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Background: Compression therapy is an important part of the treatment of patients with lymphedema or chronic venous disease. However, there is no validated questionnaire evaluating the effect of compression and its acceptance by the patient. Therefore, the aims of this study were to construct a questionnaire evaluating the effect of compression and its acceptance by the patient, that is, the Dutch ICC Compression Questionnaire (ICC-CQ), to investigate its reliability and validity, and to translate it into English. Methods and Results: Eleven experts in applying compression and 51 Dutch patients with experience of using compression were involved in the construction process. One part of the ICC-CQ has to be completed by the patient and evaluates seven domains. The other part has to be completed by the health care provider and comprises three domains. Reliability and validity of the final version was investigated in a new group of 79 Dutch-speaking patients with lymphedema or chronic venous disease, wearing compression garments (N = 52) or bandages (N = 27). Except for one domain, the Intraclass Correlation Coefficients for test-rest/interrater reliability ranged from 0.55 to 0.93. Cronbach's alpha for internal consistency ranged from 0.71 to 0.97. Eighty-nine percent of the patients fully understood the questionnaire indicating good face validity, and 87% found it complete indicating good content validity. Construct validity was considered good since 10 out of 11 hypotheses were accepted. Conclusion: The ICC-CQ is the first reliable and valid questionnaire evaluating different kinds of compression and the experience by patients with lymphedema or chronic venous disease. ispartof: LYMPHATIC RESEARCH AND BIOLOGY vol:20 issue:2 pages:191-202 ispartof: location:United States status: published

BACKGROUND: The treatment of chronic venous disease, has largely shifted from high ligation and stripping to endovenous thermal ablation (EVTA) techniques, because of its comparable efficacy and lack of invasiveness. This clinical trial aimed to compare the efficacy of two thermal ablation techniques, endovenous laser ablation (EVLA) 1470-nm with Tulip-TipTM fiber and radiofrequency ablation (RFA) ClosureFastTM using a non-inferiority design for occlusion rate (primary outcome). METHODS: A prospective multicenter randomized clinical trial randomized 280 patients for the treatment of great saphenous vein (GSV) reflux. Primary outcome was the GSV occlusion rate, secondary outcome factors were the possible side-effects of the treatment such as pain, ecchymosis, quality of Life (CIVIQ-20), revised Venous Clinical Severity Score (r-VCSS). One-year follow-up period. RESULTS: The total occlusion rates at one year follow-up were 96.4% and 94.5% in the EVLA and RFA groups respectively (P=0.15). Regarding secondary outcomes, such as postoperative CIVIQ-20, r-VCSS, analgesia, absenteeism, there was no significant difference between both treatment groups. CONCLUSIONS: RFA and EVLA, using a 1470 nm laser with Tulip-TipTM fiber, of the GSV results in equal occlusion rates at one year, with comparable postoperative pain and improved quality of life. ispartof: INTERNATIONAL ANGIOLOGY vol:41 issue:4 pages:322-331 ispartof: location:Italy status: published

Background: The Lymphedema Functioning, Disability, and Health questionnaire for Upper Limb Lymphedema (Lymph-ICF-UL) is a health-related quality-of-life questionnaire for patients with breast cancer-related lymphedema. Previous testing of this questionnaire showed very good psychometric properties; however, responsiveness has not yet been established. The aim of this study was to determine its internal and external responsiveness. Methods and Results: Ninety-five patients treated with decongestive lymphatic therapy in a longitudinal trial were recruited. Patients completed the Lymph-ICF-UL twice within a time interval of 7 weeks ("intensive group" receiving intensive treatment; n = 73) or 3 months ("stable group" receiving maintenance treatment; n = 22), and once the Global Perceived Effect (GPE) questionnaire at the second time point. The significance of change in scores and standardized response mean (SRM) were determined for the total and domain scores. Correlations between Lymph-ICF-UL and GPE were ascertained. In addition, the minimal clinical important difference (MCID) was determined. The Lymph-ICF-UL total score changed significantly in the intensive group (p 0.05). There was a significant difference in mean total score changes between responders and nonresponders (p

