Endovascular repair of bilateral isolated common iliac artery aneurysms with unsuitable anatomy utilizing an aortic bifurcated unibody endograft and modified sandwich technique to preserve pelvic blood flow: a case series.

Bilateral isolated common iliac artery aneurysms (CIAAs) are rare, and endovascular repair of CIAAs has emerged as an alternative to traditional open surgical repair. The primary goal of therapy is to exclude the aneurysm sac while maintaining perfusion of at least one internal iliac artery (IIA) to prevent pelvic ischemia. Although the iliac branch device (IBD) has improved the feasibility of preserving the IIA, its applicability is limited to a specific subset of aneurysm anatomy. We present a case series of three patients with bilateral isolated CIAAs in whom preoperative CT scans revealed an absence of a landing zone, the diameter of proximal CIA diameter was less than 13.0 mm, and normal diameter of the nonaneurysmal infrarenal aorta, making it challenging to use an IBD alone or a standard bifurcated aortic endograft to provide a proximal landing zone for iliac artery stenting. To overcome the small diameter of the infrarenal aorta, we implanted an aortic bifurcated unibody endograft. Then, we utilized a balloon-expandable covered stent-graft with overdilation as a modified sandwich technique to create an "eye of the tiger" configuration to prevent gutter leakage. The final angiography performed during the procedure revealed successful exclusion of the aneurysms, with blood flow to the right IIA and no type III endoleak. During the postoperative follow-up period, no patients exhibited symptoms associated with pelvic ischemia. There were no endoleaks or sac expansions on the two-year follow-up CT scans, and all external and internal iliac graft limbs were patent. This study demonstrated that a combination of an aortic bifurcated unibody endograft and a modified sandwich technique can effectively treat bilateral isolated CIAAs with certain anatomical constraints.

[Partial Arch Repair for Reruptured Aortic Arch Aneurysm due to Endoleak After 2-debranching Thoracic Endovascular Aortic Repair:Report of a Case].

A 67-year-old male was admitted to our hospital for sudden onset chest pain and hoarseness. He underwent 2-debranching thoracic endovascular aortic repair for a ruptured aortic arch aneurysm four years prior. However, computed tomography (CT) revealed an aneurysmal rerupture due to a typeⅠa endoleak. We performed partial arch replacement with uncovered stent removal under intermittent hypothermic circulatory arrest. We needed to be more careful than usual open heart surgery because a non-anatomical bypass procedure was performed. The surgery was successful without any major complications, and the patient was discharged on the 23th postoperative day. Reinterventions post-endovascular repair are sometimes difficult;thus, open surgery could be useful for arch replacement.

Outcomes of thoracic endovascular aortic repair using fenestrated stent grafts in patients with thoracic aortic distal arch aneurysms.

OBJECTIVES: Thoracic endovascular aortic repair (TEVAR) for aortic arch aneurysms is challenging because of anatomical restrictions and the presence of cervical branches. Revascularization of the cervical branch is required when conventional commercial stent grafts are used. TEVAR using fenestrated stent grafts (FSG) often does not require additional procedures to revascularize cervical branches. This study aimed to evaluate the features and initial and midterm outcomes of TEVAR using fenestrated stent grafts. METHODS: From April 2007 to December 2016, 101 consecutive patients underwent TEVAR using fenestrated stent grafts for distal aortic arch aneurysms at a single centre. Technical success, complications, freedom from aneurysm-related death, secondary intervention and aneurysm progression were retrospectively investigated. RESULTS: All the patients underwent TEVAR using fenestrated stent grafts. The 30-day mortality rate was zero. Cerebral infarction, access route problems and spinal cord injury occurred in 4, 3 and 2 patients, respectively. Each type of endoleak was observed in 38 of the 101 patients during the course of the study; 20/38 patients had minor type 1 endoleaks at the time of discharge. The endoleak disappeared in 2 patients and showed no significant change in 8 patients; however, the aneurysm expanded over time in 10 patients. Additional treatment was performed in 8 of the 10 patients with type 1 endoleaks and dilatation of the aneurysm. The rate of freedom from aneurysm-related death during the observation period was 98%. CONCLUSIONS: TEVAR with FSG is a simple procedure, with few complications. Additional treatment has been observed to reduce aneurysm-related deaths, even in patients with endoleaks and enlarged aneurysms. Based on this study, the outcomes of endovascular repair of aortic arch aneurysms using a fenestrated stent graft seem acceptable.

