March 2020 | Educational Supplement

This educational supplement has been sponsored by JOTEC, a fully owned subsidiary of CryoLife Inc

One solution for your aorto-iliac needsA detailed look at the E-tegra and E-liac stent graft systems

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JOTEC: AAA solutions

High precision technology for exact treatment of aorto-iliac aneurysmsGottfried J Mommertz outlines the benefits of JOTEC's E-tegra for the treatment of complex aneurysms and details a case study using the device.

Case study figures

Introduction

internal iliac artery occlusions are described, which leads to a one year freedom from occlusion of 92%. In the first 30 days after implantation, 15 patients showed a Type II endoleak. However, only one persisted out to 12-month follow-up without aneurysm enlargement. No other complications were reported.8

We have been using IBDs since 2016. Before then, there was no need for the bell-bottom or sandwich technique. From our point of view, these latest techniques are merely bailout solutions, because of the applicability of the JOTEC E-liac within the E-xtra DESIGN ENGINEERING with customised configurations based on the

ALTHOUGH PRESERVING THE perfusion of the hypogastric artery (HA) increases the complexity of endovascular repair and raises the rates of Type Ib endoleak, limb occlusion and secondary rupture,1 it seems clear that it is worthwhile preserving the HA, because occlusion of the HA may lead to bowel ischaemia and buttock claudication without any advantage relating to the technical success and reintervention rates.2,3

Bell-bottom reconstruction (Figure 1) is one option to preserve the perfusion of the HA, which has shown better results than coiling the HA related to combined perioperative complications and reinterventions.4 However, a recent study showed a five-fold higher risk of Type Ib endoleak for flared legs (>20mm).5

Another option is the sandwich technique (Figure 2), in which two endografts are implanted in parallel in the leg of the main body of the aorto-biiliac endograft, one goes into the external iliac artery, and the other ends up in the HA. In most cases a brachial approach is needed to bring in the second stent graft.6 Midterm follow-up results show that the initially detected Type I (5%), Type II (10%), and Type III (2.5%) endoleaks either resolved spontaneously (Type II and III) or were successful treated with cuffs (Type I). Buttock claudication was described in 4.2%, which had resolved by midterm follow-up, and erectile dysfunction, which did not resolve, developed in 2.5% of patients.7

Iliac branch devices are the next technical step used for these pathologies; the Zenith IBD (Cook Medical), Excluder IBE (W.L. Gore & Associates), and the E-liac IBD (JOTEC GmbH) are available.

Focusing on the JOTEC E-liac, 12-month follow-up of prospective data shows a technical success rate of 100% in 82 implantations (70 patients). Two type Ib endoleaks were successfully treated with covered stent extensions. During follow-up, two common iliac, two external iliac and one

morphology to be treated. There was no patient we were not able to treat with the JOTEC E-liac, either alone or in combination with the E-tegra abdominal stent graft, in the last four years.

Our reasons to treat these patients with JOTEC E-liac are numerous. Firstly, the quality of the material is high. Self-expandable nitinol stents achieve superior flexibility compared to steel, and the asymmetrical configuration allows for it to adapt well to the vessel anatomy in order to avoids kinks. There are sophisticated radiopaque gold markers that give excellent information during positioning and rotation of the endoprosthesis. The quality of the coverage (woven polyester) provides excellent patency rates.9 Secondly, the comfortable delivery system makes it possible to treat both sides using a bifemoral approach.

With E-liac alone, as well as combined with E-tegra, we have very good options to treat patients with these complex aneurysms.

Case descriptionOn 6 December 2019, we saw a 72-year-old man with a common iliac artery aneurysm, which had a maximum diamter of 5cm on the left side. The abdominal aorta also showed an aneurysm with a maximum diameter of 4.4cm (Figure 3a). The basic facts showed a coronary vessel disease with three aorto-coronary bypasses, arterial hypertension, and resection of the lung due to cancer. Missing an adequate proximal landing zone, we decided to perform an aorto-biiliac EVAR including an iliac side branch for the left common iliac artery aneurysm. We planned to use JOTEC devices: the E-tegra stent graft, which has excellent new features, such as the redesigned springs for better sealing, better flexibility and kink resistance of the main body, and enhanced patency of the legs due to an improved flow divider, in combination with the E-liac.

