Conference Coverage

VQI-VVR registry data eyed for guiding development of ethical standards



– Registry data can be used to craft guidance for determining the appropriateness of procedures at vein centers, based on data presented by Thomas W. Wakefield, MD at the 2018 Veith Symposium.

Dr. Thomas Wakefield is the Stanley Professor of Vascular Surgery at the University of Michigan and section head, vascular surgery, University of Michigan Cardiovascular Center, Ann Arbor

Dr. Thomas Wakefield

The Vascular Quality Initiative Varicose Vein Registry (VQI-VVR), initiated in 2014 by the Society for Vascular Surgery in conjunction with the American Venous Forum, captures procedures that are performed in vein centers, office-based practices, and ambulatory or inpatient settings. The VVR looks at ablation and phlebectomy techniques and captures data including patient demographics, history, procedure data, plus early and late office-based and patient-reported follow-up in order to benchmark and improve outcomes and develop best practices and to help meet vein center certification requirements. The VVR includes 39 centers and more than 23,000 procedures.

Dr. Wakefield, who heads the VVR, used this registry as a means to illustrate how VQIs could be used to establish whether “the expected health benefit exceeds the expected negative consequences by a sufficiently wide margin that the procedure is worth doing.” This can be considered to be “appropriateness, which is part of ethical treatment.” Dr. Wakefield is the Stanley Professor of Vascular Surgery at the University of Michigan and section head, vascular surgery, University of Michigan Cardiovascular Center, Ann Arbor.

Data from the VQI registry (of which the VVR is a component) are now being used to generate appropriateness reports, said Dr. Wakefield.

The VQI represents a large comprehensive database of long-term data to define appropriate care. In addition, the VQI infrastructure is already geared to producing these reports both at a center and at a surgeon level. One disadvantage of the VVR registry, however, is low participation – only the 39 centers – and that it doesn’t capture cosmetic procedures and lesser (C1) disease. Further, it’s “likely the VQI participants are the ‘good actors,’ ” he added.

Targets for appropriateness include the proportion of patients undergoing ablation C2 or C4 disease or greater, the mean number of ablations per patient, the mean number of ablations per limb, and the proportion of perforated ablations for greater than C4 disease. Plotting out the data for these procedures at the center level can be assessed against current thinking on best practices in the various areas. For example, “the mean number of ablations per patient has been suggested at 1.8 to be about the right number,” and he used the graph of the center performance in this area to show that most of the centers were below this objective.

In an even more appropriate example of how this kind of data could be used to determine appropriateness, Dr. Wakefield described how perforated ablations should be performed for greater than C4 disease, but not for C2 disease. He described how, according to the actual data in the registry, there have been 870 total perforated treatments recorded, 38% for C2 disease, and of these 332 procedures, almost half of these were performed at one center only, with two other centers reporting 30 such procedures. “So clearly there are three centers that are doing perforated ablations for patients that are outside the guidelines,” Dr. Wakefield pointed out.

In future, payer demand is likely to demand that each treating physician provide evidence of the appropriateness of procedures performed, as well as appropriate patient selection and adherence to best practices, and good outcomes, which is part of what a society-based registry such as the VVR can provide.

“I believe the VQI-VVR is well-positioned to meet these needs. And if we ask the question ‘can VQI be used as a benchmark for setting ethical standards,’ I think it can certainly be used to help set appropriate standards, and since appropriateness is one part of ethical standards, I believe it has a role,” he concluded.

Dr. Wakefield reported that he had no disclosures.

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