Boergermann, Jochen and Holzhey, David M. and Thielmann, Matthias and Girdauskas, Evaldas and Schroefel, Holger and Hofmann, Steffen and Treede, Hendrik and Matschke, Klaus and Hilker, Michael and Strauch, Justus T. and Carrel, Thierry and Wahlers, Thorsten and Diegeler, Anno and Kempfert, Joerg and Walther, Thomas (2017) Transcatheter aortic valve implantation using the ACURATE TA (TM) system: 1-year outcomes and comparison of 500 patients from the SAVI registries. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY, 51 (5). pp. 936-942. ISSN 1010-7940, 1873-734X
Full text not available from this repository. (Request a copy)Abstract
OBJECTIVES: The ACURATE TA (TM) system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine. METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2. RESULTS: Patients were 80.8 +/- 6.1 years old, the mean logistic EuroSCORE-I was 23.4 +/- 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage >= 2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up. CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TA (TM) device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HEART-VALVE; TAVI; BIOPROSTHESIS; REGURGITATION; STENOSIS; THERAPY; DEVICES; Transcatheter aortic valve; Transcatheter heart valve; ACURATE; Transapical; Self-expanding; Registry |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2018 13:10 |
| Last Modified: | 20 Feb 2019 14:52 |
| URI: | https://pred.uni-regensburg.de/id/eprint/940 |
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