Background: Local tissue water in patients with breast cancer-related lymphedema (BCRL) can be assessed by measurement of the tissue dielectric constant using the MoistureMeterD Compact® (MMDC) device, or by performing the pitting test. Although these assessment methods are commonly used in clinical practice, literature shows a lack of research on their clinimetric properties. Therefore, the aim of this study was to investigate reliability of both methods, in assessing the upper limb in BCRL. Methods and Results: Thirty women with BCRL were enrolled. Local tissue water was evaluated at nine reference points on the upper limb and trunk, using both methods. To determine intra- and inter-rater reliability of the MMDC device (using the absolute percentages of water content [PWC%] and interarm PWC% ratios based on single and multiple measures), intraclass correlation coefficients (ICCs), and standard errors of the measurement were calculated. To determine intra- and inter-rater agreement of the pitting test, Cohen's kappa coefficients were calculated as well as percentages of agreement. MMDC measurements yielded moderate to very strong intra- (ICC 0.648-0.947) and inter-rater (ICC 0.606-0.941) reliability, depending on the measurement location on the edematous limb. The pitting test showed a very strong intrarater agreement at nearly all defined points, but a weak inter-rater agreement, especially at the medial elbow and the breast. Conclusion: This study supports the MMDC device and pitting test as being useful tools in the clinical evaluation of BCRL. However, further research into the concurrent validity of both tools is warranted. ispartof: LYMPHATIC RESEARCH AND BIOLOGY vol:18 issue:2 pages:116-128 ispartof: location:United States status: published

INTRODUCTION: Lymphedema of the upper extremity is one of the most feared complications following breast cancer treatment. Lymphofluoroscopy is a sensitive instrument for detection of lymphedema and visualization of superficial lymphatic transport, thus suitable for early detection. Early detection of lymphedema is important as it can prevent lymphedema to progress into more severe stages and minimalize impact on quality of life and medical costs. OBJECTIVE: To determine agreement between the presence of early disturbance of the lymphatic transport and outcome of clinical measurement tools evaluating the development of lymphedema. METHODS: A prospective study was conducted in 128 breast cancer patients scheduled for breast cancer surgery. Patients were evaluated before surgery and 1, 3-, 6-, 9-, and 12-months' post-surgery. Cohen's Kappa was used to determine agreement between presence of early disturbance in lymphatic transport and presence of pitting/increased skinfold thickness/increased Percentage Water Content ratio (PWC)/increased arm-hand volume (circumference measures and water displacement). RESULTS: For pitting status (Kappa 0.23), for skinfold thickness (Kappa 0.29) and the PWC ratio (Kappa 0.21) a minimal agreement was found. The circumference measurement had a minimal agreement for 5% volume difference (Kappa 0.22) and no agreement for 3% volume difference (Kappa 0.19). Sensitivity was weak for all clinical assessments. The specificity was excellent for pitting status, skinfold thickness, PWC ratio, and for 5% volume difference. For 3% a high specificity was found. CONCLUSION: The clinical tools assessed in this study were not able to predict an early disturbance of the lymphatic transport seen on lymphofluoroscopy. ispartof: CLINICAL BREAST CANCER vol:22 issue:1 pages:E37-E47 ispartof: location:United States status: published

Little is known about the overall prevalence of lymphoedema in children and the types of paediatric lymphoedema seen by specialist centres. Therefore, this study was aimed to provide a profile of children with primary or secondary lymphoedema seen by the expert centres of the paediatric and primary lymphoedema working group (PPL-WG) of VASCERN and to compare the profile between the different countries. A retrospective review of all children (aged up to 18 years) seen for the first time by the expert centres over one year (2019) was carried out. Lymphoedema-, patient- and genetics-related data was collected and described for the whole group and compared between the different European countries/UK. In 2019, a total of 181 new children were seen by eight expert centres. For primary lymphoedema, the phenotype was based on the St George's classification of lymphatic anomalies. The percentages diagnosed according to each category were: 7.2% for syndromic lymphoedema, 2.8% for systemic/visceral involvement, 30.4% for congenital, 35.9% for late-onset lymphoedema and 19.3% for vascular/lymphatic malformations. 4.4% had secondary lymphoedema. Nearly 10% of all children had had at least one episode of cellulitis. The median delay from onset of symptoms to being seen by an expert centre was 2.4 years. In 44.4% of the children with primary lymphoedema a genetic test was performed, of which 35.8% resulted in a molecular diagnosis. Across the different centres, there was a wide variety in distribution of the different categories of paediatric lymphoedema diagnosed and the frequency of genetic testing. In conclusion, this paper has demonstrated that there is a large delay between the onset of paediatric lymphoedema and the first visit in the expert centres and that an episode of cellulitis is a relatively common complication. Diagnostic variation across the centres may reflect different referral criteria. Access to genetic testing was limited in some centres. It is recommended that these issues are addressed in the future work of the PPL-WG to improve the referral to the expert centres and the consistency in service provision for paediatric lymphoedema in Europe. ispartof: EUROPEAN JOURNAL OF MEDICAL GENETICS vol:65 issue:12 ispartof: location:Netherlands status: published

