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Papers presented to the French Society for Vascular and Endovascular Surgery (SCVE)| Volume 72, P1-56, April 2021

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Disparities Between International Guidelines (AHA/ESC/ESVS/ESVM/SVS) Concerning Lower Extremity Arterial Disease: Consensus of the French Society of Vascular Medicine (SFMV) and the French Society for Vascular and Endovascular Surgery (SCVE)

Open AccessPublished:December 23, 2020DOI:https://doi.org/10.1016/j.avsg.2020.11.011
Disparities Between International Guidelines (AHA/ESC/ESVS/ESVM/SVS) Concerning Lower Extremity Arterial Disease: Consensus of the French Society of Vascular Medicine (SFMV) and the French Society for Vascular and Endovascular Surgery (SCVE)
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      Several international guidelines concerning lower extremity arterial disease (LEAD) have been published recently, in particular, by the American Heart Association the European Society of Cardiology/European Society for Vascular Surgery, the European Society for Vascular Medicine and the Society for Vascular Surgery. These guidelines differ in some respects and certain issues are not addressed. The objective of this consensus driven by the French Societies of vascular Medicine and surgery was to analyze the disparities between the different guidelines, as well as certain issues not covered, and develop proposals with regard to these points. The following fields of LEAD have been explored: 1) classifications, 2) clinical evaluation, 3) diagnostic criteria, 4) quantification of arterial stenosis using duplex ultrasound, 5) detection of asymptomatic multisite lesions, 6) screening for LEAD in the context of cardiac disease, 7) medical treatment, 8) supervised exercise therapy, 9) revascularization and revascularization of the internal artery stenosis, 10) management of chronic limb ischemia, 11) longitudinal follow-up, and 12) diet.

      Introduction

      Several international guidelines concerning lower extremity arterial disease (LEAD) have been published recently, in particular by the American Heart Association (AHA),
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      the European Society of Cardiology/European Society for Vascular Surgery (ESC/ESVS),
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      the European Society for Vascular Medicine (ESVM),
      • Frank U.
      • Nikol S.
      • Belch J.
      • et al.
      Guideline on peripheral arterial disease.
      Vasa. 2019; 48: 1-79
      and the Society for Vascular Surgery (SVS).
      • Conte M.S.
      • Pomposelli F.B.
      Society for Vascular Surgery Lower Extremity Guidelines Writing G
      Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication.
      J Vasc Surg. 2015; 61: 2S-41S
      These guidelines differ in some respects, and certain issues are not addressed. In 2019, the ESC also published updated guidelines relating to dyslipidemias, as well as diabetes, prediabetes, and cardiovascular (CV) diseases.
      • Mach F.
      • Baigent C.
      • Catapano A.L.
      • et al.
      2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk.
      Eur Heart J. 2019;
      ,
      • Cosentino F.
      • Grant P.J.
      • Aboyans V.
      • et al.
      2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD.
      Eur Heart J. 2020; 41: 255-323
      The objective of this project was to analyze the disparities between the different guidelines, as well as certain issues not covered, and develop proposals with regard to these points.

      Achievement of Consensus

      The steering committee, comprising 12 vascular physicians and surgeons with expertise in LEAD, identified the disparities between the various international recommendations, as well as the issues not addressed, and drafted a set of proposals. The steering committee reviewed these proposals and suggested revisions during a plenary meeting.
      The resulting text was submitted to a multiregional panel comprising 45 experts, vascular medicine physicians and vascular surgeons, for appraisal and grading of the proposals by vote in accordance with the Delphi method. It should be emphasized that no member of the steering committee was involved in grading these proposals. This step was entrusted to the panel of experts, who received the text developed by the steering committee as well as a link enabling online responses and a vote on each of the proposals. The 45 experts were requested to indicate for each proposal if they
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      strongly agreed,
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      tended to agree,
      • Frank U.
      • Nikol S.
      • Belch J.
      • et al.
      Guideline on peripheral arterial disease.
      Vasa. 2019; 48: 1-79
      had no opinion,
      • Conte M.S.
      • Pomposelli F.B.
      Society for Vascular Surgery Lower Extremity Guidelines Writing G
      Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication.
      J Vasc Surg. 2015; 61: 2S-41S
      tended to disagree, or
      • Mach F.
      • Baigent C.
      • Catapano A.L.
      • et al.
      2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk.
      Eur Heart J. 2019;
      totally disagreed. A space was provided for comments on each proposal, constituting a source of possible explanations for the respondent's attribution of a particular grade. Consensus was considered to have been achieved if more than 80% of the responses corresponded to either “agreement” (grades 1 and 2) or “disagreement” (grades 4 and 5). It is important to note that the percentage consensus was calculated on the basis of all the responses submitted by the experts, including those stating “no opinion”. If consensus was not achieved, a second vote was organized after clarification of the text and modification of the proposals if these were considered to be unclear. A total of 41 experts participated in this second round.
      The votes were recorded progressively and the text was finalized at a plenary consensus meeting of experts by attribution of one the following 4 grades to each proposal:
      • •
        Grade 1+: strong positive recommendation: “we recommend doing or prescribing”
      • •
        Grade 2+: positive suggestion, “we suggest doing or prescribing”
      • •
        Grade 1-: strong negative recommendation, “we recommend not doing or prescribing”
      • •
        Grade 2-: negative suggestion, “we suggest not doing or prescribing”
      On completion of this Delphi procedure, consensus had still not been achieved with regard to certain proposals. The steering committee for this project did not wish to take a stance on the proposals concerned and preferred to discuss these in the light of the reasons given by the experts for attributing a particular grade. The absence of consensus on certain issues clearly indicated that these are in abeyance and need to be further clarified.

      Glossary of Abbreviations and Definitions

      There is consensus on most of the definitions used in the various international recommendations (Table I).
      Table IGlossary
      LEADLower extremity artery disease.
      Occult LEADPatients with occult LEAD are asymptomatic owing to the presence of certain comorbidities (e.g. respiratory insufficiency, heart failure, neuropathy)
      ABIAnkle-brachial index: calculated ratio between the systolic BP measured at the ankle (in the anterior tibial or dorsalis pedis artery and the posterior tibial artery, retaining the higher value) and the brachial systolic BP (measured in both arms, retaining the higher value). The reference values are as follows:

      ≤0.90: LEAD

      0.91–1.40: Normal

      >1.40: Noncompressible arteries

      Values between 0.91 and 1.00, although within the normal range, are considered as indicative of borderline LEAD.
      TBIToe-brachial index: calculated ratio between the systolic BP measured at the hallux and the brachial systolic BP (measured in both arms, retaining the higher value)

      Normal value ≥ 0.70.
      Acute ischemiaAcute, severe hypoperfusion (symptom onset < 2 weeks previously), characterized by pain, absence of pulse, pallor, and cold skin. Neurological disorders, paresthesia, and paralysis are signs of serious disease.
      Chronic limb ischemia, also known as permanent chronic ischemia (CLI)Severe LEAD, manifested by permanent pain at rest or tissue loss during at least 15 days, confirmed by hemodynamic criteria.
      Chronic limb-threatening ischemia (CLTI) (ESC-ESVS)Limb ischemia with threatened viability related to several factors (neurologic, infectious…). This term was proposed by the ESC and ESVS groups in the guidelines published in 2017.
      ClaudicationPain, cramp, or muscular fatigue of arterial origin, induced by exercise in the active muscle group and relieved by rest (within a few minutes)
      Maximum walking distanceMaximum walking distance in meters before the onset of severe pain precludes further walking.
      Resting TcPO2Transcutaneous oxygen pressure measured at rest
      Minor amputationDistal amputation preserving the heel LEAD
      Major amputationAmputation involving loss of the heel LEAD
      Endovascular treatmentAny endoluminal treatment, irrespective of the method used, as opposed to open surgery.

      Classifications and Stages

      International recommendations use either the Leriche-Fontaine classification or the Rutherford classification. The working group wished to include further specifications in the classification of LEAD and, in clinical practice, prefers the classification proposed by the French College of Vascular Medicine Teachers (CEMV) and the French College of Vascular Surgery Teachers (CECV). This classification defines 3 stages of LEAD, characterized respectively by absence of symptoms, exercise-induced ischemia, and chronic limb ischemia (CLI) at rest (also called chronic limb-threatening ischemia by the ESC/ESVS) (Table II).
      • Mahe G.
      • Jaquinandi V.
      [Diagnosis of lower limb peripheral artery disease].
      Presse Med. 2018; 47: 47-55
      Table IIThe different clinical classifications used for LEAD
      • Mahe G.
      • Jaquinandi V.
      [Diagnosis of lower limb peripheral artery disease].
      Presse Med. 2018; 47: 47-55
      Fontaine stageClinical characteristicsRutherford classificationClinical characteristicsCEMV
      CEMV: French College of Vascular Medicine Teachers.
      classification
      IAsymptomatic0AsymptomaticAsymptomatic
      IIaWalking distance without pain >200 m1Mild intermittent claudicationExercise-induced ischemia
      2Moderate intermittent claudication
      IIbWalking distance without pain <200 m3Severe intermittent claudication
      IIIPain at rest4Pain at restChronic limb ischemia at rest or chronic limb-threatening ischemia
      IVUlcer, necrosis, gangrene5Distal tissue loss
      6Tissue loss extending beyond the proximal metatarsal level
      ∗ CEMV: French College of Vascular Medicine Teachers.

