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Background Aortic aneurysms, a significant cause of mortality, particularly in individuals aged 55 years and older, have witnessed a transformative shift in treatment strategies with the advent of endovascular surgery. Cydar-EV is an innovative image fusion technology that can augment preoperative planning and surgical guidance of endovascular aneurysm repair (EVAR). The ARIA trial aims to evaluate the efficacy of using Cydar-EV with EVAR procedures to reduce operating time while enhancing procedural precision, patient outcomes, and cost-effectiveness. This paper describes the statistical analysis plan for the study. Methods/design The ARIA trial, a phase III, multi-centre, open-label, two-armed, parallel groups randomised controlled surgical trial, seeks to recruit 340 patients diagnosed with abdominal or thoraco-abdominal aortic aneurysms. Participants are randomly assigned to receive either standard endovascular repair or an endovascular repair assisted by Cydar-EV for planning and surgical guidance. Primary and secondary outcomes are assessed at baseline, 4–12 weeks, and 52 weeks. The primary outcome measure is procedure duration at baseline, while additional secondary outcomes are recorded at various time points and include indicators for technical effectiveness, patient outcomes, procedure efficiency, and cost-effectiveness. We plan to analyse the patient outcome data according to the treatment they received regardless of initial allocation. The statistical analysis plan outlines methods for handling missing data, covariates for adjusted analyses, and planned sensitivity analyses to ensure robust evaluation of treatment effects. Trial registration The trial was registered with the ISRCTN register on 03/12/2021, number ISRCTN13832085.

ObjectivesEspecially patients with aortic aneurysms and multiple computed tomography angiographies (CTA) might show medical conditions which oppose the use of iodine-based contrast agents. CTA using monoenergetic reconstructions from dual layer CT and gadolinium (Gd-)based contrast agents might be a feasible alternative in these patients. Therefore, the purpose of this study was to evaluate the feasibility of clinical spectral CTA with a Gd-based contrast agent in patients with aortic aneurysms.MethodsTwenty-one consecutive scans in 15 patients with and without endovascular aneurysm repair showing contraindications for iodine-based contrast agents were examined using clinical routine doses (0.2 mmol/kg) of Gd-based contrast agent with spectral CT. Monoenergetic reconstructions of the spectral data set were computed.ResultsThere was a significant increase in the intravascular attenuation of the aorta between pre- and post-contrast images for the MonoE40 images in the thoracic and the abdominal aorta (p < 0.001 for both). Additionally, the ratio between pre- and post-contrast images was significantly higher in the MonoE40 images as compared to the conventional images with a factor of 6.5 ± 4.5 vs. 2.4 ± 0.5 in the thoracic aorta (p = 0.003) and 4.1 ± 1.8 vs. 1.9 ± 0.5 in the abdominal aorta (p < 0.001).ConclusionsTo conclude, our study showed that Gd-CTA is a valid and reliable alternative for diagnostic imaging of the aorta for clinical applications. Monoenergetic reconstructions of computed tomography angiographies using gadolinium based contrast agents may be a useful alternative in patients with aortic aneurysms and contraindications for iodine based contrast agents.Key pointsPatients with aortic aneurysms may show contraindications for iodine based contrast agents but need multiple follow-up examinations.Monoenergetic reconstructions of computed tomography angiography using gadolinium based contrast agents is feasible in patients with aortic aneurysms.Dual-layer spectral computed tomography may therefore be a useful tool in patients with aortic aneurysms needing follow-up scans.

