Vascular News 79 — September 2018

Sept

Issue

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Recruitment for vascular disease management struggles to keep up with expected demands on the workforce

Alison Halliday:

Profile

Shortages in the US vascular surgery workforce was the focus of this year’s Stanley Crawford Critical Issues Forum at the Society for Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM; 20–23 June, Boston, USA). The session highlights a problem faced by governments and healthcare providers across the world, as specialists struggle to keep up with increasing older demographics and a globally escalating vascular disease burden.

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Post-atherectomy IVUS better than angiography for dissection detection

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he annual Critical Issues Forum, as explained by SVS president Michel Makaroun, focuses each year on a “very important topic facing our specialty and practice”. Opening the session, Makaroun said “most of you are well aware that we have a national surgeon shortage”, and it is true that the challenge facing vascular surgery in the USA is one that has been discussed frequently in recent years. A report on behalf of the SVS and published in the Journal of Vascular Surgery in 1996 identified future workforce issues in the field, and proposed ways to mitigate this problem. Makaroun acknowledged that although “it is not a new problem, unfortunately, it seems all we have been doing about it so far is applying band-aids—and the problem keeps on getting worse.”

Similar warnings have been raised in other countries, as a 2014 survey of the UK vascular surgeon workforce carried out by the Vascular Society of Great Britain and Ireland reported: “As we anticipate the changing demographics and treatable disease patterns over the next 40 years, we consider it inevitable that our specialty will be in short supply at a time when demand for our services is growing rapidly”. Sophie Renton, consultant vascular surgeon at the London North West Healthcare NHS Trust and member of the vascular Specialty Training Committee in London, UK, tells Vascular News “It is anticipated that there will be a shortage of vascular surgeons in the UK. We recruit less than 30 vascular trainees every year, the number is

a little variable. We also recognise that up to 50% of our established consultants will retire in the next five years.

At the same time, we recognise that the need for vascular surgeons will increase with the increasingly elderly population and the increase in diabetic foot disease.”

A 2013 study published in Health Affairs by Timothy Dall and colleagues similarly posited the problem that “An ageing population and growing disease burden will require a large and specialised healthcare workforce by 2025”, and goes on to project that “the demand for adult primary care services will grow by approximately 14% between 2013 and 2025. Vascular surgery has the highest projected demand growth (31%), followed by cardiology (20%) and neurological surgery, radiology, and general surgery (each 18%).” Five years have passed since that paper, as Makaroun argued at SVS VAM: “The shortage is not really in the future. The shortage is really upon us, right now.”

The age of the vascular surgeon—and the patient

The ageing population, often mentioned in the context of the so-called “baby boomer generation”, is a problem faced across the Western world. The continuing swell in numbers of this demographic comes with clear implications for the vascular workforce, as Makaroun points out this is the Continued on page 6

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A study published in the Journal of Invasive Cardiology has found that dissections post atherectomy are grossly under-appreciated on angiogram when compared to intravascular ultrasound (IVUS) and calls for a multicentre registry to correlate these findings with clinical outcomes.

N

icolas Shammas (Midwest Cardiovascular Research Foundation, Davenport, USA) and colleagues explain that cine angiography has been widely utilised as the main tool to evaluate and treat the infrainguinal arteries. However, they write, “angiographic images are suboptimal in identifying the severity of calcium, presence of intraluminal thrombus, plaque morphology, true vessel diameter, and residual narrowing post intervention. Also, the number and severity of dissections including medial and adventitial injury have long been suspected to be under-estimated on angiography”.

In various studies atherectomy has been reported to reduce angiographic dissections and therefore bailout stenting. The extent and nature of dissections following atherectomy, however, Shammas et al write, may have been under-appreciated on cine angiography.

Atherectomy has not been shown to be superior to angioplasty in reducing target-lesion revascularisation (TLR) or restenosis, which may be partly explained by undetected deeper dissections on an angiogram.

The authors therefore present data on the number and severity of dissections as seen on IVUS following atherectomy based on the iDissection classification and Continued on page 4

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4

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Dissection detection

Post-atherectomy IVUS better than angiography for dissection detection Continued from page 1

the National Heart, Lung and Blood Institute (NHLBI) classification for coronary dissections.

They explain that the iDissection classification combines depth of injury from intima to adventitia with the circumference of dissection as seen on IVUS. This classification exhibits six dissection grades (A1, A2, B1, B2, C1, and C2). Grade A involves the intima, grade B involves the media, and grade C involves the external elastic lamina.

Number 1 indicates the circumference of the dissection is <180°, whereas number 2 indicates ≥180°. Similarly, the NHLBI classification is angiography based and also uses six dissection grades (A–F). Grade A is a minor radiolucent area, grade B is a linear dissection, grade C indicates contrast outside the lumen, grade D indicates a spiral dissection, grade E indicates persistent filling defects, and grade F indicates a total occlusion.

The study prospectively enrolled a total of 15 patients undergoing atherectomy of the femoropopliteal arteries for de novo or restenotic disease (non-stent restenosis). Thirteen of the 15 patients were treated with Jetstream atherectomy (Boston Scientific) and two patients were treated with the investigational B-laser device (Eximo Medical) as part of the Eximo X-PAD trial. Cine angiography and IVUS using the Eagle Eye Platinum ST catheter (Philips) were performed on the treated segments at baseline, post atherectomy, and post adjunctive balloon angioplasty. Adjunctive balloon angioplasty was left to the operator’s preference for the choice of the balloon (non drug-coated, drug-coated, lithoplasty balloon, or combination) sized 1:1 to the vessel size. The segment to be analysed for dissections was marked on a radiopaque ruler and images obtained with cine and IVUS were analysed within the same segment length.

Cine angiograms were obtained on two orthogonal views.

Cine images were analysed at the centre’s Quantitative Vascular Laboratory using CAAS software (Pie Medical) and IVUS images were analysed independently using Echoplaque software (INDEC Systems, Inc). Disagreements on IVUS image interpretations were reviewed by the principal investigator (NWS) and a consensus was obtained.

Dissections on cine images were classified based on the NHLBI classification. Dissections on IVUS images were classified using the iDissection classification. The number and grade of dissections seen on cine angiography were compared with those identified on IVUS findings for the same segments analysed. Since co-registration is not available for peripheral applications using IVUS, a direct comparison of cine dissection to IVUS dissection was not feasible; therefore, only total and severity of dissections could be quantitated within the same segment using both imaging modalities, the authors explain.

Demographics, clinical variables, and angiographic variables were collected on all patients. Procedural success was defined as obtaining <30% residual narrowing after adjunctive treatment. Device success was defined as a residual stenosis of <50% after atherectomy alone.

Dissection length (mm) was determined based on the number of frames the dissection starts and ends. Given the total number of frames/run, the length of the run as measured by the ruler, and the number of frames/dissection, the dissection length was then calculated as: number of frames per dissection, total lesion length (mm)/total number of frames per total lesion length.

The mean age of the study cohort was 70.6±8 years.

Diabetes and claudication were present in 60% and 73%, respectively. The majority of patients had history of hyperlipidemia, hypertension, and smoking. Critical limb ischaemia was present in almost 27% of patients.

Mean baseline, post-atherectomy, and post-adjunctive angioplasty stenosis severity rates were 71.4%, 38.1%, and 19.7%, respectively. The PACCS classifications for calcium grading were 40%, 20%, 26.7%, and 13.3% for grades 4, 3, 1, and 0, respectively. Lesion length was 108.5±43.1 mm. Procedural and device success rates were 86.7% and 66.7%, respectively.

Post atherectomy, there were 46 dissections identified on IVUS versus eight dissections identified on angiogram (p<0.01) (ratio, 5.75 to 1). Post adjunctive angioplasty, there were 39 dissections identified on IVUS versus 11 identified on angiogram (p<0.01) (ratio, 3.55 to 1). Of these dissections, 13% and 30.8% were ≥180° in circumference post atherectomy and adjunctive balloon angioplasty, respectively. Also, 39.1% and 33.3% involved the media and/or adventitia as seen on IVUS post atherectomy and adjunctive balloon angioplasty, respectively.

A1 to C1 dissections were 40/46 (87%) post atherectomy versus 27/39 (69%) post adjunctive angioplasty. There was no statistical difference between the dissection pattern and number of dissections between post atherectomy and post adjunctive balloon angioplasty (p=0.64). A to C dissections were 7/8 (87%) post atherectomy and 10/11 (91%) post adjunctive angioplasty. Intramural haematoma was also seen in 2/15 patients (13.3%) post atherectomy and adjunctive balloon angioplasty.

Using binomial analysis for predictors of severe postatherectomy dissections (≥180°), balloon pressure, inflation time, critical limb ischaemia, and degree of calcium did not correlate with dissection severity as seen on IVUS. Longer lesions, however, correlated with more dissections post atherectomy on IVUS (p=0.03) but not on cine angiogram (p=0.28). Dissection lengths were not different after atherectomy (12.2±11mm) versus adjunctive balloon

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angioplasty (11.4±9mm) (p=0.99).

“In this small series of patients undergoing atherectomy, there were significantly more dissections noted by IVUS when compared to cine angiography. Angiography has been the main modality used for evaluating the peripheral arteries, but it has consistently under-estimated the severity of calcium, the presence of thrombus, the true vessel size, and lesion severity. In contrast to the NHLBI classification, the iDissection classification reveals the extent of injury and its depth. Pathologic studies have shown that deeper injuries into the media and adventitia correlate with loss of patency and increase in TLR rate. These deeper injuries were also identified on IVUS. The identification of deeper injury that cannot be seen on angiography may offer an explanatory mechanism for the occurrence of restenosis in otherwise successful procedures as seen on angiography following atherectomy,” Shammas et al report.

They add that although data indicate that atherectomy reduces angiographic dissections and stenting compared to balloon angioplasty, this concept may need to be revisited with IVUS-based imaging. Data from the THUNDER trial and from Japan indicate that type C or higher dissections on angiogram correlate with poorer outcomes with balloon angioplasty. However, Shammas et al point out, the THUNDER trial also indicated that drug-coated balloon use seems to partly mitigate this negative outcome. The contribution of these dissections (particularly the deeper and more extensive ones) to restenosis following drug-coated balloon is unknown.

In terms of the limitations of this study, Shammas et al explain that they could not match dissections seen on cine angiogram with the exact dissections seen on IVUS since co-registration is not yet available for peripheral vascular applications.

However, they state, “given the larger number of dissections on IVUS compared to angiogram, it is clear that normal-looking segments on angiogram can have under-appreciated significant dissections”. Further, this study is single centre and focused predominantly on the use of the Jetstream atherectomy system (13/15 patients). It is unclear how other atherectomy devices behave. The clinical impact of these dissections is unclear in the drugcoated balloon era. Also, it is unclear how repair of these dissections with a traditional stent or the Tack Endovascular System (Intact Vascular) would alter the outcome.

Finally, Shammas et al write about the need for a large, multicentre registry to correlate dissection presence and subtypes with outcomes such as patency and freedom from target lesion revascularisation.

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6

Sept

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18 79

Vascular workforce shortage

Recruitment for vascular disease management struggles to keep up with expected demands on the workforce

Continued from page 1

patient age group in which vascular disease is more prominent. Changing demographics are impacting most areas of healthcare and surgery, as discussed by neurosurgeon Richard Kerr (Oxford University Hospitals, Oxford, UK) for the UK Royal College of Surgeons’ ongoing Commission on the Future of Surgery: “patient numbers are going to continue to rise. The age of the patient population we are going to treat will continue to rise. The complexity of those patients and particularly the comorbidities they carry, is going to continue to rise.” In the Commission’s collection of oral evidence, the impact of older demographics were clarified

by Nick Wareham, director of the MRC Epidemiology Unit in Cambridge, UK, who explained that the current UK population of 65 million people is expected to measure at 74 million in 2039. At the same time, “the proportion of people aged over 65 is really shooting up.” In 1976 this age group represented 14.25% of the total population, “but by 2036 it will be 23.9%. So, it is a bigger proportion of a bigger population.”

But the baby boomer phenomenon is not only a problem when it comes to patients: the vascular surgery specialty will see a significant portion of their ranks retire in the next decade, as well as the older general and thoracic surgeons still providing approximately 10% of vascular services, Makaroun points out. In the UK, the national survey carried out by the Vascular Society in 2014 found that as much as 35% of the consultant vascular workforce intended to retire in the next decade, by 2024. A more recent survey by the SVS in the USA reflect a working demographic that Makaroun describes as “scary”, with 41.7% of practicing vascular surgeon respondents over the age of 55.

In both USA and the UK, vascular specialists are also reporting high rates of burnout due to poor work-life balance and heavy workload. In 2017, the SVS found that 46.2% of its US based vascular surgeons take less than three weeks of vacation per year.

Denis Harkin

“almost the entire country falls below that level”. In their paper, Williams et al conclude that “the paucity of properly trained surgeons entering the workforce needs to be addressed before this shortage becomes a larger burden on healthcare providers and governmental spending.”

Training for the future

The number of fellowship pathways in vascular surgery have remained stagnant over the last decade according to Makaroun, despite efforts to restructure the specialist training programme with the ‘0+5’ five-year integrated residency Michel Makaroun training pathway, which has seen a modest increase in number of trainees Diabetes, peripheral arterial since it was introduced in 2006. disease and co-morbidities on A study co-authored by Makaroun and the rise presented by Jeffrey Jim (Washington In addition to ageing, lifestyle and dietary University, St Louis, USA) at the SVS changes across the world are having an VAM examined the efforts in the USA to impact on disease burdens, as diabetes increase the supply of vascular surgeons and vascular diseases are projected to over the last decade. Authors obtained reach epidemic levels worldwide. A 2013 data from several large national databases paper in The Lancet by Alan Hirsch and including the United States Census Sue Duval refers to peripheral arterial Bureau, the American Board of Medical disease as a “global pandemic”, affecting Specialties and American Medical over 200 million people. Indeed, the Association. Jim and his colleagues British Heart Foundation have recently found that although the 0+5 integrated estimated that the national rate of stroke pathway led to increase in medical student and heart attack in the UK is set to rise by interest, “there remains a predicted deficit 29% by 2035, as a result of an increased of vascular surgeons in the future”, with diabetes population. The Foundation a need for an additional 1,833 vascular states that diabetic patients are expected to surgeons by 2030. This is despite the an increase from four million to five million increase in training positions by 56%, within the next 20 years, leading to a as applicants have increased by 42%. “sharp increase” in heart and circulatory Presenting the data, Jim concluded “this is conditions such as atherosclerosis and an international phenomenon and it is not peripheral arterial disease. unique to the USA”, adding that further At the International Symposium evaluation is required on the topic of the for Endovascular Therapy (ISET; 2–3 uneven geographical distribution of the February, Hollywood, USA), Richard workforce.

F Neville (INOVA Heart and Vascular The Vascular Society’s 2014 Institute, Falls Church, USA) also UK workforce report stated in its highlighted the increase in diabetes and recommendations: “Additional training the effect it will have on the demand numbers are urgently required to fill for vascular surgery. Referring to the the vacancies created by the 35% of International Diabetes Federation’s Consultant Vascular workforce who annually updated Diabetes Atlas, Neville intend to retire within the next 10 reported, “diabetes continues to explode years.” The report adds, “We may around the world,” adding that for the need to train and appoint as many as 500,000 million people globally projected 291 new consultant vascular surgeons to have diabetes by 2030 “we are not in the UK over the next 10 years to training enough vascular surgeons”. maintain the status quo in respect to Writing in Vascular in 2016, Katherine the current level of service. […] If we J Williams and colleagues at the Icahn are to meet the minimum projections of School of Medicine at Mount Sinai, New future demand we may need to increase York, USA projected the number of US National Training Numbers (NTNs) in vascular surgeons to “linearly rise to Vascular Surgery significantly from the 3,573” by 2040. “In 2030,” they write, “an current allocation of 20 per annum.” estimated 3,333 vascular surgeons will be Renton spoke to Vascular News available for 180,000,000 people with at about her experience as a member least one risk factor for peripheral arterial of the Vascular Surgery Specialty disease.” At ISET, Neville elucidated, Training Committee in London, UK, these numbers translate to merely one noting that there are many challenges vascular surgeon per 50,377 patients facing trainees, which impacts on with peripheral arterial disease—“not to recruitment. “Attracting new trainees mention arterial disease, carotid disease to the speciality is difficult,” Renton and other types of disease.” According says, as “medical students are much to Makaroun, the best estimate for how less likely to be exposed to vascular many vascular surgeons are needed is 1.4 surgery during their training than in the per 100,000 total population, stating that past due to changes in the curriculum”.

These challenges are multifacetted, with a recent study published in the European Journal of Vascular and Endovascular Surgery finding that 46% of members in a national UK vascular trainee organisation responding to a survey were experiencing or witnessing bullying, undermining or harassment. Authors Robert Fisher and colleagues expand: “Although not previously recognised in UK vascular training, this has been reported in other specialties in Britain and internationally.”

“We have an active programme to recruit in to the speciality,” Renton says.

“We hold Introduction to Vascular Surgery sessions twice a year, as a course at the Vascular Society Annual Meeting, as well as at the Charing Cross Symposium.

We also have a medical student essay prize and a poster prize.” The Specialty Training Committee is further piloting a programme to recruit to the specialty at an earlier stage, “just two years out of medical school”, Renton explains. “We will be recruiting to this pilot programme in January 2019 with the first of these trainees entering training in August 2019.”

Sophie Renton

Urbanisation of vascular surgery

The 2017 survey carried out by the SVS found that only 6% of its US vascular surgeons practice in rural settings, with an overwhelming majority 85.4% of respondents practicing in cities with populations over 100,000. As the population ages, demand in the non-urban areas can for some countries increase, as Wareham alluded to in his oral evidence contribution to the Royal College of Surgeon’s Commission on the Future of Surgery: “My understanding is that cities ‘do not age’”, he said, meaning that urban areas like London remain largely inhabited by younger people, who then tend to retire in more rural or remote areas.

“I think that has implications for how we plan healthcare services,” Wareham added, “because we might be looking at a greater proportion of elderly people living quite a long way from major cities.”

In his presentation at SVS VAM, Makaroun explained that the concentration Continued on page 8

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Vascular workforce shortage

Recruitment for vascular disease management struggles to keep up with expected demands on the workforce Continued from page 6

of vascular surgeons in certain areas of the USA and shortages in others can to some extent be linked with the location of training centres, suggesting that vascular specialists tend to remain in the area where they trained. “There is a big part of the country that does not even have vascular training programmes”, and by adding such programmes in underserved locations, Makaroun argued they might be able to retain some practicing vascular surgeons in these areas.

Also speaking at the SVS VAM Critical Issues Forum, Anton Sidawy (George Washington University, Washington, DC, USA) presented conclusions from the American College of Surgeon’s 2017 Position Paper on Graduate Medical Education Reform. The paper expands on Makaroun’s argument for a regionalised education structure which places training programmes in underserved areas, further postulating that medical centres could be more successful at retaining trainees if they prioritise recruitment of trainees already local to the area. However, Sidawy warned, “the problem is more immediate”, and long-term strategies to mitigate it “will take a long time to be executed”.

In 2011, Alan J Grant et al argued in the British Medical Journal that although it has long been proposed that optimum care can

best be provided by centralising expertise to major care centres, this effort could leave rural areas at a disadvantage. Grant and colleagues write: “Attention must be paid to attracting trainees to a career in rural healthcare, and care must be taken to ensure that this training is adequate to perform the tasks required.”

Denis Harkin and colleagues published a study on the future workforce shortages in Vascular in 2016, observing that “in several UK Regions there are a large number of relatively small teams (three or less) of vascular surgeons working in separate NHS Trusts in close geographical proximity.

“In developed countries, both the number and complexity of vascular surgery procedures (open and endovascular) per capita population is increasing, and concerns have been raised that demand cannot be met without a significant expansion in numbers of vascular surgeons.” Speaking to Vascular News, Harkin adds that in the UK, “the crisis is most acute in Northern Ireland, where we only have three vascular trainee funded posts, instead of the minimum advised six.” Although he has spent several years assessing and projecting future shortages in the UK vascular surgery workforce, Harkin also notes, “predictions regarding growth in demand are complex, and like all

predictions, they are uncertain”.

Though the worldwide vascular disease burden is predicted to rise dramatically, the projected recruitment trajectory of vascular specialists is less clear and not as well-studied for many regions outside the UK and USA. Vascular News reached out to the European Society for Vascular Surgery (ESVS), and its president Alison Halliday, who reported that the ESVS do not yet have an estimate of the number of vascular surgeons currently practicing in Europe, nor how that number is expected to change in the future. Vincent Jongkind, secretary general of the ESVS’ subsidiary European Vascular Surgeons in Training, tells Vascular News that although they currently have 463 members, a number which Jongkind says has remained “more or less stable” over recent years, “it is almost impossible to predict the number of future vascular surgeons”.

The Union Européenne des Médecins Spécialistes (UEMS), does not have further information on the future of the vascular workforce number and demand in Europe either, according to its secretary general Armando Mansilha. He tells Vascular News it is a “very interesting” topic, which he is looking to put to the national delegates of the UEMS Council meeting, held at the ESVS annual meeting

Armando Mansilha

(25–28 September, Valencia, Spain) to determine whether they are able to provide answers to these questions. The ESVS meeting will also host a session on surgeon burnout, to present a survey of burnout in the USA and discuss the prevalence of this problem in Europe.

