Urška Bregar Boltin1, Jernej Grmek2, Marko Miklič3, Nina Ostaševski Fernandez4, Matija Kozak5 One Year Patient Follow-Up Results after Endovascular Abdominal Aortic Aneurysm Repair at University Medical Centre Ljubljana ABSTRACT KEY WORDS: EVAR, endoleaks BACKGROUNDS. Endovascular abdominal aortic aneurysm repair (EVAR) is commonly used to treat abdominal aortic aneurysms (AAA). In our department, the outcomes following EVAR after 30 days, one year and later have been monitored systematically in all patients since 2023. METHODS. All the patients after EVAR, which were hospitalized at our department from January 2023 until May 2024, have been included in our analy- sis. Our aim is to follow the outcomes in patients after EVAR during hospitalization, after 30 days, one year and later. RESULTS. This analysis included 107 patients after EVAR (elective and urgent) since the first of January 2023, of these 87 were men and 20 were women (mean age 74.4 ± 5.2). The mean AAA diameter was 58 ± 7 mm. We analysed the duration of hospitalization in elective and urgent patients (5.6 ± 2.9 days and 16.2 ± 8.2 days, respectively). 50% of patients after EVAR had a haematoma on the puncture site. 69 patients already had CT angiography after EVAR by the end of April 2024; there were 23 endoleaks detected (type 2 in 21 patients, type 1 in one patient and type 3 in one patient). DISCUSSION. Since January 2023 and up until now, 107 patients have been treated with EVAR at our centre. The presence of endoleaks type 1, 2 and 3 and other complications are comparable with the data from other registries. 1 Dr. Urška Bregar Boltin, dr. med., Klinični oddelek za žilne bolezni, Univerzitetni klinični center Ljubljana, Zaloška cesta 7, 1000 Ljubljana; urska.bregar@gmail.com 2 Jernej Grmek, dr. med., Klinični oddelek za žilne bolezni, Univerzitetni klinični center Ljubljana, Zaloška cesta 7, 1000 Ljubljana 3 Marko Miklič, dr. med., Klinični oddelek za žilne bolezni, Univerzitetni klinični center Ljubljana, Zaloška cesta 7, 1000 Ljubljana 4 Nina Ostaševski Fernandez, dr. med., Klinični oddelek za žilne bolezni, Univerzitetni klinični center Ljubljana, Zaloška cesta 7, 1000 Ljubljana 5 Prof. dr. Matija Kozak, dr. med., Klinični oddelek za žilne bolezni, Univerzitetni klinični center Ljubljana, Zaloška cesta 7, 1000 Ljubljana; Katedra za inteno medicino, Medicinska fakulteta, Univerza v Ljubljani, Zaloška cesta 7, 1000 Ljubljana 5Med Razgl. 2024; 63 Suppl 2: 5–10 • doi: 10.61300/anga11 Angioloski 2024_Mr10_2.qxd 19.9.2024 8:46 Page 5 6 One Year Patient Follow-Up Results after Endovascular Abdominal Aortic Aneurysm Repair at … BACKGROUNDS Endovascular abdominal aortic aneurysm repair (EVAR) has become a key treatment option for patients with an abdominal aor- tic aneurysm (AAA) and at our centre it is offered to patients eligible for EVAR accor- ding to the guidelines of the European Society for Vascular Surgery (ESVS) (1). It is the preferred option since both short and mid-term outcomes are as good as or be- tter than open surgical repair, but mid- and long-term complications such as endoleaks, graft infection, graft migration, graft obstruction or post-EVAR rupture can lead to endovascular reintervention or conver- sion to open surgical repair (1, 2). The University Medical Centre (UMC) Ljubljana is a high-volume centre, and the majority of procedures nationwide are per- formed here. The outcomes in patients that have been treated with EVAR will be compared with data from other studies and registries, which will allow us to eva- luate the quality and possible deficiencies of this treatment at our centre. Data on early and late complications, post-operative com- puter tomography angiography (CTA) or ultrasound and follow-up after 30 days, one year and later are collected. METHODS Our data was collected on an observation- al, non-randomised, prospective »all comer« basis. All patients, who underwent EVAR and were hospitalized at our department, were included. Information on AAA dia- meter, duration of hospitalization, early complications during the procedures and during hospitalization (haematoma, other early complications), outcomes after 30 days, one year and later (endoleaks, aneurysm sac growth, infections, ruptures, other adverse events, death) were collected and analysed. Our follow-up included a CTA and a cli- nical examination after EVAR at recom- mended intervals. All patients after EVAR were included, be it elective or urgent, but there were no patients with a ruptured AAA. RESULTS From January 2023 until May 2024, a total of 107 patients underwent EVAR and were admitted before the procedure and hospi- talized at our department, of that 87 were men (82%) and 20 were women (18%). The average patient age was 74.4 ± 5.2 years. 