Stefano Cannata1, MD; Caterina Gandolfo1, MD; Flavio L. Ribichini2, MD; Nicolas van Mieghem3, MD; Sergio Buccheri4, MD; Marco Barbanti5, MD; Sergio Berti6, MD; Rui Campante Teles7, MD; Antonio L. Bartorelli8, MD; Giuseppe Musumeci9, MD; Tommaso Piva10, MD; Luis Nombela-Franco11, MD; Ketty La Spina1, MD; Tullio Palmerini12, MD; Rik Adrichem3, MD; Augusto Esposito6, MD; Pedro Lopes7, MD; Paolo Olivares8, MD; Gianmarco Annibali9, MD; Elisa Nicolini10, MD; Luis Marroquin11, MD; Corrado Tamburino6, MD; Giuseppe Tarantini13, MD; Francesco Saia12, MD
1. Unit of Interventional Cardiology, Department of Cardiothoracic Surgery, IRCCS-ISMETT (Mediterranean Institute for Transplantation and Advanced Specialized Therapies), UPMC, Palermo, Italy; 2. Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy; 3. Department of Cardiology, Erasmus University Medical Center, Thorax Center, Rotterdam, the Netherlands; 4. Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden; 5. Division of Cardiology, AOU Policlinico “G. Rodolico − San Marco”, Catania, Italy; 6. UOC Cardiologia Diagnostica e Interventistica, Fondazione C.N.R. Reg. Toscana G. Monasterio, Massa, Italy; 7. Hospital de Santa Cruz, CHLO, Nova Medical School, CEDOC, Lisbon, Portugal; 8. Centro Cardiologico Monzino IRCCS, University of Milan, Milan, Italy; 9. Department of Cardiology, Mauriziano Hospital, Turin, Italy; 10. Interventional Cardiology, Ospedali Riuniti di Ancona, Ancona, Italy; 11. Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Madrid, Spain; 12. Cardiology Unit, Cardio-Thoracic-Vascular Department, IRCCS University Hospital of Bologna, Policlinico S. Orsola, Bologna, Italy; 13. Interventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy
Background: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce.
Aims: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3).
Methods: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year.
Results: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups.
Conclusions: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.
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femoralmiscellaneousparavalvular leaktavitransthoracic echocardiogram
Interventions for valvular diseaseTAVI
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