Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F16%3A00060057" target="_blank" >RIV/00023001:_____/16:00060057 - isvavai.cz</a>
Result on the web
<a href="http://ejcts.oxfordjournals.org/content/50/3/548" target="_blank" >http://ejcts.oxfordjournals.org/content/50/3/548</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1093/ejcts/ezw169" target="_blank" >10.1093/ejcts/ezw169</a>
Alternative languages
Result language
angličtina
Original language name
Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes
Original language description
OBJECTIVES: The objective of this study was to describe the operative experience and 30-day outcomes of patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS) during the Conformite Europeenne (CE) Mark clinical trial. METHODS: Adult patients met inclusion and exclusion criteria defining advanced-stage heart failure and included the indications of bridge to transplant and destination therapy. Operative parameters, outcomes, adverse events, physical status and quality-of-life parameters were assessed in the first 30 days after LVAS implant. RESULTS: Fifty patients were implanted with the HeartMate 3 at 10 centres in 6 countries. The 30-day survival rate was 98%. The median operative and cardiopulmonary bypass times were 200 (range: 95-585) min and 84 (range: 47-250) min, respectively. Patients required transfusion with packed red blood cells (3.6 +/- 2.3 units), fresh frozen plasma (6.5 +/- 5 units) and platelets (2 +/- 1 units). Six patients (12%) required reoperation for postoperative bleeding and 10 patients (20%) did not require blood transfusion. The median intensive care time was 6 days (range: 1-112 days) and the total hospital stay was 28 days (range: 14-116 days). The most common adverse events were bleeding (15, 30%), arrhythmia (14, 28%) and infection (10, 20%). There were 2 (4%) strokes. CONCLUSIONS: The 30-day outcomes following implantation of the HeartMate 3 demonstrates excellent survival with low adverse event rates. The LVAD performed as intended with no haemolysis or device failure.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FA - Cardiovascular diseases including cardio-surgery
OECD FORD branch
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Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European journal of cardio-thoracic surgery
ISSN
1010-7940
e-ISSN
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Volume of the periodical
50
Issue of the periodical within the volume
3
Country of publishing house
GB - UNITED KINGDOM
Number of pages
7
Pages from-to
548-554
UT code for WoS article
000386056400040
EID of the result in the Scopus database
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