OBJECTIVE: Advanced pneumatic compression devices (APCDs) have been shown to be effective in treatment of lower extremity lymphedema in the home setting. However, adherence to self-care has been poor, and APCD\'s require patients to remain immobile during treatment. We evaluated the safety and efficacy of a novel non-pneumatic compression device (NPCD) for treating lower extremity lymphedema vs and APCD.
METHODS: A randomized, crossover head-to-head study was performed at nine sites in 2023. Patients were randomized to either the NPCD or a commercially available APCD. Patients used the randomly assigned initial device for 28 days with a 4-week washout period before a comparable 28-day use of the second device.
RESULTS: A total of 71 patients (108 affected limbs) with lower extremity lymphedema were analyzed. Compared with the APCD, the NPCD was associated with a greater mean reduction in limb edema volume (a mean limb volume reduction of 369.9 (± 68.19) mL p<0.05 vs 83.1 (± 67.99 mL) p<0.05). Significant improvement in Quality of Life was achieved for NPCD and but not for APCD treatment (score improvement of 1.01 (± 0.23) (p<0.05) for NPCD vs 0.17 (± 0.18) (p>0.05) for APCD). Patients reported greater adherence (81% vs 56%, p<0.001) and satisfaction with the NPCD (78% vs 22%) compared to APCD. No device related adverse events were reported.
CONCLUSIONS: The novel NPCD is an effective treatment for reducing limb volume in patients with lower extremity lymphedema. The NPCD was more effective than an APCD and resulted in superior limb volume reduction, greater improved QoL, adherence, mobility, and patient satisfaction.

BACKGROUND: Phlebolymphedema is a challenging condition to manage, with limited options for effective treatment. For patients, this may be debilitating and lead to infection, loss of independence and affect quality of life. This study aims to evaluate patient-reported outcomes of an advanced pneumatic compression device (APCD) in the treatment of lower extremity phlebolymphedema.
METHODS: Patients with diagnosis of lower extremity phlebolymphedema at an acute care facility within the New York City Health and Hospitals Cooperation treated with the Flexitouch (FLX) (Tactile Systems Technology, Inc, Minneapolis, Minnesota) APCD from December 2021 to March 2023 were evaluated. Patient-perceived subjective outcomes were assessed via a short questionnaire, with subsequent analysis using chi-squared test. Primary end points were subjective improvements in 1) swelling, 2) pain, and 3) ease of use of device as surrogates for patient satisfaction. Secondary end point was subjective patient-reported compliance, obtained by investigating 1) if patients were trained to use device, and 2) if patients were using the device.
RESULTS: A total of 52 participants were included in this study, consisting of 30.8% male and 69.2% female patients with a mean age of 71.7 years. While selection criteria did not exclude unilateral disease or alternative etiologies, we note that the entire study population had been diagnosed with bilateral lower extremity lymphedema in the setting of chronic venous insufficiency. Other patient characteristics including race, comorbidities and smoking status were documented in Table 1. Table 2 demonstrates the results of chi-squared analysis. This study noted significant patient-perceived improvement in swelling and pain (91.4% with P < 0.00001; 85.7% with P = 0.00002 respectively) and patient-reported ease of use of the FLX device (85.7% with P = 0.00002). Additional secondary findings included a majority of patients reporting being trained on how to use FLX and also maintaining compliance with the device (69.2% with P = 0.005; 67.3% with P = 0.012 respectively).
CONCLUSIONS: FLX APCD use has been found to demonstrate desirable patient-reported outcomes as a general trend. The participants in this study noted statistically significant subjective improvement in swelling and pain, ease of use of device and adherence to training and compliance with device. FLX appears to be positively received by patients, and the authors recommend its consideration for management of bilateral lower extremity phlebolymphedema.

