Vascular News Medtronic supplement – April 2020

April 2020 | Educational Supplement

Expanding treatment possibilities in TEVAR

vascularnews.com

This educational supplement has been sponsored by Medtronic

Trial results

One-year findings and insights with the new Navion™ thoracic stent graft

Can you please share your clinical experiences with the Valiant Navion™ thoracic stent graft one year after its launch?

I had the pleasure to be the European principal investigator of the Valiant Navion™ global clinical trial, a prospective, multicentre, premarket, non-randomised, single-arm trial, intended to test the safety Fabio Verzini discusses his clinical experience with the new Navion™ thoracic and effectiveness of the new generation stent stent-graft, one year after its launch. graft from Medtronic, Valiant Navion™.

Being part of such a project has been an honour.

Can you please share your is advantageous to have both I believe this device will help opinion on the design of the options and customise the implant make thoracic endovascular Valiant Navion™ thoracic stentbased on a patient’s anatomy. aortic repair (TEVAR) easier graft system?

Moreover, it provides a “soft and will help physicians treat Yes, Navion™ is a completely reimagined touch” when approaching acute more patients and deliver optimal thoracic stent graft design in many ways. aortic dissections and intramural outcomes for all descending With Navion™, we have multiple new haematoma (IMH), also known as thoracic aorta pathologies. Navion options, such as tapered configurations fragile aortas. provides the features needed to up to 6mm, which is very helpful with Fabio Verzini successfully approach different dissections. It also has the new Navion™ Valiant Navion™ is built anatomies and the one-year CoveredSeal, meaning no metal protrudes with the engineering clinical results are very good. from the proximal edge of the graft, which knowledge of a proven platform Regarding proximal and distal sealing has a “W” stent specifically designed like Valiant Captivia™. How is this performance, for example, just one patient to allow circumferential radial pressure reflected in the performance of required a reintervention due to aneurysm distribution and, at the same time, avoid inthe device? sac growth in a patient population where the folding. Navion™ has the same tip capture Valiant Navion™ is a completely rethoracic aorta tortuosity index was classified mechanism to provide the well-known engineered stent graft system design from as high by the core lab in 86.5% of cases. deployment accuracy of Valiant Captivia™. with old Captiva™. That said, I found the This speaks to the quality of the graft design.

Furthermore, the shorter stents allow for same excellent accuracy (now extended In fact, it is not just a matter of lower profile increased conformability, while the shorter to Navion™ CoveredSeal) with improved in TEVAR. Ideally, the proximal and distal tip of the delivery system, coupled with conformability, clearly visible as the anatomy stent graft edge keeps the graft in place a longer catheter working length, is respected after device deployment, with and the stent graft body should adapt to the offers excellent maneuverability in outstanding wall apposition and sealing. It anatomy. These are all features embedded in the proximal arch. is important to highlight that, compared to the Valiant Navion™ device. ™ ™ Valiant Captivia , Navion is a different Where does Navion CoveredSeal device with a different delivery system the Fabio Verzini is a professor at the fit in your practice? deployment steps provided by Medtronic Department of Surgical Sciences, Turin I use CoveredSeal in all the anatomical should be followed. Clearly, 20 years of University (Turin, Italy), the A.O.U. Città scenarios when a bare stent is not needed, clinical evidence and learnings collected della Salute e della Scienza, Molinette such as when impinging on the arch vessel through Medtronic trials and R&D Hospital, (Turin, Italy) and Fellow of the ostia, or landing in a non-healthy aorta. It developments are integrated into this device.

European Board of Vascular Surgery.

Case study Fig 1: Preoperative images of a patient presenting with an Acute Type B Dissection Fig 2: Postoperative images, showing precise positioning and exclusion of the false lumen

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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 Xxxxxxx and the featured physicians and may not reflect the views of Vascular News.

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April 2020

Key features

New technologies

Valiant Navion™ thoracic stent graft system: A single, low-profile platform tailored for fragile aortas Santi Trimarchi considers how the Valiant Navion™ thoracic stent graft offers a new technological solution to address unmet clinical needs in the treatment of a fragile aorta. He concludes that the new, low-profile Valiant Navion™ system provides an advancement in contemporary endovascular management of challenging thoracic aorta pathologies, particularly fragile aortas.

