ECU DaVinci Robot Articles - Winston-Salem/Forsyth County Schools

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  • 1. Articles from East Carolina University<br /><br />FDA approves first cardiac use of da Vinci Surgical System after successful trial led by ECU surgeons GREENVILLE, N.C. (11/13/02 ) -- Cardiac surgeons at the Brody School of Medicine at East Carolina University have led a successful national multi-center clinical trial studying the use of the da Vinci Surgical System for mitral valve repairs. This breakthrough robotic surgical procedure was approved for its first cardiac use by the U.S. Food and Drug Administration Nov. 12.Dr. W. Randolph Chitwood Jr., chairman of the Department of Surgery at East Carolina University, served as principal investigator of the 10-hospital study. He has performed 51 mitral valve surgeries using the da Vinci system - more than any other cardiac surgeon in the world. After receiving word of the authorization Tuesday, Chitwood performed the first post-approval mitral valve repair using the robotic device on a 74-year-old woman from Idaho Falls, Idaho. She is recovering well, Chitwood said.The multi-center FDA trial involved 112 patients, with ECU enrolling 22 patients. All ECU patients in the trial had their surgeries performed at Pitt County Memorial Hospital, the affiliated teaching hospital of the medical school. Before participating in the trial, surgeons at the nine other medical centers received training using da Vinci for this procedure through the Minimally Invasive Surgery/Computer Enhanced Training Center at ECU, the only site in the world offering certified mitral valve training on the robotic device.The clinical trial studied the safety and efficacy of the minimally invasive, robotic-assisted technique versus traditional sternotomy, or open-chest procedure, in repairing defective mitral valves. Cardiothoracic surgeons use mitral valve repair to treat a narrowing or leakage of the mitral valve. The mitral valve has two leaflets, or flaps, and allows blood to flow from the heart’s left atrium into the left ventricle. When the valve leaks, blood backs up into the lungs and causes the ventricle to pump more blood. Symptoms include irregular heart rhythms, shortness of breath and fatigue.Traditional open-heart surgery requires surgeons to make an 8- to 10-inch incision by sawing through the sternum and opening the rib cage to gain access to the heart.With the da Vinci Surgical System, Chitwood and his colleagues make a 4-centimeter incision between the ribs in the right chest and two other 1-centimeter incisions before inserting three robotic arms into the chest. One arm holds a tiny camera that projects 3-D images onto a monitor in front of the surgeon. The lens system magnifies millimeter-sized arteries and veins 10 times, to the size of drinking straws. The other two arms hold the pencil-sized instruments, which have tiny computerized mechanical "wrists" designed to transmit the dexterity of the surgeon’s forearm and wrist into the chest at the operative site.Seated at a computer console located apart from the operating table, the surgeon views a magnified, 3-D image while manipulating the surgical instruments using two joystick-like devices."Clearly there is a shorter learning curve with the da Vinci Surgical System than with standard laparoscopic surgery," Chitwood said. "The operative times fall very rapidly within the first 20 cases. These operations still are somewhat longer than conventional breast-bone incision operations, but proven data suggests improvement in the patients' recovery with less complications in the selected patients upon whom we have operated thus far for mitral valve disease."A continuum of improvements could make robotic telemanipulation supplant conventional mitral valve surgery; however, it will require wide acceptance of surgeons who will look for facilitating adjunctive technologies to apply with the robot method," he said. "This is to say that new devices are being developed to work with the robot to decrease operative times, such as valve implantation clips to replace sutures that must be tied."ECU is the leading international training site for the da Vinci Surgical System for all surgical disciplines. To date, more than 150 surgical teams from throughout the United States, Europe and Asia have trained at the ECU facility. With the green light from FDA, 15 surgical teams are already scheduled to receive cardiac training at ECU.Chitwood pointed out that even though the FDA has approved da Vinci for its first cardiac use, surgeons must complete certified training before offering the procedure at their hospitals."Approval (of this device) means a wider usage of the technology in the United States," Chitwood said. "However, clearly an entire cadre of surgeons must be trained first to use this device appropriately to provide optimal patient care with the benefits of true minimally invasive cardiac surgery."Earlier this