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At a glance
Intuitive Surgical Inc. says the da Vinci Surgical System:
•Was cleared for use by the Food and Drug Administration in 2000
•Uses incisions of less than 1/2 inch to 1 inch long to insert surgical tools
•Was used in about 450,000 procedures in 2012, a 25 percent increase over 2011
•Was installed in 2,025 hospitals worldwide for a total of 2,585 active systems as of Dec. 31
•Is used in 4 of 5 radical prostate removal surgeries in the U.S.
Source: Intuitive Surgical’s website
Photos by Cathie Rowand | The Journal Gazette
Nurse Michelle Rietdorf, left, and technician Laurie Peters prepare a da Vinci machine for surgery at Dupont Hospital.

Robot-assisted operation

Da Vinci surgical device plays growing role in local operating rooms

Peters places sterile coverings on the surgical arms of the da Vinci robot before an operation.
Cathie Rowand | The Journal Gazette
Surgeons use hand controls to guide the surgical arms of a da Vinci system with steadiness and precision they can’t achieve alone.

More than three dozen local surgeons are credentialed to operate using robotic equipment owned by three Fort Wayne hospitals.

Physicians performed 453 robot-assisted surgeries at Parkview hospitals in 2012 alone. Almost double that number was done at Lutheran Health Network facilities last year: More than 800 robot-assisted surgeries were performed at Dupont and Lutheran hospitals, officials said.

But as use of the da Vinci system increases rapidly, some critics are questioning the safety and the added cost of robotic-assisted surgery.

Intuitive Surgical Inc., the company that makes da Vinci systems, has issued a flurry of incident reports over the last nine months. In March, officials dismissed speculation that the increase meant their premier product wasn’t safe.

Officials said they changed their reporting process last September.

The new protocol resulted in more device malfunction reports. The most common problem was instrument cable breaks that disable the equipment but can be replaced quickly. None of the new reports involved injury or death, and the rate of problems remains low, officials said.

Intuitive’s leaders are facing multiple challenges these days.

The company saw U.S. sales fall 27 percent in the second quarter ended June 30. And the company’s stock was trading last week at less than $400 a share, 20 percent less than the $500 that shares were selling for before the company released second-quarter-sales numbers July 8.

The performance follows a statement released in March by a group of physicians who called into question the value of the da Vinci approach versus alternatives.

Local surgeons and hospital officials recently expressed confidence in the da Vinci system and what it allows them to do. They are unshaken by others’ doubts.

But they caution that the approach isn’t right for every patient or surgery.

“That is a very personal decision made by the patient and by the doctor in the doctor’s office,” said Chad Towner, Dupont Hospital’s CEO. “We are very focused on making sure we have a well-informed patient.”

Costs and cautions

The American College of Obstetricians and Gynecologists agrees that robotic surgery isn’t right for everyone.

In fact, the industry group in March seemed to question whether it’s right for anyone having a routine hysterectomy as opposed to complex cases involving cancer and removal of lymph nodes.

The Washington-based group said using robotic technology adds $2,000 on average to the cost of a basic hysterectomy – or removal of a woman’s uterus and, sometimes, ovaries.

“Vaginal hysterectomy, performed through a small opening at the top of the vagina without any abdominal incisions, is the least invasive and least expensive option,” the nonprofit said in a statement.

Intense marketing has driven the increase in robotic surgery, but “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,” the organization said.

The other minimally invasive option is laparoscopic surgery, which involves inserting a thin, lighted tube and surgical tools through small incisions in the abdomen. The surgeon controls the instruments while looking at a two-dimensional monitor to see the interior view provided by the laparoscope.

By contrast, the da Vinci system consists of a console that displays high-definition, three-dimensional images and three or four interactive arms equipped with surgical instruments. Surgeons see the real image, not a simulated one, and directly control equipment maneuvers in real time.

Intuitive Surgical officials also say the da Vinci system’s use is more intuitive than laparoscopy technology – hence the company’s name – because with laparoscopy, surgeons must rotate their hands left to make the equipment turn right and vice versa.

