Page 1

JULY-AUGUST 2013

Foam Sclerotherapy of Saphenous Veins: Results and Side Effects PAGE 8

Effect of foam sclerotherapy on healing and longterm recurrence in chronic venous leg ulcers PAGE 11


Foam Sclerotherapy of Saphenous Veins: Results and Side Effects

8

Contributing Editor/Reviewer: Andrew Bradbury, BSc, MB ChB Hons, MD, MBA, FEBVS, FRCSEd

Contributing Editor/Reviewer: Melvin Rosenblatt, MD, FACPh

14

Performance of endovenous foam sclerotherapy in the USA

Contributing Editor/Reviewer: Felizitas Pannier, MD

5

Effect of foam sclerotherapy on healing and long-term recurrence in chronic venous leg ulcers

11

Contributing Editor/Reviewer: Steven E. Zimmet, MD RVT FACPh

Cost and Effectiveness of Laser with Phlebectomies Compared with Foam Sclerotherapy in Superficial Venous Insufficiency. Early Results of a Randomised Controlled Trial

Randomized clinical trial of ultrasoundguided foam sclerotherapy versus surgery for the incompetent great saphenous vein

European Guidelines for Sclerotherapy in Chronic Venous Disorders

july - aug ‘13

Dr. Nick Morrison

contents

From the Editor-in-Chief

Contributing Editor/Reviewer: Lars Rasmussen, MD, DMSC

18

Contributing Editor/Reviewer: Paul Pittaluga, MD

Editor’s Note: Letter to the Editor from Prof. Ken Meyers

24

Dr. Nick Morrison

27

21


the world of vein care unites in Boston this September

Hosted by the American College of Phlebology in conjunction with the International Union of Phlebology, the XVII UIP World Meeting will bring together respected faculty, physicians and health care professionals from across the globe this September 8-13 to showcase the most advanced research, technology and treatments in the field of vein care.

This truly historic event will include sessions covering the wide spectrum of phlebology, including: + More than 300 internationally recognized speakers

+ More than 85 event exhibitors showcasing the world's

from around the world

+ Innovative and clinically relevant educational sessions + Hands-on simulation workshops and demonstrations with international faculty

+

most advanced products, pharmaceuticals and medical devices Opportunities for all levels of skill, from basic through advanced, to improve your practice and patients' care

NAL NATIO E DE PHL TER

LOGIE EBO

UNION IN

Join the ACP at the XVII UIP World Meeting in Boston, September 8-13 for this extraordinary event.

A

N AL

HL

EB

RN

OLO

GY

INTE TIO

UNIO N OF P

World Meeting of the International Union of Phlebology /// September 8–13, 2013 Hynes Convention Center • Boston, Massachusetts • USA

HOSTED BY

510.346.6800 | www.uip2013.org | www.phlebology.org advancing vein care


2013 Compression Hosiery and support Wear Buyer’s Guide n

Everything you need to know about over-the-counter and medical compression therapy products

n

Photos and detailed product information from eleven manufacturers

n

Compression stockings, pantyhose, thigh-highs, maternity, travel and sports socks, plus lymphedema products and armsleeves

n

Direct-from-the-factory discounts for individuals or medical professionals

www.BrightLifeDirect.com Your one-stop shop for compression therapy.

to request your FREE copY or Call 1-877-545-8585

6925-D Willow Street NW • Washington, DC 20012

Find tREatmEnt solutions FoR Tired & Achy Legs • Varicose Veins • Vascular Disease • Swelling & Lymphedema • Ulcers • Fragile/Sensitive Skin • DVT Prevention

View past issues of Phlebology Forum at

www.phlebology.org


disclosure of interests

Name

ACP Role

Date Submitted

Disclosure

Stephanie Dentoni, MD

Recruitment & Retention (Chair)

6/25/12

Nothing to Disclose

Mark Forrestal, MD, FACPh

ACP

6/25/12

New Star Lasers Cooltouch: Speaker, Trainer

Mitchel Goldman, MD, FACPh

Phlebology Forum Task Force

2/14/2013

American Society for Dermatologic Surgery, President-Elect; Merz Aesthetics/Kreussler, Consultant

Jean-Jerome Guex, MD, FACPh

ACP BOD, Communications, Standing Committee, Leadership Development, UIP 2013 Task Force, AMA HOD Task Force, International Affairs (Chair),

6/14/12

Kreussler: Speaker; Sigvaris: Speaker, Investigator, Consultant; Innotech: Principal Investigator; Pierre Fabre: Consultant; Boerighr Ingelheim: Consultant, Medical Writer; Servier: Investigator, Consultant, Speaker

Lowell Kabnick, MD, FACS, FACPh

UIP 2013 Task Force

7/17/12

Angiodynamics: Consultant, Shareholder, Patent; Vascular Insights: Scientific Advisory Board

Neil Khilnani, MD, FACPh

ACP BOD, Member Services (Chair)

7/24/12

Sapheon: Data Safety Board Member

Ted King, MD, FAAFP, FACPh

ACP BOD, Leadership Development, PES-QM Task Force, Public Education

6/14/12

BTG: Investigator; Merz: Speaker

Mark Meissner, MD

ACP BOD, Education Standing Committee

7/13/12

Nothing to Disclose

Nick Morrison, MD, FACS, FACPh

UIP 2013 Task Force (Chair), Phlebology Forum Task Force (Chair), Annual Congress Planning Committee (Chair)

6/13/12

Medi: Speakers Bureau; Merz: Speakers Bureau; Sapheon: Principle Investigator; VeinX: Scientific Advisory Board

Eric Mowatt-Larssen, MD

ACP CME Committee

6/25/12

BTG International, Inc.: Consultant

Diana Neuhardt, RVT, RPhS

ACP BOD, Member Services, Audit, UIP 2013 Task Force, Phlebology Forum Task Force, Veinline, Recruitment & Tetention, CME, Distance Learning, Public Education (Chair)

