The American Venous Forum’s American Venous Registry is helping physicians and allied health care professionals improve patient care by providing them with a source of valuable data on venous disease treatments and outcomes. It is the first and only nationwide evaluation of venous disease treatment across multiple specialties.
The AVF created the registry to fill a gaping need for a compendium of data on the treatment and diagnosis of venous diseases. In 2006, during the AV F’s Pacific Vascular Forum, the AV F leadership decided to create a registry as a way to improve patient care through the collection, analysis and sharing of data. Subsequently, the AV F formed a steering committee, chaired by Brajesh K. Lal, MD , to develop the registry. Dr. Lal is an associate professor and chief of vascular surgery, physiology and bioengineering at the University of Maryland, Baltimore. The registry will help identify disease patterns and help doctors compare data, Dr. Lal said.
“Venous disease is highly prevalent, affecting at least 25% of the US and world-wide population. However, the management of venous disease is not standardized. The care for venous problems is currently being undertaken by a multiplicity of professionals with varied training backgrounds, with varied access to and knowledge of clinical protocols, with varied levels of introspection or analysis of outcomes,” said Dr. Lal. “There is a great need for identifying venous disease practice patterns across specialties and geographic boundaries in a standardized fashion. In the process, we will facilitate comparisons of indications, diagnostic accuracy, and treatment efficacy. It is anticipated that this will, in turn, enable implementation of focused improvements in multiple aspects of the management of venous disease.”
The AVF is an organization well suited to creating the registry, Dr. Lal noted. “The AV F has been a leader in developing venous anatomic terminology (nomenclature), tools to categorize venous disease classes (CEA P), and systems to measure disease severity (VC SS). Its members have participated in the development of functional outcome assessment tools (CIVI Q). The AVR will be an important educational tool to disseminate these standardized tools to diagnose and classify venous disease. It will standardize the collaborative collection and analysis of clinical information on venous disease. For the first time, large outcome reports using standardized methodology and terminology will enable both physicians and industry to draw valid conclusions regarding treatment efficacy.”
The registry consists of five modules. The modules on varicose veins, venous stenting and vena cava filters are accepting data; the modules on thrombectory/thrombolysis and upper extremity venous treatment will soon be live. Jose Almeida, MD , headed the varicose vein module. Drs. Lal and Almeida and the steering committee published data from the varicose vein module in January 2012 in the module’s first annual report.
About 200 physicians at 40 hospitals and clinics across the country have entered patient data into the varicose vein module. Clinical sites participating in the varicose vein module include Emory Healthcare, Miami Vein Center, New Jersey Medical School, New York University, State University of New York at Buffalo, and the University of Michigan, as well as numerous other universities and independent vein clinics.
The number of physicians participating in the registry exceeded projections, said Dr. Lal. “Both the number of physicians participating in the registry and the number of patients entered into the registry have surpassed expectations. We had targeted for an enrollment of 1,000 patients in the first year. After going live in Feb 2010, we had already enrolled over 2,500 prospective patients and over 1,500 retrospective patients with prospective followup by the time we did our first analysis in October 2011 (approximately 1 1/2 years).”
The registry is a real-time clinical practice tool for physicians participating in it, added Dr. Lal. “The AVR is designed to provide a real-time clinical practice tool to participating physicians that will assist the practices of individual participants, allow benchmarking of their results with respect to the national aggregate, track data mandated by CM S or JCA HO for quality assurance purposes, and assemble reports for their boards to facilitate re-certification.”
Patient demographic data
The varicose vein module annual report includes data from 4,014 patients collected between 2007 and September 2011. The majority of the patients were Caucasian women: 70.5% of patients were Caucasian and 76.6% were female. Only 2.5% of patients were African American and less than 1% were Hispanic.
Patients ranged in age from less than 30 to more than 80 years old, but the majority of patients were between 40 and 64 years old. Out of nearly half of the female patients in the database, 40% were normal weight or underweight, but only 20% of male patients were normal weight or underweight, suggesting, according to the annual report summary, that obesity may play a larger role in the development of venous disease in men than in women.
The majority of patients—about 80% of the women and 75% of the men–entered into the database were undergoing their first treatment for varicose veins. Of the patients who had previously been treated for varicose veins, however, only 27.7% used compression therapy before their treatment. This finding “indicates room for improvement in their management,” according to the annual report summary. Most patients reported either mild (30.6%) or moderate (50.9%) pain. The severity of the varicose veins for most patients was either assessed as being mild (26.8%) or moderate (40.4%). Nearly one-quarter of patients (24.1%) had varicose veins that were assessed as being severe, while only 8.8% of patients had no visible varicose veins. Nearly half of the patients (41.7%) had no venous edema, about a quarter had mild edema (28.5%) and a quarter had moderate edema (24.4%). More than three-fourths of the patients had no inflammation (82.2%) or induration (88.7%) on their legs. Only about one-quarter (26.5%) of patients had mild, moderate or severe skin pigmentation on their legs; the rest had no skin pigmentation at all.
The great saphenous vein was the vein most often treated (79%), followed by the small saphenous vein and the anterior accessory saphenous vein. Most patients received only one form of treatment endovenous laser ablation, radio frequency ablation, sclerotherapy or surgery. Of those treatment methods, endoluminal laser ablation was the one most commonly used in the registry patients (60.2% of treated legs), followed by surgery (primarily phlebectomies) (33 .9%), radiofrequency ablation (32.6%) and, finally, sclerotherapy (16.3%). About one-third of legs—36.1% of right legs and 37.8% of left legs—received combination therapy. Post-operative complications were low, occurring in less than 1% of unilateral procedures and 3.6% of bilateral procedures.
Ninety-five percent of patients used compression therapy during the 48 hours following treatment. About threefourths of patients—70%—were treated with bandage compression therapy and about 40% were treated with compression stockings. Most patients wore the compression bandages or stockings both day and night.
The data indicates that varicose vein treatments are both effective and long lasting. According to the registry data, the median venous clinical severity score dropped from 7 before treatment to a 4 on post-operative day 35. Patients also reported a significant drop in their pain levels. The three-year, complication-free rate was 85%.