Clinical impact: Our study demonstrated the clinical impact in real-world practice of using In-situ fenestration TEVAR with the innovative dedicated perforation-needle technique, which is characterized by an immediate availability as off-the-shelf device, compatibility with the various pathologies and anatomies, as well as minimal invasiveness in comparison to the debranching bypass-procedure for the preservation of the supra-aortic vessels during the endovascular repair of aortic arch pathologies. According to center experience, this approach can applied in elective cases, however, due to its practicability, it can be especially valuable in emergencies, when the other methods are considered as an unfavorable.
Clinical impact: The present paper highlighted a significant feasibility rate for the Gore Thoracic Branch Endoprothesis among patients previously treated with TEVAR and proximal landing in zone. The limited number of stent-graft configurations that could have been implanted in a considerable portion of our cohort could help clinicians to develop a proper endovascular inventory related to this device, paving the way for its wide application.
Clinical impact: This technical note introduces the first open surgical conversion after a failed branched endovascular repair of a thoracoabdominal aortic aneurysm, using the new hybrid Thoracoflo device. This innovative technique reduces reno-visceral ischemia time and can be performed through a xipho-pubic laparotomy without the need for extracorporeal circulation. It offers a safe and effective solution for complex thoracoabdominal aortic diseases, and can also serve as a bailout option following endovascular failure.
Purpose: Geriatric nutritional related index (GNRI) is a simple and well-established screening method of nutritional status. We aimed to develop and validate a scoring system including GNRI to predict long-term outcomes in patients with chronic limb-threatening ischemia (CLTI) undergoing endovascular treatment (EVT).
Materials and methods: Patients undergoing EVT for symptomatic LEAD from August 2015 to August 2016 were enrolled into the I-PAD NAGANO registry, a prospective, multicenter, observational registry. We identified predictors of amputation-free survival (AFS) at 5 years using Cox proportional hazards regression and developed a risk scoring system. The predictive performance of the risk score was assessed.
Results: A total of 126 patients with CLTI were analyzed. Cox multivariate analysis revealed GNRI score <92 points, ≥72 years of age, hemodialysis, heart failure, and anemia to be significant predictors. We developed a 5-item risk score (I-PAD CLTI score) assigning points to each factor based on the magnitude of association with AFS at 5 years. The I-PAD CLTI score showed a c-index of 0.80 for 5-year AFS. Patients with high score (≥7 points, n=50) had an increased risk of AFS at 5 years compared with those with low score (<7 points, n=68) (26.5% vs 72.1%, p<0.001).
Conclusion: A simple 5-item risk score including nutritional status showed reasonable discriminative and prognostic ability for long-term AFS among patients with CLTI.
Clinical impact: The I-PAD CLTI score, a simple five-item risk score including nutritional status determined by geriatric nutritional related index, showed reasonable discriminative and prognostic ability for long-term amputation free survival among patients with chronic limb-threatening ischemia. This risk score may be useful for clinicians to accurately predict patient's prognosis and thus identify high-risk patients who may derive the greater clinical benefit from more intensive risk modification. Further research is required to test the clinical utility of risk-score-based treatment approach to improve the prognosis of patients with chronic limb-threatening ischemia.
Purpose: The purpose of this study is to describe a new bailout maneuver for use during fenestrated thoracic endovascular aneurysm repair (fTEVAR) in the event of wire wrap or wire entanglement with the proximal graft fabric.
Technique: A 68-year-old-man with hypertension and chronic atrial fibrillation underwent elective thoracic endovascular aneurysm repair (TEVAR) with a left subclavian fenestration to treat a residual arch and thoracic aortic aneurysm after previous type A dissection repair. The procedure was challenging due to malrotation of the main body graft, as well as wire entanglement of the precannulated through-and-through wire on the leading edge of the main body fabric. A novel bailout maneuver is described. Through-and-through access was maintained, and a long 8F sheath was delivered through the fenestration from femoral access, and an 8.5F steerable sheath was delivered through upper extremity access. This allowed coaxial snaring of a new through-and-through wire via the gutter between the stent-graft and native aorta in the seal zone, which both reoriented the fenestration, and permitted placement of a bridging stent to the left subclavian artery.
Conclusion: The retrograde-access gutter snare (RAGS) technique described above provides a streamlined approach to achieve technical success in challenging fenestrated thoracic endovascular aneurysm repair (fTEVAR) cases.
Clinical impact: This technical note describes the retrograde-access gutter snare (RAGS) technique that can provide a successful bailout maneuver for fenestrated TEVAR (fTEVAR) devices. The RAGS technique offers an approach to be used with precannulated custom-made or physician-modified fTEVAR devices in which wire wrap or wire entanglement precludes access through the fenestration after deployment of the main body device. Instead of traditional attempts at de novo cannulation of the fenestration from upper extremity or femoral access, the maneuver offers an approach to maintaining through-and-through access to facilitate snaring a new wire proximal to the leading edge of the main body fabric, which can then be used to deliver a covered stent into the fenestration from either the upper extremity or femoral access. This technique offers an added benefit of potentially realigning malrotated fenestrations via tensioning of the new through-and-through wire.
Background: The Nexus stent graft offers a minimally-invasive option for treating aortic arch aneurysms (AArA). Despite strict instructions for use (IFU), it is sometimes applied in complex anatomies for patients who are surgically inoperable or unsuitable for other devices. This study evaluates outcomes in patients treated outside the IFU, providing real-world insights.
Methods: We analyzed patients treated with the Nexus endograft outside its IFU between January 2022 and August 2024. The primary endpoint was the occurrence of major adverse cardiovascular and cerebral events (MACCE) such as death, stroke, or myocardial infarction. Secondary endpoints included the reasons for outside-IFU implantation, technical success, any aortic-related adverse events and postoperative endoleaks.
Results: Thirteen patients underwent endovascular treatment for AArA outside IFU. Five (38.5%) had a post-type A dissection, 5 had de novo AArA (38.5%), and 3 (23%) lacked a landing zone in zones 1 to 3 of the aortic arch for thoracoabdominal aortic repair. Seven patients (54%) received the Nexus One device, while 6 (46%) received the Nexus Duo endograft. No perioperative MACCE occurred. Mean follow-up was 17 ± 12 months, with a 79% survival rate at 1 year. Primary reasons for outside IFU use included an inner ascending length <30 mm and a descending aortic diameter >40 mm in 46% of patients accordingly. Technical success was achieved in all cases. A type Ic endoleak (7%) due to aneurysmatic degeneration of the brachiocephalic artery was identified at 2 years. No further aortic-related adverse events were reported.
Conclusions: The Nexus endograft demonstrated a favorable safety profile and promising clinical outcomes at 1 year, even in patients treated outside IFU criteria, with high technical success and no evidence of stroke. Reassessment of certain IFU criteria could enhance the device's applicability.
Clinical impact: Our findings highlight the potential for expanding the clinical use of the Nexus stent-graft beyond its current IFU, offering a safe and effective alternative for complex aortic arch anatomies. With high technical success and no perioperative cerebrovascular events, these results suggest that carefully selected patients who are otherwise ineligible for surgery may still benefit from endovascular repair. This study provides real-world evidence supporting the reconsideration of IFU criteria, potentially broadening treatment options. The innovation lies in demonstrating that even outside IFU conditions, the Nexus endograft maintains a strong safety profile, paving the way for more inclusive patient selection.