robot

Even before laparoscopic surgery took off around 1990, several companies, backed by U.S. defense grants, were at work on robotic surgical systems.

Laparoscopic surgery has proven to be a significant medical advance, turning major surgeries that kept patients in the hospital for several days and left big scars behind into fairly minor procedures. As robotic surgical systems moved through research and testing, many doctors hoped the new technology would double down on those advances.

The companies building surgical robots were certainly optimistic. In product names like Zeus, Aesop, and da Vinci, one can hear great humanitarian aspirations.

Zeus and Aesop were slain by da Vinci, whose Silicon Valley manufacturer, Intuitive Surgical, bought the company that made them and scrapped the projects. But many of those hopes still hang on da Vinci, which was first approved for clinical use by the Food and Drug Administration in 2000.

The da Vinci surgical system continues to be the shiny new toy that hospitals and private surgical practices boast about on billboards and websites. The system doesn’t resemble a robot so much as a video game: The surgeon sits comfortably behind a screen and looks at a magnified view of the surgical site while operating the machine’s robotic arms.

The robotic arms can ostensibly get into hard-to-reach places, promising patients less bleeding, faster recovery, less chance of damage to important nerves, and smaller scars than traditional surgeries.

Da Vinci’s price tag partly explains why buyers might want to brag: A single robot costs about $2 million. Some of the attachments that go on the arms are disposable, and their sole manufacturer is Intuitive. Robotic surgery generally costs as much as $3,500 more than a comparable laparoscopic operation.

So is this the brave new world of medicine or an expensive boondoggle?

‘A Solution in Search of a Problem’

One thing is certain: The da Vinci hasn’t improved patient outcomes as dramatically as the first wave of minimally invasive surgery did. A decade into its use, the laparoscope had proven that patients fared better with its smaller incisions than they did with “open” surgeries, or those that require a large incision.

“As laparoscopic surgery has continued to succeed, I don’t think there’s a person on the planet who would have an open operation. And that’s only over 20 years or so, so that’s a rapid shift,” said Dr. Jay Redan, the president of the Board of Trustees of the Society of Laparoendoscopic Surgeons and a charter member of the Society of Robotic Surgery.

Fifteen years into use of the da Vinci system, evidence that it trumps other methods is lacking.

The ECRI Institute, a nonprofit organization that synthesizes data on medical procedures, drugs, and devices to support hospitals and doctors in creating quality protocols, has analyzed more than 4,000 studies on robotic surgery.

“The evidence isn’t strong enough to determine whether or not a robot is better than traditional minimally invasive surgery, but the evidence does indicate that it’s better compared to open surgery — more evidence from higher quality studies may change this conclusion,” said Chris Schabowsky, Ph.D., a program manager at ECRI.

To justify its price — roughly ten times that of a high-end laparoscope — da Vinci would need to do a lot better overall.

“This is a technology that is costing the healthcare system hundreds of millions of dollars and has been marketed as a miracle — and it’s not,” said Dr. John Santa, medical director at Consumer Reports Health. “It’s a fancier way of doing what we’ve always been able to do.”

This is a technology that is costing the healthcare system hundreds of millions of dollars and has been marketed as a miracle — and it’s not.
Dr. John Santa, Consumer Reports Health

Da Vinci was originally designed to do cardiovascular surgery, but it’s fallen out of favor for heart surgeries. Next it was picked up for gynecological surgeries. In 2013, the American College of Obstetricians and Gynecologists said it wasn’t the best or even the second-best option for non-cancerous gynecological surgeries. Some critics called the da Vinci a “solution in search of a problem.”

Da Vinci finally hit its groove in urology. Prostate removals were difficult to do laparoscopically, and many surgeons continued to use open incisions. The da Vinci made it easier to do minimally invasive prostatectomies. Nearly 90 percent of these surgeries are now done robotically.

Patients lose less blood, but in the measurements that count most — how likely they are to be impotent or incontinent after surgery — the robot is no better than open surgery.

There are horror stories about robotic surgeries gone awry found in the pages of thousands of lawsuits. But experts interviewed by Healthline lay the blame for these negative outcomes at the surgeons’ feet, not at the robot’s. Whenever a new technique enters the operating room, some doctors make mistakes with it. They are, after all, only human.

“When [laparoscopic surgery] was introduced, there was a spike in patient complications. That was because, in general, the surgical field was getting trained; there were errors, there were mistakes. Now fast-forward, this is just kind of par for course when it comes to introducing a disruptor. You’re going to run into these issues,” said the ECRI Institute’s Schabowsky.

