The ARIA trial protocol: a randomised controlled trial to assess the clinical, technical, and cost-effectiveness of a cloud-based, ARtificially Intelligent image fusion system in comparison to standard treatment to guide endovascular Aortic aneurysm repair.

BACKGROUND: Endovascular repair of aortic aneurysmal disease is established due to perceived advantages in patient survival, reduced postoperative complications, and shorter hospital lengths of stay. High spatial and contrast resolution 3D CT angiography images are used to plan the procedures and inform device selection and manufacture, but in standard care, the surgery is performed using image-guidance from 2D X-ray fluoroscopy with injection of nephrotoxic contrast material to visualise the blood vessels. This study aims to assess the benefit to patients, practitioners, and the health service of a novel image fusion medical device (Cydar EV), which allows this high-resolution 3D information to be available to operators at the time of surgery. METHODS: The trial is a multi-centre, open label, two-armed randomised controlled clinical trial of 340 patient, randomised 1:1 to either standard treatment in endovascular aneurysm repair or treatment using Cydar EV, a CE-marked medical device comprising of cloud computing, augmented intelligence, and computer vision. The primary outcome is procedural time, with secondary outcomes of procedural efficiency, technical effectiveness, patient outcomes, and cost-effectiveness. Patients with a clinical diagnosis of AAA or TAAA suitable for endovascular repair and able to provide written informed consent will be invited to participate. DISCUSSION: This trial is the first randomised controlled trial evaluating advanced image fusion technology in endovascular aortic surgery and is well placed to evaluate the effect of this technology on patient outcomes and cost to the NHS. TRIAL REGISTRATION: ISRCTN13832085. Dec. 3, 2021.

Editor's Choice - Infective Native Aortic Aneurysms: A Delphi Consensus Document on Terminology, Definition, Classification, Diagnosis, and Reporting Standards.

OBJECTIVE: There is no consensus regarding the terminology, definition, classification, diagnostic criteria, and algorithm, or reporting standards for the disease of infective native aortic aneurysm (INAA), previously known as mycotic aneurysm. The aim of this study was to establish this by performing a consensus study. METHODS: The Delphi methodology was used. Thirty-seven international experts were invited via mail to participate. Four two week Delphi rounds were performed, using an online questionnaire, initially with 22 statements and nine reporting items. The panellists rated the statements on a five point Likert scale. Comments on statements were analysed, statements revised, and results presented in iterative rounds. Consensus was defined as ≥ 75% of the panel selecting "strongly agree" or "agree" on the Likert scale, and consensus on the final assessment was defined as Cronbach's alpha coefficient > .80. RESULTS: All 38 panellists completed all four rounds, resulting in 100% participation and agreement that this study was necessary, and the term INAA was agreed to be optimal. Three more statements were added based on the results and comments of the panel, resulting in a final 25 statements and nine reporting items. All 25 statements reached an agreement of ≥ 87%, and all nine reporting items reached an agreement of 100%. The Cronbach's alpha increased for each consecutive round (round 1 = .84, round 2 = .87, round 3 = .90, and round 4 = .92). Thus, consensus was reached for all statements and reporting items. CONCLUSION: This Delphi study established the first consensus document on INAA regarding terminology, definition, classification, diagnostic criteria, and algorithm, as well as reporting standards. The results of this study create essential conditions for scientific research on this disease. The presented consensus will need future amendments in accordance with newly acquired knowledge.

Automated Image Fusion Guidance during Endovascular Aorto-Iliac Procedures: A Randomized Controlled Pilot Study.

BACKGROUND: The benefits of imaging guidance using a new fully automated fusion process (CYDAR) have been demonstrated during endovascular aortic aneurysm repair, but little is known about its use during aorto-iliac occlusive disease endovascular revascularization. The aim of this study was to evaluate the influence of CYDAR image fusion guidance during endovascular treatment of symptomatic aorto-iliac occlusive lesions, compared with control patients treated using standard 2D fluoroscopy alone. METHODS: This is a single-center randomized controlled pilot study that recruited patients undergoing aorto-iliac endovascular revascularization. RESULTS: Between January 2019 and February 2020, 37 patients with symptomatic aorto-iliac lesions were enrolled: 18 were assigned to the fusion group and 19 to the control group. Patients and lesions characteristics were well balanced between both study groups. The technical success of the procedure was 100% in the Fusion group and 94% in the control group. All radiation-related parameters were lower in the fusion compared to the control group, including: median DAP 18.5 Gy.cm2 vs. 21.8 Gy.cm2; Air Kerma 0.10 Gy vs. 0.12 Gy; fluoroscopy dose 4.2 Gy.cm2 vs. 5.1 Gy.cm2; and number of DSA 7.5 vs. 8. The volume of iodinated contrast used was higher in the fusion group: 41 mL vs. 30 mL. The total procedure time was the same in both groups:60 min vs. 60 min. CONCLUSIONS: The results of this pilot study suggest the use of fusion imaging in endovascular treatment of aorto-iliac disease results in reduction in radiation-related measured parameters with no change in procedure time and higher doses of iodinated contrast used. These results need to be further investigated in a larger, adequately powered study.

