Endovascular Abdominal Aneurysm Repair Research Articles

Clinical and Radiological Outcomes of Accessory Renal Artery Exclusion during Endovascular Repair of Abdominal Aortic Aneurysms.

Accessory renal arteries (ARAs) frequently coexist with abdominal aortic aneurysms (AAA) and can influence treatment. This study aimed to retrospectively analyze the ARA's exclusion effect on patients undergoing standard endovascular aneurysm repair for AAA. The study focused on medium- and long-term outcomes, including type II endoleak, aneurysmal sac changes, mortality, reoperation rates, renal function, and infarction post-operatively. 76 patients treated with EVAR for AAA were included. One hundred and two ARAs were identified: 69 originated from the neck, 30 from the sac, and 3 from the iliac arteries. The ARA treatment was embolization in 15 patients and coverage in 72. Technical success was 100%. One-month post-operative computed tomography angiography (CTA) revealed that 76 ARAs (74.51%) were excluded. Thirty-day complications included renal deterioration in 7 patients (9.21%) and a blood pressure increase in 15 (19.73%). During follow-up, 16 patients (21.05%) died, with three aneurysm-related deaths (3.94%). ARA-related type II endoleak (T2EL) was significantly associated with the ARA's origin in the aneurysmatic sac. Despite reinterventions were not significantly linked to any factor, post-operative renal infarction was correlated with an ARA diameter greater than 3 mm and ARA embolization. ARAs can influence EVAR outcomes, with anatomical and procedural factors associated with T2EL and renal infarction. Further studies are needed to optimize the management of ARAs during EVAR.

Can HALP score predict post-contrast acute kidney injury and 6-year mortality in patients undergoing endovascular abdominal aneurysm repair?

The aim of this study is to investigate the relationship between HALP score and post-contrast acute kidney injury (PC-AKI) and average 6-year mortality in patients undergoing endovascular abdominal aortic aneurysm repair (EVAR). 125 patients who underwent EVAR between January 2015 and December 2020 were included in our study. HALP score was calculated with the formula "hemoglobin × albumin × lymphocyte count/platelet count." In the first phase of the study, two groups were developed: those who developed PC-AKI and those who did not. In the second stage, statistical analysis was performed by creating two groups: average 6-year mortality and survivors group. HALP score was found to be lower in the PC-AKI group [26.12 (14-61.54) versus 40.53 (7.22-103.61); p < .001]. Low HALP score was found to be both a dependent and independent predictor of the development of PC-AKI (p = .019). HALP score was also found to be lower in the mortality group compared to the survivors [28.97 (12.6-103.61) versus 40.81 (7.22-99) p = .004]. Low HALP score was found to be only a dependent predictor of mortality. The development of PC-AKI was found to be an independent predictor of mortality (p = .042). The HALP score, which can be calculated with a simple formula, can be used to predict PC-AKI and medium-long-term mortality in EVAR patients.

Impact of iliac access in elective and non-elective endovascular repair of abdominal aortic aneurysm.

Endovascular aortic repair (EVAR) is nowadays the establishment treatment for patients with abdominal aortic aneurysm (AAA) both in elective and urgent setting. Despite the large applicability and satisfactory results, the presence of hostile iliac anatomy affects both technical and clinical success. This narrative review aimed to report the impact of iliac access and related adjunctive procedures in patients undergoing EVAR in elective and non-elective setting. Hostile iliac access can be defined in presence of narrowed, tortuous, calcified, or occluded iliac arteries. These iliac characteristics can be graded by the anatomic severity grade score to quantitatively assess anatomic complexity before undergoing treatment. Literature shows that iliac hostility has an impact on device navigability, insertion and perioperative and postoperative results. Overall, it has been correlated to higher rate of access issues, representing up to 30% of the first published EVAR experience. Recent innovations with low-profile endografts have reduced large-bore sheaths related issues. However, iliac-related complications still represent an issue, and several adjunctive endovascular and surgical strategies are nowadays available to overcome these complications during EVAR. In urgent settings iliac hostility can significantly impact on particular time sensitive procedures. Moreover, in case of severe hostility patients might be written off for EVAR repair might be inapplicable, exposing to higher mortality/morbidity risk in this urgent/emergent setting. In conclusion, an accurate anatomical evaluation of iliac arteries during preoperative planning, materials availability, and skilled preparation to face iliac-related issues are crucial to address these challenges.