Multi-Energy Low-Kiloelectron Volt versus Single-Energy Low-Kilovolt Images for Endoleak Detection at CT Angiography of the Aorta.

Purpose To compare image quality, diagnostic performance, and conspicuity between single-energy and multi-energy images for endoleak detection at CT angiography (CTA) after endovascular aortic repair (EVAR). Materials and Methods In this single-center prospective randomized controlled trial, individuals undergoing CTA after EVAR between August 2020 and May 2022 were allocated to imaging using either low-kilovolt single-energy images (SEI; 80 kV, group A) or low-kiloelectron volt virtual monoenergetic images (VMI) at 40 and 50 keV from multi-energy CT (80/Sn150 kV, group B). Scan protocols were dose matched (volume CT dose index: mean, 4.5 mGy ± 1.8 [SD] vs 4.7 mGy ± 1.3, P = .41). Contrast-to-noise ratio (CNR) was measured. Two expert radiologists established the reference standard for the presence of endoleaks. Detection and conspicuity of endoleaks and subjective image quality were assessed by two different blinded radiologists. Interreader agreement was calculated. Nonparametric statistical tests were used. Results A total of 125 participants (mean age, 76 years ± 8; 103 men) were allocated to groups A (n = 64) and B (n = 61). CNR was significantly lower for 40-keV VMI (mean, 19.1; P = .048) and 50-keV VMI (mean, 16.8; P < .001) as compared with SEI (mean, 22.2). In total, 45 endoleaks were present (A: 23 vs B: 22). Sensitivity for endoleak detection was higher for SEI (82.6%, 19 of 23; P = .88) and 50-keV VMI (81.8%, 18 of 22; P = .90) as compared with 40-keV VMI (77.3%, 17 of 22). Specificity was comparable among groups (SEI: 92.7%, 38 of 41; both VMI energies: 92.3%, 35 of 38; P = .99), with an interreader agreement of 1. Conspicuity of endoleaks was comparable between SEI (median, 2.99) and VMI (both energies: median, 2.87; P = .04). Overall subjective image quality was rated significantly higher for SEI (median, 4 [IQR, 4-4) as compared with 40 and 50 keV (both energies: median, 4 [IQR, 3-4]; P < .001). Conclusion SEI demonstrated higher image quality and comparable diagnostic accuracy as compared with 50-keV VMI for endoleak detection at CTA after EVAR. Keywords: Aneurysms, CT, CT Angiography, Vascular, Aorta, Technology Assessment, Multidetector CT, Abdominal Aortic Aneurysms, Endoleaks, Perigraft Leak Supplemental material is available for this article. © RSNA, 2024.

Thoraflex Hybrid Prosthesis (THP): the profile.

INTRODUCTION: With the incidence of thoracic aortic disease on the rise, total arch replacement (TAR) with frozen elephant trunk (FET) remains the gold-standard management strategy due to optimal results. Several FET devices exist commercially on the global market. However, the mainstay and most commonly used and reported device is the Thoraflex Hybrid Prosthesis (THP), with several recent reports suggesting its superiority. AREAS COVERED: This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy, and graft kinking. In addition, the design features of THP is discussed, and an overview of market competitors is also highlighted. EXPERT OPINION: THP consistently demonstrates its effectiveness in treating complex thoracic aortic pathology through favorable clinical outcomes, which can be attributed to its unique and innovative design. Rates of early mortality ranged 0.6-14.2%, neurological complications 0-25%, endoleak 0-8.4% and dSINE 0-14.5%, with minimal incidence of graft kinking and coagulopathy. Aortic remodeling is favorable and comparable to competitors. All this evidence solidifies THP as the leading FET device, particularly when combined with appropriate patient selection and surgical planning.

Contrast-Enhanced Ultrasound after Endovascular Aortic Repair: Supplement and Potential Substitute for CT in Early- and Long-Term Follow-Up.

