Jang, Kuk Jin

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Now showing 1 - 9 of 9
  • Publication
    Computer Aided Clinical Trials for Implantable Cardiac Devices
    (2018-07-12) Jang, Kuk Jin; Weimer, James; Abbas, Houssam; Jiang, Zhihao; Liang, Jackson; Dixit, Sanjay; Mangharam, Rahul
    In this paper we aim to answer the question, ``How can modeling and simulation of physiological systems be used to evaluate life-critical implantable medical devices?'' Clinical trials for medical devices are becoming increasingly inefficient as they take several years to conduct, at very high cost and suffer from high rates of failure. For example, the Rhythm ID Goes Head-to-head Trial (RIGHT) sought to evaluate the performance of two arrhythmia discriminator algorithms for implantable cardioverter defibrillators, Vitality 2 vs. Medtronic, in terms of time-to-first inappropriate therapy, but concluded with results contrary to the initial hypothesis - after 5 years, 2,000+ patients and at considerable ethical and monetary cost. In this paper, we describe the design and performance of a computer-aided clinical trial (CACT) for Implantable Cardiac Devices where previous trial information, real patient data and closed-loop device models are effectively used to evaluate the trial with high confidence. We formulate the CACT in the context of RIGHT using a Bayesian statistical framework. We define a hierarchical model of the virtual cohort generated from a physiological model which captures the uncertainty in the parameters and allows for the systematic incorporation of information available at the design of the trial. With this formulation, the CACT estimates the inappropriate therapy rate of Vitality 2 compared to Medtronic as 33.22% vs 15.62% (p
  • Publication
    Electroanatomic Mapping to Determine Scar Regions in Patients with Atrial Fibrillation
    (2019-04-24) He, Jiyue; Jang, Kuk Jin; Walsh, Katie; Mangharam, Rahul; Liang, Jackson; Dixit, Sanjay
    Left atrial voltage maps are routinely acquired during electroanatomic mapping in patients undergoing catheter ablation for atrial fibrillation (AF). For patients, who have prior catheter ablation when they are in sinus rhythm (SR), the voltage map can be used to identify low voltage areas (LVAs) using a threshold of 0.2 - 0.45 mV. However, such a voltage threshold for maps acquired during AF has not been well established. A prerequisite for defining a voltage threshold is to maximize the topologically matched LVAs between the electroanatomic mapping acquired during AF and SR. This paper demonstrates a new technique to improve the sensitivity and specificity of the matched LVA. This is achieved by computing omni-directional bipolar voltages and applying Gaussian Process Regression based interpolation to derive the AF map. The proposed method is evaluated on a test cohort of 7 male patients, and a total of 46,589 data points were included in analysis. The LVAs in the posterior left atrium and pulmonary vein junction are determined using the standard method and the proposed method. Overall, the proposed method showed patient-specific sensitivity and specificity in matching LVAs of 75.70% and 65.55% for a geometric mean of 70.69%. On average, there was an improvement of 3.00% in the geometric mean, 7.88% improvement in sensitivity, 0.30% improvement in specificity compared to the standard method. The results show that the proposed method is an improvement in matching LVA. This may help develop the voltage threshold to better identify LVA in the left atrium for patients in AF.
  • Publication
    Computer Aided Clinical Trials for Implantable Cardiac Devices
    (2016-08-19) Abbas, Houssam; Jiang, Zhihao; Jang, Kuk Jin; Beccani, Marco; Liang, Jackson; Dixit, Sanjay; Mangharam, Rahul
    In this effort we investigate the design and use of physiological and device models to conduct pre-clinical trials to provide early insight in the design and execution of the actual clinical trial. Computer models of physiological phenomena like cardiac electrical activity can be extremely complex. However, when the purpose of the model is to interact with a medical device, then it becomes sufficient to model the measurements that the device makes, e.g. the intra-cardiac electrograms (EGMs) that an Implantable Cardioverter Defibrillator (ICD) measures. We present a probabilistic generative model of EGMs, capable of generating exemplars of various arrhythmias. The model uses deformable shape templates, or motifs, to capture the variability in EGM shapes within one EGM channel, and a cycle length parameter to capture the variability in cycle length in one EGM channel. The relation between EGM channels, which is essential for determining whether the current arrhythmia is potentially fatal, is captured by a time-delayed Markov chain, whose states model the various combinations of (learned) motifs. The heart model is minimally parameterized and is learned from real patient data. Thus the statistics of key features reflect the statistics of a real cohort, but the model can also generate rare cases and new combinations from the inferred probabilities. On the device end, algorithms for signal sensing, detection and discrimination for major ICD manufacturers have been implemented both in simulation and on hardware platforms. The generated arrhythmia episodes are used as input to both the modeled ICD algorithms and real ICDs as part of a Computer Aided Clinical Trial (CACT). In a CACT, a computer model simulates the inputs to the device (such as a new, investigational ICD), and the device’s performance is evaluated. By incorporating these results into the appropriate statistical framework, the Computer Aided Clinical Trial results can serve as regulatory evidence when planning and executing an actual clinical trial. We demonstrate this by conducting a mock trial similar to the 2005-2010 RIGHT trial which compared the discrimination algorithms from two major ICD manufacturers. The results of the CACT clearly demonstrate that the failed outcome of the RIGHT trial could have been predicted and provides statistical support for deeper results that could have been captured prior to the trial.