Outcomes of standard EVAR for juxtarenal abdominal aortic aneurysm in patients unsuitable for fenestrated EVAR and open repair.

To evaluate the long-term outcomes of standard endovascular aneurysm repair (S-EVAR) of juxtarenal abdominal aortic aneurysms (JAAAs). Data of patients with JAAAs who were unsuitable for fenestrated endovascular aneurysm repair (F-EVAR) and open repair (OR) and underwent treatment from January 2015 to December 2021 were retrospectively reviewed. Computed tomography angiography and ultrasonography of the aorta were performed before discharge, at 6 and 12months postoperatively, and annually thereafter. The main outcome measures were mortality, type Ia endoleaks, and reintervention. A total of 62 patients (mean age, 72.1 ± 7.3years) underwent S-EVAR. The mean aneurysm length and diameter and the proximal neck length and diameter were 110.4 ± 30.9mm, 57.2 ± 15.9mm, 8.09 ± 0.97mm, and 26.05 ± 0.49mm, respectively. The mean suprarenal and infrarenal aortic angles were 162.9 ± 26° and 144.1 ± 31°, respectively. The mean follow-up duration was 40.6 ± 23.4 months and the 5-year survival rate was 62.2%. Six (9.8%) patients experienced type Ia endoleaks, of whom three underwent endovascular repair at 12, 18, and 24months, one underwent conversion to OR for AAA rupture at 7days and died, two had minor endoleaks and were kept under observation, and one declined reintervention at 36months. The 5-year freedom from reintervention rate was 84.4%. The aneurysm diameter shrank in 50 cases (81%), remained stable in 5 cases (8%), and increased in 7 cases (11.3%). A suprarenal aortic angle <114° was associated with type Ia endoleak (p = .005). In patients unsuitable for F-EVAR and OR and with a suprarenal aortic angle >114°, the use of S-EVAR for JAAAs can be considered safe and effective. In this study, early and long-term postoperative outcomes demonstrated that S-EVAR achieved satisfactory results in the prevention of aneurysm rupture and associated mortality.

Relationship Between Abdominal Aortic Aneurysm and Inflammatory Markers

Objective: In this study, we aimed to investigate the relationship between abdominal aortic aneurysm and systemic immune inflammation index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and other inflammatory markers, especially those derived from complete blood count. &#x0D; Methods: Retrospectively, 72 consecutive patients admitted to our clinic for Abdominal Endovascular Aneurysm Repair (EVAR) for abdominal aortic aneurysm (AAA) between January 2019 and January 2022 were included in the study. Routine blood samples were taken before EVAR operation. NLR, PLR, SII of the patients were calculated and, RDW, Mean Platelet Volume (MPV), C-reactive protein values and other laboratory tests were recorded. They were compared with an age-matched control group.&#x0D; Results: The age of the patients included in the study was 67.7 ± 10.6 years and the majority were male. The frequency of hypertension and coronary artery disease was also higher. In the comparison of hematologic parameters with the control group, MPV was 10.4(9.6-11.2) versus 9.5(8.6-10.1), p

Real-World Evaluation of the Off-the-Shelf Precannulated Inner-Branched Endograft for Pararenal Aortic Aneurysms.

