经导管主动脉瓣置换术过程中使用Sentinel脑保护装置的效果和安全性分析Effectiveness and safety of the use of Sentinel cerebral embolic protection device during transcatheter aortic valve replacement
谭冠昶,李炜杰,李捷,谭健锹,罗淞元,赵巧仪,罗建方
摘要(Abstract):
目的 探讨Sentinel脑保护装置(CEPD)在接受经导管主动脉瓣置换术(TAVR患者中的应用效果和安全性。方法 回顾性分析从2017年3月至2022年10月在澳门镜湖医院进行的TAVR过程中置入CEPD的患者。随访时间截点为7d和30d,主要观察终点包括全因死亡、症状性脑卒中、短暂性脑缺血发作(TIA)、CEPD置入成功率、置入CEPD路径的血管并发症、CEPD成功捕获物质事件。绘制CEPD置入的操作时间折线图评价CEPD置入的学习曲线。结果 共29例患者纳入分析,所有患者均成功置入CEPD。女性13例(44.8%),平均年龄为(78.3±7.3)岁。三叶瓣患者16例(55.2%),二叶瓣患者13例(44.8%)。所有患者TAVR所使用的的瓣膜均为自膨胀瓣膜,其中55.2%为Evolut R/PRO,44.8%为Venus-A/A Plus。随访7 d和30 d时,29例患者均未出现全因死亡、症状性脑卒中、TIA及桡动脉或肱动脉的血管并发症。根据主动脉瓣的类型将患者分为三叶瓣组和二叶瓣组,两组患者的钙化积分、人工瓣膜类型、置入CEPD操作时间比较,差异均无统计学意义(均P>0.05)。在肉眼观察下,两组均各有7例患者在CEPD中发现捕获血栓、钙化物质或瓣膜组织碎片等,组间比较差异无统计学意义(P>0.05)。随着手术例数的增加,CEPD的操作时间逐渐缩短,从第6例手术开始,操作时间均在11 min以内。结论 在TAVR术中置入CEPD的可操控性强,手术学习周期短且安全性高。Sentinel CEPD能明确捕获术中产生的部分血栓、钙化物质或瓣膜组织碎片,但在国内人群中使用Sentinel CEPD预防脑栓塞事件的有效性尚需要更多大规模随机对照研究的证实。
关键词(KeyWords): 经导管主动脉瓣置换术;脑保护装置;脑栓塞
基金项目(Foundation):
作者(Author): 谭冠昶,李炜杰,李捷,谭健锹,罗淞元,赵巧仪,罗建方
参考文献(References):
- [1] Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease:executive summary:a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines[J]. Circulation, 2021, 143(5):e35-e71.DOI:10.1161/CIR.0000000000000932.
- [2]中国医师协会心血管内科医师分会结构性心脏病专业委员会.中国经导管主动脉瓣置换术临床路径专家共识(2021版)[J].中国介入心脏病学杂志,2022, 30(1):7-16.DOI:10.3969/j.issn.1004-8812.2022.01.002.
- [3] Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in lowrisk patients[J]. N Engl J Med, 2019, 380(18):1695-1705.DOI:10.1056/NEJMoa1814052.
- [4]李捷,孙英皓,李光,等.经导管主动脉瓣置换术在外科低危主动脉瓣狭窄患者中的疗效分析[J].中国介入心脏病学杂志,2018, 26(11):619-621. DOI:10.3969/j.issn.1004-8812.2018.11.004.
- [5] Habertheuer A,Gleason TG,Kilic A,et al. Impact o f perioperative stroke on midterm outcomes after transcatheter aortic valve replacement[J]. Ann Thorac Surg, 2020, 110(4):1294-1301.DOI:10.1016/j.athoracsur.2020.01.074.
- [6] Muralidharan A, Thiagarajan K, Van Ham R, et al. Metaanalysis of perioperative stroke and mortality in transcatheter aortic valve implantation[J]. Am J Cardiol, 2016, 118(7):1031-1045.DOI:10.1016/j.amjcard.2016.07.011.
- [7] Kapadia S, Agarwal S, Miller DC, et al. Insights into timing, risk factors, and outcomes of stroke and transient ischemic attack after transcatheter aortic valve replacement in the PARTNER trial(Placement of Aortic Transcatheter Valves)[J]. Circ Cardiovasc Interv, 2016, 9(9):e002981.DOI:10.1161/CIRCINTERVENTIONS.115.002981.
- [8] Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients[J]. N Engl J Med, 2011, 364(23):2187-2198.DOI:10.1056/NEJMoa1103510.
- [9] Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients[J]. N Engl J Med, 2016, 374(17):1609-1620.DOI:10.1056/NEJMoa1514616.
- [10] Demir OM, Iannopollo G, Mangieri A, et al. The role of cerebral embolic protection devices during transcatheter aortic valve replacement[J]. Front Cardiovasc Med, 2018, 5:150. DOI:10.3389/fcvm.2018.00150.
- [11] Huded CP, Tuzcu EM, Krishnaswamy A, et al. Association between transcatheter aortic valve replacement and early postprocedural stroke[J]. JAMA, 2019, 321(23):2306-2315.DOI:10.1001/jama.2019.7525.
- [12] MesséSR, Acker MA, Kasner SE, et al. Stroke after aortic valve surgery:results from a prospective cohort[J].Circulation, 2014, 129(22):2253-2261.DOI:10.1161/CIRCULATIONAHA.113.005084.
- [13] Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation:a diffusion-weighted magnetic resonance imaging study[J]. Circulation, 2010, 121(7):870-878.DOI:10.1161/CIRCULATIONAHA.109.855866.
- [14] Floyd TF,Giovannetti T. Neurocognitive outcomes in older adults after transcatheter aortic valve replacement[J]. J Thorac Cardiovasc Surg, 2012, 144(6):1539.DOI:10.1016/j.jtcvs.2012.08.050.
- [15] Seeger J, Kapadia SR, Kodali S, et al. Rate of periprocedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement:a patient-level propensity-matched analysis[J]. Eur Heart J, 2019, 40(17):1334-1340. DOI:10.1093/eurheartj/ehy847.
- [16] Seeger J, Gonska B, Otto M, et al. Cerebral embolic protection during transcatheter aortic valve replacement signifi cantly reduces death and stroke compared with unprotected procedures[J]. JACC Cardiovasc Interv, 2017, 10(22):2297-2303. DOI:10.1016/j.jcin.2017.06.037.
- [17] Haussig S, Mangner N, Dwyer MG, et al. Ef fect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis:the CLEAN-TAVI randomized clinical trial[J]. JAMA, 2016,316(6):592-601. DOI:10.1001/jama.2016.10302.
- [18] Kapadia SR, Makkar R, Leon M, et al. Cerebral embolic protection during transcatheter aortic-valve replacement[J]. N Engl J Med, 2022, 387(14):1253-1263.DOI:10.1056/NEJMoa2204961.
- [19] Kapadia SR, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement[J]. J Am Coll Cardiol, 2017, 69(4):367-377. DOI:10.1016/j.jacc.2016.10.023.
- [20] Xiong TY, Zhao ZG,Chen M. Bicuspid aortic stenosis in transcatheter aortic valve replacement era:emerging confusions hindering the standardization of the procedure[J]. Cardiol J,2018, 25(4):542-544.DOI:10.5603/CJ.2018.0089.
- [21] Généreux P, Piazza N, Alu MC, et al. Valve Academic Research Consortium 3:updated endpoint defi nitions for aortic valve clinical research[J]. Eur Heart J, 2021, 42(19):1825-1857. DOI:10.1093/eurheartj/ehaa799.