Heart Valve Replacement Possible Without Open Heart Surgery

The Edwards Sapien transcatheter heart valve (THV) is an investigational device that is being evaluated for the treatment of patients with severe calcific aortic stenosis who are considered too high-risk or nonoperable for conventional open-heart valve replacement surgery. The THV is a combined tissue valve built into a metal stent, which comes in two sizes (23 mm and 26 mm). The THV is placed either through a transfemoral (via the RetroFlex 3 transfemoral delivery system) or transapical (via the Ascendra transapical delivery system) approach; a catheter is then used to deliver the THV to the aortic valve, where it is positioned within the damaged valve. The procedure is performed on the beating heart, without the need a bypass machine, thus avoiding additional risks.

The Edwards Sapien THV is under development by Edward Lifesciences (Irvine, CA, USA), and is currently classified as an investigational device undergoing clinical trials, as approved by the U.S. Food and Drug Administration (FDA).

"This dramatic new procedure offers a new lease on life for patients with severe aortic stenosis, severe narrowing of the heart valve, and highlights Ochsner's continuing efforts to place patient care first by offering a minimally invasive alternative to open heart surgery, which may reduce morbidity and recovery time,” said cardiologist Stephen Ramee, M.D., of the Ochsner Medical Center (New Orleans, LA, USA), which is one of the centers participating in the Placement of AoRTic traNscathetER valves (PARTNER) clinical trial.

The PARTNER trial is prospective randomized study with two separate treatment arms. The surgical arm features 690 high-risk patients who are candidates for conventional open-heart surgery. Randomized, these patients receive either the Edwards Sapien THV or an Edwards surgical valve to demonstrate that the transcatheter heart valve is not statistically inferior to conventional surgery. The nonsurgical arm features 350 nonoperative patients who will be evenly randomized to receive either the Edwards Sapien THV or appropriate medical therapy, to demonstrate that the transcatheter heart valve is statistically superior to medical management.

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