Editor's Choice - Long-term Survival and Risk Analysis in 136 Consecutive Patients With Type B Aortic Dissection Presenting to a Single Centre Over an 11 Year Period.

OBJECTIVES: To evaluate, in patients with acute type B aortic dissection, the results of medical and endovascular treatment in a large single centre experience and to investigate the clinical and imaging features on presentation that relate to poor outcome. METHODS: This was a retrospective analysis of prospectively collected clinical and CT imaging data. Consecutive patients (136) with acute type B aortic dissection were included in the study over an 11 year period. The characteristics of patients receiving endovascular (complicated) or medical treatment (uncomplicated) were compared. Kaplan-Meier estimators were used to estimate cumulative overall survival and survival free of aortic events. Factors associated with overall and aortic event free survival were also explored using Cox proportional hazards models. RESULTS: The mean follow up was 51 months (1-132), during which time 33 deaths and 48 aortic events occurred. At one and five years, overall survival was 94.0% and 74.8%, respectively, and freedom from aortic events was 75.6% and 58.7%. There was no difference in all cause survival and aortic event free survival at one and five years between the patients treated endovascularly and those receiving medical treatment alone. Risk analysis for aortic events demonstrated the maximum size of the proximal entry tear, the maximum thoracic aortic diameter, and the thoracic aortic false lumen maximum diameter to have a significant effect on the incidence of aortic events. CONCLUSIONS: Active management of patients with type B aortic dissection results in good long-term survival even in the presence of features traditionally associated with adverse outcomes. All patients require close lifetime surveillance as aortic events continue to occur during follow up even after endografting.

Multimodality Imaging of Thoracic Aortic Diseases in Adults.

In diagnosing and following patients with acute aortic syndromes and thoracic aortic aneurysms, high-quality imaging of the thoracic aorta is indispensable. Mainstay modalities for thoracic aortic imaging are echocardiography, computed tomographic angiography, and magnetic resonance angiography. For any given clinical scenario, the imaging modality and protocol chosen will have a significant impact on sensitivity and specificity for the aortic diagnosis of concern. Imaging can also provide important ancillary information regarding myocardial performance, aortic valve morphology and function, and end-organ perfusion. Surveillance of patients following thoracic aortic surgery with serial imaging studies can identify complications that may require reintervention, and imaging has played an integral role in development of new surgical and interventional methods. Emerging techniques in thoracic aortic imaging include positron emission tomography, which addresses vessel wall inflammation, and 4-dimensional magnetic resonance angiography, which illustrates flow dynamics.

Impact of the Management of Type B Aortic Dissection on the Long-Term Blood Pressure.

Ambulatory blood pressure (BP) measurement (ABPM) is recommended to assess optimal BP control, and we studied its influence after an acute type B aortic dissection (ATBAD). We retrospectively collected data from 111 patients with ATBAD from January 2004 to September 2014. Controlled BP group was defined according to a 24-hour BP under 130/80 mm Hg during chronic phase. The population consisted of 85 men, with a mean age of 61 ± 13 years and mean body mass index of 28 ± 6 kg/m2. The median delay between ambulatory BP measurement and ATBAD was 2 (0.3 to 4) months. The mean 24-hour BP of the entire population was 124/71 ± 15/8.8 mm Hg. BP was not controlled in 41 patients (37%). The treatment score at discharge was 3.9 ± 1.4. The mean glomerular filtration rate was 83 ± 28 ml/min/1.73 m2, with no difference between groups. Visceral stent implantation in the acute phase (odds ratio [OR] 3.857 [1.199 to 12.406], p = 0.023), higher left ventricular ejection fraction (OR 1.092 [1.005 to 1.187], p = 0.038), and higher platelet count at discharge (OR 1.064 [1.018 to 1.112], p = 0.006) were identified as predictors of good BP control by multivariate analysis. The analysis showed that nighttime systolic BP was associated with aortic events during follow-up (hazard ratio [HR] 5.2 [1.01 to 27.2], p = 0.049), particularly for a threshold of 124 mm Hg or more (HR 1.967 [1.052 to 3.678], p = 0.0341). Nighttime pulse pressure showed also its significance (HR 20.1 [1.4 to 282.7], p = 0.026). In conclusion, subclinical renal malperfusion revascularization seems to improve BP control. A greater nighttime systolic BP was associated with the risk of new aortic events during follow-up.

