Standard Endovascular Aortic Repair Research Articles

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.

Outcome Analysis of Speed Gate Cannulation during Standard Infrarenal Endovascular Aneurysm Repair.

Endovascular aortic repair (EVAR) is generally performed with bi/trimodular stent-grafts requiring retrograde contralateral gate cannulation (CGC). In the case of tricky CGC, an increased EVAR procedural time and radiation exposure have been reported. Herein, we compare the outcomes of conventional CGC and CGC using the speed gate cannulation (SGC) technique in standard EVAR for a propensity-matched cohort. A total of 371 patients were retrospectively analyzed. Inclusion criteria were fulfilled in 172 patients who underwent propensity score matching. Primary outcomes included operative time, CGC time, mean contrast medium, fluoroscopy time, and CGC fluoroscopy time. After matching, 78 patients were included in each group (SGC vs. standard). Primary outcomes registered a significant reduction in CGC time (4 [1-6] vs. 8 [6-14] min; p = 0.001) and fluoroscopy time (12 [9-16] vs. 17 [12-25] min). In this preliminary experiment, the use of SGC was feasible with no significant registered postoperative complications. A significant reduction in contrast medium usage, radiation exposure, and CGC time was observed with the use of SGC. SGC is a simple adjunctive technique, and its use should be considered in standard EVAR, especially in emergency scenarios, where time is of the essence.

Influence of Patient Anatomy on Intraoperative Radiation Exposure and Operation Time during Standard EVAR.

Endovascular aortic repair (EVAR) is the primary treatment for abdominal aortic aneurysms (AAAs). To optimise patient safety during the standard EVAR procedure, we aimed to investigate the influence of patient anatomy on intraoperative radiation exposure and surgical time. This retrospective study comprised 90 patients (mean age 73.4 ± 8.2 years; 92.2% male) with an infrarenal aortic aneurysm who underwent a standard EVAR procedure. The relationships between dose area product, operating time, and anatomical conditions were investigated in preoperative computed tomography angiography using open-source software. Logistic regression analysis indicated that only body mass index (BMI) had predictive value for radiation exposure. The accuracy of the model was 98.67%, with an area under the curve of 0.72. The duration of surgery was significantly correlated with an increased BMI (odds ratio (OR) = 1.183; p < 0.05), the tortuosity of AAAs (OR = 1.124; p < 0.05), and the left common iliac artery (OR = 1.028; p < 0.05). Thus, BMI impacts the prediction of intraoperative radiation exposure more significantly than the anatomical characteristics of the infrarenal aorta and iliac arteries, and the duration of surgery significantly correlates with both BMI and the tortuosity of the infrarenal aorta and iliac arteries.

Early experience with bridging stent graft deployment without sheath support in branched and fenestrated endovascular aortic repair

ObjectiveTo assess the early experience with modified version of simplified bare-wire target vessel (SMART) technique, implying delivery of bridging stent grafts without historically established sheath support, and to compare its outcome to standard endovascular aortic repair procedures with fenestrated/branched devices. MethodsA retrospective analysis of 102 consecutive patients treated with fenestrated/branched devices from January 2020 to December 2022 was undertaken. The study population was divided into three groups—a sheath group (SG), SMART group, and nonsheath group (NSG). Primary end points were radiation exposure (dose-area product), fluoroscopy time, dose of contrast agent, operation time, and incidence of intraoperative target vessel (TV) complications and additional procedures. Freedom from secondary TV related reinterventions at the three follow-up phases were defined as secondary end points. ResultsA total of 183 TVs (38.8% visceral arteries [VA]; 56.3% renal arteries [RA]) in the SG, 36 TVs (44.4% VA, 55.6% RA) in the SMART group, and 168 TVs (47.6% VA; 50% RA) in the NSG were accessed. The mean number of fenestrations and bridging stent grafts was equally distributed in all three groups. The SMART group only included cases treated with fenestrated devices. The dose-area product was significantly lower in the SMART (median, 203 Gy × cm2; interquartile range [IQR], 179-365 Gy × cm2) and NSG (median, 340 Gy × cm2; IQR, 220-651 Gy × cm2) groups vs the SG (median, 464 Gy × cm2; IQR, 267-871 Gy × cm2; P = .007). Operation time was also significantly lower in the NSG (median, 265 minutes; IQR, 221-337 minutes) and SMART (median, 292 minutes; IQR, 234-351 minutes) groups vs the SG (median, 326 minutes; IQR, 277-375 minutes; P = .004), respectively. Intraoperative TV-related complications were most frequently observed in the SG (9/183 TVs; P = .008). ConclusionsThis study reports the outcomes of three currently available TV stenting approaches. Previously reported SMART technique, and its modified version (NSG) proved to be a safe alternative to historically established TV stenting technique with sheath support (SG).

