Elective 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.

Efficacy of Sac Coil Embolization in Endovascular Aortic Repair for Sac Shrinkage in Patients at a High Risk of Type II Endoleak from Lumbar Arteries

In endovascular aortic repair (EVAR), preemptive embolization of sac branch vessels is effective in preventing postoperative type II endoleak (T2EL). However, this technique has not been widely adopted especially for lumbar arteries (LAs) because of technical difficulties and time constraints. This study aimed to investigate the efficacy of nonselective sac coil embolization, which is a simpler surgical method, in postoperative sac shrinkage for patients at a high risk of T2EL from LAs. We retrospectively assessed 76 patients who underwent elective EVAR for abdominal aortic aneurysm with 4 or more patent LAs or at least 1 patent LA of ≥2mm at our hospital between January 2014 and December 2022. The patients who underwent sac coil embolization were included in Group Ⅰ (n=20), and the others were divided into 2 groups: those with an inferior mesenteric artery that was originally occluded or embolized by coils or stent graft bodies (Group Ⅱ, n=21), and those without that (Group Ⅲ, n=35). In Group Ⅰ, 0.035-inch coils were inserted into the sac after complete stent graft deployment. The cumulative incidence of sac shrinkage (≥5mm) was compared between the groups. Further, univariable and multivariable Cox regression analyses were used to determine the predictors of sac shrinkage. Sac shrinkage (≥5mm) was observed more frequently in Group Ⅰ (50%) than in Group Ⅱ (19%) and Group Ⅲ (17%) (P=0.052 and 0.043, respectively). The cumulative incidence of sac shrinkage was significantly higher in Group Ⅰ than in Group Ⅱ (log-rank P=0.039) and Group Ⅲ (log-rank P=0.024). Multivariable Cox regression analyses revealed that sac embolization was a significant predictor of sac shrinkage (hazard ratio, 4.23; 95% confidence interval, 1.66-10.8; P=0.003). Nonselective sac coil embolization in EVAR is potentially effective for sac shrinkage in the early postoperative phase in patients at high risk of T2EL from LAs. This simple procedure may improve prognosis after EVAR.

Endovascular navigation in patients: vessel-based registration of electromagnetic tracking to preoperative images

Electromagnetic tracking of instruments combined with preoperative images can supplement fluoroscopy for guiding endovascular aortic repair (EVAR). The aim of this study was to evaluate the in-vivo accuracy of a vessel-based registration algorithm for matching electromagnetically tracked positions of an endovascular instrument to preoperative computed tomography angiography. Five patients undergoing elective EVAR were included, and a clinically available semi-automatic 3D–3D registration algorithm, based on similarity measures computed over the entire image, was used for reference. Accuracy was reported as target registration error (TRE) evaluated in manually selected anatomic landmarks on bony structures, placed close to the volume-of-interest. The median TRE was 8.2 mm (range: 7.1 mm to 16.1 mm) for the vessel-based registration algorithm, compared to 2.2 mm (range: 1.8 mm to 3.7 mm) for the reference algorithm. This illustrates that registration based on intraoperative electromagnetic tracking is feasible, but the accuracy must be improved before clinical use.

Development and Validation of a Novel Preoperative Risk Score to Identify Patients at Risk for Nonhome Discharge after Elective Endovascular Aortic Aneurysm Repair (EVAR)

Nonhome discharge (NHD) to a rehabilitation or skilled nursing facility after elective endovascular aortic repair (EVAR) is uncommon. However, NHD after surgery has an important impact on patient quality of life and postdischarge outcomes. Understanding factors that put patients undergoing EVAR at high risk for NHD is essential to providing adequate preoperative counseling and shared decision making. This study aimed to identify independent predictors of NHD following elective EVAR and to create a clinically useful preoperative risk score. Elective EVAR cases were queried from the Society for Vascular Surgery Vascular Quality Initiative 2014-2018. A risk score was created by splitting the data set into two-thirds for development and one-third for validation. A parsimonious stepwise hierarchical multivariable logistic regression controlling for hospital level variation was performed in the development dataset, and the beta-coefficients were used to assign points for a risk score. The score was then validated, and model performance assessed. Overall, 24,426 patients were included and 932 (3.8%) required NHD. Multivariable analysis in the development group identified independent predictors of NHD, which were used to create a 20-point risk score. Patients were stratified into 3 groups based upon their risk score: low risk (0-7 points; n=16,699) with an NHD rate of 1.8%, moderate risk (8-13 points; n=7,315) with an NHD rate of 7.3%, and high risk (≥14 points; n=412) with an NHD rate of 21.8%. The risk score had good predictive ability with c-statistic=0.75 for model development and c-statistic=0.73 in the validation dataset. This novel risk score can predict NHD following EVAR using characteristics that can be identified preoperatively. Utilization of this score may allow for improved risk assessment, preoperative counseling, and shared decision making.

