Sclerotherapy of lower limb veins: Indications, contraindications and treatment strategies to prevent complications - A consensus document of the International Union of Phlebology-2023.

BACKGROUND: Sclerotherapy is a non-invasive procedure commonly used to treat superficial venous disease, vascular malformations and other ectatic vascular lesions. While extremely rare, sclerotherapy may be complicated by serious adverse events. OBJECTIVES: To categorise contraindications to sclerotherapy based on the available scientific evidence. METHODS: An international, multi-disciplinary panel of phlebologists reviewed the available scientific evidence and developed consensus where evidence was lacking or limited. RESULTS: Absolute Contraindications to sclerotherapy where the risk of harm would outweigh any benefits include known hypersensitivity to sclerosing agents; acute venous thromboembolism (VTE); severe neurological or cardiac adverse events complicating a previous sclerotherapy treatment; severe acute systemic illness or infection; and critical limb ischaemia. Relative Contraindications to sclerotherapy where the potential benefits of the proposed treatment would outweigh the risk of harm or the risks may be mitigated by other measures include pregnancy, postpartum and breastfeeding; hypercoagulable states with risk of VTE; risk of neurological adverse events; risk of cardiac adverse events and poorly controlled chronic systemic illness. Conditions and circumstances where Warnings and Precautions should be considered before proceeding with sclerotherapy include risk of cutaneous necrosis or cosmetic complications such as pigmentation and telangiectatic matting; intake of medications such as the oral contraceptive and other exogenous oestrogens, disulfiram and minocycline; and psychosocial factors and psychiatric comorbidities that may increase the risk of adverse events or compromise optimal treatment outcomes. CONCLUSIONS: Sclerotherapy can achieve safe clinical outcomes provided that (1) patient-related risk factors and in particular all material risks are (1a) adequately identified and the risk benefit ratio is clearly and openly discussed with treatment candidates within a reasonable timeframe prior to the actual procedure; (1b) when an individual is not a suitable candidate for the proposed intervention, conservative treatment options including the option of 'no intervention as a treatment option' are discussed; (1c) complex cases are referred for treatment in controlled and standardised settings and by practitioners with more expertise in the field; (1d) only suitable individuals with no absolute contraindications or those with relative contraindications where the benefits outweigh the risks are offered intervention; (1e) if proceeding with intervention, appropriate prophylactic measures and other risk-mitigating strategies are adopted and appropriate follow-up is organised; and (2) procedure-related risk factors are minimised by ensuring the treating physicians (2a) have adequate training in general phlebology with additional training in duplex ultrasound, procedural phlebology and in particular sclerotherapy; (2b) maintain their knowledge and competency over time and (2c) review and optimise their treatment strategies and techniques on a regular basis to keep up with the ongoing progress in medical technology and contemporary scientific evidence.

The ICC Compression Questionnaire: A Comprehensive Tool to Evaluate Compression Materials or Devices Applied in Subjects with Lymphedema or Chronic Venous Disease.

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.

Compression treatment in acute symptomatic proximal deep venous thrombosis - Results of a worldwide survey.

OBJECTIVES: The aim of this study was to illustrate how compression is performed worldwide in proximal DVT and if compression management has changed recently. METHODS: A global online survey, consisting of 36 questions, was used. The survey was solicited from membership lists of Union Internationale de Phlébologie (UIP) membership societies. For differences between the continents in comparison to Western Europe odds ratios and 95% Confidence Intervals (95%CI) where calculated. RESULTS: We received 626 answers from 41 countries. Compression is routinely used in proximal DVT in all regions (82.8%). 81.4% start compression immediately after diagnosis. In the acute phase of DVT reduction of pain and swelling (91.7%) and PTS prevention (66.2%) are the main reasons for compression. 33.2% recently changed their compression management with 43.5% starting compression earlier and 7.0% later. CONCLUSIONS: Compression is still used routinely in proximal DVT in addition to anticoagulation. The changes in international guidelines towards the non-routine use of compression in proximal DVT have not caused significant changes in DVT management.

Compression Stocking With 100% Donning and Doffing Success: An Open Label Randomised Controlled Trial.

