Venous News Issue 11 (US)

September 2019 | Issue 11

SUPER trial demonstrates benefits of intermittent pneumatic compression for high-risk VTE patients

Oliver Lyons: Pharmacotherapy for lymphoedema

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Efthymios Avgerinos: SUNSET sPE interim outcomes

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Kurosh Parsi:

Profile

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“Fascinating vision” of noninvasive varicose vein treatment with echotherapy discussed at EVF A new study on the application of intermittent pneumatic compression (IPC) for surgical patients with a high risk of venous thromboembolism (VTE) has revealed that a combination of IPC and standard prophylaxis reduces the incidence of postoperative VTE. These findings differ from those of the PREVENT trial, which concluded that there is no benefit to the use of IPC for those admitted to an intensive care unit.

R

esults of the IPC-SUPER trial conducted by Pirogov Russian National Research Medical University were presented at the European Venous Forum (EVF; 27–29 June, Zurich, Switzerland)

by Kirill Lobastov, who emphasised that IPC achieves a beneficial outcome without increasing rates of leg skin injury or bleeding. He added: “Previously, I have reported that patients with Caprini scores of 11 or more have an extremely high risk of postoperative VTE, and it can be found in about 50% of this kind of patient.”

The aim of the study, as underlined by Lobastov, was to determine both the efficacy and safety of Cardinal Health’s sequential IPC device—the Kendall SCD 700 Series Controller—for the prevention of postoperative

VTE in high-risk patients. With a sample size of 400 participants, who were randomised into either an IPC or control group following major surgery, the two-centre clinical trial had the primary endpoint of asymptomatic deep vein thrombosis (DVT) being revealed by duplex ultrasound.

Patients enrolled in the trial met a range of inclusion criteria, which required all participants to be over the age of 40, present a high risk of postoperative VTE and have Caprini scores of 11 or more. In addition, the exclusion criteria for the trial removed those with acute DVT at baseline, lower limb soft tissue infections and a range of other conditions that would be contraindications to IPC. Continued on page 2

ECHOTHERAPY—also known as high-intensity focused ultrasound—is a recent addition to venous disease treatment options, with a new device applying the technique to treat superficial veins in a non-invasive procedure. Alfred Obermayer (Melk, Austria), who first presented his initial findings at the 2019 Charing Cross Symposium (CX; 15–18 April, London, UK), gave an update to the delegates attending this year’s European Venous Forum (EVF; 27–29 June, Zurich, Switzerland), stating “we have successfully obliterated insufficient veins using high-intensity focused ultrasound, completely extracorporally.”

Obermayer presented the idea behind highintensity focused ultrasound (HIFU), describing it as a “fascinating vision” of procedures without anaesthesia, catheters, incisions, surgical site infections, or scarring. The HIFU system Continued on page 2

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September 2019 | Issue 11

Conference coverage

SUPER trial demonstrates benefits of intermittent pneumatic compression for high-risk VTE patients

“Fascinating vision” of non-invasive varicose vein treatment with echotherapy discussed at EVF

Continued from page 1

Both the IPC and control groups began taking a daily course of 40mg enoxaparin periprocedurally, and wore anti-embolic graduated compression stockings for a duration of one month following their procedure. For the IPC group alone, treatment with the Cardinal Health device and Kendall SCD thigh-length comfort sleeves began periprocedurally just before or after surgery, and was applied round-the-clock in the intensive care unit of two hospitals. As part of the study, each participant received a daily clinical examination throughout the entire period of inpatient treatment, as well as a duplex ultrasound every three to five days to check for silent venous thrombosis.

Lobastov explained how the study continued after inpatient treatment had finished: “We followed up with our patients after one month and six months with a duplex ultrasound, clinical examination or a phone call to make sure they had no symptomatic VTE events.”

In terms of the primary outcome, DVT occurred in just one patient (0.5%) of the IPC group, compared to 34 patients (16.7%) in the control group. There was also a significant difference in secondary outcomes, as venous thromboembolism affected just one patient of the IPC group (0.5%) compared to 35 control patients (17.2%). While more patients in the IPC cohort did develop a leg skin injury, there was only a 5% difference in this outcome with the control group, and four fewer patients treated with intermittent pneumatic compression suffered from bleeding.

Throughout the course of outpatient treatment, no further VTE events were recorded in either group. Lobastov concluded: “Intermittent pneumatic compression in addition to standard prophylaxis allows the reduction of the incidence of postoperative VTE in patients at an extremely high risk without increase in the rates of leg skin injury or bleeding.”

Lobastov also commented on the differences between IPC-SUPER and PREVENT, a trial that involved over 2,000 participants and rejected the potential benefits of IPC. “First of all, in our study we looked at the calf veins of our patients […] In the PREVENT study it was not obligatory to look at the calf veins,” he said.

The PREVENT trial did not include an assessment of Caprini scores either, added Lobastov, who stated “when we made this group analysis, only patients with Caprini scores of 11 or more benefitted from IPC.”

Continued from page 1

(SONOVEIN, Theraclion) received CE mark earlier this year, based on Obermayer and colleagues’ feasibility study. The device design includes a HIFU transducer at 3MHz producing a focal heat deposition of 85°C, as well as an embedded ultrasound at 7.5MHz for visualisation of the target vein, and a single-use membrane and liquid for cooling and coupling which is designed to protect the skin against burns. Following ethical approval for the study in Austria, Obermayer and his colleagues treated 50 legs (62% [31/50] recurrent; 74% [33/50] C4–C6), following patients for three months.

In the discussion that ensued after his presentation of the feasibility study’s initial results, delegates queried whether there was potential to burn the skin or surrounding tissue, asking whether the investigators had experienced any side effects or complications. However, as Obermayer maintained, no significant side effects such as skin changes or skin burns were observed.

“Very mild and transient dysesthesia was reported at early follow-up in four cases,” noted Obermayer, adding there was no occurrence of thrombosis or pulmonary embolism in the study, despite the lack of anticoagulation medication. Indeed, although 66% of patients had local anaesthesia, no sedation or other medication was used in the study. On the topic on anaesthesia, Obermayer explained anecdotally to the audience that one patient participating in the study who had “a lot of tattoos” reportedly compared the pain of the procedure to the pain of receiving a tattoo. Thirty-four per cent of patients in the study elected to undergo the HIFU procedure without any anaesthesia.

One delegate asked, in comparison to lithotripsy devices which can focus on larger areas of 1.5cm, how big the focus of HIFU is. “This is a very technical question,” Obermayer responded, explaining that the area of heat deposition will depend on the method of

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Alfred Obermayer

delivering the energy. “Firstly [with HIFU], the vein must be compressed during the procedure, squeezing it completely flat. This is because the blood flow has an enormous cooling effect. Once the vein is completely compressed, you can set the system to focus only at one static point, or to move slightly within a specific area.

At first, the size of this heat deposition is equivalent to a rice grain. But imagine, if you heat a rice grain for a period of time, the heat will continue to expand to the surrounding area. So of course this will depend on the duration of ultrasound delivery.” Some cases, in which the target vein is too close to the surface of the skin (within 5mm), require some “tricks”, as Obermayer described the use of subcutaneous infiltration to correct the distance between the target of the device focus area and the skin. “The whole procedure is automatic,” he assured, explaining that the system calculates the appropriate positioning of the device in relation to the patient anatomy, and does not allow for use in ways that are likely to cause burns or adverse events.

Outlining the initial results of the feasibility study, Obermayer reported that the procedure had been feasible for all patients selected for the study, with structures treated including recurrences, neovascularisation at the stump, perforators, great saphenous veins and anterior accessory saphenous veins.

Whether or not this technology will revolutionise treatment of varicose veins remains to be seen, but the audience described Obermayer’s presentation of the results and technique as “fascinating” and “fantastic”.

Nevertheless, limitations of the study include the lack of long-term data, and Obermayer expressed a need to continue collecting data to take into account physicians’ learning curves with the new technology.

We have successfully obliterated insufficient veins using HIFU, completely extracorporally.”

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September 2019 | Issue 11

Lymphoedema and vein treatments

Pharmacotherapy for lymphoedema may be on the horizon Oliver Lyons Comment & Analysis Oliver Lyons outlines what is currently known about pharmacotherapy options for lymphoedema, and what to expect from new research in the near future.

THERE ARE MANY drugs available for treating disorders of the blood circulation, but there are none for use in lymphoedema. The lymphatic system is complex and its physiology, for example the mechanisms controlling active lymphatic pumping in vivo, remains less well understood. The scientific challenge in treating primary lymphoedema is enormous. Over 20 different genes may be mutated causing a primary lymphoedema. The resulting anatomical and functional deficits in each disease can be surprisingly different. For example, Milroy’s disease (caused by mutations in FLT4, encoding VEGFR3) leads to a capillary uptake problem on scintigraphy, whilst mutations in the transcription factor FOXC2 most commonly lead to hyperplastic channels and dermal reflux.

Correcting the underlying problem in each of many different genetic diseases may require many different therapies (albeit some may be grouped together).

There have been many historical trials of therapeutic agents for lymphoedema, including over 15 trials assessing the Benzo-pyrones, but without any convincing evidence of clinical benefit, and with concerns around hepatotoxicity.

