Phlebology Forum Nov-Dec 2011 Issue

forum NOV - DEC 2 0 1 1

The treatment of varicose veins:

an investigation of patient preferences and expectations.

page 6

Long-term lowmolecular weight heparin

and the post-thrombotic syndrome: A systematic review. page 14

Technical feasibility and

early results of radiologically guided foam sclerotherapy for treatment of varicose veins.

page 21

Don’t Search for an EMR in VAIN...

Discover the Best EMR in VEIN

The Best Kept Secret In Vascular and Vein Software VeinSpec EMR Corporate Office: 12221 Towne Lake Dr., Suite A, Fort Myers, FL 33913 Ph: (239) 225-6993 Fax: (239) 225-6988 Email us at: sales@emrgence.com

Contributing Editor/Reviewer: G. Mark Malouf, FRACS

Contributing Editor/Reviewer: Fedor Lurie, MD, PhD

6

Associate Editor: Pauline Raymond-Martimbeau, MD, FACPh

Associate Editor: Lowell Kabnick, MD, FACS, FACPh

9

High production of Endothelin after foam sclerotherapy: a new pathogenetic hypothesis for neurological and visual disturbances after sclerotherapy.

Long-term lowmolecular weight heparin and the post-thrombotic syndrome: A systematic review.

Contributing Editor/Reviewer: Jean-Luc Gillet, MD

Contributing Editor/Reviewer: Malay Patel, MD

Associate Editor: Jean-Jerome Guex, MD, FACPh

11

Associate Editor: Stephanie Dentoni, MD

Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins UIP consensus document.

Technical feasibility and early results of radiologically guided foam sclerotherapy for treatment of varicose veins.

Contributing Editor/Reviewer: Alessandro Pieri, MD

Contributing Editor/Reviewer: Mitchel P. Goldman, MD, FACPh

Associate Editor: Diana Neuhardt, RVT, RPhS

nov-dec ‘11

Modelling the effect of venous disease on quality of life.

contents

The treatment of varicose veins: an investigation of patient preferences and expectations.

17

Associate Editor: Mitchel P. Goldman, MD, FACPh

21

14

disclosure of interests

Name

Role

Disclosure

Stephanie Dentoni, MD

Recruitment & Retention Cmte (C), Leadership Development

Nothing to Disclose

Mark Forrestal, MD, FACPh

ACP

CoolTouch: Stockholder

Mitchel P. Goldman, MD, FACPh

Merz: Grant/Research Support, Consultant, Speakers’ Bureau; Bioniche: Consultant; STD Pharmaceudicals: Consultant; BTG: Grant/ Research Support, Consultant; New Star Lasers: Stock and/or Shareholder; Lumens: Consultant, Stock and/or Shareholder

Jean-Jerome Guex, MD, FACPh

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

Innotech International- Investigator; Pierre Fabre: Consultant; Sigvaris: Investigator; Vascular Insights, LLC: Scientific Advisory Board; ServierEutherapie: Speaker

Lowell Kabnick, MD, FACS, FACPh

ACP BOD, Education Standing Committee (C), UIP 2013 Task Force, Exhibitor Advisory (C), Phlebology Forum, Program Development, Leadership Development

Angiodynamics: Consultant, Scientific Advisory, Stockholder; Merz: Speaker; Vascular Insights LLC: Consultant, Scientific Advisory

Neil Khilnani, MD, FACPh

ACP

Sapheon: Consultant

Ted King, MD, FAAFP, FACPh

ACPF BOD

Angiodynamics: Investigator; BTG: Investigator; Merz: Speaker, Consultant

Mark Meissner, MD

ACP

Nothing to Disclose

Eric Mowatt-Larssen, MD

CME Committee

BTG: Consultant

Nick Morrison, MD, FACS, FACPh

ACP

BTG: Principal Site Investigator; Vascular Insights LLC: Scientific Advisory Board; VenX: Scientific Advisory Board; Medi: Speakers Bureau

Diana Neuhardt, RVT, RPhS

ACP BOD, Member Services Standing Committee, Education Standing Committee, Public Education (C), Recruitment & Retention, UIP 2013 Task Force, CME Committee, Distance Learning, Leadership Development

Nothing to Disclose

Pauline Raymond-Martimbeau, MD, FACPh

UIP 2013 Task Force

Nothing to Disclose

4

From The

Editor-in-Chief Dear Readers, Please allow me to introduce to you Phlebology Forum. Since the retirement of John Bergan many have missed the reviewed articles presented in Veinous Digest, so the American College of Phlebology decided to produce its own iteration, Phlebology Forum. We have assembled an eager Editorial Board of volunteers from the ACP to choose articles from the phlebologic literature as well as from specialty journals to which many of us do not have access. These articles will be reviewed by an international Contributing Editorial Board including many renowned investigators with great expertise on particular subjects of interest to phlebologists. Each bi-monthly issue will include articles across the spectrum of phlebology and it is anticipated that Phlebology Forum will be another project of great usefulness to members of the ACP and others.

