经导管肺动脉瓣置换术
针对存在右心室与肺动脉通道异常(反流或狭窄)的患者,经导管肺动脉瓣置换术 (transcatheter pulmonary valve replacement, TPVR) 作为较外科手术更为微创的治疗方式正在兴起。现可使用将三叶牛颈静脉缝入球囊的可扩张支架,欧洲及美国已有数项临床试验显示了较高的手术成功率,鲜有手术并发症,并能保持肺动脉瓣的完整性。[18]Khambadkone S, Coats L, Taylor A, et al. Percutaneous pulmonary valve implantation in humans: results in 59 consecutive patients. Circulation. 2005 Aug 23;112(8):1189-97.http://circ.ahajournals.org/content/112/8/1189.longhttp://www.ncbi.nlm.nih.gov/pubmed/16103239?tool=bestpractice.com[19]McElhinney DB, Hellenbrand WE, Zahn EM, et al. Short and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010 Aug 3;122(5):507-16.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4240270/http://www.ncbi.nlm.nih.gov/pubmed/20644013?tool=bestpractice.com 2010 年,美国食品药品监督管理局 (FDA) 批准对功能不全(反流或狭窄)的右心室流出道进行经导管肺动脉瓣置入术。[19]McElhinney DB, Hellenbrand WE, Zahn EM, et al. Short and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010 Aug 3;122(5):507-16.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4240270/http://www.ncbi.nlm.nih.gov/pubmed/20644013?tool=bestpractice.com 人们对此治疗存在的顾虑之一便是支架断裂,其发生率高达 25%。[20]McElhinney DB, Cheatham JP, Jones TK, et al. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody valve trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14.http://www.ncbi.nlm.nih.gov/pubmed/22075927?tool=bestpractice.com 一项获批后的研究目前已经完成了 1 年的随访。[21]Armstrong AK, Balzer DT, Cabalka AK, et al. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62.https://www.sciencedirect.com/science/article/pii/S1936879814012308?via%3Dihubhttp://www.ncbi.nlm.nih.gov/pubmed/25459038?tool=bestpractice.com 研究涉及 100 例植入这种瓣膜的患者,结果显示操作成功率依然很高 (98%),短期瓣膜功能高(96.7% 的患者在 6 个月时获得了可接受的血流动力学表现),1 年时的再次介入率和再次手术率低。 7 例患者发生支架折断,其中一例由于严重狭窄但无肺动脉瓣反流,需要再次介入操作。 另一种用于治疗同样适应症的经导管心脏瓣膜已经在一项多中心 1 期临床试验中接受了评估。 这项 1 期临床试验的结果证明了这种瓣膜的安全性和短期耐久性。[22]Kenny D, Hijazi ZM, Kar S, et al. Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. J Am Coll Cardiol. 2011 Nov 15;58(21):2248-56.https://www.sciencedirect.com/science/article/pii/S0735109711030828?via%3Dihubhttp://www.ncbi.nlm.nih.gov/pubmed/22078433?tool=bestpractice.com 明确经导管肺动脉瓣置换术在这一人群中的手术时机和作用尚需更多长期随访资料。