Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04532450
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2020-07-09
Brief Title:
Outcomes of FEVAR and BEVAR to Treat Secondary Type 1 Endoleak After EVAR A Prospective Multicentre Study
Sponsor:
University Paul Sabatier of Toulouse
Organization:
University Paul Sabatier of Toulouse
Study Overview
Official Title:
Outcomes of Fenestrated and Branched Stent Grafts to Treat Secondary Type 1 Endoleak After Endovascular Aneurysm Repair A Prospective Multicentre Study
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 FBEVAR 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 FBEVAR 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
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 FBEVAR 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 FBEVAR 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 n85 who developed after EVAR a secondary type IA endoleak and received a FBEVAR 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 15 mm slices
All FBEVAR 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 FBEVARs which were approved by the Zenith cook planning centre
Procedures were performed under general epidural or local anaesthesia depending on the preference of the anesthesiologist surgeon or patient Procedures were performed in a conventional operating theatre or a hybrid room as described elsewhere
General postoperative complications included any cause mortality Acute kidney injury was defined following the KDIGO criteria and myocardial infarction according to the generally accepted criteria Postoperative respiratory complications were defined by the need for mechanical ventilation for more than 48 hours or re-intubation SCI was classified according to the severity of the American Spinal Injury Association score and stroke was classified according to National Institute of Health Stroke Scale NIHSS
The European Society for Vascular Surgery guidelines were used to define technical success major adverse events aneurysm sac changes endoleak and device integrity
FBEVAR procedures were analysed in an intention to treat A procedure was considered successful if the 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 performed within the first week following the procedure Target artery instability was defined as any branch-related death rupture occlusion or reintervention for stenosis kink endoleak or disconnection Monitoring during follow-up was carried out by CTA at 3 6 and 36 months thereafter Any endovascular or open revision related to the procedure was recorded during follow-up
Univariate analysis was performed using t-tests for normally distributed continuous variables and Wilcoxon rank sum test for non-normally distributed continuous variables Chi-square or Fisher tests was used when appropriate for categorical variables Time dependent outcomes including patient survival freedom from reintervention freedom from endoleak and target arteries patency were reported using Kaplan-Meier time-to-event method A p-value 05 was used to assess statistical significance All analyses were performed with SPSS V26 IBM Corp and Medcalc
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 15 mm slices
All FBEVAR 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 FBEVARs which were approved by the Zenith cook planning centre
Procedures were performed under general epidural or local anaesthesia depending on the preference of the anesthesiologist surgeon or patient Procedures were performed in a conventional operating theatre or a hybrid room as described elsewhere
General postoperative complications included any cause mortality Acute kidney injury was defined following the KDIGO criteria and myocardial infarction according to the generally accepted criteria Postoperative respiratory complications were defined by the need for mechanical ventilation for more than 48 hours or re-intubation SCI was classified according to the severity of the American Spinal Injury Association score and stroke was classified according to National Institute of Health Stroke Scale NIHSS
The European Society for Vascular Surgery guidelines were used to define technical success major adverse events aneurysm sac changes endoleak and device integrity
FBEVAR procedures were analysed in an intention to treat A procedure was considered successful if the 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 performed within the first week following the procedure Target artery instability was defined as any branch-related death rupture occlusion or reintervention for stenosis kink endoleak or disconnection Monitoring during follow-up was carried out by CTA at 3 6 and 36 months thereafter Any endovascular or open revision related to the procedure was recorded during follow-up
Univariate analysis was performed using t-tests for normally distributed continuous variables and Wilcoxon rank sum test for non-normally distributed continuous variables Chi-square or Fisher tests was used when appropriate for categorical variables Time dependent outcomes including patient survival freedom from reintervention freedom from endoleak and target arteries patency were reported using Kaplan-Meier time-to-event method A p-value 05 was used to assess statistical significance All analyses were performed with SPSS V26 IBM Corp and Medcalc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None