The VIRTUE Registry
Matt Thompson, MB, FRCS, discusses the design and status of this registry and necessary outcomes to show that the Valiant endograft is a viable treatment option for patients with type B dissections.
How would you describe the goals and study design of the VIRTUE Registry?
The goal of the VIRTUE Registry is to help define outcomes of the endovascular treatment of type B thoracic dissections. The VIRTUE Registry is a prospective registry that will enroll patients with type B dissections who are treated with the Valiant thoracic endograft (Medtronic, Inc., Santa Rosa, CA).
The aim of the registry is principally to determine the efficacy of the Valiant endograft in the treatment of these patients. In addition, the registry will give valuable information regarding the morphology of type B dissections after endovascular treatment, and any differences that exist between the three subcategories of type B dissections.
A particular strength of the registry is the establishment of a core laboratory being overseen by Hence Verhagen, MD, which will give very detailed morphology assessment of patients undergoing endovascular treatment for type B dissection.
Which patients will be included, and which will be excluded? Will both chronic and acute dissections be part of the registry?
Three groups of patients are included in the study: those with complicated acute dissections and complicated chronic dissections, as well as a group of patients with so-called subacute dissections.
What is the current status of the registry? How many cases have been enrolled?
The registry has been established in a number of countries across Europe. Recruitment is approximately two-thirds complete, and we hope to recruit the entire patient cohort (100 patients) by the end of the year.
Are any data currently available? Based on your experiences with the device in the UK, and the collective experience of the dissection subgroup in the Valiant Thoracic Registry, do you feel the device can also successfully treat type B dissections in appropriately selected patients?
We have been particularly careful not to start subanalyzing the VIRTUE Registry prior to completion of the recruitment cohort. However, I authored a multicenter retrospective study of the treatment of aortic dissections with the Valiant endograft in 2007. This demonstrated that the Valiant endograft appeared to be extremely good at treating both acute and chronic dissections.
In your opinion, what will the final data need to include in order for the registry to confirm that the Valiant device is a viable treatment option in patients with type B dissections?
I think that the registry is going to provide safety data regarding the use of the Valiant endograft in dissection. This will, of course, be able to be compared with other devices treating patients with similar indications. In addition, for the first time, the study will provide some long-term morphological data on the response of dissections to treatment with the Valiant endograft.
Matt Thompson, MB, FRCS, is Professor, St. George's Vascular Institute, in London, UK. He has disclosed that he is a paid consultant to Medtronic. Professor Thompson may be reached at +44 208 725 3205; email@example.com.