Edwards Sapien Transcatheter Heart Valve shows positive one-year outcomes in post-market study


Martyn Thomas reported 25 May 2010 that the Edwards Sapien transcatheter heart valve (Edwards Lifesciences) demonstrated promising one-year mortality rates for high-risk patients, many of whom were too sick to undergo traditional open-heart surgery.

The 1,038-patient SOURCE Registry is the largest reported experience in the world with one-year adjudicated data on consecutive patients treated with transcatheter heart valves with either a transfemoral or transapical approach.

The data presented at EuroPCR showed a one-year survival rate of 81.1% in transfemoral procedures and 72.1% in transapical procedures.

“The encouraging outcomes add to the evolving body of clinical evidence that demonstrates transcatheter aortic valve implantation is a viable option for this high-risk patient population. The data provide valuable, real world insights that enable the continued advancement of this important treatment for patients in need of alternative therapies to traditional open-heart surgery,” said Thomas, director of cardiothoracic services, Guys and St Thomas’ NHS Foundation Trust in London, UK.

The SOURCE Registry includes outcomes data from 100% of patients treated with the Edwards Sapien transcatheter heart valve at 32 European centres from November 2007 to January 2009 in its initial Cohort I. One year follow-up data was obtained on 98% of studied patients. Thomas also announced that 30-day results on an additional cohort of 1,301 patients (Cohort 2) enrolled in 2009 will be reported in the fall.

“The SOURCE Registry is unprecedented in its rigor as a commercial registry, which is critical for our understanding of the developing therapy of transcatheter aortic valve implantation. The one-year outcomes continue to demonstrate that European clinical teams are translating early clinical learnings into successful therapy in an appropriate patient population,” said Olaf Wendler, clinical director for Cardiology and Cardiothoracic Surgery, King’s College Hospital in London.