Vascular News – CX Special Edition 2022 US

April 2022

CHARING CROSS SPECIAL EDITION

Featured in this issue:

www.vascularnews.com

17

A Year in Profiles Ali AbuRahma, Michael Jenkins, Joseph Bavaria and Palma Shaw page 20

AVF 2022 Venous stenting in the spotlight

The 21 studies eligible for qualitative analysis reported on 1,929,966 patients with diagnosed PAD.

Vascular & Endovascular

Challenges Update Aortic Challenges

Peripheral Arterial Challenges

Venous & Lymphatic Challenges

Acute Stroke Challenges

Vascular Access Challenges

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1,929,966

Meta-analysis: PAD symptoms in men vs. women page 29

26–28 APRIL 2022 TUESDAY-THURSDAY IN PERSON AND VIRTUAL

The Hurting Leg

H I LT O N L O N D O N M E T R O P O L E , U N I T E D K I N G D O M

Challenges

CX 2022 to face challenges and opportunities in the vascular world Anticipation is building for the Charing Cross International Symposium 2022, which this year will address some of the key challenges currently facing the vascular field—from the ongoing impact of COVID-19 on vascular patients and providers, to the pressing matter of the “hurting leg” and unnecessary amputations.

The symposium will bring together world-leading experts in the space and feature three days of in-person education in London, UK, as well as virtual and on-demand viewing options for a wider global audience.

R

unning from 26–28 April, the programme will explore challenges to practice in all vascular domains, including peripheral arterial, aortic, venous, vascular access, acute stroke, and vascular trauma.

Podium 1st presentations, live and edited cases, and workshop demonstrations will punctuate the three-day agenda to offer attendees a comprehensive educational experience.

CX 2022 has been accredited with 24 reciprocal EU/US CME credits, covering in-person, livestreamed, and on-demand content.

The symposium will open with

a dedicated session on COVID-19 challenges. Speakers from around the world will share their experiences of how the pandemic continues to affect vascular surgery patients, and representatives from multiple societies will address the pandemic’s effect on surgical training and how to move forward.

Another important focus at this year’s meeting will be the reduction of amputation. This pressing issue is due to be addressed in the peripheral arterial session and also as part of a day-long session dedicated to chronic limb-threatening ischaemia (CLTI) and “hurting leg” challenges.

Witness cutting-edge techniques and technologies

The CX Innovation Showcase returns for 2022, bringing to the fore an array of cutting-edge technologies and techniques covering peripheral, aortic, cardiovascular and venous interventions.

Among various presentations, the CX audience can expect to see a CEO roundtable discussion in which speakers from Europe and the USA will debate vascular innovation in the COVID-19 era.

Enhance skills at hands-on workshops

A series of workshops will provide attendees with the opportunity to test and improve their practical skills at handson stations showcasing techniques and technologies across all three days of the

IN.PACT™ Admiral™ Drug-Coated Balloon (DCB)

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meeting. In a dedicated Workshop Wing, attendees will have the opportunity to visit the vascular access workshop on Tuesday 26 April, venous workshops on Wednesday 27 and Thursday 28 April, and a “hurting leg” workshop on Thursday 28 April.

Celebrate the return of inperson CX

Join us at the CX 2022 Evening Reception in one of London’s most unforgettable and unique venues—The Natural History Museum—to celebrate the in-person return of CX. Taking place on the night of Tuesday 26 April, guests will enjoy an evening of drinks and canapés in the venue’s iconic event space.

For more information and to register for CX 2022, visit www.cxsymposium.com.

See five years of data at Medtronic.com/ 5yearDCB ©2022 Medtronic. All rights reserved. Medtronic and the Medtronic logo are trademarks of Medtronic.

All other brands are trademarks of a Medtronic company.

UC202215449 EN 03/2022

TRANSFORM YOUR AV FISTULA CREATION The Ellipsys™ vascular access system offers a fast, nonsurgical approach to AV fistula creation, enabling a reproducible, minimally invasive procedure that requires no implant or suture, and allows patients to leave with just a single needle stick.1

91.6 % cumulative patency at two years2

REFERENCES 1 Hull JE, Jennings WC, Cooper RI, Waheed U, Schaefer ME, Narayan R. The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access. J Vasc Interv Radiol. February 2018;29(2):149-158.e5.

2 Beathard GA, Litchfield T, Jennings WC. Two-year cumulative patency of endovascular arteriovenous fistula. J Vasc Access. May 2020;21(3):350-356.

3 Data on file at Medtronic.

4 Shahverdyan R. Comparison of Surgical (sAVF) and Percutaneous (pAVF) Arteriovenous Fistulae. Presented at LINC. January 2021.

Indications: The Ellipsys™ system is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0 mm and less than 1.5 mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

Contraindications: The Ellipsys™ system is contraindicated for use in patients with target vessels that are < 2 mm in diameter. The Ellipsys™ System is contraindicated for use in patients who have a distance between the target artery and vein > 1.5 mm.

18+ peer-reviewed publications3

Warnings § The Ellipsys™ system has only been studied for the creation of an AV fistula using the proximal radial artery and the adjacent perforating vein. It has not been studied in subjects who are candidates for surgical fistula creation at other locations, including sites distal to this location. § The Ellipsys™ system is not intended to treat patients with significant vascular disease or calcification in the target vessels. § The Ellipsys™ system has only been studied in subjects who had a patent palmar arch and no evidence of ulnar artery insufficiency. § Use only with the Ellipsys™ Power Controller, Model No. AMI-1001. § The Ellipsys™ Catheter has been designed to be used with the 6 F Terumo Glidesheath Slender™*. If using a different sheath, verify the catheter can be advanced through the sheath without resistance prior to use. § Use ultrasound imaging to ensure proper placement of the catheter tip in the artery before retracting the sheath, since once the distal tip of the catheter has been advanced into the artery, it cannot be easily removed without creation of the anastomosis. If the distal tip is advanced into the artery at an improper location, complete the procedure and remove the catheter as indicated in the directions for use. It is recommended that a follow-up evaluation of the patient is performed using appropriate clinical standards of care for surgical fistulae to determine if any clinically significant flow develops that require further clinical action.

Learn more about our new percutaneous solution for AV fistula creation

Ellipsys™

medtronic.com/ellipsys

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3,000+ successful endoAVF procedures3

HIGH technical success, maturation, and cannulation rates1,3,4

Precautions § This product is sterilized by ethylene oxide gas. § Additional procedures are expected to be required to increase and direct blood flow into the AVF target outflow vein and to maintain patency of the AVF. Care should be taken to proactively plan for any fistula maturation procedures when using the device. § In the Ellipsys™ study, 99% of subjects required balloon dilatation (PTA) to increase flow to the optimal access vessel and 62% of subjects required embolization coil placement in competing veins to direct blood flow to the optimal access vessel.

Prior to the procedure, care should be taken to assess the optimal access vessel for maturation, the additional procedures that may be required to successfully achieve maturation, and appropriate patient follow-up. Please refer to the “Arteriovenous Fistula (AVF) Maturation” section of the labeling for guidance about fistula flow, embolization coil placement, and other procedures to assist fistula maturation and maintenance. § The Ellipsys™ System is intended to only be used by physicians trained in ultrasound guided percutaneous endovascular interventional techniques using appropriate clinical standards for care for fistula maintenance and maturation including balloon dilatation and coil embolization. § Precautions to prevent or reduce acute or longer-term clotting potential should be considered. Physician experience and discretion will determine the appropriate anticoagulant/antiplatelet therapy for each patient using appropriate clinical standards of care.

Potential Adverse Events: Potential complications that may be associated with creation and maintenance of an arteriovenous fistula include, but may not be limited to, the following: § Total occlusion, partial occlusion or stenosis of the anastomosis or adjacent outflow vein § Stenosis of the central AVF outflow requiring treatment per the treatment center’s standard of care § Failure to achieve fistula maturation § Incomplete vessel ligation when using embolization coil to direct flow § Steal Syndrome § Hematoma § Infection or other complications § Need for vessel superficialization or other maturation assistance procedures.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Important Information: Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device.

UC202204790 EN ©2021 Medtronic. All rights reserved. Medtronic and the Medtronic logo are trademarks of Medtronic.All other brands are trademarks of a Medtronic company. For distribution in the USA only. 08/2021

4

CHARING CROSS SPECIAL EDITION

CX 2022

Peripheral Arterial Challenges

Present and future COVID-19 challenges in focus

Data, live cases, and discussion to tackle key peripheral arterial challenges Peripheral Arterial challenges Tuesday 26 April Kensington 1 An important focus at this year’s meeting will be challenges associated with the reduction of amputation. CX 2022 executive board member Robert Hinchliffe (Bristol, UK) will address the topic first, opening the peripheral arterial challenges session with a presentation on “Timely interventions by specialists and guideline-based treatment to reduce amputation rates,” followed by audience discussion.

The peripheral arterial session will also feature a talk on a new angioplasty balloon designed to maximise dilatation efficiency, due to be delivered

by CX 2022 executive board member Andrew Holden (Auckland City Hospital, Auckland, New Zealand), and one centred around a new hybrid approach to limit blood loss while treating large popliteal artery aneurysms, among various other presentations.

Key data in the peripheral arterial space will be highlighted in this session, including a Podium 1st on the randomised controlled NeSIC trial regarding the place of neuromuscular electrical stimulation for intermittent claudication. In addition, the CX audience will hear a 36-month update on the ZILVERPASS study, including a financial update.

Proximal arterial challenges will be another element of the session, and will feature a series of presentations on paclitaxel treatment in the femoropopliteal segment, including a US Food and Drug Administration (FDA) update on the topic.

The session will conclude with “CX Best of Peripheral Abstracts”. This will feature a series of abstract presentations, including “The OAC3-PAD risk score predicts major bleeding events at one year after hospitalisation for peripheral artery disease”, due to be presented

by Christian-Alexander Behrendt (University Heart & Vascular Center, Hamburg, Germany), as well as a systematic review and network metaanalysis on antithrombotic therapy for peripheral arterial disease. The value of duplex ultrasound surveillance protocol in early detection and salvage of failing infrainguinal bypass vein grafts will also be underlined.

CX Peripheral Techniques & Technologies (live & edited live cases) Wednesday 27 April Kensington 2 A new feature of the peripheral arterial programme this year will be a whole day of live and edited cases. The session will feature a series of live cases with Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany), a member of the CX 2022 executive board, interspersed with edited cases by Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium), Michael Lichtenberg (Vascular Center Arnsberg, Klinikum Hochsauerland, Arnsberg, Germany) and Arne Schwindt (St Franziskus Hospital, Münster, Germany).

COVID challenges 08:00–10:00 Tuesday 26 April Kensington 1 CX 2022 will open with a dedicated session on the effect of COVID-19 challenges upon vascular management, addressing present and future issues.

Speakers from around the world— including from the UK, Mexico, Finland, Italy, France, and The Netherlands—will share their experiences of how the pandemic has affected and continues to affect vascular surgery patients.

The session will also address how COVID-19 poses a significant challenge to skills learning and training of vascular specialists across the globe.

Representatives from a number of societies will take to the podium: ● J ames Rammell (Freeman Hospital, Newcastle, UK) will deliver the Rouleaux club view, speaking on COVID-19 and vascular surgical training in Great Britain and Ireland ●S tefano Ancetti (Sant’Orsola-Malpighi Hospital, Bologna, Italy) will give a presentation on COVID-19 as seen by the European Society for Vascular Surgeons in Training (EVST) ●S ophie Renton (North West London Hospitals National Health Service Trust, London, UK) will outline COVID-19 challenges in the final Board Qualification in Surgery ●P alma M Shaw (Upstate Medical Center, Syracuse, USA) will highlight the standpoint of the World Federation of Vascular Societies (WFVS) ● J ason T Lee (Stanford University, Stanford, USA) will give the Society for Vascular Surgery (SVS) view.

CHARING CROSS SPECIAL EDITION Editor-in-chief:

Roger Greenhalgh

Publisher:

Roger Greenhalgh

Content Director: Urmila Kerslake

Editor:

Jocelyn Hudson Jocelyn@bibamedical.com

Editorial contribution:

Jamie Bell, Sarah Croft, Bryan Kay and Will Date

April 2022

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26–28 APRIL 2022 TUESDAY-THURSDAY

IN PERSON AND VIRTUAL

NEW VENUE H I LT O N L O N D O N M E T R O P O L E , U N I T E D K I N G D O M

Aortic Challenges

Peripheral Arterial Challenges

Venous & Lymphatic Challenges

Acute Stroke Challenges

Vascular Access Challenges

The Hurting Leg Challenges

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2 10:54

April 2022

CHARING CROSS SPECIAL EDITION

CX 2022

Aortic Challenges

Arch repair, radiation reduction and stroke prevention Abdominal Aortic Challenges Wednesday 27 April Kensington 1 Thoracic Aortic Challenges Thursday 28 April Kensington 1 The aortic challenges programme aims to highlight novel approaches to the most pressing abdominal, thoracic and juxtarenal aortic, as well as radiation, challenges and focus on advancements at the forefront of the aortic field.

According to Stéphan Haulon (Hôpital Marie Lannelongue, GHPSJ, Paris, France), arch repair is among the important areas for discussion in the aortic space. “The next challenge in the aortic world is the repair of the arch,” Haulon, a member

Vascular Access Challenges

Vascular Access Masterclass to address challenges in creation, maturation, maintenance and salvage Wednesday 27 April Richmond This year’s Vascular Access Masterclass will cover challenges in creation, maturation, maintenance and salvage of vascular access.

New approaches, new devices and new evidence that have come to the forefront in recent years will also be discussed.

An array of case studies in access, featuring interactive, multidisciplinary discussion with the CX audience, will complement a series of presentations.

Robert Jones (University Hospital

of the CX 2022 aortic executive board, comments, reflecting on the important talking points ahead of the April event. “We now have a couple of devices with three branch options—total endovascular repair of the arch, a percutaneous approach, or to have a less or minimally invasive approach.

Tara Mastracci (Barts Health NHS Trust, London, UK) reflects on the importance of developing more accurate fusion technologies and non-ionising radiation guidance. Techniques and technologies aimed at reducing radiation dosage and exposure are set to feature prominently throughout the CX 2022 programme.

“Technically, intraoperatively, getting more accurate fusion technology is something that I am super excited about, and I am excited to learn more about aortic deformation,” says Mastracci. “I cannot wait to see how the technologies emerge for non-ionising radiation guidance and other ways that we can use vessel guidance in the operating room that does not expose us to radiation.”

New techniques to prevent stroke in thoracic endovascular aortic repair (TEVAR) are among the important areas highlighted by Tilo Kölbel (University Heart Center Hamburg, Hamburg, Germany), who also sits on the CX 2022 aortic executive board.

“The most pressing aortic challenges that I look forward to learning more about at CX 2022 and seeing the discussion about new techniques is stroke during TEVAR,” says Kölbel. “There are some new techniques that make stroke less likely to occur during TEVAR including carbon dioxide flushing. I know that there are new data prepared to be shown at CX 2022 and I look forward to seeing those.”

Birmingham NHS Foundation Trust, Birmingham, UK) will talk through a case entitled “When lines don’t work”, Robert Shahverdyan (Asklepios Clinic Barmbek, Hamburg, Germany) will speak on non-maturing endovascular arteriovenous fistulas (AVF), Alexandros Mallios (Groupe Hospitalier Paris Saint Joseph, Paris, France) will outline a procedure featuring perforator stenosis in a percutaneous AVF, and Ulf Hedin (Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden) will address haemodialysis vascular access in elderly patients.

Non-dialysis vascular access will be another topic on the agenda, covering issues such as vascular access hyperlipidaemia and therapeutic apheresis, vascular access and haemorrhagic and thrombotic disorders, vascular access and sickle cell disease, and vascular access and neurological diseases.

In addition, CX viewers will hear presentations on new technologies and new sites, including an edited case

by Panagiotis Kitrou (University of Patras, Patras, Greece) entitled “Not just creating an endovascular AVF, making a difference”.

The CX audience can expect to see Podium 1st presentations on 12-month results from the ISABELLA trial and on 36-month results from the IN.PACT AV Access study in this session.

Venous & Lymphatic Challenges

7

Programme highlight:

Live and edited cases to show cutting-edge techniques CX Aortic Techniques & Technologies Tuesday 26 April Richmond The aortic programme will also feature a session on techniques and technologies. This will consist of a series of 10-minute videos, each followed by 10 minutes of discussion. Challenges associated with procedure approach and the aortic arch will be addressed, after which experts in the field will showcase various aortic techniques. CX viewers will have the opportunity to watch a series of live and edited cases from specialists including Martin Funovics (Medical University of Vienna, Vienna, Austria), Maani Hakimi (Lucerner Kantonsspital, Lucern, Switzerland), Kevin Mani (Uppsala University, Uppsala, Sweden), Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands), and Giovanni Torsello (St Franziskus Hospital, Münster, Germany). One edited case will also be a Podium 1st presentation, during which Reijnen will present three-year ANCHOR study results on wide necks, arguing that “ESAR is more than reinforced proximal seal”. The audience will also have the chance to view a live G-Branch (Lifetech Scientific) case from Wei Guo (Chinese PLA General Hospital, Beijing, China)—another Podium 1st presentation.

Venous and lymphatic session to tackle appropriate care conundrums

Tuesday 26 April Kensington 2 CX 2022 executive board members Stephen Black (King’s College London, London, UK), Manjit Gohel (Addenbrooke’s Hospital, Cambridge, UK), Armando Mansilha (University of Porto, Porto, Portugal), and Erin Murphy (Sanger Heart and Vascular, Atrium Health, Charlotte, USA) have designed a comprehensive venous and lymphatic programme spanning the superficial, deep and pelvic veins, as well as the lymphatic system and venous wounds. This year’s programme will cover various challenges in the field—ranging from appropriate care conundrums to venous challenges in relation to the “hurting leg”.