Objective To assess the three year clinical outcomes and cost effectiveness of a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair for patients with suspected ruptured abdominal aortic aneurysm.Design Randomised controlled trial.Setting 30 vascular centres (29 in UK, one in Canada), 2009-16.Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm, of whom 502 underwent emergency repair for rupture.Interventions 316 patients were randomised to an endovascular strategy (275 with confirmed rupture) and 297 to open repair (261 with confirmed rupture).Main outcome measures Mortality, with reinterventions after aneurysm repair, quality of life, and hospital costs to three years as secondary measures.Results The maximum follow-up for mortality was 7.1 years, with two patients in each group lost to follow-up by three years. After similar mortality by 90 days, in the mid-term (three months to three years) there were fewer deaths in the endovascular than the open repair group (hazard ratio 0.57, 95% confidence interval 0.36 to 0.90), leading to lower mortality at three years (48% v 56%), but by seven years mortality was about 60% in each group (hazard ratio 0.92, 0.75 to 1.13). Results for the 502 patients with repaired ruptures were more pronounced: three year mortality was lower in the endovascular strategy group (42% v 54%; odds ratio 0.62, 0.43 to 0.88), but after seven years there was no clear difference between the groups (hazard ratio 0.86, 0.68 to 1.08). Reintervention rates up to three years were not significantly different between the randomised groups (hazard ratio 1.02, 0.79 to 1.32); the initial rapid rate of reinterventions was followed by a much slower mid-term reintervention rate in both groups. The early higher average quality of life in the endovascular strategy versus open repair group, coupled with the lower mortality at three years, led to a gain in average quality adjusted life years (QALYs) at three years of 0.17 (95% confidence interval 0.00 to 0.33). The endovascular strategy group spent fewer days in hospital and had lower average costs of −£2605 (95% confidence interval −£5966 to £702) (about €2813; $3439). The probability that the endovascular strategy is cost effective was >90% at all levels of willingness to pay for a QALY gain.Conclusions At three years, compared with open repair, an endovascular strategy for suspected ruptured abdominal aortic aneurysm was associated with a survival advantage, a gain in QALYs, similar levels of reintervention, and reduced costs, and this strategy was cost effective. These findings support the increasing use of an endovascular strategy, with wider availability of emergency endovascular repair.Trial registration Current Controlled Trials ISRCTN48334791; ClinicalTrials NCT00746122.

Repair of Abdominal Aortic Aneurysm This clinical trial compared endovascular with open repair of unruptured abdominal aortic aneurysm. An early survival advantage with endovascular repair was not sustained after 3 years. Aneurysm rupture remains a concern with this type of repair. Each year, 40,000 patients in the United States undergo elective procedures to repair abdominal aortic aneurysms. 1 These procedures result in about 1250 perioperative deaths — more than for any other general or vascular surgical procedure, with the exception of colectomy. 2 Endovascular repair was introduced in the 1990s as a less invasive method than traditional open repair. Randomized trials have shown that endovascular repair reduces perioperative mortality, 3 – 5 but in the United Kingdom Endovascular Aneurysm Repair 1 (EVAR 1) trial 3 and the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, 4 this advantage was lost within 2 years owing to excess late deaths . . .

Patients with aortic enlargement are recommended to undergo serial imaging and clinical follow-up until they reach surgical thresholds. This study aimed to identify aortic diameter and care of patients with aortic imaging before aortic dissection (AD). In a retrospective cohort of AD patients, we evaluated previous imaging results in addition to ordering providers and indications. Imaging was stratified as >1 or <1 year: 62 patients (53% men) had aortic imaging before AD (most recent test: 82% echo, 11% computed tomography, 6% magnetic resonance imaging). Imaging was ordered most frequently by primary care physicians (35%) and cardiologists (39%). The most frequent imaging indications were arrhythmia (11%), dyspnea (10%), before or after aortic valve surgery (8%), chest pain (6%), and aneurysm surveillance in 13%. Of all patients, 94% had aortic diameters below the surgical threshold before the AD. Imaging was performed <1 year before AD in 47% and aortic size was 4.4 ± 0.8 cm in ascending aorta and 4.0 ± 0.8 cm in sinus. In patients whose most recent imaging was >1 year before AD (1,317 ± 1,017 days), the mean ascending aortic diameter was 4.2 ± 0.4 cm. In conclusion, in a series of patients with aortic imaging before AD, the aortic size was far short of surgical thresholds in 94% of the group. In >50%, imaging was last performed >1 year before dissection.

This study utilized multidimensional dynamic computed tomography angiography (MD-CTA) to analyze the biomechanical characteristics of ascending thoracic aortic aneurysms (ATAA) in 30 subjects: 20 ATAA patients (12 with Marfan syndrome and 8 without) and 10 healthy individuals without ascending aortic disease. Aortic models were reconstructed from CTA images, and multi-phase displacement data were obtained via image registration. The inverse finite element method (iFEM) was applied to calculate wall tension, and displacement data was used to calculate wall strain, from which strain–tension curves were fitted. Based on these curves, we calculated the previously proposed mechanical parameters SSI and dSSI to assess wall mechanics. Given the considerable deformation of the ascending aorta, two additional parameters—potential energy reserve index (PERI) and strain resistance (Rs)—were used to evaluate energy storage. Mann–Whitney U tests revealed that both SSI and dSSI were significantly higher in the non-Marfan ATAA group compared to the Marfan and control groups, but showed no significant difference between the latter two groups. PERI and Rs were higher in the non-Marfan group compared to two other groups, reaching significance only between the non-Marfan and control groups, while the Marfan and control groups showed no significance. With further validation, these in vivo biomechanical markers may be used as complementary metrics for assessing patient-specific risk of aneurysm rupture.

