Vascular News – CX Special Edition 2020 US by BIBA Publishing

Charing Cross Special Edition

Global vascular community to strive for consensus at CX

The Charing Cross Symposium (CX; 21–24 April, London, UK) is the longest-running vascular and endovascular global symposium, and an important source of Education, Innovation, and Evidence as the vascular field in 2020 seeks clarity and truth.

our CX Special Sessions have been introduced to the programme to focus on those topics that are seen as most central to the vascular community and warrant highlighting

Paclitaxel-coated device update

On Tuesday 21 April, the first CX Special Session will address the latest hypotheses and controversies in the debate

surrounding the use of paclitaxel-coated devices in the lower limb. New meta-analyses into the use of paclitaxel-coated devices in chronic limb-threatening ischaemia patients will be reported. The purpose will be to summarise what is new and learned in paclitaxel usage. CX 2020 will distil the science from the hype, and tease out the evidence from the opinion—all the while keeping

| March 2020

patients, and their physicians, front and centre. This Special Session will include input from the world-class CX Faculty, the regulatory bodies and from an expert audience.

Durability of EVAR, sac diameter and NICE guidelines

The second CX Special Session, on Wednesday 22 April, will focus on the durability of endovascular aneurysm repair (EVAR), the importance of sac diameter, and the draft National Institute for Health and Care Excellence (NICE) aortic aneurysm guidelines. The draft guidelines, published in May 2018, recommended UK healthcare professionals to favour open repair for aneurysms over endovascular repair. While the final guidelines remain unpublished at the time of writing, they could—if implemented—change vascular practice significantly. Elective aortic EVAR would not be funded, as it is said not to be cost-effective in secondary and tertiary care. New approaches will be described. In addition, collaboration will be a key theme, with a number of experts in the

field detailing efforts to seek consensus amid uncertainty.

Type B aortic dissections consensus

Another aortic Special Session, scheduled to take place on Thursday 23 April, will be devoted to reaching consensus in the field of type B aortic dissection. One CX Debate will address whether or not early intervention is less risky in the modern endovascular era, while another will consider the motion that many uncomplicated type B dissections do not need repair. Furthermore, a number of experts will discuss updates in treatment.

Endo AVF Virtual Reality edited cases

The fourth CX Special Session at this year’s meeting will take place on Wednesday 22 April during the Vascular Access Masterclass. The session will cover virtual reality edited cases with endovascular arteriovenous fistula (Endo AVF) technologies. Delegates will have the opportunity to immerse themselves in the experience with the use of highresolution goggles.

Charing Cross Special Edition | March 2020

CX 2020

Aortic Special Sessions to focus on aortic aneurysm guidelines and type B dissection consensus

Aortic Consensus

Abdominal Aortic Consensus 10:00–18:00 Wednesday 22 April Upper Main Auditorium

The Abdominal Aortic programme will host the second CX Special Session, which will shed light on the durability of endovascular aneurysm repair (EVAR), sac diameter, and the status of the National Institute for Health and Care Excellence (NICE) UK aortic aneurysm guidelines. This session will include aortic collaborations in progress and feature a live case transmission on how to overcome challenges in aortoiliac aneurysm cases with a low-profile stent graft. The Abdominal Aortic programme will also address preoperative considerations, with abdominal aortic aneurysm (AAA) GetFit, LIMIT and TEDY trials results. CX Debates will consider the following statements: “The size threshold for repair of any iliac artery aneurysms should be 4cm” and “AAAs with large diameter infrarenal neck (>28mm) should be treated with fenestrated endovascular, not standard endovascular repair”. In addition, the Abdominal Aortic

programme will seek to reach consensus on centralisation and emergency EVAR. Alongside the plenary programme, CX 2020 will also offer the CX Aortic Workshop on Tuesday 21 and Wednesday 22 April. This practical skills course will provide delegates with the opportunity to hear from globally-recognised aortic experts on how to overcome challenges in aortic procedures and on how to optimise durability and outcomes in EVAR and TEVAR through highend imaging. Kevin Mani (Uppsala University; Uppsala University Hospital, Uppsala, Sweden) and Anna Prent (Royal Free London NHS Foundation Trust, London, UK), CX Executive Board Members, told Vascular News that the CX Aortic Workshop 2020 “offers an opportunity for CX participants to interact with clinical experts and industry. The workshop showcases state-of-the-art techniques used to facilitate standard and complex endovascular aortic interventions, including assessment management, perioperative imaging guidance, and aortic devices.”

Podium 1st Aortic session Abdominal 08:00–10:00 Wednesday 22 April Upper Main Auditorium

• US clinical trial results, new evidence and updated outcomes with low-profile abdominal stent graft • Long-term follow-up in complex iliac anatomy and hypogastric preservation: The GALICIAN registry • Raising the proximal sealing ring with a new AAA endograft—one-year results from the ELEVATE IDE trial • ESAR in a challenging sealing zone can be an effective treatment: Early mid-term results • Safety and efficacy in the ZEPHYR study of a low-profile AAA endograft—30-day outcomes

Thoracic Thursday 23 April

• US and French clinical trial results, new evidence and updated outcomes with a hybrid device • Wrapping of the ascending aorta as an option for acute type A dissections • Final results from the European SURPASS registry • Branch patency of a thoracoabdominal stent graft: Oneyear follow-up

Thoracic Aortic Consensus 08:00–18:00 Thursday 23 April Upper Main Auditorium

The Thoracic Aortic programme will feature the third Special Session, which will aim to seek type B dissection consensus. This session will feature two CX Debates: one on the timing of intervention for acute type B dissection and another on whether or not uncomplicated type B dissections need repair.

The Thoracic Aortic programme will seek aortic arch consensus, including chimney on-the-table fenestration and in-situ fenestration technique, options for left subclavian branch, and feasibility of endovascular arch repair post type A dissection. In terms of aortic arch aneurysms, experts will consider which treatment is best and when: total

endovascular, hybrid, open or frozen elephant trunk? With regards to the Stroke from Thoracic Endovascular Procedures (STEP) study, experts will consider the value of diffusion weighted MR imaging to reduce stroke, based on the combined arch reconstruction experience of Paris and Hamburg.

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Charing Cross Special Edition | March 2020

CX 2020

Peripheral Arterial Consensus

Peripheral Arterial programme to give paclitaxel update

Peripheral Proximal Arterial Ischaemia Consensus 08:00–18:00 Tuesday 21 April Upper Main Auditorium

Considering the aim of this year’s CX Peripheral Arterial programme, CX Executive Board Member Andrew Holden (Auckland University School of Medicine; Auckland City Hospital, Auckland, New Zealand) tells Vascular News that it will provide a “comprehensive update of latest innovations and controversies in peripheral arterial intervention”, adding that of particular interest to him will be a series of presentations providing new data on the endovascular management of aortoiliac disease. These will be discussed in the Peripheral Arterial Challenges programme, which runs through all of Tuesday 21 April in the Upper Main Auditorium. This year, CX will seek consensus in various aspects of peripheral proximal arterial ischaemia, including preoperative considerations, techniques and outcomes, popliteal artery treatment, vessel preparation, and intervention. CX will also hold a dedicated Podium 1st session on Thursday 23 April, presenting a record amount of new data in peripheral arterial disease. This format makes it easier for attendees to engage with the late-breaking trial results and

Peripheral Critical Ischaemia Consensus 08:00–10:00; 13:30–18:00 Thursday 23 April Lower Main Auditorium iLegx returns to CX in the Critical Limb Ischaemia programme on Thursday 23 April in the Lower Main Auditorium, with presentations on the underdiagnosis and undertreatment of critical limb ischaemia and guidelines to support CLTI studies and evaluation. The Peripheral Critical Ischaemia programme will also pursue consensus on the optimum method of assessing ischaemia in the lower leg and techniques for CLI intervention.

the cutting-edge research that is most relevant to them. The first of this year’s CX Special Sessions will take place during the Peripheral Arterial programme and will focus on paclitaxel-coated devices, aiming to consolidate the latest evidence. Last year, CX told the paclitaxel story since the publication of Katsanos et al’s JAHA meta-analysis from December 2018. While the discussion moved the story forward and saw the publication of regulatory statements on paclitaxel-coated devices, the debate has re-emerged one year on, as new, conflicting meta-analyses and data have since appeared. According to Holden, the paclitaxel safety issue “will be a focus, with not only an update on mortality in claudicants with femoropopliteal disease, but recent publications evaluating paclitaxel devices used in below-the-knee arteries in patients with critical limb-threatening ischaemia.” He tells Vascular News: “New efficacy data from trials evaluating drug-eluting technologies will be presented and the latest developments in critical limb-threatening ischaemia will be discussed, including techniques to assess tissue perfusion.”

Podium 1st Peripheral Arterial session 10:30–12:30 Thursday 23 April Lower Main Auditorium

• 24-month ZILVERPASS results • IN.PACT BTK European study: First presentation of the nine-month primary outcomes • TOBA III data presentation (spot stenting following DCB) • Mid-term follow-up, safety and efficacy of patients treated with a rotational atherectomy device • Drug-eluting stent global data analysis—which patients get better and which do not • MIMICS-2 study three-year results • Absence of long-term benefit of revascularisation in claudicants—five-year results from the IRONIC randomised controlled trial • Value of a new balloon-expandable stent graft in treating challenging aortoiliac occlusive lesions—three-year results, advantages, and limitations • IN.PACT Global Study four-year outcomes— stented versus non-stented subset • Renal denervation—results from SPYRAL HTN-OFF MED, a prospective, randomised, sham-controlled trial

News in brief

The latest stories from the vascular world

n COMPARABLE RESULTS FOR HIGH- AND LOW-DOSE PTX BALLOONS: In the first study to directly compare drug-coated balloons (DCBs) with different paclitaxel doses for femoropopliteal interventions, both types of balloons exhibited comparable results with excellent effectiveness and safety through 12 months, including a wide range of lesion lengths. Results were presented at this year’s Leipzig Interventional Course (LINC 2020; 28–31 January, Leipzig, Germany).

For more on this story go to page 22 n CENTRALISATION IN AORTIC CARE: At this year’s Controversies and Updates in Vascular Surgery annual meeting (CACVS; 23–25 January, Paris, France), Dittmar Böckler (University Hospital Heidelberg, Heidelberg, Germany) made a case for the centralisation of aortic surgery, detailing 10 reasons why this is “imperative” for patient outcome and safety, cost saving, and education.

For more on this story go to page 24 n NEW DEVELOPMENTS IN INTRAOPERATIVE NAVIGATION: The early months of 2020 have seen the emergence of new developments in the intraoperative navigation space. Two such developments—Philips’ Fiber Optic RealShape (FORS) technology and Centerline Biomedical’s IntraOperative Positioning System (IOPS)—have shown promising results in early studies and demonstrate a trend towards reduced radiation and better imaging.

For more on this story go to page 26

CX 2020 to showcase Peripheral Techniques & Technologies 09:30–18:00 Thursday 23 April Lower Main Auditorium

The Live and Edited Cases at CX are more than a simple technology showcase session: each case has been carefully selected with the intention of illustrating central points from the plenary programmes. At CX, education is always the priority, with new and exciting ways of disseminating information in an engaging way being developed each year. In 2020, live and edited cases will demonstrate new peripheral arterial techniques and technologies. The cases will provide important insights into the management of peripheral arterial disease in clinical practice.

Charing Cross Special Edition | March 2020

CX 2020

Acute Stroke Consensus

08:00–12:30 Friday 24 April Upper Main Auditorium

CX 2020 seeks Acute Stroke Consensus through debate and audience participation

In a return to the original format, the Acute Stroke programme at CX is on the final morning of the conference, and closes a week of Education, Innovation, and Evidence. CX 2020 will come to an end with a morning of the challenging carotid and stroke areas of vascular surgery. A great number of debates have been confirmed, building on from the similarly interactive programme with plenty of debates that was last year. The first session will address challenges in carotid artery disease, with debates on the viability of intracranial stenting for stenosis, the influence of atrial fibrillation on whether you should operate in asymptomatic carotid stenosis, the consideration of extracranial and intracranial cerebral arteries for stenting, and the outcomes of carotid artery stenting in selected patients compared to endarterectomy. This session will also feature presentations on operating on a carotid artery in patients undergoing carotid artery bypass graft (CABG) surgery, indications and techniques for intervention in carotid artery

aneurysms, and the safety of carotid endarterectomy in octogenarians and beyond. The next session will open with three different speakers arguing that standard carotid endarterectomy is superseded by eversion carotid, the via media, and carotid stenting, respectively. This will be followed by audience participation and discussion of the options. Other talks in this session will cover complex carotid body tumours and the value of adjunctive endovascular treatment, international variation in carotid surgery, the impact of carotid patch type following carotid endarterectomy, diagnosis and management of internal carotid artery “string sign”, and results of a population-based cohort study on the risk of cardiovascular events in patients with asymptomatic bilateral carotid artery stenosis. The session will end with a debate on whether or not carotid artery stenting in symptomatic patients should be performed with proximal embolic protection. A 30-minute session on thrombectomy will end the Acute Stroke programme at CX 2020, and will feature presentations on how and when to treat tandem pathology, how late to treat and how to select patients,

and on validation studies of virtual reality simulation performance metrics for mechanical thrombectomy in ischaemic stroke. The session will end with a talk on validation studies of virtual reality simulation performance metrics for mechanical thrombectomy in ischaemic stroke. Additional Acute Stroke activities at CX 2020 include CX Acute Stroke Global Stars and Rising Stars, and CX Acute Stroke Abstracts. This year, the Acute Stroke Global Stars and Rising Stars will include presentations on arterial virtual endoscopy using 3D tomographic ultrasound, a multicentre, postmarket clinical trial to confirm safety and performance of an absorbable haemostatic material for the management of bleeding in vascular surgery, and remote robotic thrombectomy. The Acute Stroke Abstract session will include presentations on the external validity of carotid randomised controlled trials, a systematic review and meta-analysis on the efficacy and safety of carotid artery stenting with the transcervical approach, and urgent carotid endarterectomy in neurologically unstable patients.

iWounds programme and village provide interdisciplinary forum for chronic wound care

08:00–12:30, Wednesday 22 April London Room Learning Centre

Now in its second year, the iWounds programme at CX 2020 promises to be “bigger and stronger” than last year’s inaugural agenda, CX Executive Member Keith Harding (Cardiff University, Cardiff, UK) tells Vascular News. “The range of established and new speakers has increased. The issues around diagnostics, topical treatment, compression and surgery are updated and debated, and the service structure required to make a difference in coordinating care is also included.” He adds that this year’s meeting will be “essential for all involved in treating patients with wounds”. Harding posited that delegates will not only learn from the sessions and enjoy them, but also be able to take back to their practice tips on how best to manage patients.

Topics to be covered this year will focus on the interdisciplinary nature of the field and highlight the need for teamwork. For example, speakers will cover the challenges and solutions of providing evidence-based leg ulcer care, the need for integrated care in the management of diabetic foot ulcers, and the development and delivery of an integrated crosssectoral collaborative approach to wound care—the Manchester Amputation Reduction Strategy (The MARS Project). At the iWounds Workshop, taking place on Wednesday 22 and Thursday 23 April, delegates will have the opportunity to learn about wound ultrasound diagnosis and assessment, negative wound pressure therapy, and the prevention of recurrence in the diabetic foot, among a number of other topics. In addition to a dedicated programme on Wednesday 22 April, the iWounds Village will feature hands-on activities and edited cases, demonstrating the innovations and techniques for wound care that are discussed in the plenary programme.

The iWounds Village on the Exhibition Floor provides a hub of overlapping areas of peripheral and venous disease to cover wound management, for wounds caused by vascular and non-vascular conditions such as diabetes. Running parallel and in close proximity to the Venous workshop, participants are encouraged to visit both, as well as the related workshops in the Peripheral Village on the previous days. Together, these three areas will encompass a full range of wound care and bring the challenges of chronic wound management to the forefront. Taking part in the iWounds initiative is the American College of Wound Healing and Tissue Repair (ACWHTR) and the Association for Advanced Wound Care (AAWC), whose representatives join an international list of speakers in the iWounds programme. Attendees of the iWounds sessions will hear about wound care challenges as they appear in different healthcare systems, identifying needs for structural and patient pathway

changes for these conditions. The importance of collaborative work will be emphasised, and discussion will consider the integration of wound care into vascular services. Another focus of the iWounds programme is on innovations in wounds care, in which dressings, compression wear and imaging and monitoring technology take centre stage, showcasing the latest developments in the broad spectrum of tools for treatment of wound patients. With the aim of reducing the number of lower limb amputations due to conditions underlying chronic wounds, this interdisciplinary and interspecialist initiative is based on the iLegx project, with its focus on three main strategic workstreams: interdisciplinary education, early referral pathways, and implementation of raised awareness in practice. The goal of iWounds, like iLegx, is to increase early diagnosis of the underlying conditions of tissue loss in the lower limbs, and to promote collaboration across disciplines, from the acute to longterm community services.

Charing Cross Special Edition | March 2020

CX 2020

Vascular Access Consensus

CX 2020 Vascular Access programme: Defining an algorithm for access preservation and maintenance

08:00–18:00 Wednesday 22 April Pillar Hall Learning Centre

This year’s CX Vascular Access programme will focus on an algorithm approach to vascular access preservation and maintenance. The three days of vascular access activities will include the Vascular Access Masterclass, CX Vascular Access Workshop, CX Vascular Access Global Stars and Rising Stars, and the Abstract session. Speaking to Vascular News, CX Executive Board Member, Nicholas Inston (University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK) comments that “creating access is only part of the workload. The whole pathway of access care is covered in this year.” The Vascular Access Masterclass will take place in Pillar Hall on Wednesday 22 April. One of the highlights of this year’s CX will be a virtual reality session showcasing endovascular creation of fistulae. Inston will open the masterclass with an introductory talk on the access algorithm, aiming to answer the question, “Can we define an algorithmic approach to vascular access preservation and maintenance?” The programme will then cover preoperative topics, including the use of artificial intelligence and machine learning in planning access, preoperative vein enhancement and FACT trial preliminary results, and a National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NFK KDOQI) update.

A session on fistula formation will consider vessel preparation, the RADAR technique for a surgical fistula, and how to improve outcomes and patient care when using grafts for early access in selected patients. The programme will also consider how to maintain and salvage failing fistulas. The value of early cannulation grafts will be considered, as well as whether stent graft placement or angioplasty is better for recurrent stenosis. Another session will aim to interpret the latest data in vascular access, during which contemporary AV access maintenance metaanalyses will be discussed in terms of how they apply to clinical practice. CX 2020 will aim to reach consensus in imaging vascular access, investigating 3D modelling in training and practice. Finally, the CX Vascular Access Masterclass will give an update on balloons in vascular access. Presentations will be given on both the Ranger DCB and the In.Pact DCB, and a podium 1st presentation will be given by Sapan Desai (Northwest Community Hospital, Arlington Heights, USA) on multi-institutional two-year outcomes in dialysis access management. A debate will consider the role of surveillance in vascular access, and the controversy of whether to treat or leave alone a symptomatic stenosis will be addressed. The CX Vascular Access Workshop will take

New EndoAVF virtual reality session The Vascular Access Masterclass will include a Highlight Session on virtual reality edited cases with new Endo AVF technologies: Ellipsys and WavelinQ. High-resolution goggles will be available to delegates for a fully immersive experience. Nick Inston, who will chair the session, tells Vascular News that the Vascular Access programme at CX “is not just about lectures and podium presentations”. He explains: “CX is about innovation and this is being applied to the content and also the delivery of the CX programme. As a world first we will be using virtual reality presentations for an unforgettable immersive experience. “The CX Vascular Access programme has evolved over the last few years into a comprehensive offering, covering all aspects of vascular access and is aimed at the multidisciplinary team who are involved in access care. New innovations are being applied to vascular access with increasing frequency. The use of percutaneous endovascular techniques to create fistulas is an example of an exciting new approach and this year a section of the programme is dedicated to this area. “The Masterclass is entitled ‘the access algorithm’ with an ambitious goal of exploring and hopefully defining those areas where a defined treatment approach can be applied. This will be interactive and in real time with audience participation to aim to highlight not only what we know, but where gaps in knowledge and evidence exist. Only through such processes can we apply our efforts to improve.”

place on Thursday 23 April. This practical skills session will feature hands-on tutorials covering topics such as autologous arteriovenous fistula access, implantation techniques for arteriovenous fistula grafts, and complications of access. Inston gives an overview of the programme “There will be a busy hands-on section with state of the art simulators and expert demonstrators from around the world. Within the workshop and the program will be those that matter most, the patients. The CX vascular access section recognises the key part patients have in their own care.” He also considers the importance of the Masterclass for the development of dialysis access care: “Clinicians involved in dialysis care will often have multiple interactions over many years with their patients. We recognise that we can and should learn from them and their experiences. Whilst we can strive for an algorithm to ensure expert care is delivered with the best possible evidence, the individual receiving this must be acknowledged as the driver of this. In many situations the focus should go back to ‘the right access for the right patient at the right time’. Tailored individualised care is often required and to do this best requires a knowledge of what is available and how it can be applied. The Vascular Access programme at CX 2020 aims to deliver that in a creative and exciting programme, and we hope that you are an active part of it.”

CX Innovation Showcase to address artificial intelligence 08:00–18:00 Thursday 23 April Pillar Hall Learning Centre

This year’s CX Innovation Showcase assembles an array of talent to inform the physician inventor on how to take their early-stage idea forward, from prototype to commercialisation. Course director Stephen Greenhalgh outlines some of this year’s programme highlights: “First, we hear from my fellow course director, Bob Mitchell, that MedTech innovation is far from dead followed by Lindsay Machan, who is perhaps most widely known for his contribution to developing and commercialising the paclitaxelcoated stent, speaking about the new era of artificial intelligence (AI)-driven healthcare. There are also a number of talks from physician inventors such as Chris Zarins who will talk about the lessons from the Heartflow journey and Kieran Murphy who will give his three things that a physician inventor needs to succeed!” Greenhalgh notes that Brexit may have a silver lining. Whilst Jeff

Jump will focus on the fact the EU MDR may sound the death knell for MedTech innovation in Europe, Chas Taylor will see if the UK’s proposed Medicines and Medical Devices Bill that aims to give patients access to the most cutting-edge treatments is a step in the right direction. “The Peripheral Innovation section is packed with interesting topics and earlystage technologies,” Greenhalgh adds. “The first talk is by Kenneth Ouriel, Founder of Syntactx, who will focus on the inadequacy of paclitaxel coated balloon trial design.” There will be talks on the Xtreme Touch sirolimus-eluting drug coated balloon and an update on the Selution sirolimus drug coated balloon. Following the presentations is a mini-symposium on the impact of AI on vascular disease management chaired by Bob Mitchell and Jan Heyligers, Tilburg, The Netherlands. Finally, delegates will hear from previous winners of the CX Dragons’ Den, before 10 or more people step into the Den to compete for the £1,000 CX Innovation Prize.

Charing Cross Special Edition | March 2020

CX 2020

New session launched to showcase innovation and consensus in Major Vascular Trauma On Wednesday 22 April CX will launch a new session, Major Vascular Trauma, which will cover vascular trauma practice and bleeding control techniques. Course directors Christopher Aylwin (Imperial College Healthcare NHS Trust, London, UK) and Ross Davenport (Barts Health NHS Trust; Queen Mary University of London, London, UK) have assembled an expert Faculty who will seek consensus on vascular injury and interventions. Speaking to Vascular News, Aylwin stresses the importance of highlighting vascular trauma at CX: “Trauma is the leading cause of death in the under 40s, and a growing burden on healthcare resources worldwide. Haemorrhage may account for 40% of deaths, and the role of surgeons to provide rapid haemorrhage control is crucial in improving outcomes. We are delighted that CX has set aside a full session to showcase innovation and consensus in vascular trauma, and we have assembled a fantastic faculty to address topics that many vascular surgeons may not have encountered before. We hope this is the beginning of a long relationship with the Symposium and look forward to developing it in the years ahead.

The first to be addressed will be major vascular trauma, with Aylwin addressing damage control surgery for vascular surgeons, followed by Davenport giving a presentation on catastrophic vascular haemorrhage. The second topic to be covered will be aorta injury and interventions. Ounali Jaffer (Walton on Thames, UK) will give a presentation on blunt aortic injury, considering when to intervene, difficult landing zones and surveillance, Tim Stansfield (Leeds, UK) will talks about REBOA (resuscitative endovascular balloon occlusion of the aorta) as an adjunct for control of vascular trauma haemorrhage, discussing its pros and cons, as well as international experience, with the aim of “moving to a consensus”. Finally, Robert Lendrum (London, UK), will discuss the UK REBOA trial and its role in prehospital case. Next on the agenda will be extremity vascular trauma, with Elika Kashef (London, UK) giving a talk on when and for how long to use IVC filters, Kaji Sritharan (Liverpool, UK) weighing the benefits versus the risks of venous repairs, and Tom Konig (London, UK) considering when, how, and why to use shunting.

