Journal of Endovascular Therapy最新文献

{"title":"Type IA Endoleak Correction With Fenestrated Devices After EVAR: Outcomes and Predictors of Secondary Failure.","authors":"Thomas Mesnard, Michel Daher, Benjamin O Patterson, Maxime Lebaz-Dubosq, Richard Azzaoui, Louis Pruvot, Stéphan Haulon, Jonathan Sobocinski","doi":"10.1177/15266028251319140","DOIUrl":"https://doi.org/10.1177/15266028251319140","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this study was to review the results of fenestrated stent-graft (Fenestrated Endovascular Aortic Repair [FEVAR]) implantation to treat patients with type IA endoleaks after prior infrarenal endovascular aortic repair (EVAR).</p><p><strong>Methods: </strong>A retrospective single-center analysis of prospectively collected data was conducted, including consecutive patients who underwent FEVAR to correct a type IA endoleak between November 2009 and April 2021. All devices were manufactured by Cook Medical (INC, Bloomington, Indiana). Demographic details, anatomical features, fenestrated stent-graft configuration, technical success, and major adverse events (MAEs) were recorded according to current SVS standards. The primary endpoint was freedom-from-significant aneurysm sac expansion (≥5 mm) and survival according to the Kaplan-Meier analysis. Secondary endpoints included 30-day outcomes, freedom-from-all-cause mortality, and aortic-related secondary interventions. Multivariate Cox regression was performed to identify factors associated with the study endpoints.</p><p><strong>Results: </strong>Overall, 47 patients (89% male, median age 80) were included. Median time from initial EVAR was 60 months [41-72]. Median pre-FEVAR maximal aneurysm diameter was 68mm [62-79]. Median fluoroscopy time and dose area product were, respectively, 49 min [36-63] and 66 Gy.cm<sup>2</sup> [38-101]. Technical success rate was 96% with no 30-day deaths reported. Two (4.3%) renal MAE occurred. Median follow-up was 22 months [12-36]. Two-year freedom-from-aneurysm sac expansion and aortic-related secondary intervention were 80% [66-96] and 69% [55-87], respectively. From the multivariate analysis, the configuration of the fenestrated device was not predictive of aneurysm sac expansion, whereas only the preoperative aneurysm maximal diameter was an independent predictor (hazard ratio [HR] [per 1 mm increment]=1.05 [1.01-1.10]; p=0.016) and was associated with a higher risk of aortic-related secondary intervention (HR [per 1 mm increment]=1.07 [1.02-1.12]; p=0.006). Other predictors of aortic-related secondary intervention were pre-existing type IB or III endoleak (HR=7.89 [1.39-44.8]; p=0.020) and aortic degeneration above the primary EVAR (HR=16.6 [1.88-147], p=0.011).</p><p><strong>Conclusion: </strong>Late type IA endoleak after EVAR can be treated safely with a fenestrated stent-graft; preoperative maximum aneurysm diameter is associated with an increased risk of later aneurysm sac growth. Close follow-up is mandatory in this subgroup of patients given the high reintervention rate.</p><p><strong>Clinical impact: </strong>Type IA endoleak following endovascular aneurysm repair (EVAR) can be treated using a fenestrated stent-graft (FEVAR). Treatment options include the addition of a fenestrated cuff alone or complete relining of the previous graft with either a 3-component device or a unibody bifurcated FEVAR. Regardless of the dev","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251319140"},"PeriodicalIF":1.7,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143450872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"European Single-Center Experience Using In Situ Fenestration TEVAR in Treating the Aortic Arch Pathologies.","authors":"Marwan Youssef, Meera Gunaseelan, Feras Jawish, Sina Moshar","doi":"10.1177/15266028251316780","DOIUrl":"https://doi.org/10.1177/15266028251316780","url":null,"abstract":"<p><strong>Clinical impact: </strong>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.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251316780"},"PeriodicalIF":1.7,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anatomical Suitability of a Standard Subclavian Branched Endograft in Previous Zone 2 Thoracic Endovascular Aortic Repair.","authors":"Nicola Leone, Francesco Andreoli, Luigi Alberto Maria Bartolotti, Andrea Ferri, Roberto Silingardi, Stefano Gennai","doi":"10.1177/15266028251316153","DOIUrl":"https://doi.org/10.1177/15266028251316153","url":null,"abstract":"<p><strong>Clinical impact: </strong>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.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251316153"},"PeriodicalIF":1.7,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Systematic Review and Meta-Analysis of the Efficacy and Safety of Limus-Coated/Eluting Devices in Peripheral Arterial Disease.","authors":"Michelle Kam Yan Mok, Iris Ho Ching Wu, Kenneth Hong Kit Yau, Yiu Che Chan","doi":"10.1177/15266028251315442","DOIUrl":"https://doi.org/10.1177/15266028251315442","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Aim: &lt;/strong&gt;Limus-based balloons, stents, and scaffolds are alternatives to paclitaxel-coated devices in peripheral endovascular treatment. This study aims to review contemporary evidence on the efficacy and safety of limus-coated devices in the treatment of lower extremity peripheral arterial disease (PAD).