Venous News 8 — November Issue

Nov

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18 08 Alison Hopkins: Changing the narrative on light compression

Page 12

Una Adderley: Choosing the right compression

Ramesh Tripathi: Page 8

Strategies needed to address radiation exposure risks during venous procedures Research presented at the European Society for Vascular Surgery’s annual meeting (ESVS; 25–28 September, Valencia, Spain) has shone a light on the potentially high cumulative radiation exposure associated with certain venous procedures. Addressing the issue, Stephen Black (Guy’s and St Thomas’ Hospital, London, UK) called for further studies to identify strategies that can reduce radiation exposure, and highlighted the need for increased awareness among interventionalists.

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Nationwide study finds no significant differences between rivaroxaban and apixaban for VTE patients A recent Danish study, examining a nationwide cohort of 8,187 patients with venous thromboembolism (VTE) treated with one of two new oral anticoagulant therapies, reports no significant differences between the drugs in risk of all-cause mortality, recurrent VTE or hospitalised bleeding.

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lack indicated that there has been an increase in treatment options for deep vein thrombosis (DVT) in particular and for chronic venous patients over the last few years. While the advances are exciting, it is easy to forget that they come with potentially harmful side effects. Black compared modern venous procedures with endovascular aneurysm repair (EVAR), drawing particular attention to the young age at which venous patients typically require treatment, corresponding with a much longer lifetime of follow-up and potential reintervention procedures.

“It is important to highlight the potential for harm in this patient group who are an average age of 30–40 years, as opposed to the older patients who typically undergo EVAR, for example. The EVAR 1 trial reported an increased incidence of malignancy in patients treated endovascularly after 15 years follow-up. Patients who need thrombolysis or inferior vena cava (IVC) reconstruction are often younger than those with arterial problems and may also require long-term surveillance and secondary interventions, exposing them to further radiation,” Black pointed out.

To investigate the radiation exposure associated with venous procedures, Black and colleagues conducted a retrospective cohort study of patients with symptomatic ilio-femoral deep vein thrombosis and chronic IVC reconstruction, followed for a minimum of one year in order to capture reintervention data. Estimated radiation

Profile

exposure from the related preoperative, index and postoperative interventions were measured in dose-area product and fluoroscopy time.

At St Thomas’s Hospital, Black explained that all procedures are performed in either the hybrid vascular theatre or in the angiosuites. Default background settings are used with a fluoroscopy pulse rate of 7.5/ second in the hybrid operating theatre, 3.0/second in the angiosuite and two frames per second for digital subtraction angiography acquisitions for all rooms.

The 39 patients enrolled in the study were a median age of 35 years (range=18–73) and 27 were male.

Nineteen patients were treated for lower extremity DVT and 20 for upper extremity DVT, and these two groups were looked at separately to observe any differences.

In terms of the configuration of stents for IVC reconstruction and the level of disease, three patients Continued on page 4

THE STUDY BY Caroline Sindet-Pedersen and colleagues has been published in the European Heart Journal, and includes all Danish residents with an inpatient or outpatient diagnosis of deep vein thrombosis or pulmonary embolism between 1 January 2015 and 30 June 2017, who were also prescribed medical therapy of either apixaban or rivaroxaban, within a week following their diagnosis. Apixaban and rivaroxaban are both novel oral anticoagulants (NOACs), which in contrast to warfarin—a widely used anticoagulant—are nonvitamin K antagonists. Other such NOACs, including dabigatran and edoxaban, were not examined in this study, and patients prescribed with any NOAC other than either rivaroxaban or apixaban, or with a vitamin K antagonist drug, were excluded from the analysis.

Based on these exclusion criteria as well as a range of others (e.g. patients with atrial fibrillation or mechanical heart valves), the cohort was reduced from a total 12,130 patients with VTE to the final population of 8,187. Of these, 1,504 (18%) were treated with apixaban while 6,683 (82%) were treated with rivaroxaban.

Continued Continued onon page page 002

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Varicose veins

Nationwide study finds no significant differences between rivaroxaban and apixaban for VTE patients Continued from page 1

“We found no significant differences in a nationwide cohort of VTE patients treated with rivaroxaban or apixaban regarding the short term risks of all-cause mortality, recurrent VTE, or hospitalised bleeding”, Sindet-Pedersen et al write.

“Our study compared rivaroxaban and apixaban, using an observational study design, and gives an insight into the absolute risks of recurrent VTE and bleeding when rivaroxaban and apixaban are used in the everyday clinical practice.”

The results showed markedly similar outcomes for the two groups, with recurrent VTE rates at 180 days for 2.16% in the apixaban group (95% CI, 4.08– 6.08%) and 2.22% in the rivaroxaban group (95% CI, 1.89–2.52%). Hospitalised bleeding at 180 days was seen in 1.73% (95% CI, 1.22–2.35%) of patients with apixaban versus 1.89% (95% CI, 1.56–2.20%) of

patients with rivaroxaban, and all-cause mortality was 5.08% (95% CI, 4.08–6.08%) in the apixaban group and 4.6% (95% CI, 4.13–5.18%) in the rivaroxaban group. While still far from a significant difference, the authors suggest that the difference in all-cause mortality may be affected by “major differences” observed between the groups, with an older and more comorbid patient population in the apixaban cohort.

“Thus it may be”, Sindet-Pedersen et al add, “that patients in the apixaban group also had a higher risk of bleeding.”

Expanding on what the authors perceived to be the major limitations of the study, they note: “Significantly more patients in the apixaban group had pulmonary embolism as index event. This can possibly be explained by pulmonary embolism being a condition that affects more elderly patients, thus

because patients in the apixaban group were older than the patients in the rivaroxaban group, this can explain the difference. However, we adjusted for these major differences in age and comorbidities, and thus, within the limitations of correct specifications of our models, these differences should not bias our results.

“Another limitation is the potential for residual confounding as potential confounders were not available in the registries. These include: body mass index, smoking status, and important clinical parameters such as eGFR, hepatic status, blood pressure, and lipid status. This argues for a headto-head randomised trial, which could provide more causal results. Such a study has been scheduled and will be of high relevance to both the medical field and patients.”

MOCAP linked with improved quality of life and fewer reinterventions for varicose veins A study presented at the European Society for Vascular Surgery’s annual meeting (ESVS; 25–28 September, Valencia, Spain) has concluded that mechanochemical ablation with concomitant ambulatory phlebectomy (MOCAP) results in greater early improvement in quality of life and significant reduction in reintervention rates when compared to mechanochemical ablation (MOCA) alone.

PRESENTER ABDURAHEEM MOHAMED (Hull Royal Infirmary, Hull, UK) explained that MOCA is becoming increasingly popular as a treatment method for varicose veins, perhaps because it is purported to be less painful than thermal ablation. However, he questioned what should be done with the varicosities once the axial reflux has been treated. There are two schools of thought on this—some argue that you should treat them in the same sitting, with whatever means are available, and others argue that you should leave them alone because they will regress and become asymptomatic.

The advocates of MOCA, he indicated, say that the scleroscent distributes into the tributaries after the axial reflux has been treated, which might occlude them sufficiently to eliminate the need for them to be further treated. At the moment

there is no evidence for either approach with regards to MOCA. The aim of the study presented was therefore to compare the clinical and technical outcomes of MOCA alone against MOCA with concomitant ambulatory phlebectomy.

The investigators performed a nonrandomised comparative study where patients self-selected the arm in which they were enrolled—either MOCA alone or MOCA with phlebectomy. The primary outcome was the disease-specific Aberdeen Varicose Veins Quesionnaire and the secondary outcomes (measured at one, six, 26 and 52 weeks) included VCSS, EQ5D, complications and technical outcomes.

Mohamed reported that 33 patients were included in the MOCA group and 50 patients in the MOCAP group. He said that the baseline characteristics

were similar between the two groups in terms of the severity of the disease, the diameter of the vein and quality of life scores, with the only noticeable difference found in age, where older patients chose MOCA alone.

In terms the primary endpoint, Mohamed explained that while at baseline and at one week the two groups remained similar, at six weeks, those who underwent phlebectomy, were ahead in terms of quality of life and performed better. This remained at six months, and only levelled out a year later. “It takes about a year for those who have undergone MOCA alone to catch up in terms of quality of life after treatment,” he clarified.

As it relates to secondary outcomes, the investigators found a higher rates of reinterventions in the MOCA alone group (18%, n=6) compared to the

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MOCAP group (4%, n=2), p=0.032. The advantage of the MOCA alone group, Mohamed said, was that the procedure time was 15 minutes shorter and less painful. However, looking at the return to work time and the time to return to normal activity, he pointed out that it was the same in both groups.

When compared to MOCA alone, MOCAP results in greater early improvement in quality of life, significant reduction in reintervention rates, modest increase in procedure duration and an increase in procedural pain of questionable significance.

As for whether the addition of phlebectomy makes the procedure more difficult for the operator, Mohamed explained that the procedure was carried out by trainees and can therefore be considered relatively straightforward.

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18 08

Radiation exposure

Strategies needed to address radiation exposure risks during venous procedures Continued from page 1

had unilateral iliac stents into the IVC, but the dominant group were either to the suprarenal component or a stent extension to the hepatic confluence.

The cumulative radiation exposure to patients undergoing IVC reconstruction was predictably higher, Black reported, with a mean dose-area product of 81,131Gy-cm2. Additionally, fluoroscopy time was long, with some procedures taking up to six hours. Level of radiation exposure also depended on the region which was stented.

