Feasibility and Outcomes of Endovascular Aneurysm Repairs (EVARs) Without Arterial Line Monitoring

Launched by NOVA SCOTIA HEALTH AUTHORITY · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to perform a procedure called Endovascular Aortic Aneurysm Repair (EVAR) for patients with abdominal aortic aneurysms. Traditionally, this procedure requires constant monitoring of the patient's blood pressure through an arterial line, which is a tube placed in the artery. However, our hospital has safely conducted some EVARs without this monitoring in certain patients. The trial will compare the outcomes of patients who have the procedure with and without this arterial line to see if it can be done safely without it, while also looking at how satisfied the medical staff is with this approach.

To participate in this trial, you must be an adult patient scheduled to have a minimally invasive EVAR at the Queen Elizabeth II Health Sciences Center between June 1, 2024, and May 31, 2025. However, certain patients won't be eligible, such as those needing more complex surgical methods or those with specific health conditions that increase risks. If you join the study, you'll receive the same care as usual, but researchers will gather information about your health before and after the procedure to help improve future treatments for aortic aneurysms. Your participation could contribute to safer and more effective ways to manage this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients undergoing percutaneous EVAR at the Queen Elizabeth II Health Sciences center from June 1st 2024 - May 31st 2025.
• Exclusion Criteria:
• • Patients requiring surgical femoral exposure.
• • Patients requiring fenestrated endografts: these are more complex cases, take a longer duration, usually require a general anesthetic and are at higher risk of arterial rupture, and thus cannot safely be performed without an arterial line.
• • Patients undergoing EVAR with an Endologix endograft: there is a small risk of anaphylaxis with the polymer used with the Endologix endograft, and thus the arterial line is required for beat-to-beat monitoring during graft deployment.
• • Patients with heavily calcified iliac or femoral arteries: this increases the risk of arterial rupture, and thus requires beat-to-beat arterial monitoring.
• • Absence of significant co-morbidities: no severe aortic stenosis (AS) (suspected AS and echo diagnostic criteria: max jet velocity \>4.0 m/s, mean gradient \>40 mmHg, valve area \<1 cm²); No congestive heart failure (CHF) (CHF diagnostic criteria: ejection fraction (EF) below 50% and natriuretic (NT) pro-Brain Natriuretic Peptide (BNP) levels based on the following age-adjusted cutoff limits.
• • Age \< 50 years: NT pro-BNP greater than 450 ng/L.
• • Age 50-75 years: NT pro-BNP greater than 900 ng/L.
• • Age \> 75 years: NT pro-BNP greater than 1800 ng/L.); Blood pressure below 180/120 on the morning of the operation day; Surgeon and/or anesthesiologist discretion.