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A systematic literature review was performed using PubMed, Web of Sciences, OvidSP, and EMBASE, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Efficacy endpoints were primary patency (PP), freedom from clinically driven target lesion revascularization (CD-TLR) and Rutherford-Becker improvement; safety endpoints included target limb amputation and all-cause mortality.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;From a primary search of 453 articles between 27th June 2002 to 15th September 2024, 30 publications, among which were 27 prospective trials, 10 multicenter studies and 11 double-arm studies, with 2325 patients were analyzed. The numbers for above-the-knee (ATK) limus-balloons, stents, scaffolds and below-the-knee (BTK) limus-balloons, stents, scaffolds were 76, 333, 35, 55, 1445, 381 respectively. With a mean 12-month follow-up, PP for ATK lesions was 86.50% for sirolimus-coated balloons (SCB), 86.80% for sirolimus-eluting stents (SES), 72.60% for everolimus-eluting stents (EES), 86.20% for everolimus bioresorbable vascular scaffold (EBVS); whereas PP for BTK lesions was 72.60%, 73.20%, 71.60 and 83.80% respectively. Absence of CD TLR for ATK lesions was 96.50%, 95.50%, 87.60%, 89.20% respectively; meanwhile 84.90%, 75.80%, 87.70%, 94.30% for BTK lesions respectively. Rutherford-Becker improvement with 86.70%, 84.50%, 79.80 and 90.80% were seen in ATK lesions respectively, similarly, 76.50%, 81.90%, 79.50%, 92.30% respectively were observed in BTK lesions. Efficacy and clinical outcomes of SES, EES and EBVS in BTK lesions were significantly superior, where vascular complications had no proven significant difference regardless of lesion locations nor device types.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Limus-coated/eluting balloons, stents, and scaffolds are safe adjuncts and potentially superior alternative in endovascular treatment for lower extremity PAD, especially well proven in BTK lesions. However, more statistically significant evidence is recommended to validate the long-term efficacy on ATK lesions and overall use of non-SES devices regardless of locations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinical impact: &lt;/strong&gt;Limus (siro-, zotaro-, evero-, bio-, amphi-, tacrolimus) have potent antiproliferative effects in atherosclerosis. This systematic review analyzes evidence for the efficacy and safety of limus devices (balloons, stents, and scaffolds) in the treatment of femoropopliteal and below-the-knee PAD. There were 5 single-arm studies with 309 patients on femoropopliteal disease, and 11 studies with 679 patients on below-the knee (BTK) diseases. The overall primar","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251315442"},"PeriodicalIF":1.7,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Open Conversion After Branched Endovascular Aortic Repair With a Novel Hybrid Graft.","authors":"Karolina Daria Malik, Sebastian Debus, Florian K Enzmann, Leonie Schulte-Uentrop, Tilo Kölbel, Sabine Wipper","doi":"10.1177/15266028251315030","DOIUrl":"https://doi.org/10.1177/15266028251315030","url":null,"abstract":"<p><strong>Clinical impact: </strong>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.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251315030"},"PeriodicalIF":1.7,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing Trustworthy Artificial Intelligence Models to Predict Vascular Disease Progression: the VASCUL-AID-RETRO Study Protocol.","authors":"Lotte Rijken, Sabrina Zwetsloot, Stefan Smorenburg, Jelmer Wolterink, Ivana Išgum, Henk Marquering, Jan van Duivenvoorde, Corrette Ploem, Roosmarie Jessen, Fabio Catarinella, Regent Lee, Katarzyna Bera, Jenny Buisan, Ping Zhang, Marina Dias-Neto, Juliette Raffort, Fabien Lareyre, Catelijne Muller, Igor Koncar, Ivan Tomic, Maja Živković, Tamara Djuric, Aleksandra Stankovic, Maarit Venermo, Riikka Tulamo, Christian-Alexander Behrendt, Noeska Smit, Marlies Schijven, Bert-Jan van den Born, Ronak Delewi, Vincent Jongkind, Venkat Ayyalasomayajula, Kak Khee Yeung","doi":"10.1177/15266028251313963","DOIUrl":"10.1177/15266028251313963","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Abdominal aortic aneurysms (AAAs) and peripheral artery disease (PAD) are two vascular diseases with a significant risk of major adverse cardiovascular events and mortality. A challenge in current disease management is the unpredictable disease progression in individual patients. The VASCUL-AID-RETRO study aims to develop trustworthy multimodal predictive artificial intelligence (AI) models for multiple tasks including risk stratification of disease progression and cardiovascular events in patients with AAA and PAD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The VASCUL-AID-RETRO study will collect data from 5000 AAA and 6000 PAD patients across multiple European centers of the VASCUL-AID consortium using electronic health records from 2015 to 2024. This retrospectively-collected data will be enriched with additional data from existing biobanks and registries. Multimodal data, including clinical records, radiological imaging, proteomics, and genomics, will be collected to develop AI models predicting disease progression and cardiovascular risks. This will be done