6/15/12

Nothing to Disclose

Pauline RaymondMartimbeau, MD, FACPh

UIP 2013 Task Force

6/22/12

Nothing to Disclose

6


From the

Editor-in-Chief Dear Readers This issue of Phlebology Forum is a special one focusing on foam sclerotherapy for venous disorders. Many practitioners use it routinely but there remain some concerns among others about efficacy and safety. We have chosen a number of foam sclerotherapy articles and asked some of the world’s leading experts to review and comment on these papers. I believe you will find their reviews insightful and well worth your time. And do not miss Professor Ken Myers’ letter to the editor regarding a new sclerotherapy technique for treatment of larger tributary and truncal veins. As he points out, trials will be required to confirm his clinical results but, as he often does, Prof. Myers brings new and innovative information to the cutting edge of the treatment of venous disorders. And finally don’t forget: UIP XVII World Congress, September 8-13, 2013 BOSTON! BOSTON! BOSTON! Nick Morrison, MD Editor-in-Chief Phlebology Forum

7


Foam Sclerotherapy of Saphenous Veins Results and Side Effects Author: Jean-Luc Gillet Vascular Medicine and Phlebology, 51 bis Avenue Professeur Tixier, F-38300 Bourgoin-Jallieu, France Contributing Editor/Reviewer: Andrew Bradbury, BSc, MB ChB Hons, MD, MBA, FEBVS, FRCSEd


ABSTRACT

...foam is clearly superior The distinguished author, Professor Gillet, has reviewed the current (March 2013) evidence base

to liquid sclerotherapy for

(randomised, case-control, and large observational

treating truncal and major

studies) for the role of ultrasound guided foam

tributary saphenous

sclerotherapy (UGFS) in the management of lower limb venous disease and linked his conclusions to some of the recommendations contained within the European Guidelines for Sclerotherapy

disease, but that there remains some uncertainty

in Chronic Venous Disorders (CVD). The analysis

regarding the optimum

is comprehensive, thorough, authoritative and

choice of sclerosant as

well written. Professor Gillet, I think quite rightly, concludes that UGFS is a safe, and highly clinically and cost-effective, treatment for saphenous vein reflux. This is an excellent review article that will be

well as concentration, dosing, and method

of great value to clinicians interested in UGFS and

of preparation (air vs.

the treatment of saphenous disease.

physiological gases).

COMMENTARY Results of UGFS In the first section of the article, the author reviews the large and growing body of evidence from randomised, case-control, and large observational studies that supports UGFS as a valuable part of the clinician’s armamentarium for treating lower limb venous disease secondary to saphenous vein reflux. It is concluded that foam is clearly superior to liquid sclerotherapy for treating truncal and major tributary saphenous disease but that there remains some uncertainty regarding the optimum choice of sclerosant as well as concentration, dosing, and method of preparation (air vs. physiological gases). Further trials are also required to define the optimum nature and duration of post-sclerotherapy compression in different types of disease and patients. Although it is recognised that some disappointing results have been published following UGFS, it is usually possible to trace these back to elements of sub-optimal technique and, where best practice has been followed, the patient reported outcome measures (PROMs) following UGFS have not been shown to be clinically significantly different from surgery or the other popular endovenous techniques. However, much of the published data on endovenous treatments relate to short-term outcomes and further long-term follow-up studies are clearly required. The author also quite rightly points out that researchers, when reporting their results, should adhere to standardised reporting methods so that different experiences and techniques can be properly and fairly compared. Professor Gillet also draws attention to the tension that can exist between, on the one hand, highly satisfactory PROMs and, on the other hand, sometimes

9


disappointing recanalisation rates on duplex Doppler ultrasound observed following UGFS and, indeed, other endovenous (and surgical) interventions. In this respect, there appears to be a growing consensus that we should be treating the patient, not the duplex scan.

Safety The second section of the review deals with the possible side-effects of UGFS; namely, venous thrombo-embolism (VTE) and neurological complications. Professor Gillet quite rightly points out that many large studies have shown that the VTE rate following UGFS is very low (probably a fraction of 1%) provided that optimum technique is observed and appropriate VTE prophylaxis is used. Some of the relevant recommendations from the European Guidelines for Sclerotherapy in CVD are presented and endorsed. With regard to neurological complications, the important distinction between visual disturbances (ViD) and cerebrovascular accidents (CVA) (stroke and transient ischaemic attack, TIA) is appropriately emphasised. Professor Gillet points out that many millions of UGFS sessions have now been performed worldwide and that no death or CVA with significant after-effects has yet to be reported. Quite rightly, routine screening for patent foramen ovale is not recommended. A further distinction is drawn between CVA of delayed onset (a few days), which may be related to paradoxical venous embolism (and so not specifically related to UGFS), and those of immediate onset that may be related to air embolism (and so specific to foam sclerotherapy). Although the risks of permanent neurological damage following UGFS are miniscule, several sensible recommendations regarding technique are made to try to reduce the risk still further. Lastly, the potential, but as yet unproven benefits, of using a physiological gas mixture as opposed to air are discussed.

Conclusion Professor Gillet concludes that UGFS is a safe, and highly clinically and cost-effective treatment for saphenous vein reflux. This is an excellent review article that will be of great value to clinicians interested in UGFS and the treatment of saphenous disease.