OBJECTIVE: The aim of this study was to test whether an investigational two layer stocking exerting 27-29 mmHg pressure at the medial supramalleolar level, but without compression in the foot and heel, is easier to put on and take off than a standard stocking of the same compression class (23-32 mmHg), and also to assess the prevention of diurnal oedema with both types of stocking. METHODS: This was an open label randomised controlled trial, which included 47 patients. All participants were at least 65 years of age and suffered from chronic venous disease class C3 - C6 in one leg. The primary end point was donning success; secondary endpoints were doffing success, prevention of diurnal oedema over one day, and the comfort of wearing the stocking. Patients were randomly allocated to one of two groups. Both types of compression stocking were compared in each group for ease of donning and doffing in the manner of a crossover study. Subsequently, patients wore the stocking type assigned to their group for a whole day to evaluate comfort and the effect on diurnal leg volume. RESULTS: All participants were able to don the investigational stocking unaided, compared with 75% for the standard stocking (p < .001). Unaided removal success was 100% with the investigational stocking vs. 66% for the standard stocking (p < .001). There was no significant difference in leg volume reduction between the study groups after a day of wear. The investigational stocking was also rated as being more comfortable than the standard stocking (p < .001). CONCLUSION: The investigational stocking, which has no compression in the foot or heel area, is significantly easier to don and doff, with no inferiority in oedema prevention, compared with a standard stocking of the same compression class.

Compression Therapy Is Not Contraindicated in Diabetic Patients with Venous or Mixed Leg Ulcer.

The aim of this study was to investigate if compression therapy (CT) can be safely applied in diabetic patients with Venous Leg Ulcers (VLU), even when a moderate arterial impairment (defined by an Ankle-Brachial Pressure Index 0.5-0.8) occurs as in mixed leg ulcers (MLU). MATERIALS AND METHODS: in one of our previous publications we compared the outcomes of two groups of patients with recalcitrant leg ulcers. Seventy-one patients were affected by mixed venous and arterial impairment and 109 by isolated venous disease. Both groups were treated by tailored inelastic CT (with compression pressure <40 mm Hg in patients with MLU and >60 mm Hg in patients with VLU) and ultrasound guided foam sclerotherapy (UGFS) of the superficial incompetent veins with the reflux directed to the ulcer bed. In the present sub analysis of the same patients we compared the healing time of 107 non-diabetic patients (NDP), 69 with VLU and 38 with MLU) with the healing time of 73 diabetic patients (DP), 40 with VLU and 33 with MLU. RESULTS: Twenty-five patients were lost at follow up. The results refer to 155 patients who completed the treatment protocol. In the VLU group median healing time was 25 weeks for NDP and 28 weeks in DP (p = 0.09). In the MLU group median healing time was 27 weeks for NDP and 29 weeks for DP (p = -0.19). CONCLUSIONS: when providing leg ulcer treatment by means of tailored compression regimen and foam sclerotherapy for superficial venous refluxes, diabetes has only a minor or no effect on the healing time of recalcitrant VLU or MLU.

Risks and contraindications of medical compression treatment - A critical reappraisal. An international consensus statement.

OBJECTIVES: Medical compression therapy is used for non-invasive treatment of venous and lymphatic diseases. Medical compression therapy-associated adverse events and contraindications have been reported, although some contraindications are theoretically based. This consensus statement provides recommendations on medical compression therapy risks and contraindications. METHODS: A systematic literature search of medical compression therapy publications reporting adverse events up until November 2017 was performed. A consensus panel comprising 15 international experts critically reviewed the publications and formulated the recommendations. RESULTS: Sixty-two publications reporting medical compression therapy adverse events were identified. The consensus panel issued 21 recommendations on medical compression therapy contraindications and adverse event risk mitigation, in addition to reviewing medical compression therapy use in borderline indications. The most frequently reported non-severe medical compression therapy-associated adverse events included skin irritation, discomfort and pain. Very rare but severe adverse events, including soft tissue and nerve injury, were also identified. CONCLUSION: This consensus statement summarises published medical compression therapy-associated adverse events and contraindications, and provides guidance on medical compression therapy. Severe medical compression therapy-associated adverse events are very rarely encountered if compression is used correctly and contraindications are considered.

