PMID- 30948210
OWN - NLM
STAT- MEDLINE
DCOM- 20200924
LR  - 20200924
IS  - 1557-3117 (Electronic)
IS  - 1053-2498 (Print)
IS  - 1053-2498 (Linking)
VI  - 38
IP  - 4
DP  - 2019 Apr
TI  - Outcomes with ambulatory advanced heart failure from the Medical Arm of 
      Mechanically Assisted Circulatory Support (MedaMACS) Registry.
PG  - 408-417
LID - S1053-2498(18)31686-3 [pii]
LID - 10.1016/j.healun.2018.09.021 [doi]
AB  - BACKGROUND: The outlook for ambulatory patients with advanced heart failure (HF) 
      and the appropriate timing for left ventricular assist device (LVAD) or 
      transplant remain uncertain. The aim of this study was to better understand 
      disease trajectory and rates of progression to subsequent LVAD therapy and 
      transplant in ambulatory advanced HF. METHODS: Patients with advanced HF who were 
      New York Heart Association (NYHA) Class III or IV and Interagency Registry for 
      Mechanically Assisted Circulatory Support (INTERMACS) Profiles 4 to 7, despite 
      optimal medical therapy (without inotropic therapy), were enrolled across 11 
      centers and followed for the end-points of survival, transplantation, LVAD 
      placement, and health-related quality of life. A secondary intention-to-treat 
      survival analysis compared outcomes for MedaMACS patients with a matched group of 
      Profile 4 to 7 patients with LVADs from the INTERMACS registry. RESULTS: Between 
      May 2013 and October 2015, 161 patients were enrolled with INTERMACS Profiles 4 
      (12%), 5 (32%), 6 (49%), and 7 (7%). By 2 years after enrollment, 75 (47%) 
      patients had reached a primary end-point with 39 (24%) deaths, 17 (11%) 
      undergoing LVAD implantation, and 19 (12%) receiving a transplant. Compared with 
      1,753 patients with Profiles 4 to 7 receiving LVAD therapy, there was no overall 
      difference in intention-to-treat survival between medical and LVAD therapy, but 
      survival with LVAD therapy was superior to medical therapy among Profile 4 and 5 
      patients (p = 0.0092). Baseline health-related quality of life was lower among 
      patients receiving a LVAD than those enrolled on continuing oral medical therapy, 
      but increased after 1 year for survivors in both cohorts. CONCLUSIONS: Ambulatory 
      patients with advanced HF are at high risk for poor outcomes, with only 53% alive 
      on medical therapy after 2 years of follow-up. Survival was similar for medical 
      and LVAD therapy in the overall cohort, which included the lower severity 
      Profiles 6 and 7, but survival was better with LVAD therapy among patients in 
      Profiles 4 and 5. Given the poor outcomes in this group of advanced HF patients, 
      timely consideration of transplant and LVAD is of critical importance.
CI  - Copyright (c) 2018 International Society for Heart and Lung Transplantation. 
      Published by Elsevier Inc. All rights reserved.
FAU - Ambardekar, Amrut V
AU  - Ambardekar AV
AD  - Department of Medicine, Division of Cardiology, University of Colorado, Aurora, 
      Colorado, USA. Electronic address: amrut.ambardekar@ucdenver.edu.
FAU - Kittleson, Michelle M
AU  - Kittleson MM
AD  - Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
FAU - Palardy, Maryse
AU  - Palardy M
AD  - Department of Internal Medicine/Cardiovascular, University of Michigan, Ann 
      Arbor, Michigan, USA.
FAU - Mountis, Maria M
AU  - Mountis MM
AD  - Division of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
FAU - Forde-McLean, Rhondalyn C
AU  - Forde-McLean RC
AD  - Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, 
      USA.
FAU - DeVore, Adam D
AU  - DeVore AD
AD  - Division of Cardiology and Duke Clinical Research Institute, Duke University 
      Medical School, Durham, North Carolina, USA.
