Contents: 2 Introduction 3 Treatment algorithm
4-5 Case report 6 Case report 7 Case report
Contents: 2 Introduction 3 Treatment algorithm
4-5 Case report 6 Case report 7 Case report
The E-liac stent graft system (Artivion/Jotec), according to the clinical data and expert experience, has the potential to overcome the pressing challenge of preserving the hypogastric artery in patients with an abdominal aortic aneurysm (AAA) undergoing endovascular repair.
ONE OF THE MAJOR ANATOMICAL challenges of endovascular aortic repair in patients with AAA is concomitant iliac artery aneurysms. Iliac artery aneurysms are known to exacerbate the complexity of endovascular aneurysm repair and increase the incidence of type Ib endoleaks, iliac limb occlusions and aneurysm ruptures. Furthermore, occlusion of the internal iliac artery (IIA) can cause ischaemic manifestations such as erectile dysfunction, buttock claudication and colonic ischaemia.1–3 Therefore, the European Society for Vascular Surgery recommends to avoid bilateral interruption of the IIAs, at least in standard-risk patients.4
The E-liac stent graft system is indicated for both aortoiliac and isolated iliac aneurysms, has a pre-cannulated side branch, and is designed for a broad range of anatomies. The device offers an endovascular solution for preserving the hypogastric artery and is indicated for the treatment of patients with unilateral, bilateral aortoiliac or isolated iliac aneurysms provided the following preconditions are met:5
For isolated aneurysms:
● Non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm ≥20mm
● Diameter of common iliac artery in the proximal landing area: 12–17mm
For isolated and aortoiliac aneurysms:
● Diameter of the external iliac artery (EIA) in the distal landing area: 8–13mm
The E-liac stent graft system has been tested in multiple studies where its safety and efficacy to maintain pelvic blood flow have been proven.
The device has high patency rates and low reintervention rates according to multiple
studies,5–7 and there have now been over 7,500 implantations.
In one study, published in 2016, Spyridon N Mylonas (University of Cologne, Cologne, Germany) et al outlined their 12-month experience with the E-liac device for the revascularisation of hypogastric arteries. The team enrolled 70 patients and reported a 0% rate of buttock claudication, an 11% rate of E-liac-related reintervention, a 97% primary patency rate in the EIA and a 100% rate in the IIA.5
In 2018, Susanne Anton (University Hospital of Schleswig-Holstein, Lübeck, Germany) and colleagues shared their initial experience with the E-liac device for the endovascular aortic repair of aortoiliac aneurysms. They followed 21 patients up for 12 months and reported that the rate of buttock claudication was 5%, with an 8.7% rate of E-liac-related reintervention. Primary patency in both the EIA and IIA was 100%.6
The following year, Jan S Brunkwall (University Clinic of Cologne, Cologne, Germany) et al announced 12-month results
of a prospective study of the E-liac device in patients with common iliac artery aneurysms. In 42 patients, the buttock claudication rate was 2.4%, the E-liac-related reintervention rate was 5%, and the primary patency rate was 98% in both the EIA and IIA.7
Read ahead for some case-based reports on the E-liac stent graft system, as well as other devices in the Artivion portfolio, with experience from University Hospital Münster (Münster, Germany), Zuyderland Medical Center (Heerlen, The Netherlands), Athens Medical Center (Athens, Greece), and the University of Siena (Siena, Italy) illuminating how these products have influenced aortic practice across Europe.
1. Rayt HS, Bown MJ, Lambert KV, et al. Buttock claudication and erectile dysfunction after internal iliac artery embolization in patients prior to endovascular aortic aneurysm repair. Cardiovasc Intervent Radiol. 2008;31: 728–34.
2. Lin PH, Chen AY, Vij A. Hypogastric artery preservation during endovascular aortic aneurysm repair: is it important? Semin Vasc Surg. 2009;22: 193–200.
3. Pavlidis D, Hormann M, Libicher M, et al. Buttock claudication after interventional occlusion of the hypogastric artery—a mid-term follow-up. Vasc Endovascular Surg 2012;46: 236–41.