CX Vascular Malformations to provide expert updates in areas of new development 10:30–12:30 Tuesday 21 April London Room Learning Centre The CX Vascular Malformations programme will showcase some particularly challenging cases with seemingly no way out. CX Executive Board Member Jocelyn Brookes (University College Hospital, London, UK), remarks on the importance of the Vascular Malformations programme and how it both reflects and generates developments in the field: “There is a growing understanding of the complex molecular pathways and genetic mutations that cause these lesions. This scientific progress has led to new techniques in diagnosis and classification, directly correlating to appropriate (new) and successful

interventions. The popular Vascular Malformation programme at CX brings together a Faculty of UK and international experts in this exciting field.” Commenting on the interactive nature of the session, Brookes notes: “Some of the delegates are very experienced in their own right and interactive discussion between speakers and delegates is not only encouraged but is educational and stimulating (if not sometimes entertaining!) for delegates of levels of experience to enjoy. All participants are asked to bring along cases for discussion if they wish, to challenge the experts and share learning and experience for the benefit of all patients who live with these difficult conditions.”

In the section of the session dedicated to the management of neck trauma, Karim Brohl (London, UK) will give a presentation on blunt cerebrovascular management, before Davenport and Aylwin talk through two cases representing a “worst day at the office”—one a vertebral artery injury; the other, a subclavian artery avulsion. The session will move towards a focus on training and the future of vascular trauma practice. Rachel Bell (London, UK) will aim to answer the question “I am not a paediatric surgeon… what does a vascular surgeon need to know?”, Ben Singer (London, UK) will talk about ECMO and selective arch perfusion in major trauma, Simon Glasgow (London, UK) will consider the role of TARN in UK vascular trauma practice, before Martin Griffiths (London, UK) looks to the future by addressing training for vascular trauma in 2025. The inaugural Major Vascular Trauma session will end with a CX Debate, with Gary Maytham (London, UK) putting forward a case for the motion that vascular surgeons should be primary responders to all major haemorrhage protocol trauma calls, and Adam Stannard (Yarm, UK) arguing against.

CX Abstract sessions to showcase latest research and ideas 08:00–18:00 Wednesday 22 April Pillar Hall Learning Centre

The CX Global Stars and Rising Stars category in the Abstracts sessions returns at CX 2020, with another increase in abstracts received that were found to be of CX-Faculty quality. Such abstracts are awarded with the designation Rising Star for junior presenter. The Global Stars are abstracts submitted by non-junior presenters, often Faculty members who are leaders in their field. CX Abstract sessions therefore give attendees yet another opportunity to exchange ideas and research across all levels of expertise. The Abstract sessions take place from Tuesday 21 to Friday 24 April, and are divided into the main programmes of the symposium. The Peripheral Abstracts include presentations on the role and technique of embolisation in deep venous arterialisation, the cost efficiency of peripheral arterial disease (PAD) technologies, and how best to choose between open and endovascular therapy for lower extremity PAD. The Venous Abstracts include a Podium 1st presentation on estimating the extent of postthrombotic iliocaval obstructions prior to endovascular recanalization through a comparison of different imaging modalities. A Podium 1st on minimising anatomical challenges with pre-procedural planning and patient suitability through results of an update from a Canadian multicentre registry on abdominal endograft will be presented as an Abdominal Aortic Abstracts. The Acute Stoke Abstracts will include presentations on arterial virtual endoscopy using 3D tomographic ultrasound and the feasibility of remote robotic thrombectomy. The Vascular Access Abstracts will include presentations on endovascular arteriovenous (endoAVF) creation and intravascular ultrasound (IVUS).

Charing Cross Special Edition | March 2020

CX 2020

CX 2020 Floorplan

Stairs to Gallery Suite & Dark Room Learning Centres

Pillar Hall Learning Centre

Upper Main Auditorium Accessable via Staircase

Gallery Suite Learning Centre

390

CX Abstracts

480

490

An Introduction to Vascular Surgery

CX Vascular Access Village

CX Aortic Village

470 736

457

463

467

550

540

446

451

447

443

Faculty Lounge

Speaker Ready Room

Dark Room Learning Centre

Gallery Suite & Dark Room Learning Centres Situated on the Gallery level above the Olympia Room

734

Entrance to

536

431

437

235

425

521 732

Stairs to Gallery and

Auditorium

Faculty Registration

Upper Main Auditorium

380

390

370 Catering

245

438

430

338

336

332

241

233

Lead Retrieval

Book & Bag

Registration

231

720

Stairs to Gallery and

725

718

390

Upper Main Auditorium

280

270

260

268

258

250

246

240

234

Entrance

Lower Main

421

230

BIBAMedTech Insights

290

147

130

143

132

151 137

169

London Room Learning Centre

133

164

166

Entrance to

167

135

Lower Main Auditorium

CX Peripheral Village

CX Venous City

Lower Main Auditorium Pavilion Sponsors Bayer

250

Concept Medical Cook Medical Getinge Gore

Exhibitors AesthetiCare

720

470

Avenu Medical

732

270

BALTON SP.ZOO

430

280

BIBA Medtech Insights

220

CACVS/i-MEET/DIVINE ID

tbc

Medtronic

380, 390 480

CX Live

219

Terumo Aortic

370

Cydar Medical

336

Edizioni Minerva Medica

tbc

ESVS

tbc

Major Sponsors BD

290

EVC

tbc

Bentley

440

EVF

tbc

Boston Scientific

245

EVT

tbc

CryoLife – JOTEC

467

F Care Systems

130

Endologix 463

Intact Vascular

246

LeMaitre

580

Kinepict Health

235

Lombard Medical

451

Laminate Medical

338

Merit Medical

490

LINC tbc

Philips 258

LSO Medical

RD Global – Invamed

268

Medistim 164

Siemens Healthineers

457

241

Upper Main Auditorium

Ground Floor MERMAID MEDICAL 137

VSGBI

MicroPort Endovastec

447

Wisepress 725

tbc

Molnlycke

169

Ziehm Imaging

Olympus

230

optimed

240

Orbus Neich

332

443

Penumbra 234 Pie Medical Imaging

433

PIUR IMAGING

147

R&D Surgical

718

RF Medical

166

Scalan International, Inc.

231

Shockwave Medical

437

SIGVARIS GROUP Britain

135

STARmed 143 STILLE

260

Teleflex

536

Therenva

260

Vascular News

220

Venous News

220

Veryan Medical

438

Aortic Workshop

Vascular Access Village

Pillar Hall Learning Centre Faculty Lounge

Lower Main Auditorium

Gallery Suite Learning Centre & Dark Room Gallery level

Venous City and Venous Edited Cases

Entrance

London Room Learning Centre

March 2020 | Charing Cross Special Edition

CX 2020

CX 2020 Sponsors and Exhibitors A–Z Pavilion sponsors Bayer

Booth 250

Bayer is a global enterprise with core competencies in the Life Science fields of healthcare and agriculture. Its products and services are designed to benefit people and improve their quality of life.

www.bayer.com

Concept Medical Booth 470

Concept Medical Inc (CMI) is an establishment with the vision of “inspiring innovation”. CMI was founded in the year 2008, having the mission of “converting concepts into reality” in the drug delivering medical devices industry. Based in Tampa, Florida, Concept Medical strives to find solutions to improve and elevate health. With the attribute of being the first in class and to take care of well-being in a natural way, it has committed itself to the field of coronary and peripheral arterial disease.

www.conceptmedical.com

Cook Medical Booth 270

A global pioneer in medical breakthroughs, Cook Medical is committed to creating effective solutions that benefit millions of patients worldwide. Today, we combine medical devices, drugs, biologic grafts, and cell therapies across more than 16,000 products serving more than 40 medical specialties. Founded in 1963 by a visionary who put patient needs and ethical business practices first, Cook is a family-owned company that has created more than 10,000 jobs worldwide.

www.cookmedical.eu

Getinge

Booth 280

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimise workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science. Getinge employs over 10,000 people worldwide and the products are sold in more than 135 countries.

www.getinge.com

Gore

Booth 380, 390

Gore Medical Products Division engineers devices that treat a range of cardiovascular and other health

conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education, and quality initiatives.

www.goremedical.com/eu

Medtronic Booth 480

Making healthcare better is our priority and we believe technology can play an even greater role in improving people’s lives. In addition to alleviating pain, restoring health, and extending lives, we work in partnership with others to create seamless, more efficient care.

www.medtronic.com

Terumo Aortic Booth 370

At Terumo Aortic, we understand that no two aortas are alike. We are 100% focused on the aorta, from the aortic root to the iliacs. With our comprehensive portfolio of surgical, endovascular, and hybrid technologies and services, we help you address your patients’ unique challenges—so no patient is left behind.

www.terumoaortic.com

Major sponsors BD

Booth 290 www.bd.com

Bentley

Booth 440

Bentley’s passion is the development, manufacturing, and distribution of innovative implants for minimally invasive treatments of vascular diseases. Since market launch in 2012 we rapidly expanded worldwide. Thanks to our international network of exclusive distribution partners we are represented in more than 80 countries—in some we are already market leader.

www.bentley.global

Boston Scientific Booth 245

Boston Scientific is a leading global healthcare company with approximately 32,000 employees and revenue of US$9.8 billion. Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

www.bostonscientific.eu

CryoLife JOTEC Booth 467

CryoLife is a leader in the manufacturing and distribution of medical devices focused on aortic repair; devices include implantable tissue, mechanical heart valves, surgical adhesive, and a comprehensive portfolio of customised surgical and endovascular stents and grafts. CryoLife markets products in over 100 countries.

www.cryolife.com www.jotec.com

Endologix Booth 463

Endologix offers personalised AAA care for each patient with options to treat even the most challenging anatomies on IFU. Our portfolio is designed to improve outcomes and solve key challenges like access, bifurcation preservation, and aneurysm sealing. We are committed to physician collaboration for solutions that revolutionise aortic care for life.

www.endologix.com

LeMaitre Booth 580

LeMaitre Vascular is a provider of devices, implants, and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide. The company develops, manufactures, and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon. The company’s diversified product portfolio consists of brand name devices used in arteries and veins outside of the heart.

www.lemaitre.com

Lombard Medical Booth 451

Lombard Medical Limited is an Oxfordshire, UK-based medical device company focused on the minimally invasive treatment of abdominal aortic aneurysms (AAAs). The company has global regulatory approval for Aorfix, an endovascular stent graft that has been specifically designed to treat patients with the broadest range of AAA anatomies, including aortic neck angulation up to 90 degrees. The company has also achieved CE mark for the Altura endograft system, an innovative ultra-low profile endovascular stent graft that offers a simple and predictable solution for the treatment of more standard AAA.

www.lombardmedical.com

Merit Medical Booth 490

Merit Medical® offers an integrated portfolio of products designed to support your vascular surgery procedures, dialysis, peripheral vascular interventions, interventional radiology, and cardiology. Merit Medical® brings

you innovative solutions for vascular challenges. Discover our wide range and complete portfolio at our booth (number 490) and visit our website

www.merit.com

Philips

Booth 258

Enabling better health and better care at lower cost. Philips is a leading health technology company focused on improving people’s lives. Applying advanced technologies and deep clinical and consumer insights, Philips delivers integrated solutions that improve people’s health and enable better outcomes. Partnering with its customers, Philips seeks to transform how healthcare is delivered and experienced. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring, and health informatics, as well as in consumer health and home care.

www.philips.com/igtdevices

RD Global-Invamed Booth 268

RD Global is a company that dictates human healthcare and welfare above everything. Our mission is to contribute to heritage of humanity by achieving the best in multiple disciplines of medicine and biomedical engineering in order to serve optimal healthcare solutions.Our purpose is to improve the health of the patients all around the world with our strong, hard-working, dedicated, and clinically-driven biomedical solutions team. Our products and technologies are mostly focused on endovascular treatment solutions with the addition of a wide range of medical conditions.

www.rdglobal.com/tr

Siemens Healthineers Booth 457

Siemens Healthineers AG is shaping the future of healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalising healthcare. In fiscal 2019, which ended on 30 September 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of €14.5 billion and adjusted profit of €2.5 billion.

www.siemens-healthineers.com

Exhibitors AesthetiCare Booth 720

Ferndale Pharmaceuticals Ltd with its

Charing Cross Special Edition | March 2020

CX 2020

CX 2020 Exhibitors A–Z contd. commercial divisions Ferndale Clinical and AesthetiCare, is a UK health and well-being company. The portfolio consists of medicines, medical devices, and cosmetic skincare products and devices. We market products and brands from companies we work with in exclusive partnerships and those that are our own.

dependability. Cydar EV uses patented computer vision with “massively parallel” computing to watch the live X-ray images and track the patient throughout a procedure. The result is unprecedented accuracy, consistency, and dependability.

www.cydarmedical.com

www.aestheticare.co.uk

F Care Systems

Avenu Medical Booth 732

F care Systems is a Belgian limited company which develops, produces, and distributes highly-qualified medical and medical-aesthetical equipment. Our company focuses on the treatment of various types of varicose veins and haemorrhoids based on the principle of thermocoagulation.

Avenu Medical Inc was founded in 2010 to pursue unmet clinical needs in the ESRD and vascular access market. The company has developed the Ellipsys® Vascular Access System which is an innovative, ultrasound-guided, single catheter endoAVF® system used to percutaneously create an arteriovenous (AV) fistula for haemodialysis access.

www.avenumedical.com

BALTON SP.ZOO Booth 430

Balton is a Polish manufacturer with 40 years history. We are producing medical equipment for interventional radiology, cardiology, phlebology, anaesthesiology, urology, dialysis, surgery, and gynaecology. Thanks to our clinical experience and strong R&D department we have an impressive range of innovative products used in almost 100 countries around the world.

www.balton.pl

BIBA Medtech Insights Booth 220

BIBA MedTech Insights is a leading provider of market analysis services. We serve medical professionals and organisations in the medical device industry in Europe and North America. Our research products include quarterly monitors, customised research, and tailored services.

www.bibamedtech.com

CX Live

Booth 219

The CX Live studio is run by the BLearning video production division of BIBA Medical. The BLearning team makes professional, compelling medical videos with editorial input from experienced medical journalists and a high-end production team in a bespoke studio environment. Contact nathalie@bibamedical.com for all your video production needs at Charing Cross Symposium 2020.

www.blearning.net

Cydar Medical Booth 336

Cydar EV is cloud-based software medical device that incorporates Artificial Intelligence and supercomputing to deliver image fusion with exceptional accuracy and

Booth 130

www.fcaresystems.com

Intact Vascular Booth 246

Intact Vascular is committed to developing safe, efficacious, and easy-to-use products for patients with vascular disease and the physicians who treat them. Founded in 2011, our core technology, the Tack Endovascular System® is a first-of-its-kind dissection repair device that is purpose-built and designed to provide precision treatment of peripheral arterial dissections following balloon angioplasty, in either above- or below-the-knee therapeutic interventions.

www.intactvascular.com

Laminate Medical Booth 338

Laminate Medical Technologies is developing a new, external support device for AV fistulas, to be implanted during the fistula creation surgical procedure. The device aims to drive a change in the haemodialysis vascular access treatment paradigm and bring about a significant reduction in the annual fistula failure rate.

www.laminatemedical.com

LSO Medical Booth 241

Founded in 2002, LSO Medical is a French company which designs, manufactures, and sells medical Lasers systems. With almost 20 years’ experience, LSO Medical is expert in Endovenous Thermal Therapy with the laser Endotherme 1470nm and its Ringlight radial fibres. In view to evolving Endovenous Thermal Therapy, LSO Medical has developed the SnakeBack technology, guaranteeing an accurate energy delivery while simplifying the EVLT procedure. At Charing Cross 2020, come to discover the new SnakeBack technology on booth 241.

www.lsomedical.com

Medistim Booth 164

Medistim is the market leader in intraoperative quality assessment and ultrasonic surgical guidance. The Medistim MiraQ™ Vascular system offers both transit time flow measurement (TTFM) and highfrequency ultrasound imaging (HFUS) in one system. With this dual technology, you can assess the haemodynamics and vessel morphology intraoperatively, reveal any technical imperfections and undo before closure. Surgical findings can be documented through flow tracings and images by the system and greatly increase the probability of a positive outcome and lessen the chance for unnecessary surgical reinterventions.

www.medistim.com

Mermaid Medical Booth 137

Mermaid Medical Group is a global manufacturer and distributor of not only biopsy needles, drainage catheters, Co2 delivery, and CIVCO needle guidance products, but now a range of stents and balloons, a Microwave Ablation System Helios licensed for thyroid use and the new SpeedWire, making complex femoral access procedures into an easy routine procedure. We welcome your visit to Booth 137 to see our simulation models, and book an evaluation.

www.mermaidmedical.dk

Microport Endovastec Booth 447

Dedicated to the global healthcare industry, Shanghai MicroPort Endovascular MedTech Co Ltd was founded in Shanghai in 2012, with a focus on the treatment of aortic and peripheral vascular diseases and the R&D, manufacturing, and sales of minimally invasive medical devices. It has grown into one of the leading companies of interventional medical devices for aortic vascular diseases in China.

www.microport.com

Molnlycke Booth 169

Mölnlycke is a world-leading medical solutions company. We are here to advance performance in healthcare across the world, and we aspire to equip everybody in healthcare with solutions to achieve the best outcomes. We collaborate with customers to understand their needs. We design and supply medical solutions to enhance performance at every point of care— from the operating room to the home.

www.molnlycke.co.uk

Olympus Booth 230

Olympus, as a worldwide leading manufacturer of cutting-edge advanced

energy devices, as well as sophisticated imaging systems, aims to provide innovative and safe products for vascular specialists. The PRECISION System generator and ProCurve V applicator allow for highly accurate and customised treatment of varicose veins. Using bipolar radiofrequency technology, the “Pulse RFITT” mode (radiofrequency induced thermotherapy) along with the unique “auto-stop” function, veins are occluded gently and efficiently. Visit our booth for more information about the Olympus PRECISION System for varicose veins treatment.

www.olympus.co.uk

optimed

Booth 240

optimed, based in Ettlingen, Germany, was founded in 1995. The company is engaged in the research and development, production, and global distribution of medical products for minimal invasive therapy. optimed employs more than 100 people in its administration centre and two production sites in Ettlingen near Karlsruhe. As optimed continuously invests in the research, development, and production of the products of tomorrow, we are the ideal partner for innovative medical practitioners working in the field of minimal invasive therapy, specifically in interventional radiology, vascular interventions, urology, and gastroenterology.

www.optimedhealthcare.co.uk

Orbus Neich Booth 332

OrbusNeich® is a global pioneer in the provision of life-changing vascular solutions. Our portfolio includes peripheral devices; JADE®, Sapphire II Pro PTA®, Scoreflex® PTA balloons & Teleport®/Teleport® Control microcatheters together with coronary stents, balloons and microcatheters. OrbusNeich is the exclusive distributor of the Stealth 360® Peripheral Orbital Atherectomy System from Cardiovascular Systems Inc outside of the USA & Japan.

www.orbusneich.com

Penumbra Booth 234

Penumbra Inc, headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets innovative products and has a broad portfolio that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and vascular.

www.penumbrainc.com

Continued on page 18

Charing Cross Special Edition | March 2020

CX 2020

CX 2020 Exhibitors A–Z contd. Pie Medical Imaging Booth 433

Pie Medical Imaging (PMI) is a global leader in cardiovascular analysis software. PMI’s customers include (interventional) cardiologists, vascular surgeons, leading research centres and core labs, as well as major equipment manufacturers and device vendors. PMI is well known for its 3mensio products for advanced CT imaging with dedicated workflows for planning of EVAR, TEVAR, and f-EVAR procedures. With its CAAS product line PMI delivers also software solutions for X-ray, MRI and IVUS/OCT analysis. Please visit our booth 421 to learn more about our software solutions.

Shockwave Medical Booth 437

Shockwave Medical is a company focused on developing and commercialising products intended to transform the way calcified cardiovascular disease is treated. We aim to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which we refer to as Intravascular Lithotripsy.

www.shockwavemedical.com

www.piemedicalimaging.com

SIGVARIS GROUP Britain

PIUR IMAGING

SIGVARIS GROUP manufacture medical compression products that combine textile intelligence with modern technology. We are committed to providing innovative products to people suffering from oedema and venous disease and are contributing each day to making the SIGVARIS GROUP the world leader and expert in medical compression garments.

Booth 147

PIUR IMAGING is a medical technology company headquartered in Austria and specialised in Tomographic Ultrasound diagnostic solutions. The innovative “PIUR tUS Infinity” turns any standard ultrasound system into a tomographic imaging device, bridging the gap between 2D ultrasound and regular tomographic imaging modalities.

www.piurimaging.com

R&D Surgical Booth 718

R&D Surgical serve the vascular community with innovative products which include Xenosys headlight offering freedom and convenience at only 30 grams weight, a full range of Xenosys custom surgical loupes, and Xenosys wireless portable HD camera system. In addition to a range of consumables that provide cost savings without compromise on quality.

www.randdsurgical.com

RF Medical Booth 166

RF Medical is dedicated to popularising radiofrequency ablation treatments since 2003. Our extensive product range spans from tumour ablation to thyroid nodules to even varicose vein treatments. With advanced technology and proven quality, we have spread our business to more than 50 countries and gained a strong reputation on the market.

www.rfa.co.kr

Scalan International Inc Booth 231

The highest quality surgical instruments designed and manufactured by the Scanlan Family since 1921. You deserve the best. Experience the Scanlan difference at our exhibit #231.

www.scalaninternational.com

Booth 135

www.sigvaris.com/uk

STARmed Booth 143

STARmed Co Ltd is a young and fast-growing company from South Korea, specialising in radiofrequency technology. Passionately working on the best possible RF treatment, STARmed has collaborated with a number of key opinion leaders in developing innovative electrodes and leading-edge RF technology specific to certain tumour types and clinical applications, in thyroid, liver, lung, kidney, myoma, bone etc. Further to these successes with our innovative RF technology, STARmed has recently developed a new RF device that effectively treats varicose veins and has vascular surgeons impressed.

www.starmed4u.com

STILLE

Booth 260

STILLE develops and produces unique products to the world’s leading surgeons to enable safer and more efficient procedures, as well as solutions that help to reduce the degree of harmful radiation exposure to patients and clinicians. The result is surgical instruments with unrivalled precision, giving surgeons a unique feeling for their craft, and C-arm tables that are so easy to use despite being among the most advanced in the world. In the end, it’s all about creating Surgical Perfection. For Life.

www.stille.se

Teleflex

Booth 536

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation—a relentless pursuit of identifying unmet clinical needs—to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anaesthesia, cardiac care, urology, emergency medicine, and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference.

www.teleflex.com

Therenva Booth 260

The Therenva team develops imageguided planning (EndoSize®) and 3D navigation systems (EndoNaut®) helping physicians and industry professionals optimally treat cardiovascular diseases using minimally invasive techniques. Based on cutting-edge image processing algorithms, deep learning and biomechanical simulation, the fusion technology of EndoNaut® increases procedure safety while reducing X-ray and contrast doses.

www.therenva.com

Vascular News Booth 220

Vascular News is a trusted and editorially-independent newspaper for vascular and endovascular specialists. It provides physicians with the latest news, conference coverage, comment and analysis by thought-leaders, and industry news in the vascular and endovascular world. Please visit booth 220 for a free subscription.

www.vascularnews.com

Venous News Booth 220

Venous News is a trusted and editorially-independent newspaper for venous and phlebology specialists. It provides physicians with the latest news, conference coverage, comment and analysis by thought-leaders, and industry news in the venous and phlebology world. Please visit booth 220 for a free subscription.

www.venousnews.com

Veryan Medical Booth 438

Veryan Medical has developed BioMimics 3D®, a self-expanding, nitinol SFA/prox pop stent which imparts a natural, 3D curvature to the artery, to generate swirling flow, increase wall shear and reduce intimal hyperplasia. In the MIMICS-RCT study BioMimics 3D, the Swirling Flow® Stent, achieved

significantly better performance than straight control stents. Swirling Flow: nature’s alternative to drug elution. Veryan is an Otsuka Medical Devices company.

www.veryanmed.com

Wisepress Booth 725

Wisepress.com, Europe’s leading conference bookseller, has a complete range of books and journals relevant to the themes of the meeting. Books can be purchased at the stand or, if you would rather not carry them, posted to you—Wisepress will deliver worldwide. In addition to attending 200 conferences per year, Wisepress has a comprehensive medical and scientific bookshop online with great offers.

www.wisepress.com

Ziehm Imaging Booth 443

Founded in 1972, Ziehm Imaging has stood for the development, manufacturing, and worldwide marketing of mobile X-ray-based imaging solutions for more than 45 years. Employing approximately 700 people worldwide, the company is the recognised innovation leader in the mobile C-arm industry and a market leader in Germany and other European countries.

www.ziehm.com

Charing Cross Special Edition | March 2020

Peripheral

New meta-analysis finds “no observed difference” in mortality between paclitaxel and uncoated device use in CLTI patients February 2020 brings another paclitaxel device meta-analysis of randomised controlled trials in chronic limb-threatening ischaemia (CLTI) patients. Krystal Dinh (Westmead Hospital, Sydney, Australia) et al report online ahead of print that the risk of all-cause mortality after treatment with paclitaxel-coated devices versus uncoated controls in patients with CLTI in the Journal of Endovascular Therapy (JEVT) very differently than did Katsanos and colleagues earlier this year. In fact, Dinh et al, due to the clear benefit and no suggestion of a link between the use of paclitaxel-coated devices and mortality, “recommend their continued use in this high-risk patient population”.

inh and colleagues, including Ramon Varcoe (Prince of Wales Hospital, Sydney, Australia), Andrew Holden (Auckland Hospita, Auckland, New Zealand) and Peter Schneider (University of California San Francisco, San Francisco, USA) performed a systematic review on 5 November 2019 to identify randomised controlled trials using intention-totreat analysis to compare a paclitaxel-coated device to an uncoated device in peripheral arterial disease patients having clinical follow-up of at least six months. Half of the study population had to have CLTI, or extractable data on the CLTI subgroup, if this constituted less than 50%, write the authors. The search revealed 11 trials with 1,450 patients who were randomised to treatment with a paclitaxel-coated device (n=866) or an uncoated control (n=584). The group included 94.3% (1,367) patients with CLTI. The single endpoint was all-cause mortality, which was analysed by pooling the mortality data in a random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Importantly, Varcoe clarified that this meta-analysis included the five-year IN.PACT DEEP results that were overlooked by Katsanos and colleagues. Further, they included only studies that were published, or those that authors were able to confirm had been accepted for publication and were in press. As described in JEVT, the mean follow-up was 25.6 months (range 6–60) and 10 of 11 studies reported a

minimum 12-month follow-up. There were 18.6% (161) deaths in the 866 patients in the paclitaxel device group and 19.9% (116) deaths in 584 patients who received treatment with a non-coated device (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). This led the investigators to conclude that “there was no observed difference in short- to mid-term mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls”.

