Department of Vascular Medicine and Vascular Surgery, HELIOS Hospital Bad Saarow, Bad Saarow, Germany.
Department of Vascular Medicine, German Aortic Center Hamburg, University Heart Center, Hamburg, Germany.
J Vasc Surg. 2018 Oct;68(4):956-964. doi: 10.1016/j.jvs.2018.01.037. Epub 2018 Mar 27.
The objective of this study was to assess the early and midterm outcomes of endovascular repair of complex aortic aneurysm cases using the Multilayer Flow Modulator (MFM; Cardiatis, Isnes, Belgium) endograft in Germany.
A retrospective study including patients presenting with abdominal aortic aneurysm (AAA), thoracic aortic aneurysm, or thoracoabdominal aortic aneurysm treated with the MFM was conducted in Germany. Mortality and morbidity (in terms of spinal cord ischemia, visceral ischemia, and stroke) at 30 days postoperatively were evaluated. In addition, during follow-up, freedom from reintervention, rupture, and failure mode were also assessed.
Between 2009 and 2014, a total of 61 patients with AAA, thoracoabdominal aortic aneurysm, or thoracic aortic aneurysm were treated with the MFM endograft in 29 hospitals around Germany. However, data of 40 patients with a mean age of 73.4 ± 11.2 years (72.5% male; 29/40) and mean aortic aneurysm diameter of 60.3 ± 16.6 mm from 14 hospitals were available for this retrospective study. Thirty-seven (93%) patients were treated urgently. In 12 cases (12/40 [30%]), patients were treated outside instructions for use because of aortic aneurysm diameter >65 mm. A total of 69 MFM stents were used (1.7/patient). The technical success rate was 95% (38/40). Postoperatively, no patient presented with spinal cord ischemia, renal function deterioration, stroke, or intestinal ischemia, except for one patient who developed multiorgan failure because of early stent migration. The intraoperative and 30-day mortality rate was 0% and 2.5%, respectively. The mean follow-up was 12.9 months (±14.9 months), with a survival rate at 1 month, 6 months, and 12 months of 97%, 78%, and 70%, respectively. Freedom from failure mode (type I or II) at 1 month, 6 months, and 12 months was 97.5%, 88%, and 86%, respectively, and visceral vessel patency was 99.3% (155/156 available). During follow-up, 4 patients (4/39 [10%]) had an aneurysm sac rupture and 10 (10/39 [25%]) underwent a reintervention. Freedom from rupture and freedom from reintervention at 1 month, 6 months, and 12 months were 97.5% and 100%, 96% and 84%, and 86% and 75%, respectively.
The use of the MFM for endovascular treatment of complex aortic aneurysm in urgent cases appears to be technically feasible in terms of mortality and morbidity, with moderate 30-day and acceptable midterm outcomes. Reinterventions may be needed to expand the utility of outcomes.
本研究旨在评估在德国使用多层流调节装置（Multilayer Flow Modulator，MFM；Cardiatis，Isnes，比利时）进行复杂主动脉瘤血管内修复的早期和中期结果。
本研究对在德国接受 MFM 治疗的腹主动脉瘤（AAA）、胸主动脉瘤或胸腹主动脉瘤患者进行了回顾性研究。评估术后 30 天的死亡率和发病率（包括脊髓缺血、内脏缺血和中风）。此外，在随访期间，还评估了免于再次干预、破裂和失效模式的情况。
2009 年至 2014 年间，德国 29 家医院共对 61 例 AAA、胸腹主动脉瘤或胸主动脉瘤患者使用 MFM 血管内移植物进行了治疗。然而，在 14 家医院中有 40 例患者的数据可用于这项回顾性研究，这些患者的平均年龄为 73.4±11.2 岁（72.5%为男性；29/40），平均主动脉瘤直径为 60.3±16.6mm。37 例（93%）患者为紧急治疗。在 12 例（12/40 [30%]）患者中，由于主动脉瘤直径>65mm，使用该移植物不符合使用说明。总共使用了 69 个 MFM 支架（1.7/例）。技术成功率为 95%（38/40）。术后无脊髓缺血、肾功能恶化、中风或肠缺血发生，除 1 例因支架早期迁移导致多器官衰竭外。术中及 30 天死亡率分别为 0%和 2.5%。平均随访时间为 12.9 个月（±14.9 个月），1 个月、6 个月和 12 个月的生存率分别为 97%、78%和 70%。1 个月、6 个月和 12 个月时免于失效模式（I 型或 II 型）的比例分别为 97.5%、88%和 86%，内脏血管通畅率为 99.3%（155/156）。随访期间，4 例（4/39 [10%]）患者发生动脉瘤囊破裂，10 例（10/39 [25%]）患者接受再次干预。1 个月、6 个月和 12 个月时免于破裂和免于再次干预的比例分别为 97.5%和 100%、96%和 84%、86%和 75%。
在紧急情况下使用 MFM 进行复杂主动脉瘤的血管内治疗，从死亡率和发病率方面来看，技术上是可行的，30 天和中期结果适中且可接受。可能需要再次干预来扩大结果的应用范围。
