Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry
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, Won-Keun Kim, 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, Won-Keun Kim
Abstract
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 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.
Conclusions: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.
Source: PubMed