There were no complications during implantation on 13 December 2019 (Figure 3b) and the clinical course of the patient, who left the hospital on 17 of December 2019, was good. The CT imaging after implantation showed no endoleaks and preserved perfusion in the left hypogastric artery as well in both external iliac arteries (Figures 3c–d). He showed no buttock claudication, no deterioration of renal function, and primary undisturbed wound-healing.

Gottfried J Mommertz is a vascular surgeon at Marienhospital Aachen, Aachen, Germany.

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

References 1. Hobo R, Sybrandy JE, Harris PL, Buth J. Endovascular repair

of abdominal aortic aneurysms with concomitant common iliac artery aneurysm: Outcome analysis of the EUROSTAR experience. J Endovasc Ther 2008;15(1):12–22.

2. Kouvelos GN, Katsargyris A, Antoniou GA, et al. Outcome after interruption or preservation of interal Iliac artery flow during endovascular repair of abdominal aorto-iliac aneurysms. Eur J Vasc Endovasc Surg 2016;52(5):621–634.

3. Verzini F, Parlani G, Romano L, et al. Endovascular treatment of iliac aneurysm: Concurrent comparison of side branch

endograft versus hypogastric exclusion. J Vasc Surg 2009;49(5):1154–1161.

4. Naughton PA, Park MS, Kheirelseid EAH, et al. A comparative study of bell-bottom technique versus hypogastric exclusion for the treatment of aneurysmal extension to the Iliac bifurcation. J Vasc Surg 2012;55(4):956–962.

5. Gray D, Shahverdan R, Reifferscheid V, et al. EVAR with flared iliac limbs has a high risk of late Type Ib EL. Eur J Vasc Endovasc Surg 2017;54(2):170–176.

6. Shiro BJ, Gandhi RT, Pena CS, et al. Endovascular management of iliac aneurysmal disease wih hypogastric artery preservation. Cardiovasc Diagn Ther 2018;8(Suppl 1):168–174.

With E-liac alone, as well

as combined with E-tegra, we have very good options to treat patients with these complex aneurysms.”

Gottfried J Mommertz

Figure 3b: Intraoperative angiography after implantation of the E-tegra and E-liac devices.

Figures 3c–d: CTA three days after implantation of E-tegra and E-liac, showing no endoleak and preserved perfusion of the iliac branches.

Figure 1: Computed tomography angiography (CTA) after endovascular repair of an aortic and right iliac aneurysm, pointing out the bell-bottom reconstruction in the distal common iliac artery (right).

Figure 3a: CTA showing the giant aneurysm of the left common iliac artery and abdominal aorta.

1

3b 3c 3d

2

3a

7. Lobato AC, Camacho-Lobato L. The sandwich technique to treat complex aortoiliac or isolated iliac aneurysms: results of midterm follow up. J Vasc Surg 2013;57(Suppl 2):26–34.

8. Mylonas SN, Rümenapf G, Schelzig H, et al. A multicenter 12-month experience with a new iliac side-branched device for revascularisation of hypogastric arteries. J Vasc Surg 2016;64(6) 1652–1659.e.1.

9. Brunkwall J, Vaquero Puerta C, Heckenkamp J et al. Prospective study of the E-iliac stent graft system in patients with common iliac artery aneurysms: 12 months results. Eur J Vasc Endovasc Surg 2019 Dec;58(6):831–838.

Figure 2: Intraoperative angiography after implantation of two endografts in the right leg of the aorto-biliac endograft to repair the common iliac artery aneurysm on the right side in a sandwich technique

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JOTEC: AAA solutions Case report

detected. Both renal arteries were open. All distal vessels and stents were patent (Figure 3). Total procedure time was 181 minutes, with 200cc of blood loss. The postoperative computed tomography after four weeks showed adequate positioning of the grafts (Figures 4 and 5) and there was no sign of endoleak.

The new E-tegra stent graft is easy to handle, with smart engineering, and seems to be a mature stent graft, able to compete with the dominant players in the field. In order to see if it lives up to high expectations, it is of utmost importance that a multicentre registry is set up.

