2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC) 2016
DOI: 10.1109/embc.2016.7590667
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In-silico pre-clinical trials for implantable cardioverter defibrillators

Abstract: Regulatory authorities require that the safety and efficacy of a new high-risk medical device be proven in a Clinical Trial (CT), in which the effects of the device on a group of patients are compared to the effects of the current standard of care. Phase III trials can run for several years, cost millions of dollars, and expose patients to an unproven device. In this paper, we demonstrate how to use a large group of synthetic patients based on computer modeling to improve the planning of a CT so as to increase… Show more

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Cited by 13 publications
(17 citation statements)
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“…An attack is effective when it compromises the decision of the discrimination algorithm in such a way that the a required therapy is prevented (e.g., during VF), or an inappropriate therapy is introduced (e.g., during SVT). Our attack model is concerned with inducing at least one compromised decision, which suffices to cause adverse or even fatal effects: depriving a patient of treatment for VF can lead to sudden cardiac death, while inappropriate shocks can result in damaging heart-tissue remodeling and cause significant psychological distress [14]. Note that the unaltered parameters can themselves have a low rate of inappropriate or missed therapy [2], which is, however, negligible compared to that for malicious parameters.…”
Section: Attack Modelmentioning
confidence: 99%
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“…An attack is effective when it compromises the decision of the discrimination algorithm in such a way that the a required therapy is prevented (e.g., during VF), or an inappropriate therapy is introduced (e.g., during SVT). Our attack model is concerned with inducing at least one compromised decision, which suffices to cause adverse or even fatal effects: depriving a patient of treatment for VF can lead to sudden cardiac death, while inappropriate shocks can result in damaging heart-tissue remodeling and cause significant psychological distress [14]. Note that the unaltered parameters can themselves have a low rate of inappropriate or missed therapy [2], which is, however, negligible compared to that for malicious parameters.…”
Section: Attack Modelmentioning
confidence: 99%
“…(12) and (13) consider the opposite situation that the algorithm stays in the VF/VT duration mode, in which case the corresponding clock is updated. (14) and (15) express that the VF and VT duration clocks are set to zero when the algorithm is outside the corresponding duration mode, or the mode has just ended. Finally, we introduce the predicate Th k indicating whether or not therapy is administered at the k-th cycle, in this way providing a symbolic representation of the therapy signal, i.e., for signal s and parameters p, Th k corresponds to d(p)(s)[k].…”
Section: Omt Encodingmentioning
confidence: 99%
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“…The three versions were run on a database of 960 EGMs, equally divided into 480 SVTs and 480 VTs. The beat timing in the EGMs (in other words, the boolean stream s) was generated by the heart model of [36], [37]. Briefly, this model can simulate beat generation and propagation at different rates, from different locations in the heart.…”
Section: B Validation Of the Qre Implementationmentioning
confidence: 99%