For surgeons, advertised advantages also include better vision, precision, dexterity and control than with hands-on procedures, because even the steadiest ones have a slight hand tremor.

‘It’s not perfect’

Parkview Health first bought the da Vinci technology about 10 years ago, said Dennis Warner, director of perioperative and ambulatory services for Parkview Hospital and affiliates.

The decision was prompted, he said, by interest from both patients and doctors.

About 100 of the procedures it was used for were at Parkview Randallia. The rest were at Parkview Regional Medical Center, where Parkview Health moved its first da Vinci Surgical System just in time for the medical center’s March 17, 2012, opening.

Officials added a second da Vinci system to the regional hospital in the fall and expect Parkview’s total robot-assisted surgeries to increase by 20 percent this year compared with last, spokesman Eric Clabaugh said.

Dr. Donald Urban, a urologist with Parkview Physician Group, enthusiastically embraces the use of robotic technology in the operating room.

Even so, he said, patients are the ones who typically push for it. Urban, who is chairman of the Robotic Surgery Executive Committee for Parkview Hospital and affiliates, said patients tend to read about the da Vinci Surgical System online, then seek out surgeons who use it.

Urban’s specialty is using da Vinci to remove diseased prostates. A decade ago, about 10 percent of prostate surgeries were performed using robotic assistance, he said. Today, that percentage is about 85.

Similar growth is happening in other types of surgery, Urban said. The da Vinci system can be used to remove kidneys and gallbladders in addition to prostates, uteruses and other organs.

“Open surgeons in urology became kind of dinosaurs,” he said.

Other specialists use da Vinci for heart, colorectal and ear-nose-throat surgeries.

Even so, Urban said, the best surgical approach is the one your physician is most comfortable with. Many surgeons coming out of medical residency now have trained on da Vinci, and many older surgeons are getting trained, he said.

“It’s not perfect. By any means, it’s not perfect,” he said of the technology.

But, Urban added, problems are typically due to operator error rather than trouble with the technology.

Patients are drawn to promises of shorter hospital stays, less scarring, less pain and shorter recoveries.

Creating demand

It seems that Intuitive’s marketing strategy is working.

About 450,000 da Vinci procedures were performed in 2012, a 25 percent increase over 2011, according to Intuitive’s website.

Intuitive describes itself as the industry leader in robotic-assisted surgery. The company sold 143 da Vinci systems during the quarter, and procedures performed using the technology increased by 18 percent.

Second-quarter revenue, reported July 18, was $578 million, an 8 percent increase from the prior year. Earnings were $159 million, up slightly from $155 million for 2012’s second quarter.

But even the Sunnyvale, Calif.-based company doesn’t claim da Vinci is best for every operation.

“While clinical studies support the effectiveness of the da Vinci Surgical System when used in minimally invasive surgery for specific indications, individual results may vary. There are no guarantees of outcome. All surgeries involve the risk of major complications,” the company says on its website.

Patients should opt for open surgery if they’ve had previous abdominal surgeries, which could leave scarring and adhesions and make robot-assisted surgery more challenging, Urban said. Bulky tumors, including large kidney cancers, are another good reason to forgo da Vinci, he said.

Dupont, Lutheran and Parkview hospitals each have a physician-led review board that decides whether individual surgeons have completed appropriate training and have enough hands-on experience to be credentialed to perform procedures at that health care facility.

Dupont has credentialed 36 local doctors to use da Vinci, and Lutheran has approved 28. Parkview has extended credentials to 29 surgeons. Some physicians are on more than one list, officials said. Approvals aren’t automatic and don’t last forever at any of the hospitals, officials for both health care systems said.

And despite the estimated $1.5 million price tag, plus annual maintenance fees, hospital officials say they don’t pressure surgeons to use da Vinci technology.

“I’m very confident in what we’re doing here every day,” Dupont’s Towner said. “My No. 1 job is patient safety.”