  • Publication
    Benchmark: Nonlinear Hybrid Automata Model of Excitable Cardiac Tissue
    (2016-03-20) Abbas, Houssam; Jang, Kuk Jin; Mangharam, Rahul
    Implantable cardiac devices like pacemakers and defibrillators are life-saving medical devices. To verify their functionality, there is a need for heart models that can simulate interesting phenomena and are relatively computationally tractable. In this benchmark we implement a model of the electrical activity in excitable cardiac tissue as a network of nonlinear hybrid automata. The model has previously been shown to simulate fast arrhythmias. The hybrid automata are arranged in a square n-by-n grid and communicate via their voltages. Our Matlab implementation allows the user to specify any size of model $n$, thus rendering it ideal for benchmarking purposes since we can study tool efficiency as a function of size. We expect the model to be used to analyze parameter ranges and network connectivity that lead to dangerous heart conditions. It can also be connected to device models for device verification.
  • Publication
    The Challenges of High-Confidence Medical Device Software
    (2015-11-12) Jiang, Zhihao; Abbas, Houssam; Jang, Kuk Jin; Mangharam, Rahul
  • Publication
    Robustness Evaluation of Computer-aided Clinical Trials for Medical Devices
    (2019-03-14) Jang, Kuk Jin; Pant, Yash Vardhan; Zhang, Bo; Weimer, James; Mangharam, Rahul
    Medical cyber-physical systems, such as the implantable cardioverter defibrillator (ICD), require evaluation of safety and efficacy in the context of a patient population in a clinical trial. Advances in computer modeling and simulation allow for generation of a simulated cohort or virtual cohort which mimics a patient population and can be used as a source of prior information. A major obstacle to acceptance of simulation results as a source of prior information is the lack of a framework for explicitly modeling sources of uncertainty in simulation results and quantifying the effect on trial outcomes. In this work, we formulate the Computer-Aided Clinical Trial (CACT) within a Bayesian statistical framework allowing explicit modeling of assumptions and utilization of simulation results at all stages of a clinical trial. To quantify the robustness of the CACT outcome with respect to a simulation assumption, we define δ-robustness as the minimum perturbation of the base prior distribution resulting in a change of the CACT outcome and provide a method to estimate the δ-robustness. We demonstrate the utility of the framework and how the results of δ-robustness evaluation can be utilized at various stages of a clinical trial through an application to the Rhythm ID Goes Head-to-head Trial (RIGHT), which was a comparative evaluation of the safety and efficacy of specific software algorithms across different implantable cardiac devices. Finally, we introduce a hardware interface that allows for direct interaction with the physical device in order to validate and confirm the results of a CACT for implantable cardiac devices.
  • Publication
    Towards Model Checking of Implantable Cardioverter Defibrillators
    (2016-03-03) Abbas, Houssam; Jang, Kuk Jin; Jiang, Zhihao; Mangharam, Rahul
    Ventricular Fibrillation is a disorganized electrical excitation of the heart that results in inadequate blood flow to the body. It usually ends in death within a minute. A common way to treat the symptoms of fibrillation is to implant a medical device, known as an Implantable Cardioverter Defibrillator (ICD), in the patient's body. Model-based verification can supply rigorous proofs of safety and efficacy. In this paper, we build a hybrid system model of the human heart+ICD closed loop, and show it to be a STORMED system, a class of o-minimal hybrid systems that admit finite bisimulations. In general, it may not be possible to compute the bisimulation. We show that approximate reachability can yield a finite simulation for STORMED systems, and that certain compositions respect the STORMED property. The results of this paper are theoretical and motivate the creation of concrete model checking procedures for STORMED systems.
  • Publication
    High-Level Modeling for Computer-Aided Clinical Trials of Medical Devices
    (2016-08-16) Abbas, Houssam; Jiang, Zhihao; Jang, Kuk Jin; Beccani, Marco; Liang, Jackson; Dixit, Sanjay; Mangharam, Rahul
  • Publication
    CloudMat: Context-aware Personalization of Fitness Content
    (2015-06-27) Jang, Kuk Jin; Ryoo, Jungmin; Telhan, Orkan; Mangharam, Rahul
    Digital video content via broadcast television, Internet and other content distribution networks provide limited interaction for fitness and wellness activities. The content delivery is one-way only and provides no personalization to the pace, programming and progress of the user’s exercise routine. Furthermore, the content is to be viewed only on a screen which makes it awkward and incompatible with full-body activities such as yoga, pilates and T’ai chi. We present CloudMat, a system for context-aware personalization of fitness content with cloudenabled connected surfaces. CloudMat provides real-time closedloop feedback between the state of the user on the physical mat and the state of the content in the cloud service. Content is tagged with actuation signals where events are delegated from the screen to display on an electroluminescent lighting layer on the mat, which provides spatial guidance to the end-user. Through the sensor-layer embedded in the mat, the physical interface captures the pose and timing of the user activity and relays it to the Context-aware Personalization cloud service. This service coordinates sensing and actuation between the content stream and mat by generating pose templates and metadata files about the exercise routine to be delivered to the user. Through this interactive process between the physical mat and the content service, the feedback provided by the user performing the routine continuously adapts the pace and programming to maintain the desired user experience. We demonstrate the utility of the system and evaluate the system performance with a case study on interactive yoga.