Intuitive's da Vinci robot and Estech's RAP catheter used in USA's first closed-chest heart bypass operation

Mountain View 17 January 2002A team of cardiac surgeons led by Dr. Michael Argenziano from the New York Presbyterian Hospital's Columbia Presbyterian Medical Center has completed the first ever closed-chest, totally endoscopic coronary artery bypass (TECAB) surgery in the United States. This TECAB procedure, which was performed on January 15, 2002, using the da Vinci Surgical System and the Estech Remote Access Perfusion (RAP) catheter from start to finish, begins Intuitive Surgical's Food and Drug Administration (FDA) TECAB clinical study which will involve several major medical centres in the United States.

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Heart disease is the leading cause of death in the United States and coronary artery bypass grafting or "CABG" is the most commonly performed heart operation. Approximately 375.000 bypass surgeries are performed each year in the United States. Traditionally, heart bypass surgeries require a large 8- to 10-inch incision through the chest wall. In contrast, TECAB procedures using the da Vinci System require only three or four pencil-sized holes or "ports" made between the ribs. Through these ports, two robotic "arms" and a camera system gain exposure to the heart, allowing the surgeon to perform surgery without opening the chest.

The surgery was successfully performed by Dr. Michael Argenziano, Director of Robotic Cardiac Surgery at Columbia Presbyterian Medical Center, and Dr. Craig Smith, Chief of Cardiothoracic Surgery, on a 71-year-old retired businessman from New Jersey. He was the first patient in the United States to receive robotically assisted coronary artery bypass surgery without a chest incision of any kind. The surgery required four small access sites for the robotic arms and a small groin incision for the catheter.

Estech Inc. offers a complete system of products for "Least Invasive Cardiac Surgery" (LICS) for both beating and stopped heart surgical approaches. The company's beating heart products have been used in more than 25.000 procedures. The highly reproducible mode of totally endoscopic bypass with the da Vinci System offers several potential clinical benefits to patients. For example, studies show that patients who have minimally invasive operations may be able to leave the hospital days earlier than patients recovering from conventional cardiac surgery.

Dr. Argenziano stated: "The three-dimensional visualisation and precise, intuitive instrument control allowed us to perform a coronary bypass operation exactly as we do in conventional cases, except without an incision. It is this ability of the da Vinci System to literally transport the surgeons hands and eyes inside the chest that makes it a revolutionary technology in cardiac surgery. The Estech Remote Access Perfusion catheter allowed us to support the patient during the robotic procedure through a small incision in the leg. This is critical technology for enabling closed-chest and less invasive heart surgery techniques."

Recent published articles have shown a reduction in stroke with the usage of the Estech RAP catheter. Dr. Argenziano commented: "Innovative technology such as the Estech RAP catheter will help us to develop safer and less traumatic cardiac surgical procedures." The Estech RAP catheter is designed to deliver oxygenated blood to patients undergoing "stopped heart" surgical procedures without requiring an opening through the chest. The RAP catheter is inserted through a small access site in the groin. The catheter is then guided into the aorta and provides oxygenated blood to the body. Instead of clamping the aorta to block blood flow as in conventional procedure, the Estech RAP catheter occludes the aorta by simple inflation of an atraumatic balloon.

Although this is the first closed-chest, totally endoscopic bypass procedure ever performed in the United States, the da Vinci System has already been used to perform over 200 TECABs at multiple sites throughout Europe. "To be able to offer this same benefit to American patients and surgeons is very rewarding. We are thrilled to be part of a team that is delivering totally endoscopic solutions to the cardiac care patient group", commented Lonnie Smith, President and CEO of Intuitive Surgical Inc.

Intuitive Surgical is also conducting two other FDA-sanctioned cardiac clinical studies. "We are already well into our ten-site clinical study for Mitral Valve Repair with the da Vinci System, and our study for Atrial Septal Defect closure is progressing well. The results thus far appear quite promising", stated Mr. Smith.

The da Vinci Surgical System was first cleared by the FDA in 1997 for assisting surgery, and in July 2000 for actual surgery. FDA clearances so far include use in laparoscopic, thoracoscopic, and radical prostatectomy surgeries. The da Vinci System, however, is not yet cleared for any type of cardiac surgery in the United States.

More news on the clinical trials with and the performance of the da Vinci robot in cardiac surgery is available in the following VMW articles:


Leslie Versweyveld

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