潘文志,周达新,Hijazi ZM,Shakeel AQ,Worakan P,冯沅,张戈军,刘先宝,潘欣,陈良龙,曹期龄,霍勇,王建安,葛均波

• 1:中国医师协会心血管内科医师分会结构性心脏病学组
• 2:亚洲心脏病学会
• 3:国家放射与治疗临床医学研究中心
• 4:复旦大学附属中山医院

摘要(Abstract)：

经导管肺动脉瓣置换术（TPVR），又称经皮肺动脉瓣置入术，是指在心脏不停跳状态下，使用X线和（或）超声影像作为引导，将人工肺动脉瓣通过经导管介入的方式置入到病变的肺动脉瓣处，在功能上完成肺动脉瓣置换的一种微创操作技术。近年来，TPVR领域在器械研发、循证医学证据及应用经验等方面取得了重要的进展。为及时更新对TPVR的认识，紧贴最新研究及实践，促进我国TPVR规范、健康地发展，专家组撰写了此共识。本共识对相关文献进行系统性回顾后，对8个核心问题作出深入分析，形成8个核心观点，包括适应证推荐、器械选择、围术期评估、手术操作注意事项、并发症预防处理等几个方面。

关键词(KeyWords)： 经导管肺动脉瓣置换术;经皮肺动脉瓣置入术;专家共识

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 潘文志,周达新,Hijazi ZM,Shakeel AQ,Worakan P,冯沅,张戈军,刘先宝,潘欣,陈良龙,曹期龄,霍勇,王建安,葛均波

