Both FDA-cleared da Vinci robot and "port-access" approach to score in heart surgery

Oak Lawn and New Brunswick 20 November 2002Heart surgeons from throughout the United States gathered at Advocate Christ Medical Center in Oak Lawn, Illinois, on November 21, for the nation's first conference on the use of robotic technology in repair of the heart's mitral valve. In the same week, cardiologists heard about the benefits of robotic heart surgery using the da Vinci Surgical System at the annual Scientific Sessions of the American Heart Association. While this technique offers some benefits, other minimally invasive heart surgery approaches may be more patient-friendly.

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Imagine a mechanic fixing your car's engine without lifting the hood. Impossible, right? Now consider a heart surgeon repairing a hole in your heart without cutting open your chest. Sounds impossible, but thanks to breakthrough robotic technology, doctors in the United States have performed more than a dozen open-heart surgeries without opening the chest.

At the American Heart Association's Scientific Sessions 2002, researchers presented preliminary results of the study. In this procedure, surgeons remotely manoeuvre robotic arms from a seat in front of a console away from the patient. Traditionally open-heart surgery requires that surgeons make a foot-long chest incision to cut patients' breastbones in half, but instead of opening the chest and cutting the skin and muscle to view the area, surgeons make four holes - 8 to 15 millimeters each - through which robotic arms are inserted.

The robotic arms include one with a camera-like device to transmit the image to the console; the other arms are fitted with operating instruments. Surgeons used this new procedure to successfully repair the hearts of patients with atrial septal defect (ASD) or patent foramen ovale, conditions in which people are born with an opening between the heart's two upper chambers. It is repaired either by plugging the hole with a patch or suturing the hole closed. During 12 months, 15 patients - aged 22 to 68 - underwent ASD repair using the robotic technology, called the Da Vinci system.

Researchers found robot-assisted endoscopic heart surgery takes a little longer than the traditional technique, but that might be attributable to the learning curve necessary to use the new approach. Patients in the study had no major complications and the average length of stay in the intensive care was 18 hours, which is about the same as for the traditional approach. The average hospital stay was three days, two to four days shorter than for a traditional operation and patients return to work and normal activity about 50 percent faster than those who have the open procedure. The patients also had improved social functioning and less pain with the new technique.

On the other hand, the "port-access" approach to mitral valve replacement surgery, performed at Robert Wood Johnson University Hospital and only a handful of other medical centres, may save patients half the amount of time in surgery as well as money for additional staffing, as compared to robotic surgery. Robotic-assisted surgeries cost about $2000 more per operation. Such was stated also at the American Heart Association's Scientific Sessions.

"The data is still coming in. But as of right now, robotic mitral surgery appears to have no real benefit over the port-access approach", noted Dr. Mark Anderson, Director of the hospital's Minimally Invasive Cardiac Surgical Programme and Associate Professor of Surgery at UMDNJ-Robert Wood Johnson Medical School.

As in robotic mitral surgery, patients who undergo Robert Wood Johnson University's "port-access" approach also reap the benefits of smaller scars, less pain and fewer complications. Instead of making a 12-inch vertical incision down the centre of the chest and breaking open the rib cage, surgeons at Robert Wood Johnson need only make a simple two-to-three-inch incision along the right chest between the ribs.

"This technique takes our programme to a new level, making what was once impossible now a safe and relatively painless procedure", stated Dr. Anderson. "By embracing technological evolutions like this, we continue to rank at the top in New Jersey."

Located on the left side of the heart, the mitral valve separates the left atrium from the left ventricle or pumping chamber. Blood from the lungs arrives at the left atrium and travels through the mitral valve into the left ventricle. As the pumping phase begins, the mitral valve closes, allowing for the forward flow of blood into the circulation. Abnormalities in the mitral valve cause reversal of blood flow and can result in congestive heart failure.

The "port-access" approach is made possible by specialised endovascular catheters and trans-esophageal echocardiography. Surgeons make the small incision in the right anterior chest. Cardiopulmonary bypass is established via the groin. This minimally invasive approach can be used for most mitral valve surgery. Patients who require coronary artery bypass grafting at the time of their valve surgery may not be good candidates, nor patients with significant peripheral vascular disease.

