PMID- 30077993
OWN - NLM
STAT- MEDLINE
DCOM- 20200507
LR  - 20200507
IS  - 1468-201X (Electronic)
IS  - 1355-6037 (Linking)
VI  - 105
IP  - 21
DP  - 2019 Nov
TI  - Five-year outcomes of transcatheter reduction of significant mitral regurgitation 
      in high-surgical-risk patients.
PG  - 1622-1628
LID - 10.1136/heartjnl-2017-312605 [doi]
AB  - OBJECTIVES: This study evaluates the 5-year clinical outcomes of transcatheter 
      mitral valve (MV) repair with the MitraClip device in patients at high risk for 
      MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II 
      High Risk Study (HRS). METHODS: Patients with mitral regurgitation (MR) 3+ or 4+ 
      and predicted surgical mortality risk >/=12% or surgeon assessment based on 
      prespecified high-risk factors were enrolled. Patients prospectively consented to 
      5 years of follow-up. RESULTS: At 5 years, clinical follow-up was achieved in 90% 
      of 78 enrolled patients. The rate of postprocedural adverse events declined from 
      30 days to 1 year follow-up and was stable thereafter through 5 years. Two 
      patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV 
      surgery, including one due to MS. A total of 42 deaths were reported through 5 
      years. Effectiveness measures at 5 years showed reductions in MR severity to </=2+ 
      in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume 
      (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 
      95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart 
      Association (NYHA) functional class improved from baseline to 5 years (p<0.005), 
      and septal-lateral annular dimensions remained stable with no indication of 
      mitral annular dilation through 5 years. CONCLUSIONS: The EVEREST II HRS 
      demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk 
      patients through 5 years. The observed mortality was most likely a consequence of 
      the advanced age and comorbidity profile of the enrolled patients, while 
      improvements in NYHA class in surviving patients were durable through long-term 
      follow-up. TRIAL REGISTRATION NUMBER: NCT01940120.
CI  - (c) Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and 
      permissions. Published by BMJ.
FAU - Kar, Saibal
AU  - Kar S
AD  - Cedars-Sinai Medical Center, Heart Institute, Los Angeles, California, USA.
AD  - Heart Institute, Cedars Sinai Medical Center, Los Angeles, California, US.
FAU - Feldman, Ted
AU  - Feldman T
AD  - Northshore University Health System, Evanston, Illinois, USA.
FAU - Qasim, Atif
AU  - Qasim A
AD  - University of California, San Francisco, California, USA.
FAU - Trento, Alfredo
AU  - Trento A
AD  - Cedars-Sinai Medical Center, Heart Institute, Los Angeles, California, USA.
FAU - Kapadia, Samir
AU  - Kapadia S
AD  - Cleveland Clinic Foundation, Cleveland, Ohio, USA.
FAU - Pedersen, Wesley
AU  - Pedersen W
AD  - Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA.
FAU - Lim, D Scott
AU  - Lim DS
AD  - Division of Cardiology, University of Virginia, Charlottesville, Virginia, USA.
FAU - Kipperman, Robert
AU  - Kipperman R
AD  - Oklahoma Heart Hospital, Oklahoma City, Oklahoma, USA.
FAU - Smalling, Richard W
AU  - Smalling RW
AD  - Memorial Hermann Heart and Vascular Institute/UT Health, Houston, Texas, USA.
FAU - Bajwa, Tanvir
AU  - Bajwa T
AD  - Aurora Cardiovascular Services, Aurora Sinai/Aurora St Luke's Medical Centers, 
      Milwaukee, Wisconsin, USA.
FAU - Hermann, Howard C
AU  - Hermann HC
AD  - Division of Cardiology, Department of Medicine, University of Pennsylvania, 
      Philadelphia, Pennsylvania, USA.
FAU - Hermiller, James B
AU  - Hermiller JB
AD  - St Vincent Medical Group, Indianapolis, Indiana, USA.
FAU - Lasala, John M
AU  - Lasala JM
AD  - Washington University, St Louis, Missouri, USA.
FAU - Reisman, Mark
AU  - Reisman M
AD  - Division of Cardiology, University of Washington Medical Center, Seattle, 
      Washington, USA.
FAU - Glower, Donald
AU  - Glower D
AD  - Duke University Medical Center, Durham, North Carolina, USA.
FAU - Mauri, Laura
AU  - Mauri L
AD  - Harvard Medical School, Harvard Clinical Research Institute, Brigham and Women's 
      Hospital, Boston, Massachusetts, USA.
FAU - Whitlow, Patrick
AU  - Whitlow P
AD  - Cleveland Clinic Foundation, Cleveland, Ohio, USA.
CN  - EVEREST II Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT01940120
PT  - Journal Article
PT  - Multicenter Study
DEP - 20180804
PL  - England
TA  - Heart
JT  - Heart (British Cardiac Society)
JID - 9602087
SB  - IM
MH  - Aged
MH  - Cardiac Catheterization/*methods
MH  - Echocardiography
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Valve Prosthesis Implantation/*methods
MH  - Heart Ventricles/diagnostic imaging/*physiopathology
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Mitral Valve/diagnostic imaging/*surgery
MH  - Mitral Valve Insufficiency/diagnosis/mortality/*surgery
MH  - Postoperative Complications/*epidemiology
MH  - Prospective Studies
MH  - Risk Assessment/*methods
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Survival Rate/trends
MH  - Time Factors
MH  - United States/epidemiology
MH  - Ventricular Function, Left/physiology
OTO - NOTNLM
OT  - mitral regurgitation
OT  - transcatheter valve interventions
COIS- Competing interests: SK is a consultant for and has received 
      honoraria/institutional research support from Abbott, Boston Scientific, WL Gore, 
      Mitralign, Edwards. TF is a consultant for and has received 
      honoraria/institutional research support from Abbott, Boston Scientific, Edwards 
      and WL Gore. AQ has received research grant from Abbott. DSL is a consultant for 
      and has received research grants from Abbott. RWS has received grant support from 
      Abbott Vascular. HCH has received institutional research support from Abbott 
      Vascular, Boston Scientific, Edwards Lifesciences, St Jude Medical, Medtronic, 
      Cardiokinetx, Gore and Mitraspan; is a consultant for Edwards Lifesciences and 
      Siemens; and has equity ownership in Microinterventional Devices. LM's 
      institution has received research grants from Abbott Vascular, Boston Scientific, 
      Cordis, Medtronic, Eli Lilly, Daiichi Sankyo, Bristol-Myers Squibb and 
      Sanofi-Aventis. All other authors have reported they have no relationships 
      relevant to the contents of this paper to disclose.
EDAT- 2018/08/06 06:00
MHDA- 2020/05/08 06:00
CRDT- 2018/08/06 06:00
PHST- 2017/10/25 00:00 [received]
PHST- 2018/04/16 00:00 [revised]
PHST- 2018/04/23 00:00 [accepted]
PHST- 2018/08/06 06:00 [pubmed]
PHST- 2020/05/08 06:00 [medline]
PHST- 2018/08/06 06:00 [entrez]
AID - heartjnl-2017-312605 [pii]
AID - 10.1136/heartjnl-2017-312605 [doi]
PST - ppublish
SO  - Heart. 2019 Nov;105(21):1622-1628. doi: 10.1136/heartjnl-2017-312605. Epub 2018 
      Aug 4.