Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast-Track EVAR Cohort | 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). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | 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 | Intra-operative |
| 30-Day Aorta-Related Mortality | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Length of Stay (LOS) | The duration of the hospital stay, calculated from the date of admission for the procedure to the date of hospital discharge. | From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days |
| ICU Admission Rate |
Not provided
Inclusion criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population consists of adult patients diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) or Penetrating Aortic Ulcer (PAU) referred to the Vascular Surgery Unit of Policlinico Sant'Orsola (a tertiary academic medical center). Participants are selected from the standard waiting list for elective repair based on anatomical suitability for a percutaneous approach (Green/Yellow patterns) and social eligibility for the fast-track early discharge protocol.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29268916 | Background | Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044. | |
| 21334928 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| D017543 | Iliac Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Time Frame: Intra-operative up to Post-Operative Day 1 |
| 30-Day Mortality and Morbidity | 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 | 30 days |
| Patient Turnover Rate | 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 | 1 year |
| Faggioli G, Scalone L, Mantovani LG, Borghetti F, Stella A; PREFER study group. Preferences of patients, their family caregivers and vascular surgeons in the choice of abdominal aortic aneurysms treatment options: the PREFER study. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):26-34. doi: 10.1016/j.ejvs.2010.12.025. Epub 2011 Feb 19. |
| 31899100 | Background | Antoniou GA, Antoniou SA, Torella F. Editor's Choice - Endovascular vs. Open Repair for Abdominal Aortic Aneurysm: Systematic Review and Meta-analysis of Updated Peri-operative and Long Term Data of Randomised Controlled Trials. Eur J Vasc Endovasc Surg. 2020 Mar;59(3):385-397. doi: 10.1016/j.ejvs.2019.11.030. Epub 2019 Dec 30. |
| 36322642 | Background | Isselbacher EM, Preventza O, Hamilton Black J 3rd, Augoustides JG, Beck AW, Bolen MA, Braverman AC, Bray BE, Brown-Zimmerman MM, Chen EP, Collins TJ, DeAnda A Jr, Fanola CL, Girardi LN, Hicks CW, Hui DS, Schuyler Jones W, Kalahasti V, Kim KM, Milewicz DM, Oderich GS, Ogbechie L, Promes SB, Gyang Ross E, Schermerhorn ML, Singleton Times S, Tseng EE, Wang GJ, Woo YJ; Peer Review Committee Members. 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Dec 13;146(24):e334-e482. doi: 10.1161/CIR.0000000000001106. Epub 2022 Nov 2. |
| 38307694 | Background | Wanhainen A, Van Herzeele I, Bastos Goncalves F, Bellmunt Montoya S, Berard X, Boyle JR, D'Oria M, Prendes CF, Karkos CD, Kazimierczak A, Koelemay MJW, Kolbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Bjorck M, Coscas R, Dias NV, Kolh P, Lepidi S, Mees BME, Resch TA, Ricco JB, Tulamo R, Twine CP; Document Reviewers; Branzan D, Cheng SWK, Dalman RL, Dick F, Golledge J, Haulon S, van Herwaarden JA, Ilic NS, Jawien A, Mastracci TM, Oderich GS, Verzini F, Yeung KK. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2024 Feb;67(2):192-331. doi: 10.1016/j.ejvs.2023.11.002. Epub 2024 Jan 23. |
| 35658387 | Background | Pratesi C, Esposito D, Apostolou D, Attisani L, Bellosta R, Benedetto F, Blangetti I, Bonardelli S, Casini A, Fargion AT, Favaretto E, Freyrie A, Frola E, Miele V, Niola R, Novali C, Panzera C, Pegorer M, Perini P, Piffaretti G, Pini R, Robaldo A, Sartori M, Stigliano A, Taurino M, Veroux P, Verzini F, Zaninelli E, Orso M; Italian Guidelines for Vascular Surgery Collaborators - AAA Group. Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE). J Cardiovasc Surg (Torino). 2022 Jun;63(3):328-352. doi: 10.23736/S0021-9509.22.12330-X. |
| D001018 |
| Aortic Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |