国产新型冠状动脉覆膜支架单中心临床应用回顾性分析——基于11例患者的初步经验A retrospective analysis of the clinical application of domestic new coronary covered stents in a single center——Based on the initial experience on 11 patients
王婧雅,刘明森,万勃楷,沈鑫,阿德力江,王钊,杨毅宁,余小林
摘要(Abstract):
目的 探讨国产新型冠状动脉覆膜支架在冠状动脉穿孔中的临床疗效及安全性。方法 回顾性分析2023年3月至2025年3月新疆维吾尔自治区人民医院收治的11例冠状动脉穿孔患者,均采用国产新型冠状动脉覆膜支架进行紧急封堵。记录患者基线资料、病变特点、穿孔分型(Ellis分型)、手术成功率、围手术期并发症及随访结果等。结果 11例患者年龄(65.63±8.80)岁,全部为男性(11/11)。11例患者中,EllisⅡ型穿孔6例,Ⅲ型5例。覆膜支架置入成功率为100%(11/11),术后即刻造影显示穿孔完全封堵100%(11/11),1例存在边支血管压迫受累。围手术期主要并发症包括心包积液27.3%(3/11),无死亡病例。中位随访12个月,无主要不良心血管事件及术后抗栓治疗相关并发症发生。结论 国产新型冠状动脉覆膜支架在本中心11例冠状动脉穿孔患者中表现出良好的即刻封堵效果和短期安全性,但其长期预后及广泛安全性仍需进一步验证。
关键词(KeyWords): 冠状动脉穿孔;覆膜支架;国产器械;经皮冠状动脉介入治疗
基金项目(Foundation): “天山英才”医药卫生高层次人才培养计划项目(TSYC202401B021)
作者(Author): 王婧雅,刘明森,万勃楷,沈鑫,阿德力江,王钊,杨毅宁,余小林
参考文献(References):
- [1]Mikhail P,Howden N,Monjur M,et al. Coronary perforation incidence, outcomes and temporal trends(COPIT):a systematic review and meta-analysis[J]. Open Heart,2022,9(2):e002076. DOI:10.1136/openhrt-2022-002076.
- [2]葛均波,王建安.内科学心血管内科分册[M]. 2版.北京:人民卫生出版社,2022:674.
- [3]王小明,刘毅,李斌,等.冠状动脉穿孔的研究进展及治疗方法探讨[J].临床心血管病杂志,2018,34(10):946-951.DOI:10.13201/j.issn.1001-1439.2018.10.003.
- [4]Shaukat A,Tajti P,Sandoval Y, et al. Incidence,predictors, management and outcomes of coronary perforations[J]. Catheter Cardiovasc Interv, 2019, 93(1):48-56.DOI:10.1002/ccd.27706.
- [5]Ellis SG, Ajluni S, Arnold AZ, et al. Increased coronary perforation in the new device era. Incidence, classification,management, and outcome[J]. Circulation, 1994, 90(6):2725-2730. DOI:10.1161/01.cir.90.6.2725.
- [6]Hirai T, Nicholson WJ, Sapontis J, et al.A detailed analysis of perforations during chronic total occlusion angioplasty[J].JACC Cardiovasc Interv, 2019, 12(19):1902-1912.DOI:10.1016/j.jcin.2019.05.024.
- [7]Chowdhury MA, Sheikh MA. Coronary bypass graft perforation during percutaneous intervention[J]. Cardiovasc Revasc Med, 2016, 17(1):48-53. DOI:10.1016/j.carrev.2015.11.004.
- [8]胡文涛,宋丹,徐承义.冠状动脉穿孔的特点及主要治疗策略[J].心肺血管病杂志,2023, 42(6):638-641. DOI:10.3969/j.issn.1007-5062.2023.06.023.
- [9]张涛,张宇晨,冯婷婷,等.自制覆膜支架在冠状动脉穿孔封堵治疗中的应用[J].中国介入心脏病学杂志,2023, 31(3):195-200. DOI:10.3969/j.issn.1004-8812.2023.03.005.
- [10]A n W , Ye J , Han B, et al.Effi cacy and safety of selfmade covered coronary stent in the treatment of coronary artery perforation[J]. BMC Cardiovasc Disord, 2023, 23(1):537. DOI:10.1186/s12872-023-03575-3.
- [11]Lee WC, Hsueh SK, Fang CY, et al.Clinical outcomes following covered stent for the treatment of coronary artery perforation[J]. J Interv Cardiol, 2016, 29(6):569-575.DOI:10.1111/joic.12347.
- [12]Takagi K, Yoshida R, Fujita T, et al.Bail-out techniques in percutaneous intervention for Ellis gradeⅢcoronary perforation in left main distal bifurcation lesions[J]. J Soc Cardiovasc Angiogr Interv, 2023, 2(3):100609. DOI:10.1016/j.jscai.2023.100609.
- [13]Scalamogna M, Kuna C, Voll F, et al. Modified balloons to prepare severely calcified coronary lesions before stent implantation:a systematic review and metaanalysis of randomized trials[J]. Clin Res Cardiol,2024, 113(7):995-1005. DOI:10.1007/s00392-023-02324-y.
- [14]Kufner S, Schacher N, Ferenc M, et al. Outcome after new generation single-layer polytetrafluoroethylene-covered stent implantation for the treatment of coronary artery perforation[J].Catheter Cardiovasc Interv, 2019, 93(5):912-920. DOI:10.1002/ccd.27979.
- [15]Birkemeyer R, Olivecrona GK, Hellig F, et al.Sealing of coronary perforations with a second-generation covered stent graft-results from the PAST-PERF registry[J].Cardiovasc Revasc Med, 2021, 25:20-26. DOI:10.1016/j.carrev.2020.10.012.
- [16]王泉,黄河,吉港,等.血管内超声检测成年国人左前降支外弹力膜直径的变化[J].中国介入心脏病学杂志,2022,30(5):359-365. DOI:10.3969/j.issn.1004-8812.2022.05.007.
- [17]Moore KL,Dalley AF,Agur AMR. Clinically oriented anatomy[M]. 9th ed. Philadelphia:Wolters Kluwer,2023:182.
- [18]Masoomi R, Burke CR, Del Cid Fratti J, et al.Left atrial compression syndrome secondary to coronary artery perforation:Pathophysiology, diagnosis, and management strategies[J].Catheter Cardiovasc Interv, 2024, 104(4):759-766.DOI:10.1002/ccd.31182.
- [19]Gercken U, Lansky AJ, Buellesfeld L, et al.Results of the Jostent coronary stent graft implantation in various clinical settings:procedural and follow-up results[J]. Catheter Cardiovasc Interv, 2002, 56(3):353-360. DOI:10.1002/ccd.10223.
- [20]Ford TJ,Adamson C,Morrow AJ,et al. Coronary artery perforations:glasgow natural history study of covered stent coronary interventions(GNOCCI)study[J]. J Am Heart Assoc,2022,11(19):e024492. DOI:10.1161/JAHA.121.024492.
- [21]Harnek J, James SK, Lagerqvist B. Very long-term outcome of coronary covered stents:a report from the SCAAR registry[J].EuroIntervention,2019, 14(16):1660-1667. DOI:10.4244/EIJ-D-18-00855.
- [22]Kirtane AJ, Généreux P, Lewis B, et al.Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcifi ed lesions eligible for both treatment strategies(ECLIPSE):a multicentre, open-label, randomised trial[J]. Lancet, 2025,405(10486):1240-1251. DOI:10.1016/S0140-6736(25)00450-7.