“If we look at the difference between the two, it is clear that the stents that extended into the hepatic segment were associated with significantly more radiation exposure than those that remained below the infrarenal component. The cumulative radiation exposure, if we include all the follow-up, remains relatively similar in both the acute and chronic IVC stent extension patients. Further, we found that in patients with upper extremity DVT, the procedure was far quicker and therefore associated with far less radiation than lower extremity DVT. The same applies for cumulative dose-area product and fluoroscopy time for all the reinterventions that occurred in the year after the initial procedure and the surveillance,” Black reported.

Comparing radiation dose measurements for IVC reconstruction with other vascular procedures, Black

Stephen Black

noted that it is significantly higher than lysis, for example, which has a median radiation exposure of 9Gy-cm2 and 981 seconds of fluoroscopy time compared with 60.8Gy-cm2 and 2,846 seconds for IVC. Compared to procedures such as EVAR and

The initial procedure for acute DVT is relatively low, but it is not insignificant—these patients really are much younger than the arterial population, and we need to be much more aggressive in reducing their exposure early on.

thoracic EVAR (TEVAR), however, the venous treatments do remain lower—especially complex procedures which have been associated with 287Gy-cm2 dose-area product and 4,152 seconds fluoroscopy time—but Black maintained that there should still be concern for the amount of radiation venous intervention patients are exposed to.

“This does not really change the story for venous patients. We can see that IVC reconstruction does have a high dose of radiation exposure, with cumulative radiation over 40–50 years of a patient’s life really needing to be taken into account. The initial procedure for acute DVT is relatively low, but it is not insignificant, and these patients really are much younger than the arterial population and we need to be much more aggressive in reducing their exposure early on,” Black stated.

At his hospital, he said that they have moved to using magnetic resonance (MR) venogram instead of computed tomography (CT) scan in all of these patients for their initial work-ups, so as not to expose them to additional radiation dose.

In particular, he added, the use of intravascular ultrasound (IVUS), helps to reduce radiation exposure in the form of contrast-enhanced runs, and is one of the main strategies he uses to reduce dose.

“As interventionalists, we have to learn that often we use another run as time to think about how to proceed, and we have to start getting out of these habits that expose not only ourselves but the patients to more radiation,” Black said.

He concluded, adding that more needs to be done to raise awareness about the importance of reducing radiation dose wherever possible, and maintained that more strategies, such as the use of IVUS, need to be identified and put into practice.

Use of diode laser to treat venous malformations effective and safe in eight-year experience A report of an eight-year experience using diode laser for the treatment of congenital diffuse venous malformations, has shown the modality to be effective and safe with a low number of complications.

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he experience from the Vascular Anomalies Unit in Hospital Universitario La Paz (Madrid, Spain) was presented at the European Society for Vascular Surgery’s annual meeting (ESVS; 25–28 September, Valencia, Spain) by Alexia Paluso (Hospital Universitario La Paz, Madrid, Spain). This work is part of a line of research on the treatment of diffuse venous malformations lead by Elena Marín Manzano.

According to Paluso, venous anomalies are the most frequent vascular anomalies. While they are benign, they affect young patients and grow as the patient does.

They are associated with pain, oedema, deformity, venous stasis and thrombosis.

Some of the possible treatment options for venous malformations are surgery, which can be aggressive, requiring a large resection of tissue, with a high risk of bleeding and risk of injuring other surrounding tissues; and endovascular techniques, where the limiting condition of some agents resides in the high doses needed, due to the complex network these malformations have, and their toxic effect. On the other hand, Paluso noted, diode laser is a safe and effective treatment of which the mechanism of action is by thermal injury.

To come to that conclusion, the investigators reviewed patients with symptomatic congenital diffuse venous anomalies with an impact in their quality of life, treated at their centre between 2010 and 2018. The patients were treated with diode laser radial fibre (810–1470nm).

Data were registered in three categories, including that related to the patient (gender, age, type of vascular anomaly, location, symptoms), the procedure (anaesthesia, wavelength, power, energy), and to the outcome (visual analogue scale for pain, D-dimer, clinical improvement, complications, MRI).

All cases were performed under general anaesthesia and with percutaneous access. Only three cases needed open surgical access due to one hip replacement and two knee replacements simultaneously.

Overall, at their centre, the investigators have performed 26 procedures in 16 patients with a mean age of 30 years, 13 of whom were women. The most common symptom was pain (n=14), followed by deformity (n=3) and haemorrhage (n=3). The types of venous malformations included simple venous malformations (n=10), glomuvenous (n=3), capillary-

venous (n=2) and capillary-lymphatic-venous (n=1).

“We found that we could perform repeated sessions of diode laser in patients, with no limitation on the number, and there is no limitation of whether the patient has been treated previously with another technique. The power we used was between 10–15W and the pain tested before and after the procedure had an overall tendency to decrease,” Paluso reported.

Further, she stated, the results showed pain reduction in 11 out of 16 patients and a visualised lesion size reduction in nine patients. In terms of complications, the investigators observed three skin burns with consequent cutaneous necrosis; and one sciatic nerve neuropathy, one false aneurysm and arteriovenous fistula which needed repairing.

“In conclusion, this technique is safe and effective and is well tolerated by patients who are discharged within 24 hours. It also reduces the size of the lesions and the associated symptoms. It can be combined with other techniques, such as sclerotherapy, surgery or embolisation. There are no reports on dose limitation or number of procedures, and there was a low number of complications,” Paluso said.

The study investigators are Alexia V Paluso Montero, Elena Marín Manzano, Covadonga Mendieta Azcona, Carlos Renato Jiménez Román, Teresa Hernández Ruiz, Marta Lavirgen Labrador, Beatriz Martínez Turégano and Juan Carlos López Gutiérrez.

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Compression therapy

Changing the narrative around light compression Alison Hopkins Comment & Analysis At the Royal Society of Medicine (RSM) Venous Forum meeting (25–26 June, London, UK), Alison Hopkins was asked to speak about managing painful leg ulcers. She took the opportunity to focus on the need to improve the art of compression therapy if we are to deliver successful management of leg ulcers across the UK. The contention, she argues, is that without greater understanding and successful compression therapy, patients will remain in pain despite effective medical management.

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f, like me, you have been involved in community leg ulcer management for many years, you will have noted that the use of high compression therapy is frequently now defaulting to light or reduced compression bandaging. We see this through audits of care1 or analysis of bandage usage.2 There is no nationally available data on compression usage in the UK, but a recent report

by Guest et al estimated that compression therapy provision can be as low as 30%.3 Compression therapy is a clinical intervention and high compression therapy produces better healing rates than no compression;4 compression therapy delivers results when a high sub-bandage pressure is delivered to the limb accompanied by a high static stiffness index.5 Unfortunately, despite nearly 30 years of education, there remains a lack of understanding about the role of this important therapeutic intervention and the art required in enabling patients to tolerate the regime. To the untrained ear, reduced or light compression sounds friendly—a kind response to a challenging situation. What would happen if we changed our language and called these reduced regimes weak, ineffectual or sub-optimal? A change in terminology may make all of us wake up to what is happening, and the subsequent harm to patients’ lives.

When compression is not applied well, is applied inconsistently or cannot be tolerated, this creates a non-therapeutic environment. It simply will not do the intended job. The result is non-healing or, even worse, uncontrolled oedema that creates maceration, skin breakdown and repeated infection. Lives are destroyed and jobs are lost. All the while, compression bandaging is being applied very neatly and repeatedly, but sadly for the patient it is weak and inadequate.

Meanwhile, healthcare professionals are frustrated with the lack of progress, the strike through, pseudomonal infections and unremitting pain for their patient. The connection between this and the ongoing delivery of sub-optimal care has not been grasped. A simple review of English FP10 prescription form data demonstrates the changing trend towards a “lite” version of compression bandage products (Graph 1) and the impact of this on an increasing spend on extra large dressing pads (Graph 2). This in turn creates an enormous workload and emotional burden for a community nursing workforce already under extreme pressure.

What causes inadequate wound care?

We do have to question the reasons why compression therapy is applied deliberately or inadvertently at reduced compression.

Before we blame the patient for requesting a lighter bandage, let us look first at ourselves and the culture we work within.

Leg ulcer management within the community is left largely to tissue viability nurses and community nursing. There are few medical practitioners that work within a community or primary care context. Thus the local guidelines are seen as the decisive framework for directing care. Like the Scottish Intercollegiate Guidelines Network (SIGN)4 or National Institute of Health and Care Excellence (NICE) guidelines, unfortunately there is no Plan B if the patient fails to progress or cannot tolerate the therapy. Even in circumstances where the guidelines have been used to the letter, and progress has not been made, specialist nurses are reluctant to challenge the standardised advice. There is an increasing culture of risk adverse nursing, even in the face of failing care.

However, our tissue viability colleagues across the country have been inundated by the workload associated with pressure ulcer management, prevention and reporting. Leg ulcer management has taken a back seat, an unintended consequence of such an important focus.

Meanwhile, community nursing is experiencing unprecedented vacancy rates.

Four steps towards improving compression care There are some simple but bold steps that need to be taken.

1. Ensure pain is managed effectively prior to commencing compression therapy.

If the bandage or technique used increases the pain, then no one should expect the patient to keep it on. Ulceration is painful and, inadequately managed, pain is often accompanied by neuropathic pain.

2. Ensure that the compression bandage delivers healing and provides a therapeutic intervention: healing and exudate reduction must be evident. If it is not, review whether compression therapy is at the most appropriate level, as well as whether it is consistent and comfortable. The need for daily bandage changes and recurrent infection point to inadequate compression that is not managing the oedema.