[Importance of adequate pressure in compression therapy : Basis for successful treatment]. / Bedeutung des adäquaten Drucks in der Kompressionstherapie : Basis der erfolgreichen Behandlung.

BACKGROUND: The pressure exerted by a compression device on a part of the body corresponds to the dosage of the compression therapy. Therefore, the pressure course under compression materials should be investigated in different clinical situations. MATERIAL AND METHODS: Pressure measurements were carried out under different compression materials in lying, standing and walking positions within the framework of training, self-experimentation and in patients with venous leg ulcers. RESULTS: The results showed that the pressure varied considerably depending on the material used, the firmness of application, the local configuration (body position) and the time interval between applications. A loss of pressure occurred under each compression therapy, especially under inelastic short-stretch material, mainly due to movement and edema reduction. This pressure loss is decisive for the timing of dressing changes and a reason for the good tolerance of high-pressure levels in mobile patients. CONCLUSION: Low pressures are particularly suitable for edema reduction. Hemodynamic effects require higher pressures (60-80 mmHg). For this purpose, inelastic materials are preferred which enable lower pressures when lying down (40-60 mmHg). As compression bandages are too loosely applied by many users, pressure indicators on bandages or adaptive bandages with templates are helpful to apply the material with the correct pressure. As a consequence of these findings it is postulated that, at least in studies comparing different compression media, pressure measurements should be carried out in the future, whereby the measuring point and body position should be documented.

A Wearable Compression Device to Normalise Calf Muscle Pump Function in Chronic Venous Insufficiency for Each Postural Position.

BACKGROUND: For the currently used compression therapy, the applied compression pressure is usually inadequate to exert an effective impact on the veins in different body positions. The aim was to assess the venous ejection fraction achieved by a new compression device which automatically adjusts the interface pressure to body position in an acute experimental setting. METHODS: A new portable, battery driven compression device providing pressure adjusted to allow for body position, and connected to a less or very stiff calf cuff wrap was tested. In patients with superficial venous incompetence, the ejection fraction (EF) of the calf pump was measured by strain gauge plethysmography. Applied in a random sequence, values achieved without compression, with the two cuffs, and with compression stockings exerting 23-32 mmHg, were compared. The applied compression pressures were simultaneously recorded in the supine and standing positions, and during walking. Comfort was assessed by a visual analogue scale (VAS) with 0 corresponding to very low comfort and 10 to very comfortable. RESULTS: In 16 patients with CEAP clinical stage C3-C6, EF without compression was 37%, increasing to 46.9% with stockings, to 64.8% (p < .001) by less stiff and to 75.5% (p < .001) by stiffer wraps. The median interface pressure (supine/standing) was 31/56 mmHg for the less stiff device, 32/68 mmHg for the stiffer device, and 23/26 mmHg for the stockings. The static stiffness index and the walking pressure amplitudes were significantly higher than those generated by the stocking, and the highest values were found with the stiffer wrap material. The device comfort was high both in the supine and standing positions (VAS 8 ± 2). CONCLUSIONS: The tested devices were comfortable at rest and haemodynamically effective during walking by automatically adjusting compression pressures to body position. They are significantly more effective than elastic stockings in improving EF. The system is able to overcome the problems of fast pressure loss by continuously re-adjusting the compression pressure.

Do Compression Sleeves Reduce the Incidence of Arm Lymphedema and Improve Quality of Life? Two-Year Results from a Prospective Randomized Trial in Breast Cancer Survivors.

