The Pennsylvania State University ©1997

Winter 2000 — Penn State Medicine magazine

ROBOTS USHER IN NEW ERA IN HEART SURGERY
By Leilyn Perri

As you look at the operating room of Ralph J. Damiano, Jr., M.D., you get the feeling that you are looking at a movie about the future. Damiano sits in a chair about 15 feet from his patient, facing a large TV monitor and wearing a headset with a microphone.

"Aesop, move right. Aesop, move in," commands Damiano. Aesop is a voice-controlled robot and part of the Zeus surgical system that has assisted Damiano in performing the first robotically assisted coronary artery bypass surgery.

While it may look like a scene from the movies, it is actually some of the most high-tech, experimental heart surgery in the world.

"Minimally invasive surgery will help patients by causing less pain and reducing their hospital stay," says Damiano. "For surgeons I feel that robotically assisted work will have a revolutionary impact in the future of cardiac surgery."

Damiano and his team performed animal studies at Penn State’s College of Medicine for several years before the first human robotically assisted surgery took place in December 1998. Since then he has performed the operation 15 times and will do a total of 20 surgeries as part of the phase 1 clinical trial approved by the Food and Drug Administration. Damiano has been working closely with Computer Motion of California, manufacturer of the robot.

In conventional open-heart surgery, a 12-to-15-inch incision is required to split a patient's breastbone to provide a surgeon direct access to the heart. Computer Motion's ZEUS Robotic Surgical System is designed to enable a surgeon to perform the delicate maneuvers necessary to suture the tiny vessels in heart bypass surgery through small pencil-sized ports. A tiny camera that is inserted into the chest through a small port, and is held by a voice-controlled robotic arm, provides visualization. Eliminating the large incision would provide the benefits of significantly reduced patient pain and trauma, shorter recovery times and convalescent periods, and overall improved outcome. In the United States alone, more than 450,000 open-heart surgeries are performed annually, the vast majority of which currently require the full 12-to 15-inch breastbone incision.

ZEUS consists of three interactive robotic arms placed at the operating table, a computer controller and an ergonomic surgeon console. One robotic arm is used to position the endoscope (a special, slender camera) while the other two robotic arms manipulate surgical instruments under the surgeon's direct control. While seated at the console, the surgeon can view the operative site in either 3-D or 2-D, depending on preference. The surgeon controls the movements of the endoscope with simple spoken commands. Movements of the surgical instruments are controlled via handles that resemble conventional surgical instruments. The movements of the instrument handles are scaled and tremor is filtered so that the surgeon will be able to perform fully endoscopic, minimally invasive microsurgery.

Damiano, professor of surgery and chief of cardiothoracic surgery at the college of medicine, says there is a learning curve for using the robotic equipment. "Learning to use this equipment takes several months. It is really developing a whole new way to operate," says Damiano.

Once Damiano has completed 20 cases, the data will go to the FDA as it studies the safety and efficacy of the device. Because there have been no problems so far, Damiano estimates the FDA may allow widespread clinical trials later this year. Last fall, permission was granted to expand the trial to two other centers, one in Dallas and one in Sarasota, Florida. This marked the first time surgeons other than Damiano performed this work. If the FDA does give its approval, the trial would then increase to a national multicenter trial.

"We know the real benefits for patients will come when we perform a totally closed procedure," says Damiano. "We look forward to doing that in the next few months."

Damiano came to Hershey Medical Center in 1996. He previously was an associate professor of surgery at both the Medical College of Virginia and McGuire Veterans Administration Hospital in Richmond. He also was the medical director of the Richmond Memorial Hospital/Medical College of Virginia Heart Program and director of both the surgical electrophysiology and cardiothoracic surgical research laboratories.

He has published numerous papers in peer-reviewed scientific journals and belongs to many professional organizations. He was the recipient of the American College of Surgeons Faculty Fellowship Award from 1991 to 1993.

Damiano received his undergraduate degree from Dartmouth College and went on to medical school at Duke University School of Medicine. He completed his residency and fellowship in surgery at Duke University Medical Center.

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Since being the first patient in the United States to undergo heart bypass surgery with the help of a robot, 70-year-old Elsie Leffler of Lebanon has been very busy. In addition to spending time with her children and grandchildren, she has done interviews with members of the local media as well as being on national television and even on TV in some other countries.

"I had no idea this would be such a big thing," says Leffler. ‘I knew I wanted to do this and hopefully in some way help others who needed this surgery."

Leffler, who was able to go home a few days after her surgery, had suffered a heart attack several months before her robotically assisted surgery. She has a family history of heart problems and realized she would need bypass surgery. As part of the FDA regulations, only one of Leffler’s three bypasses had robotic aid.

Damiano says Leffler’s experience will help others who follow her.

Today, more than a year after the historic surgery, Leffler reports feeling very good and is still keeping up with her grandchildren around her home and staying very active.