This study aimed to investigate the effects of complex decongestive therapy (CDT) applied to the lower extremities of patients with lymphedema of different causes on the extremity volume, quality of life (QoL), and functionality.
The study included 90 patients, of whom 28 had primary lymphedema, 30 had secondary lymphedema, 18 had phlebolymphedema, and 14 had lipolymphedema. A total of 137 extremities were treated with CDT. The patients who received CDT for 5 days a week for 3 weeks (15 sessions in total) were included in the sample. Extremity volume was measured using a tape measure. The lymphedema QoL-Leg Questionnaire was used to evaluate QoL, and the lower extremity functional scale (LEFS) was administered to assess lower extremity functionality.
The changes in QoL before and after treatment significantly differed in the primary lymphedema, phlebolymphedema, and lipolymphedema groups (p < 0.05). The post-treatment LEFS scores indicated a significant decrease in the phlebolymphedema and lipolymphedema groups compared to the pre-treatment scores (p < 0.05).
The difference in appearance, which is one of the sub-parameters of QoL, significantly decreased in the comparisons performed between the groups, whereas the changes in the remaining parameters were not significant.
Investigar los efectos de la terapia descongestiva compleja (TDC) aplicada a las extremidades inferiores de pacientes con linfedema de diferentes causas sobre el volumen de la extremidad, la calidad de vida y la funcionalidad.
Se incluyeron en el estudio 90 pacientes, de los cuales 28 tenían linfedema primario, 30 linfedema secundario, 18 flebolinfedema y 14 lipolinfedema. Un total de 137 extremidades fueron tratadas con TDC. Se incluyeron en la muestra pacientes que recibieron TDC durante 5 días a la semana durante 3 semanas (15 sesiones en total). El volumen de las extremidades se midió con una cinta métrica. Se utilizó el Cuestionario de calidad de vida (QoL) de las piernas para el linfedema para evaluar la calidad de vida, y se administró la Escala funcional de las extremidades inferiores (LEFS) para evaluar la funcionalidad de estas.
Los cambios en la calidad de vida antes y después del tratamiento difirieron significativamente en los grupos de linfedema primario, flebolinfedema y lipolinfedema (p < 0.05). Las puntuaciones LEFS posteriores al tratamiento indicaron una disminución significativa en los grupos de flebolinfedema y lipolinfedema en comparación con las puntuaciones previas al tratamiento (p < 0.05).
La diferencia de apariencia, que es uno de los subparámetros de la calidad de vida, disminuyó significativamente en las comparaciones realizadas entre los grupos, mientras que los cambios en los demás parámetros no fueron significativos.

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/m2. 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.

OBJECTIVE: The aims of this study were: to define the incidence of cellulitis in patients with lymphedema (LED) overall and relate this to the etiology of LED; to determine how this rate might be affected by recurrence of cellulitis; and to quantify the contemporary economic burden of treatment. Understanding these factors is essential in developing targeted cellulitis prevention strategies and reducing health care costs.
METHODS: The IBM MarketScan Research Database was examined from April 2013 to March 2019 for patients with a new diagnosis of LED (n = 85,601). Based on International Classification of Diseases (ICD)-9/ICD-10 diagnosis codes, the incidence and cost of cellulitis were ascertained during the 3-year follow-up period. Incidence rates (per 100 patient-years [PYs]) and cost (per patient per year) of cellulitis were evaluated among all patients with LED and within subgroups of LED etiologies.
RESULTS: Among the three most common morbidities associated with LED (breast cancer-related lymphedema [BCRL], n = 17,954 [20.97%]; gynecological cancer-related LED [GCRL], n = 1256 [1.47%]; and phlebolymphedema [PLED], n = 8406 [9.82%]), rates of cellulitis were markedly lower for BCRL (8.9; 95% confidence interval [CI], 8.7-9.2) and GCRL (14.8; 95% CI, 13.4-16.4) vs PLED (47.7; 95% CI, 46.7-48.8). Patients with a history of cellulitis had markedly higher cellulitis rates during follow-up than those without-overall, 74.0% vs 16.4%; BCRL, 42.9%; 95% CI, 39.7%-46.3% vs 7.6%; 95% CI, 7.3%-7.9%; GCRL, 67.5%; 95% CI, 56.4%-80.8% vs 11.0%; 95% CI, 9.8%-12.4%; and PLED, 81.7%; 95% CI, 79.4%-84.1% vs 30.4%; 95% CI, 29.4%-31.4%, respectively. The mean $/patient/year of cellulitis-related costs for a patient with PLED ($2836; 95% CI, $2395-$3471) was significantly greater than that for BCRL ($503; 95% CI, $212-$1387) and GCRL ($609; 95% CI, $244-$1314).
CONCLUSIONS: The incidence of cellulitis associated with LED varies by the etiology of LED. PLED has the highest rates of both an initial cellulitis episode and recurrent cellulitis events. Additionally, PLED has one of the largest cellulitis-related total costs per patient per year. Prevention, as well as early identification and treatment of PLED-associated cellulitis, could significantly decrease health care costs and improve patient quality of life.