This subset of PAD patients has the most to lose if paclitaxelcoated devices were to become unavailable.” They write: “This meta-analysis has demonstrated that there is no increased risk of all-cause mortality in a predominately CLTI patient population treated with paclitaxelcoated versus uncoated devices. With clear benefit and no suggestion of a link between the use of paclitaxel-coated devices and Ramon mortality, we recommend their Varcoe

Interdisciplinary wound care teams are integral for CLTI patients’ care, ISET session concludes The 32nd International Symposium on Endovascular Therapy (ISET; 22–25 January, Hollywood, USA) had a particular focus on treating critical limb-threatening ischaemia (CLTI). In the session “Improving outcomes and prognosis for CLI”, conference attendees learnt about the global scale of the disease, the importance of adequate wound care post-treatment, and the possibility of revascularisation in the outpatient environment. The session was co-developed and sponsored by the CLI Global Society, a patient advocacy organisation that aims to improve patients’ quality of life by preventing amputations and death due to the condition. MICHAEL JAFF (HARVARD Medical School, Newton, USA), vice president and founding board member of the CLI Global Society, spoke first to define CLTI and to outline the risks it poses

to patients. “This is obviously a very important session for all of us who deal with these patients for a whole host of reasons,” he said. “We need to recognise that these patients are begging for our

continued use in this high-risk patient population.” Dinh and colleagues note that the present study was performed “in direct response” to the meta-analysis by Konstantinos Katsanos (University of Patras, Patras, Greece) and colleagues, published in the Journal of the American Heart Association (JAHA) in December 2018, that identified higher mortality rates in PAD patients with claudication who underwent endovascular treatment of the lower extremity with paclitaxel-coated balloons and stents. “In contrast to those findings,” the authors note, “this study found no such association for patients undergoing treatment for CLTI, with similar overall death rates of 18.6% and 19.9% in the drug-coated and uncoated device control groups, respectively”. He continued: “We also observed no effect of paclitaxel dose, target vessel location, or length of the lesion on morality rates”. Considering the wider debate surrounding drugcoated devices, Dinh et al note that there is a great deal of ongoing work to determine whether the safety signal observed in patients with claudication represents a drug toxicity effect or a statistical association. However, they also remark that the benefits of paclitaxel-coated devices are “well established” and “withholding their use in CLTI patients is likely to detrimentally affect patient outcomes as patients are subjected to increased numbers of interventions and high-risk open surgical procedures, likely leading to increasing rates of amputation and mortality”. They add: “This subset of PAD patients has the most to lose if paclitaxel-coated devices were to become unavailable, which suggest there is no increase in allcause mortality.” The authors note a few limitations of the present study. Firstly, they mention that the number of studies and participants was smaller than that of the 2018 Katsanos et al meta-analysis. Therefore, they suggest, this analysis may be “underpowered” and “susceptible to type II error,” particularly at the time points beyond one year. Also, like the 2018 Katsanos et al meta-analysis that preceded it, this investigation was performed at a summary level that was unable to collect patient level data and specific causes of death. “Further insights are likely to come from a more detailed metaanalysis performed at an individual patient level,” they remark.

help.” He pointed out that patients with the most advanced class of the disease, categorised as Rutherford class 6, “had the highest prevalence of bilateral limb amputations before coming for this intervention”. He called this the “striking, sobering reality” of CLTI in the USA. “The prognosis for one year after the diagnosis of CLTI is terrible: 25% of patients will have died, and 30% are still alive but have had a major amputation,” he disclosed. “Patients with chronic CLTI have a three-year limb-loss rate of approximately 40%, and quality of life indices of CLTI patients are very similar to end-stage cancer. Readmission rates are very high. We must identify these patients early, and we must have a sense of urgency for revascularisation. Amputation has to be considered the last possible option, not the first.” Iterating this message, ISET founder and president of the CLI Global Society Barry Katzen (Miami Heart and Vascular Institute, Miami, USA) said: “Part of what we are trying to do is get this call to arms, and hearing Michael [Jaff]’s

sentinel announcement about how vigilant all of us have to be to implement change is an important part of the message we would like to deliver.” As the only society in the world dedicated to serving this patient population, the CLI Global Society is using its resources to get more data on the disease. Katzen explained to the ISET audience: “One thing you might know from your own hospitals is there are insignificant DRG [diagnosis-related group] codes, it is hard to actually

We need to raise disease awareness.” quantify the cost impact, and the federal government and payers do not really understand or recognise CLTI as an entity or a disease, which leads to a lack of financial resources, payment for physicians, and payment for hospitals.

March 2020 | Charing Cross Special Edition So one of the things that the CLI Global Society did is invest its resources in creating science.” Citing a recent CLI Global Society study published in the Journal of the American Heart Association (JAHA) that used Medicare data to investigate the impact of CLTI on the US population, Katzen said that patients with this disease have a poor longterm prognosis following their initial diagnosis, specifically pointing out that through four years, only 42% were alive and free from major amputation. “We need to raise disease awareness,” he said, echoing Jaff, “and we need to implement coding to better define CLTI, so that when you are looking after these patients, CMS can actually identify them. This is a major initiative of the CLI Global Society.” The CLI Global Society, as “a nonprofessional society without political turf”, in Katzen’s words, has forged a coalition between the Society for Vascular Surgery (SVS), the Society for Cardiovascular Angiography and Interventions (SCAI), the Society of Interventional Radiology (SIR), and the Society for Vascular Medicine aimed at initiating a coding change regarding CLTI. Katzen anticipates this being implemented in October 2020. Richard Neville (Inova Heart and Vascular Institute, Falls Church, USA) took to the podium next to discuss the importance of an integrated approach to the CLTI patient. “It is frustrating,” he said, “because I feel as though I have been giving this presentation for about 20 years. I was talking with Vickie [Driver, Brown University School of Medicine, Providence, USA, fellow panellist] earlier, and we were saying how this idea of a multidisciplinary team started with the diabetic foot. It seems that they have had a lot more progression and moved things along faster than we have with these CLTI teams. But we have to keep pushing forward—I think as more people get interested and recognise this is an important disease entity.” Promoting the idea of an integrated limb preservation team, Neville said the ultimate goal is to decrease the rate of amputation. The team would also work together to decrease the rate of patient mortality and medical comorbidity, address the current disparity of care, and raise awareness of endovascular methods of limb preservation. A multidisciplinary approach to CLTI treatment would streamline care, he argued, and would provide a referral source for the community, as well as a forum for research and both patient and physician education. “There has been good data across the world showing that these teams can reduce amputation rates,” Neville disclosed, highlighting data from the USA (82% reduction), Sweden (78% reduction), and the UK (62% reduction). Generalising rules for establishing a multidisciplinary team is challenging, he continued, as the development of an integrated CLTI group depends on the people and facilities available

locally. However, Neville emphasised that one commonality was the need for a physician champion: “You need somebody in the system that just takes this to heart. I would argue that you need someone that wants to take care of the vascular needs of the patient, someone that wants to work on their soft tissue, and we are now going to add vascular medicine in the mix. But you need someone who is passionate who wants to put a team together, go to conferences, and talk to people.” Describing giving a similar talk in Beijing, China, Neville shared some advice from his Asian colleagues: “We used to call this the limb salvage centre [where the interdisciplinary CLTI team

Peripheral

Wound care is never basic in a CLTI patient. In fact, it requires advanced care before and after vascular interventions.” were based], but the gentleman who was hosting me in Beijing told me we cannot call it that—in Mandarin, the same Chinese character for ‘salvage’ is the

same as for ‘trash’. So it is now the limb preservation programme!” Commenting on the limb salvage versus limb preservation debate, Driver began her talk with an anecdote from her military days: “A general came to see me one day, he had been in Afghanistan and Iraq overseeing 35,000 of our [US] troops. He was diagnosed with diabetes. How was he diagnosed with a foot sore that would not heal and an infection? He went on to lose part of his foot. He said to me, ‘Thank god you do not call it limb salvage anymore’.” She continued: “Wound care is never basic in a CLTI patient. In fact, it requires advanced care before and after vascular interventions.”

Charing Cross Special Edition | March 2020

Peripheral

High- and low-dose paclitaxel-coated balloons exhibit comparable results At the 2020 Leipzig Interventional Course (28–31 January, Leipzig, Germany), Sabine Steiner (University of Leipzig, Leipzig, Germany) presented one-year results of the COMPARE trial of low-dose versus high-dose paclitaxel balloons—the first study to directly compare drug-coated balloons (DCBs) with different paclitaxel doses for femoropopliteal interventions. Both types of balloons exhibited comparable results with excellent effectiveness and safety through 12 months, including a wide range of lesion lengths. The results have also been published online ahead of print in the European Heart Journal. THE AUTHORS OF the study—Steiner and colleagues—aimed to directly compare the efficacy and safety of a high-dose (In.Pact, Medtronic) versus a lowdose (Ranger, Boston Scientific) DCB, with nominal paclitaxel densities of 3.5 vs. 2μg/mm2, respectively, for the treatment of femoropopliteal disease in Rutherford class 2–4 patients. Between December 2015 and September 2018, 414 patients were enrolled across 15 sites in Germany and randomised in a 1:1 fashion (207 low-dose DCB, 207 high-dose DCB). The primary endpoints consisted of primary patency through 12 months. The investigators chose a non-inferiority margin of -10% for their analysis. Primary safety was a composite endpoint of major adverse events also through 12 months with the same non-inferiority margin. Steiner detailed that COMPARE is an investigatorinitiated, prospective, multicentre, non-inferiority trial. “Importantly,” she added, “we had a stratification for lesion length,” in order to ensure the inclusion of a substantial proportion of long, complex lesions. Regarding lesion characteristics, Steiner explained that the study team stratified lesions into three categories of length: below 10cm, 10–20cm, and 20–30cm. Steiner and colleagues included a high proportion of complex lesions, resulting in the mean lesion length being around 13cm. Moving on to the results, presented for the first time at LINC, Steiner first detailed the primary endpoint outcomes. Firstly, she noted that primary patency was 83% for the low-dose DCB cohort vs. 81.5% for the high-dose DCB group, yielding a difference of 1.5%. In addition, the primary endpoint for non-inferiority was met. In terms of safety, Steiner reported a 91% safety rate in the low-dose group and a corresponding figure of 92.6% in the high-dose group. Again, the primary endpoint for non-inferiority was met. With regards to secondary endpoints, Steiner highlighted in particular the all-cause mortality results. “We observed five deaths in the low-dose group and three deaths in the high-dose group. None of these deaths were considered device- or procedure-related by the clinical events committee,” Steiner explained. Looking at the Kaplan-Meier analysis, Steiner showed a graph for primary patency detailing that this rate was “almost overlapping for the first year,” with a patency rate at one year around 88–89% for both DCBs. “Similarly, we have a very good freedom from clinically-driven target lesion revascularisation. In the low-dose DCB group, at 365 days, it is around 93%; in the high-dose group this figure is around 95%,” she elaborated. Considering the results as a whole, Steiner summarised: “These very good results with respect to patency were paralleled by a good clinical result. Around 75–80% of patients presented in Rutherford category 0 or 1 at six and 12-month follow-up.”

Background

In the European Heart Journal article, Steiner and colleagues detail that, as standard balloon angioplasty

for femoropopliteal disease is limited by high restenosis rates up to 70% in complex lesions, novel treatment modalities have been developed to improve patency rates. In particular, the development of DCBs has been a “major step forward” by inhibiting neointimal hyperplasia and smooth muscle cell proliferation through brief exposure of the vessel to an antiproliferative agent. “Importantly,” Steiner et al comment, “several DCBs

of these devices. In terms of lesion length, the authors note that prior randomised trials have demonstrated superior patency and target lesion revascularisation (TLR) rates for DCB versus conventional balloon angioplasty for endovascular treatment of femoropopliteal lesions with moderate complexity, i.e. short and middle length lesions. “Our study extends the existing evidence by adding a direct comparison of two DCBs with distinct coating formulations in a cohort comprising three different lesion length strata with a high proportion of total occlusions,” Steiner and colleagues explain. They continue: “Despite the inclusion of more complex and longer lesions, both groups exhibited excellent 12-month patency and freedom from TLR rates >80% and 90% respectively. These rates are comparable to the results observed in the initial proofof-concept trials comparing DCB versus plain balloon angioplasty in less complex lesions.” Considering the limitations of COMPARE, the authors admit that their study was “solely designed to assess non-inferiority for primary patency and a combined safety endpoint, but not for functional outcomes.” While the observed attrition rate was similar to prior studies comparing DCB and plain balloon angioplasty, and has been accounted for in the sample size calculation, the imbalance between the groups with a lower follow-up rate in the high-dose DCB arm was “unexpected and reasons remain unclear”, they note.

LINC audience largely convinced of paclitaxel safety

Sabine Steiner

Dierk Scheinert

Primary patency was 83% for the low-dose DCB cohort vs. 81.5% for the high-dose DCB.” News in numbers

Five key figures you need to know ● 414 patients were enrolled across

15 sites

●M ean lesion length was 13cm ● Primary patency was 83% for the low-

dose DCB cohort vs. 81.5% for the high-dose group ● The safety rate was 91% in the lowdose group, compared to 92.6% in the high-dose group ● 85.2% of audience at LINC believe there is an acceptable risk–benefit ratio and use DCBs/drug-eluting stents (DESs) in many patients with different coating formulations were successfully tested for femoropopliteal interventions against plain balloon angioplasty using various excipients and different nominal doses of paclitaxel ranging from 2 to 3.5μg/mm2.” Various studies have suggested that the coating technology and formulation of the active drug may affect the extent of drug delivery and clinical efficacy, and in particular, the dosing of paclitaxel could have a relevant impact on the antiproliferative capacity

The COMPARE study forms part of an ongoing debate around paclitaxel safety, which first emerged in December 2018 with the publication in the Journal of the American Heart Association (JAHA) of a metaanalysis by Konstantinos Katsanos (University of Patras, Patras, Greece) and colleagues, which identified a late mortality signal beyond two years in patients who were treated with paclitaxel-coated devices compared to uncoated control devices. While an association between paclitaxel dose and all-cause mortality was postulated in this meta-analysis, Steiner and colleagues note in their discussion that subsequent publications of individual patient-level data and registries “did not corroborate this assumption”. As a consequence, regulatory agencies currently advise cautionary use of DCBs, preferentially in patients at high risk of restenosis. In the COMPARE study, the authors observed a low 12-month mortality rate without group difference. “As a consequence of the ongoing discussion, we modified the study protocol to ensure a five-year follow-up for safety endpoints.” Going into detail about the COMPARE follow-up protocol, Steiner and colleagues explain: “Importantly, we have in-house visits up to two years and telephone calls will follow-up our patients up to five years for safety issues. Patients were phoned one month after the procedure for evaluation of clinical status, medication compliance, and adverse events. In-house follow-up visits were scheduled at 6, 12, and 24 months with assessment of medical conditions, Rutherford category, WIQ, medication, and patency evaluated by duplex ultrasound. Additional follow up for safety events (death, amputation, and TLR) is performed via an annual telephone call through five years.” Following Steiner’s presentation for the COMPARE results, Dierk Scheinert (University of Leipzig, Leipzig, Germany)—lead author of the study and session moderator—asked the LINC audience: “What is your opinion on paclitaxel safety?” The majority (85.2%) replied that they believe there is an acceptable risk– benefit ratio and use DCBs/drug-eluting stents (DESs) in many patients. In summary, both the low-dose Ranger DCB and higher dose In.Pact DCB “performed extremely well” in the COMPARE randomised controlled trial, with Steiner et al concluding that “longer follow-up will reveal if these positive results can be maintained.”

March 2020 | Charing Cross Special Edition

Paclitaxel mortality signal inconsistent across different geographies While drug-coated balloons (DCBs) have been “consistently efficacious” across various studies, the mortality signal has not, Peter Schneider (University of California San Francisco, San Francisco, USA) noted at this year’s Leipzig Interventional Course (LINC 2020; 28–31 January, Leipzig, Germany).

chneider began his talk in the paclitaxel update session at LINC 2020 by stating that he wanted to focus on the consistency of the mortality signal. “If something is dangerous, it should be dangerous everywhere,” he hypothesised. Referring to the US Food and Drug Administration (FDA) panel on paclitaxel safety, held in June 2019, he quoted the findings directly: “There is no clear evidence of a dose effect on mortality, no identifiable pathophysiological mechanism for late deaths,” adding that these words were subsequently confirmed by the Vascular and Interventional Advances (VIVA) individual patient data metaanalysis conducted in November of the same year. Schneider noted that efficacy results have been consistent across devices. The In.Pact (Medtronic) investigational device

exemption (IDE) trial, which was carried out in the USA and in the European Union (EU), and the In.Pact Japan trial, both show a “dramatic, very consistent” improvement in patency at three years. In contrast, Schneider remarked that, the mortality risk has not been steady. “The hazard ratio seems to be disappearing before our eyes, and it is a little hard to tell what is going on,” he commented. “Why are we having so much trouble finding this signal in our real-world experience, both in our individual practices but also in these accumulations of now tens of thousands of patients, and why is there this dropping signal each time the RCT data is reevaluated?” he questioned. In search of an explanation, Schneider first considered patients lost to followup. He noted that the FDA did their own analysis of US RCTs, which they repeated after some of the patients lost to follow-up

Peripheral were found. This data was presented at the FDA panel in June and showed that, at five-year follow-up, initial relative risk of 1.72 is reduced to 1.57 after finding some of the patients that were lost to followup. This is a decrease in the mortality signal of 21%. Schneider went on to reference the In.Pact series where the follow-up is now at 97%, in which “the same thing happened”: the hazard ratio decreased from 1.63 to 1.39—a decrease of 38%. “This indicates that patients are randomised on the way into the study, but they are not randomised in the way they are lost to follow-up. As we are finding them, we are revealing an ascertainment bias that influenced mortality results”. Schneider also pointed out that the

The [paclitaxel] mortality signal has not been apparent in the real-world data and it is not consistent within the randomised controlled trials.” drop in mortality signal between the FDA and the VIVA analysis can be explained by considering geography. While the FDA included trials that were performed

“to receive approval in the USA” and were therefore mostly conducted in the USA, in the VIVA analysis, trials were included that were performed outside the USA on devices that were approved in the USA. “If you look at it another way,” he explained, “the studies conducted outside the USA have hazard ratios that hovered around one, whereas most of those conducted inside the USA had hazard ratios of up to 1.8”.Considering this on a “granular” level, patients who were entered into the In.Pact IDE trial from the USA had a substanially higher hazard ratio for mortality than the patients who were from outside the USA, Schneider commented. The same thing can be observed in the Levant II trial, he added. “To evaluate whether there was actually some treatment bias going on here, the attendance to followup visits was evaluated, it turned out to be lower among the PTA [percutaneous transluminal angioplasty] patients than the DCB patients across all regions [the USA, EU and Japan], but the largest gap was in the USA, and that is where the increased hazard ratio was,” Schneider explained. Schneider concluded that, while DCBs have been “consistently efficacious,” the mortality signal has not. “It has not been apparent in real-world data and it is not consistent within the randomised controlled trials, which is where we found [the signal] in the first place”. He posited that this is partly because of ascertainment bias, but also because of a treatment bias across different geographies.

Charing Cross Special Edition | March 2020

Aortic surgery

Centralisation of aortic surgery is “imperative” At this year’s Controversies and Updates in Vascular Surgery annual meeting (CACVS; 23–25 January, Paris, France), Dittmar Böckler (University Hospital Heidelberg, Heidelberg, Germany) made a case for the centralisation of aortic surgery, detailing 10 reasons why this is “imperative” for patient outcome and safety, cost saving, and education. BÖCKLER BEGAN BY outlining major challenges in the healthcare system, including staff shortages, increasing costs, and quality control becoming increasingly important. He acknowledged that while medical care differs between countries, challenges in healthcare are “very similar”, at least among industrialised nations. He noted that since the 1970s there has been a move in Denmark towards there being a small number of large-volume hospitals. This change has occurred not only in the vascular space but in medical care overall. In comparison, there are roughly 2,000 hospitals in Germany, with over half a million hospital beds. Looking at the treatment of abdominal aortic aneurysms (AAA) in Germany in particular, a quality assurance survey revealed that 60% of hospitals perform less than five procedures per year. “There is a problem in my mind,” Böckler commented. Benchmarking the country, Böckler noted that Germany is the third ranked country with the most hospital beds, and second after the USA in terms of money spent on the healthcare system. In the Heidelberg catchment area, 72 hospitals offer round-the-clock

aortic surgery on their website. “I do not believe that,” remarked Böckler, adding that in London, there are just six or seven specialised vascular centres.

volume, not only in AAA care but also in fenestrated and very complex aortic procedures,” he added. 6. Centralisation will impact emergency management. “In terms of ruptured AAA Ten reasons for centralisation (rAAA) we have data showing that in a After outlining the situation in Germany, low-volume, low-bed capacity, you have Böckler detailed 10 reasons why aortic higher mortality and a higher turndown surgery should be centralised: rate, meaning you do not treat as many 1. The prevalence and incidence of AAA patients, even those who may be treated by is falling in both men and women, largely endovascular means,” Böckler detailed. due to smoking cessation, which is leading Dittmar Böckler 7. Centralisation leads to specialisation to a change in epidemiology. and that will influence outcome. 2. There is a “huge diversity” of aortic pathologies Considering data related to speciality and mortality, and treatment modalities in open surgery, requiring Böckler pointed out that general surgeons have a 50% complication prevention and management. Böckler morality at 30 days treating rAAA compared to 33% for stressed, for example, that there needs to be one to two vascular surgeons. aortic specialists on call 24/7 and the availability of an 8. There is a correlation between infrastructure and intensive care unit (ICU) 24 hours a day. outcome, “which is mainly better in bigger hospitals,” 3. There is a correlation between caseload and Böckler remarked. He then noted that larger hospitals are outcome. Böckler detailed European Society for Vascular more likely to have a hybrid operating room (OR), for Surgery (ESVS) clinical practice guidelines on the example, which he sees as crucial for EVAR surgery. management of abdominal aorto-iliac artery aneurysms, 9. Centralisation will help to improve the education which recommended that AAA repair should only be of the next generation of surgeons. “We need experience considered in centres with a minimum caseload of 30 and therefore volume in order to educate and train,” said repairs and should not be performed in centres with a Böckler. yearly caseload of less than 20. 10. Hospital volume correlates with costs of inpatient 4. There is a correlation between surgeon volume and surgery. In general, lower volume hospitals have higher outcome. Böckler outlined a study by James T McPhee costs for inpatient surgery and you have a higher 30-day (Boston Medical Center, Boston, USA) et al, published readmission rate, which in turn costs money. “You save in the Journal of Vascular Surgery in 2010, which some money for the system if you treat patients in large analysed 5,972 open repair cases and 8,121 endovascular volume hospitals,” Böckler concluded. aneurysm repair (EVAR) cases. Mortality was 8.7% Böckler concluded: “Firstly, there is a strong relation with low-volume surgeons, 4.8% with medium-volume between hospital volume, infrastructure, and quality. surgeons, and 3.3% with high-volume surgeons (p=0.02). Secondly, mortality is influenced by many factors, such 5. Hospital volume influences the method of treatment. as operator caseload, protocols, experience, and finally, Böckler presented a graph showing that in a low-hospital complex aortic especially really is cost-effective only if volume you are less likely to adapt endovascular you do it with high caseload. Patient outcomes, safety, treatment options, whereas higher volume institutions cost control, education, and the management/changing offer more endovascular treatment, even in emergency. framework of the healthcare system depends on the “Success and quality really depends on experience and centralisation of aortic surgery.”