To analyze the early performance and efficacy of the first commercially available off-the-shelf precannulated multibranched endograft in the endovascular repair of pararenal abdominal aortic aneurysms (PAAAs). The device received European marketing approval in late 2020. Between January 2021 and June 2023, a retrospective analysis of prospectively collected data from all consecutive patients with pAAAs undergoing implantation of the E-nside precannulated inner-branched endograft was conducted in 2 centers. The primary outcome measure was technical success defined as the composite endpoint of successful (1) delivery of the 24F endograft, (2) use of the precannulation tubes, and (3) implantation of the bridging stent-grafts (BSGs) to the target vessels. Main secondary endpoints were mortality, target vessel instability (TVI), absence of type I or III endoleak, reintervention, spinal cord ischemia, and supra-celiac aortic coverage. Twenty-one patients (20 men, mean age: 71 years) were included in this study with a mean follow-up of 14±7.7 months. Nine patients had a symptomatic aneurysm (43%). Technical success amounted to 95% (in one patient, an iliofemoral conduit was necessary to advance the device). One out of 112 BSGs (1%, right renal artery) occluded at 30 days, resulting in freedom from TVI and reintervention rate at 12 months of 95%. No type I or III endoleaks were identified during follow-up. One patient (5%) died at 13 months due to non-aneurysm-related death, and 1 patient (5%) developed spinal cord ischemia. No other major perioperative complications were observed. Mean supra-celiac aortic coverage reached 52±8%. Given the imperative need for an off-the-shelf endograft tailored to address PAAAs, the E-nside stent-graft demonstrated encouraging outcomes in this study. Nevertheless, it is essential to emphasize that the extent of aortic coverage mandates the production of a truncated variant. The endovascular repair of urgent pararenal aortic aneurysms remains still an unsolved problem in the endovascular era since there are no available off-the-shelf dedicated fenestrated or branched endografts. This paper confirms the safety and efficacy of the off-the-shelf precannulated inner branched endograft for this specific indication.

Side branch embolization before endovascular abdominal aortic aneurysm repair to prevent type II endoleak: A prospective multicenter study

PurposeThe purpose of the study was to evaluate the efficacy and safety of pre-emptive transcatheter arterial embolization (P-TAE) of aortic side branches to prevent type II endoleak in patients with abdominal aortic aneurysm after endovascular abdominal aneurysm repair (EVAR). Materials and methodsThis multicenter, prospective, single-arm trial enrolled 100 patients with abdominal aortic aneurysm from nine hospitals between 2018 and 2021. There were 85 men and 15 women, with a mean age of 79.6 ± 6.0 (standard deviation) years (range: 65–97 years). P-TAE was attempted for patent aortic side branches, including the inferior mesenteric artery, lumbar arteries, and other branches. The primary endpoint was late type II endoleak incidence at 6 months post-repair. Secondary endpoints included changes in aneurysmal sac diameter at 6 and 12 months, complications, re-intervention, and aneurysm-related mortality. Aneurysm sac changes at 6- and 12 months was compared between the late and no-late type II endoleak groups. ResultsCoil embolization was successful in 80.9% (321/397) of patent aortic side branches, including 86.3% of the inferior mesenteric arteries, 80.3% of lumbar arteries, and 55.6% of other branches without severe adverse events. Late type II endoleak incidence at 6 months was 8.9% (8/90) (95% confidence interval: 3.9, 16.8). Aneurysm sac shrinkage >5 mm was observed in 41.1% (37/90) and 55.3% (47/85) of the patients at 6- and 12-months post-EVAR, respectively. Patients with late type II endoleak had less aneurysm sac shrinkage than those without type II endoleak at 12 months (˗0.2 mm vs. ˗6.0 mm; P = 0.040). No patients required re-intervention for type II endoleak, and no aneurysm-related mortalities occurred. ConclusionP-TAE is safe and effective in preventing type II endoleak, leading to early sac shrinkage at 12 months following EVAR.

