The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.

Background: There is uncertainty whether elderly patients with symptomatic carotid stenosis have higher rates of adverse events following carotid endarterectomy. In trials, recurrent stroke risk on medical therapy alone increased with age, whereas operative stroke risk was not related. Few octogenarians were included in trials and there has been no systematic analysis of all study types. We aimed to evaluate the safety of carotid endarterectomy in symptomatic elderly patients, particularly in octogenarians. Methods: We did a systematic review and meta-analysis of studies (from January 1, 1980 through March 1, 2022) reporting post carotid endarterectomy risk of stroke, myocardial infarction, and death in patients with symptomatic carotid stenosis. We included observational studies and interventional arms of randomized trials if the outcome rates (or the raw data to calculate these) were provided. Individual patient data from 4 prospective cohorts enabled multivariate analysis. Results: Of 47 studies (107 587 patients), risk of perioperative stroke was 2.04% (1.94–2.14) in octogenarians (390 strokes/19 101 patients) and 1.85% (1.75–1.95) in nonoctogenarians (1395/75 537); P =0.046. Perioperative death was 1.09% (0.94–1.25) in octogenarians (203/18 702) and 0.53% (0.48–0.59) in nonoctogenarians (392/73 327); P <0.001. Per 5-year age increment, a linear increase in perioperative stroke, myocardial infarction, and death were observed; P =0.04 to 0.002. However, during the last 3 decades, perioperative stroke±death has declined significantly in octogenarians (7.78% [5.58–10.55] before year 2000 to 2.80% [2.56–3.04] after 2010); P <0.001. In Individual patient data multivariate-analysis (5111 patients), age ≥85 years was independently associated with perioperative stroke ( P <0.001) and death ( P =0.005). Yet, survival was similar for octogenarians versus nonoctogenarians at 1-year (95.0% [93.2–96.5] versus 97.5% [96.4–98.6]; P =0.08), as was 5-year stroke risk (11.93% [9.98–14.16]) versus 12.78% [11.65–13.61]; P =0.24). Conclusions: We found a modest increase in perioperative risk with age in symptomatic patients undergoing carotid endarterectomy. As stroke risk increases with age when on medical therapy alone, our findings support selective urgent intervention in symptomatic elderly patients.