Pub Date : 2026-03-19DOI: 10.1177/15266028261423521
Leszek Kukulski, Karin Pfister, Georgios Sachsamanis, Wilma Schierling, Ali Badrouni, Thomas Betz
Introduction: A consensus exists among vascular surgery societies that blunt thoracic aortic injury (BTAI) should be treated with thoracic endovascular aortic repair (TEVAR) in patients with favorable aortic anatomy. However, selecting the correct landing zones and endograft sizing remains challenging in patients with BTAI. To overcome these limitations, conformable endografts are often used for TEVAR, even in patients with BTAI. This study aimed to analyze the outcomes of these patients with respect to anatomical and technical factors.
Methods: This retrospective study included all patients with BTAI who underwent TEVAR at a tertiary vascular center. The primary endpoint was aortic-related reintervention-free survival. Secondary endpoints were 30-day in-hospital mortality, postoperative complications, and radiological findings. Patients were divided into 2 groups: group 1, patients with a conformable endograft (cTAG Gore), and group 2, patients with a nonconformable endograft.
Results: Between June 2001 and May 2019, 57 patients (50 men; mean age, 37.3 years) with BTAI received 30 (52.6%) conformable (Gore cTAG) and 27 (47.4%) nonconformable endografts. The 1-, 3-, and 5-year aortic-related reintervention-free survival was 100%, 100%, and 96.7% in group 1 and 81.4%, 81.4%, and 77.7% in group 2, respectively (p=0.03). Two postoperative type Ia endoleaks and 3 postoperative type II endoleaks were observed in group 2. The bird beak sign was noted more often in group 2 (70.4% vs 53.3, p=0.32).
Conclusions: This study, in a small cohort of patients, demonstrated that the Gore cTAG, when properly selected according to the patient's anatomy, appears to provide better outcomes after TEVAR for patients with BTAI than nonconformable devices. A bird beak sign occurred frequently in both groups and were not associated with poor outcomes. Further studies are required to confirm these findings.Clinical ImpactThis study in a small cohort of patients demonstrated that the Gore cTAG endoprosthesis, when properly selected to match the patient's anatomy, appears to result in better outcomes after TEVAR in patients with BTAI than nonconformable devices. In addition, the BBS was common in both groups of patients and was not associated with a worse outcome.
血管外科学会一致认为,对于主动脉解剖结构良好的患者,钝性胸主动脉损伤(BTAI)应采用胸血管内主动脉修复(TEVAR)治疗。然而,在BTAI患者中,选择正确的着陆点和内移植物大小仍然具有挑战性。为了克服这些局限性,适形内移植物经常用于TEVAR,即使是BTAI患者。本研究旨在分析这些患者在解剖学和技术因素方面的结果。方法:本回顾性研究纳入了所有在三级血管中心接受TEVAR治疗的BTAI患者。主要终点是主动脉相关的无再干预生存期。次要终点是30天住院死亡率、术后并发症和放射学结果。将患者分为2组:1组为合格内移植物患者(cTAG Gore), 2组为不合格内移植物患者。结果:2001年6月至2019年5月,57例BTAI患者(50名男性,平均年龄37.3岁)接受了30例(52.6%)符合(Gore cTAG)和27例(47.4%)不符合的内移植物。组1、3、5年无主动脉相关再干预生存率分别为100%、100%、96.7%,组2为81.4%、81.4%、77.7% (p=0.03)。2组术后Ia型内陷2例,II型内陷3例。2组鸟喙征发生率更高(70.4% vs 53.3%, p=0.32)。结论:本研究在一小组患者中表明,当根据患者解剖结构正确选择Gore cTAG时,对于BTAI患者TEVAR后的结果似乎比不符合要求的装置更好。两组患者均出现鸟喙征,且与预后不佳无关。需要进一步的研究来证实这些发现。临床影响本研究对一小群患者进行了研究,结果表明,当正确选择与患者解剖结构相匹配的Gore cTAG内假体时,BTAI患者在TEVAR后的结果似乎比不符合要求的装置更好。此外,BBS在两组患者中都很常见,并且与较差的结果无关。
{"title":"Conformable Endograft as a Standard Treatment for Thoracic Endovascular Aortic Repair in Patients With Blunt Thoracic Aortic Injury.","authors":"Leszek Kukulski, Karin Pfister, Georgios Sachsamanis, Wilma Schierling, Ali Badrouni, Thomas Betz","doi":"10.1177/15266028261423521","DOIUrl":"https://doi.org/10.1177/15266028261423521","url":null,"abstract":"<p><strong>Introduction: </strong>A consensus exists among vascular surgery societies that blunt thoracic aortic injury (BTAI) should be treated with thoracic endovascular aortic repair (TEVAR) in patients with favorable aortic anatomy. However, selecting the correct landing zones and endograft sizing remains challenging in patients with BTAI. To overcome these limitations, conformable endografts are often used for TEVAR, even in patients with BTAI. This study aimed to analyze the outcomes of these patients with respect to anatomical and technical factors.</p><p><strong>Methods: </strong>This retrospective study included all patients with BTAI who underwent TEVAR at a tertiary vascular center. The primary endpoint was aortic-related reintervention-free survival. Secondary endpoints were 30-day in-hospital mortality, postoperative complications, and radiological findings. Patients were divided into 2 groups: group 1, patients with a conformable endograft (cTAG Gore), and group 2, patients with a nonconformable endograft.</p><p><strong>Results: </strong>Between June 2001 and May 2019, 57 patients (50 men; mean age, 37.3 years) with BTAI received 30 (52.6%) conformable (Gore cTAG) and 27 (47.4%) nonconformable endografts. The 1-, 3-, and 5-year aortic-related reintervention-free survival was 100%, 100%, and 96.7% in group 1 and 81.4%, 81.4%, and 77.7% in group 2, respectively (p=0.03). Two postoperative type Ia endoleaks and 3 postoperative type II endoleaks were observed in group 2. The bird beak sign was noted more often in group 2 (70.4% vs 53.3, p=0.32).</p><p><strong>Conclusions: </strong>This study, in a small cohort of patients, demonstrated that the Gore cTAG, when properly selected according to the patient's anatomy, appears to provide better outcomes after TEVAR for patients with BTAI than nonconformable devices. A bird beak sign occurred frequently in both groups and were not associated with poor outcomes. Further studies are required to confirm these findings.Clinical ImpactThis study in a small cohort of patients demonstrated that the Gore cTAG endoprosthesis, when properly selected to match the patient's anatomy, appears to result in better outcomes after TEVAR in patients with BTAI than nonconformable devices. In addition, the BBS was common in both groups of patients and was not associated with a worse outcome.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261423521"},"PeriodicalIF":1.5,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147482096","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}
Pub Date : 2026-03-17DOI: 10.1177/15266028261428271
Chiara Barillà, Alessandra Fittipaldi, Gabriele Passari, Giuseppe Giuffrè, Giovanni De Caridi, Filippo Benedetto
Introduction: Injuries of the inferior vena cava (IVC) secondary to blunt trauma is a rare life-threatening condition that has a mortality rate up to 70%. Prompt diagnosis and treatment is mandatory. Endografts are commonly used in arterial trauma, but their use in veins injury is rarely reported in literature.