Locoregional Anesthesia Has Lower Risks of Cardiac Complications Than General Anesthesia After Prolonged Endovascular Repair of Abdominal Aortic Aneurysms

ObjectivesWhile general anesthesia is the primary anesthesia in endovascular aneurysm repair (EVAR), some studies suggested locoregional anesthesia could be a feasible alternative for eligible patients. However, most evidence was from retrospective studies and was subjected to an inherent selection bias that general anesthesia is often chosen for more complex and prolonged cases. To mitigate this selection bias, this study aimed to compare 30-day outcomes of prolonged non-emergent intact infrarenal EVAR in patients undergoing locoregional or general anesthesia. In addition, risk factors associated with prolonged operative time in EVAR were identified. Designretrospective large-scale national registry study. SettingAmerican College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) targeted database from 2012-2022 Participants4075 out of 16,438 (24.79%) patients had prolonged EVAR. Among patients with prolonged EVAR, 324 (7.95%) were under locoregional anesthesia. There were 3,751 (92.05%) under general anesthesia, where 955 of them were matched to the locoregional anesthesia cohort. InterventionsPatients undergoing infrarenal EVAR were included. Exclusion criteria included age<18 years, emergency cases, ruptured AAA, and acute intraoperative conversion to open. Only cases with prolonged operative times (>157 minutes) were selected. A 1:3 propensity-score matching was used to address demographics, baseline characteristics, aneurysm diameter, distant aneurysm extent, and concomitant procedures between patients under locoregional and general anesthesia. Thirty-day postoperative outcomes were assessed. Moreover, factors associated with prolonged EVAR were identified by multivariable logistic regression. Measurements and Main ResultsExcept for general anesthesia contraindications, patients undergoing locoregional or general anesthesia exhibited largely similar preoperative characteristics. After propensity-score matching, patients under locoregional and general anesthesia had a lower risk of myocardial infarction (0.93% vs 2.83%, p=0.04) but comparable 30-day mortality (3.72% vs 2.72%, p=0.35) and other complications. Specific concomitant procedures, aneurysm anatomy, and comorbidities associated with prolonged EVAR were identified. ConclusionsLocoregional anesthesia can be a safe and effective alternative to general anesthesia, particularly in EVAR cases with anticipated complexity and prolonged operative times, as it offers the potential benefit of reduced cardiac complications. Risk factors associated with prolonged EVAR can aid in preoperative risk stratification and inform the decision-making process regarding anesthesia choice.

How does totally percutaneous femoral artery access compare with surgical cut-down femoral artery access for adults undergoing elective bifurcated abdominal endovascular aneurysm repair?

How does totally percutaneous femoral artery access compare with surgical cut-down femoral artery access for adults undergoing elective bifurcated abdominal endovascular aneurysm repair?

Results of the Italian Collaborators for Evar Registry on Acute Kidney Injury After Elective Endovascular Aortic Repair of Infrarenal Abdominal Aortic Aneurysm.

To analyze the incidence and predictive factors of postoperative acute kidney injury (AKI) after elective standard endovascular aortic repair (EVAR) in a large recent, multicenter cohort. This is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study. Between January 2018 and March 2021, only patients treated with elective standard EVAR for infrarenal non-infected abdominal aortic aneurysm were analyzed. Patients already on hemodialysis (HD) were excluded. AKI was defined as an increase in serum creatinine (sCr) ≥0.3 mg/dL within 48 hours or an increase in sCr to ≥1.5 times baseline known or presumed to have occurred within 7 days, or a urine volume of <0.5 mL/kg/h for 6 hours. Primary outcomes of interest were AKI incidence at 30 days and freedom from HD at 1-year follow-up. Secondary outcomes were freedom from severe postoperative complication, and freedom from aorta-related mortality (ARM) at 1 year. The final cohort analyzed 526 (29.8%). There were 489 (93%) males and 37 (7%) females: the median age was 76 years (interquartile range [IQR], 71-81). Chronic kidney disease (CKD) was present in 86 (16.3%) patients. Early mortality was observed in 8 (1.5%) patients, none was aorta-related. Complication rate was 17.1% (n=89). AKI was observed in 17 (3.2%). Renal replacement therapy was needed in 4 (0.8%). HD was transitory in 2 cases and definitive in 1. Binary logistic regression analysis identified CKD (odds ratio [OR]: 4.68, 95% confidence interval [CI]: 2.10-10.45, p<0.001), and the presence of renal artery stenosis (OR: 3.80, 95% CI: 1.35-10.66, p=0.011) to be associated with an increased risk of postoperative AKI. Estimated freedom from ARM was 94.9% at 1 year. Estimated freedom from HD rate at 1 year was 94%: This was significantly different between patients with preoperative CKD and those who did not have preoperative CKD (log-rank, p=0.042). AKI after elective standard EVAR still occurs but with an acceptably low incidence rate. Preoperative CKD is the most important predictor for postoperative AKI, which was not associated with the need for HD at 1-year follow-up but with a higher propensity of mortality. This "real world" experience confirm that EVAR performed with standard contrats agent protocol remains safe for acute kidney injury development. Therefore, only patients presenting with preoperative borderline or ascertained chronic kidney disease will take the most advantage from the use of carbon dioxide contrast.

