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

Official title

Fast-Track Protocol for Infrarenal EVAR

Overview

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.

Primary outcome measures

• Technical Success [Time frame: Intra-operative]
• 30-Day Aorta-Related Mortality [Time frame: 30 days]

Secondary outcome measures (4)

• Mean Length of Stay (LOS) [Time frame: From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days]
• ICU Admission Rate [Time frame: Time Frame: Intra-operative up to Post-Operative Day 1]
• 30-Day Mortality and Morbidity [Time frame: 30 days]
• Patient Turnover Rate [Time frame: 1 year]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 29268916
• 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. PMID 21334928
• 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. PMID 31899100
• 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. 2 PMID 36322642
• 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, PMID 38307694
• 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. Guidelin PMID 35658387

Identifiers

NCT: NCT07431047 · EVAR-FT-BO2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