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    Summary of key evidence on liposuction for chronic lymphoedema

    Study 1 Chang DW (2021)

    Study details

    Study type

    Systematic review, meta-analysis, and consensus conference statement*

    Country

    Not reported for individual studies

    Recruitment period

    Publication date: database inception to 2019

    Study population and number

    n=371, 9 studies

    Adult people with lymphoedema.

    Age and sex

    Not reported for individual studies

    Patient selection criteria

    Inclusion criteria: Adult people with primary or secondary lymphoedema. Surgical interventions for treatment of lymphoedema included lymphovenous bypass, (lymphaticovenular anastomosis), vascular lymph node transplantation, and liposuction. Studies that used a combination of techniques were included.

    Exclusion criteria: Paediatric people were excluded. Other types of surgery (for example excisional) and microsurgery (for example lymph vessel transplant) used for the treatment of lymphoedema were excluded.

    Technique

    Not reported for individual studies

    Follow-up

    9 to 24 months

    Conflict of interest/source of funding

    Conflict of interest: the authors state that they do not have a financial interest in any of the products or devices mentioned.

    Funding source: not reported.

    *Consensus statements are described in the Existing assessments of this procedure section.

    Analysis

    Study design issues: This systematic review and meta-analysis investigated the safety and efficacy of surgical interventions for upper and lower extremity lymphoedema. The results of this were then used by the authors to inform consensus statements. The primary outcomes were reduction in limb volume (as a percentage or in millilitres) as measured by a validated system for limb volume measurement and reduction in limb circumference (as a percentage or in centimetres).

    Meta-analysis was conducted if the interventions, patient groups, and outcomes were sufficiently similar. For dichotomous outcomes obtained from case-control and cohort studies, ORs and 95% CIs were calculated. For dichotomous outcomes from randomised controlled trials, risk ratios and 95% confidence intervals were calculated. For continuous outcomes, the mean differences and 95% confidence intervals were calculated. Heterogeneity was assessed using the chi-square test. A value of p=0.10 was considered statistically significant. The I2 statistic was used to quantify heterogeneity.

    Key efficacy findings

    Limb volume

    Number of people analysed: 25/46

    Follow-up: 12 months

    • In a meta-analysis of 2 studies, 25 people who had liposuction and controlled compression therapy had a statistically significant 63.95% greater reduction in limb volume compared to 23 people who had controlled compression therapy only (95% CI: 49.57 to 78.33%; Figure below, panel A).

    • In a meta-analysis of 2 studies, 46 people who had liposuction and controlled compression therapy statistically significantly reduced their lymphoedema volume by 895.81 ml more than 23 people who received controlled compression therapy only (95% CI: -1,140.63 to -650.98 ml; Figure below, panel B).

    Reduction in limb volume in percentage (above) and in ml (below), liposuction versus controlled compression therapy (refer to Chang, 2021 supplementary material)

    [Figure removed for publication]

    Limb excess reduction

    Number of people analysed: 163/294

    Follow-up: 9 to 24 months (varying between studies)

    • In a meta-analysis of 2 studies (163 people), liposuction and compression therapy statistically significantly reduced excess limb volume by an average of 26.59% (95% CI: 18.64 to 34.54%; Figure below, panel A).

      • In 78 people with arm lymphoedema, liposuction and compression therapy statistically significantly reduced excess limb volume by 28.68% (95% CI: 6.06 to 51.29%; Figure below, panel A).

      • In 89 people with leg lymphoedema, liposuction and compression therapy statistically significantly reduced excess limb volume by 29.23% (95% CI: 5.56 to 52.90%; Figure below, panel A).

    • In a meta-analysis of 6 studies (256 people), liposuction and compression therapy statistically significantly reduced excess limb volume by an average of 1,524.93 ml (95% CI: 748.84 to 2,301.01 ml; Figure below, panel B). [Note: there are discrepancies in the figures quoted in the publication text and figure. The reduction in excess volume reported in the text is 1,702.44 ml (95% CI: 1,558.64 to 1,846.23 ml)].

