Biodesign: Engineering an aortic endograft explantation tool.

Endovascular aortic repair (EVAR) graft failure can be as high as 16% to 30% owing to endoleak, graft migration, or infection, often necessitating explantation, leading to potential morbidity (31%) and mortality (6.3%). Graft prongs frequently tear through the endothelium during explantation, leading to endothelial damage and subsequent fatal bleeding. The current standard of care involves different suboptimal techniques such as the syringe technique in which a cylinder is improvised by cutting a syringe in half and pushed over the graft hooks in a rotating motion, until covered for manual explantation. Because there is no commercially available product to address this shortcoming in graft explantation, we engage in the biodesign process to produce a functional explantation device. We designed and prototyped multiple potential solutions to remove EVAR endografts safely. Silicone tubing with EVAR endografts deployed in the lumen were used to simulate a grafted aorta and test each prototype. Prototypes were compared in their ability to meet design criteria including decrease in graft diameter, prevention of arterial dissection, ease of use, and decrease in procedure time. After determining the single best prototype, surgeon feedback was elicited to iteratively improve the original design. The most effective design uses a tapered lumenal geometry that decreases the EVAR graft diameter and uses stainless steel beads to prevent shear stress to the simulated aorta. A distal grip allows for easy single hand manipulation of the device, while a latching mechanism allows for smooth placement and removal over the endograft. After rigorous prototyping, our device proved feasible and effective for safe EVAR explantation, allowing this procedure to be performed safely.

Transarterial Coil Embolization for Type II Endoleak After Endovascular Aneurysm Repair (EVAR).

Background Endovascular aneurysm repair (EVAR) has evolved into treatment of choice for infrarenal abdominal aortic aneurysms (AAA). Type II endoleaks, although frequently benign, can lead to sac enlargement and rupture. Management of these endoleaks by endovascular means can be quite challenging and may require complex techniques and assistance of interventional radiologists, not always available in all vascular units. This is a single-center study of management of type II endoleaks with transarterial coil embolization performed by vascular surgeons and with minimum requirements regarding the necessary equipment. Methods From 2017 to 2022, 13 patients with type II endoleak were treated. Local anaesthesia and transfemoral or transbrachial approach was used. The superficial mesenteric artery (SMA) was catheterized and through the Riolan arch, coiling of the inferior mesenteric artery and/or the sac aneurysm was performed. Results The mean time period between the primary EVAR procedure and the transarterial intervention for the endoleak was 3.9 years. Primary technical success was achieved in 11 (84.6%) patients, while secondary technical success was 12 (92.3%). In the mean follow-up period, which was 2.6 years, the endoleak was treated successfully in 11 (84.6%) patients.  Conclusions Transarterial coil embolization of type II endoleaks is a minimal low-cost procedure, with small percentage of complications, high technical and treatment success rates. It could be considered as a first-line treatment of unresolvable type II endoleaks, minimizing the need for open repair.

Use of ultra-low contrast dose CT aortography for the management of aortic aneurysmal disease.

PURPOSE: Computed tomography aortography (CTA) is used in the assessment of aortic pathologies and planning of surgical intervention. However, its dependence on iodinated contrast can result in development of contrast-induced acute kidney injury (CI-AKI). The potential concern of CI-AKI has spurred research into the potential of administration of low contrast volumes in CTA investigations while maintaining overall diagnostic appeal. Several studies have shown that CTA using contrast volumes as low as 30 mL (equivalent to 10.5 g of iodine) can still yield scans of diagnostic quality. We present a retrospective pilot study to evaluate the feasibility of utilising an ultra-low volume of iodinated intravenous contrast in a population of patients with severe renal insufficiency with referral from our vascular surgery unit for CTA evaluation of the thoracic and abdominal aorta. METHODS: This retrospective pilot study examined 12 CTA scans performed with 20 mLs of iodinated contrast and assessed image quality with both quantitative and qualitative markers. All scans were performed on a Siemens SOMATOM Force dual-source CT scanner. Quantitative assessment values were measured via attenuation values at eight aortoiliac locations and used to calculate a signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) at each location. Qualitative analysis of image quality and viability for surgical intervention was obtained from subjective clinical assessment by an interventional radiologist and vascular surgeon. RESULTS: Obtained quantitative assessment values included mean attenuation 189.9 HU, mean SNR 9.6 and mean CNR 8.0. All 12 scans demonstrated individual mean SNR values above predetermined quality thresholds while only five scans produced individual mean CNR values above threshold. Eleven of 12 scans were determined to be of sufficient quality for diagnosis and planning of surgical intervention. CONCLUSIONS: Our results suggest that CTA utilising an ultra-low contrast dose of 20 mLs (6 g iodine) yields scans of diagnostic quality for therapeutic decision-making in vascular surgical intervention.

