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VDM Speaks with Peter J. Pappas, MD, FACS, President of the American Venous Forum
Why has venous disease been understudied compared to other types of disease?
Venous disorders represent a wide spectrum of disease states that includes varicose veins, venous ulcers, hypercoaguable states, venous thrombo-embolism, pulmonary emboli, post-thrombotic syndrome and congenital arteriovenous malformations. It is easier to focus on a specific disease state when conducting basic and clinical science research rather that a disease spectrum. For example, a great deal of work has been done on venous thrombo-embolic disease, but little work on the other disease states discussed above.
What do we currently know about the impact of venous disease on public health?
In the United States, 10–35% of the population has some form of venous disorder. The incidence of venous ulceration in patients older than 65 is 4.5%, with a direct cost for wound care of over 1 billion dollars. Over 4.6 million workdays are lost every year directly related to patients seeking medical care for their venous disorders. Over 600,000 patients die annually from pulmonary emboli, and venous disease care encompasses 1.5% of healthcare expenditures in the United States. Therefore, venous disorders pose a huge economic burden to the U.S. healthcare system.
What are the most prevalent types of venous disease in the U.S. today?
Although varicose veins are the most prevalent form of venous disease in the United States, venous thrombo-embolic disorders are the most life-threatening.
Tell us about the soon-to-be launched American Venous Registry.
The AVR is a registry composed of five modules: Varicose Veins, Venous Stenting, Pharmaco-mechanical Thrombolysis, Vena Caval Filter Devices and Upper Extremity Venous Thrombo-embolic Disease. The Varicose Vein module will be launched at this year’s annual meeting and the Stent module is currently being revised. All modules will be pre-loaded with data from high-volume centers, allowing users to immediately perform comparative effectiveness studies on their patients compared to a national dataset. The registry meets the meaningful use criteria for designation as a registered Electronic Medical Record, making users eligible for the 2% bonus from the Centers for Medicare and Medicaid Services (CMS).
What are the goals for this registry?
The primary goal of the registry is to obtain real-world outcome data on therapies that are currently being performed on patients and generate data for future clinical studies. Participation in the registry will assist board-certified physicians with maintenance of certification requirements and streamline office practices through the use of the numerous clinical practice tools.
What changes in approaches to vein disease therapy do you anticipate once the American Venous Registry is well established?
The data generated from the registry will provide real-world outcome data that will elucidate the effectiveness of venous therapies currently offered to patients. The registry will also provide the preliminary data and hypotheses needed for future clinical trials. Finally, the registry will provide a mechanism for practitioners to evaluate their own performance by comparing their outcomes to a national dataset. It is our hope that data generated from the registry can be utilized by government and third-party payors to develop medical necessity and treatment guidelines directed at improving the care of venous patients.
How many years’ worth of registry data will be needed to provide solid information for the establishment of treatment standards?
The answer to this question depends on the clinical problem under investigation. Vein recanalization after endothermal ablation stent patency is best assessed at 1-, 5- and 10-year intervals due to the chronicity of the disease. Vein recanalization after treatment for a venous thrombo-embolism or the incidence of post-thrombotic syndrome can be assessed after 2 years. Therefore, the answer to your original question is that it depends on the problem being studied.
What are your thoughts on the early (and controversial) reports on treatment of chronic cerebrospinal venous insufficiency (CCSVI) for multiple sclerosis patients?
The concept that cerebral venous hypertension may contribute to multiple sclerosis exacerbations is intriguing. Given the high morbidity associated with multiple sclerosis, any and all reasonable clinical therapies should be explored. At this point, the early results are highly suggestive. We clearly need more patients with longer follow-up periods before any credible assessments of treatment efficacy can be made.
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For the past 15 years, Dr. Peter Pappas has held a variety of positions at University of Medicine and Dentistry of New Jersey (UMDNJ)-New Jersey Medical School. He attained the rank of Full Professor in the Department of Surgery, Division of Vascular Surgery and the Department of Pharmacology and Physiology. Dr. Pappas has served as Residency Program Director for the General Surgery residency program and the Vascular Surgery residency as well as Director of the Division of Vascular Surgery and the Vascular Laboratory. He currently is the Chairman of the Department of Surgery at The Brooklyn Hospital in Brooklyn, New York. Dr. Pappas has received extra-mural funding for his interest in chronic venous disorders and authored over 60 peer-reviewed manuscripts. He has held numerous leadership positions in local, regional and national vascular societies, and is currently the president of the American Venous Forum, a nationally and internationally recognized society dedicated to improving the care of patients with venous and lymphatic disorders. Dr. Pappas holds a Bachelor of Science degree in Biology from Rutgers University and received his MD in 1987 from Robert Wood Johnson Medical School. He completed a General Surgery Residency in 1993 at Cooper Hospital University Medical Center and a Vascular Residency in 1995 at UMDNJ-New Jersey Medical School under the directorship of Robert W. Hobson, II, MD.