Melas Nikolaos, Stavridis Kyriakos, Saratzis Athanasios, Lazarides John, Gitas Christos, Saratzis Nikolaos
Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece.
Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece University of Leicester, Leicester, UK
J Endovasc Ther. 2015 Apr;22(2):174-8. doi: 10.1177/1526602815573232.
To investigate the performance of a new device that uses the STRATA polytetrafluoroethylene graft material and a mechanism that provides active proximal sealing in order to prevent type Ia endoleak during endovascular aneurysm repair (EVAR).
Between April 2013 and July 2014, 21 consecutive patients (all men; median age 71 years, range 60-84 years) with abdominal aortic aneurysm (median diameter 5.9 cm, range 4.9-7.8 cm) and suitable anatomy were offered elective EVAR using the AFX endograft. These patients had an irregular, conical, tapered, or bulging proximal neck, for which this specific device was considered appropriate. Aneurysm exclusion and incidence of type Ia endoleak were the primary outcomes; secondary outcomes included mortality, morbidity, migration, and other graft-related complications.
Primary technical success was 90%; 2 intraoperative type Ia endoleaks due to low endograft deployment were treated with additional proximal cuffs. During a median follow-up of 10 months (range 2-15 months), no type I endoleak was observed. One type II endoleak was encountered, with no associated sac enlargement. There was no stent-graft migration or any other device-related complication. One patient had a nonfatal myocardial infarction and another developed renal failure requiring transient dialysis. No deaths occurred.
In this early experience, this newly available device appears to be safe and efficient in providing seal along irregularly shaped necks over the short term.
研究一种使用STRATA聚四氟乙烯移植物材料和提供主动近端密封机制的新装置，以预防血管内动脉瘤修复（EVAR）期间的Ia型内漏。
在2013年4月至2014年7月期间，连续21例患者（均为男性；中位年龄71岁，范围60 - 84岁）患有腹主动脉瘤（中位直径5.9 cm，范围4.9 - 7.8 cm）且解剖结构合适，被提供使用AFX腔内移植物进行择期EVAR。这些患者的近端颈部不规则、呈锥形、渐缩或膨出，认为该特定装置适用于此类情况。动脉瘤排除和Ia型内漏的发生率是主要结局；次要结局包括死亡率、发病率、移植物移位和其他与移植物相关的并发症。
主要技术成功率为90%；2例因腔内移植物释放位置低导致的术中Ia型内漏通过额外的近端袖带进行了处理。在中位随访10个月（范围2 - 15个月）期间，未观察到I型内漏。遇到1例II型内漏，未伴有瘤腔扩大。没有支架移植物移位或任何其他与装置相关的并发症。1例患者发生非致命性心肌梗死，另1例发生肾衰竭需要进行短期透析。无死亡病例。
在这项早期经验中，这种新可用的装置在短期内沿不规则形状的颈部提供密封方面似乎是安全有效的。
