Division of Vascular and Endovascular Surgery, The University of North Carolina, Chapel Hill, NC.
Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.
J Vasc Surg. 2021 Aug;74(2):353-362.e1. doi: 10.1016/j.jvs.2020.12.096. Epub 2021 Feb 4.
Open repair of complex aortic aneurysms is frequently not an option for octogenarians because of prohibitive surgical risks. This study aimed to analyze the outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) in octogenarians (≥80 years old) compared with nonoctogenarians (<80 years old).
We reviewed 893 patients with pararenal or extent I to V thoracoabdominal aneurysms, enrolled in six prospective physician-sponsored investigational device exemption studies from 2012 to 2018. All patients were treated with either company-manufactured off-the-shelf or patient-specific F-BEVAR stent grafts. Data analyzed included demographics, cardiovascular risk factors, history of active cancer, American Society of Anesthesiologists classification, aortic anatomy characteristics, and procedural data. End points included mortality, major adverse events (all-cause mortality, stroke, paralysis, acute kidney injury [RIFLE criteria], dialysis, myocardial infarction, respiratory failure, and bowel ischemia), technical success, hospital length of stay, target artery instability (occlusion/stenosis, endoleak, rupture or death), and secondary interventions.
During the study period, 195 octogenarian patients (22%) and 698 (78%) nonoctogenarian patients were treated with F-BEVAR. Octogenarians presented more frequently with a history of cancer (17% vs 11%; P = .01), whereas nonoctogenarians more frequently had hyperlipidemia (76% vs 65%; P = .003), chronic obstructive pulmonary disease (42% vs 33%; P = .04) and American Society of Anesthesiologists class III to V (78% vs 70%; P = .02). Male sex was similar between groups (68% [octogenarians] vs 70% [nonoctogenarians]; P = .62). Octogenarians had a larger mean aneurysm diameter (67 ± 1 mm vs 65 ± 1 mm; P = .002). The thoracoabdominal classification and the use of upper extremity access were similar between groups. Estimated blood loss was also similar (484 ± 454 mL [octogenarian] vs 416 ± 457 mL [nonoctogenarian]; P = .07). Octogenarians had an increased mean number of vessels incorporated into the repair (3.1 ± 1.4 vs 2.7 ± 1.7; P < .001). The technical success rate was 99% for octogenarians and 97% for nonoctogenarians (P = .19). The 30-day mortality rate was 0.5% for octogenarians and 1.3% for the nonoctogenarians (P = .70). Major adverse events (9.2% vs 9.7%), types I/III endoleak (4.6% vs 2.4%) access complication (3.1% vs 3.3%), and length of stay (8.2 ± 27 days vs 5.7 ± 6.3 days) were all similar between the groups. Freedom from target artery instability and freedom from secondary interventions at 3 years were similar between the groups. Octogenarian survival was lower at 3 years compared with nonoctogenarians on univariate analysis (log-rank P < .01) and on multivariable analysis after adjusting for history of active cancer, hyperlipidemia, and chronic obstructive pulmonary disease.
Despite small differences in demographics, anatomic factors, and procedural data, F-BEVAR was safe and effective with nearly identical early outcomes in octogenarians in these experienced aortic centers. More extensive clinical experience and longer follow-up are needed to better delineate factors impacting longer term mortality.
由于手术风险过高,80 岁以上的高龄患者通常不选择开放修复复杂的主动脉瘤。本研究旨在分析腔内分支型主动脉修复术(fenestrated-branched endovascular aortic repair,F-BEVAR)在 80 岁以上高龄患者(≥80 岁)和非高龄患者(<80 岁)中的治疗效果。
我们回顾了 2012 年至 2018 年期间,6 项由医生主导的前瞻性器械豁免研究中纳入的 893 例肾周或Ⅰ至Ⅴ型胸腹主动脉瘤患者。所有患者均接受公司生产的定制或定制的 F-BEVAR 支架移植物治疗。分析的数据包括人口统计学、心血管危险因素、活动性癌症史、美国麻醉师协会(American Society of Anesthesiologists,ASA)分类、主动脉解剖特征和手术过程数据。终点包括死亡率、主要不良事件(全因死亡率、卒、瘫痪、急性肾损伤[RIFLE 标准]、透析、心肌梗死、呼吸衰竭和肠缺血)、技术成功率、住院时间、靶动脉不稳定(闭塞/狭窄、内漏、破裂或死亡)和二次干预。
在研究期间,195 例 80 岁以上高龄患者(22%)和 698 例非高龄患者(78%)接受了 F-BEVAR 治疗。高龄患者中癌症史更为常见(17%比 11%;P=0.01),而非高龄患者中高脂血症更为常见(76%比 65%;P=0.003)、慢性阻塞性肺疾病(42%比 33%;P=0.04)和 ASA Ⅲ至Ⅴ级(78%比 70%;P=0.02)更为常见。两组的男性比例相似(68%[高龄患者]比 70%[非高龄患者];P=0.62)。高龄患者的平均动脉瘤直径较大(67±1mm 比 65±1mm;P=0.002)。胸腹主动脉分类和上肢入路的使用在两组间相似。估计失血量也相似(484±454ml[高龄患者]比 416±457ml[非高龄患者];P=0.07)。高龄患者纳入修复的血管数量平均增加(3.1±1.4 比 2.7±1.7;P<0.001)。高龄患者的技术成功率为 99%,非高龄患者为 97%(P=0.19)。高龄患者的 30 天死亡率为 0.5%,非高龄患者为 1.3%(P=0.70)。主要不良事件(9.2%比 9.7%)、Ⅰ/Ⅲ型内漏(4.6%比 2.4%)、入路并发症(3.1%比 3.3%)和住院时间(8.2±27 天比 5.7±6.3 天)在两组间均相似。两组的靶动脉不稳定和二次干预的无事件率在 3 年时相似。高龄患者的 3 年生存率低于非高龄患者,单因素分析(对数秩检验 P<0.01)和多因素分析(校正活动性癌症、高脂血症和慢性阻塞性肺疾病后)。
尽管在人口统计学、解剖因素和手术过程数据方面存在微小差异,但在这些有经验的主动脉中心,F-BEVAR 在 80 岁以上的高龄患者中是安全有效的,并且早期结果几乎相同。需要更多的临床经验和更长时间的随访,以更好地确定影响长期死亡率的因素。