Seeking Phlebologist, Interventional Radiologist, General/Vascular Surgeon Total office based care for vein disorders. Serving NE WI and upper MI. Prefer experience in duplex ultrasound, endovascular. Will train Phlebology. Vein Care with Excellence and Distinction! Terry Gueldner, MD, FACS, RPhS Member: AVF, ACP, Vein Experts 940 Maritime Drive Manitowoc, WI 54220 920.686.7900 • www.wivein.com


Effect of foam sclerotherapy on healing and long-term recurrence in chronic venous leg ulcers Authors: Kulkarni S R, Slim F J A, Emerson L G, Davies C, Bulbulia R A, Whyman M R and Poskitt K R. Phlebology 2013;28:140-46. Contributing Editor/Reviewer: Steven E. Zimmet, MD RVT FACPh

Abstract Introduction: The aim of this study is to assess the effect of foam sclerotherapy on ulcer healing and recurrence in chronic venous leg ulcers. Methods: Chronic venous leg ulcers (CEAP 5- healed within last 6 months and CEAP 6) with superficial venous reflux were treated between March 2006 and June 2011 with ultrasound-guided foam sclerotherapy (UGFS; 3% sodium tetradecyl sulfate mixed with room air 1:4, Tessari) and compression. Venous duplex was performed on all legs before and after treatment.

11


Twenty-four-week ulcer healing and one- and four-year ulcer recurrence rates were calculated using Kaplan– Meier survival analysis. Results: Two hundred legs (186 patients) with chronic venous ulcers (CEAP 5: n = 163 and CEAP 6: n = 37) were treated with foam sclerotherapy. Complete occlusion was achieved in 185/200 (92.5%) limbs, short segment occlusion in 14/200 (7%) limbs and one leg segment failed to occlude. One patient suffered an asymptomatic non-occlusive deep vein thrombosis (DVT) diagnosed on duplex scan at one week and one presented with an occlusive DVT three weeks following a normal scan at one week. One patient developed an asymptomatic occlusive DVT at two weeks following a non-occlusive DVT diagnosed on initial one-week scan. Eighteen patients were lost to follow-up (3 moved away and 15 died of unrelated causes). The 24-week healing rate was 71.1% and one- and four-year recurrence rates were 4.7% and 28.1%, respectively.

Venous ulcers are by far the most common cause of chronic wounds, and place a heavy burden on patients with them and on society that provides care for them.

Conclusion: Foam sclerotherapy is effective in abolition of superficial venous reflux and may contribute to similar ulcer healing and exhibit long-term recurrence rates equal to superficial venous surgery. Foam sclerotherapy is an attractive alternative to surgery in this group of patients.

Commentary Venous ulcers are by far the most common cause of chronic wounds, and place a heavy burden on patients with them and on society that provides care for them. The annual cost of CVI in the US is estimated to be about one billion dollars.1 Approaches that speed ulcer healing and reduce recurrence, or better yet prevent ulceration in the first place in a costeffective way would be highly valuable. The ESCHAR trial showed ulcer healing rates at three years of 89% in the compression group and 93% in the compression plus surgery group (P=0.737).2 While ulcer healing rates were similar between surgical and compression groups, ulcer

1 Simka M, Majewski E. The social and economic burden of venous leg ulcers: focus on the role of micronized purified flavonoid fraction adjuvant therapy. Am J Clin Dermatol. 2003;4(8):573-81. 2 Gohel MS, Barwell JR, Taylor M, Chant T, Foy C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ. 2007 Jul 14;335(7610):83.

12


recurrence rates at four years were significantly lower in the compression plus surgery group compared with the compression group (31% v 56%; P<0.001). In patients with isolated superficial reflux, recurrence rates at four years were 51% for the compression group and 27% for the compress plus surgery group (P<0.01). What’s often forgotten is that 19% of patients randomized to surgery refused to have surgery. All analyses were done on an intention to treat basis, suggesting that the benefits of surgery may have been underestimated. A review of the literature suggested that superficial venous surgery was associated with a similar rate of healing to compression alone, but with less ulcer recurrence, and also found a significant proportion of ulcer patients were not surgical candidates.3 Minimally-invasive alternatives to surgery offer obvious benefits, not the least of which is the possibility that fewer ulcer patients would be unwilling to undergo treatment or be considered unsuitable for treatment. This may be particularly relevant given that large ulcer size may be associated with delayed healing (p<0.01) 4; earlier treatment may be better. In the present study, data was collected prospectively on consecutive patients. There was no control group. An independent sonographer off-site did follow-up duplex imaging. This study is the largest to date looking at the effect of UGFS on ulcer healing and long-term recurrence. 123 of 135 legs (91%) with GSV reflux had “complete” occlusion, defined as 85% or more complete occlusion of the treated saphenous reflux or tributary with abolition of reflux, after a maximum of two UGFS sessions. 35/36 SSV (97%) achieved this endpoint, with a median of 5 mL of foam, after one treatment session. 79% of legs were treated with 5 mL or less. Using Kaplan–Meier survival analysis 71.1% of ulcers healed at 24 weeks and 91.2% at one year, and one- and four-year recurrence rates were 4.7% and 28.1%, respectively. It is feasible that recurrence rates may have been lower had the protocol involved follow-up assessment by duplex at one year with treatment of residual/recurrent reflux. Foam sclerotherapy is inexpensive, quick, requires no anesthesia, has an easy recovery and is readily repeated. Further, foam may be delivered into incompetent saphenous veins and tributaries, including those around and underlying a venous ulcer. It is feasible that this could lead to improved healing and perhaps lower recurrence. One study of 130 consecutive C5-6 patients found a 4.9% Kaplan-Meier estimate of recurrence at 2 years, which is lower than that reported followed surgical interventions.5 This present study, despite limitations such as the lack of randomization and a control group, lends merit to the idea that UGFS is a useful modality in the management of venous ulcers, and may be especially useful in patients unwilling or unable to undergo more invasive methods. Adequately powered randomized comparative trials would be useful.