Case report: We report a case of a 72-year-old foreign woman with IVC injuries at confluence treated in an emergency setting. She arrived at the emergency room after a car crash. Computed tomography (CT) angiography showed rupture of iliocaval confluence with massive active bleeding. Endovascular repair was promptly performed using an aortic unibody stent graft to achieve bleeding control. One month CT angiography showed patency of the endograft and of both iliac veins, and no evidence of thrombotic apposition.
Conclusion: Inferior vena cava injury has high mortality rate, and this novel approach may allow iliocaval repair in a successful and rapid manner. Moreover, the unibody endograft is suitable for reconstructing the IVC and both iliac veins simultaneously, showing great adaptability to the venous system.Clinical ImpactThis case suggests a new, although experimental, path for addressing severe venous traumas. The innovation lies in demonstrating that an "off-label" unibody aortic endograft can provide a minimally invasive option for highly complex ilio-caval confluence ruptures, where few other solution exist, potentially improving outcomes in these challenging scenarios.
{"title":"Emergency Treatment of Iliocaval Vein Injury With an Aortic Unibody Stent Graft.","authors":"Chiara Barillà, Alessandra Fittipaldi, Gabriele Passari, Giuseppe Giuffrè, Giovanni De Caridi, Filippo Benedetto","doi":"10.1177/15266028261428271","DOIUrl":"https://doi.org/10.1177/15266028261428271","url":null,"abstract":"<p><strong>Introduction: </strong>Injuries of the inferior vena cava (IVC) secondary to blunt trauma is a rare life-threatening condition that has a mortality rate up to 70%. Prompt diagnosis and treatment is mandatory. Endografts are commonly used in arterial trauma, but their use in veins injury is rarely reported in literature.</p><p><strong>Case report: </strong>We report a case of a 72-year-old foreign woman with IVC injuries at confluence treated in an emergency setting. She arrived at the emergency room after a car crash. Computed tomography (CT) angiography showed rupture of iliocaval confluence with massive active bleeding. Endovascular repair was promptly performed using an aortic unibody stent graft to achieve bleeding control. One month CT angiography showed patency of the endograft and of both iliac veins, and no evidence of thrombotic apposition.</p><p><strong>Conclusion: </strong>Inferior vena cava injury has high mortality rate, and this novel approach may allow iliocaval repair in a successful and rapid manner. Moreover, the unibody endograft is suitable for reconstructing the IVC and both iliac veins simultaneously, showing great adaptability to the venous system.Clinical ImpactThis case suggests a new, although experimental, path for addressing severe venous traumas. The innovation lies in demonstrating that an \"off-label\" unibody aortic endograft can provide a minimally invasive option for highly complex ilio-caval confluence ruptures, where few other solution exist, potentially improving outcomes in these challenging scenarios.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261428271"},"PeriodicalIF":1.5,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147469997","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}
Pub Date : 2026-03-17DOI: 10.1177/15266028261434102
Lei Zhang, Dexiang Xia, Rui Li, Quanming Li, Chang Shu, Xin Li
<p><strong>Objective: </strong>To compare perioperative outcomes between resuscitative endovascular balloon occlusion of the aorta (REBOA) and non-REBOA management in ruptured abdominal aortic aneurysm (rAAA) repair, and to perform an exploratory comparison of REBOA outcomes between open surgical repair (OSR) and endovascular aortic repair (EVAR).</p><p><strong>Methods: </strong>A retrospective analysis was conducted of 107 consecutive rAAA patients (2013-2022), stratified by surgical approach (OSR vs EVAR) and REBOA utilization. Propensity score matching (1:2) was performed based on preoperative shock, comorbidities, and aneurysm morphology, yielding 22 REBOA and 44 non-REBOA patients. Outcomes were compared statistically.</p><p><strong>Results: </strong>Resuscitative endovascular balloon occlusion of the aorta was utilized in 22 patients (10/45 [22.2%] OSR and 12/62 [19.4%] EVAR), with a 100% technical success rate. One Clavien-Dindo grade I access site hematoma occurred (4.5%). No instances of aortic injury, distal embolization, limb ischemia, or balloon failure were observed. After matching, 30-day mortality did not differ significantly (13.6% vs 22.7%, p=0.555). Resuscitative endovascular balloon occlusion of the aorta was associated with a significantly reduced rate of major adverse cardiovascular event (MACE) (4.5% vs 20.5%, p=0.043) and a higher intraoperative diastolic blood pressure (BP) (mean difference+6.7 mm Hg, p=0.031). Blood loss, intensive care unit stay length, and costs were comparable between groups. Long-term survival was similar (log-rank p=0.375). In an exploratory analysis, outcomes between REBOA-OSR (n=10) and REBOA-EVAR (n=12) subgroups showed no significant differences in mortality or MACE, although this analysis was underpowered.</p><p><strong>Conclusions: </strong>Resuscitative endovascular balloon occlusion of the aorta demonstrated high technical success and an excellent safety profile in rAAA repair. Its use was associated with improved intraoperative hemodynamic stability (higher diastolic BP) and a reduced rate of MACE, although it did not significantly impact mortality or survival. Larger, prospective trials are warranted to confirm the observed reduction in MACE. The comparative outcomes of REBOA in OSR versus EVAR settings remain inconclusive due to the limited sample size.Clinical ImpactThis study demonstrates that resuscitative endovascular balloon occlusion of the aorta (REBOA) in ruptured abdominal aortic aneurysm (rAAA) repair is safe and feasible, and is associated with improved intraoperative hemodynamics and reduced major adverse cardiovascular events. For clinicians, these findings support its use for unstable rAAA patients, particularly those with refractory shock or challenging anatomy. Resuscitative endovascular balloon occlusion of the aorta may serve as both a resuscitative and a cardioprotective strategy by augmenting coronary perfusion. The innovation lies in validating its contemporary safety
