title: European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry.
abstract: OBJECTIVE
  The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting.
  
  
  BACKGROUND
  Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath.
  
  
  METHODS
  The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure.
  
  
  RESULTS
  The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) 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%). 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 nontransfemoral approach (hazard ratio [HR]: 1.84; p < 0.0001), renal insufficiency (HR: 1.53; p < 0.0001), liver disease (HR: 1.67; p = 0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p = 0.0019), porcelain aorta (HR: 1.47; p = 0.0352), and atrial fibrillation (HR: 1.41; p = 0.0014), with 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.
  
  
  CONCLUSIONS
  The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting. (SOURCE XT Registry; NCT01238497).
authors.affiliation: Medical Clinic IV, Department of Cardiology, Municipal Hospital Karlsruhe, Karlsruhe, Germany. Electronic address: gerhard.schymik@klinikum-karlsruhe.de.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schymik
authors.affiliation: Institut Hospitalier Jacques Cartier, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: Centro Cardiologico Monzino, Universita di Milano, Milan, Italy.
authors.forename: Antonio L
authors.initials: AL
authors.lastname: Bartorelli
authors.affiliation: Casa di Cura Montevergine, Mercogliano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
authors.affiliation: Universitatsklinikum Eppendorf, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.affiliation: Kerckhoff Klinik, Bad Nauheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
authors.affiliation: Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital, Muenster, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Baumgartner
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Kings College Hospital, London, United Kingdom.
authors.forename: Olaf
authors.initials: O
authors.lastname: Wendler
authors.affiliation: Cardiovascular Department, Hôpital de La Tour, Geneva, Switzerland.
authors.forename: Philip
authors.initials: P
authors.lastname: Urban
authors.affiliation: Edwards Lifesciences Corporation, Irvine, California.
authors.forename: Lazar
authors.initials: L
authors.lastname: Mandinov
authors.affiliation: Cardiovascular Services, St. Thomas' Hospital, London, United Kingdom.
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Cardiology Department, Bichat University Hospital, Paris, France. Electronic address: alec.vahanian@bch.aphp.fr.
authors.forename: Alec
authors.initials: A
authors.lastname: Vahanian
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D015897:Comorbidity; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: aortic valve stenosis; minimally invasive; transapical; transcatheter; transfemoral