AORTIC FRAGILITY IN ACUTE dissection and intramural haematoma puts patients at higher risk for adverse aortic events. These patients have an increased inflammatory state, risk of hypertension, and aortic wall stress that impact the thoracic endovascular aortic repair (TEVAR) procedure, which may result in even more complexity in the presence of challenging anatomies. In addition to acute conditions, the thoracic aorta can be affected by a wide variety of pathologies, which underscores the need to design endovascular devices with specific features. The selected stent graft must simplify vessel access and track easily through calcified and tortuous anatomy to reach the intended target with precision.

The new Valiant Navion™ thoracic stent graft system meets these clinical needs in an 18F profile and is broadly indicated to treat all pathologies of the descending thoracic aorta: aneurysms, dissections, transections, intramural haematoma (IMH), and penetrating aortic ulcers (PAU).

Valiant Navion™ is tailored for fragile aortas

The Valiant Navion™ system offers proximal device configuration options and thereby expands device choice, which is a key benefit when selecting the appropriate device for a patient with greater aortic fragility. The following benefits of the Valiant Navion™ system make it a suitable choice for the treatment of fragile aortas, minimising the impact on the native vessel: CoveredSeal Completely Covered Proximal Edge is tailored for a soft touch: it eliminates bare metal interaction with the aorta for decreased vessel trauma Accurate deployment: deploy at target without the need for repositioning Enhanced seal: increased flexibility and conformability

Tailored for a soft touch for decreased vessel trauma

Valiant Navion™ CoveredSeal is a true nonApril 2020

Santi Trimarchi

bare stent with the proximal edge fully enclosed within the graft fabric. This eliminates bare metal interaction with the aorta, aiming to decrease vessel trauma. The Valiant Navion™ CoveredSeal provides physicians a compelling option for the treatment of fragile aortas.

Reduced manipulation and movement in the thoracic arch

In fragile aortas, it is critical to limit the number of manipulations in the arch to avoid further insult to the aorta.

While other devices promote the possibility to “reposition” the graft to optimise placement, the potential adverse consequences of excessive manipulation in the thoracic aorta should be considered.

Selecting an accurate graft that can precisely track and deploy at the intended target is of importance.

The Valiant Navion™ system was specifically designed to reduce manipulation and movement in the thoracic arch where mitigation Valiant of neurological events Navion is critical, especially System in thrombus-burdened pathologies. The Valiant Navion™ system is pull-loaded into the delivery system, more closely approximating the deployed length of the stent graft, enabling deployment of the device at the intended location without the need for repositioning. Delivery and deployment success in the Valiant Navion™ system’s global clinical trial was 100%, with 85.7% of subjects having high thoracic aorta tortuosity per Core Lab.

Tailored for increased flexibility and conformability for enhanced seal

The design of the Valiant Navion™ system is also tailored for fragile aortas as it adapts to the inner and outer curve of the thoracic aorta even in the most challenging anatomy.

The Valiant Navion™ system features aligned peaks/valleys and shorter struts designed for increased conformability, and a “W-stent” designed to reduce in-folding and enhance seal.

Expanded options: CoveredSeal and FreeFlo

The Valiant Navion™ system allows physicians to choose the desired proximal device configuration for varied anatomies.

The CoveredSeal Proximal Configuration with Tip Capture eliminates unsupported proximal bare metal/uncovered interaction with aortic wall and provides circumferential distribution of proximal radial force.

The FreeFlo Proximal Configuration with Tip Capture allows perfusion into proximal vessels and provides greater fixation and conformability.

The new, low-profile Valiant Navion™ system is an advancement in contemporary endovascular management of challenging thoracic aorta pathologies, particularly fragile aortas.

Santi Trimarchi is head of the vascular surgery section at the Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan (Milan, Italy) and associate professor of vascular surgery and director of the Vascular Surgery Residency Program at the University of Milan in Milan, Italy.

For complete product and risk information, visit www.medtronic.com/manuals.

Consult instructions for use at this website.

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Survey results

Type B aortic dissections: A key question answered Preferred proximal features TypeType B Aortic Dissections Preferred proximal features B Aortic Dissections

BIBA MedTech Insights survey results reveal which proximal features of a thoracic stent graft physicians prefer when treating type B aortic dissections.

Q2.

Q2. Which Which of of the the following following proximal proximal features features of of aa Thoracic Thoracic stent stent Q2.