Though the USA and SVS are leading the inquiry into—and communication of—future workforce shortages, countries like the UK are similarly being made aware of the extent of this ‘critical issue, and it seems that all affected regions of the world must soon be sure to follow.

New surgical navigation system could help to eliminate radiation fears A new surgical navigation system, Intra-Operative Positioning System (IOPS) that is being developed by Centerline Biomedical along with Cleveland Clinic in the USA could help to do away with concerns around operator exposure to radiation during endovascular procedures.

T

he concept of the system was presented by Matthew Eagleton (Massachusetts General Hospital, Boston, USA) at the International Symposium on Critical Issues in Aortic Endografting (29–30 June, Malmö, Sweden).

While imaging is a key component of endovascular therapy, especially in terms of anatomy visualisation and endovascular tool localisation, it comes with caveats, such as radiation exposure. Eagleton explored currently available methods of imaging and vessel navigation, including CT-fusion, which provides high-definition image, but requires some radiation exposure and the need to coordinate images with anatomy (fusion); and ultrasound or intravascular ultrasound (IVUS), which is associated with limited imaging quality and some difficulty converting to a real-time image, but no risk of radiation exposure.

On the other hand, the IOPS described by Eagleton provides interactive 3D vascular imaging and electromagnetic tracking of endovascular tools within the vascular tree. He explained that the system was originally based on a mathematical model for vascular image construction. The model was generated from DICOM CT data and tested by assessing the relative geometry of the aortic branches. The algorithm is patient specific and automatic and the system was further developed so that it could “understand” the geometry.

According to Eagleton, the benefits of the model are that it is calculated automatically from a properly segmented DICOM CT scan, each model is concise (<100kB) and can be transferred over networks quickly, a multi-phase CT scan can have sequential models and differences between each phase can be interpolated readily, and the results are repeatable, so that there is no unpredictable “black box”.

As for how IOPS works, he explained that it is deployed in the operating room and the registration process is similar to fluoroscopy overlay. The tracking system attaches to the table quickly without tools, the field generator has radiotransparent supports and is empty in the middle to allow for an unobstructed fluoroscopy while it is in place, and the patient-mounted tracking pad maintains registration even in the context of gross patient motion. The electromagnetic tracking and sensor-equipped instruments mean no radiation exposure risk.

Further, he explained, IOPS provides enhanced three-dimensional imaging, the ability to manipulate the imaging to provide multiple, ideal views, the ability to track the endovascular tools within the vascular image—correlating directly with in vivo localisation—and provides superior imaging and navigation to standard 3D fluoroscopy.

The system has gone through bench testing and a

porcine study and Eagleton reported that Centerline Biomedical plans US regulatory submission in the near future and CE mark submission in 2019. In the meantime, advanced research and development is ongoing, focusing on the refinement of sensorequipped tools, the application to additional indications and the expansion of modelling capabilities.

Matthew Eagleton

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10

Sept

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Peripheral arterial disease

Peripheral arterial disease patients at increased risk for high opioid use Patients with peripheral arterial disease (PAD) are found to have an increased risk for high opioid use. Nathan Itoga and colleagues from the University of Stanford (Stanford, USA), presented the findings of a recent study analysing data from the 2007–2015 Truven Marketscan database that identified patients with opioid prescriptions and comorbidities, at the Society for Vascular Surgery’s Vascular Annual Meeting (VAM; 20–23 June, Boston, USA).

T

he number of deaths from prescription opioid pain relievers has continued to increase in recent years, with the “epidemic” affecting both males and females. According to Itoga, this now poses great concern to the USA. Although the USA is only 5% of the world’s population, the country consumes 99% of available hydrocodone and 85% oxycodone (opioid derivatives). Itoga emphasised that not only are there prescription related deaths, but the majority of new heroin abusers begin with opioids. Furthermore, over the past two years, opioid-related deaths have been linked to a decrease in life expectancy in the country.

Itoga also noted that the current literature indicates a lack of studies surrounding prescribing patterns. One of the goals of Itoga et al’s study was to investigate the effects of peripheral arterial disease (PAD) on opioid prescription patterns.

Additionally, the authors sought to evaluate high opioid users in patients. For these reasons, Itoga stated that providers need to be vigilant in their prescribing patterns.

Using the 2007–2015 Truven Marketscan database, Itoga and colleagues retrospectively identified patients with opioid prescriptions as well as comorbidities. They further investigated the impact of PAD related procedures, including open and endovascular revascularisation procedures as well as amputations above the ankle.

Given that the authors used a de-identified national private insurance claims database, they included patients with ≥ two ICD-9 diagnosis codes

of PAD ≥ two months apart with at least two years of continuous enrolment. Critical limb ischaemia (CLI) was defined as rest pain, ulcers or gangrene.

The primary outcome was high opioid use, defined as ≥ two opioid prescriptions within a one-year period. Opioid prescriptions were excluded if filled within 90 days of a PAD-related procedure, identified by CPT codes for lower extremity open and endovascular revascularisation or amputation.

A total of 182,186 patients with PAD met the inclusion criteria, 27.1% of whom had CLI. An average of 24.4% of patients with PAD met the high opioid use criteria in any given calendar year, with a decreasing trend for patients meeting criteria beginning in 2010 (p<0.01). Of high opioid users, 26% continued to meet criteria for five years.

High opioid use was more common for patients with CLI (32.2% vs. 21.4%, p<0.01). During years of high opioid use 5.9±5.3 yearly prescriptions were filled. The multivariate analysis indicated that illicit drug use and back pain were the strongest predictors of high opioid use (p<0.001).

Additionally, a new diagnosis of PAD increased high opioid use (21.3% before PAD diagnosis vs. 26.9% after PAD diagnosis, p<0.01). This association was seen for patients without CLI (20.2% to 24.1%, p<0.01) and with CLI (27.5% to 37.7%, p<0.01).

PAD treatment—after excluding peri-procedural opioid prescriptions—was found to increase high opioid use percentage, even after excluding 90-day related prescriptions—as the percentage increased

Nathan Itoga

from 25.6% pre-treatment to 29.2% post-treatment (p<0.01).

Itoga noted limitations of the retrospective study.

As the authors derived data from a claims database, it would have been prone to residual confounding.

Limited information regarding physician practices as well as the private insurance aspect of the sample also reduced the validity; with the latter limiting generalisability to patients above the age of 65.

Irrespective of the current limitations, Itoga concluded that patients with PAD are at increased risk for high opioid use, with nearly one-quarter meeting described criteria. CLI additionally increases opioid utilisation, but PAD treatment does not appear to decrease high opioid use.

In relation to moving forward, Itoga said that in addition to heightened awareness and active opioid management, the findings warrant further investigation into causes and deterrence of high-risk opioid use, and further reiterated that providers in particular should be aware of those diagnoses when prescribing opioids to patients.

DETOUR I 12-month data show promising durability of bypass system Results from the DETOUR I trial evaluating the DETOUR System (PQ Bypass) for percutaneous bypass showed promising 12-month durability for patients with extremely long blockages in the superficial femoral artery (SFA). The data were presented as a late-breaking clinical trial session last week at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (20–23 June, Boston, USA).

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he trial enrolled lesions longer and more complex than those typically studied in SFA clinical trials, with an average lesion length of 37cm, 100% TASC II C/D, 96% chronic total occlusions (CTO), and 81% with moderate-to-severe calcification.

The DETOUR I trial, a prospective, single-arm, multicentre, core labadjudicated study, enrolled and treated 77 patients and 81 lesions. Primary and primary-assisted patency at 12 months in all lesions of the DETOUR I trial was 73% and 80%, respectively.

Secondary patency was achieved in 94% of patients. Additional safety and effectiveness outcomes include 100% freedom from amputation, 99%

freedom from acute limb ischaemia, and Rutherford improvement of ≥2 classes in 90% of patients.

“The lesions treated in DETOUR I were more than just long, they were extremely long, completely blocked, and severely calcified,” said Dainis Krieviņš, vascular surgeon and director of the Institute of Research at Pauls Stradins Clinical University Hospital, Riga, Latvia. “Endovascular devices currently approved for use on these incredibly challenging lesions have surprisingly low durability in lesions that are half the size of the average DETOUR lesion and fail approximately 40% of the time by the 12-month milestone. This truly highlights the need for the minimally invasive

DETOUR procedure for long, complex SFA lesions.”

Percutaneous femoropopliteal bypass (the DETOUR procedure) is an entirely new procedure enabled by the DETOUR System. The DETOUR procedure creates a pathway with PQ Bypass’s proprietary stent grafts, originating in the SFA, travelling through the femoral vein, and ending in the popliteal artery, bypassing the diseased part of the artery. The stent grafts re-direct oxygen-rich blood around the blockage, restoring blood flow to the lower leg and foot of the patient.

“These results represent exciting promise for patients with long, complex SFA lesions, a growing, yet

severely underserved population,” said Heather Simonsen, VP of Global Therapy Development at PQ Bypass.

“By routing blood around the disease, rather than forcing a way through it, the DETOUR System is designed to treat extremely long lesions that are not well-addressed by current endovascular devices. We look forward to continuing the collection of clinical data in our US IDE to build upon the outcomes observed in DETOUR I.”

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12

Sept

Issue

18 79

Abdominal aortic aneurysms

Population-based AAA screening of women would yield “little benefit”, says SWAN study The findings of the SWAN (Screening women for abdominal aneurysms) project, recently published in The Lancet, have indicated that an abdominal aortic aneurysm (AAA) screening programme for women in the UK—similar to that which has proved successful for men— would not be cost-effective and would yield little benefit.

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tudies, including four randomised trials, have shown a benefit of population-based screening in men in reducing AAA-related mortality by up to 40% although any reduction in all-cause mortality is small. Several countries have introduced costeffective population screening programmes for AAA in men aged at least 65 years.

Study authors Michael Sweeting and colleagues explain that there would be no quick answers from doing a randomised trial of AAA screening in women, because of the large sample size and long-term follow-up that would be required. The alternative is long-term modelling. This requires contemporary and reliable estimates of parameters that can influence the clinical and cost-effectiveness of screening in women.

The aim of Sweeting et al’s project was to obtain this information and then apply discrete event simulation modelling to explore the hypothesis that a variation of the current AAA screening programmes for men might prove clinically beneficial and cost-effective in reducing deaths from ruptured AAA in women.

A decision model was developed to assess the differences in life-years, quality-adjusted life-years (QALYs) and costs for a population of women invited to AAA screening versus a population who were not invited to screening (the status quo).

The reference case assessed the long-term costeffectiveness of an invitation to a single ultrasound screen for all women in the UK at age 65 years, based on the UK National Abdominal Aortic Aneurysm Screening Programme (NAAASP) for men; namely a diagnosis of AAA when aortic diameter was at least 3cm, annual surveillance for individuals with the smallest AAA (3–4.4cm) at their most recent scan, a surveillance scan every three months for those with a medium AAA (4.5–5.4cm), and referral to a vascular surgeon for a large AAA (5.5cm). Those with no AAA detected would not be rescreened. A UK National Health Service (NHS) perspective was taken for costs including invitation, screening, consultations, elective surgery, and emergency surgery for ruptured AAAs. A total of 12 different screening options were assessed, including changing the age at screening from 65 to 70 years, lowering the diagnosis threshold from 3cm to 2.5cm (on the basis of available data on aortic diameter distribution in older women), and reducing the intervention threshold from 5.5cm to 5cm or 4.5cm. The most cost-effective option was selected as the best alternative screening strategy.

“Using the same screening protocol as for 65-year-old men in NAAASP, screening detected AAA in 0.31% of the population resulting in 23% more AAAs detected in total from age 65 to 95 years, leading to an additional 452 elective operations per one million women invited to screening, 21% more than predicted to occur under no screening. Most of these additional operations occurred between the ages of 67 and 77 years.

By contrast, there were 97 (4%) of 2336 fewer emergency operations, and 396 (4%) of 9235 fewer AAA ruptures, predominantly occurring after age 70 years. Approximately half of the AAA ruptures in the group invited to screening occurred in women with aortic diameter of less than 3cm at initial screening. There were 85 (7%) of 1269 fewer AAArelated deaths in the first 10 years after screening

Based on current evidence and definitions of AAA in men, population AAA screening of women would yield little benefit. and 257 (3%) of 8388 fewer deaths overall from age 65 to 95 years. For every four women who avoided an AAA-death because of successful screening, one woman died due to additional elective repair (342 avoiding AAA-related deaths because of screening versus 85 deaths caused by elective surgery after screening). There was an early negative effect of screening on deaths due to AAA because of the high operative mortality for elective repair, particularly since less than half of the repairs in women aged younger than 75 years used EVAR. Overall, 3900 women would need to be invited to screening to prevent one AAA-related death,” the authors report.

They further explain that for those women invited to screening, the increase in mean QALYs was 0.0011 (SD 0.0008) and costs, which were discounted at 3.5% per year, increased by a mean of £34 (4.7), which gave an incremental cost-effectiveness ratio (ICER) of £30,000 (95% CI 12,000–87,000) per QALY gained. The ICER fell considerably as the model time horizon increased because benefits from screening continued to accrue over a 30-year period.

The wide confidence interval for the ICER was mainly due to uncertainty in the incremental QALYs. A best alternative strategy was considered: offering screening at age 70 years, together with lowering the threshold for AAA diagnosis to 2.5cm and lowering the threshold for considering surgery to 5cm, Sweeting et al explain.

This, they write, “resulted in a substantially

larger number of screen-detected AAAs (1.2% of the population) and more elective repairs were done because of the screening programme (1301 more elective repairs in the best alternative strategy versus 452 more elective repairs in the reference case per one million invited women), attributable to the higher age and lowered intervention threshold. There was a greater overall reduction in emergency operations and AAA-related deaths, with 229 (12%) of 1914 fewer AAA-related deaths from age 70 to 80 years and 566 (8%) of 6886 fewer deaths overall from age 70 to 95 years, per one million women. However, there was also an increase in the number of AAA-deaths after elective repair: for every seven women who avoided an AAA-related death because of successful screening, two women died due to elective repair of screen-detected AAA (789 avoiding AAA-related deaths because of screening versus 223 deaths caused by elective surgery after screening). About a quarter of AAA ruptures in the group of women invited to screening occurred in those who initially had aortic diameter of less than 2.5cm. Overall, 1800 women would need to be invited to screening to prevent one AAA-related death”.

They conclude that “based on current evidence and definitions of AAA in men, population AAA screening of women would yield little benefit.

Other screening options have more favourable costeffectiveness but could lead to more overdiagnosis and overtreatment. Further research on the population-based aortic size distribution in older women is needed, to provide a female-specific definition of AAA, together with better quantitative studies of the effect of screening on quality of life”.

The study authors maintain that urgent research on the population-based aortic diameter distribution in older women, and on the quality of life decrements associated with screening, is necessary before closing the door on the possibility that in some healthcare systems, population screening for AAA in women might be cost-effective.

The results of the SWAN study were presented for the first time at the Charing Cross Symposium in 2017.

14

Sept

Issue

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Training

Augmented reality can lend you the “eyes of the first operator” GIANPAOLO CARRAFIELLO COMMENT & ANALYSIS In February 2018, the first European case of endovascular aneurysm repair (EVAR) for the treatment of an abdominal aortic aneurysm was performed using a prototype device based on augmented reality by Nyali Swiss, an advisory company based in Lugano, Switzerland, write Anna Maria Lerardi, Mario Petrillo, Salvatore Alessio Angileri and Gianpaolo Carrafiello (pictured), from Milan, Italy.

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he procedure was performed in the angiosuite of San Paolo Hospital, in Milan, Italy. In real time, several doctors, residents and students, watched (via live streaming) the procedure above with “the eyes of the first operator”. The “spectators” were in Pisa, Italy, where the first edition of the European Campus in Interventional Radiology took place, dedicated to Italian and European residents.

The prototype device used is based on “space-cognizant” augmented reality that is able to superimpose virtual objects on the surroundings. The “virtual objects” represented in each scenario can have spatial relationships with real objects in 3D space: in our case an external operator was able to draw arrows or annotation on specific points on the patient’s skin or in other locations in the angiosuite.

The result was a strong interaction between the first operator, external consultants and the “spectators” in Pisa. All subjects were able to see and interact with the first operator.

In the meanwhile, the first operator was able to consult some virtual objects located in the angiosuite like the CT scan of the patient and some other documents that were able to help

during the procedure. These were all superimposed as holograms in specific areas of his field of view.

Many start-ups are currently using augmented reality technologies for employee training: the aim is to familiarise trainees with different environments or specific scenarios. This approach is derived from the military, which has been experimenting in augmented reality interfaces for years.

It is now being exploited in interventional radiology to enable a consultant to virtually (outside of the operating theatre, at home or anywhere in the world) make suggestions to the first operator to decide on strategies, or issue warnings that are useful for the correct execution of the treatment by sharing the same field of view and the same information. In more and more cases, non-expert operators may deal with challenging situations by calling upon help “from home”. This could be a more expert colleague (at home; in another room; or somewhere else in the world entirely) who is now able to see the procedure and suggest real-time operating strategies.

Our experience could be considered a milestone in augmented reality applied to interventional radiology, switching

as we were from a virtual scenario to the patient bedside.

We have observed a faster learning curve for novice operators compared with the usual coaching when we have used augmented reality. More students, residents and interested physicians may follow the procedure from outside the operating room.

Our aim is to use augmented reality to help manage the pain and distress associated with a wide variety of interventional radiology procedures by using different strategies focused on integrating analgesia with anxiety reduction. To this end, patients can wear special glasses equipped with immersive virtual reality and dial up a scene from a beach or any other different relaxing scenarios during different interventional procedures (whether they are oncological or not).

The aim is to investigate and capture the compliance and experience of patients with and without glasses.

In our department, we routinely perform percutaneous thermal ablation of solid tumours under mild sedation that provides both analgesia and anxiety reduction. We have undertaken a study that was based on the premise

that virtual reality glasses can serve to “distract” the patient from the pain of the procedure and preliminary results are showing that a lower dose of benzodiazepine was used in patients who wore glasses. We are also performing the same investigation in a non-oncological setting, specifically in the context of interventions to treat low back pain. Every year, we treat almost 200 patients with percutaneous lumbar and cervical disc decompression and our idea is to compare the dose of analgesics administered in patients wearing virtual reality glasses with those who do not. Moreover, a questionnaire to investigate patient compliance during the procedure will be proposed to every patient.

Virtual and augmented reality are new, evolving fields with several applications that need testing in clinic in order to help the technology mature and go beyond just entertainment.

Anna Maria Lerardi, Mario Petrillo, Salvatore Alessio Angileri and Gianpaolo Carrafiello (professor and chief of Diagnostic and Interventional Radiology Unit) are from the University of Milan, Milan, Italy.

One in five UK doctors say understaffing has affected patient safety The annual census of UK consultants and higher speciality trainees—Focus on Physicians 2017–2018—indicates that more than half of all consultants and two thirds of trainees reported frequent gaps in trainees’ rotas, with one in five respondents saying these are causing significant problems for patient safety in hospitals.

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he report, which has been jointly published by the Royal College of Physicians and Surgeons of Glasgow, the Royal College of Physicians of Edinburgh, and the Royal College of Physicians of London, also shows: Almost half of advertised consultant posts remain unfilled because of a lack of suitable applicants Consultants and trainees are working around 10% more than their contracted hours. This equates to trainees working an extra six weeks and consultants an extra month unpaid a year 33% of the current consultant workforce are

predicted to reach their intended retirement age in the next decade. Medical student places need doubling now to fill this and the gap left generally by doctors leaving the profession Satisfaction among consultants and trainees with working in general internal medicine remains significantly lower than with specialty-working.

Commenting on the findings of the census David Galloway, president of the Royal College of Physicians and Surgeons of Glasgow, says: “I am glad that the three Royal Colleges have once again joined together to produce this important piece of

work. It is vital that everyone involved in the NHS now reflects on these findings and takes all the action necessary to replicate best practice and address the challenges that this document has highlighted. What is of particular concern is the finding that almost one in five consultants across the UK reported that rota gaps cause significant problems for patient safety in their hospital. This is an unsustainable situation which must be addressed as a matter of urgency.”

He adds that while the colleges welcome the shortterm actions that UK governments (England & Wales and Scotland) are taking, they believe “consistent and sustained action” is needed if the situation is to be addressed in the longer term. “Government, patients and the medical profession must work hand in hand if we are to deliver the best possible NHS for all,” Galloway comments.

16

Sept

Issue

18 79

Peripheral

Higher proportion of limb salvage and lower amputation rates: The impact of a wound centre on a vascular surgery practice The opening of an outpatient wound centre has been associated with a significant increase in peripheral vascular practice and a significant decrease in amputation rate.

Venita Chandra and colleagues Alyssa M Flores, Matthew W Mell and Ronald L Dalman (Stanford University, Stanford, USA) believe that such centres result in synergistic systems that promote more aggressive and effective limb salvage strategies. Chandra presented the findings of a recent study analysing the clinical impact of a wound care centre on a vascular surgery practice, at the Society for Vascular Surgery’s Vascular Annual Meeting (VAM; 20–23 June, Boston, USA).

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ccording to Chandra, chronic wounds remain a growing problem, not only in the USA but worldwide—with many patients at risk of limb loss presenting as particularly challenging. This cohort requires complex and resource-intensive medical care, reported Chandra.