      Clinical Evaluation

      The AHA, ESC-ESVS, ESVM, and SVS guidelines are concordant with regard to the clinical evaluation of LEAD. The AHA specifies that most patients present atypical symptoms or even no symptoms at all.
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      The ESC-ESVS state that the sensitivity and reproducibility of the physical examination are low.
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      A systematic physical examination is nevertheless obligatory. Asymmetry of brachial pressure is of prognostic value.
      • Clark C.E.
      • Taylor R.S.
      • Shore A.C.
      • et al.
      Association of a difference in systolic blood pressure between arms with vascular disease and mortality: a systematic review and meta-analysis.
      Lancet. 2012; 379: 905-914
      The proposals comprise the following:
      • -
        Assessment of CV risk factors, comorbidities, lifestyle habits, dietary patterns, and physical activity including walking,
      • -
        Reconstitution of symptom history, including pain characteristics, type of ischemia (exercise-induced or permanent), and circumstances exacerbating or attenuating symptoms,
      • -
        Consideration of alternative diagnoses, notably pseudoclaudication of neurological, rheumatological, or other origin,
      • -
        Measurement of systolic blood pressure (BP) in both arms (abnormal if asymmetry ≥ 15–20 mm Hg),
        • Gerhard-Herman M.D.
        • Gornik H.L.
        • Barrett C.
        • et al.
        2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
        Circulation. 2017; 135: e726-e779
        ,
        • Aboyans V.
        • Ricco J.B.
        • Bartelink M.E.L.
        • et al.
        Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
        Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      • -
        Palpation of the pulses in all four limbs (characterized as absent, diminished, normal, or bounding) and auscultation of the carotid, subclavian, iliac, femoral, and popliteal arteries (comparative examination),
      • -
        Examination of the feet and legs (noting absence of hair growth, dry skin, skin color and temperature, persistent distal tissue loss, neuropathy, deformation of the feet, loss of muscle mass),
      • -
        Search for relevant family medical history: coronary, cerebrovascular, or lower-limb artery disease, aortic aneurysm.

      Diagnostic Criteria for Lower Extremity Artery Disease

      Resting Ankle-Brachial Index

      The resting systolic ankle-brachial index (ABI), corresponding to the ratio of ankle and arm systolic BP, was first proposed by Winsor in 1950.
      • Winsor T.
      Influence of arterial disease on the systolic blood pressure gradients of the extremity.
      Am J Med Sci. 1950; 220: 117-126
      A study reported sensitivities ranging from 68 to 84% and specificities ranging from 84 to 99% for the diagnosis of LEAD in patients suspected of having this disease.
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      In 2012, the AHA issued recommendations for determining this index.
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      These recommendations advise measuring systolic BP using a continuous-wave Doppler probe, after a 5- to 10-minute rest, in the following order: right brachial artery, right posterior tibial artery, right dorsalis pedis artery, left posterior tibial artery, left dorsalis pedis artery, left brachial artery, and then once again the right brachial artery. The choice of this order is arbitrary and is above all of interest in the research context, its value in clinical practice being more controversial. The second measurement of BP in the right brachial artery is designed to offset a possible initial “white coat” effect. Based on these measurements, an index of resting systolic BP in the right and left lower limbs can be calculated on the basis of the highest BP measured in each leg divided by the highest pressure determined in the 2 arms.
      Some publications have reported the possibility of using a Doppler probe in color flow imaging or pulsed-wave mode to measure BP.
      • Baste IB C.
      • Constans J.
      • Conri C.
      Validation de la mesure de l’index de pression systolique (IPS) selon deux méthodes : Doppler pulsé et Stéthoflux.
      J Mal Vasc. 2008; 33: 91
      ,
      • Gestin S.
      • Delluc A.
      • Saliou A.H.
      • et al.
      [Ankle brachial pressure index (ABPI): color-Doppler versus ultrasound Doppler correlation study in 98 patients after analysis of interobserver reproducibility].
      J Mal Vasc. 2012; 37: 186-194
      In another study, no difference was observed between arm BP values measured by an automatic BP monitor and those determined using a continuous-wave Doppler probe.
      • Gardner A.W.
      • Montgomery P.S.
      Comparison of three blood pressure methods used for determining ankle/brachial index in patients with intermittent claudication.
      Angiology. 1998; 49: 723-728
      To optimize efficacy in routine clinical practice, measurement of brachial BP using devices other than a continuous-wave Doppler probe (e.g. an automatic BP monitor or stethoscope) may therefore be proposed. The use of an automatic device for measuring BP in the arms may also be justified by the possibility of measuring the postexercise ABI, which may be accomplished more rapidly and by a single operator using an automatic system.
      • Stivalet O.
      • Paisant A.
      • Belabbas D.
      • et al.
      Exercise testing criteria to diagnose lower extremity peripheral artery disease assessed by computed-tomography angiography.
      PLoS One. 2019; 14: e0219082
      The use of automatic oscillometric devices to measure BP for ABI calculation has also been proposed, but is controversial.
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      ,
      • Aboyans V.
      • Lacroix P.
      • Doucet S.
      • et al.
      Diagnosis of peripheral arterial disease in general practice: can the ankle-brachial index be measured either by pulse palpation or an automatic blood pressure device?.
      Int J Clin Pract. 2008; 62: 1001-1007
      , 
      • Verberk W.J.
      • Kollias A.
      • Stergiou G.S.
      Automated oscillometric determination of the ankle-brachial index: a systematic review and meta-analysis.
      Hypertens Res. 2012; 35: 883-891
      , 
      • Hamel J.F.
      • Tanguy M.
      • Foucaud D.
      • et al.
      [Comparison of the automated oscillometric method with Doppler ultrasound method to access the Ankle-Brachial Pressure Index (ABPI)].
      J Mal Vasc. 2010; 35: 169-174
      The sensitivities and specificities achieved using oscillometric methods of measurement range from 67 to 97% and from 62 to 96%, respectively.
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      ,
      • Aboyans V.
      • Lacroix P.
      • Doucet S.
      • et al.
      Diagnosis of peripheral arterial disease in general practice: can the ankle-brachial index be measured either by pulse palpation or an automatic blood pressure device?.
      Int J Clin Pract. 2008; 62: 1001-1007
      Furthermore, these methods overestimate BP values when those determined using a continuous-wave Doppler probe are low.
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      The place of oscillometric methods of BP measurement therefore remains to be determined.
      All the guidelines insist on the importance of measuring the ABI for the diagnosis of LEAD. However, slight discordances were found concerning normal values. The SVS, AHA, and ESC-ESVS consider values ranging from 0.91 to 1.40 as normal,
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      ,
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      whereas the ESVM proposes a normal range of 0.90 to 1.30.
      • Frank U.
      • Nikol S.
      • Belch J.
      • et al.
      Guideline on peripheral arterial disease.
      Vasa. 2019; 48: 1-79
      The resting ABI nevertheless has certain limitations,
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      ,
      • Paul E.
      • Jaquinandi V.
      • Larralde A.
      • et al.
      [Contribution of the maximal exercise test to diagnosis the vascular origin of leg pain in athletes].
      J Med Vasc. 2018; 43: 379-383
      namely
      • -
        overestimation in the context of arterial rigidity, as in diabetic patients or those with renal insufficiency, as well as in elderly patients;
      • -
        low sensitivity in patients presenting minor lesions or lesions manifested only during exercise.
      For all these reasons, it seems more judicious to consider the resting ABI as one diagnostic method among others and not as the primary method of diagnosis. In diabetics, notably, measurement of the ABI may aid risk classification (grade IIb in accordance with the 2019 ESC guidelines).
      • Cosentino F.
      • Grant P.J.
      • Aboyans V.
      • et al.
      2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD.
      Eur Heart J. 2019;
      Normal values of the resting ABI range from 0.91 to 1.40 inclusive. For values exceeding 1.40, the term “noncompressible arteries” should be used in preference to that of medial calcinosis which denotes a particular pathological process. The AHA considers values between 0.91 and 0.99 inclusive as limit or borderline values.
      • Le Bivic L.
      • Magne J.
      • Guy-Moyat B.
      • et al.
      The intrinsic prognostic value of the ankle-brachial index is independent from its mode of calculation.
      Vasc Med. 2019; 24: 23-31
      ,
      • Espinola-Klein C.
      • Rupprecht H.J.
      • Bickel C.
      • et al.
      Different calculations of ankle-brachial index and their impact on cardiovascular risk prediction.
      Circulation. 2008; 118: 961-967
      Values between 0.80 and 0.90 inclusive should prompt consideration of a second measurement before conclusively diagnosing LEAD.
      • Le Bivic L.
      • Magne J.
      • Guy-Moyat B.
      • et al.
      The intrinsic prognostic value of the ankle-brachial index is independent from its mode of calculation.
      Vasc Med. 2019; 24: 23-31
      ,
      • Espinola-Klein C.
      • Rupprecht H.J.
      • Bickel C.
      • et al.
      Different calculations of ankle-brachial index and their impact on cardiovascular risk prediction.
      Circulation. 2008; 118: 961-967
      For asymptomatic patients, the AHA, ESC-ESVS, and SVS envisage screening for LEAD in patients presenting risk factors such as age over 65 years, with no other CV risk factor, or age over 50 years associated with other risk factors such as smoking, diabetes, or dyslipidaemia. The ESVM does not take any stance on screening.
      • Frank U.
      • Nikol S.
      • Belch J.
      • et al.
      Guideline on peripheral arterial disease.
      Vasa. 2019; 48: 1-79
      However, the VIVA study showed that screening of a population of men aged from 65 to 74 years led to a reduction in LEAD-related mortality, abdominal aortic aneurism (AAA), and hypertension.
      • Lindholt J.S.
      • Sogaard R.
      Population screening and intervention for vascular disease in Danish men (VIVA): a randomised controlled trial.
      Lancet. 2017; 390: 2256-2265
      Screening for LEAD therefore seems justifiable.

