Mortola Lorenzo, Ferrero Emanuele, Quaglino Simone, Ferri Michelangelo, Viazzo Andrea, Manzo Paola, Gaggiano Andrea
Vascular and Endovascular Surgery Unit, University Hospital of Novara, Novara, Italy.
Vascular and Endovascular Surgery Unit, Mauriziano Umberto I Hospital, Turin, Italy.
J Vasc Surg. 2021 Oct;74(4):1204-1213. doi: 10.1016/j.jvs.2021.02.035. Epub 2021 Mar 5.
Despite promising early results, midterm failures of the Nellix endovascular aneurysm sealing (EVAS) system (Endologix Inc, Irvine, Calif) have been reported at higher than expected rates. The management of proximal endoleaks and migration differs from those after conventional endovascular aortic aneurysm repair (EVAR) owing to the peculiar design of the Nellix device. In the present study, we report a monocentric experience in the management of EVAS complications using various techniques. We also performed a comprehensive review of the relevant literature on both open surgical and endovascular management of proximal failure of EVAS from the MEDLINE database.
We retrospectively analyzed the reinterventions for type Ia endoleak and migration after elective infrarenal EVAS at our institution. We collected preoperative, intraoperative, and follow-up data. Open and endovascular techniques are described. Overall survival, aortic-related mortality, and the technical success rate (rate of exclusion of endoleaks) with endovascular techniques were the primary outcomes.
We performed 101 infrarenal elective EVAS procedures from 2013 to 2018. Of the 101 patients, 20 (19.8%) had required reintervention for proximal sealing failure. The indications were type Ia (Is2, Is3) endoleak, migration >5 mm, sac expansion >5 mm, and secondary rupture. Of the 20 patients, 6 (30%) were treated with endovascular techniques-2 with a chimney Nellix-in-Nellix application and 4 with proximal relining with a covered stent. The remaining 14 patients (70%) were treated with late open conversion (OC). The average time from EVAS to reintervention was 36.1 months (range, 3-65 months). Six patients (30%) had undergone OC in an emergent setting because of secondary rupture. The technical success rate for the patients treated with endovascular reinterventions was 100%. The 30-day mortality was 20% (4 of 20), all emergent cases (four of six emergent repairs; 67%). The overall survival for the 20 patients was 75% (n = 15) at a mean follow-up of 15.1 months (range, 2-47 months). One patient had died after 7 months of non-aortic-related causes.
The high reintervention rate of the Nellix graft mandates careful evaluation for its further use with the revised instructions for use, and it should not be used off-label. OC remains the strategy of choice when managing Nellix proximal sealing failures in fit patients. Chimney Nellix-in-Nellix application and transcatheter embolization are feasible alternative techniques. Proximal relining also appears to be an effective alternative to more complex interventions, although it requires further studies for validation.
尽管早期结果令人鼓舞，但据报道，内利克斯血管内动脉瘤封堵（EVAS）系统（Endologix公司，加利福尼亚州欧文市）的中期失败率高于预期。由于内利克斯装置的特殊设计，近端内漏和移位的处理与传统血管内主动脉瘤修复（EVAR）术后不同。在本研究中，我们报告了使用各种技术处理EVAS并发症的单中心经验。我们还对MEDLINE数据库中关于EVAS近端失败的开放手术和血管内处理的相关文献进行了全面综述。
我们回顾性分析了我院择期肾下EVAS术后Ia型内漏和移位的再次干预情况。我们收集了术前、术中和随访数据。描述了开放和血管内技术。血管内技术的总生存率、主动脉相关死亡率和技术成功率（内漏排除率）是主要结局指标。
2013年至2018年，我们共进行了101例肾下择期EVAS手术。在这101例患者中，20例（19.8%）因近端封堵失败需要再次干预。指征包括Ia型（Is2、Is3）内漏、移位>5 mm、瘤囊扩张>5 mm和继发性破裂。在这20例患者中，6例（30%）接受了血管内技术治疗，2例采用烟囱式内利克斯置入内利克斯技术，4例采用带覆膜支架近端内衬技术。其余14例患者（70%）接受了晚期开放转换（OC）治疗。从EVAS到再次干预的平均时间为36.1个月（范围3 - 65个月）。6例患者（30%）因继发性破裂在急诊情况下接受了OC治疗。接受血管内再次干预的患者技术成功率为100%。30天死亡率为20%（20例中的4例），均为急诊病例（6例急诊修复中的4例；67%）。20例患者的总生存率在平均随访15.1个月（范围2 - 47个月）时为75%（n = 15）。1例患者在7个月后因非主动脉相关原因死亡。
内利克斯移植物的高再次干预率要求根据修订的使用说明对其进一步使用进行仔细评估，不应超适应证使用。对于适合的患者，OC仍然是处理内利克斯近端封堵失败的首选策略。烟囱式内利克斯置入内利克斯技术和经导管栓塞是可行的替代技术。近端内衬似乎也是一种有效的替代更复杂干预的方法，尽管需要进一步研究进行验证。