Addressing appropriate care challenges, experts will speak on the extent of the ‘overtreatment’ problem in venous disease, consider the value of the recently published European Society for Vascular Surgery (ESVS) venous guidelines for promoting evidence-based care, deliberate how to curtail inappropriate care in venous disease interventions, and highlight the importance of registries in promoting good venous management.

Another subject on this year’s programme is venous stenting. While this is “primarily a deep venous intervention,” says Murphy, she stresses that the superficial and deep venous systems are related and that both need to be taken into account in the patient interest. “It is really not unusual anymore that we need to be considering both interventions,” Murphy believes.

New to this year’s venous and lymphatic programme will be the inclusion of a series of edited cases within the main programme to illustrate data, a change endorsed by Murphy, who explains that she will be presenting cases focusing on the recognition and management of some venous complications that have recently come to the attention of specialists. “We are starting to see some very unusual things along with stent occlusions,” she notes. Murphy stresses the importance of seeing not only how these complications can be fixed, but also how they can be prevented in the first place.

8

CHARING CROSS SPECIAL EDITION

CX 2022

The Hurting Leg Challenges

CX 2022: A conversation with Robert Hinchliffe 10:30–12:30 Thursday 28 April Kensington 2

Robert Hinchliffe (University of Bristol, Bristol, UK) shares his excitement about attending the upcoming CX Symposium in April. “CX has always represented an unprecedented opportunity to share new techniques and to analyse the latest and best clinical trials across vascular interventions,” the CX 2022 executive board member tells Vascular News. This year, a highlight for Hinchliffe will be a session on the “hurting leg,” which is due to take place on the final day of the in-person and virtual meeting. “We would all agree that a large component of our practice is patients who present with lower limb problems,” says

Acute Stroke Consensus

Dedicated session to address key acute stroke challenges 16:00–18:00 Tuesday 26 April Kensington 1 This year’s acute stroke programme will feature a series of debates on key topics in the space.

Opening the session, Michael Stoner (University of Rochester Medical Center, Rochester Hills, USA) and Gert Jan de Borst (University Medical Centre Utrecht, Utrecht, The Netherlands) will consider whether or not transcarotid artery revascularisation (TCAR) is a safe and effective alternative to transfemoral carotid artery stenting (CAS) or carotid endarterectomy (CEA) in the treatment of patients with symptomatic internal carotid artery stenosis.

“Treatment of asymptomatic

April 2022

Hinchliffe, emphasising the significance of the to raise awareness of the hurting leg. He notes topic. He also highlights the fact that patients are that, in other cardiovascular arenas in the UK, presenting late in many cases—which could well a number of campaigns to raise the awareness explain high amputation rates. In light of of stroke, and the timely treatment of this, he previews that CX 2022 “will be stroke, appeared to be “very effective”. a really fantastic opportunity to assess “Clearly, there needs to be research to these really troublesome patients”. understand how to make the biggest “Hurting legs are a very emotive issue difference and how to reach those for patients,” Hinchliffe relays, adding hard-to-reach groups,” he urges. that they are a “common problem” for “Fundamentally, I think it is a question of vascular specialists. Unfortunately, Robert Hinchliffe raising awareness both among patients however, he highlights that “these problems are not managed particularly well within vascular centres, and it is unclear why this is the case”. Hinchliffe hopes that “CX 2022 will really shine a spotlight on the need to improve evidence in this area, and give an opportunity to share the latest ideas and cutting-edge research”.

In his own practice, Hinchliffe recognises outcome variation between regions and within regions. He points out that while this is “complex problem,” patient engagement is “really quite key”. Another issue lies in the interdisciplinary nature of patient management, says Hinchliffe. He elaborates that patient management spans primary care, all the way through to more specialist interventions by other and healthcare professionals and usually in vascular surgeons, interventional radiologists, or primary care.” cardiologists. “We really have not fostered good This year, the CX Symposium will be held in relationships between professionals,” he says, person for the first time since 2019. After a twounderlining the problem. Hinchliffe believes that year COVID-19-induced hiatus, Hinchliffe is keen CX 2022 “presents an opportunity to deal with, to get back to face-to-face meetings. “It will be and shine a light on these problems, providing really fantastic to be back at the CX Symposium,” the opportunity to improve communication and he says, describing it as “an opportunity to meet pathways between groups of professionals”. old friends and hopefully meet some new ones” in Finally, Hinchliffe highlights an ongoing need addition to its educational offerings.

internal carotid artery stenosis should only be performed when there is a risk of periprocedural 30-day stoke and a death rate of 2% or less” will be the topic of a debate between Hans-Henning Eckstein (Technical University of Munich, Munich, Germany) and Alison Halliday (University of Oxford, Oxford, UK), after which Alun Davies (Imperial College & Imperial Healthcare NHS Trust, London, UK) and Pirkka Vikatmaa (University of Helsinki and Helsinki University Hospital, Helsinki, Finland) will consider the motion “50–70% of symptomatic carotid artery stenosis should be managed with best medical treatment without carotid endarterectomy”.

In another debate, Dominick McCabe (Tallaght University Hospital/Adelaide and Meath Hospital, Dublin, Ireland) and Henrik Sillesen (University of Copenhagen, Copenhagen, Denmark) will deliberate whether or not the majority of patients with transient ischaemic attack (TIA)/ischaemic stroke who have concomitant atrial fibrillation and carotid artery stenosis should be treated with anticoagulation alone.

Finally, Gert Jan de Borst and Domenico Valenti (King’s College Hospital, London, UK) will address the motion “Dissecting aneurysms should only be treated medically, not with stenting or surgery”.

CX 2022 will really shine a spotlight on the need to improve evidence in this area, and give an opportunity to share the latest ideas and cutting-edge research.”

Vascular Trauma

Vascular trauma challenges

08:00–10:00 Thursday 28 April Richmond In the vascular trauma challenges session at CX 2022, experts will cover a range of topics, including endovascular bridges to definitive care, neck and extremity vascular trauma, and torso challenges.

This year’s programme—compiled by CX 2022 executive board members Christopher Aylwin (Imperial College Healthcare NHS Trust, London, UK) and Ross Davenport (Queen Mary University of London, London, UK)—will feature a series of presentations as well as a CX debate, all punctuated by audience discussion.

The session will first address endovascular bridges to definitive care, with speakers addressing the P-PRO trial on pre-hospital resuscitative endovascular balloon occlusion of the aorta (REBOA) and extracorporeal membrane oxygenation (ECMO) in trauma.

Addressing neck and extremity vascular trauma, presenters will cover topics including blunt subclavian injury, penetrating neck injuries, and the management challenges associated with knee dislocation for trauma units.

Torso challenges will also be addressed, with experts due to highlight open approaches to visceral arterial and portal vein injuries, as well as five-year results from the RESCUE trial on the management and treatment of patients with blunt trauma aortic injury. The endovascular treatment of traumatic aortic injuries will be considered, as will and inferior vena cava (IVC) filters in trauma and non-trauma use.

This part of the programme will also feature a CX debate, in which Rachel Bell (Freeman Hospital, Newcastle, UK) and a second speaker to be confirmed will deliberate whether or not outcomes in vascular trauma patients should be included in the National Vascular Registry.

Programme highlight: DATA: Five-year results from the RESCUE trial on the management and treatment of patients with blunt trauma aortic injury.

CHARING CROSS SPECIAL EDITION

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April 2022

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April 2022

CHARING CROSS SPECIAL EDITION

CX 2022 11

AT-A-GLANCE GUIDE

CX 2022 exhibitors and major sponsors A-Z PLATINUM SPONSORS ■ Gore Booth 26

With more than 50 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers.

www.goremedical.com

■ Medtronic Booth 25

We lead global healthcare technology, boldly attacking the most challenging problems. Our mission—to alleviate pain, restore health, and extend life—unites a global team of 90,000+ people, and our technologies transform the lives of two people every second, every hour, every day. Expect more from us. Medtronic. Engineering the extraordinary.

www.medtronic.com

GOLD SPONSORS ■ Artivion Booth 11

Artivion is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major product groups include: aortic stents and stent grafts, surgical sealants, mechanical heart valves, and implantable cardiac/vascular human tissues.

www.artivion.com

■ Concept Medical Booth 12

Concept Medical, headquartered in Tampa, USA, specialises in developing drug-delivery platform technology and products for the treatment of coronary and peripheral arterial disease (PAD).

Concept Medical has developed sirolimus-coated balloons with the help of its proprietary Nanolute technology like the MagicTouch PTA for superficial femoral artery (SFA) and below the knee (BTK), and MagicTouch AVF for dysfunctional arteriovenous fistula/ graft (AVF/G). MagicTouch PTA is CE approved for PAD treatment and has received Breakthrough Device designation in BTK indications by the US Food and Drug Administration (FDA). MagicTouch AVF is CE approved for the treatment of

dysfunctional AVF and AVG and has received US FDA Breakthrough Device designation for both these indications.

Visit Concept Medical at booth #12 and watch the scientific session to know more about the innovative and upcoming treatment strategy in PAD.

www.conceptmedical.com

■ Cook Medical Booth 9

Since 1963, Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today, we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: our patients, our employees and our communities. Visit our website to find out more, and for the latest news, follow us on Twitter, Facebook and LinkedIn.

www.cookmedical.com

■ Getinge Booth 10

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

■ Terumo Aortic Booth 8

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

www.terumoaortic.com

SILVER SPONSORS ■ BD Booth 2

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of

care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare.

www.bd.com

■ Bentley Booth 6

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 have 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 the market leader.

www.bentley.global

■ Cordis Booth 7

With a more than a 60-year history of pioneering products to treat millions of patients, Cordis is a worldwide leader in the development and manufacturing of interventional cardiovascular technology. Cordis established a legacy of high-quality and minimally invasive cardiovascular products; and has built a robust global footprint with operations in more than 60 countries around the world. As of 2 August, 2021, Cordis is an independent company and is committed to investing US$300 million to accelerate innovation and broaden its product portfolio offering. Building on our storied brand, we are unleashing our potential to be a 10X valued leader bringing new technology to the market through bold action at speed.

www.cordis.com/emea/home

■ Endologix Booth 5

Endologix is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. We have a therapeutic portfolio designed to treat diseases that currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.

With a robust pipeline of disruptive technology, our vision is to provide physicians with the best device for each patient; because, when it comes to ensuring patient wellbeing, we are never satisfied with the status quo.

www.endologix.com

■ Philips Booth 13

At Philips, we look beyond technology to the experiences of consumers, patients, providers and caregivers across the health continuum—from

healthy living and prevention to diagnosis, treatment and home care. We unlock insights leading to innovative solutions that address the quadruple aim: improved patient experience, better health outcomes, improved staff experience, and lower cost of care. With leading research, design and innovation capabilities, we partner with our customers to transform the delivery of healthcare.

www.philips.com

■ Shockwave Booth 14

Shockwave Medical is 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 the treatment of calcified atherosclerotic cardiovascular disease through our differentiated and proprietary local delivery of sonic pressure waves called ‘Intravascular Lithotripsy’.

www.shockwavemedical.com

EXHIBITORS ■ Boston Scientific F20

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

■ BIBA MedTech Insights and BIBA Publishing Ground floor

BIBA MedTech Insights is a leading provider of market analysis services.

We serve medical professionals and organisations in the medical device industry worldwide. Our research products include quarterly monitors, customised research, and tailored services. BIBA Publishing is a specialist publisher of nine news titles for different medical communities, including Vascular News, Venous News, Interventional News, Renal Interventions, Cardiovascular News, Vascular Specialist, and NeuroNews.

www.bibamedtech.com www.bibapublishing.com

■ CX Live Studio Level 2

The CX Live Studio is run by the video production division of BIBA Medical. The 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 2022.

www.cxsymposium.com/cx-news

Advancing Aortic Technologies with Purpose™ Our decades of expertise in providing cardiac and vascular surgeons with solutions to treat patients with aortic diseases—coupled with our recent acquisitions and partnerships— have collectively empowered our intentional focus on offering life-changing aortic-centric technologies.

Artivion, CryoLife, and Jotec are trademarks owned by Artivion, Inc. or its subsidiaries. © 2022 Artivion, Inc. All rights reserved. Note: All products and indications are not available/approved in all markets.

MLENG1528.000 (2022-01)

Learn more at artivion.com

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April 2022

CHARING CROSS SPECIAL EDITION

CX 2022 13

AT-A-GLANCE GUIDE

CX 2022 exhibitors and major sponsors A-Z contd.

■ Cydar Medical F15

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

■ Inari Medical Booth 4

Inari Medical is a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases. Inari has developed two minimally invasive, novel, catheterbased mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purposebuilt its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism (VTE): deep vein thrombosis and pulmonary embolism.

www.inarimedical.com

■ Kreussler Pharma F14

The company Kreussler Pharma is the originator of Aethoxysklerol (API Polidocanol) for sclerotherapy of all types of varicose veins. Sold in more than 50 countries, Aethoxysklerol is considered as the world’s leading sclerosing agent. Since the end of 2018, Aethoxysklerol is registered as a liquid sclerosant and foam application in the UK.

www.kreussler.com

■ Laminate Medical F12

Laminate Medical Technologies develops solutions for the most significant challenges preventing fistula use in dialysis patients. Laminate’s flagship product, the VasQ external support, is implanted around the arteriovenous anastomosis during fistula creation and aims to address the high rate of primary failure and repeat procedures experienced by haemodialysis patients.

www.laminatemedical.com

■ LimFlow SA

When all other therapeutic options have been exhausted and a chronic limb-threatening ischaemia (CLTI) patient is facing major amputation, the minimally invasive LimFlow system is

designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins. For many patients, restoring perfusion in the lower limbs resolves chronic pain, improves quality of life, enables wound healing, and prevents major amputation.

www.limflow.com

■ Lombard Medical Booth 15

Lombard Medical is a UK-based medical device company focused solely on the minimally invasive treatment of abdominal and thoracic aortic disease. Our partnership with MicroPort Endovastec allows us to span the endovascular aneurysm repair (EVAR), thoracic endovascular aortic repair (TEVAR) and fenestrated EVAR (FEVAR) markets, adding even more treatment options to the physician’s armamentarium.

www.lombardmedical.com

■ LSO Medical Booth 21

Founded in 2002, LSO Medical is a French company that designs, manufactures and sells lasers. With tens of thousands of procedures performed per year, the laser Endotherme 1470 has become a highly qualitative solution worldwide to ensure an optimal efficacy and safety in varicose vein treatment. At CX 2022, LSO Medical will present its new endovenous laser: the Lumeseal.

www.lsomedical.com

■ MedAlliance Booth 17

MedAlliance, a privately owned medical technology company, develops breakthrough proprietary technology for the treatment of peripheral and coronary artery disease. Selution SLR, the latest generation of sirolimus drug-eluting balloon (DEB) technology is specifically designed for peripheral uses, offering a prolonged therapeutic effect thanks to its unique sustained drug release for up to 90 days.

www.medalliance.com

■ Merit Medical Booth 16

Merit Medical offers an integrated portfolio of products designed to support your vascular surgery procedures, dialysis, peripheral vascular interventions, interventional radiology, and cardiology. We bring you innovative solutions for vascular challenges. Join our educational sessions and stop by our booth to learn more.

www.merit.com

■ Penumbra Booth 3

Penumbra, headquartered in Alameda, USA, is a global healthcare company focused on innovative therapies.

Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra supports healthcare providers, hospitals and clinics in more than 100 countries. For more information, visit our website and connect on Twitter and LinkedIn.

www.penumbrainc.com

■ Pie Medical Imaging F11

Pie Medical Imaging is simplifying clinicians’ daily practice with the user friendly 3mensio vascular preoperative planning software; developed specifically for endovascular aneurysm repair (EVAR), thoracic endovascular aortic repair (TEVAR) and fenestrated EVAR (FEVAR) interventions. We cordially invite you to our booth during Charing Cross to test-drive 3mensio yourself.

www.piemedicalimaging.com

■ Scanlan Booth 1

Celebrating 100 years and our journey continues. The highest quality surgical instruments designed and manufactured by the Scanlan family since 1921. Experience the Scanlan difference at our exhibit at booth #1.

www.scanlaninternational.com

■ Shanghai MicroPort Endovascular MedTech Booth 15

Endovastec is a listed medical device company owning 18 approved, selfdeveloped products and more than 170 authorised patents. Since being founded in 2012, the company has been devoted to providing trustworthy and universal solutions for unmet clinical demands in vascular circulatory diseases in order to benefit more patients.

www.endovastec.com/en

■ Shape Memory Booth 22

Shape Memory Medical is reshaping clinical success through the science of smart polymer. Smart polymer upgrades device performance and redefines embolisation possibilities. Our conformable smart polymer delivers unparalleled volume, returns imaging clarity, and promotes healing as the material absorbs. We continue to drive a cross-speciality portfolio to meet procedural demands.

www.shapemem.com

■ Stille Booth 23

Stille is one of the oldest medical device companies in the world. At Stille, we develop, produce, and sell high-quality surgical instruments and

surgical imaging tables to physicians worldwide, and have done so for about 180 years.

www.stille.se

■ Teleflex Booth 24

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, surgery, 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

■ VB Devices F13

VB Devices is a Barcelona-based startup founded in 2016 by vascular surgeon Enric Roche. The company develops unique medical devices that resolve practical clinical needs in vascular medicine and at the same time add standardisation and versatility.

www.vbdevices.com

■ Veryan Medical Booth 20

Veryan Medical, an Otsuka Medical Devices company, is committed to transforming the lives of patients suffering from peripheral vascular disease. Its BioMimics 3D stent has a unique three-dimensional helical shape, designed to impart natural curvature to the femoropopliteal artery to promote swirling flow and elevate wall shear, which are patency-protective.

www.veryanmed.com

■ Wisepress Medical Bookshop Booth 18

Wisepress.com, Europe’s leading conference bookseller, attends around 200 conferences every year. We have an extensive range of books and journals relevant to the themes of this conference available at our booth.

