Application of drug-coated balloon in coronary artery intervention： challenges and opportunities

In recent decades, the outcomes of coronary heart disease （CHD） have markedly improved, which can be partly attributed to the use of novel drugs （especially statins and antiplatelet drugs） and partly to the evolution ofpercutaneous coronary intervention （PCI）. From percutaneous transluminal coronary angioplasty to bare-metal stent and then to drug-eluting stent, every step of PCI is attractive to interventional cardiologist, great progress has been made for patients with CHD. In the past few years, some successor devices for treating CHD have cmerged. Undoubtedly, drug-coated balloon （DCB）, which was recommended by 2014 ESC Guidelines on myocardial revascularization, is a ＂shining star＂ among them. DCB involves a semi-compliant angioplasty balloon coated with an anti-proliferative agent that can exert antirestenotic efficacy by permeating into the vessel wall during balloon contact. This review discusses the conception and merits, preclinical data, emerging clinical indications, and results from clinical trials of this novel interventional technology. Although DCB has shown authentic efficacy in the treatment ofin-stent restenosis, its use in de novo coronary lesions is still in dispute. Hence, concerns and the future direction of DCB are also covered in this paper.

A Case Summary of the Application of a Drug-eluting Stent Combined with a Drug-Coated Balloon in Left Main Coronary Artery Disease

Objective:To evaluate the clinical efficacy of a drug-eluting stent(DES)combined with a drug-coated balloon(DCB)in the treatment of left main coronary artery bifurcation lesions.Methods:A retrospective analysis was conducted on the clinical data of eight patients with left main coronary artery bifurcation lesions treated with a DES combined with a DCB who were admitted to our hospital from July 2016 to July 2017.These eight patients all underwent DES treatment for their left main coronary artery and left anterior descending coronary artery lesions,and DCB treatment at the ostium of the left circumflex artery;six of the patients underwent surgical procedures under the guidance of intravascular ultrasonography.Immediate postoperative angiography was used to evaluate the patency of the diseased vessels,and the restenosis rate at the 6-month follow-up after the operation and the incidence of serious clinical events within 6 months were assessed as well.Results:The use of a DES combined with a DCB in the treatment of left main coronary artery bifurcation lesions had a low restenosis rate(left main coronary artery(8.4±5.3)%,left anterior descending coronary artery(18.2±5.0)%,left circumflex artery(30.5±16.5)%).No serious clinical events occurred in any patients.Conclusion:A DES combined with a DCB is a safe and effective interventional treatment for left main artery coro-nary bifurcation lesions.

A simple practical balloon anchoring technique within the guide catheter for chronic total occlusion (CTO) of the coronary artery

Dear Editor： Chronic total occlusions （CTOs） of the coronary artery are commonly encountered complex lesionst11. Percutaneous coronary intervention （PCI） for CTO is technically challenging due to low procedural success ratesTM. Microcatheter is one of the important devices for treatment of CTOTM. It has been widely used attributed to the excellent crossability whenever angula- tion and tortuousity of the coronary artery is encoun- tered. In the process, the microcatheter has to be withdrawn from the guide wire after the wire is proved to locate in the true lumen.

Drug-coated balloons for treating de novo lesions in large coronary vessels:A case report

BACKGROUND Percutaneous transluminal coronary angioplasty,while an effective intervention,can frequently lead to acute occlusion with severe consequences.Although clinical trials have demonstrated the efficacy of drug-coated balloons(DCB)in treating acute coronary artery occlusion and in preventing restenosis,there has been limited exploration on the use of DCB in treating de novo lesions in large vessels.Currently,DCB are only recommended for patients with small vessel lesions and in-stent restenosis lesions,those at high risk of bleeding,and other special groups of patients.CASE SUMMARY This report presents a case of successful drug-coated balloon treatment of de novo lesions in large coronary vessels.Postoperatively,the patient demonstrated favorable recovery,with subsequent examination results revealing no significant differences from the previous examination.CONCLUSION The successful treatment of the patient in our case highlights the potential of DCB in the treatment of de novo lesions in large coronary vessels.

