Regulatory Editor

WASHINGTON – Cardiologists often cite what they believe is a link between diseases of the peripheral vasculature and those of the heart, but a recent report by the U.S. Agency for Healthcare Research and Quality (AHRQ), prepared in advance of a Medicare advisory meeting, indicated that the evidence behind several diagnostic modalities and treatment regimes for lower extremity chronic venous disease (LECVD) is spotty at best.

The Medicare Evidence Development and Coverage Advisory Committee (MedCAC) met in July 2015 to address three aspects of peripheral artery disease (PAD), and the scheduled July 20, 2016, MedCAC meeting for LECVD suggests the agency is not yet finished in its efforts to come to some determinations regarding these classes of vascular disorders. The 2015 meeting regarding PAD concluded with little conviction about the evidence regarding treatments for PAD, but the AHRQ report suggests that the evidence for LECVD might be even more tenuous.

The AHRQ report made note of more than 100 studies said to have "contributed evidence," including seven studies of comparative imaging for diagnosis in heterogenous populations. The authors said the evidence regarding duplex ultrasound (DUS) was insufficient to recommend for or against this modality's use as either a first-line diagnostic test or as an evaluation tool for patients scheduled for invasive treatment of LECVD.

The evidence behind radiofrequency ablation and high ligation plus stripping suggested no difference in long-term outcomes between the two approaches, although ablation is said to have scored better on several points, including fewer adverse events and faster improvement of symptoms.

The authors reviewed several other treatments and diagnostic work-ups, concluding that study heterogeneity, driven by comparisons of multiple treatment options, disparate time points of measurement, and varied use of outcome measures, limits the utility of the existing data. The net effect, the authors added, was to suggest a need for further research.

No Comments