Nick Morrison, Editor-in-Chief

5

The treatment of varicose veins:

an investigation of patient preferences and expectations

Phlebology / Venous Forum of the Royal Society of Medicine. Apr 2010;25(2):54-65.

Reviewer: G. Mark Malouf, FRACS surgeon@varicoseveins.com.au

6

REVIEW: This straightforward paper analyses the results of a 5 page / 13 multi-part questionnaire completed by 111 patients referred by their general practitioners to the vascular surgical clinic at Charing Cross Hospital, London, for treatment of their symptomatic, presumably uncomplicated varicose veins.

The stated aim of the study was to evaluate patient knowledge of varicose veins treatments and to assess the factors that patients considered important when contemplating therapy. The questions concerned what worried the patients about their varicose veins, what varicose veins treatments they knew of and what treatment did they prefer, and finally what factors or whose advice would influence their choice of varicose veins treatment.

Most patients were concerned regarding leg pain, discomfort (75%) and/or appearance of the veins (77%). Most patients (89%) knew of surgical treatment. 23% expressed a preference for non-surgical treatments, and of these, laser was the most popular choice, yet 72% stated that they did not know enough about the treatments to express a preference.

Factors influencing patient decisions for varicose veins treatment were interesting. 80% said that their decision on treatment would be influenced by the opinion of their vascular

80% said that their decision on treatment would be influenced by the opinion of their vascular surgeon.

surgeon. The location of treatment had no bearing in 64% of patients, but 22% said they preferred office-based or outpatient treatment.

The majority of patients expressed a preference for total treatment to take place in a single visit (71%) rather than several visits, and for treatment to be carried out under local anaesthetic (63%) rather than GA. However, anaesthesia and number of visits were unlikely to influence their decision on treatment, despite their preferences.

7

Discomfort after treatment and the chance of the veins recurring were of concern in the majority of patients.

Most (56%) patients were not concerned regarding the period of time off work after treatment. Previous experience of varicose veins treatments would have no influence on the treatment choice in 46%. Most patients stated that information they read in magazines or in newspapers or on the internet would have no influence on their treatment choice.

Discussion in the paper emphasized that the majority of patients in this study had little or no knowledge of varicose veins treatments and stressed the importance of providing such information. Most patients relied heavily on the advice regarding the options given by the treating doctor. In this case, the treating doctor was a vascular surgeon. A minority of patients did have a specific treatment preference and this related to various factors in their history.

DISCUSSION: This paper accurately reflects the situation regarding most patients in our varicose veins practices. These patients have simply NOT acquired enough information about their vein problems and the treatment options that may or may not be relevant to make a definitive decision on treatment. Almost all patients are strongly influenced by a discussion with their treating doctor. In this paper the treating doctor was a vascular surgeon in a major teaching hospital whose department could provide any or all treatment options as required. Irrespective of the level of specialist training or experience or capital expenditure of the treating doctor, it is incumbent on us all to provide each varicose veins patient with details of all the treatment options. This must include what each option entails and what the risks are and what the long-term outlook for control of the venous disease is likely to be with each treatment. This advice must include discussion on adequate follow-up in the future and early intervention to treat recurrent varicosities if and when they occur.

Offering treatment according to what the patient WANTS is often not the best option for their veins, but must of course be a major consideration in the choice. The patient’s concept of a varicose veins treatment is often wildly inaccurate . The treating doctor must correct those inaccuracies , and place the treatment options in the context of the patient’s actual venous problem. Patients come to us for advice. Even well informed and highly motivated patients become confused with the multiple treatment options and want someone to advise on the way forward.

This paper does not intend to deal with other major constraints to varicose vein treatment options. These include: COST of various treatments to the patient, government health service, or insurance funds; AVAILABILITY of the treatment options in the treating doctor’s practice – many of us are solo practitioners who are not able to offer all options and so our advice is skewed accordingly, and that is not ideal for truly exploring all options; Government and health fund REGULATIONS and rules are another constraint that may affect the final treatment choice.

I commend reading this paper to gather the patient’s perspective in viewing their varicose veins treatments. The patient’s perspective is one of a number of factors to be considered before the choice of treatment is made.

This is only after the patient is adequately educated by the doctor about the venous problem, and all treatment options are explained in detail.