BACKGROUND: Endoleaks are the most common complication after endovascular aneurysm repair (EVAR). Computed tomography angiography (CTA) is presently the golden standard for lifelong surveillance after EVAR. Several studies and meta-analyses have shown contrast-enhanced ultrasound (CEUS) to be a good alternative. The main goal of our study was to further validate the inclusion of CEUS in follow-up examination protocols for the systematic surveillance after EVAR. METHODS: A retrospective analysis of patients who had received CEUS as part of their routine surveillance after EVAR at our center was conducted. Detection rate and classification of endoleak types were compared between available postinterventional CTA/magnetic resonance angiography and follow-up CEUS examinations. Last preinterventional CTAs before EVAR served as baselines with focus on potential cofactors such as age, body mass index, maximum aortic aneurysm diameters, endoleak orientation, and distance-to-surface influencing detection rates and classification. RESULTS: In total, 101 patients were included in the analysis. Forty-four endoleaks (43.5% of cases) were detected by either initial CEUS or CTA, mostly type II (37.6% of the included patients). Initial CEUS showed an endoleak sensitivity of 91.2%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 84.6%. No covariate with an influence on the correct classification could be identified either for CEUS or CT. CONCLUSIONS: CEUS should be considered a valid complementary method to CTA in the lifelong surveillance after EVAR. As type II endoleaks seem to be a common early-term, sometimes spontaneously resolving complication that can potentially be missed by CTA, we suggest combined follow-up protocols including CEUS in the early on postinterventional assessment.

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

BACKGROUND: Local anesthesia (LA) is sparsely used in endovascular aneurysm repair (EVAR) despite short-term benefit, likely secondary to concerns over patient movement preventing accurate endograft deployment. The objective of this study is to examine the association between anesthesia type and endoleak, sac regression, reintervention, and mortality. METHODS: The Vascular Quality Initiative database was queried for all EVAR cases from 2014 to 2022. Patients were included if they underwent percutaneous elective EVAR with anatomical criteria within instructions for use of commercially approved endografts. Multivariable logistic regression with propensity score weighting was used to determine the association between anesthesia type on the risk of any endoleak noted by intraoperative completion angiogram and sac regression. Multivariable survival analysis with propensity score weighting was used to determine the association between anesthesia type and endoleak at 1 year, long-term reintervention, and mortality. RESULTS: Thirteen thousand nine hundred thirty two EVARs met inclusion criteria: 1,075 (8%) LA and 12,857 (92%) general anesthesia (GA). On completion angiogram, LA was associated with fewer rates of any endoleaks overall (16% vs. 24%, P < 0.001). On multivariable analysis with propensity score weighting, LA was associated with similar adjusted odds of any endoleak on intraoperative completion angiogram (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.47-0.68) as well as combined type 1a and type 1b endoleaks (OR 0.72, 95% CI 0.47-1.09). Follow-up computed tomography imaging at 1 year was available for 4,892 patients, 377 (8%) LA and 4,515 (92%) GA. At 1 year, LA was associated with similar rate of freedom from any endoleaks compared to GA (0.66 [95% CI 0.63-0.69] vs. 0.71 [95% CI 0.70-0.72], P = 0.663) and increased rates of sac regression (50% vs. 45%, P = 0.040). On multivariable analysis with propensity score weighting, LA and GA were associated with similar adjusted odds of sac regression (OR 1.22, 95% CI 0.97-1.55). LA and GA had similar rates of endoleak at 1 year (hazard ratio [HR] 0.14, 95% CI 0.63-1.07); however, LA was associated with decreased hazards of combined type 1a and 1b endoleaks at 1 year (HR 0.87, 95% CI 0.80-0.96). LA and GA had similar adjusted long-term reintervention rate (HR 0.77, 95% CI 0.44-1.38) and long-term mortality (HR 1.100, 95% CI 079-1.25). CONCLUSIONS: LA is not associated with increased adjusted rates of any endoleak on completion angiogram or at 1-year follow-up compared to GA. LA is associated with decreased adjusted rates of type 1a and type 1b endoleak at 1 year, but similar rates of sac regression, long-term reintervention, and mortality. Concerns for accurate graft deployment should not preclude use of LA and LA should be increasingly considered when deciding on anesthetic type for standard elective EVAR.

