Jim Jeffrey, Sanchez Luis A, Rubin Brian G, Criado Frank J, Fajardo Andres, Geraghty Patrick J, Sicard Gregorio A
Section of Vascular Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.
Ann Vasc Surg. 2010 Oct;24(7):851-8. doi: 10.1016/j.avsg.2010.05.015.
Although endovascular aneurysm repair has been shown to be an effective way to treat abdominal aortic aneurysm (AAA), certain anatomic characteristics such as a short aortic neck, limit its applicability. Initially, commercially available devices were approved only for the treatment of AAA with an aortic neck length ≥ 15 mm. The purpose of this study was to evaluate the outcomes of the recently approved Talent endograft for AAAs with a short aortic neck length (10-15 mm).
Data were obtained from the prospective, nonrandomized, multicenter Talent enhanced Low Profile Stent Graft System trial which enrolled patients between February 2002 and April 2003. A total of 154 patients with adequate preoperative imaging were identified for this study. Subgroup analyses were performed for AAA with 10-15 mm aortic neck and those with >15 mm neck. Safety and effectiveness endpoints were evaluated at 30 days, 1 year, and 5 years postprocedure.
Patients treated with aortic neck lengths of 10-15 mm (n = 35) and those with >15 mm (n = 102) had similar age, gender, and risk factor profile. Both groups had similar preoperative aneurysm morphology in terms of maximum aneurysm size, degree of neck angulation, or proximal neck diameter. There were no statistically significant differences in freedom from major adverse events and mortality rates at 30 and 365 days. Similarly, there was no difference in the effectiveness endpoints at 12 months. At 5 years, there was no difference in migration rate, endoleaks, or change in aneurysm diameter from baseline. In addition, there is no difference in freedom from aneurysm-related mortality (94% vs. 99%).
AAAs with short aortic necks (10-15 mm) and otherwise suitable anatomy for endovascular repair can be safely and effectively treated with the Talent endograft with excellent 1 and 5 year outcomes.
尽管血管内动脉瘤修复术已被证明是治疗腹主动脉瘤(AAA)的有效方法,但某些解剖特征,如主动脉颈部较短,限制了其适用性。最初,市售装置仅被批准用于治疗主动脉颈部长度≥15mm的AAA。本研究的目的是评估最近批准的Talent腔内移植物治疗主动脉颈部长度较短(10 - 15mm)的AAA的疗效。
数据来自于2002年2月至2003年4月进行的前瞻性、非随机、多中心Talent增强型低轮廓支架移植物系统试验。本研究共纳入154例术前影像学检查充分的患者。对主动脉颈部为10 - 15mm的AAA患者和颈部>15mm的患者进行亚组分析。在术后30天、1年和5年评估安全性和有效性终点。
主动脉颈部长度为10 - 15mm(n = 35)和>15mm(n = 102)的患者在年龄、性别和危险因素方面相似。两组在最大动脉瘤大小、颈部成角程度或近端颈部直径方面术前动脉瘤形态相似。在30天和365天时,两组在无重大不良事件和死亡率方面无统计学显著差异。同样,在12个月时有效性终点也无差异。在5年时,两组在移位率、内漏或动脉瘤直径相对于基线的变化方面无差异。此外,在无动脉瘤相关死亡率方面也无差异(94%对99%)。
主动脉颈部较短(10 - 15mm)且其他方面适合血管内修复的AAA,使用Talent腔内移植物可安全有效地治疗,1年和5年疗效良好。