经前臂桡/尺动脉入径微创化冠状动脉介入治疗系列研究
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摘要
现代微创化冠状动脉介入治疗的理念就是以最小的创伤为患者带来最大的临床获益。1989年，Campeau首次报道了经桡动脉入径行选择性冠状动脉造影的有效性与安全性。1992年，Kiemeneij完成了首例经桡动脉入径冠状动脉支架植入手术，开创了经桡动脉入径冠状动脉介入治疗时代。与传统的股动脉入径或肱动脉入径相比，桡动脉入径的优势在于减少了局部穿刺部位的并发症，术后患者无体位限制，提高了患者术后的舒适程度以及提高了成本效益。近期的临床研究还证实在急性ST段抬高型心肌梗死患者PPCI（Primary Percutaneous Coronary Intervention）过程中，桡动脉入径比股动脉入径不仅减少了局部并发症而且减少了住院期间患者死亡率，这一结果进一步奠定了经桡动脉入径冠状动脉介入治疗的地位。
虽然目前关于经前臂动脉入径冠状动脉介入治疗的研究较多，但关于前臂动脉血管解剖结构特点的相关研究较少，全面了解和掌握前臂动脉血管解剖结构特点，有助于术者在冠状动脉介入治疗时进行优化的血管入径选择。前臂动脉血管的舒缩状态也是影响前臂动脉入径使用的重要因素。前臂动脉痉挛是经前臂动脉入径冠状动脉介入治疗过程中主要并发症之一，前臂动脉痉挛可引起动脉穿刺失败，患者前臂疼痛，影响手术操作甚至无法完成手术。因此有必要寻找有效的措施预防前臂动脉痉挛的发生，提高经前臂动脉入径冠状动脉手术操作的成功率，并减少围手术期并发症的发生率。
临床上由于Allen试验异常，桡动脉血管环，严重迂曲，桡动脉发育细小，起源异常，桡动脉痉挛，桡动脉穿刺失败等原因，使得临床约有5-15%患者不适合经桡动脉入径行冠状动脉介入治疗操作。尺动脉作为肱动脉的两大分支之一，与桡动脉有着相似的解剖结构特点，理论上也可作为冠状动脉介入治疗操作的入径血管选择，但经尺动脉入径冠状动脉介入治疗的相关研究较少，结果也不一致，其作为冠状动脉介入治疗操作的常规入径血管仍需要进一步的评价。
随着冠状动脉介入治疗技术的不断完善成熟，冠状动脉介入治疗的适应症也逐步扩展，近年来一些复杂的冠状动脉病变也开始通过介入技术进行治疗。目前存在的主要瓶颈问题是能否经前臂动脉入径应用7F指引导管进行复杂冠状动脉介入手术操作，因为当面对复杂冠状动脉病变时，如复杂的分叉病变，严重钙化需要进行旋磨操作，复杂的CTO（Chronic TotalOcclusion）术式等，应用6F指引导管处理上述复杂病变时将面临手术操作困难，器械无法通过，增加手术风险等问题。由于前臂动脉血管细小，当需要应用7F指引导管进行手术操作时术者往往选择股动脉入径，目前关于经前臂动脉入径应用7F指引导管行冠状动脉介入治疗的相关研究较少，需要进一步的进行临床研究评价7F指引导管经前臂动脉入径冠状动脉介入治疗的可行性及安全性。
本研究分为三个部分：第一部分通过应用高频血管超声测量前臂动脉血管直径，管腔面积及血流速度，以及前臂动脉血管的皮下距离，并进行桡动脉与尺动脉解剖结构的比较，评价经尺动脉入径冠状动脉介入治疗在解剖学上的可行性，并观察硝苯地平对前臂动脉血管舒缩状态的影响及其对前臂动脉痉挛的预防作用。第二部分通过与桡动脉入径进行比较，评价在非选择人群中经尺动脉入径冠状动脉介入治疗的可行性及安全性。第三部分探讨在血管扩张药物的干预下经前臂动脉入径应用7F指引导管处理复杂冠状动脉分叉病变的可行性及安全性。
第一部分前臂动脉血管结构特点及血管活性药物对其舒缩状态的影响
目的：本研究通过高频血管超声测量前臂动脉血管直径，管腔面积及收缩期峰血流速度以及前臂动脉血管的皮下距离，并进行桡动脉与尺动脉解剖结构的比较，评价经尺动脉入径冠状动脉介入治疗在解剖学上的可行性；并观察血管活性药物硝苯地平对前臂动脉血管的扩张作用及对术中痉挛的预防作用。
方法：入选于河北医科大学第二医院心内五科欲行冠状动脉造影检查及介入治疗的患者。术前采用美国产Terason T3000便携式彩色超声影像系统，12L5A型探头，探头频率5～12MHz可调，进行前臂动脉超声检查。分别测量桡动脉与尺动脉血管的直径及管腔面积，前臂动脉血管的皮下距离，采用脉冲多普勒测量前臂动脉收缩期峰血流速度。
入选患者随机分为硝苯地平组和对照组，硝苯地平组患者于术前20分钟舌下含服硝苯地平片10毫克，于含药前，含药后5分钟及含药后15分钟重复测量患者前臂动脉血管直径及管腔面积等参数。对照组患者按常规术前准备进行。记录前臂动脉穿刺过程中及手术操作过程中前臂动脉痉挛的发生率。
结果：自2012年3月至2013年3月共入选428例行冠状动脉造影及冠状动脉介入治疗的患者。通过高频血管超声检查，测得患者右侧桡动脉血管的平均直径为2.70±0.52mm，右侧尺动脉血管的平均直径为2.71±0.54mm，桡动脉与尺动脉血管直径比较无明显差异（P=0.781），男性桡动脉血管直径明显大于女性桡动脉血管直径（2.75±0.45mm vs.2.54±0.41mm, P<0.05），男性尺动脉血管直径明显大于女性尺动脉血管直径（2.76±0.47mm vs.2.55±0.44mm, P<0.05）。桡动脉血管与尺动脉血管的横截面积比较无明显差异（5.08±1.62mm2vs.5.12±1.68mm2, P=0.723）。桡动脉的皮下距离为4.16±1.72mm，尺动脉的皮下距离为6.24±1.88mm，尺动脉的解剖位置明显比桡动脉解剖位置深（P<0.001）。6F指引导管是经前臂动脉入径冠状动脉介入治疗时的主要导管选择，94.6%桡动脉血管直径和95.8%尺动脉血管直径大于6F指引导管的外径，7F指引导管常用于处理复杂的冠状动脉病变，80.8%的桡动脉和82.4%尺动脉的血管直径大于7F指引导管外径。
患者舌下含服硝苯地平15分钟后通过血管超声检查发现桡动脉与尺动脉血管直径均明显增大，桡动脉在服药前、服药后5分钟、服药后15分钟时的血管直径分别为2.71±0.53mm、2.78±0.51mm、2.89±0.54mm,服药后桡动脉直径明显增大（P=0.001）；尺动脉在服药前，服药后5分钟、服药后15分钟时的血管直径分别为2.72±0.55mm、2.79±0.50mm、2.91±0.53mm，尺动脉血管直径在服药后明显增大（P=0.001）。
穿刺过程中硝苯地平组患者前臂动脉痉挛的发生率较对照组低（8.4%vs.15.9%，P=0.026），手术操作过程中硝苯地平组患者前臂动脉痉挛发生率也低于对照组（5.1%vs.11.7%，P=0.022）。应用多变量Logistic回归分析探讨穿刺过程中前臂动脉痉挛的危险因素及保护因素，结果显示女别、吸烟、服用β受体阻滞剂、穿刺时间大于80秒为促使前臂动脉发生的危险因素，而术前服用硝苯地平是前臂动脉痉挛的保护性因素(OR0.178,95%CI0.040to0.784, P=0.023)。
小结：
1尺动脉与桡动脉有着相似的血管形态结构，其血管直径与管腔面积与桡动脉无明显差异，同样具备了作为冠状动脉介入治疗的入径血管条件。
2血管活性药物可增加血管直径及管腔面积，预防血管痉挛发作，有利于动脉穿刺与导管操作。第二部分非选择人群中经尺动脉入径冠状动脉介入治疗的可行性与安
全性的对照研究
目的：本研究通过在连续的非选择人群中，随机分组，比较经桡动脉入径与经尺动脉入径冠状动脉介入治疗时的入径血管穿刺成功率,手术操作的成功率及术后并发症的发生率的差别，评价经尺动脉入径冠状动脉介入治疗操作的可行性及安全性。
方法：连续入选于河北医科大学第二医院心内五科行冠状动脉造影及介入治疗的患者，随机分成桡动脉组和尺动脉组。主要终点为桡动脉和尺动脉血管穿刺成功率，手术操作成功率以及入径相关的并发症的发生率。入径相关并发症包括前臂局部血肿，桡动脉和尺动脉血管的闭塞，动静脉瘘，假性动脉瘤，神经损伤。次要终点包括桡动脉和尺动脉血管穿刺次数，穿刺时间，手术操作时间，X线透视时间及随访期间的主要不良心血管事件，包括死亡，非致命性心肌梗死，再发心肌缺血，紧急靶血管重建等。