      Suggestions and Recommendations

      • 1.
        We suggest that the resting ABI should be used as one means of diagnosis among others and not as the primary criterion for diagnosis (grade 2+).
      • 2.
        We recommend defining the normal values of the resting ABI as 0.91 to 1.40 inclusive (grade 1+).
      • 3.
        We recommend diagnosing LEAD when the ABI is ≤ 0.90 (grade 1+).
      • 4.
        We recommend diagnosing incompressible arteries when the ABI is > 1.40 (grade 1+).
      • 5.
        If a continuous-wave Doppler probe is not available for determination of the ABI, we suggest using a pulsed-wave Doppler probe to measure ankle BP (grade 2+).
      • 6.
        To determine the ABI, we suggest measurement of brachial BP using either an automatic BP monitor or a stethoscope if a continuous-wave Doppler probe is not available (grade 2+).
      • 7.
        Given the impact of LEAD on therapeutic strategy, we suggest screening for this disease by measuring the ABI in patients aged over 50 years with another CV risk factor (grade 2+).
      • 8.
        In asymptomatic diabetic patients, we suggest screening for LEAD based on a distal hemodynamic criterion (the ABI, toe-brachial index (TBI), or Doppler waveform) (grade 2+).

      Issues in Abeyance (IiA, Full Consensus not Achieved During the Delphi Procedure)

      • IiA-1.
        If a continuous-wave Doppler probe is not available, we suggest using Doppler color flow imaging of the lower limbs to measure ankle BP. Only 66% of the experts agreed with this proposal. The other experts justified their position on the grounds that the proposal was based on the results of a single study
        • Gestin S.
        • Delluc A.
        • Saliou A.H.
        • et al.
        [Ankle brachial pressure index (ABPI): color-Doppler versus ultrasound Doppler correlation study in 98 patients after analysis of interobserver reproducibility].
        J Mal Vasc. 2012; 37: 186-194
        and that the efficacy of this method depends too much on equipment calibration and is substantially reduced in the presence of calcifications.
      • IiA-2.
        For measurement of the ABI in clinical practice, we suggest not to necessarily respect the sequence of BP measurements in the 4 limbs recommended by the AHA. This proposal obtained a consensus agreement of 76%. In the second round of voting, 12% of the experts still expressed no opinion.
      • IiA-3.
        In view of the impact of LEAD on therapeutic strategy, we suggest screening for this disease based on the ABI in patients aged over 65 years even in the absence of any other CV risk factor. This proposal obtained a consensus agreement of 78%, 3 experts expressing no opinion. This absence of full consensus may be explained by the controversy with regard to screening asymptomatic patients as there is no consensus regarding their treatment. Detection of a decreased ABI in an asymptomatic patient may nevertheless result in a change in his/her class of CV risk and consequently lead to modifications in therapeutic strategy. Furthermore, it is conceivable that the suggested age limit of 65 years may have hindered acceptance of this proposal. Effectively, it could lead to numerous consultations in a context in which the therapeutic strategy is controversial. The AHA (2005) recommended screening for LEAD in patients aged over 70 years even in the absence of any other CV risk factor.
        • Hirsch A.T.
        • Haskal Z.J.
        • Hertzer N.R.
        • et al.
        ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American association for vascular surgery/society for vascular surgery, society for cardiovascular angiography and interventions, society for vascular medicine and biology, society of interventional radiology, and the ACC/AHA task force on practice guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease): endorsed by the American association of cardiovascular and pulmonary rehabilitation; national heart, lung, and blood institute; society for vascular nursing; TransAtlantic inter-society consensus; and vascular disease foundation.
        Circulation. 2006; 113: e463-e654
        The guidelines published by the ESC-ESVS
        • Aboyans V.
        • Ricco J.B.
        • Bartelink M.E.L.
        • et al.
        Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
        Eur J Vasc Endovasc Surg. 2018; 55: 305-368
        and the AHA
        • Gerhard-Herman M.D.
        • Gornik H.L.
        • Barrett C.
        • et al.
        2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
        Circulation. 2017; 135: e726-e779
        propose such screening from the age of 65 years onward, whereas this is not recommended by the ESVM.
        • Frank U.
        • Nikol S.
        • Belch J.
        • et al.
        Guideline on peripheral arterial disease.
        Vasa. 2019; 48: 1-79

      Post-exercise Ankle-Brachial Index

      The AHA, ESC-ESVS, ESVM, and SVS guidelines all propose measurement of the postexercise ABI in patients with suspected LEAD presenting an ABI at rest >0.90
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      , 
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      , 
      • Frank U.
      • Nikol S.
      • Belch J.
      • et al.
      Guideline on peripheral arterial disease.
      Vasa. 2019; 48: 1-79
      ,
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      However, there is no consensus on how to measure the postexercise ABI. The following method may be proposed for this purpose. The ABI is determined 1 min after the cessation of exercise. The physician measures the ankle BP in the both legs, starting with the symptomatic leg, in the ankle artery used as the reference artery for measurement of the resting ABI.
      • Mahe G.
      • Jaquinandi V.
      [Diagnosis of lower limb peripheral artery disease].
      Presse Med. 2018; 47: 47-55
      ,
      • Stivalet O.
      • Paisant A.
      • Belabbas D.
      • et al.
      Exercise testing criteria to diagnose lower extremity peripheral artery disease assessed by computed-tomography angiography.
      PLoS One. 2019; 14: e0219082
      ,
      • Stivalet O.
      • Laneelle D.
      • Omarjee L.
      • et al.
      Post-exercise criteria to diagnose lower extremity peripheral artery disease: which one should I use in my practice?.
      Vasc Med. 2019; 24: 76-77
      The position of this artery should be marked in pencil on the skin at the time of resting BP measurement to minimize difficulties in locating the artery after exercise. A second person should simultaneously measure the brachial systolic pressure to enable calculation of the postexercise ABI.
      • Mahe G.
      • Jaquinandi V.
      [Diagnosis of lower limb peripheral artery disease].
      Presse Med. 2018; 47: 47-55
      Ideally, the brachial BP should be measured using a Doppler probe, but for practical reasons, it may also be measured using an automatic BP monitor if the operator is alone.
      • Stivalet O.
      • Paisant A.
      • Belabbas D.
      • et al.
      Exercise testing criteria to diagnose lower extremity peripheral artery disease assessed by computed-tomography angiography.
      PLoS One. 2019; 14: e0219082
      The AHA, ESC-ESVS, and SVS propose the use of 2 threshold criteria to confirm the diagnosis of LEAD: either a fall in the ABI after exercise >20% of the resting ABI or a fall in absolute ankle BP > 30 mm Hg, whereas the ESVM proposes solely a fall in the ABI after exercise >20%.
      • Aboyans V.
      • Criqui M.H.
      • Abraham P.
      • et al.
      Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association.
      Circulation. 2012; 126: 2890-2909
      ,
      • Ouriel K.
      • McDonnell A.E.
      • Metz C.E.
      • et al.
      Critical evaluation of stress testing in the diagnosis of peripheral vascular disease.
      Surgery. 1982; 91: 686-693
      ,
      • Laing S.
      • Greenhalgh R.M.
      The detection and progression of asymptomatic peripheral arterial disease.
      Br J Surg. 1983; 70: 628-630
      However, these criteria were validated without taking into account resting ABI values and using treadmill protocols now rarely used [1.5 mph (miles per hour, corresponding to 2.4 km/h) with a 7% slope,
      • Ouriel K.
      • McDonnell A.E.
      • Metz C.E.
      • et al.
      Critical evaluation of stress testing in the diagnosis of peripheral vascular disease.
      Surgery. 1982; 91: 686-693
      or 4 km/h with a 10% slope
      • Laing S.
      • Greenhalgh R.M.
      The detection and progression of asymptomatic peripheral arterial disease.
      Br J Surg. 1983; 70: 628-630
      ]. Furthermore, it has been shown that these 2 criteria do not identify the same patients suffering from LEAD in 1 out of 5 cases.
      • Mahe G.
      • Pollak A.W.
      • Liedl D.A.
      • et al.
      Discordant diagnosis of lower extremity peripheral artery disease using American heart association postexercise guidelines.
      Medicine (Baltimore). 2015; 94: e1277
      A study in symptomatic patients subjected to exercise on a treadmill set at 3.2 km/h with a 10% slope showed that a decrease in the ABI after exercise ≥ 18.5% may be retained as a diagnostic criterion for ≥50% arterial stenosis in patients with a resting ABI >0.91 experiencing exercise-related pain
      • Stivalet O.
      • Paisant A.
      • Belabbas D.
      • et al.
      Exercise testing criteria to diagnose lower extremity peripheral artery disease assessed by computed-tomography angiography.
      PLoS One. 2019; 14: e0219082
      . On the basis of a retrospective study, it was proposed to adopt a postexercise ABI <0.90 as a criterion.
      • Aday A.W.
      • Kinlay S.
      • Gerhard-Herman M.D.
      Comparison of different exercise ankle pressure indices in the diagnosis of peripheral artery disease.
      Vasc Med. 2018; (1358863X18781723)
      However, the procedure used to measure the postexercise ABI in this study was not reported; several different imaging procedures were used, and the treadmill used was set at 2.4 km/h with a slope of 10% for a maximum duration of 5 min.
      • Aday A.W.
      • Kinlay S.
      • Gerhard-Herman M.D.
      Comparison of different exercise ankle pressure indices in the diagnosis of peripheral artery disease.
      Vasc Med. 2018; (1358863X18781723)
      The proposed postexercise criteria therefore warrant confirmation. Exercise tests performed for diagnostic purposes can be accomplished using treadmill speeds and slopes adapted to the patient, but the threshold values of the ABI in these cases remain to be defined.