Embolization of a type 2 endoleak using a micropuncture introducer set and a triple-coaxial system through the deep iliac circumflex artery via the ipsilateral femoral artery.

An 83-year-old man underwent embolization for a type 2 endoleak following endovascular aortic repair for an abdominal aortic aneurysm. The type 2 endoleak originated from the left iliac circumflex artery, which was located very close to the puncture site in the left femoral artery. This proximity made the embolization procedure challenging; however, by employing a combination of a micropuncture introducer set and a triple-coaxial system, embolization with N-butyl-2-cyanoacrylate was successfully achieved.

Low-Profile Minos TM Stent-Graft System for Endovascular Abdominal Aorta Aneurysm repair. Early and late outcomes in Elective and Emergent situations.

BACKGROUND: The aim of the study was to present the results of a novel abdominal stent graft for patients with Abdominal aortic aneurysm (AAA), through 2 years follow-up. METHODS: A single-center retrospective review with prospectively collected data was performed to assess the safety and effectiveness of the Minos Abdominal stent device for treating abdominal aortic aneurysms. We estimated technical success rate, in-hospital and 30-day mortality, and mortality at the end of follow-up as well as complication and reintervention rate in our study cohort. Follow-up imaging assessments consisted of computed tomography angiography (CTA) at 1 and 6 months and yearly thereafter. RESULTS: A total of 52 patients (92% males; mean age, 74±6 years) were enrolled with Minos Abdominal stent device from July 2020 until September 2023. Thirty one (60%) patients were asymptomatic while 21 (40%) were symptomatic. The technical success of the endovascular aortic repair (EVAR) was 95% (49/52 patients). In 5% (3/52) of the cases, cannulation of the contralateral limb was unsuccessful and was converted to aorto-uni-iliac graft (AIU). Two (4%) aortic related death were recorded during the 30-day period. The major adverse event rate was 3.8%. The overall mean follow-up was 30±6 months; no aorta-related deaths or graft related complications were observed. Sac shrinkage (>5mm) has been observed in 70% of patients. CONCLUSIONS: Minos endoprosthesis seems to be safe, effective and durable for treating AAA either in elective or emergent situations.

Simultaneous Endovascular Aortic Repair Expands Transcatheter Aortic Valve Replacement Eligibility to Patients With Hostile Aortic Pathology.

BACKGROUND: In recent years, Transcatheter Aortic Valve Replacement (TAVR) has become a primary modality of therapy in moderate-high risk patients with symptomatic aortic stenosis. Although clinicians remain vigilant about screening for both aortic stenosis, many patients still, nevertheless, often present only when they are symptomatic. Unfortunately, when isolated TAVR is performed in the context of hostile aortic pathology, it has been reported that patients suffer from higher rates of complications such as rupture, dissection, or death post-operatively. OBJECTIVES: To explore the utility of a simultaneous TAVR and endovascular aortic repair in addressing symptomatic aortic stenosis in challenging patients with hostile aortic pathology. METHODS: Retrospective case series within a tertiary care hospital between May 2017 and December 2023. RESULTS: A total of 11 patients underwent simultaneous endovascular aortic repair and TAVR. TAVR was performed first in 9/11 (82%) of the procedures while endovascular aortic repair was performed first in 2/11 procedures (18%). The median age was 84 years old (IQR = 77-86 years old). The median LOS was 3 days (IQR = 2-10 days). The median procedure time was 155 minutes (IQR = 111-202 minutes) and the median contrast amount was 100 CC (IQR = 65-139 CC). 2 patients (18%) experienced post-operative complications. Both of these patients required re-intervention. This cohort of patients did not experience any mortality at 30 days related to pertinent complications or adverse MACE events. All patients were transferred to the PACU and ultimately discharged home. CONCLUSIONS: Extending TAVR eligibility to high-risk patients with hostile aortic pathology through the implementation of simultaneous endovascular aortic repair, performed via the same access site, is an effective strategy for management of symptomatic aortic stenosis in the context of extensive cardiovascular co-morbidities.

