Nishibe Toshiya, Iwahashi Toru, Kamiya Kentaro, Kano Masaki, Maruno Keita, Fujiyoshi Toshiki, Iwahori Akinari, Suzuki Shun, Kawago Koji, Takahashi Satoshi, Ogino Hitoshi, Koizumi Jun, Dardik Alan
Department of Cardiovascular Surgery, Tokyo Medical University, Tokyo, Japan.
Department of Cardiovascular Surgery, Tokyo Medical University, Tokyo, Japan.
Ann Vasc Surg. 2019 Aug;59:54-62. doi: 10.1016/j.avsg.2018.12.090. Epub 2019 Feb 23.
The goals of this study were to evaluate mid-term outcome in endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) using a GORE C3 EXCLUDER and compare results between patients treated within and outside the instructions for use (IFU).
Over a 3-year period spanning October 2013 to September 2016, consecutive patients undergoing EVAR for AAA using the C3 EXCLUDER at Tokyo Medical University Hospital were registered on a prospectively maintained database. The data thus obtained were retrospectively analyzed.
A total of 109 AAA patients underwent EVAR using the C3 EXCLUDER. The median follow-up duration was 729 days (interquartile range, 542-1,069 days). Technical success was achieved in 98.2% of cases. Adjunctive, unplanned proximal cuff-extender implantation was required in 8 patients (9.2%). Of the total number, 29 (24.8%) were categorized as being treated outside the IFU. No significant difference was observed in freedom from overall mortality or aneurysm-related mortality between patients treated within and outside the IFU. Freedom from reintervention tended to be lower in patients treated outside the IFU. There was aneurysm sac shrinkage (≥5 mm) in 30.3% and 39.1%; stable aneurysm sac in 69.7% and 56.3%; and aneurysm sac expansion (≥5 mm) in 0% and 4.7% of cases at 1 and 2 years, respectively. No significant difference was observed in aneurysm sac shrinkage between patients treated within and outside the IFU.
The C3 EXCLUDER showed good clinical performance and aneurysm sac shrinkage, regardless of whether the patient was treated within or outside the IFU. The results suggest, however, that in those treated outside the IFU, precise planning, careful operative procedure, and subsequent follow-up are required to obtain short-term and mid- to long-term success in EVAR for AAA using the C3 EXCLUDER.
本研究的目的是评估使用GORE C3 EXCLUDER进行腹主动脉瘤（AAA）血管内修复术（EVAR）的中期结果，并比较在使用说明书（IFU）范围内和范围外接受治疗的患者的结果。
在2013年10月至2016年9月的3年期间，东京医科大学医院连续使用C3 EXCLUDER进行AAA-EVAR的患者被登记在一个前瞻性维护的数据库中。对由此获得的数据进行回顾性分析。
共有109例AAA患者接受了使用C3 EXCLUDER的EVAR治疗。中位随访时间为729天（四分位间距，542 - 1069天）。98.2%的病例获得技术成功。8例患者（9.2%）需要辅助性、非计划性近端袖带延长器植入。在总数中，29例（24.8%）被归类为在IFU范围外接受治疗。在IFU范围内和范围外接受治疗的患者之间，在全因死亡率或动脉瘤相关死亡率方面未观察到显著差异。在IFU范围外接受治疗的患者再次干预的自由度倾向于较低。在1年和2年时，分别有30.3%和39.1%的病例出现瘤囊缩小（≥5 mm）；69.7%和56.3%的病例瘤囊稳定；0%和4.7%的病例瘤囊扩张（≥5 mm）。在IFU范围内和范围外接受治疗的患者之间，在瘤囊缩小方面未观察到显著差异。
无论患者是在IFU范围内还是范围外接受治疗，C3 EXCLUDER均显示出良好的临床性能和瘤囊缩小效果。然而，结果表明，对于在IFU范围外接受治疗的患者，需要精确规划、仔细的手术操作以及后续随访，以在使用C3 EXCLUDER进行AAA-EVAR时获得短期和中长期成功。
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