使用美敦力Melody瓣膜和爱德华SAPIEN瓣膜经导管肺动脉瓣植入术的长期疗效

Long-term outcomes of transcatheter pulmonary valve implantation with melody and SAPIEN valves.

作者信息

Houeijeh Ali, Batteux Clement, Karsenty Clement, Ramdane Nassima, Lecerf Florence, Valdeolmillos Estibaliz, Lourtet-Hascoet Julie, Cohen Sarah, Belli Emre, Petit Jérôme, Hascoët Sébastien

机构信息

Department of Congenital Heart Disease, Marie Lannelongue Hospital, BME lab, Centre Constitutif Réseau M3C Cardiopathies Congénitales Complexes, Groupe Hospitalier Paris Saint Joseph, Faculté de Médecine, Université Paris-Saclay, 133 avenue de la résistance, 92350 Le Plessis Robinson, France; Department of Congenital Heart Disease, Lille University Hospital, Faculté de médecine, Laboratoire EA4489, Université Lille II, Lille, France.

出版信息

Int J Cardiol. 2023 Jan 1;370:156-166. doi: 10.1016/j.ijcard.2022.10.141. Epub 2022 Oct 22.

DOI:10.1016/j.ijcard.2022.10.141

PMID:36283540

Abstract

BACKGROUND

Transcatheter pulmonary valve implantation (TPVI) is effective for treating right ventricle outflow tract (RVOT) dysfunction. Factors associated with long-term valve durability remain to be investigated.

METHODS

Consecutive patients successfully treated by TPVI with Melody valves (n = 32) and SAPIEN valves (n = 182) between 2008 and 2020 at a single tertiary centre were included prospectively and monitored.

RESULTS

The 214 patients had a median age of 28 years (range, 10-81). The RVOT was a patched native pulmonary artery in 96 (44.8%) patients. Median follow-up was 2.8 years (range, 3 months-11.4 years). Secondary pulmonary valve replacement (sPVR) was performed in 23 cases (10.7%), due to stenosis (n = 22, 95.7%) or severe regurgitation (n = 1, 4.3%), yielding an incidence of 7.6/100 patient-years with melody valves and 1.3/100 patient-years with SAPIEN valves (P = 0.06). The 5- and 10-year sPVR-freedom rates were 78.1% and 50.4% with Melody vs. 94.3% and 82.2% with SAPIEN, respectively (P = 0.06). The incidence of infective endocarditis (IE) was 5.5/100 patient-years with Melody and 0.2/100 patient-years with SAPIEN (P < 0.0001). Factors associated with sPVR by univariate analysis were RV obstruction before TPVI (P = 0.04), transpulmonary maximal velocity > 2.7 m/s after TPVI (p = 0.0005), valve diameter ≤ 22 mm (P < 0.003), IE (P < 0.0001), and age < 25 years at TPVI (P = 0.04). By multivariate analysis adjusted for IE occurrence, transpulmonary maximal velocity remained associated with sPVR.

CONCLUSIONS

TPVI is effective for treating RVOT dysfunction. Incidence of sPVR is higher in patients with residual RV obstruction or IE. IE add a substantial risk of TPVI graft failure and is mainly linked to the Melody valve.

SOCIAL MEDIA ABSTRACT

Transcatheter pulmonary valve implantation is effective for treating right ventricular outflow tract dysfunction in patients with congenital heart diseases. Incidence of secondary valve replacement is higher in patients with residual obstruction or infective endocarditis.

摘要

背景

经导管肺动脉瓣植入术（TPVI）对于治疗右心室流出道（RVOT）功能障碍有效。与瓣膜长期耐用性相关的因素仍有待研究。

方法

前瞻性纳入并监测了2008年至2020年在一家三级中心连续接受Melody瓣膜（n = 32）和SAPIEN瓣膜（n = 182）TPVI成功治疗的患者。

结果

214例患者的中位年龄为28岁（范围10 - 81岁）。96例（44.8%）患者的RVOT为补片修补的天然肺动脉。中位随访时间为2.8年（范围3个月 - 11.4年）。23例（10.7%）患者因狭窄（n = 22，95.7%）或严重反流（n = 1，4.3%）接受了二次肺动脉瓣置换（sPVR），Melody瓣膜的发生率为7.6/100患者年，SAPIEN瓣膜为1.3/100患者年（P = 0.06）。Melody瓣膜和SAPIEN瓣膜的5年和10年无sPVR率分别为78.1%和50.4% 以及94.3%和82.2%（P = 0.06）。感染性心内膜炎（IE）的发生率Melody瓣膜为5.5/100患者年，SAPIEN瓣膜为0.2/100患者年（P < 0.0001）。单因素分析显示与sPVR相关的因素有TPVI前RV梗阻（P = 0.04）、TPVI后经肺动脉最大流速>2.7 m/s（P = 0.0005）、瓣膜直径≤22 mm（P < 0.003）、IE（P < 0.0001）以及TPVI时年龄<25岁（P = 0.04）。经多因素分析校正IE发生情况后，经肺动脉最大流速仍与sPVR相关。