High proportion of undiagnosed diabetes in patients surgically treated for infrarenal abdominal aortic aneurysm: findings from the multicentre Norwegian Aortic Aneurysm and Diabetes (ABANDIA) Study.

BACKGROUND: The aim was to investigate the total prevalence of known and undiagnosed diabetes mellitus (DM), and the association of DM with perioperative complications following elective, infrarenal, open surgical (OSR) or endovascular (EVAR), Abdominal Aortic Aneurysm (AAA) repair. METHODS: In this Norwegian prospective multicentre study, 877 patients underwent preoperative screening for DM by HbA1c measurements from November 2017 to December 2020. Diabetes was defined as screening detected HbA1c ≥ 48 mmol/mol (6.5%) or previously diagnosed diabetes. The association of DM with in-hospital complications, length of stay, and 30-day mortality rate were evaluated using adjusted and unadjusted logistic regression models. RESULTS: The total prevalence of DM was 15% (95% CI 13%,17%), of which 25% of the DM cases (95% CI 18%,33%) were undiagnosed upon admission for AAA surgery. The OSR to EVAR ratio was 52% versus 48%, with similar distribution among DM patients, and no differences in the prevalence of known and undiagnosed DM in the EVAR versus the OSR group. Total 30-day mortality rate was 0.6% (5/877). Sixty-six organ-related complications occurred in 58 (7%) of the patients. DM was not statistically significantly associated with a higher risk of in-hospital organ-related complications (OR 1.23, 95% CI 0.57,2.39, p = 0.57), procedure-related complications (OR 1.48, 95% CI 0.79,2.63, p = 0.20), 30-day mortality (p = 0.09) or length of stay (HR 1.06, 95% CI 0.88,1.28, p = 0.54). According to post-hoc-analyses, organ-related complications were more frequent in patients with newly diagnosed DM (n = 32) than in non-DM patients (OR 4.92; 95% CI 1.53,14.3, p = 0.005). CONCLUSION: Twenty-five percent of all DM cases were undiagnosed at the time of AAA surgery. Based on post-hoc analyses, undiagnosed DM seems to be associated with an increased risk of organ related complications following AAA surgery. This study suggests universal DM screening in AAA patients to reduce the number of DM patients being undiagnosed and to improve proactive diabetes care in this population. The results from post-hoc analyses should be confirmed in future studies.

THE ASSOCIATION BETWEEN PLASMA PROINFLAMMATORY CYTOKINE CONCENTRATIONS AND ENDOLEAK AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR.

BACKGROUND: The most common complication after endovascular aneurysm repair (EVAR) is continuous sac perfusion, known as endoleak. Evaluating markers released from the aneurysm wall into circulation has been suggested as a possible alternative for detecting endoleaks. The aim of this study was to examine whether circulating concentrations of different proinflammatory interleukins (IL-1ß, IL-2, IL-6, IL-8), monocyte chemoattractant protein-1 (MCP-1), and tumor necrosis factor alpha (TNF-α) were elevated in patients with endoleak after EVAR. METHODS: A prospective observational study with 100 patients undergoing elective EVAR was conducted. Blood samples were taken before surgery, at 7 days, 6 months, and 12 months after EVAR to quantify the mentioned cytokines using a Bio-Plex assay. Patients were followed up for 12 months to detect endoleak occurrence. RESULTS: In patients with endoleak, mean concentrations of certain cytokines in plasma differed significantly from those without endoleak: preoperative IL-8 (9.83; p<0.001), preoperative MCP-1 (75.94; p=0.003), preoperative TNF-α (5.46; p=0.05), among others. A binary logistic regression analysis revealed that preoperative IL-8 (p=0.003), MCP-1 at 7 days postoperative (p = 0.002), and IL-1 at 12 months postoperative were significantly associated with endoleak, with IL-1 being the most influential biomarker (OR=2.2). A ROC curve showed an area under the curve of 0.7, with cutoff points of 33.4 for preoperative IL-8, 145 for MCP-1 at 7 days postoperative, and 2.3 for IL-1 at 12 months postoperative. CONCLUSIONS: This study suggests that inflammatory biomarkers such as IL-1, IL-8, MCP-1, and TNF-α have the potential to serve as important adjuncts to conventional imaging techniques in monitoring patients post-EVAR. These biomarkers may help identify individuals at higher risk of developing endoleaks, guiding more focused and timely imaging follow-up. However, their practical applicability requires further investigation.