Access-related Outcomes After Infrarenal Endovascular Aortic Aneurysms Repair: A Multicenter Retrospective Cohort Study

Endovascular aortic repair (EVAR) is the first-line treatment for abdominal aortic aneurysms (AAAs) in fit patients. Percutaneous vascular access (pEVAR) allows to ulteriorly decrease the invasivity of EVAR procedures in comparison to femoral cutdown (sEVAR); however, controversies remain regarding postoperative complications and mortality. The aim of this study is to compare the outcomes of these techniques and their impact on operative time, hospitalization, short-term complications, and mortality. This is a retrospective, observational cohort study from four tertiary referral university hospitals. Baseline and peripoperative data of all patients undergoing EVAR procedures were collected in a prospectively managed dataset at each institution and merged in the Italian Collaborators for EVAR (ICE) registry. Study cohort included standard EVAR interventions between January 2018 and February 2021. Mortality and complication risks have been calculated with dedicated scores (Society for Vascular Surgery/American Association for Vascular Surgery score system, American College of Surgeons [ACS] risk calculator). Primary outcomes were pEVAR technical success (absence of surgical conversion), 30-day mortality, and access-related complications. Operative time, length of hospital stay (LOS), 90-day readmission rate, and type of anesthesia were considered secondary outcomes. During the study time, 608 consecutive patients underwent standard EVAR procedures: 373 (61.3%) pEVAR and 202 (33.2%) sEVAR; 33 (5.4%) patients with one surgical and one percutaneous access were excluded from the final analysis. A higher estimated ACS risk for surgical site infection (0.80% ± 0.65% vs 0.65% ± 0.53%; P = .008) and death (1.66% ± 3.55% vs 0.76% ± 1.60%; P = .001) was found in the pEVAR group. Operative time (median, 80.00 minutes [interquartile range (IQR), 60.00-110.00 minutes] vs 112.50 minutes [IQR, 90.00-144.00 minutes]; P < .001), 90-day readmission rate (1.4% vs 6.9%; P = .001), and LOS (4.00 days [IQR, 3.00-7.00 days] in pEVAR vs 5.00 days [IQR, 3.25-8.00 days] in sEVAR; P = .012) were lower among pEVAR group. Higher rates of local anesthesia were observed in the percutaneous group (71.7% vs 22.8%; P < .001). Technical success rate of pEVAR was 97.3% with lower rates of 30-day mortality (1.4% pEVAR vs 6% sEVAR; P = .004). Early access-related complications showed a higher rate in sEVAR group (5.4% in sEVAR vs 1.6% in pEVAR; P = .02). Percutaneous access for EVAR is safe and feasible when compared with surgical access with a high technical success rate and low complication rate. The results of our analysis demonstrate that percutaneous access was associated with decreasing operative time, length of hospital stay, the use of general anesthesia, and readmission rate. The lower mortality rate, despite a higher estimate, is certainly a promising factor; however, further studies are needed to assess the significance of this results.

Results of the Italian Collaborators for EVAR (ICE) Registry on Acute Kidney Injury After Elective Endovascular Aortic Repair of Infrarenal Abdominal Aortic Aneurysm

The aim of this study was 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 noninfected 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. AKI severity stage was classified according to the Acute Kidney Injury Network (AKIN) criteria. Primary outcomes were AKI incidence at 30 days and freedom from HD at 1 year of follow-up. Secondary outcomes were freedom from severe postoperative complication, and freedom from aorta-related mortality (ARM) at 1 year. We analyzed 526 patients (86.5%). There were 489 males (93%) and 37 females (7%): the median age was 76 years (interquartile range, 3-8 years). AKI was observed in 17 patients (3.2%): it was classified as AKIN stage 1 in 12 (2.3%), AKIN stage 2 in three (0.6%), and AKIN stage 3 in two (0.2%). Renal replacement therapy was needed in four (0.8%): HD in three (0.6%, transitory in 2), and continuous veno-venous hemofiltration in one (0.2%). Binary logistic regression analysis identified chronic kidney disease (odds ratio [OR] 4.68; 95% confidence interval [CI], 2.10-10.45; P < .001), and the presence of renal artery stenosis (OR, 3.80; 95% CI, 1.35-10.66; P = .011) to be associated with an increased risk of postoperative AKI. Freedom from ARM was 99.2% at 1 year. Both serum creatinine and estimated glomular filtration rate were significantly different in comparison with preoperative and postoperative level. Of the patients who developed AKI postoperatively, 15 (88.2%) did not require further renal replacement therapy at 1 year; only two patients (0.4%), who already required HD postoperatively, remained on renal replacement therapy by HD at 1 year. Mortality at 1 year was higher in patients who developed postoperative AKI (18.7% vs. 5%; OR, 5.63; P = .051). AKI after elective standard EVAR still occurs but with an acceptably low incidence rate. Preoperative chronic kidney disease is the most important predictor for postoperative AKI, which was not associated with the need of HD at 1-year follow-up but with a higher propensity of mortality.

