摘要
研究背景
分叉病变在所有冠心病介入治疗患者中约占10-20%,其中大部分位于前降支和对角支分叉。由于分叉特殊的解剖特点,分叉病变的介入治疗一直是当今经皮冠状动脉介入治疗(PCI)技术的难点和挑战。虽然药物洗脱支架(DES)的出现提高了分叉病变的治疗效果,但其并没有从根本上解决分叉病变治疗上的困境,冠状动脉分叉病变介入治疗无论在即时造影成功率、住院期间心肌梗死率、还是长期随访的主要心血管病事件发生率(MACE)、再狭窄率和血栓发生率都明显高于非分叉病变。
当前,流行的分叉病变治疗方法是根据分叉部位的病变解剖特征,选择相应的单或双支架置入方式。对于分叉病变,在很多情况下单支架并不能解决问题,为了改善对于这部分病人的介入治疗效果,人们发明了各种针对分叉病变的支架置入方法,这些双支架的术式不仅大多操作复杂,而且其总体效果并不尽人意。分支开口的再狭窄率较高依然是困扰人们的难题。为了解决这一难题,针对分叉病变的专用分叉支架应运而生。近年来,各种新型分叉支架的早期研究资料在各种会议和学术交流中不断被报道。虽然分叉支架研究已取得了一些成绩,但就目前来讲大多数分叉支架还是存在效果不确定、操作复杂、适应症较窄和成功率较低等问题。分叉病变最佳的治疗方法还在讨论和探索中。
目的
为了改善分叉病变的介入治疗效果,我们根据分叉部位的解剖学特点,设计了分支斜面支架。理论上,理想的斜面支架置入既可全面覆盖病变,又可改善分叉部位支架贴壁不良,多层支架重叠等问题,同时也简化了分叉病变操作难度。我们希望这种新型支架能提高分叉病变治疗成功率、改善分叉病变的治疗预后。本研究主要目的是对我们开发的分支斜面支架植入过程进行评价,对分支斜面支架置入在分叉处的定位性能和置入后对再狭窄的影响作一初步了解。为下一步研究打下基础。
方法
一共19只小型猪拟置入分支斜面支架,2只造影后无合适分叉未入选,2只手术过程中死亡,1只饲养过程中死亡。6只小型猪置入分支斜面支架后即刻处死观察支架定位情况,8只小型猪置入10枚分支斜面支架饲养1月后造影观察直径狭窄情况。共计17个冠状动脉分叉分支置入分支斜面支架,主支置入普通支架。我们在分支斜面支架置入过程中评价其推送性能、支架膨胀性能、支架支撑力、支架球囊回撤性能及在支架未释放和释放后支架marker在X线下显影情况。6只小型猪支架置入后即刻解剖评价X线定位评价和解剖定位评价的相关性、观察支架的纵向和轴向定位情况、支架贴壁情况、支架支撑性能、分叉部位是否存在支架重叠或裸区。最后对该支架定位性能进行综合评价。8只小型猪共10个分叉置入10个分支斜面支架,一月后造影,了解其晚期官腔丢失情况、≥50%直径狭窄发生率。分析直径狭窄和支架定位之间的关系。
结果
本实验一共治疗17个分叉病变,所有分叉置入分支斜面支架和主支支架。每个分叉治疗平均耗时34.4±13.2分钟;分支斜面支架的支撑能力、膨胀能力良好。支架推送力比同类普通支架稍差。分支斜面支架上marker在支架打开后显影良好,在支架未打开时显影欠佳。X线确定分支斜面支架定位情况和解剖所见有良好的相关性。在定位性能上,分支斜面支架纵向定位性能良好,放置后分叉解剖显示纵向误差5个分叉＜1.5mm,1个分叉在1.5mm左右。轴向定位功能尚可。分叉解剖显示轴向定位误差2例＜15°,3例在15°-30°之间。1例在31°-45°之间。1月后10个分叉平均直径狭窄25.9%,平均晚期官腔丢失0.65mm,＞50%直径狭窄发生率在20%。两例＞50%直径狭窄发生可能和支架定位偏差相关。
结论
分支斜面支架置入过程简单、成功率高,其在分叉处定位比较准确。初步观察再狭窄率较低。该支架值得进一步研发。
Background
Bifurcation lesions account for 10-20% in the sufferers of in percutaneous coronary intervention (PCI) , most of which are in the bifurcation of anterior descending branch and diagonal branch. For the distinctive anatomy characteristic of bifurcation, the interventional therapy of bifurcation lesions has been a difficulty and challenge for modern PCI technology. Although the usage of drug-eluting stent (DES) improved the treatment effect of bifurcation lesions, the treatment dilemma of bifurcation lesions haven't been changed by the roots, no matter in the success rate of real-time visualization, the incidence of myocardial infarction in hospital, or in the incidence of restenosis and thrombosis, the PCI of bifurcation lesions are clearly higher than non-bifurcation lesions.