The purpose of this study was to investigate the effectiveness of fluoroscopy-guided manual lymph drainage (MLD) versus that of traditional and placebo MLD, when added to decongestive lymphatic therapy (DLT) for the treatment of breast cancer-related lymphedema (BCRL), on the suprafascial accumulation of lymphatic fluid and skin elasticity.In this multicenter, 3-arm, double-blind randomized controlled trial (EFforT-BCRL trial), 194 participants (mean age = 61 [SD = 10] years) with unilateral BCRL were recruited. All participants received standardized DLT (education, skin care, compression therapy, exercises) and were randomized to fluoroscopy-guided, traditional, or placebo MLD. Each day participants received 60 minutes of treatment during the 3-week intensive phase and 18 sessions of 30 minutes during the 6-month maintenance phase. Participants were instructed to wear a compression garment, to perform exercises, and to perform a self-MLD procedure once daily. This study comprises secondary analyses of the EFforT-BCRL trial. Outcomes were the amount of fluid accumulation in the suprafascial tissues (local tissue water, extracellular fluid, and thickness of the skin and subcutaneous tissue) and skin elasticity at the level of the arm and trunk. Measurements were performed at baseline; after intensive treatment; after 1, 3, and 6 months of maintenance treatment; and after 6 months of follow-up.At the level of the arm, there was a significant improvement over time in the 3 groups for most of the outcomes. At the level of the trunk, no remarkable improvement was noted within the individual groups. No significant interaction effects (between-group differences) were present. Only skin elasticity at the level of the arm, evaluated through palpation, showed a significant interaction effect.All 3 groups showed similar improvements in response to DLT, regardless of the type of MLD that was added. The effect of the addition of MLD to other components of DLT for reducing local tissue water and extracellular fluid or skin thickness and for improving skin elasticity and fibrosis in participants with chronic BCRL was limited.

PURPOSE: Decongestive lymphatic treatment (DLT) is still the gold standard for treatment of breast cancer-related lymphedema (BCRL). With up to 17% of the patients treated for breast cancer developing BCRL, this morbidity imposes a tremendous financial burden for patients and society. Knowledge about this economic burden related to BCRL and its conservative treatment in a European setting is lacking. The aim of this prospective, longitudinal cohort study was to estimate the direct healthcare costs related to BCRL and its treatment in a European setting. METHODS: Patients with BCRL were treated with DLT consisting of an intensive treatment phase of 3 weeks, followed by a maintenance treatment phase of 6 months. Additionally, the follow-up period comprised 6 months. During these 3 weeks and 12 months, all direct costs associated with the treatment of BCRL and its sequelae were documented through billing prices and a self-developed questionnaire which was administered after the intensive treatment phase, and subsequently 3-monthly during the entire period. RESULTS: A total of 194 patients were enrolled in this study. Of these, 17% (n = 32) showed lymphedema stage I, 56% (n = 109) had lymphedema stage IIa, and 27% (n = 53) had lymphedema stage IIb. Total direct healthcare costs per patient were €2248.93 on average during the entire period of 3 weeks of intensive treatments and 12 months of maintenance decongestive therapy. Within these mean direct costs, €1803.35 (80%) was accounted for statutory health insurances, and €445.58 (20%) was out-of-pocket expenses for patients. CONCLUSION: This study is one of the first standardized high-quality health economic analyses of BRCL treatment in Europe. The present study indicates that the price tag of BCRL treatment in Belgium is high not only for the health insurance but also for the patients Clinical trial registration number The study makes part of a double-blind, multi-center, randomized controlled trial (EFforT-BCRL trial), which is registered in clinicaltrials.gov (NCT02609724). CME reference S58689, EudraCT Number 2015-004822-33. ispartof: Supportive Care In Cancer vol:29 issue:7 pages:3801-3813 ispartof: location:Germany status: published

