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Ochsner Replaces Heart Valve Without Open Heart Surgery
Date:8/27/2009

lve, where it positions the new valve within the damaged one. This procedure is performed in a state-of-the-art cath lab on a "beating heart," without the need for bypass machine, which can pose additional risks. As with any research trial, no guarantees can be made about outcomes. Study benefits and risks along with alternatives are reviewed in detail before a person enrolls.

Ochsner was chosen for the trial due to its expertise in valve replacement surgery and vast experience in interventional procedures. "This is an interdisciplinary study in which Ochsner's Cardiovascular Medicine, Cardiothoracic Surgery, and Anesthesia departments are working collaboratively, using the best techniques from all three specialties, to advance the standard of care for our patients," explains Dr. Gene Parrino, co-investigator in the trial.

A prospective randomized study, PARTNER has two separate treatment arms. The surgical arm features 690 high-risk patients who are candidates for conventional open-heart surgery. Randomized, these patients will receive either the Edwards SAPIEN transcatheter heart valve or an Edwards surgical valve to demonstrate that the transcatheter heart valve is not statistically inferior to conventional surgery. The non-surgical arm will feature 350 non-operative patients who will be evenly randomized to receive either the Edwards SAPIEN transcatheter heart valve or appropriate medical therapy in order to demonstrate that the transcatheter heart valve is statistically superior to medical management.


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SOURCE Ochsner Health System
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