      Suggestions and Recommendations

      • 9.
        For patients presenting exercise-induced symptoms in the lower limbs, with a normal resting ABI at rest or a noncontributory duplex ultrasound (DUS) at rest, we recommend measurement of the postexercise ABI as a basis for diagnosing LEAD (grade 1+).
      • 10.
        We recommend measuring the postexercise ABI not later than 1 min after the cessation of exercise (grade 1+).
      • 11.
        We suggest starting with the symptomatic leg when measuring the postexercise ABI (grade 2+).
      • 12.
        We suggest as the diagnostic criterion a decrease in the ABI after exercise ≥18.5% using a treadmill set at 3.2 km/h with a 10% slope (grade 2+).

      Toe-Brachial Index

      The AHA, ESC-ESVS, ESVM, and SVS guidelines
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      ,
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      ,
      • Conte M.S.
      • Pomposelli F.B.
      Society for Vascular Surgery Lower Extremity Guidelines Writing G
      Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication.
      J Vasc Surg. 2015; 61: 2S-41S
      also propose the TBI as a criterion for diagnosing LEAD. Use of this index circumvents the problem of increased rigidity of large- and medium-caliber arteries.
      • Carter S.A.
      • Lezack J.D.
      Digital systolic pressures in the lower limb in arterial disease.
      Circulation. 1971; 43: 905-914
      Before measuring toe pressure, it is important to check local skin temperature at the site of measurement (using an infra-red thermometer or laser probe) to ensure that this is not below 30°C,
      • Sawka A.M.
      • Carter S.A.
      Effect of temperature on digital systolic pressures in lower limb in arterial disease.
      Circulation. 1992; 85: 1097-1101
      as a low skin temperature may lead to falsely low pressure measurements. These measurements may be accomplished using a laser Doppler probe or by plethysmography.
      • Perez-Martin A.
      • Meyer G.
      • Demattei C.
      • et al.
      Validation of a fully automatic photoplethysmographic device for toe blood pressure measurement.
      Eur J Vasc Endovasc Surg. 2010; 40: 515-520
      Pressure is generally measured on the hallux, but the second or third toe may also be used.
      • Watanabe Y.
      • Masaki H.
      • Kojima K.
      • et al.
      Toe-brachial index in the second toe: substitutability to toe-brachial index in the great toe and ankle-brachial index.
      Ann Vasc Dis. 2016; 9: 300-306
      The sensitivity of the TBI ranges from 45 to 100% and its specificity from 17 to 100%.
      • Tehan P.E.
      • Santos D.
      • Chuter V.H.
      A systematic review of the sensitivity and specificity of the toe-brachial index for detecting peripheral artery disease.
      Vasc Med. 2016; 21: 382-389
      The pathological threshold is a matter of debate, but the guidelines propose using a threshold of <0.70.
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      ,
      • Hoyer C.
      • Sandermann J.
      • Petersen L.J.
      The toe-brachial index in the diagnosis of peripheral arterial disease.
      J Vasc Surg. 2013; 58: 231-238
      AHA and ESC guidelines propose measurement of the TBI when the resting ABI exceeds 1.40.
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      ,
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      The ESVM proposes measurement of the TBI in any diabetic patient presenting a tissue lesion as well as in patients with a resting ABI >1.30.
      • Frank U.
      • Nikol S.
      • Belch J.
      • et al.
      Guideline on peripheral arterial disease.
      Vasa. 2019; 48: 1-79
      The prevalence of pathological values of the TBI in patients with the resting ABI >0.90 varies in studies from 9 to 27% in populations comprising more than 100 patients.
      • Hoyer C.
      • Sandermann J.
      • Petersen L.J.
      The toe-brachial index in the diagnosis of peripheral arterial disease.
      J Vasc Surg. 2013; 58: 231-238
      The TBI could nevertheless be measured directly as the primary diagnostic criterion in diabetic patients, patients with renal insufficiency, and very elderly patients, given the increased arterial wall rigidity in these populations.

      Suggestions and Recommendations

      • 13.
        We suggest that the diagnosis of LEAD may be based on toe pressure as a diagnostic criterion on a par with the resting ABI (grade 2+).
      • 14.
        We recommend a threshold value of <0.70 to confirm the diagnosis of LEAD (grade 1+).
      • 15.
        For asymptomatic diabetic patients at intermediate CV risk, we suggest measuring the TBI (grade 2+).
      • 16.
        We recommend measuring toe pressure in diabetic patients (grade 1+).
      • 17.
        We recommend measuring toe pressure in patients with renal insufficiency (grade 1+).
      • 18.
        We suggest measuring the TBI in patients with diabetes if the resting ABI is normal (grade 2+).
      • 19.
        We suggest measuring the TBI in patients with renal insufficiency if the resting ABI is > 0.90 (grade 2+).
      • 20.
        We suggest measuring the TBI at the second or third toe if the hallux is missing (grade 2+).
      • 21.
        When measuring the TBI, we suggest checking the skin temperature at the site of measurement (grade 2+).