Cut-off values of lesion and vessel quantitative flow ratio in de novo coronary lesion post-drug-coated balloon therapy predicting vessel restenosis at mid-term follow-up

Background:Drug-coated balloons(DCBs)have emerged as potential alternatives to drug-eluting stents in specific lesion subsets for de novo coronary lesions.Quantitative flow ratio(QFR)is a method based on the three-dimensional quantitative coronary angiography and contrast flow velocity during coronary angiography(CAG),obviating the need for an invasive fractional flow reserve procedural.This study aimed to assess the serial angiographic changes of de novo lesions post-DCB therapy and further explore the cut-off values of lesion and vessel QFR,which predict vessel restenosis(diameter stenosis[DS]≥50%)at mid-term follow-up.Methods:The data of patients who underwent DCB therapy between January 2014 and December 2019 from the multicenter hospital were retrospectively collected for QFR analysis.From their QFR performances,which were analyzed by CAG images at follow-up,we divided them into two groups:group A,showing target vessel DS≥50%,and group B,showing target vessel DS<50%.The median follow-up time was 287 days in group A and 227 days in group B.We compared the clinical characteristics,parameters during DCB therapy,and QFR performances,which were analyzed by CAG images between the two groups,in need to explore the cut-off value of lesion/vessel QFR which can predict vessel restenosis.Student's t test was used for the comparison of normally distributed continuous data,Mann-Whitney U test for the comparison of non-normally distributed continuous data,and receiver operating characteristic(ROC)curves for the evaluation of QFR performance which can predict vessel restenosis(DS≥50%)at mid-term follow-up using the area under the curve(AUC).Results:A total of 112 patients with 112 target vessels were enrolled in this study.Group A had 41 patients,while group B had 71.Vessel QFR and lesion QFR were lower in group A than in group B post-DCB therapy,and the cut-off values of lesion QFR and vessel QFR in the ROC analysis to predict target vessel DS≥50%post-DCB therapy were 0.905(AUC,0.741[95%confidence interval,CI:0.645,0.837];sensitivity,0.817;specificity,0.561;P<0.001)and 0.890(AUC,0.796[95%CI:0.709,0.882];sensitivity,0.746;specificity,0.780;P<0.001).Conclusions:The cut-off values of lesion QFR and vessel QFR can assist in predicting the angiographic changes post-DCB therapy.When lesion/vessel QFR values are<0.905/0.890 post-DCB therapy,a higher risk of vessel restenosis is potentially predicted at follow-up.

Postoperative nursing and prevention of complications in patients receiving coronary artery bypass grafting with the application of Swan-Ganz balloon floating catheter

Background The patients having received CABG are more likely to suffer from cardiac dysfunction and hemodynamic instability. Floating catheter provides a full set of hemodynamic parameters in an accurate manner.Methods From January 6,2018,to December 29,2018,101 patients receiving CABG in our department were selected. Among them,53 patients indwelt with Swan-Ganz balloon floating catheters. The correct application of indwelling Swan-Ganz balloon floating catheter was analyzed targeting 53 patients receiving CABG to standardize nursing and prevent complications. Results Of the 53 patients recruited,48 cases recovered,3 cases had clinical death,and 2 cases were automatically discharged. There are 16 cases subject to complications and adverse reactions. In 4 cases with catheter obstruction in SICU where CVP could be measured,floating catheters were removed in time within 24 hours after catheterization in 3 cases and 1 d22 h in 1 case. In 2 cases,catheter obstruction happened in SICU after CO measurement and before CVP measurement,where catheter obstruction was observed 1 d8 h after catheterization,and floating catheters were removed within 2 d22 h in all cases. There were 3 cases who had capillary hemorrhage at puncture sites,where compression hemostasis with cigarette coils and gauze blocks was performed in all cases,followed by 3 M TegadermTMtransparent film dressing for sterile covering at the puncture site. 4 cases suffered from transient premature ventricular contraction(PVC),which was alleviated without malignant arrhythmia after immediate suspension of operation. In addition,2 cases were subject to balloon catheters in the right ventricle and 1 case had balloon catheter in pulmonary artery,where CO,CI,SVR and other values except for the pulmonary capillary wedge pressure(PCWP)could be measured in all cases. Balloon rupture,pulmonary embolism,pulmonary hemorrhage,and pulmonary artery rupture,catheter knotting and catheter rupture or phlebitis and complications of catheter-related bloodstream infection(CRBI)were not found in the 53 patients. Conclusions The application of Swan-Ganz balloon floating catheter can provide hemodynamic monitoring data and guidance for monitoring the treatment of patients receiving CABG.Scientific application and management of pulmonary artery floating catheters and effective nursing can prevent complications and adverse reactions.[S Chin J Cardiol 2019;20(2):95-102]