Introduction Acute Stanford type A aortic dissection (ATAAD) is a lethal emergency. However, even with instant surgical repair, early mortality is up to 20%. ATAAD complicated by coronary artery involvement is considered rare but life-threatening because this can cause coronary artery malperfusion which results in acute myocardial infarction. In particular, left coronary artery malperfusion can bring worse outcomes than right coronary artery malperfusion, but there are few reports of left coronary artery involvement secondary to ATAAD. Case presentation We present a case of a woman who got emergency open heart surgery due to ATAAD. After the hemiarch replacement, the first weaning from bypass was relatively smooth. However, as soon as starting infusion protamine, we found out sudden regional wall motion abnormality at the diffuse anteroseptal to the lateral wall on echocardiography and ST depression on leads II and V5 electrocardiogram after several ventricular fibrillation. We recognized by echocardiography that intimal dissection flap extended to the left coronary artery ostium and dynamically obstructed left coronary artery blood flow, because the true lumen collapsed dynamically during the diastolic phase. Upon re-establishing bypass, proximal aortic false lumen was obliterated with BioGlue again. Smooth weaning from bypass proceeded at last. Finally, the blood flow to the left coronary artery ostium was good, and the wall motion abnormality was improved. Conclusion Our report suggests the importance of the degree of myocardial damage caused by coronary artery malperfusion which is a major predictor of patient outcome. To reduce complications and minimize the mortality rate, an instant treatment plan is needed. However, limited options for exact surgical treatment directions or guidelines for coronary artery malperfusion secondary to ATAAD are available so far. We emphasize that we should not neglect any signs indicative of coronary artery malperfusion appear such as changes of electrocardiogram and echocardiography. Moreover, our report contributes to a profound understanding among clinicians regarding the necessity of practical treatment guidelines about coronary artery malperfusion due to ATAAD based on various surgical experiences and studies.

IntroductionEndovascular aortic aneurysm repair (EVAR) requires long-term surveillance to detect and treat postoperative complications. However, prediction models to optimise follow-up strategies are still lacking. The primary objective of this study is to develop predictive models of post-operative outcomes following elective EVAR using Artificial Intelligence (AI)-driven analysis. The secondary objective is to investigate morphological aortic changes following EVAR.Methods and analysisThis international, multicentre, observational study will retrospectively include 500 patients who underwent elective EVAR. Primary outcomes are EVAR postoperative complications including deaths, re-interventions, endoleaks, limb occlusion and stent-graft migration occurring within 1 year and at mid-term follow-up (1 to 3 years). Secondary outcomes are aortic anatomical changes. Morphological changes following EVAR will be analysed and compared based on preoperative and postoperative CT angiography (CTA) images (within 1 to 12 months, and at the last follow-up) using the AI-based software PRAEVAorta 2 (Nurea). Deep learning algorithms will be applied to stratify the risk of postoperative outcomes into low or high-risk categories. The training and testing dataset will be respectively composed of 70% and 30% of the cohort.Ethics and disseminationThe study protocol is designed to ensure that the sponsor and the investigators comply with the principles of the Declaration of Helsinki and the ICH E6 good clinical practice guideline. The study has been approved by the ethics committee of the University Hospital of Patras (Patras, Greece) under the number 492/05.12.2024. The results of the study will be presented at relevant national and international conferences and submitted for publication to peer-review journals.

It was recently submitted that the rupture risk of an ascending thoracic aortic aneurysm (ATAA) is strongly correlated with the aortic stiffness. To validate this assumption, we propose a non-invasive inverse method to identify the patient-specific local extensional stiffness of aortic walls based on gated CT scans. Using these images, the local strain distribution is reconstructed throughout the cardiac cycle. Subsequently, obtained strains are related to tensions, through local equilibrium equations, to estimate the local extensional stiffness at every position. We apply the approach on 11 patients who underwent a gated CT scan before surgical ATAA repair and whose ATAA tissue was tested after the surgical procedure to estimate the rupture risk criterion. We find a very good correlation between the rupture risk criterion and the local extensional stiffness. Finally it is shown that patients can be separated in two groups: a group of stiff and brittle ATAA with a rupture risk criterion above 0.9, and a group of relatively compliant ATAA with a rupture risk below 0.9. Although these results need to be repeated on larger cohorts to impact the clinical practice, they support the paradigm that local aortic stiffness is an important determinant of ATAA rupture risk.