Department of Surgery, Division of Vascular Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands.
Department of Surgery, Division of Vascular Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands; Faculty of Medicine, Maastricht University, Maastricht, The Netherlands.
J Vasc Surg. 2024 Mar;79(3):569-576. doi: 10.1016/j.jvs.2023.10.054. Epub 2023 Nov 2.
The MANTA device is a plug-based vascular closure device (VCD) designed for large bore femoral arterial access site closure. It showed promising results in transcatheter aortic valve replacement cases. In this study, we report our results and evaluate the MANTA VCD in percutaneous endovascular aortic aneurysm repair (pEVAR).
All data of consecutive patients who underwent an elective pEVAR between October 2018 and December 2022 were retrospectively reviewed. In all patients at least one common femoral artery was intended to close with the MANTA VCD. Depending on the sheath size, the 14Fr or 18Fr MANTA VCD was used. On the preoperative computed tomography scan, the diameter of the common femoral artery (CFA) was measured and the amount of calcification based on the Peripheral Arterial Calcium Scoring System (PACSS) was scored. Primary outcome was procedural technical success. Procedural technical success was defined as placement of the MANTA closure device resulting in vascular closure with patent CFA, without requiring immediate open or endovascular surgery. The secondary outcomes were access site complications requiring reintervention and all-cause mortality at 30-day follow-up.
In total, 152 consecutive patients underwent pEVAR with 291 common femoral artery closure procedures with the Manta VCD. Mean age was 74.1 ± 6.4 years, with a mean body mass index of 27.7 ± 4.4 kg/m. The mean diameter of the CFA was 10.5 ± 1.9 mm. In 52.6% of the cases, there were no calcification on the preoperative computed tomography scan. The 18Fr and 14Fr Manta VCD were used 169 and 122 times, respectively. The technical success rate was 96.6%. Major vascular complications were reported in 4.5% of the cases, without any death-related events.
This single-center retrospective cohort study analyzed the procedural technical success, major vascular complications and all-cause mortality at 30-day follow-up of the MANTA vascular closure device in 152 pEVAR patients with 291 common femoral artery closure procedures. The technical success rate was 96,6%. Major vascular complications were reported in 4.5% of the cases, without any death related events. We concluded that the MANTA device is a safe and feasible option with a high rate of technical success in patients undergoing pEVAR.
MANTA 装置是一种基于塞子的血管闭合装置（VCD），设计用于大口径股动脉入路闭合。它在经导管主动脉瓣置换病例中显示出良好的效果。在本研究中，我们报告了我们的结果，并评估了 MANTA VCD 在经皮腔内血管修复术（pEVAR）中的应用。
回顾性分析 2018 年 10 月至 2022 年 12 月期间连续接受择期 pEVAR 治疗的患者的所有数据。所有患者至少有一条股总动脉拟采用 MANTA VCD 闭合。根据鞘管的大小，使用 14Fr 或 18Fr MANTA VCD。在术前 CT 扫描上，测量股总动脉（CFA）的直径，并根据外周动脉钙评分系统（PACSS）对钙化程度进行评分。主要结局为手术技术的成功率。手术技术成功定义为放置 MANTA 闭合装置后血管闭合，股总动脉通畅，无需立即进行开放或血管内手术。次要结局为需要再次介入治疗的入路部位并发症和 30 天随访时的全因死亡率。
共 152 例连续患者接受了 pEVAR 治疗，共进行了 291 次股总动脉 MANTA VCD 闭合术。平均年龄为 74.1±6.4 岁，平均体重指数为 27.7±4.4kg/m。股总动脉的平均直径为 10.5±1.9mm。在 52.6%的病例中，术前 CT 扫描未见钙化。18Fr 和 14Fr MANTA VCD 的使用次数分别为 169 次和 122 次。技术成功率为 96.6%。4.5%的病例报告了主要血管并发症，无死亡相关事件。
本单中心回顾性队列研究分析了 152 例接受 pEVAR 治疗的患者 291 次股总动脉 MANTA 血管闭合装置的手术技术成功率、主要血管并发症和 30 天随访时的全因死亡率。技术成功率为 96.6%。4.5%的病例报告了主要血管并发症，无死亡相关事件。我们得出结论，在接受 pEVAR 治疗的患者中，MANTA 装置是一种安全可行的选择，技术成功率高。
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