SVS and STS release new reporting standards for type B aortic dissections

The Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) are releasing new reporting standards to ensure patients with type B aortic dissections (TBAD) receive appropriate treatment and care.

he care of patients with type B dissections has evolved over time and now includes medical, surgical and endovascular therapies. This is often in a multidisciplinary environment, and performed by several specialties, including vascular surgery, cardiothoracic surgery, interventional radiology and cardiology. However, TBAD remains a lifethreatening problem whose treatment has been confused by differences in nomenclature and terminology. This combined effort by the SVS and STS provides a consensus on reporting, nomenclature and classification of TBAD and was led by Joseph Lombardi of SVS and Chad Hughes of STS. “The new reporting standards represent the culmination of more than a year-long effort by a writing team consisting of subject matter experts from the SVS and STS,” said Hughes. “The multidisciplinary input from both

vascular and cardiothoracic surgeons is unique and has resulted in a document that will define proper reporting for this complex topic. Uniform reporting will allow standardised comparisons across series between different institutions worldwide with the goal being data that will best inform outcomes and guide best practices going forward.” Acute aortic dissection is the most common emergency affecting the aorta, with high mortality and morbidity rates without appropriate and timely care. “With the recent blanket US Food and Drug Administration (FDA) approval of endovascular stent grafting for type B aortic dissection, as well as our maturing understanding of the anatomy and pathophysiology of the disease, there has been an explosion of literature in multiple specialty journals regarding TBAD presentation, treatment and outcomes,” Lombardi said. “The purpose of this document is to provide

structure to the reporting of TBAD, with particular attention to those attributes of TBAD which, based on the best available evidence to date, would appear to impact outcomes.” The SVS/STS Reporting Standards introduce a new classification system with several new and easy-to-use features created by combining previous classification systems with the wellknown anatomic zones of the aorta. “The new classification system provides an easy way to be descriptive of patients’ anatomy using language that is relevant

The purpose of this document is to provide structure to the reporting of TBAD.”

to the way we currently treat patients,” said Lombardi. Another important area described is the need for a clear and consistent definition of chronicity of aortic dissections. The new standards also provide definitions of “uncomplicated” and “complicated” dissections and includes a new “high risk” category of dissections that is defined by the presence of specific ominous clinical and radiographic features when a patient presents with a TBAD. These reporting standards also provide definitions of the common complications of dissections and how they should be described and reported. “The document addresses limitations of the current literature by bringing consistency to all aspects of type B dissection reporting such as definitions of dissection chronicity, complicated versus uncomplicated versus highrisk dissection status, classification of dissections involving the aortic arch which are not well described using the current Stanford and DeBakey systems, as well as a uniform definition of ‘aortic remodelling,’ among others,” said Hughes. These are just some of the new features that will make these SVS/STS Reporting Standards an essential tool by providing a common language around dissections for clinicians, investigators, industry partners and regulatory agencies, SVS and STS representatives said.

Charing Cross Special Edition | March 2020

New technologies

New developments in intraoperative navigation show “revolutionary” potential The early months of 2020 have seen the emergence of new developments in the intraoperative navigation space. Vascular News considers two such developments— Philips’ Fiber Optic RealShape (FORS) technology and Centerline Biomedical’s IntraOperative Positioning System (IOPS)—data on which have been presented at various meetings in recent months.

FORS technology “will reduce X-ray doses and contrast volume”

At the 2020 Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany) and, more recently, Critical Issues America (7–8 February, Coral Gables, USA), Tilo Kölbel (University Medical Center Hamburg, Hamburg, USA) spoke about how the recently-launched FORS technology enables 3D navigation using laser light in complex aortic repair. At Critical Issues America, Kölbel began his presentation on FORS technology by comparing its introduction in 2020 to the establishment of colour TV in 1958. He detailed that the new technology, which has received CE mark—is composed of two catheters and a hydrophilic guidewire, adding that “embedded optical fibre enables real-time 3D [three dimensional] visualisation of the full shape of devices inside the body without the need for fluoroscopy”. Kölbel concluded that FORS technology allows 3D navigation by visualising catheters and guidewires in full shape 3D using laser light, adding that there is a high potential for reduction of radiation and workflow improvement by intuitive virtual biplane visualisation. “Revolutionary new tools are on the horizon,” he informed delegates. At this year’s Controversies and Updates in Vascular Surgery annual meeting (CACVS; 22–25 January, Paris, France), Joost van Herwaarden (UMC Utrecht, Utrecht, the Netherlands) discussed the benefits of FORS technology to reduce contrast volume and X-ray dose. Van Herwaarden began by outlining the disadvantages of X-ray navigation, noting in particular the poor quality of the greyscale images produced by 2D navigation. He then mentioned that with FORS, it is now possible to show guidewires in 3D and in distinctive colour using light instead of X-ray. Comparing the current “gold standard” of 2D imaging to imaging with FORS, van Herwaarden reported cannulation times of 45 minutes with the former and 2 minutes 20 seconds, respectively. Coresponding fluoroscopy times were 5 minutes 45 seconds with 2D imaging compared to no time at all with FORS. Van Herwaarden then announced clinical results of a first-in-human study. He outlined that the objective was to assess the feasibility of using FORS technology in endovascular aortic and peripheral procedures. Consecutive patients scheduled for standard or complex (fenestrated/branched) endovascular aneurysm repair (EVAR) or for iliac or superficial femoral artery (SFA) percutaneous transluminal angioplasty (PTA) were included between July and December 2018. In all, 21 patients were assessed: 14 endovascular aortic repairs and eight peripheral endovascular procedures. A total of 66 navigation tasks were set, including passing stenotic lesions and the catheterisation of contralateral limb or target vessels. Sixty of these tasks were completed successfully using a FORS catheter and/or FORS guidewire, representing 91% of the target. Five tasks could not be completed successfully with FORS because different catheter shapes were needed, and one task, a recanalisation, failed. Van Herwaarden concluded that FORS appears

to be a “promising new technology”, making navigation possible without fluoroscopy. “It is very likely that use of FORS will reduce X-ray doses and contrast volume,” he added. Looking to the future, van Herwaarden noted that expansion of the FORS platform and further clinical trials are needed to prove the benefits.

IOPS: “A way to leverage the capabilities of AR and AI” Another emerging technology is Centerline Biomedical’s advanced surgical navigation system known as IOPS. The company’s IOPS platform is a navigation system for minimally invasive surgery, leveraging anatomical mapping and electromagnetic

There is a high potential for reduction of radiation and workflow improvement.” tracking to provide 3D colour visualisation and realtime guidance during endovascular interventions with minimal need for fluoroscopy. During the panel discussion following Kölbel’s FORS presentation at this year’s Critical Issues America meeting, Mark Farber (University of North Carolina, Chapel Hill, USA) spoke about the benefits of IOPS, noting in particular that IOPS is “a separate unit that can work with pretty much any imaging system—Philips, GE, Siemens”. The first IOPS product from Centerline, recently granted US Food and Drug Administration (FDA) 510(k) clearance, allows doctors to navigate catheters and guidewires through complex anatomy with highly intuitive and safe imaging. The pipeline advancement technologies, still in preliminary stages of growth, are intended to develop the technology to the next generation, with augmented reality (AR) visualisation

and software assistance in guidance. According to a press release from Centerline, IOPS technology represents a “revolutionary step forward” and it is hoped that it will provide a way to leverage the maturing capabilities of AR and artificial intelligence (AI). As the IOPS data platform grows, AI may be able to provide further navigational aids based on prior surgical experience. By simplifying complex procedures and making them faster, safer, and more accurate, Centerline hopes to decrease costs while improving access to care. At VEITHsymposium 2019 (19–23 November, New York, USA), Matthew Eagleton (Massachusetts General Hospital, Boston, USA) announced first-inhuman use of IOPS and speake in detail about the technology on behalf of Centerline. Eagleton described how Ezequiel Parodi (University of North Carolina, Chapel Hill, USA) joined staff at the Clinical Centre of Serbia Vascular Centre in repairing two patients’ aortic aneurysms. Attending surgeon Igor Končar (University of Belgrade, Belgrade, Serbia) noted that IOPS enabled manipulation of guidewires and catheters without the need for active radiation, commenting, “Using IOPS I released the fluoroscopy pedal and felt a sense of calm which I never had before, because for the first time I was navigating without hearing the pumps and sounds of the fluoro system.” Končar was also able to identify a possible new use for the system. “We cannulated the AAA [abdominal aortic

aneurysm] contralateral limb on the first attempt with IOPS.” Both patients are doing well and the surgeons are pleased with the system, he noted. At the Vascular and Interventional Advances 2019 meeting early that month (VIVA; 2–7 November, Las Vegas, USA), Centerline was one of 11 companies selected to present during sessions on disruptive technology for endovascular therapy. Company chief technology officer Vikash Goel presented the IOPS technology to an audience of vascular surgeons, interventional radiologists, other clinicians, representatives from the endovascular device industry, and regulators. In the presentation, Goel shared information about the first product, recently cleared by the FDA and preparing for market launch, and discussed results in testing pipeline technologies which leverage augmented reality for next-generation guidance. Goel was joined at the conference by the other lead inventor of IOPS, Karl West, who currently serves as director of medical device solutions at Cleveland Clinic (Ohio, USA), as well as Centerline’s new CEO Phil Rackliffe, who brings significant experience in global healthcare product launches. The company is presently preparing for a market launch this year, while continuing to develop and expand the technology platform and pursue European market clearance.

Charing Cross Special Edition | March 2020

Interview

A year in profiles The last year of Vascular News profile features have seen pioneering and influential leaders of the vascular and endovascular fields share some of their most important lessons and advice based on long, notable careers. This overview of their individual in-depth interviews is an annual look back at their insights and experiences.

Kim Hodgson KIM HODGSON, PRESIDENT of the Society for Vascular Surgery (SVS) 2019–2020, spoke to Vascular News when he was president-elect of the society. In this interview, Hodgson discusses his career and research interests, how he came to be involved in the SVS, and what his goals are for the coming year. “My interests have always tended towards the biological sciences so my pursuit of medical training following college just seemed like a natural evolution. After briefly flirting with psychiatry, it was surgery that captured my attention, and once in residency, vascular surgery that provided me with the right mix of technical challenges and opportunities for intellectual growth,” Hodgson revealed. Hodgson went on to describe how his entry into the SVS was his endovascular skillset, “a relative rarity” among vascular surgeons at the time, afforded to him by working in a smaller institution without the “rigid specialty politics typically present in the more storied programmes”. He elaborated: “There was great opposition from the

leaders of vascular surgery at that time to incorporating endovascular training into vascular surgery fellowship programmes, but the need to do so was recognised by some—as was my ability to contribute in that way.” Over the next few years, Hodgson hopes to see a number of new advances and developments in the field of vascular surgery. In particular, “we need to reach clarity about the proper role of endovascular and open surgical revascularisations in an accountable care world. Clearly an endovascularfirst approach for all is wasteful, if not harmful, to patients with severe disease, surgical options, and a reasonable life expectancy,” he explained.

After briefly flirting with psychiatry, it was surgery that captured my attention.”

Alan Lumsden ALAN LUMSDEN IS chair of the Department of Cardiovascular Surgery and medical director at the Houston Methodist DeBakey Heart and Vascular Center in Houston, USA. He spoke to Vascular News about his current research interests and the three rules of endovascular surgery: imaging, imaging, and more imaging. Early on in his career, Lumsden was “fascinated with trauma”. During his first night on call at Grady Memoral Hospital in Atlanta, USA, he recalls that two people came in shot. “I was thinking, Oh my goodness have I made a big mistake! But you get used to it, and it is the best of training for a young surgeon. The greatest challenges were the major vascular injuries. At that time, I wanted to be a trauma surgeon and that was the reason I did a vascular fellowship. But after you have been doing trauma for five years in residency, you realise that is going to be a tough lifestyle, and I became fascinated by the vascular surgery,” Lumsden explained. Considering the most significant ways he has seen the vascular field develop over the course of his career, Lumsden remarked that the “main

change is in introducing imaging into our operating environment and bringing in the devices,” adding that he considers the “first, second and third rules of endovascular surgery to be “imaging, imaging and more imaging.” Lumsden commented that his current areas of research and work are about integrating imaging into our operative environment. It is also focused on transcranial Doppler—“This is the only tool which allows us to real time see what is happening in the head as we work downstream,” he told Vascular News. In response to a question about what he considers to be the biggest challenges currently facing vascular surgeons and specialists, Lumsden replied: “Easy: preventing loss of open surgical skills. I ran one of the first endografting courses in Atlanta, USA, and now I am running an open aortic training course in Houston. This is going to be a problem.” Lumsden ended his interview by telling readers how he likes to spend time outside of work: “Kayak fishing and cycling with my partner Merrilee. We both love the outdoors.”

March 2020 | Charing Cross Special Edition

Interview

Ian Loftus PAST-PRESIDENT OF THE Vascular Society of Great Britain and Ireland (VSGBI), Ian Loftus spoke to Vascular News about various aspects of his professional life and gave his perspective on the biggest challenges currently facing vascular surgery. Looking back on his time as president of the VSGBI, Loftus noted the good and the bad. “On a positive note, I am very proud of a Quality Improvement Programme for patients with lower limb ischaemia. The Audit and Quality Improvement Committee of the Vascular Society under the auspices of Jonathon Boyle has produced an ambitious care pathway and timelines for the management of patients, especially for critical ischaemia, which is now the focus of a national Quality Improvement Programme. We are appointing two research fellows to assess the impact on outcomes across the country, jointly funded by the Circulation Foundation and the Royal College of Surgeons of England. However, much of his period as president was “consumed with dealing with the controversies surrounding the draft NICE guidelines for the management of patients with aortic aneurysms, put out for a period of consultation in 2018.” He posited:

“Until this is resolved to a satisfactory conclusion, it will be difficult to feel I have achieved enough. I, and the current Council of the Society, feel it is vital to the future of vascular services in the UK to have a more balanced approach to aortic aneurysm repair than the guidelines in their draft form would allow, incorporating patient choice and a personalised approach to treatment.” Loftus also details what what are the biggest challenges currently facing vascular surgery: “Demonstrating that what we do is clinically- and costeffective in the long term. As practice has shifted more to the endovascular approach, so we rely on technology to match our ambition. We have seen problems with the adoption and late failure of some of these technologies, and the draft NICE guidelines have challenged the cost effectiveness of endovascular aneurysm repair more broadly. Other therapies may suffer the same fate.” He continued: “We have to strive to demonstrate that what we do is always in the best interests of the patient, but also be conscious of the financial restraints of a tax-based healthcare system in the UK. We must also overcome the interdisciplinary frictions and anxieties that surround the endovascular work.”

Ronald Dalman

The societal and financial trends driving the volume-to-value transition are an undeniable and relentless catalyst for change.”

PRESIDENT OF THE Society for Vascular Surgery, Ronald Dalman, spoke to Vascular News about various aspects of his career. He also considered future development in the field and offered advice to aspiring surgeons. Vascular News spoke to Dalman when he was president-elect of the SVS. Commenting on the role of the SVS and what he hopes to achieve as president, Dalman remarked: “In survey after survey, our members convey pride in the care they provide to some of most vulnerable members of our society, while at the same time expressing frustration at the lack of recognition that vascular surgeons receive for the essential role(s) they play in the healthcare system. As a corollary to Michel Makaroun’s access to care focus in 2019, the SVS launched a multi-pronged effort to accurately value and brand the essential services vascular surgeons provide to our society. Both my immediate predecessor Kim Hodgson and I are building off these efforts to ensure that quality vascular care is appropriately recognised and rewarded by the public and our many partners in healthcare financing and delivery.” Anticipating how the field of vascular surgery might change in the next decade, Dalman noted: “The societal and financial trends driving the volume to value transition are an undeniable and relentless catalyst for change. We will almost certainly see an ever-increasing

emphasis on quality and cost-effective outcomes with a framework of population-health considerations.” Finally, for anyone starting their career in vascular surgery, Dalman had some advice: “First, know yourself— develop your own career path, be the surgeon/investigator/partner/mentor you want to be, not who you think others want you to be. Secondly, strive to understand what is expected of you in all circumstances. Thirdly, collaborate aggressively and ambitiously across disciplines—for myself, the strongest and most powerful collaborations arose from individuals and groups far afield from my department and school. Finally, own the problem—we in our specialty are uniquely privileged to provide full spectrum care for an increasingly common, morbid, and highly expensive spectrum of disease. As emphasised on the #comprehensivevascularcare Twitter thread, our future depends in the breath of our expertise and ability—not mere technicians, diagnosticians, risk-factor experts or public health advocates, but rather all of that, and more: vascular surgeon specialists. Our value is, and should remain, as experts of the disease process we have worked so hard to understand. That expertisde provides our patients the ever-improving quality of life they have gained under our care and the success and influence our specialty enjoys today.”

Charing Cross Special Edition | March 2020

Endovascular aortic surgery

Preliminary experience with LSA branched devices shows promising results Preliminary experience with left subclavian artery (LSA) branched devices indicates low morbidity and stroke rates with high patency rates. This was the conclusion of Gustavo Oderich (Mayo Clinic, Rochester, USA) at this year’s Controversies and Updates in Vascular Surgery annual meeting (CACVS; 22–25 January, Paris, France).

derich elaborated that thoracic endovascular aortic repair (TEVAR) without extension into Zone 2, and LSA coverage, is needed in up to 34–60% of patients. Furthermore, LSA coverage without revascularisation has been associated with higher rates of arm ischaemia and stroke, and with higher rates of spinal cord injury in patients with thoracoabdominal aortic aneurysms. The morbidity of carotid-LSA bypass is higher than previously reported, with a particularly high rate of phrenic nerve injury (25%). Considering TEVAR with or without LSA revascularisation, Oderich detailed a paper by Rhiannon Bradshaw (East Virginia Medical School, Norfolk, USA) et al, which appeared in the Journal of Vascular Surgery in 2017. This reported that out of 96 patients undergoing Zone 2 TEVAR (42 without [44%] and 54 with [56%]), stroke occurred in 1.9% of patients undergoing

revascularisation compared to 14.3% of patients undergoing LSA coverage. The respective figures for mortality were 11% and 14%. Oderich then detailed thoracic aortic disease guidelines, noting in particular a Society for Vascular Surgery (SVS) systematic review, which found that that LSA coverage increases the risk of arm ischaemia, vertebrobasilar ischaemia, and possibly spinal cord ischaemia (SCI) and anterior circulation stroke. European practice guidelines state that LSA revascularisation should be considered

in patients at risk for neurological injury undergoing TEVAR. Exploring the risk of endovascular thoracoabdominal aortic aneurysm (eTAAA) repair, with intentional occlusion of hypogastric and vertebral arteries, Oderich referenced a paper by Matthew J Eagleton (Massachusetts General Hospital, Boston, USA) et al, published in the Journal of Vascular Surgery, which found that occlusions of one single collateral bad (hypogastric or vertebral) were associated with significantly higher rates

The morbidity of carotidLSA bypass is higher than previously reported, with a particularly high rate of phrenic nerve injury (25%).”

Transabdominal open AAA repair shows higher rate of late reintervention than retroperitoneal approach Repair-related reinterventions and readmissions are lower after retroperitoneal compared with transabdominal open abdominal aortic aneurysm (AAA) repair, according to a large multicentre retrospective review published in the January edition of the Journal of Vascular Surgery. FOR THOSE PATIENTS undergoing open surgical repair of AAA, the decision as to how to approach the aneurysm surgically is multifactorial. Familiarity with the approach, access to intra-abdominal organs, and the right iliac system, favours the transabdominal approach. Conversely, avoidance of a hostile abdomen, access to the visceral aorta and potential early return of bowel function favors the retroperitoneal approach. “There is very limited data with regards to comparing these approaches long-term,” said first author Sarah Deery (Massachusetts General Hospital, Boston, USA). “Our aim in this study was to evaluate late mortality, readmissions and reinterventions, including aneurysm-related reinterventions, for both approaches, thus allowing surgeons and patients to consider these factors in their decision-making.” A multicentre team led by Marc Schermerhorn (Beth

Israel Deaconess Medical Center, Boston, USA) used prospectively collected data from the Vascular Quality Initiative (VQI) linked to Medicare data to compare the two approaches. VQI, a joint venture of M2S Inc and the Society for Vascular Surgery (SVS), collects and analyses data to improve the quality of vascular care. Researchers evaluated 1,282 patients whose operation was performed between 2003 and 2015. The transabdominal approach was utilised in 914 patients (71%) versus the retroperitoneal approach in 368 patients (29%). Baseline characteristics between the two groups were similar except: ❏ Transabdominal procedures had more concomitant iliac artery aneurysms (28% vs. 17%). ❏ Retroperitoneal procedures had higher rates of suprarenal clamping (61% vs. 36%).

of immediate SCI post-fenestrated or branched EVAR (F/BEVAR) and with lack of recovery. Oderich then considered morbidity of carotid-LSA bypass by mentioning a paper by Soraya L Voigt (Duke University Medical Center, Durham, USA), from the Journal of Vascular Surgery in 2019. This paper referenced a study that included 112 patients treated at a single centre. Early complications occurred in 29% of patients and primary patency was 97% at five years. In terms of the Mayo Clinic experience with the LSA Gore TBE, the centre enrolled ten patients in either a prospective feasibility or pivotal study. They reported no neurological events, no type Ia or III endoleaks, no reinterventions, no LSA occlusions, and the median follow-up was two and a half years. Finally, Oderich mentioned the Medtronic Valiant MONA LSA feasibility study. He detailed that in this study, 32 patients were enrolled: 22 degenerative TAAs, four PAUs, and six chronic post-dissection TAAs. Preliminary results of the feasibility study, presented by Frank Arco (Sanger Heart and Vascular Institute, Charlotte, USA) at VEITHsymposium 2019 (19–23 November, New York, USA) showed no perioperative strokes and 100% patency of the LSA branch. Gustavo Oderich

Early 30-day mortality was equivalent for both approaches (4.7% for transabdominal, 3.8% for retroperitoneal). Other postoperative complications, such as bowel ischaemia, renal complications, wound complications and reoperation occurred at similar rates. Long-term (five-year) outcomes included: ❏ Similar rates of survival (62% for transabdominal, 61% for retroperitoneal). ❏ Repair-related reintervention and readmission were significantly higher for transabdominal (42% vs. 34%). ❏ Abdominal wall reoperations were significantly higher for transabdominal (13% vs. 6%). “Even after adjustment for sex, age, symptom status, and anatomic differences, the transabdominal approach was associated with a 40% higher rate of late reintervention and readmission (hazard ratio, 1.4, 95% CI 1.1–1.7),” said Deery. “Given changes in open training across vascular surgery, some surgeons may have especially limited exposure to the retroperitoneal approach to AAA repair compared with the transabdominal approach. Ultimately, surgeons will likely achieve better outcomes using the approach they are most comfortable with which may mean performing a transabdominal repair.” As noted, many factors go into choosing the right approach for open AAA repair. This important and large series provides new, long-term data that enhances a professional’s decision-making, the authors said.

There are very limited data with regards to comparing these approaches long-term.”

