中短瘤颈亚组数据课件

Measured in Results UC201300742b EE Medtronic, Inc. 2013. All Rights Reserved. Not for distribution in the USA or France. 04/13 Endurant在复杂的患者亚组中结果 UC201300742b EE 1 Measured in Results UC201300742b EE Medtronic, Inc. 2013. All Rights Reserved. Not for distribution in the USA or France. 04/13 Endurant腹主动脉覆膜支架系统 (IFU) 近端瘤颈长颈长度 10 mm angulation 45 angulation 60 近端瘤颈长颈长度 15 mm* angulation 60 angulation 75 Aortic diameter of 19-32 mm Iliac artery diameter 8-25 mm Iliac fixation length 15 mm (L1) Neck length (D1a) Neck diameter (D1b) *CE mark indication only. IFU, instructions for use. 2 D. 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. UC201300742aEE Measured in Results UC201300742b EE Medtronic, Inc. 2013. All Rights Reserved. Not for distribution in the USA or France. 04/13 Endurant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. UC201300742aEE Measured in Results UC201300742b EE Medtronic, Inc. 2013. All Rights Reserved. Not for distribution in the USA or France. 04/13 EVAR 器械最小瘤颈颈要求 CE Mark Indication 最小瘤颈长颈长 度 US Indication AFX15mm15mm Anaconda15mmNot Approved Aorfix10mm10mm Endurant10mm10mm Excluder C315mm15mm Incraft15mmNot Approved Ovation7mm7mm Nellix5mm10mm (IDE) Zenith/Zenith LP 15mm15mm (LP IDE) 各种支架的IFU上标明的瘤颈长度 9 Verhagen, 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 Measured in Results UC201300742b EE Medtronic, Inc. 2013. All Rights Reserved. Not for distribution in the USA or France. 04/13 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 10 ENGAGE 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%ns At 2-Years I 或 III型内漏 0%0%1.5%ns 移位 0%0%0%ns Through 2-Years ns= not significant; *p values are from comparison of 10-15mm vs. 15mm UC201300742bIE Verhagen, Hence. The Hostile Neck: What are the anatomic limits? Charing Cross 2013 and Data on file at Medtronic UC201300742aEE Measured in Results UC201300742b EE Medtronic, Inc. 2013. All Rights Reserved. Not for distribution in the USA or France. 04/13 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 Endu