参考文献(References)：

• [1]中华医学会心血管病学分会结构性心脏病学组,中国医师协会心血管内科医师分会结构性心脏病学组.经皮肺动脉瓣置入术中国专家建议[J].中国介入心脏病学杂志,2016,24(10):20-24.DOI:10.3969/j.issn.1004-8812.2016.10.001.
• [2]纪广玉,徐志云,王志农,等.成人法洛四联症外科治疗的远期疗效[J].中国胸心血管外科临床杂志,2010,17(4):287-291.DOI:1007-4848(2010)04-0287-05.
• [3]Kaza AK,Lim HG,Dibardino DJ,et al.Long-term results of right ventricular outflow tract reconstruction in neonatal cardiac surgery:options and outcomes[J].J Thorac Cardiovasc Surg,2009,138(4):911-916.DOI:10.1016/j.jtcvs.2008.10.058.
• [4]Chaturvedi RR,Redington AN.Pulmonary regurgitation in congenital heart disease[J].Heart,2007,93(7):880-889.DOI:10.1136/hrt.2005.075234.
• [5]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.
• [6]Murphy J G,Gersh BJ,Mair DD,et al.Longterm outcome in patients undergoing surgical repair of tetralogy of Fallot[J].N Engl J Med,1993,329(9):593-599.DOI:10.1056/NEJM199308263290901.
• [7] Nollert GD,Dabritz SH,Schmoeckel M,et al.Risk factors for sudden death after repair of tetralogy of Fallot[J].Ann Thorac Surg,2003,76(6):1901-1905.DOI:10.1016/s0003-4975(03)01065-8.
• [9]Van den Eynde J,Sa M,Vervoort D,et al.Pulmonary valve replacement in tetralogy of Fallot:an updated meta-analysis[J].Ann Thorac Surg,2022,113(3):1036-1046.DOI:10.1016/j.athoracsur.2020.11.040.
• [9]Muller J,Engelhardt A,Fratz S,et al.Improved exercise performance and quality of life after percutaneous pulmonary valve implantation[J].Int J Cardiol,2014,173(3):388-3 92.DOI:10.1016/j.ijcard.2014.03.002.
• [10]Hager A,Schubert S,Ewert P,et al.Five-year results from a prospective multicentre study of percutaneous pulmonary valve implantation demonstrate sustained removal of significant pulmonary regurgitation,improved right ventricular outflow tractobstruction and improved quality of life[J].EuroIntervention,2017,12(14):1715-1723.DOI:10.4244/EIJ-D-16-00443.
• [11]Georgiev S,Ewert P,Eicken A,et al.Munich comparative study:pro spective 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.
• [12]Hribernik I,Thomson J,Ho A,et al.Comparative analysis of surgical and percutaneous pulmonary valve implants over a 20-year period[J].Eur J Cardiothorac Surg,2022,61(3):572-579.DOI:10.1093/ejcts/ezab 3 68.
• [13]Caughron H,Kim D,Kamioka N,et al.Repeat pulmonary valve replacement:similar intermediate-term outcomes with surgical and transcatheter procedures[J].JACC Cardiovasc Interv,2018,11(24):2495-2503.DOI:10.1016/j.jcin.2018.07.042.
• [14] Ribeiro JM,Teixeira R,Lopes J,et al.Transcatheter versus surgical pulmonary valve replacement:a systemic review and meta-analysis[J].Ann Thorac Surg,2020,110(5):1751-1761.DOI:10.1016/j.athoracsur.2020.03.007.
• [15]McElhinney DB,Zhang Y,Levi DS,et al.Reintervention and survival after transcatheter pulmonary valve replacement[J].J Am Coll Cardiol,2022,79(1):18-32.DOI:10.1016/j.jacc.2021.10.031.
• [16]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].Circulation,2019,139(14):e698-e800.DOI:10.1161/CIR.0000000000000603.
• [17]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/ehaa5 54.
• [18] Kenny D,Hijazi ZM,Kar S,et al.Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position[J].J Am Coll Cardiol,2011,58:2248-2256.DOI:10.1016/j.jacc.2011.07.040.
• [19] 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 multicenter clinical trial[J].J Am Coll Cardiol Intv,2018,11:1920-1929.DOI:10.1016/j.jcin.2018.06.001.
• [20]Virk SA,Liou K,Chandrakumar D,et al.Percutaneous pulmonary valve implantation:a systematic review of clinical outcomes[J].Int J Cardiol,2015,201:487-489.DOI:10.1016/j.ijcard.2015.08.119.
• [21]Cools B,Brown S,Budts W,et al.Up to 11 years of experience with the Melody valved stent in the right ventricular outflow tract[J].EuroIntervention,2018,14(9):e988-e994.DOI:10.4244/EIJ-D-18-00054.
• [22]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.
• [23] Houeijeh A,Batteux C,Karsenty C,et al.Long-term outcomes of transcatheter pulmonary valve implantation with melody and SAPIEN valves[J].Int J Cardiol,2023,370:156-166.DOI:10.1016/j.ijcard.2022.10.141.
• [24]Gillespie MJ,Bergersen L,Benson LN,et al.5-year outcomes from the harmony native outflow tract early feasibilitystudy[J].JACC Cardiovasc Interv,2021,14(7):816-817.DOI:10.1016/j.j cin.2021.01.046.
• [25]Lee SY,Kim GB,Kim SH,et al.Mid-term outcomes of the Pulsta transcatheter pulmonary valve for the native right ventricular outflow tract[J].Catheter Cardiovasc Interv,2021,98(5):E724-E732.DOI:10.1002/ccd.29865.
• [26]Zhou D,Pan W,Jilaihawi H,et al.A self-expanding percutaneous valve for patients with pulmonary regurgitation and an enlarged native right ventricular oufflow tract:one-year results[J].Euro Intervention,2019,14(13):1371-1377.DOI:10.4244/EIJ-D-18-00715.
