Page 12 - Journal of Structural Heart Disease Volume 1, Issue 3

Original Scientific Article 118
Figure 10: The Venus A valve. A self-expandable valve composed of a nitinol stent frame carrying a trileaflet bioprosthetic valve made of porcine pericardial leaflets.
Edwards Lifesciences Centera
The self-expandable CENTERA valve (Edwards Lifesciences, Irvine, CA, USA) is an ultra-low-profile valve that consists of three treated bovine peri- cardial tissue leaflets attached to a nitinol frame with a polyethylene terephthalate skirt intended to minimize PV-AR [28] (Figures 8 and 9). Current- ly, the valve is available in 23- and 26-mm sizes; an additional valve size of 29 mm is anticipated. The stent frame does not have a flared distal section that extends into the ascending aorta and there- fore is shorter than that of other self-expandable valves. This facilitates self-centering and seating of the valve within the annulus, and it may also help to improve paravalvular sealing with minimal pro- trusion of the valve frame into the left ventricle. The delivery system consists of a delivery catheter and a detachable, battery-powered motorized han- dle, which can be delivered by the transfemoral or subclavian approaches. The capability to re-sheath and reposition in situ prior to complete valve de- ployment is an expected feature and may reduce the risk of valve malposition or embolization. The
delivery system is compatible with a 14 Fr eSheath. The dynamic expansion mechanism of the eSh- eath allows for transient sheath expansion during valve delivery. Immediately after the valve passes through the sheath, the sheath return to a low- profile diameter thus reducing the time the access vessel is expanded, and minimizing the risk of vascular trauma.
The CENTERA valve was implanted in 15 patients with symptomatic severe AS via transfemoral (n=11) or transaxillary (n=4) approaches [29]. All 15 implan- tations were successful. Post-procedurally, AVA in- creased from 0.7±0.1 cm2 to 1.6±0.4 cm2 (p < 0.01) and mean trans-aortic gradient decreased from 36.3±14.2mmHg to 10.6±5.4mmHg (p <0.001). PV-AR at 30-day follow-up was none or trivial in 23%, mild in 69% and moderate in 8% of the patients. Survival was 87% at 30 days and 80% at 1 year, and four pa- tients (27%) received a new permanent pacemaker.
The safety and performance study of the Edwards CENTERA self-expanding transcatheter heart valve trial is currently ongoing (ClinicalTrials.gov Identifier: NCT01808274).
Structural Heart Disease, August 2015
Volume 1, Issue 3: 112-126