Pinar Ulug, Colin D Bicknell, Rachel Bell, Jonathan R Boyle, Michael Jenkins, Jeanette Oliver, Shaneel Patel, Chris Twine, Srinivasa Rao Vallabhaneni
{"title":"British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry: An Analysis of Aortic Neck Coverage of the GORE<sup>®</sup> EXCLUDER<sup>®</sup> Conformable AAA Endoprosthesis With ACTIVE CONTROL System.","authors":"Pinar Ulug, Colin D Bicknell, Rachel Bell, Jonathan R Boyle, Michael Jenkins, Jeanette Oliver, Shaneel Patel, Chris Twine, Srinivasa Rao Vallabhaneni","doi":"10.1177/15266028251344812","DOIUrl":"10.1177/15266028251344812","url":null,"abstract":"<p><strong>Objective: </strong>Primarily to evaluate the area of neck coverage and secondarily, technical and clinical outcomes of the GORE<sup>®</sup> EXCLUDER<sup>®</sup> Conformable AAA Endoprosthesis (EXCC), designed to treat patients with significant angulation of the aortic neck, in routine clinical treatment of patients with abdominal aortic aneurysm (AAA).</p><p><strong>Design: </strong>A prospective, multicentre, observational cohort study.</p><p><strong>Materials and methods: </strong>Patients aged >55 years with a nonruptured infrarenal AAA requiring treatment, were enrolled into the registry from June 2019 to December 2021. Baseline clinical, procedural, and follow-up data were collected pre-, peri-, and postoperatively at 3 and 12-months. CT images were assessed using a strict protocol at a core laboratory. The primary outcome was the estimated percentage of the total aortic neck that remained uncovered by the graft assessed on the first follow-up CT scan.</p><p><strong>Results: </strong>One hundred five patients with AAA underwent endovascular aneurysm repair (EVAR) with the EXCC device in 13 UK study centers (mean age 77.5 years, 14/105 female, 7/105 symptomatic). One hundred two participants with available CT scans were placed into group A-beta angulation <60° and aortic neck >10 mm (51/102); group B-beta angulation <90° and >60° and aortic neck >15 mm (37/102); and group C-those outside of instructions for use (14/102). The primary outcome of median percentage of neck that remained uncovered after EVAR was 5.1% [IQR 1.9-12.4]; 4.8% in group A, 6.0% in group B, and 3.8% in group C. Overall technical success was 96% (97.9%, 100%, and 84.6% in group A, B, and C, respectively). One-year overall and aneurysm related mortality was 9.1% and 0%. Four patients required re-intervention for proximal neck complications (including 2/14 patients in group C).</p><p><strong>Conclusion: </strong>The EXCC device can be accurately placed even in patients with significant angulation of the aortic neck. Clinical outcomes are acceptable to 1 year; however, physicians should exercise caution when treating patients where the graft is placed outside the instructions for use.Clinical ImpactThis prospective registry assessed the performance of a novel device with greater conformability, and angulation control of the delivery system to treat abdominal aortic aneurysm (AAA) with up to 90° neck angulation within instructions for use (IFU). In 105 patients, the primary outcome of estimated median percentage of uncovered aortic neck was 5.1% [IQR 1.9-12.4]. In patients with anatomy conforming to IFU, there was no difference in the percentage of neck that was uncovered in angulated (>60°) versus nonangulated patients (0-60°) and no early type 1a endoleak. This suggests excellent apposition of the graft to the aortic wall despite significant angulation of the aortic neck. Clinical outcomes were acceptable to 1 year.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2469-2480"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13571003/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144668842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Endovascular Septal Fenestration and Stenting Under Intravascular Ultrasound Guidance for Complicated Acute Aortic Dissection.","authors":"Roberto G Aru, Alexis L Lauria, James H Black","doi":"10.1177/15266028251384188","DOIUrl":"10.1177/15266028251384188","url":null,"abstract":"<p><p>Percutaneous septal fenestration and stenting is a useful technique in acute aortic dissection when there is persistent malperfusion of renovisceral vessels, despite primary stenting of the thoracic aorta or when coverage of the primary entry tear is not technically feasible. Intravascular ultrasound provides