NeuroNews Stryker Supplement September 2021

September 2021 | Educational Supplement

With you all the way

At Stryker, we’ve always been by your side—for service, education and innovations that advance stroke care. That’s why we offer our complete stroke portfolio and a complementary array of tools that are designed to deliver uncompromised performance.

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This educational supplement has been sponsored by Stryker

Introduction

Contents: 3

Target Detachable Coil: The evolution of the detachable coil, and what makes it a coil for every case

4–5 Surpass Evolve Flow Diverter: A welcome addition to the toolbelt for the treatment of wide-necked intracranial aneurysms 6

SKILL Assist: Remote training for the modern stroke care environment

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Trevo NXT Retriever: Latest data and experience on the Trevo NXT Retriever

8–9 AXS Vecta Aspiration Catheter: Lessons from an aspiration-first pioneer 9

Synchro SELECT Guidewire: Fundamentals in selecting a guidewire

10 Partnerships: Stryker’s partnership ethos 11 StrokEnomics: Solving the economic piece of the stroke care puzzle

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Mark Paul, president of Stryker's Neurovascular division outlines the company’s end-to-end approach to stroke care.

For decades, in over 70 countries around the world, Stryker has worked tirelessly with our customers to make healthcare better. Today, as one of the world’s leading medtech companies, Stryker remains fully committed to innovation, clinical studies and market development that helps our customers effectively treat patients suffering from haemorrhagic and ischaemic stroke.

When thinking about stroke care, it is impressive how far we have come. We are truly in the “golden era” of neurovascular innovation. At the same time, I think about how far we can still go. As technology advances, and as clinical questions are answered, it is the honour of a lifetime to be a part of an organisation that helps save lives around the world; and it is exciting to see the evolution of technologies happening up close.

As a neurovascular team more tenured than most in our industry, we know the challenges our customers face. We are proud of the innovations developed with our customers, such as the Target Detachable Coil, Surpass Evolve Flow Diverter, Trevo NXT ProVue Retriever and AXS Vecta Intermediate Catheter, as well as other diagnostic and therapeutic devices. Ours is a portfolio we have advanced in substantial ways, supported by clinical outcomes—such as the DAWN Trial and other studies—that have helped formulate stroke care guidelines worldwide. We will continue innovating and breaking boundaries to remain a trusted partner, dedicated to being there and supporting our customers all the way.

We know that improving stroke care starts before—and goes beyond—the point of treatment. That is why we pursue partnerships that enhance our traditional product portfolio. By joining forces with passionate, determined leaders in other areas of stroke care, we are able to offer our customers end-to-end solutions that can improve care across the care continuum.

For us, medical education is critical. We are dedicated to helping physicians continuously improve their skills and stroke practice. SKILL is one way we are doing this—our customised medical education programme that fosters peer-to-peer connection, tailored for each stage of the physician’s career. Available to physicians anywhere, anytime, SKILL comprises the latest in communication technology to create a dynamic experience that brings learning to the cutting edge.

We are also committed to helping physicians address the challenges of stroke management with programmes like StrokEnomics. Equipped with the highest level of clinical and economic data, we form strategies that help customers navigate funding barriers, therefore increasing patient access to the best treatment modalities and quality of care.

At the end of the day, our Neurovascular division is driven by the Stryker mission. We remain fully dedicated to growing our partnerships, investing in clinical research and generating clinical evidence to increase medical knowledge that prevents, diagnoses and treats stroke.

Customers can count on us—today and tomorrow. We're with them all the way.

September 2021

Target® Detachable Coil

With you all the way

Reach for Target Coils first— a coil range for every case Innovation is at the heart of the story of the Target Detachable Coil (Stryker).

The legacy began in 1990, with the invention of the Guglielmi Detachable Coil (GDC). Named after its inventor Guido Guglielmi (University of California, Los Angeles [UCLA], Los Angeles, USA), and developed in partnership with Stryker, the introduction of detachable coils completely changed the landscape of how aneurysms were treated and is now the primary endovascular treatment across the world. Following the revolutionary launch of the GDC, Stryker introduced the Target Detachable Coil in 2010. With over a decade of treating patients, and across several iterations, the device is the next chapter in the GDC story.

“PARTNERING WITH PHYSICIANS was our legacy and continues on today,” says Clifford Teoh, senior principal engineer for Stryker’s Hemorrhagic Coils Group, discussing the impact and evolution of the Target Detachable Coil. “Listening to physicians’ needs, and iterating designs to meet their needs is evident from our breadth of offerings throughout the years. With 10 years of coil innovation and more than 500,000 patients treated, Stryker offers a full line of four softness levels, three coil shapes and two primary diameters—truly a coil range for every case.”

Since its first-in-human use, the device has been enhanced to respond to the needs of patients and evolving interventional practice. Using the coil offers access to three shapes—360, 3D and Helical—all designed to frame securely, fill uniformly, and seek voids within the aneurysm.

The Target 360 Coil is at the forefront of coil shape technology, providing uniform distribution, concentric filling, and aneurysm neck coverage. The 360-degree shape is designed to seek the outer wall and leave an open centre for concentric filling. The first 1.5 distal loops are 25% smaller than the stated secondary coil diameter, a feature

Images courtesy of Dr. Alessandro Pedicelli

2011

Target 360 Coil introduces a smooth and stable platform

2010

Target Detachable Coil first used in humans

2012

Target Nano, the softest finishing coil on the market

September 2021

Bi-lobe ACA aneurysm treated with Target Detachable Coils

designed to reduce coil herniation. Target 360 Coil features an open loop configuration, conforming to multiple aneurysm shapes, while minimising compartmentalisation.