March 2020 | Charing Cross Special Edition

Long-term exercise may lead to aortic enlargement and remodelling Vascular remodelling may occur in response to sustained, regular exercise, suggests a study of aortic dilatation among long-term endurance athletes. Timothy W Churchill (Massachusetts General Hospital, Boston, USA) et al found a “marked increase in the prevalence of aortic dilatation based on established population nomograms. This finding was consistent between men and women, and across athletes participating in two of the most common endurance sports [running and rowing]”. The elevated prevalence was found without clear explanatory risk factors. WRITING IN JAMA CARDIOLOGY, Churchill and colleagues say: “It appears that the aorta is an exerciseresponsive plastic organ that remodels in the setting of long-term exercise. Further longitudinal study will be required to establish definitive clinical correlates of these findings.” The study aimed to assess the prevalence of aortic dilatation among long-term masters-level male and female athletes with about two decades of exercise exposure. Before the present cross-sectional study, the distribution of aortic sizes in veteran endurance

Journal coverage athletes was unknown, as was whether it represents aortic adaptation to long-term exercise, similar to that of ventricular remodelling. Researchers evaluated aortic size in masters-level rowers and runners aged 50–75 years enrolled from competitive athletic events across the USA between February and October 2018. The primary outcome was aortic size at the sinuses of Valsalva and the ascending aorta, measured using transthoracic echocardiography. Aortic dimensions were compared with age, sex, and body size-adjusted predictions from published nomograms, and z scores were calculated where applicable. Among 442 athletes (mean age 61 years, standard deviation [SD] 6; 267 men [60%]; 228 rowers [52%], 214 runners [48%]), clinically relevant aortic dilatation, defined by a diameter at sinuses of Valsalva or ascending aorta of ≥40mm, was found in 21% (n=94) of all participants (83 men [31%] and 11 women [6%]). The authors say it represents “a marked increase in the prevalence of aortic dilatation compared with that predicted by established age- and sex-specific population nomograms [all p<0.001]”. Overall, 105 individuals (24%) had at least one z score of 2 or more, indicating an aortic measurement greater than two SDs above the population mean. In multivariate models adjusting for age, sex, body size, hypertension, and statin use, both elite competitor status (rowing participation in world championships or Olympics or marathon time under two hours and 45 minutes) and sport type (rowing) were independently associated with aortic size. The study team say that the findings have “potentially important clinical implications”, and “fill an important gap in our understanding of how long-term participation in endurance sport affects the cardiovascular system”. They speculate that mild to moderate dilatation of the ascending aorta among long-term exercisers may “represent a previously unrecognised and benign

adaptation to sport, similar to exercise-induced eccentric left ventricular (LV) hypertrophy”. An alternative hypothesis is that “aortic dilatation in the setting of long-term endurance training may represent a novel form of acquired overuse pathology with attendant implications on morbidity and mortality”. Because the study excluded athletes with bicuspid aortic valves, to maximally isolate the effect of longterm exercise, the authors suggest that the findings may be “conservative estimates for the overall population of masters-level athletes”. But, as experienced well-trained athletes participating in two common endurance sports were assessed, Churchill et al caution that the findings may not be generalisable to more recreational exercisers, and to athletes participating in other endurance disciplines. Other limitations are that the study was cross-sectional and thus “can neither establish causality between exercise and aortic dilatation nor permit conclusions about the natural history and clinical risk profile of aortic dilatation among long-term competitive athletes”. In addition, exercise exposure measures did not include data defining exercise training intensity and blood pressure response to exercise, “both of which may represent mechanistic underpinnings of our findings”, say the researchers. And, because those taking echocardiographic measurements were not blinded to the sport status of participants, bias may have been introduced. “Future studies aimed at defining the natural history of aortic dilatation in this population with an emphasis on clinical outcomes, including the incidence of acute aortic syndromes and elective aortic surgical intervention, will be required to resolve this fundamental uncertainty,” conclude the investigators. “In the absence of such data, clinical implications of our findings remain uncertain and will require individualised assessment.”

March 2020 | Charing Cross Special Edition

FDA grants de novo clearance to Bluegrass Vascular for Surfacer system

Bluegrass Vascular Technologies (Bluegrass Vascular) has announced that the US Food and Drug Administration (FDA) has granted a de novo classification order for its Surfacer Inside-Out access catheter system. The Surfacer system is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. WavelinQ (BD)

LINC 2020: Positive new data for AV access interventions released New arteriovenous (AV) access results were presented at the 2020 Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany), including data on percutaneous AV fistula creation and also the use of drug-coated balloons (DCBs) in AV access interventions. While Robert Jones (University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK) opened the session by revealing a high functional patency for endoAVF at six months, Andrew Holden (Auckland University School of Medicine, Auckland, New Zealand) revealed a sustained patency advantage for a DCB compared to percutaneous transluminal angioplasty (PTA).

EndoAVF shows high functional patency at six months

Jones opened the session by presenting initial multicentre experience results of the WavelinQ catheter. Concluding that “AV is now endovascular,” results of an EU and Canada post-market study showed 95% functional patency at six months as well as a limited need for secondary procedures. “This is the first time that this additional data on the multicentre WavelinQ study has been seen,” Jones began. Endovascular AV fistula (endoAVF) devices—created with the intention of improving fistula outcomes—have performed well in clinical studies. “There are high rates of technical success in terms of creation, higher rates of maturation and patency and low rates of complications. But we have got to bear in mind that these closely monitored clinical trials are not the real world,” Jones commented. At the University Hospitals Birmingham NHS Foundation Trust Jones and colleagues carried out a matched comparison of WavelinQ fistulas with surgical fistulas. They had 30 in the WavelinQ arm and 40 in

the surgical arm. Patency results showed that WavelinQ fistulas outperformed those created surgically. In terms of the post-market study, this was intended to collect data on WavelinQ cathether performance and outcomes in a prospective, multicentre, international study, which recruited 100 patients across 13 sites in

We have got a 95% functional patency at six months with a limited need for secondary interventions.” the EU and Canada. Jones remarked: “The post-market study forms part of a wider programme of clinical trials looking at the WavelinQ device, most of which have already either completed or been published”. Continued on page 34

“THE SURFACER SYSTEM offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites,” stated Mahmood Razavi, interventional radiologist at St. Joseph Hospital in Orange, USA and lead principal investigator of the SAVE-US (Surfacer system to facilitate access in venous Occlusions—United States) IDE study. “This is an unmet clinical need for patients who require life-saving therapies, such as dialysis, and who have limited options due to venous obstructions.” The Surfacer system is the first FDA cleared medical device to facilitate upper body central venous access in patients with venous obstructions or other conditions that preclude access by conventional methods. Approval is based on the results of the SAVE-US trial. Of the thirty enrolled patients, 90% met both the primary and secondary efficacy endpoints despite a complex patient population comprised largely of Type 3 and 4 obstructions (three or more obstructed vessels). No device related adverse events were reported, confirming the safety and performance of the Surfacer system. “Thoracic central venous obstruction (TCVO) is a costly problem associated with increased patient morbidity and reduced quality of life,” stated Bart Dolmatch, interventional radiologist at The Palo Alto Medical Foundation (Palo Alto, USA). “We have recently published reporting standards that create a common language for understanding and describing signs, symptoms, functional impairment, and anatomy of TCVO. BVT incorporated elements of these reporting standards into the SAVE-US trial, demonstrating the clinical impact of the Surfacer system. Now that it has been FDA cleared, the Surfacer will be part of the treatment algorithm for my patients with TCVO.” While permanent arteriovenous fistulas are the preferred form of vascular access for haemodialysis patients, central venous catheters continue to serve as an important bridge to securing long-term access for life-saving haemodialysis treatment.

Charing Cross Special Edition | March 2020

LINC 2020: Positive new data for AV access interventions released Continued from page 33

Looking to the future, Jones informed the LINC audience that there are two other studies that are being lined up—a prospective, multicentre study in the USA, which aims to recruit 250 patients and a global study looking at another 100 patients. “Hopefully both of these will be rolled out in 2020,” Jones added. Jones concluded: “In summary, this is the first time that this post-market data is being seen. We have got 95% functional patency at six months with a limited need for secondary interventions.”

DCB shows sustained patency advantage over PTA

Subsequently, Holden presented 12-month outcomes of the IN.PACT AV access study, showing a 63.8% target lesion primary patency in the DCB arm compared to 43.6% in the PTA arm, with no difference in mortality. The AV access investigational device exemption (IDE) trial was designed to evaluate safety and effectiveness of the IN.PACT AV DCB compared to PTA for de novo or restenotic obstructive lesions of native AV fistulae in the upper limbs. This was performed in the USA, in Japan and in New Zealand. A total of 330 patients were randomised 1:1. The primary safety endpoint was serious adverse event rate within 30 days and primary effectiveness endpoint was

target lesion primary patency through six months, which is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or access circuit thrombosis measured to six months post-procedure. It was revealed last year that IN.PACT AV access was the first DCB versus angioplasty trial to meet its primary effectiveness endpoint—a “highly impressive” primary patency of 82.2% at six months compared to 59.5% with PTA with high statistical significance and also a significant advantage in terms of freedom from CD-TLR. “I am delighted to share, for the first time, the 12-month primary effectiveness endpoint. Again, a highly significant difference in target lesion primary patency—63.8% in the DCB arm compared to 43.6% for the PTA arm,” Holden revealed, adding that “there was

For the first time we have seen sustained patency advantage for a DCB over PTA.” also a highly significant difference in CD-TLR, at 35% for the DCB arm and 54.3% in the PTA arm”. Holden added that there was less than half the rate of access circuit thrombosis in the DCB arm. “This is such a severe and catastrophic complication that, even though it did not reach clinical significance, I think is worth mentioning”. In terms of safety at 12 months, the serious adverse event rate for the DCB arm was 46.9% compared to

Improved patient outcomes with DCBs in AV access may afford “substantive” savings

Based on 12-month outcomes of the IN.PACT AV access trial, improved patient outcomes are expected to lead to significant per patient and healthcare delivery savings out to three years followup. This was the conclusion of Robert Lookstein (The Mount Sinai Hospital, New York, USA) at this year’s Leipzig Interventional Course (LINC 2020; 28–31 January, Leipzig, Germany).

ookstein, co-principal investigator of the In.Pact AV access trial, was presenting results of an economic analysis of the use of the IN.PACT drug-coated balloon (DCB) versus plain balloon angioplasty in both the German and US healthcare systems. Data for the budget impact model was extrapolated from 12-month outcomes of the In.Pact AV access trial, presented for the first time by Andrew Holden (Auckland University School of Medicine, Auckland, New Zealand) at LINC 2020. The group of patients included in the economic analysis were assembled at the trial’s inception. “If we look at CMS [Centers for Medicare and Medicaid Services] data from as recently 2017, there are just under half a million patients in the USA and approximately 75,000 patients in Germany that are receiving haemodialysis,” Lookstein began, adding that the preferred method of receiving haemodialysis is through fistulas or grafts, particularly in the upper extremity. However, he noted, these interventions are “fraught with high rates of dysfunction and

requirement of procedures to maintain patency”. The IN.PACT AV DCB may address this, with 12-month In.Pact AV access outcomes demonstrating the safety and clinical benefit of the DCB compared to balloon angioplasty for dysfunctional native arteriovenous fistulas. Lookstein detailed that he and his colleagues’ approach to the economic analysis was a decision analytic markov model. “We captured the index procedure rates of reintervention and projected vascular access management cost based on not only the 12-month data, but also projected out to 36 months using reintervention as a constant hazard,” he elaborated. The group then compounded that—using the cost data referenced from the current 2020 fee schedules, based on the inpatient DRG (diagnosis related group) payment schemes for Germany, and on the facility and physician fee schedules in the USA. Reiterating the 12-month IN.PACT AV access data, Lookstein noted that the number of reinterventions required to maintain access circuit patency at 12-months was approximately 0.65 per

69.2% for the PTA group. In the DCB arm, 40.1% had lesion revascularisations compared to 62.4% in the PTA arm. Holden added that there is “absolutely no mortality signal between the two groups at 12 months,” detailing that freedom from all-cause mortality in DCB arm was 90.6% and in PTA arm was 90.4%. Holden summarised: “For the first time we have seen sustained patency advantage for a DCB over PTA using a combination of vessel preparation with a high-pressure balloon and DCB angioplasty with a target lesion primary patency of 63.8% for the DCB compared to 43.6% for PTA arm. Fewer interventions were required to maintain target lesion primary patency in the DCB arm compared to the PTA arm, and we also saw the incidence of access circuit thrombosis more than half— something I think is very important given the severity of that complication—and no difference in mortality out to 12 months.”

IN.PACT (Medtronic)

patient, whereas the figure for plain balloon angioplasty was 1.05. He added that this translated to an access circuit primary patency of 53.8% at 12-months in the DCB group, compared to 32.4% for the plain balloon angioplasty cohort. Lookstein detailed that, in the economic analysis, the group incorporated the fact that the mean number of DCBs used per procedure was 1.23, and also acknowledged a greater mortality rate for the end stage renal disease population. In terms of the fee schedule the group used, the figure is just over €3,000 for a plain balloon angioplasty in a dialysis

Medicare could potentially save US$400 million over three years as compared to standard of care.” access circuit, which increases slightly based on incremental reimbursement in the German healthcare system. For a reintervention, the cost is just over €3,400, taking into consideration a 10% incidence of stent placement or surgical reintervention. Looking at the US model, the figures are US$3,100 for plain balloon angioplasty, with no additional costs in the US health system for the use of DCBs. The cost of a reintervention is US$3,475, incorporating again a

10% incidence of stent placement or thrombectomy or surgical reintervention as observed in the In.Pact AV access trial. In the German healthcare system, the 12-month IN.PACT AV access data corresponded to a saving at at the six-month follow-up of over €1,000. At 36-months follow-up, the figure increases to €3,300 savings seen per patient. Based on the same modelling for the US healthcare delivery system, Lookstein and colleagues reported a US$1,300 saving at the 12-month time point and a US$3,500 saving at the 36-month timepoint. Lookstein noted that, based on the costs of DCBs in the USA, which is not currently reimbursed, “there is a cost-neutral, or break-even strategy at approximately the two-year timepoint”. Lookstein concluded: “Based on the 12-month IN.PACT AV access data, improved patient outcomes are expected to lead to substantive per patient and healthcare delivery savings out to three year follow-up, with the savings actually increasing as the analysis translates from 12 months out to 36 months. The reductions in reinterventions observed not only reduce patient morbidity but improve their quality of life.” Considering these results from a macro-economic perspective, Lookstein posited that these improved outcomes “should lead to healthcare savings for payers in these respective countries”. He elaborated: “If you look at 5,000 cases used annually with IN.PACT AV access in the German healthcare delivery system, in the inpatient setting, savings that could be realised amount to over €16 million at 36-month follow-up.”

Charing Cross Special Edition | March 2020

New Covera vascular covered stent data presented at LINC 2020 In the “New concepts for arteriovenous (AV)-shunt revascularisation and central vein stenosis” session at this year’s Leipzig Interventional Course (LINC 2020; 28–31 January, Leipzig, Germany), Bart Dolmatch (The Palo Alto Medical Foundation, Mountain View, USA) presented new data on the Covera vascular covered stent (BD). He first announced a 24-month update on the first-in-man AVeVA study for the treatment of venous anastomotic lesions in AV grafts, followed by 12-month results on the AVeNEW trial for outflow stenosis in AV fistula circuit. DOLMATCH BEGAN HIS first presentation, on the 24-month AVeVA results, by stating the objective of the study: to use the Covera stent to treat venous

anastomotic stenosis in AV grafts. He added that the study addresses the “Achilles’ heel” of an AV graft—the venous anastomosis. He described the study as a prospective, multicentre, non-randomised, single-arm investigation designed to assess the effectiveness of the Covera stent, using predictive goals based on those of other studies. The investigators enrolled 110 patients across 14 US study sites. The primary endpoints include safety at 30 days and efficacy at six months. “You can see that the predicted goal for safety was 88%, and this was more than exceeded with the 30-day endpoint for the AVeVA study, at 96.4%,” Dolmatch explained. At six-months, the predicted goal of patency for the target lesion was 40%; the actual result was almost 70%. Dolmatch showed a Kaplan-Meier plot demonstrating that the loss of target lesion primary patency was 54% at one year and 37% at two years. In terms of secondary outcomes, circuit patency— which at six months was 40% and at 12 months was 17%—was 8% at 24 months. Dolmatch described secondary patency out to 24 months as “excellent”: at six months, secondary patency was 92%, decreasing to 85% at one year, and then to 74% at 24 months. Dolmatch concluded: “In the AVeVA study, results exceeded predicted safety and efficacy goals at six months and, at 24 months, target lesion patency was 37%, and assisted circuit patency was 74%.” The presentation of the 24-month AVeVA results acted as a “segue” into the AVeNEW update, remarked

Dolmatch. “[AVeNEW] is really an exceptional trial, because it is assessing use of the Covera covered stent in a prospective, multicentre, randomised trial in AV fistulae,” which “has never been done to this size before and in this way”. Dolmatch noted that the objective of the AVeNEW trial is to compare the Bart Dolmatch Covera vascular covered stent to angioplasty for treating stenotic lesions in upper extremity arteriovenous fistulae. He added that the 280 patients who were enrolled in the study were randomised 1:1 to either balloon dilation or balloon dilation with Covera at the time of the procedure. Patients were enrolled across 24 international sites. In terms of freedom from a primary safety event— one of the primary endpoints—the investigators observed no difference between the covered stent group and the angioplasty group out to 30 days and six months. In summary, the first study of its type and size to prospectively compare outcomes using a covered stent versus angioplasty to treat AV fistulae stenosis showed superior target lesion and circuit patency for the covered stent out to 12 months.

Analysis of DCB use for treatment of central venous stenosis shows promising safety and efficacy According to the findings of a European multicentre retrospective analysis, the use of drug-coated balloons (DCBs) for the treatment of symptomatic central venous stenosis in dialysis patients is demonstrably safe. Presented at the Leipzig Interventional Course 2020 (LINC; 28–31 January, Leipzig, Germany), the investigation adds to a growing evidence-base for DCBs as a potential treatment for patients in dialysis access.

anagiotis Kitrou (University of Patras, Patras, Greece), discussing the retrospective analysis, began his talk by explaining how patients in dialysis access develop central venous stenosis. “It is mainly due to the current or prior use of foreign materials, especially left-sided subclavian central venous catheters, and of course because of the actual use of the access circuit for dialysis,” he said. In terms of the treatment options available for this condition, Kitrou underlined that percutaneous transluminal angioplasty (PTA) is the current gold standard, despite the fact that patency rates with this treatment can be as low as 29% at six months. However, as the speaker noted, this figure does seem to double—to about 60% patency at six months—with the use of a high-pressure balloon. “Stent placement, according to guidelines, can be used as a bailout option, but it is a much more aggressive treatment, with patency as low as 25% at one year,” Kitrou added. Shifting his focus to the existing evidence for DCB use, Kitrou cited the findings of a retrospective analysis performed in 2015 by Alexander Massmann (Saarland University Medical Center, Saar, Germany) et al, which enrolled 10 patients who were treated with DCBs. Although this study also included axillary veins, as well as central

venous stenosis, the outcome Policlinico Umberto I, Rome, measure of freedom from Italy; Hospital “S Eugenio”, target lesion revascularisation Rome, Italy; Ambroise Paré did show a significant University Hospital, Paris, difference in favour of DCB France; Lumiar Vascular use. Access Center, NephroCare, Kitrou also drew Portugal; St Franziskus attention to the randomised Hospital, Muenster, Germany; controlled trial that he and University Hospital of Panagiotis Kitrou his colleagues conducted in Muenster, Germany; and Bart’s 2017. Including de novo, restenotic and Health NHS Trust, London, UK. occluded lesions, and using the Lutonix Inclusion criteria for the analysis DCB as part in the investigation arm required patients to have an ipsilateral of the trial, a significant difference was arteriovenous fistula (AVF) or graft found in favour of DCB use, in terms (AVG), stenosed central vein (subclavian of the primary endpoint of a clinicallyvein, innominate vein, or superior vena assessed intervention-free period. While cava), and clinical signs of central venous these results show promise, Kitrou was stenosis, such as arm/neck swelling eager to assert that the evidence-base so or inadequate dialysis performance. far is fewer than 30 patients. “Outcome measures for this study were Commenting on his latest clinically assessing the interventioninvestigation, the presenter said: free period of the treated segment at six “This was a multicentre, single-arm months and procedure-related minor and retrospective analysis, evaluating the major complications,” Kitrou explained. outcomes of DCB use for the treatment Examining the findings, Kitrou of symptomatic central venous stenosis highlighted that the primary patency rate in arteriovenous dialysis access.” As part at six months was 62.7%, while the rate of the study, 87 patients were included, of access circuit survival was 87.7%. “I while 17 physicians from 11 participating think it is also very important to note that centres across Europe were also involved. the patient-survival rate at 24 months was These included Patras University 79.7%,” he emphasised. Hospital, Patras, Greece; Schön Klinik, Observational analysis did not show Düsseldorf, Germany; Institut Mutualiste any significant variation in terms of Montsouris, Paris, France; Attikon different lesion sizes, or whether the University Hospital, Athens, Greece; subclavian, brachiocephalic, or superior

vena cava were treated. However, it was found that the bigger the diameter of the balloon, the better the result. On this point, Kitrou commented: “These findings are even more significant if you look at diameter-assisted patency, with the curve analysis showing that 12mm balloons have more than 50% patency at two years. Kitrou concluded: “In this European, multicentre, retrospective analysis, DCB use in symptomatic central venous stenosis for dialysis access patients was safe. Furthermore, the figures are comparable to previous randomised controlled trials and the balloon size has a significant effect on patency rates.”

The figures are comparable to previous randomised controlled trials and the balloon size has a significant effect on patency rates.”

Charing Cross Special Edition | March 2020

Venous

Venous & Lymphatic Consensus

Venous and Lymphatic Consensus highlights at CX 2020

Towards Venous and Lymphatic Consensus in CX 2020 programme This year, the CX Symposium will focus on achieving venous and lymphatic consensus within the venous community, with more activities and exciting venous education than ever before. Across the four days of the Symposium (21–24 April 2020, London, UK), venous specialists will have the opportunity to attend a dedicated programme of sessions covering a wide array of topics.

he main Venous programme at CX 2020 will take place on Tuesday 21 April, and consists of discussions, debates and presentations on a number of issues— from interventions for superficial venous disease and lymphoedema, to complications in the deep veins and a special iWounds consensus.

Discussion and debate

Leading the conversation, a series of

venous specialists from around the world are set to take to the stage at the CX Symposium, all of whom will have the chance to discuss their ideas and latest research with an expert audience. In order to reach consensus, discussion between a world class faculty and expert audeince is crucial. One of the vital talks then, at CX 2020, will focus on the subject of whether the treatment of venous disease has become the “wild west”, and the implications of

inappropriate growth in superficial and deep venous interventions. Another crucial topic is the matter of pelvic venous disease and, as part of this year’s programme, a Podium 1st presentation will be delivered on the use of coils and foam to occlude pelvic vein incompetence.

Programme highlights

Shifting focus to the superficial venous field, the programme will address several contemporary issues making waves in the venous community. This session will include discussion of the 2020 European Society of Vascular Surgery (ESVS) guidelines for venous thrombosis, and their implications

Venous specialists will have the opportunity to attend a dedicated programme of sessions covering a range of topics.”

Venous Workshop and edited cases to cover latest technologies and techniques 22–23 April 2020 Venous City

Now in its 12th year, the Venous Workshop will once again be at the heart of the CX Symposium’s Venous City, offering attendees the chance to take part in one-to-one demonstrations by leading experts in the field. Since its inception, the Workshop has continued to grow, with more stations, techniques, and hands-on skills now accessible to those visiting Venous City. This year, the CX Venous Workshop is bigger and better than ever, consisting of multiple training stations devoted to diverse and cutting-edge aspects of phlebology. Taking place on Wednesday and Thursday, each day of the Workshop will take a different focus. On Wednesday 23 April, the theme will be “Superficial veins”, including demonstrations on aesthetic phlebology, sclerotherapy and compression techniques, as well as other

interactive sessions on new interventions and technologies, such as the use of cynoacrylate glue and methods of plethysmography. The focus shifts towards “Deep veins” on Thursday 24 April, with demonstrations planned for subject areas such as pelvic vein disorders, the use of vena cava filters and acute venous thrombosis, in addition to stations on intravascular ultrasound (IVUS) and stenting procedures. Once again, there is flexibility to the Venous Workshop at CX 2020, which is not a structured programme and allows attendees to get involved in the activities of any station they might be interested in, and for as long as they wish. Also running across the two days of the Venous Workshop, CX Venous Techniques and Technologies will highlight a series of edited cases, with presentations set to explore new methods of managing venous disease.

for superficial venous thrombosis, as well as a debate that is expected to shed light on whether non-thermal modalities will replace endothermal ablation in the treatment of superficial venous reflux. In the deep venous section of the programme, a Podium 1st talk will be given on results from the CLEARDVT study, while 12-month findings from the ABRE study are also set to be presented by Venous News editorin-chief Stephen Black (Guy’s and St Thomas’ NHS Foundation Trust, London, UK). Additionally, the audience at CX 2020 can expect to hear the final results of a study into highintensity focused ultrasound (HIFU) for varicose veins.

iWounds consensus

Wounds related to venous insufficiency will receive a spotlight at this year’s CX Symposium. In this session, speakers will try to reach a consensus on such matters as adjuvant wound therapies for intractable venous leg ulceration, and long-term outcomes from the EVRA trial; the latter will see Alun Davies, also editor-in-chief of Venous News, discuss the implications of this study for international practice.

