Edwards Lifesciences Corporation announced the results from its first post-market study of consecutively enrolled Edwards SAPIEN transcatheter aortic valve patients at EuroPCR 2009. The data demonstrated the successful commercialization of the Edwards SAPIEN valve with high device success and low 30-day mortality.
The SOURCE serial registry reported results on 1,038 patients, or 100 percent of patients treated with the Edwards SAPIEN valve at 32 European commercial centers from November 2007 to January 2009. The data showed a 30-day survival rate of 93.7 percent in transfemoral procedures (valve delivered via the femoral artery), and 89.7 percent in transapical procedures (valve delivered via a small incision between the ribs) – rates that were better than the predicted surgical survival in this high-risk patient cohort. Implant procedure safety with the Edwards SAPIEN valve was strongly demonstrated with low incidences of valve malposition (1.5 percent), coronary obstruction (0.6 percent), stroke (2.5 percent), conversion to surgery (2.7 percent), need for permanent pacemaker (7 percent), and significant aortic regurgitation (4.7 percent).
SOURCE sets a new standard for the evaluation of the commercial experience of transcatheter aortic valve implantation in a high-risk patient population. In order to preserve the integrity of the study data, each adverse event was individually reviewed by the study’s principal investigators. Additionally, to avoid patient selection bias, those centers unable to provide all data on all patients were excluded from the report, said Martyn Thomas, M.D., director of cardiothoracic services, Guys and St. Thomas’ NHS Foundation Trust in London, and a paid consultant to Edwards. 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 presented was the first complete six-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 percent freedom from structural valve deterioration. PARTNER EU was designed to evaluate the Edwards SAPIEN valve in a setting where, for the first time, 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 valuable lessons about patient selection that were incorporated into SOURCE and the PARTNER Investigational Device Exemption (IDE) Trial.
We are very proud of the robust clinical results presented today at EuroPCR, and the rigorous scientific approach we have taken in the study of this transcatheter valve, said Michael A. Mussallem, Edwards’ chairman and CEO. In particular, the 30-day results for the initial commercial experience with the Edwards SAPIEN valve validate the effectiveness of the valve and its two delivery options, as well as the strength of the physician partnership approach.