3 Howard DP, Howard A, Kothari A, Wales L, Guest M, Davies AH. The role of superficial venous surgery in the management of venous ulcers: a systematic review. Eur J Vasc Endovasc Surg. 2008 Oct;36(4):458-65. 4

William A. Marston, MD, Robert E. Carlin, MD, Marc A. Passman, MD, Mark A. Farber, MD, Blair A. Keagy, MD. Healing rates and cost efficacy of outpatient compression treatment for leg ulcers associated with venous insufficiency. Journal of Vascular Surgery Volume 30, Issue 3, September 1999, Pages 491–498.

5

5. Pang KH, Bate GR, Darvall KA, Adam DJ, Bradbury AW. Healing and recurrence rates following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration. Eur J Vasc Endovasc Surg. 2010 Dec;40(6):790-5.

13


European Guidelines

for Sclerotherapy in Chronic Venous Disorders Authors: Rabe E, Breu F, Cavezzi A, Smith PC, Frullini A, Gillet J, Guex J, Hamel-Desnos C, Kern P, Partsch B, Ramelet A, Tessari L, Pannier F; Phlebology. 2013 Apr 4. Contributing Editor/Reviewer: Melvin Rosenblatt, MD, FACPh

14


ABSTRACT For many years injection sclerotherapy has been used to chemically ablate abnormal veins of all sizes. Sclerotherapy techniques and outcomes vary dramatically among physicians who often rely on their own personal experiences to guide their practice. This has created a great deal of confusion as to what constitutes best practice as it relates to the chemical ablation of veins. In an effort to create evidence â&#x20AC;&#x201C;based guidelines, physicians representing the interests of 23 European Phlebological Societies convened a conference in Mainz Germany, to review the present state of knowledge as reflected in published literature. Focusing on polidocanol and sodium tetradecyl sulfate, 32 recommendations concerning indications, contraindications, side effects, concentrations, volumes, techniques and efficacy of liquid and foam sclerotherapy were developed. Each of these guidelines is graded according to the American College of chest physiciansâ&#x20AC;&#x2122; task force recommendations on grading strength of recommendations.

COMMENTARY Various guidelines for the treatment of venous disease have been published in the past few years. These recommendations are based on the best

These recommendations are based on the best available evidence at the time of their creation and require frequent review and modification as additional scientific literature becomes available.

available evidence at the time of their creation and require frequent review and modification as additional scientific literature becomes available. The comprehensive guidelines presented in this paper were created only one year ago and are the most current available. As a consequence, they differ in some respects from other published guidelines. In addition there are several variations between common practice in United States and the recommendations set forth in this paper. Although many of these differences are slight some are more significant and warrant some discussion.

One interesting difference between these guidelines and others published just one year earlier relates to the treatment of great saphenous vein reflux. In these guidelines the use of a sclerosing agent for this purpose is given a 1A recommendation. This is in contrast to the recommendations put forth by the Society of Vascular Surgery (SVS) and

15


the American venous forum (AVF) that suggested that this treatment is an option, but gave it a 2C recommendation1,2. This difference in the strength of recommendation could in part be related to the availability of new data but more likely represents practice difference between Europe and the United States. In Europe foam sclerotherapy is a relatively common, cost effective and accepted means of treating saphenous venous reflux while in the US endovenous thermal ablation is considered safer and more effective.

Another difference between these two sets of recommendations relates to the treatment of perforator reflux. In the European guidelines, incompetent perforating veins are considered a good indication for treatment with sclerotherapy (GRADE 1B). In stark contrast, a strong recommendation (GRADE 1B) against treatment in patients with C2 disease is advocated by the SVS/AVF Venous Guidelines Committee1,2. In C6 patients both recommend treatment of incompetent perforating veins around an ulcer, but the strength of this recommendation is much stronger in the European guidelines (GRADE 1B vs. GRADE 2C). Once again these differences are not entirely explained by the availability of new data but reflect a cognitive difference in the way perforator reflux is perceived. In the setting of an isolated lateral thigh perforator as the sole source of varicosities, injection sclerotherapy is a very reasonable treatment. However, incompetent perforator treatment in the lower calf, after, or in conjunction with treatment of saphenous reflux, is a much more complicated issue. In this case the benefit of treatment in the moderately symptomatic patient is questionable. It is this latter type of perforator reflux that is likely the focus of the SVS/AVF Venous Guidelines while the European guidelines reflect the former clinical scenario.

When the European guidelines are compared to the ACP/SVM/AVF/ SIR quality improvement guidelines for the use of foam sclerotherapy other differences are noted. The most pertinent differences relate to the more definitive recommendation made 1 Gloviczki P, Gloviczki ML. Guidelines for the management of varicose veins. Phlebology / Venous Forum of the Royal Society of Medicine. Mar 2012;27 Suppl 1:2-9. 2 Gloviczki P, Comerota AJ, Dalsing MC, et al. 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. Journal of vascular surgery. May 2011;53(5 Suppl):2S-48S.

16


in the European guidelines regarding maximal foam sclerotherapy dosing, removal of post sclerotherapy coagulum, and routine investigations for right to left shunts. These guidelines recommend a maximal dose of 10 ml of foam per session (recommendation 24), strongly recommend against pre-sclerotherapy work-up for PFOs (recommendation 15) and advocate for the removal of superficial clots to prevent hyperpigmentation (recommendation 10). The ACP/ SVM/AVF/SIR quality improvement guidelines conclude that there is insufficient evidence to make any definitive recommendations on these issues3.

Another point of interest is how these recommendations differ from current medical practice in the United States. In the use of foamed sclerosants many clinicians will use up to 20 mls per treatment session and will elevate the leg immediately after injection4. These actions are contrary to recommendations 24 and 30 which suggest that these actions are not safe practices. In addition, typical post sclerotherapy compression garment use ranges between 3-7 days which is in contrast to the 21 day recommendation in these guidelines4.