The Safety and Outcomes of Elective Endovascular Aneurysm Repair in the Elderly: A Systemic Review and Meta-Analysis.

PURPOSE: Prevalence of abdominal aortic aneurysms (AAAs) increases with age. Previous trials confirm that elective endovascular aneurysm repair (EVAR) is an effective intervention for AAA. However, few elderly patients were recruited into randomized trials, whereas in contemporary clinical practice, elective repair is commonly performed on octogenarians. We evaluated the safety and outcome of elective EVAR in elderly patients to inform clinical practice and vascular service provision. METHODS: A systematic review and meta-analysis of studies reporting risk of complications and death in patients undergoing elective EVAR was performed (PROSPERO CRD: 42022308423). Observational studies and interventional arms of randomized trials were included if the outcome rates or raw data were provided. Primary outcome was 30-day mortality. Secondary outcomes were longer-term mortality, 30-day major adverse events, and aneurysm-related mortality. Primary and secondary outcomes were compared between octogenarians and non-octogenarians. Exclusion criteria were emergency procedures, non-infrarenal aneurysms, and lack of octogenarian data. RESULTS: A total of 41 studies were eligible from 10 099 citations, including 10 national and 5 international registries, 26 retrospective studies, and our own prospective cohort. The analysis included 208 997 non-octogenarians (mean age=70.19 [SD=0.62]) and 106 188 octogenarians (mean age=83.75 [SD=0.35]). The 30-day mortality post-elective EVAR was higher in octogenarians (1.08% in non-octogenarians, 2.31% in octogenarians, odds ratio [OR]=2.27 [2.08-2.47], p<0.0001). Linear regression demonstrated a 0.83% increase in 30-day mortality for every 10-year age increase above 60 years old. Mortality for octogenarians increased significantly during follow-up: 11.35% (OR=1.87 [1.65-2.13], p<0.001), 22.80% (OR=1.89 [1.52-2.35], p<0.001), 32.00% (OR=1.98 [1.66-2.37], p<0.001), 47.53%, and 51.08% (OR=2.40 [1.90-3.03], p<0.001) at 1-through-5-year follow-up, respectively. The 30-day major adverse events after elective EVAR were higher in octogenarians (OR=1.75-2.83, p<0.001). CONCLUSIONS: Octogenarians experience higher but acceptable peri-operative morbidity and mortality compared with younger patients. However, 3-year to 5-year survival is very low among octogenarians. Our findings challenge the notion of routine intervention in elderly patients and support very careful selection for elective EVAR. Many octogenarians with peri-threshold (<6 cm) AAAs may derive no benefit from EVAR due to limited 3-year to 5-year overall survival and low risk of aneurysm rupture with conservative management. An adjusted threshold for intervention in octogenarians may be warranted. CLINICAL IMPACT: Octogenarians with infra-renal AAA are increasingly managed with elective EVAR. Previous studies have demonstrated that EVAR is safer than open repair for octogenarians, with lower peri-operative mortality and major adverse events. However, randomised trials, on which much of contemporary evidence is based, recruited a relatively younger population of participants. This systematic review and meta-analysis provides a contemporary synthesis of the literature comparing outcomes in octogenarians to younger patients. The results of this analysis, together with low rupture rates amongst octogenarians in existing literature, question the benefit of routine elective intervention for peri-threshold aneurysms and an adjusted threshold for intervention in octogenarians may be warranted.