结果：2012年3月至2013年2月，535名在我科行冠状动脉造影及介入治疗的患者，随机分为尺动脉组（271例）和桡动脉组（264例）。两组患者在年龄、性别、体重指数、冠心病危险因素、临床表现、疾病分布、药物治疗上差异无统计学意义。桡动脉穿刺置管成功率为95.1%，尺动脉穿刺置管成功率为91.5%，两组比较差异无统计学意义（P=0.141）。尺动脉组的平均穿刺次数多于桡动脉组（1.6±0.9vs.1.4±0.7，P=0.004），差异有统计学意义。尺动脉组与桡动脉组一次穿刺成功率为（72%vs.86.4%，P<0.001），尺动脉组低于桡动脉组，两组比较差异有统计学意义。在穿刺时间上，尺动脉组的穿刺时间明显长于桡动脉组（142±71s vs.119±63s，P<0.001）。动脉穿刺成功后两组患者均顺利完成冠状动脉造影检查，桡动脉组与尺动脉组患者介入治疗的手术操作成功率无明显差异（97.8%vs.96.2%, P=0.644）。两组患在手术操作时间，X线透视时间上差异无统计学意义。通过前臂动脉造影发现尺动脉解剖变异少于桡动脉（1.9%vs.6.0%,P<0.001）。前臂局部血肿是主要的入径相关的并发症，本研究中尺动脉组前臂局部血肿的发生率较桡动脉组有增高的趋势，但两组比较差异无统计学意义（7.7%vs.4.2%, P=0.100），所有前臂局部血肿经保守治疗后均好转，无需外科手术治疗。尺动脉组1例患者术后出现手部感觉及运动障碍本研究中未发现动静脉瘘及假性动脉瘤的发生。尺动脉组3例患者及桡动脉组8例患者术后出现入径血管闭塞，两组比较差异无统计学意义（P=0.137），尺动脉组26例患者及桡动脉组31例患者术后出现入径血管狭窄，但均没有出现手部缺血症状。尺动脉组患者无心血管事件生存率为90.6%，桡动脉组为91.3%，两组比较差异无统计学意义（P=0.985）。小论：
1在连续的非选择人群中经尺动脉入径行冠状动脉介入治疗操作与经桡动脉入径无明显差异，尺动脉可随时作为冠状动脉介入治疗的入径血管选择。
2与桡动脉入径相比，经尺动脉入径冠状动脉介入治疗不增加术后局部并发症的发生率。
第三部分血管扩张药物对前臂动脉血管与导管相容性的影响及其临床意义
目的：本研究通过血管扩张药物干预下应用7F指引导管与应用6F指引导管经前臂动脉入径治疗复杂冠状动脉分叉病变，比较两组患者的动脉鞘管置入成功率，手术操作成功率，手术操作时间，X线透视时间，及术后入径血管闭塞发生率，前臂血肿发生率，评价血管扩张药物干预下应用7F指引导管经前臂动脉入径治疗复杂冠状动脉分叉病变的可行性及安全性。
方法：入选于河北医科大学第二医院心内五科行冠状动脉介入治疗的患者。入选条件1：患者有心绞痛症状或心肌缺血的临床证据，2：冠状动脉造影示分叉病变，并且适合介入治疗，3：分支血管较大，直径2.0mm以上，预计分支需要植入支架或行球囊对吻操作。符合入选条件的患者根据1:1原则随机分配到6F指引导管组和7F指引导管组。观察两组患者动脉鞘管置入的成功率，手术操作成功率，手术操作时间， X线透视时间，造影剂用量，以及术后入径血管闭塞发生率，前臂局部血肿发生率随访期间主要不良心血管事件。随访期间主要不良心血管事件包括死亡，再发心绞痛，急性心肌梗死，靶病变重建。
结果：2012年1月至2013年10月，于河北医科大学第二医院心内五科行冠状动脉造影，符合入选标准的112例冠心病患者入选本研究。入选患者随机分为6F指引导管组57人，7F指引导管组55人。6F指引导管组有2例患者为左主干病变，由于手术操作的要求，换用7F指引导管进行手术操作。两组患者在年龄、性别、体重指数、危险因素、临床表现、住院时间等方面差异无统计学意义。两组患者在冠状动脉造影手术操作时间，造影剂用量等方面差异无统计学意义，两组患者的分叉病变类型，分叉病变部位分布上差异无统计学意义。7F指引导管组患者均成功完成了动脉鞘管的置换。两组患者均成功接受了冠状动脉介入手术治疗。在手术操作时间上，6F指引导管组为60±10.7min，7F指引导管组为52±9.2min，两组患者在手术操作时间上比较差异有统计学意义（P<0.001）。6F指引导管组与7F指引导管组在指引导管到位时间上无明显差异（2.2±0.7min vs.2.4±0.9min，P=0.109），说明指引导管从鞘管至冠状动脉开口的操作时间上两组比较无明显差异，7F指引导管进入升主动脉后往往需要普通导丝引导。在指引导管选择上，7F指引导管组倾向于选择Judkins系列导管，占63.7%，而6F指引导管组更倾向于支撑力较强的EBU系列导管，占71.9%，右冠状动脉选择SAL指引导管，占14.0%。
6F指引导管组和7F指引导管组在球囊对吻操作上无明显差别（84.2%vs.90.9%，P=0.432），但术中6F指引导管组球囊应用数量比7F指引导管组明显增多。在X线透视时间上7F指引导管组为24±8.2min，比6F指引导管组28±9.4min短，差异有统计学意义（P=0.018）。在造影剂用量方面，7F指引导管组为152±25.8ml，6F指引导管组为158±23.5ml，两组比较差异无统计学意义（P=0.201）。术后2天6F指引导管组和7F指引导管组入径血管闭塞的发生率为（3.5%vs.7.2%，P=0.434），两组比较差异无统计学意义。术后30天入径血管闭塞的发生率（1.8%vs.3.6%，P=0.615）差异无统计学意义。两组患者术后均无手部缺血的临床表现。
小结：
1前臂动脉局部应用血管扩张药物后，增加了血管与导管的相容性，可允许大于血管直径的鞘管置入。
2经前臂动脉入径应用7F指引导管处理复杂冠状动脉分叉病变可减少手术操作时间，减少X线透视时间，减少术中球囊的应用。
3经前臂动脉入径应用7F指引导管行冠状动脉介入治疗，未增加术后前臂动脉闭塞的发生率及前臂血肿的发生率。
The minimal invasion and the largest clinical benefits are the principlesof modern percutaneous coronary intervention (PCI). The safety and feasibilityof transradial angiography was first introduced by Campeau in1989. Onlythree years later, in1992, Kiemeneij performed the first coronary angioplastyvia radial approach, and the era of transradial approach PCI was beginning.Radial artery approach had shown many advantages over the conventionalfemoral and brachial approaches due to the lower incidence of vascularcomplications, more rapid ambulation, greater postprocedural comfort andcost effectiveness. The results of RIVAL， RIFLE-STEACS andSTEMI-RADIAL showed lower complications via transradial artery approachcompared with those via femoral artery approach in PPCI. The mortality ofSTEMI patients was also decreased via transradial artery approach in PPCI.
Many researches about transforearm artery appoach PCI were reported,but few of researches mentioned about anatomical features of forearm artery.Learning and mastering anatomical features of forearm artery is helpful tooptimize access artery selection. The status of constriction or relaxation offorearm artery is also a influence factor for transforearm artery appoach PCI.Forearm artery spasm is one of the complications of transforearm arteryapproach PCI and it maybe lead to failure of artery puncture, forearm pain,and failure of PCI procedure. So it is necessary to discover preventive strategyabout forearm artery, and that maybe improve the success rate of the PCIprocedure and reduce complications.
