主动脉腔内全程重塑装置(AERD)治疗Stanford A型主动脉夹层的临床疗效分析

Assessment of the clinical effect of aortic endovascular remodeling device(AERD)for type A aortic dissection

目的探讨主动脉腔内全程重塑装置(aortic endovascular remodeling device,AERD)在Stanford A型主动脉夹层Ⅱ型杂交手术中的早中期结果,评价其临床疗效。方法2021年2月至2023年10月,共纳入46例Stanford A型主动脉夹层患者,男32例,女14例,参与四川大学华西医院单中心临床试验,接受Ⅱ型杂交手术(Bentall/升主动脉置换术+AERD主动脉腔内修复)。通过对术后死亡比例、心脑血管意外、截瘫、脏器缺血等临床指标,以及真假腔体积变化、弓上分支血流量等血流情况进行分析,探讨AERD在Stanford A型主动脉夹层Ⅱ型杂交手术中的安全性及有效性。研究方案已在中国临床试验注册中心注册(ChiCTR2000036883)。结果随访期间死亡3例(6.52%),其中手术相关死亡2例(4.35%)。余43例随访(25.53±9.60)个月,术后发生卒中事件2例(4.35%),未发现截瘫、急性肾功能不全等其他严重并发症。随访过程中,主动脉弓上分支血流通畅,术前及各随访时间点分支血流量均无明显差异;术后真腔血流量较术前显著增加,假腔随时间逐渐血栓化,腔内血流量减少。术后2年时,支架部分真腔体积相较术前扩大59.0%,假腔体积缩小82.4%。结论AERD在治疗急性Stanford A型主动脉夹层的Ⅱ型杂交手术中安全有效,有助于提高该类患者围术期及近远期生存率,降低并发症发生率,改善临床结局。

Objective To investigate the early and mid-term outcomes of aortic endovascular remodeling device(AERD)for Stanford type A aortic dissection(TAAD)in typeⅡhybrid surgery,and to evaluate its clinical efficacy.Methods 46 patients with TAAD,including 14 females and 32 males,participated in the single-center clinical trial of West China Hospital of Sichuan University and underwent type II hybrid surgery(Bentall/ascending aorta replacement+AERD implantation)from February 2021 to October 2023.The safety and efficacy of AERD in typeⅡhybrid surgery for TAAD were estimated by clinical indicators(postoperative mortality,cardiovascular and cerebrovascular accidents,paraplegia,ischemia),and blood flow condition(volume of the true and false lumen,and suprachial branches).Results Three patients(6.52%)died during the follow-up period,and the operation-related mortality was 4.35%(2/46).The remaining 43 patients were followed up for an average of(25.53±9.60)months.There were two cases(4.35%)of stroke after the operation,and paraplegia,acute renal insufficiency,and other severe complications were not noticed.The blood flow of the superior branch of the aortic arch was unobstructed,and there was no significant difference in the blood flow of the branch before the operation and at each follow-up time point.Compared to the pre-operation,the true lumen volume of the stent part increased by 59.0%and the false lumen volume decreased by 82.4%.Conclusion AERD is a safe and effective alternative in type II hybrid surgery for acute TAAD,which is helpful in improving perioperative and short-and long-term survival rates and clinical outcomes.