This report originally appeared in the June 2010 issue of DOTmed Business News

If there are two things that Dr. Ash Tewari loves, they're cricket and robotic surgery. The walls of his cozy office, tucked away on the ninth floor of the New York Presbyterian Hospital/Weill Cornell Medical Center, are covered with cricket memorabilia, including a framed poster that explains the sport to strangers of the game. It shares the space with glossy magazine covers about robotic surgery and the top surgeons who perform the procedure.

It's just before 3 p.m. on a windy spring day and Dr. Tewari has already completed four robotic prostatectomies. He is the professor of urology and outcomes at the Weill Cornell Medical Center and the director of the Lefrak Institute of Robotic Surgery at New York Presbyterian Hospital.

"I got involved with robotic surgery about 10 years ago," says Dr. Tewari. "Since then, robotic procedures have become quite popular."

Years ago, patients would have to demand the surgery be done using the technique, but today, it is the golden standard used for the removal of prostate cancer cell masses.

"Last year, just for prostate cancer, out of about 70,000 prostatectomies being done in the U.S. 70 to 80 percent of them were done using a robot," says Dr. Tewari.

Surgeons cite a number of advantages to robotic surgery, such as minimal blood loss, less discomfort, faster recovery time and higher likelihood of urinary and sexual functions returning to normal. The surgeons also physically benefit from the procedure, experiencing less physical strain because they are sitting at the console while operating the robot. This allows them to perform more surgeries in a day and have better vision of the organs they are operating on.

"The surgical platform is quite immersive," says Dr. Tewari. "You can actually see things in three dimensions. The third dimension makes you feel as if you are inside the patient's body, very close to the organ you are working on and you are a part of that process."

Wearing 3-D glasses and watching the procedure on a big screen in Dr. Tewari's office is like having a front row seat to the prostatectomy (hold the popcorn). While the robotic arms work swiftly and delicately, it is easy to forget that the surgeon is controlling the instruments that are cutting and cauterizing the tissue from just a few feet away.

A shift in tradition
If anyone is a robotic prostatectomy expert, it's Dr. Vipul Patel, the director of urologic oncology and medical director of the Global Robotics Institute at Florida Hospital. He has performed more than 3,500 robotic procedures to date, more than anyone else in the world.

"It allows us to remove the prostate safely and effectively, while at the same time, achieving excellent cancer control, return of continence and also return of sexual function and we can do it in a minimally invasive way," says Dr. Patel. "I trained in the era of open surgery and then I did a fellowship in laparoscopy, but when I saw the robotic applications, I really felt [it was the future] because we could do everything we could do with open surgery and more."

Dr. Patel is one of the founders of the Journal of Robotic Surgery and the Society of Robotic Surgery. He sees the journal as a way to disseminate new data about techniques and outcomes and the society as a place for education. More than 1,100 surgeons attended this year's World Robotic Symposium in April.

"They came from 37 different countries from around the world," says Dr. Patel. "It's the first time that so many people from so many different countries have come to one place just to learn about robotics in all of their different specialties."

Attendees discussed technology, outcomes, simulations, techniques and future applications at the conference.

St. Luke's Hospital and Health Network in Pennsylvania offers a limited clinical guarantee on its robotic prostatectomies. Urologic surgeons developed a set of strict guidelines for the surgery. The hospital guarantees that if the surgeons fail to abide by the established regulations or if a patient develops specific complications due to the surgery within 30 days of the procedure, the operation is free of charge. When the technique was in its early stages of development, the surgeons at the hospital realized that the expertise of the team actually doing the procedure is far more important than the instruments themselves. This prompted the idea of offering a limited guarantee to their patients.

"When the decision was made to advertise the fact we do robotic surgery, one of the things we wanted to stress is, it's one thing to advertise a given service, but it would be nice to be able to substantiate that or offer some sort of background or proof that the results are there," says Dr. Eric Mayer, chief of minimally invasive urologic surgery at St. Luke's Hospital and Health Network.

At St. Luke's, most patients scheduled for prostate cancer surgery choose robotic prostatectomy.