The key is for patients to minimize their chances of being one of the mistakes by ensuring their surgeons have ample experience with any device they plan to use in the OR. That information can be hard to get, the experts agreed — only cardiac surgeons currently make such records available to the public.

But consumers aren’t doing their part, either.

Dude, Where’s My Robot?

American consumers want the newest, shiniest thing in the operating room as much as they do in the living room.

“Americans tend to think that the latest and greatest technology has got to be better, and it’s not in this case,” said Santa, of Consumer Reports Health.

Intuitive has greased the wheels by undertaking direct-to-consumer marketing for its robots. As a result, patients often demand robotic surgery, doctors said. (Intuitive declined Healthline’s requests for an interview.)

“I can’t tell you how many patients come in who say, ‘I want robotic surgery with a laser’ — and they’ll find somebody to do that,” said Dr. Eric Genden an ear, nose, and throat surgeon at the Mount Sinai Hospital in New York. “This is a beautiful illustration of how American medicine and the patients tend to become enamored of technology without ever really asking the question, ‘What are we getting for the technology?’”

Redan agreed.

“Patients will go to someone who has the robot because it’s been marketed so much,” he said.

Hospitals advertise their da Vinci machines in part as a response to perceived consumer demand. They see the robots as a way to bring more patients through their glass doors rather than their competitors’, studies have shown. But hospital advertisements also help drive the perception that robots make the best surgeons.

One study of how hospitals talk about robotic surgery found that many copied directly from Intuitive’s marketing materials. Only a minority pointed to potential risks. Unlike doctors and drug companies, hospitals aren’t required to disclose risks in their advertising.

Marketing has played such a big part in drumming up demand for da Vinci machines that one surgeon who has developed a substantial online following under the pen name Skeptical Scalpel concluded in a blog post on robotic surgery that, “The decline of medicine as a profession began when it became legal for doctors and hospitals to advertise.”

Dr. Fabrizio Michelassi, the chair of the department of surgery at Weill Cornell Medical Center in New York and chair of the board of governors of the American College of Surgeons, said surgeons are obligated to educate their patients on what the evidence says are the pros and cons of robotic surgery.

“Unless we inform the patient population on this, there will be a drive from the consumer that trumps everything else, because at that point hospitals and physicians are caught in a difficult dilemma,” Michelassi said. “Hospitals and physicians are caught in the dilemma to either continue to deliver optimal care or to respond to market requests.”

Balance Is Due

The irony is that hospitals lose money on robotic surgeries because insurance companies reimburse all minimally invasive surgeries, whether laparoscopic or robotic, at the same rates.

Dr. Richard Newman, a pancreatic and endocrine surgeon at Saint Francis Medical Group in Hartford, Connecticut, researched the cost-effectiveness of the da Vinci by pairing cases of gallbladder removal with identical outcomes, one laparoscopic, one robotic. He found that the robotic surgeries cost three times more.

“I don’t think it’s a good deal for the hospitals,” he said. “The administrators that are in place have been in a very volume-driven field, where if the competition across town gets one, you get one.”

Hospitals do seem to recoup the cost of the robots through volume.

One way is by using the machine as much as possible. Several doctors uncomfortably confirmed that hospital administrators, who are the gatekeepers for their rooms, staff, and equipment, are inclined to okay robotic surgeries to defray the cost of the multimillion-dollar machines.

The ECRI Institute ranks robotic surgery among its top 10 healthcare hazards for 2015; it appeared on the same list in 2014. ECRI doesn’t fault the device. Instead, it points to inadequate certification requirements at the hospitals that use it. The group is pushing hospitals to develop appropriate processes for approving doctors to use the robotic systems.

Some hospitals may require a surgeon to perform three robotic surgeries before giving him or her the okay to operate on a patient with a robot; others may require 50 or 100 operations. Hospital policies are not routinely disclosed to the public.

“You do three robotic cases and you’re credentialed,” Redan said, by way of example. “But people spend a year in their fellowships learning how to do conventional surgeries.”

In some of the lawsuits pending against Intuitive, some plaintiffs claim that the company lobbies hospitals to ease their so-called credentialing requirements to allow more doctors to use the machines.

Intuitive has expanded the training it offers doctors to get them started. But many still think it’s not enough. Although device manufacturers aren’t required to train doctors on their equipment, experts say Intuitive has done more to push patient demand than to train surgeons.