More recently, researchers at Stanford University (Stanford, USA) have taken a different approach. The chronic interstitial fluid accumulation in lymphoedema leads both to changes in the structure of the skin and also to impaired clearance of inflammatory cells and mediators, with dysregulated regional immune responses.

Adipose tissue deposition and fibrosis lead to progressive anatomic distortion and eventually loss of function in the affected areas. Rather than trying to target the specific defect causing the lymphoedema, scientists have targeted these downstream inflammatory processes by reducing the production of Leukotriene B4, a shortlived inflammatory mediator that at higher concentrations inhibits lymphatic

endothelia. This approach, targeting a “common pathway”, might prove to be helpful in all forms of lymphoedema, and several drugs are known to inhibit the production of Leukotriene B4, including Ketoprofen and the Leukotriene A4 hydrolase inhibitor Ubenimex.

In a small randomised controlled trial in a group of patients with primary or secondary lymphoedema, treatment with Ketoprofen did not reduce lower limb swelling, but did produce improvements in skin histology. Unfortunately after study recruitment was completed, the US Food and Drug Administration (FDA) issued a black box warning for Ketoprofen, and there are concerns about the long-term use of this drug. Whilst this is disappointing, the ability to produce histological improvement in patients with lymphoedema is nevertheless a positive step in the right direction. A further trial is examining Ubenimex, which is more targeted in its action than Ketoprofen; unlike Ketoprofen it does not inhibit Cyclooxygenase 1 or 2. Unfortunately the study sponsor, Eiger BioPharmaceuticals, have released a statement (in October 2018) indicating that the primary endpoint of skin thickness and secondary endpoints of limb volume and bioimpedance have not been met. Full publication of the results of this study is still awaited and it remains unknown whether certain groups of patients might respond better than others to particular treatments.

In comparison to primary lymphoedema, secondary lymphoedema might prove to be an easier target for pharmacotherapy. Whilst there are some genetic polymorphisms (e.g. in GJC2) that may increase a person’s risk of secondary lymphoedema (e.g. after treatment of breast cancer), the lymphatics should more readily respond to stimulation.

The central molecule that directs

US study finds racial disparities in outcomes of superficial vein treatments A US-based multicentre study has found that while chronic venous insufficiency is “primarily observed in white women”, there are other notable differences in the incidence and prevalence of disease severity and outcomes when comparing patients’ racial groups, with African Americans requiring a higher number of superficial vein treatments to achieve good results. Peter J Pappas (Center for Vein Restoration, Greenbelt, USA) presented the findings at the European Venous Forum (EVF; 27–29 June) in Zurich, Switzerland.

“I

nterestingly, if you look at the prevalence of disease by age and by race, most of the studies that have been presented have indicated that with progressive deciles, as you increase in age, the prevalence also increases,” explained Pappas. However, his group found that for some racial groups, prevalence was seen to decrease with age instead. This was observed in African American and Hispanic patients. “To my knowledge,” said Pappas, “this is the first time that the incidence of disease is reported to decrease based upon duration of presentation.” Furthermore, while African American patients needed a higher number of superficial vein treatments and interventions in order to attain the same results as other patient groups, Pappas et al also found that African American patients had the lowest recommendation rates for ablation, ultrasound-guided

foam sclerotherapy and phlebectomy. To explain the low recommendation rates, Pappas pointed to the observation that one third of African American patients presented with C0 disease, which “may be secondary to higher BMIs and an increased incidence of osteoarthritis in this group”.

Pappas also highlighted cultural reasons for certain findings, including the higher rate of C1 disease presented in Hispanic patients, as this group is more likely to seek treatment for spider veins and C1 disease.

The retrospective chart review of prospectively collected data analysed a cohort of 66,621 patients with chronic venous insufficiency across 78 centres in the USA. Patients were divided into five racial groups, including African American, Asian, Hispanic, White, and Other (race not recorded). Each group was further stratified by CEAP class for sub-group analysis. Average

proliferation and migration of lymphatic endothelial cells is vascular endothelial growth factor C (VEGFC), acting through VEGFR3. VEGFC has been used successfully in murine and swine models of secondary lymphoedema. Herantis Pharma (based in Finland) have now taken this forwards in the AdeLE trial, which examines the effect of combining lymph node transfer with adenoviral delivery of VEGFC in women with breast cancer. The Phase 1 results have not raised safety concerns, and efficacy results are anticipated in 2020.

Globally, the most common cause of lymphoedema is infection with filarial worms. In a randomised controlled trial in a single setting (Ghana) assessing the use of Doxycycline for the treatment of filiariasis, it was found that patients’ lymphoedema stage improved regardless of the presence of active infection. This led the authors to suggest that a wider group of patients with lymphoedema might benefit from annual courses of doxycycline. It is, however, too early to recommend routine use of doxycycline in patients with non-filarial lymphoedema, and further research is ongoing.

In summary, great progress is being made in this field, and has been marked by the first pharma-sponsored trial of a drug therapy for lymphoedema, and by the first clinical-stage gene therapy that aims to repair damaged lymphatics.

The development of histological outcome measures (rather than simply limb swelling) is another important step forwards. Further collaborative trials will be needed in order to bring pharmacotherapy for lymphoedema into routine clinical use.

Oliver Lyons is an honorary clinical lecturer in Vascular Surgery at King’s College London, UK.

patient age was 56.8±14.7, with 77% being female and 23% male. Of the total cohort, 17% were African American, 3% were Asian, 18% Hispanic, 55% White and 8% Other.

While incidence of disease was seen to decrease over the time period 2015–2017 for African Americans (20% vs. 15% incidence) as well as Asians (4% vs. 2% incidence), the same remained stable in the Hispanic group over time (18%) and increased for the Other and White categories (7% vs. 9% and 52% vs. 56%, respectively). Regarding prevalence, Pappas noted it was “similar between African Americans and Hispanics—the lowest group that presented with venous disease was Asians, and as expected, the highest prevalence was found for people who self-identified as White”. Furthermore, the “vast majority” of disease was seen in women across all patient race groups, with the exception of Hispanic patients who were more often male with a 5:1 ratio.

Pappas’ group had previously published outcomes data in Medicare and non-Medicare beneficiaries, and demonstrated differences in presentation and number of procedures needed in patients older than 65 years of age, as opposed to younger patients. Furthermore, Pappas explained, “we determined that progressive increases in BMI are associated with worse outcomes after endothermal ablations, phlebectomies and ultrasoundguided foam sclerotherapy”. Their past publications and results led Pappas et al to launch an investigation into potential differences in presentation and treatment outcomes of chronic venous insufficiency, based upon patient ethnicity.

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September 2019 | Issue 11

Deep vein interventions

Thrombophilia not an independent risk factor for venous stent patency loss or reintervention A recent study has concluded that patients with inherited or acquired thrombophilia should not be excluded from iliofemoral venous stenting, Adam Gwozdz (St Thomas’ Hospital, London, UK) reported at the European Venous Forum (EVF; 27–29 June, Zurich, Switzerland). “By all means,” Gwozdz said of the results, “we should not exclude patients with inherited or acquired thrombophilia from venous stenting.” The study gives a “very clear message” according to EVF board chairman Andrew Nicolaides, “that thrombophilia is not an independent risk factor for reintervention or stent patency loss.”

O

utlining the background for the study, Gwozdz explained that iliofemoral venous stenting in patients with thrombophilia is controversial.

“We know that inherited and acquired thrombophilia increase the risk of venous thromboembolism (VTE), and in particular, the antiphospholipid syndrome (APS), which is an acquired thrombophilia, is associated with an increased risk of recurrent VTE, and has associations with arterial problems as well.”

Gwozdz and colleagues aimed to examine the association of thrombophilia with cumulative patency of reintervention rates following stenting for postthrombotic occlusion, and included 146 patients who received a nitinol venous stent for post-thrombotic disease between 2012 and 2017. Minimum follow-up for all included patients was 18 months.

Thrombophilia testing was performed in 105 patients (76%), when VTE occurred at a younger age, with weak provoking factors, strong family history or recurrence, as per clinical guidelines. Of these patients, thrombophilia was detected in 50 (48%) with an equal split between inherited and acquired thrombophilia (25 vs. 25, respectively). The majority of inherited thrombophilia was Factor V Leiden, Gwozdz highlighted, at 72% of this subgroup.

Anticoagulation with vitamin K antagonists (VKA) was prescribed for six months, following from two weeks of post-procedural low molecular weight

heparin therapy. At six months, patients with APS continued on a long-term VKA treatment plan, while all other patients switched to direct oral anticoagulant, rivaroxaban. Follow-up assessment of stent patency with duplex ultrasound was carried out at 24 hours, two weeks, six weeks, three months, six months, 12 months and annually post intervention. “We reintervened if the stent diameter reduction became greater than 50%, and this was associated with symptom recurrence” Gwozdz noted.

Reintervention rates for patients tested versus not tested for thrombophilia, presented on a Kaplan-Meier analysis, revealed an increase in reintervention for the tested group—i.e., those patients who had met criteria for testing. However, upon closer inspection and using Kaplan-Meier analysis to compare patients with and without thrombophilia in the tested group, Gwozdz and colleagues observed “no difference” between

We should not exclude patients with inherited or acquired thrombophilia from venous stenting.”