Drug-coated balloon-only strategy for percutaneous coronary intervention of de novo left main coronary artery disease: the importance of proper lesion preparation

This retrospective single-center registry study included all consecutive patients who underwent percutaneous coronary intervention (PCI) for a de novo left main coronary artery lesion using drug coated-balloon (DCB)-only strategy between August 2011 and December 2018. To best of our knowledge, no previous studies of DCB-only strategy of treating de novo left main coronary artery disease, exist. The primary endpoint was major adverse cardiovascular events (MACEs) including cardiac death, non-fatal myocardial infarction, and target lesion revascularization (TLR). The cohort was divided into two groups depending on weather the lesion preparation was done according to the international consensus group guidelines. Sixty-six patients (mean age 75±8.6, 72% male), 52% of whom had acute coronary syndrome, underwent left main PCI with the DCB-only strategy. No procedural mortality and no acute closures of the treated left main occurred. At 12 months, MACE and TLR occurred in 24% and 6% of the whole cohort, respectively. If the lesion preparation was done according to the guidelines, the MACE and TLR rates were 21.2% and 1.9%. Left main PCI with the DCB only-strategy is safe leading to acceptable MACE and low TLR rates at one year, if the lesion preparation is done according to the guidelines.

经皮冠状动脉腔内冲击波球囊导管成形术治疗冠状动脉钙化病变的研究进展

冠状动脉钙化通常导致动脉血管顺应性下降,诱发术后支架膨胀不全、支架内再狭窄等并发症,最终造成介入治疗失败。传统的钙化病变处理策略受限于钙化斑块的性质和病变特征等,且操作较为复杂,手术并发症多,术后不良心血管事件发生风险增高。经皮冠状动脉腔内冲击波球囊导管成形术,又称为血管内碎石术,基于球囊的导管系统,能够安全有效地修饰浅表与深层钙化、同心或偏心钙化,从而明显改善血管顺应性,有利于后续介入治疗。目前血管内碎石术成为治疗冠状动脉钙化病变越来越重要的方法。本文主要对血管内碎石术的作用机制及治疗冠状动脉钙化病变的研究进行综述。

高值医用耗材集采控费效果的中断时间序列分析──以药物涂层冠脉球囊导管为例

目的以药物涂层冠脉球囊导管集采为例,分析集中带量采购两轮降价前后患者住院总费用和费用结构变化情况,探讨实施效果。方法采用中断时间序列分析方法,获取2021年1月至2023年9月1468例患者病案首页的费用数据及高值耗材的采购数据,描述数据变化趋势,分析集中带量采购两轮降价对患者住院总费用和费用结构的影响。结果集采政策实施前综合医疗费用呈现上升趋势,集采一轮降价时,各项费用瞬时下降,其中住院总费用和医用材料费瞬时下降110.94万元和78.04万元。集采一轮降价后,住院总费用以10.52万元/月的增速上升。治疗费、诊断费和药品费均快速上升,治疗费占比和耗占比仅瞬时变化显著,药占比长期趋势缓慢上升。集采二轮降价,所有费用瞬时变化不显著(P>0.05),长期趋势均由上升转为下降(P<0.01)。住院总费用以32.51万元/月的速度快速下降,医用材料费以18.67万元/月的速度下降。综合医疗费占比和药占比增加,诊断费占比降低。结论集中带量采购政策实施后,患者就医负担减轻。费用结构有待进一步优化,耗占比仍维持高位,医务工作人员的技术劳务价值体现不充分,医用耗材的综合改革任重道远。为形成政策合力,应充分发挥“三医联动”机制在高值医用耗材治理中的引导作用。

