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Purpose: To define the learning curve of a widely employed stent-graft for thoracic endovascular repair (TEVAR) by analyzing procedural variables and their impact on long-term outcomes., Materials and Methods: Standard TEVARs for each major aortic thoracic disease were included excluding procedures using thoracoabdominal, arch fenestrated/branched devices and/or chimneys. The primary outcome was the learning curve analysis using the cumulative sum chart method. The secondary outcomes, presented as early (Q1-Q2) versus latest (Q3-Q4) quartiles of experience, were 30-day major adverse events (MAEs); procedural details (additional maneuvers, operative and fluoroscopy time, and contrast volume); 30-day clinical success; endoleak; aorta-related reintervention; and overall and aorta-related survival., Results: Between November 2005 and September 2021, 220 consecutive TEVAR procedures involving the Relay endograft (Terumo Aortic, Sunrise, FL, USA) were performed and included in the present analysis. The mean follow-up was 4.5 ± 3.9 years. The learning curve was reached after 10 patients. Secondary outcomes improved significantly over experience. Thirty-day MAE occurrence was 14.5% versus 11.8% (p=0.550). Additional maneuvers (p=0.009), access-vessel additional maneuvers (p=0.010), operative time (p=0.004), Relay Plus (p=0.001), and implantation of multiple stent-grafts (p=0.034) were independent risk markers for MAEs. Operative time (125.9 ± 66.7 vs 86.7 ± 48.5 minutes, p<0.001), contrast volume (185.4 ± 112.8 vs 140.5 ± 88.2 mL, p=0.003), and fluoroscopy time (12.4 ± 12.7 vs 8.8 ± 7.5 minutes, p=0.017) decreased significantly. Late endoleak occurrence was 19.5% with a nonsignificant reduction (21.8% vs 17.3%, p=0.395). Fluoroscopy time (hazard ratio [HR]=1.0; 95% confidence interval [CI]=1.0-1.1; p=0.008), contrast volume (HR=1.0; 95% CI=1.0-1.1; p=0.018), and type III aortic arch (HR=3.3; 95% CI=1.7-6.4; p<0.001) were independent risk markers for endoleak. Fluoroscopy time (HR=1.0; 95% CI=1.0-1.1; p=0.032) and type III aortic arch (HR=3.6; 95% CI=1.7-7.4; p=0.001) confirmed their significant association in a multivariable analysis., Conclusion: In a high-volume center with a consistent previous endovascular experience, the Relay graft presented satisfactory long-term results with a short learning curve supporting its reliability., Clinical Impact: The manuscript addresses the understanding of how many TEVAR procedures with a currently implanted device have been required to reach the learning curve for an endovascular skilled center. Our TEVAR experience with the Relay stent-graft (Terumo Aortic) demonstrated that ten implantations were required to achieve the device-related learning curve. The fifteen-year analyzed period showed that intraoperative learning-related variables were associated with long-term clinical outcomes and both improved over time. The Relay stent-graft presented satisfactory long-term results along with a short learning curve in a high-volume endovascular center supporting its ongoing implantation., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: The objective of this study was to assess the primary endpoint defined as the detection of micro-embolic signals (MES) by the use of transcranial Doppler (TCD) in patients with asymptomatic carotid stenosis (≥70%) scheduled for carotid endarterectomy. The secondary endpoint consisted of testing the association of MES with stenosis severity, histopathological, and ultrasound characteristics., Methods: This was a single-center, single-arm, prospective, observational trial. Computed tomography angiography and ultrasound assessment (Geroulakos classification) were mandatory as well as being under best medical therapy. MES number and characteristics were investigated in Holter mode TCD-X device with a standard 1.5 MHz probe. The time points of evaluation were: 24 hours preoperative, 24 hours postoperative, and 30 days postoperative. The histopathological analysis was performed according to the modified American Heart Association classification. One-way analysis of variance tested MES differences over time. Univariable and multivariable logistic regression tested variables potentially associated with MES., Results: A total of 120 patients demonstrated a significant reduction of the mean number of MES (3.35 ± 10.04 and 0.82 ± 2.39; pre- and post-carotid endarterectomy, respectively), becoming undetectable at 30 days (P = .001). Hypoechogenic plaques assessed by ultrasound were a significant risk factor for MES (P = .001). The features of plaque vulnerability, such as hemorrhagic component (P = .011), neovascularization (P = .025), signs of inflammation (P = .027), and rupture of the fibrous cap (P = .002) were predictors of MES. Cap rupture was the only predictor in the multivariate analysis (odds ratio, 5.98; P = .030). The stenosis severity was not associated with MES (P = .95) CONCLUSIONS: Patients under best medical therapy had a preoperative embolic activity becoming no more detectable after surgery. Both ultrasound and histologic markers of vulnerability were predictors of MES, and stenosis severity was not associated. TCD gives better insight into the real embolic risk, and future studies should evaluate clinical results coming from its implementation with standard imaging techniques., Clinicaltrial: gov registration number NCT05134493., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)