Graph 1

Graph 2

3. Standard care is great—for standard patients. If they are tall, they may require a higher level of working pressure;2 the UK guidance views 35mmHg at the ankle as high compression whilst this has been described as moderate by an International Consensus document.4 Likewise, the site of the ulcer needs consideration. The retromalleolar area receives very little direct compression thus a technique of compression strapping has been found useful.6 4. If the bandage is not comfortable, ask the patient what will make the difference.

They need to understand the aim of the therapy and what you are trying to achieve. They need confidence in such difficult treatment. They may also point out that with Nurse X they can tolerate the bandage, but dread Nurse Y walking through their door. This is a common issue and needs to be managed sensitively, but ultimately they need to be in receipt of good care for their ulcer to heal.

We have to appreciate that compression bandaging in the right hands is an art. Put this together with knowledge, skill and empathy, it becomes a potent therapy that needs to be optimised.4 This therapeutic intervention is so much more than a task, and cannot be left to the untrained. Compression bandaging or hosiery remains the cornerstone of effective treatment; if it is not working, we must ask why, and be prepared to be creative. One size does not fit all.

Nevertheless, change is afoot. NHS

England is embarking on a Wound Care Strategy that recognises leg ulceration as one of the biggest unmet health needs and a considerable cost to the economy and patients’ lives. The Legs Matter campaign launched in April 2018, as a coalition aiming to raise the awareness and expectation of patients.

We all have our part to play in ensuring patients get the care they need. If not, is this not harm?

Alison Hopkins is a nurse specialised in wound care, as well as the chief executive officer at UK-based Accelerate CIC, a social enterprise working within the NHS to provide specialist care for chronic wounds and lymphoedema patients. Hopkins has been awarded a Member of the Most Excellent Order of the British Empire (MBE) for her services to nursing.

References 1. King BM. Leg ulcer audit report. Leg Ulcer Forum J 2016;28:16-9.

2. Guest JF et al. Health Economic burden that wounds impose on the National Health Service in the UK. BMJ Open 2015;5 3. Hopkins A, Bull R and Worboys F, 2017 Veins and Lymphatics 2017; https://www.pagepressjournals.org/index.php/vl/article/ view/6630/6336 4. Scottish Intercollegiate Guidelines Network (SIGN).

Management of chronic venous leg ulcers. Clinical guideline No. 120. Scottish Intercollegiate Guidelines Network; 2010. Available from: www.sign.ac.uk 5. World Union of Wound Healing Societies (WUWHS).

Principles of best practice: compression in venous leg ulcers. A consensus document. London: MEP Ltd.; 2008.

Available from: http://www.woundsinternational.com/ media/issues/65/files/content_25.pdf 6. Hopkins A, Worboys F, Partsch H (2013) Using strapping to increase local pressure. Veins and Lymphatics. Vol 2,12 https:// www.pagepressjournals.org/index.php/vl/article/view/vl.2013. e12/pdf

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Venous leg ulcers

Choosing compression to heal venous leg ulceration Una Adderley Comment & Analysis There is a robust evidence base to support the use of compression therapy for healing venous leg ulceration and for preventing ulcer recurrence. The most recent version of the Cochrane Review1 on the effectiveness of compression and the relative effectiveness of different compression systems on venous leg ulcer healing included 48 randomised controlled trials (RCTs) reporting 59 comparisons. Although the methodological quality of the evidence is variable, there is overwhelming evidence that multi-layer high compression systems greatly increase the chances of healing compared to no compression. A more recent review and update of the evidence came to the same conclusion.2 Similarly, although there is very little evidence on the use of compression to prevent recurrence of venous ulcers, the overwhelming evidence of effectiveness for healing makes it highly likely that compression is also highly effective at preventing recurrence.3

H

owever, a series of audits show that a significant proportion of patients with venous leg ulcers never get compression or their compression will not be sufficiently high to be effective. A point prevalence survey of wounds in North East England found that 46% of people with venous leg ulceration were not in compression.4 A subsequent survey using similar methodology undertaken in one English healthcare district found that 25% of people with venous leg ulcers were not in compression.5 A more recent survey found a slightly better situation, with 87.6% of people with venous leg ulcers in compression but only 67.8% were in full compression (i.e. equivalent to the recommended 40mmHg).6 In a recent retrospective cohort analysis of patient records, more than 50% of people with a leg ulcer had no recorded diagnosis.7 Not all these patients will have ulceration due to venous disease, but those that do are unlikely to be in compression. Although some of these audits are now quite old, the recent publications suggest that the situation may have worsened. The reasons for the suboptimal use of compression are unclear but are likely to be with lack of confidence8 and lack of knowledge.

According to the meta-analyses cited above,1,2 multicomponent systems are more effective than singlecomponent systems, but two-component systems appear equivalent to four-layer bandaging in terms of healing.

The Cochrane meta-analysis suggests faster healing with four-layer bandaging than with short-stretch bandaging, but high-compression stockings are associated with better healing at two to four months than short-stretch bandaging.

In terms of cost-effectiveness, four-layer is more cost effective than short-stretch bandaging. However, since the meta-analyses were conducted, the VenUS IV trial9 has found no difference in venous ulcer healing between four-layer bandaging and two-layer below-the-knee compression hosiery. Nevertheless, hosiery is slightly more cost-effective, with a slightly higher quality of life.

Recently, velcro wrap devices (which have traditionally been used to manage lymphoedema) are being marketed to treat venous leg ulceration. These offer a potentially useful new way to apply compression, but their clinical and cost effectiveness is currently unknown. The Human Tissue Authority has recently advertised for expressions of interest to undertake an RCT into this intervention for healing venous leg ulceration.

the beginning of treatment. We need to address pain, and offer appropriate analgesic therapy.12 In the UK, cost is less of an issue from the patient perspective as most products are available on prescription. However, there are cost implications from the healthcare provider perspective. We need to be aware of the issue of cost-effectiveness and make informed decisions about the products we recommend to our patients. Finally, we need to accept that patients do not like wearing thick, unflattering hosiery.13 Appearance matters, so it is important to find an acceptable compression solution.

In an ideal world we would be able to offer each patient a wide selection of compression options, but this is not without its challenges. The different types of compression all require considerable knowledge and skill in application, and this is especially true of compression bandaging. Furthermore, patients vary widely in shape and length of leg and what they find acceptable.

Ideally, a patient will receive care from a clinician who has expert knowledge about them as an individual, coupled with expert knowledge about all the available forms of compression. In reality, this is unlikely. All we can do is try to be as knowledgeable as possible about the patient in front of us by listening to them, making sure we keep our tool box of compression therapies adequately stocked, and develop skills and knowledge about the systems we use.

Una Adderley is the Director of the National Wound Care Strategy programme in the UK, as well as a lecturer in Community Nursing at the University of Leeds, Leeds, UK.

The challenge is in how to translate this research evidence into clinical practice. Firstly, we should be offering compression as a first-line treatment, but we need to acknowledge the challenges around receiving compression therapy. As a treatment, it has a major impact on the patient experience.

People with venous leg ulcers are more likely to wear compression if they believe it is effective. As clinicians, we need to share our knowledge with our patients, so they can make a truly informed choice.10 Patients are also more likely to wear compression if it is comfortable, so we need to help them choose an effective system that they are likely to tolerate.11 Finally, we need to be realistic about pain: leg ulcers and compression can be very uncomfortable, especially at

References 1. O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD000265. DOI: 10.1002/14651858.CD000265.pub3.

2. Nelson EA, Adderley U. Venous leg ulcers. Systematic review 1902. BMJ Clinical Evidence. http://clinicalevidence.bmj.com/x/systematic-review/1902/ overview.html 2016 January 3. Nelson EA, Bell‐Syer SEM. Compression for preventing recurrence of venous ulcers. Cochrane Database of Systematic Reviews 2014, Issue 9. Art. No.: CD002303. DOI: 10.1002/14651858.CD002303.pub3.

4. Srinivasaiah, N., Dugdall, H., Barrett, S. & Drew, P. J. 2007. A point prevalence survey of wounds in north-east England. Journal of Wound Care, 16, 413-419.

5. Vowden, K. & Vowden, P. 2009. The prevalence, management and outcome for patients with lower limb ulceration identified in a wound care survey within one English health care district. Journal of Tissue Viability, 18, 13-19.

6. Cullum N, Buckley H, Dumville J, Hall J, Lamb K, Madden M, et al. Wounds research for patient benefit: a 5-year programme of research. Programme Grants Appl Res 2016;4(13) 7. Guest, J. F., Ayoub, N., Mcilwraith, T., et al. 2015. Health economic burden that wounds impose on the National Health Service in the UK. BMJ Open [Online], 5.

8. Adderley, U. J. & Thompson C. Confidence and clinical judgement in community nurses managing venous leg ulceration – A judgement analysis.

Journal of Tissue Viability , Volume 26 , Issue 4 , 271 - 276 .

9. Ashby RL, Gabe R, Ali S, et al. VenUS IV (Venous leg Ulcer Study IV) compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decision-analytic model. Health Technology Assessment (Winchester, England). 2014;18(57):1-vi. doi:10.3310/hta18570.

10. Jull, A.B; Mitchell, N; Aroll, J et al Factors influencing concordance with compression stockings after venous leg ulcer healing Journal of Wound Care, 03/2004, Volume 13, Issue 3.

