Abdominal Aortic Aneurysm, Iliac Aneurysm, Infrarenal Abdominal Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)
Conditions
Keywords
EVAR, Fast-track Surgery, Local Anesthesia, Percutaneous Access, Cost-Benefit Analysis
Brief summary
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.
Detailed 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.
Interventions
None listed
Sponsors
University of Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Intra-operative | Technical success is defined as a single composite endpoint. A participant is considered to have achieved technical success only if all of the following criteria are met: successful deployment of the endograft with exclusion of the aneurysm, absence of type I/III endoleaks, patent access vessels, and no conversion to open surgery.. Unit of Measure: Percentage of participants |
| 30-Day Aorta-Related Mortality | 30 days | This outcome is reported as a single overall percentage. Aorta-related mortality is defined as death resulting from any of the following causes: directly attributable to the aortic pathology (e.g., rupture, progression of disease) OR complications related to the procedure/device. A participant experiencing death from any of these specific causes is counted only once towards this single aggregate percentage. Unit of Measure: Percentage of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Length of Stay (LOS) | From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days | The duration of the hospital stay, calculated from the date of admission for the procedure to the date of hospital discharge. |
| ICU Admission Rate | Time Frame: Intra-operative up to Post-Operative Day 1 | The overall rate of admission to the Intensive Care Unit (ICU). This includes both planned and unplanned admissions. It will be reported as a single overall percentage of participants who required an ICU stay. Unit of Measure: Percentage of participants |
| 30-Day Mortality and Morbidity | 30 days | This is defined as a single composite endpoint. It will be reported as the overall percentage of participants who experience at least one of the following events: all-cause mortality OR major adverse events (specifically: re-intervention, conversion to open surgery, or access site complications). A participant experiencing more than one of these events is counted only once towards this single aggregate percentage. Unit of Measure: Percentage of participants |
| Patient Turnover Rate | 1 year | Description: The percentage increase in the total annual volume of Endovascular Aneurysm Repair (EVAR) cases treated at the study site(s) during the 1-year study period, calculated relative to the baseline year of 2025. This outcome is evaluated at the institutional level and will be reported as a single overall percentage. Unit of Measure: Percentage |
Outcome results
None listed