“[Intuitive’s] direct-to-consumer marketing is just criminal. Their lack of training, in my opinion it borders on criminal.
Dr. Eric Genden, the Mount Sinai Hospital

“Intuitive are probably the worst at doing this and probably the most responsible. Their direct-to-consumer marketing is just criminal. Their lack of training, in my opinion it borders on criminal,” said Genden.

Intuitive has also continued to push into new surgical departments, making the case most recently that da Vinci works well for head and neck surgery and even the open, and usually relatively low-cost, category of general surgery.

For example, based on his experience using the da Vinci, Mount Sinai's Genden said it had been a boon for trans-oral surgeries to remove tumors in the throat, shaving hours off the operating time — which correlates with lower patient risk, Genden said.

But rather than stop there, Intuitive has pushed for the da Vinci to be used for thyroid removal. Although thyroidectomy is generally done with an open incision, the robotic procedure took significantly longer and didn’t give better results, Genden added.

The Mount Sinai Hospital does not offer robotic thyroidectomies. But here’s what Intuitive had to say about the procedure in its 2013 annual report, the most recent one available: “Open surgery is an effective surgery in terms of oncologic control and has low complication rates. However, it leaves a prominent neck scar. Surgeons, predominantly in Asia, are now using the da Vinci Surgical System to perform thyroidectomies entering the body from the axilla (armpit) in order to avoid the visible scar on the neck.”

Intuitive is hardly unique in its efforts to find new uses for its product, said Santa, of Consumer Reports Health.

“It highlights another problem in our system, which is oftentimes nobody’s happy confining something to a fairly narrow corridor. They want to make as much money as they can off of it,” he said. “We see this with drugs, we see this with devices, that if it works for A, B, and C, let’s try it for D.”

Genden
Mount Sinai's Dr. Genden prepares the da Vinci robot.

Da Vinci is both a cause and a symptom of a U.S. healthcare system that costs far more than comparable systems in other countries without offering better results.

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There’s some evidence that among consumers, who may see surgery under the care of an unerring robot as less scary, and hospitals, pressured to recoup the costs of the robot, the result may be surgeries in cases where they’re not entirely necessary.

As robotic surgery has become the most common way to do prostatectomies, the number of these surgeries has risen against a backdrop of medical guidance that increasingly identifies the best way to treat prostate cancer as “watch and wait.”

Dr. Quoc-Dien Trinh, a Harvard urologist who uses the da Vinci, was reluctant to conclude that people who don’t need surgery are getting surgery. But the data nevertheless points in that direction.

“It’s hard to incriminate the individual, but if you look at general trends in the population, that’s what it shows. These new technologies have always disseminated mostly in low-risk populations,” he said.

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Redan has an idea of how to rein it all in.

“Currently, I think robots should just be used in certain centers of excellence where they are evaluating the efficacy, efficiency, and economics of this type of surgery,” he said.

Bureaucrats to the Rescue?

There’s another possible hero in 21st century medicine, though it’s far less sexy than a robotic surgeon: the beleaguered Affordable Care Act.

The law establishes a new compensation model, called Accountable Care Organizations, that rewards doctors and hospitals for good results. Part of that effort includes pushing Medicare-certified hospitals to publicize information on how their patients fare. Many hope that medical professional groups will follow suit.

That information would let patients have more informed conversations about whether to undergo robotic surgery.

Accountable care is a radical shift from the status quo, in which doctors are paid based on the volume of care they provide. Few hospitals or doctors are sure exactly how it will work yet. But doctors are increasingly evaluating care in terms of value, defined as the quality of the medical outcome divided by the cost of treatment.

That approach will put the squeeze on high-cost procedures, like robotic surgery, that don’t demonstrate any big advantages over cheaper alternatives.

“If you do the same equation of outcome divided by cost, you’ve got to get a really better outcome to justify the cost, because the cost is immense,” said Michelassi of the American College of Surgeons.

Of course, it’s also possible that technological innovation will prevail in the end. The da Vinci could get even shinier and more high-tech, or it could hit upon a new innovation that will deliver on its promises to send patients home sooner with better long-term results.

“I remember when we started to perform laparoscopic surgery, the instrumentation was very rough. Now, 25 years later, there is no question that some operations are easier laparoscopically than open, but for a while then every operation was more difficult laparoscopically. Maybe the da Vinci platform will continue to evolve to a point of becoming much more affordable or offering major advantages over other surgical approaches,” Michelassi said.

We’re just not there yet.