Development of Off-the-shelf Stent Grafts for Juxtarenal Abdominal Aortic Aneurysms

AbstractIntroductionThe use of EVAR for more complex aneurysm anatomy has become more widespread over the past decade. Fenestrated and branched stent grafts for the visceral and iliac segment show promising short- and midterm outcome and these procedures have become routine in many vascular centers. However, at present, such grafts are customized to the individual patient and planning and manufacturing leads to significant treatment delay subjecting the patients to the risk of rupture during the waiting period. The purpose of this report is to describe the first experience in treating juxta/suprarenal aneurysms using the first version of a new fenestrated stent graftMaterial and MethodsA fenestrated device was designed with two renal fenestrations, an SMA fenestration and a scallop for the coeliac artery. The renal arteries were designed with an inner 6 mm fenestration and an outer 15 mm diameter creating a dome to allow renal artery catheterization for a range of renal artery distribution. Seven patients with complex visceral artery anatomy were treated with customized stent grafts containing these pivot renal fenestrations.ResultsTechnical success was uniform with 100% target vessel catheterization and 0% 30-day mortality. In one case, the graft was displaced slightly during delivery resulting in a renal artery stent occlusion at 2 months postoperatively.ConclusionsThe development of a modified fenestrated device has shown this to be feasible and it has the potential to reduce the need for extensive preoperative graft customization and establishing a true off the shelf platform for juxta- and suprarenal AAA

Vascular PET Prostheses Surface Modification with Cyclodextrin Coating: Development of a New Drug Delivery System

AbstractPurposeCyclodextrins (CDs) are torus shaped cyclic oligosaccharides with a hydrophobic internal cavity and a hydrophilic external surface. We performed and analysed an antibiotic binding on Dacron (polyethyleneterephtalate, PET) vascular grafts, previously coated with CDs based polymers.MethodsThe CDs coating process was based on the pad-dry-cure method patented in our laboratory. The Dacron prostheses were immersed into a solution containing a polycarboxylic acid, a cyclodextrin and a catalyst, and placed into a thermofixation oven before impregnation with an antibiotic solution (Vancomycin). Biocompatibility tests were performed with L132 human epithelial cells. The antibiotic release in an aqueous medium was assessed by batch type experiments using UV spectroscopy.ResultsViability tests confirmed that the CDs polymers coating the Dacron fibers were not toxic towards L132 cell. Cell proliferation was similar on coated and uncoated grafts.A linear release of Vancomycin was observed over 50 days.ConclusionOur results demonstrate the feasibility of coating CDs onto vascular Dacron grafts. Biological tests show no toxicity of the different cyclodextrins coated. A linear release of antibiotics was depicted over 50 days, demonstrating that cyclodextrin grafting was an efficient drug delivery system

Women undergoing endovascular thoracoabdominal aortic aneurysm repair differ significantly from their male counterparts preoperatively and postoperatively

OBJECTIVE: A rational approach to the management of aortic aneurysm disease relies on weighing the risk of aneurysm rupture against the complications and durability of operative repair. In men, seminal studies of infrarenal aortic aneurysm disease and its endovascular management can provide a reasoned argument for the timing and modality of surgery, which is then extrapolated to the management of thoracoabdominal aortic aneurysms (TAAAs). In contrast, there is less appreciation for the natural history of TAAA disease in women and its response to therapy. METHODS: We used a retrospective cohort design of women, all men, and matched men, fit for complex endovascular thoracoabdominal aneurysm repair at two large aortic centers. We controlled for preoperative anatomic and comorbidity differences, and assessed technical success, postoperative renal dysfunction, spinal ischemia, and early mortality. Women and matched men were reassessed at follow-up for long-term durability and survival. RESULTS: Assessing women and all men undergoing complex endovascular aortic reconstruction, we demonstrate that these groups are dissimilar before the intervention with respect to comorbidities, aneurysm extent, and aneurysm size; women have a higher proportion of proximal Crawford extent 1, 2, and 3 aneurysms. Matching men and women for demographic and anatomic differences, we find persistent elevated perioperative mortality in women (16%) undergoing endovascular thoracoabdominal aneurysm repair compared with matched men (6%); however, at the 3-year follow-up, both groups have the same survival. Furthermore, women demonstrate more favorable anatomic responses to aneurysm exclusion, with good durability and greater aneurysm sac regression at follow-up, compared with matched men. CONCLUSIONS: Women and unmatched men with TAAA disease differ preoperatively with respect to aneurysm extent and comorbidities. Controlling for these differences, after complex endovascular aneurysm repair, there is increased early mortality in women compared with matched men. These observations argue for a careful risk stratification of women undergoing endovascular thoracoabdominal aneurysm treatment, balanced with women's good long-term survival and durability of endovascular aneurysm repair

