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Sapien transcatheter heart valve 

Caption: The Sapien transcatheter heart valve was approved by the FDA in 2011 for the treatment of severe aortic stenosis.

UPMC Media Relations 

Relief for Aortic Stenosis: UPMC First in Region to Implant New Valve

PITTSBURGH, Feb. 15, 2012 – UPMC is the first hospital in the region to successfully implant a newly FDA-approved valve in patients suffering from severe aortic stenosis, a debilitating narrowing of the heart’s aortic valve that often causes shortness of breath, lightheadedness and fatigue.

Called the Sapien Transcatheter Heart Valve, this new treatment option has been shown to greatly improve the quality of life for those who suffer from aortic stenosis, which affects as many as 500,000 people in the U.S. This condition can interfere with day-to-day activities such as walking or climbing stairs. Traditionally, a patient’s only option was to have open-heart surgery to replace the aortic valve, but the procedure was often deemed too risky for elderly patients, who are most prone to the condition.

The Sapien valve is implanted via catheter  making the procedure less invasive and more appropriate for patients deemed too high risk or unsuitable for open-heart surgery.

“Unfortunately, we’re seeing an increased number of patients who are not good surgical candidates. This is a promising alternative and we’re pleased to provide this option to our patients,” said Joon Sup Lee, M.D., co-director of the UPMC Heart and Vascular Institute.

UPMC cardiologists implanted the valves in two patients last month, including a 91-year-old man with a previous history of open-heart surgery who was considered too high risk for open heart aortic replacement surgery.

“A day after the procedure, he was walking. This is making a real difference in his quality of life,” said William Anderson, M.D., an interventional cardiologist who performed the procedure with Thomas G. Gleason, M.D., co-director of UPMC’s Center for Heart Valve Disease.

The FDA approved the use of the Sapien valve, made by Edwards Lifesciences, in November 2011.

In addition to offering the Sapien valve, UPMC’s Heart and Vascular Institute is also a participating center in the Medtronic CoreValve pivotal trial, which is evaluating the safety and effectiveness of the CoreValve aortic heart valve system. The CoreValve System, which has a similar purpose as the Sapien valve but a slightly different design, is not FDA-approved and is available only to patients enrolled in the study.

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