"Of those patients who undergo surgery, I would say roughly 98 percent undergo the robotic approach. The 2 percent that we do traditionally are usually done this way because they have certain contrary indications to the robotic surgery," says Dr. Mayer. "For example, if they're morbidly obese or if they had multiple abdominal surgeries in the past, the robotic instrumentation might not have safe access. It's pretty far and few between that we do have to do open surgeries," he says.

Tech for toddlers
When children first find out that they'll be operated on with a robot, their imagination runs wild.

"They have this incredible vision of the machine coming in, walking and talking to them," says Dr. Hiep Nguyen, co-director of the Center for Robotic Surgery and director of robotic surgery research and training at Children's Hospital Boston.

Understandably, the reactions of the parents are more varied. Parents who express interest and willingness for the surgery tend to be more tech-savvy. Others are fearful of the idea that a robot will be operating on their child.

"That's why having a dedicated team like we have is very helpful. We go in and reassure [the parents] that even though [the child] is being operated on with the robot, the surgeon is still in control. There will be humans in the room with the patient at all times, and they're the ones responsible for the care," says Dr. Nguyen. "Right now clinically, robots are just an extension of the surgeon's hands and eyes. And therefore it is very, very safe. It's not like there isn't anyone in the room with the patient. There are actually more people in the room than there are during regular open surgery," he says.

Children's Hospital Boston is a pioneer of pediatric robotic procedures. In 2001, it was the first pediatric hospital to purchase a surgical robot. More recently, it became the first pediatric hospital in the world to acquire the latest model of the da Vinci Si HD Surgical System, manufactured by California-based Intuitive Surgical, Inc.

The most common pediatric surgical procedure at the hospital is a pyeloplasty or the repair of a blockage in the kidney. Before robotic surgery, this procedure required a significant open incision and intrusion through the muscle, which resulted in a lengthy recovery for kids. The surgery also involved delicate suturing, which meant that only very skilled surgeons were able to perform this complex procedure.

"Then came the robot," says Dr. Nguyen. "The three-dimensional imaging and dexterity that it provided allowed you to do very delicate suturing simply and the skill required to do this wasn't as great as conventional laparoscopy. So for us, that was a big revolution in technical development. Now we are able to perform this surgery all laparoscopically using the robot."

In addition to pyeloplasty, the surgeons at Children's Hospital Boston also perform robotic procedures such as intravical ureteral reimplantation, continent urinary diversion and bladder augmentation.

"Unlike many adult surgeries, where they are removing organs, most of our surgeries involve reconstruction," says Dr. Nguyen. "A lot of the reconstruction requires very delicate suturing and because of that, the robot was just perfect."

When performing any surgical procedures on children, special considerations must be taken into account. When the robot first came out, a lot of people thought it was "overkill" for pediatric surgery, says Dr. Nguyen.

"But what we found is, no matter what the size of the patient, you can do things safely as long as you have a team that works with the robot regularly," he says.

For example, adults can sustain the weight of the robot's arms on their bodies because of ample fat and muscle, but this can cause injury to a child. The extent of laparoscopy can also be minimized with the work of anesthesiologists, who use carbon dioxide to inflate the abdomen to create room for the robotic arms. The anesthesiologists must have a firm grasp of pediatric physiology to ensure that the anesthesia is administered safely.

The average patient at Children's Hospital Boston is about 3 to 4 years old, but the number tends to change with the advancements in robotic techniques.

"Around the country, most people who do pediatric robotic surgery are using it for pyeloplasty. For us, we expand to so many other indications that the age varies significantly," says Dr. Nguyen.

So far, Dr. Nguyen's youngest surgical patient was about 3 months old.

Learning the ways of the robot
With any surgical procedure, practice is key in mastering the technique and robotic surgery is no exception.

"Robotic surgery does have a significant learning curve," says Dr. Patel. "It's not really technology itself alone, actually the experience of the surgeon performing the procedure is more important than the technology itself."

There are currently 20 robotic surgery training centers across the United States, according to Intuitive Surgical, Inc. As of yet, there are no formalized guidelines from any of the major medical societies or associations about robotic surgery standards. It's an internal and hospital specific process.

"People have actually done research in terms of what the minimal case volume need to be in order to be at least somewhat facile with this particular technique," says Dr. Mayer. "The general rule is that the surgeon should be doing at least 20 of these a year and have done at least 100 cases to be reasonably comfortable with this particular technique."

