Real-Time Analysis of the Log Files of the HeartWare Continuous-Flow Left Ventricular Assist Device for the Early Diagnosis of Pump Thrombosis: a Step Forward Toward Clinical Translation

J Cardiovasc Transl Res. 2022 Apr;15(2):408-415. doi: 10.1007/s12265-021-10157-1. Epub 2021 Jul 19.

Abstract

We evaluated the real-time diagnostic capability of a new tool enhancing early diagnosis of pump thrombosis (PT) of the HeartWare left ventricular assist device via time-frequency analysis (TFA) of the log files. We analyzed 173 log files, including 24 (14%) associated with a clinical diagnosis of PT and 149 (86%) controls. The 30-day log file records were discretized into consecutive windows of a 24-h duration, which were iteratively acquired and processed via TFA. This way, we simulated longitudinal acquisition of pump parameters and provided real-time analysis of consecutive data, thus resembling the clinical scenario. Sensitivity and specificity of the tool were 79% and 84%, respectively. Sensitivity against PT events with progressive "build-up" thrombus increased up to 95%, and early signs of a forthcoming PT were identified 10±8 days prior to its clinical manifestation. This study demonstrates high reliability and the potential for effective clinical translation of this prognostic tool.

Trial registration: ClinicalTrials.gov NCT03255928.

Keywords: Circadian rhythm; Left ventricular assist device; Log files; Pump thrombosis; Time-frequency analysis.

MeSH terms

  • Early Diagnosis
  • Heart Failure* / diagnosis
  • Heart Failure* / therapy
  • Heart-Assist Devices* / adverse effects
  • Humans
  • Reproducibility of Results
  • Retrospective Studies
  • Thrombosis* / diagnosis
  • Thrombosis* / etiology

Associated data

  • ClinicalTrials.gov/NCT03255928