Longitudinal Assessment of Quality of Life, and Clinical Outcomes with at Home Advanced Pneumatic Compression Treatment of Lower Extremity Lymphedema

Wednesday, September 20, 2023

9:06 AM – 9:16 AM US EDT

Location: Grand Ballroom A

Introduction, Objectives, and/or Purpose:

Purpose: This prospective pragmatic study describes the results of at home treatment with a proprietary Advanced Pneumatic Compression Device (APCD) in patients with lower extremity Lymphedema (LED).

Methods:

Methods: Following IRB approval, five participating VA centers enrolled LED patients from February 2016 - 2023. Primary outcome measures included the Limb Lymphedema Quality of Life Questionnaire (LYMQOL) and SF-36 generic QoL performed 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:

Results: 179 patients had 52-week follow-up, while 121 had complete measurements at all time points (during COVID). Baseline characteristics were: mean age 66.9 +/- 10.8 years, 91% male, and mean BMI 33.8 +/- 6.9. 92.2% had bilateral LED. Chronic venous insufficiency 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%). 68.4% of patients were classified as ISL stage one, while 27.6% and 4.1% were stage two and three, respectively
Primary outcome measures: The SF-36 demonstrated statistically significant improvements at 52 weeks for physical function, bodily pain, physical component (p < 0.0001), social functioning (p = 0.0185), role-physical (p < 0.0015), and mental health (p < 0.0336).
Statistically significant improvements were observed in all LYMQOL domains of function, appearance, symptoms, emotion, and overall score after 12 weeks of treatment (p < 0.0001) and through 52 weeks of follow-up.
Secondary Outcome Measure: Limb Girth Measurements in ISL stage 2/3 limbs decreased by 1.8 cm (5.6%). New episodes of cellulitis in patients with previous episodes (21.4% vs 6.1%, p=0.001) was reduced. The 75% patients with skin hyperpigmentation at baseline decreased to 40% (p < 0.01) at 52 weeks. Compliance with a 5 -7 day/week APCD use was reported in 72% and elastic stockings in 74% at 52weeks.

Conclusion(s):

Conclusions: This longitudinal study of VA patients with LED demonstrated improved generic and disease specific quality of life through 52 weeks with the home use of an APCD. Limb girth, cellulitis episodes and skin discoloration were reduced, while compliance was maintained.

Presenting Author(s)

FP

Frank T. Padberg, Jr., MD, DFAVF,DFSVS, FACS

Professor of Surgery, Department of Surgery
Rutgers-New Jersey Medical School
Newark, New Jersey, United States

Tactile Medical (Products/Services: Flexitouch PCD) (Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received)

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Co-Author(s)

AU

Areck Ucuzian, MD

MD
University of Maryland School of Medicine, Maryland, United States

Tactile Medical (Products/Services: Flexitouch PC) (Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support)

HD

Hasan Dosluoglu, MD

Chief of Surgery
Buffalo VA Hospital
Buffalo, New York, United States

Tactile Medical (Products/Services: Flexitouch PCD) (Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received)

Thomas F. O'Donnell, MD

Benjamin Andrews Emeritus Professor and Chair of Surgery
Tufts Medical Center
Wellesley, Massachusetts, United States

Tactile Medical (Products/Services: no) (Consultant/Advisory Board)