96 operations were elective and 11 patients required urgent EVAR due to a symptomatic AAA (90% versus 10%). There were no patients with ruptured AAAs after EVAR since they were admitted to other depart- ments. The AAA diameter was 58 ± 7 mm; 56±6mm in elective patients, and 70±14mm in urgent patients. AAA diameter advanced with patient age (figure 1). The hospital- ization duration was different for elective and urgent patients; 5.6 ± 2.9 days (me- dian 4 days) for elective patients, and 16.2 ± 8.2 days (median 16 days) for urgent patients. 50% of patients had a haematoma on the puncture site, but only one patient required surgical revision of the pseudo- aneurysm. In the first 30 days after EVAR, two patients returned because of compli- cations on puncture sites – the first patient was re-admitted due to bleeding from the wound after EVAR and required addition- al procedures; the second patient needed additional procedures and antibiotic treat- ment due to an infection of the puncture site. Patients with a detected type 1 endoleak (1 patient) and type 3 endoleak (1 patient) at procedure were treated immediately during the procedures. One patient was re-admitted after one week due to a type B aortic dissection, which was managed conservatively. One patient was admitted after a couple of months due to graft aortitis and was treated with long-term antibiotics. One patient died six months after the procedure, her death was not aneurysm-related. Angioloski 2024_Mr10_2.qxd 19.9.2024 8:46 Page 6 So far, 69 patients have had the first CTA after EVAR at intervals, recommend- ed by an interventional radiologist or a spe- cialist of vascular medicine (one to six months after EVAR). A type 2 endoleak was detected in 21 patients (31%) with a stable aneurysm sac or detected aneurysm growth (three patients), one of them was already referred for the embolization of lumbal arteries, others will all be closely monitored. Two patients with a detected type 1 and type 3 endoleak on follow-up CTA had addition- al procedures. Patient characteristic, hos- pitalization duration and outcomes are presented in table 1. DISCUSSION The one-year follow-up of patients after EVAR has shown promising outcomes regarding early complications, the presence of endoleaks and aneurysm-related deaths in comparison with data from other reg- istries (2, 3). 7Med Razgl. 2024; 63 Suppl 2: There were no patients included with ruptured AAAs, 10% patients with AAA were admitted due to symptoms (stomach or back pain), which could not be attributed to other causes. The management and hos- pitalization of these patients were longer than for elective patients, as they needed more diagnostics and had to wait for the procedure in the hospital. Elective patients were admitted one day before the planned procedure. AAA diameter in urgent patients was larger compared to elective patients. In literature, there is not much data com- paring outcomes after EVAR in elective and urgent patients without a ruptured AAA. This distinction is taken in consideration mainly due to analysis purposes. The most frequent complication during hospitalization is a haematoma on the puncture site, which can be managed con- servatively in most cases. Only one patient needed a surgical revision of the pseudo- aneurysm. Two patients were re-admitted 0 10 20 30 40 40 45 50 50 55 60 60 65 70 70 75 up to 69 70 – 79 80 – 89 > 90 Average AAA diameterAge of patients N u m b e r o f p a ti e n ts D ia m e te r m m ( ) Distribution by decades Figure 1. Comparison of abdominal aortic aneurysm (AAA) diameter and patient age. Angioloski 2024_Mr10_2.qxd 19.9.2024 8:46 Page 7 in the first 30 days after EVAR due to either bleeding or wound infection (1.8%). In general, local wound complications include groin hematoma, infection, or lym- phocele, the incidence is 1 to 10%. Arterial thrombosis, dissection, or pseudoaneurysm formation can occur in up to 3% of EVAR procedures (4). Half of our patients had a haematoma on the puncture site, but we included all haematoma with a diameter of over 5 cm and which do not necessarily require further management. One patient was re-admitted after one week due to a type B aortic