Issue 2 September 2017

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Five-year data find foam sclerotherapy to be less effective than thermoablation or stripping for varicose veinsAccording to a study comparing the five-year outcomes of four different treatment methods for varicose veins, ultrasound-guided foam sclerotherapy (UGFS) is less effective for vein closure than thermoablation and open stripping, while radiofrequency is less painful.

Lars Rasmussen (Naestved, Den-mark), presented data to delegates at the European Venous Forum

(EVF; 29 June–1 July, Porto, Portugal) comparing the five-year outcomes of endovenous radiofrequency ablation (in this case ClosureFast, Medtronic), UGFS, endovenous laser ablation and high ligation and stripping for the treat-ment of varicose veins. Rasmussen and colleagues assessed each treatment based on technical efficacy, clinical recurrence and the rate of reoperation.

The study involved 500 patients (580 legs) with great saphenous vein reflux and varicose veins, examined and randomised to one of the four treatment methods. Follow-up of these patients included clinical and duplex ultrasound

examinations. Patient demographics were similar across the four groups.

Recovery time was shortest in patients treated with either radiofrequency ablation or UGFS, with a mean return to normal function time of one day and a return to work time of 2.9 days for both treatments (p=0.0001). Mean return to normal function

for endovenous laser ablation was three days while mean return to work time was 3.6 days, and mean return to normal function for stripping was four days with mean return to work time of 4.3 days (p=0.0001).

Over the five years of follow-up, there was a difference in the rates of great saphenous vein recanalisation (p<0.001),

recurrence (p<0.01), and reoperation rate (p<0.001) between the four treatment groups. There were eight (5.8%) recana-lisations in the radiofrequency ablation group, eight (6.8%) in the endovenous laser ablation group, 37 (31.5%) in the UGFS group and eight (6.3%) in the stripping group.

Recurrent varicose veins developed in 19 (18.7%) radiofrequency ablation cases, in 42 (38.6%) laser ablation cases, 28 (31.7%) UGFS cases and 38 (34.6%) stripping cases.

Within five years of initial treatment, there were 19 (17%) reoperations in the radiofrequency ablation group, 19 (18.7%) reoperations in the laser ablation group, 43 (37.7%) reoperations in the UGFS group, and 25 (23.4%) in the strip-ping group.

Speaking to Venous News, Rasmussen said, “We saw that patients treated with either radiofrequency ablation, laser abla-tion or stripping, performed better than the patients treated with foam.” Discuss-ing ways to improve the success of foam treatment, Rasmussen suggested, “It is clear to me, and most others, that if you

Manjit Gohel: Stent flexibility

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Profile: Marianne De Maeseneer

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Sevick-Muraca: Lymphoedema

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Questions remain over venous leg symptoms despite SYM vein consensusAt the 2017 European Venous Forum (29 June–1 July, Porto, Portugal), a presentation given by Eberhard Rabe (Bonn, Germany) questioned whether the SYM Vein Consensus clarified all aspects of venous symptoms. Speaking with Venous News, Rabe explains which questions still remain regarding venous leg symptoms and how the clinical community can best approach a difficult subject.

What was the goal of the SYM Vein Consensus statement?In the revised CEAP classifica-tion it is stated, “Each clinical class is further characterised by a subscript for the presence

of symptoms or absence of symptoms, for example, C2A or C5S. Symptoms include aching, pain, tightness, skin irritation, heaviness, muscle cramps, and other complaints attributable to venous dysfunc-

tion” (Bo Eklöf et al 2004). However, there are many open questions about the true origin

of these symptoms. The goal of the SYM Vein

Consensus was to answer the question of which of these subjective symptoms are spe-cifically attributable to venous dysfunction and to find a better system of quantitative and qualitative assessment (Perrin et al 2016).

What controversies still exist with venous symptoms?It is a fact that leg symptoms are not specific for venous

pathology (examples: leg pain in peripheral arterial occlusive disease or orthopaedic patients). Leg symptoms are, in them-selves, also not diagnostic of a venous disease and deserve to be assessed and treated appropriately. The absence of symptoms does not exclude chronic venous disorders like in asymptomatic varicose vein patients. Leg symptoms might have a high probability of being venous, but venous dysfunc-tion is not demonstrable like in

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Lars Rasmussen

Eberhard Rabe

2 September 2017Updates

repeat foam injections, you will obtain a much higher success rate, but in my opin-ion there are some veins that are quite resistant to foam.” Speaking to his own personal approach, he said, “Our way is to do a truncal ablation with foam, with phlebectomies then added to it. This way, you obtain the same result—at least in the short term—as you do with thermal ablation. The patients love this approach because it is so easy for them.”

Responding to suggestions that some

of the treatments analysed are now obsolete due to technological advances over the lifetime of the trial, Rasmussen argued, “It is absolutely not true. In sev-eral European countries, stripping is still the most used treatment and the majority of laser fibres now used in Europe are still bare fibres. These treatments that we have studied are still used a lot in Europe and in the USA.”

As to the best treatment approach, Rasmussen concluded, “We saw a higher degree of neovascularisation after laser

with the bare fibre, and after stripping, compared to radiofrequency ablation. We saw a reduced rate of recurrent varicose veins in patients treated with ClosureFast. If I was to treat my wife for varicose veins, I would use radiofrequency ablation or laser with a radial fibre, but we also have to consider that this may be slightly more expensive than laser with a bare fibre.”

Pioneers of foam sclerotherapy advo-cated that in the right hands this treat-ment modality plays an important role in the physician’s armamentarium. The late

John Bergan (professor of surgery, Uni-versity of California, San Diego) used to highlight the ease, efficacy, follow-up, low cost, and increased patient comfort using foam. In an interview with Vas-cular News following a presentation at the VEITHsymposium in 2006 he said: “Foam sclerotherapy is non-invasive, requiring only local anaesthetic and a short recovery time; it is already the therapy of choice for recurrent varicosi-ties; and it does not have a high start-up or supply costs.”

Five-year data find foam sclerotherapy to be less effective than thermoablation or open stripping for varicose veinsContinued from page 1

some C0 patients or in a popula-tion with a sitting profession but without venous pathology.

What are some of the factors that must be considered when look-ing at symptoms of po-tential venous disease?There are several categories of influencing factors. Hu-man factors that influence how both patients and practitioners describe, interpret, express and use symptoms include: language and culture; levels of tolerance to unpleasant experiences; prior experience; duration and intensity of symptoms; psychosocial gains; economic gains; the belief re-garding the relationship of symp-toms to a chronic venous disease; and psychological dysfunction and the influence of fear.

The clinical context and the specificity of leg symptoms: leg symptoms are very common in the general population while varicose veins are also highly prevalent, especially in the elderly. Leg symp-toms may also be the symptoms of other conditions not directly related to any venous dysfunction. Leg symptoms of chronic venous diseases may be confounded by coexisting conditions which have a direct effect on the manifestation of chronic venous diseases and associated symptoms.

How can one determine the strength of associa-tion of leg symptoms to chronic venous dis-ease?Venous symptoms “may be sug-gestive of chronic venous disease, particularly if they are exacerbated by heat or dependency in the day’s course, and relieved with leg rest and/or elevation,” according to Eklöf et al (2009).

A high probability appears if a relationship is straight-forward

with a clear temporal and/or spatial association like in venous claudication, phlebalgia of superfi-cial thrombophlebitis or throbbing pain associated with chronic venous ulceration. A moderate probability appears if these symp-toms may be equally attributable to other causes which need to be excluded like in sensation of heavy or swollen legs which may occur in the “otherwise well” population, and also as a feature in those with other clinical condi-tions such as knee osteoarthritis or plantar static disturbances. A low probability appears in unspecific symptoms like “impatient legs”, mimicking a minor form of rest-less legs or sensation of warm feet mainly in the first ten minutes after going to bed.

What is the relationship between venous pain and CEAP?In several studies there is a signifi-cant correlation between venous pain or symptoms and worsening of CEAP clinical classes. This was shown for instance in the Vein Consult programme (Rabe et al 2012). In our recent paper from the Bonn Vein Study we could show that the strength of the association of symptoms increases with the C-class (Wrona et al 2015).

What scoring methods are currently used for venous pain? How could these be im-proved?The CEAP classification takes into account “presence of symptoms” simply by addition of a subscript “s” without any infor-mation given about severity and type of symptoms. The VCSS uses only one symptom—pain—graded from 0–3. In patient-re-ported outcomes like the generic HRQoL scale (EQ5D-5L) or the disease-specific HRQoL scales (eg. CIVIQ, VEINES-QOL/

Sym, AVVQ ao) symptoms are more or less included but well specified.

In the SYM Vein Consensus a three-dimensional diagram is suggested with the features:

� Frequency: never=0, from time to time=1, several times per week=2, and every day=3; � Daily course: never=0, only in the evening=1, in the after-noon=2, in the morning=3; � Severity: none=0, slightly=1, moderate=2, and severe=3.This score must still be

validated before using it in randomised controlled trials.

What was the take-home message of your EVF presentation?Leg symptoms are very important in venous diseases and usually re-spond very well to non-invasive or invasive treatment. However, leg symptoms may also have other causes. In a population with a 25–30% prevalence of chronic venous diseases there is logi-cally a high overlap of venous and other common diseases. In consequence it is not always clear if a typically “venous symptom” really has a pure venous origin. Despite the controversies on ve-nous symptoms we have to keep in mind that this problem appears also for venous signs. Oedema in chronic venous disease patients may have a non-venous origin and might be caused by antihy-pertensive drugs or by inflamma-tion of other origins. A lower leg ulcer in a varicose vein patient is not automatically a “venous ulcer” but might be due to a wide variety of other reasons.

In the end, we need to know more about leg symptoms in chronic venous disease patients and include this item in our studies. The improvement of leg symptoms is one of the main goals of our treatment.

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Kabnick and Miyake join Venous News advisory board

Venous News has added two more world-leading venous specialists to its Scientific Advisory Board—Lowell Ka-bnick (New York, USA) and Kasuo Miyake (São Paulo,

Brazil)—bringing the total number of advisors to seven.

Lowell Kabnick Kasuo Myiake

Questions remain over venous leg symptoms despite SYM vein consensus

VIDIO trial results publishedThe VIDIO study, led by Paul Gagne, Southern CT Vascular Center, Darien, USA, showed that intravenous ultrasound (IVUS) is more sensitive for assessing treatable iliofemoral vein stenosis compared with multiplanar venography and frequently leads to revised treatment plans and the potential for improved clinical outcome.

The results of VIDIO (Venography versus intravascular ultrasound

for diagnosing and treating ili-ofemoral vein obstruction) were published in the September 2017 issue of Journal of Vascular Surgery – Venous and Lymphatic Disorders.

According to Gagne et al, during a 14-month period begin-ning July 2014, 100 patients with clinical class C4 to C6 venous disease and suspected iliofemoral vein obstruction were enrolled at 11 US and three European sites. The inferior vena cava and common iliac, external iliac, and common femoral veins were im-aged. Venograms were measured for vein diameter; IVUS provided diameter and area measurements. Multiplanar venograms included three views: anteroposterior and 30-degree right and left anterior oblique views. A 50% diameter stenosis by venography and a 50% cross-sectional area reduction by IVUS were considered significant.

