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An unusual thrombus location in a Heartmate 3TM device with fatal outcome

Carlo Banfi1,2,3,4, Fabio Rigamonti5, Kamran Ahmadov6

  • 1Department of Cardiothoracic Surgery, Istituto Clinico Sant'Ambrogio, Gruppo Ospedaliero, Milan, Italy.

Perfusion
|December 10, 2019
PubMed

Insights

Pump thrombosis is a complication affecting patients with the HeartMate 3 left ventricular assist device. Surgical exploration revealed clots, suggesting a design weakness that requires manufacturer modification.

Area of Science:

  • Cardiology
  • Medical Device Engineering

Background:

  • The HeartMate 3 left ventricular assist device (LVAD) is used for hemodynamic support in heart failure patients.
  • While associated with excellent outcomes, complications like pump thrombosis remain a concern.

Observation:

  • A 68-year-old male patient with an implanted HeartMate 3 LVAD developed heart failure and cardiogenic shock 19 months post-implantation.
  • Clinical assessment and device parameters did not yield a definitive diagnosis.

Findings:

  • Surgical exploration revealed the presence of blood clots within the device's tubing system, specifically between the polyethylene terephthalate (Dacron®) and polytetrafluoroethylene components.
  • This finding indicates a potential design flaw in the HeartMate 3 LVAD contributing to thrombosis.

Implications:

  • The identified clot formation presents a significant weakness in the HeartMate 3 LVAD design.
  • Recommendations are proposed to the manufacturer for design modifications to mitigate this complication and improve patient safety.

Keywords:
HeartMate 3TMadverse eventscardiogenic shock and thrombolysisleft ventricular assist devices (LVAD)pump thrombosis

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