Cardiac risk after elective endovascular repair for infrarenal abdominal aortic aneurysm: Results from the Italian Collaborators for EVAR multicenter registry

ObjectiveMajor adverse cardiac events (MACEs) were common complications after endovascular aortic repair (EVAR) causing significant postoperative morbidity and mortality. The aim of the study was to evaluate the cardiac risk after elective EVAR for uncomplicated noninfected infrarenal abdominal aortic aneurysm in a large multicenter cohort. MethodsThis is a multicenter, retrospective, financially unsupported physician-initiated observational cohort study conducted by four academic tertiary referral hospitals from January 2018 to March 2021. Baseline, perioperative, and postoperative information of elective EVARs was evaluated. The primary outcome was the incidence of MACEs after EVAR, which was defined as acute coronary syndrome, non-ST-elevation myocardial infarction, unstable angina pectoris, de novo atrial fibrillation, hospitalization for heart failure, and revascularization as well as cardiovascular death. Secondary outcomes were 1-year overall survival (all-cause mortality) and freedom from aorta-related mortality. Comparative analysis was conducted between MACE and overall population, and univariate and multivariate logistic regression analyses were used to analyze factors associated with the risk of the MACE occurrence and early 1-year mortality. ResultsThe study has enrolled 497 patients (35 females, 7%) with a mean age of 75.3 ± 7.8 years. The MACE rate was 6.4% (32/497, events/patients), and the majority of the events were recorded in the postoperative period (24/32, 75%; overall 24/497, 4.8%). One-year survival from all-cause mortality was 94% (95% confidence interval [CI]: 91-96), and the MACE population showed a significantly lower survival estimation rate (Overall - MACEs, 95.8% [95% CI: 93-97] - 67.9% [95% CI: 47-82], log-rank 41.950, P = .0001). Freedom from aorta-related mortality was 99.3% (95% CI: 98-100). The perioperative need for red blood cell transfusions was strongly related to the MACE occurrence (odds ratio: 2.67, 95% CI: 1.52-4.68, P = .001) and 1-year mortality (hazard ratio: 2.14, 95% CI: 1.48-3.09, P = .0001). ConclusionsMACEs represent a common complication in the postoperative and early period after elective EVAR. Blood loss requiring red blood cell transfusions is associated with increased postoperative MACEs and early mortality, suggesting that all the efforts should be carried out to reduce the bleeding during and after elective interventions.

Early and Midterm Outcomes of Endovascular Aneurysm Repair With Zenith Alpha Abdominal Stent-Graft: Results From a Multicenter Retrospective Tuscany Registry.