8

Modelling the effect of venous disease on quality of life Br J Surg 2011; 98(Suppl 1): 9.

Reviewer: Fedor Lurie, MD, PhD

Abstract: The sample of this cross-sectional study was drawn from a population of patients referred to a single vascular surgeon. It included 456 patients with symptomatic varicose veins and C2-6 CEAP clinical classes. Only patients with reflux limited to the GSV were included in this group. A second group consisted of 105 retrospectively selected patients previously successfully treated for varicose veins. This group was defined as C0-1 clinical class. The distribution of venous reflux in patients of the second group is unknown. Patients’ quality of life was measured using two generic instruments (SF-36, and EQ-5D) and one disease-specific instrument (AVVQ). The severity score (VCSS) was calculated, but used only to examine its relationship with QOL measurements, while patients were classified based on their clinical class “C” of CEAP. The QOL scores were compared across clinical classes, and statistically significant differences were found indicating worse QOL scores in groups of patients with higher clinical classes. However, the variation in QOL scores within each of the groups was very high. Authors concluded that venous disease is associated with significant morbidity, but “there are too many uncertainties and unanswered questions for QOL instruments to be used in individual clinical decision-making.”

9

COMMENTARY: In an ideal world, we would be able to identify what affects a specific patient’s well-being, and resolve this patient’s concerns, symptoms, and signs. In the real world the economic pressures force us to address exactly the same issues. The need for prioritization of healthcare spending requires knowledge of how much various conditions impact patients’ lives and productivity, and how much of this impact is reversible by treatment. The health-related quality of life (QOL) measurements became an attractive tool for studying these questions, and the paper by D. Carradice and co-authors is an example of recent series of publications of QOL in venous diseases.

This study demonstrated that primary chronic venous disease (CVD) significantly deteriorates patients’ well-being, especially in the advanced stages. The generic QOL data showed that five of the eight SF-36 dimensions were affected. This is not surprising to those who care for CVD patients, and confirms the importance of venous disease as a public health problem.

Apart from the overall impact, the study was focused on the effect of the progression of primary chronic disease.

It showed no difference in disease-specific QOL measurements between the groups of patients with C2, C3, and C4 clinical classes, and higher scores in C5 and C6 groups. Interpretation of these findings is challenging.

Cross-sectional design of the study and high variability of QOL data makes longitudinal inferences impossible.

A question of how the QOL of a patient changes as his disease progresses can not be directly answered. Use of the Aberdeen questionnaire (AVVQ) presented an additional interpretational challenge. This instrument includes additional points for ulceration, which automatically assign a higher score for C5 and C6 patients without taking into account the other aspects of QOL. How much of the observed differences in QOL scores were attributed to this is unknown. Including patients, who had been treated before as C0 and C1 groups, introduced significant response shift bias, a well known flaw in QOL studies. Those patients have very different perception of the impact of their venous problems on their well-being, compared to patients who have not been treated.

The conceptual framework of QOL measurements was developed in the last decade.1 2 3 Among other aspects of the interpretability, it emphasizes assessment of the QOL scores based on the magnitude of difference in values that makes it clinically meaningful (minimally important difference – MID). Large inherent variability of the QOL measurements, such as observed in this study may be partially overcome by using MID instead of comparing crude means or medians. These and other methodological challenges should be addressed by future studies, as our specialty moves into unfamiliar field of the QOL research. The paper by D. Carradice and co-authors adds to a growing body of such studies, and confirms the need and value of systematic research of the global and diseasespecific aspects of well-being of our patients.

Patrick DL, Chiang YP. Measurement of health outcomes in treatment effectiveness evaluations: conceptual and methodological challenges. Med Care.

Sep 2000;38(9 Suppl):II14-25.

1

2

3

Testa MA. Interpretation of quality-of-life outcomes: issues that affect magnitude and meaning. Med Care. Sep 2000;38(9 Suppl):II166-174.

Donaldson G. Patient-reported outcomes and the mandate of measurement. Qual Life Res. Dec 2008;17(10):1303-1313.

10

High production of endothelin after foam sclerotherapy:

a new pathogenetic hypothesis for neurological and visual disturbances after sclerotherapy Frullini et al. Phlebology 2011;26:203-208.

Reviewer: Jean-Luc Gillet, MD President of the French Society of Phlebology Vascular Medicine and Phlebology, 51 bis Avenue Professeur Tixier 38300 Bourgoin-Jallieu – France gilletjeanluc@aol.com

Abstract: Several authors have reported an increased of such transient disturbances and neurological complications after foam sclerotherapy (FS). The irritating sclerosant agent may stimulate a significant release of vasoactive substances from the venous wall, specifically endothelin 1 (ET 1).

