, Ballantyne adds. But it remains to be seen if the robot in the operating room cuts costs or generates revenue for Hackensack.
"The major economic argument is probably in cardiac surgery," Ballantyne says.
FDA approval of da Vinci as well as Zeus II and Zeus III for minimally invasive cardiac surgery is months if not years away. Cardiac surgeons testing the systems at hospitals such as NYU and 1,245-bed Beth Israel Medical Center in New York are exploring the feasibility of substituting three portholes to accommodate a camera and two robotic arms for the traditional chest-splitting incision in open-heart surgery.
In June 2000, Beth Israel sponsored its own clinical trial, using da Vinci to harvest a mammary artery from a 39-year-old male patient before performing traditional open-chest bypass surgery. The patient was discharged from the hospital in less than 24 hours. That procedure was part of the FDA's recent approval of noncardiac chest procedures.
If robotics can bring minimally invasive techniques to cardiac surgery in this and other ways--an estimated 1 million open-heart procedures are performed worldwide annually--the clinical and cost benefits could be reaped through faster patient recovery times and, subsequently, reduced lengths of stay, analysts say. Moreover, hospitals offering a procedure promising less pain and faster recovery times will naturally attract patients, they add.
Indeed, with totally endoscopic coronary bypass surgery as their Holy Grail, cardiac surgeons drove the initial sales of da Vinci, says Ott of Lehman Brothers. General surgeons began taking interest only as Intuitive began working on developing new laparoscopic procedures for which there were no parallels, such as some cancer surgeries, Ott adds. Noting that about 40 million surgical procedures are performed worldwide each year, the company says its technology could be relevant in 25% of them.
The cutting edge
Harvey Holzberg, president and CEO of Robert Wood Johnson, acknowledges there was no business strategy behind the hospital's purchase of da Vinci, meaning he didn't order a profit-loss analysis before making the decision. The $1 million investment may be risky for community hospitals, but for an academic medical center such as Robert Wood Johnson, it's the price of maintaining a reputation as a technology leader, he says.
On the other hand, NYU has taken a more conservative approach to robotics, carefully testing its potential benefits for open-heart surgery before making a large capital investment. The cardiac research program there has cobbled together a robotic system using Computer Motion's Zeus but substituting a high-definition imaging camera for the low-resolution, three-dimensional video camera that is part of Computer Motion's system. The program leases Computer Motion's equipment. Galloway, the research team chief, says Computer Motion's technology was chosen over Intuitive Surgical's simply because it is cheaper and more maneuverable than the da Vinci.
The NYU team is part of an FDA-approved clinical trial testing the device's effectiveness for mitral valve repairs or replacements. So far, seven patients have successfully undergone the procedure at NYU, which has been performing minimally invasive but nonrobotic mitral valve surgery since 1996. Galloway says he still is not convinced that the robotic device does the delicate surgery any better than the surgeons performing the more traditional minimally invasive procedure.
"I think right now it doesn't offer any advantage," Galloway says. "Maybe in four or five years, we will have something."
Galloway's colleague Grossi represents the other side of the coin. One day last month, he was in NYU's laboratory practicing his technique on a cow's heart purchased from a local butcher. Grossi argues that robotics carry great potential to make surgeons better at what they do, accomplishing technical feats unmatched by human hands. The robot also may be adept at procedures that ordinary human surgeons couldn't imagine performing, he adds. A comparable advance in the auto industry would have been the development of automatic transmissions, which enabled more people to drive, he says.
"I'm hopeful that this technology will help me to better serve my patients and do operations I can't do now," Grossi says.
Even if robotics makes good on all its promises, there are no guarantees of cost savings in total healthcare expenditures, says Michael Chernew, associate professor in the department of health management and policy in the School of Public Health at the University of Michigan, Ann Arbor. An economist, Chernew says he knows practically nothing about robotics, but he knows what drives healthcare costs. For example, in a study of laparoscopic gallbladder surgery he found some surprising results. Although the minimally invasive surgery was cheaper and produced better clinical outcomes on a per-case basis, in the long run it increased overall healthcare expenditures. Very simply, the overall number of gallbladder surgeries increased.
The availability of the minimally invasive procedure "clearly encouraged people who otherwise would not have gotten their gallbladder removed," Chernew says. "Whether they should or should not have is another question."
It's not necessarily a bad thing when the per-case cost savings is overrun by an increase in volume, Chernew adds. Generally, it's also not necessarily bad if technology drives up costs.
The key to evaluating the benefits of a new technology such as robotics, according to Chernew, is assessing whether "we select the right people and settings for it."
