国产经皮自膨胀式肺动脉瓣置入术长期疗效——单中心前瞻性经验Long-term follow-up of percutaneous pulmonary valve implantation using domestic self-expanding valve-prospective single-center experience
何芊蓓,李侨,李怡坚,李锐韬,柴博峰,陈智成,俞之翔,赵振刚,冯沅
摘要(Abstract):
目的 探讨经皮肺动脉瓣置入术(PPVI)的长期疗效及国产自膨胀式瓣膜(Venus P的耐久性。方法 前瞻性纳入2014年10月至2016年7月于四川大学华西医院就诊、经评估适合通过自膨胀式瓣膜进行PPVI治疗的外科术后右心室流出道(RVOT)功能障碍患者共8例,均使用VenusP瓣膜进行PPVI治疗。记录患者的临床、影像和手术资料、手术效果及随访结果。评估8例患者的生存率、术后围术期及远期并发症发生率、PPVI的远期疗效及Venus P的远期功能。即刻效果主要以临床瓣膜置入成功率评价,定义为瓣膜顺利置入且术后超声心动图评估的肺动脉瓣反流程度在中度以下、肺动脉瓣峰值压差<40 mmHg。结果 8例患者,其中7例女性,年龄14~36岁。初始诊断包括法洛四联症外科术后5例,法洛三联症外科术后1例,肺动脉瓣四叶瓣狭窄外科术后1例,右心室双出口外科术后1例。干预指征包括RVOT-肺动脉瓣狭窄合并反流(1例)及单纯反流(7例)。8例患者均临床置入成功,随访期间瓣膜在位,功能稳定,未发生瓣膜脱落、移位、支架断裂。术后患者症状均明显改善,术后6个月心脏磁共振成像测得右心室舒张末期容积指数(RVEDVi)相比术前明显下降[(89.99±13.85)ml/m~2比(144.93±11.28)ml/m~2,P=0.001],术后肺动脉瓣反流程度均显著改善或消失,术前及末次随访超声检查测量的跨肺动脉瓣压差的差异无统计学意义[(23.25±8.39)mmHg比(18.75±6.28)mmHg,P=0.210]。8例患者平均随访(9.25±0.71)年,1例患者术后第5年发生感染性心内膜炎,无死亡、心力衰竭恶化、恶性心律失常等并发症,无患者再次手术。所有患者均已完成8年随访,其中3例已完成10年随访,最近1次随访时评估纽约心脏病协会(NYHA)心功能分级均为Ⅰ级。结论 对于解剖条件合适的外科术后RVOT-肺动脉功能障碍患者,使用国产自膨胀式瓣膜VenusP进行PPVI是可行的治疗方案,本研究从多角度证实该瓣膜具有较好的长期疗效和耐久性,在无预支架置入固有RVOT的情况下未发生严重支架断裂。
关键词(KeyWords): 肺动脉瓣反流;自膨胀式瓣膜;前瞻性长期随访
基金项目(Foundation): 四川省科技厅重大科技专项项目(2022ZDZX0030)
作者(Author): 何芊蓓,李侨,李怡坚,李锐韬,柴博峰,陈智成,俞之翔,赵振刚,冯沅
参考文献(References):
- [1]Bonhoeffer P,Boudjemline Y,Saliba Z,et al.Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonaryartery prosthetic conduit with valve dysfunction[J].Lancet,2000,356(9239):1403-1405.DOI:10.1016/S0140-6736(00)02844-0.
- [2]Kenny D,Rhodes JF,Fleming GA,et al.3-year outcomes of the Edwards Sapien transcatheter heart valve for conduit failure in the pulmonary position from the COMPASSION multicenterclinical trial[J].JACC Cardiovasc Interv,2018,11(19):1920-1929.DOI:10.1016/j.jcin.2018.06.001.
- [3]Zhou D,Pan W,Jilaihawi H,et al.A self-expanding percutaneous valve for patients with pulmonary regurgitation and an enlarged native right ventricular outflow tract:one-year results[J].EuroIntervention,2019,14(13):1371-1377.DOI:10.4244/EIJ-D-18-00715.
- [4]Shahanavaz S,Zahn EM,Levi DS,et al.Transcatheter pulmonary valve replacement with the Sapien prosthesis[J].J Am Coll Cardiol,2020,76(24):2847-2858.DOI:10.1016/j.jacc.2020.10.041.
- [5]Wilson WM,Benson LN,Osten MD,et al.Transcatheter pulmonary valve replacement with the Edwards Sapien system:the toronto experience[J].JACC Cardiovasc Interv,2015,8(14):1819-1827.DOI:10.1016/j.jcin.2015.08.016.