目的:比较复苏血管内球囊阻断主动脉(REBOA)与非REBOA治疗腹主动脉瘤破裂(rAAA)修复术的围手术期疗效,并对开放手术修复(OSR)与血管内主动脉修复(EVAR)的REBOA预后进行探索性比较。方法:对2013-2022年连续107例rAAA患者进行回顾性分析,根据手术入路(OSR vs EVAR)和REBOA的使用情况进行分层。根据术前休克、合并症和动脉瘤形态进行倾向评分匹配(1:2),产生22例REBOA患者和44例非REBOA患者。结果进行统计学比较。结果:采用复苏血管内球囊阻断主动脉22例(OSR 10/45 [22.2%], EVAR 12/62[19.4%]),技术成功率100%。发生1例Clavien-Dindo I级通路部位血肿(4.5%)。没有观察到主动脉损伤、远端栓塞、肢体缺血或球囊衰竭的病例。配对后,30天死亡率无显著差异(13.6% vs 22.7%, p=0.555)。复苏性血管内球囊阻断主动脉与主要心血管不良事件(MACE)发生率显著降低(4.5% vs 20.5%, p=0.043)和术中舒张压(BP)升高(平均差值+6.7 mm Hg, p=0.031)相关。两组间的出血量、重症监护病房住院时间和费用具有可比性。长期生存率相似(log-rank p=0.375)。在一项探索性分析中,REBOA-OSR (n=10)和REBOA-EVAR (n=12)亚组之间的结果显示死亡率或MACE没有显著差异,尽管该分析的有效性不足。结论:复苏血管内球囊阻断主动脉在rAAA修复中具有很高的技术成功率和良好的安全性。它的使用与术中血流动力学稳定性的改善(舒张压升高)和MACE发生率的降低相关,尽管它对死亡率或生存率没有显著影响。需要更大规模的前瞻性试验来证实观察到的MACE降低。由于样本量有限,REBOA在OSR和EVAR环境下的比较结果仍然不确定。临床影响本研究表明,在腹主动脉瘤破裂(rAAA)修复中,复苏性血管内球囊闭塞主动脉(REBOA)是安全可行的,并且可以改善术中血流动力学,减少主要心血管不良事件。对于临床医生来说,这些发现支持将其用于不稳定的rAAA患者,特别是那些难治性休克或解剖结构具有挑战性的患者。复苏血管内球囊阻断主动脉可作为一种复苏和心脏保护策略,通过增加冠状动脉灌注。创新之处在于验证其当代安全性,并提出一种心脏益处机制,可能改变紧急主动脉手术的风险-益处评估。
{"title":"Perioperative Outcomes and Safety of Resuscitative Endovascular Balloon Occlusion of the Aorta in Ruptured Abdominal Aortic Aneurysm Repair: A Propensity-Matched Cohort Study.","authors":"Lei Zhang, Dexiang Xia, Rui Li, Quanming Li, Chang Shu, Xin Li","doi":"10.1177/15266028261434102","DOIUrl":"https://doi.org/10.1177/15266028261434102","url":null,"abstract":"<p><strong>Objective: </strong>To compare perioperative outcomes between resuscitative endovascular balloon occlusion of the aorta (REBOA) and non-REBOA management in ruptured abdominal aortic aneurysm (rAAA) repair, and to perform an exploratory comparison of REBOA outcomes between open surgical repair (OSR) and endovascular aortic repair (EVAR).</p><p><strong>Methods: </strong>A retrospective analysis was conducted of 107 consecutive rAAA patients (2013-2022), stratified by surgical approach (OSR vs EVAR) and REBOA utilization. Propensity score matching (1:2) was performed based on preoperative shock, comorbidities, and aneurysm morphology, yielding 22 REBOA and 44 non-REBOA patients. Outcomes were compared statistically.</p><p><strong>Results: </strong>Resuscitative endovascular balloon occlusion of the aorta was utilized in 22 patients (10/45 [22.2%] OSR and 12/62 [19.4%] EVAR), with a 100% technical success rate. One Clavien-Dindo grade I access site hematoma occurred (4.5%). No instances of aortic injury, distal embolization, limb ischemia, or balloon failure were observed. After matching, 30-day mortality did not differ significantly (13.6% vs 22.7%, p=0.555). Resuscitative endovascular balloon occlusion of the aorta was associated with a significantly reduced rate of major adverse cardiovascular event (MACE) (4.5% vs 20.5%, p=0.043) and a higher intraoperative diastolic blood pressure (BP) (mean difference+6.7 mm Hg, p=0.031). Blood loss, intensive care unit stay length, and costs were comparable between groups. Long-term survival was similar (log-rank p=0.375). In an exploratory analysis, outcomes between REBOA-OSR (n=10) and REBOA-EVAR (n=12) subgroups showed no significant differences in mortality or MACE, although this analysis was underpowered.</p><p><strong>Conclusions: </strong>Resuscitative endovascular balloon occlusion of the aorta demonstrated high technical success and an excellent safety profile in rAAA repair. Its use was associated with improved intraoperative hemodynamic stability (higher diastolic BP) and a reduced rate of MACE, although it did not significantly impact mortality or survival. Larger, prospective trials are warranted to confirm the observed reduction in MACE. The comparative outcomes of REBOA in OSR versus EVAR settings remain inconclusive due to the limited sample size.Clinical ImpactThis study demonstrates that resuscitative endovascular balloon occlusion of the aorta (REBOA) in ruptured abdominal aortic aneurysm (rAAA) repair is safe and feasible, and is associated with improved intraoperative hemodynamics and reduced major adverse cardiovascular events. For clinicians, these findings support its use for unstable rAAA patients, particularly those with refractory shock or challenging anatomy. Resuscitative endovascular balloon occlusion of the aorta may serve as both a resuscitative and a cardioprotective strategy by augmenting coronary perfusion. The innovation lies in validating its contemporary safety ","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261434102"},"PeriodicalIF":1.5,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147500591","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}
Pub Date : 2026-03-15DOI: 10.1177/15266028261433405
Lei Zhang, Dexiang Xia, Quanming Li, Ming Li, Hao He, Chang Shu, Xin Li
<p><strong>Objective: </strong>To evaluate the early-term outcomes of endovascular repair for zone 2 aortic arch pathologies using the Castor single-branched stent-graft, with adjunctive chimney technique employed when extending for proximal extension into zones 1 and 0.</p><p><strong>Methods: </strong>A <b>s</b>ingle-center retrospective study was conducted on 63 patients (mean age=57.0±13.4 years; 55 males, 87.3%) with zone 2 aortic pathologies treated between February 2023 and June 2024. Proximal landing zones determined treatment strategy: Standard zone 2 landing (n=37, Castor branch in left subclavian artery [LSA]); extended zone 1 landing (n=20, Castor branch in LSA+LCCA chimney); extended zone 0 landing (n=6, Castor branch in LCCA+innominate artery (IA) chimney+selective LSA revascularization based on vertebral artery dominance). Baseline characteristics, procedural data, and outcomes were analyzed to assess technical success, perioperative/follow-up complications, reinterventions, and branch patency. Outcomes were described separately for each landing zone cohort (zones 2, 1, and 0).</p><p><strong>Results: </strong>The overall technical success was 96.8% (61/63). No mortality, stroke, paraplegia, retrograde type A aortic dissection/ (RTAAD), endoleak, or upper limb ischemia occurred within the 30-day postoperative period. During a mean follow-up of 17.4±5.5 months, the overall endoleak rate was 1.6% (1/63), comprising a single zone 2 landing type II endoleak (LSA backflow) detected at the 3-month follow-up. No graft-related type I/III endoleaks occurred. Branch occlusion occurred in 1.6% of cases (1/63), involving the Castor LSA branch in a zone 1 landing case at 10 months. All chimney stent-grafts maintained patency. Reinterventions (3.2%, 2/63) comprised: one zone 2 landing type II endoleak, and one zone 1 landing complications (LSA occlusion). All-cause mortality was 1.6% (1/63, occurring at 11 months postoperatively in a zone 1 landing patient due to non-aortic-related causes).</p><p><strong>Conclusions: </strong>The Castor single-branched stent-graft enabled effective zone 2 reconstruction. Combined with chimney technique, it facilitated treatment extension into zone 1 and exploratory applications in zone 0. The results for each strategy demonstrate high technical success, a favorable safety profile, high branch/chimney patency rates, and low-complication rates.Clinical ImpactThis study demonstrates that the Castor single-branched stent-graft is safe and effective in endovascular repair of zone 2 aortic arch pathologies. Combined with a chimney stent, its application can be successfully extended to zone 1 and exploratory zone 0 cases. This hybrid strategy provides a minimally invasive endovascular alternative for complex arch pathologies, particularly in patients at high surgical risk or ineligible for custom-made devices. This work contributes by providing the first detailed perioperative and follow-up data for this combined approac