The objective of this study was to evaluate ET 1 production after liquid (LS) and FS in a rat model.

Method: Systemic ET 1 levels were tested in a group of 13 rats. Six were treated with 0.2 mL Lauromacrogol 400 1% foam, injected in the femoral vein; 6 with 0.2 mL of liquid Lauromacrogol 400; and 1 animal was injected with saline solution and was used as a control case.

ET 1 dosages were performed in samples of blood taken from the aorta before sclerosing injection, after 1 minute and after 5 minutes.

Results: a significant increase of ET 1 levels was detected after FS at 1 and 5 minutes, while ET 1 levels did not change significantly in control and in the group treated with LS.

11

Comments In this study, Frullini et al. present a very appealing pathophysiological theory likely to explain neurological disturbances after sclerotherapy. Neurological side effects, including visual disturbance (ViD), were described after LS1 long before the introduction of FS but appear to be more frequent after FS.

On the basis of clinical observations, we2, as other authors, have suggested that the endothelial irritation by the bubbles could release ET 1 and thereafter induce migraine with aura (MA) attack. In a study based on clinical and magnetic resonance imaging assessments2, we have demonstrated that ViDs occurring after FS correspond to MA and are not transient ischemic attack (TIA).

The hypothesis that ET could be a triggering factor of cortical spreading depression (CSD), which is the pathophysiological correlate of MA, has been demonstrated in vivo in rats by Drieir et al3. They superfused cortex of rats with ET 1 and all animals developed one to five CSDs. ET 1 is a very potent vasoconstrictor.

The credit of Frullini et al. in this study was to

ViDs occurring after FS correspond to MA and are not transient ischemic attack

demonstrate, in vivo, a release of ET 1 after FS. This step was essential to support the biochemical pathophysiological theory of neurological side effects occurring after sclerotherapy. In his study Frullini did not demonstrate an increase of ET 1 level in the group treated with liquid Lauromacrogol due to the weaker effect of LS compared to FS. One logical step for investigation of ETmediated neurological events would be to demonstrate ET elevation in patients following FS: at the last IUP chapter meeting in Prague (September 2011), Frullini presented the results of a series including 11 patients treated with FS, confirming an increase of ET 1 levels.

If the biochemical theory is very appealing, and I do believe that ET plays a key role as a pathophysiological mechanism of the side effects occurring after FS, can we consider that it is the only possible mechanism?

Paradoxical gas embolisms, which reached the cerebral circulation through a patent foramen ovale (PFO), were reported. Studies with trans-cranial Doppler (TCD) have detected high intensity transient (HIT) signals in the

Künzlberger B, Pieck C, Altmeyer P, Stücker M. Migraine ophthalmique with reversible scotomas after sclerotherapy with liquid 1% polidocanol.

Dermatol Surg. 2006;32:1410-3

1

Gillet JL, Donnet A, Lausecker M, Guedes JM, Guex JJ, Lehmann P. Pathophysiology of visual disturbances occurring after foam sclerotherapy.

Phlebology 2010, 25:261-266.

2

3

Dreier JP, Kleeberg J, Petzold G, Priller J, Windmüller O, Orzechowski HD, Lindauer U, Heinemann U, Einhäupl KM, Dirnagl U. Endothelin-1 potently induces Leão’s cortical spreading depression in vivo in the rat: a model for an endothelial trigger of migrainous aura? Brain 2002;125:102-12.

12

cerebral circulation but failed to correlate the symptoms with microembolism. For instance, Morrison presented4 a series of 59 patients treated with FS and monitored by TCD of the middle cerebral artery. HIT signals were recorded in 37% of symptomatic patients but, interestingly, also in 63% of asymptomatic patients.

Important data have been recently provided by neurologists working on migraine. They have indicated that microembolism can serve as a trigger for CSD and thereafter for MA.

As we previously said, we demonstrated that ViDs occurring after FS, combined or not with sensory symptoms and/or dysphasic speech disturbance, correspond to MA and are not TIA2. We must remember that depending on the propagation of the CSD in the cerebral cortex, aura consists of visual symptoms or sensory symptoms or dysphasic speech disturbance but not motor weakness5.

Moskowitz and his team6 have demonstrated, in mice, that microemboli of microbubbles of air, polystyrene microspheres or cholesterol crystals into carotid artery could trigger CSD without requisite tissue damage. In this study, air microemboli caused CSD in all mice. CSDs were preceded by global or regional hypoperfusion with a close correspondence between the magnitude and duration of the cerebral blood flow reduction and the appearance of CSD. Despite extensive histopathological evaluation (all animals were examined), no ischemic infarct was detected in brains after microemboli of air.

