Surgical Robot Examined in Injuries

May 6, 2010

DOVER, N.H.—Wentworth-Douglass Hospital, a small community hospital in this coastal New England town, used a college hockey game to showcase its new technological marvel: a $1.4 million surgical robot named after Leonardo da Vinci.  As the University of New Hampshire battled the University of Vermont last season before a crowd of 6,000, hospital representatives invited fans to try out the robot between breaks in the action.

Wall Street Journal

The da Vinci has been billed as a breakthrough in the quest to make surgery less invasive. With its four remote-controlled arms and sophisticated camera, it enables surgeons to operate through small incisions with greater precision and visibility.

At Wentworth-Douglass, however, the robot has been used in several surgeries where injuries occurred. One patient operated on days after the hockey game was so badly injured that she required four more procedures to repair the damage. In earlier robotic surgeries, two patients suffered lacerated bladders.

There’s no evidence to suggest the injuries at Wentworth-Douglass were caused by technical malfunctions. Surgeons who use the da Vinci regularly say the robot is technologically sound and an asset in the hands of well-trained doctors. But they caution that it requires considerable practice.

The da Vinci robot allows surgeons to operate through small incisions, avoiding the need to open up the abdomen.

As a small regional hospital, Wentworth-Douglass has used the da Vinci about 300 times in four years. That’s a fraction of the usage rate of some big medical centers and, some surgeons say, too little for the doctors at the hospital to master it.

It’s impossible to compare Wentworth-Douglass’s rate of complications from robotic surgeries to that of other hospitals. Because of peer-review regulations designed to preserve doctors’ anonymity, most hospitals don’t disclose such information.

Noreen Biehl, a spokeswoman for Wentworth, says the hospital’s da Vinci complication rates are below the rates published in two recent gynecological studies. Wentworth-Douglass adopted the robot for the good of patients and still feels it was the right decision, she says.

The price of the machine ranges from $1 million to $2.25 million, depending on the model. In addition, hospitals pay another $140,000 a year for the robot’s maintenance and $1,500 to $2,000 per surgery for replacement parts.

One study published in the Journal of Urology found that a hospital needs to do at least 520 surgeries a year with the robot to bring its costs in line with traditional surgery. That’s seven times the number of robotic surgeries Wentworth-Douglass has been averaging.

“There’s a medical arms race,” says Paul Levy, chief executive of Beth Israel Deaconess Medical Center in Boston. “Technologies are being adopted and becoming widespread based on the marketing prowess of equipment makers and suppliers, not necessarily on the public good.”

Mr. Levy initially resisted buying a da Vinci in the absence of reliable data demonstrating it was better for patients. But he eventually relented when his urology team told him the hospital was losing business to competitors that had one.

Ben Gong, a spokesman for da Vinci maker Intuitive Surgical Inc., says the robot is worth the expense: “If something doesn’t add value, it definitely should not be used. But I don’t think the da Vinci is just adding costs.”

Last year, Intuitive Surgical reported profits of $233 million on sales of $1.05 billion. Its stock price has more than doubled over the past year to $361 a share, giving the company a market value of $14 billion.

The da Vinci was introduced in the U.S. in 2000. A massive machine operated from a console with joystick-like controls, the da Vinci is now employed for a variety of surgical procedures, from removing cancerous prostates to heart surgeries.

By avoiding cutting open a patient’s abdomen, it produces less blood loss, much smaller scars and a faster recovery, while giving surgeons a range of movement greater than the human hand.

In use at 853 hospitals across the U.S., the da Vinci has become a symbol of medical progress: One of the machines was featured on the cover of U.S. News & World Report’s Best Hospitals issue last summer, while another appeared on the TV show Grey’s Anatomy. It also became a symbol of health reform when President Barack Obama was photographed trying his hand at one during his visit to the Cleveland Clinic.

However, some surgeons have questioned the way the robot has been marketed. Intuitive Surgical has marketed the da Vinci to hospitals as a way for them to increase their revenues and gain market share.

More than 800 U.S. hospitals have acquired at least one of the da Vinci machines in the past decade.

A 14-minute video on the company’s website features testimonials from surgeons and hospital administrators. A key message: The robot has been good for business. One cardiac surgeon in the video says at least 70 of his 250 annual cases are new patients who wouldn’t have been referred to him if not for the robot.

Small hospitals have been receptive to the pitch. The 853 hospitals with da Vincis include 131 hospitals with 200 or fewer beds.

Wentworth-Douglass began leasing its da Vinci in 2006. The 178-bed nonprofit facility competes for patients with six other hospitals located within a 30-mile radius in eastern New Hampshire and southern Maine. None of those hospitals had the robot, so Wentworth-Douglass saw an opportunity to gain a technological edge.

Some of the hospital’s surgeons opposed getting the robot because they felt Wentworth-Douglass didn’t perform enough surgeries to overcome the machine’s long learning curve, several current and former members of the medical staff say.

Some surgeons with extensive robotic experience say it takes at least 200 surgeries to become proficient at the da Vinci and reduce the risks of surgical complications. That’s difficult for surgeons at smaller hospitals to achieve.

Jim Hu, a surgeon at Brigham and Women’s Hospital in Boston who has done more than 1,000 surgeries with the robot, says it takes a urologist anywhere from 250 to 700 cases to master it. Dr. Hu considers the da Vinci a clear benefit for experienced surgeons, saying, “You can do a better job.” But he cautions it can do more harm than good when used without adequate training.

Aleks Cukic, Intuitive Surgical’s vice president of strategy, says the robot’s learning curve “varies from procedure to procedure and from surgeon to surgeon.” He adds: “There’s no number” of surgeries required to master the device.

