Faris Saleh, Ibraheem Obaidat, Prashant Neupane, Mohammed Ashrafi, Hiren Patel
{"title":"基于聚合物的主动脉腔内移植系统进行血管内动脉瘤修复(EVAR)的5年结果","authors":"Faris Saleh, Ibraheem Obaidat, Prashant Neupane, Mohammed Ashrafi, Hiren Patel","doi":"10.7759/cureus.93970","DOIUrl":null,"url":null,"abstract":"<p><p>Background Endovascular aneurysm repair (EVAR) is a widely used, minimally invasive alternative management option to open surgical repair for infrarenal abdominal aortic aneurysms (infrarenal AAAs). However, standard stent grafts have their challenges for complex aortic anatomies. The Ovation Abdominal Stent Graft System (Endologix Inc., Santa Rosa, CA), which is a polymer-filled sealing ring endograft, has emerged as a promising solution for patients with challenging anatomical features. This study aims to evaluate the Technical success, effectiveness, and long-term outcomes, including reintervention and survival, of the Ovation system in treating complex infrarenal AAAs. Methods We conducted a single-centre, retrospective observational study of 103 patients with anatomically challenging infrarenal AAAs treated with the Ovation stent graft between January 2015 and November 2017 in a UK-based tertiary centre. Anatomical parameters included short necks, severe angulation (>60°), significant thrombus or calcification (>180 degree of the wall diameter), non-cylindrical neck shapes, or an iliac access diameter <6 mm. Outcomes assessed included technical procedural success, Endoleak incidence, Conversion to open, reintervention rates, 30-day aneurysm-related mortality, and all-cause mortality over a 5-year follow-up. Results A total of 103 patients underwent EVAR using the Ovation stent graft between January 2015 and November 2017, with a 5-year follow-up. All patients had at least one adverse anatomical feature, including short necks, significant thrombus or calcification, severe neck angulation, or narrow iliac access. The cohort was predominantly male, comprising 80 patients (77.7%) with a mean age of 76.4 years (SD = 6.67). Technical success was achieved in 97% of cases, with Type I endoleak observed intraoperatively in 3 patients (2.9%). Intraoperative complications occurred in 4.8% of patients, with no aneurysm rupture or conversions to open surgery. The 30-day aneurysm-related mortality was 0%, and the overall reintervention rate over five years was 9.7%. The five-year all-cause mortality rate was 16.5%. Conclusions The Ovation polymer-based endograft demonstrates excellent technical success and favourable long-term outcomes in patients with infrarenal AAA with unfavourable anatomy, including low rates of type I endoleaks, reintervention, and aneurysm-related mortality. These findings support its use as a durable and effective EVAR solution in anatomically challenging cases beyond the standard IFU. Further multicentre prospective studies are warranted to confirm these promising results.</p>","PeriodicalId":93960,"journal":{"name":"Cureus","volume":"17 10","pages":"e93970"},"PeriodicalIF":1.3000,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12501807/pdf/","citationCount":"0","resultStr":"{\"title\":\"Five-Year Outcomes of Endovascular Aneurysm Repair (EVAR) Performed Using a Polymer-Based Aortic Endograft System.\",\"authors\":\"Faris Saleh, Ibraheem Obaidat, Prashant Neupane, Mohammed Ashrafi, Hiren Patel\",\"doi\":\"10.7759/cureus.93970\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Background Endovascular aneurysm repair (EVAR) is a widely used, minimally invasive alternative management option to open surgical repair for infrarenal abdominal aortic aneurysms (infrarenal AAAs). However, standard stent grafts have their challenges for complex aortic anatomies. The Ovation Abdominal Stent Graft System (Endologix Inc., Santa Rosa, CA), which is a polymer-filled sealing ring endograft, has emerged as a promising solution for patients with challenging anatomical features. This study aims to evaluate the Technical success, effectiveness, and long-term outcomes, including reintervention and survival, of the Ovation system in treating complex infrarenal AAAs. Methods We conducted a single-centre, retrospective observational study of 103 patients with anatomically challenging infrarenal AAAs treated with the Ovation stent graft between January 2015 and November 2017 in a UK-based tertiary centre. Anatomical parameters included short necks, severe angulation (>60°), significant thrombus or calcification (>180 degree of the wall diameter), non-cylindrical neck shapes, or an iliac access diameter <6 mm. Outcomes assessed included technical procedural success, Endoleak incidence, Conversion to open, reintervention rates, 30-day aneurysm-related mortality, and all-cause mortality over a 5-year follow-up. Results A total of 103 patients underwent EVAR using the Ovation stent graft between January 2015 and November 2017, with a 5-year follow-up. All patients had at least