World experts and leaders in this specialty have developed and described programmes to attempt to improve the care of these complex patients and decrease the risk of amputation, all of which involve multidisciplinary approaches. Chandra provided an example of such a programme, outlined initially by Joseph L Mills (Baylor College of Medicine, Houston, USA) who described an in-hospital based limb salvage programme, involving both podiatry and vascular surgery. This programme demonstrated an impact in terms of a significant decrease in major amputation rates, as well as an increase in the number of vascular procedures. A key component to these multidisciplinary models and the care of these chronic wound patients, Chandra noted, is wound care itself.

Would care centres with multidisciplinary teams that provide weekly standardised wound care, including debridement, offloading, oedema and fluid management, have been demonstrated to make an impact in terms of wound healing and amputation rates. However, Chandra noted the problem with these wound care centres, as they can be difficult to manage, and cost-prohibitive.

She therefore stated that one consideration when developing a wound care centre would be the downstream revenue potential, and practice-building possibilities brought on to the affiliated hospital and vascular surgery practice. For example, patients taken care of by vascular surgeons in clinics would be sent to a wound centre for standard of care, regular wound management, which has been shown to have a significant impact. Chandra said that if the system works, they hope it will attract local and regional attention, as well as increasing referrals to the centre.

Chandra’s affiliated institution—Stanford University School of Medicine—opened an outpatient wound centre in 2013, with four rooms and two hyperbaric chambers; uniquely staffed by 50% vascular surgeons and 50% plastic surgeons, along with infectious disease specialists for on-site assessment of clinically infected wounds. Chandra and colleagues then carried out a study to assess the impact of the opening of an outpatient wound centre on the practice patterns of tertiary care vascular surgery practice.

The investigators performed a retrospective review of a prospectively maintained database of vascular surgery cases and compared the three-year period before the wound centre opened with the period immediately after its opening. They included patients that underwent revascularisations, debridements and amputations, and excluded trauma and acute limb ischaemia. They supplemented their data with extensive chart review and the social security death index.

Regarding the volume of procedures, 662 procedures were identified before the wound centre opened, and 1,085 procedures afterwards that met the criteria.

A rather interesting and key finding was that there was a disproportional increase in peripheral practice— with a 64% increase in volume of lower extremity interventions. These interventions initially comprised 19% of the practice before the wound centre opened, and then increased to 26% of the practice after the wound centre opened: a statistically significant difference.

In relation to patient characteristics, Chandra referred to data demonstrating that other than the increase in patients and limbs cared for, there was no difference in terms of age, sex and comorbidities that were cared for—showing that the same type, and demographics of patients were being treated. However, there was a significant difference in the number of patients who had wounds (39% before the wound centre opened, and 45% after, p=0.05).

Venita Chandra

Data regarding the surgical indications conveyed that while the absolute number of procedures for every indication went up after the opening of the wound centre, the proportion of patients treated for claudication decreased from 36% to 30% (p=0.02). Additionally, the proportion of patients treated for diabetic foot wounds significantly increased from 12% to 17%, (p=0.007). No differences were seen in the types of revascularisation procedures performed between cohorts, although there was an increase in surgical debridements and endovascular infrapopliteal interventions in the period after the centre had opened.

The investigators performed a multivariable adjusted analysis and found that treatment after the wound centre opened was associated with a significant reduction in risk of major amputation, compared to before (HR: 0.38, p<0.001). A similar analysis was also carried out for mortality, but this did not show any significant benefit (HR: 1.10, p=0.6).

Chandra concluded by reiterating that the opening of an outpatient wound centre was associated with a significant increase in peripheral vascular practice and a significant decrease in amputation rates. Chandra and her team also believe that having vascular surgeons embedded within wound centres results in synergistic systems that promotes more aggressive and effective limb salvage strategies.

SAVAL trial of new below-the-knee drug-eluting stent begins The first patient has been enrolled in the SAVAL pivotal trial to evaluate clinical outcomes of the SAVAL below-the-knee (BTK) drug-eluting stent system (Boston Scientific) in patients with critical limb ischaemia (CLI). The SAVAL BTK stent system is the first CLI device to be recognised by the US Food and Drug Administration (FDA) Breakthrough Device programme.

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early 17 million people in the USA live with some form of peripheral arterial disease with 11% of these cases developing into CLI. Research has shown that within one year of being diagnosed with CLI, 30% of patients will have undergone amputation. Arterial blockages below the knee can be challenging to treat effectively with traditional interventional procedures due to arterial recoil, which is the natural tendency of the vessels to maintain their original shape, and the high occurrence rates of calcified lesions.

According to Boston Scientific, the SAVAL BTK stent system is the first stent system designed specifically to address these anomalies with a paclitaxel-polymer

combination to facilitate sustained release of an anti-restenotic drug proven to minimise tissue re-growth and vessel recoil, thus reducing the potential for revascularisation.

Due to the absence of effective treatment options for patients suffering from CLI, the FDA granted the Expedited Access Pathway (EAP) designation to the SAVAL BTK stent system. This programme is intended to provide patients timely access to medical devices that demonstrate the potential to address unmet clinical needs in treating life threatening or irreversibly debilitating diseases or conditions. In late 2017, EAP devices were transitioned to the FDA’s Breakthrough Device programme.

“Critical limb ischaemia is a serious condition, affecting numerous patients at increasing rates across the globe,” said Jihad Mustapha, with the Advanced Cardiac & Vascular Amputation Prevention Centers in Grand Rapids, USA, and global principal investigator of the SAVAL trial. “The commencement of the SAVAL trial signals the advancement of endovascular techniques featuring the latest in drug-eluting stent technology, with the potential to drastically improve the quality of life for patients who live in fear of losing their legs due to CLI.”

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Sept

Issue

18 79

Carotid disease

Asymptomatic carotid stenosis linked to increased risk of falls in older adults A study has found that older adults with asymptomatic carotid artery stenosis are at greater risk for falls due to impairments in mobility and cognitive function compared to similarly aged adults without stenosis. Brajesh Lal presented the findings of the study at the Society for Vascular Surgery’s Vascular Annual Meeting (VAM; 20–23 June, Boston, USA).

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therosclerosis of the carotid bifurcation with plaque formation causes asymptomatic carotid artery stenosis (ACAS), which is also associated with cerebral haemodynamic and cognitive impairments. This study, therefore, tests the hypothesis that community-dwelling, functionally independent older adults with ≥50% diameter-reducing ACAS will have greater impairments in mobility and cognitive function that heightens their risk for falls, when compared to age-matched patients without stenosis.

In the VA-Merit funded Asymptomatic Carotid Stenosis and Cognitive function Study (ACCOF), community-dwelling older adults (≥65 years of age) with no history of prior disease-associated disability performed objective measures to assess mobility and cognitive function (Short Physical Performance Battery [SPPB], Berg Balance Scale [BBS], Four Square Step Test [FSST], Dynamic Gait Index [DGI], Timed Up and Go [TUG], gait speed, Mini-Mental State Examination [MMSE]), and self-reported perceived physical activity (Physical Activity Scale for the Elderly [PASE], Activities-Specific Balance Confidence [ABC], and SF12 Physical Function Component [PCS]). Standardised velocity measurements by carotid ultrasonography classified patients into three groups: 1) no-stenosis (<50% diameter reduction), 2) moderate stenosis (50– 69%) and 3) high-grade stenosis (70–99%). Linear and logistic regression analyses assessed the associations between these measures and the degree of stenosis.

Lal and colleagues enrolled 80 older (mean age ± SD 74.2±6.4 years) male (n=47) and female (n=33) adults with no stenosis (n=54), moderate stenosis (n=17) and high-grade stenosis (n=9). Logistic regression analysis showed that reduction in objective physical and cognitive

Brajesh Lal

function and in perceived physical activity correlated with the degree of stenosis: SPPB (p=0.008), BBS (p=0.0008), FSST (p=0.005), DGI (p=0.0001), TUG (p=0.0004), gait speed (p=0.02), lower ABC (p<0.0001), SF-12 PCS (p<0.0001) and MMSE (p=0.003).

“On the tests which were scored, patients without a stenosis performed better and patients with a stenosis performed worse. On tests which were timed, patients without a stenosis performed faster, and patients with a stenosis (moderate as well as severe) took longer… All of the mobility function assessments and balance function assessments demonstrated that stenosis patients performed worse than patients without stenosis,” Lal reported.

He added that stenosis was a “very powerful” predictor of poor performance of these physical function assessments on univariate analysis, as well as on multivariate analysis after adjusting for demographic characteristics as well as vascular risk factor differences in the two subsets.

They also found that adults with moderate and highgrade stenosis had a greater incidence of falls compared to age-matched patients with no stenosis (Relative Risk,

19

RR=2.86, p=0.01), with high-grade stenosis patients reporting having fallen at least once in the last six months.

To validate their findings, Lal said that they compared them with a larger epidemiological study of mobility disability in older community-dwelling residents of the Chianti region of Tuscany, Italy (InCHIANTI study). In that study’s cohort, there were 172 patients >65 years of age with asymptomatic carotid stenosis and 768 with no stenosis. The results showed that all assessments of gait, mobility and balance function were significantly impaired in stenosis patients compared to those without a stenosis.

“In summary, stroke is certainly a relatively infrequent occurrence after carotid stenosis. Carotid stenosis may cause brain hypoperfusion and brain hypoperfusion may result in cognitive impairment and mobility impairment, and all of these findings that have been emerging in the last couple of years may require a redefinition of the socalled asymptomatic carotid stenosis label that we apply to our patients. It may identify a subset of patients that may be at an inordinately high risk for brain dysfunction.

But it is not clear, however, whether aggressive medical therapy, rehabilitation strategies or revascularisation will improve these newly discovered dysfunctions,” Lal concluded.

As for future research, Lal explained that there will be two trials. One is ongoing, in which 22 patients will be enrolled to determine whether carotid endarterectomy in particular has any impact on brain perfusion or any impact on subsequent cognitive or mobility function.

“The reason we chose carotid endarterectomy as our gold standard is because we did not want to confound the results with micro embolic hits. There is a suspicion, yet unproven, that micro embolic hits that do not cause a stroke might be impacting cognition, so we wanted to keep that question aside,” Lal explained.

The proposal for a second study, he added, asks the question whether there are cognitive and mobility function outcomes between endarterectomy and transcarotid revascularisation strategies.

Carotid disease is not a risk factor for stroke or death in TAVI patients

A new study, published in Circulation: Cardiovascular Interventions, shows that one fifth of patients undergoing transcatheter aortic valve implantation (TAVI) have evidence of carotid artery disease. It also indicates that while the presence of carotid disease may be a marker of higher cardiovascular burden, it is not itself a risk factor for stroke or mortality after TAVI.

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uthors Ajar Kochar (Duke Clinical Research Institute, Duke University of School of Medicine, Durham, USA) and others report that the biological mechanism underpinning periprocedural stroke in TAVI are “incompletely understood”.

They note that periprocedural debris embolisation is one potential mechanism of stroke in this context but add that strokes (at 30 days) still occur in patients who undergo TAVI with cerebral protection devices (such as Sentinel, Boston Scientific). “These findings suggest either current technologies do not sufficiently reduce the risk of periprocedural debris embolisation or there are other mechanisms for TAVIassociated stroke,” Kochar et al write.

According to the authors, another

potential mechanism is the presence of carotid disease—given that it is associated with an increased risk of stroke in patients undergoing surgical aortic valve replacement. Therefore, the aim of the present study was to evaluate the incidence of carotid disease among TAVI patients, the relationship between severity of carotid disease and cardiovascular outcomes, and the influence of carotid disease on 30-day and one-year stroke mortality.

Using data from three US registries, Kochar et al identified 29,143 patients who underwent TAVI between October 2013 and September 2015 (in the USA).

Of these, 6,410 had carotid disease (22%). In most cases (50–79%), the carotid disease was of moderate severity.

Looking at unadjusted outcomes, the

presence of carotid disease was associated with a significantly increased risk of stroke at 30 days and at one year. Similarly, carotid disease was associated with a significantly increased risk of mortality both at 30 days and at one year. These risks increased with increasing severity.

However, in an adjusted analysis, carotid disease was no longer associated with a significantly increased risk with stroke or mortality at 30 days.

Nor were there, after adjustment for patient characteristics, any significantly differences in the risk of stroke or mortality at one year between patients with carotid disease and those without carotid disease. The authors state: “Even after incorporating the degree of stenosis, there was no significant adjusted association between carotid disease

severity and 30-day or one-year risks of stroke or mortality.”

Kochar et al observe that, on the basis of their findings, “carotid disease is possibly a marker for patients with a higher mortality burden” but does not itself “result in a higher risk of stroke or mortality”. “Further supporting this notion that carotid disease is a marker for a large comorbidity burden are the higher unadjusted one-year cumulative incidence rates for both myocardial infarction and bleeding rates among carotid disease compared with no carotid patients,” they add.

They conclude: “Despite technological improvements, post-TAVI stroke is still a major complication; our results suggest carotid disease does not influence this risk of stroke.”

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Aortic

Final STABLE I results highlight need for long-term management of type B aortic dissection Five-year follow-up data from STABLE I, a global feasibility study of the Zenith Dissection Endovascular stent (Cook Medical), were presented by Joseph Lombardi (Cooper University Health Care, Camden, USA) at the Society for Vascular Surgery’s Vascular Annual Meeting (VAM; 20–23 June, Boston, USA). In his presentation, Lombardi highlighted the need for “commitment to long-term management of type B aortic dissection” and the risk of aortic growth following thoracic aortic endovascular repair (TEVAR).

T

he study concludes follow-up for the feasibility study, which preceded the STABLE II study. At the 2016 VAM meeting, Lombardi reported initial outcomes of the second trial, saying “These preliminary results from the STABLE II study appear favourable in terms of clinical and anatomical outcomes for the treatment of acute chronic type B aortic dissection.”

STABLE I prospectively enrolled 86 patients at centres in the USA, Europe and Australia in the years 2007– 2012. Of those patients, 89% were followed out to five years with clinical an CT follow-up. The study included patients with type B aortic dissection who required surgical intervention or were not responding well to medical treatment within 90 days of symptom onset. The primary endpoint of 30-day mortality was 4.7% (4/86), with three deaths following acute dissection (5.5%, 3/55) vs. one following non-acute dissection (1/31).

For TEVAR in treatment of complicated type B aortic dissection, Lombardi stated the management goals include prompt diagnosis, alleviation of malperfusion and containment of rupture, maximising false lumen thrombosis and minimising long-term complications.

The Zenith stent used in the STABLE trials is a composite device design, combining a proximal covered stent graft with a bare metal stent.

“Complete false lumen thrombosis in the thoracic aorta increased over time and was observed in 74% of acute and 59% of non-acute patients at five years”, Lombardi et al write in their abstract, published in the Journal of Vascular Surgery. “From before the procedure through five years, there was an overall

Joseph Lombardi

increase in true lumen diameter and concomitant decrease in false lumen diameter in both acute and non-acute patients at the level of the largest diameter in both the thoracic and abdominal aorta. At five years, 66% of acute and 81% of non-acute patients exhibited either a stable or shrinking transaortic diameter in the thoracic aorta; 52% of acute and 24% of non-acute patients experienced growth in trans-aortic diameter in the abdominal aorta.”

Commenting on the outcomes at the VAM in Boston, Lombardi said aortic remodelling was observed within

and beyond the stent-grafted segments in both acute and non-acute dissections. He also stressed that aortic growth after TEVAR for type B aortic dissection is “very real, and may be more prevalent in patients treated in the acute phase”, as well as the importance of longterm commitment to managing type B aortic dissection.

At five years, endpoints included freedom from allcause mortality (80%±6%), freedom from dissection repair-related mortality (84%±6%) and freedom from rupture (92%±4%). “Twenty-five patients underwent secondary intervention through five years,” Lombardi added, 17 of which were acute. Freedom from secondary interventions in both groups was 66%±8% at five years.

“Overall, the acute and nonacute cohorts from the feasibility study appeared to respond similarly to treatment,” Lombardi et al conclude in their abstract, “demonstrating similar clinical outcomes and favourable aortic remodelling in the thoracic and abdominal aorta.”

Reviewing the initial 30-day outcomes for STABLE I acute dissection patients, Lombardi noted at the VAM: “When we compare our data to the pooled SVS dataset

by White et al in 2011, and also the pooled results from a meta-analysis on TEVAR by Fattori et al [2013], what strikes you initially is the low mortality rate [of the STABLE I acute cohort] in comparison, and also the low paraplegia rates with the use of this combination system.” The mortality rates of the pooled datasets were 10.6% and 10.2% for White et al and Fattori et al, respectively, as compared to the STABLE I study’s 5.5% mortality at 30 days. The paraplegia rates at 1.8% were indeed also significantly lower in comparison to White et al (9.4%; paralysis or paraparesis) and Fattori et al (4.2%; 30-day or in-hospital spinal cord ischaemia) data. The non-acute group similarly showed lower mortality rates in the STABLE I study ( 3.2% vs. 7.1% and 6.6%, respectively), but no significant difference in paraplegia rates (0% vs. 0% and 1.5%, respectively).

3D printing: A novel application to complex aortic endovascular procedures A new 3D-printing technique for complex aortic endovascular procedures was revealed by Bernard Dorweiler (University Medical Centre, Mainz, Germany) at the Charing Cross Symposium (CX; 24–27 April, London, UK) with various applications, including simulation of complex anatomy, training for residents, reduction in OR-time and improved patient education and patient consent.

3D

printing itself is not so novel; with its use in industry continuing to grow.

However, its application to medicine, in this case in relation to aortic arteries, has been described as “revolutionary.”

Starting with a DICOM dataset, Dorweiler and colleagues first segmented an aortic infrarenal aneurysm, which resulted in an electronic version of this aneurysm: a 3D electronic model.

The dataset was then transferred to the electronic 3D printer, and, using plastic polymers, it was possible to ascertain patient specific anatomy.

To further illustrate this technique, Dorweiler described two cases; one of which involved a post-dissection aneurysm of an aortic arch. The team printed the model in view to subsequently implanting a double branch graft (the first implantation of this graft in Germany). Simulation was

carried out beforehand to determine the precision of the graft in the dissection.

The team also took the post-operative CT scan and again segmented the implanted stent graft using this to generate a 3D model. Dorweiler and his team were able to use both models not only to plan and simulate the procedure, but also to explain the anatomy to the patient.

Dorweiler emphasised the benefits of the patient seeing the model and visualising the anatomy, in terms of both patient consent and education about the procedure.

The second case involved a complex aortic arch aneurysm that had a congenital malformation due to an interrupted aortic arch. Over time, numerous collaterals had formed, displaying aneurysmatic degradation and thereby forming a huge aneurysm in the chest, and also in the neck. A 3D model was again generated, with the one-to-one patient specific

anatomy helping to plan the procedure.

Dorweiler noted that this was particularly useful in this case, as this aneurysm was fed through subclavian arteries.

Other than the application of 3D-printing to the simulation of complex anatomy, it also allows for a training platform for residents, in terms of wireskills (cannulation) and graft placement.

Dorweiler described a task given to the residents; requiring them to cannulate the superior mesenteric artery using a play wire on the 3D model of the human aorta. With the use of guiding catheters, the residents were able to advance the catheter, place it and cannulate the artery.

Furthermore, training results using the 3D model showed some considerable improvements, with a significant reduction in cannulation times (of various arteries) between pre- and post-training.

In relation to additional advantages, Dorweiler described two papers that have shown that using 3D-printed models in vascular surgery results in a reduction in OR time (in the range of 30% in one study and 28 in another) which is a considerable advantage as this shortens radiation exposure.

During the audience discussion, Dorweiler was questioned on how the 3D models compare to the virtual simulations in terms of cost and realism. He answered by reiterating that using 3D models, one-to-one patient specific anatomy can be visualised and the use of actual catheters, wire and grafts, where no radiation is needed, remains a distinct advantage. He also noted the drawback; in that they have to make the models themselves. However, Dorweiler said this reduces the costs of the technology.

When questioned about the future of 3D-printing for complex aortic endovascular procedures, Dorweiler said that at the current stage, they are limited by materials. However, companies are working on improvement of the polymers, and, according to Dorweiler, the appropriate polymers (flexible and translucent) will soon be available.

Irrespective of this, Dorweiler concluded with the four current applications of 3D printing in vascular surgery: simulation of complex anatomy, improved training for residents, a reduction in OR time, and importantly, an improvement in patient education and consent.

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1. Binkert C. BIOLUX P-III Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 24-month results of the BIOLUX P-III All Comers Registry in Superficial Femoral Arteries. Presented at: CIRSE 2018. Lisbon, Portugal; 2. Lichtenberg M. BIOFLEX PEACE registry: 12 and 24 month results. Presented at: LINC 2018. Leipzig, Germany; 3. Deloose K. BIOLUX 4EVER: Combining Passeo-18 Lux DCB and Pulsar-18 BMS: 24-month results of full cohort. Presented at: LINC 2018. Leipzig, Germany; 4. Mwipatay P. DEBAS First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease. Sage Journals. 2017; 0(0) 1-9, 24-month results; 5. Scheinert D, et al. Paclitaxel Releasing Balloon in femoropopliteal lesions using BTHC excipient: 12-month results from the BIOLUX P-I randomized trial. JEVT, 2015; 22(1): 14-21; 6. BIOTRONIK data on file; 7. Bosiers M. 4EVER study. J. Endovascular. Ther., 2013;20: 746-756. * The use of Passeo-18 Lux for post-dilatation is not within the indication for the product. ** Drug retention while in transit to the lesion and prolonged paclitaxel presence in the vessel wall.