Catheter-directed thrombolysis treatment for PE may significantly reduce long-term costs with better outcomes Catheter-directed thrombolysis improves outcomes and longterm cost efficiency for treatment of massive and submassive pulmonary embolism (PE), in comparison to systemic heparin administration. This was the conclusion of study investigators led

by Patrick Kelly (Sanford Health, Sioux Falls, USA), who presented the results at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM; 12–15 June, National Harbor, USA).

“AS WE ALL know,” Kelly began, “with medicine nowadays it is not only about whether we can treat and should treat, but also whether we can afford to treat— and I think we need to start asking that question.” The study carried out by Kelly and colleagues therefore sought not only to evaluate the outcomes of treatment options available for pulmonary embolism patients, but also the overall cost-efficiency for the initially more expensive catheter-directed thrombolysis treatment to the standard systemic heparin administration.

“Acute pulmonary embolisms occur often: 177 cases per 100,000 person-years, or another way to think about that is one in every 1,000 people in your community will present with a PE in a year.” He further highlighted, it is the third leading cause of cardiovascular mortality, and patients that survive acute PE, “quite often”

develop chronic pulmonary hypertension, a condition that Kelly described as “quite debilitating”. Importantly, Kelly et al note that there is a significant cost associated with treating chronic pulmonary hypertension, adding up to approximately US$100,000 per year, per patient. To investigate whether these numbers can be affected, Kelly and colleagues focused on massive and submassive PE, defined as patients who present with either systemic hypotension, cardiac arrest and/ or cardiogenic shock, or right ventricular dysfunction without systemic hypotension, respectively. For this patient group, the gold standard treatment option is systemic heparin administration, while thrombolysis is reserved “for the rescue”, said Kelly.

The retrospective, single-centre chart review study of 341 patients compared short- and long-term treatment costs

the two groups at 30 months (15 vs. 15; p=0.646).

“This is an important point,” Gwozdz highlighted, indicating that it is meeting the clinical guidelines for thrombophilia testing—rather than the actual presence of thrombophilia—that is associated with higher reintervention rates after stenting for post-thrombotic occlusion. This likely reflects the increased risk of venous thrombosis in this group of patients, and highlights that testing negative for a thrombophilia does not exclude heritable risk through as yet unrecognised mechanisms, which may contribute to a prothrombotic state.

In terms of cumulative patency, however, no significant difference was observed on Kaplan-Meier analysis between the tested and not tested group at 30 months. “So the message there,” said Gwozdz, “is that if you are vigilant and reintervene appropriately in the higher risk group of those patients meeting the criteria for testing, you will get good long-term patency.”

Outlining a set of recommendations for anticoagulation, Gwozdz maintained that if patients do meet criteria for thrombophilia testing, “the only test that makes sense from a venous stenting perspective is to test for antiphospholipid syndrome to determine which patients need to continue on long-term VKA therapy at six months”. If a patient does not have APS, the recommended pathway would be “very similar to those who do not have thrombophilia at all”.

for patients treated with gold standard systemic heparin administration versus patients who received catheter-directed thrombolysis. The study included 283 catheter-directed thrombolysis patients, and 58 patients receiving systemic heparin administration. While the baseline patient characteristics were overall “pretty balanced”, Kelly pointed to a significant age difference in the two arms, with the average age of the thrombolysis being 58.83 years vs. 68.47 years in the heparin arm (p=<0.001). Another “outlier” was the rate of current or recent cancer, seen in 39 thrombolysis patients (14%) versus 23 heparin patients (40%; p=<0.001).

Presenting the outcomes, Kelly outlined the positive results for the thrombolysis treatment arm, with “significantly reduced” length of stay (3.44 days vs.

6.47 days; p=<0.001). One hundred and sixty-four thrombolysis patients (58%) and 13 heparin patients (22%) had right heart strain (p=<0.001), and while not a significant difference, Kelly et al observed hypotension more often in the thrombolysis group (36 [12.7%]) than the heparin group (6 [10.3%]; p=0.616).

Thirty-day mortality was lower in the thrombolysis arm with 11 deaths (3.9%) vs. four in the heparin arm (6.9%), “but this again did not reach significance” noted Kelly (p=0.309). However, 30-day readmission rate was significantly lower for thrombolysis patients (18 [6.4%] vs.

9 [15.5%]; p=0.019), and return to prior living conditions was seen significantly more in thrombolysis patients than

in heparin patients (252 [89%] vs. 46 [79.3%]; p=0.042). Although the value of returning patients to society in healthy conditions is “difficult to measure” quantitively, Kelly emphasised the importance and even monetary benefit to society of this measurement. Finally, the statistical significance for bleeding complications was “much higher” for heparin patients, of which eight (13.8%) suffered bleeding complications vs.

12 (4.2%) in the thrombolysis group (p=0.005)—“not what we would initially expect”, Kelly said.

In the long-term cost analysis model, 100 patients from each treatment arm were analysed for initial cost to treat, rate of chronic pulmonary hypertension and cost of chronic pulmonary hypertension treatment over five years.

The investigators found that while thrombolysis cost approximately an additional US$31,000 per patient to treat with catheter-directed thrombolysis versus systemic heparinisation, rate of pulmonary hypertension was observed in 6.3% of thrombolysis patients versus 15.9% of heparin patients. “Over time, expecting a five-year survival, all of a sudden catheter-directed therapy becomes much more cost effective than heparinisation therapy—actually to the point where return on investment occurs at 3.2 years,” Kelly explained. The findings of this standardised cost model suggested “overall savings of US$1.7 million” at five years post treatment for the 100 patients in the thrombolysis arm.

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September 2019 | Issue 11

Venous reflux

Reflux elimination study reveals effective ultrasound method of treating leg ulcer patients A study into the efficacy of early reflux elimination for venous leg ulcer (VLU) patients has revealed that the combination of ultrasound-guided foam sclerotherapy (UGFS) only, and a hybrid method of endovenous laser treatment (EVLT) with UGFS, could present a minimally invasive method of treating superficial venous reflux.

ALEKSANDRA JAWORUCKAKaczorowska (Gorzów Wielkopolski, Poland) presented the results of the study at the European Venous Forum (EVF; 27–29 June, Zurich, Switzerland), outlining how both the UGFS-only and hybrid methods can be associated with high healing rates and low midterm recurrence rates. In addition, both approaches may prove more costeffective and popular by replacing lifelong compression therapy with a single intervention.

While compression therapy is still the “mainstay of treatment” for VLU patients, Jaworucka-Kaczorowska emphasised that “more than 85% have superficial venous reflux and are therefore candidates for intervention”. In response to the findings of the ESCHAR and EVRA trials, the elimination of axial and perforating reflux has been suggested as an adjunctive therapy for reducing

recurrence rates and accelerating healing.

In order to assess the efficacy of early reflux elimination, the study aimed to determine ulcer healing rate at 24 weeks and one year, as well as ulcer recurrence rate at one year, after the elimination of

Since long-term patient compliance to compression is relatively poor, it may prove more effective [...] to provide a single intervention to reduce recurrence, rather than life-long treatment with compression.” axial and perforator reflux in patients with active VLU. All of the participants, 69% of whom had first-time ulcers, were also treated with compression therapy as part of the study.

New research outlines correlation between venous reflux patterns and clinical severity Certain reflux patterns in patients with chronic venous disease can be associated with increased clinical severity and a lower quality of life, according to the results of a recent study conducted at Imperial College London, UK. As part of the study, a significant difference was discovered between patients with isolated superficial reflux, and those with reflux of the deep, superficial and perforator venous systems.

P

Prior to the beginning of treatment, and one, three, six and 12 months afterwards, each participant underwent a clinical assessment to measure ulcer dimensions and the wound at risk of infection (WAR) score, and a duplex assessment to determine the condition of deep and superficial veins, the presence of reflux and any post-treatment venous occlusion.

Explaining the findings of the duplex assessment, Jaworucka-Kaczorowska said: “I found perforating vein incompetency in 63% of patients and segmental deep vein incompetency in almost 16% of patients. Also, 61% of segmental deep vein reflux disappeared after ablation of the incompetent superficial veins.”

Following the first clinical and duplex assessment, patients received one of three treatments: UGFS of the incompetent superficial veins, perforating

resented at the European Venous Forum (EVF; 27–29 June, Zurich, Switzerland) by Matthew Tan (London, UK), these findings support the relationship demonstrated in previous studies between clinical severity and such factors as venous diameter, junctional incompetence and reflux patterns in the superficial venous system.

veins and tributaries (34.2%); UGFS of the incompetent perforating veins and tributaries (35%); or a hybrid method of both UGFS and EVLT (30.8%). All patients underwent pharmacotherapy

Using duplex ultrasound imaging, which, according to Tan, “provides us with both anatomical and haemodynamic information, and allows us to assess deep, superficial and perforating venous systems,” Tan and colleagues set out to further explore the correlation of specific reflux patterns to clinical severity and health-related quality of life (HRQoL) scores, as well as the impact of deep, perforator and venous incompetence.

In order to conduct the study, 490 symptomatic patients with chronic venous disease and 105 asymptomatic volunteers were recruited over a four-year period. Tan explained the methods used to assess each participant once selected: “On the day of recruitment, all participants had their limbs assessed with a duplex ultrasound and this was done by either a vascular scientist or a vascular surgeon. At the same time, clinical severity was determined by a trained clinician using the CEAP classification and venous clinical severity score (VCSS).”