      • In 207 people with arm lymphoedema, liposuction and compression therapy statistically significantly reduced excess limb volume by 1,294.16 ml (95% CI: 460.47 to 2,127.85 ml; Figure below, panel B). [Note: there are discrepancies in the figures quoted in the publication text and figure. The reduction in excess volume reported in the text is 1,666.04 ml (95% CI: 1,543.97 to 1,788.10 ml)].

      • In 49 people with leg lymphoedema, liposuction and compression therapy statistically significantly reduced excess limb volume by 2,736.60 ml (95% CI: 1,767.00 to 3,706.20 ml; Figure below, panel B). [Note: there are discrepancies in the figures quoted in the publication text and figure. The reduction in excess volume reported in the text is 2,181.22 ml (95% CI: 1,328.00 to 3,034.44 ml)].

    Reduction in limb excess volume in percentage (panel A) and in ml (panel B) (refer to Chang, 2021 supplementary material)

    [Figure removed for publication]

    Prevalence of cellulitis

    Number of people analysed: 10

    Follow-up: 25 months

    • One case series of 10 people with upper and lower extremity lymphoedema reported on before surgery and after surgery cellulitis.

      • Cellulitis was statistically significantly reduced after treatment with liposuction and compression therapy. The prevalence of severe cellulitis before surgery was 70% (7/10 people) compared with 10% (1/10 people) after surgery (OR: 21.00; 95% CI: 1.78 to 248.10).

    Key safety findings

    The following complications were reported by the studies identified:

    • Case series of 8 people reported:

      • Hyperpigmentation, n=2

      • Cellulitis, n=1

    • Case series of 41 people reported:

      • Decubitus ulcer, n=1

    Study 2 Tang NSJ (2021)

    Study details

    Study type

    Systematic review

    Country

    Not reported for individual studies

    Recruitment period

    Publication date: database inception to 2020

    Study population and number

    n=196 people, 7 studies

    Adult people with lymphoedema.

    Age and sex

    Not reported for individual studies

    Patient selection criteria

    Inclusion criteria: (i) any form of lymphoedema as the primary indication for surgery; (ii) any form of surgical management for lymphoedema; (iii) a validated QoL tool, either generic or disease-specific, with data adequately reported; and (iv) comparisons with before surgery QoL status or appropriate control.

    Technique

    Not reported for individual studies

    Follow-up

    1 to 12 months

    Conflict of interest/source of funding

    Conflict of interest: the authors declare no conflict of interest.

    Funding source: not reported.

    Analysis

    Study design issues: This systematic review investigated the effect of surgical interventions as compared to a non-operative control (including before-and-after studies that used a before surgery control) on QoL of people with lymphoedema. Outcomes included a variety of generic and disease-specific QoL instruments, including:

    • Disease-specific:

      • Derriford Appearance Scale (DAS-59): 59-item questionnaire across 5 dimensions: general self-consciousness, social self-consciousness, negative self-concept, sexual and bodily self-consciousness of appearance, and facial self-consciousness of appearance. Each item scored on a scale of 1 to 5.

      • Modified Blepharoplasty Outcomes Evaluation (MBOE): 6-item questionnaire that aims to monitor people' self-perception of appearance. Each question scored on a scale of 1 to 5. A change of 2 or more points is considered significant. Higher scores indicates improved self-perception.

      • Visual Analogue Scale pain score (VAS): 'Yes' and 'No' symptoms-based questions on a visual scale graded from 0 to 100, where 0 is considered 'normal' and 100 is considered 'extreme difficulty'.

      • Lymphoedema Quality of life Inventory (LyQLI): 45 items across overall QoL and 3 multi-item domains: physical, psychosocial, and practical. Each item scored from 0 to 3. Higher scores in individual domains indicate lower QoL. Higher scores in overall QoL items indicate higher QoL.

    • Generic:

      • Hospital Anxiety and Depression Score (HADS): 14 items across 2 subscales that describe anxiety and depression, with each item scored from 0 to 3 depending on severity of symptoms. Assesses psychological aspects of QoL.

      • Nottingham Health Profile (NHP): 2 parts – part 1: 38 items divided into 6 categories (sleep, physical mobility, pain, energy, emotion, social); part 2: 7 statements that relate to areas of life most affected by health.

      • Patient Specific Functional Scale (PSFS): 3 to 5 items chosen by the patient that are currently limited by their condition. Each item scored from 0 to 10, with higher number indicating improved function. Average of scores provides indication of QoL.

