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B型主动脉夹层腔内修复术及保守治疗效果的对比研究
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  • 英文题名:The Early and Midterm Results of Stent-graft Versus Medication Therapy for Type B Dissection
  • 副题名:START多中心前瞻性注册研究中期结果
  • 英文副题名:A Multi-center Prospective Study in China (START)
  • 作者:贾鑫
  • 论文级别:博士
  • 学科专业名称:外科学
  • 学位年度:2012
  • 导师:郭伟
  • 学科代码:100210
  • 学位授予单位:中国人民解放军军医进修学院
摘要
目的本研究为国内首个关于B型主动脉夹层的多中心、前瞻性注册研究,主要比较主动脉腔内修复术(TEVAR)和药物保守治疗(OMT)对于B型夹层的早期和中期结果。
     方法本研究纳入自2007年1月至2010年12月国内四家血管中心收治的335名B型主动脉夹层患者,其中32例为复杂型夹层,303例诊断为非复杂型夹层,其中208例纳入TEVAR治疗组,95例纳入OMT治疗组。男性246例,女性89例,平均年龄53.7±18.1岁。ASA评分大于III级者51例(15.2%,51/335)。合并严重并发症包括12例肾脏缺血,8例肠缺血,16例先兆破裂,11例下肢缺血,1例截瘫。初始影像学资料显示,第一破口距LSA开口距离为32.6±28.9mm,294例(87.8%)夹层同时累及胸腹主动脉,41例(12.2%)夹层局限撕裂至胸主动脉水平,初始胸主动脉最大直径41.2±19.1mm;腹主动脉最大直径28.1±19.3mm。
     结果本组病例TEVAR操作技术成功率100%,40%(96/240)患者需要覆盖左侧锁骨下动脉,有15例(6.25%)患者需要腹膜外入路。复杂型夹层组中,6例患者住院期间死亡,死亡率为18.7%(6/32),脊髓损伤发生于3名(9.4%,3/32)患者。Logistic多因素逐步回归分析显示,ASA评分大于III级为围手术期死亡率独立危险因素。OMT组围手术期没有死亡及严重不良事件发生。非复杂TEVAR组中,2例(0.9%,2/208)患者术中发生逆行A型夹层,2例(0.9%,2/208)患者发生急性心急梗塞,6例(0.9%,2/208)患者术后发生肱动脉穿刺点假性动脉瘤。Logistic多因素逐步回归分析显示,年龄大于75岁为围手术期不良事件发生的独立危险因素。所有病例平均随访时间28.5±16.3月(范围1-58月),68%患者随访时间超过24月。Kaplan-Meier生存曲线分析显示,复杂型夹层48月生存率为61.7%,非主动脉相关生存率48月估计为70%,无主动脉相关不良事件的生存率48月为56.3%。TEVAR组48月生存率为82.7%,而OMT组48月生存率为69.1%,Log-rank检验两组没有统计学差异(P=0.0678)。非主动脉相关死亡的生存率曲线分析,TEVAR组48月生存率为88.1%;OMT组48月为73.8%,Log-rank检验两组间有统计学差异(P=0.0392)。TEVAR组中,有94.9%(151/159)患者主动脉没有进一步增长,胸主动脉最大直径自基线值41.5+11.1mm缩小至37.3+12.8mm;OMT组中,有39.7%(27/68)患者主动脉没有持续增长,胸主动脉直径增加的患者比例明显高于TEVAR组(P=0.001)。OMT组主动脉最大直径自基线值40.7+8.6mm增长至48.1+9.3mm,同TEVAR组差别有统计学意义(P=0.002)。TEVAR组胸主动脉完全血栓和重塑率达到88.4%(157/177),而在OMT组则只有22.1%(15/68),两组间差别有统计学意义(P=0.001)。
     结论本研究初步表明,与OMT治疗相比,TEVAR治疗可以显著降低主动脉相关死亡率,可能会提高整体生存率和降低主动脉相关不良事件发生率,虽然后面两个参数在本研究中未呈现统计学差异。另外,与OMT治疗相比,TEVAR治疗可以促进夹层假腔血栓形成,提高胸主动脉重塑率,减少胸主动脉直径增长的风险。
Objective: This prospective multi-center comparative study examined earlyand midterm results of medication and stentgraft therapies on the type Baorta dissection in China.
     Methods:335patients collected from four centers in China from January2007to Dec2010with type B aorta dissection were prospectively enrolledand treated by either optimal medication therapy (OMT) or thoracicendovascular aorta repair (TEVAR). There were246male and89femalepatients with an age of53.7±18.1years. American Society ofAnesthesiologists (ASA) classification greater than class III was present in15.2%patients. The baseline maximum diameter of thoracic aorta was41.2±19.1mm, the distance from the left subclavian artery to the proximal entrytear was32.6±28.9mm, and dissection extended beyond the celiac axis in87.8%of cases.
     Results: there were208patients in the TEVAR group and95patients in theOMT group. Procedural success was100%, and there was no death duringindex hospitalization in both groups. In the TEVAR group, two patients(0.9%) suffered from retrograde type A dissection, six (2.9%) from brachialaccess pseudo-aneurysm, and two (0.9%) suffered from paraplegia orparaparesis. For in-hospital outcome, multivariate analysis showed that agegreater than75years and ASA class greater than III were independentpredictors of major early adverse events. Average follow-up time for hospitalsurvivors was28.5±16.3months (range1.0–58). In the OMT group, fivepatients died for rupture of enlarged false lumen, and six patients expiredsuddenly for unknown reasons. Fourteen cases required crossover to TEVAR (n=12) or surgical conversion (n=2). In the TEVAR group, ninepatients required reintervention or surgical conversion, and one died ofpostoperative multi-organ failure. One patient expired for delayedretrograde type A dissection, and four expired suddenly for unknownreasons. The Kaplan-Meier analysis of survival probability at two years andfour years was87.5%and82.7%with TEVAR and77.5%and69.1%respectively with OMT (log-rank test P=0.0678). The estimated cumulativefreedom from aorta-related death at two and four years were91.6%and88.1%with TEVAR and82.8%and73.8%with OMT (log-rank testP=0.0392). The maximum thoracic aorta shrank from42.4±23.1mm to37.3±12.8mm in the TEVAR group, and the maximum thoracic aorta in theOMT group expanded from40.7±18.6mm to48.1±17.3mm. Theincidence of increased thoracic aorta is significantly higher in the OMT(60.3%) than in the TEVAR (5.1%)(P=0.001).
     Conclusion: This was the first prospective multi-center comparative study onthe treatment of type B aorta dissection in China. TEVAR turned out to havea significantly lower aorta-related mortality compared with OMT, and aseemingly lower overall mortality and adverse events rate. Furthermore,TEVAR was also found to be able to enhance the thoracic remodeling rate.
引文
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