Large-Diameter Fenestrated Endograft Repair of Abdominal Aortic Aneurysms Is Not Associated With Medium-Term Outcomes.

INTRODUCTION: Recent data suggests that infrarenal abdominal aortic aneurysm (AAA) endovascular repair (EVAR) with large diameter grafts (LGs) may have a higher risk of endoleak and reintervention. However, this has not been studied extensively for fenestrated endovascular aneurysm repair (fEVAR). We, therefore, sought to evaluate the outcomes of patients undergoing fEVAR with large-diameter endografts. METHODS: Patients from the national Vascular Quality Initiative registry who underwent fEVAR for intact juxtarenal AAA were identified. Patients with genetic causes for aneurysms, those with prior aortic surgery, and those undergoing repair for symptomatic or ruptured aneurysms were excluded. Rates of endoleaks and reintervention at periprocedural and long-term follow-up timepoints (9-22 mo) were analyzed in grafts 32 mm or larger (LG) and were compared to those smaller than 32 mm (small diameter graft). RESULTS: A total of 693 patients (22.8% LG) were identified. Overall, demographic variables were comparable except LG exhibited a more frequent history of coronary artery disease (32.9% versus 25.4%, P = 0.037). There were no significant differences in the rates of endoleak at procedural completion. Overall survival at 5 y was no different. The rate of reintervention at 1 y was also no different (log-rank P = 0.86). CONCLUSIONS: While graft size appears to have an association with outcomes in infrarenal aneurysm repair, the same does not appear to be true for fEVAR. Further studies should evaluate the long-term outcomes associated with LG which could alter the approach to repair of AAA with large neck diameters traditionally treated with standard infrarenal EVAR.

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

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

Enhanced visualization in endoleak detection through iterative and AI-noise optimized spectral reconstructions.

To assess the image quality parameters of dual-energy computed tomography angiography (DECTA) 40-, and 60 keV virtual monoenergetic images (VMIs) combined with deep learning-based image reconstruction model (DLM) and iterative reconstructions (IR). CT scans of 28 post EVAR patients were enrolled. The 60 s delayed phase of DECTA was evaluated. Objective [noise, contrast-to-noise ratio (CNR), signal-to-noise ratio (SNR)] and subjective (overall image quality and endoleak conspicuity - 3 blinded readers assessment) image quality analyses were performed. The following reconstructions were evaluated: VMI 40, 60 keV VMI; IR VMI 40, 60 keV; DLM VMI 40, 60 keV. The noise level of the DLM VMI images was approximately 50% lower than that of VMI reconstruction. The highest CNR and SNR values were measured in VMI DLM images. The mean CNR in endoleak in 40 keV was accounted for as 1.83 ± 1.2; 2.07 ± 2.02; 3.6 ± 3.26 in VMI, VMI IR, and VMI DLM, respectively. The DLM algorithm significantly reduced noise and increased lesion conspicuity, resulting in higher objective and subjective image quality compared to other reconstruction techniques. The application of DLM algorithms to low-energy VMIs significantly enhances the diagnostic value of DECTA in evaluating endoleaks. DLM reconstructions surpass traditional VMIs and IR in terms of image quality.

Injection of n-Butyl-2-Cyanoacrylate into the Abdominal Aortic Aneurysm Sac during Endovascular Aortic Repair to Prevent Type II Endoleaks Caused by Lumbar Arteries.