      • Psychological General Well-Being Index (PGWBI): 22-item QoL questionnaire which produces a self-perceived evaluation of psychological well-being expressed by a summary score.

      • 36-Item Short-Form Survey (SF-36): 36 items across eight domains that describe physical and emotional dimensions:

        • Physical components: 1. physical function; 2. role physical; 3. bodily pain

        • Emotional components: 4. social function; 5. role emotional; 6. mental health

        • Joint physical + emotional components: 7. general health; 8. vitality.

    Key efficacy findings

    Disease-specific QoL

    Number of people analysed: 115

    Follow-up: 1 to 12 months

    • Five studies were identified that reported results from disease-specific QoL instruments (Table below).

    Summary of studies reporting disease-specific QoL outcomes following liposuction

    Author (year)

    People, n

    Follow-up

    Control

    QoL outcomes

    Alamoudi U, Taylor B, MacKay C et al. (2018) Submental liposuction for the management of lymphedema following head and neck cancer treatment: a randomized controlled trial. Journal of otolaryngology - head & neck surgery 47(1):22

    10

    6 months

    No intervention; before surgery QoL

    MBOE: Statistically significant improvement in overall summation of all 5 questions compared to control.

    DAS-59: Statistically significant improvement in overall summation of 5 categories compared to control.

    Brake MK, Jain L, Hart RD et al. (2014) Liposuction for submental lymphedema improves appearance and self-perception in the head and neck cancer patient. Otolaryngology - Head and Neck Surgery (United States) 151: 221-225.

    9

    12 months

    Before surgery QoL

    MBOE: Statistically significant improvement in overall summation of all 5 questions compared to control. 4 of 5 questions statistically significant improvements.

    DAS-59: General self-consciousness of appearance subsection showed statistically significant improvement. No other subgroups demonstrated statistically significant improvement.

    Brorson H, Ohlin K, Olsson G et al. (2006) Quality of life following liposuction and conservative treatment of arm lymphedema. Lymphology 39:8-25

    35

    12 months

    Controlled compression therapy; before surgery QoL

    VAS: Improved QoL regarding pain, swelling of hand, difficulties with activities of daily living at 12 months with intervention, no change in control. Improved QoL in reduced mobility, swollen arm, heavy arm, fatigue/weakness at 6, 12 months. Controlled compression therapy showed lesser changes.

    Klernas P, Johnsson A, Boyages J et al. (2018) Test of Responsiveness and Sensitivity of the Questionnaire "Lymphedema Quality of Life Inventory". Lymphatic research and biology 16(3):300-8

    50

    1 month

    Rehabilitation program; before surgery QoL

    LyQLI: Intervention group showed statistically significant improvement in QoL in physical, psychosocial, practical, Item 44, Item 45 domains. Control group demonstrated statistically significant reductions in physical, psychosocial and practical domains to a limited extent. Practical, Item 44 and Item 45 domains demonstrated statistically insignificant improvements.

    Schaverien MV, Munro KJ, Baker PA et al. (2012) Liposuction for chronic lymphoedema of the upper limb: 5 years of experience. Journal of Plastic, and Reconstructive & Aesthetic Surgery: JPRAS 65: 935-942.

    11

    3 months

    Before surgery QoL

    VAS: 3-month follow-up showed statistically insignificant improvement in VAS scores from 64.60 to 81.20.

    Generic QoL

    Number of people analysed: 127

    Follow-up: 3 to 12 months

    • Four studies were identified that reported results from generic QoL instruments (Table below).

    Summary of studies reporting generic QoL outcomes following liposuction

    Author (year)

    People, n

    Follow-up

    Control

    QoL outcomes (control vs. intervention)

    Boyages J, Kastanias K, Koelmeyer LA et al. (2015) Liposuction for advanced lymphedema: a multidisciplinary approach for complete reduction of arm and leg swelling. Annals of surgical oncology 22: 1263-1270

    21

    6 months

    Before surgery QoL

    PSFS: All people reported improvement in following standardized domains vs. control. Functional impairment upper limb (UL) (11.1 vs. 22.1), lower limb (LL) (7.4 vs. 28.0). Pain UL (3.9 vs. 0.8), LL (3.7 vs. 0.2). Heaviness UL (6.7 vs. 0.3), Lower Limb (8.2 vs. 0.4). Self-consciousness UL (6.9 vs. 0.6), LL (8.2 vs. 0). Anxious UL (5.1 vs. 0.2), LL (7.2 vs. 0). Swollen UL (6.9 vs. 1.8), LL (9.0 vs. 1.6). Emotions UL (6.0 vs. 1.0), LL (7.8 vs. 0.6).

