Multicentre randomised controlled trial to evaluate the efficacy of pre-emptive inferior mesenteric artery embolisation during endovascular aortic aneurysm repair on aneurysm sac change: protocol of Clarify IMA study

Ichihashi, Shigeo; Takahara, Mitsuyoshi; Fujimura, Naoki; Nagatomi, Satoru; Iwakoshi, Shinichi; Bolstad, Francesco; Kichikawa, Kimihiko

doi:10.1136/bmjopen-2019-031758

Cited by 12 publications

(5 citation statements)

References 28 publications

(32 reference statements)

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“…Preembolization of IMA or LAs have been performed to prevent ETII. 21,22 Li Q et al reported that pre-embolization of both IMA and LAs significantly reduced the occurrence of ETII. 22 However, not all of ETII lead to aneurysm sac enlargement, and preoperative intervention of both IMA and LAs may be excessive to prevent aneurysm sac enlargement.…”

Section: Discussionmentioning

confidence: 99%

Risk Analysis of Aneurysm Sac Enlargement Caused by Type II Endoleak after Endovascular Aortic Repair

Ide

Masada

Kuratani

et al. 2021

Annals of Vascular Surgery

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Section: Discussionmentioning

confidence: 99%

Risk Analysis of Aneurysm Sac Enlargement Caused by Type II Endoleak after Endovascular Aortic Repair

Ide

Masada

Kuratani

et al. 2021

Annals of Vascular Surgery

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“… 32 An ongoing multicenter randomized trial will try to clarify the efficacy of preoperative IMA embolization. 33 …”

Section: Discussionmentioning

confidence: 99%

Safety of preoperative branch embolization in patients undergoing evar

Suárez González,

Martínez-Luengas,

del Canto Peruyera

et al. 2024

J. vasc. bras.

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The purpose of this systematic review is to evaluate the safety of pre-endovascular abdominal aortic aneurysm repair (EVAR) embolization of aortic side branches - the inferior mesenteric artery and lumbar arteries. Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed. A search of MEDLINE and DIMENSION databases identified 9 studies published from 2011 to 2021 that satisfied the inclusion and exclusion criteria. These studies were analyzed to detect the incidence of embolization-related complications. A total of 482 patients underwent preoperative aortic side branch embolization, 30 (6.2%) of whom suffered some kind of minor complication. The only major complication observed was ischemic colitis in 4 (0.82%) patients, two (0.41%) of whom died after bowel resection surgery. Regarding these findings, aortic side branch embolization seems to be a safe procedure, with very low percentages of both minor and major complications.

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“…25,26 Further evidence from multicenter RCTs, such as the Clarify IMA trial, is awaited. 27 As for history of smoking, it significantly prohibited late complications. Since history of smoking has been validated as inhibiting type II endoleak, 21 this probably led to decrease of late complications in our study.…”

Section: Discussionmentioning

confidence: 99%

Long-term Outcomes of the Endurant and Excluder Stent Grafts for Endovascular Aneurysm Repair in a Japanese Cohort

et al. 2022

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Purpose: To compare the long-term outcomes of the most widely used third-generation stent grafts, the Endurant and Excluder stent grafts, in Japanese patients using a multicenter registry. Materials and Methods: A retrospective analysis of endovascular aneurysm repairs for abdominal aortic and iliac artery aneurysms using either the Endurant or the Excluder stent grafts from January 2012 to July 2019 at 10 Japanese hospitals was performed. Results: A total of 332 and 378 repairs using the Endurant and Excluder stent grafts, respectively, were analyzed. Although the patients’ characteristics were generally similar in the two groups, the Endurant group exhibited significantly shorter (Endurant: 31.5±18.6 mm, Excluder: 37.4±21.0 mm; p<0.001), larger (Endurant: 22.4±4.2 mm, Excluder: 21.7±3.8 mm; p=0.029), and more reversed tapered (Endurant: 12.1%, Excluder: 5.8%; p=0.003) proximal necks. The incidence of instructions for use (IFU) violations was similar between the two groups (Endurant: 59.0%, Excluder: 54.5%; p=0.223). However, the Endurant group had significantly more proximal neck-related IFU violations (54.1% and 46.3%, respectively; p=0.039), more access-related IFU violations (8.1% and 4.0%, respectively; p=0.019), and fewer bilateral hypogastric artery embolizations (5.1% and 9.3%, respectively; p=0.035) compared with the Excluder group. The incidence of intraoperative (Endurant: 3.6%, Excluder: 3.7%; p=0.950) and perioperative complications (Endurant: 3.6%, Excluder: 3.4%, p=0.899) was equivalent in the two groups. However, there was a significantly higher incidence of postoperative type II endoleaks in the Excluder group (Endurant: 28%, Excluder: 46.0%, p<0.001). Aneurysm sac regression was more frequent in the Endurant group (Endurant: 40.7%, Excluder: 31.7%, p=0.013). The Endurant group also had significantly higher rates of sac increase (Endurant: 13.0%, Excluder: 7.7%, p=0.020). Kaplan-Meier curve and log-rank analyses revealed no statistical differences in late complications (p=0.868) and overall survival (p=0.926). Conclusions: There were no statistically significant differences between the Endurant and the Excluder stent grafts in terms of intraoperative, perioperative, and late complication rates; however, the anatomical characteristics of the patients were significantly different.

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Multicentre randomised controlled trial to evaluate the efficacy of pre-emptive inferior mesenteric artery embolisation during endovascular aortic aneurysm repair on aneurysm sac change: protocol of Clarify IMA study

Cited by 12 publications

References 28 publications

Risk Analysis of Aneurysm Sac Enlargement Caused by Type II Endoleak after Endovascular Aortic Repair

Risk Analysis of Aneurysm Sac Enlargement Caused by Type II Endoleak after Endovascular Aortic Repair

Safety of preoperative branch embolization in patients undergoing evar

Long-term Outcomes of the Endurant and Excluder Stent Grafts for Endovascular Aneurysm Repair in a Japanese Cohort

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