Evaluation of a new imaging software for aortic endograft planning

Objective: The aim of this study was to evaluate a new 3D Workstation workflow (EVAR Assist, Advantage Windows, GE Healthcare, Chalfont, UK) (EA-AW) designed to simplify complex EVAR planning. Patients and methods: All pre-operative computed tomography (CT) scans of patients who underwent repair at our institution of a complex aortic aneurysm using fenestrated endovascular repair (f-EVAR) between January and September 2014, were reviewed. For each patient, imaging analysis (12 measures: aortic diameters and length and "clock position" of visceral artery) was performed on two different workstations: Aquarius (TeraRecon, San Mateo, CA, USA) and EA-AW. According to a standardized protocol, three endovascular surgeons experienced in aortic endograft planning, performed image analyses and data collection independently. We analyzed an internal assessment between observers (on the Aquarius 3DWS) and an external assessment comparing these results with the planning center (PC) data used to custom the fenestrated endografts of the patients enrolled in this study. Finally, we compared both 3DWS data to determine the accuracy and the reproducibility. A p-value < .05 was considered as statistically significant. Complete agreement between operators was defined as 1.0. Results: Intra and inter observer variability (interclass correlation coefficients - ICC: 0.81- .091) was very low and confirmed the reliability of our planners. The ICC comparison between EA-AW and Aquarius was excellent (> 0.8 for both), thus confirming the reproducibility and reliability of the new EA-AW application. Aortic and iliac necks diameters and lengths were similarly reported with both workstations. In our study, the mean difference in distance and orientation evaluation of target vessels evaluated by the two workstations was marginal and has no impact on clinical practice in term of device manufacturing. Conclusions: We showed that complex EVAR planning can be performed with this new dedicated 3D workstation workflow with a good reproducibility

Custom Made Candy Plug for Distal False Lumen Occlusion in Aortic Dissection: International Experience

Objective: To evaluate early and midterm outcomes of the Candy Plug (CP) technique for distal false lumen (FL) occlusion in thoracic endovascular aortic repair for aortic dissection (AD) in a more real world cohort of patients from an international multicentre registry. Methods: A multicentre retrospective study was conducted of all consecutive patients from the contributing centres with subacute and chronic AD treated with the CP technique from October 2013 to April 2020 at 18 centres. Results: A custom made CP was used in 155 patients (92 males, mean age 62 ± 11 years). Fourteen (9%) presented with ruptured false lumen aneurysms. Technical success was achieved in all patients (100%). Clinical success was achieved in 138 patients (89%). The median hospital stay was 7 days (1 – 77). The 30 day mortality rate was 3% (n = 5). Stroke occurred in four patients (3%). Spinal cord ischaemia occurred in three patients (2%). The 30 day computed tomography angiogram (CTA) confirmed successful CP placement at the intended level in all patients. Early complete FL occlusion was achieved in 120 patients (77%). Early (30 day) CP related re-intervention was required in four patients (3%). The early (30 day) stent graft related re-intervention rate was 8% (n = 12). Follow up CTA was available in 142 patients (92%), with a median follow up of 23 months (6 – 87). Aneurysmal regression was achieved in 68 of 142 patients (47%); the aneurysm diameter remained stable in 69 of 142 patients (49%) and increased in five of 142 patients (4%). A higher rate of early FL occlusion was detected in the largest volume centre patients (50 [88%] vs. 70 [71%] from other centres; p = .019). No other differences in outcome were identified regarding volume of cases or learning curve. Conclusion: This international CP technique experience confirmed its feasibility and low mortality and morbidity rates. Aortic remodelling and false lumen thrombosis rates were high and support the concept of distal FL occlusion in AD using the CP technique

Spondylodiscitis following endovascular abdominal aortic aneurysm repair: imaging perspectives from a single centre's experience.

OBJECTIVE: Very few reports have previously described spondylodiscitis as a potential complication of endovascular aortic aneurysm repair (EVAR). We present to our knowledge the first case series of spondylodiscitis following EVAR based on our institution's experience over an 11-year period. Particular attention is paid to the key imaging features and challenges encountered when performing spinal imaging in this complex patient group. MATERIALS AND METHODS: Of 1,847 patients who underwent EVAR at our institution between January 2006 and January 2017, a total of 9 patients were identified with imaging features of spondylodiscitis (0.5%). All cross-sectional studies before and after EVAR were assessed by a Consultant Musculoskeletal Radiologist and a Musculoskeletal Radiology Fellow to evaluate for features of spondylodiscitis. RESULTS: All 9 patients had single-level spondylodiscitis involving lumbosacral levels adjacent to the aortic/iliac stent graft. Eight out of nine patients had an extensive anterior paravertebral phlegmon/abscess that was contiguous with the infected stent graft and native aneurysm sac ± anterior vertebral body erosion. Epidural disease was present in only 3 out of 9 patients and was a minor feature. MRI was non-diagnostic in 3 out of 9 patients owing to susceptibility artefact. 18F-FDG PET/CT accurately depicted the spinal level involved and adjacent paravertebral disease in patients with non-diagnostic MRI and was adopted as the follow-up modality in 3 out of 5 surviving patients. CONCLUSION: Spondylodiscitis is a rare complication post-EVAR. Imaging features of disproportionate anterior paravertebral disease and anterior vertebral body bony involvement suggest direct spread of infection posteriorly to the adjacent vertebral column. Use of MRI versus 18F-FDG PET/CT as the optimal imaging modality should be directed by the type of stent graft deployed

Editor's Choice – European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on Radiation Safety

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