Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries.
OBJECTIVE
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.
Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany.
Jochen
J
Börgermann
Department of Cardiac Surgery, Heart Center Leipzig University, Leipzig, Germany.
David M
DM
Holzhey
Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center Essen, University Duisburg-Essen, Essen, Germany.
Matthias
M
Thielmann
Department of Cardiac Surgery, Central Hospital Bad Berka, Bad Berka, Germany.|Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
Evaldas
E
Girdauskas
Clinic for Cardiac Surgery, Karlsruhe, Germany, Department of Cardiovascular Surgery, Heart Center Freiburg, Bad Krozingen, Germany.
Holger
H
Schroefel
Schüchtermann-Schiller'sche Kliniken GmbH, Bad Rothenfelde, Germany.
Steffen
S
Hofmann
Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.|Department of Cardiac Surgery, Mid-German Heart Center, University Hospital Halle, Halle, Germany.
Hendrik
H
Treede
Department of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany.
Klaus
K
Matschke
Department of Cardiothoracic Surgery, University Medical Center Regensburg, Regensburg, Germany.
Michael
M
Hilker
Department of Cardiac and Thoracic Surgery, BG University Hospital Bergmannsheil, Bochum, Germany.
Justus T
JT
Strauch
Clinic for Cardiovascular Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
Thierry
T
Carrel
Department of Cardiothoracic Surgery, Heart Center, University of Cologne, Cologne, Germany.
Thorsten
T
Wahlers
Department of Cardiovascular Surgery, Herz-und Gefässklinik Bad Neustadt, Bad Neustadt a. d. Saale, Germany.
Anno
A
Diegeler
Department of Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.|Department of Cardiovascular and Thoracic Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany.
Jörg
J
Kempfert
Department of Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
Thomas
T
Walther
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation / Q000379:methods / Q000401:mortality / Q000706:statistics & numerical data; D016896:Treatment Outcome
ACURATE; Registry; Self-expanding; Transapical; Transcatheter aortic valve; Transcatheter heart valve