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International audience; ObjectiveThe aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs).MethodsWe reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality.ResultsA total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach.ConclusionStaging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.

Objective: The aim of this study was to compare the short and long term clinical outcomes of endovascular (EVAR) vs. open surgical repair (OSR) of juxtarenal (JAAAs) and pararenal abdominal aortic aneurysms (PAAAs) in five high volume European academic centres. Methods: This was a retrospective multicentre cohort study of five high volume European academic centres (> 50 open or 50 endovascular abdominal aortic aneurysm repairs annually) including 834 consecutive patients who were operated on and prospectively followed. Using propensity score matching (PSM) each patient who underwent OSR was matched with one patient who underwent EVAR in a 1:1 ratio (145 patients per group). The primary endpoint was long term all cause mortality, while the secondary endpoint was freedom from aortic related re-intervention. Results: After a follow up of 87 months, no difference in overall survival between the two groups was observed (38.6% for EVAR vs. 42.1% for OSR; p =.88). Patients undergoing EVAR underwent aortic related re-interventions more frequently (24.1% vs. 6.9%; p

Background: Unfractionated heparin has an unpredictable effect in an individual patient. The activated clotting time (ACT) can be used to measure the effect of heparin in the individual patient and guide additional heparin dosages. Previous cohort studies showed that a standardized bolus of 5,000 IU during noncardiac arterial procedures (NCAP) does not lead to an adequate ACT in the vast majority of patients. The aim of this study was to investigate whether an initial heparin dose of 100 IU/kg leads to an adequate but safe ACT, from 200 to 300 s. Methods: In this multicenter prospective study, 186 patients undergoing NCAP were enrolled and received an initial heparin dose of 100 IU/kg. Target ACT was set at ≥250 s initially; during the course of the study the target ACT was lowered to ≥200 s. After the initial heparin dose, additional heparin dosages were administered depending on the ACT values following a heparin dose protocol. ACT measurements and complications were monitored. Results: The mean baseline ACT was 134 ± 17 s. The mean ACT 5 minutes after the initial heparin dose was 227 ± 37 s. After the initial dose of heparin, 78 and 46% of patients reached an ACT of 200 and 250 s, respectively. Seven patients (4%) reached an ACT of 300 s or more. Ninety-four patients (51%) received at least one additional dose of heparin. After one additional dose of heparin, 91% of patients reached an ACT of 200 s and 13 patients (7%) reached an ACT of 300 s or more. Arterial thromboembolic complications occurred in 4.3% and bleeding complications occurred in 9.7%. Conclusions: A bolus of 100 IU/kg of heparin during NCAP results in adequate coagulation in most patients. ACT measurements enable accurate additional dosing, ensuring the individual patient tailored and safe coagulation. Key words: anticoagulants; heparin; blood coagulation tests; vascular surgical procedures; peripheral vascular disease