For the purposes of statistical analysis, patients and volunteers taking part in the study were categorised into eight reflux patterns that ranged from those with no reflux to those with deep, superficial, perforator reflux. Tan also underlined that the only notable difference between the patient and volunteer demographics was in terms of age, with the group showing no symptoms of chronic venous disease being significantly younger on average.

Focusing on the distribution of reflux patterns across CEAP classes, all of which were represented in the study, Tan said: “The majority of participants in the C0 and C1 clinical classes had no reflux, and the extent of reflux increased across the clinical classes.

For example, with the deep, superficial, perforator reflux pattern there were no participants in C0 and C1, and the proportion of participants with this pattern increased from C2 to C6. This trend holds true for

and a wound care strategy of surgical debridement, antiseptic and wound dressing in addition to their treatment.

The results of the trial showed an ulcer healing rate at 24 weeks of 92%, which rose to more than 98% after one year with only two leg ulcer patients failing to heal, and a median VLU healing time of 3.4 months. Furthermore, the estimated one-year recurrence rate was just 4.4%.

“I also assessed the time of healing according to ulcer area, and the bigger it was at the beginning the longer it took to heal” added Jaworucka-Kaczorowska.

Similar results were also recorded in terms of ulcer duration, with newer wounds taking less time to heal.

One hundred per cent of patients with isolated superficial reflux healed in three or fewer months, while the presence of incompetent perforating veins prolonged the healing time; 50% of patients with additional perforating vein incompetence healed in more than three months.

Patients with isolated perforating vein incompetence demonstrated the lowest healing rate, as none healed in less than six months.

“UGFS and hybrid approaches appear to be attractive, minimally invasive methods of treating superficial venous reflux. Since long-term patient compliance to compression is relatively poor, it may prove more effective as well as cost-efficient to provide a single intervention to reduce recurrence, rather than life-long treatment with compression,” Jaworucka-Kaczorowska concluded.

most of the other reflux patterns.”

In terms of VCSS, patients with different forms of reflux were once again compared to those with none.

According to the statistical analysis performed, all patterns, except for deep reflux only and perforator, deep reflux—which could be anomalous due to the small number of participants in these groups—showed a significantly higher score compared to participants with no reflux.

Additionally, the only significant difference in VCSS between patterns was with the superficial only group and deep, superficial, perforator group, a distinction that was also recorded in the comparison of the Aberdeen Varicose Vein Questionnaire (AVVQ) score, which assesses the perceived health of patients with varicose veins. “We decided to do a subgroup analysis, dividing the patients in these groups Matthew Tan further based on their junctional competence,” said Tan. While all scores were higher in the deep, superficial, perforator pattern—regardless of junctional competence—the difference was significant when compared to those with superficial only and competent junctions.

Tan concluded: “What we have shown today is that most reflux patterns are associated with increased clinical severity and a worse quality of life, when we compare them with individuals with no reflux whatsoever. However, there are only significantly higher scores when the extent of reflux increases from superficial reflux only, to deep, perforator and superficial reflux.”

Issue 11 | September 2019

Endovenous laser ablation continues to benefit healing of chronic venous ulcers Endovenous laser ablation (EVLA) of perforating veins has been further established as an effective method of treating chronic venous ulcers in patients with diabetes mellitus, according to a new study conducted in Azerbaijan.

R

esults of the study, which involved 42 patients suffering from chronic venous ulcers, were presented at the European Wound Management Association’s 29th conference (EWMA; 5–7 June, Gothenburg, Sweden) by principal investigator Vugar Fattah-Pur (Azerbaijan State Advanced Training Institute for Doctors, Baku, Azerbaijan), who carried out the trial with the support of colleagues Ismayil Asgarov and Elmaddin Akhundov, as well as Uzeyir Ismayilov (“ISTANBUL NS” Clinic, Baku, Azerbaijan).

Fattah-Pur explained that a deficiency of perforated veins causes venous insufficiency, which in turn leads to the development of chronic venous ulcers in the lower limbs. He said: “The standard treatment of chronic venous ulcers (CVU) is compression therapy, traditional surgery and foam sclerotherapy. But, at the same time there are frequent recurrences reported.

It should be noted that diabetes mellitus in its turn aggravates the course of disease and impacts the results of treatment of CVU.” By evaluating the efficiency of EVLA in the treatment of patients with chronic venous ulcers, the study’s goal was to determine whether this process offers a viable alternative to traditional surgical treatment and compression therapy.

The 42 patients taking part in the study—all of whom have diabetes mellitus—were divided into three groups. The first group of 21 underwent EVLA by a diode laser with a wavelength of 1,470nm, while a second group of 10 patients were subject to epifascial ligation of the perforated vein. A third group of 11 were treated with compression therapy until the wound had healed.

In addition to EVLA, a simultaneous miniphlebectomy was performed on five of the patients from the first group, while six others from the same group underwent foam sclerotherapy. These extra

Endovenous laser ablation is a safe, effective and less traumatic method of ablating deficient perforated veins [in] an outpatient basis.”

Venous ulcers

9

treatments were conducted “to achieve expedient satisfactory aesthetic results,” according to Fattah-Pur. All three groups also wore compression hosiery: the first and second cohorts for 4–6 weeks, and the third group for 14–18 weeks.

The first group included nine men and 33 women with an average age of 54.7 years and an average ulcer area of 2.16±0.73cm². Following EVLA, nearly 30% of these patients experienced pain, while around two thirds of the study group were affected by ecchymosis. In addition, induration was noted in the postoperative period for approximately half of the patients, and around 40% complained of paresthesia.

However, Fattah-Pur asserted that “none of the above complications have ever influenced the daily physical capabilities of patients”.

Comparing the results of these 21 patients who underwent EVLA to both the second and third groups, the speaker underlined that the average wound healing period for those in the first group was 26 days. The second group of 10 patients who underwent epifascial ligation of the perforated vein had a wound healing period of 25 days, whereas the final set of 11 patients treated with compression therapy had a wound healing period of 78 days.

Fattah-Pur concluded: “EVLA is a safe, effective and less traumatic method of ablating deficient perforated veins that is performed on an outpatient basis. This allows us to consider this technique as a successful method of eliminating reflux in perforated veins, rapid treatment of CVU and a possible replacement of the traditional surgical treatment.” It was also stated that further research is needed to evaluate the long-term results of EVLA for patients with diabetes mellitus.

Early endovenous ablation for venous leg ulcers has previously been demonstrated as an effective treatment strategy by the Early Venous Reflux Ablation (EVRA) ulcer trial, published in the New England Journal of Medicine in 2018.

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September 2019 | Issue 11

Interview

Profile

Kurosh Parsi

Kurosh Parsi, incoming president of the International Union of Phlebology (UIP), is an Australian dermatologist, phlebologist and vascular anomalies specialist. With his broad range of expertise and varied research, Parsi sees phlebology as an “inter-connected multiverse” of disciplines, in need of further recognition as a specialty.

What led you to study medicine and specialise in phlebology, dermatology and vascular anomalies?

Medicine was my second or third choice. I was more interested in physics and aeronautical engineering. I was also interested in medical research, so I decided to study Medicine. After I finished Medicine—and by pure coincidence—I attended a meeting where this enigmatic and incredible person, Dr Louis Grondin, president of the Canadian Society of Phlebology, was giving a lecture on pelvic congestion syndrome. For me that was it, and at that moment in 1994 I knew phlebology was my future field. I started working in a phlebology practice, visited Louis in Canada, and joined the Sclerotherapy Society of Australia where I met another inspirational person, Dr Paul Thibault, who taught me and many others how to perform ultrasound-guided sclerotherapy.

I then completed a Masters degree investigating the risk factors for Traveller’s Thrombosis. My supervisors were Professor Reg Lord and Dr Michael McGrath, two true vascular legends in Australia and Professor David Ma, an inspirational haematologist. Having travelled to the USA a number of times, I met Bob Weiss, Mitch Goldman and Neil Sadick, and observed how dermatology and phlebology can overlap. I decided to specialise in dermatology. After four years of fellowship training, I started working as a dermatologist at St. Vincent’s Hospital in 2004 while practicing phlebology from my private rooms. I have been the head of department for the past 10 years.

Over the years, I developed an interest in venous thrombosis and wanted to study the interaction of sclerosants with the coagulation system. This led me to a PhD with the haematology team at the Haematology Research Lab at St. Vincent’s hospital. I completed my PhD under the close supervision of David Ma and Dr Joanne Joseph. I met David Connor, another PhD student at the Haematology Research Lab and we have been friends and research collaborators since then.

Following the completion of my PhD, together with David we established the Dermatology, Phlebology and Fluid Mechanics research laboratory at St. Vincent’s Centre for Applied Medical Research.

As a dermatologist and phlebologist, I became interested in vascular anomalies, joined the International Society for the Study of Vascular Anomalies (ISSVA) and met Prof BB Lee. He has been one of my true mentors over the years. I subsequently digressed to interventional radiology and worked at Sydney Children’s Hospital for around ten years treating vascular malformations.

Currently 40–50% of my private practice is paediatric and adult vascular anomalies.

