BERLIN, June 30, 2009 -- Edwards Lifesciences Corporation (NYSE: EW), the
global leader in the science of heart valves, announced that new research
demonstrates that using its minimally invasive PORT ACCESS System in mitral
valve surgery significantly decreases the length of stay in hospitals and
intensive care units (ICU), and improves other outcomes when compared to
conventional sternotomy (an incision the length of the chest). Results
were presented today 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 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.
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