Background: Of the 1.38 million women who are diagnosed every year with breast cancer worldwide, 21% will develop arm lymphedema. Near-infrared fluorescence lymphatic imaging (NIRFLI) is an effective method for real-time evaluation of the lymphatic system. Reliability studies of the scoring of this NIRFLI are lacking. The aim of this study is to investigate if evaluation of the superficial lymphatic architecture and transport in patients with breast cancer-related lymphedema through NIRFLI can be performed in a reliable way. Methods and Results: The outcome parameters used to assess agreement were the presence of lymphatic transport from the injection sites, of dermal backflow patterns, of efferent lymphatic vessels, and of lymph nodes. The NIRFLI evaluations were scored before and after a break separately by two assessors. Twenty patients with lymphedema of the arm and/or hand were included. After the injection, there was weak to very strong agreement regarding the presence of transport from the injection sites (K = 0.459-1.000). The interpretation of the type of dermal backflow pattern varied from weak (WK = 0.452) to very strong agreement (WK = 1.000) between the two assessors. Agreement in the visualization of efferent lymphatic vessels was weak before and after the break (K = 0.490 and K = 0.571) and agreement regarding the presence of lymph nodes was very strong (K = 1.000). Conclusion: Overall, there was moderate to strong agreement between the assessors when evaluating the lymphatic architecture and transport through NIRFLI. The study has been registered at clinicaltrials.gov (NCT02609724). ispartof: LYMPHATIC RESEARCH AND BIOLOGY vol:20 issue:2 pages:133-143 ispartof: location:United States status: published

Background: To compare interrater reliability and the time-efficiency for the water displacement method, figure-of-eight method, and circumference measurements of the ankle and foot, and to investigate concurrent validity of the figure-of-eight method and circumference measurements with the water displacement method. Methods and Results: Thirty patients (21 women and 9 men) with primary or secondary lower limb lymphedema were evaluated twice. The volume of the foot and ankle was measured in three different ways: water displacement with a volumeter, figure-of-eight method, and circumference measurements at the level of the malleoli and metatarsals with a tapeline. The intraclass correlation coefficients (ICCs) ranged from good to excellent for all measurements (ICCs = 0.99 for water displacement; 0.94 for figure-of-eight; 0.80 and 0.79 for circumference measurement at malleolus and metatarsals). More time was needed to perform the water displacement method than the figure-of-eight method and the circumference measurements (p

QUESTIONS: When added to decongestive lymphatic therapy (DLT), what is the effect of fluoroscopy-guided manual lymphatic drainage (MLD) versus traditional MLD or placebo MLD for the treatment of breast cancer-related lymphoedema (BCRL)? DESIGN: Multicentre, three-arm, randomised controlled trial with concealed allocation, intention-to-treat analysis and blinding of assessors and participants. PARTICIPANTS: At five hospitals in Belgium, 194 participants with unilateral chronic BCRL were recruited. INTERVENTION: All participants received standard DLT (education, skin care, compression therapy and exercises). Participants were randomised to also receive fluoroscopy-guided MLD (n = 65), traditional MLD (n = 64) or placebo MLD (n = 65). Participants received 14 sessions of physiotherapy during the 3-week intensive phase and 17 sessions during the 6-month maintenance phase. Participants performed self-management on the other days. OUTCOME MEASURES: All outcomes were measured: at baseline; after the intensive phase; after 1, 3 and 6 months of maintenance phase; and after 6 months of follow-up. The primary outcomes were reduction in excess volume of the arm/hand and accumulation of excess volume at the shoulder/trunk, with the end of the intensive phase as the primary endpoint. Secondary outcomes included daily functioning, quality of life, erysipelas and satisfaction. RESULTS: Excess lymphoedema volume decreased after 3 weeks of intensive treatment in each group: 5.3 percentage points of percent excessive volume (representing a relative reduction of 23.3%) in the fluoroscopy-guided MLD group, 5.2% (relative reduction 20.9%) in the traditional MLD group and 5.4% (relative reduction 24.8%) in the placebo MLD group. The effect of fluoroscopy-guided MLD was very similar to traditional MLD (between-group difference 0.0 percentage points, 95% CI -2.0 to 2.1) and placebo MLD (-0.2 percentage points, 95% CI -2.1 to 1.8). Fluid accumulated at the shoulder/trunk in all groups. The average accumulation with fluoroscopy-guided MLD was negligibly less than with traditional MLD (-3.6 percentage points, 95% CI -6.4 to -0.8) and placebo MLD (-2.4 percentage points, 95% CI -5.2 to 0.4). The secondary outcomes also showed no clinically important between-group differences. CONCLUSION: In patients with chronic BCRL, MLD did not provide clinically important additional benefit when added to other components of DLT. REGISTRATION: NCT02609724. ispartof: JOURNAL OF PHYSIOTHERAPY vol:68 issue:2 pages:110-122 ispartof: location:Netherlands status: published

