Francesco Saia1, MD, PhD; Caterina Gandolfo2, MD; Tullio Palmerini1, MD; Sergio Berti3, MD; Sagar N. Doshi4, MD; Mika Laine5, MD; Chiara Marcelli1, MD; Tommaso Piva6, MD; Flavio Ribichini7, MD; Mauro De Benedictis8, MD; Francesco Cardaioli9, MD; Stefano Cannata2, MD; Giuseppe Tarantini9, MD, PhD
1. Cardiology unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy; 2. Interventional Cardiology, IRCSS-ISMETT-University of Pittsburgh Medical Center (UPMC), Palermo, Italy; 3. U.O.C Cardiologia Diagnostica ed Interventistica, Fondazione C.N.R. Reg. Toscana G Monasterio, Massa, Italy; 4. Cardiology Dept – Queen Elizabeth University Hospital Birmingham NHS Foundation Trust, Birmingham, United Kingdom; 5. Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland; 6. Interventional Cardiology, Ospedali Riuniti di Ancona, Ancona, Italy; 7. Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy; 8. Department of Cardiology, Mauriziano Hospital, Turin, Italy; 9. Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy
Aims: The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system.
Methods and results: The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4±8.3 years, average STS score 3.8±2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%.
Conclusions: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.