4. Instructions for use E-liac.
5. Mylonas SN, Rümenapf G, Schelzig H, et al. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg 2016 Dec;64(6): 1652–1659.e1.
6. Anton S, Wiedner M, Stahlberg E, et al. Initial experience with the E-liac iliac branch device for the endovascular aortic repair of aorto-iliac aneurysm. Cardiovasc Intervent Radiol 2018 May;41(5): 683–6919.
7. Brunkwall JS, Puerta CV, Heckenkamp J, et al. Prospective study of the iliac branch device E-liac in patients with common iliac artery aneurysms: 12 month results. 2019 Oct 12, 10.1016/j.ejvs.2019.06.020.
Disclaimer: The views expressed in this article are the speaker’s own and do not necessarily reflect those of Artivion, the speaker’s employer, organization, committee, or other group or individual. Unattributed data, device selection, and procedural guidance is a matter of physician preference. Refer to the Instructions for Use and other product insert documentation that accompanies each of these devices for indications, contraindications, warnings, precautions, possible complications, and instructions for use.
All rights reserved. Published by BIBA News, London T:+44 (0)20 7736 8788, publishing@bibamedical.com.
The opinions expressed in this supplement are solely those of Artivion and the featured physicians and may not reflect the views of Vascular News
The E-liac stent graft system has been tested in multiple studies where its safety and efficacy to maintain pelvic blood flow has been proven.”
E-liac stent graft system
“In the days of modern endovascular surgery, treatment should intend to preserve the hypogastric artery and its branches,” Johannes Frederik Schäfers and Alexander Oberhuber (University Hospital Münster, Münster, Germany) tell Vascular News
For decades in aortic and iliac surgery, proper treatment of the hypogastric artery with adequate preservation was put in second place. The emergence of the endovascular era did not immediately change this matter.
In fact, there are no means of predicting whether or which complications or consequences occur when hypogastric arteries are not preserved uni- or bilaterally. Today, however, there is robust evidence that maintaining hypogastric artery flow reduces major, potentially lethal, complications during aortic repair. These complications include bowel ischaemia, buttock claudication, erectile dysfunction and spinal cord ischaemia (SCI).1–3 Particularly when other parts of the aorta are treated or planned to be treated, SCI represents the main reason for hypogastric artery aneurysm preservation in contemporary aortic surgery.4
So, there is no question the hypogastric artery should be preserved. The question is whether one or two hypogastric arteries can be preserved.3
Treating abdominal aortic aneurysms (AAA) with dilated common iliac landing zones results in flared limbs or in occlusion of the hypogastric artery. Flared iliac limbs are at high risk for late type 1b endoleaks and occlusion of the hypogastric artery can result in the previously mentioned problems.5 There are several studies reporting excellent results of iliac branch devices (PLIANT study) and fewer major problems than open repair.3,6 We suggest iliac branch device implantation in all anatomically suitable patients with ectatic common iliac arteries during endovascular aneurysm repair (EVAR) or in isolated iliac aneurysms with adequate landing zone.
Failed EVAR with type 1b endoleak
or additional hypogastric artery aneurysms may require an iliac branch device in patients with EVAR in place. Since usual crossover access to the iliac branch device is blocked, an axillary or subclavian access route is needed to connect the hypogastric artery to the iliac branch device. This route poses a relevant risk for stroke and nerve injuries. The application of steerable sheaths has enabled the full femoral treatment with an iliac branch device after EVAR.7
See Figure 1.