Zenith Alpha Abdominal (Cook Medical, Bloomington, IN, USA) is one of the new-generation low-profile stent-grafts with demonstrated satisfactory early and midterm clinical outcomes for endovascular treatment of abdominal aortic aneurysms (AAAs). The aim was to evaluate early and midterm results of this device in the framework of a multicenter regional retrospective registry, with the analysis of morphological factors affecting outcomes, including different limb configurations. Between January 2016 and November 2021, 202 patients with AAA underwent elective endovascular aneurysm repair (EVAR) with implantation of a Zenith Alpha Abdominal in 7 centers. Early (30 day) outcomes in terms of technical and clinical success were assessed. Estimated 5 year outcomes were evaluated in terms of survival, freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and graft infection evaluation by life-table analysis (Kaplan-Meier test). A comparative analysis between different limb configurations (Zenith Spiral Z AAA iliac legs, codes ZISL vs ZSLE) was performed in terms of limb graft occlusion. The 30 day technical and clinical success rates were 97.5% and 99.5%, respectively. Median follow-up period was 25.5 months (interquartile range [IQR]: 12-43.25). The 5 year survival rate was 73.6%. The estimated 5 year outcomes in terms of freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and freedom from graft infection were 88.6% (95% CI [confidence interval]: 83.4%-93.1%), 95.8% (95% CI: 92.7%-97.1%), 93.6% (95% CI: 90.2%-96.8%), 87% (95% CI: 83.3%-91.6%), and 97.7% (95% CI: 95.1%-98.9%), respectively. About limb configuration, no differences were found in terms of 5 year freedom from limb graft occlusion (ZSLE 93.4% [95% CI: 89.8%-95.5%] vs ZISL 94.3% [95% CI: 90.1%-95.9%], p=0.342; log-rank 0.903). Zenith Alpha Abdominal in elective EVAR offered satisfactory early and 5 year outcomes with low complication rates. Limb graft occlusion continued to be an issue. Limb configuration did not affect outcomes. The authors describe satisfactory early and 5 year outcomes of Zenith Alpha Abdominal in elective endovascular aortic repair in the framework of a multicenter regional retrospective registry. At 5 years freedom from type I endoleak was 88.6%, and rate of endograft infections and conversions to open repair were very low. in the present study. Hot topic about about Zenith stent-graft still remains the limb graft occlusion with a 30-day overall rate of 2%, and estimated 5-year freedom from limb graft occlusion of 93.6%. Limb graft configuration did not affect limb graft occlusion rate. A standardized protocol including iliac stenting should be adopted to reduce kimb graft occlusion.

Analysis of Determinants for Suture-mediated Closure Device Failure During EVAR Procedures.

Endovascular aortic repair (EVAR) for elective and emergency infrarenal aortic pathologies is the primary approach for treatment nowadays. During such procedure, the suture-mediated closure device (SMCD) (Perclose ProGlideTM, Abbott Laboratories, Chicago, IL, USA) is commonly used. This study aimed to identify potential contributors for SMCD failure in a patient cohort of elective and emergency EVAR. Archived medical records from patients who underwent EVAR for aortic pathologies in elective and emergency setting at the University Hospital Düsseldorf, Germany were included. Patient's co-morbidities, access vessel morphologies and hemostasis-related blood parameters were evaluated on their association with SMCD failure applying different statistical methods. A total of 71 patients (139 femoral accesses) was included. The mean age was 73.5 ± 8.4years. Overall SMCD failure rate was 4.3%, 4.1% for elective and 5.9% for emergency cases, respectively. Total procedure time was longer for the SMCD failure group (323 ± 117.8min vs 171 ± 43.7min). The calcification status of the common femoral artery (CFA), the diameter of the aortic bifurcation, and dual anti-platelet therapy (DAPT) on the medication plan prior to the procedure were associated with SMCD failure. Univariate binary logistic regression analysis nominated several potentially relevant predictors for SMCD failure who underwent subsequent multivariable binary logistic regression analysis. Here, DAPT on the medication plan was identified as being promising in predicting SMCD failure (OR 30.5), while anterior plaque formation in the CFA maintained as only statistically relevant determinant (OR 44.9). This study confirms the CFA calcification status to be associated with SMCD failure. Although discontinued prior to endovascular treatment, DAPT was also found to be associated with SMCD failure. Our results may advocate to perform obligatory platelet testing prior to EVAR to maximize patient safety.

Predictive Parameters of Type 1A Endoleak for Elective Endovascular Aortic Repair: A Single-Center Experience

One of the most important factors that affects the success of Endovascular Aortic Repair (EVAR) treatment is the morphology of the neck of the aneurysm. Today, EVAR can be performed even in patients who do not meet the Instruction For Use criteria with hostile neck risk factors; thanks to the developing experience and technology. Our aim in this study was to determine risk factors for Type 1a endoleaks in patients who underwent EVAR and predictive factors for Type 1a endoleaks in patients with combinations of these risk factors. Patients who underwent elective EVAR for infrarenal abdominal aortic aneurysm in our medical center between July 2016 and January 2021 were enrolled. Of these 244 patients, 180 patients with documented preoperative and postoperative computed tomographic angiography results and a follow-up of at least 1year were included in the study. The Mann-Whitney U test and Student's t-test were used to assess the relationship between nominal data and numerical values, and the t-test and Wilcoxon test were used to compare dependent groups. Logistic regression analysis was performed to model risk factors associated with endoleaks. The results showed that a neck length less than 15mm increased the development of type 1a endoleak by 10.4 times (P<0.001). Furthermore, a neck diameter more than 28mm increased the development of type 1a endoleak by 21.9 times (P=0.04). A conical neck structure (gradual neck dilation > 2mm) increased the development of type 1a endoleaks 4.8 times (P=0.04). The presence of calcification (> 150 Hounsfield Unit and > 2mm) in the neck increased the risk of type 1a endoleaks fourfold (P=0.04). Hostile neck parameters were analyzed and patients with only 1 parameter (n=69) had a 7.2% type 1a endoleak rate, while patients with 2 parameters (n=15) had 26.6% and patients with more than 2 parameters (n=11) had 45.5% type 1a endoleak rate. Morphologic features of the neck structure of the aneurysm are among the most important parameters that affect the success of EVAR treatment. Alternative treatments should be considered in patients with more than 1 unfavorable neck parameter.

