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

描述（由申请人提供）：我们建议采用高分辨率ECG系统（PELEX），该系统包括可编程的<V分辨率ECG数据采集、无线通信、近实时高级分析算法和提供者通知功能，以识别正常婴儿和患有先天性心脏病（CHD）的婴儿在心脏手术前后的年龄和性别特异性ECG模式（PELEX- c）。婴儿和儿童心脏电活动异常与心脏手术后心力衰竭有关，是延长住院时间和猝死的重要原因。（1-28）尽管手术“成功”，婴儿冠心病患者心脏失代偿和死亡的风险在出院后仍然存在，并与术后心律失常有关。在姑息性诺伍德手术后，患有左心发育不全综合征的婴儿猝死的风险可高达16%。最近的研究应用高分辨率（<V）心电图（ECG）分析技术检测儿童冠心病的心肌缺血和损伤。（19,24-28）除了心率（HR）、心脏时间间隔（PR、QRS、QTC、）和ST段位置变化等“常规”心电图参数外，高分辨率心电图分析还可以检测到广泛的临床相关心脏波形<V变化，这些变化代表成人心律失常和死亡的风险增加，但在儿童中尚未进行类似的研究。因此，临床需要快速检测儿科患者的异常心电图模式，并有机会利用PELEX系统的特点来识别与心脏损伤/缺血相关的细微的、亚阈值的促心律失常心电图模式。（29-37）通过在临床失代偿之前治疗有发生危及生命的心律失常风险的患者，医疗干预可以优化患者的预后。具体目标1。使PELEX采集和分析算法（如心率、QRS和T波轴、去极化、复极化、时间不稳定、心律失常的规范值）适应婴儿和儿童的年龄和性别特定参数和模式（PELEX- c）。具体目标2。使用PELEX-C在健康婴儿的前瞻性横断面队列（n = 40）中获取和分析心电模式。具体目标3。在一项前瞻性横断面队列研究中，使用PELEX-C获取并分析在出生后90天内接受心脏手术（包括体外循环）的先天性心脏病婴儿（n = 20）的正常和异常心电活动。PELEX- c系统代表了fda批准的高分辨率无线个人ECG系统（PELEX）的年龄特异性扩展，适用于高危婴儿和儿童的独特亚群。对患有慢性肺病、癌症和神经系统疾病等非心脏疾病的儿童进行心电活动监测，预计将有一个更大的市场。38中,(38)。

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.