Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Zimpfer, D; Netuka, I; Schmitto, JD; Pya, Y; Garbade, J; Morshuis, M; Beyersdorf, F; Marasco, S; Rao, V; Damme, L; Sood, P; Krabatsch, T.
Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes.
Eur J Cardiothorac Surg. 2016; 50(3):548-54
Doi: 10.1093/ejcts/ezw169
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- Leading authors Med Uni Graz
- Zimpfer Daniel
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- Abstract:
- 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).
- Find related publications in this database (using NLM MeSH Indexing)
- Equipment Design - administration & dosage
- Female - administration & dosage
- Follow-Up Studies - administration & dosage
- Global Health - administration & dosage
- Heart Failure - mortality, physiopathology, surgery
- Heart Ventricles - physiopathology, surgery
- Heart-Assist Devices - administration & dosage
- Humans - administration & dosage
- Incidence - administration & dosage
- Length of Stay - trends
- Male - administration & dosage
- Middle Aged - administration & dosage
- Postoperative Complications - epidemiology, surgery
- Prospective Studies - administration & dosage
- Quality of Life - administration & dosage
- Reoperation - administration & dosage
- Survival Rate - trends
- Time Factors - administration & dosage
- Find related publications in this database (Keywords)
- Advanced heart failure
- HeartMate 3
- Magnetically levitated rotor
- 30-Day outcomes