Outcomes of endovascular repair of infrarenal penetrating aortic ulcers.

Background: To report technical success as well as perioperative outcomes of patients who underwent endovascular aortic repair (EVAR) of penetrating abdominal aortic ulcers≤35mm in diameter (PAU). Patients and methods: The abdominal aortic aneurysm (AAA) quality registry of the German institute for vascular research (DIGG) was used to identify patients with standard EVAR for infrarenal PAU≤35mm between 1/1/2019 and 12/31/2021. Infectious, traumatic, inflammatory PAUs, PAUs associated with connective tissue disease, PAUs following aortic dissection as well as true aneurysms were excluded. Demographics, cardiovascular comorbidity, technical success as well as perioperative morbidity and mortality were determined. Results: Amongst 11 537 patients who underwent EVAR during the study period, 405 with PAU≤35mm were eligible from 95 participating hospitals across Germany (22% women, 20.5% octogenarians). The median aortic diameter was 30mm (Interquartile range 27-33). Cardiovascular comorbidities were frequent with coronary artery disease (34.8%), chronic heart failure (30.9%), history of myocardial infarction (19.8%), hypertension (76.8%), diabetes (21.7%), smoking (20.8%), history of stroke (9.4%), symptomatic lower extremity peripheral arterial disease (20%), chronic kidney disease (10.4%) and chronic obstructive pulmonary disease (9.6%). Most patients were asymptomatic (89.9%). Among the symptomatic patients, 13 presented with distal embolization (3.2%) and 3 with contained ruptures (0.7%). Technical success of endovascular repair was 98.3%. Both, percutaneous (37.1%) or femoral cut-down access approaches (58.5%) were registered. Endoleaks of any type were present with type 1 (0.5%), type 2 (6.4%) and type 3 (0.3%) endoleaks. Overall mortality was 0.5%. Perioperative complications occurred in 12 patients (3.0%). Conclusions: According to this registry data, endovascular repair of PAU is technically feasible with acceptable perioperative outcomes, but further studies investigating mid- and long-term data are needed before invasive treatment of PAU disease in an elderly and comorbid patient population should be recommended.

Predictive Value of Laboratory Indicators for Endoleak During Short-Term Follow-Up After EVAR

The aim of this study was to explore the predictive value of endoleak in short-term follow-up after endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) via perioperative laboratory indicators. A retrospective study included 200 consecutive patients who received standard EVAR treatment for AAA and were followed-up for 1year. Binary logistic regression analysis was used to evaluate the correlation of the level and changes of perioperative laboratory indicators with the endoleak events during the follow-up. The receiver operating characteristic (ROC) curve was used to assess the predictive value of laboratory indicators for endoleak. A total of 45 cases of endoleak events occurred during follow-up. Binary logistic regression analysis showed that postoperative fibrinogen decrease, perioperative lymphocyte difference and lymphocyte monocyte ratio (LMR) difference were independent risk factors for short term endoleak. The area under the ROC curve (AUC) of postoperative fibrinogen was 0.596, the cut-off value was 284mg/dl, and the corresponding specificity and sensitivity were 0.644 and 0.568. The AUC of the lymphocyte difference was 0.622, the cut-off value was -0.45×109/L, and the corresponding specificity and sensitivity were 0.651 and 0.568. The AUC of the LMR difference was 0.597, the cut-off value was -1.719, and the corresponding specificity and sensitivity were 0.631 and 0.614. Decrease of postoperative fibrinogen, increase of lymphocyte difference and LMR difference were independent predictive factors for endoleak in short-term follow-up after EVAR for AAA.

Infrarenal Remains Infrarenal-EVAR Suitability of Small AAA Is Rarely Compromised despite Morphological Changes during Surveillance.

