One-Year Data Published From Edwards' European Postmarket SOURCE XT Registry

May 4, 2015—The 1-year outcomes from the SOURCE XT registry on the second-generation Sapien XT transcatheter heart valve (Edwards Lifesciences) in patients with severe aortic stenosis were published by Gerhard Schymik, MD, et al in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2015;8:657–669). The 1-year data was first presented at EuroPCR 2013 in Paris, France, by Prof. Stephan Windecker, MD.

As summarized JACC: Cardiovascular Interventions, the SOURCE XT registry is a multiregion, real-world assessment of the use and outcomes of the Sapien XT aortic bioprosthesis, a next-generation balloon-expandable valve with enhanced features allowing delivery via a lower-profile sheath. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantation at 30-days and 1-year postprocedure.

This prospective, multicenter, postapproval study analyzed data from 2,688 patients at 99 sites. The patients’ mean age was 81.4 ± 6.6 years, 42.3% were men, and the mean logistic EuroSCORE was 20.4% ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). 

The investigators reported that survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. 

Multivariable analysis identified renal insufficiency (hazard ratio [HR], 1.53; P < .0001), nontransfemoral approach (HR, 1.84; P < .0001), liver disease (HR, 1.67; P = .0453), moderate/severe tricuspid regurgitation (HR, 1.47; P = .0019), porcelain aorta (HR, 1.47; P = .0352), and atrial fibrillation (HR, 1.41; P = .0014) as having the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality.

The SOURCE XT registry demonstrated appropriate use of the Sapien XT device in the first year postcommercialization in Europe; additionally, the safety profile was sustained, and clinical benefits have been established in the real-world setting, concluded the investigators in JACC: Cardiovascular Interventions.