Initially, iliac branch devices were not intended for treatment of hypogastric artery aneurysms. A serious problem of hypogastric artery aneurysm treatment is that, in major cases of open repair, it results in ligation, and isolated endovascular treatment fails due to lack of proximal landing zone in the hypogastric artery. Occlusion of either the superior or inferior gluteal
artery followed by stent graft implantation deep in the other gluteal artery can lead to sufficient exclusion of the hypogastric artery aneurysm using off-the-shelf iliac branch devices (ABRAHAM study).8 See Figure 2
References
1. Dovzhanskiy DI, Bischoff MS, Wilichowski CD, et al. Outcome analysis and risk factors for postoperative colonic ischaemia after aortic surgery. Langenbecks Arch Surg. Nov 2020;405(7):1031–1038. doi:10.1007/s00423-020-01964-2
2. Karch LA, Hodgson KJ, Mattos MA, et al. Adverse consequences of internal iliac artery occlusion during
endovascular repair of abdominal aortic aneurysms. J Vasc Surg. Oct 2000;32(4):676–83. doi:10.1067/mva.2000.109750
3. D’Oria M, Mendes BC, Bews K, et al. Perioperative outcomes after use of iliac branch devices compared with hypogastric occlusion or open surgery for elective treatment of aortoiliac aneurysms in the NSQIP database. Ann Vasc Surg. Jan 2020;62:35–44. doi:10.1016/j.avsg.2019.04.009
4. Eagleton MJ, Shah S, Petkosevek D, et al. Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting. J Vasc Surg. Jan 2014;59(1):89–94. doi:10.1016/j.jvs.2013.07.007
5. Gray D, Shahverdyan R, Reifferscheid V, et al. EVAR with flared iliac limbs has a high risk of late type 1b endoleak. Eur J Vasc Endovasc Surg. Aug 2017;54(2):170–176. doi:10.1016/j.ejvs.2017.05.008
6. Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, et al. Prospective study of the iliac branch device E-liac in patients with common iliac artery aneurysms: 12-month results. Eur J Vasc Endovasc Surg. Dec 2019;58(6):831–838. doi:10.1016/j. ejvs.2019.06.020
7. Oberhuber A, Duran M, Ertas N, et al. Implantation of an iliac branch device after EVAR via a femoral approach using a steerable sheath. J Endovasc Ther. Aug 2015;22(4):610–2. doi:10.1177/1526602815590972
8. Dueppers P, Duran M, Floros N, et al. The Jotec iliac branch device for exclusion of hypogastric artery aneurysms: ABRAHAM study. J Vasc Surg. Sep 2019;70(3):748–755. doi:10.1016/j.jvs.2018.10.124
Johannes Frederik Schäfers is a vascular surgeon at University Hospital Münster in Münster, Germany.
Alexander Oberhuber is a full professor at University Hospital Münster.
In this case report, Ozan Yazar and Lee Bouwman (Zuyderland Medical Center, Heerlen, The Netherlands) outline the successful endovascular treatment of an aortoiliac aneurysm in the hypogastric artery—an anatomy which they stress poses various technical challenges for iliac branch endografts.
CONCOMITANT COMMON ILIAC artery (CIA) ectasia or aneurysm is revealed in up to 40% of patients with abdominal aortic aneurysm (AAA).1 Different techniques have been described to treat these patients with a diseased distal landing zone.2,3 One of the major disadvantages in placing stent grafts in these unfit zones is the hazard of type 1b endoleaks, resulting in higher reintervention rates.4 The endovascular repair
of aortoiliac aneurysms has advanced to the use of iliac branch devices, resulting in patency of the hypogastric artery and a suitable landing zone in the external iliac artery (EIA). Clinical and technical success rates are high.5 Since 2014, the E-liac stent graft system (Artivion/Jotec) has been CE marked for the treatment of iliac artery
