Pathologic analysis of 34 explanted symbion ventricular assist devices and 10 explanted Jarvik-7 total artificial

B Fyfe1, F J Schoen

  • 1Department of Pathology, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts, USA.

Insights

Thrombus formation is a major complication in Symbion ventricular assist devices and Jarvik-7 total artificial hearts. Pathological analysis revealed thrombi in most devices, primarily on valves and diaphragms, with minimal impact on function.

Area of Science:

  • Cardiovascular Engineering
  • Biomaterials Science
  • Pathology

Background:

  • Ventricular assist devices (VADs) and total artificial hearts (TAHs) are critical for end-stage heart failure treatment.
  • Thrombus formation remains a significant challenge, impacting device longevity and patient outcomes.
  • Understanding device-specific pathological findings is crucial for improving future designs.

Purpose of the Study:

  • To conduct a detailed pathological analysis of explanted Symbion VADs and Jarvik-7 TAHs.
  • To identify and characterize thrombus formation sites and prevalence.
  • To correlate pathological findings with device design features for potential redesign.

Main Methods:

  • Pathological analysis of 34 Symbion VADs and 10 Jarvik-7 TAHs used clinically.
  • Quantitative analysis of thrombus distribution using polar coordinate mapping for diaphragmatic thrombi.
  • Assessment for infection and mechanical defects.

Main Results:

  • Thrombus formation observed in 85% of VADs and 75% of TAHs, with small thrombi generally not affecting function.
  • Major thrombus sites included valves, connections, diaphragms (VADs), and paravalvular areas (TAHs).
  • Specific areas on the diaphragm were identified as highly susceptible to thrombus formation.

Conclusions:

  • Thrombus formation on valves, connectors, and diaphragms is the primary complication associated with Symbion VADs and Jarvik-7 TAHs.
  • Findings highlight specific design features requiring modification to mitigate thrombus risk.
  • Infections and mechanical defects were infrequent in this cohort.

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