Lastly, the recommendations put forth for the treatment of venous malformations can be misleading. Recommendation 29 advocates for the use of foam over liquid sclerosants for this pathology based on literature that concludes that foam is more effective.5,6,7,8 However, the articles sited focus only on ultrasound guided treatments without the use of fluoroscopy. When fluoroscopy is used, sclerosants mixed with iodinated contrast are typically used in liquid form so that their intravascular distribution can be best visualized. When they are foamed the mixture is far less radiopaque and is much more difficult to visualize. Typically the treatment of a complex large volume venous malformation would require the use of fluoroscopy.9 In these lesions large volumes of sclerosants are required to fill the malformation which may extend some distance from the point of lesion access. This is best accomplished with a liquid agent. Typically, dosages of 10ml of 3% sodium tetradecyl sulfate is diluted with iodinated contrast and injected under fluoroscopic visualization. This dose, which is common and necessary to treat these types of lesions, exceeds the recommended dose of 4ml of 3% solution suggested in this review. However, this higher dose is consistent with the limit that is published in the Physicians Desk Reference for this agent.

3 Rathbun S, Norris A, Morrison N, et al. Performance of endovenous foam sclerotherapy in the USA for the treatment of venous disorders: ACP/SVM/ AVF/SIR quality improvement guidelines. Phlebology / Venous Forum of the Royal Society of Medicine. Feb 6 2013. 4 Rathbun S, Norris A, Morrison N, et al. Performance of endovenous foam sclerotherapy in the USA. Phlebology / Venous Forum of the Royal Society of Medicine. Mar 2012;27(2):59-66. 5 Yamaki T, Nozaki M, Fujiwara O, Yoshida E. Duplex-guided foam sclerotherapy for the treatment of the symptomatic venous malformations of the face. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]. Jul 2002;28(7):619-622. 6 Yamaki T, Nozaki M, Sakurai H, Takeuchi M, Soejima K, Kono T. Prospective randomized efficacy of ultrasound-guided foam sclerotherapy compared with ultrasound-guided liquid sclerotherapy in the treatment of symptomatic venous malformations. Journal of vascular surgery. Mar 2008;47(3):578-584. 7 Yamaki T, Nozaki M, Sasaki K. Color duplex-guided sclerotherapy for the treatment of venous malformations. Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]. Apr 2000;26(4):323-328. 8

Blaise S, Charavin-Cocuzza M, Riom H, et al. Treatment of low-flow vascular malformations by ultrasound-guided sclerotherapy with polidocanol foam: 24 cases and literature review. European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. Mar 2011;41(3):412-417.

9 Rosenblatt M. Endovascular management of venous malformations. Phlebology / Venous Forum of the Royal Society of Medicine. 2007;22(6):264-275.

17


Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein Authors: Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, et al. Br J Surg. 2012 Aug;99(8):1062-70. doi: 10.1002/ bjs.8781. Epub 2012 May 25. Contributing Editor/Reviewer: Lars Rasmussen, MD, DMSC


ABSTRACT In this multicenter trial from Holland, 460 patients with great saphenous varicose veins were randomized to treatment with ultrasound-guided foam sclerotherapy (UGFS) or surgical stripping1. Follow-up with duplex ultrasound and questionnaires were performed at 3 months, 1 and 2 years after the treatment. Recurrence, defined as reflux in the treated part of the great saphenous vein (GSV) in the presence of venous symptoms, was found in 11,3 and 9 % of patients respectively (P = 0.407). Reflux in the GSV irrespective of symptoms was more frequent after UGFS at 2 years (35.0% vs 21.0%, P = 0.003). Venous Clinical Severity Score (VCSS) and health related quality of life (EQ-5DTM) improved in both groups. Mean hospital costs were â&#x201A;Ź774 for UGFS and â&#x201A;Ź1824 for stripping. Two patients had serious adverse events after UGFS, one DVT and one pulmonary embolus.

The treatment [foam sclerotherapy] appears to be efficient, quite safe, and relatively inexpensive compared to conventional stripping and thermo-ablation

COMMENTARY The present randomized trial is an appreciated step on the way to evaluate the place of UGFS in the treatment of GSV varicose veins. It represents a thorough evaluation of the efficacy, safety and costs of UGFS compared to stripping for up to 2 years.

Ultrasound guided foam sclerotherapy has become an established treatment of varicose veins. The treatment appears to be efficient, quite safe, and relatively inexpensive compared to conventional stripping and thermo-ablation2. Furthermore, the treatment can be easily repeated, as was the case in 40 patients (17,4%) in the present trial. Still, large long-term clinical trials comparing UGFS and stripping are lacking, and the need for repeated UGFS sessions in the long term is therefore not known.

The authors found comparable recurrence rates after UGFS and stripping, as defined by reflux in the treated part of

1 Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, et al. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;99(8):1062-70. 2 Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87.

19


the GSV in the presence of venous symptoms. This primary end point was chosen because it reflected the local clinical practice, where patients are only treated if they have symptomatic varicose veins. Eleven and 9% of the patients respectively developed such recurrence within 2 years after the initial treatment (NS). This is less than found in other studies, when the REVAS classification is used (presence of varicose veins after surgery).3,4 A disease specific quality of life measurement tool such as the Aberdeen Varicose Vein Quality of Life Score (AVVQ), or a simple registration of visible varicose veins after treatment, might have made a comparison with other studies of varicose veins recurrence easier. Thus, because venous symptoms are quite non-specific, the finding must be interpreted with some caution.

By contrast, 35% of foam patients and 21% of surgical patients respectively, demonstrated postoperative duplex verified reflux in the treated part of the GSV regardless of symptoms. The finding confirms previous studies showing a lower technical efficacy of UGFS compared to stripping and thermo-ablation.2,5 Since the half-life of active Polidocanol is short in blood, the technical efficacy of UGFS might have been improved if more than 1 intravenous cannula and a larger volume than 5 ml of foam had been used per session. However, the complication rate might then have increased. Furthermore, the clinical consequence of a lower technical efficacy remains to be elucidated in long-term studies.

