一项关于脱细胞同种移植物用于肺动脉瓣置换的欧洲研究：前瞻性 ESPOIR 试验的初步结果和 ESPOIR 注册数据†。
A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†.
机构信息
Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Department of Congenital Cardiac Surgery, Leiden University Medical Center, Leiden, Netherlands.
出版信息
Eur J Cardiothorac Surg. 2019 Sep 1;56(3):503-509. doi: 10.1093/ejcts/ezz054.
OBJECTIVES
Decellularized pulmonary homografts (DPH) have shown excellent results for pulmonary valve replacement. However, controlled multicentre studies are lacking to date.
METHODS
Prospective European multicentre trial evaluating DPH for pulmonary valve replacement. Matched comparison of DPH to bovine jugular vein (BJV) conduits and cryopreserved homografts (CH) considering patient age, type of heart defect and previous procedures.
RESULTS
In total, 121 patients (59 female) were prospectively enrolled (August 2014-December 2016), age 21.3 ± 14.4 years, DPH diameter 24.4 ± 2.8 mm. No adverse events occurred with respect to surgical handling; there were 2 early deaths (30 + 59 years) due to myocardial failure after multi-valve procedures and no late mortality (1.7% mortality). After a mean follow-up of 2.2 ± 0.6 years, the primary efficacy end points mean peak gradient (16.1 ± 12.1 mmHg) and regurgitation (mean 0.25 ± 0.48, grade 0-3) were excellent. One reoperation was required for recurrent subvalvular stenosis caused by a pericardial patch and 1 balloon dilatation was performed on a previously stented LPA. 100% follow-up for DPH patients operated before or outside the trial (n = 114) included in the ESPOIR Registry, age 16.6 ± 10.4 years, diameter 24.1 ± 4.2 mm, follow-up 5.1 ± 3.0 years. The combined DPH cohort, n = 235, comprising both Trial and Registry data showed significantly better freedom from explantation (DPH 96.7 ± 2.1%, CH 84.4 ± 3.2%, P = 0.029 and BJV 82.7 ± 3.2%, P = 0.012) and less structural valve degeneration at 10 years when matched to CH, n = 235 and BJV, n = 235 (DPH 61.4 ± 6.6%, CH 39.9 ± 4.4%, n.s., BJV 47.5 ± 4.5%, P = 0.029).CONCLUSIONS: Initial results of the prospective multicentre ESPOIR Trial showed DPH to be safe and efficient. Current DPH results including Registry data were superior to BJV and CH.Trial registration clinicaltrials.gov identifier: NCT02035540.
目的
去细胞肺动脉同种移植物（DPH）在肺动脉瓣置换中显示出优异的效果。然而，目前缺乏对照的多中心研究。
方法
前瞻性欧洲多中心试验，评估 DPH 在肺动脉瓣置换中的应用。比较 DPH 与牛颈静脉（BJV）移植物和冷冻同种移植物（CH），考虑患者年龄、心脏缺陷类型和先前的手术。
结果
共前瞻性纳入 121 例（59 例女性）患者（2014 年 8 月至 2016 年 12 月），年龄 21.3±14.4 岁，DPH 直径 24.4±2.8mm。在手术处理方面，没有发生不良事件；2 例早期死亡（30+59 岁），原因是多瓣膜手术后心肌衰竭，无晚期死亡（1.7%死亡率）。平均随访 2.2±0.6 年后，主要疗效终点平均峰值梯度（16.1±12.1mmHg）和反流（平均 0.25±0.48，0-3 级）均为优。1 例因心包补片引起的瓣下狭窄复发，1 例行 LPA 支架扩张术，需再次手术。ESPOIR 注册研究中纳入了在试验外或试验前接受 DPH 手术的 114 例（n=114）患者，100%随访，年龄 16.6±10.4 岁，直径 24.1±4.2mm，随访 5.1±3.0 年。包含试验和注册数据的 235 例 DPH 患者的合并队列，显示 DPH 组的无移植物生存率显著更高（DPH 96.7±2.1%，CH 84.4±3.2%，P=0.029，BJV 82.7±3.2%，P=0.012），在匹配 CH（n=235）和 BJV（n=235）的情况下，10 年时结构性瓣膜退化发生率也更低（DPH 61.4±6.6%，CH 39.9±4.4%，无显著差异，BJV 47.5±4.5%，P=0.029）。
结论
前瞻性多中心 ESPOIR 试验的初步结果表明 DPH 是安全有效的。目前包括注册研究在内的 DPH 结果优于 BJV 和 CH。
试验注册
clinicaltrials.gov 标识符：NCT02035540。
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