Verzini Fabio, Romano Lydia, Parlani Gianbattista, Isernia Giacomo, Simonte Gioele, Loschi Diletta, Lenti Massimo, Cao Piergiorgio
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
Vascular Surgery Unit, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
J Vasc Surg. 2017 Feb;65(2):318-329. doi: 10.1016/j.jvs.2016.07.117. Epub 2016 Nov 7.
Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience.
Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention.
Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034).
EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years.
腹主动脉瘤（AAA）腔内修复的长期结果受到移植物设计更新的影响，这些更新往往会改善早期假体的性能，但通常会将随访时间重置为零。本研究在单一中心经验中调查了使用仍在使用且未进行重大修改的Zenith移植物进行AAA腔内修复（EVAR）的长期结果。
2000年至2011年间，610例患者使用Zenith血管内移植物（Cook公司，印第安纳州布卢明顿）接受了择期EVAR，构成研究组。主要结局为总生存率、免于AAA破裂和免于AAA相关死亡。次要结局包括免于晚期（>30天）再次干预、免于晚期（>30天）转为开放修复、免于动脉瘤囊增大>5.0 mm以及免于EVAR失败，EVAR失败定义为AAA相关死亡、AAA破裂、AAA生长>5 mm和任何再次干预的综合情况。
平均年龄为73.2岁。平均动脉瘤直径为55.3 mm。围手术期死亡5例（0.8%），术中转为开放手术3例。平均随访时间为99.2（范围0 - 175）个月，发生7例AAA破裂，除1例外均死亡。1年时总生存率为92.8%±1.1%，5年时为70.1%±1.9%，10年时为37.8%±2.9%，14年时为24±4%。1年时免于AAA破裂的比例为99.8%±0.02（1例），5年时为99.4%±0.04（共3例），10年和14年时为98.1%±0.07。1年时免于晚期再次干预和转为开放手术的比例为98%±0.6，5年时为87.7%±1.5，10年时为75.7%±3.2，14年时为69.9%±5.2。1年时免于动脉瘤囊增大>5.0 mm的比例为99.8%，5年时为96.6%±0.7，10年时为81.0%±3.4，14年时为74.1%±5.8%。14年时132例（21.6%）患者发生EVAR失败。多因素分析显示，EVAR失败的独立预测因素为I型和III型内漏（风险比[HR]，6.7；95%置信区间[CI]，4.6 - 9.7；P <.001）、II型内漏（HR，2.3；95% CI，1.6 - 3.4；P <.001）以及美国麻醉医师协会4级（HR，1.6；95% CI，1.0 - 2.6；P =.034）。
使用Zenith移植物进行EVAR是一种安全且持久的修复方法。破裂和动脉瘤相关死亡风险较低，但总体长期生存率仍然较差。鉴于四分之一的手术患者在14年后仍存活，应测试和评估新型血管内移植物模型。
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