• [27]Morgan G,Prachasilchai P,Promphan W,et al.Mediumterm results of percutaneous pulmonary valve implantation using the Venus P-valve:international experience[J].Euro Intervention,2019,14(13):1363-1370.DOI:10.4244/EIJ-D-18-00299.
• [28] Shang X,Chen S,Zhang C,et al.First-in-man implantation of med-zenith pt-valve in right ventricular outflow tract for pulmonary regurgitation[J].JACC Cardiovasc Interv,2019,12(19):1989-1990.DOI:10.1016/j.jcin.2019.07.036.
• [29]田军,尚小珂,陈澍,等.经导管肺动脉瓣置换术的新器械与新技术进展[J].中国介入心脏病学杂志,2020,28(12):713-718.DOI:10.3969/j.issn.1004-8812.2020.12.011.
• [30] Shahanavaz S,Balzer D,Babaliaros V,et al.Alterra adaptive prestent and SAPIEN 3 THV for congenital pulmonic valve dysfunction:an early feasibility study[J].JACC Cardiovasc Interv,2020,13(21):2510-2524.DOI:10.1016/j.jcin.2020.06.039.
• [31]潘文志,周达新,葛均波.经皮肺动脉瓣置入术适应证及手术时机的研究现状[J].中华心血管病杂志,2016,44(7):639-641.DOI:10.3760/cma.j.issn.0253-3758.2016.07.019.
• [32]Hijazi ZM,Ruiz CE,Zahn E,et al.SCAI/AATS/ACC/STS operator and institutional requirements for transcatheter valve repair and replacement,PartⅢ:pulmonic valve[J].Catheter Cardiovasc Interv,2015,86(1):85-93.DOI:10.1002/ccd.25710.
• [33] Boutsikou M,Tzifa A.Noninvasive imaging prior to percutaneous pulmonary valve implantation[J].Hellenic J Cardiol,2022,67:59-65.DOI:10.1016/j.hjc.2022.06.004.
• [34]Leonardi B,Secinaro A,Perrone MA,et al.Role of cardiovascular magnetic resonance end-systolic 3D-SSFP sequence in repaired tetralogy of Fallot patients eligible for transcatheter pulmonary valve implantation[J].Int J Cardiovasc Imaging,2019,35(8):1525-1533.DOI:10.1007/s10554-019-01630-9.
• [35]Cochet H,Iriart X,Allain-Nicolai A,et al.Focal scar and diffuse myocardial fibrosis are independent imaging markers in repaired tetralogy of Fallot[J].Eur Heart J Cardiovasc Imaging,2019,20(9):990-1003.DOI:10.1093/ehjci/jez068.
• [36]Secchi F,Resta EC,Cannao PM,et al.Four-year cardiac magnetic resonance(CMR)follow-up of patients treated with percutaneous pulmonary valve stent implantation[J].Eur Radiol,2015,25(12):3606-3613.DOI:10.1007/s00330-015-3781-5.
• [37] Savage P,Cox B,Linden K,et al.Advances in clinical cardiology 2021:a summary of key clinical trials[J].Adv Ther,2022,39(6):2398-2437.DOI:10.1007/s00330-015-3781-5.
• [38]Lurz P,Schober AR.Coronary artery compression in percutaneous pulmonary valve implantation:go the distance[J].JACCCardiovasc Interv,2022,15(9):989-991.DOI:10.1016/j.jcin.2022.03.031.
• [39]Morray BH,McElhinney DB,Cheatham JP,et al.Risk of coronary artery compression among patients referred for transcatheter pulmonary valve implantation:a multicenter experience[J].Circ Cardiovasc Interv,2013,6(5):535-542.DOI:10.1161/CIRCINTERVENTIONS.113.000202.
• [40]Ran L,Wang W,Secchi F,et al.Percutaneous pulmonary valve implantation in patients with right ventricular outflow tract dysfunction:a systematic review and meta-analysis[J].Ther Adv Chronic Dis,2019,10:2040622319857635.DOI:10.1177/2040622319857635.
• [41]McElhinney DB,Sondergaard L,Armstrong AK,et al.Endocarditis after transcatheter pulmonary valve replacement[J].J Am Coll Cardiol,2018,72(22):2717-2728.DOI:10.5606/tgkdc.dergisi.2022.23 5 06.
• [42] Sharma A,Cote AT,Hosking MCK,et al.A Systematic review of infective endocarditis in patients with bovine jugular vein valves compared with other valve types[J].JACC Cardiovasc Interv,2017,10(14):1449-1458.DOI:10.1016/j.jcin.2017.04.025.
• [43]Ostergaard 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/ehx682.
• [44]Le Ruz R,Plessis J,Houeijeh A,et al.Edwards SAPIEN XT transcatheter pulmonary valve implantation:5-year follow-up in a French Registry[J].Catheter Cardiovasc Interv,2021,98(5):990-999.DOI:10.1002/ccd.29862.
• [45]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):e3 5-e71.DOI:10.1161/CIR.0000000000000932.
• [46]Lurz P,Coats L,Khambadkone S,et al.Percutaneous pulmonary valve implantation:impact of evolving technology and learning curve on clinical outcome[J].Circulation,2008,117(15):1964-1972.DOI:10.1161/CIRCULATIONAHA.107.735779.
• [47] Boudjemline Y,Malekzadeh-Milani S,Patel M,et al.Predictors and outcomes of right ventricular outflow tract conduit rupture during percutaneous pulmonary valve implantation:a multicentre study[J].EuroIntervention,2016,11(9):1053-1062.DOI:10.4244/EIJY14M09_06.
• [48]Torres AJ.Pre-stenting and melody valve stent fracture:when more is less[J].JACC Cardiovasc Interv,2017,10(17):1760-1762.DOI:10.1016/j.jcin.2017.06.008.
• [49] Lawley CM,Tanous D,O'Donnell C,et al.Ten years of percutaneous pulmonary valve implantation in Australia and New Zealand[J].Heart Lung Circ,2022,31(12):1649-1657.DOI:10.1016/j.hlc.2022.07.008.