Texas Heart Institute and Baylor St Luke's Hospital, Houston, TX, USA.
Center for Cardiovascular Innovation, University of British Columbia, Vancouver, British Columbia, Canada.
J Endovasc Ther. 2020 Jun;27(3):414-420. doi: 10.1177/1526602820912224. Epub 2020 Mar 20.
To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). The SAFE MANTA Study ( identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.
评估 MANTA 经皮血管闭合装置在接受经皮血管内动脉瘤修复术（PEVAR）或胸主动脉血管内修复术（TEVAR）的患者中的安全性和有效性。SAFE MANTA 研究（标识符 NCT02908880）是一项前瞻性、单臂、多中心研究，在北美 20 个地点进行了大口径鞘管（经导管主动脉瓣置换术、PEVAR 或 TEVAR）的血管内介入治疗的患者中进行。患者选择旨在在没有病态肥胖、严重钙化或严重疤痕股动脉入路区域的人群中测试 MANTA 装置。在主要分析队列中，263 名入组患者中有 53 名（20.2%）患者（平均年龄 74.9±8.9 岁；41 名男性）接受了 PEVAR（n=51）或 TEVAR（n=2）手术，并形成了本次亚组分析的队列。根据方案，所有 PEVAR/TEVAR 病例均使用单个 MANTA 装置进行治疗。PEVAR/TEVAR 队列的止血时间中位数为 19 秒，中位时间为 35±91 秒，而总体 SAFE MANTA 人群的中位时间为 24 秒。在 53 例 PEVAR/TEVAR 病例中，52 例（98%）符合技术成功定义，而总体 SAFE MANTA 人群中这一比例为 97.7%。与 SAFE 人群中的 14 例（5.3%）事件相比，该亚组中发生了 1 例（1.9%）主要并发症（入路部位狭窄）。在 PEVAR/TEVAR 组中，1 例患者在出院前、另 1 例在 30 天随访时和 1 例在 60 天随访时出现假性动脉瘤。1 例（1.9%）小假性动脉瘤需要超声引导下压迫治疗，另 2 例无需治疗。与其他经皮闭合装置的文献结果相比，MANTA 装置止血时间短，并发症发生率低。PEVAR/TEVAR 患者的止血时间和并发症发生率与 SAFE MANTA 研究的全部患者相似。MANTA 装置为 PEVAR/TEVAR 手术提供了可靠的闭合，只需单次经皮操作。
