Sirignano Pasqualino, Ceruti Silvia, Aloisi Francesco, Sirignano Ascanio, Picozzi Mario, Taurino Maurizio
Vascular and Endovascular Surgery Unit, Sant'Andrea Hospital of Rome, Department of Surgery "Paride Stefanini", "Sapienza" University of Rome, 00189 Rome, Italy.
Center for Clinical Ethics, Department of Biotechnologies and Life Sciences, University of Insubria, 21100 Varese, Italy.
J Clin Med. 2022 Jul 30;11(15):4460. doi: 10.3390/jcm11154460.
Endovascular aneurysm repair (EVAR) has become an accepted alternative to open repair (OR) for the treatment of abdominal aortic aneurysm (AAA) despite "hostile" anatomies that may reduce its effectiveness. Guidelines suggest refraining from EVAR in such circumstances, but in clinical practice, up to 44% of EVAR procedures are performed using stent grafts outside their instruction for use (IFU), with acceptable outcomes. Starting from this "inconsistency" between clinical practice and guidelines, the aim of this contribution is to report the technical results of the use of EVAR in challenging anatomies as well as the ethical aspects to identify the criteria by which the "best interest" of the patient can be set.
A literature review on currently available evidence on standard EVAR using commercially available endografts in patients with hostile aortic neck anatomies was conducted. Medline using the PubMed interface and The Cochrane Library databases were searched from 1 January 2000 to 6 May 2021, considering the following outcomes: technical success; need for additional procedures; conversion to OR; reintervention; migration; the presence of type I endoleaks; AAA-related mortality rate.
A total of 52 publications were selected by the investigators for a detailed review. All studies were either prospective or retrospective observational studies reporting the immediate, 30-day, and/or follow-up outcomes of standard EVAR procedures in patients with challenging neck anatomies. No randomized trials were identified. Fourteen different endo-grafts systems were used in the selected studies. A total of 45 studies reported a technical success rate ranging from 93 to 100%, and 42 the need for additional procedures (mean value of 9.04%). Results at 30 days: the incidence rate of type Ia endoleak was reported by 37 studies with a mean value of 2.65%; 31 studies reported a null migration rate and 32 a null conversion rate to OR; in 31 of the 35 studies that reported AAA-related mortality, the incidence was null. Mid-term follow-up: the incidence rate of type Ia endoleak was reported by 48 studies with a mean value of 6.65%; 30 studies reported a null migration rate, 33 a null conversion rate to OR, and 28 of the 45 studies reported that the AAA-related mortality incidence was null.
Based on the present analysis, EVAR appears to be a safe and effective procedure-and therefore recommendable-even in the presence of hostile anatomies, in patients deemed unfit for OR. However, in order to identify and pursue the patient's best interest, particular attention must be paid to the management of the patient's informed consent process, which-in addition to being an essential ethical-legal requirement to legitimize the medical act-ensures that clinical data can be integrated with the patient's personal preferences and background, beyond the therapeutic potential of the proposed procedures and what is generically stated in the guidelines.
尽管“复杂”解剖结构可能会降低其有效性，但血管内动脉瘤修复术（EVAR）已成为治疗腹主动脉瘤（AAA）的一种被认可的替代开放修复术（OR）的方法。指南建议在这种情况下避免使用EVAR，但在临床实践中，高达44%的EVAR手术使用的支架移植物超出了其使用说明（IFU），结果却可以接受。从临床实践与指南之间的这种“不一致”出发，本研究的目的是报告在具有挑战性的解剖结构中使用EVAR的技术结果以及伦理方面，以确定能够设定患者“最佳利益”的标准。
对目前关于在具有复杂主动脉颈部解剖结构的患者中使用市售腔内移植物进行标准EVAR的现有证据进行文献综述。使用PubMed界面在Medline和Cochrane图书馆数据库中进行检索，检索时间为2000年1月1日至2021年5月6日，考虑以下结果：技术成功；是否需要额外手术；转为开放修复术；再次干预；移位；I型内漏的存在；与AAA相关的死亡率。
研究人员共选择了52篇出版物进行详细综述。所有研究均为前瞻性或回顾性观察性研究，报告了在具有挑战性的颈部解剖结构患者中进行标准EVAR手术的即刻、30天和/或随访结果。未发现随机试验。在所选研究中使用了14种不同的腔内移植物系统。共有45项研究报告技术成功率在93%至100%之间，42项研究报告了需要额外手术的情况（平均值为9.04%）。30天时的结果：37项研究报告了Ia型内漏的发生率，平均值为2.65%；31项研究报告移位率为零，32项研究报告转为开放修复术的转化率为零；在报告与AAA相关死亡率的35项研究中的31项中，发生率为零。中期随访：48项研究报告了Ia型内漏的发生率，平均值为6.65%；30项研究报告移位率为零，33项研究报告转为开放修复术的转化率为零，45项研究中的28项报告与AAA相关的死亡率发生率为零。
基于目前的分析，EVAR似乎是一种安全有效的手术方法，因此即使在存在复杂解剖结构的情况下，对于被认为不适合开放修复术的患者也是值得推荐的。然而，为了确定并追求患者的最佳利益，必须特别关注患者知情同意过程的管理，这除了是使医疗行为合法化的一项基本伦理法律要求外，还确保临床数据能够与患者的个人偏好和背景相结合，超越所提议手术的治疗潜力以及指南中的一般性规定。
