We propose to adapt a high-resolution ECG system (PELEX) that includes the features of programmable 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 (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 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.
NIH Spending Category: Bioengineering; Cardiovascular; Clinical Research; Heart Disease; Networking and Information Technology R&D; Pediatric; Prevention
Project Terms: Accident and Emergency department; Address; Adult; Age; Agreement; Algorithms; Arrhythmia; base; Cardiac; Cardiac Surgery procedures; Cardiomyopathies; Cardiopulmonary Bypass; Caring; Cessation of life; Child; Childhood; Childhood Injury; Chronic lung disease; Clinical; clinically relevant; cohort; commercialization; Communication; Communities; Complement; Complex; congenital heart disorder; Data; data acquisition; Data Analyses; day; Death Rate; Detection; Deterioration; Development; Devices; Disclosure; Electrocardiogram; Event; Expert Systems; Gender; Generations; Goals; Health Professional; Healthcare; Heart Diseases; heart electrical activity; Heart failure; Heart Rate; heart rhythm; Hospital Costs; Hospitalization; Hospitals; Hypoplastic Left Heart Syndrome; improved; Infant; Injury; innovation; innovative technologies; Intervention; Ischemia; Journals; Licensing; Life; Malignant Neoplasms; Manufacturer Name; Marketing; Mechanics; Medical; Medical Device; Medicine; Monitor; Morbidity - disease rate; Myocardial Ischemia; Names; nervous system disorder; Notification; Operative Surgical Procedures; Outcome; Outpatients; Paramedical Personnel; Parents; Patients; Pattern; Pattern Recognition; Performance; Pharmaceutical Preparations; Phase; Physicians; Population; Populations at Risk; Positioning Attribute; Postoperative Period; prevent; Preventive; Procedures; prospective; Provider; Public Health; Range; Rapid Detection; Records; Reporting; Resolution; response; Risk; Site; Standards of Weights and Measures; stressor; Sudden Death; Symptoms; System; Techniques; Technology; Telephone; Testing; Time; time interval; transmission process; Variant; Wireless Technology; Work