reassurance to the interventionalist that the septal fenestration targets the level of malperfusion. Septal fenestration may promote continued false lumen perfusion into target vessels and aneurysmal degeneration, so this technique should be considered as a temporizing measure.Clinical ImpactHerein, we describe the indications and technical steps of endovascular fenestration for aortic dissection - related renovisceral or iliofemoral malperfusion. This step-by-step description and illustration will be of particular interest to endovascular aortic interventionalists, when stenting of the primary aortic entry tear is not feasible. Finally, IVUS and stenting of the septal fenestration and/or malperfused branch vessel can be useful adjuncts in these complex clinical scenarios.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2403-2407"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145349655","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}
Sanaa Kamel, Robin Chastant, Pierre Alric, Thomas Gandet, Ludovic Canaud
{"title":"Single- and Double-Fenestrated Physician-Modified Stent Grafts for Emergent Aortic Arch Lesions.","authors":"Sanaa Kamel, Robin Chastant, Pierre Alric, Thomas Gandet, Ludovic Canaud","doi":"10.1177/15266028251384226","DOIUrl":"10.1177/15266028251384226","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate and compare outcomes of single- and double-fenestrated physician-modified endovascular grafts (PMEGs) for aortic arch pathologies treated in an emergent setting.</p><p><strong>Methods: </strong>All patients consecutively treated for an emergent aortic arch pathology were included in this retrospective single-center cohort study between July 2014 and March 2023. In each case, the distal smaller fenestration for the left subclavian artery (LSA) was the only 1 stented. For a double-fenestrated endograft, a proximal larger fenestration that incorporated both the brachiocephalic trunk and the left common carotid artery was added.</p><p><strong>Results: </strong>A total of 86 patients with complicated aortic arch lesions were treated, with 74% being men and a mean age of 68 years. Of these, 63% underwent single LSA fenestration, while 37% had double-fenestrated thoracic endovascular aortic repair. The main indications for repair included acute complicated type B aortic dissection (TBAD) (54%), traumatic transection of the aorta (TTA) (19%), and other conditions such as penetrating aortic ulcer (PAU), degenerative aneurysm (DA), pseudoaneurysm (PSA), and aortic thrombus. The technical success rate was 91%, with modification times of 10 minutes for single fenestration and 23 minutes for double fenestration. Thirty-day mortality was 19%, with no significant difference between the 2 fenestration types. Neurologic events occurred in 3 patients (3%), and 3 (3%) patients had perioperative retrograde dissection. Endoleaks occurred in 5% (type 1) and 2% (type 3), with no type 2 endoleaks. Eight patients (9%) required reintervention, and all supra-aortic trunks remained patent. During a follow-up of 27.6 months, no patients experienced aortic rupture (AR), neurological events, or required conversion to open surgery.</p><p><strong>Conclusion: </strong>Single and double PMEGs are suitable and reproducible treatment for emergent serious aortic arch lesions, with comparable outcomes whatever the aortic landing zone and number of fenestrations.Clinical ImpactFenestrated physician-modified endovascular grafts for emergent aortic arch repair appear to be a promising treatment, offering reproducibility, rapid deployment, and limited manipulation of supra-aortic trunks. The standardized technique eliminates the need for complex sizing and benefits from consistent aortic arch anatomy in most patients. It provides clinicians with a practical and efficient option in emergency settings, achieving high technical success with acceptable complication rates.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2332-2343"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145460531","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}
Georgios I Karaolanis, Konstantinos Kotopoulos, Rosalinda D'Amico, Drosos Kotelis, Edin Mujagic, Vladimir Makaloski