while integrating the international ethics guidelines and legal standards for trustworthy AI, to ensure a socially-responsible data integration and analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Proposed analyses: &lt;/strong&gt;A consensus-based variable list of clinical parameters and core outcome set for both diseases will be developed through meetings with key opinion leaders. Blood, plasma, and tissue samples from existing biobanks will be analyzed for proteomic and genomic variations. AI models will be trained on segmented AAA and PAD artery geometries for estimation of hemodynamic parameters to quantify disease progression. Initially, risk prediction models will be developed for each modality separately, and subsequently, all data will be combined to be used as input to multimodal prediction models. During all processes, data security, data quality, and ethical guidelines and legal standards will be carefully considered. As a next step, the developed models will be further adjusted with prospective data and internally validated in a prospective cohort (VASCUL-AID-PRO study).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The VASCUL-AID-RETRO study will utilize advanced AI techniques and integrate clinical, imaging, and multi-omics data to predict AAA and PAD progression and cardiovascular events.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinical trial registration: &lt;/strong&gt;The VASCUL-AID-RETRO study is registered at www.clinicaltrials.gov under the identification number NCT06206369.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinical impact: &lt;/strong&gt;The VASCUL-AID-RETRO study aims to improve clinical practice of vascular surgery by developing artificial intelligence-driven multimodal predictive models for patients with abdominal aortic aneurysms or peripheral artery disease, enhancing personalized medicine. By integrating comprehensive data sets including clinical, imaging, and multi-omics data, these models have the potential to provide accurate risk ","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251313963"},"PeriodicalIF":1.7,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Derivation and Validation of Risk Score Including Nutritional Status Among Patients With Chronic Limb-threatening Ischemia: Insight From I-PAD NAGANO Registry.","authors":"Yoshiteru Okina, Yasushi Ueki, Tamon Kato, Takashi Miura, Yushi Oyama, Naoto Hashizume, Daisuke Yokota, Minami Taki, Keisuke Senda, Tadamasa Wakabayashi, Koki Fujimori, Kenichi Karube, Takahiro Sakai, Daisuke Sunohara, Hidetomo Nomi, Yusuke Kanzaki, Keisuke Machida, Daisuke Kashiwagi, Tatsuya Saigusa, Soichiro Ebisawa, Ayako Okada, Hirohiko Motoki, Koichiro Kuwahara","doi":"10.1177/15266028251314691","DOIUrl":"https://doi.org/10.1177/15266028251314691","url":null,"abstract":"<p><strong>Purpose: </strong>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).</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>A simple 5-item risk score including nutritional status showed reasonable discriminative and prognostic ability for long-term AFS among patients with CLTI.</p><p><strong>Clinical impact: </strong>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.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251314691"},"PeriodicalIF":1.7,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143257126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Retrograde-Access Gutter Snare (RAGS) Technique: A Bailout Maneuver to Maintain Patency of the Left Subclavian Artery in Fenestrated TEVAR.","authors":"John H Landau, Luc A Dubois, Adam H Power","doi":"10.1177/15266028251314780","DOIUrl":"https://doi.org/10.1177/15266028251314780","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Technique: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical impact: </strong>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.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251314780"},"PeriodicalIF":1.7,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143257129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early Experience With the Nexus Aortic Arch Endograft for Endovascular Treatment of Complex Aortic Arch Pathologies Beyond Standard Indications.","authors":"Theodosios Bisdas, Neophytos Zambas, Marios Zertalis, George Kanellopoulos, Apostolos Roubelakis, Georgios P Georghiou, Stylianos Pappas, Panagiotis Theodoridis, Christos Dimopoulos, Nikolaos Iatrou, Nikolas Charalambous","doi":"10.1177/15266028251316375","DOIUrl":"https://doi.org/10.1177/15266028251316375","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical impact: </strong>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.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251316375"},"PeriodicalIF":1.7,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Letter to the Editor on \"Results of Palliative Stenting in Malignant Superior Vena Cava Syndrome Analyzing Self-expanding Stainless Steel and Nitinol Venous Bare Metal Stents\".","authors":"Yi Deng, Wei Cui, Jing Li","doi":"10.1177/15266028251316141","DOIUrl":"https://doi.org/10.1177/15266028251316141","url":null,"abstract":"","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028251316141"},"PeriodicalIF":1.7,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143191064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}