A novel endovascular robotic-assisted system for endovascular aortic repair: first-in-human evaluation of practicability and safety

ObjectivesTo assess the practicability and safety of a novel endovascular robotic system for performing endovascular aortic repair in human.MethodsA prospective observational study was conducted in 2021 with 6 months post-operative follow-up. Patients with aortic aneurysms and clinical indications for elective endovascular aortic repair were enrolled in the study. The novel developed robotic system is applicable for the majority of commercial devices and various types of endovascular surgeries. The primary endpoint was technical success without in-hospital major adverse events. Technical success was defined as the ability of the robotic system to complete all procedural steps based on procedural segments.ResultsThe first-in-human evaluation of robot-assisted endovascular aortic repair was performed in five patients. The primary endpoint was achieved in all patients (100%). There were no device- or procedure-related complications or no in-hospital major adverse events. The operation time and total blood loss in these cases were equal to those in the manual procedures. The radiation exposure of the surgeon was 96.5% lower than that in the traditional position while the radiation exposure of the patients was not significantly increased.ConclusionsEarly clinical evaluation of the novel endovascular aortic repair in endovascular aortic repair demonstrated practicability, safety, and procedural effectiveness comparable to manual operation. In addition, the total radiation exposure of the operator was significantly lower than that of traditional procedures.Clinical relevance statementThis study applies a novel approach to perform the endovascular aortic repair in a more accurate and minimal-invasive way and lays the foundation for the perspective automation of the endovascular robotic system, which reflects a new paradigm for endovascular surgery.Key Points• This study is a first-in-human evaluation of a novel endovascular robotic system for endovascular aortic repair (EVAR).• Our system might reduce the occupational risks associated with manual EVAR and contribute to achieving a higher degree of precision and control.• Early evaluation of the endovascular robotic system demonstrated practicability, safety, and procedural effectiveness comparable to that of manual operation.

Outcomes of the Ankura Stent Graft for Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm.

The purpose of this retrospective cohort study is to report outcomes of endovascular aortic repair (EVAR) with the novel endograft, Ankura (Lifetech Scientific, Shenzen, China). We identified all patients who underwent elective EVAR with Ankura stent graft in a tertiary unit from January 2015 to November 2021. Patients with ruptured infrarenal and juxtarenal aortic aneurysms were excluded from the study. All patients were anatomically suitable according to the instructions for use (IFU). Follow-up (FU) included computed tomography angiography (CTA) at 1 month, 12 months, and yearly thereafter if endoleak (EL) was not present. Primary outcomes included technical success (primary and secondary) and 30-day overall mortality and morbidity. Secondary outcomes included late overall and aneurysm-related mortality as well as influence of suprarenal fixation of the endograft on renal function at 12 months using eGFR (CKI-EPI formula). The Ankura endograft was successfully implanted in 116 patients (mean age=71.1 years, 96.5% male). Mean aneurysm diameter was 62.3 mm. Median FU was 34 months (2-72 months). Primary and secondary technical success were 95.7% and 100%, respectively. Overall type I EL was 5% (2 proximal, 3 distal) and type II EL was 13%. Thirty days mortality and morbidity were 0% and 5.2%, respectively. All-cause mortality during FU was 13.9% (n=16); aneurysm-related mortality was 2.6% (n=3). Limb endograft patency was 100%. Freedom from reintervention was 98.2% at 2 years, and 97.4% at 4 and 6 years respectively. There was a statistically significant difference between preoperative (73.69 mL/min/1.73 m2) and postoperative (66.66 mL/min/1.73 m2) eGFR at 12 months (p<0.001). Ankura endograft has demonstrated an efficacious durability with low aneurysm-related mortality and high iliac limb patency rate. Elective EVAR is associated with significant decline in renal function at 12 months in our study. Larger series studies are necessary to evaluate long-term safety and efficacy of Ankura endograft. Ankura stent graft is a novel PTFE endograft with suprarenal fixation for infrarenal aneurysm repair. This retrospective cohort study of 116 patients provide a first "picture" of Ankura safety and efficacy in a European tertiary vascular center. High technical success rate, low aneurysm related mortality and high limb patency rate are the main findings of the study with a negative impact of suprarenal fixation on kidney function during follow up.