{"title":"The Fate of False Lumen in Type B and Residual Type A Aortic Dissection Using the Candy-Plug Technique: A Systematic Review and Meta-Analysis.","authors":"Georgios I Karaolanis, Konstantinos Kotopoulos, Rosalinda D'Amico, Drosos Kotelis, Edin Mujagic, Vladimir Makaloski","doi":"10.1177/15266028251344808","DOIUrl":"10.1177/15266028251344808","url":null,"abstract":"<p><strong>Objective: </strong>We performed a systematic review and meta-analysis to evaluate the technical and clinical success of false lumen occlusion with the Candy-plug (CP) technique in patients with type B and residual type A aortic dissection.</p><p><strong>Materials and methods: </strong>A systematic search of all the literature reported until November 2024 was performed according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. The pooled technical and clinical success and corresponding 95% confidence intervals (CIs) were estimated using fixed or random effect methods.</p><p><strong>Results: </strong>A total of 106 study titles were identified by the initial search strategy, of which 6 were considered eligible for inclusion in the meta-analysis. A total of 128 patients (83% male) were identified among the eligible studies. The pooled technical and clinical success rate among the studies were 96% (95% CI, 88-98) and 76% (95% CI, 58-88) respectively. The technical success for custom-made manufacturing device (CMD) was 98.5% (95% CI, 92-99; <i>I</i><sup>2</sup>=0%; p=0.78, 2 studies) while for the physician modified CP technique (pmCP) technique was 92.7% (95% CI, 77-98; <i>I</i><sup>2</sup>=0%; p=0.79, 4 studies). Overall, false lumen thrombosis rate was 71% (95% CI, 55-83): 80% (95% CI, 57-92; <i>I</i><sup>2</sup>=0%; p=0.90, 2 studies) for CMD while for the pmCP technique was 63% (95% CI, 27-88; <i>I</i><sup>2</sup>=0%; p=0.99, 4 studies). The pooled aortic remodeling rate was 50% (95% CI, 33-66): 63.2% (95% CI, 52.7-72.5; <i>I</i><sup>2</sup>=69%; p=0.68, 2 studies) for CMD, while for the pmCP technique was 35.9% (95% CI, 17-54%; <i>I</i><sup>2</sup>=39%; p=0.17, 4 studies). The incidence of CP related reinterventions were 7.1% [11.5% for CMD (95% CI, 0.3-8.4; <i>I</i><sup>2</sup>=0%; p=0.09, 2 studies) and 5.1% for pmCP (95% CI, 1.3-18; <i>I</i><sup>2</sup>=0%; p=0.96, 4 studies)] and 12.8% [4.5% for CMD (95% CI, 0.3-39; <i>I</i><sup>2</sup>=69%; p=0.68, 2 studies), while for the pmCP technique was 4.6% (95% CI, 0.9-19; <i>I</i><sup>2</sup>=0%; p=0.90, 4 studies)] in the early and late period.</p><p><strong>Conclusion: </strong>CP technique appears to be a promising solution demonstrating high technical success, false lumen thrombosis, and aortic remodeling rate. However, the clinical success rate tends to be lower. Life-long and strict follow-up of these patients may be necessary to monitor CP-related complications, given the limited data on the long-term durability of these devices.Clinical ImpactThis study provides detailed information on a physician-modified candy plug technique in patients with patent False lumen in Type B or residual Type A aortic dissection. As the custom-made candy plug devices have been developed, the delivery time for them varies between countries and vascular surgery services, making the planning of the procedure difficult, especially in symptomatic patients or ","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2266-2275"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144303468","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}
Emanuele Barabino, Lucia Soresini, Francesco Petrocelli, Daniele Bianco, Paolo Di Donna, Giulio Bovio
{"title":"Emergency Endovascular Stent Grafting of an Innominate Vein Injury Causing Hemothorax: The Double Balloon on a Single Wire Technique.","authors":"Emanuele Barabino, Lucia Soresini, Francesco Petrocelli, Daniele Bianco, Paolo Di Donna, Giulio Bovio","doi":"10.1177/15266028251363454","DOIUrl":"10.1177/15266028251363454","url":null,"abstract":"<p><strong>Purpose: </strong>The VIABAHN<sup>®</sup> VBX is a versatile stent graft that can be overdilated by up to 30% of its nominal diameter. However, to reach its maximum diameter, the balloon must be exchanged for a larger one. This technical note aims to illustrate a technique designed to enhance accuracy during the deployment and overdilation of a VIABAHN VBX for treating an injury to the left innominate vein (LIV).