11. Moffatt, C; Kommala, D; Dourdin, N et al Venous leg ulcers: patient concordance with compression therapy and its impact on healing and prevention of recurrence International Wound Journal, 10/2009, Volume 6, Issue 5 12. Van Hecke, Ann; Grypdonck, Maria; Defloor, Tom A review of why patients with leg ulcers do not adhere to treatment Journal of Clinical Nursing, 02/2009, Volume 18, Issue 3.

13. Madden, M. 2015. The ghost of Nora Batty: A qualitative exploration of the impact of footwear, bandaging and hosiery interventions in chronic wound care. Chronic Illness, 11, 218-229

People with venous leg ulcers are more likely to wear compression if they believe it is effective. [...]

We need to be realistic about pain: leg ulcers and compression can be very uncomfortable.

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Interview

Profile

Ramesh Tripathi

Having worked as a vascular surgeon and venous specialist in several different countries and continents, Ramesh Tripathi has a wide-ranging experience and storied career. He tells Venous News about his current areas of research, his opinion of the most important data to emerge in the last year, as well as his interests outside of medicine.

What led you to become a doctor, and why did you choose to specialise in vascular surgery and the venous field?

Growing up in India during the Cold War days, Russian literature dominated my reading. I was always intrigued about the super smart details in Anton Chekov’s short stories and plays. I discovered that he could write incisively because of his background as a physician. I confess, I fantasised being a writer and a physician like Chekov. I also chanced upon Albert Schweitzer’s book “African Notebook” in my high school library which clinched the deal for me for a career in medicine.

During my general surgical residency at the University of West Indies, I was assigned to Mr Vijay Naraynsingh, a consultant surgeon, who had recently returned after Vascular Surgery Fellowship at Albany Medical College, having made important pioneering contributions to distal bypasses for limb salvage along with Alastair Karmody. Thanks to Vijay, I was exposed to the beauty of vascular surgery from my early days.

I had never seen such beautiful dissection, confident vascular control and gratifying results and I was hooked.

When I returned to India in the mid 90’s, initially, I was mainly referred patients with non-healing venous ulcers, as well-established vascular surgeons were busy dealing with arterial surgery. This was a blessing in disguise. I saw patients struggling through their difficult lives with pain, social unacceptability, economics of ulcer care and depression. I had no choice but to get involved, find solutions towards imaging, diagnosis and treatment of these venous ulcers. I am glad for the opportunity to help so many patients.

What mentors have influenced you in your career and what did you learn from them?

Vijay Narayansingh, who taught, mentored me in my early career and became a great friend in later years.

“Hoppy” Brian Hopkinson in Nottingham and Michael Lawrence-Brown and Kishore Sieunarine from Perth who I learnt EVARs from, Bob Kistner from Straub Clinic, Hawaii, USA; Seshadri Raju, Mississippi USA, Nicos Labropoulos, New York, USA and Michel Perrin, Lyon, France, advanced my career in deep venous reconstructions. They critiqued, advised and supported my techniques of Trapdoor and RIVal deep vein valvuloplasties. Frank Veith has been my global mentor helping me evolve as an international endovascular ambassador. Peter Gloviczki showed me that it is possible to be a vascular surgery “all-rounder”, giving wings to my interests in aortic, peripheral arterial, visceral and venous surgery and endovascular interventions. I cannot thank them enough for making me the surgeon I am.

What is your current research focus?

I am currently interested in failure modes of iliac vein stents; the role of endovenectomy in improving postthrombotic stenting results; and the assessment of the haemodynamic effects of endovenectomy.

In addition, I am involved with applications of 3D printing in vascular surgery especially modelling of compressive pathology of venous choke points to understand the haemodynamics of stenotic lesions. I am also interested in developing tube models by 3D

visualisation and assessing flows and pressures to develop parameters for iliac vein stenting.

Which area of venous research do you think currently shows the most exciting or important developments?

Venous research has emerged as the “new frontier” and it is great that this “venous rising” has mainly embraced endovascular surgery. Despite the findings of ATTRACT Trial, the jury is still out regarding post DVT thrombolysis. I am excited about new studies to address this issue. Iliac vein stenting has become more common place and long term data are coming in. We need to establish the role of venous stents for NIVL. We also need to analyse the reasons for failure of iliac stents and whether we can improve on the design of the existing venous stents.

In the last year, which paper(s) have you found the most important for the venous field, and why?

K Gibson, N Morrison, R Kolluri, et al. Twenty-four month results from a randomised trial of cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.

Journal of Vascular Surgery: Venous and Lymphatic Disorders, Volume 6, Issue 5, 606–613 This paper has paved the way for increased utilisation of glue for endogenous ablation for varicose veins, minimising the discomfort and need for additional anaesthesia and reducing complications from thermal injuries.

• MS Gohel, F Heatley, X Liu, A Bradbury, R Bulbulia et al for the EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration N Engl J Med 2018; 378:2105– 2114 This trial is very significant because it scientifically proved an intuitive, long held concept of most venous surgeons that venous disease is progressive and early treatment will prevent long-term debilitating complications. This will have implications to resource allocation and funding for venous pathology, which has been rather poor in the NHS and health agencies worldwide, weighing heavily towards arterial disease.

• S Vedantham, SZ Goldhaber, JA Julian, SR Kahn, MR Jaff, DJ Cohen, E Magnuson, MK Razavi, AJ Comerota, HL Gornik et al.for the ATTRACT Trial Investigators. Pharmacomechanical CatheterDirected Thrombolysis for Deep-Vein Thrombosis N Engl J Med 2017; 377:2240-2252 This important trial confirmed for us that moderate-tosevere post-thrombotic syndrome (PTS) was significantly reduced in those patients receiving catheter directed thrombolysis. Also we need to analyse the subset of patients with iliofemoral DVT. The care of acute DVT patients may not change significantly yet as nonrandomised and smaller studies have shown benefits in patients with acute iliofemoral DVT. Unfortunately in the catheter directed thrombolysis group, many patients had no definitive corrective procedure for underlying obstructive lesions of iliac veins. Hopefully, the CAVA Trial (Catheter Versus Anticoagulation Alone for Acute Primary Ilio-Femoral DVT) will be able to answer some of the questions remaining from ATTRACT trial.

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You have worked as a vascular surgeon and venous specialist in several different countries and continents. What are the main differences you have seen in practice and education across these places?

In the affluent countries, the resources are mostly readily available. So one can practice without much thought about options for patients in terms of technology and affordability for patients. In the less resourced countries, like India, with massive inequality in terms of both affordability and the technological availability adds to the stress of clinical practice. There is also the inequity of vascular surgeon to population ratios. In India, I was fortunate to work in hospitals where poor flocked to be treated free of cost through a public-private partnership. This meant that due to the higher cost of endovascular surgery, a lot of patients were treated by the traditional open techniques. The

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will be developed for timely diagnosis and treatment.

The EVRA trial should be able to convince the funding agencies, administrators and health policy makers to make resources available to treat symptomatic chronic venous insufficiency.

Do you consider social media an important tool for physicians for sharing of emerging research?

Of course. Social media has the potential to disseminate ideas and information to a large number of people in the shortest possible time. It is heartening to see many established players are already making use of social media to share conference highlights, new publications and opinions. More vascular surgeons need to get involved to make a real difference for conversations in vascular research. It is high time medical curricula included social media interactions from an early stage to involve surgeons in their formative years.

What advice would you give to someone interested in specialising in venous disorders?

Get involved! There couldn’t be a better time in the history of vascular surgery to be specialising in venous disorders. A lot of work needs to be done towards understanding the genesis, proteomics, haemodynamics, imaging, progression of disease and treatment modalities. It is an exciting time!

What has been the proudest moment(s) of your career to date?

Foremost, my Dad being there when I received my medical graduation diploma and seeing his pride swell when I received University Honours in General Surgery. Doing the first EVAR in India in 1998.

Being given a professorial position at the age of 37 in 1999. Setting up the first hybrid lab in India in 2011.

Receiving Distinguished Fellow status of the Society for Vascular Surgery (SVS) in 2014. This year, I have been proud to receive Honorary Membership to the European Venous Forum.

What was the most memorable case of your career, and why?

There have been so many. The one I remember is a patient with a gunshot wound to the abdomen with inferior vena cava (IVC) and right iliac vein injury.

I was a chief resident and my attending asked me to start the laparotomy and said he would join me. It was my first IVC repair and I was a nervous wreck throughout the case, saved only by the thought that he presenting pathology in patients in India is varied would come in anytime. He walked in right at the end and far advanced leading to tremendous challenges of the case and congratulated me for doing a great job. in treating these patients. The education of training Then I realised he was monitoring my surgery from the of vascular surgeons in India has mainly moved from gallery ready to intervene if I faltered. The patient did overseas to mainland but needs more maturation to well and I have never needed help with another IVC reach international standards. In Australia, the challenge reconstruction in my career. I have never forgotten that is to train and motivate fellows towards venous research. night when I learnt to swim by being thrown in deep, choppy sea.

Do you think the recent outcomes of the EVRA trial will be practice-changing, and have you made any changes to your own practice?

Not really, as I have practiced its conclusions and have been an advocate for early treatment of venous diseases for the last two decades. I have seen how hard it is to heal venous ulcers, so why shouldn’t we work hard to treat it before it reaches that stage? The EVRA trial will help early referrals from GPs. Also, practice guidelines

How do you prefer to spend your time outside of work?

I solve crosswords, shoot hoops on a basketball court, listen to rock, Bollywood, classical, world and Australian Aborigine music to relax. I am a cricket fanatic. I am learning to paint in the Australian Aboriginal Art form. I also enjoy travelling and trekking with my family, experiencing nature, architecture and culture of different worlds.