As a complementary complex coil option, Target 3D Coil offers a secure foundation for consistent framing. The coil rotates 90 degrees at each small loop, creating a three-dimensional shape. The small loops add body to the coil and help maintain this shape, while the large loops appose the aneurysm wall, providing stability within the aneurysm. Target Helical Coils are designed with versatility in mind. The helical shape is available in a range of sizes and softness levels to support from start to finish for framing, filling and finishing intracranial

2013

Target XL changes the game for volumetric filling

aneurysms, and embolising vascular malformations. Additional innovations in the coil range's history offer full coverage for every case. These include four softness levels—standard (3–24mm), soft (2–20mm), ultrasoft (2–5mm), and nano (1–3.5mm)—as well as three primary diameters—Target 10size, Target XL, which offers double the fill and 40% more width, and XXL which offers triple the fill and 70% more width.

“We continuously improve our designs,” says Teoh, who adds that other developments include the replacement of the reinforced sheath with a 3.5x thicker sheath to provide greater introduction stability to the hub; enhanced proximal contact design, to make the device 10x stronger in buckling; and a laser-ablated detachment zone with a smaller gap, reducing the detachment zone by 65%.

The range of sizes and shapes of the Target Detachable Coil portfolio allow interventionalists to approach every kind of aneurysm. “In short, you get what you expect,” says Peter Schramm (Universitӓtsklinikum Schleswig-Holstein, Lübeck, Germany), offering his view on the platform. “If you are looking for a 3D shape, you get a 3D shape. If you are looking for a certain size, you will find it on the shelf. If you are treating a complex aneurysm, Target Detachable Coil makes it much easier. If you are experienced with those coils, you really feel very comfortable using them,” he adds.

Ian Rennie (Royal Victoria Hospital, Belfast, UK) echoes Schramm’s view that the range of sizes is an advantage of the portfolio. He comments: “There is a fantastic range, from very small to very large, and very long, so the range is superb, and they are predictable across that range.”

Looking ahead to the next 10 years, innovation will remain at the heart of the story. Driven by physician feedback and continuous improvement, the Target Detachable Coil will strive to be the coil range for every case.

2016

2020

XL Mini increases smaller XL mini offerings

500k+ patients treated with Target Detachable Coils

2014

2017

2014

2017

Target 3D unique omega shape loop New Target Nano offers larger size

Next Gen Target Detachable Coil improves user experience Target XXL, the largest of the coils

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Surpass Evolve™ Flow Diverter

Surpass Evolve Flow Diverter is a welcome addition to the toolbelt for the treatment of wide-necked intracranial aneurysms Detailing his early experience with the Surpass Evolve Flow Diverter, Patrick Nicholson (Toronto Western Hospital, Toronto, Canada) discusses key technical aspects of the device, including the number of wires and braid angle, as well as his deployment techniques and early clinical follow-up results.

IN THE LAST 10 YEARS OR SO, flow diverting stents (FDS) have moved to the forefront of treatment approaches for many broad-necked or giant intracranial aneurysms. By inducing stasis or slow flow within the aneurysm, as well as by providing a scaffold for endothelialisation of the stent surface, FDS have been proven in several large trials to be safe and effective in the treatment of such aneurysms. More recently, flow diversion has also been found to be safe and effective for small and medium-sized aneurysms on the internal carotid artery,1 as well as distal anatomy and posterior circulation. There are several devices currently approved worldwide, and

all differ in various aspects of their design, composition, mesh and braid structure and technical delivery nuances.

Surpass Evolve Flow Diverter is Stryker’s latest entrant into the flow diversion space.

The technology received a CE mark in March 2019 and US Food and Drug Administration (FDA) approval in May 2020. The implant is composed of cobalt-chromium wires, interspersed with 12 platinum-tungsten wires for visibility under X-ray. The smallest 2.5mm diameter implant is composed of 48 wires while the remaining diameters (3.25‒5mm) are composed of 64 wires.

Mesh density is crucially important in FDS, as consistent mesh density and braid angle

optimises flow diversion across an aneurysm neck, especially across vessels that taper in size. Increasing the number of wires also affects aneurysm inflow, and so the Surpass Evolve is designed with 64 wires instead of the more traditional 48-wire design found in many other FDS. This has resulted in optimised flow diversion in bench testing when compared with other models, a finding that has been independently confirmed in various centres internationally.2,3 The higher braid angle also has the benefit of increasing device opening and apposition, which in our experience results in less need for balloon angioplasty compared to older systems.

This increased number of wires has mechanical benefits as well, enabling the implant to have a higher radial pressure than its 48-wire counterpart. Not only does the distal end of the stent open and anchor very reliably, but it means that there is less possibility of significant twisting or kinking.

The wires themselves are also thinner—28 microns in diameter when compared with the 32-micron wires found in other devices. This means the stent is soft, flexible, and conforms nicely to the vessel wall. This also allows for more uniform wall apposition—with possibly less need for balloon angioplasty afterwards—and means that the device is easier to push and deliver intracranially, especially with tortuous anatomy.