BACKGROUND: In a previous randomized controlled trial it has been demonstrated that arm compression sleeves worn immediately after breast cancer surgery, including axillary lymph node removal in addition to physical therapy are able to reduce the occurrence of early postoperative swelling and of arm lymphedema up to 1 year and to improve quality of life. The aim of the present investigation was to check the further development of the arm swelling in patients using compression sleeves or not, and to compare the quality of life in women treated due to breast cancer 2 years after surgery. MATERIALS AND METHODS: Twenty from originally 23 patients who still wore their compression sleeves (15 mmHg) and 21 from 22 patients who had been randomized into the control group without compression could be seen after one more year. Arm volume measurements were performed and quality of life (QLQ-C30 and QLQ-BR23 questionnaires) was assessed. RESULTS: Three from 20 patients in the compression group (CG) and 6 from 21 without compression showed arm lymphedema, defined by an increase of the arm volume exceeding 10% compared with the preoperative values. Significant improvement of several quality of life parameters were found in the CG. CONCLUSION: Light compression sleeves worn for 2 years are not only able to reduce the incidence of early postoperative edema and of lymphedema, but also lead to a significant improvement of important quality-of-life parameters like physical functioning, fatigue, pain, arm and breast symptoms, and future perspectives.

Reliable self-application of short stretch leg compression: Pressure measurements under self-applied, adjustable compression wraps.

AIM: Self-application of properly performed compression bandages is generally considered as problematic. Therefore, the aim of this study was to measure the pressure of self-applied short stretch adjustable compression wrap compression systems (Juxta fit™) and to compare the results with the pressure achieved by bandaging other legs using the same material. METHODS: In the two training courses for nurses, specifically interested in leg ulcer treatment, the new bandage type of adjustable compression wrap was explained and workshops were organized, in which the interface pressure achieved by Juxta fit™ was measured. In the first course, the nurses applied the compression system to each other, and in the second course, another group did it on their own legs. Bandagers were instructed to apply the system strongly, with a target range of more than 50-60 mmHg. RESULTS: In the first course with mutual application ( n = 34), the median pressure at the medial lower leg was 58.5 mmHg (minimal 31, maximal value 137 mmHg), in the second course in which self-application was tested ( n = 36), the corresponding values were 61.5 mmHg (minimum 35, maximum 102 mmHg). No pressures less than 30 mmHg were seen on the distal calf in either group. CONCLUSIONS: In contrast to short stretch bandages that are frequently applied by bandagers with too low pressure, the adjustable compression wrap devices handled by the patients themselves produce more appropriate and more consistent pressure.

Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology.

Guideline 1.1: Compression after thermal ablation or stripping of the saphenous veins. When possible, we suggest compression (elastic stockings or wraps) should be used after surgical or thermal procedures to eliminate varicose veins. [GRADE - 2; LEVEL OF EVIDENCE - C] Guideline 1.2: Dose of compression after thermal ablation or stripping of the varicose veins. If compression dressings are to be used postprocedurally in patients undergoing ablation or surgical procedures on the saphenous veins, those providing pressures >20 mm Hg together with eccentric pads placed directly over the vein ablated or operated on provide the greatest reduction in postoperative pain.[GRADE - 2; LEVEL OF EVIDENCE - B] Guideline 2.1: Duration of compression therapy after thermal ablation or stripping of the saphenous veins. In the absence of convincing evidence, we recommend best clinical judgment to determine the duration of compression therapy after treatment. [BEST PRACTICE] Guideline 3.1: Compression therapy after sclerotherapy. We suggest compression therapy immediately after treatment of superficial veins with sclerotherapy to improve outcomes of sclerotherapy. [GRADE - 2; LEVEL OF EVIDENCE - C] Guideline 3.2: Duration of compression therapy after sclerotherapy. In the absence of convincing evidence, we recommend best clinical judgment to determine the duration of compression therapy after sclerotherapy. [BEST PRACTICE] Guideline 4.1: Compression after superficial vein treatment in patients with a venous leg ulcer. In a patient with a venous leg ulcer, we recommend compression therapy over no compression therapy to increase venous leg ulcer healing rate and to decrease the risk of ulcer recurrence. [GRADE - 1; LEVEL OF EVIDENCE - B] Guideline 4.2: Compression after superficial vein treatment in patients with a mixed arterial and venous leg ulcer. In a patient with a venous leg ulcer and underlying arterial disease, we suggest limiting the use of compression to patients with ankle-brachial index exceeding 0.5 or if absolute ankle pressure is >60 mm Hg. [GRADE - 2; LEVEL OF EVIDENCE - C].