So, how do I visualise phlebology? I think of phlebology as an interconnected multiverse, where multiple universes of vascular medicine and surgery, paediatric and adult vascular anomalies, haematology, dermatology, interventional radiology and lymphology come together. It is truly a rich and colourful specialty with a wide scope.

Who have been your professional mentors, and what lessons did you learn from them?

Louis Grondin was my first and most important inspiration. Louis has this amazing capability of seeing

what most ordinary people cannot see. Phlebology becomes a multidimensional universe when you look through Louis’ eyes. He is an extraordinary person with an extraordinary gift. He is also a gift to phlebology and we should feel lucky to benefit from his genius.

Over the years, I have met, been inspired and encouraged by other legends of phlebology such as Paul Thibault (Australia), JJ Guex (France), Michel Schadeck (France), Ken Myers (Australia), Andre van Rij (New Zealand), Mark Malouf (Australia), Hugo Partsch (Austria), Alun Davies (UK), Eberhard Rabe (Germany), AA Ramelet (Switzerland), Attilio Cavezzi (Italy), Lorenzo Tessari (Italy), Mark Meissner (USA) and Steve Zimmet (USA), amongst many more who have inspired me personally as a phlebologist. Amongst nonphlebologists, Prof David Ma (haematologist, Sydney, Australia) and Prof Steven Kossard (dermatologist and dermatopathologist, Sydney, Australia) have been great sources of inspiration and encouragement for me in the past three decades.

The most important thing I have learned from these amazing people is to stay humble and to know what I do not know; to know that we still have a long way to go and that there is still so much to learn and discover.

What are the most significant ways you have seen the venous field develop over the course of your career?

The French school of phlebology and the development of ultrasound-guided sclerotherapy (UGS) pioneered by Michel Schadeck and Frederic Vin changed the field of phlebology forever. We should all be grateful for their enormous contribution.

UGS became a much more effective procedure with the introduction of foam sclerosants pioneered by Juan Cabrera (Spain) and Lorenzo Tessari (Italy). Again, foam has made a huge difference in our treatment outcomes thanks to the genius of Juan and Lorenzo.

I pioneered catheter-guided sclerotherapy and published the technique in 1997. The catheterguided concept evolved into endovenous laser and radiofrequency ablation. Endovenous catheter-guided procedures are now the norm and the first-choice treatment in the hierarchy of treatment options for venous disease. Finally, tumescent-assisted sclerotherapy (TAS) has been pioneered by myself, Paul Thibault and Attilio Cavezzi. This will take sclerotherapy to a different level.

My ultimate aim is to gain recognition of phlebology as a multidisciplinary specialty around the globe.”

How do you anticipate the field might change in the next decade, and what would you most like to see realised?

In the last year, which new paper or presentation has caught your attention?

We desperately need better and more practical treatment options for deep venous disease and in particular deep venous reflux. Post-thrombotic syndrome desperately needs a new instrument to replace the Villalta score.

Lymphoedema needs its own ultrasound-guided intervention. With superficial venous disease, we need to define the end point of venous interventions. A lot of treatments are performed in a haphazard fashion. Veins get ablated in bits and pieces resulting in sub-optimal outcomes for patients. I am advocating an A–Z approach, where practitioners treat the vein and the associated venous system in its entire length, not skipping segments or tributaries. I would like us to be a lot more scientific in our approach to venous disease and less random.

Mark Meissner’s pioneering work with pelvic venous disease; Steve Black’s inspirational passion for venous stenting and intravascular ultrasound (IVUS); Nicos Labropoulos—I can listen to him talk about anything for ever—and Tony Comerota with his outstanding research on deep venous disease.

As president of UIP, how do you hope to shape the society and further its progress during your presidency?

My election to president was uncontested and unanimous having received 100% of the votes (90 of the 90 votes).

My colleagues’ tremendous confidence in me is a great compliment, but at the same time has given me an

Issue 11 | September 2019

Interview

11

Fact File

solid aspect of the Australasian College of Phlebology (ACP) formal Phlebology Training Program in Australia and New Zealand and have been very popular with the College trainees. The modules will support the UIP phlebology curriculum and ensure a similar level of exposure to educational materials irrespective of where people live and will introduce minimum training standards across all continents.

Why is it important that a society like UIP exists?

UIP is the peak body representing phlebology on a global level. With more than 70 member societies from across five continents, the UIP provides an international forum for the interaction of venous specialists. UIP Congresses provide a great opportunity for talented phlebologists to meet, greet, be inspired, be encouraged and be energised. The UIP Congresses remind us that we belong to a large global phlebology family. In addition, the UIP can provide support to its member societies, facilitate international guidelines and research initiatives and help with the education of both doctors and patients.

Ultimately, the UIP is there to help raise the standards of care for patients with venous disease.

What advice would you give someone at the start of their career in phlebology?

Think outside the box. Do not believe everything you read in the textbooks, especially the older ones. When people tell you “I have been doing this for 20 years and have never had any problems”, remember they may have been doing it badly for 20 years and the patients were the ones who had the problems! Question everything and think independently.

In your opinion, what are the biggest challenges currently facing specialists in this field?

unquestionable responsibility to make sure I act on behalf of all of them, representing all member societies and all countries equally. This is clearly my top mandate, to represent the UIP in its entirety, to protect the interests of the UIP and all its member societies. Their vote of confidence has also given me a strong mandate to bring about reforms to the UIP. My main aim in the next four years will be to resolve the chronic pathological problems that have entangled the UIP machinery and blunted its growth for decades. My mandate is to make the UIP processes crystal clear, structured, fair, simple, efficient, non-factional, non-political and highly organised. I need the full support of the phlebology community in the next four years to achieve tangible results. We have already started constitutional reforms and significant reforms in the congress management. I also would like to expand the UIP. By the end of the UIP Chapter meeting in Krakow, we will have more than 70 member societies in the UIP. My aim is to reach the magic number of 100 member societies by the 2023 World Congress.

Other than organisational reform, it is my personal passion to encourage true scientific activities and try to reshape the UIP from a politically-focused organisation to one renowned for science and education. Our first step was to introduce the UIP online education programme in January 2019. The educational modules have been a

Lack of recognition of phlebology as a medical specialty by health authorities has hampered our efforts in increasing the standards of care for patients with venous disease on a large scale. While standards are very high in some countries, they are very poor in many countries.

My ultimate aim is to gain recognition of phlebology as a multidisciplinary specialty around the globe. This will help to increase the standards of patient care, increase public education on important topics such as chronic venous ulcers and increase the standards of training.

Could you tell us about one of your most memorable cases?

Three-year-old child with Klippel-Trenaunay syndrome with a leg looking like a 90-year-old booked for belowknee amputation. I saved that leg, and not by a miracle, but by simply applying good phlebology skills to a complex vascular problem.

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

Receiving the Gold Medal of the Australasian College of Phlebology.

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

With my family and close friends. With my wife Yana and young daughter Parmiss doing Maths and Physics or rehearsing her presentations for school. Doing a lot of sports every day, planning our next party or trip and working on my next research paper! Finally, add learning Spanish to the list. Never a dull moment!

Current affiliations

President Union Internationale de Phlebologie (UIP) Head of department Department of Dermatology, St. Vincent’s Hospital, Sydney, Australia Conjoint associate professor St. Vincent’s Clinical School, University of New South Wales (UNSW), Sydney, Australia Honorary associate professor School of Aerospace, Mechatronic and Mechanical Engineering, University of Sydney (USYD), Australia Programme head Dermatology, Phlebology and Fluid Mechanics Research Laboratory, St. Vincent’s Centre for Applied Medical Research University of New South Wales (UNSW), Sydney, Australia

Previous appointments (selected)

2013–2018 Treasurer Union Internationale de Phlebologie (UIP) 2007–2017 President Australasian College of Phlebology (ACP) 2009–2016 Associate editor Australasian Journal of Dermatology 2009–2013 Meeting convener ACP annual Scientific Meetings 2009–2013 Vice president (Asia-Pacific) Union Internationale de Phlebologie (UIP)

Education (selected)

PhD: Interaction of Detergent Sclerosants with Coagulation, Antithrombotic and Fibrinolytic Mechanisms Haematology Research Laboratory, St. Vincent’s Hospital, Sydney University of New South Wales (UNSW), Australia Residency St. Vincent’s Hospital, Sydney, Australia MSc Medicine Departments of Vascular Surgery, Vascular Medicine and Haematology, St. Vincent’s Hospital, Sydney University of New South Wales (UNSW), Australia Internship Lidcombe/Bankstown Hospital, Bankstown, Australia MBBS Bachelor of Medicine, Bachelor of Surgery The University of Sydney, Australia

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September 2019 | Issue 11

Conference coverage

Randomised trial assesses added value of ultrasound-directed thrombolysis for submassive PE The Standard vs ultrasound-assisted catheter thrombolysis for submassive pulmonary embolism (SUNSET sPE) trial is an ongoing, randomised, head-to-head, single-blinded clinical trial comparing ultrasound-assisted thrombolysis to standard catheter-directed thrombolysis. While comparative data are not yet available, Efthymios “Makis” Avgerinos (University of Pittsburgh Medical Center, Pittsburgh, USA) presented the interim results of the overall outcomes at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM; 12–15 June, National Harbor, USA) in a late-breaking scientific session.