The system is designed to be delivered through an 0,027” Microcatheter, such as an

Case study 1 A 57-year-old patient with a symptomatic giant (15x18mm) cavernous segment right internal carotid artery (ICA) aneurysm with mass effect. Previous enucleation of their contralateral eye had been performed, and the patient was at risk of blindness as a result of mass effect on their optic nerve. A decision to treat was made in conjunction with the patient. We decided to use Surpass Evolve in this case for several reasons. The increased flow-diversion effect would presumably result in more rapid occlusion of the aneurysm, while the larger sizes available made it more appealing for this large proximal aneurysm. In addition, the anatomy was very tortuous, which would make delivery of a long stent more challenging. Image 1 shows the lateral projection of the ICA showing the aneurysm, while Image 2 also shows the challenging tortuosity of the ICA. A 5x30mm Surpass Evolve flow diverting stent was deployed (Image 3). The distal landing zone was in the distal cavernous ICA well below the ophthalmic artery origin and the proximal landing zone in the petrous/lacerum segment of the ICA. No coils were deployed, and VasoCT showed good wall apposition so no balloon angioplasty was needed. Comparing the pre-op CTA (image 4) with an MRA performed two months later (Image 5) and a CTA at one year (image 6) we see good occlusion of the aneurysm. The patient remained free of any optic nerve compression or other symptoms related to the procedure at two-year clinical follow-up.

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September 2021

With you all the way

XT-27 (Stryker), and so is easier to deploy 50% or so of the device is deployed along the more distally into the more distal intracranial vessel, maintaining a push/pull combination circulation. The implant is pre-loaded on as needed in order to both maximise wall a stent delivery wire that has an optimised apposition and keep the device in the centre flexibility profile to match the patient of the vessel. When sizing the device, the anatomy as well as the XT-27 maximum diameter of the vessel Microcatheter. In our experience, is used, rather than the mid-range Surpass Evolve Flow Diverter of the measurements as in other is easier to navigate in tortuous devices. The largest (usually anatomy than an older-generation proximal) size of the vessel is FDS. The lower forces required to used, and the charts on the device deliver the device also help when packaging will help estimate the deploying it accurately, and in our length of elongation based on experience Surpass Evolve behaves Patrick Nicholson deployment in a constrained (i.e. well when trying to accurately narrower) vessel distally. Some place the distal end, for example in a specific foreshortening is expected, but this is much internal carotid artery (ICA) segment. less than was seen with older stent systems.

Resheathing is also smoother, and minimal To date, the largest six-month follow-up force is required compared to older systems. study included 29 patients harbouring 30 We always use a triaxial system when aneurysms.4 Although limited in size and deploying the stent, consisting of an 8-French scope, the study did show encouraging guide catheter/long sheath, an intermediate results. Favourable aneurysm occlusion catheter such as AXS Catalyst 5 (Stryker), (OKM C and D) at six months follow-up and an XT-27. When delivering the stent, was achieved in 21/27 (78%) aneurysms and there are a number of differences that need to only one procedure-related complication was be taken into account. noted. However, with all new stent systems, Firstly, there is no need to ‘drag and multicentre international data are needed to drop’ the device. We usually deliver it to the validate the efficacy of the system and several anatomy of choice—or perhaps just distal to studies are underway. The IMPACT Postthe desired landing zone—before unsheathing Market Clinical Follow-up registry plans it. This unsheathing distally is key. If there to enroll 200 subjects across 20 European are any issues with sluggish opening of the centres. In addition, the EVOLVE trial seeks implant, the device can be easily resheathed to expand the FDA-approved indication which will facilitate opening. The middle of the Surpass Evolve Flow Diverter to unruptured, wide-neck intracranial aneurysms measuring ≤12mm located on the ICA or its branches. As many as 45 international centres will enroll up to 250 patients.

As we wait for these more robust data, we are encouraged by our early clinical data and case presentations. It would appear that the Surpass Evolve Flow Diverter is a welcome addition to our toolbelt for the treatment of wide-necked intracranial aneurysms.

Case study 2 A 48-year-old female with unruptured 12x8x6mm aneurysm arising from the ICA just distal to the origin of the ophthalmic artery, with a 3mm carotid cave aneurysm more proximally, and very tortuous ICA anatomy (Images 1 and 2). For reasons similar to the previous case, Surpass Evolve was chosen. An additional benefit was the accuracy of distal placement, and the planned landing zones are shown in Image 3. An SL-10 Microcatheter was jailed in the larger aneurysm and a 4.5x25mm stent deployed without incident (Image 4). VasoCT showed good wall apposition, so the next four coils were deployed in the aneurysm to promote thrombosis. The patient was discharged the next day, and followup MRA at six months showed good occlusion of all aneurysms (Image 4).

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Acknowledgements The author thanks Ronit Agid, Timo Krings and Vitor Pereira who also participated in the treatment of these patients.

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References: 1: Hanel, Ricardo A., et al. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results. J Neurointerv Surg. 2020;12.1:62–66.

2: Cancelliere NM, Nicholson P, Radovanovic I, et al.

Comparison of intra-aneurysmal flow modification using optical flow imaging to evaluate the performance of Evolve and Pipeline flow diverting stents. J Neurointerv Surg.

2020;12(8):814–817.

3: Sadasivan C, Fiorella D. Preliminary in vitro angiographic comparison of the flow diversion behavior of Evolve and Pipeline devices. J Neurointerv Surg. 2020;12(6):616–620.

