Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Asymptomatic Lower Limb Peripheral Arterial Disease and Intermittent Claudication

ESVS guidelines committee

Research output: Contribution to journalArticle (Academic Journal)peer-review

18 Citations (Scopus)

Abstract

[No abstract]
Original languageEnglish
Pages (from-to)9-96
Number of pages88
JournalEuropean Journal of Vascular and Endovascular Surgery
Volume67
Issue number1
Early online date8 Nov 2023
DOIs
Publication statusPublished - 1 Jan 2024

Bibliographical note

Funding Information:
The efficacy of exercise to improve maximum and pain free walking distance and HRQoL in patients with IC is supported by a large body of evidence from the past 30 years. 467–473 The modality that has been most studied in IC is SET, performed as treadmill based intermittent walking exercise to at least a moderate level of claudication pain followed by a short period of rest for a total duration of 30 – 60 minutes/session, three times a week for three to six months.464Although SET provides benefit for patients with IC, it remains underused. 479–481 Walking advice (WA) without any follow up or structured home based exercise therapy (HBET) with an observation component, e.g., exercise logbooks or accelerometers, to increase exercise motivation, are therefore considered interesting alternatives to SET.479 Studies supporting effects of HBET are more recent than studies supporting SET and there are conflicting results on the efficacy. A Cochrane report showed that HBET was not superior to WA and was less effective than SET in improving maximum and pain free treadmill measured walking distance.470 In addition, there were no clear differences in HRQoL parameters nor in self reported functional impairment between SET and HBET, but some improvements in HRQoL favouring SET over WA were found. Data showed no clear difference in HRQoL between the HBET and WA groups. On the contrary, a meta-analysis including a total of 11 RCTs showed that HBET improved maximum walking distance (assessed with treadmill tests and 6MWT) and pain free walking distance (assessed with treadmill tests) in the short term, compared with usual care.482 The most recent meta-analysis concluded that HBET was inferior to SET.475 In comparison between HBET and unsupervised exercise advice or controls, results were conflicting, but generally in favour of HBET. All HBET programmes included walking exercises between three and five sessions/week, typically for a total programme duration of 12 – 24 weeks. Motivational approaches in the included studies varied substantially, and findings suggest that the type of behaviour intervention was more important than the number of contacts with healthcare professionals. When evaluating effects of exercise therapy in patients with IC, it is important to consider the phenomenon, exercise on the outcome measure (i.e., the inappropriate use of treadmill walking both as part of the exercise intervention and as the trial endpoint, leading to potential imbalances between treatment arms, as one treatment arm in the study become substantially more familiar with treadmill testing) and to take note that the outcomes of walking distance obtained by treadmill tests and 6MWT cannot be used interchangeably.223Protocols for exercise therapy in patients with IC have traditionally recommended intermittent walking to moderate or higher claudication pain levels.464 As exercise related pain is considered one potential reason for poor exercise adherence,484 effects of exercise interventions including no, or mild levels of claudication pain have been considered. A systematic review suggests that pain free SET may be as beneficial as moderate pain SET for improving walking performance in patients with IC.485 Importantly, there were only two small RCTs identified, and these studies did not include a SET group exercising at maximum claudication pain. The most recently published meta-analysis concluded that there is strong evidence in support of structured high pain exercise, and some evidence in support of structured low pain exercise, to improve walking ability in patients with IC, with both performing better than unstructured exercise advice only.486Even though the evidence supporting the efficacy of SET programmes is robust, only a small proportion of all diagnosed IC patients receive this safe, efficient, and structured treatment in most countries. 79–481 According to a recently published overview from 17 European countries, SET programmes only exist in 59% of countries and SET reimbursement is available in 41% of countries.489 In another study, vascular surgeons in parts of Europe generally recognise SET to be beneficial for patients with IC, but less than one in three reported having access to SET programmes.481 Where SET programmes are available, barriers to patients are commonly described, such as poor health literacy, comorbidities, lack of motivation, claudication pain, travel expenses, and distance to the hospital. 