Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure - two-year results from the HeartMate 3CE Mark Study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F19%3A00077692" target="_blank" >RIV/00023001:_____/19:00077692 - isvavai.cz</a>

Výsledek na webu

<a href="https://onlinelibrary.wiley.com/doi/pdf/10.1002/ejhf.1284" target="_blank" >https://onlinelibrary.wiley.com/doi/pdf/10.1002/ejhf.1284</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/ejhf.1284" target="_blank" >10.1002/ejhf.1284</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure - two-year results from the HeartMate 3CE Mark Study

Popis výsledku v původním jazyce

Aim This study aimed to assess safety and outcomes of patients, 2years 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 2.2L/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 1.80.5L/min/m(2), 58% of patients were receiving inotropes, and 92% were INTERMACS profiles 2-4. At 2 years, Kaplan-Meier survival was 746%, 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&lt;0.0001). From baseline to 2 years, the mean six-minute walk distance increased from 239m to 347m (P&lt;0.0001), and the mean EQ-5D quality of life score improved from 48.2 to 70.6 (P&lt;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. : NCT02170363.

Název v anglickém jazyce

Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure - two-year results from the HeartMate 3CE Mark Study

Popis výsledku anglicky

Aim This study aimed to assess safety and outcomes of patients, 2years 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 2.2L/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 1.80.5L/min/m(2), 58% of patients were receiving inotropes, and 92% were INTERMACS profiles 2-4. At 2 years, Kaplan-Meier survival was 746%, 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&lt;0.0001). From baseline to 2 years, the mean six-minute walk distance increased from 239m to 347m (P&lt;0.0001), and the mean EQ-5D quality of life score improved from 48.2 to 70.6 (P&lt;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. : NCT02170363.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2019

Kód důvěrnosti údajů

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

Název periodika

European journal of heart failure

ISSN

1388-9842

e-ISSN

—

Svazek periodika

21

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

90-97

Kód UT WoS článku

000459741600013

EID výsledku v databázi Scopus

2-s2.0-85051062690