4. Rautio R, Alpay, K, Sinisalo M, et al. Treatment of intracranial aneurysms using the new Surpass Evolve flow diverter: Safety outcomes and six-month imaging follow-up. Journal of Neuroradiology. 2021;03:003.

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SKILL Assist™

SKILL Assist: Remote made remarkable Events of the last 18 months have highlighted the growing need for solutions to break down the barriers to medical education faced by physicians across the globe. This has led to the adoption of a wide array of smart platforms to support healthcare providers, but there is still room for innovation to enable seamless collaboration between physicians, from anywhere in the world.

THIS IS WHERE STRYKER’S SKILL Assist Remote Proctoring Solution comes in. Developed by Stryker’s neurovascular division and supported by CAREPROD technologies, in collaboration with neurovascular experts, SKILL Assist is a remote proctoring platform designed to allow remote sharing of experience and patient management, built with the needs of the neurovascular specialist in mind. “This kind of system will allow us to perform hands-on teaching in a remote fashion with a very high-level quality, and I think it is a major, major improvement in the educational process,” comments Vincent Costalat (Gui de Chauliac University Hospital, Montpellier, France).

The platform is designed to lift the physical barriers to medical education, and enable joint working across borders. The system facilitates training and collaboration during a neurovascular procedure, live.

SKILL Assist uses remote tools, including

fully HD cameras with a 360-degree range of vision capable of providing total visual and verbal control, and on-screen annotation for clear direction. Connected via synchronous video and audio transmission, a neurovascular specialist using SKILL Assist is able to connect to an expert for real-time collaboration from any location.

How does SKILL Assist work?

The platform consists of a control monitor and two automated, low-latency NDI cameras which are set up in the angiosuite. These are connected to a remote location via a secure 4G or 5G connection. On the other side of the connection, a physician-trainer has access to using a touchscreen display. This broadcasts the images from the procedure in real time, enabling the experienced physician to move the cameras for a detailed understanding of the environment.

Touchscreen functionality allows the physician to write, point, or draw on the

Proctor view The proctor can write and draw on the trainee screen in another part of the world

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screen—with the annotations beamed instantly back to the angiosuite. The movement of the pen is mirrored on both sides—every time a landing zone is marked or the curve of the vessel is traced. These features are augmented with a two-way voice connection that ensures a steady flow of communication.

The plug-and-play system is designed to be ready to use in minutes, and is portable, scalable and autonomous of any hospital internet network. The system can be ready for use in under 10 minutes. and is built with security in mind, having been engineered to meet or exceed Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR) standards.

Are there other advantages?

Among the possible benefits of using the system, is having access to a broad range of expertise and knowledge, all at the touch of a button. “You can have training from different interventional neuroradiologists across the world, lots of different opinions on how to do things, learn different techniques from different people, whereas at the moment you are just trained by the people you are working with,” says Laetitia de Villiers (Gold Coast University Hospital, Southport, Australia).

“That a very exciting prospect,” she adds.

Increasingly, environmental concerns are influencing the way that individuals and organisations choose to operate. As digital platforms have been shown to be a means of facilitating learning during the pandemic, their use as a tool to provide high-quality, hands-on education, without the cost and environmentally damaging effects of international air travel, are likely to be appealing. Being able to stand sideby-side with educators from across the globe, virtually, will undoubtedly have a role to play in the development of the next generation of neurovascular specialists.

According to Christophe Cognard (Purpan University Hospital in Toulouse, France), this is a key reason why he supports the use of SKILL Assist. He says: “There is no need to take flights or taxis, or to book a hotel room. You save lots of time and lots of energy. My real concern is the evolution of the climate on the planet, and indeed by using this system you decrease the production of carbon dioxide, tremendously.

This, for me, is something which is really essential.”

All of these arguments make a strong case for SKILL Assist to become a key component of neurovascular education in the future—breaking down the barriers to high-quality training.

September 2021

Trevo NXT® Retriever

With you all the way

Early data confirm Trevo NXT Retriever as an effective tool for mechanical thrombectomy

the ICA-T and one for the M1/M2) and the groin to reperfusion time (median 51 minutes for ICA-T vs. 34/35 minutes for M1/M2) were higher for ICA-T occlusions.

Discussing the findings, Psychogios et al highlight that the rate of first-pass complete or near complete reperfusion was achieved in 54% of cases, comparing favourably to previously published data of the predecessor device, while final mTICI ≥2c was achieved in 83% of cases and final complete Initial data pooled from four high-volume European stroke centres indicate reperfusion (mTICI 3) in 56% of the cases. that Stryker's Trevo NXT Retriever is an effective and safe tool for mechanical Regarding the technical aspects of using the thrombectomy, especially when used for combined approaches. This was Trevo NXT Retriever as a first-line device, the finding of Manina Etter, Alex Brehm and Marios-Nikos Psychogios they write that advancing the stent retriever (Department of Neuroradiology, University Hospital Basel, Basel, Switzerland) within the microcatheter was “easy” in the alongside researchers from University Hospital Heidelberg (Heidelberg, Germany), majority of cases and target placement was Hospital Clínico San Carlos, (Madrid, Spain), Careggi University Hospital, achieved in all cases. “Our impression after (Florence, Italy) and University Hospital RWTH Aachen, (Aachen, Germany), who using the 4mm Trevo NXT with 0.021” reported initial experience with the device for mechanical thrombectomy of largemicrocatheters is that the pushability of the and medium vessel occlusions in the journal Frontiers in Neurology.1 stent retriever is given even in tortuous proximal vessels. While treating distal occlusions with the 3mm MECHANICAL THROMBECTOMY range [IQR] 8–19) and median Trevo NXT, pushing the device Trevo NXT is the standard of care for ischaemic stroke Alberta Stroke Program Early through a 0.017” microcatheter Retriever caused by large vessel occlusion (LVO).

