DEBATE: Is compression after sclerotherapy mandatory?
Toledo, Ohio, USA;
University of Michigan, Ann Arbor,
Michigan, USA
The same terms frequently mean different things to different people and the term “evidence-based medicine” is no exception. It is alarming, though, when it is used to limit the clinical decision-making process to a narrow scope of specific evidence from clinical trials and systematic reviews. In fact, the clinical decision making process has always been (and should be) based on the integration of all knowledge modalities, including knowledge of relevant basic science, awareness of the social and economic environment, and a clear understanding of patient preferences.1,2
A good example of how a narrow definition of evidence-based medicine can limit patient care is in the determination of whether to use compression following sclerotherapy. The argument against the use of compression is based solely on the lack of sufficient evidence from clinical research studies demonstrating benefit of compression after treating veins with sclerotherapy. However, the limitations and deficiencies of clinical studies related to compression therapy are well known. Nearly all of the studies were underpowered to answer the key question, so interpreting their inability to detect a difference in the outcomes as an evidence of equality is classic type 2 statistical error. The dose of compression and the time of application varied from study to study and frequently it was not specified or measured. Patients’ compliance with compression was unknown and when estimated it was remarkably low. These and other deficiencies of published clinical studies often result in low or very low evidence levels for the use of compression in procedure-related outcomes; consequently, writing committees issue only weak practical recommendations.3
Using these recommendations as a guide, a practitioner may feel justified to withhold compression after sclerotherapy. However, this scenario represents a restrictive use of the concept of evidence-based medicine. Apart from the logical error that the absence of evidence is not evidence of absence, this position fails to recognize that the focus of clinical studies is on procedural outcomes, such as cosmesis and absence of side effects, which are relevant only to the treatment itself.3-5 It also fails to integrate the knowledge from other disciplines that is relevant to the debated proposition.
Sclerotherapy is used to treat patients with a variety of forms and presentations of chronic venous disease (CVD). Patients with chronic venous insufficiency (CVI; classified as clinical classes C3-C6 of the clinical, etiological, anatomical, and pathophysiological [CEAP] classification4) have complex underlying pathology that requires the use of multiple treatments, including, but not limited to, sclerotherapy. This is especially true for patients with secondary CVD and venous obstruction (Es, Po of the CEAP classification). CVD in general and CVI in particular have a progressive natural history. Currently existing interventional treatments for CVI patients are not curative, and, given sufficient time, recurrences are inevitable. Strong evidence exists that including compression therapy in the comprehensive treatment plan not only provides better clinical outcomes, but also delays CVI progression and prevents recurrences after interventions.5,6 One can reasonably conclude that, in CVI patients, compression should be used after sclerotherapy for reasons not directly related to the procedural outcomes of this modality.
Patients with disease classified as C1-C2 may have pure cosmetic reasons for selecting sclerotherapy. However, epidemiological studies have demonstrated that the majority of these patients have some venous symptoms.7 Since the cosmetic concern dominates prior to the treatment, patients may not clearly express symptom severity. Paradoxically, cosmetically successful treatment may turn patients’ attention to their subjective feelings. Itching, focal aching, and other symptoms are frequently interpreted as side effects of sclerotherapy, while they could have existed before the treatment, at least in some patients. Multiple studies have consistently demonstrated that compression therapy is effective in treating venous symptoms and, for this reason, it should be considered in symptomatic C1-C2 patients.
The pathological basis of CVD is diverse and not always easily identifiable, especially in the early stages of the disease. Initial clinical manifestations may appear at a very young age as C1a-C2a, but they ultimately progress to more advanced stages.8 This clinical progression parallels deteriorating venous pathology.9 Even at the first presentation, almost half of C0-C1 patients have venous reflux.10 More than a quarter of these patients will progress to the C2 class and more than 10% to CVI.10 Sclerotherapy of surface veins in these patients will not affect the disease progression and compression should be considered as a long-term option.
