Outcomes of FEVAR and BEVAR to Treat Secondary Type 1 Endoleak After EVAR: A Prospective Multicentre Study

NCT04532450 | Completed

• 1 other identifier: UPaulSabatierToulouse
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ten percent of the population above 60 years develops an aortic abdominal aneurysm. In case of rupture, this pathology leads to death in more than 70% of the cases. Over the past ten years, Endovascular Aortic Aneurysm Repair (EVAR) has been the most used technique for elective treatment for abdominal aortic aneurysms (AAA) in patients with a favorable anatomy. But despite excellent postoperative results with a significant reduction of mortality , a close follow-up of these patients is mandatory to detect any potential endoleaks particularly in patients with a long-life expectancy. Failed Endovascular Infrarenal Aortic Aneurysm Repair (EVAR) with development of a proximal endoleak exposes the patient to the risk of rupture and must be treated. This type of endoleaks are often related to dilatation of the proximal neck of the AAA, and of the suprarenal aorta, making the use of any aortic fixation system, or uncovered stent ineffective. In these cases, open surgical conversion with stent graft removal is possible but at the price of a significant morbidity and mortality. The alternative is the use of a fenestrated or branched stent graft (F/BEVAR) extending the proximal sealing zone to a non-diseased aorta. The goal of this study was to evaluate the technical feasibility, early and midterm outcomes of (F/BEVAR) in patients with a proximal endoleak following a standard EVAR. The investigators performed a multicentre study between January 2010 and December 2019 in 8 French University Centres which included 85 patients with 3 years of post operative follow-up.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysm; Failed EVAR; Type 1A endoleak; Fenestrated stent graft; EVAR

Outcome Measures

Primary Outcomes (6)

• Rate of technical success

  A procedure was considered successful if the fenestrated stent graft was implanted without any Type IA or type III endoleak, and with patent target arteries on peroperative angiography and on CTA or contrast enhanced ultrasound

  Up to 7 days following the procedure

• Rate of general postoperative complications

  Any cause mortality. Acute kidney injury defined by the KDIGO criteria, myocardial infarction, postoperative respiratory complications were defined by the need for mechanical ventilation for more than 48 hours or re-intubation. paraparesis or paraplegia according to the American Spinal Injury Association score and stroke according to National Institute of Health Stroke Scale (NIHSS) .

  Up to 31 days following the procedure

• Rate of late complications

  Any complication occurring during follow-up.

  36 months after the procedure

• Change in the aortic aneurysm diameter

  Aneurysm sac diameter: any change \> 5 mm

  36 months after the procedure

• Rate of unstable branches to target artery

  Any branch to target artery-related death, rupture, occlusion or reintervention for stenosis, kink, endoleak, or disconnection.

  36 months after the procedure

• Rate of endoleak or F/B stent graft abnormality.

  Any endoleak, type IA, Type IB, Type II or any F/B stent graft abnormality

  36 months after the procedure

Interventions

Branched / fenestrated aortic stent graft DEVICE

Endovascular repair of an aortic aneurysm with a branched/fenestrated stent graft to revascularise all visceral arteries together with exclusion of the aortic aneurysm.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who developed more than 1 month after initial exclusion of an aortic abdominal aneurysm by a stent graft (EVAR) a proximal endoleak treated by a fenestrated stent graft to exclude a type 1A endoleak and to revascularise the renal arteries, the superior mesenteric artery and the celiac trunk.

You may qualify if:

• All patients who developed after primary endovascular aneurysm repair (EVAR), a secondary type IA endoleak, and received a Fenestrated stent graft as treatment
• All aetiologies leading to the development of this endoleak, any abnormality of the infra-renal stent graft, any aneurysmal evolution of the neck of the infra-renal aneurysm, and of the inter-renal or thoracoabdominal aorta.
• On-label Fenestrated gaft which were approved by the Zenith cook planning centre

You may not qualify if:

• Endovascular aortic repair\<30 days
• Patients treated in emergency for aortic rupture

Sponsors & Collaborators

• University Paul Sabatier of Toulouse: lead

Related Publications (7)

• Schermerhorn ML, Buck DB, O'Malley AJ, Curran T, McCallum JC, Darling J, Landon BE. Long-Term Outcomes of Abdominal Aortic Aneurysm in the Medicare Population. N Engl J Med. 2015 Jul 23;373(4):328-38. doi: 10.1056/NEJMoa1405778.

  PMID: 26200979 BACKGROUND

• Katsargyris A, Yazar O, Oikonomou K, Bekkema F, Tielliu I, Verhoeven EL. Fenestrated stent-grafts for salvage of prior endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):49-56. doi: 10.1016/j.ejvs.2013.03.028. Epub 2013 May 1.

  PMID: 23642523 BACKGROUND

• Schanzer A, Beck AW, Eagleton M, Farber MA, Oderich G, Schneider D, Sweet MP, Crawford A, Timaran C; U.S. Multicenter Fenestrated/Branched Aortic Research Consortium. Results of fenestrated and branched endovascular aortic aneurysm repair after failed infrarenal endovascular aortic aneurysm repair. J Vasc Surg. 2020 Sep;72(3):849-858. doi: 10.1016/j.jvs.2019.11.026. Epub 2020 Mar 3.

  PMID: 32144014 BACKGROUND

• Martin Z, Greenberg RK, Mastracci TM, Eagleton MJ, O'Callaghan A, Bena J. Late rescue of proximal endograft failure using fenestrated and branched devices. J Vasc Surg. 2014 Jun;59(6):1479-87. doi: 10.1016/j.jvs.2013.12.028. Epub 2014 Jan 29.

  PMID: 24486036 BACKGROUND

• Goudeketting SR, Fung Kon Jin PHP, Unlu C, de Vries JPM. Systematic review and meta-analysis of elective and urgent late open conversion after failed endovascular aneurysm repair. J Vasc Surg. 2019 Aug;70(2):615-628.e7. doi: 10.1016/j.jvs.2018.11.022. Epub 2019 Apr 5.

  PMID: 30956006 BACKGROUND

• Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.

  PMID: 29268916 RESULT

• Hostalrich A, Mesnard T, Soler R, Girardet P, Kaladji A, Jean Baptiste E, Malikov S, Reix T, Ricco JB, Chaufour X; Association Universitaire de Recherche en Chirurgie (AURC). Prospective Multicentre Cohort Study of Fenestrated and Branched Endografts After Failed Endovascular Infrarenal Aortic Aneurysm Repair with Type Ia Endoleak. Eur J Vasc Endovasc Surg. 2021 Oct;62(4):540-548. doi: 10.1016/j.ejvs.2021.06.019. Epub 2021 Aug 5.

  PMID: 34364770 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Aurelien Hostalrich

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: August 31, 2020
• Study Start: January 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share