    Brorson H, Ohlin K, Olsson G et al. (2006) Quality of life following liposuction and conservative treatment of arm lymphedema. Lymphology 39:8-25

    35

    12 months

    Controlled compression therapy; before surgery QoL

    HADS: Intervention group showed decreased anxiety at 6 months, with no change in depression. Control group showed increased anxiety at 12 months.

    NHP: Improved in QoL in total score and domains of pain, physical mobility, housework at 6, 12 months. Emotions only improved at 6 months, with no further improvement.

    PGWBI: Intervention group showed improvements in total score and general health, with no changes in other subdomains. Control group showed no changes.

    Hoffner M, Bagheri S, Hansson E et al. (2017) SF-36 Shows Increased Quality of Life Following Complete Reduction of Postmastectomy Lymphedema with Liposuction. Lymphatic Research and Biology 15, 87-98.

    60

    12 months

    Before surgery QoL

    SF-36: 1 month after surgery – significant increase in mental health domain. 3 months after surgery – significant increase in physical functioning, bodily pain, vitality domains. 1 year after surgery – significant increase in social functioning.

    Schaverien MV, Munro KJ, Baker PA et al. (2012) Liposuction for chronic lymphoedema of the upper limb: 5 years of experience. Journal of Plastic, and Reconstructive & Aesthetic Surgery: JPRAS 65: 935-942.

    11

    3 months

    Before surgery QoL

    HADS: 3-month follow-up showed reduction in anxiety scores (9.09 vs. 4.60) and depression scores (5.73 vs. 1.70).

    Key safety findings

    No safety findings were reported.

    Study 3 Hoffner M (2018)

    Study details

    Study type

    Single arm, single centre, non-randomised, before-and-after study*

    Country

    Sweden

    Recruitment period

    1993 to 2012

    Study population and number

    n=105

    People receiving liposuction for arm lymphoedema secondary to breast cancer treatment

    Age and sex

    64 years (SD 9.9 years); 100% female

    Patient selection criteria

    Inclusion criteria: (1) diagnosis of secondary arm lymphoedema following breast cancer treatment; (2) a significant excess volume, that is the volume of the affected arm was at least 10% larger than that of the unaffected arm and concomitant subjective discomfort; (3) inability of previous conservative treatment to reduce the excess volume completely; (4) no or minimal pitting (less than 5 mm) as a sign of adipose tissue hypertrophy; and (5) accustomed to the use of compression garments before surgery.

    Technique

    Technique summary: power-assisted liposuction (Lipomatic, Nutational Infrasonic Liposculpture, Euromi, Andrimont, Belgium). Between 1993 and 1997, the 'dry technique' was used. Between 1997 and 2012, a tourniquet was used in combination with the tumescence technique to minimise blood loss.

    Infiltration volume: 1,000 ml of saline mixed with 1 mg adrenaline and 40 ml lidocaine 2% was infused subcutaneously.

    Aspiration volume: total aspirate mean volume was 1,831 ml (SD 599 ml; range 650 to 3,780 ml) for all people. The mean volume of aspirate removed when a tourniquet was applied (n=76) was 951 ml (SD 405 ml; range 310 to 2,060) and contained 94% (SD 11%; range 58 to 100%) fat.

    After surgery care: antibiotics were given intravenously for 24 hours and then orally for approximately 10 days after surgery. Compression garments were worn 24 hours per day after surgery.

    Follow-up

    5 years

    Conflict of interest/source of funding

    Conflict of interest: the authors declared no financial interest in relation to the content of the publication.

    Source of funding: supported by the Swedish Cancer Society, Stockholm, Skåne County Council's Research, and the Development Foundation, and Blekinge County Council's Research and Development Foundation.