CT Score (ASPECTS) on initial was feasible,” they write. “In our The main techniques include use of a stent imaging was 9 (IQR 8–10). subjective opinion, pushing the retriever and withdrawal of the device with or First-pass or near-complete new 3mm device through a 0.017” without flow arrest by a balloonreperfusion was achieved in microcatheter was easier compared to guide catheter; direct aspiration 43 (54%) patients, with complete previous Trevo generations, although we did technique using a large-bore reperfusion (mTICI 3) seen in 34 not compare the two devices in this study.” aspiration catheter (ADAPT), (43%). Final complete, or nearAs for the retrieval of the device into the placed at the face of the clot; or, complete reperfusion (mTICI ≥2c) aspiration catheter or balloon-guide catheter, primary combined approaches using was observed in 66 patients (83%) the authors received positive feedback. These a stent retriever and an aspiration and complete reperfusion (mTICI 3) findings are consistent with the development catheter intracranially, with in 45 (56%) patients, after a median of a hydrophilic coated polymer jacket, Marios-Nikos additional extracranial aspiration of 1.5 passes (IQR 1–3). The designed to enable smoother and easier Psychogios through the guide catheter. study’s authors note that the rate delivery and improved retraction. The authors Stryker’s Trevo stent retriever is a wellof successful reperfusion was 64% after one write that the device can be regarded as safe, established mechanical thrombectomy device, pass, and 96% at the end of the procedure. with complication rates comparable to those with earlier iterations of the device having A total of 158 passes were performed, and of the literature. In sum, the findings lead the been the most frequently used devices in no device malfunctions were observed. Four authors to conclude that, based on initial data, the MR CLEAN trial,2 and the only stent complications were seen; two subarachnoid the Trevo NXT Retriever is an effective and retriever used in the interventional arm of haemorrhages, and two vasospasms. safe tool for mechanical thrombectomy— the DAWN randomised trial. Psychogios A subgroup analysis of the angiographic especially when using combined approaches. et al assessed the new-generation Trevo results after stratification by occlusion site NXT, Retriever focusing on the efficacy and indicated higher first-pass complete or nearReferences: peri-interventional safety of the device, from complete reperfusion results in the M1 and 1: Etter M, Möhlenbruch M, Weyland C, et al. Initial experience with the Trevo NXT stent retriever. Front Neurol. Forthcoming 2021.

October 2020 to February 2021.

M2 segments compared to the internal carotid 2: Berkhemer O, Fransen P, Beumer D, et al. A Randomized Trial of The study’s primary endpoint was first-pass artery terminus (ICA-T; 53%/46% vs. 29%), Intraarterial Treatment for Acute Ischemic Stroke. N Engl J Med. 2015;372.(1):11–20. complete or near-complete reperfusion, while the number of passes (median three for defined as a modified thrombolysis in cerebral infarction (mTICI) score ≥2c. Secondary Per Pass Reperfusion Results1 endpoints included final reperfusion, National Institutes of Health Stroke Scale (NIHSS) at Pass # 1 2 3 4 5 6 24 hours and discharge. Interventionalists Number of patients 80 34 20 14 8 5 gave subjective ratings based upon their experience of delivering and retracting the mTICI <2b, n (%) 29 (36%) 18 (53%) 12 (60%) 8 (54%) 5 (63%) 3 (60%) catheter compared to previous generations. mTICI ≥2b, n (%) 51 (64%) 16 (47%) 8 (40%) 6 (46%) 3 (37%) 2 (40%) In total, 80 patients were enrolled in the mTICI ≥2c, n (%) 43 (54%) 12 (35%) 5 (25%) 3 (23%) 1 (12%) 1 (20%) study, with a mean age of 74±14 years, and 39 patients (49%) were female. The median mTICI 3, n (%) 34 (43%) 7 (21%) 2 (10%) 2 (15%) 0 (0%) 0 (0%) NIHSS at admission was 15 (interquartile September 2021

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Aspiration-first

Minutes matter: Lessons from an aspiration-first pioneer Minutes matter. That is the message of Alejandro Spiotta (Department of Neurosurgery, Medical University of South Carolina [MUSC], Charleston, USA), detailing the philosophy for the treatment of stroke at MUSC. The institution is a busy centre in what is known as the ‘stroke belt’ in the southeast of the USA, as well as being a pioneer of ADAPT—A direct aspiration first pass technique. In this interview, Spiotta discusses the continued development of ADAPT, evolution in the design—and size—of aspiration catheters, and his experience using the AXS Vecta® Aspiration Catheter platform (Stryker).

MUSC SEES A HIGH VOLUME OF stroke cases every year, according to Spiotta, who describes it as one of the top five-to-10 centres in the USA for thrombectomies— with 237 having been carried out in 2020.

Collaboration between neurology and neurosurgery departments is an important aspect of the hospital’s stroke strategy, as well as a streamlined protocol for treating ischaemic stroke patients, he explains.

