UMassMemorial Center for Complex Aortic Disease, University of Massachusetts Medical School, Worcester, Mass.
UMassMemorial Center for Complex Aortic Disease, University of Massachusetts Medical School, Worcester, Mass.
J Vasc Surg. 2021 Apr;73(4):1148-1155.e2. doi: 10.1016/j.jvs.2020.07.100.
Fenestrated/branched endovascular aneurysm repair (F/BEVAR) volume has increased rapidly, with favorable outcomes at centers of excellence. We evaluated changes over time in F/BEVAR complexity and associated outcomes at a single-center complex aortic disease program.
Prospectively collected data of all F/BEVAR (definition: requiring ≥1 fenestration/branch), procedures performed in an institutional review board-approved registry and/or physician-sponsored investigational device exemption trial (IDE# G130210), were reviewed (11/2010-2/2019). Patients were stratified by surgery date into thirds: early experience, mid experience, and recent experience. Patient and operative characteristics, aneurysm morphology, device types, perioperative and midterm outcomes (survival, freedom from type I or III endoleak, target artery patency, freedom from reintervention), were compared across groups.
For 252 consecutive F/BEVARs (early experience, n = 84, mid experience, n = 84, recent experience, n = 84), 194 (77%) company-manufactured custom-made devices, 11 (4.4%) company-manufactured off-the-shelf devices, and 47 (19%) physician-modified devices, were used to treat 5 (2.0%) common iliac, 97 (39%) juxtarenal, 31 (12%) pararenal, 116 (46%) thoracoabdominal, and 2 (0.8%) arch aneurysms. All patients had follow-up for 30-day events. The mean follow-up time for the entire cohort was 589 days (interquartile range, 149-813 days). On 1-year Kaplan-Meier analysis, survival was 88%, freedom from type I or III endoleak was 91%, and target vessel patency was 92%. When stratified by time period, significant differences included aneurysm extent (thoracoabdominal, 33% early experience, 40% mid experience, and 64% recent experience; P < .001) and target vessels per case (four-vessel case, 31% early experience, 39% mid experience, and 67% recent experience; P < .0001). There was no difference, but a trend toward improvement, in composite 30-day events (early experience, 39%; mid experience, 23%; recent experience, 27%; P = .05). On Kaplan-Meier analysis, there was no difference in survival (P = .19) or target artery patency (P = .6). There were differences in freedom from reintervention (P < .01) and from type I or III endoleak (P = .02), with more reinterventions in the early experience, and more endoleaks in the recent period.
Despite increasing repair complexity, there has been no significant change in perioperative complications, overall survival, or target artery patency, with favorable outcomes overall. Type I or III endoleaks remain a significant limitation, with increased incidence as the number of branch arteries incorporated into the repairs has increased.
开窗/分支型血管内动脉瘤修复术（F/BEVAR）的数量迅速增加，在卓越中心取得了良好的效果。我们评估了单一中心复杂主动脉疾病项目中 F/BEVAR 复杂性随时间的变化及其相关结果。
前瞻性收集了机构审查委员会批准的注册中心和/或医师发起的研究性器械豁免试验（IDE# G130210）中所有进行的 F/BEVAR（定义：需要≥1 个开窗/分支）程序的数据（11/2010-2/2019）。患者按手术日期分为三组：早期经验组、中期经验组和近期经验组。比较各组间患者和手术特点、动脉瘤形态、器械类型、围手术期和中期结果（生存、无 I 型或 III 型内漏、靶动脉通畅、免于再次干预）。
252 例连续的 F/BEVAR（早期经验组 n=84、中期经验组 n=84、近期经验组 n=84）中，194 例（77%）为公司定制的定制器械，11 例（4.4%）为公司生产的现成器械，47 例（19%）为医生修改的器械，用于治疗 5 例（2.0%）普通髂动脉、97 例（39%）肾下型、31 例（12%）肾周型、116 例（46%）胸腹主动脉型和 2 例（0.8%）弓部动脉瘤。所有患者均进行了 30 天事件的随访。整个队列的平均随访时间为 589 天（四分位距，149-813 天）。在 1 年的 Kaplan-Meier 分析中，生存率为 88%，无 I 型或 III 型内漏率为 91%，靶血管通畅率为 92%。按时间分期，显著差异包括动脉瘤范围（胸腹主动脉，早期经验组 33%、中期经验组 40%、近期经验组 64%；P<0.001）和每个病例的靶血管数（四血管病例，早期经验组 31%、中期经验组 39%、近期经验组 67%；P<0.0001）。30 天复合事件的发生率虽无显著差异，但呈改善趋势（早期经验组 39%、中期经验组 23%、近期经验组 27%；P=0.05）。Kaplan-Meier 分析显示，生存率（P=0.19）或靶动脉通畅率（P=0.6）无差异。免于再次干预（P<0.01）和免于 I 型或 III 型内漏（P=0.02）的差异有统计学意义，早期经验组的再次干预更多，近期内漏发生率更高。
尽管修复复杂性增加，但围手术期并发症、总体生存率或靶动脉通畅率无显著变化，总体结果良好。I 型或 III 型内漏仍然是一个显著的局限性，随着分支动脉数量的增加，内漏的发生率也随之增加。