    *There was likely complete patient overlap between Hoffner, 2018 and Lee, 2016 based on the similar authorship, same recruitment period, and same centre.

    Analysis

    Follow-up issues: between 1993 and 2012, a total of 127 consecutive people were operated on. Twenty-two could not be followed for 5 years and were excluded from this analysis.

    Study design issues: This single arm, single centre, non-randomised, before-and-after study evaluated the 5‑year efficacy and safety of liposuction in people with secondary nonpitting arm lymphoedema. The primary efficacy outcome was excess volume reduction, calculated by water displacement. Complications were also recorded.

    A parametric Student's paired t-test (2-tailed) was used to analyse differences between before and after surgery outcomes of surgery. No adjustment for multiple comparisons was performed. A p-value of less than 0.05 was considered statistically significant.

    Study population issues: Ninety-eight people (93%) had irradiation therapy, 81 people (77%) had axillary clearance, and 74 people (70%) had both. Fifty-seven people (54%) were affected in their dominant arm.

    Key efficacy findings

    Limb excess reduction

    Number of people analysed: 105

    Follow-up: 5 years

    • There was a statistically significant decrease in excess arm volume from before surgery assessment to 2 weeks after surgery (p<0.0001) which was maintained to 5 years.

      • The before surgery mean excess volume was 1,573 ml (SD 645 ml; range 570 to 3,520 ml), and the ratio between the lymphoedematous and healthy arm was 1.5 (SD 0.2; range 1.2 to 2.1).

      • At 6 months follow-up, the excess reduction was 107% (SD 22%; range, 73 to 179%) with an excess volume of ˗51 ml (SD 273 ml; range ˗760 to 730 ml), ratio between the lymphoedematous and healthy arm was 1.0 (SD 0.1; range, 0.8 to 1.2).

      • This was maintained throughout follow-up to 5 years.

    Key safety findings

    Number of people analysed: 105

    Follow-up: 5 years

    • In the 27 people who received the 'dry' liposuction technique without a tourniquet, there were 15 people that required blood transfusions (56%).

    • In the 35 people who received the 'dry' liposuction technique with a tourniquet, there were 5 people that required blood transfusions (14%).

    • In the 43 people who received the tumescent liposuction technique with a tourniquet, there were 0 people that required blood transfusions.

    There were no other major or minor during or after surgery complications recorded.

    Study 4 Lee DP (2016)

    Study details

    Study type

    Single arm, single centre, non-randomised, before-and-after study*

    Country

    Sweden

    Recruitment period

    1993 to 2012

    Study population and number

    n=130, all people treated by liposuction for lymphoedema secondary to breast cancer in the lymphoedema unit, Malmö, Sweden

    Age and sex

    63 years (range 39 to 89, SD 10 years), females

    Patient selection criteria

    All people treated by liposuction for lymphoedema secondary to breast cancer.

    Technique

    After surgery care: people had isoxazole penicillin (clindamycin if allergic to penicillin) before and after surgery over 7 days.

    Follow-up

    Up to 18 years

    Conflict of interest/source of funding

    Conflict of interest: not reported.

    Funding source: Supported by the Swedish Cancer Society, the Skåne County Council's Research and Development Foundation, and the the Scientific Committee of Blekinge County Council's Research and Development Foundation.

    *There was likely complete patient overlap between Hoffner, 2018 and Lee, 2016 based on the similar authorship, same recruitment period, and same centre.

    Analysis

    Follow-up issues: The maximum before and post-liposuction observation period was 38 years and 18 years respectively.

    Study design issues: This before-and-after study evaluated the incidence of erysipelas (superficial cellulitis) before-and-after liposuction in people with postmastectomy arm lymphoedema. The primary outcome was the incidence of erysipelas. Arm excess volume was also recorded.

    Parametric t-tests were used to compare the incidence of erysipelas before-and-after liposuction.

    Study population issues: All people except 8 had irradiation, lymphoedema onset occurred on average 2.9 years (range 0 to 32, SD 4.8) after mastectomy.

    Key efficacy findings

    Limb excess reduction

    Number of people analysed: 130

    Follow-up: 6 months

    • The mean before surgery excess arm volume was 1,607 ml (range 570 to 3,950 ml, SD 707 ml).

