How robotic surgeries are presented to the public
An analysis by researchers at Johns Hopkins University raised several issues about the way hospitals market the da Vinci robot on their websites. The St. Charles Health System website includes a page about its robot that includes many of the cited concerns.
The St. Charles robot page is accessible within one click of the homepage, and relies on marketing images provided by the manufacturer, both concerns raised by the Hopkins paper.
The site also cites benefits including “less scarring, fewer side effects, a shorter hospital stay and much faster recovery” without telling patients whether the gains were compared to open or laparoscopic surgery, or for what types of surgeries the robot showed gains. The webpage linked back to the manufacturer’s website for more information on the clinical benefits.
“That has been our main concern, that some of the marketing claims have been incomplete and therefore misleading because they don’t specify a comparison group,” said Dr. Marty Makary, a professor of surgery at Johns Hopkins.
Asked about the website, hospital officials acknowledged Makary’s concerns but cited a limited marketing budget.
“I do think it can be unseemly, if someone relies solely on the vendor for the promotion of the marketing of a new service or the marketing of a new device,” said Dr. Michel Boileau, chief medical officer at St. Charles. “On the other hand, when you’re starting a program, and you don’t have your own local information and your own local statistics, it makes sense to use information that is provided by the experts in the field.”
— Markian Hawryluk, The Bulletin
In 2012, St. Charles Bend became one of the last of the larger hospitals in Oregon to buy a surgical robot.
“I can tell you that we as urologists here were the reason for that,” said Dr. Michel Boileau, chief medical officer for the hospital and a urologist with Bend Urology. “We, as a group, were waiting to see what the benefits really were.”
While many proponents argue that the shiny new robot is the future of medicine, there is still considerable debate whether it should be part of the present. Critics warn that patients should be careful in assuming that robot surgery is necessarily better than the alternatives. But for the right surgeries, it could provide significant advantages.
Lured by the robot’s ability to facilitate work in the narrow, confined spaces in which they must operate, urologists nationwide have been the fastest specialty to embrace the da Vinci surgical robot.
But when local urologists looked at the research, they found little evidence the robot provided better outcomes than standard surgery. Some data suggested that fewer prostate surgery patients needed transfusions due to blood loss. Patients went home from the hospital somewhat faster and fewer required follow-up surgery due to scarring of the urethra. But the robot did not help reduce side effects such as incontinence or erectile dysfunction, and didn’t do any better at cancer control.
Yet surgery using the robot costs significantly more. With a price tag of more than $2 million for the equipment, another $140,000 a year in annual service contracts, and thousands of dollars in disposable supplies for every surgery, it was a high price to pay for essentially the same results a skilled surgeon could achieve with a scalpel.
Eventually, however, the urologists and the hospital realized they had little choice.
Prostate surgery had so thoroughly shifted from traditional open surgery to robotic procedures, the region would soon find it difficult to recruit new urologists unless it had a robot.
“The robot has made great inroads into the academic medical centers, so all the young surgeons coming out of training are robot-trained,” Boileau said. “They’re simply not going to go practice at a hospital that doesn’t have a robot.”
Like it or not, they realized, the robot is here to stay.
Four arms, high cost
Boileau said the hospital now loses money on each robotic surgery. Studies comparing robotic surgeries to traditional surgeries have found robotic surgery costs $2,000 to $3,000 more, and if the cost of the robot is considered, at least $10,000 more. Yet hospitals, for the most part, don’t get paid more by federal or private insurance plans when they use the robot.
In 2012, researchers at the University of Pittsburgh Medical Center compared the costs and payments for prostate surgery at one of their hospitals. The average open prostate surgery netted a profit of $1,325. But for each robotic prostatectomy, the hospital lost $4,013.
Some analyses have suggested that as doctors get more proficient with the robot, they could reduce the duration of surgery and length of stay in the hospital, while cutting complications and readmission rates.
“If you’re an efficient roboticist, you do three or four a day, you use the same team, your hours are lower, you can get almost close to parity,” said Dr. Benjamin Davies, an assistant professor of urology at the University of Pittsburgh and one of the co-authors of the analysis. In theory at least, hospitals could break even on robotics.