Caputi et al7 performed contrast-enhanced transcranial Doppler (ce-TCD) with air-mixed saline in 159 patients with MA. An occurrence of a typical MA attack was overall observed in 12 out of 159 patients, but arose only in PFO positive ones, immediately after ce-TCD (12/79=15.2%).

These data reinforce the demonstration that ViDs occurring after FS correspond to MA and are not transient ischemic cerebro-vascular events, whether they are induced by ET or microembolism.

I think that these two paathophysiological theories are not contradictory. Depending on the sensibility of the patient, either ET or microembolism could be the pathophysiological correlate with FS-induced MA. Both could also explain some other symptoms reported after FS, such as dry cough or chest pressure. Moreover, ET and microembolism could be combined to explain some extended MA attacks which probably occurred in patients with a large PFO and are sometimes confused with TIA.

4

Morrison N. Foam sclerotherapy: the challenge of neurological symptoms. IUP abstracts book 2009, p 73.

5

6

7

Headache Classification Subcommittee of the International headache Society. The International Classification of Headache Disorders: 2nd revision.

Cephalalgia 2004; 24 Suppl 1:9-160 Nozari A, Dilekoz E, Sukhotinsky I et al. Microemboli may link spreading depression migraine aura and patent foramen ovale. Ann Neurol 2010; 67: 2219.

Caputi L, Usai S, Carriero MR et al. Microembolic air load during contrast-transcranial Doppler: a trigger for migraine with aura? Headache 2010;50:1320-1327.

13

Long-term low-molecular weight heparin and the post-thrombotic syndrome: A systematic review.

Am J Med. 2011;124(8):756-765.

Reviewer: Malay Patel, MD

There are substantial immediate, short and long-term benefits in treating acute deep vein thrombosis (aDVT) effectively. Not only does it reduce the incidence of fatal (immediate) and non-fatal pulmonary embolism (short term), it will, substantially reduce the morbidity of post-thrombotic syndrome (PTS) and its socio-economic burden(long-term).

The analysis of 9 studies (published till 2009), in this systematic review1, attempts to validate the use of lowmolecular-weight-heparin/s (LMWHs) as first-line therapy for aDVT instead of initial heparin or LMWHs (7 to 10 days) followed by anti-coagulation with oral vitamin-K antagonists (OVKAs). It studies 9 comparisons made between use of long-term (3 to 6 months) anti-coagulation with LMWHs instead of similar duration anticoagulation with OVKAs, following an episode of aDVT of the lower extremity/ies.

1

Hull RD, Liang J, Townshend G: Long-term low-molecular-weight heparin and the post-thrombotic syndrome: A systematic review. The American Journal of Medicine. 2011: 124(8):756-765

14

The main purpose of this meta-analysis of 9 studies, is to make a strong case for using a safer, predictable and more effective treatment regime to decrease the morbidity of the PTS. It succeeds well in convincing the reader to give a serious thought to switch from OVKAs to LWWHs.

Before, we have better evidence for the routine use of thrombolysis and newer, safer and more predictable oral anticoagulants, sole therapy with LMWHs is emerging as a more reliable form of therapy in treating aDVT and minimizing the morbidity of the PTS.

aDVT has substantial socio-economic burden2 and early and effective treatment targeted towards dissolution of the thrombus, can minimize the development of PTS. PTS is estimated to affect 23-60% of individuals with aDVT3, occurring in most, within the first two years following an episode of aDVT. This led to various measures towards preventing aDVT. aDVT occurs denovo and in, hospitalized patients. aDVT prophylaxis continues to be under utilized, despite a large proportion of patients at risk4. As a consequence aDVT still occurs in a large number of individuals and patients.

Treatment is required for a large number of patients and early institution of effective therapy targeted at dissolution of the thrombus and restoration of venous valvular function, means lesser burden of PTS.

Use of adjuncts like early and continued compression therapy is unreliable as compliance is poor5 6.

Standardization of therapy for aDVT, with heparin (7-10 days), followed by anticoagulation with OVKAs (3 to 6 months), occurred over the last few decades. OVKAs require frequent monitoring. Keeping the blood ‘thin’ within a therapeutic range, and reported as an internationalized normalized ratio (INR), is a continuous process in all patients, during the course of therapy. The monitoring takes up substantial health-worker and patient time. The socio-economic burden of this is under-studied7.

