PMID- 30052304
OWN - NLM
STAT- MEDLINE
DCOM- 20190521
LR  - 20190521
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Linking)
VI  - 21
IP  - 1
DP  - 2019 Jan
TI  - Long-term evaluation of a fully magnetically levitated circulatory support device 
      for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study.
PG  - 90-97
LID - 10.1002/ejhf.1284 [doi]
AB  - AIM: This study aimed to assess safety and outcomes of patients, 2 years after 
      implantation with the HeartMate 3 Left Ventricular Assist System. METHODS AND 
      RESULTS: This study included 50 adults with New York Heart Association (NYHA) 
      class IIIB or IV symptoms or American College of Cardiology/American Heart 
      Association stage D heart failure with an ejection fraction </=25% and a cardiac 
      index </=2.2 L/min/m(2) without inotropes, or inotrope-dependent with optimal 
      medical management, or listed for heart transplant. The median duration of left 
      ventricular assist device support was 694 days (range: 19-833 days). At baseline, 
      cardiac index was 1.8 +/-0.5 L/min/m(2) , 58% of patients were receiving inotropes, 
      and 92% were INTERMACS profiles 2-4. At 2 years, Kaplan-Meier survival was 
      74 +/-6%, 5 (10%) patients were transplanted, and 32 patients (64%) remain with 
      support. Adverse event rates include bleeding requiring surgery (16%), 
      gastrointestinal bleeding (20%), driveline infection (24%), ischaemic stroke 
      (16%), haemorrhagic stroke (8%), right heart failure (14%), and outflow graft 
      thrombosis (2%). Notably, no haemolysis, pump thrombosis, or pump malfunction 
      events occurred. At 2 years, 47% of patients remained in NYHA class I and 41% in 
      NYHA class II (P <0.0001). From baseline to 2 years, the mean six-minute walk 
      distance increased from 239 m to 347 m (P <0.0001), and the mean EQ-5D quality of 
      life score improved from 48.2 to 70.6 (P < 0.0001). CONCLUSIONS: Two years 
      post-HeartMate 3 implantation, results show expected and acceptable survival, 
      enhanced haemocompatibility, improved patient functional status and quality of 
      life. This corroborates the success of HeartMate 3 since its first-in-man 
      implantation case in Germany. ClinicalTrials.gov: NCT02170363.
CI  - (c) 2018 The Authors. European Journal of Heart Failure (c) 2018 European Society of 
      Cardiology.
FAU - Schmitto, Jan D
AU  - Schmitto JD
AD  - Hannover Medical School, Hannover, Germany.
FAU - Pya, Yuriy
AU  - Pya Y
AD  - National Research Cardiac Surgery Center, Astana, Kazakhstan.
FAU - Zimpfer, Daniel
AU  - Zimpfer D
AD  - University of Vienna, Vienna, Austria.
FAU - Krabatsch, Thomas
AU  - Krabatsch T
AD  - German Heart Center, Berlin, Germany.
FAU - Garbade, Jens
AU  - Garbade J
AD  - Heart Center Leipzig, Leipzig, Germany.
FAU - Rao, Vivek
AU  - Rao V
AD  - Peter Munk Cardiac Centre, Toronto General Hospital, Toronto, Canada.
FAU - Morshuis, Michiel
AU  - Morshuis M
AD  - Thoracic and Cardiovascular Surgery Clinic, Bad Oeynhausen, Germany.
FAU - Beyersdorf, Friedhelm
AU  - Beyersdorf F
AD  - University Heart Center Freiburg-Bad Krozingen, Medical Faculty, Albert 
      Ludwigs-University, Freiburg, Germany.
FAU - Marasco, Silvana
AU  - Marasco S
AD  - The Alfred Hospital, Melbourne, Australia.
FAU - Sood, Poornima
AU  - Sood P
AD  - Abbott, Burlington, MA, USA.
FAU - Damme, Laura
AU  - Damme L
AD  - Abbott, Burlington, MA, USA.
FAU - Netuka, Ivan
AU  - Netuka I
AD  - Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
LA  - eng
SI  - ClinicalTrials.gov/NCT02170363
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180727
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
SB  - IM
CIN - Eur J Heart Fail. 2019 Jan;21(1):101-102. PMID: 30320487
CIN - Eur J Heart Fail. 2019 Jan;21(1):98-100. PMID: 30508266
MH  - Australia/epidemiology
MH  - Canada/epidemiology
MH  - Equipment Design
MH  - Europe/epidemiology
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Failure/mortality/physiopathology/*therapy
MH  - Heart Ventricles/*physiopathology
MH  - *Heart-Assist Devices
MH  - Humans
MH  - Kazakhstan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Stroke Volume/*physiology
MH  - Survival Rate/trends
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States/epidemiology
OTO - NOTNLM
OT  - Heart failure
OT  - HeartMate 3
OT  - Left ventricular assist system
OT  - Magnetic levitation
EDAT- 2018/07/28 06:00
MHDA- 2019/05/22 06:00
CRDT- 2018/07/28 06:00
PHST- 2017/12/05 00:00 [received]
PHST- 2018/06/11 00:00 [revised]
PHST- 2018/06/26 00:00 [accepted]
PHST- 2018/07/28 06:00 [pubmed]
PHST- 2019/05/22 06:00 [medline]
PHST- 2018/07/28 06:00 [entrez]
AID - 10.1002/ejhf.1284 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2019 Jan;21(1):90-97. doi: 10.1002/ejhf.1284. Epub 2018 Jul 27.