University of Rochester Medical Center, Rochester, NY                                 


Cardiac safety remains one of the most challenging hurdles in both the improvement of the general public health and the development of new chemical entities and biotechnology derived products. For instance, sudden cardiac death (SCD) is the largest cause of natural death in the U.S. causing about 325,000 adult deaths each year and SCD is responsible for half of all heart disease deaths. Despite the increased availability of medical imaging and expensive medical technologies, the surface electrocardiogram remains a routinely used test because it is inexpensive, noninvasive and provides useful information for the diagnosis and risk stratification of cardiac patients. With the escalating cost of the health care system in U.S. and world-wide, an optimal cost-benefit ratio of any medical investigations is required. Under such economic pressure and with the spread of ECG technologies in clinical and research settings, the surface electrocardiogram is expected to remain widely used and the incentive to develop new technologies is strong.

Cardiac Safety is also related to drug use and it is considered as another significant public health issue. It has been estimated that as many as 86% of all new chemical entities (NCE)s tested in pharmaceutical development show specific inhibitory activity and thus have a potential to prolong the heart’s ventricular repolarization, which in some cases can lead to Torsades de Pointes (TdPs) and potentially to SCD. According to the FDA, the main reason for the inability of the current pharmaceutical development process to effectively screen out potentially harmful drugs, while bringing safe and efficacious medicines to market is the fact that companies “are forced to use the tools of the last century to evaluate this century’s advances.” In order to address this problem “a new product development toolkit is urgently needed to improve predictability and efficiency along the critical path.”

The objective of the Telemetric and Holter ECG Warehouse (THEW) is to provide services to public, private and any legal scientific organizations world-wide by fostering and distributing the resources (data and tools) needed to conduct ECG-related research activities. The THEW Initiative deploys appropriate information technologies and computer processing power to benefit the overall scientific community. The THEW is a public/private partnership with the FDA developed under NIH-NHLBI support and led by a Steering Committee consisting of staff members of the Food and Drug Administration (FDA), the NIH, and the University Of Rochester (UR).

The THEW hosts more than 3,700 digital 24-Holter ECG recordings from 13 independent studies. In addition to the ECGs, the repository includes patient information in separate clinical database with a content varying according to the study focus. The THEW database has been accessed by researchers from 37 universities and 16 corporations located in 16 countries worldwide. Twenty publications have been released primarily focusing on the development and validation of ECG-based technologies.

THEW Mission Statement:

The objective of the Center and its Telemetric and Holter ECG Warehouse (THEW) is to provide access to continuous electrocardiographic data to for-profit and not-for-profit organizations for the design and validation of analytic methods to advance the field of quantitative electrocardiography with a strong focus on cardiac safety.