September 22, 2008 - New data on the Edwards SAPIEN transcatheter heart valve with the Ascendra transapical delivery system was presented at the 22nd annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Lisbon, Portugal.
Interim follow-up results from the pre-commercial transapical PARTNER EU registry of 67 transapical patients were presented on Sept. 13 and showed a 30-day survival of 82 percent and a six-month survival of 56 percent. PARTNER EU is a European registry conducted primarily in 2007 that represents Edwards’ early transapical experience.
The 30-day results from the post-approval commercial SOURCE registry were also presented. SOURCE is designed to evaluate commercial use of the Edwards SAPIEN valve with a prescribed training and proctoring program. It is a registry of procedural and short-term clinical outcomes. The current data reflect 309 cases at hospitals in 12 European countries. Survival at 30 days was 88 percent.
The largest single site transapical experience from Leipzig was also updated, and showed continued progress in early and late mortality on a cohort of 113 patients. Six-month survival was 74 percent and 12-month survival was 71 percent.
In addition to the data presentations, a live case transmitted from Universität Leipzig on Saturday demonstrated the transcatheter valve replacement procedure with the Ascendra transapical delivery system. The patient received a thoracic epidural and was not intubated, which allowed the patient to be awake throughout the procedure. The Edwards SAPIEN transcatheter valve was successfully deployed.
Six-month transfemoral data from PARTNER EU and 30-day transfemoral data from SOURCE will be presented at TCT 2008 in October.
The Edwards SAPIEN transcatheter heart valve is approved for commercial sale in Europe. In the U.S. it is an investigational device that is not available for sale. The Edwards SAPIEN valve is being studied in the U.S. PARTNER trial, which is a randomized trial that only recently began enrolling transapical patients.
For more information: www.edwards.com