Closing the Loop: Validation of Implantable Cardiac Devices With Computational Heart Models

• Published in: IEEE journal of biomedical and health informatics Vol. 24; no. 6; pp. 1579 - 1588
• Main Authors: Ai, Weiwei, Patel, Nitish D., Roop, Partha S., Malik, Avinash, Trew, Mark L.
• Format: Journal Article
• Language: English
• Published: United States IEEE 01.06.2020; The Institute of Electrical and Electronics Engineers, Inc. (IEEE)
• Subjects: Algorithms; Biomedical monitoring; Bradycardia; Cardiovascular Implantable Electronic Devices (CIEDs); Closed loops; Computational modeling; Computer applications; Computer Simulation; Congestive heart failure; Electrodes, Implanted - adverse effects; Electrodes, Implanted - standards; Electronic devices; Electronic equipment; Heart; heart modeling; Humans; hybrid automaton; in-silico closed-loop validation; Model testing; Models, Cardiovascular; Optimization; pacemaker mediated tachycardia (PMT); Pacemaker, Artificial - adverse effects; Pacemaker, Artificial - standards; Pacemakers; Patients; Physiology; Risk assessment; Signal Processing, Computer-Assisted; Stochasticity; Surgical implants; Tachycardia; Tachycardia - etiology; Tachycardia - physiopathology; Testing; Timing
• ISSN: 2168-2194; 2168-2208
• DOI: 10.1109/JBHI.2019.2947007

Objective: Cardiovascular Implantable Electronic Devices (CIEDs) are used extensively for treating life-threatening conditions such as bradycardia, atrioventricular block and heart failure. The complicated heterogeneous physical dynamics of patients provide distinct challenges to device development and validation. We address this problem by proposing a device testing framework within the in-silico closed-loop context of patient physiology. Methods: We develop an automated framework to validate CIEDs in closed-loop with a high-level physiologically based computational heart model. The framework includes test generation, execution and evaluation, which automatically guides an integrated stochastic optimization algorithm for exploration of physiological conditions. Conclusion: The results show that using a closed loop device-heart model framework can achieve high system test coverage, while the heart model provides clinically relevant responses. The simulated findings of pacemaker mediated tachycardia risk evaluation agree well with the clinical observations. Furthermore, we illustrate how device programming parameter selection affects the treatment efficacy for specific physiological conditions. Significance: This work demonstrates that incorporating model based closed-loop testing of CIEDs into their design provides important indications of safety and efficacy under constrained physiological conditions.