经快速交换球囊导管注射替罗非班联合硝普钠对择期PCI术中无复流的作用

目的探讨经自制带侧孔的快速交换球囊导管靶向注射替罗非班联合硝普钠对择期冠状动脉介入治疗(PCI)术中无复流(NR)的即刻疗效。方法选择2013年1月至2014年8月在该中心行择期PCI治疗中发生无复流的患者49例,随机分为经球囊导管给药组25例,经指引导管给药组24例。两组患者均给予替罗非班及硝普钠。评价给药前后冠状动脉血流心肌梗死溶栓试验(TIMI)分级及校正TIMI帧数(CTFC)。结果给药10min后,经球囊导管给药组有21例(84.0%)达到TIMI 3级血流,校正CTFC为(33.5±12.5)帧,而经指引导管给药组有13例(54.2%)达到TIMI 3级血流,CTFC为(41.9±15.3)帧,两组比较差异有统计学意义(P<0.05)。结论经自制带侧孔球囊导管靶向注射替罗非班联合硝普钠较经指引导管给药更能有效地改善择期PCI术中无复流患者冠状动脉的即刻血流。

经皮腔内血管成形术结合药物溶栓治疗动静脉内瘘急性血栓形成的疗效观察

目的:探讨超声或放射监测下经皮腔内血管成型术结合药物溶栓治疗血液透析动静脉内瘘急性血栓形成的效果。方法:选取2014年10月至2017年10月浙江大学医学院附属邵逸夫医院动静脉内瘘血管经过物理和影像学检查证实存在血栓形成和血流停滞的患者192例,血栓形成时间一般不超过72 h,排除活动性出血、严重凝血功能障碍等溶栓及手术治疗禁忌患者。在超声或放射监测下,采用尿激酶和肝素等渗氯化钠混合液溶栓,狭窄部位行球囊扩张术,使内瘘血流再通并恢复功能。结果:2014年10月至2017年10月共192例患者施行了274例次内瘘血管急性血栓形成的腔内介入手术,技术成功率为98.2%,临床成功率为93.8%,并发症发生率1.46%。自体动静脉内瘘患者术后3、6、12个月的初级通畅率分别为87.4%、76.7%、63.9%,次级通畅率分别为93.7%、91.6%、83.0%;移植血管动静脉内瘘患者术后3、6、12个月的初级通畅率分别为60.7%、51.5%、43.1%,次级通畅率分别为82.7%、77.1%、70.8%。结论:腔内介入技术结合药物溶栓是治疗动静脉内瘘急性血栓形成安全、有效的方法,能够延长内瘘的使用寿命,保护患者宝贵的血管资源。

经桡动脉入径采用球囊辅助技术协助的无鞘技术引导7 F指引导管完成冠状动脉复杂病变的初步经验

目的探讨经桡动脉入径采用球囊辅助技术(BAT)协助的无鞘技术引导7 F指引导管行经皮冠状动脉介入治疗(PCI)的可行性。方法前瞻性分析2019年1月至8月首都医科大学附属北京友谊医院心内科使用BAT协助的无鞘技术引导7 F指引导管行PCI患者的临床资料、影像资料、术后恢复情况,对该技术的可行性和安全性进行评价。结果12例患者采用BAT协助的无鞘技术引导7 F指引导管全部成功,无患者出现血管径路相关的并发症。所有患者PCI成功率为100%。结论经桡动脉入径采用BAT协助的无鞘技术引导7 F指引导管行PCI有很好的可行性和安全性,可作为部分复杂病变患者经桡动脉行PCI的首选方法。

采用OTW球囊经冠状静脉逆行灌注骨髓间充质干细胞的安全性和有效性

目的探讨采用over-the-wire（0Tw）球囊经冠状静脉逆行灌注骨髓间充质干细胞（MSCs）的安全性及有效性。方法杂种犬12只，体重（23．0±1．9）kg，采用开胸直视下完全结扎前降支（LAD）中段建立急性心梗模型。1周后采用OTW球囊将1×10^8EGFP标记的MSCs灌注到与LAD平行的前室间静脉（AIV）中段。所有实验动物分别在灌注后1h（n=4）、14d（n=4）、28d（n=4）取材，比较LAD结扎部位缺血心肌和LCX区域非缺血心肌组织中EGFP阳性细胞的数量。结果经冠状静脉逆行灌注成功率为100％（12／12），术中及术后未发生死亡、心包填塞及恶性心律失常。免疫荧光结果显示，所有时间点LAD区域内EGFP阳性细胞数均明显高于LCX区域（均P〈0．05），细胞在LAD区域内的分布也更均匀。结论采用OTW球囊经冠状静脉逆行灌注MSCs安全可行，靶向性高，细胞在缺血心肌内的分布也较为均匀、持久。

