Edwards Sapien XT TAVR Device Supported by Postmarket SOURCE XT Registry

May 21, 2013—Edwards Lifesciences (Irvine, CA) announced that 1-year data from the SOURCE XT registry continued to demonstrate positive patient outcomes, including all-cause mortality and complication rates. The SOURCE XT registry is the company's European postapproval study of the Edwards Sapien XT transcatheter aortic heart valve. The data were presented at EuroPCR 2013 in Paris, France, by Prof. Stephan Windecker, MD, Chief of Cardiology and Director of Invasive Cardiology at University Hospital Inselspital Bern in Bern, Switzerland.

According to the Edwards press release, SOURCE XT is a monitored and adjudicated prospective registry that documents the outcomes of 2,688 consecutively enrolled patients at 93 centers in Europe performing transcatheter aortic valve replacement (TAVR) with the Sapien XT. This represents more than 20% of the total patients treated with Sapien XT valves during the time period of this study, noted the company.

The registry is studying the use of the Edwards Sapien XT valve in a real-world commercial setting, treating high-risk and inoperable patients with severe symptomatic aortic stenosis. The study cited both the baseline and cardiovascular characteristics of the treated patients in confirming their high-risk profiles. Despite this patient risk level, the 1-year survival post-TAVR was 80.5%, and freedom from important procedural complications was notable: stroke occurred in 6.3% of patients, and 93.8% of patients had none/trace or mild paravalvular aortic regurgitation.

The presentation also addressed a segment of the treated patients with a EuroScore < 15%, which primarily consisted of patients who were deemed inoperable because of conditions such as porcelain aorta, liver disease, frailty, cancer, dialysis, and severe pulmonary hypertension.

Edwards Lifesciences advised that the SOURCE XT registry enrolled patients treated with the Sapien XT valve in 17 countries between July 2010 and October 2011. Patients were treated using a transfemoral (62.7%), transapical (33.3%), transaortic (3.7%), or subclavian (0.3%) approach and will be followed out to 5 years. The Edwards Sapien XT valve is an investigational device not yet available commercially in the United States, where it is being evaluated in the PARTNER II trial.