PMID- 27159659
OWN - NLM
STAT- MEDLINE
DCOM- 20170726
LR  - 20170817
IS  - 1969-6213 (Electronic)
IS  - 1774-024X (Linking)
VI  - 12
IP  - 8
DP  - 2016 Oct 10
TI  - Four-year experience with the CoreValve transcatheter heart valve.
PG  - e1039-e1046
LID - 20141205_01 [pii]
LID - 10.4244/EIJY15M10_10 [doi]
AB  - AIMS: Our aim was to evaluate the long-term device performance and clinical 
      outcomes of patients with symptomatic, severe aortic valve stenosis (AS) who 
      underwent transcatheter aortic valve implantation (TAVI) with the CoreValve 
      bioprosthesis. METHODS AND RESULTS: The CoreValve CE Pivotal Study was a 
      prospective, multicentre, single-arm TAVI trial using the CoreValve system. Valve 
      performance, patient quality of life (QoL), New York Heart Association (NYHA) 
      class, and mortality at four years were analysed in 126 patients (mean age 82.4 
      years, 42.9% male, mean logistic EuroSCORE 23.4%) with severe AS. Mean aortic 
      valve gradient decreased from 46.9+/-16.1 mmHg at baseline to 9.8+/-4.1 mmHg at 
      discharge and to 7.8+/-2.7 mmHg at four years. Mean effective orifice area 
      increased from 0.7+/-0.2 cm2 to 1.8+/-0.4 cm2 after TAVI and was 1.6+/-0.5 cm2 at four 
      years. There were no reports of structural valve deterioration or valve 
      migration. There was sustained improvement in QoL and NYHA class in surviving 
      patients. All-cause and cardiac survival was 45.3% and 62.6%, respectively, at 
      four years. CONCLUSIONS: The CoreValve bioprosthesis demonstrates long-term 
      durability, stable haemodynamic function, and no evidence of structural 
      deterioration. Most surviving patients continued to have improved NYHA class and 
      QoL at four years.
FAU - Kovac, Jan
AU  - Kovac J
AD  - Cardiovascular Biomedical Research Unit, University of Leicester, Leicester, 
      United Kingdom.
FAU - Schuler, Gerhard
AU  - Schuler G
FAU - Gerckens, Ulrich
AU  - Gerckens U
FAU - Muller, Ralf
AU  - Muller R
FAU - Serruys, Patrick W
AU  - Serruys PW
FAU - Bonan, Raoul
AU  - Bonan R
FAU - Labinaz, Marino
AU  - Labinaz M
FAU - den Heijer, Peter
AU  - den Heijer P
FAU - Mullen, Michael
AU  - Mullen M
FAU - Tymchak, Wayne
AU  - Tymchak W
FAU - Grube, Eberhard
AU  - Grube E
LA  - eng
PT  - Journal Article
DEP - 20161010
PL  - France
TA  - EuroIntervention
JT  - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on 
      Interventional Cardiology of the European Society of Cardiology
JID - 101251040
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Aortic Valve Stenosis/*surgery
MH  - *Bioprosthesis
MH  - Female
MH  - Follow-Up Studies
MH  - *Heart Valve Prosthesis
MH  - Humans
MH  - Male
MH  - Postoperative Complications/epidemiology
MH  - Prospective Studies
MH  - *Prosthesis Design
MH  - Prosthesis Failure
MH  - Severity of Illness Index
MH  - Survival Rate
MH  - Transcatheter Aortic Valve Replacement/*methods
MH  - Treatment Outcome
EDAT- 2016/05/10 06:00
MHDA- 2017/07/27 06:00
CRDT- 2016/05/10 06:00
PHST- 2016/05/10 06:00 [pubmed]
PHST- 2017/07/27 06:00 [medline]
PHST- 2016/05/10 06:00 [entrez]
AID - 20141205_01 [pii]
AID - 10.4244/EIJY15M10_10 [doi]
PST - epublish
SO  - EuroIntervention. 2016 Oct 10;12(8):e1039-e1046. doi: 10.4244/EIJY15M10_10.