Abstract

Objective: Many patients who undergo lower extremity revascularization (LER) for peripheral artery disease (PAD) continue to experience mobility impairment despite adequate revascularization. High-pressure intermittent limb compression (HPILC) has been shown to augment leg blood flow and improve walking endurance in symptomatic PAD patients. This pilot trial aimed to examine the feasibility of home-based HPILC for 2 hours daily over 3 consecutive months in patients who underwent LER for PAD. The primary outcome was the change in 6-minute walk distance from baseline to 3-month follow-up. Methods: Three months following LER, 9 participants were randomly assigned to either HPILC (n=5) or a sham (n=4) group. Participants were provided with a portable pneumatic air pump and inflatable cuffs that were wrapped around the feet, ankles, and calves (ArtAssist, ACI Medical). The inflation pressures were 120 mmHg and 30 mmHg in the HPILC and sham devices, respectively. A built-in timer, inaccessible to participants, provided one estimate of treatment compliance. Outcomes were assessed before and after the completion of the 3-month interventions. Results: Among the 9 randomized participants, one individual required reintervention and was withdrawn from the study. Adherence to treatment was 74% for HPILC and 92% for sham. As shown in Figure 1, the change in 6-minute walk distance from baseline tended to be higher in the HPILC group compared to the sham-treated group (HPILC: 35.2±38.7 m vs. Sham: -14.7±25 m, p=0.07). There were no group differences in the secondary outcomes, including the changes in the ankle-brachial index, the toe-brachial index, and the Vascular Quality of Life questionnaire scores. Conclusions: Home-based HPILC following LER for PAD is feasible, well-tolerated, and appears to improve walking performance. These preliminary findings indicate that HPILC may be a useful adjunct therapy to enhance lower extremity functioning in patients recovering from LER.

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