Purpose: Upper limb lymphedema is a vexing morbidity that can occur after the treatment for breast cancer. The Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema (Lymph-ICF-UL) is a valid and reliable tool assessing problems in functioning in patients with breast cancer-related lymphedema. Until now, a French-language version was lacking. The aim of this study was to perform a cross-cultural validation of the French version of the Lymph-ICF-UL questionnaire. Methods: A forward–backward translation process between the original language (Dutch) and the target language (French) was performed. Psychometric properties of this final French version were examined in 50 participants. Results: Intraclass correlation coefficients for test–retest reliability ranged from 0.66 to 0.95. Cronbach’s alpha coefficients for internal consistency were higher than 0.77. Face and content validity were very good because the scoring system was clear for all participants (100%), questions were understandable (100%), and all complaints due to BCRL were mentioned by 78% of the participants. Construct validity was moderate. Convergent validity was established since 3 out of 5 expected domains of the Lymph-ICF-UL showed a moderate correlation with expected domains of the 36-item Short-Form Health Survey. There was satisfactory divergent validity as 6 out of 9 hypotheses assessing divergent validity were accepted. Conclusion: The French version of the Lymph-ICF-UL is a reliable and valid questionnaire and ready for use in clinical as well as in scientific practice.Implications for rehabilitationSince the introduction of more effective treatment modalities increasing the number of breast cancer survivors, the amount of patients dealing with lymphedema is rising likewise up to a pooled incidence rate of more than 16% of the women treated for breast cancer.The French version of the Lymph-ICF-UL is a reliable and valid questionnaire for assessing problems in functioning of patients with breast cancer-related lymphedema of the arm and/or hand.As the questionnaire provides patient information in the different domains of the International Classification of Functioning, Disability and Health, it facilitates evaluating the impact of breast cancer-related lymphedema on daily functioning.Based on the outcomes of the Lymph-ICF-UL treatment goals can be set, where after the questionnaire can be used to monitor long-term results of this treatment and self-care. Since the introduction of more effective treatment modalities increasing the number of breast cancer survivors, the amount of patients dealing with lymphedema is rising likewise up to a pooled incidence rate of more than 16% of the women treated for breast cancer. The French version of the Lymph-ICF-UL is a reliable and valid questionnaire for assessing problems in functioning of patients with breast cancer-related lymphedema of the arm and/or hand. As the questionnaire provides patient information in the different domains of the International Classification of Functioning, Disability and Health, it facilitates evaluating the impact of breast cancer-related lymphedema on daily functioning. Based on the outcomes of the Lymph-ICF-UL treatment goals can be set, where after the questionnaire can be used to monitor long-term results of this treatment and self-care.

BACKGROUND: The aim of the present study is to develop relevant quality indicators (QI) to monitor and improve quality of care in vascular surgery. METHODS: The Delphi method was used to incorporate expert opinion to reach consensus on a set of QI. A national expert panel consisting of 52 vascular surgeons was installed on a voluntary basis and endorsed by the Belgian Society of Vascular Surgery and the Flemish Hospital Network KU Leuven. A task force team consisting of 12 surgeons was created to serve as a delegation of the expert panel to discuss and filter the obtained data from the different Delphi rounds. RESULTS: A total of 3 Delphi rounds were needed to reach consensus on a set of 20 QI. Each QI had a content validity index (using a 7-point Likert scale), a feasibility index, and a target level. Twelve outcome indicators and 8 process indicators on several vascular topics were selected: overall for all vascular treatments (n = 1), arterial occlusive disease in general (n = 3), arterial occlusive disease of the lower limbs (n = 4), arterial occlusive disease of the carotid arteries (n = 5), arterial aneurysm disease in general (n = 2), arterial aneurysm disease with endovascular treatment (n = 1), and venous disease (n = 4). CONCLUSIONS: This resulted in the successful identification of 20 validated and relevant vascular QI, focusing on arterial occlusive disease, arterial aneurysm disease, and venous disease. The next step in this project will be the performance of an implementation study. ispartof: ANNALS OF VASCULAR SURGERY vol:71 pages:237-248 ispartof: location:Netherlands status: published

