Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure-1 year results from the Ce mark trial
Identifikátory výsledku
Kód výsledku v 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>
Výsledek na webu
<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>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure-1 year results from the Ce mark trial
Popis výsledku v původním jazyce
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) <= 25%, cardiac index (CI) <= 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 < 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's functional status and quality of life significantly improved over time.
Název v anglickém jazyce
Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure-1 year results from the Ce mark trial
Popis výsledku anglicky
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) <= 25%, cardiac index (CI) <= 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 < 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's functional status and quality of life significantly improved over time.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30201 - Cardiac and Cardiovascular systems
Návaznosti výsledku
Projekt
—
Návaznosti
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Ostatní
Rok uplatnění
2017
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Journal of cardiothoracic surgery
ISSN
1749-8090
e-ISSN
—
Svazek periodika
12
Číslo periodika v rámci svazku
April 4
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
8
Strana od-do
"art. no. 23"
Kód UT WoS článku
000398517800002
EID výsledku v databázi Scopus
—