year, Dr. Wiley Nifong, director of surgical robotics at ECU, presented encouraging research data at the 38th annual meeting of the Society of Thoracic Surgeons in Fort Lauderdale, Fla. He reported decreased length of hospitalization for patients having mitral valve repair using the da Vinci system compared to the traditional approach and decreased surgical repair time as experience with the robotic device grew.The average length of stay for patients with robotic-assisted mitral valve repairs was 3.8 days. With traditional sternotomy incisions, hospitalization is usually seven to 10 days. Patients also have reduced pain and fewer blood transfusions because of less surgical trauma to the body compared to the traditional sternotomy approach.Even though the total operating room times were approximately 30 minutes more for the robotic-assisted approach in the first patients in the study, Nifong said that the patients have had no adverse side effects or complications. "In fact, patients recover more quickly despite being in the operating room an additional 30 minutes because of the minimally invasive approach. We are working on adjunctive technology which will allow us to decrease the operative times toward conventional procedures," he said.Also participating in the multi-center trial were cardiothoracic surgeons at Brigham and Women's Hospital in Boston, Columbia Presbyterian Hospital in New York City, Advocate Christ Hospital in Chicago, the University of Southern California in Los Angeles, Carilion Roanoke Memorial Hospital in Roanoke, Va., the Baylor College of Medicine in Dallas, the Ohio State University Medical Center in Columbus, Providence St. Vincent's Medical Center in Portland, Ore., and Inova Fairfax Hospital in Fairfax, Va.The da Vinci Surgical Systems is made by California-based Intuitive Surgical Inc.Chitwood is an internationally recognized leader in the development of robotic devices in minimally invasive cardiac surgery. He has performed more than 350 minimally invasive cardiac procedures in the United States and Europe, including work at the Heart Center at the University of Leipzig in Germany, a leader in such procedures.ECU team completes 100th robot-assisted mitral valve surgeryGREENVILLE, N.C. (9/30/03 ) -- Dr. W. Randolph Chitwood and his surgical team have performed their 100th robotic cardiac mitral valve repair using the da Vinci Surgical System--a milestone for robotic surgical technology and minimally invasive cardiac surgery. The patient, a 46-year-old emergency medicine physician from the Charlotte area, Dr. Robert Petrilli, did well during the Monday surgery and is recuperating comfortably today, Chitwood said. Petrilli suffered from severe mitral valve regurgitation and prolapse, defects that Chitwood was able to repair using the surgical robot. Chitwood is professor of surgery, chief of cardiothoracic and vascular surgery, and senior associate vice chancellor for health sciences at the Brody School of Medicine at East Carolina University. The operation was performed at Pitt County Memorial Hospital, the affiliated teaching hospital for ECU's medical school. In May 2000, Chitwood performed the first total heart valve surgery using robotic technology in North America. Since then, he has taught more than 150 heart surgeons from around the world how to use the da Vinci for cardiac and mitral valve surgery through the Minimally Invasive Surgical Training Center at ECU. Data compiled by Dr. Wiley Nifong, director of surgical robotics at the Brody School of Medicine, shows that time on the heart-lung machine has decreased by 30 minutes in those 100 procedures. Furthermore, length of stay in the hospital is less than four days compared to eight days for conventional open-heart procedures. Most patients are back to work in 10 to 14 days. Each year, more than 50,000 procedures are performed on the mitral valve, which regulates the blood flow from the left atrium, or holding chamber, to the left ventricle, the heart's main pumping chamber. "During these first 100 operations, we have learned that cardiac surgery can be done safely using robotic techniques with the same results as a full sternotomy (full chest incision). Visualization and dexterity are much better," Chitwood said. "There is a learning phase and during that time operations take longer but have similar results. However, after this early period surgeons with some experience in endoscopy easily adapt to this advancement in technology. "The early adopters are becoming more convinced of the efficacy of mitral valve surgery done robotically. Now the more traditional majority has become interested and we have trained more than 50 surgical teams in these methods. This 100th case signifies that surgeons and staff at our institution and those trained by us now have full confidence in these robotic assistants in surgery and that they are safe and effective." With the da Vinci Surgical System, Chitwood and his colleagues make three dime-sized incisions in the chest, through which they insert three robotic arms. 