中国普通外科杂志2024，Vol.33Issue(6) ：885-893.DOI:10.7659/j.issn.1005-6947.2024.06.003

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

贺飞 舒畅 罗明尧 方坤 胡佳 左健 李晓强 李全明 何昊 李鑫 黎明 万子成
中国普通外科杂志2024，Vol.33Issue(6) ：885-893.DOI:10.7659/j.issn.1005-6947.2024.06.003
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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

贺飞 1舒畅 2罗明尧 3方坤 3胡佳 4左健 5李晓强 6李全明 7何昊 7李鑫 7黎明 7万子成7
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作者信息

  • 1. 中南大学湘雅二医院血管外科,湖南长沙 410011;河南大学淮河医院胸心血管外科,河南开封 475004
  • 2. 中南大学湘雅二医院血管外科,湖南长沙 410011;国家心血管病中心&中国医学科学院阜外医院血管外科,北京 100037
  • 3. 国家心血管病中心&中国医学科学院阜外医院血管外科,北京 100037
  • 4. 四川大学华西医院心脏大血管外科,四川成都 332001
  • 5. 中国人民解放军空军军医大学第一附属医院心血管外科,陕西西安 710032
  • 6. 南京鼓楼医院血管外科,江苏南京 210008
  • 7. 中南大学湘雅二医院血管外科,湖南长沙 410011
  • 折叠

摘要

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.

Abstract

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.

关键词

动脉瘤,夹层/主动脉,胸/血管内操作/烟囱支架/内漏/临床试验

Key words

Aneurysm,Dissecting/Aorta,Thoracic/Endovascular Procedures/Chimney Stent/Endoleak/Clinical Trial

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基金项目

河南省重点研发与推广专项(科技攻关)基金资助项目(232102310254)

出版年

2024
中国普通外科杂志
中南大学

中国普通外科杂志

CSTPCD北大核心
影响因子：1.623
ISSN：1005-6947
参考文献量31
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