{"title":"Early Outcomes of Castor Single-Branched Stent-Graft for Zone 2 Aortic Arch Pathologies and Exploratory Use in Proximal Extension to Zone 1/0 With Chimney Techniques.","authors":"Lei Zhang, Dexiang Xia, Quanming Li, Ming Li, Hao He, Chang Shu, Xin Li","doi":"10.1177/15266028261433405","DOIUrl":"https://doi.org/10.1177/15266028261433405","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the early-term outcomes of endovascular repair for zone 2 aortic arch pathologies using the Castor single-branched stent-graft, with adjunctive chimney technique employed when extending for proximal extension into zones 1 and 0.</p><p><strong>Methods: </strong>A <b>s</b>ingle-center retrospective study was conducted on 63 patients (mean age=57.0±13.4 years; 55 males, 87.3%) with zone 2 aortic pathologies treated between February 2023 and June 2024. Proximal landing zones determined treatment strategy: Standard zone 2 landing (n=37, Castor branch in left subclavian artery [LSA]); extended zone 1 landing (n=20, Castor branch in LSA+LCCA chimney); extended zone 0 landing (n=6, Castor branch in LCCA+innominate artery (IA) chimney+selective LSA revascularization based on vertebral artery dominance). Baseline characteristics, procedural data, and outcomes were analyzed to assess technical success, perioperative/follow-up complications, reinterventions, and branch patency. Outcomes were described separately for each landing zone cohort (zones 2, 1, and 0).</p><p><strong>Results: </strong>The overall technical success was 96.8% (61/63). No mortality, stroke, paraplegia, retrograde type A aortic dissection/ (RTAAD), endoleak, or upper limb ischemia occurred within the 30-day postoperative period. During a mean follow-up of 17.4±5.5 months, the overall endoleak rate was 1.6% (1/63), comprising a single zone 2 landing type II endoleak (LSA backflow) detected at the 3-month follow-up. No graft-related type I/III endoleaks occurred. Branch occlusion occurred in 1.6% of cases (1/63), involving the Castor LSA branch in a zone 1 landing case at 10 months. All chimney stent-grafts maintained patency. Reinterventions (3.2%, 2/63) comprised: one zone 2 landing type II endoleak, and one zone 1 landing complications (LSA occlusion). All-cause mortality was 1.6% (1/63, occurring at 11 months postoperatively in a zone 1 landing patient due to non-aortic-related causes).</p><p><strong>Conclusions: </strong>The Castor single-branched stent-graft enabled effective zone 2 reconstruction. Combined with chimney technique, it facilitated treatment extension into zone 1 and exploratory applications in zone 0. The results for each strategy demonstrate high technical success, a favorable safety profile, high branch/chimney patency rates, and low-complication rates.Clinical ImpactThis study demonstrates that the Castor single-branched stent-graft is safe and effective in endovascular repair of zone 2 aortic arch pathologies. Combined with a chimney stent, its application can be successfully extended to zone 1 and exploratory zone 0 cases. This hybrid strategy provides a minimally invasive endovascular alternative for complex arch pathologies, particularly in patients at high surgical risk or ineligible for custom-made devices. This work contributes by providing the first detailed perioperative and follow-up data for this combined approac","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261433405"},"PeriodicalIF":1.5,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147464246","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}
Background: Distal aortic expansion (DAE) after thoracic endovascular aortic repair (TEVAR) remains a critical long-term outcome-related determinant. The aim of this study was to identify risk factors for postoperative DAE through a meta-analysis and meta-regression.
Methods: In this systematic review and meta-analysis, the PubMed, Embase, and the Cochrane Library databases were searched from database inception to April 1, 2025. The primary outcome was the incidence of distal aortic expansion (DAE) after TEVAR. Pooled effect estimates were calculated using random-effects models, and heterogeneity was assessed with Cochran's Q test and the I2 statistic. Meta-regression was performed to explore potential predictors of DAE. Publication bias was evaluated using Egger's test and funnel plots.
Results: Twenty-four studies were included, with a pooled DAE incidence of 27% (95% CI: 21%-35%). Meta-regression indicated that male sex (RR = 3.00, p=0.020), myocardial infarction (RR = 5.98, p<0.001), peripheral vascular disease (RR = 3.39, p=0.007), malperfusion (RR = 1.52, p=0.050), and postoperative false lumen expansion (RR = 1.18, p=0.046) were associated with increased DAE risk. Older age, prior cardiac surgery, congestive heart failure, residual dissection, and post-false lumen (FL) complete thrombosis (distal) were protective factors.
Conclusions: DAE after TEVAR is determined by a combination of patient comorbidities and aortic remodeling features. Identifying high-risk profiles-such as male sex, cardiovascular comorbidities, and persistent false lumen-may help optimize surveillance and reduce late aortic complications.Clinical ImpactDistal aortic expansion (DAE) remains a major determinant of late failure after TEVAR for type B aortic dissection. This study provides a comprehensive quantitative synthesis of clinical and remodeling-related predictors of DAE, highlighting high-risk profiles such as male sex, hypertension, prior myocardial infarction, peripheral vascular disease, and persistent false lumen patency. By integrating demographic, comorbidity, and morphological factors, the findings support a risk-adapted surveillance strategy rather than uniform follow-up protocols. Importantly, the study underscores the prognostic significance of false lumen dynamics, reinforcing the role of adjunctive techniques aimed at promoting distal thrombosis. These insights may facilitate individualized monitoring, earlier intervention, and improved long-term durability after TEVAR.