The transradial approach is not suitable for5–15%of patients for reasonsincluding an abnormal Allen’s test, significant anatomical variations such asloops and tortuousness, artery stenosis, hypoplasia, aberrant origin, andvasospasm leading to radial artery access failure. The ulnar artery which is one of the two branches of the brachial artery has similar anatomic characteristicswith radial artery and it may be as a potential approach for coronarycatheterization. Few of studies were concerned about transulnar arteryapproach and the results were inconsistent. Ulnar artery as a routine accessartery for PCI needs to be researched.
More of complex lesions were treated by PCI procedure while the PCItechnique was developing and mature. Most of PCI procedures could beperformed via forearm artery approach. The bottleneck problem of forearmartery approach was whether a7F guiding catheter would be used in PCI viaforearm artery approach. Although most experienced ‘‘radialists’’ couldperform complex interventions using a6F guiding catheter via forearm arteryapproach, but they still to face the difficult of operation and increase the riskof procedure. Femoral artery will be chosen when a large bore guidingcatheter was needed to perform bifurcation stenting, large burr rotationalatherectomy, and complex CTO procedure interventions. The research ofsafety and feasibility about7F guiding catheter via transforearm arteryapproach to perform PCI was fewer, so it was need to further evaluate.
The study consists of three parts, part I was to investigate the anatomicalfeatures of forearm artery with ultrasound and evaluate the preventive effectsof nifedipine to forearm artery spasm during percutaneous coronaryintervention. Part II was to evaluate the safety and feasibility of transulnarapproach as a default access for coronary catheterization compared withtransradial approach. Part III was to evaluate the safety and feasibility of7Fguiding catheter via transforearm artery approach to treat complex bifurcationlesions.
Part I The anatomical features of forearm artery and the effect ofvasoactive agent on the status of constriction or relaxation offorearm artery
Objective: To investigate the anatomical features of forearm artery byultrasound and evaluate the effect of vasoactive agent on the status ofconstriction or relaxation of forearm artery, and the preventive effects of nifedipine on forearm artery spasm during PCI.
Methods: Patients who admitted to the cardiology department of theSecond Hospital of Hebei Medical University for angiography or angioplastywere randomly assigned to control group or nifedipine group.
The diameter of forearm artery, the cross sectional area of forearm artery,the peak flow velocity, and the depth of forearm artery were measured for allof patients using Terason T3000Ultrasound system. Patients assigned tonifedipine group were sub-lingual administrated10mg nifedipine20minutesbefore procedure. The diameter of forearm artery and the cross sectional areaof forearm artery were measured at time of5minutes,15minutes afteradministration of nifedipine for patients in nifedipine group using TerasonT3000Ultrasound system. Patients assigned to control group were givenroutine preparation. Forearm artery spasm during puncture or procedure wasrecorded.