We also have a comprehensive range of STM titles available on our online bookshop. Follow us on Twitter at @ WisepressBooks.

www.wisepress.com

■ Ziehm Imaging Booth 19

Since 1972, Ziehm Imaging has produced technologies that enhance imaging and streamline clinical workflows. Our devices’ exceptional image quality and flexibility in the operating room serve as an important basis for treatment success.

Ziehm Imaging is specialised in the development and manufacture of mobile C-arms.

www.ziehm.com

CHARING CROSS SPECIAL EDITION

14 CX 2022

CX 2022 highlights new data in the vascular world

Hospital, Arnhem, The Netherlands), who will deliver three-year ANCHOR study results on wide aortic necks as well as an edited case on the topic. ● Wednesday 27 April

April 2022

give a presentation on how endovascular repair computed tomography (CT) scans can predict patients at risk for failure after ruptured abdominal aortic aneurysm.

As part of the Vascular Access Masterclass, Tjun Tang (Singapore General Hospital, Singapore) will deliver 12-month results from the ISABELLA trial on endovascular salvage of failing arteriovenous fistulas (AVFs) utilising sirolimus-eluting balloons, and Andrew Holden (Auckland City Hospital, Auckland, New Zealand) will present 36-month results from the IN.PACT AV Access study.

The abdominal aortic programme features three Podium 1st presentations: Cydar executive director Tom Carrell (Barrington, UK) will speak on how artificial intelligence can make aortic A series of 15 Podium 1st presentations repair outcomes more predictable; Fadi Taher will punctuate the comprehensive CX 2022 (Klinik Ottakring, Vienna, Austria) will outline the programme, highlighting new data in all technical success of fenestrated endovascular vascular domains. aortic repair after prior endovascular ● Thursday 28 April repair, and Kevin Mani (Uppsala ● Tuesday 26 April University, Uppsala, Sweden) will In the thoracic aortic session, Jeandiscuss the relation between Pierre Becquemin (Hospital Paul In the peripheral arterial session, Alun Davies volume and outcome in aortic D Egine, Champigny-sur-Marne, (Imperial College London, London, UK) will surgery and failure to rescue.

France) will deliver a Podium speak on the place of neuromuscular electrical Speaking on type II endoleak 1st on the validation of thoracic stimulation for intermittent claudication, challenges, Hence Verhagen endovascular delivering results from the randomised controlled (Erasmus Medical Centre, aortic repair results across multiple NeSIC trial.

Rotterdam, The Netherlands) will diseases based on a French Scheduled to address the audience of the offer key insights from the ENGAGE experience. deep venous session, Mitchell Silver (Riverside registry, detailing how sac regression at Radiation reduction will be a key 15 Podium Methodist Hospital, Columbus, USA) will deliver one year affects all-cause mortality at topic on the aortic agenda, which 1st presentations new results from the CLEAR-DVT trial, designed extended includes a Podium 1st on the role to assess contemporary endovascular therapies time points. of intravascular ultrasound (IVUS) for in situ in the treatment of acute iliofemoral deep vein Results from the CARIBE study on sizing and technical assessment of directional thrombosis (DVT). preservation of the iliac arteries, due to be branches during branched endovascular aortic The aortic programme will feature a session on delivered by Fabio Verzini (University of Turin, repair, due to be presented by Michele Antonello techniques, during which the CX audience will Turin, Italy), will also feature on the aortic (University of Padua, Padua, Italy). Finally, have the opportunity to watch Wei Guo (Chinese programme. addressing chronic limb-threatening ischaemia PLA General Hospital, Beijing, China) perform a In the ruptured abdominal aortic session, challenges, Andrew Holden will outline a G-Branch (Lifetech Scientific) live case. Viewers Jean Paul de Vries (University Medical Centre first-in-human experience with an ai16486549595_CX2022 EVENING RECEPTION-INHOUSE-HALFPAGE-220X153.pdf 1 30/03/2022 16:42:39 will also hear from Michel Reijnen (Rijnstate Groningen, Groningen, The Netherlands) will intravascular lithotripsy system.

Join us at one of London’s most unforgettable and unique venues, the Natural History Museum, to celebrate the return of CX coming together, sharing ideas, best practice and consensus. Taking place on the Tuesday night of the CX Symposium, guests will enjoy an evening of drinks and canapés in the venue’s most iconic event space.

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CX2022 EVENING RECEPTION

Tickets are subject to availability online and onsite at registration, £50 per person. www.cxsymposium.com/cx2022reception Location: Natural History Museum, Cromwell Road, SW7 5BD

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Date: Tuesday 26th April 2022

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T U E S D AY 2 6 A P R I L 2 0 2 2

Timings: 7pm - 9pm

N AT U R A L H I S T O R Y M U S E U M

Coaches will be provided from the Hilton London Metropole from close of programme on the 26 April

www.cxsymposium.com/cx2022reception

Dress code: Smart casual

WWW.CXSYMPOSIUM.COM

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April 2022

CHARING CROSS SPECIAL EDITION

VENOUS

Conference Coverage 17 for acute thrombotic, post-thrombotic and non-thrombotic indications at their institution between 2014 and 2021, grouping patients based on the use of novel dedicated venous stents versus non-dedicated stents during their treatment.

The team measured 30-day stent failure and one-year patency rates as primary outcomes, Tran detailed, adding that secondary outcomes included stent technical considerations and sizing and extension. stent attributes. “In addition to A total of 135 patients (186 adequate sizing and consistency limbs) were treated in the in deployment, […] venous study, Tran told AVF attendees, stents must establish a balance specifying that 63 limbs were between radial force, flexibility treated using novel dedicated Lillian Tran and crush resistance,” she stents, while 123 were treated informed the audience. Tran using the traditional Wallstent or detailed that dedicated, nitinol-based another non-dedicated stent. stents have been developed to meet these The team noted no preference in requirements and are now on the market stent type in treating acute thrombotic in the USA and Europe. Four of these or post-thrombotic lesions at their stents have been approved by the US Food and Drug Administration (FDA) for venous indications, the presenter relayed, noting however that the Vici (Boston Scientific) and the Venovo (BD) stents were recalled last year.

Outcomes data from investigational device exemption (IDE) trials of the four dedicated venous stents have demonstrated excellent patency rates, Tran communicated. However, she highlighted that head-to-head, comparative performance data against the more traditional Wallstent (Boston Scientific) and other non-dedicated stents are limited.

Tran et al therefore performed a retrospective review of all patients who underwent iliofemoral venous stenting

Dedicated vs. non-dedicated: Researchers place venous stenting under the spotlight at AVF 2022 VENOUS STENTING WAS A HOT topic on the agenda of the recent American Venous Forum (AVF) annual meeting (23–26 February, Orlando, USA). Catching the audience’s attention, one presenter highlighted a head-to-head study of dedicated versus non-dedicated stents.

“Iliofemoral venous obstruction, when not adequately treated, results in chronic debilitating disease and poor quality of life,” said Lillian Tran (University of Pittsburgh Medical Center, Pittsburgh, USA), who noted that deep venous stenting is “increasingly preferred” as the mainstay treatment over medical therapy alone.

According to Tran, this move towards stenting necessitates studies comparing the performance of novel, dedicated venous stents with more traditional, nondedicated stents. At AVF, Tran reported the findings of such a head-to-head study at a single centre, detailing that the use of dedicated venous stents was associated with a significant reduction in extension into the inferior vena cava (IVC) without reduced early patency rates compared to non-dedicated stents.

The presenter stressed that outcomes after iliac vein stenting rely on multiple

We found a significant reduction in extension into the IVC, total number of stents deployed and mean stent diameter with the use of novel dedicated venous stents.”

Six-month CLOUT data indicate ClotTriever can effectively remove full spectrum of thrombus Six-month outcomes from the ongoing CLOUT registry demonstrate the “safety and efficacy” of the ClotTriever thrombectomy system (Inari Medical) in a real-world deep vein thrombosis (DVT) population regardless of clot chronicity level, the 2022 annual meeting of the American Venous Forum (AVF; 23–26 February, Orlando, USA) heard.

DAVID DEXTER (EASTERN Virginia Medical School and Sentara Vascular Specialists, Norfolk, USA) was delivering the latest subgroup analysis update from the prospective, multicentre study on behalf of the CLOUT registry investigators based on the first 250 patients enrolled at 24 sites. “We were able to meet the performance goal of greater than 75% in all three [chronicity] groups,” Dexter told attendees. “We had remarkably low device-related serious adverse events at one month. And our rates of post-thrombotic syndrome [PTS]—including moderate to severe—at six months were similarly low.”

The data from the registry show 33% of the 250 patients with acute thrombus, 35% with subacute and 32% with chronic.

Almost all procedures were single session, with an average of four passes using the ClotTriever device for all chronicity subgroups, Dexter said. No patients required adjunctive thrombolytics. Adjuvant angioplasty was used in 73% (acute: 70%; subacute: 68%; chronic: 84%) and stents in 47% (acute: 46%; subacute: 42%; chronic: 50%) of cases.

Complete or near-complete thrombus removal was

achieved in 85% (acute: 90%; subacute 81%; chronic: 84%) of limbs, including 51% (acute: 54%; subacute: 49%; chronic: 49%) with 100% thrombus removal.

The post-thrombectomy median hospital stay was one day for all subgroups.

At six months, 90% (acute: 86%; subacute: 89%; chronic: 96%) of the treated limbs had flow present, and 90% (acute: 84%; subacute: 90%; chronic: 91%) were compressible. Any PTS at six months was about 20% in the acute, 25% in the subacute and 30% in the chronic arms.

“Statistically, this has a p value of 0.5—we will see how that holds out in another two years when we have finished enrolment of 500 patients,” Dexter said. On the other hand, moderate-tosevere PTS, “was remarkably low at 5% in the acute arm, and about 10% in the subacute and chronic arms.”

Major adverse events and serious

institution, however they did observe that novel dedicated venous stents were more likely to be used in nonthrombotic lesions.

Addressing the AVF audience, Tran reported that fewer stents were deployed per limb with the use of novel dedicated venous stents. In addition, she revealed that one patient had a stent fracture without thrombosis, and that there were no cases of deployment failure or stent migration in either group.

Additionally, larger size was observed in limbs using the Wallstent alone compared to novel dedicated venous stents and proximal stent extension into the IVC greater than 50% was significantly reduced with the use of novel dedicated venous stents compared to the non-dedicated stents, Tran detailed.

The presenter relayed some further key outcomes from the study: “Overall, dedicated venous stent use was not significantly associated with differences in early stent patency rates, nor was it a predictor of 30-day stent failure using a logistic regression analysis.”

In addition, she reported that primary patency rates remain comparable between novel venous stents and nondedicated stents at one year.

“In our experience, we found a significant reduction in extension into the IVC, total number of stents deployed and mean stent diameter with the use of novel dedicated venous stents compared to Wallstents alone,” Tran concluded. In addition, she recapped that there were no significant differences in early outcomes between the two stents.

adverse “were similar and also rare,” Dexter added.

“All-cause mortality was three patients throughout the first 250.”

Furthermore, in terms of venous clinical severity score (VCSS) scores, at 30 days and six months numbers were “nicely low” at 3 and 2 for the acute group, 4 and 3 among subacute patients, and 4 and 4 in the chronic subset, Dexter pointed out. Pain score numbers were “essentially zero across the board.”

We had remarkably low device-related serious adverse events at one month. And our rates of post-thrombotic syndrome [PTS]— including moderate to severe—at six months were similarly low.”

The same was true when measuring quality of life, he said. “The average quality of life went back to the patient’s baseline regardless of the chronicity believed to be in the clot for acute, subacute and chronic.” The CLOUT registry’s follow-up out to two years is ongoing. Total enrolment of 500 patients at up to 50 sites has the intention of probing all-comers—across acute, subacute David and chronic clot subgroups.

Dexter

CHARING CROSS SPECIAL EDITION

18 Conference Coverage

VENOUS

designation late last year—“has been under evolution such that we are just starting to do bicuspid valves and, in fact, we are scheduled to do the first one in the USA next week,” Marston said. “The device we are using today is quite different from the one we used 18 months ago.”

The system involves retrograde access; a presented with a venous clinical severity score high-pressure balloon expanded to force the (VCSS) of 15, and 70% had a previous deck of the device up against the vein wall; technical success history of DVT (six on the ipsilateral an advanced needle that enters the vein among the first limb). wall and hydrodissects a flap; and then a Marston told AVF attendees how the nitinol dissector advanced into the flap, US investigators had achieved success expanding and deepening the formation to in nine out of the 10 patients, with the create a valve cusp. treated in the USA mean number of leaflets formed standing Improvements made to the latest at 1.7. He further noted how procedure time generation of the device means the valve cusp was currently decreasing, explaining how the system formed has more depth and a deeper capture of requires a period of adjustment as physicians adapt to blood after creation, Marston elaborated. Additionally, patient and equipment positioning. Marston pointed “the device balloon has been strengthened to help out two minor device deficiencies that did not lead to puncture post-thrombotic veins, as most of the patients any complications. enrolled are post-thrombotic.” Marston drew attention In terms of VCSS among the first six subjects with to one of the study cases with one year of follow-up follow-up out to 12 weeks, investigators saw a mean to demonstrate the BlueLeaf system’s evolution. The decrease of 2.3, he said, though he cautioned the early53-year-old male patient, who had two monocuspid stage nature of the data. Marston reported no major valves created, showed no DVT through 365 days adverse events, one partial valve pocket thrombosis at follow up and a VCSS improvement from a baseline of one day and one partial distal intraluminal thrombosis.

9 to 6. Marston noted how the valve cusp still showed Both were asymptomatic and no longer seen after 30some motion at one year compared to initial formation. day duplex follow-up, he added.

“We would like to see more but this was with a very The process behind the development of the BlueLeaf early version of the device,” he said. “The cusps are system—which gained FDA Breakthrough Device now deeper and wider and hopefully will move better at 365 days than we see here. But this patient did have a well-preserved improvement in VCSS.” Concluding, Marston told the AVF meeting the BlueLeaf procedure “is technically feasible,” capable of forming valve cusps and under “continual improvement.” “The cusps we are forming today are much better than they were a year ago,” he said, pointing to an “exciting” future.

Emerging venous valve formation system sees “continual improvement” AN EMERGING ENDOVENOUS VALVE formation system designed to treat patients with chronic venous insufficiency (CVI) with evidence of deep venous reflux has demonstrated continual improvement since US investigators started performing clinical cases with the device 18 months ago, according to recently presented early data.

The BlueLeaf procedure, currently undergoing clinical research worldwide, has shown a rate of 90% technical success among the first 10 patients treated in the USA, William Marston (University of North Carolina at Chapel Hill, Chapel Hill, USA), one of the INFINITE-US early feasibility study investigators, told the 2022 annual meeting of the American Venous Forum (AVF; 23–26 February, Orlando, USA).

These data are part of a total of 30 patients treated at sites worldwide, demonstrating a 93% technical success rate of forming at least one valve, said Marston, who disclosed a consultancy relationship with InterVene, the company behind the BlueLeaf device.

Enrolled patients, classed as C5–6 on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification of disease severity, all had significant deep vein reflux in two main segments between the knee and the common femoral vein, adequate inflow and no acute deep vein thrombosis (DVT), Marston explained. Thus far, all subjects in the study have had a maximum of two valves formed using the device— most performed on the right leg and all monocuspid valves (US Food and Drug Administration [FDA] approval has now been granted to form bicuspid valves). The patient pool has a mean age of 59,

VenoValve improvement “maintained” for 2.5 years without adverse events Envveno Medical announced positive 30-month data from the first-in-human trial of the VenoValve bioprosthetic potential venous valve replacement during the 2022 American Venous Forum (AVF; 23–26 February, Orlando, USA).

THE RESULTS SHOWED THAT VenoValve recipients—now an average of 30 months post-VenoValve implantation—continue to benefit from the device and have experienced no relapses of severe chronic venous insufficiency (CVI), no recurrences of venous ulcers, and no material adverse safety events, the company reported.

Average improvement in reflux was 55%, average improvement in venous clinical severity score (VCSS) was 61%, and average improvement in

April 2022

The BlueLeaf procedure has shown a rate of

90%

10 patients

The cusps we are forming today are much better than they were a year ago.”

visual analog scale (VAS) was 81%, all compared to pre-VenoValve levels for the eight first-in-human patients who agreed to be followed, including one patient now three years post implantation.

The data were presented by Sebastian Cifuentes (Fundacion Santa Fe-Universidad de los Andes, Bogota, Colombia), who is part of a research team led by principal investigator Jorge Ulloa of the same institution.

Cifuentes told AVF 2022 delegates that patients implanted with the VenoValve showed improvement was “maintained” out to 2.5 years without the occurrence of adverse events, with no recurrence in C5 patients and no new ulcers on the ipsilateral side in C6 patients based on the CEAP (Clinical-Etiological-AnatomicalPathophysiological) classification of disease severity.