{"title":"Risk Factor Analysis of Post-TEVAR Distal Aortic Expansion: A Systematic Review and Meta-Analysis.","authors":"Dongsheng Cui, Xiang Li, Yonghui Chen, Xiaoxing Zhang, Jiangchao Huang, Jiaxue Bi, Xiangchen Dai","doi":"10.1177/15266028261428261","DOIUrl":"https://doi.org/10.1177/15266028261428261","url":null,"abstract":"<p><strong>Background: </strong>Distal aortic expansion (DAE) after thoracic endovascular aortic repair (TEVAR) remains a critical long-term outcome-related determinant. The aim of this study was to identify risk factors for postoperative DAE through a meta-analysis and meta-regression.</p><p><strong>Methods: </strong>In this systematic review and meta-analysis, the PubMed, Embase, and the Cochrane Library databases were searched from database inception to April 1, 2025. The primary outcome was the incidence of distal aortic expansion (DAE) after TEVAR. Pooled effect estimates were calculated using random-effects models, and heterogeneity was assessed with Cochran's Q test and the I<sup>2</sup> statistic. Meta-regression was performed to explore potential predictors of DAE. Publication bias was evaluated using Egger's test and funnel plots.</p><p><strong>Results: </strong>Twenty-four studies were included, with a pooled DAE incidence of 27% (95% CI: 21%-35%). Meta-regression indicated that male sex (RR = 3.00, p=0.020), myocardial infarction (RR = 5.98, p<0.001), peripheral vascular disease (RR = 3.39, p=0.007), malperfusion (RR = 1.52, p=0.050), and postoperative false lumen expansion (RR = 1.18, p=0.046) were associated with increased DAE risk. Older age, prior cardiac surgery, congestive heart failure, residual dissection, and post-false lumen (FL) complete thrombosis (distal) were protective factors.</p><p><strong>Conclusions: </strong>DAE after TEVAR is determined by a combination of patient comorbidities and aortic remodeling features. Identifying high-risk profiles-such as male sex, cardiovascular comorbidities, and persistent false lumen-may help optimize surveillance and reduce late aortic complications.Clinical ImpactDistal aortic expansion (DAE) remains a major determinant of late failure after TEVAR for type B aortic dissection. This study provides a comprehensive quantitative synthesis of clinical and remodeling-related predictors of DAE, highlighting high-risk profiles such as male sex, hypertension, prior myocardial infarction, peripheral vascular disease, and persistent false lumen patency. By integrating demographic, comorbidity, and morphological factors, the findings support a risk-adapted surveillance strategy rather than uniform follow-up protocols. Importantly, the study underscores the prognostic significance of false lumen dynamics, reinforcing the role of adjunctive techniques aimed at promoting distal thrombosis. These insights may facilitate individualized monitoring, earlier intervention, and improved long-term durability after TEVAR.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261428261"},"PeriodicalIF":1.5,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147464302","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}
Pub Date : 2026-03-10DOI: 10.1177/15266028261429915
Samet Genez, Hamza Özer, Yunus Yılmazsoy, Oya Kalaycıoğlu, Onur Taydaş, Ömer Faruk Ateş
<p><strong>Purpose: </strong>To evaluate the feasibility, technical success, and safety of ultrasound (US)-guided direct thrombolytic injection in patients with acute and early-subacute extremity arterial occlusions.</p><p><strong>Materials and methods: </strong>This retrospective, single-center study included 24 patients treated between July 2023 and January 2025 for acute (≤14 days) or early-subacute (14-21 days) arterial occlusions (Rutherford I-IIb). Under real-time US guidance, alteplase (2-10 mg total) was injected into the thrombus at 2 to 3 cm intervals using a 27-gauge (40-mm) or, for deeper targets, a 22-gauge (90-mm) needle. Doppler US was performed at 2, 4, and 6 hours to assess recanalization. The primary endpoint was Doppler US-based recanalization category at 6 hours (complete/partial/none) prior to any adjunct endovascular revascularization. Secondary endpoints included adjunct angiography/endovascular procedures, complications, and follow-up primary-assisted and secondary patency at 1, 3, and 6 months.</p><p><strong>Results: </strong>At 6 hours, complete recanalization was observed in 12/24 (50.0%), partial in 4/24 (16.7%), and no recanalization in 8/24 (33.3%). The median alteplase dose was 6 mg (range, 2-10 mg). Diagnostic angiography was performed in 15/24 (62.5%), and adjunct endovascular procedures were performed as indicated. Minor complications occurred in 10/24 (41.7%); no major bleeding or procedure-related mortality occurred. Two patients with Rutherford IIb ischemia and symptom duration >14 days ultimately underwent major amputation after refusing further revascularization. Primary-assisted patency rates were 66.7%, 58.3%, and 41.7%, and secondary patency rates were 87.5%, 79.2%, and 75.0% at 1, 3, and 6 months, respectively. In multivariable ordinal regression, shorter time to alteplase administration was independently associated with a more favorable 6-hour Doppler recanalization category (OR 15.67; 95% CI, 1.88-130.59; p=0.011), with wide confidence intervals indicating limited precision.</p><p><strong>Conclusions: </strong>US-guided direct intrathrombus alteplase injection appears feasible with an acceptable safety profile and provides an early Doppler-defined response in selected patients. Prospective comparative studies are needed to define its role and refine patient selection.Clinical ImpactUltrasound-guided direct intrathrombus alteplase injection is a feasible, minimally invasive option for selected patients with acute and early-subacute arterial occlusions. The innovation is localized, real-time US-targeted delivery of low-dose tPA without catheter placement or prolonged infusion, combined with serial Doppler assessment to guide repeat dosing and timely escalation to angiography and adjunct endovascular therapy when indicated. For clinicians, this provides a practical workflow with close non-ICU monitoring, enabling early identification of residual thrombus, distal embolization, or underlying stenosis. The s
{"title":"Ultrasound-Guided Direct Thrombolytic Injection for Acute and Early-Subacute Arterial Occlusions: Feasibility and Early Outcomes.","authors":"Samet Genez, Hamza Özer, Yunus Yılmazsoy, Oya Kalaycıoğlu, Onur Taydaş, Ömer Faruk Ateş","doi":"10.1177/15266028261429915","DOIUrl":"https://doi.org/10.1177/15266028261429915","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the feasibility, technical success, and safety of ultrasound (US)-guided direct thrombolytic injection in patients with acute and early-subacute extremity arterial occlusions.</p><p><strong>Materials and methods: </strong>This retrospective, single-center study included 24 patients treated between July 2023 and January 2025 for acute (≤14 days) or early-subacute (14-21 days) arterial occlusions (Rutherford I-IIb). Under real-time US guidance, alteplase (2-10 mg total) was injected into the thrombus at 2 to 3 cm intervals using a 27-gauge (40-mm) or, for deeper targets, a 22-gauge (90-mm) needle. Doppler US was performed at 2, 4, and 6 hours to assess recanalization. The primary endpoint was Doppler US-based recanalization category at 6 hours (complete/partial/none) prior to any adjunct endovascular revascularization. Secondary endpoints included adjunct angiography/endovascular procedures, complications, and follow-up primary-assisted and secondary patency at 1, 3, and 6 months.</p><p><strong>Results: </strong>At 6 hours, complete recanalization was observed in 12/24 (50.0%), partial in 4/24 (16.7%), and no recanalization in 8/24 (33.3%). The median alteplase dose was 6 mg (range, 2-10 mg). Diagnostic angiography was performed in 15/24 (62.5%), and adjunct endovascular procedures were performed as indicated. Minor complications occurred in 10/24 (41.7%); no major bleeding or procedure-related mortality occurred. Two patients with Rutherford IIb ischemia and symptom duration >14 days ultimately underwent major amputation after refusing further revascularization. Primary-assisted patency rates were 66.7%, 58.3%, and 41.7%, and secondary patency rates were 87.5%, 79.2%, and 75.0% at 1, 3, and 6 months, respectively. In multivariable ordinal regression, shorter time to alteplase administration was independently associated with a more favorable 6-hour Doppler recanalization category (OR 15.67; 95% CI, 1.88-130.59; p=0.011), with wide confidence intervals indicating limited precision.