Results: Between March2012and March2013, a total of428patientswere enrolled into our study. The mean diameter of radial artery was2.70±0.52mm, and the mean diameter of ulnar artery was2.71±0.54mm,There was no significant difference in diameter between radial artery andulnar artery (P=0.781). The mean diameter of radial artery in male was largerthan that in female (2.75±0.45mm vs.2.54±0.41mm, P<0.05), and the meandiameter of ulnar artery in male was larger than that in female (2.76±0.47mmvs.2.55±0.44mm, P<0.05). There was also no significant difference in crosssectional area between radial artery and ulnar artery (5.08±1.62mm2vs.5.12±1.68mm2, P=0.723). The anatomical position of ulnar artery was deeperthan radial artery (4.16±1.72mm vs.6.24±1.88mm, P<0.001). The6F guidingcatheter was the major guiding selection in transforearm artery approach PCI.The94.6%of radial artery diameter and95.8%of ulnar artery diameter arelarger than the out diameter of6F guiding catheter, and the80.8%of radialartery diameter and82.4%of ulnar artery diameter are larger than the outdiameter of7F guiding catheter. The diameters of radial and ulnar artery wereincreased after patients administrated of nifedipine. The mean diameter of radial artery was2.71±0.53mm,2.78±0.51mm, and2.89±0.54mm at time ofbefore administrated of nifedipine,5minutes administrated of nifedipine, and15minutes administrated of nifedipine (P=0.001). The mean diameter of ulnarartery was2.72±0.55mm,2.79±0.50mm, and2.91±0.53mm at time of beforeadministrated of nifedipine,5minutes administrated of nifedipine, and15minutes administrated of nifedipine (P=0.001). The incidence of forearmartery spasm during puncture was lower in patients administrated of nifedipinecompared with patients in control group (8.4%vs.15.9%，P=0.026). Therewas also lower incidence of forearm artery spasm during procedure innifedipine group compared with control group (5.1%vs.11.7%，P=0.022).The result of logistic analysis was shown that female, smoking, puncturetime>80s, and oralβreceptor blocker were risk factor of spasm duringpuncture, and oral nifedipine was protective factor of spasm during puncture.
Conclusions:
1The artery diameter and cross sectional area are similar between radialartery and ulnar artery, so the ulnar artery may be a potential access artery forPCI.
2The forearm artery can be dilated by nifedipine which can also producepreventive effects on forearm artery spasm during PCI.
Part II Safety and feasibility of transulnar versus transradial arteryapproach for coronary catheterization in non-selective patients
Objective: To evaluate the safety and feasibility of transulnar arteryapproach for coronary catheterization in non-selective patients by comparingaccess-artery cannulation, interventional procedure and complications withtransradial approach.
Methods: Patients who admitted to the cardiology department of theSecond Hospital of Hebei Medical University for angiography or angioplastywere randomly assigned to transulnar approach group (TUA group) ortransradial approach group (TRA group). The primary endpoints of study werethe rate of successful artery cannulation, the rate of successful procedure andthe access-site related complications including of the occurrence of hematoma, artery stenosis, artery occlusion, arteriovenous fistula, pseudoaneurysm, andnerve injury. The secondary endpoints included the number of needlepunctures, the time of punctures, total time for the procedure, total time underfluoroscopy, and major adverse cardiac events (MACE) during follow up.
Results: Between March2012and February2013, a total of535consecutive patients were randomly assigned to a transulnar approach group(271) or transradial approach group (264) upon arrival at the catheterizationlaboratory. There were no significant differences between the two groups interms of age, gender, body mass index, risk factors, distribution of disease,and medication. Successful puncture of the objective artery was obtained in91.5%of the patients in the transulnar approach group, and95.1%of thepatients in the transradial approach group (P>0.141). More punctures wererequired in the TUA group than in the TRA group (1.6±0.9vs.1.4±0.7，P=0.004). The rate of one time puncture success was72.0%in the TUA groupand86.4%in the TRA group (P<0.001). The time from first puncture to sheathinsertion was longer in the TUA group compared with the TRA group(142±71s vs.119±63s，P<0.001). The rate of successful PCI procedure was nosignificant difference between the two groups (97.8%vs.96.2%, P=0.644).Less anatomical variations were observation in ulnar artery compared withradial artery (1.9%vs.6.0%, P<0.001). There was no significant difference inhematoma complications between the two groups (7.7%vs.4.2%, P=0.100). Amotor abnormality of the hand was observed in one patient in the ulnar groupwhich was considered to be a nerve injury caused by local hematoma. Therewere no arteriovenous fistula or pseudoaneurysm observed in our study. Three(1.1%) patients in the TUA group and8(3.0%) patients in the TRA group hadocclusion of the access artery after procedure (P=0.137), Access arterystenosis was observed in26patients (9.6%) in the TUA group and31patients(11.7%) in the TRA group after procedure, but none of the patients hadsymptoms or signs of hand ischemia. There were no significant differences inMACE between the two groups during follow-up.
Conclusion: The transulnar approach is an effective and safe technique for coronary catheterization in non-selective patients.
Part III The effect and clinical significance of vasodilate agent on thecompatibility between forearm arteries and guiding catheter
Objective: To evaluate the safety and feasibility of preproceduralvasoactive agent and using7F guiding catheter via transforearm arteryapproach to treat complex bifurcation lesions. The rate of successful arterialsheath placement, the rate of successful procedure, procedure time, X-rayfluoroscopy time, and contrast dosage were compared between two groups ofpatients. In order to evaluate the safety of7F guiding catheter, access arteryocclusion and the incidence of forearm hematoma were also comparedbetween two groups of patients after procedure.
Methods: Patients who admitted to the cardiology department of theSecond Hospital of Hebei Medical University for angiography were screened,the inclusion criteria was following,1: Patients with angina pectoris ormyocardial ischemia evidence,2: Bifurcation lesions were found duringcoronary angiography and the lesion were suitable for interventional treatment,3: The diameter of branch vessels is2.0mm or more, and the branch vesselswould be required placing stents or kissing balloon procedure. Patients whomet these inclusion criteria were enrolled into the current study and wererandomly assigned to6F guiding catheter group or7F guiding catheter groupaccording to the principle of1:1ratio. The rate of successful arterial sheathplacement, the rate of successful procedure, procedure time, X-rayfluoroscopy time, and contrast dosage were observed. Access artery occlusion,major adverse cardiac events (MACE) and the incidence of forearm hematomawere also observed after procedure. Death, recurrent angina, acute myocardialinfarction, target lesion revascularization, and emergency CABG wereconsidered as MACE.
Results: Between January2012and October2013, a total of112patientswho met the inclusion criteria were randomly assigned to6-Fr guidingcatheter group (57patients) or7F guiding catheter group (55patients). Therewere2patients in6F guiding catheter group crossover to7F guiding catheter group due to the need of procedure. There were no significant differencesbetween the two groups in terms of age, gender, body mass index, risk factors,clinical presentation, and hospitalization. There were also no significantdifferences between two groups with regard to the time of angiographyprocedure, contrast volume, bifurcation distribution. All patients were receivedsuccessful interventional procedure. The time of angioplasty procedure waslonger in6F guiding catheter group compared with7F guiding catheter group(60±10.7min vs.52±9.2min， P<0.001). The time of guiding cathetercannulation was no significant difference between two groups (2.2±0.7min vs.2.4±0.9min，P=0.109). There was no significant difference in the procedure offinal kissing (84.2%vs.90.9%，P=0.432). There were more balloons used in6F group compared with7F group. The mean time of X-ray fluoroscopy was24±8.2minutes in7F guiding catheter group and28±9.4minutes in6Fguiding catheter group (P=0.018). There was no significant difference in theuse of contrast. Access artery occlusion was observed in3.5%of patients in6Fguiding catheter group and7.2%of patients in7F guiding catheter group2days after procedure (P=0.434). At30days after procedure, Access arteryocclusion was observed in1.8%of patients in6F guiding catheter group and3.6%of patients in7F guiding catheter group (P=0.615). There was no handischemia observed in both groups of patients.