The VenoValve is currently being evaluated in the SAVVE (Surgical antireflux venous valve endoprosthesis) US pivotal trial, with a primary safety endpoint of absence of material adverse safety events in 26% or less of the patients at one month post-implantation, and a primary effectiveness endpoint of improvement in reflux of at least 30% measured at six months.

Improved limb reflux prevalence and severity following iliac vein stent placement IN PATIENTS WITH CHRONIC VENOUS DISEASE (CVD) AND associated ipsilateral limb reflux, iliac vein stenting was shown to improve the prevalence of reflux and severity in the long term. This is the main concluding finding of a single-centre retrospective analysis of prospectively collected data published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (online).

Authors Seshadri Raju and Michael Lucas (The Rane Center, Jackson, USA) analysed a total of 1,387 limbs in 1,228 patients deemed eligible for analysis. A total of 747 (54%) limbs had no pre-stent reflux, but 632 (46%) limbs had pre-stent reflux.

Stented patients were examined for reflux during the follow-up period (1–⁠26 years) at least once a year. In this analysis, segmental reflux prevalence, referred to as “reflux”, was detected by ultrasound. The severity of reflux was graded by three methods: reflux segmental score based on a total number of refluxive segments (range 0–7) in each limb, air plethysmography (venous filling index; [VFI90]), and ambulatory venous pressure measurement (venous refilling time [VFT]).

Pre-stent duplex reflux was present across superficial, deep, and perforator segments varying from 51% prevalence at the popliteal segment, and 7% at the deep femoral segment. The resolution of post-stent reflux ranged from 21% at the femoral vein segment, to 58% in perforators; reflux completely resolved in 23% of limbs with no residual reflux at any of the 7 valve segments studied per limb. The onset of new reflux following iliac vein stent placement was rare, with a median of only 7% of segments at risk.

The functional tests of reflux demonstrated improvement of 60% and 52% for VFI90 and VFT respectively. VFI 90 and VFT normalised in 31% and 24% of limbs respectively, with pre-stent reflux. The authors conclude that reflux prevalence and severity improve following iliac vein stenting in the long term. They hypothesise that the improvement/resolution of reflux is related to decompression of the valve station following stent placement. Collateral reflux completely resolved in some patients following stent placement.

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20 Interviews

A Year in Profiles

The last year of Vascular News profiles has seen key leaders in the field share important lessons and advice based on notable careers. This overview of their individual in-depth interviews is an annual look back at their insights and experiences.

Joseph Bavaria

Issue 91 September 2021

In the next decade, there is going to be a push towards treating areas that we have not been able to treat before.”

IN JULY 2021, Ali AbuRahma spoke to Vascular News ahead Issue 90 of becoming Society for July 2021 Vascular Surgery (SVS) president to share details of some of the defining moments of his career.

AbuRahma looked back to his medical training and the factors that led him to embark upon a career in vascular surgery, recalling: “During my medical school years in Alexandria, I was very impressed with the work of cardiac surgeons.

However, I was also negatively impacted by the unsatisfactory outcomes after many of the cardiac surgeries I witnessed during those early years of my career. When I moved to the USA, I worked with a chair who was a cardiovascular surgeon during my surgical residency. He suggested I try vascular surgery because it would give me the career I wanted and had commonality with cardiac surgery. That is what eventually led me to pursue a career in vascular surgery, which I do not regret.”

At the time of speaking to Vascular News, AbuRahma and colleagues had just completed the SVS clinical practice guidelines for management of extracranial cerebrovascular disease. “These documents cumulated the hard work of 11 writing group members of the SVS who were selected based on their interest, expertise, and publications in this field,” he detailed.

Due to the “evolving” nature of the vascular surgery specialty, AbuRahma advised anyone looking to pursue a career in the field to “be open minded towards new therapies and new endovascular skills”. However, he cautioned against “jumping too quickly to these new technologies until you feel not only comfortable

Ali AbuRahma

THE 52ND PRESIDENT OF THE SOCIETY OF THORACIC Surgeons (STS), Joseph Bavaria spoke to Vascular News in September 2021. Bavaria first studied engineering before pursuing a career in cardiovascular surgery, starting as an attending surgeon in 1993 in time to partake in the endovascular “revolution” of the mid to late 1990s.

Bavaria cited this endovascular “revolution” as one of the most important developments in cardiovascular surgery since he entered the profession. He said: “At the very beginning of my career, we did not have these things, but it came pretty quickly after I started in 1993 as an attending physician, and by the mid to late 1990s the endovascular revolution was beginning and on its way. Frankly, I am doing this interview because I was on the ground floor of that revolution and in two different domains: the first one was endovascular treatment of thoracic aortic disease, and the second one was endocardiac treatment of valvular heart disease.”

Considering how the cardiovascular field might change in the next decade, Bavaria expressed his belief that the “continual march” towards increasingly precise endovascular treatment and endocardiovascular treatment will continue. “There is going to be a push towards treating areas that we have not been able to treat before, such as the proximal aorta, some of the more complex heart valves, and some of the more complex and anatomical arrangements within the human body including the aortic arch and the thoracoabdominal aorta.

April 2022

with them, but also find there is strong evidence for these advances.”

AbuRahma also detailed one of his most memorable cases to date. He recollected: “During my first week of practice in vascular surgery, one of my senior colleagues felt I should handle a case that was referred to him for a patient with pararenal aortic aneurysm with bilateral renal artery stenosis. I was thrilled to take on this challenging case in my early career and in the first two hours of the procedure things were going very smoothly. However, when I took out the suprarenal aortic clamp the whole aorta broke apart. Whether that was secondary to the clamp or because I did not pick a good segment to clamp with less calcification, or a combination of both, I was not really sure. However, we lost so much blood and after moving the clamp into

I recommend the younger generation surround themselves with good mentors in order to mature and harness their skills.” a higher location at least a couple of times, we still had a difficult time controlling the aortic disruption. A procedure that should have only taken a few hours ended up taking close to 10 hours and due to several complications the patient was in the intensive care unit for almost two weeks. At one stage, I did not think he would make it. However, he eventually improved and was discharged after a long hospitalisation. That case shook the heck out of me and made me question whether I picked the right specialty.”

I think that is going to be a revolution in the next 10 years.”

Bavaria also conveyed his prediction that, over the course of the next decade, “there is finally going to be recognition that type A aortic dissection is a total aortic catastrophe, not just a localised catastrophe, and that the treatment paradigm is going to have to include both an open and an endovascular solution in its entirety. I think that we are finally going to be able to do that with advanced surgical techniques and advanced endovascular techniques.”

“The other thing is that we are going to be very focused on decreasing stroke and decreasing cerebral complications from these procedures,” Bavaria relayed.

“One of my main areas of research has to do with understanding the genetic basis of aneurysmal disease, so genetically-triggered aortic conditions, especially in the proximal aorta,” Bavaria told Vascular News.

“This represents a huge knowledge gap that must be addressed. It is also really important because, unfortunately, it is not acquired disease, it is just fate, and it usually affects younger people.”

Another area of his research is the application of endovascular treatment into the proximal aorta. “This is the biggest therapeutic area that we are working on,” he noted.

Looking to the future of cardiovascular surgery, Bavaria forecasted that advanced technologies and techniques will open up new possibilities in treatments, but stressed that such developments must be democratised.

April 2022

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Michael Jenkins

Issue 92 November 2021

Interviews 21

“GO FOR IT!” MICHAEL JENKINS URGED ANYONE looking to start a career in medicine, in an interview with Vascular News in November 2021. Since starting out in vascular surgery, Jenkins communicated that he has seen a shift towards a more minimally-invasive endovascular approach. He stressed, however, that “there is still much work to be done” in the field of endovascular surgery, predicting a “temporary swing” back in favour of open surgery for some aortic conditions.

At the time of the interview, Jenkins was president of the Vascular Society of Great Britain and Ireland (VSGBI) and had overseen a “busy year” at its helm. When asked what had been the proudest moment of his career date, Jenkins responded: “Undoubtedly, being elected as president of the VSGBI by my peers. It is humbling and an honour.”

“I think I have always learned something from everyone I have worked for, but was always particularly impressed by good operators as I saw how their patients did better postoperatively,” Jenkins told Vascular News, reflecting on who have been some of his career mentors. “My early experience at the beginnings of endovascular aneurysm repair (EVAR) using homemade devices with Mo Adiseshia was memorable as was my time at the Royal Brompton Hospital (London, UK) with Magdi Yacoub and Chris Lincoln. Visits to Hazim Safi in Houston, USA, were always inspirational as well.”

Jenkins also considered some of the biggest challenges currently facing vascular surgery. “I think globally this depends on the local healthcare sector,” he said. “Typically, most arterial patients are elderly and undergo expensive “AS VASCULAR surgeons, we never stop learning,” Palma Shaw told Vascular News Issue 93 in a March 2022 interview. This March 2022 is one of the key attractions of the specialty for Shaw, who recalled various aspects of her career to date—from her early days learning endovascular surgery from Frank Veith to impacting the learning of others and addressing disparities in education across the globe in her role as secretary general of the World Federation of Vascular Societies (WFVS).

Considering how she would like to see the field of vascular surgery develop over the next decade or so, Shaw conveyed: “A balance needs to be reached between cost of care and quality of care.

The durability and efficacy of interventions needs to be considered as endovascular interventions are performed more often and by a variety of interventionalists. In addition, a patient-centred approach will provide the best outcomes.”

Shaw detailed some of the highlights of her role as secretary general for the WFVS so far, and what further goals she would like to pursue while in the post: “My involvement with the WFVS as secretary general has given me a wonderful opportunity to collaborate with leaders in the global vascular community. I joined at a time of transition in the middle of the pandemic when this federation needed to evolve into something more purposeful and modern. The executive council and the council members representing the different societies have redefined our mission, created new bylaws, realigned the website and defined future projects which are

Palma Shaw

treatments. It can be difficult to make the fiscal case sometimes as traditional cost-effectiveness calculations are not helpful, so having to be the patient advocate all the time can be challenging.

“Workforce demands are also an increasing challenge, certainly in the UK. Newly-appointed consultants are probably better trained than ever before, but less experienced and need mentoring. At the other end of the scale, senior surgeons are not incentivised to stay (the inverse is probably true) and this needs to be addressed urgently to avoid a workforce crisis.”

Reflecting on how the COVID-19 pandemic affected vascular surgery, Jenkins remarked: “It certainly provoked new ways of working during the lockdown episodes.

Having to make decisions under such circumstances was refreshing in that it bypassed some of the red tape which can sometimes delay introduction of new ways of working.

Emergency treatment actually became easier as it was not competing with elective activity.

“Hot clinics and direct entry of patients into accelerated pathways have been very successful and I am hopeful some of these changes will endure, but dealing with the backlog of cases (in some specialties) cannot be underestimated.”

Workforce demands are an increasing challenge, certainly in the UK”

in line with our mission. The goal is to improve the quality of care for vascular patients worldwide by providing a forum for the international exchange of scientific and educational knowledge related to the diagnosis, treatment and prevention of vascular diseases. We plan to address disparities in education by exploring alternative methods including access to a virtual educational programme and exploration of training paradigms which can help teach on a global scale. Limb preservation globally is a concern and collaboration between the WFVS and the Japanese Society for Vascular Surgery will expand the opportunity for trainees across continents to participate in their Distal Bypass Olympics remotely.”

Shaw also spoke on her involvement in the new Women’s Section of the Society for Vascular Surgery (SVS). “More than 20 years ago I decided to pursue a career in vascular surgery. I found very few female mentors at that time. We had no one to ask about how to manage our time if we wanted to have a family. We were afraid to speak up and ask to have the same opportunities as the men. Over time, pushing through many barriers, I met other women in vascular surgery who have fought similar battles.

At this time, the SVS has committed to be supportive of diversity and equity.

Women can be women, mothers and vascular surgeons. One of my mentors, Amy Reed, suggested that we form a section within the SVS to provide a more formal network of women who can help each other reach our potential. I founded this with Amy Reed, Linda Harris and Audra Duncan. We plan to hold our first session at the Vascular Annual Meeting in Boston this year.”

Women can be women, mothers and vascular surgeons.”

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April 2022

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Advertorial 23

THIS ADVERTORIAL IS SPONSORED BY BENTLEY

Investigator-initiated studies pave the way for on-label bridging stent use in complex aortic procedures Bridging stents have been used in fenestrated and branched endovascular aneurysm repair (F/BEVAR) for many years. However, their use has always been off-label. In cooperation with Bentley, two investigator-initiated studies are set to create the necessary evidence to shift the use of balloon-expandable covered stents from offlabel to on-label in complex aortic procedures.

E

ric Verhoeven (General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany) is leading a study focused on bridging stents in FEVAR procedures, for which enrolment is almost complete. A similar study, headed by Martin Austermann (St Franziskus Hospital, Münster, Germany), is ongoing for BEVAR. Here, Verhoeven and Austermann speak to Vascular News about the importance of having on-label bridging stents, what makes the BeGraft stents (Bentley InnoMed GmbH) stand out, and how the FEVAR and BEVAR studies will pave the way for on-label bridging stent use and further innovation in the space.

Why is it so important to have a bridging stent available as on-label for F/BEVAR?

How do the BeGraft products compare to other covered stents on the market?

MA: In Münster, we have conducted some bench tests on the two grafts—the BeGraft and the BeGraft PLUS—over the past few years. Our results regarding the BeGraft PLUS, for branches, show that it is a very durable stent, with a double-layered stent and polytetrafluoroethylene (PTFE) design. We found that, after 100 million cycles in our machine, the stent performed far better than expected. Another important feature of the BeGraft PLUS is the kink resistance.

You can bend the stent more than 90 degrees and it does not create a kink, it creates a curve.

The regular BeGraft stent, which is being assessed in the FEVAR study, has good flexibility, which is a big advantage due to the fact that the renal arteries move around a lot with every breathing movement.

EV: We have used bridging stents in F/BEVAR cases for many years. In the past, however, companies were not interested in developing dedicated Why do you think it has taken Case image from the covered bridging stents, because they until now for these studies to FEVAR BeGraft study did not see the purpose. That changed be conducted? when it became clear that both FEVAR and BEVAR MA: The market was very small for many years. enjoyed widespread use and were here to stay.

Twenty years ago, a couple of centres started to use In addition, I think covered stents will be increasingly fenestrated and branched technologies, and, over the used in other diseases, like peripheral arterial disease years, they showed that these procedures work and (PAD), or in other small aneurysms and small vessels. that patients survive. Physicians and patients started So, while covered stents have a clear future in many to observe that the use of fenestrated or branched different procedures, an on-label indication in FEVAR devices resulted in better survival than open repair. is needed. This is why it is great to see that a company like Bentley is supporting the FEVAR and BEVAR studies, which will result in an on-label indication for covered stents in complex aortic procedures.

MA: It is crucial that bridging stent grafts work in F/BEVAR procedures. If you exclude a complex aneurysm with involvement of the renal or the visceral arteries in fenestrated and branched repairs, it is vital that these bridging stents perform well. If they fail, the complete repair fails, and can lead to complications such as dialysis or an endoleak. So, we have to know how bridging stents perform in this indication, and a clinical study is the best environment in which to evaluate them and create the evidence.

While covered stents have a clear future in many different procedures, an on-label indication in FEVAR is needed.”

In addition, it solved some other problems, like spinal cord ischaemia, for which we have now reduced the risk to around Eric Martin Verhoeven Austermann 2%. It was noted that bridging stents were crucial to these complex repairs. For many years, there was only one covered stent available, which was used off-label. However, as the procedure gained popularity, the market grew. Eventually, it became clear that a dedicated stent is necessary, and therefore I am happy that Bentley is supporting studies to learn more about bridging stents, which is the first step towards dedicated bridging stents for complex aortic procedures.

When can we expect the first outcomes of the FEVAR study and, further down the line, the on-label indication?

EV: I think once enrolment is complete, which will be very soon, we should be able to provide one-month results quite quickly. The rest is about durability. It is difficult to say when the on-label indication will be approved, because the process is thorough and can therefore take a long time.

Will the study change the FEVAR procedure?

EV: I think the study will change the FEVAR procedure, yes. For a long time now, there have been no on-label covered stents for complex aortic procedures, and so our only option has been to use what is available. When a covered stent gains an onlabel indication, however, there will be a clear choice.

The availability of a validated, on-label covered stent for fenestrated grafts will, I think, be a decisive advantage in the market, and also I believe other companies will move forward as a result.

Where do things stand with the BEVAR study?

MA: We are still recruiting patients, but the first results seem very promising. We have faced some challenges, but this points to a big advantage of the study—that we are open to saying, ‘this stent works in this indication, but maybe this is a border, and we should respect it’. I think it is important to document all experiences—good and bad—in every study, and to have the next generation of devices in your head.

Bentley has good stents available, but what makes our job so difficult is that no patient is the same, and therefore there is no ‘one-size-fits-all’ solution.

Clinical evidence will bring us to the next step, which will lead to the next generation of devices.

Could you give a few details about the FEVAR study design and any key updates?

EV: We are almost at full enrolment, and so inclusion has been quite fast. The purpose is to include as many suitable patients/vessels as possible. About one-third to one-quarter of patients we regularly treat with FEVAR are not in the study, for reasons such as their target vessels being too small or having too sharp take-off angles. The endpoints are safety and effectiveness, so we are looking at patency and long-term outcomes. It is also important to note that the study is not linked to one dedicated fenestrated graft company; many patients were treated with Cook fenestrated grafts but we allow the use of other fenestrated stent grafts.