</p><p><strong>Conclusions: </strong>US-guided direct intrathrombus alteplase injection appears feasible with an acceptable safety profile and provides an early Doppler-defined response in selected patients. Prospective comparative studies are needed to define its role and refine patient selection.Clinical ImpactUltrasound-guided direct intrathrombus alteplase injection is a feasible, minimally invasive option for selected patients with acute and early-subacute arterial occlusions. The innovation is localized, real-time US-targeted delivery of low-dose tPA without catheter placement or prolonged infusion, combined with serial Doppler assessment to guide repeat dosing and timely escalation to angiography and adjunct endovascular therapy when indicated. For clinicians, this provides a practical workflow with close non-ICU monitoring, enabling early identification of residual thrombus, distal embolization, or underlying stenosis. The s","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261429915"},"PeriodicalIF":1.5,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147437080","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}
Pub Date : 2026-03-06DOI: 10.1177/15266028261424752
Daniel Becker, Georgios I Karaolanis, Ahmed A Ali, Konstantinos Kotopoulos, Vaiva Dabravolskaite, Drosos Kotelis, Vladimir Makaloski, Michel Joseph Bosiers
<p><strong>Introduction: </strong>Fenestrated endovascular aneurysm repair (FEVAR) has emerged as a standard treatment for complex abdominal and thoracoabdominal aortic aneurysms (CAAAs/TAAAs), yet target vessel instability (TVI) remains a concern. This study evaluates mid-term outcomes and anatomical predictors of TVI following FEVAR using the Anaconda custom-made fenestrated stent-graft system (Terumo Aortic, Inchinnan, Scotland, UK).</p><p><strong>Methods: </strong>A retrospective single-center study included all consecutive patients treated with FEVAR using Anaconda stent-graft between September 2013 and December 2023. Preoperative and postoperative vessel geometry was assessed using Aquarius iNtuition software (TeraRecon, Foster City, CA). Primary endpoints were TVI (occlusion, stenosis, type I/III endoleak, or re-intervention) and freedom from re-intervention at 12 months. Secondary endpoints were intraoperative technical success and 30-day major adverse events (MAEs) rate.</p><p><strong>Results: </strong>A total of 101 patients with 359 target vessels were analyzed. Technical success was 97%. The 30-day MAE rate was 21.7%, with no mortality. Target vessel instability occurred in 7.8% (4.5% type IIIc endoleak, 1.4% stenosis, and 1.9% type Ic endoleak) during a median follow-up of 36 months (interquartile range [IQR]=22-55 months). Multivariate analysis identified increased sealing length (odds ratio [OR]=1.080, 95% confidence interval [CI]: 1.002, 1.164, p=0.044) and intra-aortic stent protrusion≥7 mm (OR=1.406, 95% CI: 1.067, 1.852, p=0.015) as independent predictors of TVI in visceral vessels. In renal target vessels, protrusion ≥ 7 mm (OR=1.284, 95% CI: 1.019, 1.618, p=0.034) was significantly associated with occlusion. Cumulative incidence of TVI with death as competing risk was 3.1%, 3.6%%, and 5.9% at 1, 2, and 5 years, respectively.</p><p><strong>Conclusion: </strong>Fenestrated endovascular aneurysm repair using the Anaconda stent-graft system demonstrates high technical success and mid-term freedom from TVI. Extended intra-aortic stent protrusion and sealing length, significantly impact TVI adversely. Optimizing bridging stent geometry may reduce re-intervention rates and improve outcomes in complex aortic repairs.Clinical ImpactThis study demonstrates that fenestrated endovascular aneurysm repair using the Anaconda custom-made fenestrated stent-graft system provides high technical success and durable mid-term target vessel stability in complex aortic aneurysm repair. Importantly, it identifies modifiable anatomical predictors-excessive intra-aortic bridging stent protrusion and increased sealing length-as independent risk factors for target vessel instability. These findings shift attention from device selection alone to precise geometric optimization of bridging stents during procedural planning and deployment. For clinicians, careful control of protrusion length and sealing configuration may reduce endoleaks and re-interventions
{"title":"Geometrical Analysis of Target Vessel Instability After FEVAR With Anaconda Stent-Graft System.","authors":"Daniel Becker, Georgios I Karaolanis, Ahmed A Ali, Konstantinos Kotopoulos, Vaiva Dabravolskaite, Drosos Kotelis, Vladimir Makaloski, Michel Joseph Bosiers","doi":"10.1177/15266028261424752","DOIUrl":"https://doi.org/10.1177/15266028261424752","url":null,"abstract":"<p><strong>Introduction: </strong>Fenestrated endovascular aneurysm repair (FEVAR) has emerged as a standard treatment for complex abdominal and thoracoabdominal aortic aneurysms (CAAAs/TAAAs), yet target vessel instability (TVI) remains a concern. This study evaluates mid-term outcomes and anatomical predictors of TVI following FEVAR using the Anaconda custom-made fenestrated stent-graft system (Terumo Aortic, Inchinnan, Scotland, UK).</p><p><strong>Methods: </strong>A retrospective single-center study included all consecutive patients treated with FEVAR using Anaconda stent-graft between September 2013 and December 2023. Preoperative and postoperative vessel geometry was assessed using Aquarius iNtuition software (TeraRecon, Foster City, CA). Primary endpoints were TVI (occlusion, stenosis, type I/III endoleak, or re-intervention) and freedom from re-intervention at 12 months. Secondary endpoints were intraoperative technical success and 30-day major adverse events (MAEs) rate.</p><p><strong>Results: </strong>A total of 101 patients with 359 target vessels were analyzed. Technical success was 97%. The 30-day MAE rate was 21.7%, with no mortality. Target vessel instability occurred in 7.8% (4.5% type IIIc endoleak, 1.4% stenosis, and 1.9% type Ic endoleak) during a median follow-up of 36 months (interquartile range [IQR]=22-55 months). Multivariate analysis identified increased sealing length (odds ratio [OR]=1.080, 95% confidence interval [CI]: 1.002, 1.164, p=0.044) and intra-aortic stent protrusion≥7 mm (OR=1.406, 95% CI: 1.067, 1.852, p=0.015) as independent predictors of TVI in visceral vessels. In renal target vessels, protrusion ≥ 7 mm (OR=1.284, 95% CI: 1.019, 1.618, p=0.034) was significantly associated with occlusion. Cumulative incidence of TVI with death as competing risk was 3.1%, 3.6%%, and 5.9% at 1, 2, and 5 years, respectively.</p><p><strong>Conclusion: </strong>Fenestrated endovascular aneurysm repair using the Anaconda stent-graft system demonstrates high technical success and mid-term freedom from TVI. Extended intra-aortic stent protrusion and sealing length, significantly impact TVI adversely. Optimizing bridging stent geometry may reduce re-intervention rates and improve outcomes in complex aortic repairs.Clinical ImpactThis study demonstrates that fenestrated endovascular aneurysm repair using the Anaconda custom-made fenestrated stent-graft system provides high technical success and durable mid-term target vessel stability in complex aortic aneurysm repair. Importantly, it identifies modifiable anatomical predictors-excessive intra-aortic bridging stent protrusion and increased sealing length-as independent risk factors for target vessel instability. These findings shift attention from device selection alone to precise geometric optimization of bridging stents during procedural planning and deployment. For clinicians, careful control of protrusion length and sealing configuration may reduce endoleaks and re-interventions","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261424752"},"PeriodicalIF":1.5,"publicationDate":"2026-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147370605","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}