Global speakers and abstract presentations in Venous City 22–23 April 2020 Venous City At CX 2020, Venous City will play host to a series of key presentations and talks from global speakers and “rising stars”, who will be in attendance to discuss their original research and underline new developments taking shape within the venous space. A particular highlight of this programme, which takes place throughout Wednesday and Thursday, is a Podium 1st presentation from Oliver Schlager on estimating the extent of post-thrombotic iliocaval obstructions prior to endovascular recanalisation. Also returning this year are live abstract presentations, providing members of the venous community another opportunity to present their work on superficial and deep venous issues.

March 2020 | Charing Cross Special Edition

Venous

Reviewing evidence for and against IVC filters in 2020 Following the publication of “Another nail in the cofﬁn for vena cava ﬁlters” in the British Journal of Surgery, which considered potential problems with the use of inferior vena cava (IVC) filters, authors Andrew Doyle and Narayan Karunanithy (Guy’s and St Thomas’ Hospital, London, UK) speak to Venous News about the existing evidence available for IVC filters, the patients in whom they remain an option, and any potential advances in technology that could make them viable again. What is the current evidence for IVC filters in 2020?

A recently published multicentre randomised controlled trial (RCT) evaluating IVC filter use in severe trauma patients demonstrated no overall survival benefit (defined as a composite of all cause 90-day mortality and symptomatic pulmonary embolism [PE]).1-2 The rate of late presentation PE was significantly lower in the filter group. These results are in line with other studies, including PREPIC 1 and 2, which have demonstrated that use of IVC filter results in lower rates of symptomatic PE but no overall survival benefit, as well as an increase in the rate of caval and lower limb deep vein thrombosis (DVT). The problem with filters is confounded by the failure to remove them when no longer needed. Even in the setting of an RCT, the failure-to-retrieve rate was 31%.2 Hence, centres placing IVC filters must have a robust filter removal programme, as failure to do so increases long-term complications, including caval thrombosis, recurrent DVT, filter migration, and caval perforation.

Are there any specific patients in whom an IVC filter should be implanted, in particular those at high risk of bleeding with anticoagulation? There is a lack of high-level evidence to support the routine use of IVC filters. However, their use should be considered on a case-by-case basis for patients where thromboprophylaxis is required and alternative pharmacological and mechanical options have been considered and deemed unsuitable. Typical scenarios in our practice include those diagnosed with acute venous thromboembolism (VTE) that cannot be anticoagulated, owing to major active bleeding or imminent major surgery.

Do you think that the atmosphere of litigation in certain countries, such as the USA, and a focus on the importance of removing IVC filters will stop physicians from implanting them in patients who might really need one? Clinicians are generally making more measured decisions about their use, which is reflected in our own clinical practice, where we have seen fewer filter insertions. The decisions are also being made upon consensus opinion between relevant specialities including haematology, interventional radiology, and vascular surgery.

In patients for whom the implantation of an IVC filter is unsuitable, what other options are available for thromboprophylaxis?

The alternative options are pharmacological thromboprophylaxis, typically with either unfractionated

following stroke, but recent studies have shown no additional benefit in the critical care setting when used in conjunction with anticoagulation. In the immediate perioperative period, they can be a useful option until anticoagulation can be restarted.

Are you optimistic about the potential of advanced IVC filters that bioconvert in the vessel and how can this innovation solve a problem? Andrew Doyle

Narayan Karunanithy

or low-molecular-weight heparin, and/or mechanical thromboprophylaxis with intermittent pneumatic compression devices. With pharmacological thromboprophylaxis, continued clinical assessment is key. Heparin should be introduced as early as possible, once the bleeding risk has reduced sufficiently. For example, following emergency surgery, anticoagulation can potentially be introduced after six to eight hours—cautiously upping titrating doses—rather than avoiding its use. Mechanical thromboprophylaxis can also be considered in the setting of VTE prevention. The role of intermittent pneumatic compression devices needs to beexplored further. They are extensively used in patients

The problem with filters is confounded by the failure to remove them when no longer needed.”

We are cautiously optimistic of the initial results of Sentry Bioconvertible IVC filter device study. A multicentre study has shown the rate of symptomatic PE was 0% at one year and 2.4% at two years.3 Successful filter bioconversion rate was 95.7%, 96.4%, and 96.5% at six months, one year, and two years, respectively. Caval thrombosis was low at 1.6%. Larger scale studies and longer-term data are awaited. References: 1. D oyle AJ, Karunanithy N, Hunt BJ. Another nail in the coffin of vena cava filters? Br J Surg. 2020 Jan; 107(1): 9-10 2. H o KM, Rao S, Honeybul S. et al. A multicenter trial of vena cava filters in severely injured patients. N Engl J Med. 2019 Jul 25; 381(4):328-337 3. D ake MD, Murphy TP, Krämer AH. et al. Final two-year outcomes for the sentry bioconvertible inferior vena cava filter in patients requiring temporary protection from pulmonary embolism. J Vasc Interv Radiol. 2020 Feb; 31(2):221-230

Andrew Doyle is a senior clinical research fellow in haemostasis at Guy’s and St Thomas’ NHS Foundation Trust, London, UK. Narayan Karunanithy is an honorary senior lecturer at the School of Biomedical Engineering and Imaging Sciences, King’s College London, UK, and a consultant interventional radiologist at Guy’s and St Thomas’ NHS Foundation Trust, London, UK. The authors have no disclosures.

First-in-man trial of prosthetic VenoValve demonstrates promise for improving clinical outcomes INITIAL RESULTS OF an ongoing first-in-man study in Colombia, which saw the implantation of a prosthetic venous valve in 15 patients, have demonstrated an improvement in clinical outcomes and quality of life. The promising findings were presented at the Southern Association for Vascular Surgery (SAVS) annual meeting (8–11 January 2020, Palm Beach, USA). According to trial investigator Jorge H Ulloa (Universidad de los Andes, Bogota, Colombia), there was also a marked reduction in pain among “a complex and difficult-to-treat patient population”. In the USA, 2.4 million people are affected with chronic venous insufficiency, Ulloa et al noted. Moreover, one million people are treated for venous stasis ulcers, with few options available to patients who develop postthrombotic disease secondary to deep venous reflux. The new venous prosthetic valve, known as the VenoValve, is a combination of a stainless-steel frame and porcine aortic monocusp leaflet, and was developed to be surgically implanted into the deep venous system—the femoral popliteal vein—of patients with C5–C6 disease. Endpoints of the study were to evaluate safety, “which is very important in a first-in-man study,” said Ulloa. He continued: “These [endpoints] include reflux by duplex ultrasound and femoral popliteal vein, as well as clinical assessment by a vascular surgeon. Also, pain scoring, the visual analogue scale (VAS) score and quality of life outcomes were evaluated by the patients during this study.” In the trial, researchers included actual venous reflux greater than one second in C5 and C6 patients. “Superficial reflux was controlled or ablated prior to patients enrolling into this study,” Ulloa said. “All of

[the patients] were able to walk by themselves and peripheral arterial disease (PAD) was ruled out by alternating blood flow (ABF).” Ulloa went on to explain that just three weeks prior to his presentation at the SAVS podium, the research team had completed its 11th case. He drew attention to six patients who averaged at least six months of follow-up. “We have seen a 40% reduction in reflux, a 61% improvement in [the] Venous Clinical Severity Score (VCSS) or significant clinical improvement, and all patients at six months have noted a significant reduction in their pain by the VAS score. Patient six increased the VAS and VCSS due to poor anticoagulation therapy and by lack of compliance.” Ulloa added: “All cases have demonstrated a marked improvement in the reflux, with most of them reaching baseline except in patient six. Significant clinical improvements were also observed. Many patients went from moderate to severe to mild disease by clinical assessment.” Summing up his findings, Ulloa concluded: “We had an overall improvement in reflux by 40%, a clinical improvement by 61%, with an average of 8.4 points, and a 57% pain improvement. The implantation technique has evolved a great deal since the first case was performed, with an average timing of 40 minutes. Our results of this feasibility study are on the way.” “We will evolve to a second phase, which will include a pivotal trial with more recruiting centres and increasing the number of cases to assess the performance of this prosthetic valve as an option for patients with C4B to C6 disease. Reflux quality calculations will be included in the next phase.”

Charing Cross Special Edition | March 2020

Venous

Debate

Debate on varicose vein guidelines highlights potential uncertainty over selection of treatment

and in action. In Germany or France, though, where patients with private insurance have had access to endovenous treatment for more than 15 years, the majority of patients with public insurance—90% in Germany, for instance—still undergo high ligation and stripping. This shows that the national societies active in phlebology were not able to implement this information, and these guidelines, into public healthcare.” Proebstle concluded: “For the well-trained, specialised physician, current available international guidelines are accurate enough.”

system reimbursement, and the patient’s preference. With these variables in mind, Mansilha questioned whether it is possible to use the same method for all varicose vein patients. “Is only one technique for all of them enough? I do not think that this is true. If you analyse the different guidelines, Thomas [Proebstle] has already shown that. The AVF’s guidelines of 2011 favour endothermal procedures over surgery with a 1B grade of recommendation,” he said. “The EVF, in 2014, gave thermal ablation a grade of 1A, sclerotherapy 1A, and open surgery 1B. The European Society for Vascular Surgery guidelines followed one year later, with a 1A recommendation of thermal ablation in preference to surgery, and a 1A recommendation of thermal ablation in preference to foam sclerotherapy. The Latin American Venous Forum gave a 1A recommendation to thermal ablation, 1B to foam sclerotherapy and 1B to open surgery.” Interrogating the accuracy of these guidelines, Mansilha continued: “For small saphenous veins, again we treat different patients with different varicose veins; even in the same anatomical area, the patterns are different. Is it possible then for us to choose the right answer for all of these patients by reading the guidelines?” No, he continued, because

Thomas Proebstle

Armando Mansilha

“When we are talking about varicose veins, we are talking about patients, all of whom have different patterns of varicose veins,” stated Armando Mansilha (University of Porto, Porto, Portugal), responding to the argument of Thomas Proebstle (University of Mainz, Mainz, Germany) that “If currently available guidelines would even partially penetrate […] healthcare systems, all patients could be happy”.

he debate, on whether current international guidelines are accurate to define the best interventional technique for varicose veins, was held at the Controversies and Updates in Vascular Surgery 2020 meeting (CACVS; 23–25 January, Paris, France), with Proebstle and Mansilha arguing for and against the motion, respectively. Taking to the stage first, Proebstle explained that “in the last century, treatment was just high ligation, stripping, sclerotherapy, and compression, which did not change for 50 years or so”. However, he also discussed more recent developments, highlighting that “since 2000, we have seen the development of several new technologies by a number of creative people”. Turning his attention back to the question at hand, he posed a tripartite question: “Do we have enough international guidelines to define the best treatments, are they up to date, and do these guidelines penetrate international healthcare systems?” According to the presenter, guidelines have not changed in the last decade, with 2011 guidelines from the Society for Vascular Surgery (SVS) and American Venous Forum (AVF) “still telling the whole story”. “If you look at this recommendation, it still favours thermal ablation over surgery, and nothing has changed. Furthermore, sclerotherapy is not recommended for the saphenous vein because it has a higher rate of recanalisation; there are plenty of other recommendations like this,” Proebstle noted. Other guidelines were also highlighted by the speaker, who acknowledged the success of Alun Davies et al in evaluating the impact of National Institute of Health and Care Excellence (NICE) recommendations on the UK’s National Health Service (NHS), ahead of their publication in 2013. As Proebstle noted, this led to an increase in endothermal procedures and a reduction of surgery, in line with the guidelines from SVS and AVF. “Endothermal procedures are always favoured over surgery then, and if this option does not work or is unsuitable, foam should be tried. If foam is not possible as well, surgery is the next option: this is very clear,” he emphasised. “Two-year data from the Europeans are also the same: again, there is a strong recommendation for endothermal ablation, in preference to surgery.” Given the consensus of European, SVS/AVF and NICE guidelines, Proebstle pondered what else would be needed in order to determine the best interventional technique for varicose veins. He said: “Venous specialists should also keep in mind that scientific evidence should always be combined with a physician’s clinical experience and patients’ preference. In addition, we also have to face the fact that parts of the world cannot afford all of the latest, newest technologies.” While these recommendations set a framework for practice, the presenter was eager to underline the reality of their current implementation in developed countries. He posited: “In the UK, The Netherlands, and Switzerland, current guidelines are fully adopted

Venous specialists should also keep in mind that scientific evidence should always be combined with a physician’s clinical experience and patient’s preference.” Interrogating the accuracy of international guidelines

Following the talk by Proebstle, it was the turn of Mansilha to consider why existing guidelines may not be useful enough in determining which are the best interventional treatments for varicose vein patients. Hinging his case on the notion that all patients are different, and therefore require a different approach, he said: “Not all of them are symptomatic, not all of them are dependent on the saphenous trunk, and not all of them are only treated for cosmetic reasons. “My question today is this: if I read the different international guidelines, can I find the right answer to treat all of these patients?” Mansilha asked. Profiling the interventional options currently available, the speaker asserted how selection of treatments is dependent on several factors, including the existing evidence, skills of the specialist, national healthcare

these different international guidelines gave a 1A or 2B level of evidence for this question, and a grade of recommendation which is “absolutely not the same”. Summarising his thoughts, Mansilha commented further that “when choosing between interventional modalities to treat patients, with different patterns of varicose veins, one must always take into account the mechanism of action and limitations of different devices, the operator skills required for different techniques, mid- and long-term results, as well as reimbursement policies and cost-effectiveness”. On that final point of cost-efficiency, Mansilha said: “We must have, in our department, people with enough skills to treat different patients with different techniques. Currently, the differences between treatments are negligible in terms of clinical outcomes, so the treatment with the lowest cost appears to be the most cost-effective.”

March 2020 | Charing Cross Special Edition

Improved followup measures needed to fill knowledge gap in long-term PE outcomes “We need to check for signs of recurrence and functional impairment, and follow these patients much more closely,” urged Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA), speaking on the long-term outcomes for pulmonary embolism (PE) patients at the International Symposium on Endovascular Therapy (ISET; 22–25 January 2020, Hollywood, USA).

osenfield opened his talk by emphasising that “while the annual incidence of pulmonary embolism continues to increase, case fatality rates appear to be improving over time”. However, he asserted that a number of patients are affected by chronic thromboembolic pulmonary hypertension (CTEPH) and other less severe forms of post-PE syndrome. Explaining the problem further, Rosenfield said: “CTEPH occurs when a patient with a PE has incomplete resolution of the thrombus and experiences compromise of flow to their pulmonary vascular bed. These patients can develop progressive pulmonary hypertension and right heart failure.” CTEPH patients, according to the speaker, are best treated with open

Venous

surgical pulmonary thromboembolectomy (PTE), though restoration of quality of life? The reality is that there is balloon pulmonary angioplasty (BPA) is also an option. a lack of knowledge and understanding about the longAlthough Rosenfield was eager to affirm that term outcomes and consequences of PE.” this post-PE syndrome is “a very treatable form of “No matter what parameter you look at, whether it is pulmonary hypertension”, he also underlined that pulmonary pressures, exercise tolerance, quality of life, “if you have CTEPH and associated or even psychological well-being, there is severe pulmonary hypertension with a clearly a significant proportion of patients peak pulmonary artery pressure above who do not fully recover,” Rosenfield 50mmHg, and do not receive treatment, argued, turning his attention to the you are basically dead within five years. EINSTEIN PE study as one data source. Treatment then is critical, especially for This investigation demonstrated that at more severe patients.” three weeks after acute treatment for PE, Citing data from the New England the mean relative decrease in pulmonary Journal of Medicine, which estimates that vascular obstruction (PVO) was 71% and overall incidence of CTEPH following 67%, respectively, in rivaroxaban and Kenneth Rosenfield PE is approximately 3–5%, the presenter enoxaparin treatment groups. Moreover, commented that while the figure is complete resolution was achieved in 44% not that high, it remains significant. He continued: and 31% of these patients, respectively. “In addition to those with CTEPH, there is this other Rosenfield added: “For patients followed up beyond group of patients that do not get back to baseline and six months, there is very little evidence, especially in still experience long-term functional impairment. randomised trials. In the PEITHO study’s long-term We categorise these patients as having chronic follow up—out to a year—ECHO findings showed thromboembolic disease (CTED), an entity that needs that 63 patients (36%) in the tenecteplase arm, and 55 further exploration. Overall, we as a medical community (30.1%) in the placebo arm, reported persistent clinical must think more about the long-term outcomes after symptoms after PE (p=0.23). So, the incidence of PE, and how we define and track recovery. Is full disability is higher than previously thought.” recovery defined by clot resolution, by recovery of RV In addition to functional limitations, psychosocial dysfunction, by return to normal functional status and aspects of venous thromboembolic disease were also highlighted. “Perhaps many of you in the audience have seen patients with post-traumatic stress disorder after acute PE,” the speaker proposed, citing a study into a small subset of patients, which found that it takes six to 12 months to resume everyday activities. “The reality is that most patients’ symptoms improve almost completely by three months, but post-PE syndrome is not uncommon. Whether thrombolysis and other treatment modalities change the natural history is yet to be determined.”

For patients followed up beyond six months, there is very little evidence, especially in randomised trials.”

Charing Cross Special Edition | March 2020

Venous

ATTRACT analysis finds improved quality of life for iliofemoral DVT patients treated with PCDT

An analysis of data from the ATTRACT trial, published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, reveals that quality of life measures improve after pharmacomechanical catheterdirected thrombolysis (PCDT). According to the findings of the analysis, this is particularly true early on and for iliofemoral deep venous thrombosis (DVT). IT IS SAID that, despite treatment with anticoagulation and compression stockings, up to 50% of patients with proximal DVT develop post-thrombotic syndrome, which causes patients to experience severe pain and swelling of the limb, as well as increasing the risk of pulmonary embolism (PE). As Venous News has previously reported, the results of the ATTRACT trial showed that PCDT

does not reduce the occurrence of post-thrombotic syndrome (PTS) at two years but does lessen its severity, as well as treating acute symptoms faster. In this analysis, lead investigator Susan Kahn (Jewish General Hospital, Montreal, Canada) and colleagues aimed to assess the effect of PCDT on both shortterm and long-term quality of life in all of the patients enrolled in the ATTRACT trial—as well as predefined subgroups with (iliofemoral DVT) or without (femoralpopliteal DVT) involvement of the iliac or common femoral vein—before examining whether this effect differed over time. As part of the investigation, quality of life was evaluated in a total of 692 patients between 2009 and 2014, with follow-up taking place at one, six, 12, 18 and 24 months. Randomisation resulted in 337 being allocated to PCDT, and 355 to no PCDT; upon analysis, it was found that VEINES-QOL change scores were greater (and therefore better) in the PCDT cohort versus no PCDT from baseline to one month (difference, 5.7, p=0.0006), and from baseline to six months (5.1, p=0.0029). For all other intervals, no difference was found by the analysis.

Could interventional treatment of iliofemoral DVT be viable? Anna Pouncey Comment & Analysis ATTRACT compared outcomes following pharmacomechanical thrombolysis (PMT) versus standard medical therapy (SMT), and while no benefit with PMT was demonstrated for femoropopliteal DVT, subgroup analysis of iliofemoral DVT demonstrated a reduction in moderate-to-severe post thrombotic syndrome (PTS).1,2 However, was the benefit demonstrated enough to counteract the increased cost of PMT? In this article for Venous News, Anna Pouncey (Guy’s and St Thomas’ Hospital, London, UK) explains.

recent cost-effectiveness analysis on the ATTRACT trial, published in Circulation, presents a discouraging picture.3 The model yielded an estimated ICER (Incremental Cost Effectiveness Ratio) of US$137,526 per QALY (Quality Adjusted Life Year) for PMT of iliofemoral DVT.3 In contrast, prior work from CaVenT presented an economically favourable ICER of US$20,439 per QALY gained with use of CDT versus anticoagulation. So, what could have led to such a drastically divergent conclusion? Firstly, clinical benefit observed in the ATTRACT trial was much smaller than that observed in the CaVenT trial (+0.12 [+US$16,473] vs. +0.63 [+US$12,843]

QALYS), which had a negative effect on model outcome.3,4 Authors state that from this model, the relative risk (RR) of development of PTS would need to be <0.65 to be cost effective. This may be achievable with careful patient selection and modern practice today. Indeed, a Cochrane review of 17 studies with 1,103 participants found the RR of PTS associated with thrombolysis to be 0.64 (95% CI 0.52–0.79, P<0.0001).5 Controversially, authors chose to incorporate femoropopliteal patients into the cost-effectiveness model. Interventional treatment for femoropopliteal DVT was not clinically effective, and therefore could not be costeffective. Disappointingly, secondary

Susan Kahn

According to the 36-item Short Form Health Survey (SF-36) physical component summary, scores were greater in PCDT vs. no PCDT from baseline to one month (difference, 2.4; p=0.01), but not for other intervals. However, among iliofemoral DVT patients, VEINESQOL change scores from baseline to all assessments were greater in the PCDT versus no PCDT group, and this was statistically significant in the intention-to-treat analysis at one month (difference, 10; p<0.0001) and six months (8.8; p<0.0001). SF-36 physical component summary change scores were greater in PCDT versus no PCDT from baseline to one month (difference, 3.2; p=0.0010), but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in both cohorts. Commenting on these findings, Kahn said: “Most of the improvement in quality of life was in the first six months, and the trial did find that PCDT reduced clot burden and early leg pain and swelling over no PCDT, and was associated with a reduced point prevalence of PTS at six months, but not thereafter. Though PCDT did not prevent post-thrombotic syndrome, it did reduce its severity.” Furthermore, the Society for Vascular Surgery (SVS) noted that the decision to proceed with lytic therapy for patients with iliofemoral DVT can be complicated. “These data support offering this therapy to selected patients with severe symptoms, low bleeding risk and a willingness to undergo a catheter-based procedure,” a statement read.

analysis of the clinically relevant iliofemoral DVT cohort, for whom outcomes and costs are quite different, is not clearly described. Thus, we arrive at the same quandary as the primary outcome of the ATTRACT trial, with the strength of analysis muddied by inclusion of femoropoliteal DVT. A major driver in determining costbenefit from interventional treatment of iliofemoral DVT is from the reduction in PTS. In this model, insufficient emphasis was placed on long-term increased healthcare costs associated with increased PTS severity. Costing was not in line with prior work done by MacDougall, who estimated a US$4,726 average annual cost difference for a patient with PTS (US$6132 in 2017 dollars).6,7 The cost of ulcers (which occur in 5–10% of PTS cases, costing roughly $10,000 per year) is also underestimated.8,9 Several assumptions were also made regarding the impact of PMT on PTS outcomes that are not empirically verifiable, such as the assumption that transition to less severe PTS categories (improvement in symptoms) beyond the first six months could not occur.3 Costs at the index event are also much less in the SMT arm than typical Medicare events seen in 2017 for diagnostic-related groupings 294 and 295 (US$3,877 vs. US$7,843). The ATTRACT report does not go into detail about the costing of the control arm, but this difference in cost may reflect treatment of patients with less severe presentations in the outpatient setting. Additionally, ATTRACT findings may have incorporated some bias, as late intervention was discouraged, substantial loss to follow up occurred, and patient selection criteria led to a study population sample with limited generalisability.10 So, could interventional treatment for

iliofemoral DVT be shown to be viable? Yes, potentially, if modern practice delivers good outcomes and if costing for PTS is fully accounted for. But, once again, this study has concluded that the strength of ATTRACT data for iliofemoral DVT is lacking.³ If we want an answer, there is a need for the venous community to move on from ATTRACT and return to a state of equipoise, enabling well-designed prospective studies that generate representative data. References: 1. Comerota AJ, Kearon C, Gu C-S, Julian JA, Goldhaber SZ, Kahn SR, et al. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation 2019;139:1162–73. 2. Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, et al. Pharmacomechanical CatheterDirected Thrombolysis for Deep-Vein Thrombosis. N Engl J Med 2017;377:2240–52. 3. Magnuson EA, Chinnakondepalli K, Vilain K, Kearon C, Julian JA, Kahn SR, et al. Cost-Effectiveness of Pharmacomechanical Catheter-Directed Thrombolysis Versus Standard Anticoagulation in Patients With Proximal Deep Vein Thrombosis: Results From the ATTRACT Trial. Circ Cardiovasc Qual Outcomes 2019;12:e005659. 4. Enden T, Wik HS, Kvam AK, Haig Y, Kløw NE, Sandset PM. Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study 2013:1–7. 5. Watson L, Broderick C, Armon MP. Thrombolysis for acute deep vein thrombosis. Cochrane Database Syst Rev 2014:CD002783. 6. Kachroo S, Boyd D, Bookhart BK, LaMori J, Schein JR, Rosenberg DJ, et al. Quality of life and economic costs associated with postthrombotic syndrome. Am J Heal Pharm 2012;69:567–72. 7. MacDougall DA, Feliu AL, Boccuzzi SJ, Lin J. Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome. Am J Heal Pharm 2006;63:S5–15. 8. Heit JA, Rooke TW, Silverstein MD, Mohr DN, Lohse M, Petterson TM, et al. Trends in the incidence of venous stasis syndrome and venous ulcer: A 25-year population-based study 2001;55905:1022–7. 9. Barnsbee L, Cheng Q, Pacella R, Tulleners R, Lee X. Measuring costs and quality of life for venous leg ulcers 2019:112–21. 10. Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, et al. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med 2017;377:2240–52.

