Moellmann, Helge, Hengstenberg, Christian, Hilker, Michael, Kerber, Sebastian, Schaefer, Ulrich, Rudolph, Tanja, Linke, Axel, Franz, Norbert, Kuntze, Thomas, Nef, Holger, Kappert, Utz, Walther, Thomas, Zembala, Michael O., Toggweiler, Stefan and Kim, Won-Keun (2018). Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry. EuroIntervention, 13 (15). S. 1764 - 1771. TOULOUSE CEDEX 6: EUROPA EDITION. ISSN 1969-6213
Full text not available from this repository.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 post-dilatation 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 cm (2) 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.
| Item Type: | Journal Article | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| URN: | urn:nbn:de:hbz:38-196420 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| DOI: | 10.4244/EIJ-D-17-00628 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Journal or Publication Title: | EuroIntervention | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Volume: | 13 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Number: | 15 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Page Range: | S. 1764 - 1771 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date: | 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Publisher: | EUROPA EDITION | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Place of Publication: | TOULOUSE CEDEX 6 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ISSN: | 1969-6213 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Language: | English | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Faculty: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Divisions: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Subjects: | no entry | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Refereed: | Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| URI: | http://kups.ub.uni-koeln.de/id/eprint/19642 |
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