Which of the following proximal features of ado Thoracic stent Which of the following proximal features ofType a thoracic stent graft you when graft do you prefer when treating B Aortic Dissections ?? prefer graft do you prefer when treating Type B Aortic Dissections treating type B aortic graft dodissections? you prefer when treating Type B Aortic Dissections ?

Low Low profile profiledelivery delivery system system Low profile delivery system Stent Stent Graft Graftlength length >200mm >200mm Stent Graft length >200mm Proximal ProximalCovered Covered configuration configuration (No (No bare… bare…

Proximal Covered configuration (No bare…

Proximal ProximalBare Bare spring springor orstent stent Proximal Bare spring or stent Pre-curved Pre-curved delivery delivery system system Pre-curved delivery system Standard Standard tapering tapering (4mm) (4mm) Standard tapering (4mm) Extreme 55 Extreme tapering tapering(6mm) (6mm) Extreme tapering (6mm) Distal 33 DistalBare BareStent Stent Component Component Distal Bare Stent Component Barbs 33 Barbsor orhooks hooks Barbs or hooks Other 33 Other (Please (Please Specify) Specify) Other (Please Specify) No 55 No preference preference No preference 00

55

25 25 18 18 14 14

14

13 13

13

13 13 11 11

18

13 11

5 3 3 3 5

10 15 20 25 10 15 20 25 0Number of 5mentions (multiples 10 are15 possible) 20

30 30 25

Share Share of of Sample Sample Share of Sample 42% 42% 25 42% 30% 30% 30% 23% 23% 23% 22% 22% 22% 22% 22% 22% 18% 18% 18% 8% 8% 8% 5% 5% 5% 5% 5% 5% 13% 13% 13% 8% 8% 8%

Number of mentions (multiples are possible) 22 Type Aortic 22respondents respondentsexcluded excludeddue dueto toanswering answeringthe thefollowing: following:“I“Ido donot notuse usethoracic thoracicstent stentgrafts graftsto totreat treat TypeofBBmentions AorticDissections” Dissections” Number (multiples are possible) 22 respondents excluded due to answering the following: “I do not use thoracic stent grafts to treat Type B Aortic Dissections”

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n=60 n=60 22

NAVION DISEASE and anatomy SPECIFIC CONFIGURATIONS More Options

CoveredSeal (no proximal bare metal) and FreeFlo stent options

All descending thoracic pathologies (including fragile aortas)

Smaller delivery system profile (down to 18F o.d.)

Challenging iliac accesses and tortuous anatomies

Extreme tapering (5-6mm difference from proximal to distal)

Dissections

Longer lengths (up to 225 mm)

Longer lesions

Shorter lengths (down to 60 mm)

Focal lesions

Smaller diameters (down to 20 mm)

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Wider Range of Anatomies

Traumatic injuries

April 2020

n=60 2

Consensus

New technologies

Application of Heli-FX EndoAnchor implants to improve complex TEVAR outcomes: A consensus document

By Vincent Riambau, Robin Heijmen, Hervé Rousseau, Theodoros Kratimenos, Andrés Reyes

Introduction

Thoracic endovascular aortic repair (TEVAR) is currently accepted as the standard of care for the treatment of descending thoracic aortic aneurysms.1 Nevertheless, there are certain anatomical scenarios that can put standard TEVAR at risk for early failure and in other conditions where TEVAR is contraindicated, more complex repairs with proximal extension in the aortic arch may be required. Several authors reported an overall endoleak rate of 7.3%–38%2 after standard TEVAR, the vast majority being type I and III, half of which required reinterventions.

Several studies have examined haemodynamics in the thoracic aorta and related morphological changes from physiological to pathological conditions such as aneurysms.3,4 An evaluation of aortic stiffness changes after TEVAR has highlighted the need of more compliant endografts to reduce left ventricle stroke work and consequent adverse left ventricle remodeling.4 A new generation endograft (Valiant NavionTM, Medtronic) has improved conformability, significant profile reduction, and encouraging short-term outcomes.

Moreover, in the past several months, a new software has been developed and validated in order to better visualise apposition and position in the descending thoracic aorta after TEVAR.22 Additional evaluations on larger patient populations will further assess this software’s best use and application in the decision-making process of reinterventions to prevent complications before they occur.

