The “Impact of Sex in Vascular Diseases and Implications for Therapies” symposium uncovered a series of knowledge gaps related to the sex differences in vascular disease, its symptoms, risk factors and response to treatment. Conference recommendations could make a significant impact on the health care industry ranging from clinical trials to the development of medical technology and therapies. Preliminary findings reveal that the basic biological make up of the heart and blood vessels differs significantly between men and women and may have a direct and dramatic impact on the prevention, diagnosis and treatment of heart attacks, strokes and other forms of vascular disease. Symposium faculty also report that reproductive hormones such as estrogen heavily influence the progression and treatment of vascular disease.
The Symposium's panel of experts identified seven key preliminary findings that address the inherent differences between men and women that could redefine sex-based medicine and research methodology in vascular disease. The seven key findings include:
- Sex Differences in Cardiovascular Disease: A knowledge gap exists in the understanding of male and female patterns of cardiovascular disease, symptoms and response to treatment. The differences must be incorporated into all aspects of future research including drug therapy and medical device development.
- Sex Differences in Clinical Research: The predominant pattern in clinical trials is to combine males and females regardless of the potential sex differences. To advance vascular medicine, clinical research methodology must incorporate sex differences when evaluating responses to treatments and test performance. In addition, there is a general failure to note women's hormonal status (i.e., premenopausal or postmenopausal) when evaluating their responses to testing—a situation that needs to be rectified.
- Sex Differences Applied to Research Study Design: The role of sex should not be limited to specifying the number of women enrolled in a study. Methodology needs to include the comparison of females to males; how study design identifies sex differences; and how results are interpreted relative to sex.
- Sex Differences and Interdisciplinary Research: In general, national conferences, scientific meetings and research investigators tend to focus on a particular, isolated area of research. By contrast, interdisciplinary gatherings can identifycollaborative areas of study and investigation.
- Sex Differences in Regenerative Medicine: Sex differences in regenerative medicine suggest that female stem cells, when infused with male stem cells, support tissue regeneration, whereas male stem cells alone are less successful. More research is needed to understand what appears to make female stem cells superior in this application.
- Sex Differences and the Role of Reproductive Hormones: While it is clear that hormones such as estrogen have an impact on processes throughout the body, more study is needed to better understand and identify how hormones impact heart rate, blood pressure and other body processes, and particularly how they affect vascular disease.
- Sex Differences in Cellular Environment: Advances in biology underscore the message that cellular environment must be conducive for the growth and function of the cell. Investigation designed to identify optimal surfaces to attract the growth of healthy endovascular cells needs to be a priority for further research.
The first-of-its-kind scientific symposium exploring sex-based medicine's impact on the treatment of a wide array of vascular diseases was conducted in February 2008 at Cedars-Sinai Medical Center in Los Angeles. Co-chaired by Noel Bairey Merz, M.D., and Saralyn Mark, M.D, the conference brought together a renowned panel of physicians and clinical research scientists to devise a plan of action to address the significant discrepancies existing between men and women in the prevention, diagnosis and treatment of vascular disease.
According to Dr. Bairey Merz, “The goal of the symposium was to address the increasingly alarming discovery that women do not appear to be receiving maximum benefit from our current strategies for cardiovascular disease (CVD). A recent publication showed that while overall CVD has declined by 52 percent in men and 49 percent in women, there is an actual increase in CVD related deaths in younger, middle-aged women, despite increased overall use of diagnostic procedures and preventative medications.”
“Vascular disease is the leading killer of both men and women and yet little knowledge exists with regard to how sex differences impact the development of these conditions,” acknowledges Dr. Mark. “These preliminary findings are a significant step toward eliminating the knowledge gaps in vascular health and ideally will eventually change how the medical and pharmaceutical industries identify and evaluate the sex-based discrepancies in the diagnosis and treatment of vascular disease.”
“These preliminary findings will have a significant impact on how the medical device industry designs and develops medical technology and therapies for vascular medicine,” said Christina Anné, vice president of Cook Medical's Women's Health business unit. “A one-size-fits-all approach to medical technology is no longer effective when treating male and female patients. We are committed to working closely with symposium participants and other scientific and medical community members to provide minimally invasive medical devices that address gender-based differences.”
Sponsored by Cook Medical, symposium participants included Drs. Leslee Shaw, Prediman K. Shah, Barbara Boyan, Doris Taylor, Noel Bairey Merz, Alice Jacobs and Eduardo Marbán. Representatives of the Organization for the Study of Sex Differences (OSSD), the American College of Cardiology (ACC), and the National Heart, Lung and Blood Institute (NHLBI) also participated.
About Cook Medical:
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.