Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes

Daniel Zimpfer, Ivan Netuka, Jan D. Schmitto, Yuriy Pya, Jens Garbade, Michiel Morshuis, Friedhelm Beyersdorf, Silvana Marasco, Vivek Rao, Laura Damme, Poornima Sood, Thomas Krabatsch

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27 Citations (Scopus)

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. CLINICALTRIALS.GOV IDENTIFIER: NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark).

Original languageEnglish
Pages (from-to)548-554
Number of pages7
JournalEuropean Journal of Cardio-Thoracic Surgery
Volume50
Issue number3
DOIs
Publication statusPublished - Sep 2016
Externally publishedYes

Keywords

  • 30-Day outcomes
  • Advanced heart failure
  • HeartMate 3
  • Magnetically levitated rotor

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