The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Sapien 3 Ultra balloon-expandable transcatheter aortic valve: in-hospital and 30-day results from the multicentre S3U registry

DOI: 10.4244/EIJ-D-19-00541

1. Cardiology unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Policlinico S.Orsola-Malpighi, Bologna, Italy, Italy
2. Interventional Cardiology, IRCSS-ISMETT-University of Pittsburgh Medical Center (UPMC), Palermo, Italy
3. Cardiology Unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy
4. U.O.C Cardiologia Diagnostica ed Interventistica, Fondazione C.N.R. Reg. Toscana G Monasterio, Massa, Italy
5. Cardiology Dept – Queen Elizabeth University Hospital Birmingham NHS Foundation Trust, Birmingham, UK
6. Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland
7. Cardiology Unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy
8. Interventional Cardiology, Ospedali Riuniti di Ancona, Ancona, Italy
9. Division of Cardiology, Department of Medicine, University of Verona, Italy
10. Department of Cardiology, Mauriziano Hospital, Torino, Italy
11. Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy
12. Interventional Cardiology, IRCSS-ISMETT-University of Pittsburgh Medical Center (UPMC), Palermo, Italy
13. Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy
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Aims:. To evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, CA) system. 

Methods and results:. The S3U Registry is a physician-led, post-approval, multicenter, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14F expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at 9 participating centers 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 anesthesia (28.8%) or conscious sedation (68.3%). Balloon pre-dilatation was performed in 30 patients (21.6%), post-dilatation in 3 (2.2%). In-hospital, there were no cases of death, stroke, conversion to open-heart surgery. Major vascular complications occurred in 3 patients (2.2%), as well as major or life-threatening bleedings (2.2%). There were 2 moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was 3 days (IQR 3-5 days). At 30-day there were no deaths, MI, or strokes and the incidence of new permanent pace-maker was 4.4%. 

Conclusions:. This first multicenter international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows excellent in-hospital and 30-day clinical outcomes.

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