    • At follow-up, the mean excess volume was -43 ml (range -945 to 1,390 ml, SD 379 ml), corresponding to a statistically significant reduction of 109% (p<0.001).

      • This reduction persisted throughout the follow-up period, to a maximum of 18 years.

    Incidence of erysipelas

    Number of people analysed: 130

    Follow-up: 6.3 to 13.5 years (dependent on subgroup)

    • Before surgery incidence of erysipelas: 76 people, 534 episodes over 1,147 person years – 0.47 bouts/year (range 0 to 5, SD 0.8)

    • After surgery incidence of erysipelas: 16 people, 60 episodes over 983 person years – 0.06 bouts/year (range 0 to 3, SD 0.3)

    • This corresponds to a statistically significant incidence reduction of 87% (p<0.001).

    Key safety findings

    Number of people analysed: 130

    Follow-up: 13.5 years

    • Of 54 people who were not diagnosed with erysipelas before surgery, 6 (11.1%) had erysipelas in the follow-up period.

    Study 5 Stewart CJ (2018)

    Study details

    Study type

    Single arm, single centre, non-randomised, before-and-after study

    Country

    UK

    Recruitment period

    2007 to 2016

    Study population and number

    n=69

    People with leg lymphoedema treated with liposuction

    Age and sex

    46 years; 90% female

    Patient selection criteria

    Inclusion criteria: a non-pitting lymphoedema of the leg and a lack of volume reduction by conservative treatment.

    Technique

    Technique summary: power-assisted liposuction (Microaire) under general anaesthesia using a tourniquet.

    Procedural frequency: for people with bilateral lower leg oedema, liposuction was performed on each leg separately, with a minimum of 3 months between operations.

    Infiltration volume: 20 ml of 0.5% levobupivicaine (5 mg/ml) and 1 mg of 1:1000 adrenaline in 1,000 ml of Hartmann's solution.

    Aspiration volume: the mean volume of aspirate was 4,550 ml (range 575 to 12,150 ml), and the proportion of fat in the aspirate was 71% (range 15% to 100%).

    After surgery care: people received bed rest and intravenous antibiotics for the first 48 hours, then oral antibiotics for 7 days. Thrombosis prophylaxis was given daily. People wore compression garments after surgery and were remeasured after 2 weeks.

    Follow-up

    Up to 9 years

    Conflict of interest/source of funding

    Conflict of interest: the authors declared no conflict of interest.

    Funding source: not reported.

    Analysis

    Follow-up issues: 17 people were lost to follow-up at a mean of 16 (range 6 to 48) months.

    Study design issues: This single arm, single centre, non-randomised, before-and-after study assessed the long-term outcomes of liposuction for people with leg lymphoedema. Outcomes included limb volume, calculated by circumferential measurements, and complications.

    No statistical analysis was performed.

    Study population issues: All people were of an International Society of Lymphology Stage 2 or 3. Sixty-six people had unilateral leg oedema, and 3 people had bilateral leg oedema (1 bilateral primary, 1 bilateral secondary, and 1 initially treated for unilateral secondary lymphoedema, who subsequently developed contralateral primary lymphoedema).

    Key efficacy findings

    Limb excess reduction

    Number of people analysed: 69

    Follow-up: up to 9 years

    • Liposuction substantially reduced the mean leg excess volume from 4,372 ml before surgery to 1,005 ml at 3 months follow-up. No test of statistical significance was reported.

    • This reduction in leg excess volume was maintained to 9 years follow-up.

    Mean leg excess volume throughout the follow-up period

    Assessment time

    Number of legs

    Mean leg excess volume, ml (range)

    Before surgery

    72

    4,372 (229 to 15,166)

    3 months

    72

    1,005 (1,987 to 5,613)

    6 months

    60

    822 (1,168 to 5,161)

    1 year

    60

    768 (761 to 4,952)

    2 years

    41

    629 (1,088 to 3561)

    3 years

    31

    393 (1,321 to 2,799)

    4 years

    24

    478 (1,190 to 3,214)

    5 years

    15

    695 (911 to 3,284)

    6 years

    10

    549 (1,037 to 2,722)

    7 years

    7

    801 (408 to 2,660)

    8 years

    6

    600 (211 to 2,097)

    9 years

    5

    406 (405 to 1,497)

    Prevalence of cellulitis

    Number of people analysed: 69

    Follow-up: up to 9 years

    • There were 3 episodes of cellulitis in the follow-up period. Before surgery, 21 people had cases of cellulitis.

