Assessment of quality of life changes in patients with lower extremity lymphedema using an advanced pneumatic compression device at home.

ABSTRACT

OBJECTIVE: Lymphedema is associated with significant morbidity and healthcare resource usage. Conventional therapy efficacy has been limited, with poor surgical salvage options. Preliminary studies have demonstrated that the use of advanced pneumatic compression devices (APCDs) improves clinical outcomes. However, limited evidence regarding their role in healthcare cost mitigation or health-related quality of life (QOL) is available. METHODS: The present postmarket, multicenter, single-arm, observational clinical trial conducted in the Veterans Affairs Healthcare System evaluated patients with a diagnosis of primary or secondary edema of unilateral or bilateral lower extremities treated with the Flexitouch APCD (Tactile Medical, Minneapolis, Minn) from February 2016 to March 2019. The patients were assessed at baseline and 12, 24, and 52 weeks from enrollment by limb circumference, QOL assessments (short form-36 and Lymphedema Quality of Life), device compliance, cellulitis episodes, and lymphedema-related healthcare use since the previous visit. The primary endpoints of interest were the QOL at baseline compared with at 12 weeks, unscheduled lymphedema-related clinic visits, and hospital admissions at 52 weeks. The secondary endpoints included the change in limb girth and QOL at 52 weeks compared with baseline. RESULTS: A total of 178 patients with lower extremity lymphedema were prospectively enrolled. The present study reports the interim data for the first 74 subjects to complete 52 weeks of APCD treatment. The cohort was predominately male (94.6%), elderly (mean age, 67 years), obese (median body mass index, 32 kg/m2), and most commonly enrolled for the treatment of phlebolymphedema (71.6%) with largely bilateral lower extremity involvement (91.9%). No significant difference was seen in QOL at 12 weeks. However, at 52 weeks, the Lymphedema Quality of Life scores had significantly improved from baseline (6.3 vs 7.4; P < .0001) and the short form-36 had demonstrated significant improvement from baseline in the physical component (38.6 vs 40.8; P = .035), with an effect toward overall improvement in the mental component (49.9 vs 51.3; P = .549). The limb circumference had decreased significantly at 12 weeks compared with baseline (28.5 cm vs 27.7 cm; P = .0005) in the most affected lower extremity, and this reduction had remained stable for the study duration. APCD treatment was associated with a significant reduction in cellulitis episodes (24.3% vs 8.1%; P = .005), lymphedema-related clinic visits (2.2 vs 0.7; P = .02), urgent care visits (1.2 vs 0.3; P = .004), and hospital admissions (0.5 vs 0.1; P = .047) per patient. CONCLUSIONS: The Flexitouch APCD resulted in initial significant limb girth reduction as early as 12 weeks and a steady and sustained improvement in health-related QOL for ≤1 year. The latter was likely reflective of a decrease in cellulitis episodes and fewer associated lymphedema-related clinic and urgent care visits and hospital admissions.