Author + information
- Received December 14, 2017
- Revision received March 9, 2018
- Accepted March 13, 2018
- Published online July 16, 2018.
- Won-Keun Kim, MDa,b,∗ (, )
- Christian Hengstenberg, MDc,d,e,
- Michael Hilker, MDf,
- Sebastian Kerber, MDg,
- Ulrich Schäfer, MDh,
- Tanja Rudolph, MDi,
- Axel Linke, MDj,
- Norbert Franz, MDk,
- Thomas Kuntze, MDl,
- Holger Nef, MDm,
- Utz Kappert, MDn,
- Michael O. Zembala, MDo,
- Stefan Toggweiler, MDp,
- Thomas Walther, MDq,r and
- Helge Möllmann, MDa,s
- aDepartment of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
- bDepartment of Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
- cKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
- dDeutsches Zentrum für Herz- und Kreislauf-Forschung e.V. (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany
- eUniversitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie, Medizinische Universität Wien, Vienna, Germany
- fDepartment of Cardiothoracic Surgery, University Medical Center Regensburg, Regensburg, Germany
- gDepartment of Cardiology, Herz- und Gefässklinik Bad Neustadt, Bad Neustadt an der Saale, Germany
- hDepartment of Cardiology, University Heart Center Hamburg, Hamburg, Germany
- iDepartment of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany
- jDepartment of Cardiology, Heart Center Leipzig University, Leipzig, Germany
- kDepartment of Cardiology, Schüchtermann-Schiller’sche Kliniken, Bad Rothenfelde, Germany
- lDepartment of Cardiac Surgery, Central Hospital Bad Berka, Bad Berka, Germany
- mDepartment of Cardiology, University Hospital Giessen and Marburg, Giessen, Germany
- nDepartment of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany
- oDepartment of Cardiac, Vascular and Endovascular Surgery and Transplantology, Medical University of Silesia in Katowice, Silesian Center for Heart Diseases in Zabrze, Zabrze, Poland
- pHeart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland
- qDepartment of Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
- rDepartment of Thoracic and Cardiovascular Surgery, University Hospital, Frankfurt, Germany
- sDepartment of Internal Medicine-I, Cardiology, St. Johannes-Hospital, Dortmund, Germany
- ↵∗Address for correspondence:
Dr. Won-Keun Kim, Kerckhoff Heart Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.
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.
This study was sponsored by Symetis, a Boston Scientific company. Dr. Kim is a proctor for Symetis/Boston Scientific; and has received speaking honoraria from Symetis/Boston Scientific, Edwards Lifesciences, and St. Jude Medical. Prof. Dr. Hengstenberg is a proctor for and has received speaking honoraria from Edwards Lifesciences and Symetis/Boston Scientific. Prof. Dr. Hilker and Prof. Dr. Schäfer are proctors for Symetis/Boston Scientific; and have received speaking honoraria from Symetis/Boston Scientific. Prof. Dr. Rudolph is a proctor for Edwards Lifesciences; and has received speaking honoraria from Edwards Lifesciences and Symetis/Boston Scientific. Prof. Dr. Linke has received speaking honoraria or served as a consultant for Medtronic, St. Jude Medical, Claret Medical, Edwards Lifesciences, Symetis/Boston Scientific, and Bard; and owns stock options in Claret Medical. Dr. Toggweiler serves as a proctor and consultant to Symetis/Boston Scientific; is a consultant to New Valve Technology; and has received speaking fees from Symetis/Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Zembala serves as a proctor and a consultant to Symetis/Boston Scientific, AtriCure, and Abbott. Prof. Dr. Walther is a proctor for Symetis/Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Kim and Hengstenberg contributed equally to this work.
- Received December 14, 2017.
- Revision received March 9, 2018.
- Accepted March 13, 2018.
- 2018 The Authors