Both treatments improved VCSS and quality of life to the same degree, confirming that they have similar clinical efficacy within 2 years. Such improvements are also well described in other studies, where GSV varicose veins are treated with conventional surgery, endovenous laser and radiofrequency as well as UGFS.

Complications, such as thrombophlebitis and hyperpigmentation were more common in the UGFS group. This is well described. One case of DVT and 1 pulmonary embolus were more serious complications in the UGFS group. When all hospital costs were included, treatment with UGFS was less costly than stripping, which was performed under general or regional anesthesia in the present study. Such treatment is more costly than if stripping is performed using tumescent local anesthesia, which is also an option.2 The cost of lost work was not included in the calculations. Whether UGFS remains to be less costly in the long term will probably be revealed in ongoing trials, including the present, when long-term follow-up is available.

In conclusion, at 2-year-follow-up, UGFS was not inferior to surgery with regards to reflux associated with venous symptoms. However, the technical failure rate, as defined by reflux in the treated GSV, was higher in the UGFS group. Time will hopefully show if such difference in reflux has any clinical significance when follow-up continues. Not unexpectedly, in-hospital costs of UGFS were cheaper than of surgery.

3 Perrin MR, Guex JJ, Ruckley CV, dePalma RG, Royle JP, Eklof B, et al. Recurrent varices after surgery (REVAS), a consensus document. REVAS group. Cardiovasc Surg. 2000 Jun;8(4):233-45. 4 Rasmussen LH, Bjoern L, Lawaetz M, Lawaetz B, Blemings A, Eklof B. Randomised clinical trial comparing endovenous laser ablation with stripping of the great saphenous vein: clinical outcome and recurrence after 2 years. Eur J Vasc Endovasc Surg. 5

Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, et al. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. Journal of vascular surgery. 2013 Jun 12.

20


Cost and Effectiveness of Laser with Phlebectomies Compared w ith Foa m S cl e ro t h e ra py i n Superficial Venous Insufficiency. Early Results of a Randomised Controlled Trial Authors: Lattimer CR et al European Journal of Vascular and Endovascular Surgery (2012), doi:10.1016/j.ejvs.2012.01.032 Contributing Editor/Reviewer: Paul Pittaluga, MD

21


Abstract This is a single-centre prospective randomised controlled trial comparing the cost-effectiveness of the treatment of the GSV for varicose veins by endovenous laser ablation (EVLA) with ultrasound-guided foam sclerotherapy (UGFS). One hundred patients were treated in equal proportion with EVLA with additional phlebectomies under local anesthesia (50 patients) or UGFS (50 patients). At 3 months, there was no significant difference between the two groups for the effectiveness according to the quality of life assessement (AVVQ), the VCSS score, the hemodynamic evaluation by airplethysmography and the GSV occlusion rate evaluated by ultrasound-duplex. UGFS had significantly better results for the cost, treatment duration, postoperative pain and time to recovery, but with a higher number of additional foam procedures.

Commentary This article is a very interesting contribution for clarifying the choice for the treatment of varicose veins nowadays. As several techniques of treatment for varicose veins are currently performed with equivalent results, we need some rationale in order to choose an option. The costeffectiveness approach makes sense for making this choice at the time where healthcare rationing is predominant.

As several techniques of treatment for varicose veins are currently performed with equivalent results, we need some rationale in order to choose an option.

According to the conclusion of the authors, at 3 months of follow-up UGFS gives the same results as EVLA with an impressive cost-saving of 68% (£230.24 vs £724.72), even for GSV with large diameters. After having read this conclusion, one could consider that UGFS should be the first line option to treat varicose veins from the GSV. However, there are some limitations on this statement, as mentioned by the authors themselves. The difference of environment in which the treatment has been performed (day surgery theater for EVLA and outpatient consultation room for UGFS) induced a major difference of cost which could be questionable since EVLA is not performed in a surgery theater in many countries.1 In addition, the performance of bilateral EVLA procedures may decrease the cost of disposable laser fibers as Lattimer and colleagues noted in the paper.

1 Hamel-Desnos C, Gérard JL, Desnos P. Endovenous laser procedure in a clinic room: feasibility and side effects study of 1,700 cases. Phlebology. 2009;24:125-30

22


Furthermore, it has been shown that UGFS has a higher failure rate than EVLA after 3 months.2,3 Therefore there is a high probability that UGFS needs additional procedures beyond the 3 month follow-up and that would increase the global cost. These additional foam procedures would burden with debt the quality of life. It has been shown in a paper authored by Gohel4 that taking into account the overall health assessment using the Quality Adjusted Life Years tool (QUALY) leads to the conclusion that there is no significant difference at 5 years of follow-up for the cost-effectiveness comparing surgery (under local anesthesia, ambulatory), EVLA, RFA and UGFS because of the additional procedures after UGFS. Considering that venous insufficiency is an evolutive disease with recurrence, it seems more relevant to evaluate the costeffectiveness of a treatment beyond the 3rd month of follow-up.

Lattimer et al reported in this paper a pretty high level of side effects after EVLA 1470 nm wavelength, with a pretty high median pain score; 3 severe procedural pain (one conversion to UGFS and one requiring a general anesthesia), 8 patients re-attended, 5 due to pain and 3 for dermal thermal injury. That is in contrast with other studies highlighting the value of 1470 nm wavelength for the postoperative pain, with 50% of patients with no pain for Pannier5 or a very low postoperative pain score for Can Callistan6. This contrast could be explained by the fact that in the study of Lattimer et al, some of the EVLA procedures might have been performed by a trainee with a non-achieved learning curve. In addition, the treatment of epifascial tributary varicose veins with UGFS may induce inflammation and thrombosis with pain as reported by many patients, which is not reported in this work.