One of the training centers is at Children's Hospital Boston, where physicians of all specialties are trained to do robotic surgery. The trainee first goes through a standard online training course, then performs inanimate work on pegs and then moves on to an animal model (a pig). Once the surgeon learns how to do the procedures on the animal, a minimum of five cases is proctored. Depending on the level of comfort after that, the surgeon either moves on to solo surgeries or continues working with a mentor.

"Being comfortable is not just knowing how to do the surgery but understanding how to handle different situations - how to undock the robot quickly in case of emergency, learning how to deal with mechanical failures, learning about when things don't work right, how to change the situation so that the robot works much better," says Dr. Nguyen. "Because unlike a lot of other equipment, there's a certain set-up that needs to be in place so the robot works best. There's a lot of learning about how to properly set the robot."

One manufacturer is catching on to the training needs for robotic surgeons. Simulated Surgical Systems, a New York-based company, introduced its Robotic Surgical Simulator (RoSS) at the International Robotic Urologic Symposium (IRUS) in January. RoSS simulates the experience of working at the master console of a da Vinci Surgical System.

"Sometimes for a hospital, it's like a chicken and an egg problem: should we buy the robot and then look for the surgeon or find the surgeon and then look for the robot?" says Kesh Kesavadas, co-founder of the company.

RoSS was created in 2006 and is currently in beta testing. Kesavadas envisions the use of the simulator for training in medical colleges and hospitals nationwide.

"One of the advantages of the simulator is that you don't have to train people inside the O/R the simulator can be anywhere in the hospital with easy access for the trainees," he says.

The design of the latest da Vinci Si HD Surgical System is equipped with dual-console capability for training and collaboration.

"Currently, we have the newest robotic system that has a training console, so it's almost like the old driver education car, where there are two steering wheels, two brakes and two accelerators," says Dr. David Wood, professor of urology and chief of urologic oncology at the University of Michigan. "Both people are seeing the same thing. It's going to be a major help in training other physicians on how to use the robot."

It may not be too long before standardized regulations are established for robotic surgery.

"I think the Society of Robotic Surgery is uniquely positioned to actually put some guidelines out there and we're working on those now," says Dr. Patel. "Some guidelines for credentialing and training and what we would consider acceptable standards. This is one of the projects the society will undertake."

Dr. Robot amidst criticism
The Food and Drug Administration (FDA) approved the first surgical robot in 2001, unleashing a wave of excited speculation about its many capabilities. But recently, the robot has been under attack.

"A lot of people showed enthusiasm for the robotic initiative, but right now there's kind of a backlash," says Dr. Nguyen. "People are saying it's too expensive and no better than open surgery."

Critics say that hospitals are marketing and advertising robotic procedures without much comprehensive clinical data to support the claim that it is, in fact, better than other treatment options. In 2009, the Institute for Clinical and Economic Review (ICER), an academic comparative research and policy program based at the Institute of Technology Assessment at Massachusetts General Hospital, released a report comparing the different approaches to managing prostate cancer. It found that, "rates of survival and tumor recurrence are similar among the most common treatment approaches, although costs can vary considerably."




In another study published in the May issue of the Journal of Urology, researchers did a prospective analysis and looked at the baseline function and bother scores of 785 patients who underwent treatment for localized prostate cancer between 2000 and 2008. The study considered four different options: open or robotic prostatectomy, cryoblation and brachytherapy.

The researchers attempted to determine if robotic surgery made a major difference in the patients' quality of life, to find out if it justified the higher cost involved. Dr. Michael Fabrizio, division chief of urology at the Sentara Medical Group in Virginia and an associate professor of urology at the Eastern Virginia Medical School, is one of the study's authors.

"Quite to our surprise, there's not a significant difference between the open and robotic approaches with respect to urinary function, sexual function or bowel function or bother," says Dr. Fabrizio. "But there was a dramatic difference in recovery when you look at brachytherapy and cryoblation with respect to urinary function and with sexual function in respect to brachytherapy. There was a threefold greater chance that you would return to baseline function if you had brachytherapy at the end of a two-year interval as opposed to if you had surgery," he says.

The researchers were surprised with the differences in the return to function scores when it came to robotic surgery.