The aim was to analyze small abdominal aortic aneurysm (AAA) morphology during surveillance with regard to standard endovascular aortic repair (EVAR) suitability. This retrospective single-center study included all patients (n = 52, 48 male, 70 ± 8 years) with asymptomatic AAA ≤ 5.4 cm undergoing ≥2 computed tomography angiography(CTA)/magnetic resonance imaging (MRI) studies (interval: ≥6 months) between 2010 and 2018. Aneurysm diameter, neck quality (shape, length, angulation, thrombus/calcification), aneurysm thrombus, and distal landing zone diameters were compared between first and last CTA/MRI. Resulting treatment plan changes were determined. Neck shortening occurred in 25 AAA (mean rate: 2.0 ± 4.2 mm/year). Neck thrombus, present in 31 patients initially, increased in 16. Average AAA diameters were 47.7 ± 9.3 mm and 56.3 ± 11.6 mm on first and last CTA/MRI, mean aneurysm growth rate was 4.2 mm/year. Aneurysm thrombus was present in 46 patients primarily, increasing in 32. Neck thrombus growth and neck length change, aneurysm thrombus amount and aneurysm growth and aneurysm growth and neck angulation were significantly correlated. A total of 46 (88%) patients underwent open (12/46) or endovascular (34/46) surgery. The planned procedure changed from EVAR to fenestrated EVAR in two patients and from double to triple fenestrated EVAR in one. Thus, standard EVAR suitability was predominantly maintained as the threshold diameter for surgery was reached despite morphological changes. Consecutively, a possibly different pathogenesis of infra- versus suprarenal AAA merits further investigation.

The influence of narrow aortic bifurcation on limb graft patency: a two-center retrospective study.

Narrow aortic bifurcation (NAB) has been considered as a potential risk factor for graft limb thrombosis after endovascular aortic repair (EVAR). The aim of this study was to compare mid- and long-term outcome of EVAR in patients with NAB and standard aortic bifurcation (SAB). Data from patients receiving EVAR were prospectively collected and retrospectively analyzed. In case of angiographic limb stenosis (>50%), additional stenting was performed. Patients with a NAB (≤20mm) were included in the NAB group, the remaining patients in the SAB group. Primary endpoints were limb thrombosis rate and technical success. A total of 902 patients were included; 18.3% (N.=165/902) in the NAB and 81.7% (N.=737/902) in the SAB group. Mean follow-up time was 43 months (range 0-198 months). Bilateral stenting of the aortic bifurcation was performed in 2.7% (N.=27/902), 8.5% (N.=14/165) in the NAB and 1.4% (N.=10/737) in the SAB group (P=0.001). Limb thrombosis was found in 2.8% (N.=25/902), 3.6% (N.=6/165) in the NAB and 2.6% (N.=19/737) in the SAB group (P=0.55). Technical success was 97.8%, 98.8% in the NAB and 97.6% in the SAB group (P=0.33). Device related reintervention rate was 16% (N.=144/902), 15.2% in the NAB and 16.1% in the SAB group (P=0.75). Standard EVAR could safely be performed in patients with NAB (≤20mm) when a low threshold for additional stenting was applied. This resulted in no significant higher incidence of limb thrombosis. Additional stent deployment did not increase the complication rate.

Infrarenal EVAR for Penetrating Aortic Ulcer: A Comparative Study with Abdominal Aortic Aneurysm

