Sultan Sherif, Kavanagh Edel P, Stefanov Florian, Sultan Mohamed, Elhelali Ala, Costache Victor, Diethrich Edward, Hynes Niamh
Department of Vascular and Endovascular Surgery, Western Vascular Institute, Galway University Hospital, National University of Ireland, Galway, Ireland; Department of Vascular and Endovascular Surgery, Galway Clinic, Doughiska, Galway, Ireland.
Department of Vascular and Endovascular Surgery, Galway Clinic, Doughiska, Galway, Ireland.
J Vasc Surg. 2017 Apr;65(4):940-950. doi: 10.1016/j.jvs.2016.09.059.
Reported are initial 12-month outcomes of patients with chronic symptomatic aortic dissection managed by the Streamliner Multilayer Flow Modulator (SMFM; Cardiatis, Isnes, Belgium). Primary end points were freedom from rupture- and aortic-related death, and reduction in false lumen index. Secondary end points were patency of great vessels and visceral branches, and freedom of stroke, paraplegia, and renal failure.
Out of 876 SMFM implanted globally, we have knowledge of 542. To date, 312 patients are maintained in the global registry, of which 38 patients were identified as having an aortic dissection (12.2%). Indications included 35 Stanford type B dissections, two Stanford type A and B dissections, and one mycotic Stanford type B dissection.
There were no reported ruptures or aortic-related deaths. All cause survival was 85.3% Twelve-month freedom from neurologic events was 100%, and there were no incidences of end-organ ischemia, paraplegia or renal insult. Morphologic analysis exhibited dissection remodeling by a reduction in longitudinal length of the dissected aorta, and false lumen volume. A statistically significant reduction in false lumen index (P = .016) at 12 months, and a borderline significant increase in true lumen volume (P = .053) confirmed dissection remodeling.
The SMFM is an option in management of complex pan-aortic dissection. Results highlight SMFM implantation leads to dissection stabilization with no further aneurysm progression, and no retrograde type A dissection. Thoracic endovascular aneurysm repair by SMFM ensued in freedom from aortic rupture, neurologic stroke, paraplegia and renal failure. Further analysis of the global registry data will inform long-term outcomes.
报告采用Streamliner多层血流调节器(SMFM;比利时伊斯内斯市Cardiatis公司)治疗慢性症状性主动脉夹层患者的最初12个月结果。主要终点是无破裂和主动脉相关死亡,以及假腔指数降低。次要终点是大血管和内脏分支通畅,以及无卒中、截瘫和肾衰竭。
在全球植入的876个SMFM中,我们了解到542个的情况。迄今为止,312例患者被纳入全球注册研究,其中38例被确定患有主动脉夹层(12.2%)。适应证包括35例斯坦福B型夹层、2例斯坦福A和B型夹层以及1例霉菌性斯坦福B型夹层。
未报告破裂或主动脉相关死亡。全因生存率为85.3%。12个月无神经系统事件发生率为100% , 且无终末器官缺血、截瘫或肾损伤事件发生。形态学分析显示,通过减少夹层主动脉的纵向长度和假腔容积,夹层得到重塑。12个月时假腔指数有统计学意义的降低(P = 0.016),真腔容积有临界显著增加(P = 0.053),证实了夹层重塑。
SMFM是治疗复杂性全主动脉夹层的一种选择。结果表明,植入SMFM可使夹层稳定,无进一步动脉瘤进展,也无逆行A型夹层。采用SMFM进行胸主动脉腔内修复术可避免主动脉破裂、神经卒中、截瘫和肾衰竭。对全球注册研究数据的进一步分析将为长期结果提供信息。