"The patients who had the robotic prostatectomy, they did well, but when you look at an outcome study, a prospective study, I think some of that data are surprising in the fact that they didn't do as well as you probably thought they were doing," says Dr. Fabrizio.

The ICER report also found that "there are no definitive head-to-head studies" that compare the available treatment options, a fact that prompts much of the criticism about the effectiveness of robotic surgery.

"There's never been a randomized, blind study of the patient looking at open versus robotic surgery, in part because no entity would pay you to do that study," says Dr. Wood. "There is a lack of clear benefit but on the other hand, there are very few operations that have ever been tested against the gold standard to see if it's better because surgery continually improves," he says.

Dr. Wood has been performing robotic surgery for eight years but doesn't think that the technique is necessarily better than open surgery.

"I think that you can do a great open surgery and you can do a great robotic surgery," he says. "It's just that because of better vision and a more controlled environment, you are more likely, case after case, to have good results with the robot than you are with the open surgery because of reproducibility."

Dr. Patel believes that it would be hard to directly compare the two surgical methods because patients want to be in control of their treatment options.

"Patients don't want the flip of a coin to decide which surgery they're going to have. I think the actual comparison will be very difficult to do," he says.

Many of the immediate benefits of robotic surgery are clear and the focus of more and more studies is shifting to evaluating long-term outcomes. At St. Luke's Hospital, the limited clinical guarantee also serves a research purpose.

"The future of health care reimbursement is such that I think a lot of things are going to be predicated on outcomes, quality and patient satisfaction. When it comes to robotic surgery, it doesn't really exist," says Dr. Mayer. "In other words, no one has done that before or done the research as part of the background of seeing what those measurements are. So we thought of it not only as an advertising modality, but as a way of generating data in order to build a case for this type of a procedure," he says.

Others argue that it takes time to produce comprehensive data and that a lot of information is already out there.

"Our institution is publishing many articles on patient satisfaction, we're publishing on long-term outcomes, things that need a little time," says Dr. Nguyen. "A lot of people have a reaction, but robotic surgery has not been around long enough to make those kinds of decisions already. Major institutions should continue to do [robotic surgeries] so we can see the long-term benefits," he says.

An important lesson that Dr. Fabrizio took away from doing the study is the fact that most facilities in the United States don't keep prospective quality of life outcome data for their radical prostatectomy or prostate cancer patients.

"I think that's important because one part of the prostate cancer equation is cure but the second part of the equation is quality of life and we need to balance both the cure and the quality of life. I think you need to track both data," he says.

No matter how many new robotic surgery studies trickle in, surgeons emphasize that the role of the expert trumps the type of the treatment.

"I think one thing that everybody agrees on is that prostate cancer surgery is very difficult and it's the experience of the surgeon that is most important in the outcome, not necessarily the technology," says Dr. Patel. "However, I can tell you that if you do have experience, the robot does help you achieve very, very good outcomes. And [the outcomes] have been published; they are out there. People have to read them."

Many robots, one creator
Intuitive Surgical, Inc. is the sole manufacturer of the robotic system used in hospitals nationwide. There are 1,091 da Vinci Surgical Systems in place in the United States., 264 in Europe and 127 in other world markets, according to Aleks Cukic, vice president of strategy for Intuitive Surgical.

"We are focused on trying to create products that work for all size hospitals," says Cukic. "There are various price configurations for various price points that range somewhere between $1 million and roughly $2.3 million for the da Vinci System. There is some price stratification that does work for hospitals regardless of their size."

The company has released three versions of its da Vinci System so far. It generated $329 million in revenue in the first quarter of 2010, up from $188 million for the first quarter of 2009. Profits for instruments and accessories also went up to $123 million in the first quarter of this year from $80 million in the first quarter of 2009.

Some surgeons say the cost of the system, its parts and service contracts is a huge burden on their practice.

"If anything holds the further developments in robotic surgery, it's price. There's only one company right now that has a clinical robot and they have a monopoly on that," says Dr. Nguyen. "Because of that monopoly, they have different attitudes about customer service and about how to make things cheaper. You either deal with them or you don't deal with the robot at all and that's very difficult."

Dr. Nguyen says many of the instruments can only be used a specific number of times before they are locked out and need to be replaced. Compared to the cost of open surgery, the robotic approach is much more expensive.

Cukic says that the parts must be replaced because of safety concerns.