Pub Date : 2026-03-05DOI: 10.1177/15266028261425070
Manuela Cherchi, Johanna H Nederhoed, Martina Bastianon, Giovanni Pratesi, Davide Esposito, Caterina Melani, Vincent Riambau, Trijntje Bloemert-Tuin, Constantijn E V B Hazenberg, Joost A van Herwaarden, Ron Balm, Rutger J Lely, Bram B van der Meijs, Jan D Blankensteijn, Arjan W J Hoksbergen, Vincent Jongkind, Kak Khee Yeung
{"title":"Midterm Results of Custom-Made Fenestrated TREO Abdominal Stent-Graft in Endovascular Repair of Complex Abdominal Aortic Aneurysms.","authors":"Manuela Cherchi, Johanna H Nederhoed, Martina Bastianon, Giovanni Pratesi, Davide Esposito, Caterina Melani, Vincent Riambau, Trijntje Bloemert-Tuin, Constantijn E V B Hazenberg, Joost A van Herwaarden, Ron Balm, Rutger J Lely, Bram B van der Meijs, Jan D Blankensteijn, Arjan W J Hoksbergen, Vincent Jongkind, Kak Khee Yeung","doi":"10.1177/15266028261425070","DOIUrl":"https://doi.org/10.1177/15266028261425070","url":null,"abstract":"","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261425070"},"PeriodicalIF":1.5,"publicationDate":"2026-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147357315","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}
Pub Date : 2026-03-05DOI: 10.1177/15266028261423157
Gergana T Taneva, Jaime Muñoz Castellanos
<p><strong>Purpose: </strong>To systematically review the current evidence on the use of sirolimus-coated endovascular devices for the treatment of femoropopliteal peripheral artery disease (PAD), focusing on efficacy, safety, and clinical feasibility.</p><p><strong>Materials and methods: </strong>A comprehensive systematic review was conducted according to PRISMA guidelines. PubMed, Scopus, and Medline were searched from inception to July 2025, along with ClinicalTrials.gov and the EU Clinical Trials Register. Eligible studies included clinical trials in humans evaluating sirolimus-eluting balloons or sirolimus-eluting stents (DES) for femoropopliteal lesions. Data extracted included patient characteristics, lesion complexity, follow-up duration, primary patency (PP), freedom from clinically-driven target lesion revascularization (CD-TLR), and bailout stenting rates.</p><p><strong>Results: </strong>Fifteen studies encompassing 2960 patients (2439 with femoropopliteal disease) were included. Randomized controlled trials were limited (SIROCCO I-II, SIRONA, ASCLEPIOS), with most data derived from prospective registries. Six studies incorporated independent core laboratory adjudication. Mean lesion length ranged from 5.8 to 27.7 cm, with total occlusions reported in up to 100% of cases and severe calcification (PACSS grade 4) in up to 48%. At 12 months, primary patency ranged from 58.1% to 94%, while freedom from CD-TLR varied between 74.3% and >95%. Three-year outcomes demonstrated sustained efficacy, with PP of 74.7% and CD-TLR freedom of 92.9% in selected studies. Bailout stenting was generally low (0%-38%). Early sirolimus DES trials did not demonstrate superiority over bare stents, but newer devices (eg, NiTiDES) showed improved outcomes. No sirolimus-specific adverse safety signals have been reported; however, long-term data beyond 36 months are missing.</p><p><strong>Conclusion: </strong>Sirolimus-coated devices offer a promising alternative to paclitaxel-based technologies for femoropopliteal PAD, with encouraging efficacy and a favorable short- to mid-term safety profile. Outcomes are comparable to those of paclitaxel devices, even in complex lesions. Nevertheless, current evidence is limited by heterogeneous study designs, small sample sizes, and relatively short follow-up. Larger randomized trials with independent adjudication and extended surveillance are required to define the long-term safety and clinical role of sirolimus in femoropopliteal interventions.Clinical ImpactThis systematic review consolidates the emerging clinical evidence on sirolimus-coated technologies for femoropopliteal disease, offering clinicians a structured appraisal of efficacy and safety across devices and lesion complexities. In the context of persistent debate surrounding paclitaxel, sirolimus represents a mechanistically distinct, cytostatic alternative with encouraging short- and mid-term outcomes and no current safety signal. For practicing interventionists
{"title":"Emerging Sirolimus-Based Drug-Coated Technologies for Femoropopliteal Disease: A Systematic Review.","authors":"Gergana T Taneva, Jaime Muñoz Castellanos","doi":"10.1177/15266028261423157","DOIUrl":"https://doi.org/10.1177/15266028261423157","url":null,"abstract":"<p><strong>Purpose: </strong>To systematically review the current evidence on the use of sirolimus-coated endovascular devices for the treatment of femoropopliteal peripheral artery disease (PAD), focusing on efficacy, safety, and clinical feasibility.</p><p><strong>Materials and methods: </strong>A comprehensive systematic review was conducted according to PRISMA guidelines. PubMed, Scopus, and Medline were searched from inception to July 2025, along with ClinicalTrials.gov and the EU Clinical Trials Register. Eligible studies included clinical trials in humans evaluating sirolimus-eluting balloons or sirolimus-eluting stents (DES) for femoropopliteal lesions. Data extracted included patient characteristics, lesion complexity, follow-up duration, primary patency (PP), freedom from clinically-driven target lesion revascularization (CD-TLR), and bailout stenting rates.</p><p><strong>Results: </strong>Fifteen studies encompassing 2960 patients (2439 with femoropopliteal disease) were included. Randomized controlled trials were limited (SIROCCO I-II, SIRONA, ASCLEPIOS), with most data derived from prospective registries. Six studies incorporated independent core laboratory adjudication. Mean lesion length ranged from 5.8 to 27.7 cm, with total occlusions reported in up to 100% of cases and severe calcification (PACSS grade 4) in up to 48%. At 12 months, primary patency ranged from 58.1% to 94%, while freedom from CD-TLR varied between 74.3% and >95%. Three-year outcomes demonstrated sustained efficacy, with PP of 74.7% and CD-TLR freedom of 92.9% in selected studies. Bailout stenting was generally low (0%-38%). Early sirolimus DES trials did not demonstrate superiority over bare stents, but newer devices (eg, NiTiDES) showed improved outcomes. No sirolimus-specific adverse safety signals have been reported; however, long-term data beyond 36 months are missing.</p><p><strong>Conclusion: </strong>Sirolimus-coated devices offer a promising alternative to paclitaxel-based technologies for femoropopliteal PAD, with encouraging efficacy and a favorable short- to mid-term safety profile. Outcomes are comparable to those of paclitaxel devices, even in complex lesions. Nevertheless, current evidence is limited by heterogeneous study designs, small sample sizes, and relatively short follow-up. Larger randomized trials with independent adjudication and extended surveillance are required to define the long-term safety and clinical role of sirolimus in femoropopliteal interventions.Clinical ImpactThis systematic review consolidates the emerging clinical evidence on sirolimus-coated technologies for femoropopliteal disease, offering clinicians a structured appraisal of efficacy and safety across devices and lesion complexities. In the context of persistent debate surrounding paclitaxel, sirolimus represents a mechanistically distinct, cytostatic alternative with encouraging short- and mid-term outcomes and no current safety signal. For practicing interventionists","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261423157"},"PeriodicalIF":1.5,"publicationDate":"2026-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147357336","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}
Purpose: Infrapopliteal arterial disease represents a complex subtype of peripheral artery disease (PAD). This study aimed to develop an interpretable machine learning model to assess the severity of infrapopliteal artery lesions.
