A new European-wide Venous Registry, designed to collect individual patient records focusing on the natural history, medical and surgical treatment of venous insufficiency, was launched at this year’s European Venous Forum (EVF) meeting, in London, UK. This initiative is the result of collaboration between the EVF, the Vascular Independent Research and Education European Organisation (VAS), based in Milan, Italy, and Dendrite Clinical Systems Ltd.
Historically, vascular surgery audit has been confined at a hospital and national level to arterial surgery, whilst fewer surgeons have concentrated on collecting information on patients with venous disease. However, the last few years have witnessed changes in management. Symptomatic venous insufficiency affects some 1-15% of adult men and 20-25% of adult women in the UK. In addition, these advances in technology and an increase in treatment modalities, such as endoluminal laser treatment, radiofrequency ablation (RFA) and foam schlereotherapy, has resulted in a renewed interest in trying to compare and contrast treatments.
Furthermore data on the use of compression hosiery is important, as again, it is used variably in clinical practise. The Registry is a web-based system whereby the individual clinician can enter patient information onto a database whether at home, in hospital or from an office-based practice. Clinicians can add as many cases as they wish and where possible they will be encouraged to put on retrospective data (if applicable).
The Registry is entirely voluntary; however, recently published UK National Institute of Clinical Excellence guidelines state that if a clinician uses devices such as lasers, schlereotherapy or RFA, they must follow “the normal arrangements in place for consent, audit and clinical governance,” (thereby recommending that clinicians place the data into a registry).
Speaking to Vascular News, Mr Alun Davies, President of the EVF, commented: “We hope that by establishing the Venous Registry we can collate information on the natural history of venous disease and the treatment variations dependent a variety of demographics. Participation is voluntary and we would hope to generate interest and have at least 1,000 contributors.”
The Venous Registry, which should see the first test patients entered into the database by the Autumn of 2006, will initially cover seven treatments and procedures: compression therapy; deep vein reconstruction; drug therapy; endoluminal laser ablation; foam schlerotherapy; traditional surgery; and RFA. It is hoped that the registry will eventually expand to include all treatments and procedures for patients with venous disorders. “Thus far, the Registry has the support of the EVF, the Venous Forum at the Royal Society of Medicine (UK) and the American Venous Forum, in principle.” Davies added, “And the response from industry, as well as clinicians, has been very positive indeed.”
The aim of the Venous Registry is to produce an annual publication similar to the vascular and adult cardiac surgical reports (also produced by Dendrite Clinical Systems, in conjunction with the Vascular Society of the European Association of CardioThoracic Surgeons, respectively) that will outline which patients are at higher risk from particular venous diseases and the treatments that are being applied in that country.
Peter Walton, Managing Director, Dendrite Clinical Systems Ltd, told Vascular News that; “Initially, the data will be published in a simple analysis to demonstrate that it can be done. It is designed to give us a very broad demographic comparison. For example, in France we think there is much more drug therapy prescribed for venous disease than in England – so just looking at the most basic comparisons of treatment patterns should be interesting. In addition, we will also be able to look at the demographics and risk factors in different populations.”
However, he added that it is important to remember that the caveat of any registry is that it is not a controlled trial; therefore any conclusions reached must be treated with great very caution, especially concerning the differences in outcomes from different treatments, from country to country. It is hoped however, that the registry outcomes will identify where and how trials are established. “The conclusions reached by the data from the Venous Registry will be an hypothesis generator, rather than a hypothesis solver,” Walton concluded. It is important to note that the data submitted will be owned by the Societies involved.