"Our instruments are designed to be used as much as they can. Most of them can be used 10 times," he says. "Whatever the limit is on its life is based on its performance. If it's programmed to work for 10 uses, then we weren't able to get it to be safe and efficacious beyond 10 because of stretching of cables or dulling of knife blades or whatever the rate-limiting factor was. That's comparable to basic disposable laparoscopic instruments that are used once and are thrown away."

Dr. Nguyen says that to lower the cost of the surgeries, his surgical team tries to control the length of the time it takes to complete a procedure in the O/R. In addition to the clinical robot, Children's Hospital Boston also has a research robot. However, the hospital had to cancel its service contract for that machine because it was too expensive.

Other surgeons recognize the problem of having one manufacturer dominate the market, but also point out that the company made the technique a reality.

"Intuitive Surgical is the only manufacturer of the robot, but they've built a field out of nothing, so that tells you that they've done some things right, but not everyone is perfect," says Dr. Patel. "The good thing is that they have introduced a technology that we can utilize and has become widespread. It made a big contribution to medicine because the technology has helped hundreds of thousands of people around the world."

Although Dr. Wood, who compares Intuitive Surgical to "Shell Oil in the 1920s," hopes to see other manufacturers enter the market, he isn't too optimistic about the success of potential competitors.

"From a business standpoint, I think it's going to be highly unlikely, because most hospitals have already made this very large capital equipment purchase," he says. "And then to go ahead and just throw that away and go with a new vendor that's clearly not going to have the same track record would be difficult."

There are somewhere between 400 and 500 different patents on the da Vinci Surgical System, according to Cukic. The company is also the only manufacturer of all the parts and the specific software for the robot. Cukic says that competition that exists today consists of other ways to manage an illness or disease, like using pharmacological and radiological approaches. Cukic says the company does expect to face competition in the future, although there are many technical, clinical and physical challenges to getting into the robotic surgery business.

"From a direct robotic approach, there really isn't anybody who is doing what we are doing," he says.

Dr. Nguyen hopes that the arrival of other competitors in the future will eventually drive down the cost of robotic surgery.

"They are a business and I don't blame them. Their goal is to sell robots. And for me, as a physician, I'm not so happy with that. I want my industry to be my collaborators, I want them to work with me," he says.

Intuitive Surgical plans to continue on the path of its current business model, says Cukic.

"There is a lot of open surgery that we believe we can help convert to minimally invasive surgery," he says. Over the long term, I think what we'd really like to do is penetrate and add value to many of those open operations by improving the efficacy or reducing the invasiveness."

The O/R of the future
Despite the challenges, robotic surgery is here to stay. In addition to urological cancers, cervical and endometrial cancers are also being addressed using the robotic method. There is a growing interest around complex benign hysterectomies and head and neck surgeries. Just recently, transoral procedures received the go ahead for the robotic method.




"It allows surgeons to actually operate inside of the mouth and remove things like base of tongue cancers that historically have required very disfiguring surgeries and jaw splitting operations," says Cukic. "And now, they're going in through the natural orifice of the mouth and are able to reach down to the base of the tongue with better visualization and controls and remove those cancers."

The biggest challenge for Intuitive Surgical lies in managing the scale of its growth, says Cukic. As minimally invasive surgery continues to thrive, the company must work on the appropriate instrumentation, training routines and system configurations.

"They're nice problems to have, but they're problems nonetheless," he says.

The Global Robotics Institute recently received a $4.2 million grant from the U.S. Department of Defense to do research on telesurgery or remote site surgery.

"I think that's the next generation, being able to operate from one institution at another," says Dr. Patel. "It will have a huge humanitarian effect because patients in underserved areas will be able to be operated on by experts. Surgeons who might get in trouble surgically can be bailed out by experts around the world, who can log into their robot, take over control and help them get out of trouble."

Many surgeons who have never done robotic surgery attended the World Robotic Symposium. More and more young surgeons are drawn to the robotic approach. As the interest in reducing the invasiveness of surgical procedures continues to increase, those in the medical realm hope to see reductions in cost and improvements in effectiveness.

"The robot gave us the first step toward using this technology to improve patient outcomes," says Dr. Patel. "The future of surgery is now going to be using more technology to enhance what we've built upon."