Cornelis JJM Sikkink and Lee H Bouwman are vascular surgeons at the Zuyderland Medical Centre in Heerlen, the Netherlands.

References 1. Indrakusuma R, Jalalzadeh H, Vahl AC, Koelemay MJW, Balm

R. Sex-related differences in perioperative mortality after elective repair of an asymptomatic abdominal aortic aneurysm in the Netherlands: A retrospective analysis of 2013 to 2018. Eur J Vasc Endovasc Surg 2019; 58(6): 813–820.

2. Teijink JAW, Power AH, Böckler D, Peeters P, van Sterkenburg S, Bouwman LH, Verhagen HJ, Bosiers M, Riambau V, Becquemin JP, Cuypers P, van Sambeek M. Five-year outcomes of the Endurant stent graft for endovascular abdominal aortic aneurysm repair in the ENGAGE registry. Eur J Vasc Endovasc Surg 2019; 58(2): 175–181.

Treatment of an aorto-iliac aneurysm: Case report and first experience with a new stent graftCornelis JJM Sikkink and Lee H Bouwman discuss the treatment of an aorto-iliac aneurysm, giving details of a case involving their first clinical experience with the new E-tegra stent graft system. They begin by acknowledging that, while stent grafts used for this purpose have undergone a “tremendous development” in the past twenty years, the search for the “ideal” stent graft continues.

aneurysms were treated. On the right side, the E-liac stent graft was placed and the aneurysm of the internal iliac artery was treated with coiling of a side branch and very distal stenting with E-ventus stents (JOTEC GmbH) (Figure 1). On the left side, no coiling was needed. After the iliac part, the main body of the new E-tegra was introduced from the right groin. Introduction was very easy, without any resistance. Precise

placement of the main body was possible using the squeeze-to-release deployment system (Figure 2). After positioning of the main body, the contralateral leg was cannulated and bridging stents were placed on both sides. Visibility of the stent grafts was good, with markers on all essential spots. Tip retrieval into the sheath was easy. Completion angiogram showed the aimed position of the grafts. No endoleak was

CaseA 76-year-old male presented at our outpatient clinic with asymptomatic bilateral iliac aneurysms. CTA showed that the iliac arteries were 26mm on the right and 43mm on the left. The diameter of the right internal iliac artery measured 15mm. The abdominal aorta was slightly enlarged at 32mm. There was no relevant medical history. Treatment options were discussed in a multidisciplinary team. Endovascular repair was proposed using bilateral E-liac stent grafts and the new E-tegra. The procedure was carried out under general anesthesia. Prophylactic antibiotics were administered and 5000IE of heparin. The procedure was performed percutaneously. First, the iliac

DURING THE LAST TWO DECADES, endovascular treatment of aortic and aorto-iliac aneurysms has become standard of care. In the early days, only a limited percentage of patients was considered EVAR (endovascular aneurysm repair) suitable, with the majority of patients being treated with open surgery. Nowadays, the percentage of endovascular repair in the developed world is significantly higher than open surgery.1 The stent grafts used for this purpose have undergone a tremendous development in the past twenty years in order to deal with the complications which are related to endovascular repair. Despite all this effort, endoleak, migration, sac enlargement, and even rupture are still complications that are encountered after EVAR.2 Therefore, despite the evident decrease in perioperative mortality, the search for the “ideal” stent graft continues. It is questionable whether all the aforementioned problems can be tackled by means of adjustments to stent grafts alone.

Nevertheless, technical evolution increases the options for further optimalisation and the testing of new products. New, promising stent grafts are being launched regularly, and the choice for users is enormous. These newcomers are supposed to have many different properties, and distinguish themselves from earlier generations in a

positive way. They should take care of durable exclusion of the aneurysm, with lower risks of endoleak and migration, have low profiles in order to prevent access issues, and, not unimportantly, they should be very easy to handle.

