Predictors of 30-day Postoperative Outcome After Elective EVAR

Predictors of 30-day Postoperative Outcome After Elective Endovascular Abdominal Aortic Aneurysm Repair

This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Other: 30-day postoperative outcome

Detailed Description

The study included 322 consecutive AAA patients treated electively with EVAR from March 2016 to February 2019 at a tertiary referral center.

Early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. Any adverse event, such as major adverse cardiovascular events (MACE), post-implantation syndrome (PIS), acute kidney injury (AKI), and deaths of any cause were recorded.

• Study Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • University Hospital of Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study included consecutive AAA patients treated electively by EVAR

Description

Inclusion Criteria:

• Only patients managed with EVAR using standard bifurcated devices in elective setting were included.

Exclusion Criteria:

• Patients treated for ruptured, symptomatic, inflammatory or infectious AAA were excluded. Furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. Additional exclusion criteria were the presence of any trauma or surgery within two months before EVAR, any autoimmune or systemic inflammatory disease and any malignancy. Of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an EVAR until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EVAR; Patients with AAA, treated electively by EVAR. The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed.	Other: 30-day postoperative outcome; The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with major adverse cardiovascular events	Number of participants with major adverse cardiovascular events	30rd day post-operatively
Number of patients with acute kidney injury	Number of participants with acute kidney injury according to the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria	30rd day post-operatively
Number of patients with post-implantation syndrome	Number of participants with post-implantation syndrome SIRS, without any apparent sign of infection	30rd day post-operatively
Deaths of any cause	Number of participants who died from any cause	30rd day post-operatively

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Study Chair: Eleni Arnaoutoglou, Professor, University of Thessaly

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): January 13, 2021

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 30-day outcome, EVAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No