Zusammenfassung
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, ...
Zusammenfassung
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.
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