      Doppler Waveform Analysis

      Doppler waveform analysis may enable both diagnosis of LEAD and location of the arterial lesions.
      • Norgren L.
      • Hiatt W.R.
      • Dormandy J.A.
      • et al.
      Inter-Society consensus for the management of peripheral arterial disease (TASC II).
      J Vasc Surg. 2007; 45: S5-S67
      , 
      • Criqui M.H.
      • Vargas V.
      • Denenberg J.O.
      • et al.
      Ethnicity and peripheral arterial disease: the san Diego population study.
      Circulation. 2005; 112: 2703-2707
      , 
      • Kim E.S.
      • Scissons A.M.
      • Dawson R.
      • et al.
      Interpretation of peripheral arterial and venous Doppler waveforms: A Consensus Statement from the Society for Vascular Medicine and Society for Vascular.
      Ultrasound Vasc Med. 2020;
      A study in diabetic patients showed that the estimated prevalence of LEAD was higher if the patients were evaluated by Doppler waveform analysis (93%) rather than by measurement of the TBI (72%) or the resting ABI (57%).
      • Azzopardi Y.M.
      • Gatt A.
      • Chockalingam N.
      • et al.
      Agreement of clinical tests for the diagnosis of peripheral arterial disease.
      Prim Care Diabetes. 2019; 13: 82-86
      In the San Diego study, LEAD was diagnosed in 104 patients out of 2343 (based on a resting ABI ≤ 0.90 or an abnormal Doppler waveform, defined by the absence of a negative component).
      • Criqui M.H.
      • Vargas V.
      • Denenberg J.O.
      • et al.
      Ethnicity and peripheral arterial disease: the san Diego population study.
      Circulation. 2005; 112: 2703-2707
      Among these 104 patients, a total of 69 legs showed both a pathological ABI and abnormal Doppler waveforms, 60 legs a pathological ABI alone, and 33 legs an abnormal Doppler waveform alone.
      • Criqui M.H.
      • Vargas V.
      • Denenberg J.O.
      • et al.
      Ethnicity and peripheral arterial disease: the san Diego population study.
      Circulation. 2005; 112: 2703-2707
      Another study conducted in 81 patients, over 60% of whom were at the stage of permanent ischemia, showed that measurement of the ABI and Doppler waveform analysis were complementary.
      • Gale S.S.
      • Scissons R.P.
      • Salles-Cunha S.X.
      • et al.
      Lower extremity arterial evaluation: are segmental arterial blood pressures worthwhile?.
      J Vasc Surg. 1998; 27 ([discussion 8-9]): 831-838
      One of the main difficulties in Doppler waveform analysis is that the description of these waveforms varies widely between different countries, including the United States, France, and China.
      • Scissons R.P.
      Characterizing triphasic, biphasic, and monophasic Doppler WaveformsShould a simple task Be so difficult?.
      J Diagnost Med Sonogr. 2008; 24: 269-276
      , 
      • Omarjee L.
      • Stivalet O.
      • Hoffmann C.
      • et al.
      Heterogeneity of Doppler waveform description is decreased with the use of a dedicated classification.
      Vasa. 2018; 47: 471-474
      , 
      • Heiss H.W.
      Investigation of vascular disorders.
      in: Cardiology C. AN Nicolaides and JST Yao. Churchill Livingstone. 1981
      , 
      • Wen C.
      • Gao M.
      • Fu Y.
      • et al.
      A high variability of arterial Doppler waveform descriptions exists in China.
      Vasc Med. 2020; (1358863X20903808)
      In a study in which 19 vascular medicine students were asked to describe Doppler waveforms, the mean number of different terms used was 9 ± 4. In contrast, when the descriptions were based on a classification system, the mean number of terms used fell to 2±1.
      • Omarjee L.
      • Stivalet O.
      • Hoffmann C.
      • et al.
      Heterogeneity of Doppler waveform description is decreased with the use of a dedicated classification.
      Vasa. 2018; 47: 471-474
      In 2017, the CEMV proposed to use the simplified Saint-Bonnet classification as a consensus basis for describing these waveforms (Fig. 1).
      • Mahe G.
      • Boulon C.
      • Desormais I.
      • et al.
      [College of the French vascular medicine Teachers (CEMV) statement: arterial Doppler waveforms analysis (simplified saint-bonnet classification)].
      J Med Vasc. 2018; 43: 255-261
      ,
      • Mahe G.
      • Boulon C.
      • Desormais I.
      • et al.
      Statement for Doppler waveforms analysis.
      Vasa. 2017; 46: 337-345
      Figure thumbnail gr1
      Fig. 1Saint-Bonnet classification of Doppler waveforms according to Mahé et al.
      • Mahe G.
      • Boulon C.
      • Desormais I.
      • et al.
      [College of the French vascular medicine Teachers (CEMV) statement: arterial Doppler waveforms analysis (simplified saint-bonnet classification)].
      J Med Vasc. 2018; 43: 255-261
      A French multicentre study revealed that more waveforms could be categorized using the Saint-Bonnet classification than with use of the classifications proposed by Cathignol and Descotes and by Spronk (article submitted for publication). By analogy with the definition of an abnormal waveform used in the San Diego study (absence of a negative component and broadened),
      • Criqui M.H.
      • Vargas V.
      • Denenberg J.O.
      • et al.
      Ethnicity and peripheral arterial disease: the san Diego population study.
      Circulation. 2005; 112: 2703-2707
      the Saint-Bonnet waveforms B, CD, E, or 0 with or without the presence of a continuous flow may be considered as pathological. In asymptomatic patients, the arterial Doppler waveforms should be recorded in addition to measuring the ABI or TBI. Exclusion of the diagnosis of resting LEAD is then based on a normal value of the ABI or TBI as well as on either triphasic or biphasic Doppler waveform morphology (N or A in accordance with the Saint-Bonnet classification).

      Suggestions and Recommendations

      • 22.
        For the diagnosis of LEAD, we recommend analyzing Doppler waveform morphology in addition to measuring the ABI (grade 1+).
      • 23.
        For the diagnosis of LEAD, we recommend analyzing Doppler waveform morphology as a diagnostic criterion on a par with the ABI and TBI (grade 1+).
      • 24.
        We recommend using a classification system for categorizing arterial Doppler waveforms (grade 1+).
      • 25.
        We suggest using the Saint-Bonnet classification for describing these waveforms (grade 2+).
      • 26.
        We suggest considering as pathological the waveforms C, D, and E in the Saint-Bonnet classification with or without continuous flow (grade 2+).
      • 27.
        We suggest considering as pathological the waveform O (i.e. absence of a waveform) in the Saint-Bonnet classification (grade 2+).
      • 28.
        If the ABI or TBI is normal, we recommend additionally recording distal arterial Doppler waveforms, which should be Saint-Bonnet N or A, before excluding the diagnosis of resting LEAD (grade 1+).

      Issues in Abeyance (Full Consensus not Achieved during the Delphi Procedure)

      • IiA-4.
        We suggest considering as pathological the waveform B in the Saint-Bonnet classification with or without continuous flow. This proposal achieved a 78% consensus agreement. Six experts had no opinion on this issue. As the Saint-Bonnet classification was published recently (in 2016), it is more than likely that all the panel participants were not familiar with it. This might explain the absence of full consensus.

      Measurement of Resting Transcutaneous Oxygen Pressure

      Measurement of resting transcutaneous oxygen pressure (TcPO2) is a means of evaluating tissue viability and is proposed as a diagnostic criterion of chronic limb ischemia (CLI).
      • Becker F.
      • Robert-Ebadi H.
      • Ricco J.B.
      • et al.
      Chapter I: definitions, epidemiology, clinical presentation and prognosis.
      Eur J Vasc Endovasc Surg. 2011; 42: S4-S12
      However, this parameter must be measured under strictly controlled temperature conditions to avoid erroneous conclusion of ischemia. TcPO2 is affected by numerous factors, including inflammation, edema, hypoxia, and fever, which can result in misleading values. It is better to abstain from measuring this parameter if the conditions are unfavorable, for example, in the presence of a nearby infected wound.
      A value of TcPO2 at rest <10 mm Hg is an unfavorable prognostic factor.
      • Maufus M.
      • Sevestre-Pietri M.A.
      • Sessa C.
      • et al.
      Critical limb ischemia and the response to bone marrow-derived cell therapy according to tcPO2 measurement.
      Vasa. 2017; 46: 23-28
      When performed at successive levels on an ischemic limb, measurement of this parameter aids decision on the level of amputation.
      • Sarin S.
      • Shami S.
      • Shields D.A.
      • et al.
      Selection of amputation level: a review.
      Eur J Vasc Surg. 1991; 5: 611-620
      A value of TcPO2 at rest >30 mm Hg is a favorable indicator of wound healing.
      • Wang Z.
      • Hasan R.
      • Firwana B.
      • et al.
      A systematic review and meta-analysis of tests to predict wound healing in diabetic foot.
      J Vasc Surg. 2016; 63: 29S-36S
      ,
      • Yamada T.
      • Ohta T.
      • Ishibashi H.
      • et al.
      Clinical reliability and utility of skin perfusion pressure measurement in ischemic limbs--comparison with other noninvasive diagnostic methods.
      J Vasc Surg. 2008; 47: 318-323
      AHA, ESC-ESVS, ESVM, and SVS guidelines all advocate adopting a threshold value of <30 mm Hg for the diagnosis of CLI
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      , 
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      , 
      • Frank U.
      • Nikol S.
      • Belch J.
      • et al.
      Guideline on peripheral arterial disease.
      Vasa. 2019; 48: 1-79
      , 
      • Conte M.S.
      • Pomposelli F.B.
      Society for Vascular Surgery Lower Extremity Guidelines Writing G
      Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication.
      J Vasc Surg. 2015; 61: 2S-41S
      ,
      • Constans J.
      • Bura-Riviere A.
      • Visona A.
      • et al.
      Urgent need to clarify the definition of chronic critical limb ischemia - a position paper from the European Society for Vascular Medicine.
      Vasa. 2019; 48: 223-227
      (see section 10).

      Suggestions and Recommendations

      • 29.
        We recommend adopting a resting TcPO2 value of <30 mm Hg as a hemodynamic diagnostic criterion for CLI (grade 1+).