PURPOSE: To evaluate midterm results of whether the strategy to occlude target lumbar arteries using n-butyl-2-cyanoacrylate (nBCA) injection during endovascular aneurysm repair (EVAR) reduced the incidence of Type II endoleak (T2EL) after EVAR. MATERIALS AND METHODS: Between 2013 and 2020, 187 patients underwent EVAR; 106 in the treatment group received nBCA injection during EVAR, whereas 81 in the historical control group did not. The incidence of T2EL at 7 days, need for reintervention, and post-EVAR aneurysmal shrinkage were compared between the groups. RESULTS: Between the treatment group and the control group, significant differences were achieved in the incidence of T2EL (2.8% vs 28.4%; P < .0001) and decreased aneurysmal diameter was observed at 1 year after EVAR (-5.2 vs -3.8 mm; P = .034). In multivariate analysis, nBCA injection (odds ratio [OR], 0.04; P = .001) and younger age (OR, 0.92; P = .036) were significantly associated with a reduced incidence of T2EL. As a possible adverse event associated with nBCA injection, 2 cases of transient lower-limb motor dysfunction (1.9%) were observed. Propensity score analysis revealed that the treatment group had a significantly lower incidence of T2EL than that in the control group (P = .0002) even though there was no difference in the incidence of inferior mesenteric artery coil embolization between the groups. The survival rate without aneurysm sac enlargement (100.0% vs 69.8%; P = .014) and the reintervention-free rate (100.0% vs 63.1%; P = .034) in the treatment group were significantly higher than those in the control group. CONCLUSIONS: Concomitant nBCA injection can provide durable EVAR without T2EL, as supported by the avoidance of reintervention associated with aneurysm sac enlargement.

One-year follow-up after active aortic aneurysm sac treatment with shape memory polymer devices during endovascular aneurysm repair.

OBJECTIVE: To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. METHODS: Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. RESULTS: Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was -28.8% (95% CI, -35.3 to -22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was -5.9 mm (95% CI, -7.5 to -4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. CONCLUSIONS: Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.

CIRSE Standards of Practice on Management of Endoleaks Following Endovascular Aneurysm Repair.

BACKGROUND: Endoleaks represent the most common complication after EVAR. Some types are associated with ongoing risk of aneurysm rupture and necessitate long-term surveillance and secondary interventions. PURPOSE: This document, as with all CIRSE Standards of Practice documents, will recommend a reasonable approach to best practices of managing endoleaks. This will include imaging diagnosis, surveillance, indications for intervention, endovascular treatments and their outcomes. Our purpose is to provide recommendations based on up-to-date evidence, updating the guidelines previously published on this topic in 2013. METHODS: The writing group was established by the CIRSE Standards of Practice Committee and consisted of clinicians with internationally recognised expertise in endoleak management. The writing group reviewed the existing literature performing a pragmatic evidence search using PubMed to select publications in English and relating to human subjects up to 2023. The final recommendations were formulated through consensus. RESULTS: Endoleaks may compromise durability of the aortic repair, and long-term imaging surveillance is necessary for early detection and correct classification to guide potential re-intervention. The majority of endoleaks that require treatment can be managed using endovascular techniques. This Standards of Practice document provides up-to-date recommendations for the safe management of endoleaks.

Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany.

BACKGROUND: Beyond a certain threshold diameter, abdominal aortic aneurysms (AAA) are to be treated by open surgical or endovascular aortic aneurysm repair (EVAR). In a quarter of patients who undergo EVAR, inversion of blood flow in the inferior mesenteric artery or lumbar arteries may lead to type II endoleak (T2EL), which is associated with complications (e.g. AAA growth, secondary type I endoleak, rupture). As secondary interventions to treat T2EL often fail and may be highly invasive, prevention of T2EL is desirable. The present study aims to assess the efficacy of sac embolization (SE) with metal coils during EVAR to prevent T2EL in patients at high risk. METHODS: Over a 24-month recruitment period, a total of 100 patients undergoing EVAR in four vascular centres (i.e. Klinikum rechts der Isar of the Technical University of Munich, University Hospital Augsburg, University Hospital Dresden, St. Joseph's Hospital Wiesbaden) are to be included in the present study. Patients at high risk for T2EL (i.e. ≥ 5 efferent vessels covered by endograft or aneurysmal thrombus volume <40%) are randomized to one group receiving standard EVAR and another group receiving EVAR with SE. Follow-up assessments postoperatively, after 30 days, and 6 months involve contrast-enhanced ultrasound scans (CEUS) and after 12 months an additional computed tomography angiography (CTA) scan. The presence of T2EL detected by CEUS or CTA after 12 months is the primary endpoint. Secondary endpoints comprise quality of life (quantified by the SF-36 questionnaire), reintervention rate, occurrence of type I/III endoleak, aortic rupture, death, alteration of aneurysm volume, or diameter. Standardized evaluation of CTA scans happens through a core lab. The study will be terminated after the final follow-up visit of the ultimate patient. DISCUSSION: Although preexisting studies repeatedly indicated a beneficial effect of SE on T2EL rates after EVAR, patient relevant outcomes have not been assessed until now. The present study is the first randomized controlled multicentre study to assess the impact of SE on quality of life. Further unique features include employment of easily assessable high-risk criteria, a contemporary follow-up protocol, and approval to use any commercially available coil material. Overcoming limitations of previous studies might help SE to be implemented in daily practice and to enhance patient safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT05665101. Registered on 23 December 2022.