INTRODUCING THE PRESENTATION, Avgerinos explained that pulmonary embolism is classified in three categories, based on mortality risk: from non-massive pulmonary embolism with low risk of mortality (<1%), to submassive pulmonary embolism at intermediate risk (3–15%), up to massive pulmonary embolism with a high mortality risk of 30% or more. Calculating the appropriate care for pulmonary embolism therefore similarly creates a scale of intervention, from anticoagulation alone to systemic thrombolysis. “Anticoagulation is the standard of care for all these patients [with pulmonary embolism], but as the severity increases, we need to escalate our treatment,” Avgerinos explained, “and we traditionally use systemic thrombolysis.”

Catheter-directed interventions for the treatment of patients with submassive pulmonary embolism (sPE) have shown promise in rapidly improving right heart strain and preventing decompensation to massive pulmonary embolism, Avgerinos and his co-investigators argue. Ultrasound-assisted thrombolysis has been at the forefront of these interventions and it has been shown that—at least in vitro—ultrasound can enhance thrombus breakdown, he told the VAM audience, maintaining that if this technique can be translated to clinical practice, the potential benefits can be numerous. However, Avgerinos noted, “it is unclear whether ultrasoundassisted thrombolysis is clinically superior to thrombolysis

Efthymios Avgerinos

provided by a standard multiple side hole catheter. […]

There is a lot of literature supporting EKOS (BTG), and right now it is the only FDA [US Food and Drug Administration] approved thrombolytic catheter that we have for pulmonary embolism, but the reality is that there is no robust evidence of clinical superiority to justify a tenfold increase in cost compared to the standard catheter.”

The SUNSET sPE trial therefore set out to shed light on the issue with randomised evidence, by enrolling adult patients presenting to the University of Pittsburgh Medical Center with sPE as determined by a multidisciplinary pulmonary embolism response team

algorithm. Participants are randomised 1:1 to treatment with EKOS or standard catheter thrombolysis. The study began in 2017 and anticipates completion in spring of 2020, according to Avgerinos.

The primary endpoint is thrombus reduction assessed by post-procedural CT angiogram, and the study is powered for 80 patients to detect a 50% improvement in pulmonary artery thrombus clearance. Secondary outcomes include 48-hour RV/LV ratio improvement

by CT pulmonary arteriogram, and three- and 12-month functional capacity as well as quality-of-life measures.

“We are presenting 45 patients today, but we have recently enrolled our 49th patient,” Avgerinos reported, showing data of 23 patients in the EKOS arm and 22 in the standard catheter arm (mean age 55±15 years old, 62.2% male and 66.7% with concurrent deep vein thrombosis), all with acute sPE. On average, patients were lysed for 13 hours (±6 hours).

The investigators oreport that mean RV/LV ratio was reduced from 1.59±0.29 at baseline to 1.11±0.23 within 48 hours. One (2.2%) major event of haemorrhagic stroke with no neurologic deficits by discharge and two (4.4%) minor bleeding episodes were observed during the postinterventional period. At 30 and 90 days, there were no deaths and no recurrent venous thromboembolism was reported.

Avgerinos underlined these findings at VAM, highlighting that “there was no decompensation and no associated mortality”. Looking at functional capacity, a six-minute walking test at three months showed a 22% exercise intolerance or dyspnea at rest, while 56% developed “very light or light” dyspnea after a six-minute walk. “Regarding the quality of life,” Avgerinos said, “it was not as good as you would expect for the general population, but still the scores did not qualify for a poor quality of life.”

Comparative data is set to be announced at the completion of the study enrolment—“hopefully early next year”, said Avgerinos, “but we can conclude that catheter thrombolytic techniques can achieve significant quick thrombus and RV/LV ratio reduction, and that catheter thrombolysis is safe and effective”.

Establishing a pathway for the assessment and pre-treatment of venous leg ulcers In her presentation at the Royal Society of Medicine Venous Forum (RSMVF; 17–19 June, London, UK), consultant vascular surgeon Emma Wilton (Oxford University Hospitals, Oxford, UK) outlined the important process for identifying which patients with leg ulceration require deep venous intervention. Upon the suspicion of the obstructive venous pathology, Wilton argued that there are a number of steps which should be taken before treatment is applied, including imaging and an inflow assessment.

C

hronic venous insufficiency currently affects 7–9% of the UK population and is caused by such complications as valvular incompetence, chronic obstruction and calf pump failure, “all of which lead to the final pathway of elevated ambulatory venous pressure within the lower limb and venous hypertension,” according to Wilton.

Other problems that can result in this insufficiency range from both superficial and deep venous reflux to causes of outflow obstruction, which include post-thrombotic syndrome and either malignant or non-malignant iliac veins.

Explaining the assessment procedure which should be followed in cases like this, Wilton said: “At our institution, we have a pathway for chronic obstructive venous disease. If suspected, the patient

undergoes imaging, a multidisciplinary team meeting, clinic follow-up and further investigation before finally agreeing on treatment.”

The first clinical assessment stage involves an analysis of both the symptoms and signs of venous insufficiency, as well as a review of the patient’s history. Key areas of attention, as listed by the speaker during her presentation, comprise of aching or cramping, swollen limbs and skin discolouration, in addition to more obvious and immediate symptoms such as varicose veins and venous ulcers.

Patients with either their own or a family history of venous disease should be noted, as well as any patient who has been an intravenous drug user in the past.

Following this initial review, the

imaging stage is conducted. As Wilton describes, “first of all, everyone undergoes a venous duplex scan of the lower limb with a full assessment of deep and superficial systems”. This is said to highlight the presence of deep vein thrombosis, chronic scarring and venous reflux and helps to determine, or at least offer a suspicion, of deep venous disease.

The next step would involve a magnetic resonance venography or computed tomographic venography ranging from the upper thigh to the lower diaphragm. While the former aids with a clinical assessment of venous reflux and reveals the extent of occlusive disease, the latter helps to identify postthrombotic stenotic change and can be performed on either directly or indirectly.

In order to establish the adequacy of

inflow vessels of patients identified as having venous disease, direct venography would also be performed.

By following this sequence of assessments, it becomes clearer which patients should receive treatment. Wilton said: “We would suggest that you treat patients with symptoms of chronic venous insufficiency that you can see is due to severe post-thrombotic syndrome or significant venous disease attributable to iliac veins and outflow obstruction.”

Other factors that should influence the decision of whether or not to treat the patient include life expectancy, functional status and their bleeding risk. Pregnancy and ongoing intravenous drug use were also listed as contraindications to treatment.

Wilton concluded: “As mentioned, they need to have at least a good, if not adequate, inflow, they need to be able to be fully anticoagulated, they need to be compliant with their medication, and they need to be fully informed about the procedure and follow-up schedule, as well as the potential need for reintervention.

You need to meet the criteria for intervention, it is not for everybody.”

On the potential of deep venous stenting for treating leg ulcers, she added: “The evidence is relatively limited, though here have been some retrospective case series looking at deep venous stenting and the healing up of leg ulcers, showing about a 60% healing rate.”

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September 2019 | Issue 11

MedTech Insights

Private equity firm invests in UK centre performing EVLA for varicose veins A PRIVATE EQUITY firm, Palatine (Manchester, UK), has announced that it has made a “significant investment” into a UK centre—Veincentre—that provides endovenous laser ablation (EVLA) for the management of varicose veins. The investment, according to Palatine, is the fourth to be made from the firm’s £100m “Impact Fund” that “targets companies with a social and/or environmental impact, alongside industry-standard returns”.

A press release reports that, in the UK, the NHS withdrew funding for varicose veins treatment after determining it was “non-essential”. Last year, the NHS released a consultation document on stopping or reducing the routine commissioning of 17 interventions for which “less invasive, safer treatments are available and just as effective”. One of these interventions was surgery for varicose veins, with the document noting that patients with varicose veins should only be referred for treatment when they meet specific criteria (such as having a venous leg ulcer). It states: “For patients whose veins are purely cosmetic and are not associated with any symptoms, do not refer for NHS treatment.”

According to the press release announcing the investment from Palatine, EVLA reduces recovery times associated with traditional forms of treatment (i.e. conventional surgery) and significantly reduces scarring. David West, the clinical

director of Veincentre, says: “With the help of the Palatine team, our aim to bring this specialist, yet affordable treatment to as many people as possible seems more achievable than ever. The work we do has become increasingly important following falling NHS funding in the sector, and now with the help of this investment, we will be able to offer a necessary social service where access might otherwise be scarce.”

Veincentre now plans to continue to build on its recent nationwide expansion, opening new clinics in Glasgow and Leeds later this year, before carrying out a plan to open two new centres across Britain annually. Beth Houghton (head of the Impact Fund, Palatine) comments: “We are very excited to work with Veincentre; with the lack of NHS funding for what can for some people be a debilitating condition, it is important that people are able to access treatment at affordable prices, in convenient locations. With the planned roll-out of clinics to Scotland and Yorkshire, Veincentre will be able to offer treatment in almost every major region in the nation, and the management team has ambitions to offer full coverage of the UK. Veincentre is exactly the type of business we want to support, and we look forward to working with the management team in order to help accelerate growth and consolidate the company’s position as a leader in the industry.”

