BIO19: Patient-Specific Econotherapeutic Closed-Clinician/Engineer-in-the-loop Framework for VAD Physiological Control (2023)

Background: Mechanical circulatory support therapy essentially restricts patients to the hospital. Numerous clinical publications and national/international presentations indicate the need for early patient discharge, both from a quality of life and economic viewpoint. An alternative strategy is to look at providing time-appropriate VAD support to temporize patients for transplantation or other definitive therapy. However, current VAD systems do not possess high-level feedback control targeting therapy-specific objectives. Current Controllers (i) operate in open-loop fixed-average-speed mode (do not adjust to match physiological demand or cardiac function) and (ii) have minimal ability to assess and respond to adverse events. Therefore, our group is embarking on developing an Intelligent VAD ControllerTM (iVC™) with advanced, modern features that address the deficits of prevailing technologies. Methods: As an initial step towards the design of an Intelligent VAD ControllerTM (iVC™), we developed an Econotherapeutic framework based on concepts of modern control theory, inter-operator communication (Kanban Method), and industrial supply-demand management (Tanpin-Kanri System). The design inputs included considerations for 1. collaboration of clinician and engineer; 2. patient-specific therapeutic goals; 3. fusion of multiple control objectives; 4. non-invasive monitoring of the patient and hardware, and 5. considerations of the financial/resource cost. From the perspective of a control problem, we extend the engineering theory behind its implementation by including, in our framework, the therapy and healthcare protocols to the control problem as constraints. Results: The resulting Econotherapeutic framework is depicted schematically in Figures 1 and 2 below. Figure 1 outlines the framework’s architecture, which includes two sub-frameworks: Therapeutic and Economical. The outlines of the framework’s functions are provided to optimize patient-specific therapy and follow-up and the economic burden of care and control. Figure 2 outlines the inter-operator communication (inspired by Kanban Methods) protocols that form the basis for the framework in terms of roles and responsibilities, design aspects of the control, and implementation steps (including support). The framework addresses the design inputs with the outlines mentioned in Figure 1 as to what the framework addresses, with the implementation of the framework specific to a patient carried out by the protocols outlined in Figure 2. Conclusion: A VAD closed-loop physiological control is, in essence, a multi-disciplinary optimization problem driven by both medical and engineering considerations. The econotherapeutic framework derived above provides a framework for developing an iVC. We will now proceed to develop, in conjunction with clinicians, the possible details of the framework and, using The PediaFlowTM Pediatric VAD, conduct feasibility studies of the iVC that tests the framework.Figure 1. Architecture of the Econotherapeutic FrameworkFigure 2. The Design, Management and Monitoring Communication protocols of the Econotherapeutic Framework for iVC for every individual patient.