PMID- 30165521
OWN - NLM
STAT- MEDLINE
DCOM- 20191129
LR  - 20191129
IS  - 1522-9645 (Electronic)
IS  - 0195-668X (Linking)
VI  - 39
IP  - 37
DP  - 2018 Oct 1
TI  - Six-month outcomes after treatment of advanced heart failure with a full 
      magnetically levitated continuous flow left ventricular assist device: report 
      from the ELEVATE registry.
PG  - 3454-3460
LID - 10.1093/eurheartj/ehy513 [doi]
AB  - AIMS: The ELEVATE registry was planned to study post-approval outcomes with 
      HeartMate 3 (HM3), a fully magnetically levitated continuous flow left 
      ventricular assist device (LVAD). METHODS AND RESULTS: A total of 482 patients 
      provided consent to participate in ELEVATE (enrolled cohort). Data collection 
      included baseline demographics, survival, adverse events, quality of life (QOL) 
      [EuroQoL-5 Dimensions visual analogue scale (VAS), and 6-minute walk distance 
      (6MWD)]. An additional 58 patients were implanted with HM3 during the same period 
      but expired or were explanted prior to consent, and only survival data were 
      collected (anonymized cohort). We report the 6-month outcomes of the patients who 
      received HM3 as their primary implant (n = 463) and the survival of the 540 
      patients in the full cohort (enrolled + anonymized). Baseline characteristics 
      included a mean age of 55.6 +/- 11.7 years, 89% male, 48% ischaemic aetiology, and 
      70% on inotropes. The majority of patients (66%) were bridge-to-transplantation 
      (BTT) and 32% were INTERMACS profile 1-2. Full cohort survival at 6 months was 
      82 +/- 2%. In the enrolled primary implant patients, there was no incidence of pump 
      thrombosis, major bleeding was 25%, major infection 35%, and any stroke type 5%. 
      Functional capacity improved significantly (Delta6MWD 230 +/- 191 m) as did QOL (DeltaVAS 
      31 +/- 23). Freedom from unplanned rehospitalizations at 6 months was 68 +/- 2%. 
      CONCLUSION: The 6-month outcomes of the HM3 LVAD demonstrate a highly reliable, 
      thrombosis free, device with low incidence of stroke and improved functional 
      capacity, and QOL. CLINICALTRIALS. GOV IDENTIFIER: NCT02497950.
FAU - Gustafsson, Finn
AU  - Gustafsson F
AD  - Rigshospitalet, Department of Cardiology, University of Copenhagen 9 Blegdamsvej, 
      Copenhagen, Denmark.
FAU - Shaw, Steven
AU  - Shaw S
AD  - Manchester University NHS Foundation Trust, Southmoor Road, Manchester, UK.
FAU - Lavee, Jacob
AU  - Lavee J
AD  - Heart Transplantation Unit, Sheba Medical Center and Sackler Faculty of Medicine, 
      Tel Aviv University, Tel Hasomer, Ramat Gan, Israel.
FAU - Saeed, Diyar
AU  - Saeed D
AD  - Cardiovascular Surgery, University Hospital of Duesseldorf, Moorenstrasse 5, 
      Dusseldorf, Germany.
FAU - Pya, Yuriy
AU  - Pya Y
AD  - National Research Cardiac Surgery Center, 38 Turan Street, Astana, Kazakhstan.
FAU - Krabatsch, Thomas
AU  - Krabatsch T
AD  - German Heart Center, Augustenburger Platz 1, Berlin, Germany.
FAU - Schmitto, Jan
AU  - Schmitto J
AD  - Hannover Medical School, Carl-Neuberg Strasse 1, Hannover, Germany.
FAU - Morshuis, Michiel
AU  - Morshuis M
AD  - Department of Cardiothoracic Surgery, Herz- und Diabeteszentrum NRW, Georgstrasse 
      11, Bad Oeynhausen, Germany.
FAU - Chuang, Joyce
AU  - Chuang J
AD  - Abbott, Abbott Park Road, Abbott Park, Chicago, IL, USA.
FAU - Damme, Laura
AU  - Damme L
AD  - Abbott, Abbott Park Road, Abbott Park, Chicago, IL, USA.
FAU - Zimpfer, Daniel
AU  - Zimpfer D
AD  - Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, 
      Waehringer Guertel 18-20, Vienna, Austria.
FAU - Garbade, Jens
AU  - Garbade J
AD  - Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, 
      Struempellstr. 39, Leipzig, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02497950
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Eur Heart J
JT  - European heart journal
JID - 8006263
SB  - IM
CIN - Eur Heart J. 2018 Oct 1;39(37):3461-3463. PMID: 30202964
MH  - Adult
MH  - Aged
MH  - Female
MH  - *Heart Failure/mortality/surgery
MH  - *Heart-Assist Devices/adverse effects/statistics & numerical data
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications/epidemiology/mortality
MH  - Prospective Studies
MH  - Registries
MH  - Treatment Outcome
EDAT- 2018/08/31 06:00
MHDA- 2019/11/30 06:00
CRDT- 2018/08/31 06:00
PHST- 2018/01/04 00:00 [received]
PHST- 2018/08/05 00:00 [accepted]
PHST- 2018/08/31 06:00 [pubmed]
PHST- 2019/11/30 06:00 [medline]
PHST- 2018/08/31 06:00 [entrez]
AID - 5084900 [pii]
AID - 10.1093/eurheartj/ehy513 [doi]
PST - ppublish
SO  - Eur Heart J. 2018 Oct 1;39(37):3454-3460. doi: 10.1093/eurheartj/ehy513.