PMID- 25425552
OWN - NLM
STAT- MEDLINE
DCOM- 20160408
LR  - 20150627
IS  - 1873-734X (Electronic)
IS  - 1010-7940 (Linking)
VI  - 48
IP  - 1
DP  - 2015 Jul
TI  - First registry results from the newly approved ACURATE TA TAVI systemdagger.
PG  - 137-41
LID - 10.1093/ejcts/ezu367 [doi]
AB  - OBJECTIVES: The novel ACURATE TA transcatheter aortic valve (Symetis, Ecublens, 
      Switzerland) is composed of a self-expanding nitinol stent covered by an 
      anti-paravalvular leak skirt designed for transapical implantation. Since 
      Conformite Europeenne (CE)-mark approval, the first 250 patients implanted with 
      the newly approved device have been included in this post-market, multicentre 
      registry. METHODS: The registry was conducted at 17 sites in Germany, Italy, 
      Switzerland and Argentina to treat 250 high-risk elderly patients. This 
      all-comers population presented preoperatively with a 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 majority of patients (93%) 
      were in New York Heart Association (NYHA) class III/IV. All patients were treated 
      within a multidisciplinary Heart Team. RESULTS: The procedural success rate was 
      98% (n = 245) with two valve-in-valve procedures and three conversions to 
      conventional surgery. The 30-day mortality rate was 6.8%. Postimplant 
      echocardiography revealed a relevant paravalvular leak (moderate 2+) in 2.3% of 
      patients, with all other patients demonstrating either none/trace or a 1+ leak. 
      The 30-day stroke rate was 2.8% and the mean transvalvular gradient was 12.4 +/- 
      5.8 mmHg. A new pacemaker implantation was required in 10.0% of patients and 85% 
      of patients returning for the follow-up presented in NYHA class I/II. 
      CONCLUSIONS: The short-term result of the registry shows a safety and efficacy 
      profile comparable, if not improved in some aspects, with previously approved 
      transcatheter aortic valve implantation devices. These 'real-world' data 
      highlight an excellent functional outcome, especially in regard to a low rate of 
      relevant paravalvular leak.
CI  - (c) The Author 2014. Published by Oxford University Press on behalf of the European 
      Association for Cardio-Thoracic Surgery. All rights reserved.
FAU - Kempfert, Jorg
AU  - Kempfert J
AD  - Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, Germany 
      kempfertj@gmail.com.
FAU - Holzhey, David
AU  - Holzhey D
AD  - Department of Cardiac Surgery, Heart Center University of Leipzig, Leipzig, 
      Germany.
FAU - Hofmann, Steffen
AU  - Hofmann S
AD  - Department of Cardiac Surgery, Schuchtermann-Schillersche Kliniken, Bad 
      Rothenfelde, Germany.
FAU - Girdauskas, Evaldas
AU  - Girdauskas E
AD  - Department of Cardiac Surgery, Zentralklinik Bad Berka, Bad Berka, Germany.
FAU - Treede, Hendrik
AU  - Treede H
AD  - Department of Cardiac Surgery, Heart Center University of Hamburg, Hamburg, 
      Germany.
FAU - Schrofel, Holger
AU  - Schrofel H
AD  - Department of Cardiac Surgery, Clinic for Heart Surgery Karlsruhe, Karlsruhe, 
      Germany.
FAU - Thielmann, Matthias
AU  - Thielmann M
AD  - Department of Cardiac Surgery, West German Heart Center University of Essen, 
      Essen, Germany.
FAU - Walther, Thomas
AU  - Walther T
AD  - Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim, Bad Nauheim, 
      Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20141125
PL  - Germany
TA  - Eur J Cardiothorac Surg
JT  - European journal of cardio-thoracic surgery : official journal of the European 
      Association for Cardio-thoracic Surgery
JID - 8804069
SB  - IM
MH  - Aged, 80 and over
MH  - Aortic Valve/*surgery
MH  - Female
MH  - *Heart Valve Prosthesis/adverse effects
MH  - Heart Valve Prosthesis Implantation/instrumentation/methods/mortality
MH  - Humans
MH  - Male
MH  - Registries/statistics & numerical data
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Aortic valve implantation
OT  - Minimally invasive
OT  - Transapical
EDAT- 2014/11/27 06:00
MHDA- 2016/04/09 06:00
CRDT- 2014/11/27 06:00
PHST- 2014/04/25 00:00 [received]
PHST- 2014/08/15 00:00 [accepted]
PHST- 2014/11/27 06:00 [entrez]
PHST- 2014/11/27 06:00 [pubmed]
PHST- 2016/04/09 06:00 [medline]
AID - ezu367 [pii]
AID - 10.1093/ejcts/ezu367 [doi]
PST - ppublish
SO  - Eur J Cardiothorac Surg. 2015 Jul;48(1):137-41. doi: 10.1093/ejcts/ezu367. Epub 
      2014 Nov 25.