Although new generation devices have been successful, achieving good proximal and distal sealing and fixation can still be challenging in

certain scenarios such as tortuous descending thoracic aortas (DTA), large aneurysms, and short and/or wide sealing zones. Recent evidence have shown a non-negligible rate of type I endoleaks, especially distal type Ib, which were responsible for reinterventions and ruptures over time.5 These kinds of complications may be underestimated and underreported in current literature, indicating a potential need for additional tools to reduce reinterventions and ruptures after TEVAR.

Heli-FX technology

The Heli-FXTM EndoAnchor system (Medtronic) has been extensively described with endovascular aneurysm repair (EVAR) and is used to strengthen sealing and fixation, especially in cases of hostile proximal necks (short, wide, angulated, conical). The Heli-FXTM system replicates a vascular surgery anastomosis to reduce any potential leakage from the proximal sealing zone, even minimal and undetected at CT scan or MRI. Both multicentre studies and registries7–18 have reported promising results with EndoAnchor implants, especially in patients treated prophylactically. Heli-FX EndoAnchor implants are also approved to be used in combination with TEVAR, both proximally and distally, but very few publications describe this application.19,20 The goal of our board was to achieve an initial consensus on Heli-FX EndoAnchor use in TEVAR including identifying indications and contraindications as well as validating preoperative planning.

Board consensus for prophylactic thoracic endovascular suture aortic repair (TESAR) Indications

Standard TEVAR is at higher risk of complications when anatomical challenges threaten proximal and distal sealing. The acronym SWACY (short, wide, angulated, conical, young patient) has been used for indications of endovascular suture aneurysm repair (ESAR) in the abdominal aorta.14 We examined the same anatomical and patient characteristics and the additional risk that they pose for TEVAR. Notably, this consensus is primarily directed towards the treatment of thoracic aortic aneurysms and blunt thoracic aortic injuries, and not for more fragile aortas like type B aortic dissections and intra-mural haematoma.

Neck length

Proximal neck length should be ≥2cm for a successful thoracic endovascular suture aortic repair (TESAR). Although anecdotal experiences from single centres have shown positive results in necks shorter than 2cm,19

Distal prophylactic use of Heli-FX EndoAnchor implants in tortuous DTA (Courtesy of Andres Reyes)

there is insufficient evidence to recommend TESAR in necks shorter than 2cm. Some authors even report an ideal proximal sealing zone of at least 3cm for a safe seal, so we suggest the use of Heli-FX EndoAnchor for necks shorter than 3cm without pushing Proximal prophylactic use of Heli-FX EndoAnchor implants (Courtesy of Hervé Rousseau)

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Consensus Application of Heli-FX EndoAnchor implants to improve complex TEVAR outcomes: A consensus document Continued from page 5

most proximal edge of the sealing zone and the diameter at the most distal edge of the sealing zone. If the increase in diameter was greater than 10%, it was agreed that it is no longer considered a neck and instead is the beginning of the aneurysm. The panel agrees to Heli-FX EndoAnchor use in conical necks where the neck length is ≥2cm but acknowledges most neck lengths in these cases will be shorter than 2cm.

Life expectancy

The panel believes that the generic definition of young patient that is currently applied in the abdominal use of Heli-FX EndoAnchor needs to be rephrased as life expectancy longer than 10 years. The panel also agrees on the use of Heli-FX EndoAnchor for patients that have a life expectancy ≥ than 10 years.

Three cm upward distal migration, treated and fixed by Heli-Fx EndoAnchor implants (Yellow circle; image courtesy of Vincent Riambau)

Proximal revision case to treat type Ia endoleaks (lack of proximal wall apposition) with zipper technique (progressive implants from distal to proximal; courtesy of Hervé Rousseau)

the boundaries of instructions for use of the chosen stent graft.

The same concepts apply for distal sealing length. When a long distal thoracic aorta coverage is required, a very precise distal deployment resulting in necks ranging between 2cm and 3cm is paramount in order to avoid type Ib endoleak and/or celiac trunk coverage. Distal thoracic aorta tortuosity increases the risk of upward migration by up to 60% at five years for necks ranging 1.5–3cm in length, as recently presented at the VEITH Symposium by Vincent Riambau, and the use of Heli-FX EndoAnchor has the potential to prevent upward migration and type Ib endoleak in such challenging scenarios.