The E-tegra stent graft system has been on the market since November 2014. In November 2019, the E-tegra update was launched. This new E-tegra was designed in order to enhance sealing and conformability for better long-term results for patients with an aneurysm of the abdominal aorta. It is available as a bi- and trimodular stent graft design. The cover consists of thin woven polyester with nitinol stents. The laser-cut crown stent has integrated hooks for active fixation. The two proximal and newly-designed sealing stents are W-shaped

for enhanced sealing and fixation. Another change is the proximal cauterisation of the fabric to prevent in-folding. New asymmetrical springs at the trunk of the main body were designed for increased flexibility and radial force. Furthermore, the oval shaped bifurcation spring is supposed to optimise flow and patency at the flow divider. The squeeze-to-release deployment mechanism of the delivery system remains the same and allows for stepwise and precise placement of the graft. The main body is available with proximal diameters from 23–36mm. Sizes go up with 3mm steps from 23–32mm and a 4mm step from 32–36mm. Distally, the sizes of iliac extensions range from 10–27mm.

The new E-tegra is easy to

handle, with smart engineering, and seems to be a mature stent graft, able to compete with the dominant players in the field.”

Technical evolution

increases the options for further optimalisation and testing of new products.”

Cornelis JJM Sikkink Lee H Bouwman

Figure 1 Figure 2 Figure 3 Figure 4 Figure 5

Case study figures

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JOTEC: AAA solutionsCase report Interview

Jacek Kurnicki talks through the key features and benefits of the new JOTEC E-tegra stent graft system and the E-liac stent graft.

How can JOTEC/CryoLife meet the requirements of an EVAR stent graft?JOTEC/CryoLife understands the patient’s and their doctor’s needs and offers a wide armamentarium. According to the IFU, their infrarenal stent graft E-tegra is suitable for AAA with the following preconditions:● Infrarenal proximal landing zone ≥15mm● Angle of the infrarenal aorta distal to the

landing zone ≤75°● Diameter of the proximal neck 19–

32mm● Distal landing zone length in the

common iliac artery ≥15mm ● Distal landing zone diameter in the

common iliac zone 8–25 mmThese are the preconditions which should be met to use the infrarenal stent graft E-tegra. JOTEC also offers their E-xtra DESIGN ENGINEERING products for anatomies that are not suitable for the E-tegra as a standard off-the-shelf product.

Pararenal/juxtarenal or thoracoabdominal aneurysms could be treated with fenestrated or branched devices provided by E-xtra DESIGN ENGINEERING. These customised devices fit very well to the aortic morphology and, despite the experience needed for such procedures, simply facilitate the stent graft’s implantation.

Patients with aorto-iliac or isolated iliac aneurysms can be treated with dedicated E-liac stent graft systems. The E-liac stent graft system can be implanted in combination with the E-tegra stent graft system.

What are the key features and benefits of the new E-tegra?JOTEC redesigned their abdominal working horse—E-tegra. The newly designed proximal W-shaped springs remarkably improve sealing in the proximal landing zone. The newly designed bifurcation spring of the main body is designed to provide better comformability to the whole main body and to guarantee improved flow and

patency to both limbs. At the proximal end of the E-tegra main body, the fabric is flared inbetween the struts of the bare stent, and that helps avoid the infolding of the fabric and consequently reduce the risk for Type I endoleaks. The redesigned sealing stent ensures better alignment and conformability. The above mentioned enhancements lead to an excellent sealing performance even in short infrarenal and highly angulated necks.

The new asymmetric springs enhance conformability without diminishing columnary strength.

What are the key features and benefits of the E-liac?The most important benefit of the E-liac stent graft system is the possibility to treat patients with aorto-iliac as well as isolated iliac aneurysms. JOTEC is the only provider of an endovascular product for the treatment of isolated iliac aneurysms. The delivery system is simple and comfortable to use and the overall endovascular procedure is easy to perform. A wide range of anatomies can be treated due to the various sizes of the product.

None of my patients treated with the iliac branch stent graft, E-liac, complained of buttock claudication or colonic ischaemia. Furthermore, there was also no sign of Type

II endoleak coming from the hypogastric artery on the side of the iliac branch device. So far, I consider preserving the hypogastric arteries with dedicated stent grafts to be a safe operation.