      Exercise TcPO2

      Exercise TcPO2 was suggested as a diagnostic criterion for LEAD in the 1980s.
      • Hauser C.J.
      • Shoemaker W.C.
      Use of a transcutaneous PO2 regional perfusion index to quantify tissue perfusion in peripheral vascular disease.
      Ann Surg. 1983; 197: 337-343
      ,
      • Grard C.
      • Desmytterre J.
      • Vinckier L.
      • et al.
      [Value of transcutaneous staged dynamic oximetry of stage II arteritis of the leg].
      Arch Mal Coeur Vaiss. 1990; 83: 51-57
      However, the use of this parameter is not mentioned in any current guideline. In 2003, the delta from resting oxygen pressure (DROP) was proposed for the evaluation of proximal claudication using a treadmill with a slope of 10% set at a speed of 3.2 km/h.
      • Abraham P.
      • Picquet J.
      • Vielle B.
      • et al.
      Transcutaneous oxygen pressure measurements on the buttocks during exercise to detect proximal arterial ischemia: comparison with arteriography.
      Circulation. 2003; 107: 1896-1900
      This technique was later also proposed for the exploration of distal claudication.
      • Bouye P.
      • Picquet J.
      • Jaquinandi V.
      • et al.
      Reproducibility of proximal and distal transcutaneous oxygen pressure measurements during exercise in stage 2 arterial claudication.
      Int Angiol. 2004; 23: 114-121
      Calculation of the DROP necessitates use of a dedicated software package.
      • Poulin A.
      • Guilcher A.
      • Omarjee L.
      • et al.
      Validation of a software to perform exercise oximetry to diagnose arterial stenosis of the lower limbs.
      Atherosclerosis. 2018; 278: 325-327
      The Oxymonitor® software package, which can be downloaded online, has been validated and may be used (https://imagemed.univ-rennes1.fr/en/oxymonitor/download.php).
      • Poulin A.
      • Guilcher A.
      • Omarjee L.
      • et al.
      Validation of a software to perform exercise oximetry to diagnose arterial stenosis of the lower limbs.
      Atherosclerosis. 2018; 278: 325-327
      A threshold value of −15 mm Hg is considered significant for the presence of arterial stenosis and has been observed in several populations.
      • Abraham P.
      • Picquet J.
      • Vielle B.
      • et al.
      Transcutaneous oxygen pressure measurements on the buttocks during exercise to detect proximal arterial ischemia: comparison with arteriography.
      Circulation. 2003; 107: 1896-1900
      ,
      • Koch C.
      • Chauve E.
      • Chaudru S.
      • et al.
      Exercise transcutaneous oxygen pressure measurement has good sensitivity and specificity to detect lower extremity arterial stenosis assessed by computed tomography angiography.
      Medicine (Baltimore). 2016; 95: e4522
      ,
      • Mahe G.
      • Kaladji A.
      • Le Faucheur A.
      • et al.
      Internal iliac artery stenosis: diagnosis and how to manage it in 2015.
      Front Cardiovasc Med. 2015; 2: 33
      This evaluation seems to be indicated in particular when patients complain of proximal pain (in the buttocks, thighs, and lumbar region) as in these contexts, the ABI may be falsely normal in 1 patient in 7.
      • Gernigon M.
      • Marchand J.
      • Ouedraogo N.
      • et al.
      Proximal ischemia is a frequent cause of exercise-induced pain in patients with a normal ankle to brachial index at rest.
      Pain Physician. 2013; 16: 57-64
      ,
      • Mahe G.
      • Kalra M.
      • Abraham P.
      • et al.
      Application of exercise transcutaneous oxygen pressure measurements for detection of proximal lower extremity arterial disease: a case report.
      Vasc Med. 2015; 20: 251-255
      It also appears to be of value in patients with complicated pathological conditions (e.g. diabetes, narrowing of the lumbar spinal canal).
      • Mahe G.
      • Kaladji A.
      • Le Faucheur A.
      • et al.
      Internal iliac artery stenosis: diagnosis and how to manage it in 2015.
      Front Cardiovasc Med. 2015; 2: 33
      ,
      • Mahe G.
      • Kalra M.
      • Abraham P.
      • et al.
      Application of exercise transcutaneous oxygen pressure measurements for detection of proximal lower extremity arterial disease: a case report.
      Vasc Med. 2015; 20: 251-255
      Its place in patient care is at present poorly defined. A recent study showed that its sensitivity and specificity in detecting arterial stenoses ≥50% are fairly similar to those of the postexercise ABI.
      • Stivalet O.
      • Paisant A.
      • Belabbas D.
      • et al.
      Exercise testing criteria to diagnose lower extremity peripheral artery disease assessed by computed-tomography angiography.
      PLoS One. 2019; 14: e0219082
      However, 2 other recent studies showed that the postexercise ABI and exercise TcPO2 did not identify the same patients among those with suspected lower limb LEAD presenting a resting ABI > 0.90.
      • Mahe G.
      • Catillon F.
      • Tollenaere Q.
      • et al.
      Confirmation of discrepancies between exercise oximetry and American Heart Association post-exercise criteria to diagnose peripheral artery disease in patients with normal ankle-brachial index at rest.
      Pflugers Arch. 2020; 472: 321-322
      , 
      • Abraham P.
      • Hersant J.
      • Ramondou P.
      • et al.
      Comparison of exercise oximetry and ankle pressure measurements for patients with intermittent claudication: an observational study of 433 patients.
      Pflugers Arch. 2020; 472: 293-301
      , 
      • Mahe G.
      • Catillon F.
      • Tollenaere Q.
      • et al.
      Discordance of peripheral artery disease diagnosis using exercise transcutaneous oxygen pressure measurement and post-exercise ankle-brachial index.
      Sci Rep. 2020; 10: 7419
      Exercise TcPO2 is now rarely used as a diagnostic criterion owing to technical constraints, the time required for its evaluation, and its cost. Its place in the decision tree for the diagnosis of LEAD remains to be defined.

      Suggestions and Recommendations

      • 30.
        In the event of difficulty in diagnosing or excluding LEAD, we suggest proposing the measurement of exercise TcPO2 to patients with complicated pathological conditions (e.g. diabetes, narrowing of the lumbar spinal canal) (grade 2+).

      Issues in Abeyance (Full Consensus not Achieved during the Delphi Procedure)

      • IiA-5.
        We suggest proposing exercise TcPO2 when the patient manifests normal resting and postexercise ABI values, but presents symptoms evoking exercise-induced ischemia in areas vascularized by the internal iliac artery (IIA). This proposal was approved by 71% of the panel experts, 6 experts expressing no opinion. This absence of full consensus may be explained by the limited availability of this technique in France. In addition, for most practitioners, the postexercise ABI and exercise TcPO2 are examinations identifying the same patients with LEAD. Three studies were published in 2020, after grading of the proposals by the panel of experts.
        • Mahe G.
        • Catillon F.
        • Tollenaere Q.
        • et al.
        Confirmation of discrepancies between exercise oximetry and American Heart Association post-exercise criteria to diagnose peripheral artery disease in patients with normal ankle-brachial index at rest.
        Pflugers Arch. 2020; 472: 321-322
        , 
        • Abraham P.
        • Hersant J.
        • Ramondou P.
        • et al.
        Comparison of exercise oximetry and ankle pressure measurements for patients with intermittent claudication: an observational study of 433 patients.
        Pflugers Arch. 2020; 472: 293-301
        , 
        • Mahe G.
        • Catillon F.
        • Tollenaere Q.
        • et al.
        Discordance of peripheral artery disease diagnosis using exercise transcutaneous oxygen pressure measurement and post-exercise ankle-brachial index.
        Sci Rep. 2020; 10: 7419
        All 3 studies showed that these tests do not in fact identify the same patients among those with suspected LEAD. Further studies are warranted to define more precisely the place of each test in the management of LEAD.

