Apr 102013


“This device, when used in an appropriate way by a properly trained surgeon, will give results you wouldn’t believe.”

Dr. W. Randolph Chitwood

director of the East Carolina Heart Institute

By Michael Abramowitz

Wednesday, April 10, 2013

A Greenville-based pioneer in robotic surgery said on Tuesday that he has full confidence in the capabilities of a robotic tool that has come under close scrutiny for reported problems in other parts of the country.

A million-dollar, multi-armed robot named da Vinci, is manufactured in California by Intuitive Surgical. It was used in nearly 400,000 surgeries nationwide last year and is being linked to surgical problems, including several deaths, that may be linked with it.

The Food and Drug Administration is looking into a spike in reported problems during robotic surgeries. Earlier this year, the FDA began a survey of surgeons using the robotic system. The agency conducts such surveys of devices routinely, but FDA spokeswoman Synim Rivers said the reason for it now “is the increase in number of reports received” about da Vinci since early last year, including at least five deaths.

Some doctors said their enthusiasm for the machine has been abated over concerns that physicians’ fascination with robotic devices and heavy marketing have boosted their use. They said more research is needed to determine whether robotic surgery is at least as good or better than conventional surgeries.

Most reported problems do not trace back to the daVinci or other robotic tools, but with the hands that guide them and the people who train them, according to heart surgeon Dr. W. Randolph Chitwood, director of the East Carolina Heart Institute and senior associate vice chancellor for health sciences at the Brody School of Medicine.

“This device, when used in an appropriate way by a properly trained surgeon, will give results you wouldn’t believe,” Chitwood said. “From what I’ve seen, problems occur when someone has not had a lot of experience at robotic minimally invasive surgery and thinks the machine will make him a better surgeon.”

The second part of the failure equation is tied to the surgical team, he said.

“Working with a robotic surgical device requires a total team approach,” Chitwood said. “Our team is absolutely in sync; it’s almost like they cling together.”

Chitwood said he frequently is asked to train surgeons at robotic surgery, but he has very tight standards.

“I won’t train anyone who isn’t already a highly experienced mitral valve surgeon using the traditional approach, and I won’t train anybody unless they bring the whole team, including the anesthesiologist, scrub nurse and circulating nurse,” he said.

Chitwood credits his and the heart institute’s success with the da Vinci to the serious approach he and his staff take toward its use.

“We haven’t had any of the kinds of problems with the da Vinci (at ECU) that have been reported elsewhere,” he said. “We haven’t had to abandon an operation because of the machine in more than 10 years.”

Chitwood performed the first camera-assisted mitral valve replacement surgery in the United States in 1996, after dozens of trials with it, and became interested in moving the field of surgery toward minimally invasive techniques, he said. He first worked with the da Vinci when it was a prototype. It saw its first commercial use in 1999 in Greenville, he said, with two generational upgrades since.

“The device allows for fantastic, three-dimensional visualization of the surgical field and better ergonomics for fine valve reconstruction work,” Chitwood said. “It is minimally invasive, using a much smaller incision and entry with very little bleeding. You can access and put a stitch anywhere with ambidextrous ease. You have to see it to believe it.”

The da Vinci also is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has increased worldwide, but the system is most popular in the United States.

Chitwood and other advocates said patients have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.

Whether there truly are more problems recently is uncertain. Rivers said she couldn’t quantify the increase and that it simply may reflect more awareness among doctors and hospitals about the need to report problems. Doctors are not required to report such things; device makers and hospitals are.

A spokesperson at Vidant Medical Center said the hospital has two da Vinci robots, performing about 400 surgeries per year and growing in use. They are used in cardiac surgery, primarily for mitral valve repairs, thoracic surgery for lung resections, in urology, primarily for removing prostates and for hysterectomies. Prices range from $1 million to $1.5 million for the device.

Information about incidences of harm or infection associated with use of the da Vinci at Vidant was not readily available, the official said.

Contact Michael Abramowitz at mabramowitz@reflector.com or 252-329-9571.

via The Daily Reflector.


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