Venous Ulcer Guidelines of AVF and SVS
By: Thomas F. O'Donnell Jr., MD
Venous leg ulcers (VLU) have a profound socioeconomic impact, which is related to both VLU’s prevalence of 1 to 1.5 percent and its high recurrence rate. The direct cost of VLU has been estimated to approximate 1% of total annual healthcare budgets of some Western European Countries. In addition VLU is frequently associated with pain and a marked alteration in the quality of life due to the open ulcer, which have indirect cost implications, due to disability and subsequent time lost from work.
The role of Guidelines: Guidelines have been defined by the Institute of Medicine as “systematic statements to assist both the practitioner’s and patient’s decisions about appropriate healthcare for specific clinical circumstances”, while presenting a synthesis of evidence-based recommendations for the diagnosis and treatment of a specific medical condition. The value of a guideline is that it provides consistency among treatment protocols provided to patients and as a result both the efficacy and the quality of care should be improved best practices to achieve the best outcomes for the most reasonable expenditure of the healthcare dollar. Guidelines are usually prepared by specialty societies, which validate and transfer new techniques through evidenced based systematic reviews as exemplified by the series of vascular guidelines sponsored by the Society for Vascular Surgery.
The genesis of The AVF/SVS VLU guidelines: The SVS/AVF guidelines arose out of the Sixth Pacific Vascular Symposium, which was sponsored by the AVF. The mission of this initiative was to decrease VLUs by 50% in the next decade. One of the key desired outcomes of the symposium was to develop a set of VLU guidelines. A preparatory systematic analysis of 14 published VLU guidelines was performed to synthesize a composite set of guidelines, which was composed of those with strong recommendations and secondly to identify areas of disagreement and weak recommendations for further research and refinement. Several areas of controversy were identified due to lack of agreement among the various guidelines and/or weak evidence: the role of iliac obstruction and the need for stenting, treatment of perforating veins, the necessity for physical therapy to preserve ankle mobility and the use of skin grafts and artificial skin. These areas would be a focal point of the AVF guideline committee as well as the well-studied areas of compression and wound care
The Venous Ulcer Initiative Committee of the AVF, which met at least monthly, was instrumental in advancing the development of the VLU guidelines. As a result, this committee responded to an RFP from the SVS Guidelines Committee for new vascular guidelines and our proposal for a VLU Guideline was approved by the SVS.
The SVS/AVF Guidelines Committee under co-editors Tom O’Donnell and Marc Passman, was divided into six working groups, each with the specific purpose of analyzing one aspect of venous ulcer management. The diagnosis group was chaired by Mark Passman and with members: Rob McLafferty, Bill Marston, Lori Pounds and Peter Henke. The compression group was chaired by Fedor Lurie with members: Tom Wakefield, Cynthia Shortell, Monika Gloviczki, Bo Eklof and Hugo Parch. The wound care group was co-chaired by Bill Ennis and Bill Marston and was comprised of Emily Cummings, Lori Pounds and Tom O’Donnell. The surgery/endovascular group was co-chaired by Bob Kistner and Mike Dalsing with members: Julianne Stoughton, David Gillespie, Peter Gloviczki, Bo Eklof and Seshadri Raju. The ancillary group was chaired by Monika Gloviczki with members: Cynthia Shortell, Bill Ennis, and Julianne Stoughton. Finally, the primary prevention/recurrence group was chaired by Peter Henke with Fedor Lurie, Emily Cummings and Mike Dalsing. Multiple telephone conference calls were held to accomplish the final work product.
As in the development of any guideline document, the first task of the committee was to compose a critical, but broad set of questions: 1) what are the best strategies for treatment of active versus healed ulcer 2) what are the best strategies for prevention of recurrence and 3) what are the best strategies for prevention of the post-thrombotic syndrome? Each group then performed a review of the literature in their respective area to determine the best method for developing guidelines for that area from the following: 1) de novo development- the development of novel recommendations from a formal systematic review of the literature; 2) build on existing guidelines with a complimentary literature search; 3) adaptation of existing guidelines and 4) total adoption of existing guidelines. This process served to determine the need for systematic review and meta-analysis for each section. This analysis was performed under M. Hassan Murad’s leadership and his team from the Department of Medicine and the Knowledge and Encounter Research Unit at the Mayo Clinic. Two areas were chosen for a systematic review and meta-analysis-1) compression and 2) surgery/endovascular. Following multiple reviews by each section and the co-editors the entire Guideline document and the two systematic reviews were reviewed by the SVS Document Committee and their comments were incorporated into the final revision. In addition, to make the product a true intersocietal consensus document the VLU Guidelines were submitted to several societies for review and endorsement. The American College of Phlebology and the Union de International Phlebologie responded with questions before endorsement. After these were answered their respective boards approved an endorsement of the guidelines.
The target audience for the AVF/SVS VLU Guidelines is specialists: vascular surgeons, phlebologists, wound care physicians, and plastic surgeons, which differs from some previous guidelines where the target audience was primary care physician or nurse specialists. Our guidelines focused on those areas which were identified as knowledge gaps in our systematic review of previous venous ulcer guidelines. The Venous Ulcer Guideline document was published in the Journal of Vascular Surgery as a supplement to the August 2014 issue (Volume 60). There were a total of 65 recommendations, which followed the GRADE method. This is the first set of guidelines to fully explore the role of surgery in the management of venous ulcers. Specific recommendations were made for endovenous ablation of superficial venous reflux, direct percutaneous ablation of “pathologic perforators” and stenting of outflow obstruction. Finally, a section of the guidelines emphasized primary prevention and future directions.