The results showed that venog-raphy identified stenotic lesions in

51 of 100 patients, whereas IVUS identified lesions in 81 of 100 patients. Compared with IVUS, the diameter reduction was on average 11% less for venography (p<0.001). The intraclass correla-tion coefficient was 0.505 for vein diameter stenosis calculated with the two methods. IVUS identified significant lesions not detected with three-view venography in 26.3% of patients. Investiga-tors revised the treatment plan in 57 of 100 cases after IVUS, most often because of failure of venography to detect a significant lesion (41/57 [72%]). IVUS led to an increased number of stents in 13 of 57 subjects (23%) and the avoidance of an endovascular procedure in three of 57 subjects (5%). Overall, IVUS changed the treatment plan in 57 patients; 54 patients had stents placed on the basis of IVUS detection of significant iliofemoral vein obstructive lesions not appreciated with venography, whereas three patients with significant lesions on venography had no stent placed on the basis of IVUS.

4 September 2017Updates

Adhesive closure “an effective add-on” to thermal ablationEndovenous adhesive closure systems are a useful adjunct to thermal ablation treatment for varicose veins, but it is vital that the possible side-effects of such treatments should be discussed openly with patients pre-procedurally, according to a presentation at the European Venous Forum (EVF; 29 June–1 July, Porto, Portugal).

Tobias Hirsch (Halle, Germany) gave the presentation, telling delegates that cyanoacrylate has

been used as an adhesive in medicine with various chemical derivatives since the 1960s, treating nerve le-sions, wound closure, gastrointestinal bleeding, and for intravascular use (since 1989). The first adhesive device to treat varicose veins—VenaSeal (Medtronic), with application of cy-anoacrylate adhesive via a catheter—was introduced in 2011.

Thermal ablation, recommended by both the 2011 US American Venous Forum guidelines and the 2013 UK NICE guidelines, is now a standard treatment for varicose veins. The pub-lished literature indicates that high oc-clusion rates can be achieved at three years (with rates reported at 93% for laser ablation and 93.2% for radiofre-quency ablation, compared with 93.5% for stripping) and five years (laser ablation 84.8% and radiofrequency ablation 88.7%). Hirsch noted that a 2014 review concluded, “Current data suggest that foam sclerotherapy and endovenous ablation (laser and radi-ofrequency) have similar outcomes to open surgery involving high ligation and stripping.” This success has led to a wide range of devices, of which Hirsch identified 12 for laser ablation and three for radiofrequency ablation, as of 2016.

Despite these successes, thermal ablation can have side effects, includ-ing pain and the risk of small saphen-ous vein damage of the sural and tibial

nerves and resultant paraesthesia and numbness. Existing studies report paraesthesia in 5–10% of laser and radiofrequency ablation cases, with one 2014 study (Park et al) claiming a radi-ofrequency ablation paraesthesia rate of as high as 26%.

Adhesive closure has been found to be tissue-compatible “in thousands of patients,” Hirsch said, with no indica-tions of carcinogenity. With no tumes-cent anaesthesia, this approach causes a low amount of pain and no nerve damage. Furthermore, Hirsch said, high occlusion rates following adhe-sive closure have been reported; 92% at 24 months in the feasibility study, 93% at 24 months in the eSCOPE study, and 94.4% at 36 months in the

VeClose study. The VeClose study also indicated

that this is an easy technique to learn, with first-time operators in a roll-in study achieving 100% (n=19) complete occlusion by the third month, compared with 95.4% (n=103) of radiofrequency ablation closures. That this method requires no additional devices, Hirsch suggested, is another benefit.

Discussing the cons associated with this approach, Hirsch did note that there is a more notable learning curve when using adhesive closure in the sapheno-femoral junction, which is “a little bit tricky”.

The implant used in this procedure “is something we have to talk about with our patients,” Hirsch said, as

there have been concerns over his-totoxicity, and implants take “years” to be reabsorbed. Phlebitis-like skin reactions have been reported in the literature, at a rate of up to 20% (in the WAVES trial).

Acrylates are known to cause al-lergic reactions. All the published case reports focus on contact eczema, which is a type IV allergic reaction. “The bad news is that the only way to treat a type 4 allergic reaction is to remove the implant, which is tricky due to its length,” Hirsch said. The generalised skin affections observed after varicose treatment are hives and itching which is typical for histamine dependency—a type I allergy. This can be treated using steroids and antihistamines. Skin changes like these are seen in 1–2% of cases, Hirsch continued.

“The disadvantages of the adhesive closure approach include the fact that treatment of the junctions requires some training, even though the treat-ment is easy to learn. It is necessary to inform patients about possible allergic skin reactions and how to treat these, and if your patient does not wish to get an implant, you will have to choose another treatment. At the moment, the costs are also a little higher than other procedures, which may cause issues with insurance and reimbursement.”

Hirsch concluded, “The pros of adhe-sive closure make it an effective add-on to thermal varicose vein treatment. It is important that the cons of this approach are discussed preoperatively.”

Tobias Hirsch

“Very good” four-year outcomes for saphenous vein MOCAA four-year follow-up of mechanochemical ablation (MOCA) of the saphenous vein shows a high occlusion rate without complications, even in short veins with dilation >15mm. The study, presented by Mattia Mirandola (Peschiera del Garda, Italy) at the European Venous Forum (29 June–1 July, Porto, Portugal) also recorded a recanalisation >5cm rate of just 11% between years three and four of follow-up.

From September 2012 to September 2016, Miran-dola and colleagues treat-

ed 303 saphenous veins with ClariVein MOCA (Vascular Insights). The patients involved in the study were treated on an outpatient basis and procedures were done without sedation or local anaesthesia, except at phlebectomy sites. MOCA was performed following the standard procedure detailed by ClariVein, with polidocanol at 2% concentration.

Inclusion criteria were: symptomatic incompetent great saphenous vein or small saphenous vein, with or without saphenofemoral or popliteal junction incompe-tence, vein diameter >4mm

and <2mm. Exclusion criteria were: previous thrombophle-bitis or deep vein thrombosis, too much superficial vein (<4mm from the skin), tortuos-ity more than 120 degrees, allergy to polidocanol, and pregnancy.

The treated veins included 266 great saphenous veins, 37 small saphenous veins and six cases in which anterolat-eral side branches were also treated. The mean diameter of the treated great saphenous veins was 6.8cm, the mean operating time was 12 minutes (range 8–26 minutes, excluding phlebectomy), and the technical success rate was 99% (three treatments were incomplete due to spasms). The mean follow-

up time was 19 months (range 3–51 months).

Mirandola reported occlu-sion rates of 94%, 90% and 89% at one, two and three years, respectively. No major complications were observed, while minor complications included superficial thrombo-phlebitis (3%) and induration along the course of the treated vein (6%). There was no hyperpigmentation of the skin beyond six months. There was thrombus progression in the anterior side of the deep vein in seven cases (six femoral and one popliteal vein) at one week, but thrombus was no longer visible at one month. Beyond the six-month time point there were no additional

complications or recanalisa-tions.

“The results are unrelated to the diameter of veins; half of the total recanalisations are

related to severe spasms dur-ing the procedure, which made complete treatment of the vein impossible,” Mirandola told Venous News. “The treatment is very fast and anaesthesia is not necessary, which is important for a surgeon and for nurses. In our experience, if the operator injects scle-rosant from the very start of the saphenofemoral junction, recanalisations are reduced and better results are achieved. When we used this method, we saw a 96% occlusion rate at two years.”

Mirandola now plans to further study the data using multivariate analysis to at-tempt to identify differences in recanalisation patients.

Mattia Mirandola

5September 2017 Deep vein thrombosis

ADVERTORIAL

Role of aspirational thrombectomy in the treatment of acute DVT

By Karlo Novačić

Case reportA man in his 30s presented in the thrombo-sis clinic with sudden onset of left leg pain and swelling of an unprovoked nature last-ing for 24 hours. After a duplex scan, the man was diagnosed with an acute extensive iliofemoral deep vein thrombosis (DVT). On the recommendation of a haema-tologist, he was started on anticoagulation therapy with rivaroxaban (15mg bd). On a follow-up visit two days later, he remained symptomatic and complained of reduced mobility due to pain and swelling.

Past medical history showed no comor-bidities or medical therapy, and, clinically, the patient’s cardiovascular, chest, and abdominal examinations were essentially unremarkable. The patient was presented at the vascular Multi Disciplinary Team (MDT) meeting on the same day, and a decision was made to attempt thrombec-tomy and/or catheter-directed thrombolysis (CDT) procedures in order to remove the extensive thrombus burden.

On clinical examination, the patient’s left leg was swollen, painful, and felt very tight. A duplex scan on the day of the procedure showed a patent, thrombus-free popliteal vein, a distended common femoral vein, and distended external and common left iliac veins. After signing a consent form, the patient was taken to the angiography suite, where he was transferred to the angiogra-phy table in the prone position.

Prior to the thrombectomy procedure, an optional inferior vena cava ALN filter (ALN Implants Chirurgicaux) was placed in the infrarenal inferior vena cava (IVC) using a right transjugular approach.

The patient was then moved to the supine position. An ultrasound-guided puncture of the left popliteal vein was followed by the introduction of a 10F vascular sheath. A venogram confirmed thrombotic occlusion of the left common femoral and the external and common iliac veins. The patient was given 5,000 units of heparin intravenously. Both a hydrophilic 0.35” angled Terumo® wire and a 5F, 65cm-long vertebral shape diagnostic catheter were used to recanalise the occluded vein segments.

Direct mechanical aspiration thrombec-tomy was performed using the Indigo® Mechanical Thrombectomy System (Penumbra), which consisted of CAT8 catheter, SEP8 separator, and aspiration pump (PUMP MAX™).

Using direct aspiration, six passes with the Indigo CAT8 catheter were performed

with resultant partial thrombus removal from the blocked veins, demonstrating restored retrograde flow towards the IVC. Due to the significant thrombus load that was still present, a CDT was initiated, using a 5F infusion catheter (Cook multi-side port infusion catheter) with an infusion rate of 0.5mg of alteplase/hour for 24 hours. Before the patient was taken to High Dependecy Unit (HDU), Flowtron® boots were placed on his lower legs.

Examination of the patient the next day showed no evidence of bleeding around the popliteal vein 10F sheath. A review of the venogram demonstrated complete clear-ance of the common femoral, external iliac veins, and residual thrombus at common il-liac vein (IVC) compression site. Again, the Indigo System with a CAT8 catheter and SEP8 separator were used for aspiration and maceration of this residual thrombus with good result.

Following thrombus aspiration, balloon angioplasty of the CIV was performed using a high pressure balloon (14 x 40mm, Atlas® Gold, Bard®) with the subsequent insertion of a dedicated venous self-ex-pandable stent (16 x 100mm Zilver® Vena™, Cook Medical). Stent post dilatation and moulding were performed again, this time using a 16mm balloon.

The final venogram demonstrated excel-lent outcome with fully restored patency of iliac veins and no residual thrombi. Venoplasty and stenting procedures were performed under conscious sedation with 1mg of midazolam and 75mg of fentanyl. The patient, who reported tolerable pain during balloon inflations, maintained respiratory and haemodynamic stability throughout the procedure.

The 10F sheath was removed and manual compression was applied for haemostasis; the treated leg was wrapped up with compression bandage. The patient returned to the vascular ward with a recommendation for early ambulation four hours after procedure and continuation of anticoagulation with rivaroxaban for at least six months.

The patient was discharged from hospital the next day with complete cessation of leg swelling and with no pain.

DiscussionAcute DVT represents a significant health problem and affects more than one in 1,000 individuals annually in the United King-dom. Pulmonary embolism (PE), the most severe complication of DVT, affects 86 in 100,000 individuals (2013, NHS England). Late complications of DVT, such as recur-rence of the disease and post-thrombotic syndrome (PTS), can have devastating consequences on patients and their qual-ity of life. PTS represents a chronic and debilitating disorder with various clinical manifestation that range from pain, swell-ing, tiredness, and cramping of the affected limb to the development of a venous ulcer.