Conclusions:
16F sheath catheter can be replaced to7F sheath catheter underpreprocedural vasoactive agent.
27F guiding catheters are feasible to treat complex bifurcation lesionsvia transforearm artery approach.
3The use of7F guiding catheter will not increase the incidence of accessartery occlusion and forearm hematoma.
虽然目前关于经前臂动脉入径冠状动脉介入治疗的研究较多，但关于前臂动脉血管解剖结构特点的相关研究较少，全面了解和掌握前臂动脉血管解剖结构特点，有助于术者在冠状动脉介入治疗时进行优化的血管入径选择。前臂动脉血管的舒缩状态也是影响前臂动脉入径使用的重要因素。前臂动脉痉挛是经前臂动脉入径冠状动脉介入治疗过程中主要并发症之一，前臂动脉痉挛可引起动脉穿刺失败，患者前臂疼痛，影响手术操作甚至无法完成手术。因此有必要寻找有效的措施预防前臂动脉痉挛的发生，提高经前臂动脉入径冠状动脉手术操作的成功率，并减少围手术期并发症的发生率。
临床上由于Allen试验异常，桡动脉血管环，严重迂曲，桡动脉发育细小，起源异常，桡动脉痉挛，桡动脉穿刺失败等原因，使得临床约有5-15%患者不适合经桡动脉入径行冠状动脉介入治疗操作。尺动脉作为肱动脉的两大分支之一，与桡动脉有着相似的解剖结构特点，理论上也可作为冠状动脉介入治疗操作的入径血管选择，但经尺动脉入径冠状动脉介入治疗的相关研究较少，结果也不一致，其作为冠状动脉介入治疗操作的常规入径血管仍需要进一步的评价。
随着冠状动脉介入治疗技术的不断完善成熟，冠状动脉介入治疗的适应症也逐步扩展，近年来一些复杂的冠状动脉病变也开始通过介入技术进行治疗。目前存在的主要瓶颈问题是能否经前臂动脉入径应用7F指引导管进行复杂冠状动脉介入手术操作，因为当面对复杂冠状动脉病变时，如复杂的分叉病变，严重钙化需要进行旋磨操作，复杂的CTO（Chronic TotalOcclusion）术式等，应用6F指引导管处理上述复杂病变时将面临手术操作困难，器械无法通过，增加手术风险等问题。由于前臂动脉血管细小，当需要应用7F指引导管进行手术操作时术者往往选择股动脉入径，目前关于经前臂动脉入径应用7F指引导管行冠状动脉介入治疗的相关研究较少，需要进一步的进行临床研究评价7F指引导管经前臂动脉入径冠状动脉介入治疗的可行性及安全性。
本研究分为三个部分：第一部分通过应用高频血管超声测量前臂动脉血管直径，管腔面积及血流速度，以及前臂动脉血管的皮下距离，并进行桡动脉与尺动脉解剖结构的比较，评价经尺动脉入径冠状动脉介入治疗在解剖学上的可行性，并观察硝苯地平对前臂动脉血管舒缩状态的影响及其对前臂动脉痉挛的预防作用。第二部分通过与桡动脉入径进行比较，评价在非选择人群中经尺动脉入径冠状动脉介入治疗的可行性及安全性。第三部分探讨在血管扩张药物的干预下经前臂动脉入径应用7F指引导管处理复杂冠状动脉分叉病变的可行性及安全性。
第一部分前臂动脉血管结构特点及血管活性药物对其舒缩状态的影响
目的：本研究通过高频血管超声测量前臂动脉血管直径，管腔面积及收缩期峰血流速度以及前臂动脉血管的皮下距离，并进行桡动脉与尺动脉解剖结构的比较，评价经尺动脉入径冠状动脉介入治疗在解剖学上的可行性；并观察血管活性药物硝苯地平对前臂动脉血管的扩张作用及对术中痉挛的预防作用。
方法：入选于河北医科大学第二医院心内五科欲行冠状动脉造影检查及介入治疗的患者。术前采用美国产Terason T3000便携式彩色超声影像系统，12L5A型探头，探头频率5～12MHz可调，进行前臂动脉超声检查。分别测量桡动脉与尺动脉血管的直径及管腔面积，前臂动脉血管的皮下距离，采用脉冲多普勒测量前臂动脉收缩期峰血流速度。
入选患者随机分为硝苯地平组和对照组，硝苯地平组患者于术前20分钟舌下含服硝苯地平片10毫克，于含药前，含药后5分钟及含药后15分钟重复测量患者前臂动脉血管直径及管腔面积等参数。对照组患者按常规术前准备进行。记录前臂动脉穿刺过程中及手术操作过程中前臂动脉痉挛的发生率。
结果：自2012年3月至2013年3月共入选428例行冠状动脉造影及冠状动脉介入治疗的患者。通过高频血管超声检查，测得患者右侧桡动脉血管的平均直径为2.70±0.52mm，右侧尺动脉血管的平均直径为2.71±0.54mm，桡动脉与尺动脉血管直径比较无明显差异（P=0.781），男性桡动脉血管直径明显大于女性桡动脉血管直径（2.75±0.45mm vs.2.54±0.41mm, P<0.05），男性尺动脉血管直径明显大于女性尺动脉血管直径（2.76±0.47mm vs.2.55±0.44mm, P<0.05）。桡动脉血管与尺动脉血管的横截面积比较无明显差异（5.08±1.62mm2vs.5.12±1.68mm2, P=0.723）。桡动脉的皮下距离为4.16±1.72mm，尺动脉的皮下距离为6.24±1.88mm，尺动脉的解剖位置明显比桡动脉解剖位置深（P<0.001）。6F指引导管是经前臂动脉入径冠状动脉介入治疗时的主要导管选择，94.6%桡动脉血管直径和95.8%尺动脉血管直径大于6F指引导管的外径，7F指引导管常用于处理复杂的冠状动脉病变，80.8%的桡动脉和82.4%尺动脉的血管直径大于7F指引导管外径。
患者舌下含服硝苯地平15分钟后通过血管超声检查发现桡动脉与尺动脉血管直径均明显增大，桡动脉在服药前、服药后5分钟、服药后15分钟时的血管直径分别为2.71±0.53mm、2.78±0.51mm、2.89±0.54mm,服药后桡动脉直径明显增大（P=0.001）；尺动脉在服药前，服药后5分钟、服药后15分钟时的血管直径分别为2.72±0.55mm、2.79±0.50mm、2.91±0.53mm，尺动脉血管直径在服药后明显增大（P=0.001）。
穿刺过程中硝苯地平组患者前臂动脉痉挛的发生率较对照组低（8.4%vs.15.9%，P=0.026），手术操作过程中硝苯地平组患者前臂动脉痉挛发生率也低于对照组（5.1%vs.11.7%，P=0.022）。应用多变量Logistic回归分析探讨穿刺过程中前臂动脉痉挛的危险因素及保护因素，结果显示女别、吸烟、服用β受体阻滞剂、穿刺时间大于80秒为促使前臂动脉发生的危险因素，而术前服用硝苯地平是前臂动脉痉挛的保护性因素(OR0.178,95%CI0.040to0.784, P=0.023)。
小结：
1尺动脉与桡动脉有着相似的血管形态结构，其血管直径与管腔面积与桡动脉无明显差异，同样具备了作为冠状动脉介入治疗的入径血管条件。
2血管活性药物可增加血管直径及管腔面积，预防血管痉挛发作，有利于动脉穿刺与导管操作。第二部分非选择人群中经尺动脉入径冠状动脉介入治疗的可行性与安
全性的对照研究
目的：本研究通过在连续的非选择人群中，随机分组，比较经桡动脉入径与经尺动脉入径冠状动脉介入治疗时的入径血管穿刺成功率,手术操作的成功率及术后并发症的发生率的差别，评价经尺动脉入径冠状动脉介入治疗操作的可行性及安全性。
方法：连续入选于河北医科大学第二医院心内五科行冠状动脉造影及介入治疗的患者，随机分成桡动脉组和尺动脉组。主要终点为桡动脉和尺动脉血管穿刺成功率，手术操作成功率以及入径相关的并发症的发生率。入径相关并发症包括前臂局部血肿，桡动脉和尺动脉血管的闭塞，动静脉瘘，假性动脉瘤，神经损伤。次要终点包括桡动脉和尺动脉血管穿刺次数，穿刺时间，手术操作时间，X线透视时间及随访期间的主要不良心血管事件，包括死亡，非致命性心肌梗死，再发心肌缺血，紧急靶血管重建等。
结果：2012年3月至2013年2月，535名在我科行冠状动脉造影及介入治疗的患者，随机分为尺动脉组（271例）和桡动脉组（264例）。两组患者在年龄、性别、体重指数、冠心病危险因素、临床表现、疾病分布、药物治疗上差异无统计学意义。桡动脉穿刺置管成功率为95.1%，尺动脉穿刺置管成功率为91.5%，两组比较差异无统计学意义（P=0.141）。尺动脉组的平均穿刺次数多于桡动脉组（1.6±0.9vs.1.4±0.7，P=0.004），差异有统计学意义。尺动脉组与桡动脉组一次穿刺成功率为（72%vs.86.4%，P<0.001），尺动脉组低于桡动脉组，两组比较差异有统计学意义。在穿刺时间上，尺动脉组的穿刺时间明显长于桡动脉组（142±71s vs.119±63s，P<0.001）。动脉穿刺成功后两组患者均顺利完成冠状动脉造影检查，桡动脉组与尺动脉组患者介入治疗的手术操作成功率无明显差异（97.8%vs.96.2%, P=0.644）。两组患在手术操作时间，X线透视时间上差异无统计学意义。通过前臂动脉造影发现尺动脉解剖变异少于桡动脉（1.9%vs.6.0%,P<0.001）。前臂局部血肿是主要的入径相关的并发症，本研究中尺动脉组前臂局部血肿的发生率较桡动脉组有增高的趋势，但两组比较差异无统计学意义（7.7%vs.4.2%, P=0.100），所有前臂局部血肿经保守治疗后均好转，无需外科手术治疗。尺动脉组1例患者术后出现手部感觉及运动障碍本研究中未发现动静脉瘘及假性动脉瘤的发生。尺动脉组3例患者及桡动脉组8例患者术后出现入径血管闭塞，两组比较差异无统计学意义（P=0.137），尺动脉组26例患者及桡动脉组31例患者术后出现入径血管狭窄，但均没有出现手部缺血症状。尺动脉组患者无心血管事件生存率为90.6%，桡动脉组为91.3%，两组比较差异无统计学意义（P=0.985）。小论：
1在连续的非选择人群中经尺动脉入径行冠状动脉介入治疗操作与经桡动脉入径无明显差异，尺动脉可随时作为冠状动脉介入治疗的入径血管选择。
2与桡动脉入径相比，经尺动脉入径冠状动脉介入治疗不增加术后局部并发症的发生率。
第三部分血管扩张药物对前臂动脉血管与导管相容性的影响及其临床意义
