Use of a Portable, Non-pneumatic Active Compression Device in treatment of Phlebolymphedema: a TEAYS sub-analysis.
Academic Article
Overview
abstract
OBJECTIVE: Non-pneumatic compression devices (NPCDs) have demonstrated their clinical efficacy and safety in treating lymphedema (LED) in multiple studies, including two recent multi-centered, randomized head-to-head comparative studies with advanced pneumatic compression devices (APCD). In the most recent study, TEAYS (ClinicalTrials.gov Identifier: NCT05507346), NPCDs demonstrated better clinical utility as well as greater efficacy and adherence than APCDs in the treatment of lower extremity swelling. This current sub analysis of TEAYS focuses on the outcomes for patients whose secondary lymphedema is associated with underlying venous etiology or phlebolymphedema (PLED). METHODS: This trial was a randomized, crossover head-to-head study was performed across nine sites in the US in 2023. Patients were subjected to an initial 4-week washout period and then randomized to either the NPCD or a commercially available APCD. Patients used the randomly assigned initial device for 90 days followed by a second 4-week washout period before a 90-day use of the second device. The current study focuses specifically on the sub-analysis of the cohort of PLED patients. Primary efficacy outcomes assessed in this study included change in affected limb volume between baseline (day 0) and end of treatment (day 90), change in Lymphedema Quality of Life Questionnaire (LYMQOL), and treatment adherence. RESULTS: Analysis included a total of 71 patients with lower extremity lymphedema; 35 of whom were diagnosed with PLED and this subset comprises the study cohort for the current study. In the PLED cohort 13 (37%) were male, Average BMI was 36.2 +/- 1.68, and 19 had bilateral limbs affected (54%). Most patients had clinical stage II lymphedema: I (n=6), II (n=20) and III (n=9). These PLED patients achieved statistically greater mean limb volume reduction (424.49±100.9mL) while on NPCD vs (50.8± 112.1mL) for APCD (p=.0085). NPCD also showed significantly better improvement in overall Quality of Life (1.39±0.39) vs. APCD (0.18±0.29); (p=0.01). Statistically significant improvement in adherence was also observed while on NPCD 81% vs APCD 49% (p ≤ .001). No device-related adverse events were reported. CONCLUSION: The NPCD is a clinically effective treatment for decreasing limb volume in patients with lower extremity LED. The NPCD was more effective than an APCD and resulted in superior limb volume decrease, greater improved quality of life, adherence, mobility, and patient satisfaction. The outcomes for the subset of patients diagnosed with PLED corroborates the improvements seen in the overall LED study patient population previously reported. Additionally, results suggest that PLED patients may potentially benefit even more from NPCD than non-PLED patients.
