“I have not seen anyone who has done a good amount of robotic surgery go back,” said Dr. Vipul Patel, who has done more than 3,500 robot-assisted prostate surgeries.February 14, 2010
Source: http://www.nytimes.com/2010/02/14/health/14robot.html?sq=robotic%20surgery&st=cse&scp=1&pagewanted=all By GINA KOLATA
At age 42, Dr. Jeffrey A. Cadeddu felt like a dinosaur in urologic surgery. He was trained to take out cancerous prostates the traditional laparoscopic way: making small incisions in the abdomen and inserting tools with his own hands to slice out the organ.
But now, patient after patient was walking away. They did not want that kind of surgery. They wanted surgery by a robot, controlled by a physician not necessarily even in the operating room, face buried in a console, working the robot’s arms with remote controls.
“Patients interview you,” said Dr. Cadeddu, a urologist at the University of Texas Southwestern Medical Center at Dallas. “They say: ‘Do you use the robot? O.K., well, thank you.’ ” And they leave.
On one level, robot-assisted surgery makes sense. A robot’s slender arms can reach places human hands cannot, and robot-assisted surgery is spreading to other areas of medicine.
But robot-assisted prostate surgery costs more — about $1,500 to $2,000 more per patient. And it is not clear whether its outcomes are better, worse or the same.
One large national study, which compared outcomes among Medicare patients, indicated that surgery with a robot might lead to fewer in-hospital complications, but that it might also lead to more impotence and incontinence. But the study included conventional laparoscopy patients among the ones who had robot-assisted surgery, making it difficult to assess its conclusions.
It is also not known whether robot-assisted prostate surgery gives better, worse or equivalent long-term cancer control than the traditional methods, either with a four-inch incision or with smaller incisions and a laparoscope. And researchers know of no large studies planned or under way.
Meanwhile, marketing has moved into the breach, with hospitals and surgeons advertising their services with claims that make critics raise their eyebrows. For example, surgeons in private practice at the New Jersey Center for Prostate Cancer and Urology advertise on their Web site that robot-assisted surgery provides “cancer cure equally as well as traditional prostate surgery” and “significantly improved urinary control.”
Robot-assisted prostate surgery has grown at a nearly unprecedented rate.
Last year, 73,000 American men — 86 percent of the 85,000 who had prostate cancer surgery — had robot-assisted operations, according to the robot’s maker, Intuitive Surgical, the only official source of such data. Eight years ago there were fewer than 5,000, Intuitive says.
Dr. Sean R. Tunis, director of the Center for Medical Technology Policy, a nonprofit organization that evaluates medical technology, said few other procedures had made such rapid inroads in medicine.
Medical researchers say the robot situation is emblematic of a more general issue. New technology has sometimes led to big advances, which can justify extra costs. But often, technology spreads long before investigators know whether it is worthwhile.
With drugs, the Food and Drug Administration requires extensive tests to determine safety and efficacy. But surgeons are free to innovate, and few would argue that surgery can or should be held to the same standards as drugs. Still, a situation like robot-assisted surgery illustrates how patients may end up making what can be life-changing decisions based on little more than assertive marketing or the personal prejudices of their surgeon.
“There is no question there is a lot of marketing hype,” said Dr. Gerald L. Andriole Jr., chief of urologic surgery at Washington University. Dr. Andriole does laparoscopic prostate surgery, and although he tried the robot, he went back to the old ways.
“I just think that in this particular instance, with this particular robot,” he said, “there hasn’t been a quantum leap in anything.”
Evaluating technology is complicated. As often happens in surgery, doctors can become enthusiasts without rigorous studies ever being done.
And with prostate cancer, more is at stake than just an academic dispute, said Dr. Jason D. Engel, director of urologic robotic surgery at George Washington University Medical Center in Washington. One in six American men develop prostate cancer in their lifetime. Treatment options include radiation and watchful waiting, but the most popular is surgery.
“With the stream of prostate cancer patients that come through,” Dr. Engel said, “this is a big, big business.”
Dr. Michael J. Barry, a professor of medicine at Massachusetts General Hospital in Boston, said that once a hospital invests in a robot — $1.39 million for the machine and $140,000 a year for the service contract, according to Intuitive — it has an incentive to use it. Doctors and patients become passionate advocates, assuming that newer means better.
