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NH Board of Medicine to review concerns about robotic surgery complications

New Hampshire Union Leader

April 03. 2013 10:46PM
Surgeons practice using the da Vinci robotic surgical system, which is used to repair torn heart valves without having to open an incision in the patient's chest. The system, originally designed for use in battlefield conditions during chemical or biological attacks, is used by doctors at Manhattan's New York-Presbyterian Hospital for heart operations. Intuitive Surgical, Inc./ via Bloomberg News 

The state's Board of Medicine this week is expected to discuss concerns that complications from robot-assisted surgery are on the rise nationally.

An advisory issued by Massachusetts health officials last month said some surgeons may be using robotic devices without enough training or in situations where a robotic tool is no better than a surgeon's hands. Prostate, gynecological, cardiac, colo-rectal, head and neck and other procedures are performed with the devices.

"It will be up for discussion, but at this time I don't know if the board would choose to issue a similar advisory here in New Hampshire," said Kathy Bradley, executive director for the New Hampshire Board of Medicine.

Bradley said no complaints have been filed with the New Hampshire board, but the Massachusetts board said it "has received an increasing number of safety and quality review reports of patient complications associated with robot-assisted surgery."

"Robot-assisted surgeries have a number of technical advantages, such as an improved field of view ..., but like any surgical procedure, they carry risks of complications and poor outcomes," the Massachusetts advisory said.

The most popular type of robotic technology, the da Vinci Surgical System, is used at Parkland Medical Center in Derry, Concord Hospital, Portsmouth Regional Hospital, Southern New Hampshire Medical Center and St. Joseph Hospital in Nashua, Elliot Hospital and Catholic Medical Center in Manchester, and Wentworth-Douglass Hospital in Dover.

"We are doing procedures with the robot that could not be done before, repairs we could not do at all with conventional equipment and procedures, and we're doing them safely," said Dr. Jeffrey Segil, a robotic surgeon at Wentworth-Douglass Hospital.

Debuted in 2000

The da Vinci debuted in the United States in 2000. Operated using a console with joystick-like controls, the daVinci's four robotic arms can twist and turn in more directions than a human wrist, translating the surgeon's hand movements into smaller, more precise motions.

Images of anatomy are magnified on a video screen, giving physicians a better view during procedures.

The arms operate through small incisions, typically resulting in a patient experiencing less blood loss, a smaller scar and faster recovery.

Each machine, manufactured by Intuitive Surgical Inc. of California, can cost from $1 million to $2.25 million, depending on the model.

Hospitals pay an additional $140,000 a year for maintenance on the robot and $1,500 to $2,000 per surgery for replacement parts.

Surgeons say the technology is worth the investment and provides a mechanism to operate with more precision.

In an emailed response to a reporter's question, Cristina Galli, director of marketing and public relations for HCA New Hampshire and Parkland Medical Center, said, "The benefits to robotic surgery are not inherent to the machine itself, but rather a testament to the surgical expertise of the primary surgeon and the skilled operating room team, postoperative nursing care, skilled anesthesiologists, etc. These are the ingredients that comprise a successful robotic surgical program. We are proud of our team and have never focused on the technology as an isolated phenomenon."

Said Dr. David Green, chief medical officer at Concord Hospital, "They can be less invasive. You can see anatomy like you've never seen it before. It's a valuable tool when used appropriately."

Three cases described

The Massachusetts board's advisory describes three cases in which robot-assisted surgeries went wrong.

In one, the system interfered with communication between two attending surgeons, rendering them unable to coordinate their actions.

In another, the device was being used for a new procedure, which added to the complexity of the surgery to the point where the medical team involved failed to notice that material was left inside the patient, requiring follow-up surgery.

The advisory does not mention specific hospitals, nor does it mention use of the devices in New Hampshire.

Wentworth-Douglass Hospital introduced robot-assisted surgery in March 2006 after a review by the hospital's New Technology Research and Assessment Group, hospital spokesman Noreen Biehl said.

In 2010, a lawsuit filed in New Hampshire is believed to have been the first in the country involving the da Vinci robot.

The plaintiff alleged her ureters - tubes connecting the bladder to the kidneys - were accidentally cut during a hysterectomy using the da Vinci robot at Wentworth-Douglass Hospital in 2009. Biehl said the suit was dismissed.

"There was no merit to the plaintiff's claims," Biehl said in an email. "WDH is proud of our patient safety record with the da Vinci robot and believes robotic surgery has extended the options for our patients and actually created surgical treatments not available prior to its implementation."

"We have had an ongoing monitoring process since 2006 of all robotic cases," said Dr. Anne Kalter, a gynecologist and surgeon at Wentworth-Douglass, who Biehl said has performed hundreds of robot-assisted surgeries and served as the first chairman of the hospital's robotics committee. "We maintain a very low complication rate that is also lower than national rates. We are also very aware of the issues surrounding patient positioning and resolved these issues in the very beginning of our program."

Disclosure, monitoring

Hospitals are not required to disclose the complication rates involving these devices.

Other hospitals in New Hampshire also have monitoring systems in place.

"We have a credentialing program in Concord," said Green. "You need to discuss the risks with the patient."

"For more than a year now, we have had regular meetings of a multidisciplinary Robotic Surgery Committee at Parkland to review safety concerns, monitor current and future robot use, new initiatives and the like," said Galli. "The committee uses safety and outcomes data to review and ensure ongoing best practices to ensure patient safety."

Elliot Hospital has a credentialing process surgeons must complete before using its da Vinci system.

"You must complete a specific training course on robotic techniques," said Susanna Whitcher, vice president of public affairs and marketing at Elliot. "As we do with all surgical cases, including da Vinci, we then monitor for length of stay of the patient, infection, and unplanned return to the operating room."

"You have to have a level of respect for your patients, and you have to respect the technology," said Dr. Corin Dechirico, associate vice president of medical affairs at Southern New Hampshire Medical Center.

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