张瑞涛,田振宇,曾勇,傅国胜,徐立,刘健,李建平,张志辉,胡信群,程翔,路雯,崔鸣,唐熠达

• 1:北京大学第三医院心血管内科
• 2:首都医科大学附属北京安贞医院冠心病中心
• 3:浙江大学医学院附属邵逸夫医院心血管内科
• 4:首都医科大学附属北京朝阳医院心脏中心

摘要(Abstract)：

目的 本研究旨在评估一种新型血管内碎石术（IVL）球囊——Vesscrack冲击波球囊，在重度冠状动脉钙化（CAC）患者支架置入前进行血管预处理的有效性和安全性。方法 本研究为一项前瞻性、单臂、多中心研究，于2022年6—10月在中国10家医院招募重度CAC患者，均采用Vesscrack冲击波球囊进行预处理并置入药物洗脱支架（DES）。33例患者接受光学相干断层成像（OCT）。主要终点是手术成功率即成功支架置入且残余狭窄≤30%，并且在住院期间未发生心源性死亡、靶血管相关的心肌梗死或靶病变血运重建。结果 共招募170例患者，男116例（68.2%），平均年龄（65.9±7.9）岁。应用IVL和支架置入后与基线相比，最小管腔直径显著增加[（2.34±0.40）mm比（0.95±0.33）mm,P<0.001]，狭窄程度显著减少[（13.24±6.60）%比（65.18±10.59）%,P<0.001]。手术成功率为100.0%，器械成功率为98.8%。30 d患者相关的心血管复合终点（POCE）发生率为0.0，且无靶病变失败，未观察到确认和可能的血栓事件。脉冲声波能量发生器的稳定性和使用便捷性表现优异。在接受OCT检查的33例患者中，IVL干预后，最大钙化部位的管腔面积[（3.51±1.51）mm~2比（2.85±1.80）mm~2,P<0.001]和靶病变内的最小管腔面积[（3.08±1.04）mm~2比（2.02±0.75）mm~2,P<0.001]，以及支架置入后最大钙化部位的管腔面积[（6.59±1.64）mm~2比（2.85±1.80）mm~2,P<0.001]和靶病变内的最小管腔面积[（6.19±1.45）mm~2比（2.02±0.75）mm~2,P<0.001]均显著增加，差异均有统计学意义。结论 Vesscrack冲击波球囊在支架置入前对重度CAC患者进行预处理是有效且安全的，具有显著的钙化斑块修饰效果、较高的操作成功率和极少的并发症。

关键词(KeyWords)： 冠状动脉钙化;血管内碎石术;前瞻性多中心试验;血管预处理

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 张瑞涛,田振宇,曾勇,傅国胜,徐立,刘健,李建平,张志辉,胡信群,程翔,路雯,崔鸣,唐熠达

