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Edwards Lifesciences told cardiologists in Berlin Tuesday that new data show that its minimally invasive Port Access System for mitral valve surgery significantly reduces the length of stay in hospitals and intensive care units, and improves other outcomes when compared to conventional sternotomy (an incision the length of the chest).

Results were presented at the Society for Heart Valve Disease 5th Biennial Meeting in Berlin.



"The data show statistically significant patient benefits, as well as the potential for reducing hospital costs associated with lengthy stays and certain complications, when using the Port Access System in mitral valve surgery," said the study's lead author, William H. Ryan, M.D., a cardiac surgeon with Cardiopulmonary Research Science and Technology Institute, Dallas, TX; Medical City Dallas Hospital, Dallas, TX; and the Heart Hospital Baylor, Plano, TX.

Dr. Ryan provides paid consulting services to Edwards Lifesciences as an educator and trainer for Port Access surgery.

"For mitral valve repair, Port Access surgery demonstrated substantial reductions in hospital days, ICU stay, ventilation time and return to OR for post-op bleeding," Ryan told the meeting.

Among the study's statistically significant findings:

-- The 171 patients undergoing mitral valve repair with the Port Access System had total hospital stays approximately 1.5 days less than sternotomy. In these patients, ICU stay was reduced from 82 hours to 44 hours, a 46 percent reduction.

-- In the same population, the number of patients requiring post-operative ventilation was reduced from 75.6 percent in the sternotomy group to 50.3 percent in the Port Access group.

Further, substantially fewer Port Access patients required prolonged ventilation, defined by the Society of Thoracic Surgeons (STS) as greater than 24 hours: 5.4 percent in the Port Access cohort, versus 11.8 percent with full sternotomy.

Ryan and his co-authors conducted a retrospective review of outcomes from matched patient groups at a single center undergoing mitral valve repair or replacement with either a full sternotomy or the Port Access approach through a mini-thoracotomy (an average incision of 4.1 cm in length).

Patients who were not candidates for Port Access surgery, primarily due to their vasculature, were screened out. Data were extracted from the researchers' STS-certified, audited database between January 1996 and November 2008.

The research has been accepted for publication later this year in the Journal of Heart Valve Disease. A similar analysis of aortic valve replacement and repair procedures was conducted and is expected to be presented at the Southern Thoracic Surgical Association meeting in November 2009.

Edwards' portfolio of Port Access products for minimally invasive mitral valve repair and replacement includes the proprietary EndoCPB system, including the balloon EndoClamp, vent and coronary sinus catheters, soft tissue retractors, venous and arterial cannulae, and reusable instruments. The Port Access system allows surgeons to perform minimally invasive heart valve operations through small openings, or "ports," in the spaces between the ribs, in order to avoid opening a patient's chest for a sternotomy.

Source: Edwards Lifesciences