Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study
Language English Country United States Media print
Document type Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
PubMed
26670056
DOI
10.1016/j.jacc.2015.09.083
PII: S0735-1097(15)06839-4
Knihovny.cz E-resources
- Keywords
- HeartMate 3, hemolysis, pump, quality of life, thrombosis,
- MeSH
- Survival Analysis MeSH
- Equipment Design * MeSH
- Long-Term Care methods MeSH
- Hemodynamics * MeSH
- Cardiotonic Agents therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Heart-Assist Devices * MeSH
- Prospective Studies MeSH
- Aged MeSH
- Heart Ventricles physiopathology MeSH
- Heart Failure * diagnosis mortality physiopathology surgery MeSH
- Severity of Illness Index MeSH
- Stroke Volume MeSH
- Heart Transplantation statistics & numerical data MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Names of Substances
- Cardiotonic Agents MeSH
BACKGROUND: The HeartMate 3 left ventricular assist system (LVAS) is intended to provide long-term support to patients with advanced heart failure. The centrifugal flow pump is designed for enhanced hemocompatibility by incorporating a magnetically levitated rotor with wide blood-flow paths and an artificial pulse. OBJECTIVES: The aim of this single-arm, prospective, multicenter study was to evaluate the performance and safety of this LVAS. METHODS: The primary endpoint was 6-month survival compared with INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)-derived performance goal. Patients were adults with ejection fraction ≤ 25%, cardiac index ≤ 2.2 l/min/m(2) without inotropes or were inotrope-dependent on optimal medical management, or listed for transplant. RESULTS: Fifty patients were enrolled at 10 centers. The indications for LVAS support were bridge to transplantation (54%) or destination therapy (46%). At 6 months, 88% of patients continued on support, 4% received transplants, and 8% died. Thirty-day mortality was 2% and 6-month survival 92%, which exceeded the 88% performance goal. Support with the fully magnetically levitated LVAS significantly reduced mortality risk by 66% compared with the Seattle Heart Failure Model-predicted survival of 78% (p = 0.0093). Key adverse events included reoperation for bleeding (14%), driveline infection (10%), gastrointestinal bleeding (8%), and debilitating stroke (modified Rankin Score > 3) (8%). There were no pump exchanges, pump malfunctions, pump thrombosis, or hemolysis events. New York Heart Association classification, 6-min walk test, and quality-of-life scores showed progressive and sustained improvement. CONCLUSIONS: The results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363).
Cardiothoracic Surgical Unit The Alfred Hospital Melbourne Australia
Clinical Affairs St Jude Medical Burlington Massachusetts
Department of Cardiothoracic and Vascular Surgery German Heart Center Berlin Germany
Department of Surgery Division of Cardiac Surgery Medical University of Vienna Vienna Austria
Heart Center Leipzig Department of Cardiac Surgery University of Leipzig Leipzig Germany
National Research Cardiac Surgery Center Astana Kazakhstan
Thoracic and Cardiovascular Surgery Clinic Bad Oeynhausen Germany
References provided by Crossref.org
2019 EACTS Expert Consensus on long-term mechanical circulatory support
Less invasive HeartMate 3 left ventricular assist device implantation
ClinicalTrials.gov
NCT02170363