Pre Case image from the BEVAR BeGraft PLUS study

Post

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April 2022

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Industry Update 25

VENOUS

Vesper Medical acquisition adds key piece to Philips’ venous portfolio Bert van Meurs, the chief business leader for Image Guided Therapy with Royal Philips, speaks to Venous News following the company’s acquisition of Vesper Medical in December last year. He details how the procurement will further expand Philips’ portfolio of diagnostic and therapeutic devices, considers the specific challenges of working in the venous space, and outlines what is in the pipeline for Philips’ venous business in 2022.

What will the acquisition of Vesper add to the Philips business?

Philips’ Image Guided Therapy strategy is centred around delivering more complete solutions. In the venous disease space, our teams already have a strong presence with our imaging labs—not only in hospitals but also now in office-based labs (OBLs), where more and more venous procedures are taking place. In addition, every venous procedure requires intravascular ultrasound (IVUS), and most of the IVUS that is being used during venous procedures is provided by Philips. When it comes to treatment, however, we do not have our own device, our own venous stent. A venous stent needs to be strong enough to keep the vein open, but also flexible enough so that it does not kink. The hybrid design of the Vesper

Duo venous stent offers both flexibility and strength, and therefore a good addition to our venous offering.

Philips was originally positioned in the systems space and has, for the last decade or so, been moving into the device space. How has this process evolved?

Around 10 years ago, we decided to move beyond our imaging capabilities and focus on the procedure and how we can help treat patients better. We started to think about how we could make navigation smarter, how we could develop instruments and devices that would guide themselves and therefore use fewer X-rays, or even have the ability to visualise and therefore not use X-ray at all. We developed our own technologies that helped to innovate

procedures, but we also came to the realisation that we were, in essence, an imaging company that sold systems.

Companies in the device space have a different business model, a different way of working, and we recognised that an effective way to develop in that space was to acquire those capabilities. When considering a company for acquisition, we look not only at its product portfolio, but also at its potential to help design and develop Class III medical devices and conduct premarket approval (PMA) clinical trials. We first acquired Volcano, seven years ago, followed

by Spectranetics, Intact Vascular, and now Vesper. We continue to build this device business within the Image Guided Therapy space, not as a separate business but as one that is integrated within the imaging component. We also think about how we can leverage imaging and devices together in the pursuit of our overall strategy to innovate the whole procedure, and we will continue to do so in disease-specific applications, so coronary artery disease, peripheral arterial disease, and now also venous disease. We are looking at other areas as well.

What do you think are the specific challenges of working in the venous space?

I think one of the biggest challenges is creating more awareness. Awareness of the severity of the disease among patients, and indeed physicians, is very often underestimated. If patients do not get treated or are treated too late, the consequences can be severe—a patient

can lose their leg as a result of venous disease, and it can even be fatal. Another challenge is creating better solutions for patients in a lower-cost, easy-to-access care setting. This is where OBLs can offer a solution.

What are going to be some of the milestones for Philips’ venous business in 2022?

Our first aim is to finalise the Vesper Duo stent PMA approval, and then work with the US Food and Drug Administration (FDA) on the final approval. We will also put focus on making sure that the team that created the stent can leverage the strengths of Philips, accelerate and do things that they could not do as a standalone company. The venous space is not new to us and we have fantastic customer relations as well as a number of key thought leaders who we already work with. The difference now is that we can collaborate with a much larger network of thought leaders in the venous space.

If patients do not get treated or are treated too late, the consequences can be severe— a patient can lose their leg as a result of venous disease, and it can even be fatal.”

Venous stents remain durable following pregnancy ILIAC VEIN STENTS REMAIN DURABLE following pregnancy in women implanted with them, and a possible future pregnancy should not contraindicate their usage in the treatment of pelvic venous insufficiency (PVI), according to new research published in the Journal of Vascular Surgery:Venous and Lymphatic Disorders (JVS-VL).

According to lead author Peter Pappas (Centre for Vascular Medicine, New Jersey, USA), “The standard of care for the treatment of chronic pelvic/leg pain secondary to PVI is iliac vein stenting with or without ovarian vein embolisation. As many women receiving this therapy are of childbearing age, we assessed stent patency and reintervention rates in women who became pregnant after undergoing iliac vein stenting.”

As reported in the March 2022 issue of JVS-VL, the researchers reviewed collected data from the Center for Vascular Medicine from January 2014 to December 2020. This involved 23 centres in four states.

Surgeons placed 2,046 stents in 1,698 women

Bert van Meurs

during this time. From this cohort, information on 15 women with 16 iliac vein stents for PVI who had 17 pregnancies were studied.

Characteristics of the 15 patients included: ●A verage age of 35±4 years, ●A ll were CEAP classification 0–3, ● 14 were non-thrombotic in nature, and ●A verage time between stenting and pregnancy was 31 months.

In 11 of the 17 pregnancies, patients were treated with enoxaparin.

None of the women carried the diagnosis of hypercoagulability.

All patients underwent a postpartum ultrasound revealing no stent-related issues complicating any of the pregnancies. Only one patient was lost to follow up, and in the remaining 16 pregnancies, no stent occlusions were observed at an

average time of 43±24 months following the pregnancy.

Pappas said, “A major unresolved question related to iliac vein stenting and pregnancy is in regard to the necessity of anticoagulation during and after pregnancy. The main indication for considering anticoagulation during and after pregnancy is the known increase in clotting factors during pregnancy, the increased incidence of venous thromboembolic events in pregnant women compared with nonpregnant women, and the fear of medical liability.”

Considering the general low risk for anticoagulation, it appears reasonable to anticoagulate pregnant patients with iliac stents who: ● Have a known hypercoagulable state, ● Underwent stenting for thrombotic disease, and ● Underwent stenting for nonthrombotic disease if low-risk for bleeding.

Only two other peer-reviewed publications covering this topic appear in medical journals, the press release notes, adding that the present study contains the largest number of patients.

CHARING CROSS SPECIAL EDITION

26 Journal Highlights

AORTIC

New technique outperforms manual assessment of thoracic aortic aneurysm growth Researchers have developed a novel method of measuring growth of thoracic aortic aneurysm, which they claim could significantly improve the accuracy and reliability of aortic measurements compared to standard-of-care measurement techniques.

THE TECHNIQUE, WHICH IS KNOWN AS vascular deformation mapping, measures changes in the thoracic aorta, using high-resolution computed tomography (CT) imaging to calculate threedimensional changes in the aortic wall.

The technique outperforms the standard manual rating methods performed by experts, according to the authors of the study, Zhangxing Bian (University of Michigan, Ann Arbor, USA) and colleagues, who evaluated the performance of vascular deformation mapping in a paper published in Radiology and Medical Physics.

“The technique used in this algorithm has been around for a while, but no one has ever used it to see threedimensional growth of an aneurysm of the thoracic aorta,” said Nicholas Burris (University of Michigan, Ann Arbor, USA), corresponding author of the paper. “This is a promising step towards having technology that pushes the accuracy of measurement past what human raters can achieve, allowing clinicians to have the best possible picture of a patient’s condition.”

For approximately 3% of adult patients over 50 years old with thoracic aortic aneurysm, physicians recommend they undergo regular testing, often with CT scans, to measure aortic growth and determine if surgical repair is needed.

Currently, the standard practice to measure growth is done with human “raters” who line up two images and draw a line at two points to find the change. Burris says this process is prone to error, and, in many cases,

doctors can not confidently tell if the thoracic aorta is growing, creating uncertainty regarding the best treatments and follow-up plan.

“The challenge we are faced with clinically is that a typical aneurysm in the aorta is going to grow only a fraction of a millimetre every year, and the process of manually drawing diameters that precise is very hard to reproduce,” he said. “You have a lot of variability in standard measurements relative to a very small amount of actual aneurysm growth. Basically, you rarely end up getting a confident assessment of growth, which can make it difficult to know what the patient’s actual risk is and how closely they need to be followed with repeat CT scans.”

The vascular deformation mapping technique developed by Burris’ team relies on an image analysis technique known as image registration, which

Moving from the current one-dimensional measurements to a threedimensional approach lets us see patterns of aneurysm growth in a way never before possible.”

Perioperative care in open aortic surgery: SVS and ERAS Society issue consensus statement THE SOCIETY FOR VASCULAR Surgery (SVS) and the Enhanced Recovery after Surgery (ERAS) Society have released a consensus statement intended to help address perioperative challenges faced by vascular surgery patients.

The ERAS pathways have proven beneficial for a number of surgical specialties, and the application of these pathways will be important to address the needs of patients undergoing open aortic operations, according to a press release.

With the goal of delivering highquality perioperative care and accelerating recovery, this consensus statement is intended to help address the many perioperative challenges faced by vascular surgery patients, who are often older, frailer and have more comorbidities than the average surgical patient.

This document focuses on both transabdominal and retroperitoneal

approaches—including supraceliac, suprarenal and infrarenal clamp sites— for aortic aneurysm and aortoiliac occlusive disease operations.

Recommendations for the defined, universal ERAS elements are described, and include the following: Preadmission: Screening, preoperative exercise therapy/prehabilitation, perioperative anti-platelet, anticoagulation plan Preoperative: Fasting, carbohydrate loading, venous thromboembolism prophylaxis, pre-anaesthetic sedative and analgesia medication, antimicrobials, nausea/vomiting prevention Intraoperative: Anaesthetic protocols, epidural analgesia, body temperature management, drainage of surgical site Postoperative: Multimodal analgesia and opioid reduction strategies, nasogastric drainage, oral feeding, fluid therapy, urinary drainage, glycaemic control, early mobilisation strategy,

April 2022

aligns the anatomy shown in multiple CT scans by taking any pixel on the first scan and relating its exact position to the pixel on the second scan. When they are all aligned, a three-dimensional colour map of the aorta shows how much and where the thoracic aorta has grown.

For these studies, researchers used scans from nearly 50 aortic aneurysm patients and 75 reference models with variable growth of the aortic wall. They tested the automated program against two expert manual raters and found the vascular deformation mapping outperformed the humans with higher accuracy and lower variability in the growth measurements. Vascular deformation mapping achieved an accuracy of less than 1mm in all cases when even the most experienced human analysts had measurements with errors of up to 3mm.

“Recent advances in artificial intelligence have generated a lot of interest in AI in relation to automating radiology tasks,” said Charles Hatt, coauthor of the paper and adjunct research assistant professor of radiology at Michigan Medicine. “It turns out that replacing human radiologists is not a simple task, and a more realistic goal for AI is to speed-up workflows and assist radiologists in making object, quantitative measurements that are otherwise cumbersome to perform and inherently subjective.

In this regard, vascular deformation mapping is a perfect, real-world example of how AI and quantitative imaging can improve clinical care by empowering clinicians rather than attempting to replace them.”

While these reports show vascular deformation mapping may be more useful than human rating to inform whether surgery is necessary on an aortic aneurysm, researchers say the approach must be studied further in large groups of patients in a clinic.

Burris says, the vascular deformation mapping technique can be performed on routine CT scans of the aorta, making performing larger research studies easier.

“This is a totally new way of looking at aortic aneurysm growth,” he said. “As this develops, there is a possibility to deploy this across a larger spectrum of diseases, such as abdominal aortic aneurysm. Moving from the current one-dimensional measurements to a three-dimensional approach lets us see patterns of aneurysm growth in a way never before possible.”

discharge education, audit of outcomes and reduced variation in postoperative This document additionally reviews convalescence, which promises to some traditional clinical practices improve the safety and outcomes where the literature does not allow for patients undergoing open aortic firm recommendations, such as, operations. preoperative medical risk assessment, Katharine McGinigle (University of skin preparation and intraoperative North Carolina at Chapel Hill, Chapel fluid therapy. The writing group Hill, USA), chair of the SVS writing has summarised the current state of group, stated: “The ERAS writing group knowledge because of the common and I are thrilled to share this consensus use of these practices in statement for perioperative many institutions, although best practices for open aortic they were not included in the surgery, and really believe that formal recommendations in the our patients have much to gain. consensus statement.

Each of these recommendations The recommendations for are really nothing new on their elective open aortic surgery are Chair of own, but it is the collection of the SVS important as they are the first them that makes the group of published and have summarised writing group, recommendations novel. They Katharine a large volume of heterogeneous McGinigle emphasise the coordination and studies across all ERAS elements timing of care across disciplines for operations performed for to reduce unnecessary care either aortic aneurysm disease or variation and to give our patients aortoiliac occlusive disease. As a result the best chances of an improved of this, the existence of numerous convalescence.” research gaps has been demonstrated.

This consensus statement These recommendations support the “defines current standards enabling use of care teams to enhance patient multidisciplinary teams to implement optimisation and shared decisionthese procedures in their practice making in this population. There is a with the intent of improving patient focus on physiologic stress minimisation outcomes,” the press release concludes.

April 2022

CHARING CROSS SPECIAL EDITION

Advertorial 27

THIS ADVERTORIAL IS SPONSORED BY SHAPE MEMORY MEDICAL

Stable and reliable: A vascular surgeon’s perspective on the benefits of shape memory polymer embolisation Smart Polymer is a new shape memory polymer technology, available to endovascular specialists, that is incorporated into the Impede embolisation plug family (Shape Memory Medical). Michel Reijnen, a vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands, has used the Smart Polymer devices in several aortic cases. Here, he gives his perspective on the unique properties of the polymer, and details how Smart Polymer devices may be utilised in a vascular surgeon’s practice.

Case images courtesy of Michel Reijnen.

“S

hape memory polymer is a novel material that can be very useful for a range of traditional peripheral vascular embolisation procedures, including the treatment of complications after endovascular aortic procedures,” Reijnen tells Vascular News.

Comparing the Impede embolisation plug family of devices to alternative treatment modalities, Reijnen expresses his belief that the new technology has some advantages over standard embolisation materials like coils and liquids. He elaborates that the embolic material is highly compliant and soft, which may reduce the risk of vessel trauma, and the radiolucent nature of Smart Polymer has only limited impact on imaging modalities after treatment, which makes follow-up “much more reliable”.

Reijnen describes the Smart Polymer used in the Impede device family as a biocompatible, ultralow-density polyurethane that gently expands when exposed to the warm, aqueous blood environment.

The expanded material is porous, enabling rapid formation of organised thrombus throughout its structure. Over time, the polymer stimulates thrombus remodelling and healthy tissue formation as the material gradually absorbs. These microlevel properties have been observed during device development and in animal studies on vascular plugs and coils featuring this Smart Polymer. He explains:

“When using bare metal coils, you are inducing clot formation, but we know that sometimes the vessel will reperfuse, which is not the intent.” In his experience, the other difference with Smart Polymer is that it creates a scaffold for cellular ingrowth, resulting in a “more stable occlusion of the vessel” and ultimately formation of healthy scar tissue.

The benefits of Smart Polymer have come to light in Reijnen and colleagues’ aortic practice at Rijnstate Hospital. There are several aortic applications for which the Impede embolisation plug family of devices are ideally suited, says Reijnen, who highlights its aptness for the embolisation of side branches and the treatment of endoleaks. “You can completely fill a type II endoleak [with Smart Polymer devices], and therefore the chance of developing a remaining type II endoleak is likely reduced,” he says. The high-volume filling properties of Smart Polymer have also assisted in the treatment of some particularly challenging cases at Rijnstate Hospital, specifically for the treatment of type I endoleaks. Reijnen details one case in which a patient presented with a gutter endoleak following endovascular aneurysm sealing with parallel grafts.

“There was really no regular solution other than embolisation,” says Reijnen. He recalls how the team used Impede-FX embolisation plugs to completely seal the gutter endoleak and expanding AAA sac.

“To date, the patient is in good condition—without

aneurysmal growth and without endoleak. We are now one and a half years from treatment, so this is a promising result thus far,” he tells Vascular News.

Reijnen adds that Smart Polymer devices could also be Michel Reijnen used for false lumen treatment, although development of larger plugs may be better suited for that indication. In the future, he foresees Smart Polymer devices being used in primary sac filling, as an “adjunct” to endovascular aneurysm repair (EVAR). At present, Reijnen notes that the team is currently participating in AAASHAPE, a prospective, multicentre early feasibility study of the shape memory polymer Impede-FX RapidFill® device when used for abdominal aortic aneurysm (AAA) sac management during elective EVAR. Active sac management with dedicated devices may prove to be a new and crucial step to improve long-term outcomes after EVAR. The Rijnstate Hospital team has so far only used the technology for aortic pathologies. However, Reijnen points out that it also has potential in the peripheral vasculature for visceral artery embolisation, treatment of arteriovenous fistulas, and management of pelvic congestion syndrome, just to name a few. “Due to its broad range of clinical applications, this novel technology expands embolisation options and could play an important role in one’s endovascular practice,” he concludes.

Disclaimers: Michel Reijnen is a consultant to Shape Memory Medical and principal investigator of the AAA-SHAPE_NLD trial.

Future device applications, prospective studies involving investigational devices, and investigational uses of approved devices are discussed in this interview. The content contains information about AAA-SHAPE, Shape Memory Medical’s prospective investigational studies of the Impede-FX embolisation plug and the Impede-FX RapidFill when used for prophylactic abdominal aortic aneurysm (AAA) sac filling during elective endovascular aneurysm repair (EVAR).

For more information about the AAA-SHAPE studies, please visit https:// clinicaltrials.gov/ct2/home NCT04227054 and NCT04751578 Not all devices discussed in this interview are available in all regions.

