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
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1.中南大学湘雅二医院 血管外科,湖南 长沙 410011;2.河南大学淮河医院 胸心血管外科,河南 开封 475004;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

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贺飞,中南大学湘雅二医院博士研究生/河南大学淮河医院副主任医师,主要从事血管疾病临床与基础方面的研究。

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


Results of the PATENCY clinical trial using the Longuette™ chimney stent-graft in thoracic endovascular aortic repair
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1.Department of Vascular Surgery, the Second Xiangya Hospital, Central South University, Changsha 410011, China;2.Department of Thoracic and Cardiovascular Surgery, Huaihe Hospital of Henan University, Kaifeng, Henan 475004, China;3.Department of Vascular Surgery, Fuwai Hospital, Academy of Medical Sciences & National Center for Cardiovascular Disease, Beijing 100037, China;4.Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu 332001, China;5.Department of Cardiovascular Surgery, the First Affiliated Hospital of Air Force Military Medical University, Xi'an 710032, China;6.Department of Vascular Surgery, Drum Tower Hospital, Affiliated to School of Medicine, Nanjing University, Nanjing 210008, China

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    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.

    图1 Longuette™烟囱支架与普通烟囱支架用于重建LSA的设计和效果的比较 A:Longuette™烟囱支架;B-C:Longuette™烟囱支架在体外模型中释放,箭头表示“沟槽”被Longuette™烟囱支架的外层支架填塞封堵;D-E:Longuette™烟囱支架用于治疗TBAD手术前与手术后,术后无内漏发生(箭头所示);F:普通烟囱支架;G-H:普通烟囱支架在体外模型中释放,箭头可见在烟囱支架、主动脉支架和主动脉壁之间形成的明显“沟槽”;I-J:普通烟囱支架用于治疗TBAD手术前与手术后,术后“沟槽”导致Ⅰa型内漏(箭头所示)Fig.1 Comparison of design and effectiveness of Longuette™ chimney stent-graft and regular chimney stent-graft for LSA reconstruction A: Longuette™ chimney stent; B-C: Deployment of Longuette™ chimney stent in an ex vivo model, with arrows indicating the groove being sealed by the outer stent layer of the Longuette™ chimney stent; D-E: Longuette™ chimney stent used for treating TBAD, before and after the procedure, with no endoleak after operation (shown by arrow); F: Regular chimney stent-graft; G-H: Deployment of regular chimney stent-graft in an ex vivo model, with green arrows showing the prominent groove formed between the chimney stent-graft, aortic stent, and aortic wall; I-J: Regular chimney stent-graft used for treating TBAD, before and after the procedure, with the groove causing a type Ⅰa endoleak after operation (shown by arrow)
    图2 Kaplan-Meier分析 A:术后12个月累积生存率;B:术后12个月累积LSA通畅率;C:术后12个月累积无内漏率Fig.2 Kaplan-Meier analysis A: Cumulative survival rate at 12 months after operation; B: Cumulative LSA patency rate at 12 months after operation; C: Cumulative endoleak-free rate at 12 months after operation
    表 1 参与研究的医学中心和入组患者例数Table 1 Medical centers participating in the study and number of patients enrolled
    表 3 Table 3
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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.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[J].中国普通外科杂志,2024,33(6):885-893.
DOI:10.7659/j. issn.1005-6947.2024.06.003

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  • 收稿日期:2024-04-22
  • 最后修改日期:2024-05-27
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  • 在线发布日期: 2024-07-09