Sealing Zone Failure Decreases the Long Term Durability of Endovascular Aneurysm Repair.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has a higher long term aneurysm related mortality rate compared with open surgery, mainly due to aneurysm rupture. Loss of stent graft to vessel apposition at the EVAR sealing zones is a potential cause of post-EVAR rupture. This study aimed to investigate sealing zone failure and its relationship with post-EVAR rupture. METHODS: This was a retrospective structured review of pre- and post-operative computed tomography (CT) scans of 399 consecutive patients treated with standard bifurcated EVAR. The primary outcome was total loss of seal at last post-operative CT. Secondary outcomes were partial loss of seal, standard follow up detection, post-EVAR rupture, aneurysm sac development, and endoleaks. RESULTS: During a median follow up of 5.3 years, total and partial loss of seal occurred in 85 (21.3%) and 78 (19.5%) patients, respectively. Initial mean sealing zone lengths were within current recommendations but decreased over time, mainly due to vessel dilatation. Mean proximal sealing length at the one month CT was 15.5 ± 10.5 mm (95% confidence interval [CI] 12.6 - 18.5 mm) in the group with total loss of seal, 14.3 ± 6.9 mm (95% CI 12.2 - 16.4 mm) with partial loss of seal, and 23.2 ± 7.4 mm (95% CI 22.3 - 24.0 mm) with preserved seal through follow up (p < .001). Mean iliac sealing lengths were 22.4 ± 12.1 mm (95% CI 18.9 - 25.8 mm) if total loss and 21.8 ± 10.0 mm (95% CI 19.6 - 24.0 mm) if partial loss of seal vs. 34.7 ± 12.4 mm (95% CI 33.8 - 35.7 mm) if preserved seal. Larger vessel diameters were associated with loss of seal in both the proximal and distal sealing zones. During the study period, 13 post-EVAR ruptures occurred, all preceded by CT findings of total (n = 7) or partial (n = 6) loss of seal. Aneurysm sac expansion was seen in 40% of patients with total loss of seal, 18% with partial loss of seal, and 6.6% with preserved seal. CONCLUSION: Loss of seal after EVAR is frequent and associated with post-EVAR rupture. Increased recommended sealing zones lengths and focus on sealing zones in surveillance may reduce post-EVAR ruptures and aneurysm related death.

Early and Mid-Term Results of Endovascular Aneurysm Repair with the Cordis Incraft Ultra-Low Profile Endograft: A High-Volume Center Experience.

Background/Objectives: In recent years, manufacturers have developed new low-profile stent grafts to allow endovascular treatment of abdominal aortic aneurysms (AAA) in patients with small access vessels. We evaluated the early and mid-term outcomes of the Incraft (Cordis Corp, Bridgewater, NJ, USA) ultra-low profile endograft implantation in a high-volume single center. Methods: Between 2014 and 2023, 133 consecutive endovascular aneurysm repair (EVAR) procedures performed using the Incraft endograft were recorded in a prospective database. Indications included infrarenal aortic aneurysms, common iliac aneurysms, and infrarenal penetrating aortic ulcers. Mid-term results were analyzed using the Kaplan-Meier method. Results: During the study period, 133 patients were treated with the Cordis Incraft endograft, in both elective and urgent settings. The Incraft graft was the first choice for patients with hostile iliac accesses, a feature characterizing at least one side in 90.2% of the patients in the study cohort. The immediate technical success rate was 78.2%. The intraoperative endoleak rate was 51.9% (20.3% type 1 A, 0.8% type 1 B, and 30.8% type 2 endoleak). Within 30 days, technical and clinical success rates were both 99.3%; all type 1A and 1B endoleaks were resolved at the 30-day follow-up CT-angiogram. After a mean follow-up of 35.4 months, the actuarial freedom from the re-intervention rate was 96.0%, 91.1%, and 84.0% at 1, 3, and 5 years, respectively. The iliac leg patency rate was 97.1%, 94.1%, and 93.1% at 1, 3, and 5 years, respectively. No statistically significant differences were observed between hostile and non-hostile access groups, nor between the groups with grade 1, grade 2, and grade 3 access hostility. Conclusions: The ultra-low profile Cordis Incraft endograft represents a valid option for the endovascular treatment of AAA in patients with hostile iliac accesses. The procedure can be performed with high rates of technical and clinical success at 30 days and the rates of iliac branch occlusion observed during the follow-up period appear acceptable in patients with poor aorto-iliac outflow.

Simultaneous Percutaneous Coronary Intervention (PCI) and Endovascular Aneurysm Repair (EVAR): A Preliminary Report.

