Sensing lead for denoising ambulatory ECGs and false positive event reduction

描述(申请人提供)：带内伪影和噪声是从皮下和体表心电图的动态记录中有效提取准确、可靠和可重复信息的主要障碍。由于每年有400多万患者接受心律失常的动态评估，带内伪影和噪音是一个紧迫而广泛的挑战。例如，在临床护理中，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人工过度阅读，导致操作效率低下和提供护理的成本更高。一些制造商试图通过调整心律失常检测算法以增加阳性预测值(减少假阳性事件)来解决移动事件记录器中的这一问题，但代价是灵敏度降低，从而导致遗漏事件和诊断产量的降低。除了诱发大量的假阳性事件外，噪声还可以掩盖P波，使心房颤动的明确诊断变得困难。噪声还影响对DRG安全性和有效性的研究，因为噪声在风险标记物中引入了可变性，而这反过来又增加了样本量和成本，并损害了信息的质量。为了满足这一需求，一种新型的微型(15cc)全功能Holter/Event/移动心脏遥测设备将 该设备采用已获专利的VivaQuant MDSP算法进行心电信号的实时处理。该算法可在不扭曲心电信号形态的情况下将带内噪声降低26分贝，并提供卓越的事件检测灵敏度和PPV，尤其是在有噪声的记录中。这项第二阶段的工作将建立在成功的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二阶段实施和测试。在第二阶段工作完成后，将完成对适用标准和文档的所有测试，并将510k提交给FDA。在这一多阶段的努力中开发的Holter/Event Record将显著提高医生可用诊断信息的质量，从而做出更明智的治疗决策，改善患者的生活质量，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方便患者的功能将使其佩戴更加舒适，从而提高患者的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算法商业化应用于其他需要精确超低功率心电处理的应用，如植入式环路记录器、皮下除颤器和神经刺激设备。

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.