Fate of primary determinate and indeterminate target vessel endoleaks after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The aim of this study was to investigate the outcomes of primary determinate and indeterminate target vessel endoleaks (TVELs) after fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS: We conducted a single-center retrospective study (2014-2023) on F-BEVAR for thoracoabdominal (TAAAs) or pararenal aortic aneurysms (PRAAs). TVELs were classified as "primary" if present at the first postoperative computed tomography angiogram. Endoleaks were defined "determinate" (dELs) if the cause (type Ic or IIIc) and implicated target vessel were identifiable and "indeterminate" (iELs) if contrast enhancement was detectable at the level of fenestrations/branches without any evident source. Endoleaks involving multiple inflows (type II and target vessels) were defined as "complex" (cELs). Endpoints were endoleak spontaneous resolution, 1-year aneurysm sac failure to regress (>5 mm diameter decrease), and 4-year endoleak-related secondary interventions. Kaplan-Meier estimates and Cox regression were used for the analysis. RESULTS: There were 142 patients with JRAAs/PRAAs (n = 85; 60%) or TAAAs (n = 57; 40%), with 513 target arteries incorporated through a fenestration (n = 294; 57%) or directional branch (n = 219; 43%). Fifty-nine primary TVELs (12%) were identified in 35 patients (25%), a dEL in 20 patients (14%) and iEL in 15 (11%); 22 (15%) had a determinate or indeterminate cEL. Overall spontaneous resolution rate was 75% (95% confidence interval [CI], 51%-87%) at 4 years. cELs (odds ratio [OR], 5.00; 95% CI, 1.10-49.4; P < .001) and iELs after BEVAR (OR, 9.43; 95% CI, 3.41-56.4; P = .002) were more likely to persist >6 months, and persistent forms were associated with sac failure to regress at 1 year (OR, 1.72; 95% CI, 1.03-12.59; P = .040). Overall freedom from endoleak-related reinterventions was 85% (95% CI, 79%-92%) at 4 years, 92% (95% CI, 87%-97%) for those without primary TVELs and 62% (95% CI, 46%-84%) for those with any primary TVEL (P < .001). In particular, cELs (hazard ratio, 1.94; 95% CI, 1.4-18.81; P = .020) were associated with an increased need for reintervention. In case a secondary intervention was needed, iEL or cEL had an increased risk for multiple secondary procedures (hazard ratio, 2.67; 95% CI, 1.22-10.34; P = .034). CONCLUSIONS: Primary TVELs are frequent after F-BEVAR, and a clear characterization of the endoleak source by computed tomography angiogram is not possible in 40% of patients. Most primary TVELs spontaneously resolve, but during follow-up, patients with any primary TVEL experience a worsened freedom from endoleak-related reinterventions that is mostly driven by persistence of cELs and post-BEVAR iELs. Multiple secondary procedures may be required in case of iELs or cELs.

Ultrasound Coded-Excitation Imaging for Endoleak Detection After Complex Endovascular Aortic Repair.