In countries recognising CE marking, the Impede embolisation plug, the Impede-FX embolisation plug, and Impede-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

In the USA, the Impede embolisation plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature and the Impede-FX embolisation plug is indicated for use with the Impede embolisation plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The Impede-FX RapidFill device is not approved for sale in the USA.

a Figure 1. Smart Polymer vascular plug devices. (a) The expanded form of the Impede-FX embolisation plug with Smart Polymer and a proximal radiopaque marker. (b) The Impede embolisation plug with a distal anchor coil deployed in a vessel. (c) An Impede-FX embolisation plug deployed behind the Impede embolisation plug to increase the amount of embolic material in a vessel, with minimal additional metal. (d) The use of Impede-FX embolisation plugs to treat a type II endoleak. (e) The Impede embolisation plug family of devices are pushable.

The Impede-FX RapidFill device consists of five ImpedeFX 12mm embolisation plugs preloaded in a cartridge.

Figure 2. (a) The expanded form of the Impede-FX embolisation plug with Smart Polymer and a proximal radiopaque marker. (b) The Smart Polymer pore sizes in the Impede embolisation plug family of devices are approximately ~1000–2000 microns. (c) The expanded porous matrix is haemostatic and supports rapid formation of organised thrombus throughout its structure. (d) The porous Smart Polymer matrix self-expands and conforms to the surrounding anatomy. If appropriately sized, an Impede-FX embolisation plug will expand to fill the vessel diameter. Over time, the Smart Polymer stimulates thrombus remodelling and healthy tissue formation, and the polymer gradually bioabsorbs. (e) Histology of a porcine artery implanted with the Impede embolisation plug Smart Polymer device at 60 days post implantation, illustrating uniform extracellular matrix and collagen formation throughout the vessel diameter.

b

Figure 3. Smart Polymer is radiolucent. A type I gutter endoleak following relining of a Nellix stent in a patient previously treated with Nellix-in-Nellix and parallel grafts (a). Intraoperative frame after implantation of ImpedeFX embolisation plugs (arrows show the location of select radiopaque markers) (b). A total of 23 Impede-FX embolisation plugs (~30mL when the devices are fully expanded) and two detachable coils were implanted via a transbrachial approach. Completion angiography showed resolution of the endoleak.

April 2022

CHARING CROSS SPECIAL EDITION

Journal Highlights 29

PERIPHERAL

Peripheral arterial disease symptoms differ between sexes, meta-analysis finds In future peripheral arterial disease (PAD) research, clinicians should not consider men and women as a single population and should instead report their data separately. This is the main conclusion of a systematic review and meta-analysis recently published in the European Journal of Vascular and Endovascular Surgery (EJVES), which found that symptoms of lower leg PAD present differently between men and women.

A

uthors Cindy P Porras (Utrecht University, Utrecht, The Netherlands) and colleagues write that while PAD has traditionally been labelled as a predominantly male disease, recent studies suggest that women are affected at least as often as men.

Some of these studies also describe differences in the clinical presentation of lower extremity PAD between the sexes, however the authors note that there has been no systematic review collating this information.

Therefore, the present study aimed to collate and pool the available evidence in order to evaluate differences in symptoms between men and women who present with lower limb PAD. Using PubMed, EMBASE, and the Cochrane Library, Porras et al identified all relevant studies, collecting data on study design, source of data, population characteristics, and the outcome of interest using the Newcastle–Ottawa scale and Cochrane risk of bias tool. The authors note that, using the GRADE methodology, the evidence quality was rated as high, moderate, low, or very low based on the risk of bias, inconsistency, indirectness, and imprecision. In addition, the authors detail that estimates of relative effects were pooled to generate pooled odds ratios

(ORs) and the 95% confidence interval (CI) using a random-effects model.

Porras et al relay that only studies reporting on

The 21 studies eligible for qualitative analysis reported on 1,929,966 patients with diagnosed PAD.

RECENTLY PUBLISHED research indicates that stent grafting with the Viabahn endoprosthesis (W L Gore & Associates) of long and complex superficial femoral artery (SFA) lesions in patients with claudication is a safe and effective long-term treatment option.

Writing in the Journal of Vascular Surgery (JVS), study authors Takao Ohki (The Jikei University School of Medicine, Tokyo, Japan) and colleagues detail that freedom from target lesion revascularisation (fTLR) was 79.1% and that no leg amputations, acute limb ischaemia or stent fractures were observed out to five years in a population of 103 patients.

Once consigned “almost exclusively” to bypass surgery, long and complex SFA lesions can now often be treated successfully with stent grafting, Ohki et al write, noting that primary patency rates are “approaching parity” with surgical bypass outcomes.

In order to assess the long-term

21

1,929,966

symptomatic PAD were included in their analysis.

They specify that studies were eligible if they included patients over the age of 18 with a diagnosis of PAD— established either by questionnaire, ankle-brachial index at rest, treadmill, or duplex—reported symptom

Viabahn use in claudicants with long, complex SFA lesions “safe and effective” through five years safety and efficacy of endovascular stent grafting to treat long, complex SFA lesions with the Viabahn endoprosthesis—a heparin-bonded stent graft—the researchers conducted a prospective, non-randomised, multicentre, single-arm study at 15 Japanese hospitals.

Ohki and colleagues note that patients with Rutherford category 2–5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9 and SFA lesions ≥10cm long with ≥50% stenosis were included in the study.

The key efficacy and safety outcomes were primaryassistant patency and adverse events through 24 months, respectively, and the secondary outcomes included Viabahn endoprosthesis with Propaten bioactive surface

prevalence, and presented outcomes. The authors note that review articles and case studies were excluded from their analysis.

Out of the 2,186 studies identified, a total of 21 and 20 studies were deemed eligible for qualitative and quantitative analysis, respectively. The investigators report that, of the qualitative studies, 13 were crosssectional, six were cohorts, one was a case-control study, and one was a randomised controlled trial.

Among the eligible study populations with diagnosed PAD, women represented 43.9%.

The 21 studies eligible for qualitative analysis reported on 1,929,966 patients with diagnosed PAD. According to the authors, the data from these studies show that women presented with intermittent claudication less often than men (25.9 vs. 30.2% with OR 0.78 [95% CI, 0.72–0.84; p<0.001]; very low quality of evidence). In contrast, Porras et al communicate that rest pain and atypical leg symptoms were more prevalent in women—12.8% vs. 9.2%; OR 1.4 [95% CI, 1.22–1.6]; very low quality of evidence, and 22.8% vs. 19.8%; OR, 1.18 [95% CI, 0.96–1.45; very low quality of evidence, respectively.

The authors acknowledge some limitations of the present study. They recognise a “substantial heterogeneity” between the studies, the fact that only studies written in English were analysed, and that not all studies reported outcomes of interest. However, Porras and colleagues express their confidence that these limitations “are unlikely to influence the results significantly” as the lower prevalence of intermittent claudication in women was consistent over several subgroups and in sensitivity analyses.

primary patency, secondary patency, fTLR and Vascular Quality of Life questionnaire score, the authors communicate.

Ohki et al detail that, of the 103 patients included in the study, the mean age was 74.2±7 years, 82.5% were male and 100 (97.1%) had intermittent claudication. They add that the average lesion length was 21.8±5.8cm and that 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively.

Ohki and colleagues report in JVS that the Kaplan-Meier-estimated primary-assisted patency, primary patency and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3–91.5%), 78.8% (95% CI, 68.8– 85.9%) and 92% (95% CI, 82.4–96.5%) at 24 months, respectively. The mean ankle brachial index was 0.64±0.12 at baseline and 0.94±0.19 at 24 months (p<0.0001).

They also reveal that fTLR was 87.2% (95% CI, 78.9–92.3%) and 79.1% (95%

CI, 67.9–86.8%) at 24 and 60 months, respectively. In addition, no deviceor procedure-related life- or limbthreatening critical events or acute limb ischaemia cases were observed through five years, and no stent fractures were detected on the annually-scheduled follow-up radiographs.

Furthermore, the authors advise that the vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at one through 24 months compared with the baseline scores (p<0.0001 for both), and that one patient had required conversion to open bypass during five-year follow-up.

No leg amputations, acute limb ischaemia or stent fractures were observed out to five years in a population of 103 patients.”

CHARING CROSS SPECIAL EDITION

30 Vascular Training

Launch Pad

Launch Pad: A voice for vascular trainees Welcome to Launch Pad, a brand new column by Claire Dawkins, a vascular trainee in the North East of England. The section is designed to address some of the challenges and concerns faced by those in the early stages of their careers, and give readers “something to think about”.

There is an awful lot affecting trainees currently.

Most obviously, the global pandemic has hit all of us, both personally and professionally.

I feel incredibly lucky to have my family and friends all healthy, with most of my nearest and dearest only having to deal with the slight inconvenience of not going out as much and having to wear masks when we do. I know many have not been so fortunate. From a professional standing, COVID-19 has not prevented me from progressing through my training and I have managed to keep my logbook healthy enough. However, some of my colleagues nationally have had their jobs change overnight and found themselves in unfamiliar territory to the comfortable operating theatre and surgical wards, listening to chests rather than looking at smelly gangrenous toes, a change that only a vascular surgeon would consider a negative.

They then have had the disappointment of being told their training will be extended because of it.

The fallout from the pandemic is only the tip of the iceberg. Surveys suggest that bullying,

Having a trainee voice out there, I feel, has never been so important.” undermining, and harassment is endemic in the vascular world. It is not getting better. In fact, results have worsened over the last four years. Results from equality and diversity surveys also reveal some concerning issues regarding race, gender, and sexuality. From personal experience as a woman in surgery I feel that I have escaped relatively unscathed. However, when chatting with some female surgical colleagues, it soon became apparent that most of us felt like this but each of

CAROTID

Randomised trial suggests carotid endarterectomy does not affect dementia risk

Carotid endarterectomy (CEA) does not appear to either reduce or increase the risk of dementia, despite it having been shown to reduce stroke risk. This is according to 20-year results from the ACST-1 trial, published online ahead of print in the European Journal of Vascular and Endovascular Surgery (EJVES).

ACST-1 (ASYMPTOMATIC carotid surgery trial) showed that surgery for asymptomatic carotid stenosis significantly reduces long-term stroke risk, Alison Halliday (University of Oxford, Oxford, UK) and colleagues write. They note, however, that the effect of CEA on later dementia is “uncertain”. The investigators underline the fact that prolonged follow-up of trial participants is now possible with the linkage of national electronic records.

In addition, they note that dementia records have a good positive predictive value for clinical diagnosis, though they are likely to underestimate the true risk.

The combination of these factors, the authors write, “provides the opportunity to investigate the longer-term effects of CEA on incident dementia”.

In the present study, the researchers randomly allocated all UK and Swedish

patients in ACST-1 (n=1,601/3,120) to either immediate CEA (n=796) or deferral of CEA (i.e. no intervention was performed unless or until triggered by ipsilateral transient ischaemic attack or stroke; n=805) and followed them for 16–26 years, to study effects on dementia. The median follow-up was 19.4 years (interquartile range, 16.9– 21.7).

Halliday et al report that dementia was recorded in 107 immediate CEA patients and 115 allocated delayed surgery. A total of 1,290 patients died, 1,091 before any dementia diagnosis, they add. The investigators found that dementia incidence rose with age and with female sex (men, 8.3% aged <70 years at trial entry vs. 15.1% aged ≥70; women, 15.1% aged <70 years at trial entry vs. 22.4% aged ≥70 years) and was higher in those with pre-existing

April 2022

us could still recount multiple episodes where we had been treated inferiorly to our male counterparts. This is before race, religion, and sexuality are even mentioned.

Having a trainee voice out there, I feel, has never been so important. I hope to be able to raise some of the issues faced, while not getting too bogged down in the doom and gloom of it all. After all, being able to laugh in the face of adversity (or at least make a sarcastic comment) before pushing on with a solution is a trait that many of us surgeons share. Some of what I write will be factual, but much will be a reflection of my, and my colleagues, experiences and issues faced. I am sure not everyone will agree with everything I write. Given that it is impossible to please everyone and very easy to upset them all, I am certain of this. However, I hope I do not offend anyone and that, on occasion, I give you something to think about. So, I ask you to please be patient with a trainee who may, or may not, have an appropriate grasp of her first and only language, consider how the issues I raise affect both you and your trainees, and send polite and constructive feedback to help me grow and improve as a writer and novice columnist.

cerebral infarction (silent or with prior symptoms, 20.2% vs. 13.6%, respectively). In addition, the authors relay that dementia risk was similar in both randomised groups: 6.7% vs. 6.6% at 10 years and 14.3% vs. 15.5% at 20 years, respectively. The dementia hazard ratio (HR) was 0.98 (95% confidence interval [CI], 0.75–1.28; p=0.89), with no heterogeneity in the neutral effect of immediate CEA on dementia related to age, carotid stenosis, blood pressure, diabetes, country of residence, or medical treatments at trial entry (heterogeneity values: p>0.05), Halliday and colleagues detail.

Considering the main strengths of their research, Halliday et al highlight the fact that early CEA was randomly allocated, and so intervention and control groups were matched for known confounders at recruitment. In addition, they write that the use of electronic health records reduces potential bias, because the electronic health record includes participants who may not respond to active follow-up.

The authors also recognise some

CLAIRE DAWKINS is a vascular trainee at the Newcastle Upon Tyne Hospitals NHS Foundation Trust in Newcastle, UK and a committee member for the Rouleaux Club, the UK national vascular trainee society.

limitations. They acknowledge that face-to-face interviews of participants throughout followup would have been the “ideal method” Alison to detect cognitive Halliday impairment and dementia, but this was not possible.

They also state that dementia may be under ascertained using electrical records and that there was no consistent dementia ascertainment over time. In addition, they remark that the study confidence interval did not exclude a proportional benefit or hazard of about 25%.

“European guidelines will continue to consider whether particular groups of asymptomatic patients, such as those with prior symptoms, cerebral infarction, or impaired cerebrovascular reserve, might benefit from carotid intervention, but a large, long-term, randomised study will be necessary to determine this,” Halliday and colleagues remark in their conclusion.

Prolonged follow-up of trial participants is now possible with the linkage of national electronic records.”

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October 2021 Issue 01 www.renalinterventions.net

In this issue:

Twelve-month Wrapsody results at CIRSE 2021 page 4

AN IMPLANTABLE BIOARTIFICIAL kidney device (iBAK) has moved closer to becoming a reality after being awarded a US$650,000 prize from KidneyX. The device’s creator, the Kidney Project, received this award following the first ever demonstration of its functional prototype.

The Kidney Project is a US-wide collaboration led by Shuvo Roy (University of California San Francisco [UCSF], San Francisco, USA) and William Fissell (Vanderbilt University Medical Center, Nashville, USA).

In the past few years, it has successfully tested the two essential components that make up its artificial kidney technology—a haemofilter, which removes waste products and toxins from blood, and a bioreactor, which replic ates other kidney functions, like the balance of electrolytes in blood—in separate experiments.

To secure KidneyX’s Artificial Kidney Prize, the team married these two units in a scaled-down version of the artificial kidney that is roughly the size of a smartphone and evaluated its performance in a preclinical model following successful implantation. The units worked in tandem, powered by blood pressure alone, to provide continuous renal replacement therapy without the need for blood thinning or immunosuppressant drugs. This technology, which is intended to provide patients with improved mobility and physiological outcomes compared to dialysis, will now be upscaled for more rigorous preclinical testing and, eventually, clinical trials.

For the latest step forward in the development of this device, the Kidney Project team was awarded KidneyX’s Phase 1 Artificial Kidney Prize—becoming one of six winning teams selected from a field of innovators across Canada, Israel, Japan, The Netherlands, Portugal, Singapore, South Korea, the UK, and the USA. Other recipient technologies included a wearable, lightweight, dialysate-free artificial kidney (US Kidney Research Corporation) and genetically engineered pig kidneys designed to increase supplies of transplantable organs (Makana Therapeutics).

Profile:

Alexandros Mallios page 12

Dialysis:

Latest debates in dialysis care page 17

Transplantation:

Healthcare disparities in the spotlight page 20

Renal community reckons with removal of race variable in kidney disease diagnosis

Bioartificial device receives KidneyX award after reaching preclinical testing

iBAK device

(Credit: UCSF)

Follow Renal Interventions on all our social media platforms for the latest news, insight and events in kidney care

The National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) have jointly released a report outlining a new race-free approach to diagnosing kidney disease. In its report, the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease recommends the adoption of the new estimated glomerular filtration rate (eGFR) 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation that estimates kidney function without a race variable.

and subsequent treatment of kidney diseases,” said ASN president Susan Quaggin. “By recommending the CKD-EPI creatinine equation refit without the race variable, the task force has taken action and demonstrated how nephrology continues to lead the way in promoting healthcare justice.

It is time for other medical specialties to follow our lead, and NKF and ASN stand ready to help however we can.”

In the USA, more than 37 million adults have kidney diseases and 90% are not aware they have diminished kidney function, the NKF-ASN statement adds, with a disproportionate number of these patients being Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, and Native Hawaiian or other Pacific Islander. These patient groups also face “unacceptable” health disparities and inequities in healthcare delivery.

he task force has also recommended the increased use of the protein cystatin C—a commonly used biomarker of kidney function—combined with serum (blood) creatinine as a confirmatory assessment of GFR or kidney function. The final report, which has been published online in the American Journal of Kidney Diseases (AJKD) and the Journal of the American Society of Nephrology (JASN), was drafted with “considerable input” from hundreds of patients and family members, medical students and other trainees, clinicians, scientists, healthcare professionals, and other stakeholders, to “achieve consensus for an unbiased and most reasonably accurate estimation of GFR”, according to a joint statement from the NKF and the ASN. “This recommendation by the NKF-ASN task force is an important step forward in assuring health and healthcare equity,” said NKF president Paul Palevsky. “We commend the task force for the time, thought, thoroughness and effort it took to explore this issue deeply, and recommend the best path forward for us all. The NKF and ASN urge all laboratories and healthcare systems nationwide to adopt this new approach as rapidly as possible so that we can move towards a consistent method of diagnosing kidney diseases that is independent of race. While the work of the task force is an important initial path forward, both of our organisations are committed to continuing to work to eliminate disparities in the diagnosis and treatment of kidney disease.”

