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Objective: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion)., Methods: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months., Results: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year., Conclusions: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair., Competing Interests: Disclosures M.P. reports consulting agreement with Artivion. G.P. reports fee for employ tutoring with Artivion. M.A. reports consulting agreement with Artivion., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: By this survey, we aim to gain national-based information regarding trends in endovascular repair (ER) for the treatment of aortic disease in patients with genetically-triggered aortic disease (GTAD) and connective tissue disorder (CTD) over the last two decades., Methods: All Italian vascular surgery centers (N.=80) were invited to participate in an anonymous electronic cross-sectional survey on ER for GTAD/CTD., Results: Overall, 29 institutions completed the survey, thereby yielding a 36% response rate. The percentage of responding institutions rises to 64% if only regional hubs were considered (23/36). The median number of index procedures per center was 6.2, and a steady increase in the overall number of interventions over time was also noted. Most patients were males (73%) with a median age of 48 years. The most common endovascular procedure was TEVAR (N.=101), followed by F/BEVAR (N.=43) and EVAR (N.=37). The overall technical success rate was 83.4% while major adverse events and mortality at thirty days were reported at 18.2% and 9.9%, respectively. An additional 5.0% mortality rate was noted for an overall one-year mortality of 14.9%, while 3.7% of all treated patients were diagnosed with a type 1 endoleak., Conclusions: This national cross-sectional survey, investigating trends in ER of GTADs and CTDs over two decades, highlights a consistent increase in the use of endovascular techniques for their treatment. Early mortality was acceptably low, yet influenced by the urgency of presentation. At one-year follow-up, a 5% additional death rate was noted, and the reintervention rate remained below one in ten.

Background: Endovascular treatment is nowadays accepted as first-line treatment for most patients with aorto-iliac obstructive disease (AIOD), including those with Trans-Atlantic Inter-Society Consensus II (TASC-II) lesion types C and D. Aim of the study was to evaluate the role of Viabahn VBX (W. L. Gore and Associates, Flagstaff, AZ, USA), in patients with chronic occlusive aorto-iliac disease (ChO)., Methods: A retrospective review of patients undergone elective endovascular repair with VBX (W. L. Gore and Associates) for ChO at five referral vascular institutions in Italy from 2018 to 2022 was conducted. Primary endpoints were technical success and the incidence of any early and midterm procedure-related reintervention. Secondary endpoints were clinical success, primary and secondary patency., Results: Among 89 included patients, technical success was obtained in 87 patients (97.8%). Postoperative complication requiring early surgical reintervention was necessary in 5 (6%), all but one for arterial bleeding. Clinical improvement of at least 3 classes was observed in 49 (55%). After a mean follow-up of 24.1 months ±14.1, primary patency and freedom from any procedure-related reintervention at 12, 24 and 36 months was 83.0% and 94.8%, 80.0% and 91.5%, 77.9% and 89.3%, respectively. Secondary patency was 100%. TASC-II D lesion (OR=3.67, 95% CI: 1.1289-11.9823, P=0.03) and Grade III iliac calcification (OR=3.41, 95% CI: 1.0944-10.6428, P=0.03) were identified as independent predictors for procedure-related reintervention., Conclusions: Use of VBX (W. L. Gore and Associates) in ChO was safe and effective with low rate of stenosis/occlusion in the early and mid-term follow-up. TASC-II D and Grade III calcifications resulted as independent predictors for procedure-related reintervention.

Background: To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease., Methods: This was an international, prospective, single-arm study in patients diagnosed with thoracic aorta disease (aneurysm, pseudoaneurysm, dissection, penetrating atherosclerotic ulcer, or intramural hematoma) and treated with a RelayPro stent-graft (in bare stent and/or nonbare stent configurations). The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance., Results: A total of 31 patients were treated with the RelayPro thoracic stent-graft between 2014 and 2015 at 8 sites in Italy and Spain. Mean age was 72.1 (±10.2) years and 77% were male, 74% with hypertension, and 42% with a history of smoking. Twenty-four (77%) had aneurysms (fusiform in 46%, saccular in 42%, pseudoaneurysm in 12%); 5 (16%) had penetrating atherosclerotic ulcer; and 2 (6%) had chronic Type B dissection. Mean vascular access diameter was 9.1 mm (6-13 mm); 7 patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted primary, 10%). Freedom from aneurysm/dissection-related mortality through 30 days was 100%. Freedom from device-related major adverse events through 30 days was 94%. At 1 year, there was 1 (3%) type Ib and 1 (3%) type II endoleak, 1 (3%) nonaneurysm-related late death, and 1 (3%) secondary intervention (to correct type Ib endoleak)., Conclusions: The RelayPro has a 3-4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies. This study shows good initial stent-graft performance and a favorable early safety profile., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)