Endovascular aortic repair (EVAR), currently the preferred treatment for abdominal aortic aneurysm (AAA), has been described also for penetrating aortic ulcers (PAU) of the infrarenal aorta. However, data on its performance in this particular setting are still sparse in the literature. Aim of this study is to compare patient clinical characteristics, aorto-iliac features, and post-operative outcomes between infrarenal PAU and AAA treated by standard EVAR. In this retrospective observational case-control multicenter study, the patients treated for infrarenal PAU (G1) with EVAR in 2 high-volume European centers from January 2014 to December 2019 were prospectively entered into a dedicated database and retrospectively analyzed. A 4-fold control group (G2) of infrarenal AAA patients, homogeneous for age and gender, was also considered. Preoperative clinical characteristics, aorto-iliac features (rupture, aortic maximum diameter, proximal neck diameter and length, aortic bifurcation diameter, distance between the lowest renal artery and the aortic bifurcation [RA-AoBi], severe aortic calcification), technical success, 30-day (morbidity, reintervention, complications, mortality) and follow-up outcomes (freedom from reintervention [FFR] and survival) were compared in the 2 groups (chi square/Fisher exact test, t-student test, Mann-Whitney test, logistic regression and Kaplan-Meier analysis). Seventy-three patients (age 78±7years; male 84.9%) were included in G1 and 299 (age 78.4±6.6years; male 89.3%) in G2. At the time of diagnosis, G1 patients were more often symptomatic compared with G2 (odds ratio OR 10.21, 95% confidence interval CI 4.17-24.99, P<0.001). At preoperative computed tomography angiography, G1 patients had more ruptures (OR 8.11, 95% CI 3.50-18.78, P<0.001), smaller maximum diameter (OR 1.05, 95% CI 1.03-1.08, P<0.001), longer and narrower proximal neck (OR 0.97, 95% CI 0.95-0.99, P=0.020 and OR 1.47, 95% CI 1.32-1.64, P<0.001, respectively) narrower aortic bifurcation (OR 1.34, 95% CI 1.24-1.45, P<0.001), lower RA-AoBi (OR 1.09, 95% CI 1.07-1.12, P<0.001), and more severe aortic calcification (OR 57, 95% CI 16-198, P=0.001). Technical success (G1 98.6% vs G2 95.7% P=0.320), 30-day morbidity (G1 2.7% vs G2 8.7% P=0.133), reintervention (G1 2.7% vs G2 2.3% P=0.691), complications (G1 6.8% vs G2 8% P=0.737) and mortality (G1 1.4% vs 2% P=0.720) were comparable in the 2 groups. The mean follow-up was 17.7±16.4months in G1 and 18.8±15.1 in G2 (P=0.576). Late FFR and survival were comparable in the 2 groups (1-year FFR: G1 94.8% vs G2 97.5%, P=0.995; 1-year survival: G1 91.7% vs G2 92.3%, P=0.960). Infrarenal PAU are more often symptomatic with a higher rupture rate compared to infrarenal AAA. Despite some negative anatomical characteristics (narrower aortic bifurcation, lower RA-AoBi, extensive calcification), the results of EVAR are extremely satisfactory in this setting, suggesting that endovascular exclusion could be considered a valid treatment for infrarenal PAU.

Radiographically quantified sarcopenia and traditional cardiovascular risk assessment in predicting long-term mortality after endovascular aortic repair

ObjectiveThis study evaluated radiographically quantified sarcopenia and the patient's comorbidity burden based on traditional cardiovascular risk assessment as potential predictors of long-term mortality after endovascular aortic repair (EVAR). MethodsThe study included 480 patients treated with standard EVAR for intact infrarenal abdominal aortic aneurysms. Patient characteristics, comorbidities, aneurysm dimensions, and other preoperative risk factors were collected retrospectively. Preoperative computed tomography was used to measure psoas muscle area (PMA) at the L3 level. Patients were divided into three groups based on American Society of Anesthesiologists (ASA) score and PMA. In the high-risk group, patients had sarcopenia (PMA <8.0 cm2 for males and <5.5 cm2 for females) and an ASA score of 4. In the medium-risk group, patients had either sarcopenia or an ASA score of 4. Patients in the low-risk group had no sarcopenia and the ASA score was less than 4. Risk factors for long-term mortality were determined using multivariable analysis. Kaplan-Meier survival estimates were calculated for all-cause mortality. ResultsPatients in the high- and medium-risk groups were older than those in the low-risk group (77 ± 7, 76 ± 6, and 74 ± 8 years, respectively, P < .01). Patients in the high-risk group had higher prevalence of coronary artery disease, pulmonary disease, and chronic kidney disease. There were no differences in 30-day or 90-day mortality between the groups. The independent predictors of long-term mortality were age, ASA score, PMA, chronic kidney disease, and maximum aneurysm sac diameter. The estimated 1-year mortality rates were 5% ± 2% for the low-risk, 5% ± 2% for the medium-risk, and 18% ± 5% for the high-risk group (P < .01). Five-year mortality estimates were 23% ± 4%, 36% ± 3%, and 60% ± 6%, respectively (P < .01). The mean follow-up time was 5.0 ± 2.8 years. ConclusionsBoth ASA and PMA were strong predictors of increased mortality after elective EVAR. The combination of these two can be used as a simple risk stratification tool to identify patients in whom aneurysm repair or the intensive long-term surveillance after EVAR may be unwarranted.