- [6]中国医师协会心血管内科医师分会结构性心脏病学组,亚洲心脏病学会,国家放射与治疗临床医学研究中心.经导管肺动脉瓣置换术亚洲专家共识[J].中国介入心脏病学杂志,2023,31(6):404-412.DOI:10.3969/j.issn.1004-8812.2023.06.002.
- [7]中国医师协会心血管分会结构性心脏病学组,周达新,吴永健.结构性心脏病介入治疗2023年度报告精要[J].中国介入心脏病学杂志,2024,32(3):121-135.DOI:10.3969/j.issn.1004-8812.2024.03.001.
- [8]Morgan G,Praichasilchai P,Promphan W,et al.Mediumterm results of percutaneous pulmonary valve implantation using the venus P-valve:international experience[J].EuroIntervention,2019,14(13):1363-1370.DOI:10.4244/EIJ-D-18-00299.
- [9]周达新,潘文志,管丽华,等.经皮肺动脉瓣置入二例报道[J].中国介入心脏病学杂志,2013,21(5):332-334.DOI:10.3969/j.issn.1004-8812.2013.05.015.
- [10]Jin Q,Long Y,Zhang G,et al.Five-year follow-up after percutaneous pulmonary valve implantation using the Venus P-valve system for patients with pulmonary regurgitation and an enlarged native right ventricular outfflow tract[J].Catheter Cardiovasc Interv,2024,103(2):359-366.DOI:10.1002/ccd.30916.
- [11]Gatzoulis MA,Balaji S,Webber SA,et al.Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot:a multicentre study[J].Lancet,2000,356(9234):975-981.DOI:10.1016/S0140-6736(00)02714-8.
- [12]Jones TK,McElhinney DB,Vincent JA,et al.Longterm outcomes after melody transcatheter pulmonary valve replacement in the us investigational device exemption trial[J].Circ Cardiovasc Interv,2022,15(1):e010852.DOI:10.1161/CIRCINTERVENTIONS.121.010852.
- [13]Nordmeyer J,Lurz P,Khambadkone S,et al.Pre-stenting with a bare metal stent before percutaneous pulmonary valve implantation:acute and 1-year outcomes[J].Heart,2011,97(2):118-123.DOI:10.1136/hrt.2010.198382.
- [14]Baddour LM,Cahill TJ,Prendergast BD.Infective endocarditis complicating transcatheter pulmonary valve replacement:more data,more to learn[J].J Am Coll Cardiol,2021,78(6):590-593.DOI:10.1016/j.jacc.2021.05.043.
- [15]Georgiev S,Ewert P,Eicken A,et al.Munich comparative study:prospective long-term outcome of the transcatheter melody valve versus surgical pulmonary bioprosthesis with up to 12 years of follow-up[J].Circ Cardiovasc Interv,2020,13(7):e008963.DOI:10.1161/CIRCINTERVENTIONS.119.008963.
- [16]McElhinney DB,Zhang Y,Aboulhosn JA,et al.Multicenter study of endocarditis after transcatheter pulmonary valve replacement[J].J Am Coll Cardiol,2021,78(6):575-589.DOI:10.1016/j.jacc.2021.05.044.
- [17]?stergaard L,Valeur N,Ihlemann N,et al.Incidence of infective endocarditis among patients considered at high risk[J].Eur Heart J,2018,39(7):623-629.DOI:10.1093/eurheartj/ehx6 82.
- [18]Stout KK,Daniels CJ,Aboulhosn JA,et al.2018 AHA/ACC guideline for the management of adults with congenital heart disease:a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines[J].J Am Coll Cardiol,2019,73(12):e81-e192.DOI:10.1016/j.jacc.2018.08.1029.
- [19]Baumgartner H,De Backer J,Babu-Narayan SV,et al.2020ESC Guidelines for the management of adult congenital heart disease[J].Eur Heart J,2021,42(6):563-645.DOI:10.1093/eurheartj/ehaa554.
- [20]Iannaccone G,Bautista-Rodriguez C,Kacar P,et al.Early failure of VenusP-Valve in pulmonary position:thrombosis and inflammation?[J].JACC Cardiovasc Interv,2024,17(14):1738-1740.DOI:10.1016/j.jcin.2024.04.045.
- [21]Pilati M,Duong P,Bordonaro V,et al.Auto-expandable pulmonary valve leaflet microthrombosis:a subtle and dangerous phenomenon[J].Eur Heart J Cardiovasc Imaging,2023,25(1):e56.DOI:10.1093/ehjci/jead260.
- [22]Borik S,Crean A,Horlick E,et al.Percutaneous pulmonary valve implantation:5 years of follow-up:does age influence outcomes?[J].Circ Cardiovasc Interv,2015,8(2):e001745.DOI:10.1161/CIRCINTERVENTIONS.114.001745.