Fast-Track Protocol for Endovascular Aneurysm Repair (EVAR) of Infrarenal Abdominal Aortic Aneurysms

University of Bologna

Status: Not yet enrolling

Conditions: Penetrating Aortic Ulcers (PAUs); Iliac Aneurysm; Abdominal Aortic Aneurysm; Infrarenal Abdominal Aortic Aneurysm

Study type: Observational

Funder types: Other

Identifiers

NCT07431047

EVAR-FT-BO2026

Details and patient eligibility

About

The study aims to evaluate the clinical and economic efficacy of a "Fast-Track" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). The protocol minimizes invasiveness through the use of local/locoregional anesthesia, a total percutaneous approach, and the avoidance of routine Intensive Care Unit (ICU) admission. The primary goal is to reduce hospital Length of Stay (LOS) to <48 hours and decrease procedural costs, while maintaining safety and increasing patient turnover compared to the standard of care.

Full description

Endovascular Aneurysm Repair (EVAR) is the guideline-recommended treatment for AAA. Despite its minimally invasive nature, standard pathways often involve general anesthesia (80% of historical cases at the institution) and ICU monitoring. The Vascular Surgery Unit at Policlinico Sant'Orsola proposes a structured Fast-Track protocol involving:

1. Strict Patient Selection: Based on anatomical suitability ("Green/Yellow" criteria) and social support availability.
2. Peri-operative Management: Same-day admission, procedure performed in a Hybrid Operating Room under local/locoregional anesthesia with percutaneous access. Minimization of invasive monitoring (no central venous catheter, no urinary catheter).
3. Post-operative Care: Early mobilization, oral intake on Day 0, and planned discharge on Post-Operative Day (POD) 1 or 2.
4. Follow-up: Telemedicine assessment on POD 3, outpatient visit on POD 6, and CT Angiography at 30 days. The study compares outcomes against historical data (Year 2025) to assess reductions in ICU usage, complications, and costs.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Patient diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) indicated for elective endovascular repair.
• Patient diagnosed with Penetrating Aortic Ulcer (PAU) indicated for elective endovascular repair.
• Patient resident in the Bologna metropolitan area OR able to remain within the area for at least 7 days post-procedure.
• Patient with a cohabitant or caregiver available (cannot live alone) to ensure safety during the early post-discharge phase.
• Signed informed consent specifically for local/locoregional anesthesia, the procedure and the specific fast-track pathway.
• Common femoral arteries diameter > 7 mm
• Common femoral arteries free of severe calcification (< 50% of vessel circumference), suitable for percutaneous closure device
• Proximal aortic neck length > 15 mm
• Proximal aortic neck diameter < 30 mm
• Proximal aortic neck without severe angulation (<60°) or circumferential thrombus <50%

Exclusion Criteria:

• Patient resident outside the Bologna metropolitan area or unable to remain within the area for at least 7 days post-procedure.
• Patient without a cohabitant or caregiver available
• Common femoral arteries diameter <7 mm
• Common femoral arteries with severe calcification (> 50% of vessel circumference), unsuitable for percutaneous closure device
• Proximal aortic neck length < 15 mm
• Proximal aortic neck diameter > 30 mm
• Proximal aortic neck with severe angulation (>60°) or circumferential thrombus >50%
• General anesthesia
• Open conversion
• Medical contraindication to local/locoregional anesthesia or patient refusal/inability to cooperate during the procedure.
• Severe Chronic Kidney Disease (glomerular filtration rate > 30 ml/min) requiring exclusively CO2 angiography
• Ruptured or symptomatic aneurysms requiring emergency repair.
• Clinical condition requiring intensive invasive monitoring (e.g., CVC, urinary catheter) prior to the procedure.

Trial design

50 participants in 1 patient group

Fast-Track EVAR Cohort

Description:

Patients with infrarenal Abdominal Aortic Aneurysm (AAA) undergoing elective Endovascular Aneurysm Repair (EVAR) under local or locoregional anesthesia, managed with the multidisciplinary Fast-Track protocol (percutaneous access, early mobilization, and planned discharge within 24-48 hours).