目的：本研究通过血管扩张药物干预下应用7F指引导管与应用6F指引导管经前臂动脉入径治疗复杂冠状动脉分叉病变，比较两组患者的动脉鞘管置入成功率，手术操作成功率，手术操作时间，X线透视时间，及术后入径血管闭塞发生率，前臂血肿发生率，评价血管扩张药物干预下应用7F指引导管经前臂动脉入径治疗复杂冠状动脉分叉病变的可行性及安全性。
方法：入选于河北医科大学第二医院心内五科行冠状动脉介入治疗的患者。入选条件1：患者有心绞痛症状或心肌缺血的临床证据，2：冠状动脉造影示分叉病变，并且适合介入治疗，3：分支血管较大，直径2.0mm以上，预计分支需要植入支架或行球囊对吻操作。符合入选条件的患者根据1:1原则随机分配到6F指引导管组和7F指引导管组。观察两组患者动脉鞘管置入的成功率，手术操作成功率，手术操作时间， X线透视时间，造影剂用量，以及术后入径血管闭塞发生率，前臂局部血肿发生率随访期间主要不良心血管事件。随访期间主要不良心血管事件包括死亡，再发心绞痛，急性心肌梗死，靶病变重建。
结果：2012年1月至2013年10月，于河北医科大学第二医院心内五科行冠状动脉造影，符合入选标准的112例冠心病患者入选本研究。入选患者随机分为6F指引导管组57人，7F指引导管组55人。6F指引导管组有2例患者为左主干病变，由于手术操作的要求，换用7F指引导管进行手术操作。两组患者在年龄、性别、体重指数、危险因素、临床表现、住院时间等方面差异无统计学意义。两组患者在冠状动脉造影手术操作时间，造影剂用量等方面差异无统计学意义，两组患者的分叉病变类型，分叉病变部位分布上差异无统计学意义。7F指引导管组患者均成功完成了动脉鞘管的置换。两组患者均成功接受了冠状动脉介入手术治疗。在手术操作时间上，6F指引导管组为60±10.7min，7F指引导管组为52±9.2min，两组患者在手术操作时间上比较差异有统计学意义（P<0.001）。6F指引导管组与7F指引导管组在指引导管到位时间上无明显差异（2.2±0.7min vs.2.4±0.9min，P=0.109），说明指引导管从鞘管至冠状动脉开口的操作时间上两组比较无明显差异，7F指引导管进入升主动脉后往往需要普通导丝引导。在指引导管选择上，7F指引导管组倾向于选择Judkins系列导管，占63.7%，而6F指引导管组更倾向于支撑力较强的EBU系列导管，占71.9%，右冠状动脉选择SAL指引导管，占14.0%。
6F指引导管组和7F指引导管组在球囊对吻操作上无明显差别（84.2%vs.90.9%，P=0.432），但术中6F指引导管组球囊应用数量比7F指引导管组明显增多。在X线透视时间上7F指引导管组为24±8.2min，比6F指引导管组28±9.4min短，差异有统计学意义（P=0.018）。在造影剂用量方面，7F指引导管组为152±25.8ml，6F指引导管组为158±23.5ml，两组比较差异无统计学意义（P=0.201）。术后2天6F指引导管组和7F指引导管组入径血管闭塞的发生率为（3.5%vs.7.2%，P=0.434），两组比较差异无统计学意义。术后30天入径血管闭塞的发生率（1.8%vs.3.6%，P=0.615）差异无统计学意义。两组患者术后均无手部缺血的临床表现。
小结：
1前臂动脉局部应用血管扩张药物后，增加了血管与导管的相容性，可允许大于血管直径的鞘管置入。
2经前臂动脉入径应用7F指引导管处理复杂冠状动脉分叉病变可减少手术操作时间，减少X线透视时间，减少术中球囊的应用。
3经前臂动脉入径应用7F指引导管行冠状动脉介入治疗，未增加术后前臂动脉闭塞的发生率及前臂血肿的发生率。
The minimal invasion and the largest clinical benefits are the principlesof modern percutaneous coronary intervention (PCI). The safety and feasibilityof transradial angiography was first introduced by Campeau in1989. Onlythree years later, in1992, Kiemeneij performed the first coronary angioplastyvia radial approach, and the era of transradial approach PCI was beginning.Radial artery approach had shown many advantages over the conventionalfemoral and brachial approaches due to the lower incidence of vascularcomplications, more rapid ambulation, greater postprocedural comfort andcost effectiveness. The results of RIVAL， RIFLE-STEACS andSTEMI-RADIAL showed lower complications via transradial artery approachcompared with those via femoral artery approach in PPCI. The mortality ofSTEMI patients was also decreased via transradial artery approach in PPCI.
Many researches about transforearm artery appoach PCI were reported,but few of researches mentioned about anatomical features of forearm artery.Learning and mastering anatomical features of forearm artery is helpful tooptimize access artery selection. The status of constriction or relaxation offorearm artery is also a influence factor for transforearm artery appoach PCI.Forearm artery spasm is one of the complications of transforearm arteryapproach PCI and it maybe lead to failure of artery puncture, forearm pain,and failure of PCI procedure. So it is necessary to discover preventive strategyabout forearm artery, and that maybe improve the success rate of the PCIprocedure and reduce complications.
The transradial approach is not suitable for5–15%of patients for reasonsincluding an abnormal Allen’s test, significant anatomical variations such asloops and tortuousness, artery stenosis, hypoplasia, aberrant origin, andvasospasm leading to radial artery access failure. The ulnar artery which is one of the two branches of the brachial artery has similar anatomic characteristicswith radial artery and it may be as a potential approach for coronarycatheterization. Few of studies were concerned about transulnar arteryapproach and the results were inconsistent. Ulnar artery as a routine accessartery for PCI needs to be researched.
More of complex lesions were treated by PCI procedure while the PCItechnique was developing and mature. Most of PCI procedures could beperformed via forearm artery approach. The bottleneck problem of forearmartery approach was whether a7F guiding catheter would be used in PCI viaforearm artery approach. Although most experienced ‘‘radialists’’ couldperform complex interventions using a6F guiding catheter via forearm arteryapproach, but they still to face the difficult of operation and increase the riskof procedure. Femoral artery will be chosen when a large bore guidingcatheter was needed to perform bifurcation stenting, large burr rotationalatherectomy, and complex CTO procedure interventions. The research ofsafety and feasibility about7F guiding catheter via transforearm arteryapproach to perform PCI was fewer, so it was need to further evaluate.