Background: A disturbance of the superficial lymphatic system (dermal backflow) in patients with breast cancer-related lymphedema (BCRL) can be visualized by near-infrared fluorescence imaging or lymphofluoroscopy. In clinical practice, exact measurement of the dermal backflow is difficult. The purpose of the study is to investigate the concurrent validity between the clinical assessments and the lymphofluoroscopy in patients with BCRL. Methods and Results: Forty-five patients with BCRL stage I to IIb received lymphofluoroscopy and clinical assessments of their edematous limb (pitting status, skinfold thickness, skin elasticity, water content, lymphedema volume, and extracellular fluid). The correlation between the clinical assessments and the result of the lymphofluoroscopy was determined. The best overall agreement with dermal backflow was found for the clinical assessment pitting status, skinfold thickness, and water content. Overall sensitivity was excellent for lymphedema volume (92.5%), high for skinfold thickness (86.6%) and water content (75.0%), and moderate for pitting status (67.7%). Overall specificity was excellent for skin elasticity (94.7%), high for pitting status (83.4%), and moderate for skinfold thickness (61.6%) and water content (74.8%). In the evaluation of the whole arm, measurements of the excess volume were significantly greater for patients in an advanced stage of dermal backflow in comparison with patients in an earlier stage of dermal backflow (p = 0.002). Conclusions: The clinical assessments of skinfold thickness, water content, and lymphedema volume are the most appropriate tools to detect dermal backflow according to the lymphofluoroscopic images. To confirm the absence of dermal backflow, pitting status can be recommended. ispartof: LYMPHATIC RESEARCH AND BIOLOGY vol:18 issue:6 pages:539-548 ispartof: location:United States status: published

IntroductionBreast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible.The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated.MethodologyAll patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven are being considered. Patients are assessed before surgery and at 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. At each visit, a clinical assessment is performed determining the volume difference between both arms and hands (through circumference measurements and water displacement), the water content, the extracellular fluid, the pitting status and the skinfold thickness. Quality of life questionnaires are filled in. At each visit, a lymphofluoroscopy is performed as well. When a disturbance of the lymphatic transport is seen on lymphofluoroscopy, without the presence of clinical lymphoedema, the patient is randomised in either a control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove).Ethics and disseminationThe trial is conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. This protocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses.Trial registration numberNCT03210311ConclusionThe investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance.

This study measured the prevalence of chronic venous disease (CVD, C1-C6), chronic venous insufficiency (C3-C6) in 23 countries. The possible influence of risk factors was assessed. Patient recruitment was carried out by general practitioners. Patient characteristics, prevalence of risk factors, and C-classification were recorded. We assessed differences in prevalence and risk factors between Asia (A), Eastern Europe (EE), Latin America (LA), and Western Europe (WE). A total of 99 359 patients were included. The prevalence of CVD (51.9% A, 70.18% EE, 68.11% LA, and 61.65% WE) was significantly ( P < .001) lower in A. Risk factors such as age, obesity, smoking, having regular exercise, use of birth control pills, prolonged standing and sitting, and having a positive family history differ significantly between regions. After model-based probabilities corrected for risk factors, significant differences in the probability of having CVD were only found in the older age-group (>65 years). The lowest prevalence was noted in A. Chronic venous disease is very common and the prevalence varies between different geographical areas. After correcting for risk factors, these differences diminished.

Objectives Lymphoedema is a dreadful complication following breast cancer therapy. According to the International Society of Lymphology, the consensus treatment for breast cancer-related lymphoedema (BCRL) is the decongestive lymphatic therapy. This is a two-phase treatment and combines different treatment modalities including skin care, manual lymphatic drainage (MLD), compression therapy and exercise. However, the additional effect of MLD is debated since pooled data only demonstrated a limited non-significant additional value. A possible explanation is that in previous studies MLD has been applied blind, without knowledge of patient-specific lymphatic routes of transport. In addition, the MLD hand manoeuvres used by the therapists in previous studies, possibly did not optimally stimulate lymphatic transport. Recently, near-infrared fluorescence imaging has been introduced to visualise the superficial lymphatic network which allows MLD at the most needed location. The aim of the present study is to determine the effectiveness of the fluoroscopy-guided MLD, additional to the other parts of the decongestive lymphatic therapy and compared to the traditional or a placebo MLD, in the treatment of BCRL. Study design A three-arm double-blinded randomised controlled trial will be conducted in different university hospitals in Belgium. Based on a sample size calculation, 201 participants with chronic BCRL stage 1 or 2 of the arm or hand, with at least 5% difference between both sides (corrected for hand dominance) need to be recruited. All participants receive the standard treatment: skin care, compression therapy and exercises. The intervention group additionally receives fluoroscopy-guided MLD. One control group additionally receives the traditional ‘blind’ MLD and a second control group receives a placebo MLD. All subjects receive 3 weeks of daily intensive treatments and 6 months of maintenance treatment. Follow-up period is 6 months. The primary outcomes are the reduction in lymphoedema volume of the arm/hand and the change in stagnation of lymph fluid at level of the shoulder/trunk.