    Key safety findings

    Number of people analysed: 69

    Follow-up: up to 9 years

    • Temporary peroneal nerve palsies, n=2 (2.9%)

      • Due to tight compression garments; resolved at 6 months after surgery.

    • Skin necrosis, n=3 (4.3%)

      • One of which required excision and direct closure.

    • After surgery blood transfusion, n=2 (2.9%)

      • Neither had above average volume excess or aspirate.

    Study 6 Granoff MD (2020)

    Study details

    Study type

    Single arm, single centre, non-randomised, before-and-after study

    Country

    US

    Recruitment period

    2017 to 2020

    Study population and number

    n=39

    People with chronic lymphoedema receiving liposuction

    Age and sex

    58 years (SD 14 years); 87.2% female

    Patient selection criteria

    People were selected for liposuction via a multidisciplinary evaluation. People had confirmed lymphoedema diagnosis, were appropriate surgical candidates, and had moderate-severe fat hypertrophy.

    Technique

    Technique summary: power-assisted liposuction (MicroAire Surgical Instruments, Virginia, USA) with a tourniquet.

    Infiltration volume: the proximal limb, unable to be controlled by tourniquet, was tumesced with 1,000 (upper extremity) or 2,000 (lower extremity) ml of tumescent solution (50 ml 2% lidocaine, 1 ml epinephrine in 1,000 ml Lactated Ringers).

    Aspiration volume: for liposuction of the arm, the mean volume of aspirate removed was 855 ml (SD 398 ml). For liposuction of the leg, the mean volume of aspirate removed was 2,550 ml (SD 907 ml).

    After surgery care: people were admitted to the hospital for after surgery monitoring. During this time, people worked closely with physical therapy regarding garment and skin care. People with arm lymphoedema were educated on the management of hand swelling. Compression garments were worn immediately after liposuction.

    Follow-up

    1 year

    Conflict of interest/source of funding

    Conflict of interest: the authors report that they have no financial disclosures or conflicts of interest.

    Funding source: the authors reported that they did not receive any funding for this study.

    Analysis

    Study design issues: This single arm, single centre, non-randomised, before-and-after study assessed the efficacy and safety of liposuction in people with lymphoedema. Outcomes included excess volume reduction (measured by both circumferential measurement and perometry), QoL (using the LYMQOL instrument), and complications. The LYMQOL is scored on a scale from 0 (poor QoL) to 10 (excellent QoL).

    Before and after surgery data were compared using paired Wilcoxon signed-rank tests. p<0.05 was considered statistically significant.

    Study population issues: The main aetiology of lymphoedema was cancer-related (84.6%), 63.6% of which was secondary to breast cancer, 33.3% to gynaecologic cancer, and 3.0% to Hodgkin's Lymphoma.

    Key efficacy findings

    Limb excess reduction

    Arm lymphoedema

    Number of people analysed: 23

    Follow-up: up to 1 year

    • By circumferential measurement, there was a statistically significant decrease in the excess arm volume from a median of 799 ml (IQR 638 to 1,125 ml) before surgeryly to 60 ml (IQR -76 to 202 ml) at 1 month follow-up (p<0.002). This was maintained throughout the follow-up period where median excess volume reduction by circumferential measurement was 93% at 1 month (n=19, p=0.002), 107% at 3 months (n=17), 111% at 6 months (n=16), and 116% at 12 months (n=8).

    • By perometry, there was a there was a statistically significant decrease in the excess arm volume from a median of 1,038 ml (IQR 763 to 1,273 ml) before surgery to 44 ml (IQR -27 to 246 ml) at 1 month follow-up (p<0.001). This was maintained throughout the follow-up period where median excess volume reduction by perometry was 96% at 1 month (n=19, p<0.001) and 3 months, 108% at 6 months, and 116% at 12 months.

