An acoustic method for systematic ventricular assist device thrombus evaluation with a novel artificial thrombus model.

BACKGROUND: Pump thrombosis (PT) is still one of the major adverse events in patients supported with left ventricular assist devices. Nowadays, thrombus detection relies on clinical parameters like reoccurring heart failure symptoms, on changes in pump power consumption, and on laboratory parameters such as increased LDH and hemolysis. Once detected PT is most often persistent and refractory to medical therapy. We therefore designed a novel, non-invasive acoustic method for early pump thrombus detection in an in vitro artificial thrombus model. METHODS: The study was performed in vitro using a mock circulation loop, artificial blood (water-glycerin) and artificial thrombus material (silicon) allowing for repeatable and defined testing. Tested ventricular assist device (VAD) type was HVAD (Medtronic). Three different thrombus locations were evaluated: on the tilted pad of the rotor, in the primary flow path, and in the secondary flow path beneath the rotor. After evaluating baseline parameters (no thrombus, n=20 for each pump), the influence of thrombi of seven different masses (no thrombus, 0.5-5.0 mg) on pump power consumption and acoustic emission of four HVAD devices was investigated via a microphone system (Sennheiser) and subsequent frequency spectrum analysis (n=12). The acoustic analysis algorithm included the number of frequency peaks recorded. RESULTS: Measurements with thrombi on the tilted pad showed an increased number of frequency peaks with all thrombus sizes compared to baseline measurements without any thrombus (baseline: 32.7±7.4; 0.5 mg: 45.3±10.4 up to 5 mg: 80.4±5.5). Power consumption was relevantly elevated in 5mg thrombus measurement only (6.3±1.29 W compared to 4.9±0.14 W at baseline). Measurements with thrombi in the primary and secondary showed no relevant alteration in power consumption and frequency peak count. CONCLUSIONS: We present an acoustic method that detects pump thrombi located on the tilted pad of the HVAD rotor requiring ten times less mass compared to thrombi detected by power consumption alterations used in current detection algorithms. Assuming that pump thrombi are growing over several days, the presented method may detect PT much earlier thereby increasing efficacy of medical therapy and helping to avoid pump exchange.