Midterm Outcomes of Elective Endovascular Aortic Repair in Octogenarians: When Is It Too Old?

Introduction: Endovascular aortic repair outcomes in octogenarians remain unclear. We aim to investigate whether the results for octogenarians differ from those of the younger population in elective endovascular aortic repair. Materials and Methods: From January 2013 to January 2022, 313 patients were treated with elective endovascular aortic repairs. Patient demographics and perioperative and postoperative features were obtained from the hospital database. The primary goals were to explore the early mortality rates of patients aged 80 years and older and compare them with those under 80. The secondary goal was to analyze the comorbid factors. Results: A total of 245 patients were under 80 years old, and 68 patients were 80 years and older. The early mortality rate was 2.94% in the octogenarians and 0.81% in the rest, and there was no significant difference between the two (p = 0.24). However, being 80 years and older led to a significantly lower survival probability at the five-year follow-ups. The American Society of Anesthesiologists’ score was found to help predict late mortality risk and patient selection for elective endovascular aortic repair. Conclusion: As octogenarians are fragile and sensitive to complications, patient selection, careful consideration of life expectancy, and clinical assessment are key to repair. Furthermore, age should not be an independent exclusion criterion in the endovascular aortic repair treatment decision. Keywords: Aortic Aneurysm, Abdominal; Endovascular Procedure; Octogenarians.

Outcomes and Economic Impact of Hypogastric Artery Management During Elective Endovascular Aortic Repair for Aorto-Iliac Aneurysms

To analyze clinical outcomes and perform a macro-costing evaluation of endovascular aortic repair (EVAR) for aorto-iliac aneurysms. This is a retrospective, financially unsupported physician-initiated observational cohort study. Patients with iliac artery involvement treated with EVAR between January 1st 2014 and December 31st 2021 were identified. Inclusion criteria were intact aneurysm, elective EVAR with at least one hypogastric artery (HA) treatment, use of bifurcated endograft (EG), and at least 6-months of follow-up. Primary outcomes of interest were overall survival, freedom from aneurysm-related mortality (ARM), freedom from EVAR-related reintervention, and overall EVAR(procedure)-related costs. We studied 122 (9.1%) patients: 119 (97.5%) were male and 3 (2.5%) females. Median age of patients was 76 years (range, 68.75-81). Overall, 107 (87.7%) patients had both HAs preserved according to following strategy: 45 (36.9%) with flared limbs, 13 (10.6%) with bilateral branched device, and 49 (40.2%) with a combination of flared limb on one side and branched device on the contralateral side. Bilateral overstenting was performed in 15 (12.3%) patients. Estimated overall survival was not different between groups of EVAR (Log-rank, P = 0.561). There was only 1 (0.8%) ARM ascertained during the follow-up. Estimated freedom from EVAR-related reintervention was not different among groups (Log-rank, P = 0.464). During the follow-up, 9 (7.4%) patients developed buttock claudication (SVS grade 1, n = 4, SVS grade 2, n = 5), more frequently in HA overstenting (HR: 3.6; 95%CIs: 0.96-13.5, P = 0.058). When all cots were included, branched EVAR still carried the highest burden (P = 0.001) in comparison with the mixed subgroup, the overstenting subgroup, and the flared limbs subgroup. Early mortality and pelvic ischemic syndromes rate were acceptably low in all techniques. Hypogastric artery preservation showed lower complication rate in comparison with HA overstenting which, however, appears to be safe an effective for option with similar overall costs for patients who are not candidates for HA preservation based on aortic anatomy.