Total Endovascular Treatment of Aortic Arch Disease Using an Arch Endograft With 3 Inner Branches.

PURPOSE: To report early experience with a new endovascular graft developed for aortic arch aneurysm repair in patients unfit for open surgery. CASE REPORT: Three consecutive men (62, 74, and 69 years old) at high risk for open repair were treated for postdissection aortic arch aneurysms using a custom-made 3 inner branched endovascular graft. The 2 proximal branches are antegrade and perfuse the innominate artery and the left common carotid artery; the third branch is retrograde and perfuses the left subclavian artery. The latter is preloaded with a catheter and wire to aid cannulation. Technical success was achieved in each case. The mean procedure time, fluoroscopy duration, and contrast volume were 180 minutes, 35 minutes, and 145 mL, respectively. The perioperative period was uneventful. All branches were patent on 6-month computed tomography and duplex ultrasound imaging. CONCLUSION: This new patient-specific device allows total endovascular revascularization of the supra-aortic trunks during arch repair. These encouraging results support its more widespread use.

Endovascular Repair of Thoracoabdominal and Arch Aneurysms in Patients with Connective Tissue Disease Using Branched and Fenestrated Devices.

BACKGROUND: Prophylactic open surgery is the standard practice in patients with connective tissue and thoracoabdominal aortic aneurysm (TAAA) and aortic arch disease. Branched and fenestrated devices offer a less invasive alternative but there are concerns regarding the durability of the repair and the effect of the stent graft on the fragile aortic wall. The aim of this study is to evaluate mid-term outcomes of fenestrated and/or branched endografting in patients with connective tissue disease. METHODS: All patients with connective tissue disease who underwent TAAA or arch aneurysm repair using a fenestrated and/or branched endograft in a single, high-volume center between 2004 and 2015 were included. Ruptured aneurysms and acute aortic dissections were excluded from this study, but not chronic aortic dissections. RESULTS: In total, 427 (403 pararenal and TAAAs, and 24 arch aneurysms) endovascular interventions were performed during the study period. Of these, 17 patients (4%) (16 TAAAs, 1 arch) had connective tissue disease. All patients were classified as unfit for open repair. The mean age was 51 ± 8 years. Thirteen patients with TAAA were treated with a fenestrated, 1 with a branched, and 2 with a combined fenestrated/branch device. A double inner branch device was used to treat the arch aneurysm. The technical success rate was 100% with no incidence of early mortality, spinal cord ischemia, stroke, or further dissection. Postoperative deterioration in renal function was seen in 3 patients (18.8%) and no hemodialysis was required. The mean follow-up was 3.4 years (0.3-7.4). Aneurysm sac shrinkage was seen in 35% of patients (6/17) and the sac diameter remained stable in 65% of patients (11/17). No sac or sealing zone enlargement was observed in any of the patients and there were no conversions to open repair. Reintervention was required in 1 patient at 2 years for bilateral renal artery occlusion (successful fibrinolysis). One type II endoleak (lumbar) is under surveillance and 1 type III (left renal stent) sealed spontaneously. One patient died at 2 years after the procedure from nonaortic causes (endocarditis). CONCLUSIONS: The favorable mid-term outcomes in this series that demonstrate fenestrated and/or branched endografting should be considered in patients with connective tissue and TAAA and aortic arch disease, which are considered unfit for open surgery. All patients require close lifetime surveillance at a center specializing in aortic surgery, with sufficient experience in both open and endovascular aortic surgery, so that if endovascular treatment failure occurs it can be recognized early and further treatment offered.

Evidence for and risks of endovascular treatment of asymptomatic acute type B aortic dissection.

Acute aortic dissection is a challenging disease to manage. Type B aortic dissection has traditionally been divided temporally into acute and chronic cases but more recently this classification has been modified to include a sub-acute phase. Computed tomography is the imaging technique used most frequently in diagnosis and management. Active management of blood pressure is essential and should include beta-blockade unless contraindicated. In-hospital outcomes are generally acceptable in patients with medically managed acute uncomplicated type B aortic dissection, with up to 90% of patients surviving to hospital discharge but by 5 years up to 50% of patients are dead with a significant proportion dying from aortic rupture. The aim of endovascular repair is to treat the complications of the dissection, induce aortic remodeling and false lumen thrombosis and it has been shown to result in good long-term outcomes. Stent graft placement however is associated with an incidence of death, stroke, paraplegia and retrograde type A dissection. Some experts now advocate high intensity imaging in the first 14 days to detect development of complications early in the disease course, with planned elective treatment in the subacute phase.

A Community-Based Nutrition and Physical Activity Intervention for Children Who Are Overweight or Obese and Their Caregivers.