Current appointment

Adjunct Professor, Faculty of Science, Health, Education and Engineering, University of the Sunshine Coast, Sippy Downs, Queensland, Australia

Other current appointments

2017–present Consultant Vascular & Endovascular Surgeon, Buderim Private Hospital, Buderim, Sunshine Coast, Australia 2017–present Director, Pacific Coast Vascular, Sunshine Coast, Australia 2017–present Consultant Vascular & Endovascular Surgeon, Friendly Society Private Hospital, Bundaberg, Australia 2015–present Emeritus Consultant of Vascular & Endovascular Surgery, Narayana Hrudayalaya Hospitals, Bangalore, India

Visiting professorships (selected)

2017 Stanford University, San Francisco, California, USA 2017 Nassau University Hospital, Long Island, New York, USA 2017 Karolinska University Hospital, Stockholm, Sweden.

2016 University of British Columbia, Vancouver, Canada 2015 University of Lisbon, Portugal 2015 University of Cologne, Germany 2014 Division of Vascular Surgery, Mayo Clinic, Rochester, USA 2014 Jawaharlal Institute of Post-graduate Medical Education and Research, Pondicherry, India 2014 Institute of Medical Sciences, Banaras Hindu University, Varanasi, India

Awards and honours (selected)

2018 Honorary Membership, European Venous Forum for Outstanding Contribution to Venous Surgery 2017 Asterios Katsamouris Memorial Lecture,

European Society for Cardiovascular and

Endovascular Surgery 2017 Sigma Xi, Scientific Research Honor Society, USA 2015 Emeritus Consultant status, Narayana

Hrudayalaya Hospitals, Bangalore, India 2014 Distinguished Fellow, Society for Vascular

Surgery, USA

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Venous stenting

Worse outcomes in peripartum compared to non-pregnant women stented for DVT Peripartum women with deep vein thrombosis (DVT) treated with catheter-directed thrombolysis and venous stenting had significantly increased rates of reintervention and loss of stent patency compared with non-pregnant women treated at the same centre.

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atalin Lestak (St Thomas’ Hospital, London, UK) presented the outcomes from a database of patients treated at St Thomas’ Hospital at the European Society for Vascular Surgery (ESVS) annual meeting (25–28 September, Valencia, Spain).

Lestak pointed out that acute iliofemoral DVT affects around 100,000 people in the UK alone and 42% will go on to develop postthrombotic syndrome. As it stands, maternal DVT is one of the leading causes of direct mortality and morbidity in pregnant women. The current management of maternal DVT is primarily with conservative methods, but trials have shown the benefit of early clot removal and catheter-directed thrombolysis with or without stenting reducing the amount of post-thrombotic syndrome. However, pregnant women have been excluded from these trials due to the procedural risk of maternal and foetal complication.

In lieu of this, the team at St Thomas’ Hospital wanted to examine

the outcomes of peripartum women with acute iliofemoral DVT presenting to their centre who have undergone catheter-directed thrombolysis and venous stenting. They performed a retrospective review of peripartum women from a database on 190 patients treated for acute iliofemoral DVT from 2012–2017. In the study, peripartum was defined as within pregnancy or up to and including six weeks post birth.

Stent patency was assessed by duplex ultrasonography at one day, two weeks, six weeks, three months, one year and annually postintervention. It was defined as <50% reduction in stent diameter.

The results were compared to non-pregnant women from the same database. The researchers found nine peripartum women treated for acute iliofemoral DVT. Of those nine, two were treated with catheterdirected thrombolysis alone and seven were treated with catheter-directed thrombolysis and venous stenting.

Lestak reported that all patients

were in the peripartum with an average of four weeks post-birth. “This reflects the maximum risk time for maternal venous thromboembolism, which is zero to six weeks postbirth, where 50% of maternal venous thromboembolism occurs. No patients had any history of venous thromboembolism or thrombophilia and none were on any anti-coagulation.

Importantly, management by this method did not lead to any major or minor post-operative complications, including haemorrhage or other bleeding. Our rate of post-thrombotic syndrome was 14% at six-month follow-up,” she explained.

Another important and novel finding from the study, Lestak added, came when looking at cumulative rates of patency and reintervention, when substantial differences were noted between peripartum women and their non-pregnant counterparts. “When compared, peripartum women were significantly more likely to suffer loss of patency generally occurring early on, at around eight weeks post-stenting.

This then followed through into rates of reintervention, where the peripartum state once again proved to be correlated to the need for further operative management,” she emphasised.

Lestak maintained that one potential explanation for these results is the hyper coagulable post thrombotic state of pregnancy, which contributes to the increased risk of thrombus formation and therefore blocking these patients’ stents.

This study has some limitations, including its retrospective nature and small sample size. Further, all of the patients were post-partum, and the results therefore cannot be extrapolated to the period before birth.

Concluding, Lestak said that this study found that peripartum women are significantly more likely to require reintervention and experience stent patency loss compared to their nonpregnant counterparts.

“Although symptomatically these women do well, higher thresholds for intervention may need to be considered, as well as more tailored case by case management of those patients undergoing catheterdirected thrombolysis and stenting in pregnancy,” she stated.

Intraluminal narrowing as a predicting factor for stent occlusion A recent study which set out to investigate the usefulness of duplex ultrasound in monitoring stent changes over time, concludes that stent occlusion is related to the reduction of stent lumen over time—rather than the percent of the stenosis. Investigators further found a discrepancy between the diameter of the stent lumen in vitro versus after deployment.

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he study was presented at the European Society for Vascular Surgery annual meeting (ESVS; 25–28 September, Valencia, Spain) by Mohammad Esmaeil Barbati (University Hospital RWTH Aachen, Aachen, Germany). The results have also been published in Phlebology.

Barbati, along with co-investigator Houman Jalaie and colleagues, retrospectively reviewed duplex ultrasound images of patients treated with venous angioplasty and stenting, from June 2012 to December 2016, enrolling 121 patients (38.8% male, mean age 40.6 years). In this cohort, 137 limbs were treated with 210 stents for acute or chronic, occlusive or nonocclusive iliofemoral disease.

Of all used stents, the authors note, 86.2% (181) were dedicated venous stents, while 13.8% (29) were nondedicated venous stents.

“The endovascular and surgical procedures were performed without perioperative or postoperative (<30 days) mortality,” Barbati et al write, adding “there were no major bleeding, cardiac, pulmonary, or renal 30-day complications”.

In reviewing data from the

Mohammad Esmaeil Barbati

first follow-up after endovenous recanalisation, a decrease in stent area compared to the nominal stent area was observed in all patients.

Barbati et al suggest this discrepancy “reveals the high compression force of adjacent organs as well as constricting tension of intraluminal fibrosis in diseased veins and its walls which hamper the stent from expanding to its predesigned nominal size. It also emphasises the role and necessity of high radial resistive forces in venous

Houman Jalaie

stents to avoid collapsing the vein walls.”

Furthermore, their findings showed that at last follow-up or before the end of primary patency, the decrease of intraluminal area was seen to be a mean of 36.52%. They explained that stent occlusion appeared to be related to the slow narrowing of the stent lumen over time more than to any other factors (OR: 0.910; 95% CI: 0.832–0.997; p=0.042).

While concluding that duplex ultrasound is an “adequate and feasible method to evaluate stent geometry and patency”, the authors point out that the optimal assessment of in-stent changes would be to use intravascular ultrasound (IVUS), particularly to measure wall thickness, total stenosis area and any potential vessel remodelling—however, “cost and logistics prevents regular use of IVUS as a diagnostic tool in every follow-up”.

Moreover, the findings of the duplex ultrasound scans suggest that stent occlusion appears to be related to reduction of stent lumen over time, “rather than the pure percent of the stenosis”, with constant intraluminal narrowing identified as a predictor of occlusion in the stent.

The authors maintain, “[These data] express the necessity of thorough follow-ups, accompanied by measuring the diameter of stent lumen using duplex ultrasound in a timely manner. As a result, preventive reintervention should be considered in patients with clinical symptoms and persisting reduction of stent lumen even before reaching critical stenosis.”

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Lower stent patency with higher reintervention rates found in combined profundal and femoropopliteal vessel disease patients A recent study finds that combined disease in the profunda and femoropopliteal veins of patients with post-thrombotic syndrome is “common”, with a higher risk of reintervention and loss of stent patency. Adam Gwozdz of St Thomas’ Hospital in London, UK, presented the data at the European Society for Vascular Surgery 32nd annual meeting (ESVS; 24–28 September, Valencia, Spain). The results point to the importance of pre-operative identification, the increased risk for patients with disease in all three veins, and the impact of inflow vessel quality on maintaining cumulative stent patency.

“W

e know that Iliofemoral stent patency in postthrombotic limbs is inferior compared with limbs in non-thrombotic venous obstruction,” Gwozdz said, “and those with occlusion have the lowest longterm patency rates—this is likely due to frequent concomitant obstructive disease in the profundal and femoropopliteal veins, resulting in decreased inflow into the stent system. However, there is no gold standard metric by which to measure inflow, making assessment prior to stenting difficult.”

The aims of the study, Gwozdz noted, were therefore to examine whether decreased inflow to the stent, caused by intraluminal Adam Gwozdz obstructive disease, was associated with either a greater risk of reintervention or with inferior long-term patency outcomes.