“I don’t think we even come close to that,” Boileau said. St. Charles Bend already has fairly low surgical complication rates and some of the lowest readmission rates in the state, he said. “But the fact of the matter is it is a service that our community expects and it is a service that our surgeons expect.”
That expectation has primarily been driven by prostate surgery. Some 75 to 85 percent of prostate surgeries in the U.S. are now done robotically.
The da Vinci surgical robot has four arms that can be equipped with a camera and surgical instruments. The surgeon sits at a console, controlling the robot with his hands and feet watching a three-dimensional image on a computer monitor. The robot arms enter the patient’s body through small incisions, and can move and rotate within the patient to perform the surgical tasks. Many surgeons compare it to playing a video game.
It has allowed surgeons to replace open surgery, which usually requires a large incision through the lower abdomen, with a minimally invasive one. It is essentially the same procedure as a laparoscopic surgery, in which surgeons use tools on the ends of long rods. Laparoscopy helped usher in minimally invasive surgery in the 1980s, but some laparoscopic procedures, including prostatectomies, are so technically complex and difficult to master, they are rarely done.
Several studies have shown that when hospitals acquire robots, their rates of prostatectomy go up. A 2011 study published in the journal Medicare Care found that hospitals that acquired a robot between 2001 and 2005 increased the number of prostate surgeries by 29 per year, while hospitals without a robot experienced a drop of nearly five surgeries per year.
“We basically found that regions that acquired robots did more prostate surgery, and the more robots a region had, the more prostate surgery it did,” said Dr. Danil Makarov, a professor of urology at New York University’s Langone Medical Center and lead author of the study.
Subsequent analysis of the data, Makarov said, shows it was primarily teaching hospitals that first acquired surgical robots. More and more residents were trained on robotics and sought hospitals that had robots when they finished their training.
Critics of the robot maintain the widespread diffusion has more to do with the heavy marketing to consumers by the robot’s manufacturer, Sunnyvale, Calif.-based Intuitive Surgical, and by hospitals themselves, rather than medical evidence of superiority.
In regions with competing hospitals, adding a robot could raise the prestige of one institution over another. Patients tend to flock to new technology, assuming it provides better outcomes. So when one hospital added a robot, its competitors were compelled to follow suit to avoid losing market share.
That also meant hospitals have to find other uses of the robot to help spread out the capital costs. They moved into gynecological and general surgery, procedures that were already being done laparoscopically.
That distinction was often lost on patients. Hospitals and surgeons claimed robotic surgery provided a faster recovery and shorter hospital stays. That might have been true compared with open surgery, but not necessarily when compared with laparoscopic procedures. Patients came away thinking the robot was simply better all around, and hospitals did little to dispel that notion.
In 2011, Dr. Marty Makary, a professor of surgery at Johns Hopkins University School of Medicine, found that four in 10 hospitals touted the robot on their websites, relying primarily on marketing claims made by the manufacturer. They overstate the benefits of robotic surgery, he said, while largely ignoring the risks or costs.
“If you compare robotic surgery to cutting people wide open with open surgery, then there’s going to be a benefit. If you compare robot to standard minimally invasive surgery, for most procedures there’s no benefit to patients,” Makary said. “They were, in my opinion, unfairly attributing the benefits of minimally invasive surgery to the robot, and then marketing the robot in a way that is unethical.”
Despite a lack of evidence to support it, robotic surgery is starting to get a toehold for hysterectomies as well. In 2007, only 0.5 percent of hysterectomies in the U.S. were performed robotically. That rate increased to 9.5 percent by 2010, and continues to climb. A Columbia University study found patients did just as well after laparoscopic hysterectomies as they did with robotic procedures. There weren’t similar gains as with robotic prostatectomy.
“I think the problem with other procedures is, as the robot diffuses, basically you’re replacing a laparoscopic procedure with a robotic procedure,” said Dr. Jason Wright, a professor of gynecology at Columbia and lead author of the study. “It’s been much more difficult to show benefit.”
