ENGAGE中短瘤颈亚组数据

UC201300742b EE1Endurant腹主动脉覆膜支架系统 (IFU) 近端瘤 颈长 度 10 mmv angulation 45v angulation 60 近端瘤 颈长 度 15 mm*v angulation 60 v angulation 75 vAortic diameter of 19-32 mmvIliac artery diameter 8-25 mmvIliac fixation length 15 mm (L1) Neck length(D1a)Neck diameter(D1b)*CE mark indication only.IFU, instructions for use.2D. Bockler. Worldwide Mid-Term (2Y) Results of The Endurant Endograft for AAAs: Does it Expand the Proportion of Patients Who Can Undergo EVAR Safely 54(1):13-21. doi: 10.1016/j.jvs.2010.12.010. Epub 2011 Feb 16.UC201300742aEEEndurant在短瘤颈亚组中的表现扩展了标准 EVAR手术的患者适用人群瘤颈长度影响了 EVAR的可适用性8主动脉瘤颈长度是限制 EVAR使用的因素 “ 肾下瘤颈长度 15 mm与 EVAR术后短期和中期内漏相关性较大Verhagen, Hence. The Hostile Neck: What are the anatomic limits? Charing Cross 2013.UC201300742aEEEVAR 器械 最小瘤 颈 要求CE Mark Indication最小瘤 颈长 度 US IndicationAFX 15mm 15mmAnaconda 15mm Not ApprovedAorfix 10mm 10mmEndurant 10mm 10mmExcluder C3 15mm 15mmIncraft 15mm Not ApprovedOvation 7mm 7mmNellix 5mm 10mm (IDE)Zenith/Zenith LP15mm 15mm (LP IDE)各种支架的 IFU上标明的瘤颈长度9Verhagen, Hence. The Hostile Neck: What are the anatomic limits? Charing Cross 2013.15mm瘤颈要求的支架有限的临床证据少量患者在欧洲和美国的上市前临床试验中被治疗UC201300742aEE Endurant II在 10 to 15mm瘤颈患者中和 15 到 20mm瘤颈中都取得了较好的结果 Endurant在 10-15mm短瘤颈的患者中具有优秀的结果10ENGAGE Registry: Endurant II使得治疗长短瘤颈的患者结果较一致10- 15mm(n= 48)15mm- 20mm(n= 79)20mm (n=364)p-value破裂 0% 0% 0.3% ns转 开放手 术 0% 0% 1.1% ns再次介入 4.2% 6.3% 6.6% ns再次介入来 纠 正 I/III型内漏 0% 1.3% 1.9% nsAt 2-YearsI 或 III型内漏 0% 0% 1.5% ns移位 0% 0% 0% nsThrough 2-Yearsns= not significant; *p values are from comparison of 10-15mm vs. 15mm UC201300742bIEVerhagen, Hence. The Hostile Neck: What are the anatomic limits? Charing Cross 2013 and Data on file at MedtronicUC201300742aEE Endurant在短和中等长度瘤颈患者中的 I/III型内漏，破裂，转开放和二次介入上没有显著性差异 Endurant覆膜支架在短瘤颈患者中具有非常好的临床表现主要临床信息| 20