Gwozdz and colleagues designed a retrospective review with data from a prospectively maintained database. Included patients had received a dedicated nitinol venous stent for post-thrombotic disease between 2012 and 2017 (n=164). Preoperative ultrasound was used to identify intraluminal scarring and/or residual thrombosis in the femoral vein, profunda vein, and/or popliteal vein. The data was then categorised into three distinct patient groups: those with no disease (52; 32%), those with disease in a single inflow vessel (20; 12%), and those with disease in more than one inflow vessel (92; 56%).

Stent patency was assessed according to the standard surveillance schedule at the hospital, namely with duplex ultrasonography at one day, two weeks, six weeks, three months, six months, one year and then annually. Gowzdz further explained that “reinterventions were triggered when stent diameter reduction was more than 50%, or the stent was occluded.”

The reintervention rate for the three groups identified in this study were 21% (11) for patients with no inflow disease, 30% (6) for those with single inflow vessel disease and 55% (51) for patients with combined inflow disease. Performing a Kaplan-Meier analysis on the reintervention rate in this three groups at one year post intervention, the investigators saw a significant increase with increasing inflow vessel disease, “suggesting that more inflow vessels are diseased, the greater the risk of reintervention.” Looking more closely at the group that had the highest reintervention rates, Gwozdz and colleagues examined the pattern of vessel disease and found that those with triple vessel disease (25 patients) had the highest reintervention rates, at 64% (16) of the patient sub group. A Kaplan-Meier analysis and Log Rank test further revealed that while the patency rate at 12 months was 97% for patients with absent inflow vessel disease, this dropped to 78% for the high-risk group with triple concomitant vessel disease (p=0.006).

This type of combined disease in patients with post-thrombotic syndrome is common Gwozdz said, reiterating, “we see it in over half of our patients.” He noted that preoperative identification is important, and that maintaining cumulative stent patency is “influenced by the quality of inflow vessels”. He added, “high-risk patients—defined as patients with triple vessel disease—should be counselled on their increased risk of reintervention and patency loss.”

To address the needs of this high-risk patient group, Gwozdz concluded that a formal evaluation tool for inflow vessel disease “would go a long way to enhance the treatment pathway.”

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Interview

Legs Matter campaign aims to prevent and improve treatment of leg ulcers in the UK The Legs Matter campaign is an initiative driven by a coalition of multiple UK healthcare charities and non-profit organisations. Venous News speaks to Leanne Atkin (University of Huddersfield, UK), who is leading the campaign.

What is the current state of leg ulcer treatment, with associated costs and impact on quality of life in the UK?

Leg ulcers are at least four times more prevalent than pressure ulcers1 but receive much less attention.

It is estimated that 730,000 patients across the UK are currently suffering from lower limb ulceration.

There are known unwanted variations in care which lead to extended healing times, and results in increased patient suffering and unnecessary spending. Reported healing rates for venous leg ulcers in community settings are as little as 47% at 12 months,2 which is far from the healing rates which have been reported in many randomised control trials.3,4,5 The NHS needs to better understand the barriers faced by patients in receiving high quality care when they have a lower limb ulcer, and needs to actively strive to ensure equitability services are commissioned nationally, which are linked to the best evidence/guidelines to eliminate these unwanted variations in care and outcomes.

What are the key goals of the Legs Matter initiative?

Inspired by the “Stop the pressure” campaign, the Legs Matter campaign was launched on 25 April 2018 to promote good quality care of the lower leg in the UK. The campaign seeks to raise awareness and understanding of conditions of the lower leg and foot to ensure timely and effective care. In particular, it seeks to make the public more aware of conditions of the lower leg and foot, the importance of seeking out the right treatment in a timely manner and what care they have the right to expect from healthcare professionals. The campaign also aims to educate generalist healthcare professionals on the signs, seriousness and implications of lower leg and foot conditions together with the importance of considering the lower leg and foot when assessing and treating patients.

The Legs Matter campaign is being delivered by a coalition led by the Tissue Viability Society (TVS), and includes: Society of Vascular Nurses (SVN), Lindsay Leg Club Foundation, Foot in Diabetes UK (FDUK), British Lymphology Society (BLS), Accelerate CIC, The Leg Ulcer Forum (LUF).

Together, the coalition has developed a website

that offers high quality unbiased information for patients and clinicians. The website has been developed with patient and public involvement and covers a wide range of common conditions that affect the lower leg and foot. It provides evidenceinformed information and signposts to other robust and trustworthy sources of information. We hope that the Legs Matter campaign will resonate with the public and healthcare professionals who share our vision to increase awareness of lower limb conditions to reshape and improve care together.

What has Legs Matter achieved since its inception and what are the ongoing projects at the moment?

We have created a website which we hope will be the “turn to” information site for patients and one which healthcare professionals direct their patients to. The website has been developed by the coalition members with the direct involvement of three patient experts, who have now joined the board to ensure we have true patient involvement. We are all committed to ensuring that the patients have equal voice on the board, as we recognise this website is for them, so in fact they are the experts.

Regular patients have been let down by the service they have received, often resulting in delayed referrals to vascular centres and lack of evidence base care.

What can medical practitioners do to get involved with Legs Matter?

The Legs Matter campaign is ultimately a patients’ awareness campaign, so no matter what your profession or role, we would love for anyone to help share our messages by directing patients to a resource where they can learn more about their condition, read accurate information and understand better their own conditions. Additionally, in the next few months we will be creating new web pages on the site where patients will be able to gain hints and tips and living with their condition, about what to expect and how to cope with the changes in their lifestyle—these pages are being written by our patient members. We have sent out over 200 information packs to nurses, clinics and GP services, these include posters for waiting rooms and business cards to give to patients with details of the website.

These are free to all—just contact us via our website to receive an information pack.

How can the involvement of medical practitioners make a difference?

Image courtesy of Legs Matter

Leanne Atkin

Every professional in the field of lower limb conditions appreciates that regular patients have been let down by the service they have received, often resulting in delayed referrals to vascular centres and lack of evidence base care. There is

variation in commissioning and service set up nationally. We need to ensure that all patients are empowered in relation to recognising what is good quality care and what should happen if they have a venous ulcer. This will enable them to identify if the care they are receiving is not appropriate, signposting them on how to change this. This is something that no matter what your profession we all appreciate the need to address, ensuring that all patients suffering is minimised by appropriate management linked to best evidence, by supporting this campaign through raising its awareness you will be helping to inform and empower patients with the hope that a strong patient voice will ensure care is timely, appropriate and effective.

References 1. Guest JF, Ayoub N, McIlwraith T, et al. Health economic burden that wounds impose on the National Health Service in the UK. BMJ Open [Internet]. 2015 December 1, 2015; 5(12). Available from: http:// bmjopen.bmj.com/content/5/12/e009283.abstract.

2. Guest JF, Ayoub N, McIlwraith T, et al. 2017a. Health economic burden that different wound types impose on the UK’s National Health Service.

International Wound Journal, 14, 322-330.

3. F ranks P, Mccullagh L, Moffatt C. 2003. Assessing quality of life in patients with chronic leg ulceration using the Medical Outcomes Short Form-36 questionnaireOstomy Wound Manage 2003; 49(2):26–37.

Ostomy and Wound Management, 49, 26-37.

4. A shby R L, Gabe R, Ali S, Adderley U. 2014. Clinical and costeffectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): A randomised controlled trial. The Lancet (British edition), 383, 871-879.

5. M offatt C, Mccullagh L, O’Connor T. 2003. Randomized trial of four-layer and two-layer bandage systems in the management of chronic venous ulceration. Wound Repair and Regeneration, 11, 166-71.

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Thrombectomy

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Mechanical aspiration thrombectomy as an effective for treatment of acute massive or submassive pulmonary embolism A recent effectiveness study concluded that mechanical aspiration in both massive and submassive pulmonary embolism led to a significant disappearance of clinical symptoms and improved echocardiographic values. The findings were presented by Juan CiampiDopazo, Complejo Hospitalario de Toledo, Toledo, Spain, at the Cardiovascular and Interventional Radiology Society of Europe annual meeting (CIRSE; 22–25 September, Lisbon, Portugal).

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iampi-Dopazo and colleagues carried out a prospective study, consecutively analysing 33 patients (42.4% men, mean-age 60.7 years) with either massive or submassive pulmonary thromboembolism treated by mechanical aspiration thrombectomy using the INDIGO (Penumbra) 115cm 8F catheter. All patients presented with symptoms within seven days of onset of acute pulmonary embolism and had CT findings compatible with proximal pulmonary embolism.

Ciampi-Dopazo pointed to the specifics of the procedure, noting that the Indigo catheter was first placed inside the thrombus. Following this, a direct aspiration first-pass technique was performed, aiming to attach a large thombus to the catheter

tip by suction. A separator wire was repeatedly passed through the thrombus to break it up and allow it to be suctioned through the catheter.

Ciampi-Dopazo also acknowledged that occasionally, a 100cm C2 catheter was used (with a 0.035” stiff hydrophilic guide wire) to facilitate access to the lobar arteries. The procedure was terminated when the physician considered that the thrombus had been reduced by around 60–70%.

Technical success was defined as successful placement of the device and initiation of aspiration thrombectomy.

Clinical success was defined as stabilisation of haemodynamic parameters; improvement in pulmonary hypertension, right-sided heart strain, or both; and survival to hospital discharge, while complications were

also analysed. Following completion of mechanical thrombectomy, all patients resumed therapeutic parenteral anticoagulation.

Statistically significant improvements were observed for the echocardiographic measurements, including the right ventricle size, tricuspid annular plane systolic excursion and the systolic wave.

