Rotary Ventricular Assist Device Control With a Fiber Bragg Grating Pressure Sensor

Current ventricular assist devices (VADs) are rotary blood pumps used to treat end-stage heart failure. VADs are operated at a constant speed that is manually adjusted by a clinician based on the patient’s cardiac demand during routine medical examinations. VADs operated at a constant speed have inadequate passive flow regulation due to the inherent mechanical pressure-flow characteristics of the pump; this can lead to harmful situations where the VAD is overpumping or underpumping. Typically, patients on long-term VAD support are discharged to an outpatient setting where the VAD speed can remain the same for weeks or months at a time, impacting patient safety and quality of life. Previously, physiological controllers for VADs have been proposed, which automatically adjust VAD speed to meet patient cardiac demand. Clinical implementation of physiological control is currently hindered by the lack of clinically available, implantable, and continuous hemodynamic sensors. This study describes the physiological control of a VAD using a fiber Bragg grating (FBG) sensor previously developed for measuring VAD inlet pressure. The FBG sensor was used as a feedback to a Starling-like physiological controller, and the control quality was compared against the same controller with feedback from a nonimplantable industrial pressure sensor (Omega sensor). Experiments were conducted in a bench-top cardiovascular simulator under various simulated patient scenarios. The average steady-state difference in VAD flow across all experiments was 0.1 L/min with a maximum difference of −0.4 L/min. Similarly, the average steady-state difference in left ventricular end-diastolic pressure was 0.02 mmHg with a maximum difference of −0.2 mmHg. The clinically insignificant differences found between the two feedback methods indicate that the FBG pressure sensor is viable for the physiological control of VADs.

[1]  S. Gregory,et al.  In-Vitro evaluation of an adaptive Starling-like controller for dual Rotary ventricular assist devices. , 2019, Artificial organs.

[2]  S Reich,et al.  A blood pressure sensor for long-term implantation. , 2001, Artificial organs.

[3]  Mirko Meboldt,et al.  Standardized Comparison of Selected Physiological Controllers for Rotary Blood Pumps: In Vitro Study , 2018, Artificial organs.

[4]  U. Steinseifer,et al.  An advanced mock circulation loop for in-vitro cardiovascular device evaluation. , 2020, Artificial organs.

[5]  V. Jeevanandam,et al.  Invasive Hemodynamic Echocardiographic Ramp Test in the HeartAssist5 LVAD: Insights into Device Performance , 2017, ASAIO journal.

[6]  Robert F. Salamonsen,et al.  Temperature Compensated Fibre Bragg Grating Pressure Sensor for Ventricular Assist Devices* , 2018, 2018 40th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[7]  Jo P Pauls,et al.  Improving In vitro Evaluation Capabilities of Cardiac Assist Devices through a Validated Exercise Simulation , 2019, 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[8]  Robert Puers,et al.  An Implantable Intravascular Pressure Sensor for a Ventricular Assist Device , 2016, Micromachines.

[9]  Christofer Hierold,et al.  Novel Sensor Integration Approach for Blood Pressure Sensing in Ventricular Assist Devices , 2016 .

[10]  M. Wheeler,et al.  Simultaneous ramp right heart catheterization and echocardiography in a ReliantHeart left ventricular assist device , 2017, World journal of cardiology.

[11]  Heinrich Schima,et al.  Daily Life Activity in Patients with Left Ventricular Assist Devices , 2016, The International journal of artificial organs.

[12]  K. Hill,et al.  Photosensitivity in optical fiber waveguides: Application to reflection filter fabrication , 1978 .

[13]  S. Adatya,et al.  Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients. , 2018, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[14]  Matthias Kleinheyer,et al.  In Vitro Evaluation of an Immediate Response Starling‐Like Controller for Dual Rotary Blood Pumps , 2017, Artificial organs.

[15]  M. Ferratini,et al.  Quality of life and emotional distress early after left ventricular assist device implant: a mixed-method study. , 2015, Artificial organs.

[16]  William Weiss,et al.  Rotary blood pump control using integrated inlet pressure sensor , 2011, 2011 Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[17]  L. Lund,et al.  The Registry of the International Society for Heart and Lung Transplantation: Thirty-fourth Adult Lung And Heart-Lung Transplantation Report-2017; Focus Theme: Allograft ischemic time. , 2017, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[18]  E BERGLUND,et al.  Ventricular Function: I. Starling's Law of the Heart Studied by Means of Simultaneous Right and Left Ventricular Function Curves in the Dog , 1954, Circulation.

[19]  D. Mason,et al.  Response of rotary blood pumps to changes in preload and afterload at a fixed speed setting are unphysiological when compared with the natural heart. , 2011, Artificial organs.

[20]  Robert L Kormos,et al.  Eighth annual INTERMACS report: Special focus on framing the impact of adverse events. , 2017, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[21]  John F. Fraser,et al.  In Vitro Comparison of Active and Passive Physiological Control Systems for Biventricular Assist Devices , 2015, Annals of Biomedical Engineering.

[22]  Edward Bullister,et al.  Physiologic control algorithms for rotary blood pumps using pressure sensor input. , 2002, Artificial organs.

[23]  M B Visscher,et al.  The regulation of the energy output of the heart , 1927, The Journal of physiology.

[24]  Elfed Lewis,et al.  Optical Fibre Pressure Sensors in Medical Applications , 2015, Sensors.

[25]  S. Russell,et al.  Continuous flow left ventricular assist device improves functional capacity and quality of life of advanced heart failure patients. , 2010, Journal of the American College of Cardiology.

[26]  S. Gregory,et al.  A novel fibre Bragg grating pressure sensor for rotary ventricular assist devices , 2019, Sensors and Actuators A: Physical.

[27]  S. Gregory,et al.  The Importance of Venous Return in Starling‐Like Control of Rotary Ventricular Assist Devices , 2018, Artificial organs.

[28]  A. Guyton,et al.  Determination of cardiac output by equating venous return curves with cardiac response curves. , 1955, Physiological reviews.

[29]  Zhiwen Liu,et al.  An implantable Fabry-Pérot pressure sensor fabricated on left ventricular assist device for heart failure , 2012, Biomedical microdevices.