The U.S. Food and Drug Administration (FDA) approved trial, conducted to determine the feasibility of using robotics to assist in cardiac mitral valve surgery was completed on November 6, 2000. The ten patients ranged in age from 18 to 80 years old and underwent the mitral valve repair procedures with use of Intuitive's robotic technology. Due to the successful positive outcomes of these first ten patients, the FDA has already authorised an additional ten patient extension of the University's trial. This new trial started on November 7, 2000.
Mitral valve repair is a procedure performed by cardio-thoracic surgeons to treat a narrowing or leakage of the mitral valve. The mitral valve constitutes the "inflow valve" for the left side of the heart that allows blood to flow from the left atrium into the left ventricle. When the valve leaks, blood backs up into the lungs and causes the ventricle to pump more blood; thus producing symptoms of shortness of breath and fatigue.
The mitral valve may become abnormal with age due to the elongation or the rupture of the chordal apparatus, the "heart strings" which normally support the valve. The valve itself also may become generally weak from age. "Floppy valve" syndrome, a case in which all of the components of the valve are enlarged and elongated, is an example of such weakness.
"This trial was the very first of its kind in North America and it was an incredible clinical accomplishment for the entire cardiac team", stated Dr. W. Randolph Chitwood, Jr., Professor and Chairman at the Department of Surgery, Pitt County Memorial Hospital, which is an affiliate of UHS and Brody School of Medicine at East Carolina University. "We really are encouraged by our initial results with the use of robotics for mitral valve repairs. The feasibility was positive, demonstrating a reduction in the patient hospital stays by about half. This will dramatically help cut the over-all costs of this procedure and improve patient care."
During traditional mitral valve surgery, surgeons make a large sternotomy incision in the patient's chest and retract the tissue to view the operative site. Using the da Vinci Surgical System, surgeons only need to make three small incisions between the ribs, allowing for the insertion of an endoscope and two interchangeable EndoWrist instruments. The complete operation is performed through these small incisions.
Dr. Chitwood continued: "We believe this robotic technology will allow surgeons to perform an improved procedure because of the realistic three-dimensional visualisation and greater precision the system provides. The system's EndoWrist instruments act as extensions of the surgeon's hands and wrists through the small incisions at the operative site. The patients will benefit by the use of this robotic surgery, due to a shorter recovery time with less pain."
Lonnie Smith, President and CEO of Intuitive Surgical Inc. commented that Dr. Chitwood and his team demonstrated exceptional clinical performance and scientific discipline. "We are truly delighted with the progress and results to date and look forward to expanding this cardiac clinical trial to multiple centres in the near future."
University Health Systems of Eastern Carolina installed the da Vinci Surgical System in November 1999. Since the System received FDA clearance in July 2000 for laparoscopic procedures, it has been used not only by the cardiac team, but also in a number of advanced laparoscopic procedures performed by urologists, general surgeons and gynaecologists.
The da Vinci Surgical System consists of a surgeon's console, a patient-side cart, a high-performance vision system and Intuitive's proprietary EndoWrist instruments. By integrating computer-enhanced robotic technology with the technical skills of the surgeon, Intuitive is convinced that the system enables surgeons to perform better surgery in a manner never before experienced.
The da Vinci Surgical System is able to seamlessly translate the surgeon's natural hand and wrist movements on instrument controls at a console into corresponding micro-movements of instruments positioned inside the patient through small puncture incisions, or ports.
The da Vinci Surgical System is the only commercially available technology that can provide the surgeon with the intuitive control, range of motion, fine tissue manipulation capability and 3D visualisation characteristic of open surgery, while simultaneously allowing the surgeon to work through small ports of minimally invasive surgery. You can find more news about robotic surgery systems in this issue's Virtual Medical Worlds article ValleyCare Medical Center to integrate robotics for safe and patient-friendly prostate cancer treatment.