</p><p><strong>Technique: </strong>Two venous accesses were established in the left arm and in the right femoral vein. Using a rendezvous technique, a hydrophilic guidewire was snared and externalized from the arm. The balloon-expandable stent was advanced through the brachial access, and the larger balloon from the femoral access, both on the same guidewire. The balloon-expandable stent was inflated to its maximum diameter. During the retraction of the first balloon, the larger balloon was then advanced within the stent graft to perform overdilation.</p><p><strong>Results: </strong>The defect in the LIV was sealed-off without stent-graft migration and the patient showed improvement in his clinical condition.</p><p><strong>Conclusion: </strong>The VIABAHN VBX is a valid option for treating injuries to the LIV. The double-balloon on a single wire (double-BLOW) technique may be an advantageous approach to prevent migration and enhance accuracy during deployment.Clinical ImpactThe double-BLOW technique offers improved stability and enhanced precision in deliver stent grafts and it might be useful when a larger balloon is required to perform over dilatation.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2374-2379"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805204","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 Aortoiliac Artery Bifurcation Angle May Be a New Indicator for Predicting the Growth of Abdominal Aortic Aneurysm.","authors":"Xinghan Zhao, Qingpeng Song, Shuailiang Liu, Qingduo Zheng, Xuejun Wu","doi":"10.1177/15266028251339355","DOIUrl":"10.1177/15266028251339355","url":null,"abstract":"<p><strong>Objectives: </strong>The aortoiliac artery bifurcation angle (AIABA) within abdominal aortic aneurysms (AAAs) may potentially influence subsequent aneurysm growth. The goal was to investigate the role of AIABA in AAA growth via contrast-enhanced CT.</p><p><strong>Methods: </strong>A total of 142 patients with AAAs who underwent contrast-enhanced CT at baseline and follow-up (minimum follow-up duration of 3 months) were included. The AIABA, proximal landing zone distance and maximal AAA diameter were measured via multiplanar reconstruction, and the growth rate of the aneurysms was calculated. Comprehensive statistical approaches were used to determine the relationships between AIABA and aneurysm growth.</p><p><strong>Results: </strong>Mean age of patients was 69.7 ± 8.3 years and 90.8% were men. AAAs with affected bifurcations had smaller bifurcation angles (53.3° ± 20.1° vs 61.1° ± 16.4°; p<0.05) and faster growth rates (3.28 ± 1.79 vs 2.14 ± 1.42 mm/year; p<0.05). Groups 1 to 6 of all AAAs were defined by the AIABA as follows: <30°, 31° to 45°, 46° to 60°, 61° to 75°, 76° to 90° and >90°. The growth rates of the AAAs in Groups 1, 2, 3, and 6 were 2.92-, 2.91-, 1.56-, and 3.48-fold greater than those in Group 5 (p<0.05) and were 2.62-, 2.60-, 1.39-, and 3.12-fold greater than those in Group 4 (p<0.05), respectively. According to both the univariate and multivariate analyses, the AIABA was independently negatively related to the aneurysm growth rate when the AIABA <90° (univariate analysis: r=-0.83, p<0.01; multivariate analysis: r=-0.89, p<0.01).</p><p><strong>Conclusion: </strong>AIABA is an independent predictor of AAA growth.Clinical ImpactThe aortoiliac artery bifurcation angle is an independent predictor of abdominal aortic aneurysm progression. Abdominal aortic aneurysm with an aortoiliac artery bifurcation angle < 45° or > 90° are likely to grow faster. Abdominal aortic aneurysms surveillance strategies based on diameter could be modified, a risky angle (< 45° or > 90°) of bifurcation should be considered even if the maximal diameter of the AAA is within the conventional safe range.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2458-2468"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144081623","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}
Samira E M van Knippenberg, Susan van Dieren, Ron Balm, Kak Khee Yeung
{"title":"Reply on \"Re: Long-term Cardiovascular and All-Cause Mortality Following Elective Infrarenal Repair of the Abdominal Aortic Aneurysm: A Systematic Review and Meta-Analysis\".","authors":"Samira E M van Knippenberg, Susan van Dieren, Ron Balm, Kak Khee Yeung","doi":"10.1177/15266028251350068","DOIUrl":"10.1177/15266028251350068","url":null,"abstract":"","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2781-2782"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144530787","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}