Wright’s study helped prompt the American College of Gynecology to issue a statement last year warning physicians and patients that robotic surgery is neither the only minimally invasive approach for hysterectomy, nor the best.
“There is no good data proving that robotic hysterectomy is even as good as — let alone better — than existing and far less costly, minimally invasive alternatives,” Dr. James Breeden, the group’s president at the time, said.
Robot supporters counter that such studies lump together results from experienced surgeons with those new to robotics. As surgeons and their teams become more familiar with the robots, they say, outcomes will improve and costs will drop.
But Wright said with procedures like hysterectomy, there may not be that much room for improvement.
“Even in our study, complication rates in both procedures were pretty low, 5 to 5.5 percent,” Wright said. “I think no matter what your surgical experience is, how low you’re going to be able to drive your complication rate is questionable.”
Lack of data
The call might be easier to make if there were randomized controlled trials, pitting robotic surgery head-to-head against traditional surgeries. Such trials are difficult and expensive to complete, and were not required to gain Food and Drug Administration approval. (The FDA has been heavily criticized for its device approval process and is in the process of rethinking its regulations.) Patients might balk at being randomly assigned to one type of surgery over another.
The lack of such studies has stymied the robot’s critics and proponents alike. Neither can point to definitive evidence that the robot is or isn’t worth the cost. There is a question of whether such trials are even possible.
“Surgery is not like getting a pill,” Davies, the Pittsburgh urologist, said. “Every surgeon is different, every time the procedure is happens is different, so you can’t get a really true randomization.”
Davies points to the experience in the early 1980s, when surgeons began to do gall bladder surgeries with laparoscopy.
“They did a randomized control trial early on and it was horrible,” he said. “Now we do a laparoscopy and go home two hours later.”
It can be hard to distinguish in studies whether effects are due to the skill and experience of the surgeons involved, or the tools they use.
“All surgeons are not created equal. That’s just a fact,” said Chris Schabowsky, who evaluated the evidence on robotic surgery for ECRI, a sort of Consumer Reports for the health care industry. “It can be very daunting and challenging to compare outcomes when you have a subset of surgeons working on a robot and another subset working traditionally.”
There is very good evidence that links outcomes with experience. In general, the more procedures a surgeon has done, the better the results. Dr. Jim Hu, director of robotic and minimally invasive surgery at the University of California-Los Angeles, suggests the learning curve required to be extremely proficient at robotic surgery might stretch into the hundreds. He saw gains in reducing blood loss in prostate surgery only after 400 to 500 cases, and broke through a plateau in operating time only after 600 cases. Hu said it would be hard for surgeons to get that sort of caseload outside of larger academic medical centers. Patients in a surgeon’s initial cases, however, aren’t getting the same level of expertise.
“If the learning curve is a couple of hundred and to get really good, it’s at least a thousand, then in a transparent system, most hospitals don’t need a robot,” he said. “They’re enabling the situation where people are having surgeries in the first couple hundred cases.”
While newly minted surgeons might do hundreds of robotic cases under close supervision during their residency or fellowship training, surgeons who pick up robotics after being in practice for a few years won’t have that many cases under their belt for a while.
Surgeons who want to switch to robotic surgeries can complete a training program through the manufacturer that includes observing cases and conducting simulated surgeries. Initial surgeries can be done in conjunction with a trained physician in a driving-school-like setup, where the supervisor has his own console and can take control of the robot at any time.
The robot’s manufacturer, Intuitive, has come under fire for the training program, which critics suggest may not have been adequate.
“I think da Vinci did a poor job of managing expectations,” Davies said, “and probably was too aggressive in marketing their technology without having groundworks in place.”
Surgeons who have embraced the robot rave about its potential. The device provides a three-dimensional view, compared to only two dimensions for laparoscopy. The picture is clearer and ultraviolet lighting can be used to distinguish between different types of tissue.
“(With laparoscopy) the instruments are all straight sticks,” said Dr. Stephen Archer, a surgeon with Advanced Specialty Care in Bend. “And the robot allows the surgeon to have an elbow or a wrist inside the patient, which allows for more precision.”
Surgeons find the robot more comfortable and more ergonomically friendly, which might prolong the active career of the average surgeon.