Initial studies focused on patient issues and they still trouble the medics and paramedics8. In the early 2000s peer-reviewed journal articles, got published, focusing on the variation in the therapeutic range of OVKAs and

2

Guanella R, Ducruet T, Johri M et al: Economic burden and cost determinants of deep vein thrombosis during two years following diagnosis: a prospective evaluation. J Thromb Haemost. 2011 Sep 22. Doi: 10.1111/j.1538-7836.2011.04516.x. [Epub ahead of print]

3

Ashrani AA, Helt JA: Incidence and cost burden of post-thrombotic syndrome. J Thromb Thrombolysis, 2009:28(4):465-476

4

Choen AT, Tapson VF, Bergmann JF et al: Venous thromboembolism risk and prophylaxis in the acute hospital care setting(ENDORSE study): a multinational cross sectional study. Lancet, 2008 Jun 7;371(9628):1914

5

Raju s, Hollis K, Neglen P: Use of compression stockings in chronic venous disease: patient compliance and efficacy. Annals of Vascular Surgery, 2007 Nov;21(6):790-795

6

ZiajaD, Kocelak P, Chudek J et al: Compliance with compression stockings in patients with chronic venous disorders. Phlebology, 2011 Aug 2 [Epub ahead of print]

7

Pradelli L, Iannazzo S, Zaniolo O, Botrugno P: Organization and estimated patient-borne costs of oral anticoagulation therapy in Italy: results from a survey. Appl Health Econ Health Policy, 2101;8(2):119-128

8

Seliverstov l: Practical management approaches to anti-coagulation non-compliance, health literacy, and limited English proficiency in the outpatient clinic setting. J Thromb Thrombolysis, 2011:31(3):321-325

15

explanations based on the pharmacokinetcs and pharmacogenetics of OVKA absorption and metabolism were placed in the public domain. Discussions moved towards dose individualization of OKAs9. Perfection was sought in the imperfect science of maintaining a therapeutic level of OVKAs and highlighted the need for a more predictable oral anti-coagulant.

Short comings in the traditional OVKAs spurred the development of newer anticoagulants that require very little or no monitoring. They act at different levels of the coagulation cascade and target specific factors10.

In selected cases of aDVT, thrombolysis can be employed, theoretically, increasing the chances of early dissolution of the thrombus and restoration of venous valve function. Endovascular approaches for thrombolysis produce good outcomes and utilize catheter-based drug delivery systems alone or in combination with mechanical clot dissolution by high-frequency, low-power ultrasound or closed-system mechanical thrombolysis-thrombectomy with devices like the currently popular TrellisTM device. However more evidence for the routine use of endovascular techniques is required11 12.

Good quality trials, with newer oral anti-coagulants and thrombolyis-thrombectomy, will take a few more years to provide level 2-1 evidence and grade B-A recommendations.

In the interim the authors have tried to support a change in the use of the therapeutic agent, by making a case for continued use of LMWHs rather than switch to OVKAs. The main advantages are a better resolution of thrombus with safety and no requirement to monitor ‘thinning’ of blood by frequent determination of an INR.

It does not discuss the inherent practical issues of injection of the LMWHs. Patients or a relative will have to be taught to self inject. Trying to employ a health worker to do this on a daily basis would take away the cost advantage of this form of therapy.

So treating aDVT with the aim of minimizing the morbidity associated with PTS has been an evolution and the present review attempts to substantiate a safer and effective therapeutic modality for the present, before safer, more effective thrombolysis-thrombectomy regimes and newer oral anticoagulants targeted at specific coagulation factors attain a level 2-1 evidence or grade B-A recommendation.

9

10

11

12

Stehle S, Kirchheiner J, Lazar A, Fuhr U: Pharmacogenetics of oral anticoagulants: a basis for dose individualization. Clin Phamacokinet, 2008;47(9):565594 Ansell J, Askin D: New targets for anticoagulation and future perspectives. Cur Drug Discov Technol. 2011 Aug 15 {Epub ahead of print} Popuri RK, Vedantham S: The role of thrombolysis in the clinical management of deep vein thrombosis. Arterioscler Thromb Vasc Biol, 2011:31(3):479484 Wicky ST: Acute deep vein thrombosis and thrombolysis. Tech Vasc Interv Radiol 2009;12(2):148-153

16

Duplex Ultrasound Investigation of the Veins of the Lower Limbs after Treatment for Varicose Veins – UIP Consensus Document DeMaeseneer M, et al. Eur J Vasc Endovasc Surg 2011.

42(1):89-102.