Neck diameter

Neck diameter accurate measurement is extremely important during TEVAR pre-

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operative sizing. All companies provide a defined range of aortic neck diameters and appropriate oversizing recommendations for a safe sealing and/or fixation. However, some of the larger diameter aortas that are possible to be treated within the instructions for use could be considered aneurysmal when using the definition of a diameter ≥35mm and thus would be prone to enlargement over time. For distal applications, an appropriate cut-off may be 32mm. The potential benefit of Heli-FX EndoAnchor technology in preventing neck dilatation has been published for infrarenal necks in abdominal aortic aneurysm repair and we believe that same concept could be applied in both proximal and distal thoracic scenarios.18

Neck angulation

Heli-Fx EndoAnchor implants for thoracic application do not have specific indications that go beyond stent graft IFUs, so prophylactic treatment does not allow for off-label TEVAR in zone 0 and 1. For highly angulated landing zone 2 and 3 when risk of “bird beak” effect can compromise proximal sealing, we agreed that the use Heli-FX EndoAnchor technology could improve graft sealing on the inner curve of the aortic arch.

Conicity

While the definition of neck conicity has changed over time,9,11,12 we agreed to apply the one most frequently used by core labs, with an additional modification requiring the thoracic minimum landing zone to be >2cm. We then defined the neck to be conical if there was an increase in diameter of up to 10% between the diameter at the

TESAR revision

The main indications for revision cases are Type Ia and Ib correction, migration, bird beak effects, and neck dilatation.19,20 Prophylactic Heli-FX EndoAnchor use is limited to grafts that are implanted in zones 2 or lower. In contrast, Heli-FX application as a bail-out can be considered no matter which landing zone the graft was originally implanted in, including cases where the previous TEVAR was off label (zone 0-1 landing).

However, due to the complexity of manipulating on proximal-mid arch, this should be reserved to experienced users and should not encourage off label usage of the primary graft.

Technical considerations

Use of Heli-FX EndoAnchor in TEVAR follows the same deployment steps of the abdominal application since the system is the same other than the French size, devices length and steerable distal portion of the guiding sheath length. The same two-step deployment allows for partial deployment of the Heli-FX EndoAnchor, checking for the appropriate position, and retrieving/ adjustment before the second and final deployment. A minimum of six Heli-FX EndoAnchor implants are recommended

by IFUs and we suggest splitting into two rows to distribute fixation at different levels which may strengthen it even further.

Contraindications

There are anatomical scenarios where the use of Heli-FX EndoAnchor technology is contraindicated or the panel does not recommend their use. These include: ● Presence of calcium at the intended deployment location thicker than 2mm April 2020

New technologies

which may prevent from adequate penetration of the Heli-FX EndoAnchor implants through the aortic wall or even create a fracture of the anchor itself. When 50% or more of the aortic wall at the intended deployment level is calcified use of the system is contraindicated. ● If a 2mm gap between endograft and aortic wall exists due to progressive enlargement or presence of thrombus. ● As of this time, the use of Heli-FX EndoAnchor in fragile aortas like dissections, IMHs and connective tissue diseases has not been studied nor documented. We agreed to include these pathologies under contraindications with the goal of avoiding further damage to an already diseased aortic wall. ● It has been reported that deployment of Heli-FX EndoAnchor implants as reinforcement in the mid-thoracic aorta and in the middle of the stent graft can be procedurally safe and effective.

However, it can also lead to type IIIb endoleaks if upward migration occurs and therefore, we suggest avoiding Heli-FX EndoAnchor use in this application.21 ● The panel recommends following the manufacturer IFUs for their respective stent graft without pushing boundaries towards more challenging anatomies,

for example landing zones shorter than 2cm, until new evidence will show safety and effectiveness in such complex cases.

Panel conclusions

The entire panel is confident that TEVAR outcomes can be significantly improved by appropriate use of Heli-FX EndoAnchor technology especially in the abovementioned challenging scenarios. As the use of Heli-FX EndoAnchor implants with TEVAR is still relatively new, the panel believes much can be learned from current experiences and there is a need for longer follow-up. Nevertheless, the current evidence and feedback we have collected in the short term have been promising.

References 1. Riambau V et al. Editor’s Choice: Management of Descending Thoracic Aorta Diseases Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg (2017) 53, 4e52 2. Ricotta JJ et al. Endoleak management and postoperative surveillance following endovascular repair of thoracic aortic aneurysms. J Vasc Surg 2010;52:91S-99S. 3. van Bakel T et al. Blood Flow after Endovascular Repair in the Aortic Arch: A Computational Analysis. AORTA 2018;6:81–87.

