Safety and Effectiveness of a Novel Non-Pneumatic Active Compression Device for Treating Breast Cancer-Related Lymphedema, a Multi-center Randomized, Crossover Trial (NILE). Journal of vascular surgery. Venous and lymphatic disorders Rockson, S. G., Whitworth, P. W., Cooper, A., Kania, S., Karnofel, H., Nguyen, M., Shadduck, K., Gingerich, P., Armer, J. 2022


Advanced pneumatic compression devices (APCDs) have been shown to be an effective intervention for lymphedema when used as part of a self-care maintenance treatment regimen. However, adherence to self-care is poor, and APCDs require patients to be immobile during treatment. We sought to evaluate the safety and efficacy of a novel non-pneumatic compression device (NPCD) for treating lymphedema versus an APCD.A randomized, crossover head-to-head investigation at five US sites in 2021. Patients were randomized to either the NPCD or a commercially-available APCD. Subjects used the randomly assigned initial device for 28 days with a 4-week washout period prior to a comparable 28-day utilization of the second device.Data from 50 adult women with unilateral breast cancer-related lymphedema (BCRL) were analyzed. When compared with the APCD, the NPCD was associated with greater mean reduction in limb edema volume (64.6% vs. 27.7%, p<0.001), significantly greater mean improvements in quality of life scores, greater adherence (95.6% vs. 49.8%, p<0.001), and greater satisfaction with the device (90% vs. 14%, p<0.001). Patients indicated that the NPCD facilitated exercise and was convenient for travel. No adverse events were reported.The novel NPCD is an effective maintenance treatment for reducing limb volume in BCRL patients. The device was more effective than an APCD and resulted in higher adherence to self-care interventions and greater patient satisfaction.

View details for DOI 10.1016/j.jvsv.2022.06.016

View details for PubMedID 35952956