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Background

Origins of the Network

In 2002 over 400,000 open-heart surgical procedures were performed in the United States. These included valve replacements, bypass surgeries, heart transplants and other lifesaving procedures. In addition, new surgical procedures, imaging modalities, and medical devices have improved therapy for many patients and made treatment possible for others who have had few options in the past. The percent of heart surgeries performed in the elderly is increasing with new challenges and medical complications unique to this population. While improved survival has been documented for many cardiac surgical practices, stroke and neurological dysfunction have also been observed. This is particularly of interest in aging populations where cognitive function declines as a part of normal human aging and exposure to surgical procedures is increasing. Despite the lifesaving nature of cardiac surgery and the large number of patients undergoing heart surgery on health care resources, few patients undergoing heart surgery participate in clinical studies or trials. More importantly, new surgical procedures and devices are often incorporated into clinical practice without objective evaluation of their relative benefit over established therapies. It is particularly important to ensure the safety and efficacy of such treatments compared to less risky, less expensive and less invasive treatment options. The evolution of the use of cardiac surgery in modern medical practice warrants the application of clinical studies to discriminate among the relative benefits of novel procedures as compared to standard therapies and interventions.

In recognition of the need for clinical evaluations in cardiac surgery, the National Heart, Lung, and Blood Institute's Advisory Council in February 2004 proposed that the Institute formally evaluate the status of future directions in cardiac surgery. As a result, on May 7 and 8, 2004, the NHLBI convened a Working Group of cardiac surgeons to assess the state of cardiac surgery research, identify critical gaps in current knowledge, determine areas of opportunity, and obtain specific recommendations for future research activities (Circulation. 2005;111:3007-3013). The primary recommendation from this working Group was the formation of a Cardiovascular Surgery Clinical Network for relatively small, short-term clinical studies. The Working Group considered that this Network would be an important step in developing a culture of systematic scientific clinical evaluation within the field of cardiac surgery that would inform the use of new interventions in surgical practice and improve the scientific basis of care in cardiovascular disease.