“When it comes to stroke: time is brain— so everything must happen very quickly, especially in the middle of the night. It is not the time to be pondering decisions,” Spiotta says. “Everything should already be part of the protocol, so the patient comes in and there is not much of a debate or a discussion among the stroke team.”

Cases are discussed in detail, but only during daylight hours. The stroke team agrees on inclusion criteria, and the process is standardised so as not to rely solely on the judgement of individual team members who are under immense pressure when a patient arrives.

As well as being a high-volume stroke centre, MUSC is known for its pioneering of the ADAPT technique of revascularisation.

“We have done the most ADAPT procedures of any centre—currently around 1,200 since

2013,” explains Spiotta.

According to Spiotta, the biggest advantages of ADAPT are its potential savings in time and cost, as well as generating less pain for the patient. Prior to the advent of ADAPT, AXS Vecta many procedures were Aspiration performed under general Catheter anaesthesia. However, ADAPT has changed this paradigm. Spiotta says: “What we found with ADAPT is that, not only was it painless, it was so fast that often our procedures were done faster than it took the anaesthesiology team to put the patient to sleep.”

One important arm to Spiotta’s research— and that of the team at MUSC—is his contribution to the Stroke thrombectomy and aneurysm registry (STAR). STAR is a multicentre initiative to track patient outcomes after thrombectomy or endovascular aneurysm treatment using realworld data. Spiotta describes STAR as the largest research network in the neurovascular space, begun out of the need to compile and analyse data to improve patient outcomes.

The registry has grown to include more than 55 sites across five continents, enrolling 10,000 patients so far.

“A recent finding is that aspiration during posterior circulation stroke was actually associated with superior functional outcomes compared to stentrievers, and that was over the largest dataset that has ever been studied,” comments Spiotta. “With a dataset this large, and such high-quality data, we are able to answer clinical questions that were not really able to be answered before.”

Evolution of ADAPT The ASSIST Registry compares the four most commonly-used thrombectomy techniques for anterior LVOs

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Importantly, ADAPT continues to develop.

Spiotta and colleagues at MUSC now

consider the strategy to be in its third generation—what they term ADAPT 3.0.

A big development has been the use of larger-bore aspiration catheters over time—a paradigm shift, according to Spiotta. “It is not just a refinement of the technique, but also the introduction of larger and more supple catheters,” he says. “At the time of ADAPT 1.0 we were using what we considered then to be ‘large’ catheters, but now would be considered an intermediate-sized catheter.

It was a new concept at the time, and a paradigm shift to place these large-bore catheters distally in the brain arteries.

“Over time, the catheters have gotten larger and have been designed to be delivered to more distal locations, to the arteries in the brain more safely and more readily, so it is faster to deliver these catheters and to navigate them from the neck through the skull and into the brain.”

Larger-bore catheters with a larger cross-sectional lumen provide a greater aspiration force at the thrombus, Spiotta says, which can contribute to easier removal of the thrombus, requiring fewer passes, improving procedure times and potentially improving patient outcomes.

“The catheter technology has improved dramatically, in becoming larger bore, and also the technique itself has been refined, with regards to where we place the catheter in relation to the thrombus that is obstructing the artery,” he says.

AXS Vecta Aspiration Catheter experience

Stryker’s AXS Vecta Aspiration Catheter is among the latest iterations of such devices launched for direct aspiration thrombectomy. Spiotta and colleagues at MUSC are contributing to the prospective ASSIST registry headed by Rishi Gupta and Markus Mohlenbruch, which is comparing treatment of ischaemic stroke patients using various interventional techniques with Stryker Neurovascular devices for the first pass. Around 1,500 patients are planned to be enrolled, with over 90% of these already included.

“We started using AXS Vecta Aspiration Catheter in the setting of the ASSIST study,” comments Spiotta. “We have been very impressed with the results that we have obtained with the Vecta 71 as well as the 74. We found that our experience is nicely in line with the storyline of the evolution of ADAPT—with increasing catheter size, resulting in shorter procedure times and September 2021

With you all the way

improved patient outcomes, and without any additional complications.”

When using a larger-bore aspiration catheter such as AXS Vecta, Spiotta says there are several important considerations to be made. The first is to choose the access strategically. “Femoral artery access has

Slingshot technique

been the mainstay of treatment, but recently the radial artery has become an option,” he notes. Additionally, he says that, when

Guiding principles What are the important considerations when selecting guidewires for ischaemic and haemorrhagic treatments? This is among the topics discussed by Brian Jankowitz (Cooper Neurological Institute, Camden, USA), who details why he favours the use of Synchro (Stryker) guidewires, and discusses new developments with the latest iteration of the device.

Why do you choose to use Synchro Guidewires?

I like Synchro because, for me, it is consistently excellent. I am never surprised by the utility or function of that wire. I can always predict how it is going to function or react, in even the most torturous or complex anatomy. From pushability, trackability, tipshape retention, proximal support or distal softness profile, I think it hits the mark on every one of those variables.

September 2021

delivering the aspiration catheter, sufficient and it has shown great benefit to patients.” guide support is needed, and he highlights For thrombectomy procedures, Spiotta the importance of minimising the ledge effect considers that the most important measure of the aspiration catheter, which hinders of success is the time to recanalisation. successful neurointervention. Once “The most important thing is how the microcatheter and microwire fast we can get the artery open,” are delivered to the thrombus, he comments. Further to this is they are gently pulled back as the the extent of the recanalisation. aspiration catheter is advanced.