Long-term outcomes may not be the highest priority for patients with cosmetic concerns, but immediate cosmetic results always are a priority. Those results may not be ideal due to well-known side effects and complications of sclerotherapy, such as excessive thrombosis, phlebitis, matting, and pigmentation. The evidence from clinical studies regarding prevention of these conditions is even sparser than the evidence regarding compression, which is when a practitioner’s basic science knowledge should be integrated in the clinical decision-making process. Two major pathological processes behind these complications are thrombosis and inflammation.11 Individually or in combination, these two processes can cause extravasation of blood cells, hemosiderin deposits, and initiation of neovascularization. Keeping these processes under control should help minimize cosmetically unacceptable complications. Compression therapy acts upon exactly these two mechanisms. Its anti-inflammatory, antithrombotic, and thrombolytic effects have been demonstrated and used in a variety of clinical scenarios, from prevention and treatment of venous thrombosis and thrombophlebitis to cellulitis and muscle damage.12 Using compression therapy after sclerotherapy can mitigate the damaging effects of excessive activation of thrombotic and inflammatory pathways. The magnitude of the effect of compression upon the incidence of sclerotherapy complications may not be as dramatic as in the case of edema, and large clinical trials are needed to confirm such influence. However, in the absence of such evidence, the data from basic science and the consistent finding of the benefits of compression in multiple small studies provide sufficient basis for considering compression for improving cosmetic outcomes after sclerotherapy.
In summary, considering the nature of the disease, its underlying pathology, and natural history, longitudinal compression therapy is a reasonable and recommended option for the management of patients with CVD. This modality should be viewed as a component of comprehensive management and it should not be discontinued after interventions, including sclerotherapy. In addition, it is likely to improve cosmetic outcomes of sclerotherapy of reticular veins and telangiectasias. For all of these reasons, compression therapy should be used in all patients after sclerotherapy.
REFERENCES
1. Buetow S, Kenealy T. Evidence-based medicine: the need for a new definition. J Eval Clin Pract. 2000;6(2):85-92.
2. Tonelli MR. The philosophical limits of evidence-based medicine. Acad Med. 1998;73(12):1234-1240.
3. Lurie F, Lal BK, Antignani PL, et al. 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. J Vasc Surg Venous Lymphat Disord. 2019;7(1):17-28.
4. Eklof B, Perrin M, Delis KT, Rutherford RB, Gloviczki P. Updated terminology of chronic venous disorders: the VEIN-TERM transatlantic interdisciplinary consensus document. J Vasc Surg. 2009;49(2):498- 501.
5. Gloviczki P, Comerota AJ, Dalsing MC, et al; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011;53(suppl 5):2S-48S.
6. O’Donnell TF Jr, Passman MA. Clinical practice guidelines of the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF)–management of venous leg ulcers. Introduction. J Vasc Surg. 2014;60(suppl 2):1S-2S.
7. Amsler F, Rabe E, Blättler W. Leg symptoms of somatic, psychic, and unexplained origin in the populationbased Bonn vein study. Eur J Vasc Endovasc Surg. 2013;46(2):255-262.
8. Schultz-Ehrenburg U, Weindorf N, Matthes U, Hirche H. An epidemiologic study of the pathogenesis of varices. The Bochum study I-III [article in French]. Phlebologie. 1992;45(4):497-500.
9. Labropoulos N, Leon L, Kwon S, et al. Study of the venous reflux progression. J Vasc Surg. 2005;41(2):291-5.
10. Robertson LA, Evans CJ, Lee AJ, Allan PL, Ruckley CV, Fowkes FG. Incidence and risk factors for venous reflux in the general population: Edinburgh Vein Study. Eur J Vasc Endovasc Surg. 2014;48(2):208-214.
11. Goldman MP, Sadick NS, Weiss RA. Cutaneous necrosis, telangiectatic matting, and hyperpigmentation following sclerotherapy. Etiology, prevention, and treatment. Dermatol Surg. 1995;21(1):19-29; quiz 31-32.
12. Delos Reyes AP, Partsch H, Mosti G, Obi A, Lurie F. Report from the 2013 meeting of the International Compression Club on advances and challenges of compression therapy. J Vasc Surg Venous Lymphat Disord. 2014;2(4):469-476.
