US-based Edwards Lifesciences has released data from its most advanced commercially available transcatheter aortic heart valve, the Edwards SAPIEN 3 trial, at the British Cardiovascular Society (BCS) Annual Conference in Manchester, UK.
The company described results from the prospective, multicentre, non-randomised SAPIEN 3 trial showed that outcomes at 30 days as ‘excellent’.
Transfemoral SAPIEN 3 implantation was related with a very low mortality of 2.1%, a stroke rate of 1%, and very few access-site complications.
In addition, 96.6% of patients had no mild paravalvular leak and there was no severe paravalvular leak.
Kings College Hospital cardiovascular services clinical director Philip MacCarthy said this valve represents a significant step forward in providing a simpler procedure for transcatheter heart valve replacement, with fewer post-procedural complications and less paravalvular aortic regurgitation.
"Results from the trial demonstrated that the improved valve and delivery system design enabled teams to position the valve precisely, and early outcomes have been excellent," MacCarthy said.
The analysis recognised early outcomes of the first 150 high and intermediate-risk patients who were enrolled between January 2013 and November 2013, and treated with the SAPIEN 3 valve at 16 centres in Europe and Canada.
According to the company, access approaches included transfemoral and transapical/transaortic, as determined by the Heart Team, while all-cause mortality in all access approaches was reported as 5.3% in the as-treated population.
The company expects patients to be followed annually out to five years.
Edwards Lifesciences corporate transcatheter heart valves vice president Larry Wood said the SAPIEN 3 valve sets a new standard for tissue valves, combining a low-profile design with the ability to address paravalvular leak, as well as improved delivery systems.
"It is particularly encouraging that these early results showed that none of the patients were re-hospitalised during the follow-up period, which is a meaningful outcome for patients who had previously been very ill," Wood said.
The valve can be delivered through a low-profile 14 French expandable sheath (eSheath) and it also has an outer skirt, a cuff of fabric that provides a seal at the bottom of the frame designed to reduce paravalvular aortic regurgitation.
In January, the SAPIEN 3 valve was approved in Europe to treat high-risk and non-operable patients with severe aortic stenosis.
The valve is not currently approved for the treatment of intermediate risk patients in Europe.
SAPIEN 3 valve is an investigational device not yet available commercially in the US and is currently being evaluated in the US in The PARTNER II Trial.