Abstract
Introduction
Non-invasive measurement of foot perfusion is vital in the assessment of patients with peripheral artery disease. Pedal acceleration time (PAT) has emerged as a quick and effective analysis tool in the management of lower limb arterial insufficiency. This study aimed to investigate the validity of PAT in a functional measurement of foot perfusion pre- and post-revascularisation, including the differences in PAT post-revascularisation between diabetic and non-diabetic cohorts.
Method
A prospective, observational study was performed, using STROBE guidelines, between 2020 and 2022 at a single centre in New Zealand. PAT was measured on multiple pedal arteries within the foot, and the best and worst PAT values of the three arteries in the foot (i.e., low and high measurements in milliseconds [ms], respectively) were assigned to the foot for analysis.
Results
PAT measurements were performed on 443 patients during the study period, of whom 142 patients and limbs had revascularisation interventions and pre- and post-PAT measurements, and were included in the study. The mean (standard deviation [SD]) PAT at presentation were class 4 (245.2 ms ± SD 71.8 ms), and this improved to PAT class 2 (125.1 ms ± SD 45.4 ms) post-intervention. Patients with diabetes mellitus (DM) were found to have a smaller improvement in PAT post-revascularisation (difference between DM and without DM groups = 48.7 ms, 95% confidence interval 24.4–73; p < .001). Patients who underwent open revascularisation had a greater improvement in PAT compared with endovascular treatment.
Conclusion
PAT is a reliable tool to assess foot perfusion and can be used to quantify improvement post-revascularisation. The study showed that patients with DM have a smaller change in PAT post-revascularisation, and adds to the growing literature on the usefulness of PAT in arterial insufficiency management.
Keywords: Diabetes, Foot perfusion, Pedal acceleration time, Revascularisation
Highlights
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Pedal acceleration time is an effective tool in the assessment of foot perfusion pre- and post-revascularisation
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Patients with diabetes have a smaller improvement in pedal acceleration time post-revascularisation
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Open revascularisation may be associated with a larger improvement in PATs compared to endovascular intervention
INTRODUCTION
Non-invasive arterial investigations are vital in the assessment of foot perfusion for patients with peripheral artery disease (PAD). International guidelines recommend the ankle brachial pressure index (ABPI), systolic toe pressure (TP), transcutaneous oxygen pressure, and skin perfusion pressure for the assessment of limb haemodynamics.1,2 However, these modalities have their limitations, such as the inaccuracy of ABPI in severe tibial steno-occlusive disease with falsely elevated values in diabetic patients, or inability to obtain TP in patients with previous hallux and second toe amputations.3 The diagnostic capabilities of TP and ABPI in PAD remain uncertain. Direct plantar arch ultrasound imaging to measure a plantar acceleration time has therefore emerged to navigate these challenges and improve perfusion assessment.
Pedal acceleration time (PAT), first described in 2019,4 has been validated by multiple studies as a quick, efficient, reproducible, and accurate tool for assessing severity of infrainguinal vascular disease.4, 5, 6, 7, 8 Pedal acceleration time is an assessment of foot perfusion using the acceleration of blood flow in pedal vessels as a measure of the severity PAD. It has been shown to more accurately evaluate flow than velocity alone.8, 9, 10 It is measured in milliseconds (ms) and can be grouped into four categories: class 1, no ischaemia and asymptomatic (20–120 ms); class 2, mild ischaemia (121–180 ms); class 3, moderate ischaemia (181–224 ms); and class 4, chronic limb threatening ischaemia (>225 ms). It has been correlated with ABPIs, Rutherford categories and Wound, Ischemia, and Foot Infection grades.4,8
There is evidence suggesting that the presence of diabetes mellitus (DM) is associated with poorer rates of primary patency post angioplasty, amputation free survival, and mortality after revascularisation, particularly with endovascular approaches.11, 12, 13, 14 Previous studies have described an association between PAT and wound healing in diabetic foot disease, and amputation free survival.15, 16, 17, 18 However, change in PAT measurements pre- and post-revascularisation focusing on the differences in these patients with and without DM has not been reported previously.