Background: Performing percutaneous coronary intervention (PCI) and endovascular aneurysm repair (EVAR) at the same time represents a groundbreaking development in the multidisciplinary treatment of cardiovascular disease. This combined PCI-EVAR approach bridges a critical gap by offering treatment for patients who have both coronary artery disease and aortic aneurysms. This innovative strategy exemplifies the evolving landscape of cardiovascular care, providing a new solution for complex clinical situations that previously required separate procedures. Methods: Six patients with critical coronary artery lesions and asymptomatic infrarenal aortic aneurysms (AAAs) ≥ 6 cm diameter, as well as one patient with critical coronary artery lesions and endoleak type 1A with aneurysms ≥ 6 cm, underwent simultaneous coronary artery revascularization through percutaneous intervention (PCI) and endovascular aneurysm repair (EVAR). The occurrence of any intraoperative or postoperative complication was considered to be the primary endpoint of the study, including the abortion or failure of either PCI or EVAR, bleeding requiring a conversion to open surgical procedures, the failure of local anesthesia, postoperative myocardial or lower limb ischemia, and a postoperative serum creatinine level of >125 mmol/L or of >180 mmol/L in patients affected by chronic renal failure. The overall length of the procedure, X-ray exposure, the quantity of iodine contrast medium administered, and the length of recovery were considered to be secondary endpoints. Results: Postoperative complications included two episodes of acute renal failure in the two patients already affected by chronic renal failure, which were easily resolved with adequate daily hydration and the elimination of nephrotoxic drugs. In no cases did cardiac ischemia or lower limb ischemia occur. The average procedure duration was 198 min (range: 180-240 min), the average fluoroscopy duration was 41.7 min (range: 35-50 min), the average amount of iodinated contrast medium was 34.8 mL (range: 30-40 mL), and the mean length of hospitalization was 2.7 days (range: 2-5 days). Conclusions: In selected patients, this surgical approach has demonstrated safety, reduced hospitalization times, minimized risks associated with complications from the untreated condition if procedures were performed at different times, and facilitated the effective management of intraoperative complications due to the presence of a multidisciplinary team. However, the limited number of patients necessitates further research.

Feasibility of contrast-enhanced ultrasound in the detection and classification of endoleaks after endovascular aneurysm repair.

Background: Endoleaks are common complications after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). Computed tomographic angiography (CTA)/digital subtraction angiography (DSA) is considered the gold standard for evaluating contrast-enhanced ultrasound (CEUS) accuracy in the detection and classification of endoleaks. In recent years, CEUS has been widely used in this field. This study aimed to analyze the accuracy of CEUS in the detection and classification of endoleaks after EVAR. Methods: The data of 98 patients who underwent abdominal aorta CEUS from November 2017 to September 2023 in the ultrasound (US) department of Beijing Hospital were retrospectively analyzed. All the patients underwent EVAR of AAA before CEUS and CTA/DSA, and had complete clinical data. The CEUS and CTA/DSA results were compared to detect endoleaks and categorize the specific types of endoleaks. Results: Among the 98 patients, 74 were male and 24 were female. The patients had an average age of 74.8±9.8 years (range, 43-90 years). Among the 98 patients, 37 (37.8%) endoleaks were detected by CEUS, of which 8 were type Ia, 2 were type Ib, 15 were type II, 7 were type III, 2 were type IV, 2 were type Ia combined with type III, and 1 was type II combined with type III. In addition, among these 98 patients, 39 (39.8%) endoleaks were detected by CTA/DSA, of which 8 were type Ia, 3 were type Ib, 18 were type II, 6 were type III, 2 were type Ia combined with type III, 1 was type II combined with type III, and 1 was type Ib combined with type II. The sensitivity and specificity of CEUS in the detection of endoleaks were 92.3% and 98.3%, respectively. CEUS and CTA/DSA had similar diagnostic efficacy and good consistency in the detection and classification of endoleaks (Kappa value: 0.914, P<0.01). Conclusions: CEUS has high sensitivity and specificity in the detection and classification of endoleaks following EVAR, and its diagnostic efficacy is similar to that of CTA/DSA. In addition, US is safe, non-invasive and repeatable, and thus is worthy of extensive clinical application.

Identifying barriers and facilitators to follow-up after endovascular aortic repair (EVAR): Qualitative study design and protocol.

