Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure-1 year results from the Ce mark trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F17%3A00075920" target="_blank" >RIV/00023001:_____/17:00075920 - isvavai.cz</a>

Result on the web

<a href="https://cardiothoracicsurgery.biomedcentral.com/track/pdf/10.1186/s13019-017-0587-3?site=cardiothoracicsurgery.biomedcentral.com" target="_blank" >https://cardiothoracicsurgery.biomedcentral.com/track/pdf/10.1186/s13019-017-0587-3?site=cardiothoracicsurgery.biomedcentral.com</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s13019-017-0587-3" target="_blank" >10.1186/s13019-017-0587-3</a>

Result language

angličtina

Original language name

Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure-1 year results from the Ce mark trial

Original language description

Background: The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein. Methods: A prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) &lt;= 25%, cardiac index (CI) &lt;= 2.2 L/min/m(2) while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days. Results: Fifty patients-54% bridge to transplant (BTT) and 46% destination therapy (DT)-were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2-4, with cardiac index 1.8 +/- 0.5 L/min/m(2) and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P &lt; 0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006). Conclusions: The 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient&apos;s functional status and quality of life significantly improved over time.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30201 - Cardiac and Cardiovascular systems

Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of cardiothoracic surgery

ISSN

1749-8090

e-ISSN

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Volume of the periodical

12

Issue of the periodical within the volume

April 4

Country of publishing house

GB - UNITED KINGDOM

Number of pages

8

Pages from-to

"art. no. 23"

UT code for WoS article

000398517800002

EID of the result in the Scopus database

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