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FDA Consumer magazine

July-August 2005 Issue

Computer-Assisted Surgery: An Update

By Michelle Meadows

The Food and Drug Administration first cleared the da Vinci Surgical System in 2000 for general laparoscopic surgeries such as gall bladder removal and for treatment of severe heartburn. Since then, use of the system has increased and expanded into several other surgical areas. These include removal of the prostate (radical prostatectomy); non-cardiac chest procedures involving the lungs, esophagus, and a blood vessel inside the chest cavity (internal thoracic artery); and certain procedures involving surgical incisions into the heart, such as mitral valve repair.

In April 2005, the FDA cleared the da Vinci system for gynecological laparoscopic procedures. Surgeons are now able to remove the uterus (hysterectomy) and to remove uterine fibroids (myomectomy) using the device. The system has also been cleared for use in all urologic procedures. And, in 2004, the FDA broadened the application of the da Vinci system for assisting in coronary artery bypass surgery.

"The development of this system for use in the heart is a step forward in new technology that eventually could change the practice of surgery," Acting FDA Commissioner Dr. Lester M. Crawford says.

A Minimally Invasive Approach

Experts say the key benefit of computer-assisted surgery is being able to perform surgery through smaller incisions. W. Randolph Chitwood Jr., M.D., chairman of the department of cardiothoracic surgery at East Carolina University, in Greenville, N.C., says he's experienced the long healing time that comes with big incisions firsthand. For his own heart surgery in 1994, he underwent the traditional procedure for open heart surgery called a sternotomy. It involves a foot-long incision through the breast bone. "It was around that time that I became interested in minimally invasive heart surgery," says Chitwood, who has performed close to 200 mitral valve repairs using the da Vinci system.

"Making smaller incisions means the potential for less pain, less blood loss, and faster recovery for patients," Chitwood says. He is able to repair narrowing or leaking heart valves by making a few small incisions between the ribs. In 2004, the da Vinci system was used in more than 2,400 surgeries related to the heart and chest in the United States. These include mitral valve repair and coronary revascularization, a procedure that bypasses blockages in the coronary arteries so that blood flow to the heart can be restored.

While sitting at a console several feet away from the operating table, the surgeon views the inside of the patient's body by looking through lenses. A magnified 3-D vision system gives an enhanced view of the surgical field. The surgeon moves controls to manipulate the device at the operating table. The da Vinci system has up to four arms that are inserted into the patient through small incisions. One arm holds a miniature camera, and the other arms hold a variety of instruments. Chitwood says the camera serves as his "eyes." The arms have flexible wrists that give surgeons access to hard-to-reach areas. The device doesn't move on its own, but rather cuts and sews at the surgeon's direction.

"The improved vision and flexibility of the instruments allow for increased precision," says Thomas Ahlering, M.D., chief of the division of urologic oncology at the University of California, Irvine, Medical Center. Since 2002, Ahlering has used the da Vinci system to remove the prostate (prostatectomy) in men with prostate cancer. He performed about 100 radical prostatectomies with da Vinci in 2004.

"Even though it's a walnut-sized gland, the prostate is highly functional," Ahlering says. Located below a man's bladder, the prostate is surrounded by nerves and muscles that affect urinary, rectal, and sexual function. Great care and precision are required to remove the prostate without damaging these structures.

With computer-assisted surgery, Ahlering's patients have returned to work in 10 to 14 days, about half the recovery time required for conventional, open surgery, he says. Conventional surgery for removal of the prostate typically requires about a seven-inch incision in the lower abdomen.

"With the da Vinci system, the blood loss for patients is about one-fifth to one-tenth of what it would be for open surgery," Ahlering says. "Also, the urinary catheter remains in for about half as long, and patients tend to get urinary control and sexual function back more quickly." Research has shown that there is also less use of narcotic medication during the recovery period. In 2004, there were more than 8,000 radical prostatectomies performed with the da Vinci system in the United States.

Patient Safety

Ahlering says that based on his experience so far, the risks with computer-assisted surgery appear to be less than with other forms of surgery. "Risks such as bleeding and needing a transfusion or cutting into the rectum are lower with this procedure," he says.

Rarely, doctors may have to switch from the device to a traditional method of surgery. "Once a camera went out, but we had another system and were able to use that," Ahlering says. "If I didn't have another one, I would have either had to switch to open surgery or reschedule it for another day if it was early enough in the procedure."

To date, there have been no patient injuries or deaths attributed to system failures with the device, according to the da Vinci manufacturer, Intuitive Surgical Inc., of Sunnyvale, Calif. The FDA tracks adverse events related to medical devices. Chitwood says he has had one patient die during a computer-assisted procedure. "This was due to a medication reaction, not a device failure," he says.

In 2002, a Florida man died two days after blood vessels were accidentally cut during a surgery for kidney removal with da Vinci. Shortly after the death, officials at St. Joseph's Hospital in Tampa, Fla., called the incident "a tragic, isolated event."

Patients considering robotic surgery should talk with their doctors about the benefits, risks, and any factors that would exclude them as candidates. For example, previous abdominal surgery, obesity, or a prostate that's too large are among the factors that might exclude a patient from having a radical prostatectomy with da Vinci, Ahlering says. He suggests that consumers consider the experience of the surgeon and seek out medical centers that focus on computer-assisted procedures.

The da Vinci Surgical System is the only operative surgical device of its kind on the market in the United States. In 2003, Intuitive Surgical bought Computer Motion of Goleta, Calif. Computer Motion was the manufacturer of the Zeus Robotic Surgical System, which is no longer actively being marketed.

According to Intuitive Surgical, there are 286 da Vinci systems installed worldwide, including 204 in the United States, 56 in Europe, and 26 in Asia and other parts of the world.

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