      Duplex Ultrasound, Computed Tomography Angiography, Magnetic Resonance Angiography, and Catheter Angiography

      The indications for DUS examination differ between the AHA, SVS, ESC-ESVS, and ESVM guidelines.
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      , 
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      , 
      • Frank U.
      • Nikol S.
      • Belch J.
      • et al.
      Guideline on peripheral arterial disease.
      Vasa. 2019; 48: 1-79
      , 
      • Conte M.S.
      • Pomposelli F.B.
      Society for Vascular Surgery Lower Extremity Guidelines Writing G
      Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication.
      J Vasc Surg. 2015; 61: 2S-41S
      The AHA and the SVS recommend the use of this examination solely in patients scheduled for revascularization.
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      In contrast, the ESC-ESVS and ESVM propose its use for confirmation of the arterial lesions whether or not an intervention is envisaged.
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      For patients at low or moderate CV risk (Table III)
      • Mach F.
      • Baigent C.
      • Catapano A.L.
      • et al.
      2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk.
      Eur Heart J. 2019;
      and for asymptomatic diabetic patients at moderate CV risk (patients with type 1 diabetes aged under 35 years, or those with type 2 diabetes under 50 years old, with an onset of diabetes < 10 years previously and with no other CV risk) (Table IV),
      • Cosentino F.
      • Grant P.J.
      • Aboyans V.
      • et al.
      2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD.
      Eur Heart J. 2019;
      the ESC-ESVS propose a search for plaques in the carotid and/or femoral arteries to define the CV risk more precisely (grade IIa). The ESC-ESVS advise against measuring carotid intima-media thickness.
      • Cosentino F.
      • Grant P.J.
      • Aboyans V.
      • et al.
      2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD.
      Eur Heart J. 2019;
      Table IIIThe 4 classes of CV risk
      • Mach F.
      • Baigent C.
      • Catapano A.L.
      • et al.
      2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk.
      Eur Heart J. 2019;
      Very high riskPatients with any of the following risk factors:
      • -
        Atherosclerotic disease either clinically documented or confirmed by imaging. Documented atherosclerotic diseases include the following: history of acute coronary syndrome (ACS: MI or unstable angina), stable angina, coronary revascularization (percutaneous coronary intervention, coronary bypass surgery, and other arterial revascularization procedures), stroke or transient ischemic attack, and LEAD. Atherosclerotic diseases confirmed by imaging include those known to be predictive of clinical events such as the presence of plaques revealed by coronary angiography or coronary computed tomography angiography (lesions in several coronary trunks with >50% stenosis in 2 of the principal coronary arteries) or by carotid DUS.
      • -
        Diabetes involving target organ damage, or associated with at least 3 major risk factors, or early onset of type 1 diabetes (present for over 20 years).
      • -
        Severe renal insufficiency (GFR < 30 mL/min/1.73 m2)
      • -
        Calculated SCORE (risk of fatal CV event at 10 years) ≥10%
      High riskPatients with
      • -
        a markedly elevated single risk factor, in particular total cholesterol > 8 mmol/L (>310 mg/dL), LDLc > 4.9 mmol/L (>190 mg/dL), or BP > 180/110 mm Hg
      • -
        familial hypercholesterolemia or other major risk factor.
      • -
        diabetes without target organ damage, present for over 10 years or associated with another risk factor
      • -
        moderate renal insufficiency (GFR between 30 and 59 mL/min/1.73 m2)
      • -
        calculated SCORE (risk of fatal CV event at 10 years) ≥ 5% and <10%
      Moderate risk
      • -
        Young patients with diabetes (aged < 35 years for type 1 and < 50 years for type 2 diabetes) present for less than 10 years and not associated with any other risk factor.
      • -
        SCORE ≥ (risk of fatal CV event at 10 years) ≥ 1% et < 5%
      Low risk
      • -
        SCORE (risk of fatal CV event at 10 years) < 1%
      CV, cardiovascular; SCORE, systematic coronary risk estimation; GFR, glomerular filtration rate.
      Table IVLevels of CV risk in diabetic patients
      • Cosentino F.
      • Grant P.J.
      • Aboyans V.
      • et al.
      2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD.
      Eur Heart J. 2019;
      Very high riskPatients with diabetes and confirmed CV disease or with target organ damage
      Proteinuria, renal insufficiency defined by a Glomerular Filtration Rate (GFR) < 30 mL/min/1.73 m2, left ventricular hypertrophy, or retinopathy.


      Or with at least three major risk factors
      Age, hypertension, dyslipidemia, smoking, obesity.


      Or with early onset type 1 diabetes present for over 20 years.
      High riskPatients with diabetes present for 10 years or more, without target organ damage, associated with at least one other risk factor
      Moderate riskYoung patients (aged < 35 years for type 1 and < 50 years for type 2 diabetes) with diabetes present for less than 10 years, not associated with any other risk factor
      a Proteinuria, renal insufficiency defined by a Glomerular Filtration Rate (GFR) < 30 mL/min/1.73 m2, left ventricular hypertrophy, or retinopathy.
      b Age, hypertension, dyslipidemia, smoking, obesity.
      It is important to point out that certain risk factors for atherosclerotic disease are also risk factors for AAA. The prevalence of AAA is higher among persons suffering from LEAD (9%) than in the general population.
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      • Simmons M.J.
      • Torrie E.P.
      Prevalence of abdominal aortic aneurysm in patients with occlusive peripheral vascular disease.
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      • Estallo L.
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      • et al.
      Detection of abdominal aortic aneurysm in patients with peripheral artery disease.
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      , 
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      • Laurenzano E.
      • Rengo C.
      • et al.
      Abdominal aortic aneurysm in patients affected by intermittent claudication: prevalence and clinical predictors.
      BMC Surg. 2012; 12: S17
      DUS is effective in detecting aortoiliac and femoropopliteal lesions.
      • de Vries S.O.
      • Hunink M.G.
      • Polak J.F.
      Summary receiver operating characteristic curves as a technique for meta-analysis of the diagnostic performance of duplex ultrasonography in peripheral arterial disease.
      Acad Radiol. 1996; 3: 361-369
      The comparative proficiency of magnetic resonance angiography (MRA), computed tomography angiography (CTA) with injection of a contrast agent, and DUS in detecting >50% stenoses of the lower limbs was evaluated in a systematic review. MRA showed the best diagnostic performance with a sensitivity of 95% (92–99.5%) and a specificity of 97% (64–99%). The sensitivity and specificity of CTA with injection of a contrast agent were, respectively, 91% (89–99%) and 91% (83–97%), those of DUS being 90% (74–94%) and 99% (96–100%).
      • Collins R.
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      • Cranny G.
      • et al.
      Duplex ultrasonography, magnetic resonance angiography, and computed tomography angiography for diagnosis and assessment of symptomatic, lower limb peripheral arterial disease: systematic review.
      BMJ. 2007; 334: 1257
      However, both CTA and MRA are techniques necessitating the injection of a contrast agent that may be nephrotoxic and engender allergic reactions and thyroid dysfunction (CTA) or systemic nephrogenic fibrosis (MRA).
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      Rev Med Suisse. 2008; 4: 576-578
      Diagnostic catheter angiography is no longer indicated in the first instance, but remains indicated for the evaluation of infrapopliteal arterial disease in the context of planned endovascular revascularization. The guidelines concur in advising against investigations involving imaging techniques such as CTA, MRA, or catheter angiography in asymptomatic patients.
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      ,
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      The ESC-ESVS alone recommend exploration of the lower limb arteries in patients who are candidates for transcatheter aortic valve implantation (TAVI) or an intervention necessitating a risky arterial approach. Imaging of the aorta and the principal peripheral arteries by CTA is recommended before TAVI, notably to evaluate the aorta as a whole
      • Aboyans V.
      • Ricco J.B.
      • Bartelink M.E.L.
      • et al.
      Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
      Eur J Vasc Endovasc Surg. 2018; 55: 305-368
      (grade I), see section 7.7.

      Suggestions and Recommendations

      • 31.
        We recommend performing a DUS examination to characterize the arterial lesions present in patients with LEAD (grade 1+).
      • 32.
        We recommend performing a DUS examination in patients with LEAD to detect the presence of an AAA (grade 1+).
      • 33.
        We recommend not to propose invasive imaging examinations to patients presenting asymptomatic LEAD (if an AAA has been detected, the relevant specific recommendations should be followed) (grade 1-).
      • 34.
        In patients at moderate CV risk, we suggest searching for carotid and/or femoral atherosclerotic plaques by DUS to better evaluate the CV risk (grade 2+).
      • 35.
        In asymptomatic diabetic patients at moderate CV risk, we suggest searching for carotid and/or femoral atheroclerotic plaques by DUS to better evaluate the CV risk (grade 2+).

      Issues in Abeyance (Full Consensus not Achieved during the Delphi Procedure)

      • IiA-6.
        In contrast to the ESC-ESVS, we suggest not to undertake a DUS search for carotid and/or femoral atherosclerotic plaques in patients at low CV risk. This proposal achieved a consensus agreement of 61%, 3 participants expressing no opinion. Some experts are in favor of such screening as it allows treatment to be started in patients with >50% stenosis of the internal carotid artery.
        • Aboyans V.
        • Ricco J.B.
        • Bartelink M.E.L.
        • et al.
        Editor's choice - 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS).
        Eur J Vasc Endovasc Surg. 2018; 55: 305-368
        The presence of atherosclerotic plaques in the carotid or femoral arteries could have an impact on evaluation of the patient's CV risk.