The study consists of three parts, part I was to investigate the anatomicalfeatures of forearm artery with ultrasound and evaluate the preventive effectsof nifedipine to forearm artery spasm during percutaneous coronaryintervention. Part II was to evaluate the safety and feasibility of transulnarapproach as a default access for coronary catheterization compared withtransradial approach. Part III was to evaluate the safety and feasibility of7Fguiding catheter via transforearm artery approach to treat complex bifurcationlesions.
Part I The anatomical features of forearm artery and the effect ofvasoactive agent on the status of constriction or relaxation offorearm artery
Objective: To investigate the anatomical features of forearm artery byultrasound and evaluate the effect of vasoactive agent on the status ofconstriction or relaxation of forearm artery, and the preventive effects of nifedipine on forearm artery spasm during PCI.
Methods: Patients who admitted to the cardiology department of theSecond Hospital of Hebei Medical University for angiography or angioplastywere randomly assigned to control group or nifedipine group.
The diameter of forearm artery, the cross sectional area of forearm artery,the peak flow velocity, and the depth of forearm artery were measured for allof patients using Terason T3000Ultrasound system. Patients assigned tonifedipine group were sub-lingual administrated10mg nifedipine20minutesbefore procedure. The diameter of forearm artery and the cross sectional areaof forearm artery were measured at time of5minutes,15minutes afteradministration of nifedipine for patients in nifedipine group using TerasonT3000Ultrasound system. Patients assigned to control group were givenroutine preparation. Forearm artery spasm during puncture or procedure wasrecorded.
Results: Between March2012and March2013, a total of428patientswere enrolled into our study. The mean diameter of radial artery was2.70±0.52mm, and the mean diameter of ulnar artery was2.71±0.54mm,There was no significant difference in diameter between radial artery andulnar artery (P=0.781). The mean diameter of radial artery in male was largerthan that in female (2.75±0.45mm vs.2.54±0.41mm, P<0.05), and the meandiameter of ulnar artery in male was larger than that in female (2.76±0.47mmvs.2.55±0.44mm, P<0.05). There was also no significant difference in crosssectional area between radial artery and ulnar artery (5.08±1.62mm2vs.5.12±1.68mm2, P=0.723). The anatomical position of ulnar artery was deeperthan radial artery (4.16±1.72mm vs.6.24±1.88mm, P<0.001). The6F guidingcatheter was the major guiding selection in transforearm artery approach PCI.The94.6%of radial artery diameter and95.8%of ulnar artery diameter arelarger than the out diameter of6F guiding catheter, and the80.8%of radialartery diameter and82.4%of ulnar artery diameter are larger than the outdiameter of7F guiding catheter. The diameters of radial and ulnar artery wereincreased after patients administrated of nifedipine. The mean diameter of radial artery was2.71±0.53mm,2.78±0.51mm, and2.89±0.54mm at time ofbefore administrated of nifedipine,5minutes administrated of nifedipine, and15minutes administrated of nifedipine (P=0.001). The mean diameter of ulnarartery was2.72±0.55mm,2.79±0.50mm, and2.91±0.53mm at time of beforeadministrated of nifedipine,5minutes administrated of nifedipine, and15minutes administrated of nifedipine (P=0.001). The incidence of forearmartery spasm during puncture was lower in patients administrated of nifedipinecompared with patients in control group (8.4%vs.15.9%，P=0.026). Therewas also lower incidence of forearm artery spasm during procedure innifedipine group compared with control group (5.1%vs.11.7%，P=0.022).The result of logistic analysis was shown that female, smoking, puncturetime>80s, and oralβreceptor blocker were risk factor of spasm duringpuncture, and oral nifedipine was protective factor of spasm during puncture.
