de Donato Gianmarco, Setacci Francesco, Bresadola Luciano, Castelli Patrizio, Chiesa Roberto, Mangialardi Nicola, Nano Giovanni, Setacci Carlo
1 Division of Vascular Surgery, University of Siena, Italy.
2 Department of Vascular Surgery, Casa di Cura Giovanni XXIII, Monastier di Treviso, Italy.
J Endovasc Ther. 2017 Apr 1;24(2):191-197. doi: 10.1177/1526602816685581. Epub 2017 Jan 6.
To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long.
A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24-50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm).
At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was -0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group.
Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.
比较按照原始使用说明书（IFU）规定的颈部长度≥7 mm使用Ovation覆膜支架与颈部长度<7 mm的非标签（OL）使用情况。
对意大利13个中心所有使用Ovation腔内移植物进行腹主动脉瘤修复的患者的多中心回顾性注册研究（TriVascular Ovation意大利研究）数据库进行查询，以确定计算机断层扫描（CT）随访至少24个月的患者，检索89例患者（平均年龄76.4±2.4岁；84例男性）的记录，平均随访32个月（范围24 - 50个月）。独立核心实验室对标准CT扫描（术前、术后1个月和最新随访）进行形态学变化评估。分析时，根据近端颈部长度≥7 mm（IFU组，n = 57）或<7 mm（OL组，n = 32）将患者分为两组。观察指标包括无Ia型内漏、任何与器械相关的再次干预、移位和颈部增粗（>2 mm）。
3年时，无动脉瘤相关死亡、破裂、覆膜支架移位或颈部增粗。在无Ia型内漏方面（IFU组为98.2%，OL组为96.8%，p = 0.6；风险比[HR] 0.55，95%可信区间0.02至9.71）或无任何与器械相关的再次干预方面（IFU组为92.8%，OL组为96.4%，p = 0.4；HR 2.42，95%可信区间0.34至12.99）无差异。在密封区，IFU组直径平均变化为-0.05±0.8 mm，OL组为-0.1±0.5 mm。
颈部长度<7 mm的患者使用Ovation覆膜支架取得的中期结果与颈部长度≥7 mm的患者相似。这些中期数据表明，Ovation系统用于治疗肾下腹主动脉瘤不受主动脉颈部长度传统测量的限制，证实了美国食品药品监督管理局最近批准的使用说明书变更。
