Morphological applicability of currently available stent grafts in the endovascular repair of asymptomatic abdominal aortic aneurysm in East-Central European patients

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Abstract

Introduction

Currently, there is a wide range of commercially available devices for endovascular aneurysm repair (EVAR) that differ in terms of both anatomical requirements and the technology and technique of deployment.

Aim

To assess the applicability of currently commercially available devices for EVAR in the treatment of an asymptomatic abdominal aneurysm (AAA).

Material and methods

The study group included 100 patients with infrarenal AAA with a maximum diameter ≥ 50 mm, qualified for invasive treatment at the University Hospital in 2013–2014. The aortoiliac morphological characteristics of the AAA were evaluated on preoperative computed tomography angiograms using the OsiriX DICOM viewer in the 3D-MPR mode. The morphological applicability of 14 types of CE-marked and FDA-approved stent grafts was determined based on their instructions for use (IFU).

Results

EVAR was feasible with at least one of the analysed devices in 68% of patients. The morphological applicability was as follows: Excluder Conformable (65%), Ovation iX (51%), Endurant II (47%), Treo (45%), Excluder C3 (45%), AFX 2 (45%), Incraft (44%), E-tegra (44%), Zenith Alfa (41%), Zenith Flex (40%), Anaconda (39%) Aorfix (37%), Altura (34%), and E-vita (20%). The differences in the stent graft applicability were statistically significant ( p < 0.001). A wide diameter of the common iliac artery, angulated proximal neck, and diameter of proximal neck out of range constituted the most frequent causes of EVAR inapplicability.

Conclusions

The IFU-based applicability of currently available AAA stent graft systems differs significantly. Despite the constant evolution of EVAR technology, at least 32% of AAA will require a different therapeutic approach.

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Most cited references 19

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Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair.

Andres Schanzer, Roy Greenberg, Nathanael Hevelone … (2011)

The majority of infrarenal abdominal aortic aneurysm (AAA) repairs in the United States are performed with endovascular methods. Baseline aortoiliac arterial anatomic characteristics are fundamental criteria for appropriate patient selection for endovascular aortic repair (EVAR) and key determinants of long-term success. We evaluated compliance with anatomic guidelines for EVAR and the relationship between baseline aortoiliac arterial anatomy and post-EVAR AAA sac enlargement. Patients with pre-EVAR and at least 1 post-EVAR computed tomography scan were identified from the M2S, Inc. imaging database (1999 to 2008). Preoperative baseline aortoiliac anatomic characteristics were reviewed for each patient. Data relating to the specific AAA endovascular device implanted were not available. Therefore, morphological measurements were compared with the most liberal and the most conservative published anatomic guidelines as stated in each manufacturer's instructions for use. The primary study outcome was post-EVAR AAA sac enlargement (>5-mm diameter increase). In 10 228 patients undergoing EVAR, 59% had a maximum AAA diameter below the 55-mm threshold at which intervention is recommended over surveillance. Only 42% of patients had anatomy that met the most conservative definition of device instructions for use; 69% met the most liberal definition of device instructions for use. The 5-year post-EVAR rate of AAA sac enlargement was 41%. Independent predictors of AAA sac enlargement included endoleak, age ≥ 80 years, aortic neck diameter ≥ 28 mm, aortic neck angle >60°, and common iliac artery diameter >20 mm. In this multicenter observational study, compliance with EVAR device guidelines was low and post-EVAR aneurysm sac enlargement was high, raising concern for long-term risk of aneurysm rupture.

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Impact of exclusion criteria on patient selection for endovascular abdominal aortic aneurysm repair.

Judith Barker, M Golden, O Velazquez-Monroy … (2001)