And finally, the cosmetic result has not been evaluated in this study, while it could have an influence for the calculation of costs: UGFS is followed by a higher risk of skin hyperpigmentation2 which could lead to additional cosmetic procedures increasing the global costs. But the cosmetic criteria might not be relevant in the paper of Lattimer et al with regards to the population treated with 20% of C2 and 64% C4-C6.

In conclusion, this paper clearly showed that UGFS performed in an office setting is more cost-effective than EVLA done in main surgery theater for the treatment of varicose veins at 3 months of follow-up. This statement about the costeffectiveness should not be extrapolated to the performance of EVLA in a more simple setting with a longer follow-up taking into account the cost and the influence on quality of life of additional procedures.

2 Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011;98:1079-87 3

van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009;49:230-9

4 Gohel MS, Epstein DM, Davies AH. Cost-effectiveness of traditional and endovenous treatments for varicose veins. Br J Surg. 2010;97:1815-23 5 Pannier F, Rabe E, Rits J, Kadiss A, Maurins U. Endovenous laser ablation of great saphenous veins using a 1470 nm diode laser and the radial fibre--followup after six months. Phlebology. 2011;26:35-9 6 Can Caliskan K, Cakmakci E, Celebi I, Basak M. Endovenous 1470 nm laser treatment of the saphenous vein: early report of pain assessment. J Cardiovasc Surg (Torino). 2013;54:263-7

23


Performance of endovenous foam sclerotherapy in the USA Authors: S. Rathbun et al Phlebology 2012; 27: 59-66 Contributing Editor/Reviewer: Felizitas Pannier, MD

24


Abstract To evaluate the current practice of foam sclerotherapy in the USA a questionnaire was developed and distributed among the participants of the annual meeting of the American College of Phlebology (ACP) 2009. 239 participants completed the questionnaire. Four questionnaires came from non-US residents and 31 were non-users of foam sclerotherapy. According to the results more foam users came from the south-east of the USA and more non-users from the north-east. The majority of the users were surgeons, internal medicine or family doctors. The most frequent indication was recurrent varicose veins but many also reported primary treatment of varicose veins. Foam sclerotherapy in venous ulcers was another frequent indication whereas spider

the US survey of the performance of foam sclerotherapy is well in concordance with the European guidelines for sclerotherapy

veins where reported only in 7% of the foam users as an indication.

For the majority the presence of septal heart defects, patent foramen ovale and other congenital heart defects were contraindications for foam sclerotherapy. The same was true for previous neurological adverse effects. Sodium tetradecyl sulphate and polidocanol were used mainly in low concentrations. A sclerosant-to-gas ratio of 1:4 or 1:3 using the Tessari technique and room air were the most common findings. Fifty-nine percent used a maximum of up to 10 ml of foam per session whereas 41% used higher foam volumes. Echocardiographic screening prior to sclerotherapy is rare but ultrasound guidance is used by the majority during the procedure. The vast majority use compression bandages or stockings after injection with a wide variety of duration.

Commentary This is the largest survey of the use of foam sclerotherapy in the USA. However sclerotherapy of saphenous veins and non-saphenous varicose veins are not differentiated. This is a pity as the performance of saphenous veins may differ from other indications with respect to volume, concentration and ultrasound guidance.

Recently the first European evidence-based guidelines for sclerotherapy has been published and it is worthwhile to compare the recommendations there with the results of the US survey.

25


The European guidelines recommended foam sclerotherapy over liquid sclerotherapy for saphenous varicose veins (GRADE 1A) and for venous malformations (GRADE 2B) and recurrent varices after previous treatment, accessory saphenous varices, non-saphenous varices and incompetent perforating veins (GRADE 1C). Liquid sclerotherapy is recommended as the method of choice for ablation of telangiectasias and reticular varicose veins (GRADE 1A). Foam sclerotherapy of varicose veins is recommended as an alternative method (GRADE 2B). In the U.S. survey any patent foramen ovale or septal defect is considered as a foam contraindication by the majority. In contrast the European guideline recommends only the symptomatic right-to-left shunt as an absolute contraindication for foam sclerotherapy (GRADE 1C). Asymptomatic shunts which are very frequent in the general population with a prevalence of about 30% are not considered as a contraindication. Neurological disturbances, including migraine, following previous foam sclerotherapy are considered only as a relative contraindication (GRADE 1C). The authors of the guidelines recommend against routine investigation for right-to-left shunts or for the presence of thrombophilia factors in coagulation system. (GRADE 1C). High thromboembolic risk however (e.g. history of thromboembolic events, known severe thrombophilia, hyper-coagulable state, active cancer) is considered as a relative contraindication.

For routine cases a maximum of 10 ml of foam per session is recommended in the guideline (GRADE 2B) but higher volumes are applicable according to the individual risk-benefit -assessment (GRADE 2C). In the US survey it may be suspected that higher volumes are used in saphenous vein sclerotherapy and in combined cases with additional tributaries.

Pre-treatment duplex investigation is recommended in all cases of varicose veins (GRADE 1C). The guideline recommends against routine elevation of the leg or compression of the junction for safety reasons (GRADE 2C). Randomized controlled trials endorsing routine use of compression after sclerotherapy of varicose veins are rare. However the guideline recommends that after sclerotherapy, medical compression may be applied to the treated extremity. Compression can be performed using either a medical compression stockings or compression bandages. (GRADE 2C). Wearing of compression stockings (23-32 mmHg) after sclerotherapy of telangiectasias daily for three weeks enhances results (GRADE 2B).

In conclusion, the US survey of the performance of foam sclerotherapy is well in concordance with the European guidelines for sclerotherapy. However US-doctors seem to be more careful concerning contraindications like patent foramen ovale and more liberal to use higher foam volumes per session. 1

References Rabe E, Breu F, Cavezzi A, Coleridge Smith P, Frullini A, Gillet J, Guex J, Hamel-Desnos C, Kern P, Partsch B, Ramelet A, Tessari L, Pannier F; for the Guideline Group. European guidelines for sclerotherapy in chronic venous disorders. Phlebology. 2013 Apr 4. [Epub ahead of print] PubMed PMID: 23559590.

