经导管肺动脉 Sapien 3 瓣膜植入术的结果：一项国际注册研究。

Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

机构信息

Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph, Faculté de médecine Paris-Saclay, Université Paris-Saclay, BME laboratory, 133 avenue de la résistance, 92350 Le Plessis Robinson, France.

Royal Brompton Hospital, Sydney Street, London, Greater London SW3 6NP, UK.

出版信息

Eur Heart J. 2024 Jan 14;45(3):198-210. doi: 10.1093/eurheartj/ehad663.

DOI:10.1093/eurheartj/ehad663

PMID:37874971

Abstract

BACKGROUND AND AIMS

Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI.

METHODS

Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries.

RESULTS

Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively.

CONCLUSIONS

Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

摘要

背景和目的

经导管肺动脉瓣植入术（TPVI）用于治疗与先天性心脏病（CHD）相关的右心室流出道（RVOT）功能障碍。在 SAPIEN 3-TPVI 的 EUROPULMS3 注册研究中，对 SAPIEN 3 瓣膜的 TPVI 治疗结果进行了评估。

方法

本回顾性观察队列研究纳入了来自 15 个国家 35 个中心的患者相关、手术和随访结果数据。

结果

2014 年至 2021 年共纳入 840 例连续患者，中位年龄为 29.2（19.0-41.6）岁。最常见的诊断为圆锥动脉干缺陷（70.5%），50.7%的患者均存在原发性或修补后的 RVOT。瓣膜大小分别为 20、23、26 和 29mm 的患者比例分别为 0.4%、25.5%、32.1%和 42.0%。98.5%（95%置信区间（CI）：97.4%-99.2%）的患者手术成功。中位随访时间为 20.3（7.1-38.4）个月。8 例患者发生感染性心内膜炎，11 例患者需要肺动脉瓣置换，大瓣膜的发生率较低（P=0.009），4 例患者发生肺动脉瓣血栓形成，其中 1 例死亡，3 例抗凝治疗后恢复。TPVI 后 1、3 和 6 年的累积发生率（95%CI）如下：感染性心内膜炎分别为 0.5%（0.0%-1.0%）、0.9%（0.2%-1.6%）和 3.8%（0.0%-8.4%）；肺动脉瓣置换分别为 0.4%（0.0%-0.8%）、1.3%（0.2%-2.4%）和 8.0%（1.2%-14.8%）；肺动脉瓣血栓形成分别为 0.4%（0.0%-0.9%）、0.7%（0.0%-1.3%）和 0.7%（0.0%-1.3%）。