Traditional mainstay therapy of DVT with anticoagulation and compression stocking has changed little over the past 50 years. However, in recent years, this approach has been challenged by the devel-

opment of new treatment techniques, which aim to achieve rapid thrombus removal in order to preserve deep venous valves. Anticoagulation therapy does not remove or destroy thrombus; instead it relies on the body’s internal fibrinolytic mechanisms to work. The rationale for active thrombus removal is supported by good quality data that suggest early clot removal improves venous patency, restores valvular function, and reduces the severity of PTS.

Techniques for thrombus removal include CDT, a pharmacomechanical ap-proach, mechanical thrombectomy alone, or mechanical aspiration thrombectomy alone.

In order to select the appropriate tech-nique, one considers several factors, such as device availability in the angiography suite, experience of the operator, and the clinical nature of the patient—age, life expectancy, underlying malignancy, exten-sion of thrombus (ascending or descending type of DVT), and contraindications for thrombolytic drugs. All factors warrant a strong discussion of risks, benefits, and alternatives.

CDT procedures use thrombolytic agents that increase the risk of bleeding. Also, CDT patients have to be monitored in HDU, sometimes for as long as 72 hours. This can have significant cost and organisa-tional implications. Thrombectomy, on the other hand, enables rapid and effective clot removal and can be performed as single-session procedures.

Conventional percutaneous pharma-comechanical thrombectomy techniques have known limitations such as restricted trackability of catheters, risk of bleeding, ineffectiveness in organised thrombus removal (>14 days), PE, valvular damage, and, in cases of rheolytic systems, acute kidney injury.

In mechanical aspiration thrombectomy, thrombus removal is facilitated by the application of suction through the catheter using negative pressure generated by an aspiration pump. Aspiration devices have significant advantages in that they do

not require thrombolytics and are more effective in chronic, organised thrombus removal. The Indigo System has proven effective in the treatment of the peripheral venous system. Recently, the system’s indication was expanded to include the pe-ripheral arterial and venous systems. Avail-able in a selection of sizes, Indigo aspiration catheters can extract thrombus from large vessels as well as small vessels such as the upper and lower extremities.

The CAT8 catheter, an 8F catheter with three tip shapes, is used in the treatment of patients with DVT. The CAT8 catheter offers an angled atraumatic tip, allowing circum-ferential aspiration of thrombi attached to vessel walls. Another advantage of the angled, atraumatic tip is that it allows safe advancement of the catheter without support of the guidewire. Aspiration of thrombus is performed either by gentle to-and-fro and rotational motion on the guiding catheter or by withdrawal of the catheter under continu-ous suction. There is also the option to use the SEP8 separator in conjunction with the CAT8 catheter, as it helps with clot fragmen-tation and clears clot from the catheter tip.

In our institution, the Indigo System has been used as a first-line treatment in cases of acute and subacute DVT (up to 21 days after onset of symptoms). In patients with duration of symptoms lasting less than seven days, a single-session procedure is usually enough to restore the blood flow through the vein. Subacute cases usually require the additional use of CDT for 24 hours.

Initial experience with the Indigo Sys-tem in treatment of DVT is encouraging with high success rates and a high safety profile. Further confirmation through trials is needed.

Karlo Novačić is a consultant interven-tional radiologist, Barking, Havering and Redbridge University Hospitals NHS Trust, UK, co-founder of Poliklinika VeNeS

This advertorial has been sponsored by Penumbra

6 September 2017Laser ablation

Endovenous 2ring radial fibre laser may improve quality of life outcomes compared with traditional single-fibreResults from a Czech study indicate that 1470nm laser treatment of saphenous vein reflux with both radial single-ring and 2ring fibres results in clinical improvement of symptoms and comparable occlusion rates. That said, in the early postoperative period, 2ring laser radial fibre “seems to remove the quality of life limitations associated with traditional single-ring radial fibre use,” said Robert Vlachovsky (Brno, Czech Republic) when he presented his findings at the 2017 European Venous Forum (EVF; 29 June–1 July, Porto, Portugal).

Chronic venous disorder is one of the most prevalent worldwide diseases, affecting approximately

25% of the adult population, Vlachovsky told EVF delegates. It is associated with a full spectrum of clinical symptoms and includes cosmetic concerns and quality of life issues. Chronic venous insufficiency (C3–C6) has a prevalence of approximate-ly 17% worldwide.

Vlachovsky explained that the 1470nm single-radial fibre laser system creates a homogenous effect with less perforation (and therefore less pain and bruising) while sticking to the vein. The 2ring fibre laser gives an even more homogenous distribution of energy into the vein wall, with a less pronounced sticking effect, he said.

Vlachovsky and colleagues conducted their study to compare the clinical efficacy and safety of these two laser systems in endovenous laser ablation of saphenous varicose veins of the lower limb. The study was a non-randomised prospec-tive study of 94 patients with primary varicose veins, treated from January 2013 to September 2015. Patients with CEAP C2–C4 were included, and the lengths of treated great saphenous veins were all

>30cm. Great saphenous vein diameter was ≤20mm in a standing position and all patients were older than 20 years. Patient follow-up was performed at days one and seven, and then at three, six and 12 months after the procedure. No adjunc-tive treatments were performed in the 12 months post-procedure. There were no significant demographic differences between the two groups.

The primary efficacy endpoint was occlusion rate as measured by duplex ultrasound and one and six days, and three and six month post-surgery. The primary safety endpoint was incidence of pain dur-ing the same observation period.

The procedures were conducted using a 1470nm laser (ELVeS, Biolitec) with an ultrasound-guided percutaneous ap-proach. Tumescent local anaesthesia was used in the track of the great saphenous vein, with fibre inserted and positioned 1cm distal to the sapheno-femoral junc-tion. The power used was 10W with continuous fibre pullback and the linear endovenous energy dose was 80–94J/cm. Concomitant phlebectomy was used in all patients and thigh compression stock-ings were worn for three weeks.

For the single-radial fibre group, oc-clusion rates were 100% at one day and 97.9% at six days, six months and twelve months. For the 2ring fibre group, the oc-clusion rate was 100% at all time points. The differences were no statistically significant.

Rates of pain in the treated area were 14.8% for the single-radial fibre group and 3% in the 2ring fibre group, but this difference was not significant. Vlachovsky

and colleagues also recorded changes in visual analogue scale (VAS) of pain over 12 months of follow-up. The maximum mean VAS for the single-radial fibre group was 20.5±17.6 compared with 6.4±4.4 for the 2ring fibre group (p<0.0001). Bruising was more prominent in the single-radial fibre group (37%) than in the 2ring fibre group (6.5%) (p<0.0001).

The most common postoperative complications in both groups was indura-tion (single-radial fibre group 8.3% vs. 2ring fibre group 4.3%, p=0.118). Other complications in the single-radial fibre group included erythema (6.5%), tender-ness (4.3%), and paraesthesia (2.2%). Other complications in the 2ring fibre group included paraesthesia (4.2%) and erythema (2%). There was no equipment failure in this study.

“Endovenous laser treatment of saphen-ous vein reflux with 1470nm lasers using both fibre types results in clinical improve-ment of symptoms and comparable occlu-sion rates,” Vlachovsky concluded, while the 2ring laser single-radial fibre appears to remove quality-of-life limitations associated with traditional single-radial fibre, at least in the early postoperative period.

Robert Vlachovsky

7September 2017 Venous stents

The importance of flexibility and radial force in deep venous stentingAlthough the venous stent is still a young technology, it is already offering new and exciting opportunities to patients with deep venous occlusive disease.Venous News spoke to Manjit Gohel (Cambridge, UK) about how his experience in with deep venous stenting, and how he believes the field can continue to build on recent progress and move towards the “holy grail” of venous stent design—high flexibility, high radial force and high crush resistance.

What led to your focus on deep venous disease?Quite simply, patient need. For many years, the focus has been on treating superficial venous reflux and enormous advances have been made in this area. For many patients, only the superfi-cial veins need treatment, so the new generation of endovenous ablation modalities are very welcome. However, there remains a largely neglected group of patients with venous outflow ob-struction who are either undiagnosed, or have been told that there is nothing that can be done. The availability of a range of stents specifically designed for the treatment of deep venous occlusive disease has opened tremendous new opportunities for this patient group.

Which components are required to set up a deep venous practice?An effective deep venous service is much more than simply being able to offer a stenting procedure. Patients with venous disease are a complex, heterogeneous group. They are often elderly and frail, and have multiple factors contributing to their clinical presentation and promoting venous hypertension. Multidisciplinary care should be the bedrock of any service and all relevant specialties should be involved when setting up care pathways. Vascular surgeons, inter-ventional and diagnostic radiologists, haematologists and specialist nurses may all play an important role. In our practice, there is also a large emphasis on improving links with primary care physicians and community nursing teams. Most patients with advanced venous disease present to, and are managed in primary care settings. Finally, despite the widespread enthu-siasm for deep venous interventions, this is a novel and controversial area. Therefore, standardised treatment al-gorithms and robust audit of outcomes are also imperative.

How do you decide what treatment the patient will receive?Any treatment pathway should be patient-centred and focus on the severity of symptoms and impact on patient quality of life. All patients undergo detailed clinical assessment and evaluation of disease severity. In patients with significant symptoms or complications of chronic venous hy-pertension, appropriate investigations are used to identify potentially treat-able venous disease. The mainstay of venous investigation is colour venous

duplex ultrasound scanning performed by an experienced team of vascular scientists. Although detailed iliocaval venous assessment is entirely feasible using duplex alone, additional imaging using cross-sectional modalities or venography is often necessary.

In our practice, adjuvant proximal deep venous imaging is reserved for patients with strong clinical or duplex suspicion of venous outflow obstruc-tion. Venous claudication or findings such as common femoral vein post-thrombotic change or loss of normal phasicity on duplex are suspicious for proximal occlusive disease. While some clinicians may advocate routine proximal deep venous imaging, we know that incidental non-thrombotic iliac vein (NIVL) lesions are common and not always significant. The man-agement of patients with a combina-tion of venous outflow obstruction, superficial and deep reflux is a real challenge. In general, the proximal deep venous obstruction should be ad-dressed first, followed by superficial reflux. However, these decisions are often complex and should be made on an individual patient basis.

What is the importance of stent flexibility and radial force for deep venous stent-ing procedures?There are now a range of available stents, specifically designed and approved for use in the deep venous system. While our understanding is far from complete, the requirements of venous stents are entirely different to stents used in the arterial system. It is interesting that the currently available deep venous stents range from highly rigid, strong closed-cell designs offering high radial force and crush resistance, to much more flex-

ible, open-cell stents, with a range in between. It would seem logical that in the relatively immobile common iliac vein at the May-Thurner point, a stent with high radial force and crush resist-ance would be favourable. Conversely, in the distal iliac vein and common femoral vein, one could make a case for a more flexible stent as the venous segments are more mobile. However, there is little or no evidence to sup-port these assumptions and further work is urgently needed. Because of the perceived trade-off between stent flexibility and radial force/crush resistance, some believe that a single “perfect” deep venous stent is not possible. However, multiple medical device companies have taken an inter-est in deep venous stenting, resulting in rapid technology advances in this field. Stents with excellent flexibility and strength attributes are undoubted-ly feasible. Whether these mechanical attributes translate to better technical and clinical outcomes in the future remains to be seen.

