CONFERENCE COVERAGE: EuroPCR

Edwards SOURCE Registry Presented for Sapien Valve May 20, 2009—At the EuroPCR conference in Barcelona, Spain, Edwards Lifesciences Corporation (Irvine, CA) announced the results from the SOURCE serial registry, its first postmarket study of consecutively enrolled Edwards Sapien transcatheter aortic valve patients. The data demonstrated high device success and low 30-day mortality.

According to Edwards, the SOURCE registry reported results on 1,038 patients (100%) treated with the Edwards Sapien valve at 32 European centers from November 2007 to January 2009. The data showed a 30-day survival rate of 93.7% in transfemoral procedures and 89.7% in transapical procedures. The company said that these rates are better than the predicted surgical survival in this high-risk patient cohort. Implant procedure safety with the Sapien valve was demonstrated with low rates of valve malposition (1.5%), coronary obstruction (0.6%), stroke (2.5%), conversion to surgery (2.7%), need for permanent pacemaker (7%), and significant aortic regurgitation (4.7%).

"In order to preserve the integrity of the study data, each adverse event was individually reviewed by the SOURCE study's principal investigators," commented Martyn Thomas, MD. "Additionally, to avoid patient selection bias, those centers unable to provide all data on all patients were excluded from the report. This approach provided the opportunity to accurately evaluate both the effectiveness of training and the commercial launch experience of the Edwards Sapien valve, and will guide clinical practice."

Also at EuroPCR, Edwards announced the presentation of the first complete 6-month data set of the 130 patients enrolled in the PARTNER EU clinical trial. The data demonstrated strong hemodynamics and valve performance through measurements including effective orifice area and ejection fraction, as well as 100% freedom from structural valve deterioration. PARTNER EU was designed to evaluate the Edwards Sapien valve in a setting where an interventional cardiologist and cardiac surgeon partnered to screen and determine the correct treatment approach for each patient. The study was conducted in Europe from April 2007 through January 2008 and provided data about patient selection that were incorporated into SOURCE and the PARTNER investigational device exemption trial in the United States. The Edwards Sapien transcatheter aortic heart valve is approved for commercial sale in Europe. In the United States, it is an investigational device being studied as part of the PARTNER randomized, controlled clinical trial.