Currently, a prevalent treatment for bifurcation lesions is to implant single or double stents according to lesion characteristics of the bifurcation. In order to improve the treatment effect of bifurcation lesions, new technique of stents implantion for bifurcation lesions were invented, most of the techniques among which were difficult to manipulate and hard to be satisfied in whole effect all the time. A high rate of restenosis in the branch still puzzles people. Under these circumstances, some novel dedicated stent for bifurcation were introduced. In recent years, Although the early research on new bifurcation stents was reported in different journals and meetings, most of the bifurcation stents have the uncertain effectiveness, hard manipulation, small adaptation and low success rate. A better treatment method of bifurcation lesions is under discussion and exploration now.
Objective
To improve the intervention effect in bifurcation lesions, we designed an inclined bifurcation stent on the basis of anatomy features of bifurcation lesion. Theoretically, A optimal implantion of inclined bifurcation stent can reduce the incidence of stent malapposition, stent overlap and stent "bare area " at bifurcation position, meanwhile the procedure of therapy will also be simplified too. We hope this novel dedicated stent can improve the success rate of treatment of bifurcation lesions and improve the prognosis of bifurcation lesion. The premier objective of this research is to give a judgment of the implantion process of inclined bifurcation stent, and have a first grasp of the positioning performance of inclined bifurcation stent implantion in branch and the effect on restenosis after being implanted, establishing a groundwork for further research.
Methods
Totally 19 swine planed to implant inclined bifurcation stent, inclined bifurcation stent were implanted in 17 bifurcation lesions. 6 pigs among which were put to death immediately after being implanted to observe the stent positioning status, and 8 swines (10 bifurcation lesions were treated by inclined bifurcation stent) were fed for a month to observe the incidence of restenosis. During the procedure of stent implantion, the propelling movement performance, dilatability performance, holding power, balloon withdraw performance and the visualization of marker under X rays both before and after stent deployment were scored. Observe the positioning status of inclined bifurcation stent in length and cross direction. Finally give an overall evaluation of stent's positioning performance. Coronary angiography was performed after 1 month in 8 swines to learn the late lumen lose, diameter stenosis, the incidence of restenosis and analyse the the relation between restenosis and stent positioning.
Results
A total of 17 bifurcations were treated with inclined bifurcation stent. Each bifurcation treatment cost 34 minutes on the average, the support power and swelling power of inclined bifurcation stent were all right. The propelling power is a little worse than common stent. The marker on the inclined bifurcation bracket was shown well after stent plolyment and was shown a little worse before stent plolyment. There's a good correlation between the positioning status of inclined bifurcation stent fixed by X ray and shown in dissection. The positioning performance of inclined bifurcation brackets is better in length orientation, the errors in which showed there were five bifurcations≤1.5mm and one bifurcation in 1.5mm, While the positioning performance of cross orientation is tolerable. The bifurcation dissection showed that the positional error of two bifurcations was≤15°, three of them was in 15°-30°, and one in 31°-45°.After a month, the average diameter stenosis of 10 bifurcations is 25.9%, the average late lumen lose is 0.65mm, and the incidence of restenosis is 20%. The occurances of restenosis were possibly correlated with position deviation of stent implantion.
Conclusion
The implantion of inclined bifurcation stent has simple procedures, high success rates and a more accurate positioning in branch place. The restenosis rate is low after first observation. This stent is worthy to be researched and developed more.
引文
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