Reviewer: Alessandro Pieri, MD

Abstract: Duplex Ultrasound (DUS) has become the reference standard method in assessing the morphology and haemodynamics of the veins of the lower limbs. This document is based on an initiative of the Union Internationale de PhlÊbologie (UIP), with the aim to obtain a consensus of international experts on the methodology and terminology to be used for DUS assessment after treatment of incompetent superficial and perforating veins in the lower limbs. The study design consisted in a series of consensus meetings and literature review leading to a final document based on experts’ opinion and Literature data. The Authors incorporated the relevant Literature references and prepared a draft concerning the methodology, terminology and value of duplex imaging after varicose vein treatment; subsequently the draft document was circulated to a larger group of experts and revised according to the comments received. Eventually, all participants agreed upon the final version of the article. Different sections of the document cover several issues of DUS investigation after surgery and endovenous treatments of varicose veins, providing a series of recommendations and suggestions on the proper methodology to increase DUS accuracy and standardisation.

17

Comment – Alessandro Pieri M.D., Florence (Italy) To revise a revised Consensus document is really a hard task.

First of all I want to congratulate the Authors on their great effort to classify and standardise such a complex matter – the post-varicose vein treatment DUS assessment . The effort to make easy DUS investigation after any venous treatment is laudable but we cannot leave aside the method that was used to treat varicose veins and the map of the veins before intervention. These information are quite always not available at the time of a late DUS investigation: a detailed pre and post-op (4 weeks) report is needed and I think we should stress this point (possibly referring to the two previous UIP-endorsed consensus documents on DUS anatomy and basic principles in the investigation of the veins of the lower limbs ref. Coleridge-Smith EJVES 2006, Cavezzi EJVES 2006), prior to any DUS investigation after varicose vein treatment.

Drawing up of a Consensus is not easy because all events cannot be considered and the generalisation of findings and of methodology to be used exposes easy criticism.

We should always remember that we only take care of signs (varicose veins) while their pathophysiology is still under discussion. In the last decades very few literature data and articles were provided concerning possible pathogenetic hypotheses about varicose vein disease. Recurrence is to be seen as fatal if we cannot not rule out the cause underlying varicose vein development.

18

Some remarks to this comprehensive and remarkable Consensus article: Qualitative reflux assessment: based on Labropoulos’ publications, the 0,5 sec. cut-off has been considered, but this measure is highly confusing because of the well known venous compliance. How should we perform this time measure? standing? supine? A “clinically significant” reflux may last much longer and it is to be assessed

by Valsalva (preferably standardised) or by compression-release manoeuvres (not standardised and not easily standardisable): real reflux lasts all the time of Valsalva (supine) or till the achievement of pressure equilibrium between superficial and deep veins during compression-release manoeuvres (standing or sitting). Standing Valsalva is confusing, in my mind, because pressure equilibrium was already reached and the refluxing time is obviously shorter. Parana’s manoeuvre (described by Claude Franceschi) is perhaps the best standing method to evaluate reflux. A quantitative reflux assessment would be very important, but we would need computed plethismography (air? strain gauge?) and standardize this method which is mostly used for scientific purposes and not available in routine office activity. Also lipodermatosclerosis may affect any scientific assessment of quantitative reflux owing to tissue increased resistances.

DUS follow-up: is really needed to assess the short/mid/long-term results after varicose vein treatment. Patients’ satisfaction document and QOL would be needed too and added to DUS report (as the Authors correctly point out).

DUS at the SFJ: the term of varicose network at the SFJ to describe recurrences is to be considered a valid update instead of “neoreflux, cavernoma or angiodysplasia” but we should take notice of the volume and of the extension of the network (“neo”-or “old”-vascularisation) of the groin (e.g.: tiny, medium, large or similar descriptions).

Residual stump: it is a very common DUS late finding also after a correct flush ligation of the SFJ. It could merely represent the remodelling evolution of the residual “dome like” finding of the SFJ that usually follows flush ligation at early observations. Doming appearance is a long lasting finding if a competent saphenous terminal valve (TV) is still located inside it. The stump late dilation could represent its evolution (stretching of the dome) in case of an incompetent TV, but it is very difficult to evaluate it as a recurrence linked to a surgical mistake (low ligation) if there are no tributaries associated. The residual stump after EVA (Laser, Radiofrequency or Foam) procedures is the “normal” fate at this level.

SFJ recurrences after CHIVA: if the intervention was performed without surgical “crossotomy” (i.e. if only a double ligation or staples have been placed) necrosis of endothelium takes place resulting in a tiny channel newly connecting the common femoral vein and the saphenous vein: in the follow-up we can observe a progressive venous aneurysm of the proximal great saphenous vein (GSV). Its genesis may be similar to the one of poststenotic arterial aneurysms.

