Habash Nicola, Saraiya Avinash, Nooromid Michael, Salvatore Dawn, DiMuzio Paul, Abai Babak
Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.
Department of Surgery, Division of Vascular and Endovascular Surgery, Thomas Jefferson University Hospital, Philadelphia, PA, USA.
Vascular. 2025 Jan 6:17085381251313600. doi: 10.1177/17085381251313600.
We aim to evaluate the safety and effectiveness of the Zenith Dissection Endovascular System (ZDES; Zenith TX2 Dissection Endovascular Graft with Pro-Form and Zenith Dissection Endovascular Stent), which uses a proximal stent graft along with a distal bare metal stent compared to traditional stent grafts in the repair of acute, complicated Type B Aortic Dissection (AcTBAD).
This retrospective study reviews the medical charts of 32 patients with AcTBAD repaired at a single urban academic medical center. 16 of these AcTBAD cases were repaired with the ZDES (87.5% male; mean age, 63.1 years), and 16 were repaired with stent grafts (62.5% male; mean age, 60.6 years). Outcomes include 30-day morbidity, false lumen thrombosis and aneurysmal degeneration at 6 months and 1 year, thirty-day and three-year mortality, and freedom from secondary surgical intervention.
Twelve total postoperative adverse events occurred in the ZDES group compared to 37 in the stent graft group (). The notable adverse events included renal insufficiency () and refractory pain (). At the 6-month follow-up, complete or partial false lumen thrombosis was noted in 100% of patients (16/16) in the ZDES group and 56.3% of patients (9/16) in the stent graft group (). At the 12-month follow-up, complete or partial thrombosis of the false lumen was noted in 1 additional patient in the stent graft group for a total of 62.6% of patients (10/16; ). Growth (>5 mm) of the maximum transaortic diameter at 12 months was noted in 33.3% of patients (5/15) in the ZDES group and 54% of patients (7/13) in the stent graft group (). Thirty-day mortality occurred in one patient in the ZDES group and no patients in the stent graft group (). Three-year mortality occurred in four patients in the stent graft group and no patients in the ZDES group (). Although more patients in the ZDES group underwent secondary intervention to address aortic growth, there were no differences between the two groups in freedom from any secondary intervention at 365 days post-procedure ().
Patients treated with ZDES had fewer post-procedural adverse events. Although the use of the ZDES had favorable false lumen thrombosis at 6 and 12 months, the device was not associated with a statistically significant change in transaortic diameter. Our single institution study demonstrated that ZDES has favorable clinical outcomes, but further investigation is needed to better understand aortic remodeling in the distally stented regions. Additionally, further research is necessary to explore the incidence of endoleaks associated with ZDES to optimize long-term patient outcomes.
我们旨在评估Zenith夹层腔内血管系统（ZDES；带预成型的Zenith TX2夹层腔内移植物和Zenith夹层腔内支架）在修复急性复杂性B型主动脉夹层（AcTBAD）时，与传统支架型人工血管相比，使用近端支架型人工血管和远端裸金属支架的安全性和有效性。
这项回顾性研究回顾了在一家城市学术医疗中心接受AcTBAD修复的32例患者的病历。其中16例AcTBAD病例采用ZDES修复（男性占87.5%；平均年龄63.1岁），16例采用支架型人工血管修复（男性占62.5%；平均年龄60.6岁）。结果包括30天发病率、6个月和1年时的假腔血栓形成和动脉瘤样退变、30天和3年死亡率以及无需二次手术干预。
ZDES组共发生12例术后不良事件，而支架型人工血管组为37例（）。显著的不良事件包括肾功能不全（）和顽固性疼痛（）。在6个月随访时，ZDES组100%的患者（16/16）和支架型人工血管组56.3%的患者（9/16）出现完全或部分假腔血栓形成（）。在12个月随访时，支架型人工血管组又有1例患者出现假腔完全或部分血栓形成，共62.6%的患者（10/16；）。ZDES组33.3%的患者（5/15）和支架型人工血管组54%的患者（7/13）在12个月时出现最大经主动脉直径增长（>5mm）（）。ZDES组有1例患者发生30天死亡，支架型人工血管组无患者死亡（）。支架型人工血管组有4例患者发生3年死亡，ZDES组无患者死亡（）。虽然ZDES组更多患者接受了二次干预以解决主动脉生长问题，但两组在术后365天无需任何二次干预的情况无差异（）。
接受ZDES治疗的患者术后不良事件较少。虽然使用ZDES在6个月和12个月时假腔血栓形成情况良好，但该装置与经主动脉直径的统计学显著变化无关。我们的单机构研究表明ZDES具有良好的临床结果，但需要进一步研究以更好地了解远端带支架区域的主动脉重塑。此外，有必要进一步研究探索与ZDES相关的内漏发生率，以优化患者长期预后。