aneurysms. This system shows promising results at 12-month follow-up in the PLIANT registry with a device-related reintervention rate of 5% and a primary hypogastric artery patency rate of 98%.6 In a systematic review, Dube et al describe the natural progression of CIA diameter following AAA repair. They show that the growth rate is higher in large CIA (1.5mm growth in 16mm iliac arteries vs. 2.7mm growth in 20mm iliac arteries).7 Our strategy in the treatment of aortoiliac aneurysm is to perform a regular endovascular aneurysm repair (EVAR) when the CIA is 14mm or less, a flared limb when the CIA is between 15 and 20mm and if the CIA is larger than 20mm to use an iliac branch device. However, we take several factors into consideration, such as the comorbidity and life expectancy of the patient, history of intestinal surgery or thoracic EVAR, chronic hypogastric occlusion, and the sexual and daily activity of the patient. With regards to the hypogastric artery, if the diameter is more than 10mm, we prefer a healthy landing zone more distally in
the superior gluteal artery (SGA). We describe the case of a 70-year-old male patient who was admitted to our outpatient clinic due to pneumonia. The chest computed tomography (CT) scan revealed a pneumonia as well as an AAA. An additional CT angiography (CTA) was performed to view the entire aorta. CTA showed an AAA of 71mm, bilateral CIA aneurysms of 23mm and a left hypogastric aneurysm of 39mm (Figures 1a, 1b and 1c). His relevant medical history included hypertension and chronic
pulmonary disease. The patient was asymptomatic, however, due to the large AAA we decided to treat the patient within four weeks as per society guidelines. We planned a percutaneous endovascular treatment (EVAR plus left iliac branch device plus right flared limb) under local anaesthesia. Due to the large hypogastric aneurysm we decided to land in the SGA (Figure 2). We first performed a coiling embolisation of the side branch to create a safe distal sealing zone (Figure 3a) Then we deployed the iliac branch device the traditional way. Three balloon-expandable covered stents (E-ventus; Artivion/Jotec) were placed in the SGA (Figure 3b). Further deployment of the iliac branch device was performed and subsequently the E-tegra (Artivion/Jotec) EVAR procedure was performed. The completion angiography showed patency of the renal arteries, bilateral EIA, right hypogastric artery and left SGA without any endoleak (Figures 4a and 4b)
References
1. Armon MP, Wenham PW, Whitaker SC, et al. Common iliac artery aneurysms in patients with abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 1998;15(3):255–7.
2. McDonnell CO, Semmens JB, Allen YB, et al. Large iliac arteries: a high-risk group for endovascular aortic aneurysm repair. J Endovasc Ther. 2007;14(5):625–9.
Lee Bouwman3. Kalteis M, Gangl O, Huber F, et al. Clinical impact of hypogastric artery occlusion in endovascular aneurysm repair. Vascular. 2015;23(6):575–9.
4. Duvnjak S, Balezantis T. Endovascular treatment of aortoiliac aneurysms with a flared iliac limb. Int J Angiol. 2019;28(1):57–63.
5. Kouvelos GN, Katsargyris A, Antoniou GA, et al. Outcome after interruption or preservation of internal iliac artery flow during endovascular repair of abdominal aortoiliac aneurysms. Eur J Vasc Endovasc Surg. 2016;52(5):621–634.
6. Brunkwall JS, Vaquero-Puerta C, Heckenkamp J, et al. Prospective study of the iliac branch device E-liac in patients with common iliac artery aneurysms: 12-month results. Eur J Vasc Endovasc Surg. 2019;58(6):831–838.
7. Dube B, Ünlü C, de Vries JPPM. Fate of enlarged iliac arteries after endovascular or open abdominal aortic aneurysm repair. J Endovasc Ther 2016 Oct;23(5):803–8.
Lee Bouwman is a vascular and endovascular surgeon at the Zuyderland Medical Center in Heerlen, The Netherlands
Ozan Yazar is a vascular and endovascular surgeon at the Zuyderland Medical Center.
Figure 3a. Coiling of a branch of the SGA
Figure 3b. Covered stents (E-ventus)
Figure 4a. Completion angiography
Figure 4b. Patency of the left SGA
The endovascular repair of aortoiliac aneurysms has advanced to the use of iliac branch devices.”
Theodosios Bisdas (Athens Medical Center, Athens, Greece) shares a case report highlighting the benefits of the E-liac and E-tegra devices (Artivion/Jotec) for the treatment of complex abdominal aortoiliac and hypogastric artery aneurysms.