OBJECTIVES: Several imaging modalities have been suggested for surveillance after fenestrated endovascular aortic repair in general and endoleak detection in specific. In the present project a coded excitation-based ultrasound (B-Flow) was investigated for endoleak detection after complex endovascular aortic repair. METHODS: Patients post complex endovascular aortic repair (FEVAR or T/FEVAR) undergoing follow-up appointments including ultrasonography of the aorta at a vascular and endovascular surgery outpatient center were included in the study. B-Flow was compared with computed tomography angiography (CTA), Duplex ultrasound (DUS), and contrast-enhanced ultrasound (CEUS) regarding agreement and reliability for endoleak detection and characterization. RESULTS: In total, 47 follow-ups were included. They accumulated in a total of 149 imaging investigations. Endoleaks were discovered in 44.7% of B-Flow studies and a majority of these endoleaks were classified as type II. Agreement between B-Flow and other imaging modalities was good (>80.0%) in general. However, with B-Flow 6 and 2 endoleaks would have been missed compared with CEUS and CTA, respectively. Regarding endoleak classification, B-Flow had a strong agreement (94.5%) with CEUS in detected cases. Furthermore, in a limited subset analysis, imaging findings were externally validated using findings from angiography. CONCLUSIONS: Ultrasonography allows for endoleak detection and characterization without an invasive procedure or the use of potentially nephrotoxic contrast medium and can reduce radiation exposure. While CEUS mitigates issues of radiation and nephrotoxicity it still requires the intravenous application of contrast enhancers. Ultrasound coded-excitation imaging such as B-Flow could therefore further simplify endoleak surveillance after fenestrated endovascular aortic repair.

Image Guidance Techniques and Treatment Approach Optimization in the Management of Type-II Endoleak After Endovascular Aortic Aneurysm Repair.

BACKGROUND: Over the past 3 decades endovascular aortic aneurysm repair emerged as the primary approach for abdominal aortic aneurysm management, however the occurrence of endoleak following endograft implantation imposes a high toll on patients and hospitals alike. The early diagnosis and appropriate treatment of endoleaks is associated with better outcomes, which calls for more advanced imaging and a standardized approach for endoleak diagnosis and management following endovascular aortic aneurysm repair. Although conventional strategy with non-targeted deployment of coils and embolic material in the aneurysm sac is considered to be the standard approach in many hospitals, it may not prove to be a viable option, given that it affects any further follow-up imaging in the event of sub-optimal therapy and consequent recurrence. METHODS: Based on our tertiary aortic referral center experience we summarize and describe strategies for optimal selection of various treatment approaches for Type-II Endoleak management including endovascular, percutaneous and laparoscopic approaches with particular focus on intraoperative image guidance techniques. RESULTS: After failed conventional endovascular embolization attempt we recommend specific complex type II endoleak management approaches based on the location of the endoleak within the aneurysm sac along the x, y and z axis. A transabdominal or laparoscopic approach enable treatment in endoleaks located in the anterior portion of the sac. Endoleaks in the posterior portion of the sac could be treated using the transcaval or the translumbar approach, depending on whether the endoleak is situated on the left or the right side. Alternative strategies should be considered if patient anatomy does not allow for either transcaval or translumbar approach. The transgraft technique is reserved for endoleaks located in the cranial portion of the sac, while the perigraft approach could present a means of treatment for endoleaks situated in the caudal portion of the aneurysm sac. CONCLUSION: We encourage establishing a patient specific treatment plan in accordance with individual anatomy based on cross sectional imaging modality (time resolved dynamic imaging in selected cases) and intraoperative image guidance to provide a safe and accurate endoleak localization and embolization for patients undergoing type II endoleak treatment.

Stereolithographic (SLA) 3D Printing for Preprocedural Planning in Endovascular Aortic Repair of a Thoracic Aneurysm.

