Article ; Online: Longitudinal Assessment of Health-Related Quality of Life and Clinical Outcomes with At Home Advanced Pneumatic Compression Treatment of Lower Extremity Lymphedema.
Journal of vascular surgery. Venous and lymphatic disorders
2024 , Page(s) 101892
Abstract: Objective: This prospective longitudinal pragmatic study describes at home treatment with a proprietary Advanced Pneumatic Compression Device (APCD) in patients with lower extremity Lymphedema (LED).: Methods: Following IRB approval, 4 participating ... ...
| Abstract | Objective: This prospective longitudinal pragmatic study describes at home treatment with a proprietary Advanced Pneumatic Compression Device (APCD) in patients with lower extremity Lymphedema (LED). Methods: Following IRB approval, 4 participating VA centers enrolled LED patients from 2016 -2022. Primary outcome measures were Health-Related Quality of Life (HR-QoL) questionnaires; (LYMQOL-leg) and the generic SF-36v2™ obtained at baseline, 12, 24, and 52 weeks. Secondary outcome measures were limb circumference, cellulitis events, skin quality, and compliance with APCD and other compression therapies. Results: As a portion of the trial was conducted during COVID, 179 patients had 52-week follow-up, while 143 had complete measurements at all time points. Baseline characteristics were mean age 66.9 ± 10.8 years, 91% male, and mean BMI 33.8 ± 6.9. LED was bilateral in 92.2%. Chronic venous insufficiency or phlebolymphedema was the most common etiology of LED (112 patients; 62.6%), followed by trauma/surgery (20 patients; 11.2%). Cancer treatment as a cause was low at 4 patients (2.3%). Patients were classified as International Society for Lymphology (ISL) stage one (68.4%), two (27.6%) and three (4.1%) respectively. Primary outcome measures: Significant improvements were observed in all LYMQOL-leg domains of function, appearance, symptoms, emotion, and overall score after 12 weeks of treatment (p < 0.0001) and through 52 weeks of follow-up. The SF-36v2™ demonstrated significant improvement in 3 domains at 12 weeks; and at 52 weeks in 6 domains of physical function, bodily pain, physical component (p <0.0001), social functioning (p = 0.0186), role-physical (p < 0.0006), and mental health (p < 0.0333). SF-36v2™ scores <40 indicate a substantial reduction in HR-QoL in LED patients compared to US norms. Secondary Outcome Measures at 52 weeks: Compared to baseline, mean limb girth decreased by 1.4 cm (p<.0001); the maximal reduction in mean limb girth measurement was 1.9 cm (6.0%) at 12 weeks in ISL stage 2/3 limbs. New episodes of cellulitis in patients with previous episodes (21.4% vs 6.1%, p=0.001) were reduced. The 75% of patients with skin hyperpigmentation at baseline decreased to 40% (p <0.01) at 52 weeks. At 52 weeks, compliance, defined as use 5 -7 day/week, was reported with APCD in 72% and elastic stockings in 74%. Conclusions: This longitudinal study of VA 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, while maintaining excellent compliance. |
|---|---|
| Language | English |
| Publishing date | 2024-04-16 |
| Publishing country | United States |
| Document type | Journal Article |
| ISSN | 2213-3348 |
| ISSN (online) | 2213-3348 |
| DOI | 10.1016/j.jvsv.2024.101892 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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