Pediatric Cardiology, Policlinico San Donato IRCCS, San Donato Milanese, Italy.
Catheter Cardiovasc Interv. 2013 Feb;81(2):310-6. doi: 10.1002/ccd.24518. Epub 2012 Nov 14.
Percutaneous implantation of pulmonary valve has been recently introduced in the clinical practice. Our aim was to analyze data of patients treated in Italy by using the Melody Medtronic valve.
Prospective, observational, multi-centric survey by means of a web-based database registry of the Italian Society of Pediatric Cardiology (SICP).
Between October 2007 and October 2010, 63 patients were included in the registry (median age: 24 years; range 11-65 years). Forty subjects were in NYHA class I-II while 23 were in NYHA class III-IV. Patients included had a history of a median three previous surgeries (range 1-5) and a median of one previous cardiac catheterization (range 0-4). A cono-truncal disease was present in 39 patients, previous Ross operation in 9, and other diagnosis in 15. Indication to valve implantation was pure stenosis in 21 patients, pure regurgitation in 12, association of stenosis and regurgitation in 30. Implantation was performed in 61 subjects (97%). Pre-stenting was performed in 85% of cases. Median procedure time was 170 minutes (range 85-360). No significant regurgitation was recorded after procedure while the trans-pulmonary gradient reduced significantly. Early major complications occurred in seven subjects (11%). One death occurred in the early post-operative period in a severely ill subject. At a median follow-up of 30 months (range 12-48 months), three patients died due to underlying disease. Major complications occurred in six patients during follow-up (external electric cardioversion: one patient; herpes virus encephalitis: two patients; Melody valve endocarditis needing surgical explant: two patients; major fractures of the stent and need second Melody valve implantation: two patients). Freedom from valve failure at latest follow-up was 81.4% ± 9%.
Early results of the SICP registry on transcatheter Melody pulmonary valve implantation show that the procedure is safe and successful. Major concerns are related to the occurrence of stent fracture and bacterial endocarditis. Longer follow-up and larger series are needed.
经皮肺动脉瓣植入术最近已在临床实践中引入。我们的目的是分析意大利使用美敦力 Melody 瓣膜治疗的患者数据。
意大利儿科心脏病学会（SICP）通过基于网络的数据库登记进行前瞻性、观察性、多中心研究。
2007 年 10 月至 2010 年 10 月，登记处共收录 63 例患者（中位年龄：24 岁；范围 11-65 岁）。40 例患者 NYHA 心功能分级为 I-II 级，23 例为 III-IV 级。患者中位既往手术次数为 3 次（范围 1-5 次），中位心脏导管术次数为 1 次（范围 0-4 次）。39 例患者存在圆锥动脉干疾病，9 例患者曾行 Ross 手术，15 例患者存在其他诊断。21 例患者植入瓣膜的适应证为单纯狭窄，12 例为单纯反流，30 例为狭窄合并反流。61 例（97%）患者成功植入瓣膜。85%的病例行预扩张支架术。中位手术时间为 170 分钟（范围 85-360 分钟）。术后无明显反流，跨瓣压差明显降低。7 例（11%）患者发生早期严重并发症。1 例严重疾病患者术后早期死亡。中位随访 30 个月（范围 12-48 个月），3 例患者因基础疾病死亡。随访期间 6 例患者发生严重并发症（1 例患者行体外电复律；2 例患者患疱疹病毒脑炎；2 例患者因 Melody 瓣膜心内膜炎需行外科瓣膜取出术；2 例患者发生支架严重骨折，需再次植入 Melody 瓣膜）。最新随访时瓣膜无功能发生率为 81.4%±9%。
意大利儿科心脏病学会关于经导管 Melody 肺动脉瓣植入术的早期结果表明，该操作安全有效。主要关注点与支架骨折和细菌性心内膜炎的发生有关。需要进行更长时间的随访和更大规模的研究。
