Self-Expanding Heart Valve Treats Severe Aortic Stenosis

A novel transcatheter heart valve (THV) valve aids treats patients with severe aortic stenosis requiring aortic valve replacement (AVR).

The Edwards Lifesciences (Irvine, CA, USA) Centera THV system is an ultra-low-profile self-expandable valve that consists of three treated bovine pericardial tissue leaflets attached to a nitinol frame and polyethylene terephthalate (PET) fabric. The stent frame is short, and therefore does not have a flared distal section that extends into the ascending aorta, facilitating centering and seating of the valve within the annulus. The shorter frame may also help to improve paravalvular sealing due to minimal protrusion of the valve frame into the left ventricle. Centera is available in 23 mm and 26 mm sizes.

The THV is provided with the valve pre-attached to the delivery system, facilitating rapid placement using a low-profile, 14F motorized delivery system that allows single-operator repositioning and retrieval. A dynamic expansion mechanism (DEM) allows transient sheath compression during valve delivery; immediately after it passes through, the DEM allows the sheath to return to its original low-profile diameter. Buttons control valve loading and deployment, while a handle release button and valve release mechanism permit the final release of the device.

“The Edwards Centera valve demonstrates extremely favorable early clinical safety and performance outcomes in the high surgical risk TAVR population,” said Didier Tchétché, MD, of Clinique Pasteur (Toulouse, France). “In addition to excellent patient outcomes, the valve also offers several unique features and an innovative tissue design, all of which simplify the procedure for clinicians.”

THV, sometimes called transcatheter aortic valve implantation (TAVI), may be an option for people who are considered at intermediate or high risk of complications from surgical aortic valve replacement. It can also be indicated in those who cannot undergo open-heart surgery.

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