SCAI appropriate use criteria for peripheral arterial interventions: An update

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Abstract

In 2014, the Society for Cardiovascular Angiography and Interventions (SCAI) published the first Appropriate Use Criteria (AUC) for endovascular therapy (EVT) for atherosclerotic peripheral artery disease (PAD) involving the aorto-iliac, femoral-popliteal, infra-popliteal, and renal arterial circulations 1-4. These documents were developed to assist clinicians' decision-making, to improve patients' understanding regarding relative risks and benefits of a procedure, and to guide future research. Clinical scenarios were described in which catheter-based intervention was classified as “appropriate,” “may be appropriate,” or “rarely appropriate,” incorporating the best clinical and scientific evidence, cost-effectiveness data and the consensus of experts within the SCAI Peripheral Vascular Disease Committee. The purpose of this update is to provide a focused review of new clinical evidence regarding EVT, to identify novel technologies and practice changes that have been introduced since the original documents were published and to provide updated recommendations. The definition of appropriate use (AUC) is largely consistent across technologies and procedures. AUC considers the risks and benefits of a procedure while applying this balance across clinically relevant scenarios. An appropriate diagnostic or therapeutic procedure is one in which the expected clinical benefit exceeds the risks of the procedure by a sufficiently wide margin such that the procedure is generally considered acceptable or reasonable 5, 6. Experts were nominated and selected based upon their intellectual integrity and expertise with consideration of industry and intellectual bias. The writing group members are familiar with the application of the techniques and strategies under consideration to ensure that the clinical scenarios were constructed to capture the clinical applicability and limitations of the therapies. In general, the SCAI modified Delphi panel methodology employed an expert panel of clinicians who rated a series of clinical scenarios on a nine-point scale (Appropriate 7–9, May Be Appropriate 4–6, and Rarely Appropriate 1–3). The panel participated in a minimum of three rounds of ratings, with communication among the panelists after the first round. Each panelist had equal weight in determining the final rating. A synthesis of the updated scientific literature was prepared for each anatomical area for review by the rating panel. After review of the updated literature, panelists were asked to review each clinical scenario and to score it. Agreement among panelists was achieved when none of the ratings for any of the scenarios fell outside the 2-point margin of the mean score. For renal arterial revascularization, the benefits included: blood pressure improvement, renal function improvement or stabilization, and improved cardiac destabilization syndromes (heart failure and angina exacerbations) weighed against the risks of the procedure. For lower extremity arterial revascularization, the benefits included: survival or health outcomes such as symptom improvement, limb salvage, functional status and/or quality of life, weighed against the risks of the procedure. “Appropriate Care” implies that the benefits generally outweigh the risks of the procedure. The procedure is an effective option for individual care although not always required or necessary; the procedure is generally acceptable and reasonable for the indication. “May Be Appropriate Care” describes an option that is generally accepted with variable levels of supporting evidence or expert consensus regarding the risk to benefit ratio. There may be utility in selected cases based upon clinical experience in the absence of comparative evidence. The appropriateness of a specific procedure in any individual must be determined by that patient's physician in consultation with the patient considering the risk to benefit ratio. This category of procedures may be acceptable and may be reasonable for the clinical scenario. “Rarely Appropriate” care describes an option for the management of a patient with an adverse or uncertain risk to benefit ratio. The option is not commonly used as an effective therapy and the rationale for choosing this option needs to be documented. The procedure is recognized to be effective in selected situations but is not generally applied and is not generally reasonable for the indication. Procedures in this category require justification through the documentation of individual patient circumstances. Severe renal artery stenosis (RAS) is >70% diameter stenosis by visual estimation, or 50% to 70% visually estimated stenosis with a mean resting or hyperemic translesional gradient of ≥ 10 mm Hg or a systolic resting or hyperemic translesional gradient of ≥ 20 mm Hg, or a renal fractional flow reserve (Pd/Pa) of ≤ 0.8 (Table 1). Moderate RAS is 50% to 70% visually estimated stenosis without measurement of a translesional gradient, or with a resting or hyperemic translesional mean gradient 60% diameter stenosis) and hypertension did not differ between groups treated with GDMT alone compared to GDMT with renal stenting 14. The CORAL trial has limitations similar to other previous comparative renal artery stent trials 15, 16. These include enrolling patients with moderate hypertension receiving only two antihypertensive medications, not requiring maximally tolerated doses, and the majority of enrolled patients having moderate (68% diameter stenosis) renal artery stenosis and without hemodyanmic confirmation of the severity of obstruction. At baseline, CORAL participants were taking 2.1 ± 1.6 anti-hypertensive medications with a systolic blood pressure of 150 ± 23 mm Hg. At the conclusion of the trial, both the medical therapy cohort and the group that underwent renal revascularization had increased the number of medications required, 3.5 ± 1.4 versus 3.3 ± 1.5, respectively (P and both groups had in systolic blood ± mm Hg in the medical therapy group and ± mm Hg in the stent These that patients with refractory hypertension were enrolled in the CORAL consensus and evidence have determined that a renal artery diameter stenosis is when a resting or hyperemic translesional mean pressure gradient of mm Hg, a resting or hyperemic systolic translesional pressure gradient of mm Hg or renal fractional flow reserve (Table The pressure gradient is best with an pressure and not a the use of a results in a of the translesional systolic pressure gradient patients with renal with RAS or with RAS with a are to be to to renal artery stent Several 23 have shown that anti-hypertensive medications are required to blood pressure renal artery revascularization. trials may the most the of renal artery stenting only patients with as determined by measurement in a include an of anti-hypertensive and are based on blood pressure blood pressure is to the cost-effectiveness of renal artery stenting without clinical benefit in the The cost-effectiveness have of most randomized controlled a of patients with renal artery stenosis used a to a benefit of and for and medical and that a of primary renal stenting was the most in this The of arterial for and peripheral intervention has interest the application of this for renal artery most renal arteries have a may be to with a from a the compared with a from the The of and and with 150 renal artery stenting from the for most The of therapy for patients with atherosclerotic disease have not (Table The are to or the with insufficiency, to improve functional status and quality of and to cardiovascular and with and in selected revascularization. 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This summarizes new the AUC documents published for aorto-iliac, femoral-popliteal, and renal arterial 1-4. The is to improve clinical by to improve patients' understanding of the risks and benefits of and to provide with an updated review of the current literature regarding the most in the of

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