OBJECTIVE: To investigate the reliability, time efficiency and clinical feasibility of five commonly used methods for assessing excessive arm volume in patients with breast cancer-related lymphoedema (BCRL). DESIGN: Cross-sectional study. SETTING: University Hospitals Leuven, Belgium. SUBJECTS: 30 participants with unilateral BCRL. METHODS: Excessive arm volume was determined by five different methods: traditional volumetry with overflow, volumetry without overflow, inverse volumetry, optoelectronic volumetry and calculated volume based on circumference measurements. To investigate intra- and inter-rater reliability, measurements were performed twice by the same assessor and once by a different assessor. Intraclass correlation coefficients (ICCs), standard errors of the measurement (SEMs) and systematic changes between the means were calculated. To determine time efficiency, the mean setup time, execution time and total time were examined for each method. Furthermore, 12 limitations regarding clinical feasibility were listed and scored for each method. Finally, an overall ranking score was determined between the methods. RESULTS: Mean age was 65 (±8) years and mean body mass index was 28 (±4) kg/m2. Intra- and inter-rater reliability ranged between strong and very strong. Calculated arm volume based on circumferences (mean excessive arm volume: assessor A: 477 (±367) mL; assessor B: 470 (±367) mL; assessor A (second time): 493 (±362) mL) showed the highest intra- and inter-rater ICCs of .987 and .984, respectively. Optoelectronic volumetry was the fastest method, representing a mean total time of 1 minute and 43 (±26) seconds for performing a bilateral measurement. The least limitations were reported on the calculated volume based on the circumference method (3 out of 12 limitations). CONCLUSION: Calculated volume based on arm circumferences is the best measurement method for evaluating excessive arm volume over time in terms of reliability, low error rate, low cost, few limitations and the time spent. ispartof: CLINICAL REHABILITATION vol:33 issue:7 pages:1221-1232 ispartof: location:England status: published

OBJECTIVES: To provide an overview of costs associated with the treatment of breast cancer-related lymphoedema (BCRL) and its possible sequelae, borne by patients or by society. DATA SOURCES: According to the PRISMA guideline, a systematic literature search was carried out in four electronic databases: PubMed, Web of Science, Cochrane Clinical Trials and EMBASE. Searches were performed on October 1, 2018. STUDY SELECTION: Eligibility criteria: (1) expenses of adults (age > 18 years), (2) concerning patients with BCRL, (3) overview of (in)direct costs associated with BCRL, (4) expenses in which at least one type of conservative treatment modality for lymphoedema is included and/or costs for hospital admissions due to infections. Reviews and meta-analyses were excluded. DATA EXTRACTION: After assessing the risk of bias and level of evidence, quantitative data on (in)direct costs for BCRL treatment during a well-mentioned timeframe were extracted. DATA SYNTHESIS: Eight studies were included. Three studies reported on patient-borne costs related to BCRL. Mean direct costs per year borne by patients ranged between USD$2306 and USD$2574. Indirect costs borne by patients ranged between USD$3325 and USD$5545 per year. Five studies estimated society-borne costs related to BCRL from claims data, billing prices and providers' services during 12 to 24 months of follow-up. Mean direct treatment costs after 1 year of decongestive lymphatic therapy (DLT) ranged between €799 (= USD$1126.60) and USD$3165. CONCLUSION: This systematic review revealed that BCRL imposes a substantial economic burden on patients and society. However, more standardized high-quality health economic analyses among this field are required. Recent economic analyses related to BCRL treatment in Europe, Asia, Africa and South America are lacking. Worldwide, further scrutiny of the economic impact of DLT for BCRL in clinical settings is needed. CLINICAL TRIAL REGISTRATION NUMBER: The review makes part of a double-blind, multi-center, randomized controlled trial (EFforT-BCRL trial), which is registered in clinicaltrials.gov (NCT02609724). CME reference S58689, EudraCT Number 2015-004822-33. ispartof: Supportive Care In Cancer vol:28 issue:2 pages:439-449 ispartof: location:Germany status: published