Anna Pouncey is a vascular surgeon currently training in the London Deanery, London, UK. The author has no disclosures.

March 2020 | Charing Cross Special Edition

Sirolimus on the rise but paclitaxel “will probably come back again” At this year’s Leipzig Interventional Course (LINC 2020; 28–31 January, Leipzig, Germany), William Gray (Main Line Health, Philadelphia, USA) considered the future of drug-coated devices and what to expect over the next five years.

peaking during the LINC session on latest insights into the safety and efficacy of drug-coated devices, Gray began by noting the “quite remarkable and effective” nature of paclitaxel devices. In patients who benefit from a reduction in repeat target lesion revascularisation (TLR), for example, he showed that about one in five patients in the In.Pact trials did not need to undergo another TLR procedure because of the presence of paclitaxel. “This is a pretty profound effect,” he commented. In addition, Gray pointed out that antiproliferative therapies, including paclitaxel, have saved money. A 2016 meta-analysis from Katsanos et al, “a different meta-analysis”, Gray notes, showed that antiproliferative therapies have a “significantly marked effect” in cost of treatment for patients and for their outcomes. Furthermore, when devices using paclitaxel are compared, with Gray using the example of Eluvia versus Zilver, “the more effective the therapy, the more cost-effective it tends to be in

the long term”. Based on this information, and the “strength” of the available data, Gray explained that drug-eluting balloons and drug-eluting therapies were expected to grow over the next 10 years. However, he added that this growth in adoption peaked at around a 50% utilisation rate in the USA, before dropping by more than half, to just less than 25%, after the publication of the 2018 Katsanos et al meta-analysis. “There is some evidence that there is now an uptake in utilisation,” Gray added, but this is still “well below” the 50% peak, and even further below the projected utilisation curve. While his paclitaxel “speed bump” will be overcome, believes Gray, it has paved the way for the rise of an alternative drug—sirolimus. However, he noted that there are a number of challenges with this drug, including a relatively low tissue absorption in its natural state and comparatively short tissue retention times, both of which are “counterproductive” to effective treatment, Gray posited.

Future of drug-coated devices Gray then pointed out that, with the most effective paclitaxel devices, it is possible to measure tissue concentration of paclitaxel up to William Gray 180 days following a procedure. “Can we match that with sirolimus?” Gray questioned, adding that “everybody who has a paclitaxel device is looking at sirolimus as an alternative in case [paclitaxel] does not come back”. Addressing specific options available in the sirolimus market, Gray began by outlining the key features of the Selution drug-coated balloon (MedAlliance), which received CE mark approval in February 2019 and US Food and Drug Administration (FDA) breakthrough device designation a year earlier. Gray detailed that this drug-coated balloon (DCB) has microreservoir technology, which “allows for deposition and slower elution of the sirolimus over time”, adding that it also promotes adherence of the drug from the balloon into the tissue. Gray referenced pre-clinical data which is supportive of these microreservoir concept, showing that the Selution tissue concentration is available out to 60 days. “This is no small feat with sirolmius analogues,” Gray commented. Gray added that a first-in-man trial has already been conducted. At the 2019 Vascular and Interventional Advances conferences (VIVA; 4–7

November, Las Vegas, USA), Thomas Zeller (Universitäts-Herzzentrum, Bad Krozingen, Germany), revealed that the Selution DCB is safe and effective out to two years. In addition to Selution, Gray noted that the Bullfrog micro-infusion device (Mercator MedSystems), a needle-based balloon, has the benefit of being able to accurately deliver “any compound you like” through a targeted injection. He detailed that there is now a dose-blinding trial using temsirolimus below the knee which showed improvements in overall patency and clinically-driven TLR (CDTLR) using temsirolimus. In terms of clinical data, the TANGO trial is a phase II, dose escalation, double-blinded trial comparing the delivery of temsirolimus to saline control in patients with severe claudication or critical limb ischaemia. Results of the TANGO low-dose cohort, compared to controls are positive out to 12 months, were announced at VIVA 2019. Gray concluded: “The paclitaxel controversy has opened the door for alternative therapies.” However, he also acknowledged that an increasing number of paclitaxel safety studies are being published, and observed that “the more the data gets filled in, the less signal there is”. He suspects that as this data becomes more complete, “we are likely to see that signal go away”. Gray ended his presentation with the comment: “If so, paclitaxel will probably regain its pace of adoption, but it will take time.”

Charing Cross Special Edition | March 2020

Wound care

How to improve the treatment of chronic wounds—A German National Consensus Statement Martin Storck Comment & Analysis President of the German Wound Council, Martin Storck, considers how to improve the treatment of chronic wounds. While the road to better treatment “may still be long,” he says, “it is a road worth going down”.

“O

n average, a patient in Germany has to suffer from a chronic wound for three and a half years before it is properly treated—this not only means incredible pain, but is simply unacceptable in a highly developed country.” This statement by Matthias Augustin (University of Hamburg, Hamburg, Germany), former president and founder of the German Wound Council, draws a dark picture of the general situation. As director of the Institute for Health Services Research in Dermatology and Nursing Care Professions at the University Hospital Hamburg (Hamburg, Germany), he has many years of experience in health services research in the field of chronic wounds.

Good treatment can be a matter of luck

Around 900,000 people in Germany suffer from chronic wounds. How well the wounds are treated depends on the expertise of the physician a patient sees and on where a patient lives: in the

countryside, if there is no specialist or wound care centre nearby, the GP is the first physician these patients see. “But from the very outset we also need to start at other points in the chain of care in order to make changes to the treatment of chronic wounds, which is often inadequate”, says Augustin. “Because although we have guidelines on care, physicians, nurses, and physiotherapists are still unsure as to when something should be diagnosed and how it should be treated”, the expert explains. Because this state of affairs seemed untenable to them, the German Wound Council has taken the initiative and appointed 13 specialists to formulate standardised recommendations for the treatment of chronic wounds and to develop a graduated concept as to when which discipline or professional group should become involved. The working group included physicians from various fields of specialisation, representatives of the German Nursing Council, but also representatives from the Federal Associations of Health Insurance Funds

and industry, as well as lawyers and politicians.

Targeted treatment in a timely manner

The result is a consensus recommendation that factors in the experience of physicians from different disciplines and of representatives of professional associations, patient initiatives, industry, health insurance funds, hospitals and wound care centres. One of the key fundamental concepts is that the targeted diagnosis and professional treatment of chronic wounds needs to occur as early as possible. What sounds simple can prove to be difficult in practice. A chronic wound is almost always a symptom of an underlying disease. In addition to local treatment, you also need to determine whether, for example, the patient has an arterial or venous circulatory disorder, since these cause up to 90% of chronic wounds in the lower extremities”, Storck elaborates. So establishing a mandatory guideline that explains and defines which profession is responsible for what, and when specialists or wound care centres should become involved is recommended.

Timely and professional therapy can lead to excellent results when treating chronic wounds.” Networks of care and guides for the right treatment

So that a patient with, for example, an infected chronic wound progresses from the GP to the right specialist or wound care centre in a timely manner, the expert group recommends establishing networks of care. Ideally, the first physician the patient visits should see him- or herself as the patient’s guide through this network of experts. “If we

Review of dermal regenerative template demonstrates success in treatment of avascular wounds

A combined literature review and retrospective study has confirmed that the use of a dermal regenerative template (DRT) is “a viable option for providing vascularised coverage over wounds with avascular components”. Moreover, it was also found by Ronald N Bogdasarian (Rutgers New Jersey Medical School, Newark, USA) and colleagues that DRT is less successful in chronic wounds. PUBLISHED IN WOUNDS, Bogdasarian et al’s investigation was conducted on the premise that partially avascular wounds pose a significant challenge to wound care surgeons, as they “lack blood flow and the potential to heal without intervention”. Commenting further on this prevalent issue, the authors write: “Partially avascular wounds are challenging due to the multitude of options for closure, including prolonged wound care, flaps, and dermal regenerative templates (DRTs).” The main aim of this investigation into DRT was to determine the success and viability of its use in wounds

with avascular components, followed by the secondary purpose of quantifying DRT’s ability to survive while covering partially avascular wounds. In order to examine outcomes, a review of the literature was performed using Ovid MEDLINE, Google Scholar, and Cochrane Library: Bogdasarian et al explain that as part of this study, patient demographics, comorbidities, wound types, surface area of avascular tissues, and skin graft take were analysed. In addition, a retrospective review of institutional cases, at Rutgers New Jersey Medical School, was conducted.

have clear guidelines, because of their training and experience physicians can better assess what they are capable of treating and when they should refer the patient to a specialist”, says Bernd Gruber from the German Nurses’ Council. Wound care centres, which have already been established in several German states, serve as role models for these types of networks. They involve the collaboration of different professions, i.e. physicians, nurses, and physiotherapists, which needs to be both open-minded and close. “In the case of a chronic wound, no practitioner can achieve the best results on his or her own. All the necessary steps need to be coordinated with each other”, says Veronika Gerber from the Specialist Association Initiative Chronic Wounds (ICM). Quality assurance and documentation can also be achieved through certifications, says Joachim Dissemond from the University of Essen (Essen, Germany). Another issue is the reimbursement structures in Germany, which are completely non-standardised and very different from region to region.

Encouraging a wideranging discussion of the recommendations

The road to better treatment of chronic wounds may still be long—this too is something on which the 13 experts agree. Using the platform of the German Wound Council, they are seeking to encourage a wide-ranging discussion about their recommendations. But according to them it is worth going down this road. Timely and professional therapy can lead to excellent results when treating chronic wounds, and it practically always reduces the suffering of those affected and improves their quality of life. Costs induced by unnecessarily extensive treatment are also reduced. Martin Storck is president of the German Wound Council and also director of the Department of Vascular and Thoracic Surgery at Karlsruhe Academic Teaching Hospital in Karlsruhe, Germany.

Twenty-six patients were included in the retrospective review, all of whom had partially avascular wounds reconstructed with DRT. On the results of this study, Bogdasarian et al write: “Seventeen patients experienced 100% graft take, six experienced partial take, and three suffered complete loss. The percent and absolute size of avascular surface area in the wound was significantly lower in cases of complete graft take, compared with partial take and complete loss (1.9% and 2.7cm2; 9.3% and 10cm2; 18% and 9.3cm2, respectively; p<0.001).” Furthermore, it was found that chronic wound status (p<0.001) was significantly associated with less graft take. Authors of the investigation have described this study as the first to describe, quantitatively, the ability of DRT to successfully reconstruct partially avascular wounds.

Partially avascular wounds pose a significant challenge to wound care surgeons.”

Charing Cross Special Edition | March 2020

Guidelines

ESVS radiation safety guidelines will outline minimum safety requirements At this year’s Critical Issues America annual meeting (7–8 February, Coral Gables, USA), Bijan Modarai (Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, London, UK) gave a progress update on forthcoming European Society for Vascular Surgery (ESVS) radiation safety guidelines for endovascular aneurysm repair (EVAR) procedures. He concluded by underlining his hope that the guidelines will “propel” research into some unanswered questions and “insist” on a benchmark for safety. “WHILE THERE IS a plethora of guidance already published about best practice when it comes to radiation safety, very little of this is relevant specifically to vascular interventions,” Modarai began. As a result, the ESVS commissioned a committee to come up with some radiation safety guidelines, Modarai explained, adding that he co-chairs the committee with Stéphan Haulon (Aortic Centre, Groupe Hospitalier Paris Saint Joseph, hôpital Marie Lannelongue, Paris, France), with representation from the USA through Mark Farber (University of North Carolina Heath Care, Chapel Hill, USA). Modarai explained that the committee had their first “kick-off” meeting in May 2019, during which the group decided on the key areas they felt should be included in the guidelines. These areas included the basics about radiation dosimetry, how to set up the operating environment, considerations for patients, staff exposure, and best radiation safety practice. He noted that the committee also had some discussion about what the future areas of research might be. The first topic Modarai discussed at Critical Issues was reported exposures of radiation, which can vary “quite a lot”. He explained that the concept of diagnostic reference level (DRL)—an expected dose or amount

of exposure for a specific procedure—does not apply to vascular procedures, while it does apply to other specialities. Therefore, one of the recommendations that is likely to come out in these guidelines, Modarai emphasises, is the need to standardise doses. “We need to start working groups at national level that look at endovascular procedures and come up with what an expected exposure should be,” he explained. Another recommendation is likely to suggest that a significant amount of the work pertaining to reducing exposure needs to happen outside the operating theatre. “We now have access to 3D workstations, meaning we can perform detailed preoperative planning to get the angles correct to minimise radiation even before we get into the operating theatre,” Modarai detailed. In terms of patient exposure, Modarai noted that ESVS guidelines have become increasingly patientcentred as a result of consultation with patient groups. In terms of these guidelines, he noted that the committee is going to put the recommendations to patients and make a point of finding out how the group can recommend more transparency about risk and joint decision-making when it comes to the possible consequences of radiation exposure during EVAR. Modarai mentioned that an area which has been discussed in detail is exposure during pregnancy. “When you actually look at the exposure, the amount that the foetus receives is very, very small and the calculated increased risk of cancer or malformation to the foetus with these exposures is tiny,” he clarified, adding that “part of the duty we have is to inform and reduce anxiety about that”. Modarai elaborated that it is important to have a supportive environment to reduce that anxiety. Furthermore, there needs to be clarity on best practice and on the actual risks, but an acceptance that the dose rates can vary.

We have got to get away from trainees having to use ‘make-do’ protection.” Tara Mastracci (Royal Free London NHS Foundation Trust, London, UK) commented that there should also be consideration of women who are not pregnant, as they “all carry ovaries for [their] entire lives”. She added: “I would ask all of you to consider

ESVS announces the publication of new acute limb ischaemia guidelines The European Society for Vascular Surgery (ESVS) recently published the first ever 2020 clinical practice guidelines on the management of acute limb ischaemia (ALI). The writing committee—Martin Björck (Uppsala University Hospital, Uppsala, Sweden) and colleagues—developed the guidelines to “promote a high standard of care” based on the available evidence.

he guidelines document, published in the European Journal of Vascular and Endovascular Surgery (EJVES), covers many aspects of care, from diagnosis and treatment through to unresolved issues and future research. It is based on a systematic review of the literature and issues 61 recommendations for clinical practice. The authors note that the target population of the guidelines comprises

patients with acute lower and/or upper limb ischaemia. Although the guidelines focus on lower limb acute ischaemia, constituting >80% of the affected patients, a designated chapter deals with the upper limb. Björck et al stress that the document should not be viewed as a legal standard of care. Instead, the document should act as a “guiding support,” and that care given to a patient should always be dependent on the individual and the

your young, junior, female colleagues, because very frequently the nurses in the operating room will have bespoke lead, but those of us who are juniors will not have this and, frequently, PPE [personal protective equipment] does not fit women as well as it does men,” urging the committee to “expand the guidelines a bit to talk about that”. “I totally agree,” replied Modarai, adding that consideration of personalised protection will be an element of the recommendations. “We have got to get away from trainees having to use ‘make-do’ protection and introduce a minimum set that hospitals are required to have available. This is something that we will discuss in the guidelines I am sure.” Considering how to reduce exposure to the operator in general, Modarai mentioned that the amount by which particular garments reduce exposure varies, and that this is also something the guidelines will address. Following discussion of some of the key areas the recommendations will cover, Modarai also touched upon some of the areas of future research the committee believe need to be addressed, including the requirement for more data on the biological consequences of radiation exposure and individual sensitivity to radiation exposure. “We hope to propel some of this research by recommending more work in these areas,” Modarai explained. “Maybe one day these guidelines will be redundant,” Modarai posited, noting current efforts to instigate radiation-free interventions, including FORS technology and the IOPS system, adding that these will be included in the guidelines. At the end of the presentation, Farber added that the document the committee is putting together “will be the sort of document for you to take to your hospital and say ‘I need this protection’, because most of us across the world will not have that ability. It is not one document that will teach you every little thing about radiation safety, but it will give you the tools to go to your hospital and get what you need.” Modarai conclude: “We need a minimum requirement that these guidelines will hopefully insist on,” adding that “hopefully we can update with some firm recommendations at the ESVS annual meeting later this Bijan Modarai year.”

treatment setting. Although clinical diagnosis is the first fundamental step, the guidelines recommend diagnostic imaging provided that it does not delay treatment, or if the need for primary amputation is obvious. CT-angiography is recommended as the first line imaging modality. To reduce tissue damage while awaiting revascularisation, intravenous heparin, oxygen, rehydration and analgesia are all recommended. Once a diagnosis of ALI has been made, the guideline group recommends that patients should be treated by experts (usually a vascular specialist) in a hospital where assessment and treatment is available 24/7, and that can offer both open and endovascular surgery in a single procedure, noting that patients may need to be transferred urgently to a specialist hospital. The group has made recommendations about how to use the different treatments to obtain the best outcomes. In patients with Rutherford ischaemia grade IIa

(without paralysis or anaesthesia) thrombolysis is considered an alternative to open surgery. In grade IIb (with paralysis and/or anaesthesia) thrombolysis may be considered if initiated promptly and combined with aspiration or other endovascular techniques to enhance revascularisation. Some controversial issues were solved in the process of systematic review of the literature. There is no indication for continuous systemic heparinisation, nor to monitor fibrinogen, during thrombolysis. How to handle bleeding complications and post reperfusion compartment syndrome is described. There are multiple recommendations on less common situations such as popliteal artery aneurysms, acute aortic occlusions and ALI in children. “It is hoped these first ever guidelines will be used by doctors treating patients with ALI to give them the best care, thus giving them the best chance for full recovery,” the group concludes.

March 2020 | Charing Cross Special Edition

Aortic dissection in the UK

Award for film raising awareness of aortic dissection A short film (“Today is a Good Day”), which showcases the work of Aortic Dissection Awareness UK & Ireland, has won the Rare Disease Film Festival’s Peoples’ Choice award. GARETH OWENS, CHAIR of Aortic Dissection Awareness UK & Ireland, says that winning the award is “a real boost for our campaign”. He adds: “Ours was one of 50 films in the festival and we were up against many that had been professionally-produced, so it was amazing to be shortlisted and then to emerge as the overall winner in the online peoples’ vote.” With this film, the patient association are seeking to address the problem of lack of awareness surrounding aortic dissection. Owens explains that even many medical professionals are unaware of the signs and symptoms of the condition, which leads to misdiagnosis when patients present in emergency departments. This misdiagnosis, he notes, has “usually fatal” consequences for the patient.

Furthermore, the patient association hopes that the film will encourage those who treat aortic dissection to educate emergency departments and primary care practices about the condition. Aortic dissection, according to the patient association, affects about 4,000 people a year in the UK and only 1,200 of these survive long enough to be admitted to hospital. Market intelligence from BIBA MedTech Insights shows that, last year, about one in 10 of all aortic procedures performed in the UK (9,933 overall) were for aortic dissections. Of these, 63.5% were for type A dissections and 36.5% were for type B dissections (both acute and chronic). The predominant approach for treating type A dissections was open repair

BIBA MedTech Insights Aortic Segmentation Tracker

while endovascular repair was the predominant approach for type B dissections (for both acute and chronic dissections). However, the difference between open and endovascular repair procedures was

BIBA Briefings

much greater for type A dissections than for type B dissections. See Figure 1. For more information, visit: www. thinkaorta.org.

BIBA Briefings is an online platform (www.bibamedtech.com/bibabriefings) that gives an in-depth analysis of the latest market intelligence from BIBA MedTech Insights (www.bibamedtech.com). It also reviews the latest industry news and pipeline developments. For editorial enquiries, please contact Dawn Powell: dawn@bibamedical.com For sales enquiries (including BIBA MedTech Insights), please contact Merveille Anderson: merveille@bibamedical.com

Charing Cross Special Edition | March 2020

Market watch

Clinical News AngioDynamics launches PATHFINDER I registry to evaluate AURYON atherectomy system

AngioDynamics has announced the launch of the PATHFINDER I: PostMarket Registry (PATHFINDER I-Registry, EX-PAD-05), a pilot study to evaluate the safety and efficacy of the company’s AURYON atherectomy system in the treatment of de novo, restenotic, and in-stent restenosis lesions in infrainguinal arteries of patients with peripheral arterial disease (PAD). The AURYON atherectomy system, previously known as the Eximo B-Laser, is a proprietary 355nm wavelength lasertechnology platform that was acquired by AngioDynamics in October 2019. “The PATHFINDER I study will provide valuable, scientificallybacked data to further differentiate the AURYON system from competitive products in this space and build upon the excellent long-term results that patients experienced during the IDE,” says Juan Carlos Serna, AngioDynamics vice president for clinical affairs and healthcare economics. AngioDynamics’ PATHFINDER I registry is a prospective, nonrandomised, single-arm, multicentre, observational study that will evaluate the performance of the AURYON atherectomy system during procedures and measure clinical outcomes, both intermediate and long-term. A total of 100 eligible PAD patients treated with the AURYON atherectomy system in a post-market setting will be enrolled and tracked for a 36-month period after the initial procedure. Initial findings from the pilot registry study will contribute to a subsequent large pivotal phase registry that is expected to include approximately 1,000 patients. The commercial release of the AURYON atherectomy system in the USA will occur in the second half of the fiscal year.

Acceleron announces sotatercept achieved primary and secondary endpoints in the PULSAR trial

Acceleron Pharma announced that the PULSAR Phase 2 trial of sotatercept met its primary and key secondary endpoints in patients with pulmonary arterial hypertension (PAH). In patients on stable background PAH-specific therapies, sotatercept demonstrated a statistically significant reduction in pulmonary vascular resistance (PVR), the trial’s primary endpoint, at week 24 versus placebo. The trial also achieved a statistically significant improvement in the key secondary endpoint of 6MWD, as well as other secondary endpoints, including NT-proBNP, and WHO functional class. “We are thrilled to report such

Stellarex (Philips)

positive topline results from the PULSAR trial,” said Habib Dable, president and chief executive officer of Acceleron. “PAH is a debilitating disease of high unmet medical need, so we are encouraged by these data that signal that sotatercept could deliver added benefit to patients. We look forward to upcoming interactions with health authorities as we plan to globally develop and, if approved, commercialise sotatercept in PAH.” In this Phase 2, double-blind, placebo-controlled study, 106 patients were randomised to receive placebo, 0.3mg/kg of sotatercept, or 0.7mg/kg of sotatercept subcutaneously every 21 days in combination with stable background PAH-specific therapies over a 24-week treatment period. Sotatercept was generally well tolerated in the trial. Adverse events observed in the study were generally consistent with previously published data on sotatercept in other diseases. “Approved therapies for patients with PAH target three main pathways of endothelial cell dysfunction to primarily promote pulmonary vasodilation,” said Marc Humbert, professor of medicine and director of the French Pulmonary Hypertension Reference Center at the Université Paris-Saclay (Paris, France). “As a selective ligand trap for members of the TGF-beta superfamily, sotatercept is designed to rebalance BMPR-II signalling, which is a key molecular driver of PAH. The PULSAR data demonstrate that this novel approach has the potential to provide significant benefit on top of currently available therapies.” “These results are particularly impressive given the patient population, the majority of whom were on background combination therapy, including parenteral prostacyclins, had advanced haemodynamics and lengthy duration of disease,” said Vallerie McLaughlin, professor of medicine and director of the Pulmonary Hypertension Program at the University of Michigan (Ann Arbor, USA). “Exceptionally notable was the concordance of the effects across the prespecified subgroups. These clinically meaningful data raise the exciting possibility that sotatercept could potentially shift the treatment paradigm for patients with PAH.” Ninety-seven out of the 106 patients who enrolled in the PULSAR trial are currently participating in the 18-month extension period of the trial. To date, no patients have discontinued participation in the extension trial. Acceleron plans to present a detailed review of the topline results from the PULSAR Phase 2 trial of sotatercept at a medical conference later this year. Sotatercept is an investigational therapy that is not approved for any use in any country.