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.

Incidence, predictors, and prognostic impact of in-hospital serious adverse events in patients ≥75 years of age undergoing elective endovascular aneurysm repair.

This study sought to identify the factors associated with the occurrence of in-hospital serious adverse events after elective endovascular aortic repair (EVAR) in older patients within the Global Registry for Endovascular Aortic Treatment. Consecutive patients ages ≥75 years who received GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, AZ) for elective EVAR. Based on the age at index elective EVAR, patients were categorized into 3 groups for subsequent analyses: those ages 75 to 79, 80 to 84, and ≥85 years. The primary end points for this study were the incidence of serious adverse events and all-cause mortality. In-hospital complications were defined according to the International Organization for Standardization 14155 standard (https://www.iso.org/standard/71690.html) and considered serious adverse events if they led to any of the following: (1) a life-threatening illness or injury, (2) a permanent impairment of a body structure or a body function, (3) in-patient or prolonged hospitalization, or (4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function. Overall, 1,333 older patients (ages 75-79: n= 601; 80-84: n= 474; and ≥85: n= 258) underwent elective EVAR in the Global Registry for Endovascular Aortic Treatment data set and were included in the present analysis. In total, 12 patients (0.9%) died perioperatively, and 103 patients (7.7%) experienced ≥1 in-hospital serious adverse event, with 18 patients (1.3%) experiencing >1 in-hospital complications. No significant differences were seen between the age groups in the rates of in-hospital serious adverse events (7.3% vs 8.2% vs 7.8%; P= .86). In logistic regression analysis, a history of chronic obstructive pulmonary disease (odds ratio= 2.014; 95% confidence interval, 1.215-3.340; P= .006) and prior requirement for dialysis (odds ratio= 4.655; 95% confidence interval, 1.087-19.928; P= .038) resulted as predictors for occurrence of in-hospital serious adverse events. In the whole cohort, the 5-year survival was 63% for patients who did not experience any in-hospital serious adverse events compared with 51% for those who experienced any complications (P= .003). Using multivariable Cox proportional hazards models, it was found that the occurrence of in-hospital serious adverse events (hazard ratio= 6.2; 95% confidence interval, 1.8-21.317; P= .003) and being underweight (hazard ratio= 7.0; 95% confidence interval, 1.371-35.783; P= .019) were the only independent predictors of death in ≤30 days from the initial intervention. Although age did not independently affect the risk for all-cause mortality in ≤180 days after the initial intervention, increasing age was associated with a higher risk for long-term death (ie, ≥181 days from index elective EVAR) in the multivariable analysis (ages 75-79: hazard ratio= 0.379; 95% confidence interval, 0.281-0.512; P < .001; and 80-84: hazard ratio= 0.562; 95% confidence interval, 0.419-0.754; P < .001). After elective EVAR in older patients (ie, ≥75 years), the occurrence of in-hospital serious adverse events appears to increase the risk of death, particularly in ≤180 days after the initial elective EVAR intervention, and might be related to patient baseline characteristics, including history of pulmonary and renal disease.

Scoping review of radiologic assessment and prognostic impact of skeletal muscle sarcopenia in patients undergoing endovascular repair for aortic disease

The primary objectives of our scoping review were to evaluate the methods used by research groups to assess the incidence of sarcopenia in patients with aortic disease and the extent of the evidence base that links sarcopenia to the survival of patients undergoing elective endovascular aortic repair and to identify the recurring themes or gaps in the literature to guide future research. A scoping review in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) protocols extension for scoping reviews was performed. The available studies included those fully reported in English (last query, April 30, 2022). The following PICO question was used to build the search equation: "in patients with aortic disease [population] undergoing endovascular repair [intervention], what was the prevalence and prognosis of radiologically defined sarcopenia [comparison] on the short- and long-term outcomes?" A total of 31 studies were considered relevant, and 18 were included in the present scoping review. In brief, 12 studies had focused on standard endovascular aneurysm repair (EVAR), 2 on thoracic EVAR, and 4 on complex EVAR. All but two studies were retrospective in design, and only one study had included patients from a multicenter database. Sarcopenia had generally been defined using the computed tomography angiography (CTA) findings of the cross-sectional area of the psoas muscle at L3 or L4, sometimes with normalization against the height. Overall, despite the heterogeneity in the methods used for its definition, sarcopenia was highly prevalent (range, 12.5%-67.6%). The patients with sarcopenia had had higher rates of mortality (ratio ranged from 2.28 [95% confidence interval, 1.35-3.84] to 6.34 [95%confidence interval, 3.37-10.0]) and adverse events (41% vs 16%; P= .020). Sarcopenia, as identified using computed tomography angiography-based measurements of the skeletal muscle mass, was prevalent among patients undergoing elective EVAR, thoracic EVAR, or complex EVAR. The presence of sarcopenia has been shown to have a negative prognostic impact, increasing the operative risk and has been linked to poorer long-term survival.