What are your thoughts on the forces affecting the ve-nous anatomy at the inguinal ligament?In a fast-moving area, we are all learn-ing new things about the deep venous system. It is widely accepted that the key principles for successful deep ve-nous stenting are to stent from normal vein to normal vein and to ensure that adequate inflow is present. Early con-cerns about stenting across the inguinal ligament have been largely disproved and stenting into the distal common femoral vein is necessary in many patients. However, the area under the inguinal ligament is of interest, as some stent fractures have been observed in this area. The repeated focal band-like

extrinsic compression inflicted by the inguinal ligament may be a factor. In our practice, overlapping of stents in the region of the inguinal ligament is avoided wherever possible.

Which venous stents do you currently use and why?The treatment of venous outflow obstruction is an expanding field and several different stents are now available. It is important to regularly review the available technology and consider which stents to use, but there are no clinical trials directly com-paring different stents or any strong evidence to suggest that one stent is superior to others. Therefore, we have available stents with a range of attributes, including high radial force/crush resistance stents and much more flexible stents. On an individual case basis, working in a multidisciplinary team, planning decisions can be made about which specific stent should be used in which location. We commonly use a combination of different stents in the same patient. As with many areas of venous disease management, stenting choices are largely dictated by individual clinicians based on local experience and preferences, rather than high-quality evidence. Hopefully, ongoing research will help shed some light over which stent attributes are most important in which locations.

What are your predictions for the field of venous stenting over the next five years?I expect an ongoing expansion in the uptake of venous stenting procedures around the world. I hope that the provision of stenting procedures is accompanied by efforts to improve pa-tient care pathways and improve links with primary care services to target patients with advanced venous disease and ulceration. As we learn more, newer generation stents will hopefully get closer to the “holy grail” of high flexibility with high radial force/crush resistance. Hopefully, we will see an expansion in published data and great-er efforts to combine data across cen-tres. As with any novel intervention, over-diagnosis and over-treatment is a concern. We need to resist the tempta-tion to treat every lesion, but rather work towards evidence-based consen-sus over which patients benefit most from deep venous interventions.

Manjit Gohel is a consultant vascular and endovascular surgeon at Cambridge University Hospitals, Cambridge, UK

Manjit Gohel

24–27 APRIL 2018OLYMPIA GRAND • LONDON • UNITED KINGDOM

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9September 2017 Lymphoedema

Lymphatic abnormalities and dysfunction in peripheral arterial and venous diseases

Emerging evidence suggests that the lymphatics play an important role in the early pathogenesis and progression of peripheral arterial and venous diseases, suggest John Rasmussen and Eva Sevick-Muraca, writing for Venous News.

Functioning peri-adventitial lymphatics are essential for reverse cholesterol transport by macrophages to maintain or “cleanse” the arterial

walls of cholesterol.1 When there is lymphatic insuffi-ciency, localised oedema in the intima and tunica media, smooth muscle cell degeneration, and macrophage accumulation may occur and precede atherosclerotic plaque formation. Likewise in venous disease, reduced numbers of lymphatic vessels and increased lipid content has been found in the adventitia of incompetent great saphenous veins of patients presenting with ve-nous varicosities.2 Tissue oedema is also a well-known clinical symptom of peripheral vascular disease that results from (i) excess capillary filtration from inflamed or occluded blood vessels, (ii) incompetent fluid uptake and transport by an abnormal lymphatic vasculature, or (iii) a combination of both. Today, surgical treatments

focus upon revascularising the blood vasculature, but if lymphatic insufficiency is associated with pathogenesis and progression of peripheral vascular disease, then durable outcomes may be limited without considering the lymphatic component. Furthermore, if lymphatic insufficiencies are found to be an early contributing fac-tor for the development of peripheral vascular disease, then new therapeutic strategies to modulate the immune-lymphatic system could be developed as an adjuvant to improve surgical outcomes.

Using trace intradermal injections of indocyanine green (ICG) and custom, optical instrumentation that adapted night vision technology for increased imag-ing sensitivity, our team has previously shown that the lymphatic vasculature in the legs are normally straight and comprised of mini-segments termed “lymphang-ions” that actively pump lymph (often against grav-

ity in the lower extremities) and provide the driving force for the unidirectional flow through the “open” lymphatic system. However, in patients with chronic venous ulcers, we found that lymphangion pumping is impaired, presumably resulting in extravascular pooling of ICG-laden lymph at ulcer sites and at contralateral non-ulcerated ankles.3 More recently, we have begun imaging the lymphatics in the lower extremities of patients diagnosed with early venous or arterial disease. While enrolment continues, our preliminary results show dilated lymphatic vessels that exhibit varicosities and impaired lymphangion pumping in both venous and arterial disease. In addition, retrograde lymph drain-age into the dermal lymphatics, which we and others term “dermal backflow,” occurs presumably due to the weakened lymphatic pump. These functional and anatomical abnormalities are not seen in all patients, but seem to occur even in the absence of overt lymphoe-dema or phlebolymphoedema. Nonetheless, lymphatic insufficiency is evidence of an impaired immune system that may be the cause of, or contributing to peripheral vascular disease.

Comparatively little is known about the lymphangion pump and the factors that govern its activity.4 Animal studies show that pro-inflammatory cytokines, TNF, IL-1β and IL-6 result in arrest of the “lymph pump” and that administration of inducible nitric oxide synthase or an anti-TNF agent into the lymphatics can reverse this loss of lymphatic function.5,6 Whether these and other pharmaceutical strategies can be developed to stimulate lymphatic function in patients with peripheral vascular disease remains an active area of investigation. In the

Continued on page 10

EVA SEVICK-MURACA JOHN RASMUSSEN

COMMENT & ANALYSIS

10 September 2017Updates

Thrombosis: Both a physical and psychological event

There are two things you need to know about me. Firstly, I am a health psychologist, with a specialist interest in behaviour change, implementation, and impact. Secondly, through a series of deep vein thromboses (DVTs) beginning with a post-partum iliofemoral clot in 2008 and followed by an unsuccessful crossover bypass graft in 2010, I have been living with significant post-thrombotic syndrome for the last nine years. Symptomatically I have ongoing and often disabling pain, swelling and leg heaviness, all exacerbated by physical effort. Medical management involves lifelong anticoagulation (after a further DVT in 2016) and full-length class II compression stockings.

The reason for outlining the above is to set the scene for a commentary on the psychology of being a pa-

tient with long-term venous issues. This is, of course, heavily caveated by the fact all patients, presentations, diagnoses, aetiolo-gies and prognoses are different, and that the experience of chronic venous issues is not necessarily qualitatively different to other ongoing illnesses. Acute conditions may be less corrosive psychologically than more exhausting, life-changing chronic conditions, but there is no “one size fits all” reaction. Understanding such psychological challenges can help clinicians to improve the care interface, and in turn improve longer-term patient wellbeing.

Health psychology—the branch of psychology focused on preventing ill health and managing the experience of illness—tells us there are a range of cognitive and emotional factors underlying how we deal with our health. Attitudes and beliefs about the severity of the condition, its cause, how certain (or uncertain) the future is and how much control we have over whether we

“get better” all influence how we respond to being ill. The “answers” frame to us what it means to live with a condition and how substantially we may need to readjust our lives. They also influence (and are influenced by) our relationships with healthcare professionals.

Psychological challenges can emerge before or after diagnosis, and can grow or settle over time. An initial diagnosis can be traumatic, especially if its onset is unexpected and the extent severe. The diagnosis of an acute venous episode in itself is not suggestive of longer-term psychological problems, but even when physical symptoms resolve, the psycho-logical scars—such as anxiety about reoccurrence—can persist. Similarly, whilst we can cope with the pain of thrombosis for a short time, coping longer-term with a painfully debilitating, unresolving or deteriorating condition exhausts us mentally and physically; nine years on, for me it is a constant balance between stopping due to pain or choosing to live in pain.

The uncertainty which characterises

ill health can also take an enormous psychological toll. Where something is caused by something obvious (eg. post-surgical DVT), the emotional adjustment is likely to be more straight-forward than something unexpected (eg. unprovoked DVT). Similarly, condi-tions with clearer clinical expectations offer more certainty about “what life holds” than those with an unknown diagnosis or endpoint. Whilst clinicians routinely deal with uncertainty (eg. a 50% chance of ulcers… a high chance of recurrence… etc.), for patients the continued monitoring needed to assess whether ones condition is worsening can lead to agonising hypervigilance. For me, I must be ever mindful about new symptoms (indeed it was a new calf pain last year which alerted me to the most recent DVT) and skin changes which may mark the start of ulceration. The risk is that mindfulness transcends into anxiety; clinicians and patients must work together to assess appropriate and proportionate levels of monitoring.

Arguably a more hidden but intense psychological consequence of ill health is the impact on identity. Our self-esteem is a function of our self-image and our ideal self. Unsurprisingly, when we become ill it challenges our sense of who we are, a situation complicated by visible symptoms which also influence our social image. Self-esteem can drop as we struggle to reconcile our new “ill” identity with who we were before, and may even enter a grieving process if a loss is permanent. For me, my thrombosis was life chang-ing, and my identity changed from “active young woman” to “disabled new mum” in a matter of weeks. My limp, once considerable but now far reduced is a vis-ible notification to society that something is “wrong”. Over time I have absorbed the pain, limp and exhaustion into who I am, and I am lucky that I have a formal diagnosis by which I can explain my condition to others (many patients do not have this luxury and may also struggle to

be believed or supported). Ultimately, we have our own internal pic-ture of who we are as a person, and when the sands shift we are forced to integrate, rebut or work hard to ignore the new “us”. To live with a long-term painful condition you sometimes have to make it the least prominent thing about you and find ways to minimise the physical and psychologi-cal fallout. Put simply you try to be you again. Personally, I have managed to re-adjust my self-image, but it is against the bittersweet backdrop of a world moving at a pace I cannot match.

Taken together, it is not surprising that depression and anxiety are commonplace in long-term conditions, and more severe post traumatic reactions can develop if our individual coping mechanisms are continually overwhelmed. For the patient trying to continue functioning at home and at work, it can be a constant and exhaust-ing battle to maintain equilibrium. We humans are resilient beasts, but we are not unbreakable. We look to our health-care specialists for knowledge, support, action and measured hope. Whilst medical management can only ever ameliorate the physical symptoms, the supportive process of a consultation arms us to continue the fight beyond the hospital walls. I am told I am “bloody minded” enough to keep fighting but even good patients struggle.

Venous conditions can be demoralising, disabling, disenfranchising and isolating. Ultimately the impact of a condition is, or should be, judged at the level of the patient and the effect it has on their life. Thus, being “well” is as much about phys-ical improvement as it is about the patient regrouping psychologically and socially in a meaningful way. To those clinicians reading this—if you can understand the psychological toll from the patient point of view, you will already be doing far more good than you realise.

Julie Bayley is a HCPC Registered Health Psychologist at Coventry Univer-sity, Coventry, UK

COMMENT & ANALYSIS

JULIE BAYLEY

meantime, physiotherapies that include manual lymphatic drainage and pneu-matic compression devices may alleviate the lymphatic insufficiencies that may otherwise contribute to the early progres-sion of peripheral vascular diseases.

John C Rasmussen is Principal Investi-gator and Assistant Professor of Molecu-lar Medicine, and Eva M Sevick-Muraca is Professor and Kinder Distinguished Chair of Cardiovascular Research at the University of Texas Health Science Center-Houston, Houston, USA References1. Randolph GJ, and Miller NE. J Clin Invest. 2014;124(3):929–35.2. Tanaka H, Zaima N, Sasaki T, et al. J Vasc Surg. 2012;55(5):1440–8.3. Rasmussen JC, Aldrich MB, Tan IC, et al. J Vasc Surg Venous Lymphat Disord. 2016;4(1):9–17.4. Kunert C, Baish JW, Liao S,et al. Proc Natl Acad Sci USA. 2015;112(35):10938–43.5. Aldrich MB, and Sevick-Muraca EM. Cytokine. 2013;64(1):362–9.6. Aldrich MB, Velasquez FC, Kwon S, et al. Arthritis Res Ther. 2017;19(1):116.