A hemodynamic study of blood flow models on various stent graft configurations during aorto-iliac reconstruction.

To compare the hemodynamic performance of three (Bottom Up non-ballet, Top-Down non-ballet, Top Down ballet) idealized stent graft configurations used during endovascular repair of abdominal aortic aneurysms, under the influence of various rheological models. Ten rheological models are assumed and a commercial finite volume solver is employed for the simulation of blood flow under realistic boundary conditions. An appropriate mesh convergence study is performed and five hemodynamic variables are computed: the time average wall shear stress (TAWSS), oscillatory shear index (OSI), relative residence time (RRT), endothelial cell activation potential and displacement force (DF) for all three configurations. The choice of blood flow model may affect results, but does not constitute a significant determinant on the overall performance of the assumed stent grafts. On the contrary, stent graft geometry has a major effect. Specifically, the Bottom Up non-ballet type is characterized by the least favorable performance presenting the lowest TAWSS and the highest OSI, RRT and ECAP values. On the other hand, the Top Down ballet type presents hemodynamic advantages yielding the highest TAWSS and lowest OSI, RRT and ECAP average values. Furthermore, the ballet type is characterized by the lowest DF, although differences observed are small and their clinical relevance uncertain. The effect of the assumed rheological model on the overall performance of the grafts is not significant. It is thus relatively safe to claim that it is the type of stent graft that determines its overall performance rather than the adopted blood flow model.

Hypnosis during Endovascular Abdominal Aortic Aneurysm Repair.

(1) Background: Endovascular abdominal aneurysm repair (EVAR) is associated with a reduction in early morbidity and mortality compared with open repair. Procedures performed under hypnosis might represent an alternative to further reduce the risks related to general anesthesia (GA). This study aimed to assess the feasibility and safety of hypnosis and local anesthesia during EVAR. (2) Methods: All consecutive patients who underwent EVAR or fenestrated/branched EVAR (f/bEVAR) under hypnosis and local anesthesia (n = 28) between 2017 and 2019 were retrospectively studied and matched to control patients who underwent the same interventions under GA. (3) Results: There was neither a significant difference in the length of ICU stay (p = 0.06), nor in the occurrence of endoleaks, reintervention, and 30-day mortality rate (p = 1.00, 0.73, and 0.24, respectively). The hypnosis group had lower use of norepinephrine (maximum dose 0.04 ± 0.1 vs. 1.2 ± 4.0 mg·h-1, p < 0.001), shorter procedure duration (181.2 ± 71.4 vs. 214.3 ± 79.6 h, p = 0.04), and shorter length of stay (5.4 ± 3.2 vs. 8.4 ± 5.9 days, p = 0.002). (4) Conclusions: In this pioneering study, hypnosis during EVAR appears feasible and safe. It is associated with lower intraoperative use of norepinephrine, as well as procedure duration and length of in-hospital stay.

Selective aneurysmal sac neck-targeted embolization during endovascular repair of abdominal aortic aneurysm with hostile neck anatomy.

