Outflow monitoring of a pneumatic ventricular assist device using external pressure sensors
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In this study, a new algorithm was developed for estimating the pump outflow of a pneumatic ventricular assist device (p-VAD). The pump outflow estimation algorithm was derived from the ideal gas equation and determined the change in blood-sac volume of a p-VAD using two external pressure sensors.
Based on in vitro experiments, the algorithm was revised to consider the effects of structural compliance caused by volume changes in an implanted unit, an air driveline, and the pressure difference between the sensors and the implanted unit.
In animal experiments, p-VADs were connected to the left ventricles and the descending aorta of three calves (70–100 kg). Their outflows were estimated using the new algorithm and compared to the results obtained using an ultrasonic blood flow meter (UBF) (TS-410, Transonic Systems Inc., Ithaca, NY, USA).
The estimated and measured values had a Pearson’s correlation coefficient of 0.864. The pressure sensors were installed at the external controller and connected to the air driveline on the same side as the external actuator, which made the sensors easy to manage.
KeywordsStroke Volume Pressure Sensor Pump Outflow Ventricular Assist Device Differential Pressure Sensor
A ventricular assist device (VAD) is effective for treatment of systolic end-stage heart failure, and can support the patient’s blood circulation until heart transplantation [1, 2, 3, 4, 5, 6, 7, 8]. In fact, patients’ 1-year survival rates were three times higher when a VAD was used compared to drug therapies alone [6, 7, 8]. Despite the advantages of VADs, they are not widely implemented because of their high cost and risk of critical failure [6, 7, 8, 9]. Malfunctions and inappropriate control of VADs can seriously damage organs and vessels; therefore, the outflow of VADs must be monitored to detect device failure or changes in the patient’s physiology [10, 11, 12, 13, 14, 15].
The estimation of outflow using blood pressure sensors or motor speed has been studied; specifically, estimation according to the VAD outflow has been compared to that measured by an ultrasonic blood flow meter (UBF) [13, 14, 15, 16, 17, 18, 19]. The inlet blood pressure of the VAD has been shown to detect abnormal blood inflow; however, blood pressure sensors are difficult to manage for long periods because of their limited life span and difficulties in preventing thrombosis and fibrosis around the sensors [15, 16]. Outflow estimation has been studied based on the relationship between the motor speed and current consumption under normal hemodynamic conditions [17, 18, 19, 20]. However, pathological changes in the patient’s physiologic state, or unexpected device failures, change the relationship between motor speed and current consumption. Although measurement with a UBF has been used to monitor the outflow of the VAD, the large size and complicated management process requires improvement [10, 13].
Pulsatile VADs (p-VAD) or artificial hearts may provide more effective measurements, since p-VADs pulsate blood in the implanted unit with transferred air expanding the air pocket [2, 8, 12, 21, 22]. The internal pressure can change the volume of the air pocket in the implanted unit; however, the air pressure cannot be used to calculate the volume change without considering the air moving to and from the implanted unit .
Measurement of the number of molecules of air with a VAD is not possible due to the structural deformation that the devices cause, as well as regulation of pulsation and suction force. Instead, the air through the airline can be measured using two air pressure sensors . The change in volume of the air pocket in the implanted unit is calculated according to the amount of air molecules and the internal pressure in the implanted unit. In this study, a new algorithm for determining the stroke volume (SV) and outflow of p-VADs was developed by measuring the internal pressure and the number of air molecules in the external unit. The data obtained using this algorithm was verified by in vivo and in vitro experiments.
Design of the stroke volume estimation system of a p-VAD
Estimation parameters and measured
PA(t): pressure at A
PB(t): pressure at B
Pdiff(t): difference in pressure between A and B
R: gas constant (= 62.4 × 103 cc mmHg/mol K)
k1: mole number—air pressure ratio (of air passing from A to B).
PV(t): pressure at the implanted unit of the VAD
lA−V: length from A to the implanted unit of the VAD (lA−V)
lA−B: length from A to B
k2: length ratio between lA−V and lA−B.
In vitro and In vivo experiments for verifying the stroke volume
Discussion and conclusion
The estimation method suggested herein can be applied to conventional pneumatic p-VADs; however, it cannot be applied to the continuous rotary pumps that are primarily used at present . The p-VAD is currently used for children or infants, where it has been applied to pneumatic artificial hearts [2, 24]. Moreover, the suggested method can also be applied to an intracortical balloon pump (IABP) to determine any expanding of the volume of the balloon. Thus, the technique can improve the safety of medical devices that are driven by air pockets or balloons .
The technique described herein estimates the inner pressure of the air pocket and considers the load on both of the implanted devices. The previously used UBF indicated blood flow only and could not be used to determine the cause of abnormal flow. Furthermore, while the current and motor speed could not be used to determine whether the abnormal findings were due to a failure of the device or hemodynamic changes in the patient, the estimation method presented herein determined that the device failed [19, 20]. In this study, errors caused by temperature changes were not observed. During in vitro experiments with a mock circulation system, the temperature of the mock system and the air pocket were between 21° and 25°. During the in vivo experiments, the implanted unit was attached to the animal’s back and the air tube was maintained at ambient temperature.
Within a closed chamber (EBE-4HW6P4C-20, ESPEC corp., Japan) of which internal temperature was adjusted from 5° to 40°, the correlation between the estimation SV and the measured was not changed. Even when the calculated effective volume V(t) in Eq. 4 was different according to temperature changes, the SV in Eq. 5 was not changed since the peak-to-peak value of V(t) waveform was not affected by temperature. Within this temperature range, the material compliance and structural volume were not changed and the temperature seemed to equally affect to the air volumes and pressures of the air driveline near sensors and the implanted unit. When the atmospheric pressure was decrease from 770 to 680 mmHg, the LVAD outflow slightly decreased and the SV estimation also decreased same to the measurement. If the temperature and pressure were out of the measuring range, the material compliance and structural space can change and cause the estimation error. The effects of severe temperature and pressure on material, structure and SV estimation will be studied with an advanced chamber.
In this study, the preload and afterload to the VAD affected the SV estimation differently. In our estimations, the compliance of air drive line and implanted case was set a value (0.05 cc/mmHg). However, the compliance could be different according to its internal air pressure. When the internal pressure was higher than atmospheric pressure, the compliance was maintained constant value, however, when the internal pressure was −100 mmHg lower than atmospheric pressure, the tube structure were deformed and its compliance got high compliance because of the buckling phenomenon and the abnormal bending curvature of the airline. The compliance of our structure was measured from 200 to −100 mmHg and the compliance was rarely changed within this range. In the in vitro experiments that applied preload below −30 mmHg to the LVAD, temporarily low internal air pressure below −100 mmHg frequently had been shown in the air drive line and implanted case. Those unexpected compliance increase caused the error of SV estimation results when the preload was applied to the VAD.
The LibraHeart I p-VAD used in this study contains a tube-shaped blood sac that reduces stagnation, which could otherwise cause thrombogenesis in the blood sac. Although the VAD has a blood sac that is different to that of other pneumatic p-VADs, it also contains an air pocket that is driven by an external actuator. Thus, the estimation method that was applied to the LibraHeart I in this study can also be applied to other devices. The method presented herein also facilitates management of the device, since the data were obtained using sensors located on the external actuator.
KSM did in vitro experiments and wrote this manuscript, HK participated in the animal experiments. CSW analyzed obtained data. All authors read and approved the final manuscript. All authors read and approved the final manuscript.
This research was supported by a Grant (16172MFDS339) from the Ministry of Food and Drug Safety, awarded in 2016.
The authors declare that they have no competing interests.
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