Continued from page 9

Figure 1: Well-defined lymphatic vessels that drain from the feet to the inguinal lymph nodes (3); (Middle) the medial calf of a subject with arterial disease (Stage III Fontaine) showing a functional dilated lymphatic vessel and dermal backflow below the knee; (Bottom)

the lateral calf of a patient with early venous disease (C3) showing dilated, segmented lymphatic vessels that may be reflective of vessel varicosity

12 Interview September 2017

Profile Marianne De MaeseneerMarianne De Maeseneer already wanted to become a doctor by the age of 12, with her imagination captured by the idea of working in developing countries. A “series of coincidences” led her towards vascular and venous medicine, in which she decided to make a career. De Maeseneer spoke to Venous News about her journey to become a venous specialist, and shares some of the most notable experiences and lessons taken from her varied career.

Why did you decide on a career in medicine?At the age of 12, I already wanted to become a medi-cal doctor. My initial idea was to work in a “developing country”, or the third world, as it was called at that time. In secondary school I was committed in the local social council and in the “youth parliament” of schools in my hometown of Ghent, Belgium. We organised project weeks, fund raising activities, peace marches etc. This is how I got in contact with several non-governmental organisations and how the idea grew to work with one of them as a MD later on.

It was logical to start medical training at Ghent University. During the last year of medical studies, I had the opportunity to follow a five-month course at the Institute for Tropical Medicine in Antwerp, always with a view to working overseas. I found these studies very interesting, and I very much liked the exchange with international students at the course. After finish-ing my studies, it was obvious that I had to get some surgical experience, to be prepared for the work in the field. In the meantime I was on a waiting list to leave with Médecins Sans Frontières. I started working in a general surgical practice to increase my surgical skills, first in Dendermonde and then at the Antwerp Univer-sity Hospital, where there was an interim job vacant. I started enjoying surgery more and more. After some time. Professor Eric Schoofs, the head of the surgical department in Antwerp, asked me: “Marianne, did you ever think of becoming a surgeon?” This was of course a surprise for me. I gave it some thought, and, after an interval of a few months working and travelling in Peru and Bolivia, I eventually accepted! So this is how I fell into my surgical training in Antwerp, somehow by coincidence, but this is how it often goes in life.

Why vascular, and in particular venous?That is another series of coincidences. During my sixth year of surgical training, I had to take over the vascular clinic temporarily together with another senior trainee, as our vascular consultant had left the Department and we were awaiting the new one. We managed to run the clinic, start up some non-invasive diagnostics (continuous-wave Doppler at that time) and do major vascular operations, with the general surgeons supervising us. This was really fun! Once I finished my training, I was asked to stay in the Department of Surgery in Antwerp, as vascular surgery was rapidly developing as a separate entity. Non-invasive diagnostics and veins became more and more my focus. Coming back from maternity leave, after the birth of my youngest son at the end of 1988, the Department bought a first colour duplex device, and I started scanning carotids, deep and later also superficial veins, more or less as a “self-made woman”, accompanied by the first edition of the book Introduction to Vascular Ultrasonography by W Zwiebel. In the vascular clinic, an increasing number of patients presented with venous problems, and soon I had to completely stop my arterial work, to only do veins. In addition, working as a surgeon with three little children and with my husband being an anaesthesiologist was not always an easy combination. The advantage of venous surgery was that this could be easily planned and that I could have a part-time activity, which was ideal for our little family.

Who have been your most important career mentors and what wisdom did they impart?The first person playing an important role in my career has obviously been Prof Schoofs, who trained me as a surgeon. He was an excellent surgeon, and I did not only admire his

technical skills (for example he was ambidextrous), from which I learned a lot, but also liked his positive approach. He made me feel confident, and taught me how important it is to feel good, at the end of an intervention. One should always try to leave the operating room thinking: “We have done a good job. We did the best we could do for this patient”. Now that I am training juniors myself, I realise how important it is to support them, give them positive feedback and to convince them they should always aim to do the best they can for each single patient.

I am full of admiration for Prof André van Rij from Dunedin, New Zealand, who used to lead a large vascular research group at the surgical department of the University of Otago. I got in contact with him at the time I finalised my PhD thesis on recurrent varicose veins after surgery, because his team was also studying varicose vein recurrence, and neovascularisation in particular, as I did. We first met at the third meeting of the Saphenofemoral Recurrence Research Group (SRRG) in Gloucester, UK, in May 2005. Thereafter I had the opportunity to meet him on several occasions during international congresses, and it was always fascinating to exchange ideas, starting with veins and moving far beyond! I like André’s “outside the box” thinking, resulting in original research projects, such as the study on neovascular veins, where they made resin casts of tissue blocks excised during a redo procedure in the groin. I also learned a lot from his presentations at meetings; he is very didactic, has no busy slides, and gets straight to the point.

A third person is Dr Olivier Pichot from Grenoble, France. He is a specialist in vascular medicine, or an “angiologist” as they use to call them in the south of Europe. He is an excellent sonographer and I had the opportunity to scan with him on several occasions, learning about all kinds of tips and tricks useful to improve my own skills in duplex ultrasound. We also have been collaborating for several research projects and publications. Olivier is a very creative person, he always comes up with new ideas and this is what I appreciate the most.

What has been the biggest development(s) in venous medicine during your career? I think there have been three major developments in venous diagnosis and treatment during the last 30 years: first, the introduction of duplex ultrasound in daily venous practice, allowing for a detailed diagnosis of the specific “duplex anatomy” of each individual leg affected by chronic venous disease; second, the switch to mainly endovenous treatment of refluxing saphenous trunks; and third, the introduction of deep venous stenting for non-thrombotic or post-thrombotic iliac, iliocaval and iliofemoral obstructive lesions.

What are your current research interests? One of the main topics I studied recently, together with my PhD student Simone van der Velden (who finished her thesis successfully in June 2016), has been management strategies for patients with chronic venous disease, which is mainly about fine-tuning the treatment strategy, in view of the characteristics of each individual patient and the specific duplex ultrasound findings in the leg to be treated. Now that we have the evidence available about effectiveness of different treatment methods, which are reflected in recently-published international guidelines, I think we should move towards a more individualised approach; an à la carte treatment. Taking into account patient’s expectations, individual characteristics (comorbidities, anticoagulant treatment, etc.), symptoms (typically venous, or rather not), clinical signs (only varicose veins or more advanced

chronic venous disease) and finally, the specificities of the duplex ultrasound findings, this all should help the physician to make the right decision, and plan an appropriate intervention. This should be as cost-effective as possible, and I am convinced this may even reduce the global costs for the care of patients with chronic venous disease. For example, at the moment, guidelines favour endovenous thermal (or non-thermal) ablation of the incompetent saphenous trunk as the solution for all patients. However, in properly selected patients, performing ambulatory phlebectomies only, in local tumescent anaesthesia (also known as the ASVAL procedure) might be a very valid—and cheaper—alternative. In view of this hypothesis, we have set up a large randomised controlled trial at Erasmus MC in Rotterdam together with some other centres in The Netherlands—the SAPTAP trial—to compare the effect of single ambulatory phlebectomies with thermal ablation of the refluxing saphenous trunk and phlebectomies. So far we have included 300 patients, with a view to a total sample size of 540. We hope to have preliminary results next year.

Another point of interest is in optimising the preoperative duplex ultrasound work-up in patients with chronic venous disease. We still need to look at more details, beyond just looking at reflux/no reflux of the saphenous trunks. Therefore, we studied the postural diameter change of the saphenous trunk, defined as the difference between the saphenous diameter while standing vs. while lying. Postural diameter change was lower with older age, increased body mass index, in limbs with C4–6 disease, and in larger diameter veins (>7mm). It would be worthwhile to investigate this duplex parameter further in prospective studies to determine its value in determining

13InterviewSeptember 2017

Education (selected)1976 Candidate Medicine, Rijksuniver - siteit Gent, Ghent, Belgium1980 Doctor of medicine, Rijksuniversiteit Gent, Ghent, Belgium1980 Tropical medicine, Institute for Tropical Medicine, Antwerp, Belgium1987 General Surgery, Antwerp Univer- sity, Antwerp, Belgium2005 Doctor in Medical Sciences, Ant- werp University, Antwerp, Belgium

Previous positions (selected)1980–1981 Surgical trainee, General Hospital Dendermonde, Dendermonde, Belgium1981–1987 Surgical trainee, University Hospital Antwerp, Antwerp, Belgium1987–1988 Consultant in General and Vascular Surgery, University Hospital Ant werp, Antwerp, Belgium1988–2010 Consultant in the Department of Thoracic and Vascular Surgery, responsible for Phlebology, Venous Surgery and Duplex Ultrasound, University Hospital Antwerp, Antwerp, Belgium2007–2015 Associate Professor of Surgery at the Faculty of Medicine and Health Sciences, Antwerp University, Antwerp, Belgium2010–2017 Consultant, Head of Section Phlebology at the Department of Dermatology, Erasmus MC, Rott - erdam, The Netherlands

Editorial positions (selected)� Associate Editor (Venous Disease), Euro-

pean Journal of Vascular and Endovascular Surgery

� Associate Editor, Veins & Lymphatics� Reviewer, British Journal of Surgery� Reviewer and member of the editorial

board, Phlebology

International commitments � Co-director of the yearly Hands-on Workshop

of the European Venous Forum (EVF HOW)� Vice President of the International Union

of Phlebology (Union Internationale de Phlébologie)

Fact Filemanagement strategy. The same is true for vein wall thickness, focal dilatations of the saphenous trunk etc.

In daily practice, more and more patients are referred to our department with post-thrombotic syndrome and therefore our future research will mainly focus on prevention and treatment of this condition, which has a negative impact on quality of life. First we need better tools to define post-thrombotic syndrome, as the presently used Villalta scale is not completely satisfactory. Second, diagnostic protocols should be optimised. We perform a lot of abdominal duplex ultrasound of the iliocaval system at our centre, but the investigation protocol still needs improvement and it should be better defined whether and when we need additional phlebography, computed tomographic (CT) venography, magnetic resonance (MR) venography and intravascular ultrasound, to reduce unnecessary costs. Third, more work should be done to determine in which patients stenting of post-thrombotic obstructive lesions should be considered. As often very young patients are concerned, we need to look at a long-term perspective.

Finally, I am quite intrigued by a rather rare condition, which has been called absence or atresia of the inferior caval vein, leading to unilateral or bilateral iliofemoral DVT at young age. Probably inferior caval vein thrombosis at very young age also plays a role, and we should try to understand this condition better. At Erasmus MC, we are following up about 40 young patients suffering from this rare condition.

Is there still a place for open surgery in varicose vein treatment?First of all, one should realise that open surgery for varicose veins is still very popular worldwide. Even in several European countries, surgery remains the most commonly-used treatment form, mainly because of reimbursement conditions. In addition, it should be acknowledged that long-term results of well-performed open surgery are similar

to those of endovenous thermal ablation, while both are superior to

ultrasound-guided foam sclerotherapy, according to randomised controlled trials with at least five years of follow-up; surgery is a durable method, there is no doubt about that. Of course, there may be slightly more short-term morbidity and return to work/normal activity may be a little bit slower, but this does not affect long-term efficacy. One of the important disadvantages is that open surgery has to be performed in an operation room, whereas endovenous treatments can be performed in a strictly ambulatory setting and even in a simple treatment room (if permitted by local health care regulations). The latter may represent an important cost saving. In addition, it should be mentioned that, in some of the recently published long term follow-up data patients allocated to surgery were operated on under local tumescent anaesthesia. The latter is often called “modern varicose vein surgery”.

