Results from A Comparative Study to Evaluate the Treatment Effectiveness of a Non-Pneumatic Compression Device versus an Advanced Pneumatic Compression Device for Lower Extremity Lymphedema Swelling (TEAYS study).

Objectives: Advanced pneumatic compression devices (APCDs) have been shown to be effective in treatment of lower extremity lymphedema in the home setting. However, adherence to self-care has been poor, and APCD's require patients to remain immobile during treatment. We evaluated the safety and efficacy of a novel non-pneumatic compression device (NPCD) for treating lower extremity lymphedema vs and APCD.

Methods: A randomized, crossover head-to-head study was performed at nine sites in 2023. Patients were randomized to either the NPCD or a commercially available APCD. Patients used the randomly assigned initial device for 28 days with a 4-week washout period before a comparable 28-day use of the second device.

Results: A total of 71 patients (108 affected limbs) with lower extremity lymphedema were analyzed. Compared with the APCD, the NPCD was associated with a greater mean reduction in limb edema volume (a mean limb volume reduction of 369.9 (± 68.19) mL p<0.05 vs 83.1 (± 67.99 mL) p<0.05). Significant improvement in Quality of Life was achieved for NPCD and but not for APCD treatment (score improvement of 1.01 (± 0.23) (p<0.05) for NPCD vs 0.17 (± 0.18) (p>0.05) for APCD). Patients reported greater adherence (81% vs 56%, p<0.001) and satisfaction with the NPCD (78% vs 22%) compared to APCD. No device related adverse events were reported.

Conclusions: The novel NPCD is an effective treatment for reducing limb volume in patients with lower extremity lymphedema. The NPCD was more effective than an APCD and resulted in superior limb volume reduction, greater improved QoL, adherence, mobility, and patient satisfaction.