Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes
Jazyk angličtina Země Německo Médium print-electronic
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie
PubMed
27436871
DOI
10.1093/ejcts/ezw169
PII: ezw169
Knihovny.cz E-zdroje
- Klíčová slova
- 30-Day outcomes, Advanced heart failure, HeartMate 3, Magnetically levitated rotor,
- MeSH
- časové faktory MeSH
- celosvětové zdraví MeSH
- délka pobytu trendy MeSH
- design vybavení MeSH
- incidence MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- míra přežití trendy MeSH
- následné studie MeSH
- podpůrné srdeční systémy * MeSH
- pooperační komplikace epidemiologie chirurgie MeSH
- prospektivní studie MeSH
- reoperace MeSH
- srdeční komory patofyziologie chirurgie MeSH
- srdeční selhání mortalita patofyziologie chirurgie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
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 Conformité Européenne (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. CLINICALTRIALSGOV IDENTIFIER: NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark).
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
St Jude Medical Inc St Paul MN USA
The Alfred Hospital Melbourne Australia
Thoracic and Cardiovascular Surgery Clinic Bad Oeynhausen Germany
Toronto General Hospital Toronto Canada
University Heart Center Freiburg Bad Krozingen Freiburg Germany
Citace poskytuje Crossref.org
Less invasive HeartMate 3 left ventricular assist device implantation
