Longitudinal assessment of health-related quality of life and clinical outcomes with at home advanced pneumatic compression treatment of lower extremity lymphedema.

OBJECTIVE

This prospective, longitudinal, pragmatic study describes at home treatment with a proprietary advanced pneumatic compression device (APCD) for patients with lower extremity lymphedema (LED).

METHODS

Following institutiona review board approval, four participating Veterans Affairs centers enrolled LED patients from 2016 to 2022. The primary outcome measures were health-related quality of life (HR-QoL) questionnaires (lymphedema quality of life-leg and the generic SF-36v2) obtained at baseline and 12, 24, and 52 weeks. The secondary outcome measures were limb circumference, cellulitis events, skin quality, and compliance with APCD and other compression therapies.

RESULTS

Because a portion of the trial was conducted during the coronavirus disease 2019 pandemic, 179 patients had 52 weeks of follow-up, and 143 had complete measurements at all time points. The baseline characteristics were a mean age of 66.9 ± 10.8 years, 91% were men, and the mean body mass index was 33.8 ± 6.9 kg/m. LED was bilateral in 92.2% of the patients. Chronic venous insufficiency or phlebolymphedema was the most common etiology of LED (112 patients; 62.6%), followed by trauma or surgery (20 patients; 11.2%). Cancer treatment as a cause was low (4 patients; 2.3%). Patients were classified as having International Society for Lymphology (ISL) stage I (68.4%), II (27.6%), or III (4.1%). Of the primary outcome measures, significant improvements were observed in all lymphedema quality of life-leg domains of function, appearance, symptoms, and emotion and the overall score after 12 weeks of treatment (P < .0001) and through 52 weeks of follow-up. The SF-36v2 demonstrated significant improvement in three domains at 12 weeks and in the six domains of physical function, bodily pain, physical component (P < .0001), social functioning (P = .0181), role-physical (P < .0005), and mental health (P < .0334) at 52 weeks. An SF-36v2 score <40 indicates a substantial reduction in HR-QoL in LED patients compared with U.S. norms. Regarding the secondary outcome measures at 52 weeks, compared with baseline, the mean limb girth decreased by 1.4 cm (P < .0001). The maximal reduction in mean limb girth was 1.9 cm (6.0%) at 12 weeks in ISL stage II and III limbs. New episodes of cellulitis in patients with previous episodes (21.4% vs 6.1%, P = .001) were reduced. The 75% of patients with skin hyperpigmentation at baseline decreased to 40% (P < .01) at 52 weeks. At 52 weeks, compliance, defined as use for 5 to 7 days per week, was reported for the APCD by 72% and for elastic stockings by 74%.

CONCLUSIONS

This longitudinal study of Veterans Affairs patients with LED demonstrated improved generic and disease-specific HR-QoL through 52 weeks with at home use of an APCD. Limb girth, cellulitis episodes, and skin discoloration were reduced, with excellent compliance.