What has been your clinical experience with the new E-tegra device and what results have you seen?I perform about 50–75 endovascular aortic aneurysm repairs per year. About 5–10% of these procedures are aorto-iliac or, more rarely, isolated iliac aneurysm operations. Since JOTEC launched their E-tegra update, I have performed five operations using this device. I am very satisfied with the handling and the outcomes of these procedures.

What makes E-tegra and E-liac different from other devices for abdominal/aorto-iliac aneurysms?The main differences are the mechanism for the deployment of the stent graft (squeeze-to-release mechanism) and the position of the markers. The first feature makes the deployment smooth, simple and precise—I would say effortless. The second feature simplifies the positioning of the stent graft, visibility and the accurate intraoperative measurement and connection of the elements. JOTEC/CryoLife offers the complete aorto-iliac product range and provides solutions for simple and complex anatomies. The management of AAA procedure with JOTEC’s products is more flexible due to a large availability of diameters and lengths. The E-tegra has excellent sealing performance even in angulated and short necks. In addition, the service-oriented and well-trained product specialists from JOTEC ensure excellent treatment.

Jacek Kurnicki is a general and vascular surgeon and vascular consultant at the Medi-cal University of Warsaw (Warsaw, Poland).

Matthias Trenner describes a case involving the first implantation of the updated E-tegra in combination with E-liac for AAA and concomitant iliac aneurysms.

First implantation of the updated E-tegra in combination with E-liac for AAA and concomitant iliac aneurysms

bilateral renal arteries. The infrarenal neck was 17mm in length and 26mm in diameter.

After discussion in our multidisciplinary team, the patient was offered endovascular treatment with EVAR and a right-sided iliac branch device (IBD).

ProcedureThe operation was carried out under general anaesthesia. Femoral access was gained percutaneously and vascular closure devices were put in place for later haemostasis. The E-liac iliac branch device was passed to the right common iliac artery over a 0.35” stiff wire and a 0.18” up-and-over wire. An 8Fr cross-over sheath was fed in after the opening of the iliac side branch. The hypogastric artery was canulated and an E-ventus balloon-expandable stent graft was implanted as a bridging stent. To avoid kinking, the stent graft was relined using an uncovered nitinol stent. This was followed by implantation of the updated E-tegra aorto-biiliac stent graft from the contralateral side. After cannulation of the contralateral limb, a bridging stent graft (16mm) was implanted between the E-liac and E-tegra devices. On the left side, an additional 19mm limb extension was necessary to warrant

Preoperative courseA 73-year-old male was referred with an abdominal aortic aneurysm known for three years, but now growing in size. The patient has a history of smoking, hyperlipidaemia and hypertension. Ultrasound revealed a 56mm AAA and concomitant 26mm right-sided common iliac aneurysm, which was confirmed by CT angiogram (Figure 1). Furthermore, the CT revealed multiple

sufficient sealing. Completion angiogram showed no endoleak and preservation of all renal arteries and hypogastric arteries (Figure 2a/b). Haemostasis was sufficiently delivered through the placed closure devices. Total procedure time was 124 minutes.

Postoperative courseAfter four hours in recovery,

the patient was transferred to the regular ward. Postoperative controls by contrast enhanced ultrasound (CEUS) and CT angiogram confirmed successful occlusion of the aneurysm with preservation of renal and hypogastric arteries (Figure 3 a/b). The patient was discharged on the third postoperative day. Thirty days after operation no further complications occured.

Matthias Trenner is head of the Munich Aortic Centre (MAC) and consultant vascular surgeon at the Department for Vascular and Endovascular Surgery (chair: H-H Eckstein), Klinikum rechts der Isar, Technical Universi-ty of Munich, Munich, Germany. At the MAC, the team carries out >200 endovascular and open aortic repairs a year, covering all open and endovascular aortic sites from arch to iliacs.

Matthias Trenner

Figure 1: Preoperative CTA 3D reconstruction

Figure 2a/b: Intraoperative angiographic imaging Figure 3a/b: Postoperative CTA imaging

Jacek Kurnicki

Key features and benefits of the newly-updated E-tegra stent graft system and the E-liac stent graft