There is also debate about the use of endovascular or open revascularisation strategies in chronic limb threatening ischaemia (CLTI).19, 20, 21 Previous studies have compared PAT with ABPI and TP in the context of CLTI, and found that it is a useful indicator of perfusion.18,22 PAT could be considered in the monitoring of PAD and may even be of benefit in assessing the efficacy of different revascularisation strategies.
This study aimed to report the change in PAT before and after revascularisation intervention. The secondary outcome was to assess whether there is a difference in the change in PAT for patients with and without DM and if there is a difference in the change in PAT between open and endovascular revascularisation.
STUDY DESIGN
This prospective, observational study recruited patients presenting to a tertiary vascular surgery service (Waikato Hospital) between 1 January 2020 and 30 June 2022 with intermittent claudication or CLTI.
METHOD
Ethics approval for this study was granted by the New Zealand Central Health and Disability Ethics Committee (20/CEN/122) and the Waikato District Health Board Research Department (RDO020044).
The STrengthening and Reporting of Observational Studies in Epidemiology (STROBE) checklist was used in the design and reporting.23
Exclusion criteria were: age <18 years; isolated aorto-iliac disease (as previous research suggests that PAT is unreliable in this group);24 venous ulceration or mixed pathology wounds (including arteriovenous ulceration, scleroderma, or other uncommon wound aetiologies); no ischaemic symptoms, such as aneurysmal disease or atypical limb pain, in the absence of PAD; and those unwilling or unable to consent to the study.
To determine the change in PAT after revascularisation (open, endovascular, and hybrid), all patients underwent a PAT measurement a day before revascularisation intervention and PAT was repeated on day one post-revascularisation. The first technically successful revascularisation during the study period of a single limb was followed for each patient.
PAT was calculated as the time in milliseconds (ms) from the onset to the peak of systole within the vessel of interest pre- (Fig. 1) and post-intervention (Fig. 2), and was measured in the same pedal vessels pre- and post-operatively. PAT measurements were taken from the lateral plantar artery, medial plantar artery, and dorsalis pedis artery, and a mean value was calculated from three measurements conducted on each vessel. The best and worst (low and high measurements in ms) PAT value of all three vessels in the foot were assigned to the foot for analysis. PAT assessments were conducted with Philips Epiq Elite (Philips Healthcare, Andover, MA, USA) and GE Logiq E9 (GE Healthcare, Wauwatosa, WI, USA) duplex ultrasound systems using a linear array transducer with pulsed Doppler frequencies between 3 – 12 MHz. The measurements were carried out by trained sonographers who underwent supervised competency assessment in PAT measurement before undertaking the study and all had more than three years of experience in the measurement of PAT.
Figure 1.
Pedal acceleration time measurement pre-intervention.
Figure 2.
Pedal acceleration time measurement post-intervention.
PAT was classified as class 1 (0–120 ms), class 2 (121–180 ms), class 3 (181–220 ms), and class 4 (221–300 ms). A severely dampened monophasic waveform or unrecordable flow was assigned PAT class 4 (severely limited perfusion).
Data were collected in Excel software version 2406 (Microsoft, Redmond, WA, USA) and statistical analysis was performed using R (R Foundation for Statistical Computing, Vienna, Austria) and SPSS version 28 (IBM Corp., Armonk, NY, USA). The first single limb that underwent revascularisation during the study period from eligible patients was used for calculations. As PAT was measured on multiple pedal arteries within the foot, the best PAT value in one artery (i.e., lowest measurement in ms) was assigned to the foot for analysis. A sensitivity analysis was repeated using the worst PAT (i.e., highest measurement in ms) for the foot. Continuous data are reported as median (interquartile range [IQR]) and categorical data as percentages. The Pearson Chi square test was used to compare categorical variables and one way analysis of variance (ANOVA) for continuous variables. P values < .050 were considered statistically significant. Visual inspection of a normal Q–Q plot was used to assess the normality of the data. A paired sample t test was used to determine the mean change in PAT after revascularisation with 95% confidence intervals (CI) and an independent samples t test to compare groups.
RESULTS
During the study period, PAT measurements were carried out on 443 patients. Overall, 142 patients (142 limbs) underwent revascularisation intervention for IC or CLTI and had pre- and post-intervention PAT measured on a single limb (Fig. 3). The median age was 72 years (IQR 64, 79), 30% were female, and 65% had DM (Table 1).
