FDA approves second clinical trial for robotic heart surgery
(Nov. 9, 2000)
Cardiac surgeons at University Health Systems of Eastern Carolina have been granted a second clinical trial from the U.S. Food and Drug Administration to continue studying robotic surgery in the repair or replacement of heart valves. The announcement of the new trial comes on the heels of the completion of the first trial using the da Vinci Surgical System, which began May 3.
On Nov. 6, Dr. W. Randolph Chitwood completed the final case in the first round of the trial; on Nov. 7, he successfully completed the first case beginning the second trial. The first FDA clinical trial was to study the feasibility of the minimally invasive, robotic-assisted technique versus traditional sternotomy in repairing or replacing defective mitral valves. Both of this week's patients are recovering well, according to Chitwood, chief of surgery at Pitt County Memorial Hospital, a part of University Health Systems.
A 36-year-old Havelock father of three had his faulty mitral valve repaired on Nov. 6 with the da Vinci robotic device, becoming the last case for that clinical trial. He was released from Pitt County Memorial Hospital today, three days after his surgery - about half of the recovery time of traditional open-heart surgery.
Since childhood, the patient had a heart murmur caused by mitral valve regurgitation. Such leaking occurs when the mitral valve doesn't fully close and allows blood to seep back into the heart's left atrium from the left ventricle. According to Chitwood, more than 70,000 heart valve repair or replacement surgical procedures are performed each year in the United States.
The patient who was operated on Nov. 7, also a 36-year-old man, should be released Nov. 10, three days after his surgery as well. Chitwood said both patients' excellent recoveries show the benefits of the minimally invasive approach to repairing the heart.
"To cardiac surgeons, using minimally invasive robotic devices is comparable to the Wright Brothers learning to fly," said Chitwood, who is also chairman of the Department of Surgery at the Brody School of Medicine at East Carolina University. "Although we are in the early stages of developing and applying robotics to cardiac surgery, the future looks promising. Today's surgery, as well as the previous 10 surgeries in the first trial, have produced positive outcomes which we will share with the FDA."
ECU cardiac surgeon Wiley Nifong (center) describes the workings of the da Vinci surgical robot to members of the state Advisory Budget Commission, who visited Greenville Nov. 27 to learn more about the medical center's surgical robotics program.
According to Dr. L. Wiley Nifong, director of surgical robotics at ECU and University Health Systems, in the first clinical trial and the corresponding second trial 10 patients will receive either a repair or replacement procedure for their defective mitral valves using the da Vinci surgical robotic device.
Traditional open-heart surgery requires surgeons to make an 8-to-10-inch incision, saw through the sternum and open the rib cage to gain access to the heart.
With the da Vinci Surgical System, Chitwood and his colleagues make three dimed-sized incisions before inserting three robotic arms into the chest. One arm holds a tiny camera that projects three-dimensional images onto a monitor in front of the surgeon; the other two arms hold the pencil-sized instruments, which have tiny computerized mechanical "wrists" designed to transmit the dexterity of the surgeon's foreman and wrist into the chest at the operative site.
Seated at a computer console located approximately six feet away from the operating table, the surgeon views a magnified, 3-D image and manipulates the surgical instruments using two joystick-like devices.
"The robotic technology is so precise, and it eliminates all tremor that occurs with the human hand," said Chitwood. "The robotic arms en