In countries were endovenous treatments have become the treatment of choice for saphenous incompetence, there is only a very small place left for open surgery. I see only two indications: in case of a large saphenous aneurysm (>3cm diameter) close to the saphenofemoral or saphenopopliteal junction, where high ligation may be performed to avoid thromboembolic complications, and in case of extremely thin patients, with a distance between the saphenous trunk and the skin of only 1mm or 2mm, where stripping may still be preferred.

You coordinated publication of the Union Internationale de Phlébologie (UIP) consen-sus document on duplex ultrasound report-ing after varicose vein treatment. Does the use of duplex ultrasound vary globally? In most Anglo-Saxon and Scandinavian countries duplex ultrasound is mainly performed by vascular technologists, who work in close collaboration with a (vascular) surgical department. They have specific training, examinations and may obtain a degree, for instance of registered vascular technologist. The more these technologists obtain experience in venous work, and the closer they are involved with different clinical presentations of patients with chronic venous disease, the better they become, and some of them are really outstanding. Nevertheless, venous duplex ultrasound is not easy. In contrast to arterial anatomy, venous anatomy is sometimes very complex, in particular in case of recurrent disease. Moreover it is also quite demanding to unravel deep venous problems. In many other countries duplex ultrasound is performed by the medical doctors themselves, usually specialists in angiology, (vascular) surgery, dermatology, etc., who are able to directly link the duplex findings to the clinical condition of a patient and decide on an appropriate treatment strategy. I think it is indeed very important that physicians who want to treat patients with venous disease are able to perform a duplex scan themselves. For this reason, in our yearly organised comprehensive three-day course on venous disease, the European Venous Forum Hands-On Workshop, the delegates always have the opportunity to improve their duplex skills during four half-an-hour workstations with real patients.

The aim of the UIP consensus documents on duplex ultrasound (including the two previous ones published in 2006) was mainly to introduce a methodology which could be applied worldwide, and could help physicians “speak the same language”. Looking at the international literature, there is still a lot of confusion in reporting duplex ultrasound findings. Just an example, in studies on varicose vein treatment, often preoperative diameter measurement of, for instance, the great saphenous vein is mentioned. However, this can be measured at different sites, and sometimes the largest diameter is taken into account like in the CLASS trial, which makes it difficult to compare with other studies.

Outside of medicine, what are your interests?First of all I like to spend time with my family, that is always fun! I also love to be out in nature, exploring and discovering wonderful places, together with my husband. For us, outdoors activities are ideal for relaxing. Travelling and meeting local people is another passion; there are still a lot of destinations on my list!

14 September 2017Updates

Decision-making in the choice of anticoagulants following deep venous stenting

Deep venous stenting has become increasingly used to treat patients with pathological obstruction of venous return in the femoro-ilio-caval venous segment following the development of new dedicated venous stents. Patients treated range from those with an isolated non-thrombotic iliac vein lesion, to those with extensive post-thrombotic disease requiring extensive reconstruction. In this commentary article, Adam Gwozdz writes that the challenges when treating these different groups of patient can vary and the postoperative anticoagulation management often requires personalisation.

One of the biggest challenges when treating patients with any stent is maintaining patency.

Venous stent patency is likely influ-enced by a number of factors including those associated with the patient, their operation (and underlying problem), and the type of postoperative anticoagula-tion used.

Clinical guidelines from the National Institute for Health and Care Excellence (NICE) in the UK recommend the use of direct oral anticoagulants (DOACs), rivaroxaban, dabigatran, apixaban, or edoxaban, as options for treating deep vein thrombosis and pulmonary embo-lism, and preventing long-term recur-rence. However, their guidance does not extend to use in patients with venous stents. At present, there is no evidence to suggest that one anticoagulant is

superior in preventing post-procedure in-stent thrombosis, and anticoagulation choice is therefore largely personal. Our deep venous stenting programme at St Thomas’ Hospital involves review of all patients by a multidisciplinary team with a view to optimising anticoagula-tion on an individualised basis given the heterogeneity of the population we treat.

In the immediate postoperative period, all patients have two weeks of therapeutic low molecular weight heparin (LMWH) (the exception being patients with antithrombin deficiency) followed by transition to warfarin with a target internalised ratio (INR) of 2–3 (unless a higher range is indicated due to haematological comorbidities). The use of a LMWH lead in is based on the available evidence from the venous thromboembolism literature and the

potential anti-inflammatory pleiotropic effects of LMWH.

Transition to oral anticoagulation is based upon outcomes from ultrasound surveillance scans, with early reinter-vention possible without the need to wait or correct the INR. Active moni-toring gives the ability to ensure that an appropriate therapeutic window is maintained, which can be more difficult with some of the DOACs, and as it has been used for many years there is a good understanding of the pharmacoki-netics of warfarin.

Long-term anticoagulation is largely tailored to individual patients under guidance from our haematological col-leagues who form a vital component of our clinical team. However, despite sufficient therapeutic anticoagulation, we still see radiological evidence of in-stent thrombosis occurring in a number of the patients that we treat, with those who had a stent following an acute iliofemoral deep vein thrombosis or following post-thrombotic reconstruction most affected.

Little is known about the pathogen-esis of thrombosis complicating venous stent patency. Given that in-stent throm-bosis can occur despite full anticoagula-tion, it has been proposed that thrombi occurring in this setting may represent a platelet-driven process similar to that seen following arterial stenting. Further evidence supporting this hypothesis in-clude: the persistence of a platelet pro-coagulant surface expression following stenting; platelet-leukocyte interactions; and evidence that platelet inhibition with aspirin results in risk reduction of

venous thromboembolism recurrence. However, these findings are not

enough to support the routine use of antiplatelets and further investigation is needed to understand if and why an antiplatelet may have a role, particularly given the potential increase in major bleeding as a consequence of the addi-tion of anti-platelets in patients on full anticoagulation.

Additional drug strategies that may be beneficial and require further research include the potential role of statins, pos-sible use of immune suppression to limit early inflammatory mediated thrombosis and the potential for drug-eluting bal-loons or stents.

Future research will also need to focus on defining which patients benefit the most from heparin lead-in, the use of DOACs and deciding optimal treatment duration following stenting. Regardless, the anticoagulation strategy is likely to be tailored to the individual, taking into account patient preference, compliance, comorbidities, polypharma-cy, bleeding risk, aetiology of the deep vein thrombosis and risk or recurrence. This can only be achieved by con-tinuing to develop strong collaborative networks, and by working closely with our haematological colleagues. Until further data is available however, which may guide appropriate management, we advocate surveillance of all patients and early intervention if required.

Adam Gwozdz is an NIHR Academic Clinical Fellow in Vascular Surgery at King’s College London, London, UK

COMMENT & ANALYSIS

ADAM GWOZDZ

Consensus document supports benefit of compression stockings for venous and lymphatic diseaseA consensus document based on a systematic literature review has supported the use of compression stockings for venous and lymphatic disease patients, including 19/25 grade 1-rated recommendations. The document, first shown at the 2016 American College of Phlebology meeting where it won first prize for presentations, was recently presented at the 2017 European Venous Forum (29 June–1 July, Porto, Portugal) and published in Phlebology.

Eberhard Rabe (Bonn, Germany), who pre-sented the consensus

document, explained that is aim is to provide up-to-date recommendations and evidence grading on the indications for medical com-pression stockings treatment, based on evidence accumu-lated since 2008, under the auspices of the International Compression Club (ICC). This project was designed as an update of the 2008 ICC consensus statement, which Rabe noted suffered from “gaps in the available evidence”.

To do so, Rabe and col-leagues conducted a system-

atic literature review. Using PRISMA guidelines, 51 relevant publications were se-lected for an evidence-based analysis of an initial 2,407 unrefined results. Key search terms included: “acute”, “CEAP”, “chronic”, “com-pression stockings”, lymph”, “lymphatic disease”, “vein” and “venous disease”. Evi-dence extracted from the pub-lications was initially graded individually by the panel members and then refined at the consensus meeting.

Rabe reported that 25 recommendations for chronic and acute venous disorders were made. Of these, 24 rec-ommendations were graded

as: grade 1A (n=4), 1B (n=13), 1C (n=2), 2B (n=4) and 2C (n=1). The panel members found moderately robust evidence for medical compression stockings in patients with venous symp-toms and prevention and treatment of venous oedema. Robust evidence was found for prevention and treatment of venous leg ulcers. Recom-mendations for stocking use after great saphenous vein interventions were limited to the first post-interventional week. No randomised clini-cal trials are available that document a prophylactic ef-fect of medical compression stockings on the progression

of chronic venous disease. In acute deep vein thrombo-sis, immediate compression is recommended to reduce pain and swelling. Despite conflicting results from a recent study to prevent post-thrombotic syndrome, medical compression stock-ings are still recommended. In thromboprophylaxis, the role of stockings in addition to anticoagulation is limited. For the maintenance phase of lymphoedema management, compression stockings are the most important intervention.

Rabe noted that there are caveats to consider in comparing the graded recommendations between

the 2008 and 2016 statements. First, the 2008 statement was based on the CEAP classification while the 2016 statement was based on the clinical goals of treatment, and second, the 2008 statement differentiated between compression classes while the 2016 statement did not.

“The beneficial value of applying compression stock-ings in the treatment of ve-nous and lymphatic disease is supported by this document, with 19/25 recommendations rated as grade 1 evidence,” Rabe concluded. “For recom-mendations rated with grade 2 level of evidence, further studies are needed.”

15September 2017 Aesthetic phlebology

The rise of aesthetic phlebology

For many decades, the treatment of thread veins (also known as telangiectasias or spider veins)

was the simple injection of detergents, with no diagnosis. Patients would complain about anaesthetic veins and a simple question from the physician about the presence of pain and/or swelling would suffice. If the answer was no, all visible veins would be injected. The outcomes were poor, in-cluding pigmentation and even worse complications like skin ulcers or even anaphylaxis.

Due to the tropical and subtropical weather and no cultural or religious re-strictions on leg exposure, a significant aesthetic phlebology demand began to develop in Brazil with the introduc-tion of the mini-skirt and bikini in the 1960s. One of the first methods of reducing pigmentation was the mini-phlebectomy using little hooks. This was a slower and more demanding procedure but with less pigmentation and with diminished relapses.

The development of a variety of new techniques has made aesthetic phle-bology more interesting for vascular surgeons. These include ultrasound examination during consultations and procedures, endovenous ablation tech-niques, augmented reality, photo-docu-mentation, and the CLaCS (Cryo-Laser and Cryo-Sclerotherapy) technique.

The CLaCS technique (which I will address in greater detail in the next issue of Venous News) is capable of blowing cold air to decrease the skin temperature to 5–10 degrees Celsius in seconds. Transdermal laser treat-ment causes endothelium and tunica media damage leading to oedema and vein internal diameter reduction. Scle-rotherapy is performed right after this, with both are guided by augmented

reality. This synergy allows a better outcome and fewer complications, and CLaCS is already being performed in more than 20 countries.

With this, and other, advances, our approach is not only to “go and inject”; there are many technologies for diag-nosis and treatment.

It is important to discuss a com-pletely different point of view: we need to examine all patients with ultrasound and augmented reality, even those who are asymptomatic. At our clinic, 33% of asymptomatic patients com-plaining about thread veins have at least one segment of long reflux on a saphenous vein. That does not mean we are going to treat that vein, but if this segment is under a resilient thread vein area, that could be a reason to treat the refluxing saphenous vein for aesthetic purposes. It is very impor-tant to remember that it would be an aesthetic treatment and therefore paid for by the patient, and not by public healthcare or health insurance.