“In years prior, the endpoint was This allows the aspiration catheter achieving a recanalisation of to take the inside turns across greater than 50% of the territory. arterial tortuosity and aids in its The techniques have gotten better. delivery. This ‘slingshot’ technique We have gotten faster and safer. allows the aspiration catheter to Alejandro Spiotta Now, we are really aiming for travel over the thrombus, thereby 90‒100% of the territory being ingesting it. Once the aspiration force is restored,” he adds. applied to the catheter, clot retrieval is As direct aspiration thrombectomy achieved. AXS Vecta works well from both continues its rapid evolution, centres like radial and femoral approaches, Spiotta says, MUSC will be at the forefront of research adding that it is “a case of picking the right into how the refinement of the technique approach for the right patient”. and new iterations of catheters will As the number of passes required to open influence outcomes. Spiotta believes that the vessel reduces, the requirement of going research including the ASSIST and STAR to a secondary modality or a bailout strategy registries will be fundamental to the future like a stentriever has gone down, Spiotta of stroke care. “It is very important that we adds, contributing to savings in both time are continuously evaluating our path, our and cost. “We think these improvements, outcomes, and comparing techniques to each which are in the order of minutes, do matter other,” he says, “It is a rapidly evolving field, for these patients that are having a stroke, so as new techniques and new developments because, as you know, in our philosophy, come about, as they naturally will, it is every minute counts. It has really been an critical that we continuously self-evaluate as evolution of the ADAPT technique over time we go along.”

What difference have you noticed between the Synchro2 and the new Synchro SELECT Guidewire?

It is very difficult to improve upon perfection.

Brian Jankowitz The classic Synchro2 wire is excellent. The most tangible benefit to Synchro SELECT is probably the shape retention at the tip.

The most important thing about these wires is that they have maintained, from my perspective, every other significant benefit that I have grown to love about Synchro— every aspect that I expect and rely on because it is consistency that is key.

Given the range of devices on the market, what makes you return to the Synchro Guidewire?

I have always loved to speak knowledgeably about products, so I always attempt to try every new competitor device on the market at least once or twice. I am always looking for a new gold standard, and I will jump on the best product on the market, any given day.

*Shaped distal end is subjected to 20 rotations within a tortuous pathway and then remeasured to calculate tip shape loss

I recall a case when I tried a competitor wire and it did not perform as I expected. I could not categorise the aneurysm in a safe and controlled way that I am used to with my standard Synchro or Synchro SELECT. So, I did the best possible comparison—a headto-head in vivo attempt at using a competitor wire, which did not work, and then re-access with the Synchro SELECT wire, which enabled me to safely, smoothly, categorise the same aneurysm events, and micro catheter into it and successfully coil it.

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Partnerships

Partnerships build an end-toend solution for stroke care STROKE CARE HAS SEEN considerable advances in recent years, and Stryker Neurovascular has played a role in these developments. In addition to expanding its portfolio to include cutting-edge products designed to remove blood clots in the brain quickly and efficiently, the company has one of the longest-running fellows programmes in the industry, and its investments in clinical trials have led to meaningful changes in stroke treatment guidelines.

But, Stryker is not standing still, and the company is keen to build on its foundations at the vanguard of stroke care, to build commercial partnerships that go beyond its traditional portfolio, and drive efficiencies in each step of the stroke care pathway.

Already Stryker has forged a series of partnerships in its mission to offer an end-toend solution for stroke care. Among these are link-ups with stroke software providers Allm and Brainomix to close the loop on efficient stroke care in Europe. These partnerships help with the speedy diagnosis of stroke, as getting eligible patients to the right hospital for treatment remains one of the biggest challenges. Timely treatment in stroke is

critical as the brain ages approximately three weeks per minute during the course of a stroke, and endovascular therapy increases the chances of a good outcome.

Allm’s Join software helps to meet this need by enabling streamlined access to patient information and imaging, allowing hospitals to request and track patient transfers, consult on treatment decisions, and ensure the stroke team’s readiness upon a

patient’s arrival. Teams can discuss patients via video and text, securely, in real time.

Features include time stamps to document and optimise each step of the patient care workflow, tracking to monitor the patient’s route and know when they will arrive on site, a DICOM viewer, streaming images from a hosptial’s picture archiving and communication system (PACS) to a handheld device, and video calling.

Stryker’s partnership with Brainomix provides an option for European centres to access e-Stroke software. e-Stroke is an AIpowered software platform providing realtime interpretation of brain scans, enabling physicians to quickly diagnose stroke and make treatment and transfer decisions. The software employs a combination of advanced image processing and machine learning to assist with stroke-imaging interpretation, and results are presented alongside the original images, allowing the physician to confirm the software’s assessment and understand its working.

“We are now able to offer customers software that can more quickly diagnose patients,” says Mark Paul, president of Stryker’s Neurovascular division. “Helping our customers deliver the best possible outcomes for their patients is at the core of everything we do. With these partnerships, we are able to facilitate the patient’s path to timely treatment, increasing the chance for a good outcome.”

Setting the right strategy HAVING THE CHOICE OF LENGTH, diameter, and location of the stent are critical to success when performing flow diversion for the treatment of intracranial aneurysm.

With that in mind, having a tool to improve the therapeutic planning of the procedure is a potential game-changer.