Freedom from TLR = Freedom from Target Lesion Revascularization; Freedom from CD-TLR = Freedom from Clinically Driven Target Lesion Revascularization.

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Research

“Encouraging” early-term results in Valiant EVO global trial The latest 30-day outcomes from the Valiant EVO global trial investigating the use of a low-profile delivery and high comformability thoracic endograft (Valiant Navion, Medtronic) in patients with descending thoracic aortic aneurysms are “encouraging”. That is according to the trial’s US national principal investigator, Ali Azizzadeh, director, Division of Vascular Surgery, Cedars-Sinai Medical Center, Los Angeles, USA.

A

zizzadeh presented the device-related perioperative and 30-day outcomes from the Valiant EVO global clinical trial at the Society for Vascular Surgery’s Vascular Annual Meeting (VAM; 20–23 June, Boston, USA).

The new graft’s design is based on that of Medtronic’s Valiant Captivia platform. Azizzadeh explained that changes include enhancements to the delivery system, with an average of 4F reduction in profile, which is significant for improving deliverability of the device. There has also been an increase in the working length by 10cm which, he said, allows the device to be applied to more proximal lesions. The device has a lower profile than the Valiant Captivia and an expanded size matrix with configurations allowing customisation, providing for a broader range of indications. The expanded size matrix “allows the device to treat a wide range of anatomies,” Azizzadeh said, with length increased to 225mm, a smaller 20mm diameter, and refined tapering of 5 and 6mm. Further, the material of the Valiant Navion stent graft is new, improving the conformability.

The Valiant Navion has two proximal device configurations. The first, FreeFlo, is the classic configuration which allows for trans-vessel flow with a tip capture mechanism, requiring at least a 2cm landing zone. The second, newer option, is the CoveredSeal, which Azizzadeh reported is suitable for certain anatomies, such as dissection. CoveredSeal also has the tip capture mechanism with two stage deployment and requires a 2.5cm or longer landing zone.

Patients were enrolled in the prospective, nonrandomised, single-arm trial from centres across Europe and North America from April 2016 to October 2017. A composite measurement of the proportion of patients with access and/or deployment failure and/ or a major device effect within 30 days post index

procedure was assessed. Other measures of stent graft performance including procedural data, rates of secondary procedures, and frequency of endoleaks are also reported.

Of the 87 patients with 30-day data available, 38% were female and 86% presented with high thoracic aortic tortuosity. The average age was 71 years and the majority of patients were in the ASA class III or IV, representing a high-risk subgroup. The primary indication for TEVAR was fusiform aneurysms in 45.5%, saccular aneurysms in 36.8% and penetrating aortic ulcers in 20.7%.

The core lab assessed aneurysm characteristics show severe access artery tortuosity and thoracic artery tortuosity was present in a large number of patients—70.9% and 85.7%, respectively. “This made this a very high-risk cohort,” Azizzadeh pointed out.

Azizzadeh stated that mean procedure duration was 88.7±53.4 minutes, estimated blood loss was 94.0±147.1cc, and the majority of patients were treated with percutaneous access. There were no access or deployment failures and 25% (22/87) of the patients received the CoveredSeal (no bare stents) configuration as their proximal device. Only 2.3% (one-sided 97.5% upper confidence limit 8.06%; p<0.0001) of the patients had a major device effect within 30 days post index procedure.

Within 30 days, two patients required secondary procedures (n=1 retrograde type A dissection; n=1 aortic arch rupture) and two patients died (one devicerelated, retrograde type A dissection on day 1) resulting in a freedom from all-cause mortality of 97.7%. At the 30-day follow-up visit, endoleaks were reported in 2.5% of patients (n=1 type Ia; n=1 type II), but “there was no adverse event associated, no interventions were performed and there was no aneurysm expansion observed on follow-up imaging.”

“In these short-term outcomes from the Valiant EVO global clinical trial, access/deployment failures, major device effects, and endoleaks were rare. The lowprofile delivery and high stent graft conformability of the Valiant Navion thoracic stent graft system has shown encouraging early-term results.

The device is currently pending global market approval and trial patients will be continued to be followed through five years,” Azizzadeh concluded.

At the VEITHsymposium last year, another study investigator, Frank Arko, presented the initial 30-day results of this trial with very similar results. Then, the study team had evaluable data for 60 patients (36 male, 24 female) with a mean age of 70.5 years. Arko said that 78.3% of patients were assessed as having high thoracic aortic tortuosity. Thrombus was present in the intended landing zone in 18.3% of patients and calcium was present in the intended landing zone in 56.7% of patients. Percutaneous access was used in 53.3% of cases, and there were no incidences of vessel access failure. At one month, there was no loss of stent graft patency. One type Ia endoleak and one undetermined type of endoleak were observed on Core Lab. No other endoleaks were reported. Detailing the key messages of his presentation, Arko stressed that despite that “the level of thoracic aortic tortuosity in this group of patients was high”, the majority of procedures were performed percutaneously with zero access failures. The “very low” rate of endoleaks and lack of secondary procedures out to 30 days, made the results especially encouraging, Arko said.

Novel scoring system takes holistic approach to wound assessment Recent research outlining the novel 0–10 point Long Beach Wound Scores (LBWS) that utilises objective criteria to categorise wound management, was recently published in the British Medical Journal

by Michael B Strauss and colleagues from Long Beach Memorial Medical Center (Long Beach, USA). The LBWS provides a tool for both comparative effectiveness research of wound care products and quantification of minimal clinically important improvement.

A

ccording to Strauss et al, it is essential to be precise in relation to the evaluation and management of wounds, due to increasing scrutiny and authorisation requirements.

Previously published research, they argue, tends to focus solely on a particular wound assessment as a primary consideration—such as perfusion, depth or severity of infection—with assessments only recorded as present or absent. The authors note that such scoring systems do not suggest using metrics to establish progress with subsequent observations.

Considering the current state of scoring systems for wounds, the LBWS integrates important features with the addition of what they consider two essential assessments, namely, appearance of the wound base and size, to score the wound comprehensively. Each of the five assessment measures were graded on a 0-point (worst possible) to 2-point

(best possible) continuum of objective findings, reflecting the seriousness of each assessment; resulting in an “easy-tointerpret” 0–10 scale system.

The goal of developing the LBWS was to resolve concerns of current reductionist systems with a tool that predicts outcomes and guides management. The LBWS aimed to facilitate the quantification and categorisation of the seriousness of a wound from initial examination, as well as to guide management, objectify comparative effectiveness research and ascertain minimal clinically significant improvements.

Long Beach Wound Scores were determined prospectively over an 18-month period in 105 hospitalised patients, with or without diabetes, with lower extremity wounds. Wounds were categorised as healthy, problem, or end-stage from their initial LBWS. Of the 85 patients who acquired both

LBWS and outcome scores, 48 were male (56.6%; mean age 57.9 years), 34 were female (40%; mean age 57 years), and three (3.5%) had unspecified gender information. No effects of sex or ethnicity were detected in analysis.

In the healthy category, 66.7% patients healed or improved and were designated as good outcomes. In the problem category, 83.3% had good outcomes. In the end-stage category the percentage dropped, as 50% had good outcomes.

Outliers for poor outcomes in the healthy category were due to the patients’ comorbidities (such as small vasculitic ulcers), and good outcomes in the end-stage category were explained by successful revascularisations and/ or healing of minor amputations. The accuracy of the LBWS for predicting good versus poor outcomes was 75.3%.

The authors touch on several limitations of the study; the main being that although the data were analysed from 85 patients prospectively, the numbers from any single LBWS were small. Furthermore, wound care strategy was not specified, while time intervals between the initial evaluation and the final outcome grading were also not considered—with intervals varying greatly between patients.

Lastly, the authors noted that an element of subjectivity and bias is present in whether it was appropriate to include improvements as good results.

Nevertheless, the authors maintain: “The LBWS is a versatile tool that makes it possible to grade wounds easily and accurately”. They also note that the 0–10 point LBWS scoring system is “intuitively obvious”, as it uses a continuum of objective findings. Therefore, according to the authors, interventions for managing each category are clear: “Healthy wounds require simple interventions, problem wounds require strategic management and end-stage wounds almost always require revascularisations if lower limb amputations are to be avoided”.

In conclusion, the authors comment that while other wound scoring systems have face validity through their use, the LBWS is the first to have both comprehensive reliability and validation data. Finally, the LBWS facilitates improved comparative effectiveness research for wound care interventions by comparing outcomes with wounds that have similar scores, while it can also be used as a tool for quantifying minimal clinically important improvement with serial scorings of the wound.

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Conference coverage

New SVS International Lifetime Achievement Award recognises vascular pioneer Roger Greenhalgh The Society for Vascular Surgery (SVS) has introduced a new award, the International Lifetime Achievement Award, which recognises “outstanding contribution to vascular surgery” and global acclaim. Enrico Ascher (NYU Langone Health, New York, USA), who describes it as “the Nobel Prize of vascular surgery”, presented the award to Roger Greenhalgh (London, UK) at the SVS Vascular Annual Meeting (VAM; 20–23 June, Boston, USA).

A

scher—who is a former vice president, president-elect and president of the SVS— tells Vascular News, “I think this is probably the most prestigious award [in vascular surgery] that exists nowadays, because of the process—not because the SVS is sponsoring it, but because actually all the societies are involved.”

The selection process is drastically different to the long-standing general SVS Lifetime Achievement Award, which recognises one member of its society each year. Instead, the society’s International Research Committee accepted nominations for the award from “every major and regional society, as well as government agencies” worldwide, with strict eligibility requirements.

Following the externally-led nomination process, the SVS committee chose its top candidates to be considered by the society’s Executive Board, which selects the final recipient of the award.

“The nomination process is not easy,” Ascher said at the Vascular Annual Meeting, highlighting the “severe” eligibility requirements for receiving the award and the scale of the international selection process. “One vascular surgeon not only meets all the expectations, but indeed surpasses them,” Ascher noted

Roger Greenhalgh and Enrico Ascher

before presenting Greenhalgh as the recipient.

Accepting the award, Greenhalgh highlighted the many American vascular surgeons and pioneers of the field that shaped his career and his life. Greenhalgh described how he learned and benefitted greatly from mentors such as Michael DeBakey, John Bergen, James Yao and

many others. “I was privileged to learn from the masters, and tried to reproduce the SVS,” ultimately leading to creating the Charing Cross Symposium—now 40 years running. In founding the European Society for Vascular Surgery (ESVS), Greenhalgh further stated, “All I did was listen to DeBakey and Jesse Thompson, and copy the SVS.”

The inspiration from across the Atlantic can be seen in the details of Greenhalgh’s legacy, from the name of the leading European society and journal he helped establish: a society for vascular surgery and a journal of vascular surgery. In his parting contribution as chairman of the board for the European Journal of Vascular Surgery, Greenhalgh said, “I persuaded them with a narrow vote to become the journal of vascular and endovascular surgery; that is the one difference.”

“We are proud of this award and we are lucky that we were able to get Professor Greenhalgh,” Ascher told Vascular News.

“To me, he has been something close to one of my idols, in every aspect possible.

He is not only a leader in vascular surgery, he is a moral leader, which makes him unique.

“He leads by example. Not only by his contributions, or his political influence, or his knowledge, or trials, but actually as a person. As a person who is totally committed to his profession, to his family, to his friends, to his peers. He thinks first about them, and not about himself. That is what makes him a moral leader, and what sets him apart.”

Greenhalgh is also set to receive an honorary fellowship of the American College of Surgeons later this year.

Focus on the International Symposium on Endovascular Therapeutics The International Symposium on Endovascular Therapeutics (SITE) is an annual international symposium based in Barcelona, Spain, with its focus in the Spanish vascular world. Vincent Riambau, founder and chairman of SITE, spoke to Vascular News about founding the meeting, how it has developed in the 19 years since, and what sets it apart as a vascular symposium.

How have you seen the meeting develop and change since its inception in 2000?

In 2005, we introduced competition sessions, with attractive educational awards for the best challenging case, the best free paper and the best poster presentation. We increased our attendee spectrum attracting delegates from all the Latin American countries, and other different nationalities up to 54 countries in the last 2017 edition. SITE provides high performance simultaneous translation system (Spanish-English-Spanish) in order to facilitate the oral communication, discussion and interaction amongst all the participants.

Where did the concept for the SITE meeting come from?

Many years ago, at the end of the 90’s, our group in Barcelona and other colleagues in San Sebastian, initiated two very similar, small international, multidisciplinary meetings in both cities. At that time, when the endovascular techniques strongly emerged in the vascular arena, both groups were the most active in our country in that field and we needed to interchange our experiences with other selected international experts and share all this information with the rest of the Spanish vascular community. Very soon, we realised that it could be more effective being together in one single annual event. That idea became reality in 2000.

In 2005, we decided to make up one single multidisciplinary event in Barcelona, every other year, in order to have enough time to collect new endovascular techniques and emergent technology and avoid an overcrowding of endovascular meetings in the international calendar. SITE is now the largest endovascular meeting in the Iberian peninsula.

Since 2014, the SITE symposium alternates with the SITEupdate—a one-day expert meeting with the objective to identify current limitations and propose future directions to stimulate research and development.

many competition sessions related to challenging cases, free papers and poster presentations for different sectors. More recently, SITE included in its mission list, in accordance with the Endovascular Foundation, to identify and promote young talented physicians with specific educational grants and more personalised workshops and opportunities. SITE and the Endovascular Foundation should aid and buttress the next generation of endovascular specialists.

What sets SITE apart from other meetings of its kind?

The 2019 programme will include hot topics, (technical innovations, evidences, updates), disaster cases (the worst case in my life) and top secret sessions (tips and tricks) presented by expert faculty; cases in a box, free papers, a great debate and a session with a SITEupdate flavour to discuss specific unmet needs will complete the first day. On the final day of the programme, we will have some joint sessions with the China Endovascular Course. For this reason, we will include a new simultaneous translation system (ChineseEnglish-Chinese).

The main programme is running in one main auditorium.

Very few simultaneous sessions are scheduled. All the participants can get the most practical updated ideas, burning challenges and future directions concerning all the endovascular fields within two and half days.

SITE allows very compelling discussion periods that are strictly respected at the end of every session. SITEupdate sessions included in the SITE programme, are just focused on hot topic discussions about unmet needs. SITE offers

What are the main highlights for the upcoming SITE 2019 meeting?

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Interview

Profile

Alison Halliday

As her term as the first female president of the European Society for Vascular Surgery comes to end, Alison Halliday reflects on what she has achieved and her hopes for the future of the society. She also speaks to Vascular News about her current research, what is being done to encourage more women to choose the path of vascular surgery, as well as her interests outside of medicine.

What drew you to medicine and to vascular surgery in particular?

Many of my family did medicine, but I was better at English, languages and geography at school. I thought of archaeology and marine biology before deciding on medicine as the best overall education, with lots of future options. Surgery interested me right from my first attachment at Southampton and vascular surgery was my choice when I experienced the satisfaction of relieving the pain of ischaemia and preventing amputations, deaths and strokes.

Most importantly, I also really enjoy talking to patients about their problems and trying to give them hope and a plan to make their lives better.

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

My husband, my teachers and professors and my colleagues—my husband believes, like me, that you can do whatever work you want to, my teachers inspired me at school and at work and my colleagues sometimes amaze me by their energy and kindness— it’s a great job!

What have been the proudest moments of your career?

Having my family at my graduation and my inaugural lecture as a professor, presenting the results of the first ACST trial and becoming president of the European Society for Vascular Surgery.

How have you seen the field develop during the course of your career?

Better medical treatments for vascular disease, especially statins—endovascular surgery—wider co-operation between specialities for treatment planning—changes in training from general and vascular surgery, to vascular surgery as a monospecialty.

What new vascular technology are you watching closely and why?

Carotid stents (of course!)—their development was put on hold by the early trial results comparing carotid endarterectomy (CEA) with stenting in symptomatic patients. Now many new ideas— mostly concentrating on reducing embolic potential from stenting—mean that the technology can be more widely applied in a safe way and I hope this will result in surgeons becoming more engaged in training for the appropriate use of stents.

What is the most interesting paper or presentation that you have seen recently?

Two new trials, the COMPASS and MANAGE studies, have shown new applications for the use of new oral anticoagulants (NOAC) in vascular surgery. COMPASS showed how cardiovascular death, stroke, or myocardial infarction could be reduced in patients with stable cardiovascular disease by combining NOAC and aspirin treatment.

The MANAGE trial should change perioperative

monitoring in future as it clearly showed that perioperative rises in troponin (even without symptoms) called MINS (myocardial injury after non-cardiac surgery) increase the risk of cardiovascular events and deaths; anticoagulation therapy for MINS can prevent major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism.

You are the principal investigator of two of the world’s largest trials in vascular surgery (ACST-1, ACST2), how did these trials change practice and what questions remain unanswered?

ACST-1 clearly showed that, in patients with no recent symptoms from carotid stenosis which was suitable for surgery (usually 60–99%), carotid endarterectomy prevented future strokes, both disabling and fatal and nondisabling, for at least the next 10 years. These findings were clear (an absolute reduction of 6–7% for patients up to 75 years of age at trial entry) and were present even in those patients who were taking statins, in addition to other stroke prevention medicines.

ACST-2 is comparing carotid endarterectomy with stenting, in patients suitable for both procedures who have not had recent symptoms and has recruited over 80% of the planned 3,600 patients for this trial. Results are expected in 2021 and these results will, I hope, change future practice.

Unanswered questions always remain, but big questions in practice will, I hope, be addressed by these and future trials. Identifying patients at high stroke risk from their carotid disease, as with ischaemic heart disease, remains the biggest of these.

Much of your research is focused on stroke prevention, why is this an important topic and what more still needs to be done to improve patient outcomes?

Stroke is the largest cause of disability in many countries. Prevention depends on identifying the potential causes of stroke and carotid disease remains one of the most important and

potentially preventable of these.

Safe surgery and intervention is of vital importance, but patient education on risks and benefits is also essential. Public awareness is improving, but the media need to be more effective in portraying the appropriate hazards of treatments such as statins and surgery, otherwise, the risk-adverse population with carotid disease will be exposed to greater risk by avoiding these treatments.

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Fact File

You are at the end of your term as President of the ESVS. What did you accomplish during your tenure and what are your hopes for the future of the society?

As the first woman to be elected president, other women in vascular surgery have, I hope, been encouraged to apply for office. My aims on election were to increase diversity in ESVS and we have

made significant moves (including the appointment of a diversity ‘councillor’) to improve this; at ESVS I also created the Global Village—where every country is given free exhibition space to showcase their vascular services and their culture, as well as providing a networking space for the duration of the meeting. Finally, I still plan to study the Minimum Standards for Vascular Services in Europe—with my colleagues, I hope we can then demonstrate to European states the areas in which their future services may be usefully improved.

You are a committee member of the Gender Equality Advisory Group at Oxford University, and you work in a field that is largely dominated by men—what is being done to encourage more women to become vascular surgeons and what factors do you believe act as a deterrent?

There are now many more women trainees in vascular surgery and some more consultants. Mentorship has improved, but there is no doubt that women have to work hard to keep both the home and the job running smoothly. Not many men take longterm paternity leave to care for children yet!

Perhaps the biggest barrier women face is making the long term choice to stay in surgery, even though their ability and patient commitment is not in doubt. One very positive factor is the “team” development, which is a better environment than the stand-alone consultant of the past—everyone appreciates good colleagues. The model of mixed Boards in business is clearly successful and companies show better financial results.

A mixed vascular surgery consultant team should lead to better team relationships and open positive clinical development.

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

Lots are memorable! Perhaps one, where years ago a patient presented with crescendo TIAs and I was not on call, but was many miles away. I took three trains and two buses to reach the hospital and was really pleased to be able to operate successfully without further delay.

This demonstrated the benefits of good colleague cover, which followed shortly after. On the same theme, whilst others were at a meeting, I successfully operated on a colleagues’ patient with a ruptured inflammatory AAA—the benefit of being on site!

What are your interests and hobbies outside of medicine?

I love walking, as well as reading and learning about science and literature outside medicine.

Geology has become an interest since my son took up Exploration Geology and has just been awarded his MSc from Camborne School of Mines—the timescale of geology certainly puts life in context!

Current appointment

Professor of Vascular Surgery, University of Oxford Hon Consultant Vascular Surgeon, Oxford University Hospitals NHS Trust Senior Research Fellow, Green Templeton College, Oxford

Professional career

1991–1993 Senior Lecturer & Honorary Consultant Surgeon, St Thomas’s Hospital, London 1992–1995 Hon Consultant in Vascular Surgery, St Mary’s Hospital, London 1993–2010 Consultant in Vascular & General Surgery, Epsom & St George’s Hospitals 2007–2010 Professor of Vascular Surgical Sciences, St George’s, University of London 2007–2012 Honorary Consultant Vascular Surgeon, Royal Free Hospital NHS Trust

Research

Principal Investigator of the world’s largest trials in Vascular Surgery (ACST-1, ACST-2) Leader of a research team and network of colleagues worldwide Supervisor, PhD research staff and students Establishment of a productive and long-term collaboration with the world-renowned Oxford Clinical Trial Service Unit, bringing statistical and trial design expertise to their large-scale clinical surgical trials Development of the world’s largest trial database of factors affecting durability of stroke prevention after carotid endarterectomy (>20,000 patient years) Development of International Stroke Research networks between Neurologists, Vascular Surgeons, Interventional Radiologists and Cardiologists in over 30 countries Substantial contribution to the body of knowledge in Vascular Surgery, Stroke Medicine and International Clinical Trials—helped develop European guidelines on the indications for Carotid Surgery

Awards

Royal College of Surgeons, Hunterian Professorship University of Belgrade, Visiting Professor McMaster University, Hamilton, Canada - Annual Perioperative Lectureship, PHRI Anesthesiology, Perioperative Medicine and Surgery

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Minimising arteriovenous graft infections and preserving vascular access using partial graft excisions The findings of a new retrospective review carried out by Suh Min Kim (Dongguk University Ilsan Hospital, Goyang, Korea) and colleagues that aimed to establish an appropriate treatment strategy for arteriovenous graft (AVG) infection have been published in the Journal of Vascular Access. The findings indicate that partial graft extension could be a treatment option to achieve both eradication of AVG infection and preservation of vascular access in selected patients.