I PRESENT THE CASE OF A 72-year-old male undergoing total endovascular repair of a complex bilateral aortoiliac abdominal aortic aneurysm (AAA). The most relevant comorbidities of the patient included arterial hypertension, severe coronary artery disease, previous coronary artery bypass grafting with occluded venous bypasses, hypercholesterolaemia, chronic obstructive pulmonary disease and ongoing smoking. The aneurysm was found in the framework of a routine duplex ultrasound due to an asymptomatic pulsatile mass in the abdomen. The computed tomography angiography (CTA) revealed an extensive aortoiliac AAA with maximum diameter of the infrarenal aorta of 7cm and of the right and left common iliac arteries of 5cm and 6cm, respectively. In addition, a 4cm aneurysm of both hypogastric arteries was observed (Figure 1).
Considering the fragile cardiovascular profile of the patient and the risk of an open surgical repair, the patient was scheduled for an endovascular repair. The main technical challenges were the angulated and short proximal neck, the absence of thrombus in the large aneurysm sac, which would complicate the cannulation of the contralateral gate, the large aneurysms of the iliac bifurcation and finally the embolisation of the branches of the aneurysmatic hypogastric arteries in order to prevent future type 2 endoleak.
The E-tegra bifurcated endograft and the E-liac side-branched device were selected as the devices of choice for this case. After percutaneous access from both common femoral arteries, the E-liac device was placed first in the left iliac bifurcation. A contralateral 12Fr sheath was used to gain access in the hypogastric arteries through the side branch. An 8Fr, 90cm sheath was inserted via a Rosenwire (Cook Medical) into the left gluteal artery. A second puncture of the 8Fr sheath was used to insert a Berenstein catheter (Merit Medical) into the aneurysm sac of the hypogastric artery. A 2.7Fr Progreat microcatheter (Terumo Europe) was used to navigate the integrated wire into the patent branches of the sac in order to embolise them. The embolisation was done using standard Ruby coils (Penumbra). After the embolisation, the bridging between the gluteal artery and the iliac side branch was performed by implanting an 8mm E-ventus balloon-expandable stent (Artivion/Jotec) and a 100mm Viabahn endograft (W L Gore). The same procedure was followed for the contralateral iliac and hypogastric artery aneurysm. The AAA was finally excluded via implantation of the bifurcated main body and connecting it to both iliac side branch devices with the iliac limbs. The final angiogram revealed a successful exclusion of this complex aortobi-iliac aneurysm (Figure 3) The main challenges of such “large”
aortoiliac aneurysms with concomitant hypogastric artery aneurysm consist of: (1) the stability of the iliac side branch device during the cannulation of the side branch and the delivery of the different endografts, (2) the challenging cannulation and embolisation of the side branches of the aneurysmatic hypogastric artery and (3) the stability of the stents between the target branch of the hypogastric artery and the side branch of the iliac side-branched device. Both the E-liac device and the E-tegra bifurcated endograft remain user-friendly and trusted devices for such challenging anatomies with proved efficacy.1 The implantation and the behaviour of the endograft as concerns flexibility and stability were excellent in our case. The embolisation of the branches was done using the Progreat microcatheter with the integrated guidewire. In order to facilitate the navigation of the microcatheter and to avoid any accidental closure of the target artery, we prefer to first cannulate the gluteal artery and to secure it via a Rosenwire and an 8Fr sheath and then to double puncture the sheath for the delivery of the microcatheter in the rest of the branches. Finally, the bridging between the iliac side branch and the gluteal artery was performed via the combination of balloon-expandable stent grafts and the self-expandable Viabahn endograft. This technique has been reported to be effective and durable for concomitant hypogastric aneurysms.2
References
1. Mylonas SN, Ruemenapf G, Schelzig H, et al. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg 2016;64(6):1652–1659.
2. Bosiers MJ, Panuccio G, Bisdas T, et al. Longer bridging stent grafts in iliac branch endografting does not worsen outcome and expands its applicability, even in concomitant diseased hypogastric arteries. J Cardiovasc Surg (Tor) 2020;61(2):191–195.
Theodosios Bisdas is head of the Clinic of Vascular Surgery at Athens Medical Center in Athens, Greece.