Five-year outcomes of the Bi- versus Trimodular EndurantTM stent-graft in 100 patients with infrarenal abdominal aortic repair

Recent studies on the Endurant™ endografts mainly compared outcomes of the bimodular stent-graft to other manufacturer's endografts or reported results for cases outside manufacturer's instructions for use (IFU), while data on the experience of standard endovascular aortic repair (EVAR) of infrarenal abdominal aortic aneurysms (AAA) inside manufacturer's IFU comparing the bi- with the trimodular device is limited. Inclusion criteria were: 1) infrarenal aneurysms (>50 mm diameter) treated by EndurantTM II (END II) or EndurantTM IIs (END IIs) stent-graft inside manufacturer's IFU; 2) available CTA with 1 mm reconstruction of the entire aorta prior to intervention. Endpoints comparing the devices included technical success, 30-day mortality, rate of complications (bleeding with conversion to open repair, stent-graft stenosis/occlusion, acute distal embolism, infection or postprocedural necessity of dialysis), endoleaks and reinterventions (5-year follow-up). Aneurysm sac diameters were compared between baseline preinterventional CTA and last post-interventional CTA. One hundred patients (90% male, mean age 74 years) treated with END II (N.=66) or END IIs (N.=34) were included. Technical success was 99%. One procedure-related active bleeding occurred ending up in surgical conversion (END II N.=1). 30d mortality was 0%. No initial type I/III endoleaks were present. Re-interventions were required in 19/100 (19%) of patients (END II N.=10; END IIs N.=9, P=0.17). The outcome of EVAR including technical success, 30d mortality, rate of complications, endoleaks and re-interventions showed no significant differences comparing END II/IIs. Five-year outcomes of EVAR show consistently safe and effective results for either END II or IIs device.

Predictors of sac regression after fenestrated endovascular aneurysm repair

Objective: Aneurysm sac regression after standard endovascular aortic repair is associated with improved outcomes, but similar data are limited after fenestrated endovascular aortic repair (FEVAR). We sought to evaluate sac regression after FEVAR, and identify any predictors of this favorable outcome.

Abdominal aortic aneurysm neck dilatation and sac remodeling in fenestrated compared to standard endovascular aortic repair.

Contemporary commercially available endovascular devices for the treatment of abdominal aortic aneurysm (AAA) include standard endovascular aortic repair (sEVAR) or fenestrated EVAR (fEVAR) endografts. However, aortic neck dilatation (AND) can occur in nearly 25% of patients following EVAR, resulting in loss of proximal seal with risk of aortic rupture. AND has not been well characterized in fEVAR, and direct comparisons studying AND between fEVAR and sEVAR have not been performed. This study aims to analyze AND in the infrarenal and suprarenal aortic segments, including seal zone, and quantify sac regression following fEVAR implantation compared to sEVAR. A retrospective review of prospectively collected data on 20 consecutive fEVAR patients (Cook Zenith® Fenestrated) and 20 sEVAR (Cook Zenith®) patients was performed. Demographic data, anatomic characteristics, procedural details, and clinical outcome were analyzed. Pre-operative, post-operative (1month), and longest follow-up CT scan at an average of 29.3months for fEVAR and 29.8months for sEVAR were analyzed using a dedicated 3D workstation (iNtuition, TeraRecon Inc, Foster City, California). Abdominal aortic aneurysm neck diameter was measured in 5mm increments, ranging from 20mm above to 20mm below the lowest renal artery. Sub-analysis comparing the fEVAR to the sEVAR group at 12months and at greater than 30months was performed. Standard statistical analysis was done. Demographic characteristics did not differ significantly between the two cohorts. The fEVAR group had a larger mean aortic diameter at the lowest renal artery, shorter infrarenal aortic neck length, increased prevalence of nonparallel neck shape, and longer AAA length. On follow-up imaging, the suprarenal aortic segment dilated significantly more at all locations in the fEVAR cohort, whereas the infrarenal aortic neck segment dilated significantly less compared to the sEVAR group. Compared to the sEVAR cohort, the fEVAR patients demonstrated significantly greater positive sac remodeling as evident by more sac diameter regression, and elongation of distance measured from the celiac axis to the most cephalad margin of the sac. Device migration, endoleak occurrence, re-intervention rate, and mortalities were similar in both groups. Compared to sEVAR, patients undergoing fEVAR had greater extent of suprarenal AND, consistent with a more diseased native proximal aorta. However, the infrarenal neck, which is shorter and also more diseased in fEVAR patients, appears more stable in the post-operative period as compared to sEVAR. Moreover, the fEVAR cohort had significantly greater sac shrinkage and improved aortic remodeling. The suprarenal seal zone in fEVAR may result in a previously undescribed increased level of protection against infrarenal neck dilatation. We hypothesize that the resultant decreased endotension conferred by better seal zone may be responsible for a more dramatic sac shrinkage in fEVAR.