23 boulevard Saint Martin,
75003 Paris, France
Introduction
It might be surprising to question the sacrosanct compression therapy. Compression therapy is widely accepted by the majority of physicians and the reasons for its usefulness seem obvious. However, have the right questions been asked? What is its effect on the veins, how long should it be worn, and with which therapeutic class? Finally, do the patients wear the compression garments correctly and with which observance? No study makes it possible to formally assert the effectiveness of compression and give indications on the most appropriate therapeutic class as well as when it should be worn. There is no consensus on the strength or duration of compression that should be applied following a particular treatment. These are the reasons for which the guidelines can only give us suggestions, sometimes with the lowest grade (2C) and never with a recommendation.1,2
Compression therapy and evolution of varicose vein disease
even if these remarks are off-topic because it concerns the compression and not the compression after sclerotherapy it is interesting to note that, Palfreyman and Michaels3 and, more recently, the most fervent defenders of compression,4 cannot give any recommendations and conclude that insufficient data are available on the use of compression stockings for the prevention of chronic venous disease (CVD) progression. Neither compression stockings nor venoactive drugs can cure varicosities nor prevent the evolution of varicose veins and will just find their use in the presence of venous symptomatology.
What is the role of compression after sclerotherapy?
Theoretically, the purpose of compression stockings is to narrow the vein diameter, thereby reducing postoperative pain, bruising, and the risk of deep vein thrombosis. In 2005, Partsch and Partsch5 investigated the external pressure necessary to narrow and occlude leg veins in different body positions. In the sitting and standing positions, initial narrowing occurs with a pressure on the leg between 30 and 40 mm Hg. Complete occlusion of superficial and deep leg veins occurs with 20 to 25 mm Hg pressure in the supine position, between 50 and 60 mm Hg in the sitting position, and at about 70 mm Hg in the standing position.
Likewise another study,6 using a CT scan with patients in the supine position, compared the great saphenous vein at the thigh wearing no compression or compression with different classes of stockings (II, III, or IV). Regardless of the level of compression, it was not enough to shrink the great saphenous vein on the thigh. This information can easily be checked using an echography on patients in a standing position wearing compression or nothing. Measurements of the vein, even very superficial veins, are equivalent with elastic stockings (measurement through the stocking) or without (directly on the skin). Stockings at the thigh are useless because, regardless of the compression, there is no effect on the great saphenous vein on the thigh.7
More recently, using an MRI on patients in the standing position, Partsch et al8 demonstrated that compression stockings with a pressure of 22 mm Hg were able to reduce the caliber of deep calf veins, but not of superficial varices, which were compressed only by using bandages exerting pressures between 51 and 83 mm Hg. Thus, surprisingly, we learned from this study that the deeper the vein, the more effective the compression. Therefore, this assumption of narrowing of superficial veins using compression stockings is very theoretical and not realistic. Consequently, for telangiectasias, the available compression stockings cannot be effective.
Degree of graduated compression
Since at least 50 mm Hg is required to slightly compress superficial veins in a standing position, maximum compression stockings (class IV) must be provided. However, this is often not the case (in France, the maximum of stocking compression is 45 mm Hg) and there is no consensus on the subject. Consequently, to reinforce the pressure locally on certain veins, an eccentric compression device could be applied using cotton wool, cotton rolls, or rolled gauze compresses, which are affixed with tape strips or bandages. They take time to install, are painful, can irritate the skin, and may move, requiring reapplication of the materials, and can prevent regular personal hygiene. Special pads can be used, but again, these are painful and we have no idea for how long they should be worn. Al through some studies have shown good results with these special pads9,10 made of foam or silicone gel, they remain confidential, and not used regularly by the practitioners. In general, the highest level of compression that the patient can tolerate will probably be the most beneficial. Surprisingly, some studies have reported that low-compression stockings were as effective as high compression stockings, but had a better compliance rate.
Furthermore, excessive compression can sometimes be potentially deleterious.7 The common fibular nerve can be palpated behind the head of the fibula and wraps around the neck of the fibula. Probably much more with bandages than with stockings, compression especially on the lateral aspect at the upper part of the leg, could damage the fibular nerve where it is very superficial.
