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
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
PubMed
30052304
DOI
10.1002/ejhf.1284
Knihovny.cz E-resources
- Keywords
- Heart failure, HeartMate 3, Left ventricular assist system, Magnetic levitation,
- MeSH
- Time Factors MeSH
- Equipment Design MeSH
- Middle Aged MeSH
- Humans MeSH
- Survival Rate trends MeSH
- Follow-Up Studies MeSH
- Heart-Assist Devices * MeSH
- Prospective Studies MeSH
- Heart Ventricles physiopathology MeSH
- Heart Failure mortality physiopathology therapy MeSH
- Stroke Volume physiology MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Australia epidemiology MeSH
- Europe epidemiology MeSH
- Canada epidemiology MeSH
- Kazakhstan epidemiology MeSH
- United States epidemiology MeSH
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/m2 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/m2 , 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.
German Heart Center Berlin Germany
Hannover Medical School Hannover Germany
Heart Center Leipzig Leipzig Germany
Institute for Clinical and Experimental Medicine Prague Czech Republic
National Research Cardiac Surgery Center Astana Kazakhstan
Peter Munk Cardiac Centre Toronto General Hospital Toronto Canada
The Alfred Hospital Melbourne Australia
Thoracic and Cardiovascular Surgery Clinic Bad Oeynhausen Germany
References provided by Crossref.org
ClinicalTrials.gov
NCT02170363