Changes in Anesthesia Can Reduce Periprocedural Urinary Retention After EVAR

Enhanced recovery after surgery (ERAS) programs provide a streamlined approach for expedient postoperative care of high-volume procedures. Endovascular aortic repair (EVAR) has become standard treatment for abdominal aortic aneurysms and implementation of an early recovery program is warranted. Postoperative urinary retention (POUR) remains a problem lending to longer hospital stays and patient discomfort. We aim to demonstrate the utility of monitored anesthetic care (MAC) plus local anesthesia as a modality to minimize urinary retention following EVAR. Single-center retrospective review from January 2017 to March 2020 of all patients undergoing standard elective EVAR under general anesthesia or MAC anesthesia. Local anesthetic at vessel access sites was used in all patients under MAC. Ruptured pathology and female sex were excluded from analysis. Patient characteristics, operative details, prostate measurements, and outcomes were abstracted from the electronic medical record. Urinary retention was defined as any requirement of straight catheterization, urinary catheter replacement, or discharge with urinary catheter. Chi square tests and logistic regression were used to determine predictors associated with POUR and increased hospital length of stay. Among 138 patients who underwent EVAR, eight (5.8%) were excluded due to ruptured pathology. Of the cohort, 113 (86.9%) were male with mean age of 73 years. Excluding female patients, 63 (55.8%) male patients underwent general anesthesia and 50 (44.3%) underwent MAC. Male patients under general anesthesia were more likely to have intra-operative urinary catheter placement when compared to MAC (82.5% vs. 36%, respectively; P < 0.001). POUR was identified in 17 patients (13.1%) of the entire study population with 15 events (88.2%) occurring in males. Excluding patients who were admitted to the ICU, twenty-two (19.5%) male patients stayed past postoperative day (POD) one, of which those who developed POUR were more likely to experience compared to those without POUR (45.6% vs. 9.7%, respectively; P=0.001). On multivariable analysis, male patients who received MAC had a lower risk of developing POUR (OR 0.09, 95% CI 0.02-0.50). POUR was not associated with elective urinary catheter placement nor with pre-existing conditions such as diabetes, urinary retention, benign prostatic hypertrophy (BPH), or use of BPH medications. Additionally, neither prostate size nor volume was associated with developing POUR among male patients. MAC plus local anesthesia is associated with decreased rates of POUR after elective EVAR in male patients. ERAS pathways during elective EVAR interventions should implement MAC plus local anesthesia as an acceptable anesthetic option, where appropriate, in order to reduce urinary retention rates and subsequently decrease hospital length of stay in this patient cohort.

Predictors of sac regression after fenestrated endovascular aneurysm repair

ObjectiveAneurysm sac regression after standard endovascular aortic repair is associated with improved outcomes, but similar data are limited after fenestrated endovascular aortic repair (FEVAR). We sought to evaluate sac regression after FEVAR, and identify any predictors of this favorable outcome. MethodsPatients undergoing elective FEVAR using the commercially available Zenith Fenestrated device (ZFEN; Cook Medical, Bloomington, IN) from 2012 to 2018 at a single institution were reviewed retrospectively. The maximal aortic diameter was compared between the preoperative scan and those obtained in follow-up. Patients with of 5 mm or more sac regression were included in the regression (REG) group, with all others in the nonregression (NONREG) group. Outcomes were compared between groups using univariate analysis, and logistic regression analysis was performed to identify any predictive factors for sac regression. ResultsWe included 132 patients undergoing FEVAR in the analysis. At a mean follow-up of 33.1 months, 65 patients (49.2%) had sac regression of 5 mm or more and comprised the REG group (n = 65 [49.2%]). The REG group had smaller diameter devices, and were less likely to have had concomitant chimney grafts placed (P < .05). The NONREG group had a higher incidence of type II endoleak (35.8% vs 12.3%; P = .002). Sac regression was associated with a significant mortality benefit on Kaplan-Meier analysis (log rank P = .02). Multivariate analysis identified adjunctive parallel grafting (odds ratio [OR], 0.01; 95% confidence interval [CI], 0.03-0.36; P < .01), persistent type II endoleak (OR, 0.13; 95% CI, 0.02-0.74; P < .01), and a greater number of target vessels (OR, 0.25; 95% CI, 0.10-0.62; P = .002) as independent predictors of failure to regress. ConclusionsSac regression after FEVAR occurred in nearly one-half of patients, but seems to be less common in patients with persistent type II endoleaks and those undergoing concomitant parallel grafting. Sac regression was associated with a significant survival advantage, and can be used as a clinical marker for success after FEVAR.

Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation

The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014-2019. Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery. Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p<.001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p<.001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p=.018). At 24 months, 8/32 type 2El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p=.19). Kaplan-Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p<.001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p=.081), at M12 (p=.004), and M24 (p=.001). For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240).

The Efficacy of a Protocol of Iliac Artery and Limb Treatment During EVAR in Minimising Early and Late Iliac Occlusion

Iliac limb occlusion (ILO) is a complication of endovascular aortic repair (EVAR) and requires re-intervention in most cases. Attention to any intra-operative defect of iliac limbs and arteries may prevent ILO. The study aimed to analyse the long term effect of an intra-operative protocol of iliac limb treatment during EVAR on ILO. Patients treated from 2012 to 2017 for abdominal aortic aneurysm (AAA) with standard EVAR were collected prospectively. Pre-operative computed tomography angiography anatomical characteristics were evaluated. The protocol for intra-operative iliac limb management was: a. pre-EVAR angioplasty of common/external iliac artery stenosis; b. precise contralateral iliac limb deployment at the same level of the flow divider; c. iliac limb kissing ballooning with high pressure non-compliant balloons; d. iliac limb stenting for residual tortuosity/kink and adjunctive external iliac stenting for residual stenosis/dissection after EVAR. ILO was evaluated at 30 days and at follow up, which was performed by duplex ultrasonography before discharge, at three, six, and 12 months and yearly thereafter. Kaplan-Meier and Cox linear regression were used. Four hundred and forty-two patients and 884 iliac limbs were included in the study. Severe iliac tortuosity and calcification were present in 15% (132/884) and 8% (70/884), respectively. External iliac angioplasty and stenting of iliac limb were performed in 2% (18/884) and 9.5% (84/884) of limbs. The thirty day mortality was 1.6%, with no ILO. At a mean follow up of 33±12 months, ILO occurred in 7/884 (0.8%) limbs of six patients. Five ILO were treated by endovascular relining, two surgically: one by femorofemoral bypass and one by surgical explant. On univariable analysis, sac shrinkage was significantly associated with ILO (HR 1, 95% CI 0.8-2.5, p=.043). A protocol of aggressive iliac limb treatment in EVAR leads to a very low rate of late ILO. The role of sac shrinkage in ILO should be investigated further.

The Interplay between Preoperative Anemia and Postoperative Blood Transfusion on Survival following Fenestrated Aortic Aneurysm Repair

Anemia is associated with a higher mortality following standard endovascular aortic repair (EVAR). This study evaluates the impact of anemia on fenestrated endovascular aneurysm repair (FEVAR) for complex aneurysm (AAA) repair. All elective FEVARs performed between 2010 and 2018 at a tertiary vascular center were analyzed. Anemia was defined as a preoperative hemoglobin (Hb) of <120g/L for women and <130g/L for men (World Health Organization definition). Primary outcome was overall survival by Kaplan-Meier. Secondary outcomes included length of hospital stay (LOS) and myocardial infarction (MI). Cox proportional hazard analyses were conducted. In total, 132 FEVAR patients were followed up for 3.7 (2.2) years. Thirty-eight patients were anemic [average Hb of 112 (13) g/L]. Groups were comparable for age, AAA diameter, body mass index, and comorbidity. Anemic patients had a lower baseline estimated glomerular filtration rate [64.1 (23.2) vs. 70.9 (18.8) mL/min/1.73m2, P=0.022] and a longer procedural time [242 (103) vs. 195.4 (88) min, P=0.009] with no difference in the number of fenestrations (P=0.696). Kaplan-Meier analysis demonstrated a higher mortality (log-rank P=0.03) with 40% deceased versus 21% nonanemic (P=0.04) at the end of follow-up. Anemic patients had more postoperative myocardial infarctions (MIs) (4 vs. 2, P=0.037) and a longer LOS [9.2 (7.1) vs. 6.3 (6.8) days, P=0.001]. Increasing Hb increased the likelihood of survival [hazard ratio, HR -0.8 (0.65-0.94), P=0.038]. Postoperative transfusion was adversely associated with survival [HR 3.65 (1.05-12.8), P=0.043]. Anemia appears to be associated with an increased rate of postoperative MI, LOS, frequency of blood transfusion, and mortality rate following FEVAR but this surpassed by postoperative blood transfusion. Optimization of preoperative Hb should be considered as a potential target for improvements in clinical outcomes and hypothetically a consequential reduction in postoperative red blood cell transfusion need.