Duration of compression
Regularly, the optimal duration of compression has come into question. Should they be worn for 2 days, 1 to 4 weeks, or more? The UK recommendations (NICE)11 suggest not offering compression bandaging or hosiery for more than 7 days after completion of interventional treatment of varicose veins. The American recommendations1 are not very explicit and evade the question, leaving the practitioner to use his best clinical judgment to determine the duration of compression therapy after sclerotherapy.
Compliance
Compliance rate with wearing elastic compression stockings is mediocre. Only 21% of patients12,13 admit to using compression therapy as prescribed. Heat in hot countries14,15 or during the hot season aggravates this poor compliance. Furthermore, over the long term, compliance gets worse. In addition, all of these compliance rates are only subjective, depending on the allegations of the patients. Very interesting, one study16 was conducted that can give us the real compliance to compression therapy, which is objectively measured using a thermal probe inserted in the stocking that recorded the skin temperature every 20 minutes for 4 weeks. Therefore, compliance with wearing stockings was accurately recorded: the average daily wearing time was only 5.6 hours and the average number of days worn per week was only 3.4 days. When patients receive detailed recommendations, with an SMS message being sent once a week for four weeks, the average daily duration of wearing was increased to 8 hours and the average number of days worn per week was 4.8 days. Even with repeated and clear recommendations, compliance improved, but, on average, compression was not worn the entire day and not every day, which is the real objective. In order for patients to follow your recommendations, compression stockings must be carefully prescribed (neither too strong nor too light) and the benefits should be rigorously explained.
Sclerotherapy and compression
In the literature, we found 7 randomized controlled trials of compression after sclerotherapy. In 1981, Raj17 found no advantage of wearing compression bandages for 6 weeks compared with 8 hours. Compression bandages become loose with time in a walking patient, losing the benefit of the higher pressure exerted with bandages.
In 1985, Scurr18 (261 patients) recommended compression stockings rather than high-compression bandages after sclerotherapy of varicose veins. Nowadays, there is a broad consensus to recommend, for active ulcers, compression bandages over stockings; however, for varicose veins, stockings are rather prescribed because they are easier to wear, esthetic, and more comfortable during the day.
In 2007, Kern19 (96 patients) concluded that wearing compression stockings for 3 weeks improves the efficacy of sclerotherapy of leg telangiectasia at the thigh by improving the disappearance of clinical vessels in the photos according to independent experts, but patient satisfaction was similar in both groups. This is quite strange because, as we have seen previously, the compression of telangiectasia with stockings in the thigh is illusory and requiring patients to wear a compression stockings for 3 weeks is very restrictive for esthetic reasons.
In 2010, Hamel Desnos20 (60 patients) found no difference in efficacy, adverse effects, satisfaction scores, symptoms, and quality of life between the two groups, with compression during 3 weeks or without after sclerotherapy. This is the only study of the seven to give us the compliance rate and how to hope for better results with compression when you have the same efficacy without compression.
In 2010, O’hare21 (124 legs) concluded that after foam sclerotherapy, there was no advantage after foam sclerotherapy to compression bandaging (cotton wool to provide extrinsic compression plus 3 layers of bandage, which was covered with a thromboembolus deterrent stocking to hold it in place) for more than 24 hours (vs 5 days) and a thromboembolus deterrent stocking for a remainder of 14 days in both groups. Antiembolism stockings are designed for bedridden patients and do not meet the technical specifications for use by ambulatory patients.
In 2011, Hamel Desnos22 (40 patients) concluded that foam sclerotherapy has a minimal effect on some biological markers (inflammation and coagulation) and the occlusion rate of the veins was 100% with or without post treatment compression. A moderate increase in D-dimers at day 1 to day 14 was observed in either the compression group or the no compression group.
More recently, in 2019, Cavezzi23 (94 patients) concluded that compression for 24 hours per day for 7 days with 35 mm Hg versus 25 mm Hg medical compression stockings provided less adverse postoperative symptoms and better tissue healing.
