PELEX-C: A high-resolution, wireless ECG system for infants/children

描述(由申请人提供)：我们建议采用一种高分辨率心电系统(PELEX)，其功能包括可编程的&lt；V分辨率心电数据采集、无线通信、近实时的高级分析算法以及提供商通知，以识别正常婴儿和先天性心脏病(CHD)婴儿心脏手术前后(PELEX-C)特定年龄和性别的心电模式。婴儿和儿童的心脏电活动异常与心脏手术后的心力衰竭有关，是延长住院时间和猝死的重要原因。(1-28)尽管手术“成功”，但先天性心脏病婴儿在出院后心脏失代偿和死亡的风险仍然存在，并与手术后心律失常有关。在诺伍德姑息性手术后，患有左心发育不良综合征的婴儿猝死的风险可能高达16%。最近的研究应用了高分辨率(&lt；V)心电图分析技术来检测CHD儿童的心肌缺血和损伤。(19、24-28)除了心率(HR)、心脏时间间隔(PR、QRS、QTC)和ST段位置的变化等“通常”的心电图参数外，高分辨率的ECG分析可以检测到心脏波形中广泛的临床相关的&lt；V变异，这些变异表示成人心律失常和死亡的风险增加，但还没有在儿童中进行类似的研究。因此，临床上需要快速检测儿科患者的异常心电模式，并有机会利用PELEX系统的特性来识别与心脏损伤/缺血相关的微妙的亚阈值前心律失常心电模式。(29-37)医疗干预可以通过在临床失代偿之前治疗有可能发展成危及生命的心律失常的患者来优化患者的预后。具体目的1.调整PELEX采集和分析算法(例如心率、QRS和T波轴、除极、复极、时间不稳定、心律失常的标准值)以适应婴幼儿的年龄和性别特定的参数和模式(PELEX-C)。特定目的2.使用PELEX-C获取和分析健康婴儿(n=40)前瞻性横断面队列中的心电模式。具体目的3.使用PELEX-C获取和分析出生后90天内接受包括体外循环在内的心脏手术的先天性心脏病婴儿(n=20)的正常和异常心脏电活动。PELEX-C系统代表了FDA批准的高分辨率无线个人心电系统(PELEX)针对特定年龄段的扩展，适用于高危婴儿和儿童这一独特的亚群。在监测患有慢性肺部疾病、癌症和神经疾病等非心脏疾病的儿童的心电活动变化方面，预计会有一个更大的市场。 公共卫生相关性：我们建议使用高分辨率记录和多维分析来识别先天性心脏病手术后心脏电活动异常的独特模式，以便我们能够识别手术后有心律失常和临床恶化风险的患者。然后可以加强对这些高危婴儿的医疗护理，以防止术后心律失常、延长住院时间、更高的发病率和医院费用以及猝死。对于使用直接或间接影响心脏电和机械性能的药物治疗而增加心律失常风险的非心脏疾病患者，使用高分辨率分析(使用标准分析对现在被认为正常的模式进行分析)来识别心脏电活动的“危险”模式也可能非常重要。

DESCRIPTION (provided by applicant): We propose to adapt a high-resolution ECG system (PELEX) that includes the features of programmable <V resolution ECG data acquisition, wireless communication, near real-time advanced analysis algorithms, and provider notification to identify age- and gender-specific ECG patterns in normal infants and in infants with congenital heart disease (CHD) before and after cardiac surgery (PELEX-C). Abnormal cardiac electrical activity in infants and children is associated with cardiac failure following heart surgery and is an important cause of prolonged hospitalization and sudden death. (1-28) Despite a "successful" operation, the risk for cardiac decompensation and death in infants with CHD persists following hospital discharge and has been associated with post-operative arrhythmias. The risk for sudden death can be as high as 16% for infants with Hypoplastic Left Heart Syndrome following the palliative Norwood procedure. Recent studies have applied high-resolution (<V) electrocardiogram (ECG) analysis techniques to detect myocardial ischemia and injury in children with CHD.(19,24-28) In addition to the "usual" ECG parameters of heart rate (HR), cardiac time intervals (PR, QRS, QTC,), and changes in the position of ST segments, high- resolution ECG analysis can detect a broad range of clinically relevant <V variations in cardiac waveforms that represent increased risk for arrhythmia and death in adults but comparable studies have not been done in children. Thus, there is a clinical need to rapidly detect abnormal ECG patterns in pediatric patients and an opportunity to use the features of a PELEX system to identify subtle, sub-threshold pro-arrhythmic ECG patterns associated with cardiac injury/ischemia.(29-37)Medical intervention can then optimize patient outcomes by treating patients at risk for developing life-threatening arrhythmias prior to clinical decompensation. SPECIFIC AIM 1. Adapt the PELEX acquisition and analysis algorithms (e.g. normative values of heart rate, QRS and T wave axis, depolarization, repolarization, temporal instability, arrhythmia) to the age and gender-specific parameters and patterns of infants and children (PELEX-C). SPECIFIC AIM 2. Use PELEX-C to acquire and analyze cardiac electrical patterns in a prospective, cross-sectional cohort of healthy infants (n = 40). SPECIFIC AIM 3. Use PELEX-C to acquire and analyze normal and abnormal cardiac electrical activity in a prospective, cross-sectional cohort of infants with congenital heart disease undergoing cardiac surgery including cardiopulmonary bypass in the first 90 days of life (n = 20). The PELEX-C system represents an age-specific extension of the FDA-cleared, high-resolution, wireless, personal ECG system (PELEX) to a unique sub-population of at-risk infants and children. A much larger market is anticipated for monitoring changes in cardiac electrical activity in children with non-cardiac diseases such as chronic lung diseases, cancer, and neurologic disorders.(38, 38b-e). PUBLIC HEALTH RELEVANCE: We propose to identify unique patterns of abnormal cardiac electrical activity after congenital heart surgery using high-resolution recording and multi-dimensional analysis so that we can identify post- operative patients at risk for cardiac arrhythmia and clinical deterioration. Medical care can then be intensified for these high-risk infants in order to prevent post-operative arrhythmias, prolonged hospitalization, higher morbidity and hospital costs, and sudden death. Identifying "at-risk" patterns of cardiac electrical activity using high-resolution analysis (of patterns now considered normal using standard analysis) may also be very important in identifying patients with non-cardiac diseases who are at increased risk for arrhythmia due to treatment with drugs that directly or indirectly impact cardiac electrical and mechanical performance.