1. Department of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany; 2. Department of Internal Medicine-I, Cardiology, St. Johannes-Hospital, Dortmund, Germany; 3. Klinik für Herz-und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 4. Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany; 5. Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien, Vienna, Austria; 6. Department of Cardiothoracic Surgery, University Medical Center Regensburg, Regensburg, Germany; 7. Department of Cardiology, Herz- und Gefäss-Klinik Bad Neustadt, Bad Neustadt an der Saale, Germany; 8. Department of Cardiology, University Heart Center Hamburg, Hamburg, Germany; 9. Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany; 10. Department of Cardiology, Heart Center Leipzig University, Leipzig, Germany; 11. Department of Cardiology, Schüchtermann-Schiller’sche Kliniken GmbH, Bad Rothenfelde, Germany; 12. Department of Cardiac Surgery, Central Hospital Bad Berka, Bad Berka, Germany; 13. Department of Cardiology, University Hospital Giessen and Marburg, Giessen, Germany; 14. Department of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany; 15. Department of Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany; 16. Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Medical University of Silesia in Katowice, Silesian Center for Heart Diseases, Zabrze, Poland; 17. Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland
Aims: The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population.
Methods and results: From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and post-dilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak.
Conclusions: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.