      Methods of Functional Evaluation of Maximum Walking Distance

      Tests evaluating walking ability seem to be important both for precisely assessing the patient's functional impairment and for unmasking other potential causes of difficulty in walking.
      • Gerhard-Herman M.D.
      • Gornik H.L.
      • Barrett C.
      • et al.
      2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American heart association task force on clinical practice guidelines.
      Circulation. 2017; 135: e726-e779
      ,
      • Hirsch A.T.
      • Haskal Z.J.
      • Hertzer N.R.
      • et al.
      ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American association for vascular surgery/society for vascular surgery, society for cardiovascular angiography and interventions, society for vascular medicine and biology, society of interventional radiology, and the ACC/AHA task force on practice guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease): endorsed by the American association of cardiovascular and pulmonary rehabilitation; national heart, lung, and blood institute; society for vascular nursing; TransAtlantic inter-society consensus; and vascular disease foundation.
      Circulation. 2006; 113: e463-e654
      A patient's walking capacity can be evaluated by the maximum walking distance (the maximum distance covered before the patient has to stop walking owing to the intolerable pain experienced) or the relative walking distance (the distance covered before pain onset).
      • Hirsch A.T.
      • Haskal Z.J.
      • Hertzer N.R.
      • et al.
      ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American association for vascular surgery/society for vascular surgery, society for cardiovascular angiography and interventions, society for vascular medicine and biology, society of interventional radiology, and the ACC/AHA task force on practice guidelines (writing committee to develop guidelines for the management of patients with peripheral arterial disease): endorsed by the American association of cardiovascular and pulmonary rehabilitation; national heart, lung, and blood institute; society for vascular nursing; TransAtlantic inter-society consensus; and vascular disease foundation.
      Circulation. 2006; 113: e463-e654
      Various methods for evaluating walking capacity have been proposed (declared walking distance, questionnaires, treadmill tests, the 6-minute walking test, and measurement of distances covered in real life using a Global Positioning System (GPS) device). Walking distances reported by patients when questioned and those evaluated by treadmill tests are only weakly correlated, coefficients ranging from 0.39 to 0.52.
      • Frans F.A.
      • Zagers M.B.
      • Jens S.
      • et al.
      The relationship of walking distances estimated by the patient, on the corridor and on a treadmill, and the Walking Impairment Questionnaire in intermittent claudication.
      J Vasc Surg. 2013; 57: 720-727.e1
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      • Watson C.J.
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      Claudication distance is poorly estimated and inappropriately measured.
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      • et al.
      Measurement of walking distance and speed in patients with peripheral arterial disease: a novel method using a global positioning system.
      Circulation. 2008; 117: 897-904
      In one study, patients overestimated their maximum walking distance to be 300 m (163–500), whereas treadmill test results showed a maximum distance of 184 m.
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      • et al.
      Measurement of walking distance and speed in patients with peripheral arterial disease: a novel method using a global positioning system.
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      Exercise for intermittent claudication.
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      The AHA and ESC-ESVS guidelines concur in recommending objective evaluation of patients' functional impairment by a treadmill test, whereas the ESVM proposes this test principally in the case of atypical symptoms. The choice between a constant load test (strandness: slope of 10%; speed of 3.2 km/h) and an incremental test (Gardner-Skinner test: speed of 3.2 km/h; slope of 0% at the start of the test, increased by 2% every two minutes) is left to the discretion of the operator.
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      Evaluation of the maximum walking distance is recommended after treatment initiation.
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      The reference test to be performed remains a matter of debate. Certain authors advocate the 6-minute test, on the grounds that this is more representative of patients' usual walking habits and also does not require any training in walking on a treadmill, whereas others are more in favor of the treadmill test.
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      Letter by Le Faucheur et al regarding articles, "Six-minute walk is a better outcome measure than treadmill walking tests in therapeutic trials of patients with peripheral artery disease" and "The treadmill is a better functional test than the 6-minute walk test in therapeutic trials of patients with peripheral artery disease.
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      Finally, the walking test (whether treadmill or 6-minute) could enable diagnosis of masked LEAD.
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      All the various diagnostic strategies in accordance with the clinical context are presented in Figure 2.
      Figure thumbnail gr2a
      Fig. 2The different strategies for diagnosing LEAD.
      Figure thumbnail gr2bc
      Fig. 2The different strategies for diagnosing LEAD.

      Suggestions and Recommendations

      • 36.
        For objective evaluation of the maximum walking distance of a patient with LEAD, we recommend using the treadmill test (either constant load or incremental) as the reference assessment (grade 1+).
      • 37.
        We suggest using the treadmill test (either constant load or incremental) to evaluate the response to treatment (grade 2+).

      Issues in Abeyance (Full Consensus not Achieved during the Delphi Procedure)

      • IiA-7.
        For objective evaluation of the maximum walking distance of a patient suffering from LEAD, we recommend using the 6-minute walk test as the reference assessment. This proposal achieved a consensus agreement of 70%, 4 participants (10%) expressing no opinion. The debate as to which test is the best for objectively determining a patient's level of functional impairment is a recurrent issue as indicated in the literature,
        • Hiatt W.R.
        • Rogers R.K.
        • Brass E.P.
        The treadmill is a better functional test than the 6-minute walk test in therapeutic trials of patients with peripheral artery disease.
        Circulation. 2014; 130: 69-78
        ,
        • McDermott M.M.
        • Guralnik J.M.
        • Criqui M.H.
        • et al.
        Six-minute walk is a better outcome measure than treadmill walking tests in therapeutic trials of patients with peripheral artery disease.
        Circulation. 2014; 130: 61-68
        ,
        • Le Faucheur A.
        • de Mullenheim P.Y.
        • Mahe G.
        Letter by Le Faucheur et al regarding articles, "Six-minute walk is a better outcome measure than treadmill walking tests in therapeutic trials of patients with peripheral artery disease" and "The treadmill is a better functional test than the 6-minute walk test in therapeutic trials of patients with peripheral artery disease.
        Circulation. 2015; 131: e406
        clinicians currently having 3 main choices: evaluation by a treadmill test, evaluation by the 6-minute walking test, and ambulatory evaluation using a GPS device. The treadmill test presents the drawback in France of being reimbursed by the national health insurance system only if an electrocardiogram (ECG) is performed at the same time. The 6-minute walk test is reimbursable but requires the presence of adequate personnel as well as a corridor more than 20 m long, both conditions difficult to achieve in a general practice context. Finally, ambulatory evaluation is currently only feasible in a research context and is also not reimbursed.

      Focus on the Quantification of Arterial Stenoses Using Duplex Ultrasound

      Although existing guidelines describe the methodology of other functional investigations (pressure measurements), none of the guidelines compared specify the methodology and diagnostic criteria to be used for DUS examinations.
      DUS examinations enable the echographic observation of parietal abnormalities as well as their hemodynamic repercussions. In color mode, DUS detects hemodynamically relevant lesions in the form of turbulences and aliasing they induce; the degree of stenosis is quantified by pulsed-wave or continuous-wave DUS, by measuring peak systolic and end-diastolic velocities at the site of the lesion and calculating the ratio of these velocities to the corresponding velocities measured upstream of the lesion investigated (i.e. velocity at the site of the lesion divided by velocity proximal to the lesion). Thorough analysis of the Doppler signal, upstream and downstream of the lesions, enables evaluation of the hemodynamic repercussions distal to the stenoses and occlusions.
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      the CEMV proposes use of the Saint-Bonnet classification to define the hemodynamic repercussions (Fig. 1, Section 5.4). With increasing severity of the arterial lesions, the initially triphasic waveform (normal; Saint-Bonnet N) changes, becoming biphasic (Saint-Bonnet A), with loss of diastolic flow reversal, and finally monophasic (Saint-Bonnet B, CD, E). The waveform sometimes becomes continuous owing to a delayed systolic upstroke.
      Combined color-mode and pulsed-wave DUS achieved a sensitivity and specificity in diagnosing LEAD of 88% and 95%, respectively, relative to catheter arteriography.
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      The reliability of the DUS examination increases when the various criteria available are combined (peak systolic velocities, end-diastolic velocities, velocity ratios, and flow disturbances downstream of the lesions investigated).

      Occlusions

      Arterial occlusions are generally not difficult to diagnose as they result in an absence of blood flow (Doppler waveform Saint-Bonnet 0).

      Arterial Stenoses and Their Quantification

      Quantification of the degree of stenosis is based on velocimetric criteria.
      The velocities recorded under normal conditions are of the order of 1 m/s in the iliac arteries, subsequently decreasing to approximately 50 cm/s in the tibial arteries, but with substantial physiological variations.
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      Stenoses in the lower limb arteries, as at other vascular sites, are manifested by blood flow accelerations. In view of the variability of the systolic velocities in the lower limb arteries, measurement of the velocity ratios (VR = ratio of the velocity at the site of stenosis/the velocity proximal to the stenosis) has proved to be more reliable than simply the peak systolic velocity (PSV) at the site of the stenosis.
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      Several studies have investigated various criteria and have reported different thresholds of PSV or velocity ratio
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