Rajan A Ramdev, Andrew Matar, Carlos A Valdes, Shivam Patel, Bethelhem Tadesse, Marcelah I Chen, Meisam Asgari, Dean J Arnaoutakis, Jean Bismuth
{"title":"Aortic Compliance: A Narrative Review.","authors":"Rajan A Ramdev, Andrew Matar, Carlos A Valdes, Shivam Patel, Bethelhem Tadesse, Marcelah I Chen, Meisam Asgari, Dean J Arnaoutakis, Jean Bismuth","doi":"10.1177/15266028251363468","DOIUrl":"10.1177/15266028251363468","url":null,"abstract":"<p><p>Aortic compliance, the ability of the aorta to expand and recoil with each cardiac cycle, plays a crucial role in cardiovascular function and health. The present review explores the physiology of aortic compliance, evolution of various modalities and techniques to evaluate arterial stiffness, factors influencing compliance, and the clinical implications of aortic compliance when performing interventions on the aorta.Clinical ImpactA comprehensive understanding of endovascular approaches to the ascending aorta, including the aortic arch, is fundamental to evaluating the ongoing evolution of device technology and its integration with contemporary surgical strategies.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2314-2324"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144976770","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}
Barnaby JMc Farquharson, James Budge, Bilal Azhar, Aurelien Gueroult, Mital Desai, Ian Loftus, Peter Je Holt
{"title":"Pilot Study of St George's Vascular Institute Protocol for Comprehensive Assessment of Type B Aortic Dissection Morphology: A Reproducible Protocol for Clinical and Research Applications.","authors":"Barnaby JMc Farquharson, James Budge, Bilal Azhar, Aurelien Gueroult, Mital Desai, Ian Loftus, Peter Je Holt","doi":"10.1177/15266028251382092","DOIUrl":"10.1177/15266028251382092","url":null,"abstract":"<p><strong>Introduction: </strong>Aortic morphology plays a critical role in determining treatment pathways and predicting outcomes in patients presenting with acute type B aortic dissection (TBAD). However, there is no consensus on the optimal methodology for the morphological assessment of TBAD. This study aims to demonstrate the reproducibility of a comprehensive imaging protocol for the analysis of aortic morphology of TBAD for clinical and research purposes.</p><p><strong>Materials and methods: </strong>Protocol for comprehensive assessment of TBAD morphology was designed based on systematic review and expert opinion. A total of 56 morphological parameters were assessed across 6 morphological domains: aortic arch, aortic measurement, dissection morphology, false lumen morphology, endovascular intervention, and aortic remodeling. To validate the protocol, 4 observers measured these variables on 20 computed tomographic angiograms (CTAs) on a total of 10 patients using 3-dimensional imaging reconstruction software. One observer performed repeated measurements. The intraobserver and interobserver variabilities were calculated for all continuous variables. Cohen's kappa was used to assess agreement between observers for categorical variables. Measurement time for all 56 features was recorded.</p><p><strong>Results: </strong>Aortic arch, false lumen morphology, endovascular intervention, and aortic remodeling showed strong levels of agreement. Aortic measurements, including aortic diameter and false lumen diameter, showed satisfactory intraobserver and interobserver variabilities with maximum repeatability coefficient (RC) for interobserver variability of 5.02 mm and intraobserver variability of 2.42 mm across all measurements. False lumen thrombosis assessment revealed moderate to almost perfect agreement (κ range=.58-1) and almost perfect intraobserver agreement (κ range=1-1). Entry tear morphology, including primary entry tear (PET) size and distance from left subclavian artery (LSCA), showed small mean differences but was associated with high RCs. Location of PET lesser curve location was found to have moderate to almost perfect interobserver agreement (κ range=.58-1) and strong intraobserver agreement (κ=.73). The measurement protocol was completed in a median time of 28 (24, 35) minutes.</p><p><strong>Conclusion: </strong>Accurate 3-dimensional analysis of TBAD morphology can be reliably performed within a reasonable timeframe. Measurements based on consistent anatomical landmarks demonstrated the highest reproducibility. It is suggested that this protocol is adopted for clinical studies and trials on acute TBAD.Clinical ImpactThe morphological characteristics of the aorta play a pivotal role in guiding treatment strategies and prognosticating outcomes in patients with acute type B aortic dissection (TBAD). Despite its critical importance, there remains a lack of consensus regarding the optimal approach to the morphological assessment of TBA","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2633-2644"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145439885","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}