West told BIBA Briefings: “I am delighted David West

that we have teamed up with Palatine who recognise the impact varicose veins and other problems with venous insufficiency have on people’s lives and the lack of comprehensive provision of modern treatment by the NHS. Most of our patients are bothered by both the cosmetic appearance and troublesome symptoms and many tell us that treatment has changed their lives. Although in an ideal world, all UK patients would be able to access NHS treatment it is difficult to justify treating all cases at the inevitable expense of patients with other more pressing health issues. This investment ensures that we can achieve our short term expansion plans in the UK and put us on a firm footing for international growth in the future.

Veincentre also encompasses the specialist medical devices company EVLA Expert, which provides UK manufactured all in one kits for EVLA at a fraction of the price of the major laser manufacturers.

We are always on the lookout for ‘hungry’ keen vascular specialists to join our friendly multidisciplinary team of nurses, surgeons and radiologists.”

BIBA Briefings

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Clinical trials confirm efficacy of cost-saving wound dressing for the safe treatment of leg ulcers Results from two open, prospective trials have revealed that Urgo Medical’s TLC-NOSF sucrose octasulphate dressing, with polyabsorbent fibres, represents an effective and safe treatment for the local management of leg ulcers. In addition, cost-effectiveness studies examining the economic impact of the dressing have demonstrated that significant annual cost savings can be achieved with UrgoStart.

SYLVIE MEAUME (HOPITAL Rotschild, Paris, France) presented the findings of the NEREIDES and CASSIOPEE multicentre trials at the European Wound Management Association’s 29th conference (EWMA; 5–7 June, Gothenburg, Sweden). She said: “It is difficult to treat these wounds and 40–50% of venous leg ulcers remain unhealed after 12 months. Also, the problem of recurrence is a major issue, with there being more than a 70% recurrence rate within three months.”

An effective treatment of leg ulcers

The NEREIDES and CASSIOPEE trials aim to assess the efficacy and safety of the TLC-NOSF dressing in the local management of leg ulcers at different

stages of the healing process, and are being conducted across a total of 35 centres, hospitals and private practices in France. Patients with non-infected, moderately to heavily exudative leg ulcers—either of venous or mixed aetiology—were treated with the dressing and appropriate compression therapy over the course of 12 weeks.

Thirty-seven patients with wounds in the desloughing stage (70% or more sloughy tissue) entered into the NEREIDES trial, while 51 with wounds in the granulating stage (50% or more granulation tissue) were part of the CASSIOPEE study.

Other than the percentage of sloughy tissue on the wound bed at baseline, the cohorts of both studies were very similar and consisted of 90% or more

Sylvie Meaume

The conclusion of the NEREIDES and CASSIOPEE studies is that you can use this dressing; and the sooner the better.” outpatients that were predominantly female and had an average age of over 75 years. In addition to this, a majority of the patients in both NEREIDES and CASSIOPEE had a marked history of suffering with venous ulcers.

Regarding the characteristics of the patients’ wounds, Meaume said: “If we look at the wounds, they are a very similar duration and area. Half of the

wounds have a duration of more than six months despite previous compression therapy, and a third of the wounds have an area of more than 10cm³. It is important to notice that it is not just simple wounds, there are arterial wounds included in the study.”

After 12 weeks of treatment, the relative wound area reduction (RAWR) measured in both trials presented a

Issue 11 | September 2019

UrgoStart (Urgo Medical)

beneficial outcome, with patients in the NEREIDES study experiencing a 60% reduction compared to an 81% RAWR in the CASSIOPEE trial. A wound closure rate of 18% was recorded for ulcers treated with the dressing as part of NEREIDES, and 20% for wounds in CASSIOPEE. Wound healing outcomes depending on wound duration at initiation were also revealed, and Meaume described these findings as “the major result of these studies”. In the NEREIDES study, RAWR for wounds with a duration of less than six months was 85%, whereas wounds with a duration of six months or more had a reduction rate of 43%.

These results were consistent with the wound closure rate measured in the CASSIOPEE test, with 30% of ulcers less than six months old closing compared to just 11% of wounds six months or older. “The conclusion of these two studies is that you can use this dressing; and the sooner the better,” said Meaume.

In terms of safety, the dressing was well tolerated in all healing stages; a total of 19 adverse events—none of which were serious—were recorded throughout both studies.

Meaume concluded: “This result corroborates the findings of previous clinical trials on TLC-NOSF dressings and confirms the clinical interest of this new TLC-NOSF dressing with polyabsorbent fibres in the local treatment of exuding chronic wounds, at their different wound healing stages and until wound closure, in the accepted standard of wound care.”

Significant annual cost savings

Following the recent recommendation of the TLC-NOSF dressing by the UK National Institute for Health and Care Excellence (NICE), Isaac Odeyemi (Manchester, UK) also spoke at EWMA to present the results of two cost-effectiveness studies that were conducted across the healthcare systems of the UK and Germany.

Both studies involved a Markovmodel cost-effectiveness design using four states of patient health, with a further distinction made between pre- and post-amputation wounds.

Referring to the EXPLORER doubleblind randomised controlled trial,

Venous ulcers which also demonstrated the safety and efficacy of the dressing, Odeyemi noted that the trial informed the model efficacy parameters of their analysis, supplemented by estimates from the literature. In models for the UK, the EXPLORER study’s endpoint of 20 weeks was extrapolated to a base-case time horizon of one year, which was further extended to 100 weeks in the German model.

Costs were analysed from individual countries’ perspectives and adjusted for 2017 prices. As reported by NICE in their recommendation for UrgoStart dressings, Odeyemi quoted an average cost-saving of “up to £5.4 million each year, if only 25% of people having

treatment with diabetic foot ulcers in the UK use UrgoStart”.

In the UK, Odeyemi reported that the study demonstrated a cost saving of £342 per patient over one year, with a healing time reduced by “up to 60 days”. In the German study, the model demonstrated a lower cost per effectively treated bleed of €6,77.58 for the UrgoStart group, compared to €10,375.56 for the control group over the 100-week period.

Surprisingly, Odeyemi revealed that “sensitivity analyses also showed UrgoStart was dominant in terms of all the model input variables. […]

You could give any other dressing in the healthcare system for free—and

15

UrgoStart would still be cost-saving.”

This is a rare result in a health economics analysis, emphasising that the dressing was economically dominant in both the UK and the German studies, both of which provided exactly the same result.

In conclusion, Odeyemi emphasised the importance of the finding: “This is actually quite significant—it is a lot of money that healthcare systems can actually save. The main cost driver was the efficacy of the TLC-NOSF compared to neutral advanced wound care dressings. Furthermore, earlier use of the dressing resulted in even better efficacy, higher cost savings and better quality of life.”

Issue 11 | September 2019

Market watch

Product News Thrombolex announces first enrolment in early feasibility and safety study using Bashir endovascular catheter for pulmonary embolism

Thrombolex has announced the enrolment of the first patient in their Early Feasibility and Safety Study, investigating the Bashir Endovascular Catheter for the treatment of submassive pulmonary embolism (PE). The device was designed to quickly and safely dissolve thrombus and restore blood flow in patients with thrombotic vascular occlusions.

The Bashir catheter includes an expandable infusion basket comprised of six mini-infusion catheters with 48 precision, laser-drilled infusion holes.

When expanded, it can promptly restore blood flow to enable endogenous lytics in the blood to help accelerate clot lysis.

In this investigational study the device is used to administer thrombolytics through multiple cross-sections of the culprit clot to enhance clot dissolution.

“We are pleased to have been the first site to enrol a patient in the Thrombolex Early Feasibility and Safety Study,” said Parth Rali, assistant professor, Thoracic Medicine and Surgery at Lewis Katz School of Medicine at Temple University in Philadelphia, USA. “The catheter removed a large volume of clot from the pulmonary arteries efficiently, and safely restored blood flow, that resulted in a very rapid improvement in the patient’s overall clinical status.”

In this patient with a critical, large submassive PE that severely compromised blood flow to both lungs, a total of 14mg of r-tPA was administered over eight hours. “There was a dramatic improvement in the patient’s haemodynamic state and oxygenation as well as evidence of a marked reduction in clot burden as compared to what has been seen in other catheter-directed thrombolysis studies using a similar dose of r-tPA,” says Riyaz Bashir, director of Vascular

Bashir endovascular catheter

and Endovascular Medicine at Temple University Hospital. “We believe that the Bashir Endovascular Catheter may represent a quantum leap in the treatment of venous thromboembolism patients, not just acutely, but also in terms of their longer-term health status,” says Brian Firth, chief scientific officer at Thrombolex.

“Thrombolex is focused on developing more advanced therapies for treatment of patients suffering with venous thromboembolic (VTE) disorders,” said Mike Cerminaro, president & COO of Thrombolex. “We are passionate about our focus because PE is a common disease, which is the third highest cause of cardiovascular mortality and is responsible for up to 180,000 deaths annually in the USA alone.”

“Currently available infusion catheters used to treat PE and other large clots are not able to rapidly restore blood flow through the thrombus and allow for only limited radial diffusion of exogenously administered thrombolytics like r-tPA into a clot,” explained Marv Woodall, chairman & CEO of Thrombolex. The Thrombolex investigational trial is designed to examine if lower doses of thrombolytic via the Bashir Endovascular Catheter can be administered much more effectively over less time and thereby minimise major bleeding complications.