OBJECTIVE: Phlebolymphedema has been noted to be one of the most common causes of lymphedema in the lower extremity in western societies. Although complex decongestive therapy (CDT) represents the mainstay of lymphedema treatment, its role for phlebolymphedema arising from chronic iliofemoral venous obstruction (CIVO) merits further exploration. We evaluated this through the use of a protocol of CDT first for limbs with CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical C3 disease and stent correction of obstruction before CDT for those with more advanced disease (CEAP C4-C6). In the present study, we analyzed the outcomes after the use of such a protocol.
METHODS: We analyzed prospectively collected data for 192 limbs (166 patients) that underwent treatment of quality-of-life (QoL) impairing symptoms from CIVO due to lymphoscintigraphically determined phlebolymphedema between 2017 and 2022. The characteristics evaluated included CEAP clinical class, venous clinical severity score (VCSS), grade of swelling (GOS), visual analog scale (VAS) pain score, QoL (CIVIQ-20 [20-item chronic venous disease quality of life questionnaire]), stenting for CIVO, and outcomes related to CDT and stenting. For the limbs undergoing CDT or stenting followed by CDT, the outcomes were evaluated at 6 weeks and 3, 6, and 12 months after completion of CDT. Paired and unpaired t tests, χ2 tests, and analysis of variance were used for comparisons of clinical variables. Kaplan-Meier analysis was used to evaluate stent patency, with the log-rank test used to discriminate between different curves.
RESULTS: Of the 192 limbs (166 patients) in the entire cohort, 74 were in the C3 group and 118 were in the C4-C6 group. The median patient age was 63 years; 57 were men and 109 were women. In the C3 group, after CDT, improvement had occurred in the VCSS and VAS pain score at 6 weeks (P < .0001) and at 3 (P < .0001), 6 (P < .0001), and 12 (P < .0001) months. Improvement in the GOS was noted at 6 (P < .0001) and 12 (P = .0005) months. The CIVIQ-20 score improved from 63 to 38 (P = .009). Nine limbs (12%) in the C3 group required stenting after CDT. In the C4-C6 group, of the 118 limbs, 75 (64%) underwent stenting only and 43 (36%) underwent stenting followed by CDT for persistent QoL impairing symptoms. For this latter group, after CDT, improvement occurred in the VCSS, GOS, and VAS pain score at 6 weeks (P < .0001) and 3 (P < .0001), 6 (P < .0001), and 12 (P < .0001) months. The CIVIQ-20 score improved from 61 to 34 (P < .0001). The primary, primary assisted, and secondary patency in the C4-C6 group at 36 months was 92%, 100%, and 100%, respectively.
CONCLUSIONS: For CEAP C3 patients with phlebolymphedema due to CIVO, CDT should be a part of the first line of treatment. Stenting should be reserved for those with QoL impairing symptoms despite the use of CDT. Additionally, CDT helps provide symptom relief for patients with more advanced CEAP C4-C6 disease with persistent or residual edema after stenting. Further study is warranted.