Figure 3.
CONSORT diagram for recruitment into the study. IC = intermittent claudication; PAT = pedal acceleration time.
Table 1.
Demographics of patients (n = 142) who underwent pedal acceleration time (PAT) measurement before and after revascularisation.
| Characteristic | Patients (n = 142) | |
|---|---|---|
| Age – y | 72 (64, 79) | |
| Sex | ||
| Female | 42 (29.6) | |
| Male | 100 (70.4) | |
| Ethnicity | ||
| Māori | 42 (29.6) | |
| Non-Māori | 100 (70.4) | |
| Diabetes mellitus | 92 (64.8) | |
| End stage renal failure | 22 (15.5) | |
| Presentation | ||
| Short distance IC | 6 (4.2) | |
| Rest pain | 21 (14.8) | |
| Ulceration (infected) | 45 (31.7) | |
| Ulceration (non-infected) | 20 (14.1) | |
| Gangrene (infected) | 38 (26.8) | |
| Gangrene (non-infected) | 12 (8.5) | |
Data are shown as n (%) and n (IQR). IC = intermittent claudication.
The mean (standard deviation [SD]) PAT at presentation was class 4 (245.2 ms ± SD 71.8 ms), and there was a significant change to PAT class 2 (125.1 ms ± SD 45.4 ms) post-intervention (p < .001).
Patients with DM had a smaller change in the mean PAT post-revascularisation compared with patients without DM (difference between DM and without DM groups 48.7 ms, 95% CI 24.4–73; p < .001). This was similarly true when the longest pre- and post-revascularisation PAT was assessed for patients with and without DM (Table 2).
Table 2.
The difference in mean pedal acceleration time (PAT) before and after revascularisation (n = 142), with separation by diabetes status.
| Patients (%) | Mean pre- revascularisation PAT (±SD) | Mean post-revascularisation PAT (±SD) | Difference in mean PAT (95% CI) | p value | |
|---|---|---|---|---|---|
| Best PAT score | |||||
| Overall | 142 | 245.2 (71.8) | 125.1 (45.4) | 120.1 (107.9–132.3) | <.001 |
| DM | 92 (64.8) | 235.8 (71.8) | 132.9 (46.0) | 103 (88.6–117.3) | <.001 |
| No DM | 51 (35.2) | 262.5 (69.2) | 110.9 (41.2) | 151.6 (131.4–171.9) | <.001 |
| Worst PAT score | |||||
| Overall | 142 | 250.0 (68.9) | 135.5 (49.3) | 114.5 (102.4–126.7) | <.001 |
| DM | 92 (64.8) | 242.1 (68.9) | 143.6 (51.4) | 98.5 (84–113) | <.001 |
| No DM | 51 (35.2) | 264.5 (67.2) | 120.5 (41.8) | 144.0 (124–164.4) | <.001 |
PAT = pedal acceleration time; DM = diabetes mellitus.
A subanalysis was carried out looking at change in PAT for different revascularisation types. Of the 142 patients in the intervention arm, 107 underwent endovascular revascularisation, 22 open revascularisation (13 lower limb bypass and nine femoral endarterectomy), and 13 a hybrid procedure (endovascular with open surgery). Patients who underwent hybrid intervention were excluded from this subanalysis. Patients who underwent open revascularisation surgery had the larger change in mean PAT post-intervention (median PAT pre-revascularisation 256 ms (IQR 140, 200), post-revascularisation 101 ms (IQR 80, 136.8), difference 136 (IQR 52, 197.5); p < .001). In comparison, the endovascular group had a smaller change in PAT post-intervention (median PAT pre-revascularisation 240 ms [IQR 163, 300], post-revascularisation 120 ms [IQR 96, 151], difference 96 [IQR 48, 96]; p < .001) (Table 3).
Table 3.
The difference in median pedal acceleration time (PAT) in patients (n = 142) undergoing open and endovascular revascularisation.
| Procedure | Patients | Pre- revascularisation PAT | Post-revascularisation PAT | Difference in median PAT | p value |
|---|---|---|---|---|---|
| Open | 22 (15.5) | 256 (140, 200) | 101 (80, 136.8) | 136 (52, 197.5) | <.001 |
| Endovascular | 107 (75.4) | 240 (163, 300) | 120 (96, 151) | 96 (48, 96) | <.001 |
Data are shown as n (%) or median (IQR).