dissection, which 8 One Year Patient Follow-Up Results after Endovascular Abdominal Aortic Aneurysm Repair at … Table 1. Patient characteristics, duration of hospitalization and outcomes. EVAR – endovascular abdominal aortic aneurysm repair, SD – standard deviation, CTA – computer tomography angiography. Characteristic Age 74.4 ± 5.2 Sex male 87 (81%) female 20 (18%) All EVAR 107 electivež 96 (90%) urgent 11 (10%) Diameter of aneurysm 58 ± 7 mm elective 56 ± 6 mm urgent 70 ± 14 mm Duration of hospitalization mean value and SD 6.7 ± 4.2 days median 4 days min 2 days max 36 days Duration of hospitalization – elective mean value and SD 5.6 ± 2.9 days median 4 days Duration of hospitalization – urgent mean value and SD 16.2 ± 8.2 days median 16 days Presence of hematoma no hematoma 54 (50%) hematoma 53 (50%) With control CTA scan 69 no enodoleak 46 (67%) endoleak type 1 1 endoleak type 2 21 (31%) endoleak type 3 1 Angioloski 2024_Mr10_2.qxd 19.9.2024 8:46 Page 8 was a complication of EVAR – a rare but seri- ous adverse event. There have only been few reports of similar events in literature (5). Most cases of type B dissections are uncom- plicated and can be managed by medical therapy, including antihypertensive drugs, which was the case with our patient as well. One patient was admitted after a cou- ple of months due to graft aortitis, which has so far been managed conservatively with antibiotics. Due to the patient’s age and psychophysical condition, new invasive therapies or reinterventions are not re- commended. EVAR infections show high mortality rates for every kind of treatment employed, as patients unsuitable for major surgery experience the same chance of survival as patients submitted to an endo- graft explant (6). In our cohort study, endoleaks were pre- sent either at procedure or on the first fol- low-up CTA. Reinterventions were ne- cessary for type 1 and type 3 endoleaks, patients with type 2 endoleaks are currently under surveillance. Type 2 endoleaks are most common and the early incidence is usually reported to be around 25%, but most resolve spontaneously during the first six months. Up to 10% of type 2 endoleaks per- sist and they may cause aneurysm growth, in which case, treatment should be consider- ed (7). In our cohort, type 2 endoleaks are present in 31% of patients. In one patient, the embolization of lumbal arteries was already performed, other patients with a type 2 endoleak and aneurysm sac growth will be closely monitored. Limitations Registries, by nature, are observational and are not designed in the same manner as a randomized control trial would be. Maintaining adherence to follow up in patient registries is more challenging than in a trial. Data is collected in real life and although the compliance with follow up has been excellent (almost 100%) so far, we expect a drop in the following years. CONCLUSIONS The outcomes of the one-year follow-up on patients after EVAR at the UMC Ljubljana have been positive so far. There has been no rupture or aneurysm-related deaths and patients with a type 2 endoleak will be monitored further. Longer term follow up is necessary for the assessment and com- parison of the outcomes in our patients against existing data from other registries and trials. 9Med Razgl. 2024; 63 Suppl 2: Angioloski 2024_Mr10_2.qxd 19.9.2024 8:46 Page 9 REFERENCES 1. Wanhainen A, Van Herzeele I, Bastos Goncalves F, et al. 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; 67 (2): 192–331. doi: 10.1016/j.ejvs.2023.11.002 2. Teijink JAW, Power AH, Böckler D, et al. Editor’s choice – five year outcomes of the endurant stent graft for endovascular abdominal aortic aneurysm repair in the ENGAGE Registry. Eur J Vasc Endovasc Surg. 2019; 58 (2): 175–81. doi: 10.1016/j.ejvs.2019.01.008 3. Malas MB, Freischlag JA. Interpretation of the results of OVER in the context of EVAR trial, DREAM, and the EUROSTAR registry. Semin Vasc Surg. 2010; 23 (3): 165–9. doi: 10.1053/j.semvascsurg.2010.05.009 4. Maleux G, Koolen M, Heye S. Complications after endovascular aneurysm repair. Semin Intervent Radiol. 2009; 26 (1): 3–9. doi: 10.1055/s-0029-1208377 5. Khanbhai M, Ghosh J, Ashleigh R, et al. Type B aortic dissection after standard endovascular repair of abdominal aortic aneurysm. BMJ Case Rep. 2013; 2013: bcr2012007209. doi: 10.1136/bcr-2012-007209 10 One Year Patient Follow-Up Results after Endovascular Abdominal Aortic Aneurysm Repair at … Angioloski 2024_Mr10_2.qxd 19.9.2024 8:46 Page 10