Methods: Clinical data from patients with PAD treated at our institution were obtained between July 2019 and October 2024. Based on the angiographic results, patients were categorized into a mild lesion group (n=584) and a severe lesion group (n=478). Data from 2019 to 2023 were used for model development, with 70% allocated to the training set and 30% to the validation set. Clinical data from patients in 2024 served as the external test set. Feature selection was performed using 3 distinct machine learning algorithms. Subsequently, 10 different predictive models were developed and compared. The optimal model was interpreted and deployed. Finally, we conducted subgroup analyses.
Results: A total of 1062 patients were included in the study. Six predictors were identified through feature selection and used for model construction. Among the 10 models, the Gradient Boosting Machine (GBM) demonstrated the best predictive performance, achieving area under the curve (AUC) values of 0.891 in the validation set, indicating high discriminative ability. The calibration curve showed good agreement with the ideal line. Decision curve analysis demonstrated that the model provided superior net benefit within a threshold probability range of approximately 15% to 90%. Model interpretation was performed using Shapley additive explanations. Additionally, a nomogram was developed, and the model was deployed as an interactive web-based tool. The GBM model maintained robust performance across all subgroups.
Conclusions: The GBM model, developed using 6 clinically relevant variables, enables accurate prediction of infrapopliteal artery disease severity and demonstrates its significant potential to support clinical decision-making and improve risk stratification for patients with PAD.Clinical ImpactThis study introduces a Gradient Boosting Machine model to predict the severity of infrapopliteal arterial disease using six readily available variables. For clinicians, this offers a non-invasive, rapid decision-support tool. By accurately predicting lesion severity, the model enables surgeons to better stratify patients, optimize treatment planning, and potentially improve the suboptimal outcomes currently associated with infrapopliteal interventions. This innovation shifts practice towards a more personalized, data-driven approach in the initial assessment of peripheral artery disease.
目的:髌下动脉疾病是外周动脉疾病(PAD)的一种复杂亚型。本研究旨在开发一种可解释的机器学习模型来评估髌下动脉病变的严重程度。方法:获取2019年7月至2024年10月在我院治疗的PAD患者的临床数据。根据血管造影结果将患者分为轻度病变组(n=584)和重度病变组(n=478)。2019年至2023年的数据用于模型开发,其中70%分配给训练集,30%分配给验证集。2024年患者临床数据作为外部测试集。使用3种不同的机器学习算法进行特征选择。随后,开发了10种不同的预测模型并进行了比较。对最优模型进行了解释和部署。最后,我们进行了亚组分析。结果:共纳入1062例患者。通过特征选择确定了六个预测因子并用于模型构建。在10个模型中,梯度增强机(Gradient Boosting Machine, GBM)的预测效果最好,验证集的曲线下面积(area under the curve, AUC)值为0.891,表明其判别能力较强。标定曲线与理想线吻合较好。决策曲线分析表明,该模型在约15%至90%的阈值概率范围内提供了优越的净效益。模型解释采用Shapley加性解释。此外,还开发了nomogram,并将该模型部署为基于web的交互式工具。GBM模型在所有子组中都保持了稳健的性能。结论:使用6个临床相关变量建立的GBM模型能够准确预测髌下动脉疾病的严重程度,并显示出其支持PAD患者临床决策和改善风险分层的巨大潜力。临床影响本研究引入梯度增强机模型,利用六个现成的变量来预测腘下动脉疾病的严重程度。对于临床医生来说,这提供了一种非侵入性的快速决策支持工具。通过准确预测病变严重程度,该模型使外科医生能够更好地对患者进行分层,优化治疗计划,并有可能改善目前与腘窝下干预相关的次优结果。这一创新将外周动脉疾病的初步评估转向更加个性化、数据驱动的方法。
{"title":"Predicting the Severity of Infrapopliteal Artery Lesions in Patients With Peripheral Artery Disease Using Interpretable Machine Learning.","authors":"Zhian Liang, Xiang Li, Duan Wang, Bin Zhao, Jiaxue Bi, Dongsheng Cui, Jiaxin Wang, Jiayin Guo, Shuaishuai Wang, Yinghong Li, Xiangchen Dai","doi":"10.1177/15266028261425482","DOIUrl":"https://doi.org/10.1177/15266028261425482","url":null,"abstract":"<p><strong>Purpose: </strong>Infrapopliteal arterial disease represents a complex subtype of peripheral artery disease (PAD). This study aimed to develop an interpretable machine learning model to assess the severity of infrapopliteal artery lesions.</p><p><strong>Methods: </strong>Clinical data from patients with PAD treated at our institution were obtained between July 2019 and October 2024. Based on the angiographic results, patients were categorized into a mild lesion group (n=584) and a severe lesion group (n=478). Data from 2019 to 2023 were used for model development, with 70% allocated to the training set and 30% to the validation set. Clinical data from patients in 2024 served as the external test set. Feature selection was performed using 3 distinct machine learning algorithms. Subsequently, 10 different predictive models were developed and compared. The optimal model was interpreted and deployed. Finally, we conducted subgroup analyses.</p><p><strong>Results: </strong>A total of 1062 patients were included in the study. Six predictors were identified through feature selection and used for model construction. Among the 10 models, the Gradient Boosting Machine (GBM) demonstrated the best predictive performance, achieving area under the curve (AUC) values of 0.891 in the validation set, indicating high discriminative ability. The calibration curve showed good agreement with the ideal line. Decision curve analysis demonstrated that the model provided superior net benefit within a threshold probability range of approximately 15% to 90%. Model interpretation was performed using Shapley additive explanations. Additionally, a nomogram was developed, and the model was deployed as an interactive web-based tool. The GBM model maintained robust performance across all subgroups.</p><p><strong>Conclusions: </strong>The GBM model, developed using 6 clinically relevant variables, enables accurate prediction of infrapopliteal artery disease severity and demonstrates its significant potential to support clinical decision-making and improve risk stratification for patients with PAD.Clinical ImpactThis study introduces a Gradient Boosting Machine model to predict the severity of infrapopliteal arterial disease using six readily available variables. For clinicians, this offers a non-invasive, rapid decision-support tool. By accurately predicting lesion severity, the model enables surgeons to better stratify patients, optimize treatment planning, and potentially improve the suboptimal outcomes currently associated with infrapopliteal interventions. This innovation shifts practice towards a more personalized, data-driven approach in the initial assessment of peripheral artery disease.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":" ","pages":"15266028261425482"},"PeriodicalIF":1.5,"publicationDate":"2026-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147357332","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}