Wide-ranging predictions have been made about the usefulness of endovascular repair for patients with abdominal aortic aneurysms (AAAs). The availability of US Food and Drug Administration-approved devices has removed the restrictions on patient selection, which had been controlled by device trials. This study examined the applicability of endovascular AAA repair and identified the anatomic barriers to successful endovascular AAA repair that should guide future device development. All patients who came to our institution for infrarenal AAA repair between April 1998 and June 2000 were offered evaluation for endovascular repair. Thin-cut spiral computed tomography scans and arteriograms were obtained on all patients, and their anatomic characteristics were prospectively entered into a database. A wide selection of available devices allowed the treatment of diverse AAA anatomic features. A total of 307 patients were examined (264 men, 43 women). Of these, 204 patients (66%; 185 men, 19 women) underwent endovascular repair, and 103 patients (34%, 79 men, 24 women) were rejected. Reasons for exclusion included short aneurysm neck (56, 54%), inadequate access because of small iliac arteries (48, 47%), wide aneurysm neck (41, 40%), presence of bilateral common iliac aneurysms extending to the hypogastric artery (22, 21%), excessive neck angulation (14, 14%), extensive mural thrombus in the aneurysm neck (10, 10%), extreme tortuosity of the iliac arteries (10, 10%), accessory renal arteries originating from the AAA (6, 6%), malignancy discovered during the examination (5, 5%), and death during the examination interval (2, 2%). Rejected patients had an average of 1.9 exclusion criteria (range, 1 to 4). A disproportionate number of women were excluded because of anatomic findings (P = .0009). Although 80% of patients who were at low risk for surgery qualified for endovascular repair, only 49% of our patients who were at high risk for surgery were acceptable candidates (P < .001). Of the 103 patients who were excluded, 34 (33%) underwent open surgical repair, and the remaining 69 (67%) were deemed to be unfit for open surgery. Three patients (1.4%) failed endograft placement because of inadequate vascular access. Most infrarenal AAAs (66%) can be treated with endovascular devices currently available commercially or through US Food and Drug Administration-approved clinical trials. However, patients who are at high risk for surgery and might benefit most from endovascular repair are less likely to qualify for the procedure (49%). Men (70%) are more likely than women (40%) to meet the anatomic criteria for endografting. Difficulties with vascular access and attachment site geometry predominate as reasons for exclusion. Our findings suggest that smaller profile devices, which can negotiate small and tortuous iliac arteries, are needed. Proximal and distal attachment site problems require devices that can accommodate wide and angulated attachment necks and achieve short seal zones.

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Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis.

Thomas A Abbruzzese, Christopher J Kwolek, David Brewster … (2008)

We performed a device-specific comparison of long-term outcomes following endovascular abdominal aortic aneurysm repair (EVAR) to determine the effect(s) of device type on early and late clinical outcomes. In addition, the impact of performing EVAR both within and outside of specific instructions for use (IFU) for each device was examined. Between January 8, 1999 and December 31, 2005, 565 patients underwent EVAR utilizing one of three commercially available stent graft devices. Study outcomes included perioperative ( .05), but a lower freedom from GRAE (74% outside IFU vs 86% within IFU; P = .021), likely related to a higher incidence of graft thrombosis (2.3% outside IFU vs 0.3% within IFU; P = .026). The differences in outcome for grafts placed within vs outside IFU were not device-specific. EVAR performed with three commercially available devices provided similar clinically relevant outcomes at 5 years, although no graft migration occurred with a suprarenal fixation device. As anticipated, application outside of anatomically specific IFU variables had an incremental negative effect on late results, indicating that adherence to such IFU guidelines is appropriate clinical practice.

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Author and article information

Journal

Journal ID (nlm-ta): Postepy Kardiol Interwencyjnej

Journal ID (iso-abbrev): Postepy Kardiol Interwencyjnej

Journal ID (publisher-id): PWKI

Title: Postępy w Kardiologii Interwencyjnej = Advances in Interventional Cardiology

Publisher: Termedia Publishing House

ISSN (Print): 1734-9338

ISSN (Electronic): 1897-4295

Publication date (Electronic): 27 March 2021

Publication date (Print): March 2021

Volume: 17

Issue: 1

Pages: 93-100

Affiliations

[1 ]Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences, Poznan, Poland

[2 ]Department of Vascular Surgery and Vascular Diseases, Institute of Medical Sciences, University of Zielona Góra, Zielona Góra, Poland

Author notes

Corresponding author: Jolanta Tomczak MSc, Department of Vascular and Endovascular Surgery, Angiology and Phlebology, Poznan University of Medical Sciences, Poznan, Poland. phone: +48 61 854 91 41. e-mail: jolantatomczak.pte@ 123456gmail.com

Article

Publisher ID: 43643

DOI: 10.5114/aic.2021.104774

PMC ID: 8039927

PubMed ID: 33868423

SO-VID: 6bc0b468-88b9-4f90-8c98-926f98d66168

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.

Morphological applicability of currently available stent grafts in the endovascular repair of asymptomatic abdominal aortic aneurysm in East-Central European patients

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Abstract

Introduction

Aim

Material and methods

Results

Conclusions

Related collections

Orthopedics

Most cited references 19

Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair.

Impact of exclusion criteria on patient selection for endovascular abdominal aortic aneurysm repair.

Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis.

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