By simulating the endovascular deployment and apposition of devices it is possible to transform the delivery of the procedure and potentially contribute to a reduced need for corrective intervention, as well as shorter procedural times. These are some of the features of the proprietary software suite Sim&Size, a next-generation tool that sits at the heart of the Sim&Cure portfolio.

Sim&Cure is a digital startup, founded in 2014, focused on improving endovascular surgery. Sim&Size has become an important

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Copyright © 2021 Stryker AP-003473 v1.0

Sim&Size simulates endovascular deployment and apposition of devices

part of the Stryker armoury for stroke care, thanks to a partnership between the two companies that has been running for several years. Through this link-up, Stryker offers interventional neuroradiologists a customised version of Sim&Size for use with the Surpass Evolve Flow Diverter. This collaboration is intended to help define the best therapeutic strategy, whether it be coiling with a supporting stent, or flow diversion.

So, how does it work? Sim&Size is comprised of three applications sizing all types of device that are widely used to treat patients with neurovascular disorders. The

software is based upon three-dimensional rotational angiography (3D-RA) acquisition, which simulates the release of the stent, suggesting optimal sizing, and displaying the degree of wall apposition. According to the patient’s unique anatomy, Sim&Size computationally models neurointerventional devices to provide essential information for preoperative planning.

The software has already been used to treat more than 5,000 patients in over 400 hospitals worldwide and has CE mark and US Food and Drug Administration (FDA) 510(k) approvals.

September 2021

StrokEnomics®

With you all the way

StrokEnomics: Solving the economic piece of the stroke care puzzle Allied with its goal to develop innovative ischaemic and haemorrhagic stroke treatment is Stryker’s commitment to demonstrate the economic value of these treatments in a way that matters most to the physician. This is a part of the underlying principle for StrokEnomics, the data-driven health economics programme developed by Stryker. Through StrokEnomics, Stryker is committed to delivering strategies around health economic analysis and funding solutions that understand the challenges inherent in modern stroke care.

StrokEnomics uses powerful economic and clinical data to enhance both patient access and quality of care

STROKENOMICS IS A PROGRAMME designed to enhance patient access and quality of care around the world. Using economic and clinical data, Stryker is able to help healthcare professionals to create tailored solutions that may improve patient access and make care more efficient.

Armed with the highest level of clinical and economic data, StrokEnomics can strategically navigate barriers, helping to ensure that cutting-edge neurovascular care is accessible to eligible patients. The first consideration is the evidence from the real world and randomised clinical trials.

Thereafter, the economic considerations of a treatment come into view—it begins with a cost-effectiveness analysis, offering a comprehensive evaluation of the cost and effectiveness of two treatments to find the best-health, lowest-cost option. Allied to this

thrombectomy with a stent retriever in combination with intravenous tissue plasminogen activator (IV tPA) or IV t-PA alone. The two options are considered against both a cost and effectiveness metric, considering quality-adjusted life-year data from randomised trials comparing the approaches—including DAWN —and the results from both metrics are extrapolated across the patient’s lifetime horizon.

Although there is a higher cost associated with the stent retriever itself, this can be offset through the savings that result from lower long-term care costs due to improved outcomes—even for this late arrival patients.

Thus, using StrokEnomics, it is possible to demonstrate that through a particular approach further benefits can be achieved, as well as a reduction in cost, compared to the alternative treatment in a patient’s lifetime.

Cost-effectiveness analysis We comparatively evaluate the cost and the effectiveness of two treatments to identify the best-health, lowest-cost option.

is a budget impact analysis, assessing the economic impact of treating all eligible patients.

Putting this into practice—current approaches for patients suffering from ischaemic stroke and arriving up to 24 hours after symptom onset include mechanical

Budget impact analysis

We assess the economic impact of treating eligible patients with a newly adopted intervention, compared with a current intervention.

Budget pro-forma

We evaluate the financial impact of adding a stroke program based on hospital-specific data – immediately and into the future.

Cost-minimisation analysis To identify potential cost savings, we comparatively evaluate the cost of alternative interventions with equivalent efficacy.

Cost benefit analysis

For a new treatment adoption, we demonstrate the economic benefits and how its adoption can improve patient access.

All rights reserved. Published by BIBA Publishing, London T:+44 (0)20 7736 8788, publishing@bibamedical.com.

The opinions expressed in this supplement are solely those of Stryker and the featured physicians and may not reflect the views of Neuro News.

September 2021

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Together with our customers, we are driven to make healthcare better.

Stryker is one of the world’s leading medical technology companies, but it’s not only because of the products we make.

It’s also about the services, programs and partnerships we’ve established to ensure we’re with our customers all the way.

This document is intended solely for the use of healthcare professionals.

A physician must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that physicians be trained in the use of any particular product before using it in a procedure. The information presented is intended to demonstrate the breadth of Stryker product offerings. A physician must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Stryker or its affiliated entities own, use, or have applied for the following trademarks or service marks: AXS Catalyst, AXS Vecta, Nano, SKILL Assist, SL-10, StrokEnomics, Stryker, Surpass Evolve, Synchro SELECT, Target, Target XL, Trevo, Trevo NXT, XT-27. All other trademarks are trademarks of their respective owners or holders.

The absence of a product, feature, or service name, or logo from this list does not constitute a waiver of Stryker’s trademark or other intellectual property rights concerning that name or logo.

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