To evaluate the efficacy and safety of selective aneurysmal sac neck-targeted embolization in endovascular aneurysm repair (EVAR) in patients with a hostile neck anatomy (HNA). Between October 2020 and June 2022, patients with an abdominal aortic aneurysm (AAA) and HNA who underwent EVAR with a low-profile stent graft and a selective aneurysmal sac neck-targeted embolization technique were analysed. An HNA was defined by the presence of any of the following parameters: infrarenal neck angulation > 60°; neck length < 15mm; conical neck; circumferential calcification ≥ 50%; or thrombus ≥ 50%. Before occluding the entire aneurysm during the procedure, a buddy wire was loaded prophylactically into the sac through the contralateral limb side. If a type Ia endoleak (ELIa) occurred and persisted despite adjunctive treatment such as balloon moulding or cuff extension, this preloaded wire could be utilized to enable a catheter to reach the space between the stent graft and sac neck to perform coil embolization. In the absence of ELIa, the wire was simply retracted. The primary outcome of this study was freedom from sac expansion and endoleak-related reintervention during the follow-up period; secondary outcomes included technical success and intraoperative and in-hospital postoperative complications. Among the 28 patients with a hostile neck morphology, 11 (39.5%) who presented with ELIa underwent intraprocedural treatment involving sac neck-targeted detachable coil embolization. Seventeen individuals (60.7%) of the total patient population did not undergo coiling. All patients in the coiling group underwent balloon moulding, and 2 patients additionally underwent cuff extension. In the noncoiling group, 14 individuals underwent balloon moulding as a treatment for ELIa, while 3 patients did not exhibit ELIa during the procedure. The coiling group showed longer operating durations (81.27 ± 11.61 vs. 70.71 ± 7.17min, P < 0.01) and greater contrast utilization than the noncoiling group (177.45 ± 52.41 vs. 108.24 ± 17.49ml, P < 0.01). In the entire cohort, the technical success rate was 100%, and there were no procedure-related complications. At a mean follow-up of 18.6 ± 5.2months (range 12-31), there were no cases of sac expansion (19 cases of sac regression, 67.86%; 9 cases of stability, 32.14%) or endoleak-related reintervention. Selective aneurysmal sac neck-targeted embolization for the treatment of ELIa in AAA patients with an HNA undergoing EVAR is safe and may prevent type Ia endoleak and related sac expansion after EVAR.

Local Anesthesia for Endovascular Repair of Abdominal Aortic Aneurysm Allows for Accurate Graft Deployment with Durable Results

ObjectiveLocal anesthesia (LA) is sparsely used in endovascular aneurysm repair (EVAR) despite short term benefit, likely secondary to concerns over patient movement preventing accurate endograft deployment. The objective of this study is to examine the association between anesthesia type and endoleak, sac regression, reintervention, and mortality. MethodsThe Vascular Quality Initiative database was queried for all EVAR cases from 2014-2022. Patients were included if they underwent percutaneous elective EVAR with anatomical criteria within instructions for use of commercially approved endografts. Multivariable logistic regression with propensity score weighting lysis was used to determine the association between anesthesia type on the risk of any endoleak noted by intra-operative completion angiogram and sac regression. Multivariable survival analysis with propensity score weighting was used to determine the association between anesthesia type and endoleak at 1 year, long-term reintervention and mortality. Results13932 EVARs met inclusion criteria: 1075 (8%) LA and 12857 (92%) general anesthesia (GA). On completion angiogram, LA was associated with fewer rates of any endoleaks overall (16% vs 24%, p<0.001). On multivariable analysis with propensity score weighting, LA was associated with similar adjusted odds of any endoleak on intra-operative completion angiogram (OR 0.56, 95%CI 0.47-0.68) as well as combined type 1a and type 1b endoleaks (OR 0.72, 05%CI 0.47-1.09). Follow-up computed tomography imaging at 1 year was available for 4892 patients, 377 (8%) LA and 4515 (92%) GA. At 1 year, LA was associated similar rate of freedom from any endoleaks compared to GA (0.66 (95%CI 0.63-0.69) vs 0.71 (95%CI 0.70-0.72), p=0.663) and increased rates of sac regression (50% vs 45% p=0.040). On multivariable analysis with propensity score weighting, LA and GA were associated with similar adjusted odds of sac regression (OR 1.22, 05%CI 0.97-1.55). LA and GA had similar rates endoleak at 1 year (HR 0.14, 95%CI 0.63-1.07), however LA was associated with decreased hazards of combined type 1a and 1b endoleaks at 1 year (HR 0.87, 95%CI 0.80-0.96). LA and GA had similar adjusted long-term reintervention rate (HR 0.77, 95%CI 0.44-1.38) and long-term mortality (HR 1.100, 95%CI 079-1.25). ConclusionLA is not associated with increased adjusted rates of any endoleak on completion angiogram or at 1-year follow-up compared to GA. LA is associated with decreased adjusted rates of yype 1a and type1b endoleak at 1 year, but similar rates of sac regression, long term reintervention and mortality. Concerns for accurate graft deployment should not preclude use of LA and LA should be increasingly considered when deciding on anesthetic type for standard elective EVAR.

