Guardian-regularized Safe Offline Reinforcement Learning for Smart Weaning of Mechanical Circulatory Devices

We study the sequential decision-making problem for automated weaning of mechanical circulatory support (MCS) devices in cardiogenic shock patients. MCS devices are percutaneous micro-axial flow pumps that provide left ventricular unloading and forward blood flow, but current weaning strategies vary significantly across care teams and lack data-driven approaches. Offline reinforcement learning (RL) has proven to be successful in sequential decision-making tasks, but our setting presents challenges for training and evaluating traditional offline RL methods: prohibition of online patient interaction, highly uncertain circulatory dynamics due to concurrent treatments, and limited data availability. We developed an end-to-end machine learning framework with two key contributions (1) Clinically-aware OOD-regularized Model-based Policy Optimization (CORMPO), a density-regularized offline RL algorithm for out-of-distribution suppression that also incorporates clinically-informed reward shaping and (2) a Transformer-based probabilistic digital twin that models MCS circulatory dynamics for policy evaluation with rich physiological and clinical metrics. We prove that \textsf{CORMPO} achieves theoretical performance guarantees under mild assumptions. CORMPO attains a higher reward than the offline RL baselines by 28% and higher scores in clinical metrics by 82.6% on real and synthetic datasets. Our approach offers a principled framework for safe offline policy learning in high-stakes medical applications where domain expertise and safety constraints are essential.