FAU - Pamboukian, Salpy V
AU  - Pamboukian SV
AD  - Division of Cardiovascular Sciences, University of Alabama at Birmingham, 
      Birmingham, Alabama, USA.
FAU - Thibodeau, Jennifer T
AU  - Thibodeau JT
AD  - Department of Internal Medicine/Cardiology, University of Texas Southwestern, 
      Dallas, Texas, USA.
FAU - Teuteberg, Jeffrey J
AU  - Teuteberg JJ
AD  - Department of Medicine, Division of Cardiovascular Medicine, Stanford University, 
      Stanford, California, USA.
FAU - Cadaret, Linda
AU  - Cadaret L
AD  - Department of Internal Medicine, Division of Cardiology, University of Iowa, Iowa 
      City, Iowa, USA.
FAU - Xie, Rongbing
AU  - Xie R
AD  - Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, 
      USA.
FAU - Taddei-Peters, Wendy
AU  - Taddei-Peters W
AD  - Division of Cardiovascular Diseases, Advanced Technologies and Surgery Branch, 
      National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA.
FAU - Naftel, David C
AU  - Naftel DC
AD  - Department of Internal Medicine, Division of Cardiology, University of Iowa, Iowa 
      City, Iowa, USA.
FAU - Kirklin, James K
AU  - Kirklin JK
AD  - Department of Internal Medicine, Division of Cardiology, University of Iowa, Iowa 
      City, Iowa, USA.
FAU - Stevenson, Lynne W
AU  - Stevenson LW
AD  - Department of Medicine, Division of Cardiovascular Medicine, Vanderbilt 
      University, Nashville, Tennessee, USA.
FAU - Stewart, Garrick C
AU  - Stewart GC
AD  - Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, 
      Massachusetts, USA.
LA  - eng
GR  - HHSN268201100025C/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20181001
PL  - United States
TA  - J Heart Lung Transplant
JT  - The Journal of heart and lung transplantation : the official publication of the 
      International Society for Heart Transplantation
JID - 9102703
SB  - IM
CIN - J Heart Lung Transplant. 2019 Apr;38(4):418-419. PMID: 30770267
MH  - Aged
MH  - Disease Progression
MH  - Female
MH  - Heart Failure/*surgery
MH  - *Heart Transplantation
MH  - *Heart-Assist Devices
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Registries
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC6452871
MID - NIHMS1510893
OTO - NOTNLM
OT  - advanced heart failure
OT  - cardiac transplantation
OT  - mechanical circulatory support
OT  - patient decision-making
OT  - ventricular assist device
COIS- Conflict of Interest Disclosures Dr. DeVore reports receiving research support 
      from the American Heart Association, Amgen, the NIH, and Novartis and consulting 
      with Novartis. Dr. Teuteberg reports receiving advertising board and speaking 
      honoraria from Medtronic, CareDx, and Abiomed as well as receiving support from 
      Abbott for the HeartMate 3 Clinical Events Committee. The remaining authors have 
      no disclosures.
EDAT- 2019/04/06 06:00
MHDA- 2020/09/25 06:00
PMCR- 2020/04/01
CRDT- 2019/04/06 06:00
PHST- 2018/07/13 00:00 [received]
PHST- 2018/09/04 00:00 [revised]
PHST- 2018/09/25 00:00 [accepted]
PHST- 2019/04/06 06:00 [entrez]
PHST- 2019/04/06 06:00 [pubmed]
PHST- 2020/09/25 06:00 [medline]
PHST- 2020/04/01 00:00 [pmc-release]
AID - S1053-2498(18)31686-3 [pii]
AID - 10.1016/j.healun.2018.09.021 [doi]
PST - ppublish
SO  - J Heart Lung Transplant. 2019 Apr;38(4):408-417. doi: 
      10.1016/j.healun.2018.09.021. Epub 2018 Oct 1.