PMID- 27575279
OWN - NLM
STAT- MEDLINE
DCOM- 20170524
LR  - 20170829
IS  - 1879-1913 (Electronic)
IS  - 0002-9149 (Linking)
VI  - 118
IP  - 6
DP  - 2016 Sep 15
TI  - Impact of Preprocedural Left Ventricular Ejection Fraction on 1-Year Outcomes 
      After MitraClip Implantation (from the ACCESS-EU Phase I, a Prospective, 
      Multicenter, Nonrandomized Postapproval Study of the MitraClip Therapy in 
      Europe).
PG  - 873-880
LID - S0002-9149(16)31107-9 [pii]
LID - 10.1016/j.amjcard.2016.06.036 [doi]
AB  - This report describes the 12-month outcomes of the a prospective, multicenter, 
      nonrandomized post-approval study of the MitraClip therapy in Europe (ACCESS-EU 
      postapproval study of MitraClip therapy) with respect to preprocedural left 
      ventricular ejection fraction (LVEF). Transcatheter deployment of the MitraClip 
      device may be considered for patients who are not suitable for conventional 
      surgery. A total of 567 patients with significant mitral regurgitation (MR) 
      underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were 
      subdivided by preprocedural LVEF (A: 10% to 20%, B: >20% to 30%, C: >30% to 40%, 
      D: >40%). Procedural safety and efficacy and treatment outcomes including MR 
      grade, New York Heart Association (NYHA) functional class, 6-minute walk test, 
      and the Minnesota Living with Heart Failure Questionnaire were analyzed at 
      baseline, 30 days, and 12 months. Baseline mean logistic EuroSCORE was 25 +/- 19; 
      87% of patients were in NYHA classes III or IV (A: 96%, B: 83%, C: 90%, D: 86%). 
      There was no incidence of death or stroke intraprocedurally. Eleven patients died 
      within 30 days with no differences among subgroups. Kaplan-Meier survival at 
      12 months was 81.8% (A: 71%, B: 79%, C: 87%, D: 86%). There was a significant 
      improvement in MR severity at 30 days and 12 months (p <0.0001). At 12 months, 
      all subgroups experienced similar improvements in NYHA class, 6-minute walk test, 
      and Minnesota Living with Heart Failure Questionnaire. This real-world registry 
      reports promising results of MitraClip therapy in patients with FMR. In 
      conclusion, the low rates of hospital mortality and adverse events in patients 
      with FMR-even in patients with severely reduced LVEF-provide additional evidence 
      of substantial benefits after MitraClip implantation.
CI  - Copyright (c) 2016 Elsevier Inc. All rights reserved.
FAU - Schafer, Ulrich
AU  - Schafer U
AD  - Department of General and Interventional Cardiology, University Heart Centre, 
      Hamburg, Germany. Electronic address: u.schaefer@uke.de.
FAU - Maisano, Francesco
AU  - Maisano F
AD  - Department of Cardiovascular Surgery, University Hospital Zurich, Zurich, 
      Switzerland.
FAU - Butter, Christian
AU  - Butter C
AD  - Department of Cardiology, Heart Centre Brandenburg, Bernau, Germany.
FAU - Franzen, Olaf
AU  - Franzen O
AD  - Department of Cardiology, Klinik im Park, Zurich, Switzerland.
FAU - Baldus, Stephan
AU  - Baldus S
AD  - Department of Cardiology, University Heart Centre, Cologne, Germany.
FAU - Hausleiter, Jorg
AU  - Hausleiter J
AD  - Medizinische Klinik und Poliklinik I, Klinikum der Universitat Munchen, Munich, 
      Germany.
FAU - Ussia, Gian Paolo
AU  - Ussia GP
AD  - Department of Cardiology, University of Rome "Tor Vergata", Rome, Italy.
FAU - Sievert, Horst
AU  - Sievert H
AD  - CardioVascular Center Frankfurt, Frankfurt, Germany.
FAU - Geist, Volker
AU  - Geist V
AD  - Department of Cardiology, Heart Center, Segeberger Kliniken GmbH (Academic 
      Teaching Hospital of the Universities of Kiel and Hamburg), Bad Segeberg, 
      Germany.
FAU - Widder, Julian Daniel
AU  - Widder JD
AD  - Department of Cardiology and Angiology, Hannover Medical School, Hannover, 
      Germany.
FAU - Moccetti, Tiziano
AU  - Moccetti T
AD  - Division of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.
FAU - Schillinger, Wolfgang
AU  - Schillinger W
AD  - HELIOS Albert-Schweitzer-Klinik Northeim, Innere Medizin I, Northeim, Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20160820
PL  - United States
TA  - Am J Cardiol
JT  - The American journal of cardiology
JID - 0207277
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Cardiac Catheterization
MH  - Case-Control Studies
MH  - Female
MH  - Hospital Mortality
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - *Mitral Valve Annuloplasty
MH  - Mitral Valve Insufficiency/physiopathology/*surgery
MH  - *Mortality
MH  - Prognosis
MH  - *Registries
MH  - Severity of Illness Index
MH  - *Stroke Volume
MH  - *Surgical Instruments
MH  - Treatment Outcome
MH  - Walk Test
EDAT- 2016/08/31 06:00
MHDA- 2017/05/26 06:00
CRDT- 2016/08/31 06:00
PHST- 2016/03/01 00:00 [received]
PHST- 2016/06/15 00:00 [revised]
PHST- 2016/06/15 00:00 [accepted]
PHST- 2016/08/31 06:00 [entrez]
PHST- 2016/08/31 06:00 [pubmed]
PHST- 2017/05/26 06:00 [medline]
AID - S0002-9149(16)31107-9 [pii]
AID - 10.1016/j.amjcard.2016.06.036 [doi]
PST - ppublish
SO  - Am J Cardiol. 2016 Sep 15;118(6):873-880. doi: 10.1016/j.amjcard.2016.06.036. 
      Epub 2016 Aug 20.