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OA北大核心CSTPCD

Background and Aims:The chimney technique is a method for the left subclavian artery(LSA)reconstruction during thoracic endovascular aortic repair(TEVAR),with type Ⅰa endoleak being the main complication.The Longuette™ chimney stent-graft is specifically designed for the chimney technique to reduce type Ⅰa 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,type Ⅱ in 1 case,and type Ⅳ and 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 type Ⅰa endoleak,providing a new treatment option for minimally invasive management of aortic arch lesions.