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he authors acknowledge that infection is a common complication in an arteriovenous graft (AVG); the reported infection rate being fivefold higher compared to an autogenous arteriovenous fistula. Prosthetic graft infections can lead to prolonged use of a catheter, a long duration of hospitalisation and life-threatening sepsis.

Both eradication of infection and vascular access salvage are important considerations— making treatment of AVG infection particularly challenging for vascular surgeons. With regards to treatment, the authors write: “It is imperative to aim for balance between infection control and vascular access preservation, because of the limited anatomic options for vascular access creation.”

Traditionally, total graft excision (TGE) and

the insertion of a central venous catheter are recommended until the infection is controlled.

The authors report that previous studies suggest the use of a remnant cuff as a preferred method to reduce the morbidities of excision without an increased risk of recurrent infection. In addition to this, partial graft excision (PGE) with an interposition graft has been tried in order to preserve vascular access salvage in selected patients.

However, the Kim et al note the lack of data in relation to the clinical presentation and treatment outcomes in patients with an infected AVG. Furthermore, the extent of surgical excision to be performed for AVG infection remains debatable.

Therefore, the authors aimed to report their experience regarding surgical treatment of an Continued on page 30

Arteriovenous thigh graft access could be an option for haemodialysis patients A study published recently in the Journal of Vascular Access has indicated that the use of arteriovenous thigh graft access is viable as an alternative for patients who have exhausted all other access options.

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enise Kim (Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada) and colleagues performed a retrospective study of all thigh arteriovenous access grafts placed between 1995 and 2015. The clinical, demographic patient information and patency of each thigh graft was determined from the time of surgical creation placement until abandonment, transfer to other modality, or centre or end of study, and the reason for access failure documented.

In total, 44 patients received 49 thigh arteriovenous accesses.

The average age was 60 years (13–79 years); half (53%) of the patients (n=24) were female and 61% of the patients (n=30) of arteriovenous accesses were left-sided. The cumulative proportion surviving (primary patency rates) at 12, 24, and 28 months were 43% (standard error = 9%), 33% (standard error = 9%), and 13% (standard error = 9%), respectively. The cumulative proportion of surviving grafts at 12, 24, and 48 months were 61% (standard error = 8%), 58% (standard error = 9%), and 31% (standard error = 13%), respectively.

In total, 37 revisions were performed in 22 patients to maintain patency or eradicate infection. Infection occurred in 20 patients (39%) of thigh grafts requiring 16 patients (80% of those affected) to be removed; 14 patients had grafts (33.3%) that served as the lone haemodialysis arteriovenous access during the patients’ lifetime on dialysis.

Kim et al conclude that while arteriovenous thigh graft access is used infrequently, their study shows that they have an acceptable patency. They noted that some accesses require revisions and that they observed a high infection rate in their cohort of patients with arteriovenous thigh graft access. “Despite this, an acceptable proportion of leg grafts provide durable access for the dialysis lifetime of the patient,” Kim et al maintain.

Japanese study investigates new device for accurate haemodialysis catheter placement

Researchers at Okayama University report in the Journal of Vascular Access the use of a supporting device for accurately placing haemodialysis catheters in dialysis patients. The device was successfully used in a group of 10 patients and, according to the investigators, is expected to become an essential tool in situations where other, catheter-free haemodialysis approaches are not possible.

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oshiaki Ohara (Assistant Professor, Okayama University, Okayama, Japan) and colleagues developed a device which they have found helps to enable accurate tunnelled cuffed catheter (TCC) placement. The researchers’ insertion support device accommodates for individual body shape differences and is expected to decrease the rate of TCC replacements— typically ranging between 8.9% and 56%.

The device was made from expanded polytetrafluoroethylene (ePTFE). It can be described as a bendable ribbon with holes (eyelets) spaced 1cm

apart; the holes allow for the making of markings on the patient’s body with a felt-tip pen.

The insertion support device was tested on 10 Japanese adult haemodialysis patients (six men and four women with a mean age of 71.3 years) treated at Shigei Medical Research Hospital. Placement of the device on the body took place with the help of X-ray imaging: the tip of the device, for marking the TCC entry site, was laid so that it overlaps with the right heart border. With the help of the markings made on the patient’s body, the physician could insert the TCC within an error of about

1cm. The patients were observed for two months, during which there was no catheter replacement needed.

Ohara and colleagues report that the device helps to reduce catheter waste and the overall cost of haemodialysis. In addition, as the attachment of a catheter requires exposure to X-rays, it reduces accumulated radiation doses for both patients and physicians. Although the study was only carried out in 10 patients in a short observation period, the investigators “anticipate that this new device can be used for catheter intervention in many fields”.

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Minimising arteriovenous graft infections and preserving vascular access using partial graft excisions Continued from page 29

infection AVG for haemodialysis, to compare the results of PGE and TGE, and to establish an appropriate treatment strategy for both infection control and vascular access preservation.

Kim et al carried out a retrospective review, in which a total of 50 cases of AVG infection were treated between January 2005 and June 2016. The median age was 66.5 (range 29–84) years, with 33 men and 17 women. Thirty-seven (74%) had hypertension and 23 (46%) had diabetes mellitus. The median duration for which patients had been receiving haemodialysis was 37.5 months (range 2–432).

Reviewing medical records, the authors collected data pertaining to demographics, antibiotics, pathogens, types of AVG, the interval between AVG creation, or any intervention and surgical excision and complications.

The surgical methods used in the study were total graft excision (TGE; n=34), or partial graft excision (PGE) with an interposition graft (n=16). The choice of surgical methods was determined by three factors: the presence of fever (an indication for TGE), recent history of surgical manipulation mandating complete removal, and intraoperative findings. The latter was noted as a particularly important consideration, as infected prosthetic grafts do not get encased in scar tissue—but this can be easily determined by experienced vascular surgeons.

The results of the study regarding clinical manifestations include that infection was noted at a puncture site in 22 cases, at a prior incision for surgery or endovascular therapy in 20, and abandoned (currently

unused) grafts in five cases.

Additionally, infection occurred within one month after an AVG creation in only one case, while infection followed within one month of any intervention in 14 cases, and occurred more than one month after AVG creation or intervention in 35 cases. Simultaneous remote infection was identified in seven patients, two of whom underwent an operation for infective endocarditis and spondylitis.

In relation to the surgical outcomes of PGE, five patients (31.2%) having recurrent infection were treated with further graft excision; however, no patient showed life-threatening complications.

After TGE, a central venous catheter (CVC) was inserted and used for a median period of 90 days.

Among the 34 patients who underwent TGE, new vascular access was created in 18 patients at a median period of two months later, and 12 patients continued to use a CVC until last follow-up or death.

Taking into account the results of the study, the authors note some important clinical implications.

As seven patients had simultaneous remote infection and two required major surgery due to it, this type of infection must be suspected if or when the patient develops sustained fever or bacteremia after graft extension. Additionally, in 10% of the patients, infection involved an abandoned graft. As infection can occur at the site of abandoned vascular access, careful evaluation should take place if the patient is being assessed for fever, the authors recommend.

The final clinical implication the authors point to is regarding the use of an endovascular approach in

management of an infected graft. According to the authors, this approach could potentially cause septic emboli along with serious complications; meaning the possibility of infection should be evaluated when an endovascular procedure is planned for a thrombosed graft of pseudoaneurysm.

In relation to the limitations present in the study, the authors comment that they only analysed the outcomes in surgically treated patients, whereas information on the medically treated cases were not included. An interposition graft was placed after PGE using only a polytetrafluoroethylene (PTFE) graft. However, the authors comment that it would be useful to study and compare the benefits of other types of grafts, such as cryopreserved veins. Furthermore, due to the small sample size, the authors could not compare results based on microbiological studies, such as Gram-negative species.

Irrespective of the current limitations, the authors conclude that PGE should be considered in selected patients in order to achieve both infection eradication and vascular access preservation. The presence of fever and a recent history of surgical intervention would commission the use of a TGE, while intraoperative findings of a well-incorporated graft would be an indication for PGE. Yet, the authors reiterate that due to a higher risk of recurrent infection after PGE, appropriate patient selection and sufficient surgical removal (until the surgeon encounters sterile segments) are essential factors for success. Lastly, an extended courses of antibiotics and careful wound care is warranted for effective postoperative management.

The “friendly collaterals” of arteriovenous fistulae JOHN ROSS, MOHAMED SHETA AND JALAL HAKMEI COMMENT & ANALYSIS The prevalence of arteriovenous fistulae is about 63% based on the 2017 United States Renal Data System (USRDS) report. Unfortunately, there is still a considerable rate of about 36% failure to mature of all fistulae placed between June 2014 and May 2015. While most causes of failure might be attributed to technical or vascular pathology, we believe that a subset of patients’ problems might arise from a lack of recognition of the differences in haemodynamic effects on different types of collaterals.

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rteriovenous fistula collaterals are specific type of accessory veins that develop secondary to a more central stenosis. The main purpose of these collaterals is to maintain the blood circuit back to the heart. From this aspect, they are a physiological response to a possible offending pathology. After treating such stenosis, the significance of ligating these collaterals remains unclear to many interventionists.

Before answering this question, we need to review three fundamental axioms. First: the sole purpose of an arteriovenous fistula is to provide enough blood flow for adequate dialysis. Blood flow (Qb) above 600 ml/min is required to reach a satisfying Kt/V in most

instances except for unusual dialysis modalities like nocturnal hemodialysis for example. Second: achieving “anatomical purity” is attractive but sometimes expensive, exhausting and unnecessary. Third: the haemodialysis circuit starts with the arterial needle, followed by the blood pump, dialyser and ends with the venous needle. In most of cases, the arterial needle needs a relatively high blood flow (Qb >600 ml/ min) to lower the risk of recirculation in order to achieve the target Kt/v in a reasonable period of time. On the other side, the venous needle requires a low resistance outflow system to maintain the circuit. Based on the above axioms, most of the collaterals seen on angiograms are “friendly”, in the sense that they maintain

the continuity of the arteriovenous fistula vascular circuit back to the heart.

Furthermore, they insure a low resistance outflow system for the venous needle.

They can also serve as a diagnostic hint for obscured outflow lesions that can not be seen on the two dimensional picture of angiograms. Finally, some collaterals are sizable and can be used as fistula alternatives.

The only two exceptions are, firstly, when a collateral located between the arterial anastomosis and the arterial needle (Figure 1). This type of collateral can be harmful as it competes with the arterial needle. If Qb is lesser than 500ml/min, treating such collaterals is a must to restore blood flow to the arteriovenous fistula for patients on

thrice weekly incentre dialysis. Second, a collateral that cross the arteriovenous fistula at the needle stick zone causing either difficulty cannulation or haematoma if accidentally traumatised by the dialysis needles.

Surgical ligation is simple and inexpensive option. After identifying the “offending” collateral vein on angiogram, a radiopaque object can be used to mark the skin. Local anaesthesia is enough in most of cases.

Open surgical ligation can be done by making a two centimetre incision, blunt dissection can locate the collateral vein.

Two 3–0 silk ties are preferred. Before doing a complete tie, repeating the angiogram after gentle traction is useful to insure that the current collateral is the offending vein. Skin can be closed with 3–0 Prolene. Percutaneous surgical ligation is another option. Using a 3–0 Prolene, a stitch can be done through the skin. In a similar way to the open technique, repeating the angiogram should be done before doing a complete tie. If there is no flow in the collateral, a complete tie can be done. The suture can be removed in one to two weeks.

John R Ross is the medical director of the Dialysis Access Institute at the Regional Medical Center in Orangeburg, USA, where Mohamed A Sheta and Jalal E Hakmei are nephrology specialists.

Visit our booth at CIRSE 2018: #51

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The dialysis access landscape in 2018: Challenges, advances and future directions NICHOLAS INSTON COMMENT & ANALYSIS The recently published Vascular Access: 2018 Clinical Practice Guidelines of the European Society for Vascular Surgery1 give an overview of the current best evidence for vascular access for dialysis. Although these guidelines are largely similar to their predecessors, Nicholas Inston argues they may not always lead to best practice or outcomes. In this article, Inston looks at the current state of dialysis access, providing insight into the challenges and opportunities the field is facing.

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espite major advances in surgical technologies the autologous radiocephalic arteriovenous (AV) fistula first described by nephrologists over 50 years ago2 is still considered the gold standard form of vascular access for haemodialysis, and the role of the surgeon in dialysis care remains as critical as ever.

The alternatives for vascular access—the arteriovenous graft (AVG) and the central venous catheter (CVC)—are both associated with increased rates of complications and lower patient survival.

It is on this basis that guidelines have been directed towards AV fistulae as the recommended option, and this “one size fits all” approach has subsequently been adopted as policy in many healthcare systems and directed quality improvement initiatives.

Unfortunately, these policies have had the opposite effect. In the UK, the proportion of patients starting dialysis on a fistula or graft in 2011 was 41.4%.

Following the introduction of bestpractice tariff, it had dropped to 38.6% in 2015. More concerning definitive access in the prevalent dialysis population incrementally dropped from 79% in 2012 to 68.6% in 2015,3 with similar trends seen in the USA following the introduction of the Fistula First initiative.4 A possible explanation for this is a phenomenon known as “surgical fatigue”, wherein increased efforts to create AV fistulae in patients with a higher risk of failure results in patient disillusionment and disengagement.5 The use of guidelines to drive policy has inherent flaws. Firstly, the evidence base for most aspects of vascular access is poor. The very basic concept that survival is better in patients with an AV fistula is questionable. The statement may be correct, but underlying concepts such as of lead time effect and comorbidity must also be considered.

Renal failure is a chronic disease; few

patients have only one form vascular access, and many will have a lifespan of a combination of catheters, fistulae and grafts, peritoneal dialysis and/or kidney transplant(s).

The implication that catheters are inherently more dangerous than fistulae is simplistic. When patients in each group are analysed, the cause of death is not related to the device but to the comorbidity of patients.6,7 Whilst it cannot be denied that death from line sepsis is an issue, it is much less frequent than death from cardiovascular causes which accounts for around 30% of all dialysis deaths. Indeed, mortality from infection is proportionally higher for transplant patients than dialysis patients.3 Withdrawal from treatment is also a considerable cause of death in dialysis patients at around 20%, yet healthcare policy rarely includes patient choice.

Patient preferences have also been shown to be disparate to clinicians’ views.8 It is well documented that patients who start dialysis on a catheter are more likely to continue dialysis on a catheter, and an important area that avoids this is early referral to a surgeon. However, judging the time to create a fistula is difficult.

AV fistulae have a significant early failure rate and there is little that has been shown to improve this. The basic science of this problem is still poorly understood, and we have no pharmacological way of manipulating it.

Failure to mature (FTM) is furthermore likely to be underreported, as definitions of maturation are multiple and many do not involve use for dialysis. Even functional maturation does not have a clear and universal definition.

Many patients will have a series of failed fistula attempts, as FTM is unpredictable. Earlier fistula creation attempts to avoid starting patients on a catheter dialysis. Renal function (glomerular filtration rate; GMR) has traditionally been used and once it

has declined below a trigger value, a fistula is created. However, as decline is unpredictable, patients may not reach end stage and have an unnecessary operation, complications may occur, or the AV fistula may fail. More sophisticated approaches to the timing of access creation are therefore required, and kidney failure risk equations (KFRE), whilst not yet validated, may enhance this effort.9 Once a patient has an AV fistula, maintenance of it requires a multidisciplinary team of trained and enthusiastic specialists, as the combined roles of nephrologist, surgeon and radiologist are required to maintain good outcomes.

Surveillance is another ill-defined area, and studies have shown conflicting outcomes. Dialysis patients are intensively followed up, with data recorded three times per week and examined at the same time. The role of the dialysis nurse in monitoring, surveillance and diagnostics should not be underestimated, as physical examination can be as accurate as imaging. Focused and structured education for these team members is therefore essential and should be a key area to target for quality improvement.

Education of trainees is another area which should not be forgotten. The exposure to VA in training programmes is lacking. For many surgeons and radiologists, their knowledge of dialysis is limited and experience is from the clinic, theatre or interventional radiology suite rather than beside a dialysis machine.10

Progress and breakthroughs

We have recently seen some notable advances in devices for treating VA complications. However, most of the development has been rapid and lacked evidence. One such example is the management of central venous stenosis and thoracic central vein occlusion.

Treatment choices and modalities are often based on availability, experience or improvisation. The recent classification of thoracic central vein obstruction11 is welcomed and will assist in the description and study of these lesions, allowing more stringent comparisons of outcomes. It is also encouraging that a number of trials of drug-coated balloons in vascular access are currently underway.

Important advances in grafts technology have also occurred. PTFE as a material was not designed to be repeatedly cannulated, but in the last few years grafts designed specifically for dialysis and early cannulation have become available. The test bed for a novel bioengineered human artificial vessel (Humacyte graft) was in dialysis patients and the results of a large global trial are eagerly awaited. This may guide

applications in other areas of vascular practice.

Another major and novel advance is in AV fistula creation, using a nonsurgical approach. The endovascular AV fistula (endoAVF) is the first major innovation in fistula creation since the surgical fistula, with two platforms for endoAVF creation emerging simultaneously. Studies are promising, with improved functional outcomes and decreased complications.

Looking to the future

Vascular access in 2018 continues to develop rapidly, and options available to the surgeon, radiologist or interventional nephrologist are ever-increasing.

Consequently, it is imperative that those involved in performing vascular access are up to date with all the available options.

Dialysis care has also improved, and patients are now living longer. It is important that along this journey they have all the opportunities for a lifetime journey of renal replacement. Guidelines can assist in decision making, but ultimately the quality approach should be the right access, for the right patient, at the right time.

Nicholas Inston is the chairman of the Vascular Access Masterclass at the annual Charing Cross Symposium (CX) in London, UK, and a consultant renal transplant and vascular access surgeon at the University Hospitals Birmingham in Birmingham, UK. References 1. Schmidli J, Widmer MK, Basile C, et al. Editor’s Choice - Vascular Access: 2018 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Jun;55(6):757– 818. doi: 10.1016/j.ejvs.2018.02.001.

2. Brescia MJ, Cimino JE, Appel K, Hurwich BJ. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. N Engl J Med 275:1089–1092, 1966.

3. https://www.renalreg.org/reports/2016-nineteenthannual-report/ 4. Lok CE. Fistula first initiative: advantages and pitfalls.

Clin J Am Soc Nephrol. 2007 Sep;2(5):1043–53.

5. Yuan J, Dheeraj R, Bhola C, et al. Reasons for Hemodialysis Catheter Use and Its Complications: Patient and Vascular Access Coordinator Perspectives.

Presented at the spring meeting of the National Kidney Foundation; 10–14 April 2007, Orlando, USA. 6. Lee T, Allon M. Reassessing Recommendations for Choice of Vascular Access. Clin J Am Soc Nephrol.

2017 Jun 7;12(6):865-867.

7. van der Veer SN, Haller MC, Pittens CA, et al. Setting Priorities for Optimizing Vascular Access Decision Making--An International Survey of Patients and Clinicians. PLoS One. 2015 Jul 7;10(7):e0128228.

8. Ravani P, Palmer SC, Oliver MJ, et al. Associations between hemodialysis access type and clinical outcomes: a systematic review. J Am Soc Nephrol.

2013 Feb;24(3):465-73.

9. Inston N, Lok CE. Improving precision in prediction: Using kidney failure risk equations as a potential adjunct to vascular access planning. J Vasc Access.

2018 Jul 1:1129729818786630.

10. Inston N, Singh TM. Training vascular access surgeons: technicians or specialists? J Vasc Access.

2018 Mar;19(2):117-118.

11. Dolmatch BL, Gurley JC, Baskin KM, et al. Central Vein Work Group and the Technology Assessment Committee. Society of Interventional Radiology Reporting Standards for Thoracic Central Vein Obstruction: Endorsed by the American Society of Diagnostic and Interventional Nephrology (ASDIN), British Society of Interventional Radiology (BSIR), Canadian Interventional Radiology Association (CIRA), Heart Rhythm Society (HRS), Indian Society of Vascular and Interventional Radiology (ISVIR), Vascular Access Society of the Americas (VASA), and Vascular Access Society of Britain and Ireland (VASBI). J Vasc Access.

2018 Aug 13:1129729818791409

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Aneurysm screening programmes demonstrate a cost-effective reduction in all-cause and aneurysm-related mortality A new systematic review and meta-analysis investigating abdominal aortic aneurysms (AAA) has found a significant and cost-effective reduction in all-cause mortality as well as AAA-related mortality.