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 "wrist" instrument tips designed to transmit the dexterity of the surgeon's forearm, wrist and fingers into the chest at the operative site. Seated at a computer console a few feet away from the operating table, the surgeon views a magnified, three-dimensional image and manipulates the surgical instruments using two fingertip controls. Chitwood has also used the da Vinci Surgical System in his treatment of atrial fibrillation in patients who also have defective mitral valves. In atrial fibrillation the heart's two upper chambers, the atria, quiver instead of beating effectively. "We currently have performed more than 30 robot-assisted operations for atrial fibrillation either alone or combined with mitral valve surgery," Chitwood said. "The number of Americans with atrial fibrillation is staggering. This technique promises to provide the best therapy with faster and less painful recovery for thousands of patients." In addition to his mitral valve regurgitation and prolapse, Petrilli also had atrial fibrillation. Chitwood used microwave energy to ablate, or destroy, the abnormal cardiac tissue causing the atrial fibrillation. The ECU series of mitral valve surgeries report no operative mortality and a 2 percent 60-day mortality rate (high-risk patients). The ECU team also reports that operating room times have continued to decrease since the earliest cases as proficiency increased. "Our operating room times have decreased dramatically since our first cases," Chitwood said, noting that recent robotically-assisted mitral valve patients spent approximately 1 hour and 30 minutes on the heart-lung bypass machine. "These patients may spend about 30 minutes longer on the heart-lung machine (than sternotomy patients); however, they experience less pain and have decreased recovery times because of the minimally invasive approach," Chitwood said. One of the innovations that has aided Chitwood during more recent robotic operations is the self-closing U-CLIP Device made of nickel titanium (or nitinol), a class of materials known as shape memory alloys. The U-CLIPs were partially developed by Chitwood and Nifong in conjunction with Coalescent Surgical, the device manufacturer. "These clips allow surgeons to both approximate tissue and place annuloplasty rings much faster during repairs. This all paves the way for expansion of endoscopic and minimally invasive valve surgery," said Chitwood. Petrilli noted that he researched his options after being told by his cardiologist that his mitral valve disease required surgical correction. He and his cardiologist, Dr. K.D. Weeks, saw Chitwood's name associated with research data about minimally invasive robotic-assisted heart surgery. Petrilli decided that the robot and Chitwood were the combination he wanted. "I chose Dr. Chitwood for two reasons: one is his passion and skill in fixing mitral valve disease; second is the minimally invasive approach which allows you a quicker recovery time," Petrilli said. For the past 15 years, Chitwood has pioneered the development of minimally invasive cardiac surgery. He developed instruments to perform operations endoscopically and later was one of the first to use robotic technology and guide this evolution. "Most new things go through an evolutionary phase, discovery and early adopters. And then proven results are shown. Once adopted, then more people around the world begin using the technology. If all these centers accrue the numbers (that we have), then it will become the accepted standard of care," said Chitwood. He said several U.S. medical centers have done approximately 20 robotic-assisted mitral valve repairs each, and in Leipzig, Germany, cardiac surgeons have performed approximately 30. While Chitwood and his surgical team will continue to perform mitral valve procedures with da Vinci, his focus will now also include robotically assisted coronary bypass surgery. "The da Vinci robot can be deployed in a variety of ways which include complete endoscopic coronary surgery as well off-pump robot assisted coronary surgery via a two-and-a-half-inch incision. We are now using the later method until the new coronary artery to graft connectors are perfected, enabling complete closed coronary operations with ease," he said. The da Vinci Surgical System, developed and produced by Intuitive Surgical, was approved by the Food and Drug Administration for its first cardiac use (mitral valve repair) last November. Chitwood served as principal investigator for the 10-hospital study. The FDA clinical trial studied the safety and efficacy of the minimally invasive, robotic-assisted technique versus traditional sternotomy, or open-chest procedure, in repairing defective mitral valves. Office of News and InformationDivision of Health SciencesEast Carolina UniversityGreenville, NC 27858Media Contact: Jeannine Manning Hutson(252) 744-2481,<br />