4. Van Bakel TMJ et al. Cardiac remodelling following thoracic endovascular aortic repair for descending aortic aneurysms.

Eur J Cardiothorac Surg. 2019 Jun 1;55(6):1061-1070.

5. Azizzadeh A et al. Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. J Vasc Surg 2019;1-10 6. Conrad MF, et al. Results of the VALOR II trial of the Medtronic ValiantThoracic Stent Graft. J Vasc Surg 2017;66:335-42 7. Melas N et al.Helical EndoStaples enhance endograft fixation in

an experimental model using human cadaveric aortas. J Vasc Surg 2012;55:1726-33 8. Jordan WD et al. One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular 2015 0(0) 1–10 9. de Vries JPPM et al. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg 2014;60:1460-7 10. de Vries JPPM et al. Rationale of EndoAnchors in abdominal aortic aneurysms with short and angulated necks. J Cardiovasc Surg 2014; 55: 103-7 11. Jordan WD et al. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg 2014;60:885-92 12. Kopp R et al. Are EndoAnchors up to the Challenge of a Hostile Proximal Neck? Journal of Endovascular Therapy 2015, Vol. 22(2) 171–173 13. de Vries JPPM. Is it Time to Insert EndoAnchors into Routine EVAR? Eur J Vasc Endovasc Surg (2017) 53, 458e459 14. Jordan WD et al. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg 2015;61:1383-90 15. Goudeketting SR et al. Midterm Single-Center Results of Endovascular Aneurysm Repair With Additional EndoAnchors.

Journal of Endovascular Therapy 2018, 1–11 16. Jordan WD et al. Midterm Outcome of EndoAnchors for the Prevention of Endoleak and Stent-Graft Migration in Patients With Challenging Proximal Aortic Neck Anatomy. Journal of Endovascular Therapy 2015, Vol. 22(2) 163–170 17. Arko FRIII et al. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg 2019;1-9 18. Tassiopoulos AK et al. Predictors of early aortic neck dilatation after endovascular aneurysm repair with EndoAnchors. J Vasc Surg 2017; 1-8 19. Kasprzak P et al. EndoAnchor Placement in Thoracic and Thoracoabdominal Stent-Grafts to Repair Complications of Nonalignment. Journal of Endovascular Therapy 2013;20:471480 20. Ongstad SB et al. The use of EndoAnchors to rescue complicated TEVAR procedures. The Journal of Cardiovascular Surgery 2016 October;57(5):716-29 21. Müller-Eschner M et al. Type IIIB Endoleak after Thoracic Endovascular Aortic Repair Caused by Endoanchor Dislocation. Ann Vasc Surg 2015;29:1019 22. van Noort K et al. A New Methodology to Determine Apposition, Dilatation, and Position of Endografts in the Descending Thoracic Aorta After Thoracic Endovascular Aortic Repair. Journal of Endovascular Therapy 2019; 1–9

Panel tips for better placement and deployment of Heli-FX EndoAnchor implants MANUAL

VISUAL

Feeling adequate tactile feedback indicating you are pushing the applier properly on the endograft-aortic wall.

The guiding sheath and the applier should be perpendicular to the aortic wall. Always use the steerable sheath to adjust orientation before the second step of deployment.

Selection of guiding sheath size may differ for the inner and outer arch curves. In particular for the outer curve, the smallest 22mm may be easier to rotate even in large diameter endografts.

Always verify that proximal markers of the endograft are aligned.

Use of a large sheath (20F), if possible, may facilitate guiding sheath rotation/manipulation.

A better visualisation is achieved with a 14–7x zoom.

Femoral artery access is most commonly used. In some cases both No movements of the guiding sheath, applier, femoral arteries need to be accessed to be able to easily deploy the desired and Heli-FX EndoAnchor system should be seen number of Heli-FX EndoAnchor implants in the selected location. If one during deployment. femoral is highly diseased, a right axillary/subclavian access has also been described.

Use of excessive force to rotate the guiding sheath is contraindicated and may lead to guiding sheath abrasion.

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Heli-FX EndoAnchor implants should penetrate the aortic wall through adventitia.

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