Recent studies have emphasized the important role lymphatics play in the drainage of interstitial fluid and edema prevention. Although the infrainguinal lymphatics have been studied in some depth, with patterns of pathology identified, such data above the groin are sparse, especially for patients with phlebolymphedema. The present study attempts to evaluate the status of lymphatic flow above the inguinal ligament in patients presenting with edema and undergoing stenting for symptomatic chronic iliofemoral venous obstruction (CIVO).
A total of 31 lower limbs that underwent pedal lymphoscintigraphy for leg edema and subsequent stenting for symptomatic CIVO formed the study cohort. Each limb underwent intranodal lymphangiography of an ipsilateral inferior inguinal lymph node (10 mL of lipiodol) at the time of stenting. Fluoroscopic visualization of lipiodol transit was performed at 20, 40, and 60 minutes and 3 hours after injection. Enumeration of the lymph nodes and lymphatic collector vessels from above the inguinal ligament to L1, visualization of the thoracic duct, the time delay to visualization of the thoracic duct, and pathologic changes to the thoracic duct when present were all evaluated. These anomalies were independently scored, with the scores combined to generate a total suprainguinal score (range, 0-3). This score was then compared to the limb\'s lymphoscintigraphically derived infrainguinal score (total infrainguinal score range, 0-3) using the t test and Spearman correlation. The clinical outcomes (grade of swelling, venous clinical severity score) after stenting were appraised.
Of the 30 patients (31 limbs), 18 were women, with left laterality noted in 23 limbs. A nonthrombotic iliac vein lesion occurred in 9 limbs and post-thrombotic syndrome in 22 limbs. Of the 31 limbs, 24 (77%) had suprainguinal lymphatic disease (SLD), with 22 of the 24 limbs having severe SLD and 2, mild SLD. When SLD was compared with infrainguinal lymphatic disease, 6 limbs (19%) had the same degree of involvement above and below the groin (1 with normal and 5 with severe disease), 17 limbs (55%) had more severe SLD, and 8 limbs (26%) had more severe infrainguinal lymphatic disease. Three limbs with normal pedal lymphoscintigraphic findings had severe SLD. The Spearman correlation coefficient for the comparison of SLD and infrainguinal disease in the same limb was 0.1 (P = .69). At baseline, the limbs with severe SLD had the same degree of leg swelling and venous clinical severity score as the limbs with absent to mild SLD (P > .1) with similar improvements after stenting (P > .4). Seven limbs underwent complex decongestive therapy (all with severe SLD and concomitant severe infrainguinal disease in one) to treat significant residual leg edema, with improvement.
SLD appears to be common in patients with leg edema undergoing stenting for symptomatic CIVO. Such disease appears to affect the thoracic duct more commonly. Although patients with persistent or residual leg edema after stenting can benefit from complex decongestive therapy, further workup in the form of inguinal intranodal lymphangiography and targeted intervention might need to be considered for those who do not benefit from such therapy. Further study is warranted.

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.
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.
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.
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.

The objective of this study was to define the current forms of treatment in a contemporary population of lymphedema (LED) patients for LED related to breast cancer, the most prevalently diagnosed LED comorbidity in Western countries, and phlebolymphedema with venous leg ulcer (PLEDU), a sequela of chronic venous disease. The goals of LED therapy are to reduce edema, thereby improving function and related symptoms, and to improve skin integrity to prevent development of infection. Treatment is generally nonsurgical: conservative care, including complex physical therapy, manual lymphatic drainage, and compression bandaging; or pneumatic compression device (PCD) therapy by a simple nonprogrammable device or an advanced programmable device.
To determine the frequency of individual types of treatment for LED and their relationship to breast cancer-related lymphedema (BCRL) and PLEDU, we queried claims from a deidentified Health Insurance Portability and Accountability Act-compliant commercial administrative insurance database with >165 million members. A total of 26,902 patients identified with LED who had been enrolled with continuous medical benefits for 12 months before and after the index date for the complete years 2012 through 2016 were separated into four treatment categories: no treatment, conservative care, simple PCD (SPCD), and advanced PCD. LED treatment was related to the BCRL and PLEDU comorbidities.
BCRL patients, who represented 32.1% of all study patients, made up 41% of all patients receiving conservative care and 24% of patients receiving PCD therapy. By contrast, PLEDU patients (9.6% of study patients) were proportionally under-represented in the conservative care group (7.8%) but composed a disproportionately high share of the PCD therapy group (17.7%). PLEDU patients represented 23.5% of all LED patients prescribed SPCD therapy, whereas BCRL patients composed 10.3% of total LED patient SPCD prescriptions (P < .001).
Our analysis of a large health care administrative database showed clear differences between the way BCRL and PLEDU patients are treated. Compared with BCRL patients, PLEDU patients were less likely to receive conservative care and more likely to be prescribed SPCDs for pneumatic compression therapy. These differences suggest that lymphatic therapy may be undervalued for treatment of chronic venous swelling and prevention and treatment of PLEDU.