The conference at Advocate Christ Medical Center in Illinois, allowed participants to observe Christ Medical Center physicians performing a robotic operation "live" via remote video consoles. It followed the United States Food and Drug Administration (FDA) approval of the da Vinci Surgical System for mitral valve repair. The approval is the first for any operative robotic system in heart surgery. The system was developed by California-based Intuitive Surgical Inc.

Christ Medical Center has been one of only about a dozen centres in the country, and the only institution in Illinois, participating in the clinical testing of the new technology for heart surgery. During the clinical trial phase, Christ Medical Center surgeons have performed 25 mitral valve repair operations robotically and achieved among the best clinical results in the world. In fact, many of the patients who underwent robotic heart surgery at Christ Medical Center were able to leave the hospital within 24 hours or less following surgery.

The robotic technology actually communicates the surgeon's natural, intuitive hand movements at the remote console to the instruments placed inside the patient through several small incisions. The instruments move precisely and microscopically without any of the slight shakiness of the normal human hand. The surgeon at the console is able to "peer" inside the patient's chest and heart in three dimensions and maintain a wide range of movements in a way that is currently not possible with laparoscopic instrumentation.

Potential advantages to using the state-of-the-art robotic technology are minimal incisions, less pain, less scarring, decreased chances of infection and bleeding following surgery, quicker overall recovery, and reduction in the patient's health care costs.

The surgical team undertaking the groundbreaking robotic operations at Christ Medical Center was led by Drs. Patroklos Pappas, the console surgeon who manipulates the instruments; Antone Tatooles, the patient-side surgeon; and Mark Slaughter, who has served as the primary investigator for the robotic study.

During the November 21 conference, Drs. Pappas and Tatooles were in the operating room performing the robotic surgery that programme participants were able to observe. Dr. Slaughter moderated the conference, explaining to surgeons what they were seeing and answering questions during the course of the surgery.

The three Christ Medical Center surgeons emphasised that the robotic technology is FDA-approved and being used for general surgery, thoracic surgery, gynaecological and urological surgery and was recently approved for cardiotomy, which includes the majority of open-heart surgeries.

The FDA has cleared Intuitive's da Vinci Surgical System for use in mitral valve repair surgery. After reviewing the clinical data from Intuitive's endoscopic or closed chest mitral valve repair trial, the FDA concluded that the da Vinci Surgical System can be used safely and effectively for minimally invasive mitral valve repair surgery. This intracardiac FDA clearance significantly broadens potential surgical use of the da Vinci System, bringing major advantages to those hospitals that invest in Intuitive Surgical Systems and to their patients who benefit from robotic surgical treatment.

W. Randolph Chitwood, Jr., M.D., Professor and Chairman of the Department of Surgery at Brody School of Medicine at East Carolina University in Greenville, North Carolina and Principal Investigator of Intuitive's multicentre trial for mitral valve repair, stated: "For the first time, we will be able to offer to a wider range of patients a minimally invasive intracardiac procedure to repair the mitral valve. This news from the FDA will allow more patients to enjoy the benefits of high precision minimally invasive robotic surgery. These benefits include less pain and trauma, shorter hospital stays, quicker recovery and, a better cosmetic result."

With this FDA clearance, hospitals can now use the da Vinci Surgical System to perform minimally invasive mitral valve repair surgical procedures. The FDA's intracardiac clearance for the da Vinci System does not encompass coronary artery bypass, or "CABG", surgical procedures. Intuitive's multicentre clinical trial for CABG surgery continues to progress.

"At Columbia Presbyterian Hospital, we have performed nearly 100 cardiac surgery cases using the da Vinci System. When using robotics in mitral valve surgery, our post-surgery survey results show an overall increase in patient satisfaction", stated Michael Argenziano, M.D., Assistant Professor of Surgery and Director, Cardiac Robotic Surgery at Columbia University in New York City. "Initial results obtained from our post-operative surveys, which included patients from the da Vinci multicentre mitral valve repair trial, unequivocally show that robotic surgery patients have shorter recovery time and improved social functioning, and return to work sooner than patients undergoing traditional surgery."

Presently, the da Vinci System is FDA-cleared for laparoscopy, thoracoscopy, and now intracardiac mitral valve repair surgery. The da Vinci Surgical System remains in the clinical testing phase for other heart-related surgeries, including repair of defects in the heart wall. More details about the use of the da Vinci robot for mitral valve repair is available in the VMW March 2002 article East Carolina University surgeons report surprising results using da Vinci robot in mitral valve repair.


Leslie Versweyveld

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