Sensing lead for denoising ambulatory ECGs and false positive event reduction

描述（由申请人提供）：带内伪影和噪声是从皮下和体表ECG动态记录中有效提取准确、可靠和可重复信息的主要障碍。每年有超过400万患者经历心律失常的动态评估，带内伪影和噪声是一个紧迫的，广泛的挑战。例如，在临床护理中，由噪声和伪影导致的假阳性心律失常检测的高发生率可能需要昂贵的手动过度读取，导致较差的操作效率和较高的护理成本。一些制造商试图通过调整心律失常检测算法来解决动态事件记录器中的这一问题，以增加阳性预测值（减少假阳性事件），但以降低灵敏度为代价，导致遗漏事件和诊断率降低。除了诱发大量的假阳性事件外，噪声还可以掩盖P波，从而难以明确诊断房颤。噪音也会影响drg安全性和有效性的研究，因为噪音会引入风险标记的变异性，这反过来会增加样本量和成本，并损害信息质量。 为了满足这一需求，一种新型的微型（15 cc）全功能霍尔特/事件/移动的心脏遥测装置将 在第二阶段开发。该设备采用专利VivaQuant MDSP算法进行ECG的真实的实时处理。该算法可在不扭曲ECG形态的情况下将带内噪声降低>26 dB，并提供上级的事件检测灵敏度和PPV，尤其是在有噪声的记录中。第二阶段工作将建立在第一阶段工作的基础上，并将根据第一阶段研究的数值优化策略优化算法功耗和性能。其余功能（包括无线通信、数据压缩和症状事件记录）将在第II阶段实施和测试。在第二阶段工作完成时，将完成所有适用标准和文件的测试，并向FDA提交510 k。 在这一多阶段努力中开发的霍尔特/事件记录器将显著改善医生可用的诊断信息质量，从而更好地做出知情的治疗决策，提高患者的生活质量，并以更低的成本提供更高质量的护理。该设备的小尺寸和其他患者友好功能将使其佩戴更舒适，从而提高患者依从性和更高质量的诊断信息。此外，一旦嵌入式算法得到优化，我们将寻求合作伙伴关系，将MDSP算法商业化，用于需要精确超低功耗ECG处理的其他应用，例如植入式循环记录仪，皮下起搏器和神经刺激设备。

DESCRIPTION (provided by applicant): In-band artifact and noise present a major obstacle to efficient extraction of accurate, reliable, and repeatable information from ambulatory recordings of subcutaneous and surface ECGs. With more than 4 million patients a year experiencing ambulatory evaluations for cardiac arrhythmia, in-band artifact and noise is an urgent, wide-reaching challenge. In clinical care, for example, the high incidence of false positive arrhythmia detections resulting from noise and artifact can require expensive manual over-read, leading to poor operational efficiencies and higher cost of delivering care. Some manufacturers have attempted to address this issue in ambulatory event recorders by tuning the arrhythmia detection algorithm to increase positive predictive value (reduce false positive events) at the expense of decreased sensitivity, resulting in missed events and a reduction in diagnostic yield. In addition to inducing significant numbers of false positive events, noise can mask P-waves, rendering a definitive diagnosis of atrial fibrillation difficult. Noise also impacts studies of drg safety and effectiveness because noise introduces variability in risk markers which, in turn, increases sample size and cost and compromises the quality of information. To address this need, a novel miniature (15 cc) fully functioning Holter/event/mobile cardiac telemetry device will be developed in Phase II. This device employs the patented VivaQuant MDSP algorithm for real- time processing of ECGs. This algorithm provides for >26 dB reduction in in-band noise without distorting ECG morphology and provides superior event detection sensitivity and PPV, especially in noisy recordings. This Phase II effort will build upon a successful Phase I effort an will optimize algorithm power consumption and performance based upon numerical optimization strategies researched in Phase I. The remaining features including wireless communications, data compression, and symptomatic event recording will be implemented and tested in Phase II. At the completion of the Phase II effort, all testing to applicable standards and documentation will be completed and a 510k will be submitted to FDA. The Holter/event recorder developed in this multi-phase effort will result in a significant improvement in the quality of diagnostic information available to physicians, leading to better informed therapeutic decisions, improved patient quality of life, and higher-quality care delivered at a lower cost. The small size and othe patient-friendly features of the device will render it more comfortable to wear, leading to improved patient compliance and higher-quality diagnostic information. In addition, once the embedded algorithm is optimized, we will pursue partnerships to commercialize the MDSP algorithm in other applications where accurate ultra low-power ECG processing is required such as for implantable loop recorders, subcutaneous defibrillators, and neural stimulation devices.