one adverse anatomical feature, including short necks, significant thrombus or calcification, severe neck angulation, or narrow iliac access. The cohort was predominantly male, comprising 80 patients (77.7%) with a mean age of 76.4 years (SD = 6.67). Technical success was achieved in 97% of cases, with Type I endoleak observed intraoperatively in 3 patients (2.9%). Intraoperative complications occurred in 4.8% of patients, with no aneurysm rupture or conversions to open surgery. The 30-day aneurysm-related mortality was 0%, and the overall reintervention rate over five years was 9.7%. The five-year all-cause mortality rate was 16.5%. Conclusions The Ovation polymer-based endograft demonstrates excellent technical success and favourable long-term outcomes in patients with infrarenal AAA with unfavourable anatomy, including low rates of type I endoleaks, reintervention, and aneurysm-related mortality. These findings support its use as a durable and effective EVAR solution in anatomically challenging cases beyond the standard IFU. Further multicentre prospective studies are warranted to confirm these promising results.</p>\",\"PeriodicalId\":93960,\"journal\":{\"name\":\"Cureus\",\"volume\":\"17 10\",\"pages\":\"e93970\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2025-10-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12501807/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cureus\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.7759/cureus.93970\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/10/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cureus","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.7759/cureus.93970","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/10/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
血管内动脉瘤修复术(Endovascular aortic repair, EVAR)是一种广泛应用的微创治疗肾下腹主动脉瘤(infrarrenal AAAs)的开放性手术修复方法。然而,对于复杂的主动脉解剖结构,标准支架移植有其挑战。Ovation腹腔支架移植系统(Endologix Inc., Santa Rosa, CA)是一种聚合物填充的密封圈内移植物,已经成为具有挑战性解剖特征的患者的一种有希望的解决方案。本研究旨在评估Ovation系统在治疗复杂的静脉下AAAs方面的技术成功、有效性和长期结果,包括再干预和生存。方法:2015年1月至2017年11月,我们在英国三级中心开展了一项单中心、回顾性观察性研究,纳入103例解剖学上具有挑战性的经Ovation支架治疗的肾下AAAs患者。解剖参数包括短颈,严重成角(>为60°),明显血栓或钙化(>为壁直径180度),非圆柱形颈部形状或髂通路直径
Five-Year Outcomes of Endovascular Aneurysm Repair (EVAR) Performed Using a Polymer-Based Aortic Endograft System.
Background Endovascular aneurysm repair (EVAR) is a widely used, minimally invasive alternative management option to open surgical repair for infrarenal abdominal aortic aneurysms (infrarenal AAAs). However, standard stent grafts have their challenges for complex aortic anatomies. The Ovation Abdominal Stent Graft System (Endologix Inc., Santa Rosa, CA), which is a polymer-filled sealing ring endograft, has emerged as a promising solution for patients with challenging anatomical features. This study aims to evaluate the Technical success, effectiveness, and long-term outcomes, including reintervention and survival, of the Ovation system in treating complex infrarenal AAAs. Methods We conducted a single-centre, retrospective observational study of 103 patients with anatomically challenging infrarenal AAAs treated with the Ovation stent graft between January 2015 and November 2017 in a UK-based tertiary centre. Anatomical parameters included short necks, severe angulation (>60°), significant thrombus or calcification (>180 degree of the wall diameter), non-cylindrical neck shapes, or an iliac access diameter <6 mm. Outcomes assessed included technical procedural success, Endoleak incidence, Conversion to open, reintervention rates, 30-day aneurysm-related mortality, and all-cause mortality over a 5-year follow-up. Results A total of 103 patients underwent EVAR using the Ovation stent graft between January 2015 and November 2017, with a 5-year follow-up. All patients had at least one adverse anatomical feature, including short necks, significant thrombus or calcification, severe neck angulation, or narrow iliac access. The cohort was predominantly male, comprising 80 patients (77.7%) with a mean age of 76.4 years (SD = 6.67). Technical success was achieved in 97% of cases, with Type I endoleak observed intraoperatively in 3 patients (2.9%). Intraoperative complications occurred in 4.8% of patients, with no aneurysm rupture or conversions to open surgery. The 30-day aneurysm-related mortality was 0%, and the overall reintervention rate over five years was 9.7%. The five-year all-cause mortality rate was 16.5%. Conclusions The Ovation polymer-based endograft demonstrates excellent technical success and favourable long-term outcomes in patients with infrarenal AAA with unfavourable anatomy, including low rates of type I endoleaks, reintervention, and aneurysm-related mortality. These findings support its use as a durable and effective EVAR solution in anatomically challenging cases beyond the standard IFU. Further multicentre prospective studies are warranted to confirm these promising results.