“As the largest organisations representing kidney patients and health professionals, NKF and ASN are committed to eliminating health disparities that harm kidney patients, and ensuring that racial bias does not affect the diagnosis

Developing race-free recommendations Over a 10-month period, the NKF-ASN task force organised its work into three phases. The first involved clarifying the problem and evidence regarding eGFR equations in the USA; the second involved evaluating different approaches to address the use of race in GFR estimation; and the third involved providing recommendations based on this.

In April 2021, the task force published its interim report on reassessing the inclusion of race in diagnosing kidney diseases in AJKD and JASN, asserting that race modifiers should not be included in equations used to estimate kidney function, and that current, race-based equations should be replaced by a substitute that is “accurate, representative, unbiased and provides a standardised approach

T

“The NKF and ASN urge all laboratories and healthcare systems nationwide to adopt this new approach as rapidly as possible so that we can move towards a consistent method of diagnosing kidney diseases that is independent of race.”

Paul Palevsky Continued on page 2

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April 2022

CHARING CROSS SPECIAL EDITION

Journal Highlights 33

VASCULAR ACCESS

Precision banding offers “effective, low-morbidity approach” in high-flow haemodialysis accesses A retrospective review involving nearly 300 patients has concluded that precision banding as a treatment for high-flow haemodialysis accesses offers “an effective, low-morbidity approach”. The findings of the review are published in the Journal of Vascular Access (JVA).

“THIS STUDY REPRESENTS the largest series of precision banding for high-flow haemodialysis accesses, and highlights the safety and versatility of the procedure,” Rebecca Scully (Brigham and Women’s Hospital, Boston, USA) and colleagues write in JVA. “High-flow accesses were successfully banded in both symptomatic patients presenting with ischaemic steal, heart failure or pulmonary hypertension, and aneurysmal degeneration as well as atrisk patients with flow imbalance.”

The authors begin their report by noting that high-flow haemodialysis accesses are a well-recognised source of patient morbidity. They also claim that,

among available management strategies, inflow constriction based on real-time physiologic flow monitoring offers a “technically straightforward, datadriven approach with potentially low morbidity”—but large, contemporary series examining it are lacking, in spite of the benefits offered.

As such, Scully and colleagues undertook a retrospective review of a prospectively maintained clinical database in order to capture patients undergoing precision banding within a single tertiary care institution between 2010 and 2019. Multivariable logistic regression modelling was used to assess the review’s primary outcome measures, access circuit thrombosis within 30

Consistent use of VasQ device demonstrates “excellent” outcomes in radiocephalic fistula creation THE VASQ DEVICE (LAMINATE MEDICAL Technologies) appears to be a “suitable aid” in the creation of functional radiocephalic arteriovenous fistulas (AVFs). This was the concluding finding of a study in which the implantable device—an external anastomotic support system—was associated with high AVF maturation and cannulation rates.

Writing in Seminars in Dialysis, Robert Shahverdyan (Asklepios Klinik Barmbek, Hamburg, Germany) and colleagues note: “The routine use of the VasQ external support for forearm radiocephalic AVF creation resulted in high unassisted maturation rates with long-term durability of the access. It has resulted in a 95% success rate of physiologic AVF maturation, with 86% of unassisted maturation after four weeks and secondary patency rates of forearm VasQ radiocephalic AVFs of 84% at 36 months.

“These outcomes compare very favourably to previously published studies reporting outcomes of forearm AVFs and are similar in secondary patency to recent reports from dedicated centres—but with lower rates of intervention to achieve maturation.”

In an effort to overcome some of the more prominent drawbacks relating to AVFs, and in particular forearm radiocephalic fistulas—including low maturation rates, significant early thrombosis, and the fact it often takes several months before cannulations can be attempted— the researchers have adopted the routine use of VasQ at their centre in Germany. And, in light of a number of recent studies of the device in both upper-arm brachiocephalic AVFs as well as radiocephalic AVFs, which generated largely positive results regarding

days and banding failure (defined as re-banding within one year of the index banding procedure).

The researchers found that, in total, 297 patients underwent banding during the study period for a total number of 398 encounters. The median follow-up time was 157 (52–373) days, they note in their JVA report. Most arteriovenous fistula (AVF) accesses (84%) were in the upper arm of the patient with brachial artery inflow and half of the banding procedures were performed for flow imbalance based on examination, duplex ultrasound, or a fistulogram. In addition, the median, intraoperative, pre-banding flow volume—based on intraoperative thermal dilution—was 1,545ml/min, which was reduced to 640ml/min following access banding.

This represented a median reduction in flow rate of 58%.

In terms of primary outcome measures, Scully and colleagues report that the 30-day thrombosis rate after banding was 3.8% (15/397) with a total thrombosis rate of 6.5% (26/368) throughout the entire study period and a median time to event of 5.5 (2–102) days. Multivariate analysis for 30-day thrombosis identified Rebecca Scully no risk factors for

thrombosis including access type, indication for banding, and banding diameter.

Regarding banding failure, the authors relay that the re-banding rate within one year was 13.6% (54/398) with a median time to re-banding of 133 (56–224) days. During the entire study period, 26% of patients (76/297) needed to be re-banded at any time.

Multivariate logistic regression analysis here revealed that having a forearm radiocephalic AVF—compared to all other access types—was protective against need for re-banding at one year, as was flow imbalance as an indication for banding.

“This work highlights the safety and efficacy of precision banding for both symptomatic and asymptomatic access patients with high-flow volume,” Scully and colleagues write.

This study represents the largest series of precision banding for highflow haemodialysis accesses.”

fistula outcomes, they expanded the use of VasQ for all Discussing AVF cannulation outcomes, Shahverdyan radiocephalic AVFs in the hospital and retrospectively and colleagues state that the number of accesses evaluated prospective data from patients implanted reaching a dialysis status or starting apheresis at the with the device between June 2018 and August 2021. end of the retrospective review window was 81.3% The collected data included patient demographics, (122/150). One patient continued peritoneal dialysis medical history (especially diabetes status), and despite having a matured fistula, based on a personal dialysis status, while information was also collected decision, leaving 121 cases with active dialysis access reporting any secondary interventions, access-related use. Two-needle cannulation was achieved in 90% complications, time to AVF maturation, cannulation (n=109) of these patients, while radiocephalic AVF start date in dialysis patients, and assisted primary failure occurred in 6.6% (n=8), leading to a functional and secondary patency rates. The patient cohort was patency rate of 93.4%. The authors go on to report that followed up for up to 36 months, Shahverdyan and the median time to first successful cannulation for 74 colleagues detail. of the 87 patients who were on active haemodialysis Across the study period, the VasQ device was prior to AVF creation (85%) was 41 days. used to create 150 radiocephalic AVFs in a total At six, 12, 18, 24 and 30 months, rates of assisted of 148 patients. The study cohort patency (time from AVF creation until an was predominantly male (68%), AVF occlusion, which was successfully with a median age of 64 years restored) were 89%, 81%, 78%, 73%, (range=28–87 years), and the most and 73%, respectively, and secondary % % prevalent comorbidities included patency rates of 94%, 87%, 86%, arterial hypertension (72%) and 84%, and 84%, were observed too. diabetes (45%). Some 58% of Shahverdyan and colleagues further patients were receiving dialysis state that 63% of AVFs (94/150) treatment due to end-stage kidney were free from further interventions, disease at the time of access with the remaining 37% (56/150) creation as well. undergoing a total 102 interventions Regarding physiological AVF throughout the study period. As maturation, the researchers note that Regarding such, the number of interventions this was achieved in 95% of patients physiological AVF per patient year was 0.55. Ninety(142/150), while the remaining 5% maturation, the eight percent of all interventions were (8/150) failed before maturation and researchers note that successful, with the vast majority (97%) were abandoned. Seven of those failures this was achieved involving a percutaneous transluminal were converted to another access type, in 95% of patients balloon angioplasty. and one patient died prior to planned (142/150), while the Finally, touching on safety outcomes, arteriovenous graft (AVG) creation. remaining 5% (8/150) the researchers relay that the study Unassisted maturation was observed in failed before maturation achieved a 100% technical success 89% (133/150) of all cases, with 86% and were abandoned. rate on device implantation as planned, (129/150) achieving maturation four and no device-related adverse events weeks after access creation. And, from the remaining were recorded. In addition, no patients developed nine primarily non-matured AVFs, eight patients symptomatic haemodialysis access-induced distal achieved successful balloon-assisted maturation within ischaemia or high-flow AVFs (Qa≥2l/min) during the 165 days. study period.

95

5

142/150 8/150

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34 Market Watch

InspireMD announces the inclusion of its CGuard carotid stent in CREST-2 trial

Clinical News surgery at Harvard Medical School in Boston, USA. “Our hope is that the CLariTI study gives us better insights into the reintervention, amputation and death rates in no-option and highrisk patients treated with the current standard of care.”

The LimFlow system

PROMISE II US pivotal trial of device designed for ‘no-option’ CLTI patients completes enrolment

Enrolment has been completed in the PROMISE II pivotal trial of the LimFlow deep vein arterialisation system designed to prevent amputations in so-called “no-option” chronic limbthreatening ischemia (CLTI) patients, the eponymous device maker recently announced.

“The PROMISE II investigators are very encouraged by our experience using the LimFlow system to treat CLTI patients with no other options.

These are likely the sickest patients ever to have been enrolled in a limb salvage trial,” said Daniel Clair, PROMISE II principal investigator, and professor and chair of the department of vascular surgery at Vanderbilt University Medical Center Section of Surgical Sciences in Nashville, USA. “Major amputations have a devastating effect on the lives of patients and their families. We are excited about the prospect of helping improve the lives of more of these patients once this novel technology becomes broadly available.”

PROMISE II is a multicentre, prospective, single-arm study being conducted at sites in the US of 105 no-option CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing, with subjects followed out to three years. The no-option patients treated in PROMISE II were determined by an independent physician committee to be no longer eligible for conventional endovascular or surgical therapy to treat CLTI, according to LimFlow.

The company also announced completion of enrolment in the CLariTI study of approximately 200 highrisk and no-option CLTI patients.

The prospective, observational, multicentre CLariTI study will track the clinical progression of CLTI and incidence of death, amputation, and revascularisation attempts in patients undergoing standard medical management for the disease over a oneyear period.

“Despite suffering from the most advanced form of CLTI, these nooption and high risk patients have been excluded from other trials,” said Anahita Dua, CLariTI principal investigator and assistant professor of

Cardiovascular Systems announces first in-human experience with peripheral everolimus DCB

Cardiovascular Systems Inc (CSI) has announced the start of enrolment in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies (CVT).

DCBs are a widely accepted percutaneous interventional treatment option for femoropopliteal lesions in patients with peripheral arterial disease. Everolimus, the active drug in CVT’s DCB formulation, acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis and has a long history of safety and efficacy in coronary drug-eluting stent applications.

The first patient was treated

by Benjamin Honton, principal investigator at the Clinique Pasteur, Toulouse, France. The peripheral DCB was used to successfully treat a 69-year-old male with a 7.5cm lesion in his superficial femoral artery (SFA).

“We are honoured to enrol the first patient in the CVT-SFA trial,” said Honton. “We believe this promising new generation of everolimus DCBs could improve patient outcomes for those suffering from peripheral arterial disease.”

CVT intends to enrol 75 patients at a minimum of four sites in France and Germany to support an investigational device exemption (IDE) submission to the US Food and Drug Administration (FDA) and a subsequent US pivotal clinical study.

Jeffery Chambers, CSI’s chief medical officer, said: “Following the announcement of the first in-human experience with CVT’s coronary everolimus DCB in November 2021, we are thrilled to announce the first inhuman experience with the peripheral everolimus DCB. We believe these products could become important new therapies in the treatment of peripheral and coronary artery disease.”

Under the terms of the agreements signed with CVT, CSI advises that it is providing milestone-based financing to CVT for the development of coronary and peripheral DCBs. Under an acquisition option agreement, upon CVT’s completion of key technical and clinical milestones in the development programme, CSI will have exclusive rights and obligations to acquire CVT, subject to the satisfaction of closing conditions set forth in the agreement.

InspireMD has announced that its CGuard embolic prevention stent system (EPS) will be included as a device option for stenting in CREST-2 (Carotid revascularisation endarterectomy or stenting trial).

Following the recent approval of the CREST-2 investigational device exemption (IDE) supplement application from the US Food and Drug Administration (FDA), the company states that it will be evaluating strategic sites to enable expediated access.

Marvin Slosman, chief executive officer of InspireMD, commented: “This approval for use of CGuard EPS in a trial as significant as CREST-2 is proxy to the validation of our technology platform, contributing to this important work. The CREST-2 trial is widely acknowledged as the most significant ongoing trial to scientifically investigate the optimal course of treatment to prevent strokes for asymptomatic patients with significant carotid disease. The opportunity to be a part of CREST-2 is a tremendous milestone for our company, and we look forward to CGuard playing an important role in the stenting results”.

The study first enrolled patients in 2014, as two parallel multicentre randomised, observer-blinded endpoint clinical trials with the purpose of being to determine the best way to prevent strokes in patients with high-

CGuard embolic prevention system

grade carotid stenosis but no stroke symptoms related to that blockage.

According to an InspireMD press release, the trial will enrol an estimated 2,480 participants who will remain in the study for four years following the start of intervention.

“The CREST-2 executive committee is keenly focused on positioning the results of the trial to be relevant, actionable, and informative to contemporary practices,” said Thomas Brott (Mayo Clinic, Jacksonville, USA), principal investigator of the National Institute of Neurological Disorders and Stroke (NINDS)sponsored trial. “Over the course of the trial we have continually introduced state of the art medical, pharmacological therapies to reduce the risk of stroke in our randomised patient population. It is critical of any long-term study to remain aligned with evolving technology and relevant devices. After examining the extensive clinical experience with the CGuard stent and the large body of evidence to

April 2022

its effectiveness, the study executive committee felt it appropriate to include this stent as a treatment option. Patients that agree to participate in the CREST-2 trial, depending on accessibility and operator training and discretion, will now have access to this state of the art, carotid stent device.”

Humacyte announces publication of positive longterm follow-up data from phase 2 trial of HAV for haemodialysis

Humacyte recently announced that five-year data from a phase 2 clinical trial of patients receiving the investigational Human Acellular Vessel (HAV) for arteriovenous (AV) access in haemodialysis have been published in the European Journal of Vascular and Endovascular Surgery companion journal EJVES Vascular Forum. The manuscript reports the durable long-term use and ongoing clinical function of the HAV in patients with end-stage renal disease who are undergoing haemodialysis.

In the Phase 2 long-term follow-up data, the HAV was observed to provide routine and functional haemodialysis access for patients with end-stage renal disease who require dialysis three times a week. At month 60, patency allowing for reliable dialysis access cannulation was estimated at 58.2% of evaluable patients (i.e. those who completed the original 24-month study with patent HAVs and consented to participate in the long-term followup; 95% confidence interval [CI], 39.2–73.1%), after censoring for deaths and withdrawals. While there was no comparator in this phase 2 trial, historical reports of arteriovenous fistula (AVF) indicate an approximately 30% functional patency of evaluable patients at five years. In addition, no infections of the HAV were reported during the five-year follow-up period, with the HAV being well tolerated and non-immunogenic.

“Patients with end-stage renal disease require chronic vascular access for haemodialysis, and those who are not candidates for fistulas must rely on synthetic arteriovenous grafts, which have a higher rate of complications including an increased risk of infection,” said Tomasz Jakimowicz (Medical University of Warsaw, Warsaw, Poland), principal investigator of the trial. “I am encouraged by the results from this trial because in addition to retaining structural integrity needed for haemodialysis, the HAV was observed to have a low risk of infection with long-term use. These results indicate the potential of the HAV as a promising option for vascular access in haemodialysis.”

“We are pleased to share these promising data, representing the longest-term follow-up of any trial of implanted bioengineered human vascular tissue and 133 cumulative patient years of HAV exposure, with our scientific peers,” said Laura Niklason, CEO of Humacyte.

April 2022

CHARING CROSS SPECIAL EDITION

Experts launch ‘Masters of Circulation’ podcast A trio of specialists in vascular surgery and interventional radiology recently launched a new podcast—‘Masters of Circulation’—with the aim of interviewing pioneers and leaders in the field of vascular intervention.

THE PODCAST TEAM CONSISTS OF RAMON Varcoe, vascular surgeon at the Prince of Wales Hospital and associate professor of Vascular Surgery at the University of New South Wales (Sydney, Australia), Andrew Holden, director of Interventional Radiology at Auckland City Hospital and professor of Radiology at the University of Auckland (Auckland, New Zealand) and Peter Schneider, a professor of Surgery in the Division of Vascular and Endovascular Surgery at the University of California San Francisco (San Francisco, USA).

Speaking to Vascular News, Holden hones in on the goals of the project, detailing a focus on “exploring the history of what got us to where we are now, the current challenges we are all facing and those allimportant perspectives on where we are headed next”.

The group’s first interview with “eminent vascular leader” Frank Veith (New York University Langone Medical Center, New York, USA) “explored the early

Education 35 days of vascular surgery, the endovascular revolution, his approach to collaboration, his experiences at the struggles faced when embracing new technology, Massachusetts General Hospital, the development of where the VEITHsymposium came from and how VasCore and the VIVA group of physicians. He also it has evolved over the last 48 years,” Varcoe writes shares his thoughts on the future of vascular care and on Twitter. how to have a rewarding career in clinical medicine.”

