Arrhythmia Research Technology, Inc. announces positive results of the Company's Signal-Averaged Electrocardiography (SAECG) technology employed in a multi-center clinical trial that studied 484 patients with prior myocardial infarction (heart attack).
Twenty-two major cardiac centers including University of Rochester, Duke University, University of Pennsylvania and UMass Memorial Hospital participated in this study. The patients enrolled were considered at high risk of ventricular arrhythmias because of low ejection fraction (EF ≤ 35%). Patients received implantable cardiac defibrillators (ICD) as primary prevention against sudden cardiac death. The multi-center study assessed these patients for ventricular arrhythmia risk using more than ten different ECG-based diagnostic methodologies and algorithms, including 12-lead ECG, 24-hour Holter monitoring, T wave alternans and SAECG-derived parameters. From this large battery of ECG tests, only the Company's SAECG-derived low QRS waveform voltage, along with frequent premature ventricular beats from Holter recordings, were found to be significantly predictive of ventricular arrhythmias.
Dr. Wojciech Zareba, Professor of Medicine, Director of the Heart Research Follow Up Program at the University of Rochester and Principal Investigator of this NIH-funded study said, "Our multi-center study rigorously applied a large battery of clinically available ECG test methods. Out of these we found only two ECG-based test results capable of predicting ventricular arrhythmia risk: total root-mean-square voltage of less than 25 microvolts from the SAECG, and greater than 500 ventricular premature beats from 24-hour Holter recordings. We are pleased that these results demonstrate an important role of SAECG in the assessment of risk for ventricular tachycardia or fibrillation in post-myocardial infarction patients. These findings may pave the way for more targeted implantation of ICDs in heart attack patients that are most likely to develop potentially lethal ventricular arrhythmias, and hence benefit from ICD implant."
President and Chief Executive Officer of the Company, Salvatore Emma, Jr. said, "We are pleased that our patented SAECG technology made such an important contribution to this study. The ability for the Company's PREDICTOR® SAECG analysis software to provide better patient selection for ICD implantation is extremely encouraging."
Each year approximately 1.5 million Americans suffer a myocardial infarction (MI); these heart attack survivors are susceptible to sudden cardiac death, which claims an estimated 325,000 lives annually. SAECG and 24-hour Holter test results used in conjunction with low ejection fraction can potentially expand screening of these post-MI patients to better identify high risk patients for primary prevention ICD therapy.