479–481 Patient adherence to SET programmes are reported to be generally low.490,491 To increase referral and adherence to SET programmes, it is important to further understand the barriers and enablers to exercise for patients with IC. Although some may be similar across healthcare systems, others may be specific to each system. In the Netherlands, for example, a community based network for SET was implemented to solve the problems of transportation time and costs for patients, as well as the restricted capacity of hospital based SET.492 The national integrated care network (ClaudicatioNet) in the Netherlands has resulted in improved SET referral rates, for example by increased accessibility to physiotherapists, increased awareness of referring physicians and by offering full reimbursement.493 The American Heart Association (AHA) has published a practical guide for how to deliver SET programmes to patients with IC, which summarises requirements for referral and coverage of SET to increase availability of exercise.494 In addition to the IC specific evaluations of functional capacity, it is suggested by both AHA and the European Society of Cardiology (ESC) to perform a bicycle ergometry exercise stress test in patients with current or prior symptomatic cardiac disease for better evaluation of central limitations before starting a SET programme.494,495 Helping patients transition to long term maintenance of unsupervised exercise once SET is completed is a requisite to maintain and further improve exercise outcomes.494Any invasive treatment for claudication should offer long term benefit at low risk of complications.529 The revascularisation modality is an interdisciplinary decision making process and should be based on the anatomical location of disease (i.e., aorto-iliac segment, common and deep femoral artery, femoropopliteal or infrapopliteal segments or combinations) as well as the extent of arterial obstruction. The decision making process is complicated by a myriad of device technologies and surgical techniques available, the paucity of high quality randomised controlled trials (RCTs) with long term follow up, and inconsistent endpoints, as well as the heterogeneity among study participants. The guideline writing committee deemed that the previous systematic reviews and meta-analysis on this topic were inappropriate within the specific context of revascularisation for IC indications, which is why new systematic reviews and meta-analysis were performed by members of the GWC to support guideline development.5 While the primary target population reported on in this guideline document are patients with IC, older randomised trials mainly included patients with CLTI or reported on a mixture of anatomical levels treated. In the more recent RCTs more specific patient cohorts have been evaluated (often with a majority of IC patients) and while lesion characteristics were rather precisely reported only a small percentage had CLTI. Clinical and methodological heterogeneity among studies is thus substantial with respect to patient comorbidities, lesion characteristics, endovascular device features, surgical techniques used, and endpoint definitions, thereby reducing the applicability of the results. The general quality of included studies is deemed low to moderate, echoing the small scale, industry sponsored, and open label nature of many past RCTs which often displayed substantial loss to follow up and were frequently underpowered for the assessment of long term, clinical endpoints, although the more recent trials in this field of research were of higher methodological quality. Accordingly, several limitations must be considered when applying the recommendations given below. As far as possible, the revascularisation chapter as below was based on IC specific evidence.In terms of open vascular surgery in the femoropopliteal segment, three meta-analyses evaluated the outcome of above the knee femoropopliteal bypasses comparing autologous vein to prosthetic materials. 574–576 No clear difference in primary patency at three, six, or 12 months was identified, but a long term benefit for autologous vein was observed at 24 months (OR 0.59, 95% CI 0.37 – 0.94; 422 limbs, four studies, p = .030). This was reflected in the continued primary patency benefit for autologous vein over prosthetic grafts by 60 months (OR 0.47, 95% CI 0.28 – 0.80, three studies, 269 limbs, p = .005). There was no difference between Dacron and ePTFE grafts for primary patency, but Dacron may confer a slight secondary patency benefit over ePTFE in the long term (OR 1.67, 95% CI 0.96 – 2.90, two studies, 247 limbs). These findings were also supported by a study of 282 patients with IC where the primary patency rates were 76.7 ± 5.9% at one year and 59.3 ± 7.3% at five years for above knee venous bypass vs. 69.5 ± 5.3% at one year and 54.5 ± 6.2% at five years for above knee prosthetic bypass.577 In the randomised ZilverPASS study that compared paclitaxel eluting stent (Zilver PTX) treatment with prosthetic bypass surgery in TASC II C and D femoropopliteal lesions, polymer free paclitaxel eluting stenting was non-inferior to prosthetic bypass surgery. However, the ZilverPASS study was limited by imbalanced treatment arms, including a higher proportion of CLTI patients and more severe risk factor profiles in the surgical bypass arm.578 Overall, most of the studies on open surgery for femoropopliteal occlusive disease report on mixed cohorts including patients with intermittent claudication and CLTI, making it difficult to interpret the results.

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