In most communities, the diagnosis of lymphedema in the lower extremity currently rests on clinical signs. Lymphoscintigraphy, which is objective, is performed infrequently to confirm the clinical suspicion. Given absence of a curative option for lymphedema, it is essential to obtain an accurate diagnosis before committing the patient to lifelong conservative therapy. The aim of this study was to evaluate the diagnostic accuracy of clinical signs in comparison to lymphoscintigraphy, the current objective standard.
Retrospective review of contemporaneously collected data of 636 consecutive limbs with swelling (318 left, 318 right) that underwent initial evaluation during a 12-month period between 2016 and 2017 was performed. All limbs were assessed for classic clinical signs of lymphedema including dorsal hump of the foot, square toes, Kaposi-Stemmer sign, and nonpitting edema. Lymphoscintigraphy was routinely performed for objective evaluation. The 436 patients who underwent the study were scored positive for lymphedema on the basis of transit time delay for the radioisotope in minutes, presence of dermal backflow, presence of collateral channels, intensity of uptake in the main channel and lymph nodes, number of nodes in the groin, and presence of popliteal nodes. Analysis was carried out to determine sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the clinical signs in determining whether a patient had lymphedema. In addition, regression analysis was carried out to evaluate the predictive value of different clinical signs in determining lymphedema. Patients with positive clinical signs but with normal findings on lymphoscintigraphy who did not have a medical cause for swelling underwent workup to determine a possible venous cause.
Of 636 limbs with swelling, 436 (69%) underwent lymphoscintigraphy, the findings of which were normal in 178 (41%) and abnormal in 258 (59%). Of the 636 swollen limbs, 96 (15%) had clinical signs of lymphedema; 95% had dorsal hump, 37% had square toes, 32% had presence of Kaposi-Stemmer sign, and 12% had nonpitting edema. Of these 96, lymphoscintigraphy was performed on 66 (69%); 45 of 66 (68%) patients with clinical signs were positive for lymphedema; the remaining 32% were normal. Conversely, among 258 swollen limbs with abnormal findings on lymphoscintigraphy, only 45 (17%) had one or more of the clinical signs. Sensitivity and specificity of clinical signs in predicting lymphoscintigraphy-confirmed lymphedema were 17% and 88%, respectively. Overall accuracy was 47%. Of the clinical signs, only the Kaposi-Stemmer sign was a significant predictor of lymphedema (odds ratio, 7.9; P = .02). In patients with positive clinical signs but normal findings on lymphoscintigraphy, venous obstruction was the most common cause of swelling.
Clinical signs of lymphedema appear to be unreliable in making a correct diagnosis of lymphedema in one-third of patients. Conversely, in lymphoscintigraphy-confirmed lymphedema, only 17% had positive clinical signs. Of the clinical signs, only Kaposi-Stemmer sign has some predictability in determining lymphoscintigraphy-confirmed lymphedema. Venous obstruction is the most common cause of clinical signs in patients without lymphedema. Routine use of lymphoscintigraphy is recommended in patients to make an objective diagnosis of lymphedema.