“Doctors and medical centers advertise it, and patients demand it,” Dr. Barry said, creating a “folie a deux.”
The robot’s ability to reach into small spaces comes with tradeoffs. Ordinarily, doctors can feel how forcefully they are grabbing tissue, how well they are cutting, how their stitches are holding. With the robot, that is lost. And the robot is slow; it typically takes three and a half hours for a prostate operation, according to Intuitive, twice as long as traditional surgery.
A few highly experienced doctors are much faster. Dr. Vipul Patel, for example, at Florida Hospital in Celebration, Fla., has done more than 3,500 robot-assisted prostate surgeries. He often does six a day, taking about one and a half hours for each.
“From Day 1, when I sat down at that robotic console, I knew we would give patients a better outcome,” Dr. Patel said. “I have not seen anyone who has done a good amount of robotic surgery go back.”
Dr. Patel also started The Journal of Robotic Surgery to provide a forum, he said. Dr. Engel said he and others who use robots welcome it. They had had difficulty getting published in traditional journals, Dr. Engel said.
But papers in the new journal tend to report on one surgeon’s experience. Studies like that, which were also published in the past to promote traditional surgery, have methodological problems — biases in patient selection and evaluation are likely and, because the surgeons tend to be much better than average, it is hard to generalize.
In contrast, the national study of Medicare patients from 2003 to 2007, by Dr. Jim C. Hu of Brigham and Women’s Hospital in Boston, included 6,899 men who had surgery with four-inch incisions and 1,938 who had laparoscopic surgery, many with a robot.
The study was not ideal — patients were not randomly assigned to have one type of surgery or another, and laparoscopic operations done without a robot were included with the robot-assisted ones because Medicare did not distinguish between the two. But it is the only large national study that compares what is thought to be a largely robot-assisted surgery group with a group that did not have a robot.
The paper, published last October in The Journal of the American Medical Association, found that laparoscopic surgery patients had shorter hospital stays, lower transfusion rates and fewer respiratory and surgical complications. But they also had more incontinence and impotence.
It is not known whether the extra costs of robot-assisted surgery are balanced by lower costs for shorter hospital stays and fewer surgical complications.
Experts in robotic surgery say studies like Dr. Hu’s can be misleading. Medicare data, they say, include results from surgeons who may have little experience with robots.
Dr. Barry, an author of Dr. Hu’s paper, said Medicare data reflect the real world. “Everyone tends to cite data from centers of excellence as though they were their own,” he said.
Highly skilled surgeons, like Dr. Ashutosh K. Tewari at Weill Cornell Medical College in New York, say it takes about 200 to 300 robot-assisted operations to become highly proficient. Dr. Tewari has done 3,200.
Surgeons who do nonrobotic prostate surgery agree.
“What happens is that if you take leading experts, whether they do open or robotic, they are going to get good results,” said Dr. Herbert Lepor of New York University, who has done more than 4,000 traditional open prostatectomies.
“I say robotic surgery has to be better to justify its learning curve,” Dr. Lepor said, “to justify its unknown cancer control, to justify its increased cost.”
Both traditional surgeons and those who do robot-assisted surgery point to patients who did extremely well.
Among them is James Lamb, a 40-year-old New York City police officer who had robot-assisted surgery with Dr. Tewari on Jan. 5. Two days later, while he was in the hospital and still had a catheter in his penis, Officer Lamb had an erection.
Two days after that, Officer Lamb said, he was home and had sexual intercourse. (In one study by Dr. Barry, which surveyed patients a year after surgery, only half the men, regardless of surgical method, were back to their presurgery potency a year later, with or without the use of a drug like Viagra.)
But, Dr. Barry and Dr. Tewari note, an extraordinary patient or two can be misleading. “The message for patients is not to assume that newer is better,” Dr. Barry said. Measures like the number of operations a surgeon has done “still matter a lot,” he said.
Dr. Cadeddu, though, said that sort of message is falling on deaf ears. Patients want the robot. So Dr. Cadeddu has now begun offering robot-assisted surgery to those who want it.
“The battle is lost,” Dr. Cadeddu added. “Marketing is driving the case here.”
Raising the Bar