One of Wentworth-Douglass’s surgeons, Paul Butler, expressed his opposition to buying the robot in a letter to the hospital’s board of trustees.

Another surgeon, Robert Lambert, says he told one of the trustees of the staff’s opposition while the robot was being shown to the board. Both said the robot wasn’t needed at a hospital the size of Wentworth-Douglass.

Ms. Biehl says the hospital “took into account the opinions of all surgeons” before leasing the robot: “A majority were in favor and some were not in favor.”

Soon after leasing the machine in early 2006, Wentworth-Douglass began marketing it in advertisements on radio, television and in the local newspaper.

The hospital also began pressuring its surgeons to use it, the current and former members of the medical staff say. Dr. Lambert, who left to become an assistant professor of surgery at Upstate Medical University in Syracuse, N.Y., says the pressure contributed to his departure.

Ms. Biehl denies any such pressure. Wentworth-Douglass says Dr. Lambert left mainly because he couldn’t convince the hospital to start a bariatric surgery program.

Some current and former members of the medical staff say the training Wentworth-Douglass offered on the robot was insufficient. It included two days of operating on pig and human cadavers at a hospital in New Jersey.

Upon their return, the trainees started operating on live patients. Surgeons from other specialties supervised the first few da Vinci surgeries of newly trained doctors. A urologist supervised some of the hospital’s gynecologists in their first robot surgeries.

Ms. Biehl confirms the training regimen but says the urologist, who was on the staff of another hospital, had considerable experience with the robot.

Intuitive Surgical says the New Jersey hospital, Hackensack University Medical Center, is one of 20 hospitals that train surgeons on the robot. When new hospital clients buy the robot, the package includes the two-day course for two surgeons at one of the training centers, which the company pays for.

Intuitive Surgical’s Mr. Cukic says it’s up to hospitals to create guidelines for when their surgeons can do surgeries with the robot unsupervised. “That’s not for us to say,” he says.

At Wentworth-Douglass, surgeons begin doing da Vinci surgeries unsupervised after four cases.

Dr. Hu of Brigham and Women’s, who did a one-year fellowship and assisted on 400 robot surgeries before he began operating solo, says that’s much too soon. “None of us would go and get surgery if we knew the guy had done it just a couple times before,” he says.

Wentworth-Douglass’s four urologists resisted using the robot without more training, people familiar with the matter say. Three of the four ended up leaving the hospital.

Unlike the urologists, the hospital’s gynecologists started using the robot. Several complications occurred. The bladders of two female patients were lacerated during routine gynecological surgeries performed with the robot, a person with direct knowledge of those cases says.

One of the patients had to be sent to the Lahey Clinic in Burlington, Mass., for another surgery to repair the damage, the person says. The patients survived. A spokesman for the Lahey Clinic declined to comment.

Ms. Biehl says bladder injuries “are a known risk of this type of surgery” whether or not a robot is used. She declined to discuss the cases or identify the patients, citing patient privacy laws.

Mr. Cukic of Intuitive Surgical says it’s hard to draw any conclusion from the cases without knowing Wentworth’s overall rate of complications.

In June 2007, one of general surgeon David Coppola’s first da Vinci patients was an elderly man with a stomach condition. Under the supervision of a proctor, Dr. Coppola operated on the man for several hours with the robot, people with knowledge of the case say. But Dr. Coppola eventually gave up on using the robot and switched to open surgery. The patient died after his esophagus was perforated.

It’s unclear whether the esophagus was injured during the robotic part of the surgery or after Dr. Coppola opened the man’s abdomen and reverted to traditional surgery. Dr. Coppola didn’t return calls seeking comment.

Ms. Biehl declined to discuss the case, citing patient privacy laws, but she says the hospital has had “no deaths of patients related to robotic surgery injuries.” Mr. Cukic declined to comment about the case.

One of the surgeons featured in the hospital’s robot advertisements was gynecologist Elizabeth Chase. In one newspaper ad in which she posed with a smiling patient, Dr. Chase was quoted as saying that the robot enabled her “to perform intricate surgery more safely.”

On March 2, 2009, Dr. Chase proctored another Wentworth gynecologist new to the robot, Rebecca Ann Banaski, during a routine hysterectomy. During the surgery, Dr. Banaski accidentally cut both of the patient’s ureters with the robot, people familiar with the operation say.

The ureters are the tubes that connect the kidneys to the bladder. Cutting both ureters is considered a rare and serious surgical complication because it can cause the kidneys to shut down. The patient, a woman in her 40s, had to undergo four more procedures over the following eight months to repair the damage, the people with knowledge of the matter say.

After the incident, Wentworth-Douglass made Drs. Chase and Banaski undergo remedial training on the robot, the people familiar with the matter say. Dr. Chase was also temporarily barred from proctoring others and placed under the oversight of another surgeon when she resumed using the robot, they say.

The Joint Commission, an independent body responsible for hospital accreditations, investigated robotic injuries at Wentworth-Douglass in October.

Ms. Biehl says the commission came away satisfied with the quality of the hospital’s robotic program and required no improvements. A spokeswoman for the Joint Commission confirmed it issued no requirement for improvement but declined to otherwise discuss the inquiry.

Dr. Chase and Dr. Banaski didn’t return calls seeking comment.

Ms. Biehl calls Dr. Chase “an excellent surgeon” and says she is currently cleared to operate with the robot on her own. Ms. Biehl adds that no medical malpractice lawsuits have been filed against Wentworth-Douglass “related to robotic surgery.”

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