Gianmarco de Donato (University of Siena, Siena, Italy) uses a case example to highlight the benefits of Artivion/Jotec’s iliac branch device portfolio in the treatment of tortuous aortoiliac aneurysms.
A 75-YEAR-OLD WOMAN
presenting with a 5.5cm abdominal aortic aneurysm with ectatic common iliac arteries underwent endovascular aneurysm repair (EVAR) with a trimodular stent graft (Ovation iX [Endologix]: main body 26/80mm; right iliac limb 22/100mm; left iliac limb 18/100mm).
Regular follow-up was performed, with computed tomography angiography (CTA) at one month, and duplex ultrasound (DUS) at six, 12 and 24 months after implantation revealing good aneurysm sealing with sac shrinkage of 0.4cm. At three-year follow-up, a high-flow endoleak associated with sac increase of 0.7cm was suspected at DUS, and confirmed at CTA as a type 1b bilateral endoleak (Figure 1). Due to degeneration of the distal sealing zones, both iliac limbs were migrated a few centimetres into the aneurysmal sac, while the proximal sealing was still optimal.
We looked for an endovascular rescue intervention and planned a relining with a right iliac branch device with a dedicated bridging stent to the previous stent graft main body, and a limb extension at the level of the left common iliac artery. Additional anatomical challenges were represented by the tortuosity of the first portion of the right external iliac artery, and the presence of some severe eccentric calcifications (Figure 2)
Through a common femoral artery access, a 13/13x50mm E-tegra bridging stent graft (Artivion/Jotec) and a 14/10 E-liac branch device (Artivion/Jotec) were implanted (Figure 3a), while the hypogastric component was delivered through the left brachial access (7Fr, 90cm sheath plus Advanta balloon-expandable stent graft [Getinge] 10/59mm; Figure 3b).
As an adjunctive manoeuvre, we performed pre-dilation with a 12mm compliant balloon of the right main body
gate in order to reduce any potential friction or conflict during the tracking of the new components for the relining (Figure 4). This resulted in a very smooth transition of the iliac bridge and iliac branch device, and an easy orientation of the E-marker to cannulate the hypogastric ostium. The delivery of the balloon-expandable covered stent from the brachial access was performed with synchronous inflation of a 10mm compliant balloon in the external iliac portion of the iliac branch device to stabilise the implantation and avoid any conflict at the level of bifurcation.
A further relining was performed at the level of the left common iliac with a 18/100mm Ovation extension.
A CTA at 45 days after relining revealed complete aneurysm sealing, with excellent patency of the iliac components (Figure 5). In particular, it is evident how the bifurcation stent with the dedicated design allowed a flexible orientation of the side
Figure 1. High-flow endoleak associated with sac increase of 0.7cm confirmed at CTA as a type 1b bilateral endoleak
Figure 2. Additional anatomical challenges were represented by the tortuosity of the first portion of the right external iliac artery, and the presence of some severe eccentric calcifications
Figure 3a. Through a common femoral artery access, a 13/13x50mm E-tegra bridging stent graft and a 14/10–100mm E-liac iliac branch device were implanted
Figure 3b. The hypogastric component was delivered through the left brachial access
Figure 4. Pre-dilation with a 12mm compliant balloon of the right main body gate
branch; the E-liac appears nicely seated on the hypogastric bifurcation (Figure 6), the hypogastric bridging stent is securely connected thanks to the compression stent shape, while the asymmetrical spring of the external iliac segment offers good adaptability even in the presence of calcium and vessel angulation.
The 24-month DUS after iliac branch device implantation showed no endoleak and sac shrinkage of 0.5cm.
Despite meticulous initial selection, some patients will experience degeneration of the proximal and/or distal sealing zones after initial EVAR. Where feasible, the preservation of the hypogastric artery with an iliac branch device to assure antegrade flow is worthwhile in the management of aortoiliac aneurysms.
Gianmarco de Donato is a full professor of vascular surgery at the University of Siena in Siena, Italy.
Preservation of the hypogastric artery with an iliac branch device [...] is worthwhile.”Figure 5. A CTA at 45 days after relining revealed complete aneurysm sealing