Edwards Lifesciences could have been satisfied after the success of the PARTNER trials and the improvements to its balloon-expandable valve (mainly as regards the delivery system profile and paravalvular leak reduction) in its last model, SAPIEN 3. However, it was not. The company decided to keep going, developing a valve that is radically different from its traditional product. That new valve is CENTERA, a nitinol self-expanding device with a low-profile delivery system (14 Fr) that is motorized, for better implant control!
The system also allows for device repositioning. The only thing in common with Sapien 3 is that both valves are made of bovine pericardium.
Between 2015 and 2016, 203 patients with severe aortic stenosis and high surgical risk treated by transfemoral access were analyzed. The mean age for this population was 82.7 ± 5.5 years old.
At 30 days, mortality was 1%, disabling stroke occurred in 2.5% of patients, and New York Heart Association functional class I/II was observed in 93.0% of all cases. Effective orifice area increased from 0.71 ± 0.20 cm² to 1.88 ± 0.43 cm² (p < 0.001) and the mean gradient decreased from 40.5 ± 13.2 mm Hg to 7.2 ± 2.8 mm Hg at 30 days post-procedure (p < 0.001).
Paravalvular aortic regurgitation at 30 days was moderate or higher in 0.6% of patients and 4.5% of patients required a new pacemaker.
This work confirms the safety and efficacy of the new Edwards device, highlighting its very low rates of new pacemaker implantation, probably the lowest ever for a self-expanding valve.
Original title: Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients with Severe Aortic Stenosis.
Reference: Hermann Reichenspurner et al. J Am Coll Cardiol 2017;70:3127-36.
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