NCT07014839

Post-Implantation Syndrome and Laboratory Markers Following EVAR and TEVAR

Biomarkers Predicting Postimplantation Syndrome After Endovascular Aortic Repair (EVAR) and Thoracic Endovascular Aortic Repair (TEVAR)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this observational study is to investigate the relationship between postimplantation syndrome (PIS) and laboratory inflammatory parameters following endovascular aortic repair (EVAR/TEVAR). PIS is a systemic inflammatory response that may occur after EVAR or TEVAR and lacks a standardized clinical definition. This study seeks to determine whether specific laboratory biomarkers-particularly white blood cell count, C-reactive protein (CRP), interleukin levels, and neutrophil-to-lymphocyte ratio (NLR)-can serve as reliable indicators for the diagnosis and assessment of PIS.

Detailed description

Endovascular repair of thoracic and abdominal aortic aneurysms (EVAR/TEVAR) has become a preferred alternative to open surgical repair due to its association with reduced perioperative morbidity and mortality. However, a notable proportion of patients undergoing these procedures may develop postimplantation syndrome (PIS), a systemic inflammatory response first described in 1999. Despite its clinical relevance, PIS remains poorly defined, with varying diagnostic criteria across the literature. PIS is typically characterized by postoperative fever, fatigue, and an increase in inflammatory markers such as white blood cell (WBC) count, C-reactive protein (CRP), and interleukin-6 (IL-6). The neutrophil-to-lymphocyte ratio (NLR), a readily obtainable marker from complete blood count tests, has also gained attention as a reliable indicator of systemic inflammation. In contrast, procalcitonin levels in PIS patients often remain within normal limits, helping differentiate PIS from bacterial infections. In this prospective observational study, 200 patients undergoing elective EVAR or TEVAR procedures under general anesthesia were included. All procedures were performed via bilateral femoral artery access using open femoral incisions. Patients were followed postoperatively and assessed for the development of PIS based on clinical and laboratory parameters. Body temperature was measured at regular intervals, and inflammatory markers-including CRP, WBC count, IL-6, NLR, and procalcitonin-were recorded preoperatively and at 24, 48, and 72 hours postoperatively. PIS was defined as the presence of fever (\>38°C) in association with elevated CRP and/or leukocytosis, in the absence of any clinical or microbiological evidence of infection. Preliminary results showed that patients who developed PIS had significantly higher postoperative levels of WBC, CRP, IL-6, and NLR, while procalcitonin levels remained normal, supporting a non-infectious inflammatory etiology. Imaging and laboratory evaluations ruled out alternative sources of infection. No significant differences were observed in operative time or graft type between patients with and without PIS. All data were collected prospectively and analyzed using the SPSS statistical software. The study aims to clarify the diagnostic criteria of PIS by identifying specific laboratory biomarkers that can reliably differentiate PIS from other postoperative complications, particularly infection. Furthermore, by better understanding the inflammatory response following EVAR/TEVAR, the study may contribute to improved postoperative management strategies.

Conditions

• Postimplantation Syndrome
• Endovascular Abdominal Aortic Aneurysm Repair (EVAR)
• Thoracic Endovascular Aortic Repair

Interventions

Type	Name	Description
PROCEDURE	Endovascular Aortic Intervention	This intervention involves EVAR or TEVAR for the treatment of abdominal or thoracic aortic aneurysms, respectively. The procedures were performed using commercially available stent-grafts via a transfemoral approach under standard perioperative protocols. The study specifically focuses on the systemic inflammatory response following these interventions, with close monitoring of laboratory parameters including IL-6, neutrophil-to-lymphocyte ratio (NLR), CRP, leukocyte count, and procalcitonin during the early postoperative period. No adjunctive anti-inflammatory or immunomodulatory therapies were administered.

Timeline

• Start date: 2018-01-01
• Primary completion: 2024-12-31
• Completion: 2025-04-15
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

3 sites across 1 country: Turkey (Türkiye)