Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Netuka, I; Sood, P; Pya, Y; Zimpfer, D; Krabatsch, T; Garbade, J; Rao, V; Morshuis, M; Marasco, S; Beyersdorf, F; Damme, L; Schmitto, JD.
Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study.
J Am Coll Cardiol. 2015; 66(23):2579-2589
Doi: 10.1016/j.jacc.2015.09.083
Web of Science
PubMed
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- Co-authors Med Uni Graz
- Zimpfer Daniel
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- Abstract:
- 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).
- Find related publications in this database (using NLM MeSH Indexing)
- Aged - administration & dosage
- Cardiotonic Agents - therapeutic use
- Equipment Design - administration & dosage
- Female - administration & dosage
- Heart Failure - diagnosis, mortality, physiopathology, surgery
- Heart Transplantation - statistics & numerical data
- Heart Ventricles - physiopathology
- Heart-Assist Devices - administration & dosage
- Hemodynamics - administration & dosage
- Humans - administration & dosage
- Long-Term Care - methods
- Male - administration & dosage
- Middle Aged - administration & dosage
- Prospective Studies - administration & dosage
- Severity of Illness Index - administration & dosage
- Stroke Volume - administration & dosage
- Survival Analysis - administration & dosage
- Treatment Outcome - administration & dosage
- Find related publications in this database (Keywords)
- HeartMate 3
- hemolysis
- pump
- quality of life
- thrombosis