激光雕刻型支架与编织型支架治疗血栓性与非血栓性Cockett综合征中远期疗效的对比研究

Comparative study of the mid- and long-term clinical outcomes of laser-engraved versus braided stents used to treat thrombotic and nonthrombotic Cockett syndrome

目的对比分析激光雕刻型支架与编织型支架置入在治疗血栓性和非血栓性Cockett综合征的中远期临床疗效。方法回顾性队列研究。纳入蚌埠医科大学第一附属医院2015年1月—2020年5月首次接受左髂静脉支架置入治疗的611例Cockett综合征患者的随访资料。其中男216例、女395例,年龄22~83(55.0±9.9)岁,非血栓性(不合并血栓)Cockett综合征453例、血栓性(合并血栓)Cockett综合征158例。根据患者置入支架类型不同分组:激光型组490例(均置入激光雕刻型支架),编织型组121例(均置入编织型支架)。依据2组患者是否合并血栓进行观察和分层比较,观察指标:(1)术后3、6年支架一期通畅率。(2)术后3、6年的临床、病因学、解剖学、病理生理学(CEAP)分级,以及静脉临床严重程度评分(VCSS)、慢性静脉功能不全生活质量问卷(CIVIQ)-20评分较术前的变化情况。(3)围手术期相关并发症及术后下肢深静脉血栓形成等不良事件发生率。结果611例患者共置入了664枚支架,置入成功率为100%(611/611)。患者术后均获随访36.5~102.4(70.4±16.6)个月。激光型组与编织型组间以及组内血栓与非血栓患者间年龄、性别、合并基础疾病、吸烟史和静脉曲张手术史等比较,差异均无统计学意义(P值均>0.05)。患者术前CEAP分级、VCSS、CIVIQ-20评分比较,2组间差异均无统计学意义(P值均>0.05);组内分层比较,2组的CIVIQ-20评分、激光型组的VCSS评分,血栓性患者均高于非血栓性患者,差异均有统计学意义(P值均<0.05)。观察结果:(1)2组患者术后3、6年的支架一期通畅率差异均无统计学意义(P值均>0.05)。(2)2组患者术后3、6年CEAP分级、VCSS、CIVIQ-20评分均较术前明显降低,差异均有统计学意义(P值均<0.001)。术后3、6年,激光型组内的非血栓性患者较血栓性患者、编织型组非血栓性患者较激光组非血栓性患者的CEAP分级降低更明显,差异均有统计意义(P值均<0.05);术后6年,编织型组血栓性患者较激光型组血栓性患者VCSS评分的改善更小,差异有统计学意义(P=0.003);术后3年,编织型组血栓性患者较激光型组血栓性患者CIVIQ-20评分减小程度低,差异有统计学意义(P=0.048)。(3)术后有2.9%(18/611)的患者出现穿刺点周围不同程度的血肿,26.4%(161/611)的患者出现自限性腰背部疼痛症状,2组间发生率比较差异均无统计学意义(P值均>0.05)。激光型组血栓性患者术后下肢深静脉血栓形成发生率17.8%(16/90),明显高于非血栓患者的6.0%(24/400),差异有统计学意义(χ^(2)=13.60,P<0.001);编织型组内比较以及2组间比较差异均无统计学意义(P值均>0.05)。编织型组内比较以及2组间比较差异均无统计学意义(P值均>0.05)。患者均无支架移位、形变或断裂等不良事件发生。结论激光雕刻型支架和编织型支架置入治疗血栓性和非血栓性Cockett综合征的中远期支架通畅率均良好,患者的生活质量获得明显改善,方法安全,疗效确定。激光雕刻型支架较编织型支架的临床效果相对更佳。

Objective This study aimed to compare the mid-and long-term clinical outcomes of laser-engraved stents and braided stent in thrombotic and nonthrombotic Cockett syndrome.Methods This was a retrospective cohort study.The follow-up data of 611 Cockett syndrome patients who were first treated with left iliac vein stent placement from January 2015 to May 2020 in the First Affiliated Hospital of Bengbu Medical University were included.The cohort included 216 males and 395 females,aged 22-83(55.0±9.9)years old,with 453 patients of nonthrombotic Cockett syndrome and 158 patients of thrombotic Cockett syndrome.The patients were grouped according to the type of stent placed:490 patients in the laser group,all of whom were placed with laser-engraved stents;and 121 patients in the braided group,all of whom were placed with braided stents.The two groups were observed and stratified according to whether they were complicated with thrombosis.Observation indices:(1)The primary stent-patency rates at 3 and 6 years after the operation.(2)The clinical,etiologic,anatomic,and pathophysiologic(CEAP)grades,as well as the venous clinical severity score(VCSS)and chronic venous insufficiency quality of life questionnaire(CIVIQ)-20 scores and preoperative changes at 3 and 6 years after surgery.(3)The incidence of perioperative-related complications and adverse events such as postoperative lower extremity deep-vein thrombosis.Results A total of 664 stents were placed in 611 patients,and the placement success rate was 100.0%(611/611).The patients were followed up for 36.5-102.4(70.4±16.6)months after the procedure.No statistically significant difference in age,gender,and past history existed(Comorbidities,history of smoking,and history of variceal surgery)between patients with and without thrombosis in the laser-type and weaving-type groups(all P values>0.05).There was no significant difference in preoperative CEAP grading,VCSS and CIVIQ-20 scores between the two groups(all P values>0.05).The preoperative CIVIQ-20 scores and VCSS scores in the laser type group showed that patients with thrombosis were significantly higher than those without thrombosis(all P values<0.05).Observations:(1)No statistically significant difference in the primary stent-patency rate existed between the two groups of patients at 3 and 6 years after surgery(all P values>0.05).(2)CEAP grades,VCSS,and CIVIQ-20 scores were significantly lower in both groups at 3 and 6 years after surgery compared with the preoperative period,and the differences were statistically significant(all P values<0.001).At 3 and 6 years after surgery,CEAP grading was lower in the laser-type group without combined thrombus compared with the laser-type group with combined thrombus,and the braided-type group without combined thrombus,and the differences were statistically significant(all P values<0.05).VCSS scores at 6 years postoperatively in the case of braided combination with thrombus changed to a lesser extent than those in the case of laser-type combination with thrombus and the difference was statistically significant(P=0.003).CIVIQ-20 scores decreased to a lesser extent at 3 years postoperatively in the case of braided combination with thrombus than in the case of laser-type combination with thrombus,and the difference was statistically significant(P=0.048).(3)About 2.9%(18/611)of patients experienced varying degrees of hematoma around the puncture site after surgery,and 26.4%(161/611)of patients experienced self-limiting lower-back pain symptoms.No statistically significant difference existed between the two groups(all P values>0.05).The incidence of postoperative deep-vein thrombosis in the lower limbs between the two groups of patients was significantly higher in patients with laser combined thrombosis than in those without thrombosis(17.8%[16/90]and 6.0%[24/400]),and the difference was statistically significant(χ^(2)=13.60,P<0.001).No adverse events such as stent displacement,deformation,or fracture was found.Conclusion Laser-engraved stents and braided stent placement for thrombotic and nonthrombotic Cockett's syndrome have good mid-and long-term stent-patency rates,and patients'quality of life improves significantly with established efficacy.The laser-engraved stent has a relatively better clinical outcome than the braided one.