SPJ recurrences: it is mandatory to investigate with DUS for systolic reflux at this level, as it is not exceptional, and for sciatic nerve veins too (pelvic origin, pre-existing?). The pathophysiology of recurrence at SPJ is quite different from SFJ because outflow dynamic (postural) obstructions of popliteal-femoral axis (muscular or anatomic) may be

19

present. A residual stump at this level may be the expression of surgical technical difficulties due to the proximity of the common peroneal nerve/ tibial nerve to the SPJ. The continuity of the stump with any gastrocnemius veins is the expression of a pre-existing common trunk and of a correct flush ligation of the SSV at its junction with the gastrocnemius trunk. In case of CHIVA procedure the surgical “crossotomy” of the SPJ, preserving the continuity of the SSV with the Giacomini’s vein, must be well kept in mind by DUS investigators that do not usually have any information about previous surgical techniques.

Saphenous trunk reflux after EVA procedures: DUS investigators must be advised to detect very low velocity reflux, possibly evolving into major reflux, and to describe their eventual re-entry in perforating veins at the thigh level. I could observe some haemodynamic favourable outcomes like that. Table IV of the article represents another good classification effort to standardize reports but it seems too large and difficult in everyday application and perhaps confusing to be used in scientific articles to classify recurrences.

Final remarks: I hope that this very useful article, that also provides extensions (supplementary data can be found online at doi: 10.1016/j. ejves.2011.03.013), will have a large diffusion among phlebologists and DUS investigators worldwide because it represents the first great attempt after REVAS to take us out of Babylon finally using a common shared language and methodology.

I want to dedicate this comment to the memory of our good friend Mihael Georgiev. He would have greatly appreciated this Consensus

A residual stump at this level may be the expression of surgical technical difficulties due to the proximity of the common peroneal nerve/ tibial nerve to the SPJ

document.

20

Technical feasibility and early results of radiologically guided foam sclerotherapy for treatment of varicose veins.

Li, et al: Dermatol Surg 2011;37:992-998.

Reviewer: Mitchel P. Goldman, MD, FACPh This paper details the experience of a radiology group from Guangdong, China who treated 50 legs in 41 patients with radiologically guided foam sclerotherapy. While the use of fluoroscopy is NOT the standard of care worldwide nor widely available and the use of ultrasound guided sclerotherapy IS the standard of care, this well performed clinical study is interesting on many levels. This paper is accompanied by an outstanding commentary from Pauline Raymond-Martimbeau.1

Raymond-Martimbeau P: Technical feasibility and early results of radiologically guided foam sclerotherapy for treatment of varicose veins. Dermatol Surg 2011;37:1196-1197.

1

21

The authors injected a foam composed of 1% Polidocanol mixed 1:4 with air into the great saphenous vein (GSV) with a maximal volume of 20ml of foam throughout the entire GSV. The volume of foam ranged from 6 to 20ml (average dosage of 14ml).

Fluoroscopy allowed the treating physician to limit injection if the foam passed out of the target vein. In addition, if any foam reached a normal superficial vein of deep vein, maneuvers could be performed to rapidly eliminate the foam from these “non-target” veins. This procedure achieved complete closure 90% and particle closure in 10%. As usually occurs from the controlled thrombophlebitic reaction after sclerotherapy of the GSV even with successful treatment and appropriate graduated compression, skin pigmentation occurred in 46% of patients and superficial thrombophlebitis occurred in 30%.

The careful reader could take issue with the quantity of foam injected and/or the use of a relatively low potency of Polidocanol in addition to the potential sub-optimal post-treatment compression. However, the end results of both efficacy as well as adverse sequelae are within the standard reported by many others.2 3 4 5 The scientific phlebologist could also argue that foam passing into a “normal or deep vein” has little if any sclerosing power.

Those concerned with air-embolism could be comforted that no patients (even those injected with 20ml of foam) demonstrated any adverse effects such as headache, optical migraine or other central nervous system or pulmonary effects.

Finally, I believe that the major advance this paper brings to phlebology is the visualization of what happens to the foam when it is injected. The authors do point out the study limitations of a small group and only 9 month follow-up and call for further studies is warranted.

2

3

Goldman MP, Guex JJ, Weiss RA: SCLEROTHERAPY TREATMENT OF VARICOSE AND TELANGIECTATIC LEG VEINS: FIFTH EDITION. Elsevier, London 2011

Barrett JM, Allen B, Ockelford A, Goldman, MD: Microfoam Ultrasound Guided Sclerotherapy of Varicose Veins in 100 Legs Dermatol Surg 2004;30:612.

4

5

Gillet JL, Guedes, Guex jj, Hamel-Desnos C, et al: Side ffects and complications of foam sclerotherapy of the great and small saphenous veins: a controlled multicenter prospective study including 1,025 patients. Phlebology, 2009;24:131-8.

Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomized controlled trial with or without compression. Eur J Vasc Endovas Surg 2010;39:39:500-7.

22