The English anatomists Francis Glisson and Thomas Wharton introduced theories on the use of recently discovered lymphatic system in the1650s. Their main idea was that membranous tissues were supplied by nerves with a vital fluid produced within nutritive glands, to be carried to the brain and thence from the brain to all membranous tissues, including glands. They stated that the distribution of the vital fluid was based on the similarity between its ingredients and the needs of the recipient tissues, and not on the weight, size or location of pores encountered, as maintained by Descartes. Lymph, a mixture of waste from the consumed vital fluid and moisture transuded by arterial capillaries, was absorbed by the lymphatic vessels to be excreted via excretory glands, or to be diverted to the venous system by reductive glands. The theories of Glisson and Wharton were very soon rejected to be replaced by a mechanistic philosophy, a legacy of Descartes' theories. ispartof: ACTA CHIRURGICA BELGICA vol:119 issue:5 pages:340-346 ispartof: location:England status: published

Question: What are the short-term and long-term preventive effects of manual lymph drainage (MLD), when used in addition to information and exercise therapy, on the development of lymphoedema after axillary dissection for breast cancer? Design: Randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. Participants: Adults undergoing unilateral dissection for breast cancer were recruited, with 79 allocated to the experimental group and 81 to the control group. Intervention: The experimental group received guidelines about prevention of lymphoedema, exercise therapy and MLD. The control group received the same guidelines and exercise therapy, but no MLD. The interventions in both groups were delivered for 6 months. Outcome measures: The primary outcome was cumulative incidence of arm lymphoedema defined in four ways (≥ 200 ml, ≥ 2 cm, ≥ 5%, and ≥ 10% increase), which represent the difference in arm volume or circumference between the affected and healthy sides compared with the difference before surgery. Secondary outcomes included point prevalence of lymphoedema, change in arm volume difference, shoulder range of movement, quality of life and function. Results: Incidence rates were comparable between experimental and control groups at all follow-up measurements. Sixty months after surgery, the cumulative incidence rate for the ≥ 200 ml definition was 35% for the experimental group versus 29% for the control group (RR 0.89, 95% CI 0.51 to 1.54, p = 0.45); for the ≥ 2 cm definition 35% versus 38% (RR 0.93, 95% CI 0.59 to 1.45, p = 0.73); for the ≥ 5% definition 68% versus 53% (RR 1.28, 95% CI 0.97 to 1.69, p = 0.08) and for the ≥ 10% definition 28% versus 24% (RR 1.18, 95% CI 0.66 to 2.10, p = 0.57). The secondary outcomes were comparable between the groups at most assessment points. Conclusion: Manual lymph drainage may not have a preventive effect on the development of breast cancer-related lymphoedema in the short and long term. Trial registration: Netherlands Trial Register NTR 1055. [Devoogdt N, Geraerts I, Van Kampen M, De Vrieze T, Vos L, Neven P, Vergote I, Christiaens M-R, Thomis S, De Groef A (2018) Manual lymph drainage may not have a preventive effect on the development of breast cancer-related lymphoedema in the long term: a randomised trial. Journal of Physiotherapy 64: 245–254] Key words: Breast cancer, Prevention, Manual lymphatic drainage, Lymphoedema, Physical therapy

OBJECTIVE: This epidemiological study measured the prevalence of chronic venous disease (CVD) in Belgium and Luxembourg. Possible risk factors and the symptomatology were evaluated. MATERIAL AND METHODS: A survey was carried out in Belgium and Luxembourg between May and September 2013. Patient recruitment was carried out by 406 general practitioners (GPs). Each GP screened 10-20 consecutive patients older than 18 years, and in total 6009 patients were included. Patient characteristics, prevalence of risk factors, symptomatology, and C-classification were noted. The GPs diagnosed CVD and measured the need for treatment. Patients with diagnosed CVD completed a questionnaire about their history of leg problems and a quality of life score (CIVIQ-14). These data were converted into a CIVIQ Global Index Score (GIS). RESULTS: The mean age of the patients was 53.4 years, and they were predominantly female (67.5%). Among the 3889 symptomatic patients, heavy legs, pain, and sensation of leg swelling were the most common complaints. Among the included patients, 61.3% of patients were classified within C1-C6; however, only 45.9% of these patients were considered by the GPs to be suffering CVD. Treatment was offered to 49.5% of patients. Age and female gender correlate with a higher C-class (p < .001). Patients with a higher C-class (C3-C6) have significantly more pain, sensation of swelling and burning, night cramps, itching, and the sensation of "pins and needles" in the legs. Patients taking regular exercise and without a family history had a lower C-class. Higher BMI, age, female gender, family history, history of thrombophlebitis, and a higher C-class correlated with a lower GIS (p < .001). Of the patients with CVD, 10.4% had lost days of work because of their venous leg problems. CONCLUSION: CVD is a very common disease, which is underestimated. The prevalence increases with age, generates incapacity to work, and worsens the patients' quality of life.