药物洗脱球囊导管治疗冠状动脉分叉病变上市前临床试验的样本量考量

目的:通过文献检索和Meta分析方法为上市前药物洗脱球囊(DEB)导管治疗冠状动脉分支病变相关临床试验提供样本量依据。方法:目前仅有辽宁垠艺生物科技股份有限公司生产的轻舟®(Bingo®)DEB导管被国家药品监督管理局(NMPA)批准用于分支病变治疗,故可采用随机对照试验的非劣效性设计,主要评价指标为术后9个月随访时基于造影获得的分支血管靶病变节段内直径狭窄百分比(DS%)。根据产品和适应证等设定关键词检索组合,对同品种产品开展文献检索和筛选,用Meta分析方法整合已上市同类产品结果,为上市前DEB导管随机对照试验的样本量计算提供效应值、非劣效界值等依据。结果:共计筛选106篇文献,最终符合入排标准共计10篇文献(含9项研究),其中报告术后9个月DS%的5项研究,结合临床实际和Meta分析合并同品种产品研究的结果,假设两组DEB导管能够达到同样的DS%水平,即Meta合并效应值点估计27.74%,并基于所有单项研究报道结果保守估计标准差设置为±18.00%,结合4项DEB导管与普通球囊相比较的术后DS%均差Meta结果为-9.61%(95%CI:-15.29%~-3.93%),再结合临床考虑设定非劣效界值在7.00%,并以此为基础计算出最终每组需入选140例,两组共计280例。结论:以DEB导管治疗冠状动脉分支病变为例,采用文献检索和Meta分析方法可为临床试验的样本量估算提供更为稳妥的文献支持。

球囊辅助通过技术处理桡动脉痉挛的有效性和安全性

目的:探讨经皮冠状动脉介入治疗时球囊辅助通过(balloon-assisted tracking,BAT)技术辅助指引导管通过桡动脉径路痉挛血管的安全性和有效性。方法:回顾性分析2014年6月至2016年9月复旦大学附属中山医院心内科经桡动脉径路行冠状动脉介入治疗患者资料,筛选出桡动脉和(或)肱动脉痉挛患者69例。其中,应用BAT技术处理痉挛24例(BAT组),常规方法处理痉挛45例(常规组)。比较两种方法指引导管通过痉挛段血管的成功率及相关并发症的发生率。结果:BAT组24例指引导管均顺利通过痉挛或夹层段血管,成功率达100%;而常规组仅14例(31.1%)顺利通过(P=0.000)。BAT组指引导管在<5min、5~15min、>15min通过者分别为20例(83.3%)、3例(12.5%)、1例(4.2%);常规组指引导管在<5min、5~15min、>15min通过者分别为2例(14.3%)、6例(42.9%)、6例(42.9%)。BAT组和常规组患者前臂血肿发生率分别为8.3%、20%,但差异无统计学意义。结论:经桡动脉径路进行经皮冠状动脉介入术遇到血管痉挛时,采用BAT技术可高效、安全地引导指引导管通过痉挛或夹层段血管,优于常规处理技术。

气囊漂浮导管在重度冠心病冠脉搭桥术后的应用

目的探讨气囊漂浮导管对重度冠心病冠脉搭桥术后心血管功能监测的方法和结果。方法观察22例重度冠心病冠脉搭桥术后的患者,插入气囊漂浮导管同时进行血液动力学监测。对病情判断及治疗进行整体效果的评估,同时选用重度冠心病18人进行全身麻醉体外循环下搭桥并进行监测。结果该组22例患者病情好转出院,术后心指数基本正常,肾功能衰竭、高血压、围手术期心肌梗死、脑血管意外、二次开胸止血等严重并发症没有发生。两组相比,观察组总有效率高于对照组,差异有统计学意义(P<0.05)。结论气囊漂浮导管在重度冠心病冠脉搭桥术后的心血管功能监测上具有良好的效果,临床上应该推广应用。

