Won-Keun Kim1, Christian Hengstenberg2, Michael Hilker3, Sebastian Kerber4, Ulrich Schäfer5, Tanja Rudolph6, Axel Linke7, Norbert Franz8, Thomas Kuntze9, Holger Nef10, Utz Kappert11, Michael O Zembala12, Stefan Toggweiler13, Thomas Walther14, Helge Möllmann15. 1. Department of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany; Department of Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany. Electronic address: w.kim@kerckhoff-klinik.de. 2. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz- und Kreislauf-Forschung e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany; Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien, Vienna, Germany. 3. Department of Cardiothoracic Surgery, University Medical Center Regensburg, Regensburg, Germany. 4. Department of Cardiology, Herz- und Gefässklinik Bad Neustadt, Bad Neustadt an der Saale, Germany. 5. Department of Cardiology, University Heart Center Hamburg, Hamburg, Germany. 6. Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany. 7. Department of Cardiology, Heart Center Leipzig University, Leipzig, Germany. 8. Department of Cardiology, Schüchtermann-Schiller'sche Kliniken, Bad Rothenfelde, Germany. 9. Department of Cardiac Surgery, Central Hospital Bad Berka, Bad Berka, Germany. 10. Department of Cardiology, University Hospital Giessen and Marburg, Giessen, Germany. 11. Department of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany. 12. Department of Cardiac, Vascular and Endovascular Surgery and Transplantology, Medical University of Silesia in Katowice, Silesian Center for Heart Diseases in Zabrze, Zabrze, Poland. 13. Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland. 14. Department of Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany; Department of Thoracic and Cardiovascular Surgery, University Hospital, Frankfurt, Germany. 15. Department of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany; Department of Internal Medicine-I, Cardiology, St. Johannes-Hospital, Dortmund, Germany.
Abstract
OBJECTIVES: The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. BACKGROUND: The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far. METHODS: This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. RESULTS: Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. CONCLUSIONS: Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.
OBJECTIVES: The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. BACKGROUND: The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far. METHODS: This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. RESULTS: Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. CONCLUSIONS: Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.
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