Furthermore, the significant change in Pa02/Fi02 (the ratio of arterial oxygen partial pressure to fraction of inspired oxygen) before and after pulmonary thrombectomy indicated an improvement in respiratory compromise in the cohort of patients (201.13±141.26 vs. 316.67±88.31; p=0.001; respectively). Seven (21.2%) patients died; three during the thrombectomy procedure, while

intracranial bleeding occurred in a following three patients.

Additional findings included that thrombus volume reduction of more than 80% occurred in 21 (63.63%) of the patients. Hospital stay reached beyond 14 days for 12 (38.7%) of the patients, while a follow-up period of over 100 days occurred for 14 (41.7%) patients The results of the study led the investigators to conclude that mechanical aspiration in both massive and submassive pulmonary embolism leads to a significant disappearance of clinical symptoms, and therefore offers a feasible option for the treatment of pulmonary embolism in patients with haemodynamic compromise or right ventricular dysfunction.

Thrombectomy system found to be “safe, effective and efficient” for the treatment of acute deep vein thrombosis

The Jeti-8 device, a Walk Vascular thrombectomy system, reportedly appears to be safe, effective and efficient for the treatment of acute deep vein thrombosis (DVT), having displayed both high technical and procedural success. Jean Cournoyer-Rodrigue, Centre Hospitalier de l’Université de Montréal, Montreal, Canada, presented these data at the Cadiovascular and Interventional Radiological Society of Europe annual meeting (CIRSE; 22–25 September, Lisbon, Portugal).

REPORTING THAT 20–50% of people suffer from post-thrombotic syndrome after their first episode of DVT, Cournoyer-Rodrigue stated: “DVT is a major healthcare issue in our society.” He noted that while current treatment options include thrombolysis and pharmacomechanical thrombectomy, both require overnight thrombolysis in an intensive care unit and can result in an increased length of stay as well as increased cost. For this reason, he argued that there is a “serious need” for a thrombectomy device that is fast and effective and that will allow for “in-and-out treatment”.

Cournoyer-Rodrigue and colleagues therefore aimed to evaluate the safety and efficacy of the Jeti device in the treatment of acute DVT. According to Cournoyer-Rodrigue, the device has been approved by the FDA since October 2016 and (to date) although one study has been published in relation to its use in coronary occlusion, no study has been carried out with regards to the treatment of DVT. Touching upon the characteristics of the Jeti device, Cournoyer-Rodrigue said that the 8F 100cm long over-the-wire catheter can accommodate a 0.014”–0.035” guidewire. The device consists of an aspiration catheter, and uses high-pressurised saline jets at the tip of the catheter, that pulverise the thrombus, helping to prevent clogging and allowing for continuous vacuum aspiration. The current instructions for use suggest it is only indicated for vessel diameter between 4–8mm.

The investigators carried out a retrospective study between November 2016 and July 2018; inclusive

of 23 sessions in 20 consecutive patients. Technical success was defined as successful restoration of antegrade flow with elimination of any obstructing lesion without overnight catheter-directed thrombolysis, whereas procedural success was defined as technical success with overnight catheterdirected thrombolysis.

The sample consisted of 11 males and 12 females (mean age: 35±17 years). Regarding the site of DVT, 10 cases were iliofemoral, nine were acillosubclavian, two were portal vein and a further two were pulmonary artery sites. Mean symptom duration before thrombectomy was 3.4±2.2 days.

The thrombus was laced with 9.3±2.2mg of r-tPa in 21 procedures prior to percutaneous catheter thrombectomy. Mean procedure time was 73±32 minutes and mean thrombus removal with the Jeti device was 89%±18%. Percutaneous catheter thrombectomy was found to be technically successful with the device alone in 19 (83%) procedures, while subsequent catheter thrombolysis was necessary for four procedures—after which the technical success rate was 100%.

In relation to any complications, no minor or major adverse event related to the device, as well as no cases of haemoglobinuria were reported. However, mean blood loss was 526±246mL. Recurrent thrombosis was observed in four patients, three of which were successfully treated with the device.

Discussing the aforementioned technical results, Cournoyer-Rodrigue noted that in comparison with the current literature, the Jeti-8 shows similar

thrombus reduction compared to the Angiojet (Boston Scientific). Additionally, when compared to two major studies (examining the Angiojet alone for treatment of DVT, including the PEARL Registry), it became clear that the distribution of the clot removal grade was very similar between the three studies.

The range of procedural time for the device (20–160 minutes) was also very similar when compared to other commonly used devices, including the Angiojet (36–145 minutes) and the Trellis (25–185 minutes; Covidien).

For these reasons, Cournoyer-Rodrigue stated that: “The Jeti-8 shows many advantages including a high technical success, no haemolysis, no time limitation of usage, contrary to the Angiojet, and few overnight catheter-directed thrombolysis”. The only inconvenient factor that Cournoyer-Rodrigue pointed to was blood loss, which he said was associated with the aspiration mechanism.

He acknowledged certain caveats of the study, including the small sample size, the retrospective approach of the design, as well as the lack of systematic follow-up. However, he attributed the latter limitation to the fact that the study was designed as a technical study, not specifically a clinical study.

Irrespective of this, Cournoyer-Rodrigue concluded that due to the lack of complications as well as no haemolysis, high technical and procedural success and quick thrombectomy—allowing for “in-andout treatment”, the Jeti device is safe, effective and efficient for the treatment of acute DVT.

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Creation of percutaneous neo-valves is technically feasible

At the 2018 Transcatheter Cardiovascular Therapeutics (TCT) meeting (21–25 September, San Diego, USA), Ramon L Varcoe (Prince of Wales Hospital, University of New South Wales, Sydney, Australia) outlined the initial experience with a new endovenous approach for managing deep being reflux—the BlueLeaf system (InterVene), which is designed to percutaneous create new valves.

He described a case in which a 58-year-old woman with comprehensive classification system for chronic venous disorders (CEAP) 4 disease with pain in varicosities, axialised deep vein reflux, and who failed on conservative therapy underwent endovenous valve formation with the BlueLeaf system. At 30 days after the procedure, the woman did not have occlusive deep vein thrombosis, had a four-point reduction in revised Venous Clinical Severity Score (rVCSS), and there was a trend towards improvement in her modified Villalta and VEINS-QOL scores. Varcoe noted that the case showed that “creation of percutaneous neo-valves is technically feasible”, adding that the INFINITE first-in-human trial of the system was ongoing and early safety and efficacy results would be available in February 2019.

Progress made in venous ulcer drug trial The final patient in a phase 2 trial of VF00102 (Factor 2 Therapeutics), which is being evaluated for the venous leg ulcer healing, has completed their treatment in the USA. A press release reports that the completion occurred slightly ahead of schedule and

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Innovations

that Factor 2 Therapeutics is now moving ahead with final quality checks and database analysis before the expected release of top-line results in mid-November 2018. Ros Wilson, CEO of Factor Therapeutics, says: “This completion means we are now only a few weeks away from readout. In the meantime, our partnering discussions and preparations for regulatory interactions in Europe and the USA next year are continuing.”

Supplement shown to reduce risk of post-thrombotic syndrome and recurrent thrombosis A study published in Minerva Cardioangiologica indicates that French maritime pine bark extract (Pycnogenol, Horphag Research) is associated with a significant reduction in the risk of postthrombotic syndrome and recurrent thrombosis.

The study evaluated five groups of patients (815 overall) who were at risk of post-thrombosis or recurrent thrombosis for six years following a thrombotic event. The groups included a control group, an aspirin group, a ticlopidine group, a sulodexide group and a Pycnogenol group. The aim was to determine the efficacy of these treatment options for reducing occurrence of post-thrombotic syndrome and recurrent thrombosis. All study participants followed a standard management routine including the use of antithrombotic stockings, a weight control regimen and regular exercise.

According to a press release, the study showed that patients who received Pycnogenol had a significantly lower incidence of recurrent

thrombosis compared with the control group (5.8% vs. 17.2%, respectively) and a reduced occurrence of post-thrombotic syndrome (6.5% vs. 19.8%) Overall, the press release notes, the Pycnogenol group had the lowest occurrence of thrombotic events compared with other test groups.

Steven Lamm (NYU Langone, New York, USA), comments: “This research shows that Pycnogenol can significantly reduce the risk of post-thrombotic syndrome and recurrent thrombosis more effectively than aspirin, which is particularly good for people who suffer from aspirin intolerance.”

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The aim of each report is to give an overview of the key information affecting the medical device industry, enabling those working in the industry to keep abreast of the latest developments and make knowledgeable decisions.

For more information about BIBA Briefings or BIBA MedTech Insights, please contact Laura James laura@bibamedical.com

Nov

Issue

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Endovenous ablation

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Infrequent thrombotic events found after thermal ablation Thrombotic events occur infrequently following great saphenous vein (GSV) endovenous thermal ablation, according to a recent systematic review published in the European Journal of Vascular and Endovascular Surgery. Nonetheless, Donagh A Healy and colleagues from the University Hospital Limerick in Limerick, Ireland, emphasised the need for future studies to report on thrombotic complications and their clinical burden, given that the current “endovenous revolution” has been firmly established.

HEALY AND COLLEAGUES acknowledged that there has been an accelerated growth in the use of endovenous thermal ablation of varicose veins, with NICE (the National Institute for Health and Care Excellence) recommending endovenous thermal ablation as the preferred treatment option for symptomatic varicose veins back in 2013. However, this treatment modality causes heat-induced vessel wall injury with thrombotic and fibrotic occlusion and has led to concerns in relation to potential venous thromboembolism.