Vascular surgeons are not used to dealing with some requirements of a good private vein clinic. Here are some that we will discuss in next issue of Venous News:� Photo documentation� Investing in devices for your clinic� Marketing� Pricing

Nowadays, aesthetic phlebology has become an attractive area because we can offer consistent results and it is a private practice-based medicine. It is a fast growing area and there is also a huge space for scientific research. Most of the work done so far has been based on experience, and there is a low level of evidence due to the high cost and low support associated with research-ing in a private practice.

AESTHETIC PHLEBOLOGYBy Kasuo Miyake

16 September 2017Deep vein thrombosis

ACCESS PTS results provide hope for chronic deep vein thrombosis patients

Mark J Garcia, Wilmington, USA, analyses the results of the ACCESS PTS multicentre prospective single-arm study of patients with a minimum of femoropopliteal DVT that found chronic deep vein thrombosis (DVT) patients with post-thrombotic syndrome (PTS) can be treated safely and effectively with Ekos (BTG) therapy. He delineates the parallels and differences of this pivotal trial in the light of the landmark, multicentre, randomised controlled ATTRACT (Acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis) study.

The post thrombotic syndrome (PTS) is a long-term, and often debilitating complication that occurs in up to 50% of deep vein thrombosis

(DVT) patients. PTS can significantly reduce a patient’s quality of life, and unfortunately, aside from conservative therapy, treatment options are limited and often not sufficient for those suffering the signs and symptoms of PTS. A multicentre, prospective, single-arm study evaluated the efficacy and safety of endovascular recanalisation, including ultrasound-accelerated, catheter-directed thrombolysis in patients with chronic DVT and PTS.

The ACCESS PTS trial differs immensely from ATTRACT in all regards. ATTRACT was a multicentre, randomised controlled trial that evaluated patients with acute DVT (less than 14 days) and no previous signs or symptoms of PTS. The pivotal ACCESS PTS population consisted of patients with a proven history of DVT for at least six months.

These patients had to have failed at least three months of standard of care therapy and developed the signs and symptoms of PTS with a Villalta score of at least 8. The primary objective of ATTRACT was to determine if pharmacomechanical catheter-directed thrombolysis (PCDT) and anticoagulation reduced the incidence of PTS over 24 months in those with acute DVT compared to standard of care (anticoagulation alone). The ACCESS PTS primary endpoint was a reduction in Villalta scores by at least four points at 30 days in 50% of the patients who underwent ultrasound-accelerated, catheter-directed thrombolysis and recanalisation of those chronically occluded venous segments. In addition to Villalta scores, additional measures included Venous Clinical Severity Score (VCSS) and VEINES QOL at 30, 90, 180 and 360 days as compared to baseline. To date, the 180-day data has been completed. The ATTRACT trial outcomes were not as most of us had hoped. However, I think a major factor was the inability to determine which patients would develop PTS and which ones would not. Remember, 25–50% of acute DVT patients develop PTS, which means 50–75% will not. If we could determine those who will develop PTS, and randomise that population, I have no doubt the study would be overwhelmingly positive. That is why in general, I follow my acute DVT population with serial ultrasound and clinical evaluation before intervening within four weeks from the onset of symptoms. But, once they have persistent thrombus that becomes an organised and fibrotic, collagen-laden obstruction, there is little offered to those suffering from PTS. We all accept iliofemoral occlusions should be stented primarily, and that is why this study focused on femoral-popliteal diseased patients with PTS and excluded those with suprainguinal only obstructions.

For those suffering from chronic DVT, PTS and quality of life limitations, ACCESS PTS results demonstrate that there is now treatment hope.

The protocol included crossing the venous occlusions using standard chronic total occlusion techniques, followed by venoplasty to the expected “normal” size of the vessel. The Ekosonic system is then placed with transducers covering the treated segments. ultrasound-accelerated, catheter-directed thrombolysis is performed typically overnight with recombinant tissue plasminogen activator (rtPA) infusing at 0.5–1mg/hr. The patient returns the following morning for the follow-up evaluation, and if needed, adjuvant angioplasty and appropriate iliofemoral stenting if indicated.

The study population consisted of 78 patients and 82 limbs (four bilateral). The mean age was 54.6 years, with 68% being male. There were

60% left legs treated. The mean rtPA dose infused was 18.5mg for 22.8 hours. There was one major bleed (epistaxis) 72 hours after lysis, related to anticoagulation with the patient passing at 32 days from multi-organ failure. There were three recurrent DVT and one pulmonary embolism, all within 30 days of treatment.

The ACCESS PTS results were: � 67% of patients met the primary endpoint of at least a four-point improvement in Villalta score from baseline at 30 days (p=0.003). � Villalta scores at 30 days improved 6.1 points and 38% from baseline (p<0.0001). � Villalta scores at 180 days improved nearly 8 points and nearly 50% from baseline. � VCSS scores at 30 days improved 3.9 points and 32% from baseline (p<0.0001). � VCSS scores at 180 days improved over 5 points and over 40% from baseline. � VEINES QOL at 30 days improved 9.7 points and 16% from baseline (p<0.0001). � VEINES QOL at 180 days improved nearly 20 points and over 30% from baseline.The ACCESS PTS trial demonstrated that for

patients suffering from chronic DVT and PTS, endo-vascular intervention using ultrasound-accelerated, catheter-directed thrombolysis and angioplasty was a safe and effective treatment for recanalising chronic venous occlusions.

ACCESS PTS demonstrated a statistically signifi-cant improvement in Villalta and VCSS scores at 30, 90 and 180 days compared to baseline. ACCESS PTS demonstrated a statistically significant im-provement in quality of life at 30, 90 and 180 days compared to baseline.

Case presentationSixty seven-year-old male patient with history of multiple episodes of DVT in 2006, 2007 and 2013. Inferior vena cava (IVC) filter placed in 2007 after DVT while on anticoagulation and diagnosed with prothromin mutation, then placed on lifelong warfa-rin. In 2013, he developed DVT and large bilateral pulmonary embolism after discontinuing warfarin earlier in the month. Underwent DVT lysis of IVC and BLE, but no change in extensive RLE chronic DVT. In July 2014, he presented for evaluation of severe RLE PTS and was enrolled in ACCESS PTS trial (see Figures 1, 2 and 3).With regard to clinical results, at baseline the patient had scores of CEAP 4b; Villalta 20; and VCSS of 15. One month after intervention, his scores were CEAP 4b, Villalta 4; and VCSS 4. Three months after interven-tion, his scores were CEAP 2, Villalta 2 and VCSS 5. Six months after intervention his scores were CEAP 2, Villalta 3 and VCSS 5.

Mark J Garcia is an interventional radiologist in Wilm-ington, USA. He is the cofounder and medical director, Vascular and Interventional Associates of Delaware, Wilmington, USA. He reports receiving grants and con-sulting fees from BTG/EKOSReferences1. ACCESS PTS Trial. www.ClinicalTrials.gov identifier: NCT021595212. Kahn SR, Shrier I, Julian JA, et al. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med 2008;149:698–707.3. Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol 2009; 145: 286–295.4. Enden T, Wik HS, Kvam AK, et al. Health-related quality of life after catheter-direct-ed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study. BMJ Open 2013; 3: e002984.5. Schulman S, Lindmarker P, Holmstrom M, et al. Post-thrombotic syndrome, recur-rence, and death 10 years after the first episode of venous thromboembolism treated with warfarin for 6 weeks or 6 months. J Thromb Haemost 2006;4:734–42.6. Garcia MJ. Aggressive interventional treatment of chronic DVT: a new method to decrease the symptoms of the post-thrombotic syndrome: Techniques and early results. Abstract. Veith Symposium 2009.

MARK J GARCIA

COMMENT & ANALYSIS

Figure 1A Figure 1B Figure 1C

Figure 2A Figure 2B Figure 2C

Figure 1 shows initial RLE venogram with chronic change of popliteal (arrowhead) and femoral occlusion (arrow) (a and b)

and severe narrowing of common iliac (c) veins.

Figure 2 post-treatment venogram demonstrates recanalisation and patency of popliteal and femoral veins

(a, b) and common iliac post stenting (c).

Figure 3 Long-term follow-up doppler ultrasound RLE showing persistent patency of the common femoral and

femoral veins.

18 September 2017Updates

New ultrasound “drill” targets deep vein blood clots

Researchers at North Carolina State University

(Raleigh, USA) and the University of North Carolina at Chapel Hill (Chapel Hill, USA) have developed a new surgical tool that uses low-frequency intravascular ultrasound to break down blood clots that cause deep vein thrombosis.

The tool is the first ultrasound “drill” that can be aimed straight ahead, allowing doctors to better target clots—which holds promise for significantly reducing treatment time. To date, the technology has been tested only in synthetic blood vessels.

Existing intravascular ultrasound tools for clearing clots emit ultrasound waves laterally. This makes it harder to target clots exclusively, meaning that the ultrasound can also damage surrounding blood vessels. However, ultrasound breaks the

clots into very small pieces, so doctors do not need to use large doses of blood thinner to dissolve the clot remnants.

Another technique uses a diamond-tipped drill to effectively chew through clots. This is more targeted, posing less risk to blood vessels. However, this technique breaks the clot into relatively large pieces, requiring higher doses of blood-thinning drugs—which can pose risks of their own.

“Our new ultrasound tool is forward-facing, like a drill, but still breaks down clots into very fine particles,” says Xiaoning Jiang, a professor of mechanical and aerospace engineering at North Carolina State University and corresponding author of a paper describing the work. “Our approach improves accuracy without relying on high doses of blood thinners, which we hope will reduce risks across the board.”

The tool also incorporates an injection tube that allows users to inject microbubbles at the site of the clot, making the ultrasound waves more effective at breaking down the clot.

The researchers tested a prototype of the device in a synthetic blood vessel using cow’s blood.

“We found that we could dissolve 90% of a clot in 3.5–4 hours without using any blood thinners at all,” says Jinwook Kim, lead author of the paper and a student in Jiang’s lab. “That is compared to 10 hours for the combination of conventional ultrasound tools and blood thinners.”

“This is a successful proof of concept, and we are now in the process of securing funding to move forward with trials in an animal model,” Jiang says.

The VEINS at VIVA

The VEINS (Venous Endovascular Interventional Strategies) course is returning to Las Vegas for the third year and will be held on Sunday, 10 September and Monday, 11 September ahead of VIVA 17. The VEINS at VIVA offers a multispecialty, comprehensive symposium providing an in-depth look into the most exciting field in vascular medicine. Writing for Venous News, Raghu Kolluri, co-course director of The VEINS, explains how the course is contributing to the rapidly developing venous medicine arena.

The field of venous disease has seen significant recent developments. Never has there

been more attention and activity in the management of venous disease among providers and in the device industry. New venous stents, increased data in use of intravascular ultrasound (IVUS) technology, new superficial venous ablation techniques, ongoing pre-clinical work in vein valve construction, the recent release of the ATTRACT trial and its implications on

management of acute iliofemoral deep vein thrombosis and the development of pulmonary embolism response teams (PERT), are just a few of the recent innovative developments in venous disease. It truly is the hottest field in vascular medicine. There are currently ongoing efforts to obtain National Institutes of Health funding for similar C-TRACT (for chronic venous disease) and PE-TRACT (for pulmonary embolism) trials.

