Outcomes of Fenestrated and Branched Stent Grafts to Treat Secondary Type 1 Endoleak After Endovascular Aneurysm Repair : A Prospective Multicentre Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Primary Endpoint
- Rate of late complications
Study Overview
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.
Detailed Description
Between January 2010 and December 2019, all patients (n=85) who developed after EVAR, a secondary type IA endoleak, and received a F/BEVAR stent graft were entered in a prospective multicentre study bringing together 8 French university centres.
Type IA secondary endoleak was defined as an endoleak appearing during follow-up, but absent on computed tomography angiography (CTA) within 30 days of EVAR. All aetiologies leading to the development of this endoleak were recorded in the study, including any abnormality of the infra-renal stent graft, any aneurysmal evolution of the neck of the infra-renal aneurysm, and any aneurysmal evolutionof the inter-renal or thoracoabdominal aorta.
All patients gave their informed consent for the operation. Following the European regulation on data management, the database was anonymised, upon completion.
All patients had a preoperative assessment of cardiac, renal, respiratory function and underwent an ASA physical status classification. All preoperative imaging were performed on <1.5 mm slices.
All F/BEVAR were performed using a COOK Zenith stent graft (Cook Medical Inc. Bloomington, Ind). The number of fenestrations used was based on the preoperative sizing made from 3D-CTA reconstructions. The investigators only used on-label F/BEVARs which were approved by the Zenith cook planning centre.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Endovascular aortic repair<30 days
- •Patients treated in emergency for aortic rupture
Outcomes
Primary Outcomes
Rate of late complications
Time Frame: 36 months after the procedure
Any complication occurring during follow-up.
Rate of technical success
Time Frame: Up to 7 days following the procedure
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
Change in the aortic aneurysm diameter
Time Frame: 36 months after the procedure
Aneurysm sac diameter: any change \> 5 mm
Rate of general postoperative complications
Time Frame: Up to 31 days following the procedure
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) .
Rate of unstable branches to target artery
Time Frame: 36 months after the procedure
Any branch to target artery-related death, rupture, occlusion or reintervention for stenosis, kink, endoleak, or disconnection.
Rate of endoleak or F/B stent graft abnormality.
Time Frame: 36 months after the procedure
Any endoleak, type IA, Type IB, Type II or any F/B stent graft abnormality
Secondary Outcomes
No secondary outcomes reported
Investigators
Aurélien Hostalrich
Dr Aurelien Hostalrich
University Paul Sabatier of Toulouse