Furthermore, the routine use of duplex surveillance has resulted in the description of a new form of localised post-operative deep vein thrombosis (DVT): endovenous heat-induced thrombosis. Referring to the extension of the thrombus from the ablated superficial vein into the deep vein, this heat-induced thrombosis has been sub-categorised into four types dependent on the level of thrombus extension.

According to Healy and colleagues, a large number of endovenous thermal ablation procedures take place worldwide. For this reason, they emphasised the importance in that healthcare providers appreciate the true rate of venous thromboembolism complications.

The investigators therefore carried out a systematic review and meta-analysis of the incidence of venous thromboembolism complications following GSV endovenous thermal ablation; aiming to provide information that can help to guide decision making for individual patients, and may “streamline research on methods of venous thromboembolism prevention.”

Healy and colleagues strategically searched MEDLINE, Embase and conference abstracts between April 2017 and February 2018. Eligible studies included randomised controlled trials (RCTs) or case series that included at least

Donagh A Healy

100 patients who underwent GSV endovascular thermal ablation (laser ablation or radiofrequency ablation) with duplex ultrasound within 30 days of the procedure.

The systematic review focused on the complications of endovenous heat induced thrombosis, DVT and pulmonary embolism. The primary outcome for the meta-analysis was deep venous thrombotic events, defined as either DVT or endovenous heat-induced thrombosis Type 2, 3, or 4.

Secondary outcomes for the meta-analysis were endovenous heat-induced thrombosis Type 2, 3, or 4, DVT and pulmonary embolism. Additionally, subgroup analyses were performed for both the radiofrequency ablation and endovenous laser ablation groups. Proportion metaanalyses using random effects modelling were used to determine pooled proportions for the mentioned outcomes.

Fifty-two studies (16,398 patients, mean age range: 38–61 years) were included, comprised of five single-centre RCTs, five multicentre RCTs, one cluster RCT, 16 prospective single-centre case series, two prospective multicentre case series and 23 retrospective single-centre case series.

Product News BTG acquires Novate Medical

BTG has announced it has acquired Novate Medical, a medical device company focused on the prevention of pulmonary embolism in patients at high risk of venous thromboembolic events.

Novate has developed Sentry, the first bioconvertible inferior vena cava filter, which has recently been granted 510(k) regulatory clearance in the USA. Sentry’s 12 month clinical trial data demonstrated no new symptomatic pulmonary embolism and no evidence of device migration, tilt, fracture, perforation or embolization, complications which have been associated with some other inferior vena cava filters.

The unique bioconversion feature eliminates the need for an additional interventional procedure to retrieve the device.

BTG plans to launch Sentry in the US in the second half of FY2018/19 and will sell the device through its existing vascular sales force.

“This bolt-on acquisition further enhances BTG’s strength in the vascular space.” said Louise Makin, BTG’s CEO. “Novate’s unique inferior vena cava filter offers our existing customers a highly complementary product in the management

of pulmonary embolism.”

BTG paid US$20m in cash to acquire Novate and may be required to pay additional cash considerations up to US$130m if certain commercial and salesrelated milestones are met.

Positive preliminary results from trial of first non-invasive approach to treat varicose veins presented at German Society of Phlebology meeting

Theraclion has announced that Alfred Obermayer, principal investigator of the varicose vein treatment clinical trial in Austria, presented preliminary results at the Congress of the German Society of Phlebology in Bielefeld, attended by around 1,200 participants. The study aims to assess echotherapy for this new indication in terms of feasibility, efficacy and tolerability.

“With around 500 000 vein procedures (stripping, endovenous, and scerotherapy) performed annually, Germany is the biggest market in Europe.

It also is the market where endovenous procedures are the most penetrated and covered by the health insurance companies,” says Anja Kleber, vice

Thrombotic complications were found to have occurred infrequently. Twenty-five studies (inclusive of 10,012 patients; 274 events) reported that deep venous thrombotic events occurred in 1.7% of cases (95% CI: 0.9, 2.7%). A further 26 studies (10,225 patients; 249 events) found that endovenous heat-induced thrombosis Type 2, 3, or 4 occurred in 1.4% of cases (95% CI: 0.8, 2.3%). Additionally, 48 studies (15,676 patients; 48 events) yielded DVT event rate of 0.5%, while pulmonary embolism occurred in 0.1% of cases (95% CI: 0.1, 0.2%) in a further 29 studies (8223 patients; three events) The investigators also observed that similar results were found when radiofrequency and endovenous laser ablation groups were analysed separately.

Discussing the data, the authors write: “This is the largest systematic review on the topic to date and the results are timely given that chronic venous disease is highly prevalent [as well as] the enormous growth of the use of endovenous thermal ablation.”

However, Healy and colleagues point to the principal limitation of the review being the notable amount of clinical heterogeneity among the studies. Yet, the investigators said that this particular drawback only emphasised the need for improved quality of reporting in future studies to improve comparability.

In light of the findings, the authors concluded that thrombotic events occur infrequently following GSV endovenous thermal ablation. Given the large numbers of procedures worldwide and the potential for serious consequences, the authors also reiterated the need for prospective registries in order to quantify and qualify the burden of these complications and further inform the management of these thrombotic complications.

president Marketing & Market Access.

“This is why Echopulse’s first scientific varicose vein treatment presentation was unveiled in Germany.”

Three-month follow-up data were presented from cases targeting greater saphenous veins, accessory saphenous veins, perforator veins, recurrences (after surgery, foam therapy and endovenous methods) and refluxing stumps. The cases were feasible, no adjunctive methods of any kind were used during the study. No significant side effects were observed and no antithrombotic or anticoagulant drugs were administered.

“This new technique is the first non-invasive approach in the veins domain. Heat deposited for occluding an insufficient vein is transmitted percutaneously via high intensity focused ultrasound (HIFU). This means: no incision, no sterile field needed and the possibility to treat severe conditions—such as ulcers. The precision of the heat deposition allows treatment of very tortuous structures or recurrences that are difficult to treat surgically,” says Alfred Obermayer, principal investigator and surgeon at St Joseph Hospital in Vienna. “Taking into consideration my past experience with surgery, radiofrequency, laser and foam sclerotherapy approaches in this indication, I am extremely impressed by this new treatment approach which

is globally very promising.”

“We are very satisfied with these early results in the first ever human study on veins with HIFU,“ says Michel Nuta, vice president, Veins, Theraclion. “This is the next era in the therapeutic domain for veins. Some spectacular results were observed in patients with a long medical history and poor results with previous treatments using other methods. The trial confirmed that our experience very accurately deposits heat in thousands of thyroid and breast fibroadenoma patients is reproducible in veins.”

“This is the first podium presentation in one of Europe’s largest vascular veins congress and the first after completing our registration study. Feedback from Dr Obermayer and his peers throughout the world make us confident that our technology will revolutionise the treatment of varicose veins. The noninvasive capability of echotherapy to treat tortuous structures, treat severe trophic cases and reoccurrences with an image-guided robotic device is a quantum leap forward compared to current therapeutic offerings. We aim to submit a dossier for both CE marking and FDA approval by the end of 2018.

We will then aim at proposing this solution to key sites in Germany as this is our European showcase for thyroid and breast today,” says David Caumartin, CEO of Theraclion.

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Calendar of events 4–5 November

The VEINS Las Vegas, USA W vivaphysicians.org 7–9 November

EVF HOW Plus Venous Stenting and Thrombolysis Training Day London, UK W evfvip.com 8–11 November

ACP: American College of Phlebology annual meeting Nashville, USA W phlebology.org 23–24 November

EVF HOW Plus Venous Sclerotherapy & Phlebectomy Course Thun, Switzerland W evfvip.com 30 November–1 December

ISVI: 7th International Symposium on Venous Interventions Cracow, Poland W venousinterventions.com.pl

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Events

22–25 January

27–29 March

23–25 January

5–7 April

LINC: Leipzig Interventional Course Leipzig, Germany W linc2019.com vWINter Days Meeting Cortina d’Ampezzo Italian Alps, Italy W vwinfoundation.com/vwintermeeting/ 19–22 February

AVF: American Venous Forum Annual Meeting Rancho Mirage, USA W veinforum.org 10–12 March

EVC: European Vascular Course Maastricht, the Netherlands W vascular-course.com/ 12–13 March

LINC Asia-Pacific Hong Kong W linc-around-the-world.com

SITE: International Symposium of Endovascular Therapeutics Barcelona, Spain W sitesymposium.com Venous Symposium New York, USA W venous-symposium.com 15–18 April

Charing Cross Symposium (CX) London, UK W cxsymposium.com 25–27 April

IVC: International Vein Course Miami Beach, USA W ivcmiami.com 17–19 June

Royal Society of Medicine Venous Forum London, UK W rsm.ac.uk/venous-forum

12–15 June

SVS Vascular Annual Meeting National Harbor, Maryland, USA W vascular.org 27–28 June

BSET: British Society of Endovascular Therapy annual meeting Wotton-under-Edge, UK W bset.co.uk 27–29 June

EVF: European Venous Forum Annual Meeting Zurich, Switzerland W europeanvenousforum.org

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ANGIOJET™ ZELANTEDVT™ Thrombectomy Catheter

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Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Indications, operating specifications and availability may vary by country.

Check with local product representation and country-specific Information For Use for your country. Illustrations for information purposes - not indicative of actual size or clinical outcome. PSST PI-567901-AA Aug 2018.