特殊器械在冠心病介入诊疗中的应用价值

目的:分析评价特殊器械在冠心病介入诊疗中的应用价值。方法:分析328例冠心病介入诊疗患者病例资料,记录包括抽吸导管、冠脉旋磨、血管内超声显像(IVUS)、冠脉血流储备测定(FFR)及主动脉内气囊反搏(IABP)等特殊器械在各类冠心病患者的使用情况,观察使用最多的特殊器械在主要冠脉血管病变使用情况及特殊器械使用中发生慢血流、心包填塞及死亡情况。结果:特殊器械中抽吸导管使用率最高(62.5%),其余依次为IVUS(15.0%)、FFR(14.3%)、冠脉旋磨(6.4%)及IABP(1.8%);在使用率最高的血栓抽吸导管应用中,前降支病变使用率最高(42.4%),其余依次为右冠脉部位占38.1%、回旋支病变占18.6%、左主干病变占1.0%;使用血栓抽吸导管患者中4例发生慢血流情况,占特殊器械使用的(1.2%);冠脉旋磨中有1例发生心包填塞,占特殊器械使用的(0.3%)。结论:在冠心病诊疗中有选择的开展特殊器械的应用可提高冠心病介入诊疗水平。

经皮穿刺冠状动脉腔内成形术33例报告

本文通过对33例PTCA病人的临床资料总结,就其适应证、成功与失败、并发症及再狭窄等问题作初步探讨。33例病人,全部病例经冠状动脉造影证实,单支病变25例,双支病变7例,3支病变1例。本组病人PTCA成功者有24例,占72.7％,不成功者9例,占27.3％;并发症4例,占12.1％;24例成功病人中有5例发生再狭窄,占20.8％。

心肌缺血预适应在紫杉醇释放冠脉球囊导管扩张术中的应用

目的评价心肌缺血预适应在紫杉醇释放冠脉球囊导管术中应用价值。方法纳入行紫杉醇释放冠脉球囊导管患者210名,随机分为3组,一组为对照组,术中依据手术常规行药物球囊扩张术;二组为半分钟预适应组,在药物球囊扩张前,间隔3 min 2次应用非顺应性球囊扩张狭窄部位30 s;三组为1 min适应组,在药物球囊扩张前,间隔3 min 2次应用非顺应性球囊扩张狭窄部位60 s。所有患者行冠脉SYNTAX II评分,记录经皮腔内冠状动脉成形术(percutaneous transluminal coronary angioplasty,PTCA)术前及术后24 h肌酸激酶(CK)、肌酸激酶同工酶(CK-MB)、心肌肌钙蛋白I(cTnI)数值,记录术中发生心绞痛、快速型心律失常、缓慢型心律失常的情况,并随访所有患者术后180 d内发生MACE事件(包括包括心脏死亡、心肌梗死、心力衰竭、心脏原因再次入院、靶血管再次血运重建)及临床症状改善的情况。结果(1)3组患者PTCA术前CK、CK-MB、cTnI,以及术中发生心绞痛、快速型心律失常、缓慢型心律失常的情况,差异无统计学意义(P>0.05),1 min适应组患者在PTCA术后24 h的CK、CK-MB、cTnI显著低于对照组及半分钟预适应组(P<0.05);(2)1 min适应组患者在PTCA术后180 d内MACE事件发生率及临床症状改善情况显著优于对照组及半分钟预适应组(P<0.05)。结论(1)心肌缺血预适应在紫杉醇释放冠脉球囊导管术中应用可减少心肌坏死;(2)心肌缺血预适应在紫杉醇释放冠脉球囊导管术中应用可改善PTCA术预后及临床症状。

Guidezilla延长导管与拘禁球囊技术联合治疗前降支复杂病变1例

临床资料患者,男,54岁。主因间歇腰部、左臀部酸痛2个月,加重伴右足趾麻木1周入我院疼痛科。诊断为"腰椎间盘突出症",行"椎间孔径下髓核摘除术+等离子射频消融术",术后恢复良好。患者住院期间诉间歇胸闷,查心电图未见明显异常,查冠脉CTA可见多支血管钙化及重度狭窄。遂以"冠状动脉粥样硬化性心脏病"转入心内科继续治疗。既往体健,吸烟史30年,20支/d,无其他异常家族史。查体无明显阳性体征。心电图示:窦性心律,心率79次/min,正常心电图。