Andrew J Ying (Westmead Hospital, Sydney, Australia) and Eshan T Affan (Royal Prince Alfred Hospital, Sydney, Australia) who carried out the study, published in Annals of Vascular Surgery, also noted that large trials have demonstrated a mortality benefit for abdominal aortic aneurysm screening.

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ing et al report that abdominal aortic aneurysms (AAA) can cause significant mortality when ruptured, but many remain undiagnosed before this time.

According to the authors, population screening of high risk individuals and early intervention may mitigate AAArelated mortality. Yet, although large trials such have demonstrated a mortality benefit for AAA screening, adoption is not ubiquitous. Ying et al therefore sought to systematically review and consolidate recent randomised trial evidence on AAA screening with regards to efficacy as well as cost effectiveness.

In order to identify relevant randomised trials and cost-effectiveness analyses (CEAs) of AAA screening in men, the authors searched Medline, Embase and CENTRAL, as well as citation lists.

Data was extracted as hazard ratios or raw event rates. Meta-analysis was conducted using random-effects, inverse variance weighted model for continuous variables as well as Mantel-Haenszel weighting for event data. Additionally, cost estimates of screening

were subsequently adjusted for inflation.

Regarding the results, five studies were identified totalling 175,085 participants (with an age range of 64–83). The AAA detection ranged from 3.3% to 7.7%.

Furthermore, screening was found to have significantly reduced all-cause-mortality (Hazard ratio [HR]: 0.97, 95% confidence interval [CI]: 0.96–0.99, p=0.002), as well as AAA-related mortality (HR: 0.65, 95% CI: 0.48–0.89, p=0.008) and emergent AAA repair (Relative risk [RR]: 0.64, 95% CI: 0.46–0.91, p=0.02).

The authors also reported that the number needed to screen in order to prevent one AAA-related death per 10 years ranged from 209 to 769 individuals. Furthermore, 16 cost-effectiveness analyses found a mean value of US$16,854 per quality-adjusted life years (range: US$266–73,369).

Considering the results, the authors concluded that wider implementation of population based AAA screening programmes in elderly men should be advised as they continue to demonstrate a significant and costeffective reduction in all-cause-mortality, as well as AAA-related mortality.

Mass aneurysm screening for at the Veterans of Foreign Wars convention A mass screening for abdominal aortic aneurysms has been carried out at a Veterans of Foreign War convention by AAAneurysm Outreach, a non-profit organisation based in New Orleans, USA, who described the event to have been particularly successful, with “11 lives saved”.

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n the 21–24 July, Kansas City (USA) saw over 600 military veterans participate in the second annual free mass screening event for abdominal aortic aneurysms (AAAs), carried out by AAAneurysm Outreach (a non-profit organisation based in New Orleans, Louisiana).

Conducted as part of the national conventions of Veterans of Foreign Wars (VFW) and VFW Auxiliary, the event resulted in 11 aneurysms being discovered that required medical attention.

The screened veterans came from VFW posts across the USA and ranged in age from 45 to 90. Participants were assessed for risk and educated on the risk factors including high blood pressure, high cholesterol, hardening of the arteries, history of smoking, or family history of aneurysms.

Keith Allen, a vascular surgeon who provided medical expertise for the screening event, commented: “This is a really under-diagnosed problem that faces a lot of people. Until you get screened, you never know you have it.”

In addition, Don Lanman, a USA army veteran and AAAneurysm outreach board member, reiterated the importance of screening, “Most people have no idea about the dangers of this silent killer, and we are able to provide this lifesaving screening to our veterans, thanks to local professionals and national supporters.”

According to a recent press release, an abdominal aortic aneurysm rupture is the third-leading cause of sudden death in men over 60 in the USA. Moreover, it is estimated that more than one million people are living with an undiagnosed abdominal aortic aneurysm. AAA screening is recommended every five years for all those over age 60 or with risk factors. Detected early, an AAA can be treated with a variety of effective procedures.

LUCY trial one-year results show similar outcomes for men and women One-year results from the LUCY (Evaluation of females who are underrepresented candidates for abdominal aortic aneurysm repair) registry were reported at the Society for Vascular Surgery Vascular Annual Meeting (VAM; 20–23 June, Boston, USA). The LUCY study is the first to prospectively evaluate endovascular aneurysm repair (EVAR) outcomes in women who have more complex aortic anatomy and, subsequently, have worse reported outcomes than men undergoing EVAR.

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he LUCY one-year data expand on the 30-day results presented last year, showing that at least 28% more women are eligible for minimallyinvasive EVAR when using the Ovation Abdominal Stent Graft System (Endologix) than when using other EVAR systems.

The LUCY study is a prospective, consecutively enrolling, non-randomised, multicentre, post-market registry evaluating the Ovation System for the endovascular treatment of abdominal aortic aneurysms (AAA) in women. The study enrolled a total of 225 patients, including 76 females in the treatment

group and 149 males in the control group, at 39 sites in the USA. The primary endpoint of the study was the 30-day major adverse event rate and secondary endpoints included serious and nonserious adverse events through one year.

The one-year LUCY data showed that, despite having more complex anatomy at the time of the index procedure than men, women had similar outcomes to men following treatment with the ultra-low profile (14F) Ovation device: Freedom from AAA-related morality: 100% in women vs. 98.6% in men Freedom from reintervention for Type

1a endoleak: 98.6% in women vs.

97.9% in men Freedom from rupture: 100% in both women and men Freedom from conversion: 100% in both women and men Freedom from all device-related reintervention: 97.2% in both women and men.

Jennifer Ash, Christie Clinic Vein and Vascular Center and Assistant Clinical Professor of Surgery, University of Illinois College of Medicine in Champaign, USA, said, “Women have specific anatomical challenges in iliac access and proximal

Jennifer Ash

aortic neck morphology and have historically had worse outcomes from EVAR than men. The results of the LUCY study suggest that the unique features of the low-profile Ovation system may overcome these challenges and achieve similar outcomes in men and women.”

Vascular & Endovascular

Challenges Update 15–18 APRIL 2019 MONDAY–THURSDAY OLYMPIA GRAND • LONDON • UNITED KINGDOM

Aortic Challenges

Peripheral Arterial Challenges

Venous Challenges

Acute Stroke Challenges

Vascular Access Challenges

and introducing

Abstract submissions open WWW.CXSYMPOSIUM.COM/ABSTRACTS

SUBMISSION DEADLINE: 28 OCTOBER 2018

EDUCATION

INNOVATION EVIDENCE

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Critical limb ischaemia

Worth an arm and a leg: Amputation inferior to revascularisation in critical limb ischaemia treatment

Recent data, published in the Journal of the American Heart Association (JAHA), demonstrate the significant clinical and financial burden that critical limb ischaemia (CLI) poses to the US healthcare system. While primary treatment selection is still controversial, the study found that patients with more advanced peripheral arterial disease had worse survival and generated higher healthcare costs when major amputation was performed as a first-line treatment. Revascularisation, both endovascular and surgical, in contrast, had improved long-term survival rates.

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n a propensity score-matched analysis of 9,942 Medicare beneficiaries initially diagnosed with critical limb ischaemia (CLI) in 2011, fouryear survival rates were 38% with endovascular revascularisation as the first-line strategy, 40% with surgical revascularisation, and 23% with major amputation (p<0.001 for both versus amputation). The study investigators were able to stratify the clinical outcomes and costs on the basis of initial treatment strategy using procedural codes for each method.

Lead author Jihad Mustapha (Advanced Cardiac & Vascular Amputation Prevention Centers, Grand Rapids, USA) and colleagues found that subsequent major amputation rates over the follow-up period were 6.5% for endovascular revascularisation, 9.6% for surgical revascularisation, and 10.6% for primary major amputation (p<0.001 for all comparisons).

Additionally, total health costs per patient per year totalled US$49,200 for endovascular revascularisation, US$49,200 for surgical revascularisation, and US$55,700 for amputation.

“Primary major amputation portends a poor prognosis even when adjusting for demographics, medical history, and disease severity. Compared with revascularisation, primary major amputation is associated with shorter survival time, increased risk of second major amputation, and higher healthcare costs. These results were generally consistent regardless of patient characteristics and clinical presentation,” the authors write.

“Survival following CLI diagnosis is lower than that of heart failure, stroke, and most cancers. Given that CLI is underdiagnosed, increasing in prevalence, and responsible

for significant risk to life and limb, considerable efforts are needed to raise disease awareness, refine diagnostic algorithms, and establish evidence-based treatment pathways,” they continue.

While according to Mustapha et al, long-term survival and cost in CLI management is comparable between revascularisation techniques, it remains controversial which revascularisation method to opt for (open surgical or endovascular) when selecting an initial revascularisation strategy. In an analysis of 7,900 CLI patients from the Vascular Quality Initiative, three-year survival was lower with endovascular versus surgical revascularisation strategies (90% vs. 78%), whereas in the present study there was no significant difference of fouryear survival. In the First-Line Treatments in Patients with Critical Limb Ischaemia (CRITISCH) registry of 1,200 patients, no difference in one-year mortality or major amputation between revascularisation methods was identified, in accordance with these most recent JAHA findings. Additionally, the randomised BASIL (Bypass versus Angioplasty in Severe Ischaemia of the Leg) study also found no differences in long-term mortality or major amputation when comparing endovascular versus surgical revascularisation. The study authors look to the BEST Endovascular Versus Surgical Therapy for Patients with Critical Limb Ischaemia (BEST-CLI) trial in the hope of a more definitive answer to the revascularisation question. This is due for completion in 2019, and includes 2,100 participants.

There are a number of limitations to the present study, however, which muddy the results. Most significantly, the authors note that there is a susceptibility to bias caused by

the influence of confounding variables. Despite the use of propensity-score matching to adjust the selection bias among major treatments, the authors note that there is a possibility of unmeasured patient characteristics being different among treatment groups, which may have influenced outcomes.

Additionally, the rationale for treatment decisions cannot be determined from this research. For example, although primary major amputation was performed in 6% of patients, whether amputation was performed because of standard institutional practice, extensive gangrene, inability to ambulate, or otherwise is unknown.

Writing in an accompanying JAHA editorial, Javier Valle and Stephen Waldo (both University of Colorado, Denver, USA) postulate the existence of pre-existing differences in medical complexity that could represent residual confounding when assessing differential outcomes.

Valle and Waldo conclude by offering two suggestions.

Firstly, they advocate for the implementation of programmes that increase the adoption of guidelinedirected medical therapies, writing that guideline adherence is “underwhelming”, with only 32% of patients with CLI receiving all guideline-recommended medical therapies in some series.

Secondly, they emphasise that urgent revascularisation is imperative to improve outcomes in CLI patients. Noting that in this work and in previous studies investigators have found that a substantial number of individuals with CLI do not undergo any revascularisation attempt before amputation, the editorialists stress that “education about the importance of revascularisation for limb salvage among primary care practitioners and ancillary services, like podiatry, is critical to improve outcomes for this condition.”

Mixed outcomes for use of atherectomy and angioplasty over angioplasty alone for critical limb ischaemia A new study reveals atherectomy with angioplasty appears to provide similar patency rates to angioplasty alone for infra-popliteal peripheral arterial disease in critical limb ischaemia, but was associated with higher re-intervention and local complication rates. The findings were presented by Saqib Zia from Staten Island University Hospital, New York, USA, at the Society for Vascular Surgery’s Vascular Annual Meeting (VAM; 20–23 June, Boston, USA).

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ccording to Zia, advances in endovascular techniques have shifted the trend towards endovascular interventions. However, limited data is present for endovascular treatment of infra-popliteal peripheral arterial disease, when compared to the femoral and popliteal diseases.

Zia and colleagues tailored their objectives around the fact that although the use of atherectomy that has increased in the past decade has been shown to be beneficial, there is limited data that directly compares atherectomy to angioplasty in infra-popliteal peripheral arterial disease.

Therefore, the study aimed to compare the short and mid-term outcomes and procedural complications of these two modalities of revascularisation in infra-popliteal peripheral arterial disease in patients at Zia and his colleagues’ affiliated institution.

The authors carried out a retrospective, single-centre longitudinal study between January 2014 and October 2017, comparing patients undergoing either infra-popliteal atherectomy with or without angioplasty

alone for critical limb ischaemia. Patients with noncomitant iliac, femoral or popliteal interventions were included in the study.

Exclusion criteria included patients with claudication, infra-popliteal transluminal stent placement and patients with ipsilateral limb artery bypass.

During the study period, 342 infrapopliteal interventions were performed on 290 patients, with a mean age of 67.3 years (of which 61% were male); 53.5% of procedures being angioplasties and 46.5% atherectomies.

The Kaplan Meier Curve revealed that primary patency rates at three months were 91.8% (168) for angioplasty versus 92.5% (147) for atherectomy (p=0.8). Similar six-month (158, 86% vs. 135, 85% p=0.7), 12-month (156, 85% vs. 122, 77% p=0.04) and 18-month (152, 83.1% vs. 121, 76.1% p=0.08) interval patency rates were seen in two groups. Forty-five (28.3%) atherectomy patients had re-interventions versus 29 (15.8%) angioplasty patients (p=0.058) with a median of 74 days before the need for

Saqib Zia

re-intervention. Diabetes presented as the only clinical factor associated with increased risk of re-intervention (B=0.76, p=0.018) in both groups.

Primary assisted patency rates were 86.3% (158) in angioplasty vs. 76.1% (121) in atherectomy group (p=0.0174). Primary patency rates did not differ between two groups, however, the risk of re-intervention

was higher with the atherectomy group.

Thirty-day amputation rates (5, 2.7% vs.

6, 3.8% p=0.7606) and mortality rates (4, 2.2% vs. 2, 1.3% p=0.6894) were similar in angioplasty and atherectomy groups, respectively. Nevertheless, patients in the atherectomy group were found to have higher local complication rates (7, 4.4% vs.

1, 0.5% p=0.0273).

In conclusion, Zia reiterated that atherectomy with angioplasty appears to provide similar patency rates to angioplasty alone for infra-popliteal peripheral artery disease in critical limb ischaemia but was associated with higher re-intervention and local complication rates.

Moving forward in this field, he noted that a large, appropriately designed, multicentre study is required to determine the exact role of atherectomy as compared to angioplasty alone in this subset of patients. The authors wrote: “The future perspectives of this continuously evolving endovascular technique should be better defined based on robust data.”

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Similar in-hospital major events of transcarotid artery revascularisation and carotid endarterectomy Major adverse events in patients undergoing transcarotid artery revascularisation (TCAR) were similar to those receiving a carotid endarterectomy, a study has found, despite the higher medical risk in the former group. Marc Schermerhorn (Beth Israel Deaconess Medical Center, Boston, USA) et al conducted a study to compare in-hospital outcomes of the two procedures.

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Marc Schermerhorn

he data were presented by Schermerhorn at the Society for Vascular Surgery’s (SVS) Vascular Annual Meeting (VAM; 20–23 June, Boston, USA) during a Vascular & Endovascular Surgery Society paper session, and the abstract was recently published in the Journal of Vascular Surgery.

“TCAR is a promising alternative to transfemoral

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Transcarotid artery revascularisation

carotid artery stenting, with initial trials like ROADSTER reporting very low 30-day stroke rates,” Schermerhorn said at VAM. “It gives you the benefit of cerebral protection with flow reversal, and avoids aortic arch manipulation.” However, studies confirming the safety and efficacy of TCAR are limited to “highly selected patients and providers”, thus prompting this

in-hospital outcomes study.

Schermerhorn and colleagues used the SVS Vascular Quality Initiative TCAR Surveillance Project and carotid endarterectomy databases “to evaluate the safety and efficacy of TCAR in real-world practice, using a contemporary comparison to CEA.” The study included patients undergoing either procedure during the time period 2016–2017, enrolling 1,182 TCAR patients and 10,797 endarterectomy patients.

“TCAR patients were older, and they were also sicker,” Schermerhorn stated, pointing to the baseline characteristics of each group which showed higher co-morbidity rates in this group, including coronary artery disease (55% vs. 28% in the endarterectomy group, p<0.001) and chronic heart failure (20% vs. 11%, p<0.001). He added that “TCAR patients were also more symptomatic, and had a higher degree of stenosis, and were also more likely to have had prior carotid intervention.”

Unadjusted primary outcomes of stroke, death, and other major adverse events showed no statistical difference. The composite stroke/death rate was 1.6% in TCAR vs. 1.4% in carotid endarterectomy patients (p=0.33) and the stroke/death/myocardial infarction rate was 2.5% and 1.9%, respectively (p=0.16). In fact, looking at other outcomes such as haemodynamic instability, cranial nerve injury and operative time, the TCAR patients were half as likely to be treated for hypertension (10% vs. 21%, respectively; p<0.001), although “they were slightly more likely to be treated for hypotension,” Schermerhorn noted. Cranial nerve injury was reported in 0.6% of TCAR patients vs.

1.8% of endarterectomy patients (p<0.001), a three times higher rate which Schermerhorn added was “as expected.” Time in the operating room was around 30 minutes shorter for TCAR (78±33 vs. 111±43, respectively; p<0.001).

“Looking at multivariable regression, again there was no difference in stroke/death or the other major outcomes,” Schermerhorn said. When breaking out patient groups into subgroups of symptomatic and asymptomatic, the “one thing that was close” to statistically significant difference was the stroke rate in symptomatic patients.

“Despite the fact that the medical risk was substantially higher in TCAR patients, the major adverse events were similar in TCAR and endarterectomy. However, TCAR had shorter operating room time by more than 30 minutes, one third the rate of cranial nerve injury and lower postoperative hypertension requiring any medications,” Schermerhorn concluded, adding that long-term follow up will be “presented in the near future.”

TCAR suggests reduced risk of major adverse events compared to standard carotid stenting in real-world outcomes Real-world outcomes from the Transcarotid Artery Revascularisation (TCAR) Surveillance Project (TSP) were presented by Mahmoud Malas from John Hopkins Hospital (Baltimore, USA) at the Society for Vascular Surgery Vascular Annual Meeting (VAM; 20–23 June, Boston, USA). At baseline, patients undergoing TCAR had significantly higher medical comorbidities before the procedure than those who were going to receive a stent, but according to Malas they were nevertheless shown in a historical dataset to experience half the risk of in-hospital transient ischaemic attacks (TIAs), stroke, and death, compared to patients undergoing transfemoral carotid artery stenting.

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lthough carotid stenting is a minimally invasive approach, Malas said, it has failed to have similar outcomes to endarterectomy—despite “remarkable improvement” over the last 15 years. Additionally, Malas noted, physicians are seeing almost twice as much risk of stroke with stenting, specifically in patient groups that are deemed high-risk for surgery.

Transcarotid artery revascularisation (TCAR) is carried out by initially creating a small incision in the neck, connecting an arterial sheath to a venous sheath in the femoral vein and creating a dynamic reversal flow from high arterial pressure to low venous pressure. Malas stated that this idea was introduced as a “hybrid procedure that combines both carotid endarterectomy (CEA) and carotid artery stenting (CAS)”.

By placing the clamp in the carotid artery in TCAR, the surgeon is able to provide a CEA-like protection after which a carotid stent is placed.

This technique was previously published in the Journal of Vascular Surgery and previous trials such as ROADSTER I and II (The Safety and Efficacy Study for Reverse Flow Used during Carotid Artery Stenting Procedure) have

led to the approval of this technology. In relation to their outcomes, Malas pointed to the “remarkable” stroke rate of 0.7% in the ROADSTER I trial, while, at the oneyear follow-up of ROADSTER II, 99% of patients were stroke free, and 95% had a stroke-free survival (n=405).

According to Malas, the ROADSTER multicentre trials reported the lowest stroke rate in high-risk patients compared to any prospective trial of transfemoral carotid artery stenting (TFCAS). However, clinical trials have selection criteria that exclude many patients, and are highly selective of operators performing procedures, which can limit the generalisability. The prospective study conducted by Malas et al therefore aimed to compare in-hospital out-

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comes after TCAR and TFCAS as reported by the Society for Vascular Surgery (SVS) in their Vascular Quality Initiative (VQI).

The SVS VQI TCAR Surveillance project (TSP) is intended to monitor the safety and effectiveness of TCAR in real-world outcomes. The project also aimed to compare this less-invasive surgical procedure with the standard carotid endarterectomy in centres that participate in the SVS VQI. This prospective observational study initially intended to enrol 5,000 participants, but has just updated the dataset to 15,000 patients, with a plan to complete the study by 2024. Thus far, data from the initial 646 patients enrolled in the study were analysed and compared to patients who underwent TFCAS between 2005 and 2017.

In order to be included in the study, patients had to meet to the high-risk criteria; whether medical or anatomical.

Other inclusion criteria were two or more vessels with coronary artery disease and a history of angina, congestive heart failure and/or myocardial infarction more than 72 hours and less than six weeks prior to the procedure. Patients with tandem, traumatic or dissection lesions were excluded.

The primary outcome was a composite of in-hospital mortality and neurological events (all stroke and TIAs) occurring within the patient’s hospital stay.

Secondary outcomes included in-hospital mortality, ipsilateral and total stroke, transient ischaemic attacks, haemodynamic instability and hyperperfusion syndrome. Multivariate logistic regression allowed the authors to adjust for clinically significant variables and those that were significantly different between the two groups on univariate analysis.

Malas et al also carried out Coarsened Exact Matching to match patients in the TCAR group to those in the TFCAS group based on a number of variables, including usual comorbidities, degree of ipsilateral stenosis and/or the presence of anatomical or medical high-risk criteria.