This investigational study is a 10-patient prospective, multicentre clinical study to evaluate feasibility and safety of the catheter to treat patients with intermediate-risk PE. It represents the first in a series of planned clinical trials to evaluate this new platform technology that has been developed by Thrombolex.

Paediatric trial finds rivaroxaban similar to standard anticoagulation in treatment of VTE

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced new results from the Phase 3

EINSTEIN-Jr study, showing paediatric patients (aged birth to 17 years) treated with rivaroxaban (brand name Xarelto) had a similar low risk of recurrent venous thromboembolism (VTE) and similar rates of bleeding when compared to current standard anticoagulation therapy.

These results, from the largest paediatric study ever conducted for the treatment of VTE, also show that the efficacy and safety profile of rivaroxaban in a paediatric population with VTE is comparable to what has been observed in previous studies of adults with VTE. The full findings were presented during a late-breaking session at the 27th Congress of the International Society on Thrombosis and Haemostasis (ISTH; 6–10 July) in Melbourne, Australia.

While VTE more commonly occurs in adults, it affects approximately 58 per 10,000 hospitalised children in the USA. There are very limited treatment options for these young patients, and no direct oral anticoagulant is currently approved for use in this setting. Current treatment is mainly based on observational data in this group and extrapolation of data obtained in adults, even though the pathophysiology and anatomic distribution (where it occurs in the body) of VTE, along with anticoagulant responses, differ between children and adults. Until EINSTEIN-Jr, only one small randomised trial had been published evaluating the use of standard anticoagulants in paediatric patients with VTE. Current guidelines recommend that young patients with VTE be treated with standard anticoagulation therapy. For these patients, physicians manipulate adult dosage forms of these older anticoagulants, many of which require injections and regular laboratory monitoring.

“This trial examined for the first time whether a direct oral anticoagulant could alleviate the burden of blood clots in young patients, which would allow them to focus on recovering from their other health challenges,” says Christoph Male, Department of Paediatrics, Medical University of Vienna, Vienna, Austria. “The EINSTEIN-Jr study with rivaroxaban represents a significant advance for paediatric VTE treatment.”

The main efficacy outcome of EINSTEIN-Jr was symptomatic recurrent VTE (fatal or non-fatal), and the principal safety outcome was the composite of major and clinically relevant non-major bleeding. The study met.all of its pre-specified endpoints.

Recurrent VTE was similar in both treatment groups, with a numerically lower number of events in patients treated with rivaroxaban. Specifically, 1.2% of the rivaroxaban group and 3% of the standard anticoagulation group experienced a recurrent event (HR: 0.40; 95% confidence interval [CI], 0.11– 1.41); there were no fatal VTE events in either treatment arm.

Clinically relevant bleeding was also similar, occurring in 3% of the rivaroxaban group and 1.9% of the standard anticoagulation group (HR:

17

Xarelto (rivaroxaban)

1.58; 95% CI, 0.51–6.27). There were no major bleeding events in the rivaroxaban group, and two major bleeding events in the standard anticoagulant group.

In addition, the composite of recurrent VTE and major bleeding (net clinical benefit) occurred in 1.2% of the rivaroxaban group and 4.2% of the standard anticoagulation group (HR: 0.30; 95% CI, 0.08–0.93).

The efficacy of the drug was further demonstrated by reduction in clot burden on imaging tests that were conducted on patients both at baseline and at the end of the treatment period.

Complete resolution of the initial VTE mass occurred in 38.5% of the rivaroxaban group compared to 26.1% of the standard anticoagulation group (overall response: 1.72; 95% CI, 1.12–2.69).

Mentice and Siemens Healthineers bring a virtual patient to the angiosuite

Siemens Healthineers and Mentice AB have announced that they are collaborating to fully integrate Mentice’s VIST virtual patient into the Artis icono angiography system from Siemens Healthineers.

According to a press release, the VIST virtual patient thus becomes a fully integrated simulation solution for the angio-suite. The global partnership between the two companies will allow interventional radiologists, neuroradiologists, and cardiologists to perform vascular and cardiac interventions on a virtual patient inside the angiosuite.

“With an ever-increasing complexity of new interventional procedures, our customers strive to acquire and retain procedural skills while optimising their performance and improving patient safety. The Artis icono angiography system equipped with a VIST virtual patient will make it possible to train new interventional procedures directly in the angio room,” says Michael Scheuering, head of Interventional Radiology at Siemens Healthineers.

“The VIST virtual patient integration into the Artis icono angiography system will open new opportunities for clinical teams to improve their overall performance, drive operational efficiency, and, more importantly, help improve patient outcomes. By using the Artis icono system on the VIST virtual patient, clinicians may now explore new interventional procedure methods

18

September 2019 | Issue 11

Events

Product News and experience the use of new medical devices while reducing clinical training on actual patients and eliminating exposure to radiation,” comments Göran Malmberg, CEO at Mentice.

“The VIST virtual patient provides an immersive, high-fidelity, simulationbased environment accessible right from the Artis icono system, making this integration one of the most sophisticated options in the field of endovascular skills acquisition.”

Interventionalists may now perform simulated cardiac and vascular procedures by using the Artis icono controls to angulate the C-arm, move the angiography table, use the foot pedals, and review fluoroscopic images on the Artis icono screens while deploying actual medical devices in a radiationfree environment. The integrated solution will allow clinicians to perform procedures either by using Mentice’s extensive library of patient cases or by importing actual MR and CT patient data for case training and rehearsal.

Transesophageal echocardiography (TEE), intravascular ultrasound (IVUS), optical coherence tomography (OCT),

and fractional flow reserve (FFR) procedures are also available.

InterVene raises $15 Million in Series B funding for catheter-based deep venous reflux treatment InterVene has raised US$15 million in a Series B financing round. The company’s BlueLeaf Endovenous Valve Formation system is the first catheterbased solution for deep venous reflux that does not require an implant.

The system is designed to correct one of the underlying causes of chronic venous insufficiency (CVI) by forming new vein valves out of a patient’s own vein wall tissue. The funding round was led by new investor 3×5 Partners, who was joined by prior investors RiverVest Venture Partners, Boston Scientific Corporation, Correlation Ventures and others.

“The funds will be utilised to expand our clinical research programme abroad, and to initiate trials in the USA via an investigational device exemption study,” explains InterVene CEO Fletcher Wilson. “We expect to

further demonstrate safety and clinical effectiveness while we optimise the BlueLeaf system and procedure in preparation for a subsequent pivotal study.”

InterVene’s recently expanded management team includes COO Jeff Elkins, who has led numerous emerging endovascular technology companies, including his role as CEO of Veniti, which was recently acquired by Boston Scientific. Also joining the company is VP clinical affairs Tracy Roberts who has directed clinical activities for leading vascular and biomedical companies.

Approximately 6.5 million Americans suffer from deep venous reflux and moderate to severe CVI. Patients with deep venous reflux tend to progress to the most severe symptoms, including skin breakdown and chronic ulcers, which have negative impacts on their quality of life. The current standard of palliative treatment—involving compression therapy, leg elevation and local wound care—does not address the underlying problem of deep vein valve failure.

InterVene’s BlueLeaf system is the first catheter-based approach designed to address severe CVI due to deep venous reflux, by forming new vein valves for patients without the need for an implant. The system allows a physician to fashion new valves from the inner layer of the vein wall. The resulting

autogenous valves aim to reduce retrograde blood flow and alleviate the symptoms associated with elevated venous pressures.

“The BlueLeaf technology has the potential to offer a solution for patients with deep venous reflux, a current major gap in our treatment portfolio,” says William Marston, department chief of vascular surgery and professor of surgery at UNC Medical School (Chapel Hill, USA). “The reports of the initial patients treated with the procedure are promising, and if confirmed in larger studies with longer follow-up, can provide a novel, important treatment option for this underserved patient group.”

“Treatment options for patients with deep venous reflux have been limited,” says Mikel Sadek, vascular surgeon and assistant professor of surgery at NYU Langone Health (New York, USA).

“This innovative technology may offer an alternative for patients needing procedural intervention to treat their disease.”

The BlueLeaf technique is predicated on the Maleti Neovalve open-surgical procedure, but enables patients to avoid the trauma of open surgery, allows for multiple valves to be formed in a single procedure and mechanises certain aspects of the technically-difficult open surgical procedure for ease of use and repeatability.

Calendar of events 24–27 September ESVS: European Society for Vascular Surgery annual meeting Hamburg, Germany

11–12 October 8th Meeting of the American of Wound Healing and Tissue Repair Chicago, USA

7–10 November AVLS: American Vein and Lymphatic Society Phoenix, USA

27–29 November The Vascular Societies’ Annual Scientific Meeting Manchester, UK

www.esvs.org

www.acwound.org

www.avlscongress.org

www.vascularsociety.org.uk

2–3 October EVF HOW Plus Course: Venous Stenting and Thrombolysis Training London, UK

17–19 October 10th annual EVF HOW Riga, Latvia

19–23 November VEITHsymposium New York, USA

www.evfvip.com

www.veithsymposium.org

5 December Vascular Anomalies Special Interest Group Forum 2019 London, UK

www.evfvip.com

2–4 November TheVEINS at VIVA Las Vegas, USA

www.bsir.org

www.vivaphysicians.org

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