The evidence for the benefit of compression stockings in these randomized controlled trials is equivocal; further studies are needed to be able to make evidence-based recommendations. The main problem of sclerotherapy is not whether or not to wear compression stockings after treatment, but sclerotherapy itself. The guidelines for sclerotherapy treatment exist and should be well known.2,24
Phlebology is a real culture in France; the French Society of Phlebology has existed since 1947. The treatment algorithm is now well established and must be followed according to strict rules to avoid under- or overdose reactions. According to the type of vein and its diameter, the results of sclerotherapy will depend on the concentration and the volume of the sclerosing agent injected. The benefits of using sclerotherapy in liquid or foam form, with or without ultrasound control, need to be understood. Minimal training is required. Compression stockings after poorly adapted sclerotherapy treatment will not change the results.
Deep vein thrombosis and compression
Severe thromboembolic events (proximal DVT, pulmonary embolism) occur very rarely after sclerotherapy. The overall frequency of thromboembolic events is <1%. In 2007, Jia,25 in a systematic review of foam sclerotherapy for varicose veins (69 studies), found that the median rates of pulmonary embolism and deep vein thrombosis was 0.6%, where most of the DVTs are distal. Most of the cases detected by DUS imaging during routine follow up are asymptomatic.
Data on 1605 patients included in the French registry were reviewed with a maximum follow-up of 60 months, covering 3357 patient-years.26 Less than 1% of muscular vein thrombosis were observed in patients treated with liquid or foam sclerotherapy.
In Jia’s meta-analysis, it is not clear whether or not patients wear their compression stockings, but in most countries they do. It can, therefore, be assumed that less than 1% corresponds to the rate of DVT with compression. In the French study by Guex,26 they have the same rate, and, in France, most phlebologists do not usually prescribe compression treatment after sclerotherapy.
Thus, it can be hypothesized that the incidence of DVT is the same with or without compression after sclerotherapy. In contrast, the rate of DVT is more related to the use of larger volumes of sclerosant, especially in the form of foam and a maximum volume of 10 mL per session is recommended.2
Edema
The absolute rule should be that, as soon as there is leg edema, even moderate edema, compression should be used. The key word should be edema: edema = compression. Thus, compression is mandatory in the cases of C3, C4, C5, and C6 (active venous ulcer), and compression after sclerotherapy is not due to sclerotherapy, but to the disease. In the same way, the wearing of compression stockings in C1 and C2 patients with edema of the leg should be encouraged, but not because of sclerotherapy.
A systematic review of compression hosiery for uncomplicated varicose veins found that there is no evidence of an advantage of graduated compression stockings in uncomplicated varicose veins. The published literature was often contradictory and had methodological flaws.3 For the patients with clinical class C1 or C2, which occur most of the time without leg edema, compression could be prescribed in a reasonable way and never as an obligation that cannot be discussed. Thus, less than one-third of French vascular physicians regularly used elastic compression after sclerotherapy.27 As there is no convincing evidence for using or not using compression therapy, you should let people feel free to assess whether they are benefiting from it or not. Compression must be a comfort and not a constraint.
Conclusion
In view of the innocuous nature of elastic compression and its potentially beneficial effects, elastic compression stockings are routinely prescribed. However, a systematic prescription, just in case, is not reasonable. Regardless of the compression, the pressure is not enough to narrow superficial veins on the thigh. Thus, compression after sclerotherapy should not be mandatory, but should be recommended in symptomatic patients and strongly recommended to patients in case of edema. In summary, it is not compression due to sclerotherapy, but due to symptoms.
REFERENCES
1. Lurie F, Lal BK, Antignani PL, et al. Compression therapy after invasive treatment of superficial veins of the lower extremities. J Vasc Surg Venous Lymphat Disord. 2019;7(1):17-28.
2. Rabe E, Breu FX, Cavezzi A, et al. European guidelines for sclerotherapy in chronic venous disorders. Phlebology. 2014;29(6):338-354.
3. Palfreyman SJ, Michaels JA. A systematic review of compression hosiery for uncomplicated varicose veins. Phlebology. 2009;24(suppl 1):13-33.
4. Rabe E, Partsch H, Hafner J, et al. Indications for medical compression stockings in venous and lymphatic disorders: An evidence-based consensus statement. Phlebology. 2018;33(3):163- 184.