“It may not be a big deal to anyone but the surgeon, but in terms of the cost of actually training a surgeon and keeping him healthy throughout a career, it does have an impact,” Archer said.
He believes that with time, robotic surgery will begin to show a clear benefit over the alternatives.
“If one was converting from open to robotics, there would be an obvious major step,” Archer said. “Going from laparoscopic to robot is more subtle, and that’s why I think the literature is having a hard time catching up to the potential benefits.”
Dr. Darren Kowalski, a general surgeon with Bend Memorial Clinic and chairman of the robotics committee at St. Charles, said as surgeons get more expertise with the robot, costs could also come down.
“The more cases we’re doing, those OR times will come down comparable to laparoscopic or open procedures,” he said. Costs incurred by an experienced group of robotic surgeons would be lower, he said, than current calculations that include both veteran robotic surgeons and those just starting out.
Results may actually rise and fall in waves, he said. Outcomes may improve as surgeons gain expertise then take a step backward as a new cohort of less-experienced doctors come on board.
“There are advantages that are hard to define on paper, but if you’re somebody that uses that technology all the time, you know,” Kowalski said.
Despite the controversy over the benefits and costs of robotics, even many staunch skeptics agree there are certain procedures where the robot might provide tremendous benefits. Doctors have begun to use robotic surgery to remove oral cancers. Traditional surgery often required slicing open the throat and breaking the jaw bone to gain access to the tumor.
“The recovery time for something like that is gargantuan,” said ECRI’s Schabowsky. “It can take weeks and you might have difficulty swallowing or talking.”
With robot-assisted surgery, the end of the robotic arms can fit down the throat.
“A lot of surgeons are using this device to avoid this open-surgery debacle and patients are able to recover from this within a few days,” he said.
That may only account for 20,000 or 30,000 cases each year, and certainly not enough to justify a robot in every hospital. More patients might benefit from more common surgeries, like partial nephrectomies, moving to robotics.
Ten years ago, when patients had kidney tumors, surgeons would cut out the entire kidney. With time, doctors realized that patients would do better if the tumor was cut out and the rest of the healthy kidney left in place.
Open surgery, however, required cutting away a rib and cutting through a big muscle to gain access. Patients often stayed in a hospital a week or more to recover. Laparoscopic partial nephrectomies were much less invasive, cutting hospital stays to two or three days, but were very difficult to do. Robotics has made that procedure much easier.
“That’s really what took it from a couple of centers in the United States, where you really only had a couple of people competent enough to do it laparoscopically, to presenting it to the community at large,” said Dr. Matt Simmons, a urologist with Bend-based Urology Specialists of Oregon. “We now have a tool that will allow people to do this a lot more easily.”
From 2010 to 2012, there had been only six partial nephrectomies done in Bend. Most patients still underwent laparoscopic or open surgery to remove the entire kidney. In the first six months of 2013, Simmons, who was trained in robotic surgery at the Cleveland Clinic, completed 16 partial nephrectomies robotically.
Simmons only uses the robot for surgeries in which he believes the technology offers a benefit for the patient. He still does simpler procedures, like adrenal surgery, with laparoscopy.
“Partial nephrectomy has been sort of slow to be adopted across the country,” said Makarov, the NYU urologist. “What we found looking at some other data was that hospitals that acquired the surgical robot were doing a higher proportion of partial nephrectomies than hospitals that didn’t. In my mind, this is one of the true benefits of the robot.”
With time, medical research, physician guidelines and patient education may help to steer patients toward robotics when outcomes are better and toward less expensive surgical techniques when they aren’t. And many argue that investing in the technology today might lead to greater gains down the road. As competitors enter the surgical robot market, the technology could improve and costs may decline.
“People do need to think about the future generations of robots,” Hopkins’ Makary said. “I’m one to say there is a future for robotic surgery and those future generations will potentially offer some benefits.”
—Reporter: 541-617-7814, firstname.lastname@example.org
Editor’s Note: This story has been corrected. An earlier version of the story misidentified Dr. Matt Simmons’ practice. The Bulletin regrets the error.