Division of Vascular Surgery, Cooper University Hospital, Camden, NJ.
Division of Cardiothoracic Surgery, University of Maryland Medical Center, Baltimore, MD.
J Vasc Surg. 2022 Nov;76(5):1189-1197.e3. doi: 10.1016/j.jvs.2022.06.092. Epub 2022 Jul 7.
To provide the 5-year outcomes of the use of a composite device (proximal covered stent graft + distal bare stent) for endovascular repair of patients with acute, type B aortic dissection complicated by aortic rupture and/or malperfusion.
Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE) II was a prospective, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe). Patients were enrolled between August 2012 and January 2015 at sites in the United States and Japan. Five-year follow-up was completed by January 2020.
In total, 73 patients (mean age: 60.7 ± 10.9 years; 65.8% male) with acute type B dissection complicated by malperfusion (72.6%), rupture (21.9%), or both (5.5%) were enrolled. Patients were treated with either a composite device (79.5%) or the proximal stent graft alone (no distal bare stent, 20.5%). Dissections were more extensive in patients who received the composite device (408.9 ± 121.3 mm) than in patients who did not receive a bare stent (315.9 ± 100.1 mm). The mean follow-up was 1209.4 ± 754.6 days. Freedom from all-cause mortality was 80.3% ± 4.7% at 1 year and 68.9% ± 7.3% at 5 years. Freedom from dissection-related mortality remained at 97.1% ± 2.1% from 1-year through 5-year follow-up. Within the stent-graft region, the rate of either complete thrombosis or elimination of the false lumen increased over time (82.1% of all patients at 5 years vs 55.7% at first postprocedure computed tomography), with a higher rate at 5 years in patients who received the composite device (90.5%) compared with patients without the bare stent (57.1%). Throughout the follow-up, overall true lumen diameter increased within the stent-graft region, and overall false lumen diameter decreased. At 5 years, 20.7% of patients experienced a decrease in maximum transaortic diameter within the stent-graft region, 17.2% experienced an increase, and 62.1% experienced no change. Distal to the treated segment (but within the dissected aorta), 23.1% of patients experience no change in transaortic diameter at 5 years; a bare stent was deployed in all these patients at the procedure. Five-year freedom from all secondary intervention was 70.7% ± 7.2%.
These 5-year outcomes indicate a low rate of dissection-related mortality for the Zenith Dissection Endovascular System in the treatment of patients with acute, complicated type B aortic dissection. Further, these data suggest a positive influence of composite device use on false lumen thrombosis. Continuous monitoring for distal aortic growth is necessary in all patients.
提供使用复合装置（近端覆膜支架+远端裸支架）治疗急性 B 型主动脉夹层合并主动脉破裂和/或血运障碍患者的 5 年结果。
胸主动脉 B 型夹层腔内修复使用研究（STABLE）II 是一项前瞻性、多中心的 Zenith 夹层血管内系统（库克欧洲）研究。2012 年 8 月至 2015 年 1 月在美国和日本的多个地点招募了患者。2020 年 1 月前完成了 5 年随访。
共有 73 例（平均年龄：60.7±10.9 岁；65.8%为男性）急性 B 型夹层合并血运障碍（72.6%）、破裂（21.9%）或两者兼有（5.5%）患者入组。患者接受了复合装置（79.5%）或近端支架移植物单独治疗（无远端裸支架，20.5%）。接受复合装置治疗的患者夹层更为广泛（408.9±121.3mm），而未接受裸支架治疗的患者夹层范围较小（315.9±100.1mm）。平均随访时间为 1209.4±754.6 天。1 年时全因死亡率的无死亡率为 80.3%±4.7%，5 年时为 68.9%±7.3%。从 1 年到 5 年的随访中，夹层相关死亡率的无死亡率一直保持在 97.1%±2.1%。在支架移植物区域内，完全血栓形成或假腔消除的比例随时间增加（5 年时所有患者的比例为 82.1%，首次术后 CT 为 55.7%），接受复合装置治疗的患者 5 年时的比例更高（90.5%），而未接受裸支架治疗的患者比例较低（57.1%）。在整个随访期间，支架移植物区域内的真腔直径增加，假腔直径减小。5 年时，20.7%的患者支架移植物区域内的最大主动脉直径减小，17.2%的患者直径增大，62.1%的患者无变化。在治疗节段远端（但在夹层主动脉内），5 年时 23.1%的患者主动脉直径无变化；所有这些患者在手术中都放置了裸支架。5 年无再次介入治疗的无效率为 70.7%±7.2%。
这些 5 年的结果表明，Zenith 夹层血管内系统治疗急性复杂 B 型主动脉夹层患者的夹层相关死亡率较低。此外，这些数据表明使用复合装置对假腔血栓形成有积极影响。所有患者均需持续监测远端主动脉生长情况。
