First registry results from the newly approved ACURATE TA™ TAVI system
Selected in European Journal of Cardio-Thoracic Surgery by Rylski
Kempfert J, Holzhey D, Hofmann S, Girdauskas E, Treede H, Schröfel H, Thielmann M, Walther T
Eur J Cardiothorac Surg. 2015 Jul;48(1):137-41
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The authors reported on the first 250 patients who underwent transapical aortic valve implantation with the novel ACURATE TA™ system.
- Multicenter report with 17 centers in 4 countries; 250 patients included.
- Mean aortic gradient of 43.2 ± 17.4 mmHg, mean age of 80.9 ± 6.3 years, mean society of thoracic surgeons risk score of 8.0 ± 5.9% and mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 22.3 ± 12.7%.
- The technical success rate was of 98% with 2 valve-in-valve procedures and 3 conversions to conventional surgery.
- The 30-day mortality rate was of 6.8%.
- The relevant paravalvular leak (moderate 2+) was observed in 2.3%, all other had none/trace or a 1+ leak.
- The 30-day stroke rate was 2.8%.
- The pacemaker implantation was required in 10%.
ACURATE TA™ system is the third commercially available TAVI system in Europe since 2011. It comprises a self-expanding nitinol stent with a regular surgical porcine tissue valve. Nitinol stent is covered by an anti-paravalvular leak skirt. The results of this first post-market study are promising. Especially the very low rate of relevant paravalvular leak may improve the survival, since residual leak after TAVI is a well-known risk factor for mid-term mortality. It seems that the inner and outer skirts for sealing off paravalvular leak and the characteristic ‘pull-down’ manoeuvre during valve deployment, which leads to ‘capping’ the calcified leaflets within the stent, works well. The 30-day mortality rate compares well with other reports (FRANCE-2 9.7%, SENTINEL 7.4%). This novel TAVI system expands notably the armamentarium of transcatheter technics for treatment of aortic valve stenosis. Cardiac arrhythmia requiring pacemaker implantation is still an issue in TAVI technology.