Feeding Flow Velocity on Doppler Ultrasound Predicting the Outcome of Type II Endoleak following Endovascular Aneurysm Repair of Abdominal Aortic Aneurysm

Feeding Flow Velocity on Doppler Ultrasound Predicting the Outcome of Type II Endoleak following Endovascular Aneurysm Repair of Abdominal Aortic Aneurysm

Endovascular Repair of Juxtarenal and Pararenal Abdominal Aortic Aneurysms Using a Novel Low-Profile Fenestrated Custom-Made Endograft: Technical Details and Short-Term Outcomes.

The aim of this study is to share preliminary experiences and outcomes with a novel custom-made fenestrated TREO® Abdominal Stent-Graft System to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs). Juxtarenal and pararenal AAA patients treated with the custom-made fenestrated TREO® Abdominal Stent-Graft System were included from 4 high-volume European academic medical centers from June 2021 to September 2023. Technical success and 30-day/in-hospital mortality and complications were analyzed. Technical success was defined as successful endovascular implantation of the stent graft with preservation of antegrade flow to the target vessels, and absence of type 1 or 2 endoleak (EL) at the first postoperative computed tomography angiography (CTA). Forty-two consecutive patients were included. The majority of the devices were constructed with 2 (N=4; 9.5%), 3 (N=9; 21.4%), or 4 (N=27; 64%) fenestrations. In 1 case, the device was constructed with a single fenestration (2.4%) and 1 device contained 5 fenestrations (2.4%); 17% had previous AAA repair. Target vessel cannulation with placement of a bridging stent was successful in all but 1 vessel (99, 3%). One aneurysm-related death occurred in the direct postoperative period and 2 limb occlusions necessitated reintervention during admission. In the median follow-up period of 101 (2-620) days, 3 more patients died due to non-aneurysm-related causes. Technical success was achieved in 90% of the cases. Nineteen ELs were seen on the first postoperative CT scan: 1 type 1b EL (N=1; 2%), 15 type 2 ELs (N=15; 36%), and 3 type 3 ELs (N=3%). Eleven patients received more than 1 CT scan during a median follow-up of 361 days (82-620): 3 type 2 ELs resolved and 1 type 3 EL was treated in this period. In the follow-up, 1 patient had a coagulation disorder that caused occlusions of the branches. The results of the first experiences using the custom-made fenestrated TREO® Abdominal Stent-Graft System in Europe are promising. There was a low short-term mortality and morbidity rate in these patients of which 17% had previous AAA repair. Mid-term and long-term follow-up data are needed to evaluate endograft durability and performance. This study shows the first experiences and short-term results of a novel low-profile custom-made device: the custom-made fenestrated TREO® Abdominal Stent-Graft System. Showing these results and experiences can help the physicians in clinical decision-making for their patients.