BACKGROUND: When treating aortic aneurysm patients with complex anatomical features, preprocedural planning aided by 3D-printed models offers valuable insights for endovascular intervention. This study highlights the use of stereolithographic (SLA) 3D printing to fabricate a phantom of a challenging aortic arch aneurysm with a complex neck anatomy. CLINICAL CASE: A 75-year-old female presented with a 58 mm descending thoracic aortic aneurysm (TAA) extending to the distal arch, involving the left subclavian artery (LSA) and the left common carotid artery (LCCA). The computed tomography (CT) scans underwent scrutiny by radiology and vascular teams. Nevertheless, the precise spatial relationships of the ostial origins proved to be challenging to ascertain. To address this, a patient-specific phantom of the aortic arch was fabricated utilizing an SLA printer and a biomedical resin. The thoracic endovascular aortic repair (TEVAR) procedure was simulated using fluoroscopy on the phantom to enhance procedural preparedness. Subsequently, the patient underwent a right carotid-left carotid bypass and a right carotid-left subclavian bypass. After a 24-hour interval, the patient underwent the TEVAR procedure, during which a 37 mm × 150 mm stent graft (CTAG, WL Gore and Associates, Flagstaff, AZ, USA) and a 40 mm × 200 mm stent graft (CTAG, WL Gore and Associates, Flagstaff, AZ, USA) were deployed, effectively covering the LSA and LCCA. Notably, the aneurysm exhibited complete sealing, with no indications of endoleaks or graft infoldings. At the 12-month follow-up, the patient remains in good health, with no evidence of endoleaks or any other surgery-related complication. CONCLUSION: This report showcases the successful use of a 3D-printed endovascular phantom in guiding the decision-making process during the preparation for a TEVAR procedure. The simulation played a pivotal role in selecting the appropriate stent graft, ensuring an intervention protocol optimized based on the patient-specific anatomy.

Reducing aneurysm sac growth and secondary interventions following endovascular abdominal aortic aneurysm repair by preemptive coil embolization of the inferior mesenteric artery and lumbar arteries.

OBJECTIVE: Type II endoleak (EL-2) is the most common complication following endovascular aneurysm repair (EVAR), leading to continued sac growth and potential rupture. In this study, we examined the association between patency of the inferior mesenteric artery (IMA) and lumbar arteries (LAs) with respect to sac growth. The effect of preemptive embolization of the IMA and/or LAs on the need for secondary interventions for sac growth post-EVAR was also evaluated. METHODS: A retrospective cohort study was performed on consecutive patients who underwent EVAR for non-ruptured, infrarenal abdominal aortic aneurysms (AAAs) from January 2012 to December 2020. A select group of patients underwent preemptive embolization of the IMA and/or LA. Patients with any types I, III, or IV endoleaks were excluded. Patency of the IMA and LA on preoperative computed tomography angiogram (CTA) was evaluated on TeraRecon workstation. All secondary interventions to treat EL-2 were recorded. Sac growth was defined as centerline axial diameter increase of ≥5 mm on follow-up CTA. RESULTS: A total of 300 patients (mean age, 74 ± 8.5 years; 83.7% male) underwent EVAR. Ninety-nine patients had preemptive embolization of the IMA and/or LA. Mean follow-up of the cohort was 59.3 ± 30.5 months. Thirty-six patients (12%) demonstrated sac growth on follow-up; 12 of these (33.3%) had preemptive embolization. The median time until detection of sac growth was 28.8 months (interquartile range, 15.2-46.5 months), with a mean growth of 10.1 ± 6.4 mm. Sac growth was significantly associated with presence of EL-2: 27 of 36 (75%) with EL-2 vs 9 of 36 (25%) without EL-2 (P < .001). Patients with sac growth had a higher mean total number (2.6 ± 1.5) of patent lower LAs (L3, L4) compared with those without (2.0 ± 1.4; P = .03). Patency of L1, L2, and L3 LAs were not associated with sac growth. However, patency of at least one L4 LA was significantly associated with sac growth (14.8% vs 7.7%; P = .04). The highest incidence of sac growth (17.6%) was seen when both IMA and L4 LA were patent; significantly different from the lowest incidence (5.3%) when both were occluded preoperatively (P = .018). Preemptive coiling of the IMA and/or LA significantly reduced the need for post-EVAR secondary intervention for sac growth. Freedom from post-EVAR secondary intervention was achieved in 92 of 99 (92.9%) pre-EVAR coiled patients vs 163 of 201 (81.5%) patients who did not undergo pre-EVAR coiling (P = .009). CONCLUSIONS: Preemptive coil embolization of the IMA and LAs, especially L4 LA, reduces the need for secondary interventions for sac growth, potentially improving the long-term durability of EVAR.