Compared to patients undergoing TFCAS (n=10,136), those undergoing TCAR (n=638) were significantly older and had more cardiac comorbidities, while patients in the TFCAS group were more likely to be symptomatic and to have a restenotic lesion. There was no change in the odds of stroke or death in TFCAS over the study period (p>0.05).

Initial results

The rate of in-hospital transient ischaemic attacks and stroke, as well as composite rate of TIA, stroke and death were significantly higher in TFCAS compared to TCAR (3.3% vs. 1.9%, p=0.04 and 3.8% vs. 2.2%, p=0.04, respectively). In both procedures, symptomatic patients had higher rates of TIA, stroke, and death compared to asymptomatic patients, however the difference was significant only in the TFCAS (TCAR: 3.7% vs.

1.4%, p=0.06 and TFCAS: 5.3% vs. 2.7%, p<0.001). Furthermore, the multivariable analysis indicated that TFCAS was associated with twice the odds of in-hospital neurologic events and TIA, stroke and death compared to TCAR, independent of symptomatic status.

Transcarotid artery revascularisation In relation to the limitations of the study, Malas said that so far, they have only presented outcomes in the first ~650 patients, meaning they are limited by the number.

However, he reiterated that they are aiming to collect data from 5,000–15,000 patients in total. Furthermore, he touched on how they have only presented in-hospital outcomes, meaning further investigation needs to be done regarding long-term outcomes.

Nonetheless, he said, “I think this is a great example where VQI can take a new technology and evaluate it very quickly and efficiently, [especially] outside the setting of clinical trials, which are very costly and lengthy.” Malas concluded by saying that so far, they have seen very similar

results in real-world outcomes for TCAR in comparison to clinical trials.

TCAR to replace endarterectomy?

Following the presentation, Malas was questioned on whether he believes it is time to switch from carotid endarterectomy to TCAR. He replied that they are “still a long way off,” with the current study needing a much larger sample. Nevertheless, he emphasised that TCAR does allow for someone who is not very experienced at carotid stenting to carry out the procedure, hence transforming the nature of it—making it easier and safer to carry out.

Discussion with the audience at VAM highlighted next steps, including a poten-

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tial cost analysis comparing TCAR and endarterectomy, which Malas stated he believes to be an important issue, although no such cost analysis has yet been carried out or planned. Malas further noted that transfemoral stenting tends to end up costing more, due to the additional cost of the stent and filter. However, Malas et al also carried out a study looking at specific costs of complications. Interestingly, they found that when patients have a stroke after carotid artery endarterectomy, costs are often steeper than after carotid artery stenting, as the stroke after endarterectomy tends to be more severe. According to Malas, data within the literature supports this, revealing that strokes after carotid artery stenting are often minor.

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BIBA MedTech insights

BIBABriefings

Cost is biggest barrier to performing fenestrated EVAR

Most operators can use their device of choice for peripheral interventions

A survey of 172 endovascular aneurysm repair (EVAR) operators in Western Europe shows that cost is the main factor that prevents operators from performing fenestrated EVAR in patients with a short aneurysm neck (≤15mm). Fifty-two survey respondents reported that they did not perform fenestrated EVAR; of these, 58% gave cost as the reason. By contrast, according to 58 respondents who said they did not perform chimney EVAR, fear of long-term complications was the main reason for not performing chimney EVAR (60%). See Figure 1.

Overall, the survey found that, on average, an operator performs about 21 short-neck EVAR procedures per year. Of these, most (62%) are for patients with aneurysm necks of 10–15mm. Fenestrated EVAR is used as the primary technique for both necks of 10–15mm and for necks of 0–10mm (although, types of treatment are more varied for 10–15mm necks). Chimney EVAR is used in 15% and 23%, respectively, of patients with aneurysm necks of 10–15mm and 0–10mm.

A survey indicates that 95% of operators in Western Europe are able, at least in the majority of cases, to choose which device to use for peripheral intervention procedures (see Figure 2). This finding is despite 85% of those surveyed (149 overall) working in a public institution (71% in a public teaching/university hospital and 14% in a public community hospital), where cost is more likely to influence choice of treatment.

The survey also shows that, over the next 12 months, drug-coated balloons will increasingly be used to treat superficial femoral artery lesions, with a corresponding decrease in the use of percutaneous transluminal angioplasty. In particular, drugcoated balloons will be used more frequently for long lesions in 2018 than percutaneous transluminal angioplasty will be. In 2017, survey respondents reported using the latter in 26% of cases and drug-coated balloons in 21% of cases. But, their predicted use of these devices for 2018 was 19% and 29%, respectively.

Polyphenol-coated angioplasty balloon to be developed

Researchers at Louisiana State University (Louisiana State University, Baton Rouge, USA) are developing a nanoparticle that contains the polyphenols resveratrol and quercetin—both of which are found in red wine—as an alternative drug-coated balloon for peripheral arterial disease.

According to a Louisiana State University press release, Tammy Dugas discovered that the two polyphenols, in combination, may work well as a treatment for peripheral arterial disease without causing some of the side-effects seen with current treatments. She then asked Cristina Sabliov (a biological and

BIBA Briefings

agricultural engineering professor at Louisiana State University) to develop a nanoparticle to contain the two drugs.

Once developed, the press release reports, the nanoparticle will be used to coat an angioplasty balloon—which would then be delivered into the peripheral arteries as a typical drug-coated balloon. The idea is for the novel balloon to provide the benefits of a stent (i.e. vessel healing) without the side-effects.

Sabliov comments: “There are places where the stent is not suitable. You cannot have a stent in the part of the leg that bends. You want the artery to stay open but without a stent, so what do you do?

With these new drugs, the aim is to stop the artery cells from growing back and causing the artery to re-narrow.”

BIBA Briefings is a new platform that provides in-depth analysis of the latest market intelligence from BIBA MedTech Insights, which provides consulting and market analysis services to medical professionals and organisations in the medical device industry in Europe and North America.

The platform also reviews data and news.

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

Setbacks in coronary space do not deter development of peripheral bioresorbable devices

Reva Medical has become the first company to have a bioresorbable scaffold (Motiv) for the management of below-the-knee peripheral arterial disease on the European market (no bioresorbable scaffolds, for any indication, are available in the USA).

According to a recent press release, Motiv is made from Tyrocore—Reva’s proprietary polymer designed specifically for vascular scaffolds—which is inherently radiopaque.

The development of bioresorbable scaffolds for the peripheral arteries has followed the somewhat chequered experience of bioresorbable scaffolds for the coronary arteries. After the negative results for the bioresorbable vascular scaffold (Absorb) and poor commercial sales of the device, Abbott withdrew it in all markets last year; it was the only bioresorbable scaffold to have both CE mark and US Food and Drug Administration (FDA) approval for the treatment of coronary stenosis.

However, other coronary scaffolds are still available on the European market at the moment. For example, Reva Medical has the Fantom coronary scaffold.

Pipeline Insights

For more information, see: vascularnews.com Avinger has submitted a new 510(k) application to the US FDA for its Pantheris SV (Small Vessel) Lumivascular atherectomy system. Press release.

Artificial intelligence-driven HART PAD test accurately diagnoses peripheral arterial disease in diabetes mellitus patients. Presentation at 2018 European Society of Cardiology (ESC) Congress (25–29 August, Munich, Germany) Novel device, described as a bendable ribbon with eyelets spaced 1cm apart, for accurately placing haemodialysis catheters in dialysis patients has successfully been used in a group of 10 patients. Ohara T et al. The Journal of Vascular Access.

The VasQ implanted blood vessel external support device (Laminate Medical), developed for patients requiring arteriovenous fistulas, has been used in the first patients (in the forearm). Press release.

Novel surgical navigation system, Intra-Operative Positioning System (Centerline Biomedical) could help to reduce concerns around operator exposure to radiation during endovascular procedures. Eagleton M. Presentation at the International Symposium on Critical Issues in Aortic Endografting (29–30 June, Malmö, Sweden).

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Market watch

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HART PAD blood test accurately diagnoses peripheral arterial disease in diabetic patients

Prevencio has announced data demonstrating its HART PAD test accurately diagnoses peripheral arterial disease (PAD) in diabetes mellitus patients, a patient population in which PAD prevalence has traditionally been difficult to assess. Researchers believe these important findings, presented at the 2018 European Society of Cardiology Congress (ESC; 25–29 August, Munich, Germany), could lead to early identification of PAD and improve patient clinical outcomes, as well as prevent patients without PAD from undergoing unnecessary, expensive, and invasive tests.

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he study is follow-on to data presented at the American Diabetes Association (ADA) 2018 Scientific Sessions in June 2018, demonstrating that Prevencio’s HART CAD and HART CVE tests accurately diagnose coronary artery disease (CAD) and predict the risk for major adverse cardiac events (MACE) in diabetes mellitus patients. Similar to CAD, PAD is commonly due to atherosclerosis, a plaque buildup in the arteries which restricts blood flow.

In this study, researchers assessed the company’s AI-driven HART PAD diagnostic test on patients enrolled in Massachusetts General Hospital’s catheter sampled blood archive in cardiovascular disease (CASABLANCA) study.

The HART PAD test algorithmically assesses six biomarkers linked to

atherosclerosis, as well as a patient’s history of hypertension. In patients with diabetes mellitus, the HART PAD panel had excellent performance for diagnosis of PAD. Using a 5-point score, a score of 1 had a 100% negative predictive value (NPV) and a score of 5 had a 95% positive predictive value (PPV).

Additionally, the HART PAD panel was highly accurate in predicting the need for revascularisation in patients with PAD. These results were comparable to those patients without diabetes mellitus.

Principal investigator James L Januzzi, practicing cardiologist at Massachusetts General Hospital and professor of Medicine at Harvard Medical School, Boston, USA, says, “The HART PAD test may allow for the diagnosis and treatment of many more patients with currently undetected PAD. In the clinical setting,

these findings could assist physicians to identify peripheral arterial disease earlier, provide guideline-recommended care, and monitor at-risk patients for vascular complications. We believe HART tests could also play an important role in identifying high risk patients for enrolment in clinical trials, thereby saving time and lowering overall trial costs.”

PAD affects more than 202 million people worldwide and is often underdiagnosed and undertreated until the disease has reached advanced stages.

Patients with diabetes mellitus are at substantial risk of developing PAD. Patients with PAD have increased risk of CAD, heart attack, or stroke, and, if left untreated, PAD can lead to foot or leg amputation. Prevencio has also developed the HART AMP to accurately predict a patient’s risk for amputation.

According to the Centers for Disease Control and Prevention, more than 30 million people in the USA have diabetes and the total direct and indirect costs associated with patients diagnosed with diabetes total US$327 billion annually.

“This ESC presentation adds to the growing volume of presented and published scientific literature supporting the accuracy and clinical benefit of our novel HART tests,” says Rhonda Rhyne, Prevencio’s CEO. “The potential of our HART tests to fulfil the urgent need for alternative, reliable, and cost-effective cardiovascular diagnostic and monitoring solutions is encouraging, especially for diabetic patients. For this underserved patient population, PAD and CAD can result in significant morbidity and mortality due to lack of diagnosis and timely treatment.”

Product News Avinger announces 510(k) filing of Pantheris Small Vessel device

Avinger, a developer of treatments for peripheral arterial disease (PAD), has announced the Company submitted a new 510(k) application to the US Food & Drug Administration (FDA) for the Pantheris SV (Small Vessel) Lumivascular Atherectomy System.

Pantheris SV is a line extension of the Pantheris family of catheters, the first and only image-guided atherectomy devices for the treatment of PAD. Designed with a lower profile and longer length, Pantheris SV is intended to expand the number of addressable procedures for Pantheris by allowing physicians to target lesions in smaller diameter vessels and more distal regions of the vasculature. Pantheris SV incorporates key improvements introduced to the platform with the clearance of the next generation Pantheris system in May 2018, including a stiffer shaft for increased pushability, a refined optical coherence tomography imaging system, a more robust nosecone, and an enhanced cutter design.

“Effective tools to address lesions in smaller vessels represent an important unmet clinical need in the treatment paradigm for PAD,” said Jaafer Golzar, Avinger’s chief medical officer. “There is a lack of longterm durability noted with other treatment options in this area of the vasculature. However, the concept of pairing onboard image-guidance with a directional atherectomy system could provide a number of significant clinical advantages, including an enhanced safety profile, the ability to maximise luminal gain without causing vascular injury, and a potential enhancement in the uptake of anti-restenotic drug therapy,” Golzar continued.

Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular

approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionising radiation.

Gore moulding and occlusion balloon for endovascular aortic repair receives approval in the USA, Japan, and Europe

Gore has announced FDA 510(k) clearance, approval from the Japanese Ministry of Health, Labour, and Welfare, and receipt of CE mark for the innovative Gore moulding and occlusion balloon, a compliant polyurethane balloon catheter designed in close collaboration with clinicians to assist in the expansion of self-expanding stent grafts or to temporarily occlude large-diameter vessels. The new device meets all endovascular aortic repair (EVAR) procedural requirements—a single balloon that replaces the need for multiple moulding and occlusion balloons.

The device’s proven radial expansion force across the range of EVAR device sizes enables physicians to consistently seat and seal grafts with confidence. This more efficient graft seal may reduce procedural time and the risk of type I endoleaks. The device is also engineered with the lowest profile to reduce the potential of access-related complications, and its excellent pushability and trackability offers enhanced control with uncompromised inflation and deflation time.

“We have worked closely with clinicians to engineer a single balloon that truly changes both the physician and the patient experience,” said Eric Zacharias, Gore vascular business leader. “This milestone is one of several in our ongoing dedication to treating the entire aorta, and to helping physicians offer the best patient experience possible.”

The new device is supplied in a single catheter length of 90cm to enable use with current Gore Excluder devices as well as future Gore devices while still being

compatible with a 180cm length guidewire.

Besides adding value through consistently reliable technical success and patient experience, the use of a single balloon allows for efficiency and inventory optimisation. “We know our physicians are concerned with both technical performance and with economic value to their practices,” Zacharias said. “Use of a single moulding and occlusion balloon during an EVAR case reduces intraoperative waste, minimising overall instrument cost per procedure. The potential to reduce operating room and catheter lab time may contribute to faster room turnover and more on-time procedural starts.”

LIBERTY 360° two-year data show high freedom from major amputation in PAD patients

Two-year outcomes from the LIBERTY 360° study have shown a marked improvement across all Rutherford classes, as well as high freedom from major amputation. The results were presented as a late-breaking presentation at the Amputation Prevention Symposium (AMP; 8–11 August, Chicago, USA).

The LIBERTY 360° study is designed to evaluate the acute and long-term clinical and economic outcomes of peripheral vascular interventions in patients with peripheral arterial disease. With over 1,204 patients enrolled at 51 sites across the USA, it is among the first peripheral arterial disease studies to investigate patients across the spectrum of symptomatic peripheral arterial disease (Rutherford classes 2–6). As an “all comers” study, LIBERTY 360°’s trial design

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Product News included any endovascular device FDA-cleared for treatment of peripheral arterial disease.

Key endpoints include procedural and lesion success, major adverse events (MAEs), duplex ultrasound, quality of life (QoL), six-minute walk test (6MWT) and economic analysis.

The two-year study outcomes were presented by Jihad A Mustapha, Advanced Cardiac & Vascular Amputation Prevention Centers, Grand Rapids, USA. Mustapha’s presentation highlighted the continued high freedom from major amputation in all Rutherford Classifications (RC) at two years (RC2–3, 99.1%; RC4–5, 94.5%; and RC6, 79.8%).

“LIBERTY 360° represents as close to a real-world experience as possible with various endovascular strategies across Rutherford classes. Following endovascular intervention, we saw a marked improvement across all Rutherford classes at two years, as well as high freedom from major amputation. In particular, LIBERTY 360° provides compelling evidence that peripheral vascular interventions can lead to amputation free survival even in RC6 patients, which showed a 79.8% freedom from major amputation following peripheral vascular intervention,” Mustapha said.

Mustapha also noted that an orbital atherectomy (using Diamondback 360, Cardiovascular Systems Inc) sub analysis of the LIBERTY data indicated high freedom from major amputation in all Rutherford Classes (RC2–3, 100%; RC4–5, 95.3%; and RC6, 88.5%).

Cook Medical introduces a new length of Zilver PTX

Cook Medical has introduced the 140mm-length Zilver PTX drug-eluting peripheral stent in both 6 and 7mm diameters in the USA. The longer length comes after an expanded indication approval by FDA to treat total lesion lengths up to 300mm per patient. In addition, the product also received an extended shelf life of two years by the FDA. The 140mm-length stents will enable physicians when applicable to treat lesions up to 270-mm with only two stents. In addition to this benefit, the stent has been shown to cut re-interventions by nearly half in five years, compared to a combination of bare-metal Zilver stents and PTA. “We’re happy to continually broaden the Zilver PTX product offering, giving physicians more options when treating superficial femoral artery disease based on the individual patient need,” said Mark Breedlove, vice president of Cook Medical’s vascular division.

The device is the world’s first drug-eluting stent for treating peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and is the only drug-eluting SFA stent with five-year published data.

Modulated Imaging receives FDA clearance for its new Clarifi imaging system

Modulated Imaging, a company developing optical imaging solutions powered by spatial frequency domain imaging (SFDI) for noninvasive assessment of tissue health, announced that it has received FDA 510(k) clearance for its new medical device, the Clarifi imaging system.

Clarifi is the first and only commercialised diagnostic medical device to use SFDI, a patented technology based on structured light, that helps clinicians assess tissue function and compromised circulation by measuring oxygenation and haemoglobin levels in superficial tissue. This essential information can be used in the assessment, management and treatment of several challenging conditions, including peripheral vascular diseases, diabetic foot ulcers, burns, skin flaps, and chronic wounds.

Clarifi is a non-contact non-invasive system that measures tissue oxygen saturation (StO2), oxyhaemoglobin (HbO2), and deoxyhaemoglobin (HbR). In addition, it is the first noninvasive diagnostic technology to quantitatively display total

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haemoglobin levels in superficial (0­­–1mm) and subsurface (1.5–3mm) layers—HbT1 and HbT2, respectively. Clarifi’s exclusive capabilities gives clinicians greater understanding of tissue perfusion, oxygen supply, and utilisation. This critical information can be used for earlier identification of patients who are at risk for developing wounds, and to guide clinical interventions to prevent their onset or escalation.

Optimised for seamless integration into a variety of care delivery environments, Clarifi is designed to address shortcomings of existing spectral imaging systems (multispectral and hyperspectral) by incorporating structured light into the process. Clarifi is smaller, faster, and lighter than its predecessor, Ox-Imager CS, and it offers the largest optical imaging field available—approximately 225mmx300mm—and can image the entire plantar aspect of a foot. The system displays color-coded images of each biomarker to help clinicians assess oxygenation and haemoglobin delivery to superficial and subsurface tissue in any region of interest, with clarity and confidence.

“The ability to separately quantify and display in total haemoglobin and distribution in superficial and subsurface layers of tissue is a significant advancement,” said Anand S Patel, chief of Interventional Radiology at Providence Little Company of Mary Medical Center, Torrence, USA. “Modulated Imaging’s technology should enable us to better diagnose and treat patients with compromised circulation who may be at risk for lower limb diabetic complications, peripheral arterial disease, or similar conditions.”

First-ever CE mark of a bioresorbable scaffold for below-the-knee PAD

Reva Medical, a company developing bioresorbable polymer technologies for vascular applications, has announced that its Motiv bioresorbable scaffold is the first drug-eluting bioresorbable scaffold to receive CE mark approval for treatment of below-the-knee peripheral arterial disease.

Late last year, Reva announced its plans to expand use of itstechnology in peripheral arterial disease. The approval of MOTIV delivers that milestone and for the first time brings bioresorbable technology to this patient population.

Motiv is made from Tyrocore, Reva’s proprietary polymer designed specifically for vascular scaffolds. Tyrocore is inherently radiopaque, making Motiv visible under X-ray to ensure accurate placement in the artery. The company will identify over the next few months select centres to assess the product’s performance, inform future product development activities and determine its complete commercial strategy in peripheral vascular applications. Reva expects Motiv’s first use in patients to be in late 2018 or early next year.

“Reva did not just achieve its own milestone with CE mark of Motiv, we achieved a therapeutic milestone for patients with critical limb ischaemia (CLI),” said Reggie Groves, Reva’s CEO. “Tyrocore and our polymer technology have a broad range of therapeutic applications.

This is our first step beyond the coronary arteries, and we look forward to bringing a new treatment option to peripheral arterial disease patients and their physicians.”.

Research has shown that early-stage intervention is costeffective and efficacious compared to late stage treatments like amputation. These interventions are intended to restore blood flow to the blocked artery in order to reduce pain and save the limb. Drug-eluting bioresorbable scaffolds such as Motiv present a significant opportunity to improve the treatment of patients suffering from CLI because of the potential to extend drug delivery and to enable retreatment without the risks associated with metal stents.

Cardiovascular Systems, Inc. and Aerolase collaborate on laser atherectomy technology Cardiovascular Systems, Inc. (CSI), a medical device company developing and commercialising innovative interventional treatment systems for patients with

peripheral and coronary artery disease, today announced that it has signed an agreement with Aerolase Corp. to co-develop a new laser atherectomy device for treating multiple forms of arterial disease.