When taken in the long view, our

understanding of venous disease, as we know it, is in its nascent stage. Which patients truly benefit from interventions, be it for acute deep vein thrombosis, chronic deep vein thrombosis or submassive pulmonary embolism? How do we manage patients with combined deep and superficial venous disease? What is the implication of other causes of oedema in these patients and on the outcomes of interventions? What should be the ideal treatment algorithm in patients presenting with a complex set of problems? What imaging modalities and algorithms are best for assessment of a patient with venous disease? How do we curb unnecessary interventions? And finally, how do we best serve our patients with venous problems? All venous experts agree that we need to concentrate on caring for the patient rather than concentrating on his or her obstructions and/or reflux. The one and a half day interactive course, held at the Wynn Las Vegas, will focus on comprehensive analysis of these critical issues facing vascular specialists today. Attendees will not only have an opportunity to hear from like-minded, multidisciplinary, world-class faculty interpreting the available data, but they will also have

an opportunity to perfect the art of medicine in areas where there is lack of such evidence-based data.

The VEINS at VIVA, as in the past, brings the state-of-the-art content that includes basic venous topics to contemporary science along with live patient volunteer scans. There will be ample time for discussion with the faculty throughout the meeting. We hope that the knowledge gained at The VEINS will allow attendees to better manage their patients with complex venous disease.

Attendees to The VEINS are also welcome to attend the half-day “Aortic Armageddon” and critical limb ischaemia sessions on Monday. Apart from the one and a half days of The VEINS at VIVA, VIVA attendees who wish to gain further in-depth education of venous disease including, wound care, pulmonary embolism management and additional content in deep venous interventions may attend these “Venous Tracks” during VIVA 17.

To register and view invited faculty for The VEINS, please visit www.vivaphysicians.org/theveins

Raghu Kolluri is a vascular medicine specialist at OhioHealth Heart and Vascular Physicians, Columbus, USA

COMMENT & ANALYSIS

RAGHU KOLLURI

First patient enrolled in AspirexS venous catheter study

S traub Medical has announced that the first patient has been enrolled in the P-MAX study

at the Karolinen-Hospital Arnsberg, Germany.

The post-market clinical follow-up study to assess the safety and effectiveness of the AspirexS venous catheter in the treatment of deep vein thrombosis will enrol over 80 patients by the time of completion.

Michael Lichtenberg, the investi-gator who enrolled the first patient, reported that the 37-year-old woman presented with acute deep vein thrombosis and was successfully treated with AspirexS on 29 June and was discharged the following morning.

The AspirexS endovascular system

is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal re-moval of fresh thrombotic or throm-boembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial by-passes) outside the cardiopulmonary, coronary and cerebral circulations.

Capturex, a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolising proce-dures on the patient.

Both AspirexS and CaptureX are CE-marked (Class III) medical de-vices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed in a real-world setting.

AspirexS

20 September 2017Market watch

Inari Medical announces first patient treated with the ClotTriever thrombectomy systemInari Medical, a venture capital backed medical device company focused on the interventional treatment of venous thrombus, has announced the treatment of the first patient with its ClotTriever thrombectomy system.

The system received 510(k) marketing clearance from the US Food and Drug Administration on 16 February for the non-surgical removal of thrombus from the peripheral vasculature.

“We are pleased to be the first site to perform a procedure using the ClotTriever System. The ClotTriever removed clot in the iliac vein efficiently, and without the need for thrombolytic drugs,” said Mark Meissner, professor of Vascular Surgery at the University of Washington Medical Center in Seattle, USA. The ClotTriever is a promising new advancement in the treatment of thrombus in large veins,” added Sandeep Vaidya, associate professor of Interventional Radiology.

“The ClotTriever System is the second product offering in Inari’s product portfolio,” said Bill Hoffman,

Inari’s chief executive officer. “The ClotTriever is currently available for treatment of thrombus in the peripheral veins at select centres, and we plan to add more centres as we gain clinical experience. We are pleased to provide a new tool for interventionalists to treat patients with large blood clots in big vessels, while avoiding the need for, and risk of, thrombolytic drugs,” added Hoffman.

FDA grants priority review of Xarelto for a 10mg dose to reduce recurrent VTE riskThe US Food and Drug Administration (FDA) has accepted, for priority review, a supplemental new drug application (sNDA) for Janssen’s Xarelto (rivaroxaban), to include a 10mg once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy.

This application is based on data from EINSTEIN CHOICE, which is the only study to find a non-vitamin K antagonist oral anticoagulant, specifically two doses of Xarelto (10mg and 20mg), to be superior to aspirin in reducing the risk of recurrent VTE, with comparable rates of major bleeding.

VTE includes deep vein thrombosis (DVT) and pulmonary embolism (PE).

Once anticoagulant therapy is stopped, up to 10% of people will experience a recurrence during the first year and up to 20% within three years.

“The FDA’s acceptance of our sNDA for priority review marks another important step toward a potential shift in how people with VTE are managed over time,” said Paul Burton, vice president of Medical Affairs at Janssen. “We are pleased the FDA sees the urgency in offering the choice of a 10mg dose of Xarelto or the currently approved 20mg dose. This will broaden the physician’s ability to customise treatment plans based on the needs of each patient.”

The FDA grants priority review to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. This designation shortens the review period to six months compared to 10 months for standard review. This accelerated review advances the FDA’s prescription drug user fee act target date to 28 October, 2017.

Data from the EINSTEIN CHOICE study support this sNDA. This phase 3, global, randomised, double-blind, superiority study met its primary efficacy endpoint, finding both Xarelto doses

(10mg and 20mg) to be superior to aspirin in reducing the risk of recurrent VTE following at least six months of standard anticoagulation therapy. Specifically, Xarelto 10mg reduced the risk of recurrent VTE by 74% and Xarelto 20mg by 66%. All three treatment groups had low rates of major bleeding.

Xarelto currently has six indications approved by the FDA, including

the treatment of VTE (15mg twice daily for the first 21 days followed by 20mg once daily for the remainder of treatment), and reduction in the risk of recurrent VTE (20mg once daily).

Medtronic completes sale of deep vein thrombosis (compression) business to Cardinal HealthMedtronic has completed the previously announced sale of a number of its businesses to Cardinal Health, including its Deep Vein Thrombosis (compression) division. The transaction was worth US$6.1 billion.

The company has also sold its Patient Care and Nutritional Insufficiency businesses within the Patient Monitoring & Recovery (PMR) division of its Minimally Invasive Therapies Group (MITG) to Cardinal Health.

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22 Events

team

10–11 SeptemberTHE VEINSLas Vegas, USAW www.vivaphysicians.org/theveins

16–20 SeptemberCIRSE 2017Copenhagen, DenmarkW www.cirse.org

19–22 SeptemberESVS Annual MeetingLyon, FranceW www.esvs.org

27–30 SeptemberDGG—Deutsche Gesells-chaft für GefäßchirurgieFrankfurt, GermanyW www.gefaesschirurgie.de

5–7 OctoberAdvanced Therapies in Venous InterventionsTempe, USAW sirweb.org/learning-center/learning-center/active-meeting

26–28 October8th EVF Hands-on Workshop on Venous DiseaseKrakow, PolandW europeanvenousforum.org

29 October–2 NovemberTranscatheter Cardiovascular Therapeutics (TCT)Denver, USAW www.crf.org/tct

2–5 NovemberAmerican College of Phlebology (ACP) 2017Austin, USAW www.phlebology.org/education/meetings-events

14–18 NovemberVEITHsymposiumNew York, USAW www.veithsymposium.org

22–24 NovemberVascular Society Annual Scientific MeetingManchester, UK

W www.vascularsociety.org.uk

25–27 JanuaryCACVS 2018Paris, FranceW www.cacvs.org

31 January–2 FebruaryLINC—Leipzig Interventional ConferenceLeipzig, GermanyW www.leipzig-interventional-course.com

4–8 FebruaryUIP 2018Melbourne, AustraliaW www.uip2018.com

21–23 FebruaryAmerican Venous Forum Annual MeetingTuscon, USAW www.veinforum.org

2–4 MarchIMAP 2018—International Meeting on Aesthetic

PhlebologySão Paulo, BrazilW www.imap.med.br/en

5–7 AprilVenous Symposium New YorkNew York, USAW venous-symposium.org

19–21 AprilInternational Vein CourseMiami, USAW www.ivcmiami.com

28–30 JuneEuropean Venous ForumAthens, GreeceW europeanvenousforum.org

Calendar of events

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Next issueNovember 2017

September 2017

Editors-in-chief:Stephen BlackAlun DaviesIan Franklin

Scientific Advisors:Lowell Kabnick Raghu KolluriArmando MansilhaKasuo MiyakeErin MurphyRamesh Tripathi

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According to a press release, Medtronic expects modest dilution on a net basis to its fiscal year 2018 non-GAAP earnings per share of approximately US$0.18, given the transaction closed at the beginning of the company’s second fiscal quarter.

Medtronic intends to provide historical comparable financials, incorporate the divestiture into its fiscal year 2018 financial guidance, and discuss the financial impact of the divestiture when it reports its first fiscal quarter financial results.

First patients enrolled in Bluegrass Vascular post-market SAVE studyBluegrass Vascular Technologies has enrolled over one third of its patients in the company’s post-market SAVE (Surfacer System to Facilitate Access in Venous Occlusions) clinical study. The SAVE study is an international, prospective, multicentre clinical follow-up study designed to confirm clinical performance and safety of the Surfacer inside-out access catheter system, a

device indicated for obtaining central venous access to facilitate catheter insertion into the central venous system in patients with chronically occluded veins.

“I look forward to presenting initial results of my experience in the SAVE study at the upcoming CX Symposium,” states Vladimir Matoussevitch, Vascular Surgeon at the University Hospital of Cologne in Cologne, Germany and one of the multicentre Investigators of the SAVE study. “The Surfacer system is an exciting new technology that offers my patients a promising option for reliable catheter placement during arteriovenous access creation.”

Bluegrass Vascular will be co-presenting with Merit Medical Systems during a lunch symposium on April 26th from 12:30–1:30pm. The event will be presented by Gürkan Sengölge, associate professor, interventional nephrologist at the University of Vienna, Vienna, Austria, and John Gurley, interventional cardiologist at the University of Kentucky Medical Center, Lexington, USA, and founder of Bluegrass Vascular.

The company secured CE mark approval of the Surfacer system in 2016 and recently announced its worldwide distribution relationship with Merit Medical.

CorrectionIn the April edition of Venous News, it was incorrectly reported that the VenoValve (Hancock Jaff Laboratories) is undergoing an early in man trial. Hancock Jaff Laboratories is currently preparing to enter into discussions via the pre-submission provess to begin an early feasibility first-in-man study for the VenoValve, for which the study protocol is yet to be identified.

Product NewsACP names Dean Bender as new executive director

The American College of Phlebology (ACP) board of directors has selected

Dean Bender as the new execu-tive director for the ACP and ACP Foundation.

Bender has more than 30 years in global business management and considerable experience in venous and lymphatic medicine. He has served as vice president of business development and marketing for mediUSA, president of CircAid, vice president of global research and development at BSN medical, and was a business director for Bayer Chemicals.

He also has been a member of the venous community for 13 years, and served as a board member and treasurer for the ACP Foundation. He has been a member of the ACP since 2008.

“I could not be more pleased to work with Dean as the executive director,” incumbent ACP president Neil Khilnani said. “I have known him a long time and he has proven a passionate advocate for the specialty. It is that passion and commitment that will lead this organisation into the future.”

Featured Event24–27 AprilCharing Cross Symposium 2018: 40 Years of Looking ForwardOlympia GrandeLondon, UKW www.cxsymposium.com