Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial
Gerald Yong, Tony Walton, Martin Ng, Ronen Gurvitch, Stephen Worthley, Robert Whitbourn, Nigel Jepson, Ravinay Bhindi, Kan Shang, Ajay Sinhal
Heart Lung and Circulation | ELSEVIER SCIENCE INC | Published : 2020
BACKGROUND: To determine the safety and performance of the SAPIEN XT transcatheter heart valve (THV) in Australian patients with severe aortic stenosis (AS) and intermediate surgical risk. METHODS: Eligible patients in this multi-centre, prospective, consecutively enrolled, non-randomised, clinical trial, received transcatheter aortic valve replacement via femoral artery access. Follow-up visits were at discharge, 30 days, and 6, 12, and 24 months. The primary endpoint was Valve Academic Research Consortium-2 composite safety at 30 days: all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury-Stage 3, coronary artery obstruction requiring intervention, major vascular ..View full abstract
.This study was supported by Edwards Lifesciences.