Chronic kidney disease impacts outcomes after abdominal aortic aneurysm repair

ObjectiveChronic kidney disease (CKD) and end-stage renal disease are traditionally associated with worse outcomes after endovascular and open repair of abdominal aortic aneurysm (AAA). This study stratifies outcomes of AAA repair by approach, CKD severity, and dialysis dependence. MethodsAll patients undergoing elective infrarenal open aneurysm repair (OAR) and endovascular aortic repair (EVAR) with preoperative renal function data captured by the Vascular Quality Initiative between January 2003 and September 2020 were analyzed. Patients were stratified by CKD class as follows: CKD stages 1 and 2, CKD stage 3a, CKD stage 3b, CKD stages 4 and 5, and dialysis. Primary outcomes were perioperative and 1-year mortality. Predictors of survival were identified by Cox multivariate regression models. ResultsIn total, 53,867 elective AAA repairs were identified: 5396 (10%) OARs and 48,471 (90%) EVARs. Most patients were White (90%) and male (81%), with a mean age of 73 ± 9 years. Patients who underwent EVAR were older and had more comorbidities. The use of elective EVAR for AAA increased from 52% in 2003 to 91% in 2020 (P < .001). The OAR cohort had more perioperative complications and short-term mortality. The CKD 1 and 2 group had the highest 1-year survival compared with the other groups after both OAR and EVAR. On Cox regression analysis, after EVAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.93-1.68; P = .13; CKD 3b: HR, 1.74; 95% CI, 1.23-2.45; P < .050; CKD 4-5: HR, 3.23; 95% CI, 2.13-4.88; P < .001), and dialysis (HR, 4.48; 95% CI, 1.90-10.6; P < .001) were independently associated with worse 1-year survival rates. After OAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: HR, 1.08; 95% CI, 0.96-1.20; P = .20; CKD 3b: HR, 1.60; 95% CI, 1.41-1.81; P < .001; CKD 4-5: HR, 2.85; 95% CI, 2.39-3.41; P < .001), and dialysis (HR, 3.79; 95% CI, 3.01-4.76; P < .001) were independently associated with worse 1-year survival rates. ConclusionsRegardless of the treatment approach, CKD severity is an important predictor of perioperative and 1-year mortality rates after infrarenal AAA repair and may reflect the natural history of CKD. Open repair is associated with high perioperative mortality risk in patients with CKD stages 4 and 5, as well as end-stage renal disease. Individualization of patient decision-making is especially important in patients with a glomerular filtration rate of less than 45 and perhaps consideration should be given to raising the threshold for elective AAA repair in these patients. Further studies focusing on appropriate size threshold for repair in these patients may be warranted.

Association Between Psoas Muscle Sarcopenia and Long-Term Survival Following Elective Endovascular Aortic Repair