In another interview, Marianne Brodmann (Medical “Masters of Circulation” is available on all podcast University of Graz, Graz, Austria) told the team about platforms. growing up on a farm in Austria and the path that led her towards becoming an angiologist. Brodmann “speaks with passion about what it is like to be a woman in a tough, male-dominated field and revisits the paclitaxel controversy three years later,” Varcoe remarks.

The team has also interviewed Michael Dake (University of Arizona Health Sciences, Tucson, USA), who Varcoe describes as “a pioneer of interventional radiology [IR]”. “In this thoroughly entertaining interview [Dake] speaks about the evolution of IR, the early days of stent-graft treatment for thoracic aortic dissection, the value of professional collaboration, his love of art, family and travel,” Varcoe tells Vascular News. “He shares some great stories along the way.”

More recently, the team spoke with Michael Jaff, chief medical officer and vice president of Peripheral Interventions at Boston Scientific. Varcoe gives a brief overview of their conversation: “In this frank and compelling interview, Dr Jaff speaks about his early entree into vascular medicine, Ramon Varcoe, Andrew Holden and Peter Schneider

The project is focused on exploring the history of what got us to where we are now, the current challenges we are all facing and those allimportant perspectives on where we are headed next.”

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36 Market Watch

Product News

Fist Assist Devices announces Australian distribution deal and sales launch

Fist Assist Devices has announced a three-year affiliation with Regional Health Care Group to commercialise and launch sales of the Fist Assist Model FA-1 device in Australia and New Zealand.

The FA-1 device is a wearable, patent-protected, intermittent compression device that has European CE-mark clearance for use in conditions where vein dilation is desired in patients that will require or have already undergone arteriovenous fistula placement for eventual haemodialysis.

In addition, it is intended to help with infusion arm vein access for chemotherapy, radiology or phlebotomy access support. FA-1 also recently received US Food and Drug Administration (FDA) Breakthrough Device designation for presurgical vein dilation in patients with end-stage kidney disease.

“We are thrilled to combine forces with Regional Health Care Group for the official launch of the Fist Assist Model FA-1 device in Australia and New Zealand,” said Tej Singh, chief executive officer and founder of Fist Assist. “This is a huge milestone, as we now have a committed, dedicated, and exceptional commercialisation arm that is poised to deeply penetrate the Oceania market.”

“We are excited to distribute and commercialise the innovative FA-1 device,” said Scott Clissold, national business development manager of Regional Health Care Group. “We have been watching the Fist Assist technology and patiently awaiting the right time to commercialise a ground-breaking, market-changing and innovative device that will improve the patient journey with renal and cancer care in Australia.”

S.M.A.R.T. Radianz vascular stent system approved for transradial use in the USA

Cordis recently announced that the US Food and Drug Administration (FDA) has approved the S.M.A.R.T. Radianz vascular stent system, a self-expanding stent purposefully engineered for radial peripheral procedures.

The newly approved vascular stent system joins the Brite Tip Radianz guiding sheath and Saberx Radianz percutaneous transluminal

angioplasty (PTA) catheter to complete the Radianz radial peripheral system, a company press release notes.

According to Cordis, the safety and efficacy profile of S.M.A.R.T. vascular stents is validated with a solid foundation of clinical evidence and real-world experience. It claims that the S.M.A.R.T. vascular stents are the only SE lower extremity stents with 10-year follow-up, proven to provide reliable outcomes in over 3,000 patients, and that they have shown comparable one-year revascularisation rates and a significantly lower cost of hospitalisation versus drug-coated stents.

“I am excited that Cordis has committed to delivering new interventional tools that can be utilised in treating patients with cardiac or vascular disorders via a transradial access,” said Craig M Walker, president and founder of the Cardiovascular Institute of the South (Houma, USA).

“We have been constrained in the greater utilisation of this important access site associated with greater patient comfort and less major bleeding as our diagnostic and interventional

tools that can be delivered via this access have been limited. These lower profile devices should expand the utilisation of radial access in treating patients.”

Cordis advises that the S.M.A.R.T. Radianz vascular stent system features improved ergonomics and advanced one-handed deployment capability, offering excellent placement accuracy and up to 300% greater stability. The product is available in a broad size matrix to support iliac and superficial femoral artery (SFA) lesion treatment, and the rapid exchange delivery system offers more convenient wire management and device exchange compared with over-the-wire (OTW) catheter systems, the company adds.

“At Cordis, we see the Radianz radial peripheral system as a best-in-class option for treating peripheral lesions with the added benefit of reducing the cost of care,” said Matt Muscari, Cordis president, Americas. “Empowered by our legacy, we are now focused on investing in a future of innovation. We are committed to leading the way in radial access to enable the less-invasive procedures that patients prefer.”

Medtronic expands reach of AI-powered surgical video management and analytics platform Medtronic has announced that it has entered into a contract with Vizient to

add Touch Surgery Enterprise, an AIpowered surgical video management and analytics platform for the operating room (OR), to Vizient’s offerings.

In a press release, Medtronic said that Touch Surgery Enterprise simplifies the process of recording, analysing, and sharing surgical video.

The integrated, cloud-connected hardware and software system works with many laparoscopic and robotic scopes, enabling hospitals to take the first step to digitising their OR while leveraging existing equipment, the press release adds.

“Touch Surgery Enterprise allows surgeons to use data to refine the way surgery is taught and executed, and we believe that will raise the standard of healthcare for all,” said George Murgatroyd, vice president and general manager, Digital Surgery within the Surgical Robotics business, which is part of the Medical Surgical Portfolio of Medtronic. “This agreement with Vizient allows us to build on the strong interest we are seeing globally, to support hospitals in the USA who are looking to harness the power of surgical video data and analysis.”

Touch Surgery Enterprise is part of Medtronic’s portfolio of artificial intelligence (AI) and surgical robotic solutions. It is compatible with the Hugo robotic-assisted surgery (RAS) system. Vizient serves more than half the nation’s acute care providers, including academic medical centres, community hospitals, paediatric facilities, and non-acute care providers.

Touch Surgery Enterprise allows surgeons to upload, store, analyse, and share surgical videos

“Vizient’s mission is to help our member providers deliver high value care to the patients they serve. Our ability to evolve relationships with our suppliers is a critical piece to the equation as we look to deliver on a more comprehensive value proposition in the market,” said Bryan Grossman, senior vice president, Strategic Supplier Performance & Category Management, Vizient. “Touch Surgery Enterprise aligns with our mission, offering our members the ability to analyse surgical processes that can help advance patient care.”

Touch Surgery Enterprise is comprised of the DS1 computer and controller—surgical video recording hardware designed specifically for the OR. Applications of built-in AI include automatic blurring of faces and protected information to ensure data privacy compliance, automatic segmentation of surgical video into key procedural steps, and the ability to benchmark a case against a bank of

April 2022

historical cases or make comparisons across departments.

“By simplifying the process to capture and analyse surgical video, Touch Surgery Enterprise gives surgical teams a powerful new tool to advance patient care,” said Megan Rosengarten, president of the Surgical Robotics business at Medtronic. “We are excited about the impact it can make for customers today, as a solution for laparoscopic and robotic-assisted cases within their existing infrastructure, and for the possibility this technology creates in the future.”

Cardiovascular Systems partners with Innova Vascular to develop full line of thrombectomy devices

Cardiovascular Systems Inc (CSI) recently announced it has partnered with Innova Vascular (Innova) to develop a full line of novel thrombectomy devices.

According to a press release, CSI intends to acquire and commercialise novel thrombectomy devices from Innova targeting peripheral vascular disease, including deep vein thrombosis (DVT) and pulmonary embolism (PE).

Sanjay Shrivastava, CEO of Innova said: “We strive to bring solutions that are easy to use, safe, and highly effective in treating potentially devastating diseases. We are excited to partner with CSI, which has been serving the interventional cardiology, interventional radiology, and vascular surgery communities that will be the primary users of Innova products. CSI’s commercial presence in this space makes it an excellent fit for accelerating the commercialisation of Innova’s products post regulatory clearances.”

CSI claims that, pending regulatory clearance in the USA, the company could begin to commercialise a portfolio of manual aspiration and clot retrieval devices for the treatment of peripheral vascular disease in 2023.

The portfolio and corresponding indications for use are expected to be expanded to include treatment of DVT and PE following the completion of subsequent clinical trials.

Scott Ward, chairman, president and CEO, said: “The commercialisation of these thrombectomy devices will be an important addition to our growing pipeline of products. In total, developing novel drug-coated balloons, intravascular lithotripsy, mechanical circulatory support, and thrombectomy devices target some of the fastestgrowing segments within interventional cardiology. Supplementing our core orbital atherectomy devices with these technologies will greatly increase the number of patients we will reach while simultaneously expanding our total addressable market to over US$18 billion in the coming years.”

Under the terms of the agreements signed with Innova, CSI has provided financing to Innova for the development of thrombectomy devices. Under an acquisition option agreement, upon Innova’s completion

April 2022

CHARING CROSS SPECIAL EDITION

Market Watch 37

Product News of key technical, regulatory, and clinical milestones in the development programme, CSI will have exclusive rights to acquire the thrombectomy devices, subject to the satisfaction of closing conditions set forth in the agreement.

Front Line Medical expands availability of COBRA-OS aortic occlusion device

Front Line Medical Technologies has announced the expanded availability and distribution of COBRA-OS (Control of bleeding, resuscitation, arterial occlusion system), as US and Canadian hospitals continue to implement the aortic occlusion device during various surgical and emergency cases.

The COBRA-OS, which is approved

by Health Canada and cleared by the US Food and Drug Administration (FDA), is the first 4Fr REBOA (resuscitative endovascular balloon occlusion of the aorta) device and has the lowest profile on the market, according to the company. The device is guidewire-free and has a 25mm diameter compliant balloon with a uniquely designed safety shoulder reservoir incorporated into the device to help prevent aortic rupture during

inflation. Despite being so small, the device is also strong enough to hold back aortic pressure and allows for permissive hypotension in bleeding areas below the balloon. The device can be deployed quickly, in just over a minute, which is key in emergency situations, the company claims.

In addition to permitting interventional radiologists the time to perform internal iliac artery embolisation in hypotensive patients with unstable traumatic pelvic fractures, the COBRA-OS has been recently used prophylactically to treat a pregnant patient with placenta accreta, significantly reducing the risk to both mother and child.

Adam Power (Victoria Hospital in London, Ontario, Canada), vascular surgeon and co-inventor of the COBRA-OS, has successfully utilised

Cobra - OS

the device with his interventional radiology colleagues in traumatic bleeding cases to help stabilise patients.

As the device is so low profile, he has even been contacted to help with pediatric patients with uncontrolled bleeding.

“The COBRA-OS is a versatile tool that can be a Swiss army knife for interventionalists. There is no other compliant balloon medical device in the world that goes through a 4Fr sheath and can expand to 25mm diameter. I have even seen it be used coaxially in larger sheaths to occlude the aorta and allow interventions through the same single sheath which was pretty impressive,” said Power. “Access site complications are the bane of my existence as a vascular surgeon and I want to help lower their incidence, especially in extremely sick patients.”

Sky Medical Technology receives FDA clearance for (W3) Geko device

Sky Medical Technology has announced it has achieved further US Food and Drug Administration (FDA) 510(k) clearance to market the new (W3) Geko device variant, for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischaemia.

This latest (W3) Geko device 510(k) follows the company’s prior 2021 FDA clearance for the (W2) Geko device, also authorised for venous insufficiency

and/or ischaemia. The new (W3) Geko device clearance brings with it the added benefit of a third electrode, enabling greater patient reach (nerve stimulation), patient comfort, better patient outcomes, and an increase to two 12-hour therapeutic doses, whereas previously the (W2) device provided two six-hour doses.

The Geko device (W3) 510(k) adds to Sky’s portfolio of FDA clearances, which include oedema reduction and stimulation of the calf muscles to prevent venous thrombosis in both surgical and non-surgical patients.

CEO and Founder, Bernard Ross commented, “Achieving this latest 510(k) clearance for the Geko device (W3) establishes Sky’s position as a leading innovator in MedTech dedicated to improving patient outcomes. Conditions such as venous insufficiency and ischaemia are therapy areas sorely in need of innovation, and we are pleased to contribute to improvements in this care pathway that make recovery quicker, simpler, and more comfortable.”

The Geko device is a non-invasive, easy-to-use, wearable therapy device.

The size of a wristwatch and worn at the knee, the disposable device gently stimulates the common peroneal nerve activating the calf and foot muscle pumps, resulting in increased blood flow in the deep veins of the calf, at a rate equal to 60 percent of walking without a patient having to move, a press release details.

- 3rd Edition

(ECMEC®s)

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38 Market Watch

Industry News FDA advisory panel issues recommendations on lifelong surveillance and long-term postmarket data collection for EVAR

At the end of February, the US Food and Drug Administration (FDA) announced it had issued a letter to healthcare providers emphasising the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aneurysm repair (EVAR).

“Regular imaging surveillance, within 30-days of EVAR and annually thereafter, may help identify adverse events such as endoleaks, device migration, loss of patency, and failure of aneurysm sac regression before the occurrence of potentially serious and life-threatening adverse event,” the FDA communicates.

During an FDA meeting on 3 November 2021, the Circulatory System Devices Panel of the Medical Devices Advisory Committee discussed the long-term safety and effectiveness of endovascular stent grafts for AAA treatment, how to strengthen data collection on real-world device

performance for currently marketed and future devices, and input on the outcomes that are most important to capture during long-term follow-up.

According to the current announcement, the panel provided input on these topics and the FDA agrees with the panel’s conclusions, including: EVAR continues to be a safe and effective treatment option for appropriately selected AAA patients.

Patients should complete follow-up visits 30 days post implantation and lifelong annual follow-up thereafter. As is outlined in current professional society guidelines, a six-month follow-up visit should occur if concerns are identified from imaging at 30-day follow-up.

A real-world surveillance system should be created to collect data through 10 years post-EVAR. ● The surveillance system should assess the following clinical endpoints: all-cause mortality, aneurysm-related mortality, aortic rupture and aortic reintervention.

Calendar of events 26–28 April Charing Cross (CX) Symposium 2022 London, UK, in-person & virtual www.cxsymposium.com/cx2022/

9–11 May Advanced Health Education (Ahed) Advanced Endovascular Intervention Course—3rd Edition Lisbon, Portugal www.ahed.pt/en/

26–27 May Pacific Northwest Endovascular Conference (PNEC) Seattle, USA pnec-seattle.org

● The surveillance system should be designed to capture imaging endpoints including endoleaks, aneurysm size, and device patency because these endpoints are associated with adverse clinical events. Collection of high-quality imaging data using standardised imaging protocols and core lab review may be most feasibly accomplished at selected clinical centres.

Renewed efforts from physicians, health systems and medical professional societies are needed to increase patient and physician compliance with follow-up imaging recommendations post-EVAR. In their letter to healthcare providers, the FDA recommends the following: For patients that providers have treated or follow who are implanted with EVAR devices, regular clinical follow-up and imaging is critical to detect EVAR device and treatment failures to maintain favourable long-term results. ● The FDA urges physicians to ensure compliance with the followup recommendations outlined in device instructions for use (IFU) and the Society for Vascular Surgery (SVS) guidelines. SVS

April 2022

guidelines recommend follow-up visits with imaging 30-days post implantation and annual followup thereafter, with concerning findings from the 30-day imaging prompting a six-month follow-up visit.

For patients under care who are being considered for EVAR, physicians should discuss the risks and benefits of all available AAA treatment options with patients (including open surgical repair), while emphasising the need for lifelong follow-up imaging and the possibility of reinterventions following EVAR. A patient’s willingness and ability to comply with annual imaging follow-up should be considered and discussed in determining the most appropriate treatment option.

If problems with devices are observed, healthcare providers should report them to the device manufacturer and the FDA’s Voluntary MedWatch Reporting system.

These recommendations do not change or affect the Endologix AFX AAA endovascular graft recommendations from January 2022, the FDA advises.

The agency states that it will work collaboratively with key stakeholders to help drive the effort to improve EVAR patient follow-up and postmarket data collection forward.

Please be advised that the events listed below are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.

6–9 June Leipzig Interventional Course (LINC) Leipzig, Germany & virtual www.leipzig-interventional-course.com/ visitors/linc-2022/

12–14 June 25th European Vascular Course (EVC) Maastricht, The Netherlands www.vascular-course.com/

15–18 June Society for Vascular Surgery (SVS) Vascular Annual Meeting Boston, USA www.vascular.org/vam

10–14 September Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Barcelona, Spain cirse.org/events/cirse-2022

20–23 September 36th European Society for Vascular Surgery (ESVS) Annual Meeting Rome, Italy esvs.org/events/annual-meeting

31 October–3 November Vascular InterVentional Advances (VIVA) Las Vegas, USA viva-foundation.org/

15–19 November VEITHsymposium New York, USA

www.veithsymposium.org/index.php

23–25 November Paris Vascular Insights (PVI) Paris, France parisvascularinsights.com/

Vascular News is a trusted, independent source of news and opinion in the vascular and endovascular world.

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Standard Portfolio

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Visit our website for more information on use, indications, contraindications, warnings/precautions and availability within your market.

The products shown are from standard and custom solutions range, and their availability is subject to local regulatory guidelines. *Custom-made devices do not bear CE Mark. According to medical device law, physician prescription is required. Custom-made option is not available in the United States.

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