• JACC Cardiovasc Interv · Jul 2018

    Multicenter Study

    The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients.

    • Won-Keun Kim, Christian Hengstenberg, Michael Hilker, Sebastian Kerber, Ulrich Schäfer, Tanja Rudolph, Axel Linke, Norbert Franz, Thomas Kuntze, Holger Nef, Utz Kappert, Michael O Zembala, Stefan Toggweiler, Thomas Walther, and Helge Möllmann.
    • 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.
    • JACC Cardiovasc Interv. 2018 Jul 23; 11 (14): 1368-1374.

    ObjectivesThe 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.BackgroundThe 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.MethodsThis prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure.ResultsMean 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.ConclusionsTransfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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