There is a need for efficacious interventions to reduce the prevalence of childhood obesity, and a limited body of research suggests that collaborative community-based programs designed for children and their caregivers may be effective in reducing obesity rates. This paper reports the results of a community-based obesity intervention, South County Food, Fitness and Fun (SCFFF), designed for preadolescent children who are overweight or obese and their caregivers. SCFFF was developed in response to community concerns. Families were referred to the program by their physician and participated in the program at no cost. The 16-week intervention includes weekly group nutrition and physical activity sessions. Analyses determined that 65 out of the 97 children who completed SCFFF provided 2-year follow-up data and had reduced BMI z-scores over 2 years following the intervention. These participants decreased their energy, fat, carbohydrate, saturated fat, and sodium intake and increased core body strength and endurance from baseline to the end of the intervention. SCFFF was effective in reducing relative weight and improving diet and core muscle strength and endurance in children who are overweight or obese.

Rapid Aneurysmal Sac Expansion Following Endovascular Repair of a Dissecting Thoracoabdominal Aneurysm.

Endovascular repair of dissecting thoracoabdominal aneurysms (TAAA) is challenging and often requires multiple procedures. A 61-year-old man with a dissecting type-II TAAA treated first by placement of a thoracic endograft, and subsequently implantation of a fenestrated endograft. Six months postoperatively, a 10-mm increase of the aorta was observed. A reentry tear in left external iliac artery (EIA) was perfusing the false lumen in a retrograde fashion connecting with the endoleak caused by the inferior mesenteric artery and lumbar arteries. False lumen embolization of the left EIA and outflow vessels was performed. Thrombosis and rapid decrease of false lumen diameter was then observed. This case illustrates the complexity of endovascular management of extensive chronic aortic dissections.

Total Endovascular Aortic Repair in a Patient with Marfan Syndrome.

BACKGROUND: The aim of this study is to describe a total endovascular aortic repair with branched and fenestrated endografts in a young patient with Marfan syndrome and a chronic aortic dissection. Open surgery is the gold standard to treat aortic dissections in patients with aortic disease and Marfan syndrome. METHODS: In 2000, a 38-year-old man with Marfan syndrome underwent open ascending aorta repair for an acute type A aortic dissection. One year later, a redo sternotomy was performed for aortic valve replacement. In 2013, the patient presented with endocarditis and pulmonary infection, which necessitated tracheostomy and temporary dialysis. In 2014, the first stage of the endovascular repair was performed using an inner branched endograft to exclude a 77-mm distal arch and descending thoracic aortic aneurysm. In 2015, a 63-mm thoracoabdominal aortic aneurysm was excluded by implantation of a 4-fenestrated endograft. Follow-up after both endovascular repairs was uneventful. RESULTS: Total aortic endovascular repair was successfully performed to treat a patient with arch and thoraco-abdominal aortic aneurysm associated with chronic aortic dissection and Marfan syndrome. The postoperative images confirmed patency of the endograft and its branches, and complete exclusion of the aortic false lumen. CONCLUSIONS: Endovascular repair is a treatment option in patients with connective tissue disease who are not candidates for open surgery. Long-term follow-up is required to confirm these favorable early outcomes.

Thoracic endovascular aortic repair (TEVAR) in proximal (type A) aortic dissection: Ready for a broader application?

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has demonstrated encouraging results and is gaining increasing acceptance as a treatment option for aortic aneurysms and dissections. Yet, its role in managing proximal aortic pathologies is unknown-this is important because in proximal (Stanford type A) aortic dissections, 10% to 30% are not accepted for surgery and 30% to 50% are technically amenable for TEVAR. We describe our case series of type A aortic dissections treated by using TEVAR. METHODS: Between year 2009 and 2016, 12 patients with acute, subacute, or chronic type A aortic dissection with the proximal entry tear located between the coronaries and brachiocephalic artery were treated with TEVAR at 3 centers. Various stent-graft configurations were used to seal the proximal entry tear in the ascending aorta under rapid pacing. RESULTS: A total of 12 patients (9 male, 3 female), mean age 81 ± 7 years, EuroSCORE II 9.1 ± 4.5, underwent TEVAR for the treatment of type A aortic dissection. Procedural success was achieved in 11 of 12 patients (91.7%). There was 1 minor stroke and 1 intraprocedural death. No additional deaths were reported at 30 days. At 36 months, there were 4 further deaths (all from nonaortic causes). The mean survival of these 4 deceased was 23 months (range 15-36 months). Follow-up computed tomography demonstrated favorable aortic remodeling. CONCLUSIONS: TEVAR is feasible and reveals promising early results in selected patients with type A aortic dissection who are poor candidates for surgical repair. The current iteration of stent-graft technology, however, needs to be adapted to features specific to the ascending aorta.