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"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 continued.
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
patients (p < 0.001). In these patients, ICU stay was reduced from 82 hours
to 44 hours (p < 0.001), 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 (p < 0.001). Further,
substantially fewer PORT ACCESS patients required prolonged ventilation
(defined by the Society of Thoracic Surgeons, or STS, as greater than 24
hours): 5.4 percent compared to 11.8 percent with full sternotomy
(p=0.039).
Trends in the mitral valve replacement data supported the findings in the repair cohort, but due to a smaller patient population size (n=42), statistical significance was not achieved for as many endpoints. One exception was the 64 percent reduction in ICU length of stay from 147 hours in the sternotomy group to 53 hours in the PORT ACCESS group (p=0.016).
Ryan and his co-authors, including William T. Brinkman, M.D., 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 full 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.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz. Additional company information can be found at http://www.edwards.com.
Edwards is a trademark of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office. PORT ACCESS is a trademark of Edwards Lifesciences AG.
Media Contact: Amanda Fowler 949-250-5070 Investor Contact: David K. Erickson 949-250-6826
SOURCE: Edwards Lifesciences
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