IntroductionThe aims of this study were as follows: i) to identify the prevalence of sarcopenia in patients undergoing elective endovascular aortic repair (EVAR) for intact abdominal aortic aneurysm; ii) to assess its association with perioperative morbidity and long-term survival; and iii) to estimate its diagnostic accuracy for prediction of 5-year mortality following the intervention. MethodsWe performed a retrospective review of all patients who underwent elective EVAR from January 1, 2010 through December 31, 2019. The lean psoas muscle area (LPMA; cm2 × HU) was calculated on computed tomography angiography by multiplying psoas muscle area and psoas muscle density. The main exposure variable for this study was the presence of preoperative sarcopenia (LPMA value < 350), and the study cohort was divided in two groups for all subsequent analyses. The primary endpoint was all-cause mortality. ResultsThe study cohort eventually comprised 338 patients who underwent elective EVAR for intact abdominal aortic aneurysm. In the overall population, 154 patients (45.5%) were classified as sarcopenic. At baseline, patients with sarcopenia were older (mean age: 78 ± 5 versus 75 ± 7 y, P < 0.001) and had lower proportion of males (73.5% versus 93.5%, P < 0.001). At 5 y, the estimated survival rates were 52% versus 74% in sarcopenic and nonsarcopenic patients, respectively (P < 0.001). Using multivariate Cox proportional hazard regression, an independent association was identified between sarcopenia and all-cause mortality in the whole cohort (hazard ratio: 2.63, 95% confidence interval: 1.43-3.36, P = 0.009). ConclusionsSarcopenia, defined as LPMA <350 as measured on preoperative computed tomography angiography, can be highly prevalent in patients undergoing elective EVAR. Although the intervention remains safe in the short term, presence of sarcopenia was significantly associated to lower long-term survival irrespective of patients’ age or gender.

Preoperative Prediction of Mortality Within 1 Year After Elective Endovascular Aortic Repair of Aneurysms Involving the Renal-mesenteric Arteries

Treatment goals of prophylactic endovascular aortic repair of complex aneurysms involving the renal-mesenteric arteries (cEVAR) include achieving both perioperative success and long-term survival benefit. Mortality within the first postoperative year indicates ineffective therapy after cEVAR owing to associated costs and procedural complexity. Currently, there are no validated clinical decision-aid tools that reliably predict mortality after cEVAR. Therefore, the purpose of this study was to derive and validate a preoperative prediction model of 1-year mortality after elective cEVAR.

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.

Understanding who benefits from endovascular aortic repair in those deemed unfit for open repair

IntroductionPatients with abdominal aortic aneurysms (AAAs) who are deemed unacceptable candidates for open repair (UNFIT) pose a clinical challenge. The EVAR2 Trial randomized UNFIT patients to endovascular aortic repair (EVAR) vs no intervention from 1999 to 2003, concluding that survival was not improved by EVAR. However, outcomes after EVAR over the last 2 decades have dramatically changed. Thus, the purpose of this study was to evaluate outcomes after EVAR in UNFIT patients using more contemporary data and to determine which subsets of UNFIT patients may potentially benefit from EVAR. MethodsThe Vascular Quality Initiative database (2003-2020) was used to identify elective EVARs for AAAs. Patients were categorized as UNFIT or suitable (SUITABLE) for open repair by the operative surgeon. Predicted 1-year mortality of untreated AAAs was calculated via a modified Gagne Index adjusted for AAA size. The primary outcome for the study was 30-day mortality. Secondary outcomes included perioperative major adverse cardiac events (a composite of clinically significant arrhythmia, congestive heart failure, and myocardial infarction), length of stay, and 1-year mortality. ResultsA total of 31,471 patients met study criteria with 27,036 (85.9%) deemed SUITABLE and 4435 (14.1%) UNFIT. UNFIT patients were more likely to experience a perioperative major adverse cardiac event (5.1% vs 2.2%, P < .001) and had longer lengths of stay (1 day [interquartile range, 1-3 days] vs 1 day [interquartile range, 1-2 days], P < .001). The 30-day mortality was significantly higher for UNFIT patients (0.8% vs 0.4%, P < .001). UNFIT patients had worse 1-year survival compared with SUITABLE patients. However, UNFIT and SUITABLE patients had significantly improved actual 1-year mortality with EVAR compared with predicted 1-year mortality without EVAR: 9.5% vs 15.6% (P < .001) and 4.0% vs 11.7% (P < .001), respectively. The mortality benefit after EVAR in UNFIT patients was primarily restricted to those with smaller Gagne Indices and larger aneurysm diameters. Patients deemed unsuitable for open repair due to frailty or multiple reasons had significantly higher 30-day mortality rates after EVAR when compared with SUITABLE patients (1.3% vs 1.6% vs 0.4%, P < .001). Those deemed unsuitable for open repair due to frailty or multiple reasons had worse 1-year cumulative survival compared with all other UNFIT patients. ConclusionsDespite being high risk with higher perioperative morbidity and mortality, UNFIT patients have lower actual 1-year mortality with EVAR than predicted 1-year mortality without EVAR. However, this potential benefit is reserved to those with small Gagne Indices, larger AAA diameters, and lack of frailty.