    Leg lymphoedema

    Number of people analysed: 18

    Follow-up: up to 1 year

    • By circumferential measurement, there was a statistically significant decrease in the excess leg volume from a median of 3,355 ml (IQR 2,843 to 5,428 ml) before surgery to 710 ml (IQR 116 to 1,450 ml) at 1 month follow-up (p<0.001). This was maintained throughout the follow-up period where median excess volume reduction by circumferential measurement was 79% at 1 month (n=12, p<0.001), 78% (n=10) at 3 months, 82% at 6 months (n=7), and 115% at 12 months (n=5).

    • By perometry, there was a there was a statistically significant decrease in the excess leg volume from a median of 3,360 ml (IQR 2,791 to 4,639 ml) before surgery to 506 ml (IQR -27 to 1,242 ml) at 1 month follow-up (p<0.001). This was maintained throughout the follow-up period where median excess volume reduction by perometry was 85% at 1 month (n=12, p<0.001), 87% at 3 months, 91% at 6 months, and 104% at 12 months.

    Quality of life

    Arm lymphoedema

    Number of people analysed: 23

    Follow-up: 8.0 months

    • The mean overall QoL reported at the before surgery visit was 6.5 versus 8.3 (28% increase) at the last point of contact with the person, which on average was 8.0 months after surgery.

    Leg lymphoedema

    Number of people analysed: 18

    Follow-up: 9.1 months

    • The mean overall QoL reported at the before surgery visit was 5.9 versus 8.5 (44% increase) at the last point of contact with the person, which on average was 9.1 months after surgery.

    Incidence of cellulitis

    Number of people analysed: 39

    Follow-up: Up to 12 months

    • There were 2 episodes of cellulitis in the follow-up period (0.07 episodes per year). A total of 92 episodes of cellulitis were reported before surgery (0.26 episodes per year).

    Key safety findings

    Number of people analysed: 39

    Follow-up: Up to 12 months

    • Blood transfusion, n=1

    • Skin ulcers secondary to garment use, n=3 (7.7%)

      • All resolved with modification of their garments.

    Study 7 Greene AK (2016)

    Study details

    Study type

    Single arm, single centre, non-randomised, before-and-after study

    Country

    US

    Recruitment period

    2007 to 2015

    Study population and number

    n=15

    People with primary and secondary lymphoedema

    Age and sex

    Mean 45 years (17 to 71); 80% female

    Patient selection criteria

    People that had liposuction for lymphoedema between 2007 and 2015 that had after surgery follow-up.

    Technique

    Technique summary: standard or power-assisted tumescent liposuction under general anaesthesia.

    Infiltration volume: tumescent solution (1 mg 1:1000 epinephrine, 50 ml 1% lidocaine in 1,000 ml of normal saline) was infused into the subcutaneous space, not to exceed 35 mg/kg of lidocaine.

    Aspiration volume: mean lipoaspirate volume was 1,612 ml (range, 1,200 to 2,800 ml) for the arm and 2,902 ml (range, 2,000 to 4,800 ml) for the leg.

    After surgery care: operative dressings were worn for 2 to 3 days after surgery. Compression bandages were changed daily for 6 weeks when a new bandage was fitted.

    Follow-up

    Mean 3.1 years

    Conflict of interest/source of funding

    Conflict of interest: the authors declared no conflicts of interest.

    Funding source: the authors declared no funding source.

    Analysis

    Study design issues: This single arm, single centre, non-randomised, before-and-after study evaluated the efficacy and safety of liposuction for people with lymphoedema. Outcomes included improvement in symptoms, reduction of limb volume (calculated by water displacement), and complications.

    No statistical analysis was performed.

    Study population issues: 6 people had secondary upper extremity lymphoedema after breast cancer treatment and 8 people had primary lower limb disease, 1 person had obesity-induced lymphoedema of the leg and 8 people had a history of repeated cellulitis involving the lymphoedematous extremity.

    Key efficacy findings

    Limb excess reduction

    Number of people analysed: 15

    Follow-up: mean 3.1 years

    • The mean reduction in excess extremity volume was 73% (range 48 to 94%).

    Key safety findings

    Number of people analysed: 15

    Follow-up: mean 3.1 years

    • Blood transfusion, n=2 (13.3%)

      • People had localised skin loss that healed secondarily.

    • Infection that required operative debridement, n=1