Conclusions:
1The artery diameter and cross sectional area are similar between radialartery and ulnar artery, so the ulnar artery may be a potential access artery forPCI.
2The forearm artery can be dilated by nifedipine which can also producepreventive effects on forearm artery spasm during PCI.
Part II Safety and feasibility of transulnar versus transradial arteryapproach for coronary catheterization in non-selective patients
Objective: To evaluate the safety and feasibility of transulnar arteryapproach for coronary catheterization in non-selective patients by comparingaccess-artery cannulation, interventional procedure and complications withtransradial approach.
Methods: Patients who admitted to the cardiology department of theSecond Hospital of Hebei Medical University for angiography or angioplastywere randomly assigned to transulnar approach group (TUA group) ortransradial approach group (TRA group). The primary endpoints of study werethe rate of successful artery cannulation, the rate of successful procedure andthe access-site related complications including of the occurrence of hematoma, artery stenosis, artery occlusion, arteriovenous fistula, pseudoaneurysm, andnerve injury. The secondary endpoints included the number of needlepunctures, the time of punctures, total time for the procedure, total time underfluoroscopy, and major adverse cardiac events (MACE) during follow up.
Results: Between March2012and February2013, a total of535consecutive patients were randomly assigned to a transulnar approach group(271) or transradial approach group (264) upon arrival at the catheterizationlaboratory. There were no significant differences between the two groups interms of age, gender, body mass index, risk factors, distribution of disease,and medication. Successful puncture of the objective artery was obtained in91.5%of the patients in the transulnar approach group, and95.1%of thepatients in the transradial approach group (P>0.141). More punctures wererequired in the TUA group than in the TRA group (1.6±0.9vs.1.4±0.7，P=0.004). The rate of one time puncture success was72.0%in the TUA groupand86.4%in the TRA group (P<0.001). The time from first puncture to sheathinsertion was longer in the TUA group compared with the TRA group(142±71s vs.119±63s，P<0.001). The rate of successful PCI procedure was nosignificant difference between the two groups (97.8%vs.96.2%, P=0.644).Less anatomical variations were observation in ulnar artery compared withradial artery (1.9%vs.6.0%, P<0.001). There was no significant difference inhematoma complications between the two groups (7.7%vs.4.2%, P=0.100). Amotor abnormality of the hand was observed in one patient in the ulnar groupwhich was considered to be a nerve injury caused by local hematoma. Therewere no arteriovenous fistula or pseudoaneurysm observed in our study. Three(1.1%) patients in the TUA group and8(3.0%) patients in the TRA group hadocclusion of the access artery after procedure (P=0.137), Access arterystenosis was observed in26patients (9.6%) in the TUA group and31patients(11.7%) in the TRA group after procedure, but none of the patients hadsymptoms or signs of hand ischemia. There were no significant differences inMACE between the two groups during follow-up.
Conclusion: The transulnar approach is an effective and safe technique for coronary catheterization in non-selective patients.
Part III The effect and clinical significance of vasodilate agent on thecompatibility between forearm arteries and guiding catheter
Objective: To evaluate the safety and feasibility of preproceduralvasoactive agent and using7F guiding catheter via transforearm arteryapproach to treat complex bifurcation lesions. The rate of successful arterialsheath placement, the rate of successful procedure, procedure time, X-rayfluoroscopy time, and contrast dosage were compared between two groups ofpatients. In order to evaluate the safety of7F guiding catheter, access arteryocclusion and the incidence of forearm hematoma were also comparedbetween two groups of patients after procedure.
Methods: Patients who admitted to the cardiology department of theSecond Hospital of Hebei Medical University for angiography were screened,the inclusion criteria was following,1: Patients with angina pectoris ormyocardial ischemia evidence,2: Bifurcation lesions were found duringcoronary angiography and the lesion were suitable for interventional treatment,3: The diameter of branch vessels is2.0mm or more, and the branch vesselswould be required placing stents or kissing balloon procedure. Patients whomet these inclusion criteria were enrolled into the current study and wererandomly assigned to6F guiding catheter group or7F guiding catheter groupaccording to the principle of1:1ratio. The rate of successful arterial sheathplacement, the rate of successful procedure, procedure time, X-rayfluoroscopy time, and contrast dosage were observed. Access artery occlusion,major adverse cardiac events (MACE) and the incidence of forearm hematomawere also observed after procedure. Death, recurrent angina, acute myocardialinfarction, target lesion revascularization, and emergency CABG wereconsidered as MACE.
Results: Between January2012and October2013, a total of112patientswho met the inclusion criteria were randomly assigned to6-Fr guidingcatheter group (57patients) or7F guiding catheter group (55patients). Therewere2patients in6F guiding catheter group crossover to7F guiding catheter group due to the need of procedure. There were no significant differencesbetween the two groups in terms of age, gender, body mass index, risk factors,clinical presentation, and hospitalization. There were also no significantdifferences between two groups with regard to the time of angiographyprocedure, contrast volume, bifurcation distribution. All patients were receivedsuccessful interventional procedure. The time of angioplasty procedure waslonger in6F guiding catheter group compared with7F guiding catheter group(60±10.7min vs.52±9.2min， P<0.001). The time of guiding cathetercannulation was no significant difference between two groups (2.2±0.7min vs.2.4±0.9min，P=0.109). There was no significant difference in the procedure offinal kissing (84.2%vs.90.9%，P=0.432). There were more balloons used in6F group compared with7F group. The mean time of X-ray fluoroscopy was24±8.2minutes in7F guiding catheter group and28±9.4minutes in6Fguiding catheter group (P=0.018). There was no significant difference in theuse of contrast. Access artery occlusion was observed in3.5%of patients in6Fguiding catheter group and7.2%of patients in7F guiding catheter group2days after procedure (P=0.434). At30days after procedure, Access arteryocclusion was observed in1.8%of patients in6F guiding catheter group and3.6%of patients in7F guiding catheter group (P=0.615). There was no handischemia observed in both groups of patients.
Conclusions:
16F sheath catheter can be replaced to7F sheath catheter underpreprocedural vasoactive agent.
27F guiding catheters are feasible to treat complex bifurcation lesionsvia transforearm artery approach.
3The use of7F guiding catheter will not increase the incidence of accessartery occlusion and forearm hematoma.
引文
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