Four-year ILLUMENATE data reaffirm safety profile of Stellarex

Philips has announced four-year results from the randomised controlled ILLUMENATE pivotal trial in the USA. The data show similar mortality rates through four years for patients treated with Stellarex compared to those treated with percutaneous transluminal angioplasty (PTA). The results were presented at the Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany) by Sean Lyden (Cleveland Clinic, Ohio, USA), the co-primary investigator for the ILLUMENATE trial. The four-year ILLUMENATE pivotal trial data are the latest results from a series of trials evaluating the safety and efficacy of the Philips Stellarex 0.035″ low-dose drug-coated balloon (DCB) in restoring and maintaining blood flow in the superficial femoral artery and popliteal arteries of patients with peripheral arterial disease (PAD). The results were evaluated compared to PTA treatment with uncoated balloons, the current standard of care. “The four-year data from the ILLUMENATE pivotal trial further substantiate the three-year results that were presented at LINC 2019 and published in Circulation in 2019,” said Sean Lyden. “The high compliance follow-up rate further affirms the findings of these data in a complex patient population.” The study’s patient population is complex with a high proportion suffering from severely calcified lesions. The mortality rate at four years was virtually identical between the two patient groups, at 15.6% for the Stellarex patient group and 15.2% for the control group. Secondary safety outcomes were also similar across the two groups. The four-year data also show a clinically relevant lower rate of clinically-driven target lesion revascularisation (CD-TLR) in the Stellarex DCB patient group of 28.2%, vs. 34.1% in the control group. CDTLR is a commonly used indicator of treatment efficacy durability. “The ILLUMENATE pivotal fouryear data build on the robust, consistent long-term data of the Stellarex clinical evaluation programme,” said Chris Landon, general manager of image guided therapy devices at Philips. “We continue to make relevant data available to healthcare providers in order to help them make an informed decision on the optimal treatment for often complex disease patients with peripheral arterial disease.”

BD announces long-term safety data for BTK drugcoated balloon

At the 2020 Leipzig Interventional

Course (LINC; 28–31 January, Leipzig, Germany), BD announced that interim findings from the Lutonix below-theknee (BTK) investigational device exemption (IDE) trial show positive safety results at three years for freedom from mortality, freedom from major amputation, and amputation-free survival. The clinical study is a prospective, global, multicentre, single-blind, randomised (2:1 randomisation) controlled trial comparing the Lutonix 014 drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) for the treatment of narrowed or obstructed arteries below the knee. The safety endpoints were assessed using a Kaplan-Meier analysis through 36 months for the intent-to-treat population, with 70% of patients having completed three-year follow up at the time of analysis. At 1,095 days, there is no significant difference in freedom from mortality (DCB: 81% and PTA: 81%, p=0.946), freedom from major amputation (DCB: 95.5% and PTA: 93.8%, p=0.268) or amputation-free survival (DCB: 77.8% and PTA: 77.8%, p=0.495). The Lutonix 014 DCB demonstrated statistically improved primary efficacy at six months when compared to PTA (K-M analysis), with K-M curves merging at one year. There were no statistical differences in safety or

Lutonix (BD)

efficacy beyond six months in this interim analysis. These results show that the Lutonix 014 DCB versus PTA provided statistically significant efficacy outcomes at six months with no observed safety issues out to three years. “Critical limb ischemia (CLI) is an aggressive disease affecting approximately 3.4 million patients in the USA,” said JD Meler, vice president, Medical and Clinical Affairs at BD. “The interim long-term Lutonix BTK IDE safety and efficacy data presented at LINC is a step toward advancing CLI research and finding new treatment options for this difficult-to-treat disease.” The Lutonix 014 DCB has been commercially available in Europe, Canada, and Australia for treatment of the below-the-knee arteries in patients with CLI since 2013. The product is an investigational device in the USA.

Medtronic begins pilot study as part of SPYRAL HTN clinical programme for renal denervation in hypertension patients

Medtronic has announced that it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation

March 2020 | Charing Cross Special Edition

Clinical News (RDN) system using a targeted procedural approach with a reduced number of radio frequency (RF) ablations. Set to enrol 50 patients at up to 15 sites in the USA and Europe, the single-arm study is designed to focus on ablating the distal main renal artery and primary branches to lower blood pressure utilising a simplified procedural approach. “In depth anatomical study indicates the renal nerves are closer to the renal artery in the distal renal artery and branches. Focusing the procedure on these targeted locations may help us understand if we can achieve meaningful blood pressure reductions more efficiently,” said Andrew Sharp, interventional cardiologist at the University Hospital of Wales, in Cardiff, UK, and co-principal investigator of the SPYRAL DYSTAL study. “Early evidence using this modified approach has been encouraging and we intend to build on that data with the DYSTAL study.” Renal denervation is a minimally invasive procedure intended to regulate overactivity of nerves that lead to and from the kidney, which play an important role in controlling blood pressure. “As we strive to build upon the

rigorous renal denervation studies within the SPYRAL HTN clinical programme, the DYSTAL study will help inform how we can fine-tune the procedure and continue to address the unmet need in hypertension management,” said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. Spyral HTN-OFF MED pivotal trial data at ACC.20 Results from the SPYRAL HTN OFF MED pivotal trial will be presented as a late-breaking clinical trial at the American College of Cardiology 69th Annual Scientific Sessions on 29 March, 2020, in Chicago, USA. The prospective, international, randomised, sham-controlled study is investigating the blood pressure lowering effect and safety of renal denervation with the Symplicity Spyral system in the absence of medication. “Medtronic is committed to realising the full potential of renal denervation, and we look forward to the highly anticipated results of the SPYRAL HTN-OFF MED Pivotal Trial to be unveiled at ACC in March,” said Moeller.

Market watch In addition to the SPYRAL DYSTAL Study, the Medtronic SPYRAL HTN Global Clinical Program includes the SPYRAL HTN-OFF MED Pivotal and SPYRAL HTN-ON MED trials, both prospectively powered, randomised, sham-controlled studies evaluating patients with uncontrolled blood pressure in the absence and presence of prescribed anti-hypertensive medications, respectively. The program also includes the real-world GLOBAL SYMPLICITY REGISTRY that has enrolled over 2,700 patients with the Medtronic Symplicity RDN system, including 600 patients with the Symplicity Spyral catheter. Approved for commercial use in more than 50 countries around the world, the Symplicity Spyral system is limited to investigational use in the USA, Japan, and Canada.

Ra Medical Systems announces enrolment of first patient in pivotal atherectomy clinical study

Ra Medical Systems has announced enrolment of the first patient in its pivotal study to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an atherectomy device for the treatment of peripheral vascular stenoses. “My extensive experience with DABRA in treating infrainguinal vascular occlusions gives me confidence in the safety and efficacy of the device,” said Athar Ansari, director of the

California Heart & Vascular Clinic (El Centro, USA) and the study chairman. “We are thrilled to be the first centre to begin enrolment in the atherectomy study, which represents an important next step in expanding the DABRA indications for use.” “We are committed to the successful commercialisation of DABRA and we believe that initiating patient enrolment in this study is a significant step forward in achieving this goal,” said Andrew Jackson, Ra Medical Systems CFO and interim CEO. “Furthermore, we have built a team of experienced, motivated and enthusiastic physician partners and employees to execute on this goal and we look forward to providing updates on our progress.” Ra Medical received investigational device exemption (IDE) approval for the study from the FDA in January 2020. This multicentre, open-label pivotal atherectomy clinical study will enrol up to 100 patients with symptoms of PAD (Rutherford Class 2–4). Outcome measures include safety, acute technical success and clinical success. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA, before any adjunctive treatment. Major adverse events at 30 days and incidence of primary target lesion revascularisation (TLR) at six months will be the safety and clinical success endpoints.

Charing Cross Special Edition | March 2020

Market watch

Product News Intact Vascular expands Tack Endovascular System portfolio offering

Intact Vascular has announced US Food and Drug Administration (FDA) pre-market approval (PMA) for the expansion of its Tack Endovascular System (6F) portfolio. The new approved device size is indicated for repair of post-angioplasty dissections in superficial femoral and proximal popliteal arteries ranging from 4–8mm reference vessel diameter, allowing treatment of a broader range of vessels compared to the current 6F Tack implant offering. “The Tack System performs exceptionally well when repairing dissections, which are a common occurrence following balloon angioplasty in patients with peripheral arterial disease,” commented Michael KW Lichtenberg, chief of Angiology Clinic and Venous Center, Klinikum Arnsberg in Arnsberg, Germany. “The clinical benefit of Tack implants is clear and proven as demonstrated in multiple clinical trials, peer-reviewed publications, and real-world experience. I am pleased to have a larger size implant available, giving me even greater flexibility when treating larger SFA vessels.” Arterial dissections are a frequent consequence of balloon angioplasty and can compromise clinical outcomes, leading to acute thrombosis and occlusions. These complications lower long-term patency rates and result in repeat procedures, limiting future treatment options. A first-of-its-kind, minimal metal approach for focal dissection repair, the Tack Endovascular System, repairs post-angioplasty dissections to improve outcomes for patients with peripheral arterial disease (PAD). “Being able to provide the Tack implant in sizes up to 8mm is an important product offering for our customers,” remarked Steve MacKinnon, vice president of sales for Intact Vascular. “We are excited to bring a full range of implant sizes to market and further improve outcomes for endovascular interventions.”

Biolitec reveals new ELVeS Radial 2ring Pro laser fibre for severely tortuous veins Biolitec has added another laser fibre to its ELVeS Radial 2ring laser fibre family: the ELVeS Radial 2ring Pro enables the minimally invasive endovenous laser treatment of severely tortuous veins. According to a press release, the ELVeS Radial 2ring Pro fibre has an additional canal into which saline solution can be injected directly up to the tip of the fibre using a simple Luer Lock connection at the rear end of the fibre. The pressure of the incoming

saline solution straightens bent areas and thus stretches strong windings. The laser fibre can then be pushed forward in a continuous movement. This additional function also washes residual blood from the vein compressed after tumescent local anesthesia (TLA), resulting in optimal closure of the vein. This is especially advantageous for veins with a large diameter. A further advantage is the avoidance of additional punctures in complex vein structures. A maximum of 100cm of a vein can be treated with the ELVeS Radial 2ring Pro fibre. The laser fibre can be easily inserted into the vein with a standard 6F insertion set. With the first radial fibre ELVeS Radial, which biolitec launched more than 10 years ago, the company heralded a new era in endovenous laser therapy for varicosis. Due to the 360 degrees irradiation of the inner vein walls, which is achieved in the LEONARDO laser devices of biolitec with a wavelength

ELVes (Biolitec)

of 1,470nm, surrounding tissue remains undamaged. With the ELVeS Radial 2ring laser fibres, available in two different fibre diameters, truncal veins, perforating veins, and smaller lateral branches can be treated equally well.

XableCath crossing catheters have received CE mark for peripheral use

XableCath has announced that its XableCath crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in Europe in two versions, a blunt tip and an abrasion tip, in a variety of diameters and lengths. XableCath received US Food and Drug Administration (FDA) clearance for its crossing devices last year. Physicians in the USA have had remarkable success using the XableCath crossing devices to cross challenging lesions in the peripheral vasculature. The product has been used to successfully cross recalcitrant chronic venous obstructions, including what is considered by many clinicians to be the most challenging venous procedures— crossing in-stent restenosis. “I am pleased XableCath intravascular products continue to demonstrate a high degree of safety and effectiveness crossing a variety of challenging lesions successfully in both venous and arterial disease. Our devices have helped many

patients and physicians in the USA. Now that we have achieved CE mark, we will be able to offer our crossing solution to help patients and healthcare providers in Europe. In a time where the vast majority of new products are more costly and complex than the technologies they propose to displace, it is especially fulfilling to our team to bring a new product to market that is easy to use, effectively crosses occlusions, and more favourably priced than the existing crossing devices. Economic pressures on our global healthcare system are tremendous and XableCath crossing devices were conceived to improve patient care at a lower overall procedural cost, which I believe we have achieved,” said XableCath president and chief executive officer, Lisa Dunlea. “With a CE mark, we look forward to bringing this wonderful, easy to use, and highly applicable interventional device into our Neu-Bethlehemcath-lab in Germany. Our centre conducted the first-in-man studies using the device to recanalise very challenging lesions in patients with no other interventional options and critical limb ischaemia. I am excited to bring it back more fully into my lab to help me and my patients,” said Johannes Dahm, professor of MedicineCardiology-Angiology in Göttingen, Germany.

Rist Neurovascular radial artery catheter receives FDA 510(k) clearance

Rist Neurovascular recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market the Rist Cath radial access long sheath (Rist Cath) for the introduction of interventional devices into the peripheral, coronary, and neurovascular system. Rist Cath is the first device specifically designed for the unique demands of accessing the neurovasculature through the radial artery in the wrist, enabling the full gamut of neurovascular procedures to be performed transradially. “Although transradial techniques have become the standard of care in the cardiac interventional communities, neurointerventionalists have not previously had the appropriate tools to allow these advantages for patients undergoing neurovascular procedures,” said Pascal M Jabbour, professor of neurological surgery and chief of the Division of Neurovascular and Endovascular Neurosurgery in the Department of Neurological Surgery at the Sidney Kimmel Medical College at Thomas Jefferson University (Philadelphia, USA). He continued: “Clearance of the Rist Cath provides neuroendovascular specialists a safe and durable tool to perform neuroendovascular interventions via a transradial approach, and allows us to offer improved care for patients while pushing the envelope of what our field has to offer.” “The Rist Cath was developed to meet a well-documented need

expressed among physicians conducting neurovascular surgeries,” said Martin Dieck, director, Rist Neurovascular. “This FDA clearance will allow us to make the Rist Cath broadly available to these surgeons, improving care for the millions of patients undergoing procedures to treat conditions such as stroke, brain aneurysms, and other neurovascular conditions.” While the American Heart Association has recommended a radial-first strategy for acute coronary syndrome since 2018, there has never before been an FDA cleared device that enabled the use of this strategy specifically for neurointerventional procedures. Cardiology studies have demonstrated a significant reduction in access site complications as well as mortality with radial access. Furthermore, radial access procedures offer several additional advantages, including strong patient preference, immediate ambulation, and reduced costs. At the International Stroke Conference 2020 (18–21 February, Los Angeles, USA), there were several presentations exploring the benefits of radial access for neurointerventional surgery.

Contour neurovascular system receives CE mark approval

Cerus Endovascular has received CE mark approval for its lead product, the Contour neurovascular system, for the treatment of intracranial aneurysms. The system incorporates a fine mesh braid that is deployed across the neck of the aneurysm sac and provides a combination of flow diversion and flow disruption through a single device implant. According to the company’s press release, commercial sales, via a controlled market release across the EU, are expected to begin during the second quarter of 2020. CE mark approval was based on data generated from the company’s two EU studies evaluating the safety and efficacy of the Contour neurovascular system, focusing on unruptured intracranial aneurysms. The latest, completed in 2019, was conducted at six sites in Germany, Austria, and Denmark, while the earlier study included four sites in the United Kingdom and Hungary. Data from the first study has been presented at a number of scientific conferences in early 2020, while data from the second, most recent study will be presented later this year. “As our clinical data experience grows, and more physicians use the system, results continue to be compelling—providing additional confirmation that the Contour neurovascular system delivers an important clinical option and represents a new, and potentially disruptive, standalone solution for the treatment of bifurcated saccular intracranial aneurysms compared to currently available technologies,” stated Stephen Griffin, president of Cerus Endovascular. He added: “Importantly, physicians

March 2020 | Charing Cross Special Edition vascular access surgeon at University Hospitals Birmingham (Birmingham, UK), one of the largest renal/dialysis centres in Europe. He continued: “Access surgery and subsequent maturation is a major challenge and adjuncts to improve outcomes are desperately needed. Fist Assist is a creative solution which for the first time allows patients to be involved and directly influence their clinical outcomes with a comfortable and easy-to-use device.”

Product News who have used the system have highlighted the benefits inherent in its simplicity, including a simple sizing approach of the device to the aneurysm width, ease of deliverability and controlled deployment.” “CE mark approval has propelled us from the research and development stage to a commercial stage company, and we are eager to begin this next phase by making the Contour neurovascular system available to physicians and patients across the EU in a controlled roll-out,” stated Sam Milstein, chairman of Cerus Endovascular.

Fist Assist announces CE mark and European launch

Fist Assist Devices has received CE mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the EU and other CE mark countries. Fist Assist is the only wearable, patent protected, intermittent compression device to increase vein diameter prior to fistula placement and to assist in fistula vein dilation for haemodialysis for end stage renal disease (ESRD) patients. We are thrilled to have received CE mark approval for Fist Assist. It is a huge milestone as we can now expand our commercialisation efforts beyond

Market watch

CryoLife receives CE mark for On-X Ascending Aortic Prosthesis

First Assist device (Fist Assist)

India and into the European market,” said Tej Singh, chief executive officer and founder of Fist Assist Devices. “This is a very exciting time for Fist Assist, and for patients and the European ESRD community. Our goal at Fist Assist is to improve outcomes, lower costs, and improve the patients journey through ESRD by focusing on vein dilation and enhancement.” “Fist Assist provides a patientfocused evidence-based approach to surgical vein enhancement for all types of arteriovenous fistulas and can be used to enhance veins before fistula creation as well as after surgery to improve maturation,” said Nick Inston, specialist

CryoLife has announced it has received CE mark for the On-X Ascending Aortic Prosthesis (AAP), allowing resumed distribution in the EU. The On-X AAP is indicated for the treatment of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. These associated aortic root diseases coexist in as many as 10% of all aortic valve replacements. “The absence of the On-X AAP from the market since late 2016 has hindered our ability to compete for certain mechanical valve tenders in the EU. With the receipt of the CE mark on the AAP, we once again have a complete portfolio of On-X products available in Europe, allowing us to be more competitive and potentially drive market share gains in the mechanical valve

On-X (CryoLife)

market. The On-X AAP offers the best haemodynamics of any commercially available valved conduit device, and we will resume selling the On-X AAP in the EU immediately,” said Pat Mackin, chairman, president, and chief executive officer of CryoLife. The On-X AAP is part of the On-X Heart Valve portfolio, which also includes the On-X Aortic Valve and On-X Mitral Valve. The On-X Aortic Valve was the first mechanical aortic heart valve to receive both US Food and Drug Administration (FDA) and CE mark approval for labelling to permit use with a reduced warfarin dosage, based on results of the original PROACT trial that demonstrated a greater than 60% reduction in bleeding events without increased risk of stroke. The On-X Mitral Valve is currently completing enrolment in its own PROACT (Lowered INR Mitral Arm) prospective randomised clinical trial, seeking a reduced warfarin indication similar to that of the On-X Aortic Valve.

Charing Cross Special Edition | March 2020

Market watch

Product News Merit Medical’s EmboCube and Torpedo indicated for embolisation of blood vessels

Merit Medical Systems has announced that both its EmboCube (syringe-loaded embolisation gelatin foam) and Torpedo (uniform, preshaped gelatin foam loaded into a cartridge with optional blunt stylet) devices are now US Food and Drug Administration (FDA)-indicated for the embolisation of blood vessels to occlude blood flow, which helps control bleeding and haemorrhaging in the peripheral vasculature. According to a press release, EmboCube is the only gelatin foam that is delivered precut and preloaded into a syringe for efficiency and ease of use. Torpedo provides physicians a uniformly preshaped gelatin foam loaded into a cartridge with an optional blunt stylet, removing the need for manual foam shaping, providing fast and easy attachment to the catheter for delivery. EmboCube and Torpedo are made of porcine gelatin and have no ferrous composition, making it safe for use in patients undergoing magnetic resonance imaging (MRI). “Our embolisation technologies,

EmboCube

including the EmboCube and Torpedo devices, are vital parts of Merit’s core business, which delivers physicians quality products that improve the standard of care and confer tangible patient benefits,” commented Fred Lampropoulos, chairman and chief executive officer, Merit Medical. “The new indication for EmboCube and Torpedo accurately conveys its safety and efficacy for blood flow occlusion in adult patients, and the Merit team is excited to commercialise this excellent product accordingly.”

Alvimedica introduces SFA sirolimus-eluting stent

At the Leipzig Interventional Course 2020 (LINC; 28–31 January, Leipzig, Germany), Alvimedica held a Lunch Symopsium in which they introduced a new in-stent treatment of superficial femoral artery (SFA) lesions— Nitides—a technology based on the

sustained release of Sirolimus by a SX polymer-free platform. In one lecture, Stefan Müller-Hülsbeck (Diako Hospital, Flensburg, Germany) underlined the need for drug-eluting technologies (DET) in the SFA region, demonstrating the key contribution provided by the drug in optimising device efficacy and identifying the key DES role in specific anatomical and pathological SFA settings. In light of paclitaxel safety concerns, MüllerHülsbeck concluded his talk saying that “the availability of an alternative DES— able to slowly elute a non-cytotoxic drug which results in equivalent efficacy—is warranted, as it is worth investing in innovative research in order to improve patient’s clinical outcome”. Konstantinos Katsanos (University of Patras, Patras, Greece), indicating sirolimus as the non-cytotoxic drug which may substitute paclitaxel thanks to a more favourable biological profile and high anti-restenotic properties, concluded his talk by asking: “In light of paclitaxel safety concerns in the lower limbs may sirolimus be an alternative?” After these two presentations, Andrea Kahlberg (San Raffaele Scientific Institute, Milan, Italy) took the stage introducing to the audience Nitides, the sirolimus-eluting SX DES which has the potential to be a game changer in current SFA DES landscape. This device is based on three unique technologies: Abluminal Reservoir Technology,

which allows a sustain release of the drug through a polymer free platform, Amphilimus™ formulation (Sirolimus + Fatty acid), which allows a homogeneous distribution of the drug only towards the vessel wall, and Bio Inducer Surface, a pure Carbon coating which allows an increased haemo- and bio- compatibility of the nitinol platform. The clinical proof of Nitides rationale was shown by Dierk Scheinert (University Hospital Leipzig, Leipzig, Germany) who presented the two-year results of the ILLUMINA first-in-human study which has enrolled 100 patients. In his talk he has highlighted that, although the study included complex patients and complex lesions (two patients Rutherford 5, lesions up to 140mm and 55% of moderate/heavy calcifications), the results at 24 months have been remarkable: 91.9% Freedom from device related MAE confirms long-term excellent SAFETY performance, while 93.1% Freedom from TLR states that the high product EFFICACY is maintained over long time. After a discussion among all the speakers, Ralf Langhoff (Humboldt University Berlin, Berlin, Germany) concluded this symposium saying “We now have a drug-based and stent based approach, even without a toxic PTX effect on the vessel wall: NiTiDES showed superb 24 month-data for a SFA DES strategy with the lowest TLR rate ever”.

Calendar of events 22–24 March 24th European Vascular Course (EVC) Maastricht, the Netherlands

21–24 April CX Symposium London, UK www.cxsymposium.com

www.vascular-course.com

15–15 May Critical Issues in Aortic Endografting Paris, France

17–18 April XXVIIIth Annual Pennsylvania Hospital Vascular Symposium Philadelphia, USA

www.critical-issues-congress.com

www.vascularmeeting.com

25–30 May Paris Endovascular Aortic Course Le Plessis-Robinson, France www.peacworkshop.com

29–30 May Program for Advanced Limb Preservation (PALP): The AntiAmputation Meeting New York, USA

10–12 June i-MEET 2020 Nice, France www.imeetcongress.com

17–20 June SVS Vascular Annual Meeting Toronto, Canada www.vacsular.org

25–26 June BSET: British Society of Endovascular Therapy annual meeting Wotton-under-Edge, UK www.bset.co.uk

9–11 September CX Aortic Vienna Vienna, Austria www.cxsymposium.com/cxaortic

www.palpnyc.org

September

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2019 | Issue

en: Alan Lumsd

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