Michel M P J Reijnen, Bartosz Rylski, Antoine Millon, Robert H Geelkerken, Alexander Hyhlik-Dürr, Arjan W J Hoksbergen, Pierfrancesco Veroux, Ernst Weigang, Jörg Tessarek, Vincent Riambau
{"title":"The Terumo Aortic Global Endovascular Registry: A Multiarm, Multicenter, Open Label, Prospective Observational Registry to Obtain Safety and Performance Data on off-the-Shelf and Custom-Made Stent-Grafts.","authors":"Michel M P J Reijnen, Bartosz Rylski, Antoine Millon, Robert H Geelkerken, Alexander Hyhlik-Dürr, Arjan W J Hoksbergen, Pierfrancesco Veroux, Ernst Weigang, Jörg Tessarek, Vincent Riambau","doi":"10.1177/15266028251344790","DOIUrl":"10.1177/15266028251344790","url":null,"abstract":"<p><strong>Background: </strong>Approval of medical devices is typically based on data from relatively small clinical studies with a highly selected patient population. Postmarket surveillance is required by regulatory bodies after approval to collect and evaluate experience gained from real world use in larger and unselected populations. Terumo Aortic is a manufacturer of off-the-shelf and custom-made stent-grafts for endovascular repair of thoracic and abdominal aortic pathologies and is assessing device performance in a large registry.</p><p><strong>Methods: </strong>A multiarm, multicenter, open label, prospective observational registry designed to obtain both short- and long-term safety and performance data on the use of standard and custom-made Terumo Aortic endovascular devices in patients with thoracic and abdominal aortic pathologies. Eligibility requirements are minimal, and a standard-of-care protocol will ensure real-world evidence is collected as far as 10 years.</p><p><strong>Discussion: </strong>Challenges to this research reflect its real-world nature such as differences in standard of care between centers and geographies, varying levels of experience and expertise with the devices or techniques, all-comer populations that may not always be comparable, and a design specifically limited to a single manufacturer. Advantages of this registry design include long-term follow-up, different modules to collect standardized outcomes across pathologies and global reach to reflect practice in many different geographies with a wide range of latest-generation endovascular devices.</p><p><strong>Conclusion: </strong>This protocol is a large endovascular registry of all aortic pathologies that are treated by both off-the-shelf and custom-made Terumo Aortic products. It is ambitious in scope and projection and will be part of an overall response involving patients, physicians, and manufacturers to answer the remaining questions of endovascular aortic repair, contribute to continuing improvement of the techniques and technologies, and present an accurate picture of outcomes with latest generation stent-graft devices.Clinical ImpactThis large, long-term registry will generate robust real-world evidence on the safety and performance of both standard and custom-made Terumo Aortic endovascular devices in treating thoracic and abdominal aortic pathologies. By including a broad, minimally selected patient population across diverse global centers, the study mirrors everyday clinical practice and helps bridge the gap between clinical trials and real-world outcomes. Its findings will inform clinical decision-making, support regulatory compliance, and guide ongoing device development. Ultimately, the registry aims to enhance patient care by improving the understanding of endovascular treatment effectiveness and long-term durability in heterogeneous populations.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"2511-2519"},"PeriodicalIF":1.8,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144303469","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}