Purpose: The aim of this study was to assess the initial experience, technical success, and clinical benefit of AneuFix (TripleMed, Geleen, the Netherlands), a novel biocompatible and non-inflammatory elastomer that is directly injected into the aneurysm sac by a translumbar puncture in patients with a type II endoleak and a growing aneurysm. Materials and Methods: A multicenter, prospective, pivotal study was conducted (ClinicalTrials.gov:NCT02487290). Patients with a type II endoleak and aneurysm growth (>5 mm) were included. Patients with a patent inferior mesenteric artery connected to the endoleak were excluded for initial safety reasons. The endoleak cavity was translumbar punctured with cone-beam computed tomography (CT) and software guidance. Angiography of the endoleak was performed, all lumbar arteries connected to the endoleak were visualized, and AneuFix elastomer was injected into the endoleak cavity and short segment of the lumbar arteries. The primary endpoint was technical success, defined as successful filling of the endoleak cavity with computed tomography angiography (CTA) assessment within 24 hours. Secondary endpoints were clinical success defined as the absence of abdominal aortic aneurysm (AAA) growth at 6 months on CTA, serious adverse events, re-interventions, and neurological abnormalities. Computed tomography angiography follow-up was performed at 1 day and at 3, 6, and 12 months. This analysis reports the initial experience of the first 10 patients treated with AneuFix. Results: Seven men and 3 women with a median age of 78 years (interquartile range (IQR), 74-84) were treated. Median aneurysm growth after endovascular aneurysm repair (EVAR) was 19 mm (IQR, 8–23 mm). Technical success was 100%; it was possible to puncture the endoleak cavity of all treated patients and to inject AneuFix. Clinical success at 6 months was 90%. One patient showed 5 mm growth with persisting endoleak, probably due to insufficient endoleak filling. No serious adverse events related to the procedure or AneuFix material were reported. No neurological disorders were reported. Conclusion: The first results of type II endoleak treatment with AneuFix injectable elastomer in a small number of patients with a growing aneurysm show that it is technically feasible, safe, and clinically effective at 6 months. Clinical Impact Effective and durable embolization of type II endoleaks causing abdominal aortic aneurysms (AAA) growth after EVAR is challenging. A novel injectable elastic polymer (elastomer) was developed, specifically designed to treat type II endoleaks (AneuFix, TripleMed, Geleen, the Netherlands). Embolization of the type II endoleak was performed by translumbar puncture. The viscosity changes from paste-like during injection, into an elastic implant after curing. The initial experience of this multicentre prospective pivotal trial demonstrated that the procedure is feasible and safe with a technical success of 100%. Absence of AAA growth was observed in 9 out of 10 treated patients at 6 months.

Purpose Image fusion merges preoperative computed tomography angiography (CTA) with live fluoroscopy during endovascular procedures to function as an overlay 3D roadmap. However, in most current systems, the registration between imaging modalities is performed manually by vertebral column matching which can be subjective, inaccurate and time consuming depending on experience. Our objective was to evaluate feasibility and accuracy of image-based automated 2D-3D image fusion between preoperative CTA and intraoperative fluoroscopy based on vertebral column matching. Methods A single-center study with offline procedure data was conducted in 10 consecutive patients which had endovascular aortic repair in which we evaluated unreleased automated fusion software provided by Philips (Best, the Netherlands). Fluoroscopy and digital subtraction angiography images were collected after the procedures and the vertebral column was fused fully automatically. Primary endpoints were feasibility and accuracy of bone alignment (mm). Secondary endpoint was vascular alignment (mm) between the lowest renal artery orifices. Clinical non-inferiority was defined at a mismatch of Results In total, 87 automated measurements and 40 manual measurements were performed on vertebrae T12–L5 in all 10 patients. Manual correction was needed in 3 of the 10 patients due to incomplete visibility of the vertebral edges in the fluoroscopy image. Median difference between automated fusion and manual fusion was 0.1 mm for bone alignment (p = 0.94). The vascular alignment was 4.9 mm (0.7–17.5 mm) for manual and 5.5 mm (1.0–14.0 mm) for automated fusion. This did not improve, due to the presence of stiff wires and stent graft. Conclusion Automated image fusion was feasible when all vertebral edges were visible. Accuracy was non-inferior to manual image fusion regarding bone alignment. Future developments should focus on intraoperative image-based correction of vascular alignment.

