Department of Surgery, Comprehensive Aortic Center, Keck Medical Center of University of Southern California, Los Angeles, CA.
Department of Surgery, Comprehensive Aortic Center, Keck Medical Center of University of Southern California, Los Angeles, CA.
J Vasc Surg. 2024 Dec;80(6):1627-1636.e4. doi: 10.1016/j.jvs.2024.07.107. Epub 2024 Aug 22.
Fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms. Physician-modified endografting (PMEG) and the Gore thoracoabdominal multibranch endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution.
A retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician-sponsored investigational device exemption at a single institution between 2020 and 2022 were completed. Patient demographics, characteristics, and perioperative and midterm outcomes were compared.
A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often thoracoabdominal aortic aneurysm in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%; P = .013) and longer mean procedure time (247 ± 36 minutes vs 189 ± 49 minutes; P < .001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P = .412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, whereas in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. Although the overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG; P = .57), type II endoleaks accounted for all of the endoleaks in the TAMBE group, whereas type I or III endoleaks were seen in 11% of PMEG patients. At a median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P = .401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P = .646). Estimated freedom from reintervention rates at 3 years were similar (56% TAMBE vs 62% PMEG, log-rank P = .910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P = .459). The Kaplan-Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P = .157).
At experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG.
开窗分支型腔内血管修复术（FB-EVAR）在修复复杂动脉瘤和胸腹主动脉瘤方面显示出良好的结果。医师改良血管内移植物（PMEG）和戈尔胸腹主动脉多分支血管内假体（TAMBE）分别为 FB-EVAR 提供了定制和现成的装置。本研究比较了单一机构 TAMBE 和 PMEG 的结果。
回顾性分析了 2020 年至 2022 年间在一家单中心进行的多中心关键试验 TAMBE 组或前瞻性医师赞助的调查性器械豁免 PMEG 组的患者。比较了患者的人口统计学、特征以及围手术期和中期结果。
共纳入 68 例患者，其中 TAMBE 组 12 例，PMEG 组 56 例。两组的基线特征相似。两组中最常见的动脉瘤类型均为胸腹主动脉瘤（TAMBE 组 58%，PMEG 组 52%）。TAMBE 上肢通路的比例更高（100% vs 63%；P =.013），平均手术时间更长（247 ± 36 分钟 vs 189 ± 49 分钟；P <.001）。两组的其他术中指标相似。TAMBE 的技术成功率为 100%，PMEG 为 95%（P =.412）。两组均无 30 天死亡率。TAMBE 组无重大不良事件，而 PMEG 组有 2%的呼吸衰竭，2%需要透析，4%发生脊髓缺血。虽然总体内漏率相似（TAMBE 组 50%，PMEG 组 41%；P =.57），但 TAMBE 组的所有内漏均为 II 型内漏，而 PMEG 组有 11%的患者为 I 型或 III 型内漏。TAMBE 组的中位随访时间为 26.7 个月，PMEG 组为 21.2 个月，TAMBE 组有 10.4%的靶血管不稳定，PMEG 组有 6.9%的靶血管分支不稳定（P =.401）。TAMBE 组有 33%的患者需要再次干预，PMEG 组有 27%的患者需要再次干预（P =.646）。3 年无再次干预的估计生存率相似（TAMBE 组 56%，PMEG 组 62%，对数秩 P =.910）。两组 3 年无内脏肾靶血管不稳定的生存率均为 89%（对数秩 P =.459）。TAMBE 组患者的 3 年估计生存率为 100%，PMEG 组为 77%（对数秩 P =.157）。
在有经验的中心，使用 PMEG 或 TAMBE 进行 FB-EVAR 可获得类似的、极好的围手术期和中期结果。TAMBE 和 PMEG 都需要经常进行干预。