Scott Ward, CSI’s chairman, president and chief executive officer, said, “We believe there is an opportunity to leverage Aerolase’s innovative proprietary laser technology, which is FDA-cleared for dermatology and medical aesthetic uses, and supported by leading physicians in those fields. The collaboration project aims to create a significant improvement in the quality of care for patients suffering from peripheral arterial disease and in-stent restenosis.”

FDA approves Ellipsys Vascular Access System for non-surgical dialysis fistula creation

Ellipsys Vascular Access System (Avenu Medical) has been granted de novo marketing authorisation from the USFood and Drug Administration (FDA). Ellipsys is a minimallyinvasive catheter-based system designed for end-stage renal disease (ESRD) patients requiring haemodialysis.

“Good vascular access makes a tremendous difference in patient outcomes,” says long time kidney patient advocate Terry Litchfield. “This revolutionary non-surgical fistula creation can reduce the pain and suffering associated with traditional fistula surgery, lessen failed surgeries and reduce catheter time for patients.”

Since 1966, the AV fistula has been surgically created in an operating room by sewing a vein and an artery together, usually in the arm. When this is done, blood from the artery will pass through the vein increasing its flow rate and diameter. This makes the vein suitable for the insertion of the needles required for haemodialysis treatment. An AV fistula is the preferred method for vascular access as there is evidence of longer term patency, improved flow rates and fewer complications than other methods of vascular access.

A new innovation for dialysis patients and clinicians, Ellipsys is a less-invasive alternative to the traditional creation of AV fistulas and is designed to be used by a physician under local or regional anaesthesia in all sites of service including hospital outpatient departments, ambulatory surgical centres and physician offices.

According to Avenu, ultrasound is used to guide the Ellipsys catheter through the skin to the pre-determined vascular target. The catheter delivers a small amount of thermal energy that fuses a sutureless and permanent anastomosis, or connection, between the vein and artery allowing the creation of an AVF. Unlike surgery, the Ellipsys System uses a minimally invasive, endovascular approach that leaves the skin without a scar, and the vascular bed undisturbed and intact without leaving any foreign material implanted (including suture). After the procedure, the patient leaves with just a band aid.

Clearance was granted after the FDA reviewed data from a non-randomised, US multicentre study of 103 patients. The study was designed to demonstrate the safety and efficacy of the Ellipsys System for the percutaneous creation of an AV fistula.

everlinQ endoAVF receives FDA de novo marketing approval

everlinQ endoAVF System (TVA Medical) is now approved by the US Food and Drug Administration for de novo marketing. This innovative, minimally invasive technology uses magnetic catheters and radiofrequency energy to create an arteriovenous fistula (AVF) for haemodialysis access without open surgery.

“The everlinQ endoAVF System is a significant advance in the management of chronic kidney disease,” says Paul Kreienberg, vascular surgeon at The Vascular Group, Albany Medical College, Albany Medical Center Hospital, Albany, USA. “Hundreds of thousands of Americans require vascular access for lifesaving dialysis, but until now this access has required open surgery that is accompanied by high failure rates and low patient satisfaction. The everlinQ endoAVF System is transforming vascular access using a minimally invasive approach, and I anticipate a high level of interest from both patients and physicians for this compelling

Innovative thinking, determination, and dedication to excellence are hallmarks of our great field, and we recognize that clinician education must continually change as the needs of patients and the healthcare landscape change. Together with my fellow Course Directors, we’ve enhanced ISET in response to the needs of our participants, and we believe the new investments we’ve made and the new approaches we’re taking will yield the strongest ISET program yet.

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BARRY KATZEN, MD, FACC, FACR, FSIR ISET Course Director

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See 1-on-1 interviews with key thinkers in vascular medicine and intervention at VIVA Unscripted.

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Product News endovascular solution.”

According to a company release, more than 400,000 people in the USA receive haemodialysis multiple times a week for end-stage renal disease (ESRD). The current standard vascular access approach uses open surgery to create an AVF for dialysis. Surgical AVFs are associated with failure rates up to 60% and often require frequent revisions.

When a surgical AVF procedure is effective, the fistula takes on average over four months to mature before dialysis can begin. In addition, vascular access creates concern and stress for many ESRD patients, including the threat of repeat procedures and disfigurement of the arm, with up to 30% of patients refusing fistula surgery.

The FDA marketing authorisation enables use of the everlinQ endoAVF System as a Class II medical device in the ulnar artery and ulnar vein, to create an endoAVF for haemodialysis use in properly indicated patients. Data from four clinical studies using the everlinQ endoAVF System demonstrated 97% procedural success; 88% fistula maturation (suitable for dialysis) at three months; and 75% successful cannulation at six months with minimal need for re-intervention.

The everlinQ endoAVF System was reviewed by the FDA through the de novo premarket review pathway, a regulatory process for some new medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence.

The everlinQ endoAVF System received European CE mark in 2014 and Health Canada Medical Device License in 2016 for ESRD patients.

Terumo gets CE mark for Kanshas drug-coated balloon catheter for lower extremities

Terumo has announced that it acquired CE mark for the Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease.

With a September launch planned in Europe, Terumo is expected to be the first Japanese company to launch drugcoated balloon sales in Europe, and the European launch will be followed with launches in Latin America and Asia, as well.

A drug-coated balloon catheter is a medical device coated with a drug that suppresses cell proliferation on the balloon surface. When the balloon is expanded, it comes into contact with the blood vessel walls, transferring the drug to the vascular tissues, which is expected to suppress restenosis.

Kanshas can be expected to have an enhanced therapeutic effect due to Terumo’s proprietary uniform micro-crystal coating named Unicoat, which has been designed so that the coated drug is less likely to migrate before it reaches the lesion and then transfers swiftly to vascular tissue when the balloon is expanded. Product line-up of long balloon with a range up to 200mm can be treated for long lesions, which are common in the lower extremities.

Terumo is aiming to expand its peripheral vascular intervention business globally and is building up its product portfolio, a company release states. The launch of Kanshas is part of this strategy. Going forward, Terumo is determined to enhance its contribution to medical treatment in the endovascular field, the release adds.

Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral drugcoated balloons

Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat long superficial femoral artery lesions in patients with peripheral arterial disease.

“As superficial femoral artery disease progresses, we tend to see patients present with longer, more complex lesions. As a result, these lesions become incredibly challenging to treat and often require interventions with multiple technologies to effectively treat the entire segment,” said Gary Ansel, medical director for Vascular Services at OhioHealth Riverside Methodist Hospital in Columbus, USA. “The approval of the IN.PACT Admiral 200mm and 250mm balloons provides physicians with a solution to treat these long, complex lesions with fewer devices, potentially leading to shorter procedure times and reduced procedural cost.”

Complex lesions, including those over 150mm, are commonly encountered in clinical practice and remain a significant treatment challenge for physicians. In April of this year, IN.PACT Admiral received approval to treat superficial femoral artery lesions up to 360mm in length. Approval was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global Study, including long lesion, in-stent restenosis, and chronic total occlusion (CTO) groups with lesion lengths >180mm. Across these groups, a total of 227 subjects with mean lesion lengths of 28.7±7.1cm were analysed. Data showed a one-year patency rate of 89.1%

by Kaplan Meier estimate at day 360, and a clinicallydriven target revascularisation (CD-TLR) rate of 7.1%.

“In our IN.PACT Global Study, IN.PACT Admiral demonstrated safety and effectiveness in real-world patients with complex lesions, including long lesions,” said Mark Pacyna, vice president and general manager of the Peripheral business in Medtronic’s Cardiac & Vascular Group. “Our new long lesion indication, coupled with the approval of the 200mm and 250mm balloons, furthers our commitment to the clinical community by equipping them with the tools and evidence needed to effectively treat complex cases.”

First US implants of MicroStent for peripheral arterial disease take place

MicroStent (Micro Medical Solutions), a vascular stent designed to reduce below-the-knee amputations caused by critical limb ischaemia (CLI) resulting from peripheral arterial disease (PAD) has been implanted for the first time in the USA. The company received approval from the Food and Drug Administration late last year to begin a clinical trial evaluating MicroStent’s safety and efficacy.

Co-principal investigator Robert E Beasley performed the first procedure in the trial on 25 April at Mount Sinai Medical Center in Miami Beach, USA. Beasley placed two 3mmx40mm stents in the anterior tibial artery of a patient with CLI, fully restoring blood flow to an occluded vessel.

“We found implanting the MicroStent to be a very safe, quick, easy procedure. Using a retrograde pedal puncture, we used a small 3F sheath to place two of these very low-profile, easy-to-deploy stents in the anterior tibial artery in about 30 minutes. Post-procedural ultrasound taken immediately, at 14 days and at one month showed a wide-open, unobstructed artery with excellent flow,” explained Beasley. “By returning sufficient blood flow to the lower leg, we were able to ensure adequate oxygenation to the tissue. As a result, a wound on the patient’s toe is now healing, and he is unlikely to require below-the-knee amputation.”

Beasley has since performed four more MicroStent procedures. Craig Walker, co-principal investigator in the study with several cases completed, oversees the MicroStent research site at the Cardiovascular Institute of the South in Houma, USA.

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Walker noted, “With CLI, the ability to achieve patency in a vessel is paramount to saving both the vessel and the limb.

Use of MicroStent, a self-expanding stent with great radial force and very little chronic outward force, has resulted in patent arteries with low probability of long-term stenosis.

In fact, we have seen zero stenosis post-procedure on both ultrasound and angiography, and one patient remarked that dramatic pain relief occurred immediately after the MicroStent procedure. We anticipate that this critically important technology will continue to produce good outcomes and clinical results.”

MicroStent received CE mark approval in Europe in 2017 and continues to be studied internationally, as well as through this clinical trial of MicroStent in the USA.

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 embolisation, 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 USA in 2019 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 sales-related milestones are met.

AngioDynamics provides update on vascular access business

AngioDynamics has provided a corporate update and acknowledged a recent, favourable US District Court ruling that impacts its vascular access business.

A press release states that in May of 2017, AngioDynamics filed a lawsuit against CR Bard (Bard) for violating United States antitrust laws with its practice of illegally tying tip location system sales to its line of peripherally inserted central catheters (PICCs). In August, the US District Court for the Northern District of New York rejected— in its entirety—CR Bard’s motion to dismiss AngioDynamics’ lawsuit against it.

As a result of last week’s ruling, AngioDynamics’ antitrust lawsuit against Bard will proceed.

Tip location systems are devices that can be used to aid healthcare professionals in the bedside placement of a PICC. The lawsuit claims that Bard has a dominant position in the tip location system market and will only sell the proprietary stylet necessary to operate its tip location systems preloaded in its PICCs, not separately, which would allow any type of PICC to be used with the tip location systems. By doing so, customers who want to buy Bard’s tip location systems must also buy Bard’s line of PICCs, which prevents hospitals and other medical providers from purchasing BioFlo PICCs from AngioDynamics’ vascular access business.

The press release adds that AngioDynamics’ lawsuit seeks to end Bard’s violation of the antitrust laws and to recover treble damages for losses due to Bard’s violations, as well as attorneys’ fees and other costs.

AngioDynamics is represented by Philip Iovieno and Anne Nardacci of the law firm of Boies Schiller Flexner LLP.

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Events

Calendar of events 12–14 September

6th International Meeting on Aortic Diseases Liege, Belgium W www.chuliege-imaa.be 14 September

27–28 September

VASBI: Vascular Access Society of Britain & Ireland annual meeting Portsmouth, UK W www.vasbi.org.uk

i-VAS: 1st International Vascular Access Symposium Paris, France W www.ivas2018.com

11–12 October

15–16 September

17–20 October

BAVS: 3rd Barts Aortovascular Symposium London, UK W www.bartsaortovascularsymposium.org.uk 21–25 September

TCT—Transcatheter Cardiovascular Therapeutics San Diego, USA W www.crf.org/tct 22–25 September

CIRSE Lisbon, Portugal W www.cirse.org 25–28 September

CiDA: Controversies in Dialysis Access Washington, DC, USA W www.dialysiscontroversies.org 5–9 November

VIVA 2018 Las Vegas, USA W vivaphysicians.org

London Aortic Symposium London, UK W www.las.eventhq.co.uk

13–17 November

VASSA (Vascular Society of Southern Africa) Congress Cape Town, South Africa W www.vassacongress.co.za 18–21 October

World Congress of the International Union of Angiology and 14th Chinese Capital Vascular Symposium Beijing, China W www.lua2018.org 29–30 October

ESVS 32nd Annual Meeting Valencia, Spain W www.esvs.org

1–2 November

5th Aortic Live Symposium Essen, Germany W www.aortic-live.com

VEITHsymposium New York, USA W www.veithsymposium.org 6–8 December

8th Munich Vascular Course Munich, Germany W www.mac-conference.com 6–8 December

VERVE Symposium Sydney, Australia W www.vervesymposium.com 6–8 December

43rd Annual Northwestern Vascular Symposium Chicago, USA W www.northwestern.cloud-cme.com

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Industry News Endologix appoints Jeffrey S Brown as chief operations officer

Endologix has announced that it has appointed Jeffrey S Brown as the company’s chief operations officer, effective as of 13 August, 2018.

John Onopchenko, chief executive officer of Endologix, says, “I am very excited to have someone with Jeff’s credentials and industry knowledge joining our executive team. His proven track record of transformational leadership, operational excellence, and delivering results will be invaluable to Endologix. We remain focused on building a cohesive team and a strong culture of accountability, while continuing to innovate and position the company for further operational improvements.”

Brown brings to Endologix 24 years of experience as a general manager, chief operating officer, supply chain executive, sales leader, consultant and lecturer.

Most recently, he was general manager of a multi-site joint venture between Johnson & Johnson and Steris Corporation, where he led significant improvements across operations, quality, engineering, and supply chain.

Prior to that, he was chief operating officer for Chatham Industries, where he helped successfully orchestrate a leveraged buyout and turnaround of the firm. Prior to that, Brown worked for five years as general manager at Boston Scientific, where he led a critical site transformation and sat on the global supply chain management board. Brown also worked for seven years as worldwide operations manager at Johnson & Johnson and for five years leading sterilisation operations across the USA, EU, and Far East for Haemonetics Corporation.

Brown comments, “I am thrilled to be taking on this critical leadership role at Endologix, particularly during this transformational time. I look forward to working with the team to improve operations and to leverage our talent and innovative technology, with the ultimate goal of delivering superior products and services to our patients.”

Brown earned his MBA from Babson College, Wellesley, USA and his Bachelor of Science in Microbiology from University of New Hampshire, Durham, USA.

NuCryo Vascular announces commercialisation agreement with Lokai Medical for PAD treatment

NuCryo Vascular has signed a commercialisation agreement with Lokai Medical, a specialty distributor of coronary/peripheral and interventional devices, to distribute the PolarCath balloon dilatation system in the USA. Balloon cryoplasty is one of the options for treating peripheral arterial disease (PAD). The controlled cooling of the plaque and artery wall provides three potential benefits: uniform vessel dilation with less vessel trauma, reduced vessel wall recoil and induction of apoptosis, which promotes the natural cell death of the smooth muscle cells that otherwise proliferate to cause restenosis. The PolarCath cryoplasty system was invented by James Joye, an interventional cardiologist in Mountain View, USA. “We are very excited to partner with Lokai Medical and the company’s experienced sales team to help commercialise the PolarCath Balloon Dilatation System,” said Kevin Beedon, general manager and executive vice president of NuCryo Vascular. “NuCryo grew sales by 36% in 2017 vs. 2016 with an extremely small but dedicated direct sales team. The commercialisation support and clinical expertise of Lokai Medical will help NuCryo continue its double-digit growth in the expanded markets we can now serve.”

“I am very excited for the next-generation reusable Cryoplasty inflation device that NuCryo has reengineered and brought back to market,” said Jonathan Aliota, interventional cardiologist from Houston, USA.

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“As a previous Cryoplasty user with Boston Scientific, I recently reincorporated it back into my peripheral treatment algorithm and have been extremely happy with the results. In addition, the cost, ease of use, and time savings as compared to other balloons on the market have been well received at my facility.”

The PolarCath peripheral dilatation system received US Food and Drug Administration (FDA) clearance to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The device is also indicated for post-deployed stent expansion of selfexpanding peripheral vascular stents.

The device which received its first FDA clearance in 2002, was developed by CryoVascular, a company formed by Joye and collaborators. In 2005, CryoVascular was acquired by Boston Scientific, which discontinued manufacturing PolarCath at the end of 2012. NuCryo Vascular was created in 2014 for the purpose of acquiring PolarCath and resuming manufacturing of the device. The company has since re-engineered the device and received FDA approval of the non-sterile inflation device in 2015.

Boston Scientific closes acquisition of Claret Medical

Boston Scientific has announced that it has recently closed its acquisition of Claret Medical, which developed and commercialised the Sentinel cerebral embolic protection system—the only device cleared in the USA and Europe to protect patients against the risk of stroke in transcatheter aortic valve implantation (TAVI) procedures.

The company also announced that the US Centers for Medicare and Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) designation for the Sentinel system as part of the federal fiscal year 2019 Inpatient Prospective Payment System (IPPS). The NTAP designation, awarded to new medical devices determined to improve the diagnosis or treatment of Medicare beneficiaries, will be effective on October 1, 2018.

Kevin Ballinger, president, Interventional Cardiology, Boston Scientific, comments: “The Sentinel System is an exciting platform technology designed to reduce the risk of procedure-related stroke in TAVI and other left-heart and endovascular procedures, and is an increasingly important consideration for patients and physicians as the TAVI indication expands to treat a younger patient population. The recent CMS NTAP designation underscores the clinical value of the Sentinel System and will allow for accelerated adoption of this adjunctive therapy amongst structural heart centres.”

Boston Scientific announced a definitive agreement to acquire Claret Medical on July 20, 2018 for US$220 million in up-front cash with an additional US$50 million payment for reaching a reimbursement-based milestone, which has been fulfilled with the recent NTAP designation.

Cardiovascular Systems signs international distribution agreement with OrbusNeich

Cardiovascular Systems, Inc. (CSI) has signed an exclusive international distribution agreement with OrbusNeich to sell its coronary and peripheral orbital atherectomy systems (OAS) outside the USA and Japan. OrbusNeich manufactures and sells an extensive portfolio of coronary and peripheral products including stents, balloons and microcatheters. The company operates 12 regional sales offices throughout the world and their products are currently sold in over 60 countries.

Scott Ward, chairman, president and chief executive officer of CSI, said, “We are excited to expand our

strategic partnership with OrbusNeich, a globally recognised leader offering an extensive portfolio of vascular intervention products. OrbusNeich’s large international sales channel serves Europe, Asia and the Middle East and greatly accelerates our plans to introduce orbital atherectomy technology to international markets. In turn, we will focus our international efforts on physician training and education to support the expanded use of orbital atherectomy.”

CSI management will provide more details on this distribution agreement on 31 July at its Analyst Day meeting.

In January 2018, CSI announced that it was the exclusive US distributor for OrbusNeich balloon products. Ultimately, CSI will offer a full line of semi-compliant, non-compliant and specialty balloons for both coronary and peripheral vascular procedures.

OrbusNeich PCI balloons include the Sapphire II Pro, the first and only 1.0mm coronary balloon available in the USA. Currently, CSI offers both the 1.0–4.0mm Sapphire II Pro and the 2.0–4.0mm Sapphire NC Plus coronary balloons.

In November 2016, CSI announced that Medikit signed an exclusive distribution agreement to sell its coronary and peripheral OAS in Japan.

Fresenius and Humacyte enter strategic global partnership with US$150M equity investment

Fresenius Medical Care, the world’s largest provider of dialysis products and services, and Humacyte, a medical research, discovery and development company, have announced a strategic, global partnership and a US$150 million equity investment. This agreement has the potential to make Humacyte’s investigational human acellular vessel, HUMACYL, available to more patients worldwide following approval of the product.

HUMACYL is currently being investigated for vascular access for haemodialysis and may prove more effective than current synthetic grafts and fistula. Under the terms of the agreement, Fresenius Medical Care will obtain the exclusive global rights to commercialise HUMACYL. Fresenius Medical Care will be responsible for the marketing, sales and distribution of HUMACYL following approval by the relevant health authorities. In addition, Fresenius Medical Care will make a US$150 million equity investment in Humacyte to gain a 19% fully diluted ownership stake in the company. With the investment, Fresenius Medical Care will have the opportunity to bring Humacyte’s bioengineered human acellular vessels to the worldwide end-stage renal disease patient population following product approval.

The transaction is expected to close in July 2018.

“By partnering with Humacyte, Fresenius Medical Care has an opportunity to offer a dialysis vascular access option with the potential for significant clinical efficacy and safety improvements, including the potential to minimise catheter contact time to the benefit of our patients,” says Franklin Maddux, chief medical officer for Fresenius Medical Care North America.

The current vascular access modalities necessary to deliver dialysis treatment include fistulae, grafts and central venous catheters. All three options have limitations. Half of fistulae fail and do not mature in patients, delaying vascular access for dialysis treatment.

In the meantime, many patients need a central venous catheter, which significantly increases the risk of infection. Humacyte has developed a novel human tissue-based investigational product, HUMACYL, for patients with end-stage renal disease requiring haemodialysis. Compared to an arteriovenous fistula, the product can be available for use in haemodialysis within weeks and may have an overall higher rate of maturation. It also may offer a more durable, biologic alternative to synthetic grafts.

Humacyte’s bioengineered blood vessel is currently in Phase III pivotal trials in the USA and Europe, and the company plans to seek regulatory approval in both regions upon completion of the trials.

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