In vitro study of flow characteristics in abdominal aortic aneurysm

Hemodynamic factors play a key role in the endovascular aneurysm repair of abdominal aortic aneurysm (AAA). This study conducts an in vitro experiment in which a circulating platform for the experiment and modeling of the pulsatility of blood flow in the human body is established and combined with particle image velocimetry The characteristic parameter distribution of intra-tumoral flow under nonsteady conditions is investigated. Results show that counterflow is a crucial factor affecting the distribution of characteristics of nonsteady intra-tumoral flow, and the presence of single-peak pulsatile flow with counterflow causes the effects of counterflow to emerge at the tumor inlet from the near-wall region and then erode gradually to the streamwise flow region. The maximum intra-tumoral shear stress is found to be located at the near-wall region at the tumor inlet and outlet, and the counterflow formed from the attachment of vortices at the near-wall region leads to the drastic change of the intra-tumoral flow state. The results of the present experiment are useful for quantitatively evaluating the key areas of stress distribution in AAA, providing a basis for preventing risks during the implantation of medical devices.

The Semibranch: A New Tool for Complex Aortic Pathologies.

To describe the semibranch as new tool to treat patients with thoracoabdominal, para- and juxtarenal aortic pathologies. The technique is demonstrated in 2 patients with aortic pathologies. First, a 76-year-old woman with a type Ia endoleak after endovascular repair of abdominal aneurysm (EVAR). Due to the short mainbody of the EVAR and suprarenal extension of the pathology, a 4-branched device with integrated bifurcation was chosen. To realize a branched device in small diameters of the suprarenal aorta, 2 semibranches, for the superior mesenteric artery (SMA) and the celiac trunc (CT), were planned. The second patient, a 75-year-old man, had a juxtarenal aneurysm. Due to small diameters of the aorta, semibranches for the SMA and the CT were planned. In both cases, a total transfemoral approach was used with a steerable sheath. Placement, cannulation of the semibranch, forwarding of the bridging stentgraft, and sealing was uneventful. All 4 semibranches were successful in sealing the aneurysm. The semibranch is another tool in the armamentarium of the endovascular interventionalist, which can expand the range of patients that can be treated. Especially patients with small aortic diameter or short distances between target vessels with the same offspring angle can profit from the semibranch design. The semibranch is a new tool to treat thoracoabdominal as well para- and juxtarenal aortic pathologies. Due to its reduced length, packaging density can be higher and diameter of the stentgraft can be larger. It closes the gap in pathologies where fenestration are not suitable (kinked aortas) and there is not enough space for standard inner branches (small diameters).

Estimation of the Added Cancer Risk Derived From EVAR and CTA Follow-Up.

The aim of this study was to assess the risk of radiation-induced cancer development in patients that have undergone an infrarenal EVAR, stratifying the relative contributions of the procedure and the preoperative and postoperative CTAs. The organ-specific absorbed radiation doses from CTA and the EVAR procedure were estimated from the radiation exposures of 95 and 45 male patients, respectively. Lifetime attributable risk (LAR) cancer predictions were calculated for 14 different organs. Life expectancy was assumed from a previous cohort of patients undergoing infra-renal EVAR. The calculated total excess cancer risk was 0.0046, ie, 1 out of 220 patients will develop a neoplasm after being exposed to the ionizing radiation from the preoperative CTA, the EVAR and annual CTA examinations for 15 years. The procedure and the preoperative CTA contributed with 38% of the total excess risk, while the rest was derived from the follow-up. If the entire CTA based follow-up would have been eliminated, an excess risk of 0.0018 (1/560) would remain. 1 out of 219 patients who have undergone EVAR of an infra-renal AAA have a lifetime risk of developing cancer secondary to the radiation exposures related to the procedure and the CTAs used preoperatively and during follow-up. This risk derives mostly from the yearly postoperative CTAs, underlining the potential benefits of reducing or replacing their use. A simulation-based estimation reinforced the potential deleterious effects of the radiation exposure for patients undergoing Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysms (AAA) and subsequently followed by yearly Computer Tomography Angiographies (CTAs). The risk could be as high as 1 out 219 patients developing a neoplasm after 15 years. The largest exposure derives from the follow-up CTAs and efforts to minimize their use as well as the intraoperative radiation are greatly needed. The simulation-based estimations done in this study reinforce potential deleterious effects of the radiation exposure for patients undergoing EVAR of AAA. Efforts should be done to minimize the intraoperative radiation and the number of CTAs used during follow-up.

Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.

Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111.