Endovascular aortic repair (EVAR) is now first line therapy for most patients with abdominal aortic aneurysms (AAA) as it reduces perioperative morbidity and mortality compared to open surgery. However, up to 40 % of patients do not undergo recommended follow-up, increasing risk of subsequent rupture. Risk factors for loss to follow-up have been studied retrospectively, however, qualitative studies assessing perceived barriers and facilitators to follow-up have not been performed and there are few qualitative protocols within the vascular surgery literature. This article presents a qualitative descriptive study protocol aimed at understanding and improving post-operative follow-up adherence after EVAR developed through an iterative process based on the Theoretical Domains Framework of behavior change. Steps include:•Selection of target behavior and study design•Development of study materials, sampling/recruitment strategy, and data collection•Qualitative data analysis and reporting findingsWe demonstrate the feasibility of this study by pilot testing of the semi-structured interview guides on a small group of patients, healthcare providers, and key personnel. This protocol aims to describe key stakeholder experiences within the healthcare system that will ultimately serve as the basis for future multi-institutional research piloting intervention strategies to improve EVAR follow-up.

Optimizing Femoral Access in Emergency EVAR with a Decision-Making Algorithm.

Endovascular aneurysm repair (EVAR) has become the preferred approach over open repair for abdominal aortic aneurysms (AAAs) due to its minimally invasive nature. The common femoral artery (CFA) is the main access vessel for EVAR, with both surgical exposure and percutaneous access being utilized. However, in emergent cases, percutaneous access can be challenging and may result in complications such as bleeding or dissection thrombosis, leading to the need for surgical conversion. This study aimed to share experiences in implementing a decision-making algorithm to reduce surgical conversions due to percutaneous access failures. A total of 74 aortic patients treated with EVAR in emergency settings were included in this retrospective study. This study focused on various outcomes such as perioperative mortality, morbidity, procedure time, surgical exposure time, and surgical conversion rate. After the implementation of the decision-making algorithm, decreases in surgical conversions and operating time were observed. Percutaneous access was found to be more challenging in cases with specific anatomical characteristics of the CFA, such as severe atherosclerosis or smaller vessel diameter. This study highlighted the importance of carefully assessing patient anatomical features and utilizing a decision-making algorithm to optimize outcomes in EVAR procedures. Further research is needed to continue improving practices for managing aortic aneurysms and reducing complications in femoral artery access approaches.

Early Experience With the Iliac Branch Endoprosthesis (IBE) in Managing Iliac Aneurysms.

Aim The objective of this study is to evaluate the feasibility of using iliac branch endoprosthesis (IBE) devices and to examine their short-term outcomes. Materials and methods This was a descriptive, retrospective observational study involving 15 patients diagnosed with either aortoiliac or isolated iliac artery aneurysms and treated with an IBE device. Data were collected for patients who received IBE devices at Glan Clwyd Hospital in Rhyl, United Kingdom, from February 2020 to May 2023. Results Most patients presented with asymptomatic aneurysms; 86.7% (n = 13) had bilateral common iliac artery (CIA) aneurysms. The mean diameter of the CIA was 38.7 ± 8.8 mm, and the mean diameter of the abdominal aortic aneurysm (AAA) was 39.8 ± 23 mm. For the indications of IBE use, 60% (n = 9) of the patients had iliac aneurysms reaching the intervention threshold, 20% (n = 3) had AAA reaching the threshold, and 20% (n = 3) had aortoiliac aneurysms reaching the threshold. The majority of patients underwent bilateral femoral access (86.7%; n = 13), while 13.3% (n = 2) required both femoral and brachial access. Technical success was achieved in all cases. Aside from 20% (n = 3) of cases where the sac size remained static, the majority of patients (80%; n = 12) experienced sac regression. All patients were free from buttock claudication. A type II endoleak was observed in 33.3% (n = 5) of patients. No reinterventions were reported. The mean primary patency was 30.9 ± 0.7 months, and the follow-up period ranged from 12 to 36 months. Conclusions IBEs are an effective medical device, demonstrating a high rate of technical success, minimal need for additional procedures, and a low incidence of complications while maintaining a satisfactory rate of primary patency.

Real world experience with the TREO device in standard EVAR: Mid-term results of 150 cases from a German Multicenter study.