26


Editorâ&#x20AC;&#x2122;s Note Below is a personal communication from Prof. Ken Myers of Melbourne, Australia, one of the most highly respected investigators in the international phlebologic community. He has been Head of the Department of Vascular Surgery at Prince Henryâ&#x20AC;&#x2122;s Hospital and the Monash Medical Centre in Melbourne, former Chairman of the Division of Vascular Surgery of the Royal Australasian College of Surgeons. He is as past President of the Australian and New Zealand Society of Phlebology and is currently Emeritus Chancellor of the Australasian College of Phlebology. He has been at the forefront of developing new techniques such as echosclerotherapy and endovenous laser therapy.

Letter to the Editor, Phlebology Forum Re: Deactivation of sodium tetradecyl sulphate injection by blood proteins.Watkins MR. Eur J Vasc Endovasc Surg. 2011 Apr;41(4):521-5. Contributing Editor/Reviewer: Neil Sadick, MD, FACP, FACPh, FAAD, FAACS Associate Editor: Ted King MD, FAAFP, FACPh

Dear Sir, The article discussing deactivation of sclerosants in blood in the last issue1 has prompted this communication to discuss an alternative technique for ultrasound guided sclerotherapy that I have adopted over the past three years. Until then, I had followed traditional techniques for foam sclerotherapy but began to encounter a high number of internet-wise patients who were aware of the findings by Morrison and Neuhardt2 that some 14-42% of patients studied with transcranial Doppler showed foam bubbles passing through the middle cerebral artery. Being unable to tell them that this was not a potential cause for diffuse brain damage, I was reluctantly forced to return to using fluid rather than foam.

At about the same time, I became aware of in vitro studies by Parsi3 that sodium tetradecyl sulphate was 30 times more effective and aethoxysclerol a staggering 160 times more effective in saline than in blood. Accordingly, it seemed logical to extend this finding to an in vivo practice by first flushing the injection site with normal saline prior to injecting fluid sclerosant.

27


The limit allowed for the dosage of aethoxysclerol at any one sitting in Australia is approximately 4ml for an average-size patient. Progressively, lower concentrations were used and found to be equally effective so that the practice now is to make up 12ml of 1% aethoxysclerol to be administered in 2ml aliquots providing six injections.

A three-way tap system allows a preliminary flush with 3-5ml of normal saline after which the tap is turned to allow injection of the 2ml of sclerosant. The vein is then vigorously massaged with the ultrasound probe for one to two minutes. A disadvantage is that two hands are required for the procedure so that it is necessary to have an assistant hold the ultrasound probe.

The results have been most gratifying. Although no formal comparative study has been performed, the technique has required no more treatment sessions to completely occlude the diseased segment of tributaries and saphenous veins than for foam (approximately 1.4 sessions for each) while there appears to have been a marked decrease in the incidence of phlebitis and trapped blood. In addition, life-table analysis shows almost identical closure rates at one year follow up.

The present practice cannot be directly compared with past findings with foam as there is now a policy to use endovenous laser ablation for all saphenous veins and tributaries greater than 4mm diameter whereas a higher proportion of larger diameter veins were treated by foam ultrasound guided sclerotherapy in the past. Nevertheless, I consider that this alternative technique warrants more rigorous evaluation by appropriate clinical trials in the future.

28


Cardiovascular Credentialing International Credentialing Cardiovascular Professionals since 1968

www.cci-online.org  •  1-800-326-0268

Become a credentialed Phlebology Sonographer today! The Registered Phlebology Sonographer (RPhS) credential is for physicians, sonographers, nurses, physician assistants and other associate health professionals who utilize ultrasound to treat vein disorders.

What is covered in the RPhS exam?

Photo courtesy of Morrison Vein Institute and Compudiagnostics

“The development of ultrasound has been the most important single factor stimulating the creation of the specialty of phlebology and improving our understanding and treatment of chronic venous disease. The RPhS credential is important because it is the only credential we have that addresses the full breadth of the practice of ultrasound in phlebology. It addresses not only deep venous thrombosis evaluation, but venous reflux and ultrasound in venous procedures as well.” —Eric Mowatt-Larssen, MD, RPhS Vein Specialists of Monterey, California

The following examination matrix is provided to illustrate the general distribution of questions and the relative weight or emphasis given to a skill or content area on the examination. A detailed outline can be found in the CCI Examination Application and Overview booklet or at www.cci-online.org. Content Category Maintain Information, Facility, & Safety Diagnose Patients Perform Diagnostic Test Treat Patients Non-Surgically Treat Patients Surgically Total

Approx % of Exam 10% 20% 30% 12% 28% 100%

Credentials administered by CCI are accredited by the American National Standards Institute (ANSI) based on the ISO/IEC 17024 Accreditation Standard.

Photo courtesy of Quality Vascular Imaging, Inc. and The Cardiovascular & Vein Center of Florida

“I believe that the RPhS credential from CCI is the Gold Standard for venous disease ultrasound certification. It provides a solid foundation for understanding venous hemodynamics and its application towards treatment options. Competence in venous ultrasound is imperative to achieving excellent vein care and having happy patients who will speak highly of you and your practice.” —Craig Crippen, MSc, MD, CCFP, RPhS ABPh DermMedica

Profile for Phlebology Forum

Phlebology Forum July - August 2013  

Publishing digitally, Phlebology Forum is a peer-reviewed journal dedicated to important topics in phlebology. Each bi-monthly issue will in...

Phlebology Forum July - August 2013  

Publishing digitally, Phlebology Forum is a peer-reviewed journal dedicated to important topics in phlebology. Each bi-monthly issue will in...

Advertisement