Purpose: In Paget-Schroetter Syndrome (PSS), subclavian vein thrombosis is caused by external compression of the subclavian vein at the costoclavicular junction. Paget-Schroetter Syndrome can be treated nonoperatively, surgically, or with a combination of treatments. Nonoperative management consists, in most cases, of anticoagulation (AC) or catheter-directed thrombolysis (CDT). With surgical management, decompression of the subclavian vein is performed by resection of the first rib. No prospective randomized trials are available to determine whether nonoperative or surgical management is superior. We report our long-term outcomes of both nonoperative and surgically treated patients. Materials and Methods: We retrospectively analyzed all patients with PSS who were treated between January 1990 and December 2015. Patients were divided based on primary nonoperative or primary surgical therapy. Long-term outcomes regarding functional outcomes were assessed by questionnaires using the “Disability of the Arm, Shoulder, and Hand” (DASH) questionnaire, a modified Villalta score, and a disease-specific question regarding lifestyle changes. Results: In total, 91 patients (95 limbs) were included. Seventy patients (73 limbs) were treated nonoperatively and 21 patients (22 limbs) surgically. Questionnaires were returned by 67 patients (70 limbs). The mean follow-up was 184 months (range, 43–459 months). All functional outcomes were better in the surgical group compared with the nonoperatively treated group (DASH general 3.11 vs 9.86; DASH work 0.35 vs 11.47; DASH sport 5.85 vs 17.98, and modified Villalta score 1.11 vs 3.20 points). Surgically treated patients were more likely to be able to continue their original lifestyle and sports activities (84% vs 40%, p=0.005). Patients with recurrence of thrombosis or the need for surgical intervention after primary nonoperative management reported worse functional outcomes. Conclusion: Surgical management of PSS with immediate CDT followed by first rib resection leads to excellent functional outcomes with low risk of complications. The results of nonoperative management in our non-matched retrospective comparative series were satisfactory, but resulted in worse functional outcomes and more patients needing to adjust their lifestyle compared with surgically treated patients. Clinical Impact Patients with Paget-Schroetter Syndrome and their attending physicians are burdened by the lack of evidence concerning the optimal treatment of this entity. Case series comparing the outcomes of non-operative treatment with surgical treatment are scarce and often not focussed on functional outcomes. Data from this series can aid in the shared decision making after diagnosis of Paget-Schroetter Syndrome. Functional outcomes of non-operative management can be satisfying although high demand patient who are not willing to alter their daily activities are probably better off with surgical management.

Purpose: Modern endovascular hybrid operating rooms generate large amounts of medical images during a procedure, which are currently mostly assessed by eye. In this paper, we present fully automatic segmentation of the stent graft on the completion digital subtraction angiography during endovascular aneurysm repair, utilizing a deep learning network. Technique: Completion digital subtraction angiographies (cDSAs) of 47 patients treated for an infrarenal aortic aneurysm using EVAR were collected retrospectively. A two-dimensional convolutional neural network (CNN) with a U-Net architecture was trained for segmentation of the stent graft from the completion angiographies. The cross-validation resulted in an average Dice similarity score of 0.957 ± 0.041 and median of 0.968 (IQR: 0.950 – 0.976). The mean and median of the average surface distance are 1.266 ± 1.506 mm and 0.870 mm (IQR: 0.490 – 1.430), respectively. Conclusion: We developed a fully automatic stent graft segmentation method based on the completion digital subtraction angiography during EVAR, utilizing a deep learning network. This can provide the platform for the development of intraoperative analytical applications in the endovascular hybrid operating room such as stent graft deployment accuracy, endoleak visualization, and image fusion correction.

Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry (ClinicalTrials.gov; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27-86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease. On behalf of the SURPASS Registry Collaborators.

The association of an excessive blood pressure increase with exercise (i.e., an increase in systolic blood pressure with exercise ≥95th percentile) with lower risk of subsequent events in patients with known or suspected coronary artery disease has been consistently verified even in those with baseline hypertension. Nonetheless, this negative association, also confirmed in another study on a Japanese population, might depend on peak VO2, such that the prognostic value of blood pressure response might be limited in patients with preserved exercise capacity. In addition, a hypertensive response with exercise (defined as a systolic blood pressure ≥220 mmHg during the test) has also been associated with lower risk of echocardiographic myocardial ischemia. These findings might be mediated mainly by the degree of exercise-induced increase in cardiac output, which is a main determinant of blerved.ood pressure response and may be blunted or even reversed in the presence of significant coronary artery disease. Sin financiación 2.784 JCR (2018) Q1, 37/160 Medicine, General & Internal; Q2, 67/136 Medicine, Research & Experimental 1.097 SJR (2018) Q1, 470/2844 Medicine (miscellaneous), 27/133 Clinical Biochemistry; Q2, 140/462 Biochemistry No data IDR 2018 UEM