Background: The objective of the study was to analyze mid-term results of unselected patients treated with the TREO (Terumo Aortic, Florida, USA) device at six German hospital sites. Methods: A multicenter, retrospective analysis of patients treated within and outside instructions for use (IFU) from January 2017 to November 2020 was performed. Primary outcomes were technical success, mortality and endograft related complications according to IFU status. Secondary outcomes were aneurysm/procedure related re-interventions. Results: 150 patients (92% male, mean age 73 ±8 years) were treated (within IFU 84% vs. outside IFU 16%) with the TREO device for abdominal aortic aneurysms (n=127 intact, n=17 symptomatic and n=6 ruptured; p=0.30). Technical success was achieved in 147/150 (within IFU 99% vs. outside IFU 92%, p=0.08). 30-day mortality was 2%, one year and overall mortality was 3% and 5%. During a mean follow-up of 28.4 months (range: 1-67.4 months), 35 (25%; within IFU 23% vs. outside IFU 35%, p=0.23) patients suffered from endoleaks. The majority were endoleaks type II (n=33), the remaining type Ia (n=5) and type Ib (n=3). No endoleaks type III-V, migrations or aneurysm ruptures occurred. Overall, 19 patients (13%; within IFU 13% vs. 15% outside IFU, p=0.70) received a secondary intervention: nine endoleak related endovascular procedures, three open conversions, two endograft limb related interventions, four surgical revisions of the femoral access sites and two bowl ischemia related procedures, respectively. Conclusions: This non industry-sponsored, multicenter trial indicates that using the TREO device in a real-world setting (both within and outside IFU) seems feasible in the treatment of patients suffering from AAA. While the rate of complications and secondary interventions is in line with previously published data, the findings highlight the fact that standard EVAR is associated with serious adverse events.

Influence of Bridging Stent Graft Implantation into the Renal Artery during Complex Endovascular Aortic Procedures on the Renal Resistance Index.

Comparative sonographic examination of the renal resistance index (RRI) can provide evidence of renal artery stenosis. The extent to which the RRI is changed after stent graft implantation is not known. The aim of this study was to investigate the influence of stent graft implantation into non-diseased renal arteries during endovascular treatment of pararenal aortic aneurysms on the RRI. Sonographic examinations of the kidneys were conducted using a GE ultrasound system. The evaluation was performed according to the European Society for Vascular Surgery (ESVS) 2D standard criteria. RRI values were determined in consecutive patients on the day before and after stent graft implantation and compared for each kidney. A total of 32 consecutive patients (73.9 ± 8.2 years, 5 females, 27 males) were treated with a fenestrated or branched aortic stent graft including bridging stent graft implantations into both renal arteries and received pre- and postinterventional examinations. Sonomorphologically, the examined kidneys were inconspicuous. The arborisation of the renal perfusion was preserved pre- and post-implantation. The RRI did not differ (0.66 ± 0.06 versus 0.67 ± 0.07; p = ns). Successful stent graft implantation into non-stenosed renal arteries did not lead to a relevant change in RRI. Therefore, the RRI is a suitable tool for assessing renal perfusion after fenestrated or branched endovascular aortic therapy.

Differences in mortality and risk factors, two years after endovascular repair of ruptured abdominal aortic aneurysms - Reassessment analysis.

OBJECTIVE: The prevalence of abdominal aortic aneurysms (AAA) increases with age. Elective intervention for AAA is critical to prevent rupture associated with very high mortality among older males. METHODS: The aim of this study was to address the impact of post-contrast acute kidney-PC-AKI injury among patients treated with endovascular repair of ruptured AAA-EVAR on outcomes such as new onset chronic kidney disease-CKD and mortality among patients within a two-year trial. RESULTS: The same study group (of n = 192 patients) underwent reassessment, two years after EVAR treatment. The overall mortality rate was 16.67%, and it was higher in the AKI group - 38.89%. CKD patients had a mortality rate of 23.88% (n = 16). Among patients with an aneurysm diameter >67 mm mortality rate reached 20% (n = 6), while in the previously reported diabetes mellitus group 37.93% (n = 11). New onset of CKD was diagnosed in 23% of cases. Preexisting CKD patients with PC- AKI contributed to a 33.33% mortality rate (n = 8). CONCLUSION: This study concludes that PC-AKI impacts outcomes and survival in endovascularly treated AAAs. Type 2 diabetes and preexisting chronic kidney disease are associated with higher mortality within a 2-year follow-up, however gender factor was not significant. A larger aneurysm diameter is related with a higher prevalence of PC-AKI. These factors should be taken into account during screening, qualifying patients for the treatment and treating patients with AAA. It may help to identify high-risk individuals and tailor preventive measurements and treatment options accordingly, improving treatment results and reducing mortality.