胸主动脉腔内修复术采用裙边型烟囱支架(Longuette™)的PATENCY临床试验研究结果

Results of the PATENCY clinical trial using the Longuette™chimney stent-graft in thoracic endovascular aortic repair

背景与目的:烟囱技术是胸主动脉腔内修复术(TEVAR)中重建左锁骨下动脉(LSA)的方法,Ⅰa型内漏是其主要并发症。裙边型烟囱支架(Longuette™)专为烟囱技术设计,用于重建LSA时降低Ⅰa型内漏。为评估Longuette™烟囱支架联合TEVAR治疗累及LSA的Stanford B型主动脉夹层(TBAD)的疗效,笔者开展了前瞻性、多中心临床试验(PATENCY临床试验)。本研究总结PATENCY临床试验的1年结果和经验。方法:2018年10月—2022年3月,全国26家血管外科中心参与PATENCY临床试验,共纳入150例符合标准的TBAD患者。所有患者均在TEVAR术中采用Longuette™烟囱支架重建LSA。评估患者围手术期和术后12个月的临床效果和不良事件,并分析患者术后1年累积生存率、LSA通畅率和无内漏率。结果:患者年龄30~77岁,平均(54.48±11.12)岁,138例(92.0%)患者合并高血压病;急性、亚急性和慢性TBAD分别占74.7%,17.3%和8.0%。124例(82.7%)患者采用全身麻醉。手术成功率为99.33%(149/150),手术时间(91.67±41.47)min,X线暴露时间(31.36±16.71)min,手术出血量为(71.55±60.40)mL。围手术期内漏发生率为5.33%(8/150),包括Ⅰ型6例、Ⅱ型1例、Ⅳ型1例;1例(0.67%)患者发生Longuette™烟囱支架急性闭塞,再次实施腔内手术后恢复通畅;1例(0.67%)患者术后发生急性脑梗死;2例(1.33%)患者术后发生逆撕的Stanford A型主动脉夹层,其中1例术后3周死亡。术后30 d死亡2例(1.33%)。142例患者进行了密切随访,随访时间为11.67(5~16)个月。无主动脉支架和Longuette™烟囱支架移位。2例Ⅰ型内漏患者分别于术后6个月和1年进行了再次介入栓塞手术治疗,术后1年随访仍有6例患者有轻微的内漏持续存在,患者TBAD假腔保持稳定,无明显症状,均予以保守治疗。Longuette™烟囱支架内狭窄和闭塞分别发生1例和2例,逆撕的Stanford A型主动脉夹层患者1例,假腔增大,患者均无明显症状,予以保守治疗。无发生脑卒中、截瘫、左上肢缺血等并发症。术后12个月累积生存率、LSA通畅率、无内漏率分别为97.96%、97.96%和91.91%。结论:采用Longuette™烟囱支架在TBAD腔内治疗中重建LSA简便、安全、有效,其能够有效降低围手术期Ⅰa型内漏的发生率,为微创治疗主动脉弓部病变提供新的治疗方式。

Background and Aims:The chimney technique is a method for the left subclavian artery(LSA)reconstruction during thoracic endovascular aortic repair(TEVAR),with typeⅠa endoleak being the main complication.The Longuette™chimney stent-graft is specifically designed for the chimney technique to reduce typeⅠa endoleak during LSA reconstruction.To evaluate the efficacy of the Longuette™chimney stent-graft combined with TEVAR in the treatment of Stanford type B aortic dissection(TBAD)involving the LSA,we conducted a prospective,multi-center clinical trial(PATENCY clinical trial).This study was to summarize the one-year results and experiences of the PATENCY clinical trial.Methods:From October 2018 to March 2022,twenty-six vascular surgery centers nationwide participated in the PATENCY clinical trial,enrolling a total of 150 eligible TBAD patients.All patients underwent LSA reconstruction with the Longuette™chimney stent-graft during TEVAR.The clinical efficacy and adverse events were evaluated during the perioperative period and at 12 months after operation,and the cumulative survival rate,LSA patency rate,and endoleak-free rate at one year after operation were analyzed.Results:The patients'ages ranged from 30 to 77 years,with an average age of(54.48±11.12)years.Among them,138 patients(92.0%)had concomitant hypertension;acute,subacute,and chronic TBAD accounted for 74.7%,17.3%,and 8.0%of cases,respectively.General anesthesia was used in 124 patients(82.7%).The surgery success rate was 99.33%(149/150),with an average operative time of(91.67±41.47)min,X-ray exposure time of(31.36±16.71)min,and blood loss of(71.55±60.40)mL.The perioperative endoleak incidence was 5.33%(8/150),including type I in 6 cases,typeⅡin 1 case,and typeⅣand 1 case.One patient(0.67%)experienced acute occlusion of the Longuette™chimney stent,which was recanalized after another endovascular procedure.One patient(0.67%)had an acute cerebral infarction after operation,and two patients(1.33%)developed retrograde Stanford type A aortic dissection,with one death occurring three weeks after operation.Two patients(1.33%)died within postoperative 30 d.A total of 142 patients were closely followed for 11.67(5-16)months.No displacement of the aortic stent or Longuette™chimney stent-graft was observed.Two type I endoleak patients underwent reintervention with embolization at six months and one year after operation,respectively.Six patients still had minor endoleaks at the one-year follow-up,but their TBAD false lumen remained stable without significant symptoms,and they received conservative treatment.Stenosis and occlusion within the Longuette™chimney stent occurred in one and two patients,respectively,with one case of retrograde Stanford type A aortic dissection.All these patients were asymptomatic and received conservative treatment.No complications such as stroke,paraplegia,or left upper limb ischemia were observed.The cumulative one-year survival rate,LSA patency rate,and endoleak-free rate were 97.96%,97.96%,and 91.91%,respectively.Conclusion:The use of the Longuette™chimney stent in endovascular treatment of TBAD for LSA reconstruction is simple,safe,and effective.It can significantly reduce the incidence of perioperative typeⅠa endoleak,providing a new treatment option for minimally invasive management of aortic arch lesions.