Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and haemodynamic monitoring, has announced that one-year data from its European post-approval study of the Edwards SAPIEN XT transcatheter aortic heart valve continued to demonstrate positive patient outcomes, including all-cause mortality and complication rates.
Data from the SOURCE XT Registry documents the outcomes of 2,688 consecutively enrolled patients at 93 centres in Europe performing transcatheter aortic valve replacement (TAVR). This represents more than 20% of the total patients treated with SAPIEN XT valves during the time period of this study. The data were presented today at EuroPCR 2013 by Professor Stephan Windecker, MD, chief of cardiology and director of invasive cardiology at University Hospital InselSpital Bern, Switzerland.
“We are very pleased that studies across geographies and in both real-world and clinical trial settings continue to support the benefits to patients of the lower-profile SAPIEN XT valve,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter valve replacement. “This report from the SOURCE XT Registry confirms the positive impact TAVR provides for patients’ quality of life and heart function, which is once again profound.”
The SOURCE XT Registry, a monitored and adjudicated prospective 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 one-year survival post-TAVR was 80.5%, and freedom from important procedural complications was notable: the study found that stroke occurred in 6.3% of patients, and it was reported that 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 of less than 15%, which primarily consisted of patients who were deemed inoperable due to conditions such as porcelain aorta, liver disease, frailty, cancer, dialysis and severe pulmonary hypertension.
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 five years.
The Edwards SAPIEN XT valve is an investigational device not yet available commercially in the United States. It is currently being evaluated in the US in The PARTNER II Trial.