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SCAI publishes appropriate use criteria for femoral-popliteal intervention
The Society for Cardiovascular Angiography and Interventions today released a document outlining appropriate use criteria for femoral-popliteal disease.
The document, published in Catheterization & Cardiovascular Interventions, is the second in a series of documents designed to provide contemporary guidelines for the endovascular treatment of patients with peripheral arterial disease. The first document on aorto-iliac intervention was published in late May.
In this new document, experts in peripheral vascular disease, vascular medicine and endovascular intervention suggested that endovascular therapy may be useful in a broad range of lesions, patients and clinical settings due to advances in technology and operator capability. They added that high restenosis rates in the femoral-popliteal segment after endovascular therapy have been reduced by drug-eluting stents, drug-eluting balloons and possibly bio-absorbable stent platforms.
“This document was developed to guide physicians in the clinical decision-making related to the contemporary application of endovascular intervention among patients with femoral-popliteal arterial disease,” the authors wrote. “By combining lessons learned from clinical trials, international trends in clinical practice and insights regarding emerging technologies, we may appropriately tailor our application of endovascular therapy to provide optimal care to our patients.”
Summary of recommendations
The consensus panel divided the recommendations into three categories of recommendation: Appropriate Care, May Be Appropriate Care and Rarely Appropriate Care.
The following criteria were included for Appropriate Care:
- Femoro-popliteal >70% or chronic total occlusion with lifestyle limiting claudication or claudication that limits their ability to perform their job (Rutherford classification 2-3), having failed or intolerant of pharmacological therapy and/or walking therapy;
- Femoro-popliteal >70% or CTO with critical limb ischemia (Rutherford classification 4-6);
- Common femoral artery with >70% stenosis or CTO and the clinical need for vascular access (ie, intra-aortic balloon pump or large bore access for TAVR or percutaneous ventricular assist device).
In the May Be Appropriate Care category, the following criteria should be used:
- Femoro-popliteal 50% to 69% with multiple focal lesions with severe claudication or critical limb ischemia (Rutherford classification 3-6);
- Common femoral artery >70% or CTO with severe claudication or critical limb ischemia (Rutherford classification 3-6);
- Profunda femoral artery >70% or CTO with severe claudication or critical limb ischemia (Rutherford classification 3-6).
Patients in the Rarely Appropriate Care category include:
- Femoro-popliteal >70% or CTO with mild or no symptoms (Rutherford classification 0-1);
- Common femoral artery >70% or CTO with mild or no symptoms (Rutherford classification 0-1);
- Profunda femoral artery >70% or CTO with mild or no symptoms (Rutherford classification 0-1);
- Femoro-popliteal, common femoral artery, or profunda femoral artery with <50% stenosis regardless of symptoms.
AUC a ‘tool for assessing practice’
Douglas E. Drachman, MD, director of the Cardiology Fellowship Program at Massachusetts General Hospital, Boston, and senior author of the paper, discussed the document with Cardiology Today’s Intervention.
“It is clear that we now practice in an era of accountability, where patients, physicians and — increasingly — payers expect that we may demonstrate that our practice and outcomes conform to the standard of care,” he said. “As with the appropriate use criteria [AUC] for coronary intervention, it is our hope that the AUC for femoral-popliteal disease will stimulate discussion about how these guidelines may inform daily practice and may improve the care of our patients.”
Douglas E. Drachman
Drachman noted that, in the previous era defined by the TASC-II document, perspective on endovascular therapy was often substantially influenced by anatomic features of disease. Simple, focal (TASC A) lesions were felt to be more amenable to endovascular therapy, while complex, totally-occluded lesions (TASC D) were felt not to be candidate for endovascular care.
“With improvements in operator technique, interventional technology and durability of stent-based outcomes, this paradigm has become outdated,” he said. “In the current era, our focus should be less on when we can apply endovascular therapy to when we shouldapply such therapy. As a result, the AUC document places particular emphasis on patient-driven factors, such as severity of clinical symptoms rather than on the anatomic features of their vascular disease.”
Drachman was quick to note that this is “not a black-and-white document. Clinical judgment and carefully considered prospective discussion with patients and their health care teams should prevail.” Importantly, he suggested that the AUC document is a tool for assessing practice.
“The AUC document may serve as a yardstick with which we may compare individual practice patterns against those of peers,” Drachman said. “While specific circumstances may influence a provider to treat a patient in the ‘rarely appropriate care’ category, if this practice becomes routine — and that provider is, say, two standard deviations beyond their peers — the AUC metric may stimulate the need for self-reflection, ideally in a direction that would improve practice and patient outcomes.”
Although many guideline statements in recent years have appeared online in a sort of living, breathing format, Drachman indicated that there will be careful evaluation of how this paper “takes on a life of its own as it becomes incorporated into clinical practice. While there is not an immediate plan to modify the document in the short term, there may be opportunity to incorporate real-world, real-time feedback into future iterations.”
In summary, the recommendations are based on the clinical imperative for each particular patient. “We advocate for intervention for those with the greatest clinical need and don’t advocate for intervention in patients without sufficient clinical need, with anatomy assuming secondary importance,” he said. “By returning the focus of intervention to the need of the patient, the application of the AUC may elevate the quality of care delivered and help improve clinical outcomes for our patients across a spectrum of peripheral vascular disease.” – by Rob Volansky
Disclosure: Drachman receives research grant support from Atrium, iDEV and Lutonix/Bard. Two other authors report financial disclosures with Boston Scientific, Cordis, Covidien Vascular, Medtronic Vascular and The Medicines Company.