PMID- 27005980
OWN - NLM
STAT- MEDLINE
DCOM- 20170821
LR  - 20220317
IS  - 1873-734X (Electronic)
IS  - 1010-7940 (Linking)
VI  - 50
IP  - 4
DP  - 2016 Oct
TI  - No clinical effect of prosthesis-patient mismatch after transcatheter versus 
      surgical aortic valve replacement in intermediate- and low-risk patients with 
      severe aortic valve stenosis at mid-term follow-up: an analysis from the NOTION 
      trial.
PG  - 721-728
AB  - OBJECTIVES: Prosthesis-patient mismatch (PPM) after surgical aortic valve 
      replacement (SAVR) for severe aortic valve stenosis (AVS) is common, but less 
      common after transcatheter aortic valve replacement (TAVR) in patients considered 
      at high risk for death after surgery. The objectives of this study were to 
      determine incidence and clinical effect of PPM after SAVR and TAVR in a primarily 
      low-risk patient group. METHODS: Patients 70 years or older with severe isolated 
      AVS, regardless of predicted operative mortality risk, were consecutively 
      randomized 1:1 to TAVR using a self-expandable bioprosthesis (n = 145) or SAVR (n 
      = 135). Post-procedure PPM was graded after 3 months as follows: Not 
      present-mild, if indexed effective orifice area (iEOA) >0.85 cm(2)/m(2), 
      moderate, if 0.65 cm(2)/m(2) < iEOA </= 0.85 cm(2)/m(2) and severe, if iEOA </=0.65 
      cm(2)/m(2). Outcomes were major adverse cardiac and cerebrovascular events 
      (MACCE, e.g. composite rate of all-cause death, stroke, myocardial infarction or 
      valve reintervention), cardiac-related hospitalizations and New York Heart 
      Association (NYHA) functional class after 2 years. RESULTS: The incidence and the 
      severity of PPM were significantly lower after TAVR compared with SAVR (severe, 
      moderate, none-mild 14.0, 35.5, 50.4 vs 33.9, 36.7, 29.4%; P<0.001). PPM resulted 
      in similar higher mean valve gradients at 3 months for both groups. Baseline 
      characteristics related to severe PPM were younger age, absence of diabetes 
      mellitus, lower mortality-risk score for TAVR, and younger age and higher body 
      mass index for SAVR. At 2 years, there were numerical but no statistically 
      significant differences between both TAVR and SAVR patients with severe and no 
      severe PPM for MACCE (0.0 vs 12.8% for TAVR; P = 0.13, and 13.5 vs 7.0% for SAVR; 
      P = 0.27), number of cardiac-related hospitalizations (mean +/- standard deviation 
      0.4 +/- 0.6 vs 0.6 +/- 0.8; P = 0.23, and 0.4 +/- 0.8 vs 0.5 +/- 0.9; P = 0.70) and NYHA 
      functional class (Class I/II/III/IV: 64.7/29.4/5.9/0.0 vs 62.1/34.7/3.2/0.0%, 
      respectively; P = 0.91, and 71.4/25.7/2.9/0.0 vs 72.9/22.9/4.3/0.0%, 
      respectively; P = 0.92). CONCLUSIONS: The incidence of PPM was lower and less 
      severe after TAVR compared with SAVR in intermediate- and low-risk patients with 
      severe AVS. There were no significant differences in MACCE, cardiac-related 
      hospitalizations or NYHA class after 2 years for patients with versus those 
      without severe PPM.
CI  - (c) The Author 2016. Published by Oxford University Press on behalf of the European 
      Association for Cardio-Thoracic Surgery. All rights reserved.
FAU - Thyregod, Hans Gustav Horsted
AU  - Thyregod HG
AD  - Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, 
      Copenhagen University Hospital, Copenhagen, Denmark 
      hans.gustav.thyregod@regionh.dk.
FAU - Steinbruchel, Daniel Andreas
AU  - Steinbruchel DA
AD  - Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, 
      Copenhagen University Hospital, Copenhagen, Denmark.
FAU - Ihlemann, Nikolaj
AU  - Ihlemann N
AD  - Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University 
      Hospital, Copenhagen, Denmark.
FAU - Ngo, Thuc Anh
AU  - Ngo TA
AD  - Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University 
      Hospital, Copenhagen, Denmark.
FAU - Nissen, Henrik
AU  - Nissen H
AD  - Department of Cardiology, Odense University Hospital, Odense, Denmark.
FAU - Kjeldsen, Bo Juel
AU  - Kjeldsen BJ
AD  - Department of Cardiothoracic and Vascular Surgery, Odense University Hospital, 
      Odense, Denmark.
FAU - Chang, Yanping
AU  - Chang Y
AD  - Medtronic Inc., Mounds View, MN, USA.
FAU - Hansen, Peter Bo
AU  - Hansen PB
AD  - Department of Cardiac Anesthesia, The Heart Centre, Rigshospitalet, Copenhagen 
      University Hospital, Copenhagen, Denmark.
FAU - Olsen, Peter Skov
AU  - Olsen PS
AD  - Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, 
      Copenhagen University Hospital, Copenhagen, Denmark.
FAU - Sondergaard, Lars
AU  - Sondergaard L
AD  - Department of Cardiology, The Heart Centre, Rigshospitalet, Copenhagen University 
      Hospital, Copenhagen, Denmark.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160322
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
MH  - Aortic Valve Stenosis/*surgery
MH  - *Bioprosthesis
MH  - Female
MH  - Follow-Up Studies
MH  - *Heart Valve Prosthesis
MH  - *Heart Valve Prosthesis Implantation/methods
MH  - Humans
MH  - Male
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Aortic valve stenosis
OT  - Clinical outcomes
OT  - Heart valve prosthesis
OT  - Prosthesis-patient mismatch
EDAT- 2016/03/24 06:00
MHDA- 2017/08/22 06:00
CRDT- 2016/03/24 06:00
PHST- 2015/12/10 00:00 [received]
PHST- 2016/02/15 00:00 [revised]
PHST- 2016/02/22 00:00 [accepted]
PHST- 2016/03/24 06:00 [pubmed]
PHST- 2017/08/22 06:00 [medline]
PHST- 2016/03/24 06:00 [entrez]
AID - ezw095 [pii]
AID - 10.1093/ejcts/ezw095 [doi]
PST - ppublish
SO  - Eur J Cardiothorac Surg. 2016 Oct;50(4):721-728. doi: 10.1093/ejcts/ezw095. Epub 
      2016 Mar 22.