参考文献(References)：

• [1]Allison MA,Criqui MH,Wright CM.Patterns and risk factors for systemic calcified atherosclerosis[J].Arterioscler Thromb Vasc Biol,2004,24(2):331-336.DOI:10.1161/01.ATV.0000110786.02097.0c.
• [2]Sharma SK,Bolduan RW,Patel MR,et al.Impact of calcification on percutaneous coronary intervention:MACEtrial 1-year results[J].Catheter Cardiovasc Interv,2019,94(2):187-194.DOI:10.1002/ccd.28099.
• [3]胥家开,聂文畅,侯昌,等.冠状动脉钙化病变预处理手段的研究进展[J].中国介入心脏病学杂志,2024,32(3):159-163.DOI:10.3969/j.issn.1004-8812.2024.03.006.
• [4]Klein AJ,Feldman DN,Aronow HD,et al.SCAI expert consensus statement for aorto-iliac arterial intervention appropriate use[J].Catheter Cardiovasc Interv,2014,84(4):520-528.DOI:10.1002/ccd.25505.
• [5]Honton B,Monsegu J.Best practice in intravascular lithotripsy[J].Interv Cardiol,2022,17:e02.DOI:10.15420/icr.2021.14.
• [6]Brinton TJ,Ali ZA,Hill JM,et al.Feasibility of shockwave coronary intravascular lithotripsy for the treatment of calcified coronary stenoses[J].Circulation,2019,139(6):834-836.DOI:10.1161/CIRCULATIONAHA.118.036531.
• [7]Ali ZA,Nef H,Escaned J,et al.Safety and effectiveness of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses:the disrupt CADⅡstudy[J].Circ Cardiovasc Interv,2019,12(10):e008434.DOI:10.1161/CIRCINTERVENTIONS.119.008434.
• [8] Hill JM,Kereiakes DJ,Shlofmitz RA,et al.Intravascular lithotripsy for treatment of severely calcified coronary artery disease[J].J Am Coll Cardiol,2020,76(22):2635-2646.DOI:10.1016/j.jacc.2020.09.603.
• [9] Saito S,Yamazaki S,Takahashi A,et al.Intravascular lithotripsy for vessel preparation in severely calcified coronary arteries prior to stent placement-primary outcomes from the Japanese disrupt CAD IV study[J].Circ J,2021,85(6):826-833.DOI:10.1253/circj.CJ-20-1174.
• [10]王伟民,霍勇,葛均波.经皮冠状动脉腔内冲击波球囊导管成形术临床应用中国专家建议[J].中国介入心脏病学杂志,2023,31(9):641-649.DOI:10.3969/j.issn 1004-8812.2023.09.001.
• [11] Ouyang L,Su X,Li W,et al.ALKBH1-demethylated DNA N6-methyladenine modification triggers vascular calcification via osteogenic reprogramming in chronic kidney disease[J].J Clin Invest,2021,131(14):e146985.DOI:10.1172/JCI146985.
• [12]Ouyang L,Yu C,Xie Z,et al.Indoleamine 2,3-dioxygenase1 deletion-mediated kynurenine insufficiency in vascular smooth muscle cells exacerbates arterial calcification[J].Circulation,2022,145(24):1784-1798.DOI:10.1161/CIRCULATIONAHA.121.057868.
• [13]《冠状动脉钙化病变诊治中国专家共识》专家组.冠状动脉钙化病变诊治中国专家共识(2021版)[J].中国介入心脏病学杂志,2021,29(5):251-259.DOI:10.3969/j.issn.1004-8812.2021.05.002.
• [14]曹成富,马玉良,李琪,等.光学相干断层成像指导钙化病变介入治疗策略[J].中国介入心脏病学杂志,2021,29(6):345-349.DOI:10.3969/j.issn.1004-8812.2021.06.011.
• [15]Sato T,Matsumura M,Yamamoto K,et al.Impact of eruptive vs noneruptive calcified nodule morphology on acute and long-term outcomes after stenting[J].JACC Cardiovasc Interv,2023,16(9):1024-1035.DOI:10.1016/j.jcin.2023.03.009.
• [16]Ali ZA,Kereiakes D,Hill J,et al.Safety and effectiveness of coronary intravascular lithotripsy for treatment of calcified nodules[J].JACC Cardiovasc Interv,2023,16(9):1122-1124.DOI:10.1016/j.jcin.2023.02.015.
• [17] Tepe G,Brodmann M,Werner M,et al.Intravascular lithotripsy for peripheral artery calcification:30-day outcomes from the randomized disrupt PADⅢtrial[J].JACC Cardiovasc Interv,2021,14(12):1352-1361.DOI:10.1016/j.jcin.2021.04.010.
• [18]Kawai K,Sato Y,Hokama JY,et al.Histology,OCT,and micro-CT evaluation of coronary calcification treated with intravascular lithotripsy:atherosclerotic cadaver study[J].JACC Cardiovasc Interv,2023,16(17):2097-2108.DOI:10.1016/j.j cin.2023.06.021.
• [19]Kereiakes DJ,Virmani R,Hokama JY,et al.Principles of intravascular lithotripsy for calcific plaque modification[J].JACC Cardiovasc Interv,2021,14(12):1275-1292.DOI:10.1016/j.j cin.2021.03.036.
• [20]Trerotola SO,Stavropoulos SW,Shlansky-Goldberg R,et al.Hemodialysis-related venous stenosis:treatment with ultrahighpressure angioplasty balloons[J].Radiology,2004,231(1):259-262.DOI:10.1148/radiol.2311030949.
• [21]Xia S,Li J,Ma L,et al.Ultra-high pressure balloon angioplasty for pulmonary artery stenosis in children with congenital heart defects:short-to mid-term follow-up results from a retrospective cohort in a single tertiary center[J].Front Cardiovasc Med,2023,9:1078172.DOI:10.3389/fcvm.2022.1078172.
• [22]Kalogeropoulos AS,Karamasis GV,Pavlidis AN,et al.Combined shockwave intravascular lithotripsy and ultrahighpressure balloon dilatation for the treatment of stent underexpansion secondary to severe coronary calcification[J].Kardiol Pol,2021,79(2):205-206.DOI:10.33963/KP.15753.
• [23]Kundu S,Clemens R,Aziza J,et al.Ultrahigh-pressure angioplasty versus the Peripheral Cutting Balloon~(TM)for treatment of stenoses in autogenous fistulas:comparison of immediate results[J].J Vasc Access,2010,11(4):303-311.DOI:10.5301/jva.2010.101.
• [24]Shlofmitz E,Martinsen B J,Lee M,et al.Orbital atherectomy for the treatment of severely calcified coronary lesions:evidence,technique,and best practices[J].Expert Rev Med Devices,2017,14(11):867-879.DOI:10.1080/17434440.2017.1384695.
• [25]Kaur N,Pruthvi CR,Sharma Y,et al.Rotatripsy:synergistic effects of complementary technologies:a case report[J].Eur Heart J Case Rep,2021,5(4):ytab083.DOI:10.1093/ehjcr/ytab083.
• [26] Sattar Y,Ullah W,Virk HUH,et al.Coronary intravascular lithotripsy for coronary artery calcifications-systematic review of cases[J].J Community Hosp Intern Med Perspect,2021,11(2):200-205.DOI:10.1080/20009666.2021.1883219.
• [27]Vedani S,Haligür D,Jungi S,et al.Intravascular lithotripsy:a powerful tool to treat peripheral artery calcifications[J].J Cardiovasc Surg(Torino),2023,64(4):406-412.DOI:10.23736/S0021-9509.22.12535-8.