DISCUSSION
This study adds novel information regarding the use of PAT in the assessment of patients undergoing revascularisation. PAT measurements were shown to change as expected with effective revascularisation. Patients with DM had a smaller change in PAT post-revascularisation compared with patients without DM. There was a greater change in post-intervention PAT for patients who underwent open intervention compared with endovascular intervention.
Two previous studies have looked at changes in PAT post-revascularisation. Geskin et al. found a statistically significant decrease in PAT post-endovascular intervention in 38 limbs for 30 patients with CLTI from class 3 to class 2.25 Ochoa-Ayon et al. also found that all 31 patients in their cohort demonstrated a greater change in PAT measurements after endovascular revascularisation, with a mean decrease from class 3 to class 1.26 The median baseline PAT pre-intervention was shorter in both these cohorts, suggesting that patients presented with more severe PAD in the current study. However, neither study compared differences in change in PAT after intervention for patients with and without DM, neither did they assess the differences for different treatment types (open and endovascular).
Patients in this study with DM showed a smaller decrease in PAT post-revascularisation compared with patients without DM. Patients with DM had a higher incidence of tibial and pedal atherosclerotic plaque and medial arterial calcification, which poses technical challenges to effective revascularisation.27 Evidence suggests that DM negatively affects long term primary patency rates, amputation free survival, and mortality rates in patients with CLTI undergoing revascularisation.11, 12, 13, 14 These factors may contribute to the difference in PAT change after revascularisation for patients with DM observed in this study, in that patients with DM do not achieve the same change in perfusion after revascularisation. This could indicate a need for more aggressive revascularisation strategies in DM patients compared with non-DM patients, along with more nuanced patient selection and further research into the adjunctive factors to wound healing that may need addressing in the diabetic population.
In this single centre study, with few open revascularisation interventions, there was a greater change in PAT from pre-to post-revascularisation for open surgical revascularisation, thereby indicating a greater improvement in foot perfusion in this group. The most appropriate intervention strategy for PAD is still heavily debated.28,29 Endovascular revascularisation is minimally invasive, more widely used, and may offer better short and long term risk of amputation and death compared with open revascularisation, as recommended by the BASIL 2 trial.21,30 However, the BEST-CLI trial found that in patients with CLTI and an adequate single segment great saphenous vein, open revascularisation had a lower incidence of major adverse limb events and death and greater amputation free survival.20 PAT has the potential to be a useful parameter for improvement in perfusion post-revascularisation and can aid in identifying the most appropriate revascularisation technique (open or endovascular) for patients.
Strengths and limitations
This study highlights the use of PAT in assessing the efficacy of revascularisation strategies. This is the first study to describe the difference in change of PAT pre- and post-revascularisation intervention in patients with and without DM.
The study had some limitations. Some patients who presented during the study period with CLTI were not captured due to presenting out of hours or on weekends (inability to acquire PAT measurements before revascularisation for these patients). The anatomic distribution of arterial disease and thus location of revascularisation was not analysed in the open vs. endovascular revascularisation subanalysis. Hence, future larger studies are required that anatomically match revascularisation to compare endovascular with open revascularisation. Larger research cohorts are required to corroborate the findings of this study and thereby provide greater evidence for the implementation of PAT within vascular services in assessing the improvement of foot perfusion after revascularisation.
Conclusion
This study shows that PAT is a useful tool to measure foot perfusion and can be used to assess perfusion status pre-intervention and monitor improvement post-revascularisation. The study shows that patients with DM have a smaller change in PAT post-revascularisation and have a larger change in PAT after open revascularisation. Future research can identify the reasons for this to improve limb salvage in this at risk cohort.
FUNDING
O.H. is the recipient of the Reg Worcester Research Scholarship 2023 and the Professor Philip Walker Vascular Surgery Research Scholarship 2022 and 2021, with support from the Royal Australasian College of Surgeons and the Foundation for Surgery.
CONFLICT OF INTEREST
None.
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