5. Partsch B, Partsch H. Calf compression pressure required to achieve venous closure from supine to standing positions. J Vasc Surg. 2005;42:734-738.
6. Uhl JF, Lun B. Proceedings of the 11th International Symposium on Computeraided Noninvasive Vascular Diagnostics. 2004;3:135-138.
7. Gerard JL Compression therapy is not mandatory after lower limb varices endovenous treatment Phlebolymphology. 2019;26(1):37-44.
8. Partsch H, Mosti G, Uhl JF. Unexpected venous diameter reduction by compression stocking of deep, but not of superficial veins. Veins Lymphatics. 2012;1(1):e3.
9. Benigni JP. Interface pressure measurements at the thigh under eccentric compression (Mediven Post Op Kit). Int Angiol. 2009;28(4):334-335.
10. Ragg JC. Eccentric compression of large varicose veins after foam sclerotherapy using a novel silicone gel pad. Phlebologie. 2014;43:250-256.
11. National Institute for Health and Care Excellence. Varicose veins: diagnosis and management. http://guidance.nice. org.uk/cg168. Published July 24, 2013. Accessed July 16, 2019.
12. Raju S, Hollis K, Neglen P. Use of compression stockings in chronic venous disease: patient compliance and efficacy. Ann Vasc Surg. 2007;21(6):790-795.
13. Raju S. Compliance with compression stockings in chronic venous disease. Phlebolymphology. 2008;15(3):103-106.
14. Soya E, N’djessan JJ, Koffi J, Monney E, Tano E, Konin C. Factors of compliance with the wearing of elastic compression stockings in a Sub-Saharan population [article in French]. J Med Vasc. 2017;42(4):221-228.
15. Ayala Á, Guerra JD, Ulloa JH, Kabnick L. Compliance with compression therapy in primary chronic venous disease: results from a tropical country. Phlebology. 2019;34(4):272-277.
16. Uhl JF, Benigni JP, Chahim M, Fréderic D. Prospective randomized controlled study of patient compliance in using a compression stocking: importance of recommendations of the practitioner as a factor for better compliance. Phlebology. 2018;33(1):36-43.
17. Raj TB, Makin GS.A random controlled trial of two forms of compression bandaging in outpatient sclerotherapy of varicose veins. J Surg Res. 1981;31(5):440-445.
18. Scurr JH, Coleridge-Smith P, Cutting P. Varicose veins: optimum compression following sclerotherapy. Ann R Coll Surg Engl. 1985;67(2):109-111.
19. Kern P, Ramelet AA, Wütschert R, Hayoz D. Compression after sclerotherapy for telangiectasias and reticular leg veins: a randomized controlled study. J Vasc Surg. 2007;45(6):1212-1216.
20. Hamel-Desnos CM, Desnos PR, Ferre B, Le Querrec A. In vivo biological effects of foam sclerotherapy. Eur J Vasc Endovasc Surg. 2011;42(2):238-245.
21. Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. Eur J Vasc Endovasc Surg. 2010;39(4):500-507.
22. O’Hare JL, Stephens J, Parkin D, Earnshaw JJ. Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins. Br J Surg. 2010;97(5):650-656.
23. Cavezzi A, Mosti G, Colucci R, Quinzi V, Bastiani L, Urso SU. Compression with 23 mmHg or 35 mmHg stockings after saphenous catheter foam sclerotherapy and phlebectomy of varicose veins: a randomized controlled study. Phlebology. 2019;34(2):98-106.
24. Guex JJ, Hamel-Desnos C. Ultrasons et Phlébologie. Editions Phlébologiques Françaises 2016:109-121.
25. Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C. Systematic review of foam sclerotherapy for varicose veins. Br J Surg. 2007;94(8):925-936.
26. Guex JJ, Schliephake DE, Otto J, Mako S, Allaert FA. The French polidocanol study on long-term side effects: a survey covering 3,357 patient years. Dermatol Surg. 2010;36(suppl 2):993-1003.
27. Tripey V, Monsallier JM, Morello R, Hamel-Desnos C. French sclerotherapy and compression: pPractice patterns. Phlebology. 2015;30(9):632-640.
