• Helge Möllmann, Christian Hengstenberg, Michael Hilker, Sebastian Kerber, Ulrich Schäfer, Tanja Rudolph, Axel Linke, Norbert Franz, Thomas Kuntze, Holger Nef, Utz Kappert, Thomas Walther, Michael O Zembala, Stefan Toggweiler, and Won-Keun Kim.
• Department of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
• EuroIntervention. 2018 Feb 2; 13 (15): e1764-e1770.

AimsThe 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 ResultsFrom 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 postdilatation 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.ConclusionsIn this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.

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