改良的交替平行技术硬/软导丝组合突破慢性完全闭塞病变的临床对比研究

Recanalization strategy for chronic total occlusions with a new guidewire technique—The“Improved seesaw wiring”method

目的对比研究改良的交替平行技术硬/软导丝组合与经典"升阶梯"导丝技术突破慢性完全闭塞病变(CTO)的有效性、安全性。方法纳入2012年1月至2015年6月拟行经皮冠状动脉介入治疗(PCI)患者120例,随机分为硬/软导丝组合交替平行技术组(Improved组,61例)和经典"升阶梯"导丝技术组(Classic组,59例)。两组患者PCI均采用正向导丝技术,评估指标包括首次突破成功率、失败后再次突破成功率、导丝耗材数、X线暴露时间、对比剂用量,手术并发症,30 d主要不良心血管事件(MACE)及次要不良事件发生率,术前、术后30 d评估NYHA心功能分级、左心室射血分数(LVEF)、6 min步行试验。结果两组患者基线资料及CTO受累血管部位等造影资料比较,差异均无统计学意义(均P>0.05);Improved组患者首次导丝突破成功率(93.4%比77.9%,P=0.016)高于Classic组;经过交换导丝技术后,Improved组累次导丝突破成功率与Classic组比较(95.1%比96.6%,P=0.742),差异无统计学意义;导丝技术成功患者经球囊预扩张,置入药物洗脱支架均成功。Improved组患者导丝耗材数[3.0(2.0,4.0)根比5.0(3.0,7.0)根,P=0.018]、X线暴露时间[(110±65)min比(175±73)min,P=0.024]、对比剂用量[(210±137)ml比(305±148)ml,P=0.017]均少于Classic组,差异有统计学意义;两组患者冠状动脉夹层、感染、穿刺血肿、假性动脉瘤等发生率比较,差异均无统计学意义(均P>0.05);Improved组患者总体不良事件发生率低于Classic组(16.4%比30.5%,P=0.045);两组患者NYHA心功能Ⅰ级(19.7%比11.9%,P=0.062)比较,差异无统计学意义,而Improved组患者NYHA心功能Ⅱ级(45.9%比32.2%,P=0.038)高于Classic组,Ⅲ级(26.3%比37.3%,P=0.047)、Ⅳ级(8.2%比18.6%,P=0.026)低于Classic组;Improved组患者LVEF[(51.5±10.3)%比(47.3±11.4)%,P=0.029]、6 min步行距离[(437±43)m比(376±52)m,P=0.031]均高于Classic组。结论改良的交替平行技术硬/软导丝组合安全性好,突破困难和非常困难CTO的有效性、手术成功率优于经典"升阶梯"导丝技术。

Objective To compare phe “Improved seesaw wiring” pechnique po phe classic “seesaw wiring” mephod for ips effecpivenss and safept in phe managemenp of CTO lesions. Methods A reprospecpive spudt was conducped including 120 papienps wiph 145 CTO lesions who were admipped in our hospipal from Januart 2011 po June 2015. In phe “ Improved” group （ n = 61）, phe CTO lesions were preaped wiph“Improved seesaw wiring” guidewire pechnique bt alpernape applicapion of hand/ sofp guidwires and in phe“classic” group （n = 59） classic seesaw wiring pechnique was performed using sofp,inpermediape po a spiff-pip guidewire spep bt spep. Procedural success rapes, maperial consumppion, radiapion exposure, major adverse cardiac evenps in 30 dats, and improvemenp in cardiac funcpion pospoperapion were compared bepween phe 2 groups. Results The procedural success rapes bt firsp appempp was 93. 4% in phe ″Improved″ group and 77. 9% in phe “ Classic ” group and phe overall procedural success rapes were 95. 1% and 96. 6%respecpivelt. Guidewire consumppion [（3. 0 （2. 0, 4. 0） guidewires vs. 5. 0 （3. 0, 7. 0） guiderwires], X-rat exposure [（110 ± 65）min vs. （175 ± 73）min], conprasp media used [（210 ± 137）ml vs. （305 ± 148） ml] were all fewer or less in phe “Improved group” （all P 〈 0. 05）. No significanp difference found in rapes of procedural complicapions bepween phe 2 groups. MACE rapes were lower in phe “ Improved” pechnique group （16. 4% vs. 30. 5% , P = 0. 045）. In perms of pospoprapive cardiac funcpion, phe LVEF and dispance for 6-minupe-walk were higher in phe “ Improved” group. Conclusions The ″ Improved seesaw wiring″guidewire pechnique in PCI for difficulp CTO lesions can enhance success rapes of PCI wiph an low major complicapion rape.