新型自膨式经皮肺动脉瓣（Pulsta 瓣）植入术的可行性人体试验：使用编织型镍钛合金丝骨架和三叶型无α-Gal 猪心包瓣在自体右心室流出道。
Successful Feasibility Human Trial of a New Self-Expandable Percutaneous Pulmonary Valve (Pulsta Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet α-Gal-Free Porcine Pericardial Valve in the Native Right Ventricular Outflow Tract.
机构信息
From the Departments of Pediatrics (G.B.K., M.K.S., E.J.B.).
Radiology (E.-A.P., W.L.).
出版信息
Circ Cardiovasc Interv. 2018 Jun;11(6):e006494. doi: 10.1161/CIRCINTERVENTIONS.118.006494.
BACKGROUND
Self-expandable percutaneous pulmonary valve implantation (PPVI) for native right ventricular outflow tract lesions is still in the clinical trial phase. The aim of this study is to present the result of feasibility study of a novel self-expandable knitted nitinol wire stent mounted with a treated trileaflet α-Gal-free porcine pericardial valve for PPVI.
METHODS AND RESULTS
A feasibility study using Pulsta valve (TaeWoong Medical Co, Gyeonggi-do, South Korea) was designed for patients with severe pulmonary regurgitation in the native right ventricular outflow tract, and 6-month follow-up outcomes were reviewed. Ten tetralogy of Fallot patients were enrolled. Before PPVI, severe pulmonary regurgitation (mean pulmonary regurgitation fraction, 45.5%±7.2%; range, 34.9%-56%) and enlarged right ventricular volume (mean indexed right ventricular end-diastolic volume, 176.7±14.3 mL/m; range, 158.9-205.9 mL/m) were present. The median age at PPVI was 21.7±6.5 years (range, 13-36 years). Five patients were successfully implanted with 28 mm and the other 5 with 26 mm valves loaded on the 18F delivery cable. No significant periprocedural complications were noted in any patient. At the 6-month follow-up, indexed right ventricular end-diastolic volume was dramatically decreased to 126.3±20.3 mL/m (range, 99-164.2 mL/m), and the mean value of peak instantaneous pressure gradient between the right ventricle and the pulmonary artery decreased from 6.8±3.5 mm Hg (range, 2-12 mm Hg) before PPVI to 5.7±6.7 mm Hg (range, 2-12 mm Hg) without significant pulmonary regurgitation. There was no adverse event associated with the valve.
CONCLUSIONS
A feasibility study of the Pulsta valve for native right ventricular outflow tract lesions was completed successfully with planned Pulsta valve implantation and demonstrated good short-term effectiveness without serious adverse events.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02555319.
背景
自体可扩张经皮肺动脉瓣植入术（PPVI）用于治疗先天性右心室流出道病变仍处于临床试验阶段。本研究旨在介绍一种新型自膨式编织镍钛诺丝支架的可行性研究结果，该支架上安装了经处理的三叶α-Gal 无猪心包瓣，用于 PPVI。
方法和结果
设计了一项使用 Pulsta 瓣膜（TaeWoong Medical Co，京畿道，韩国）的可行性研究，用于治疗先天性右心室流出道重度肺动脉瓣反流的患者，并对 6 个月的随访结果进行了回顾。共纳入 10 例法洛四联症患者。在 PPVI 之前，患者存在严重的肺动脉瓣反流（平均肺动脉瓣反流分数 45.5%±7.2%；范围 34.9%-56%）和右心室容积增大（平均右心室舒张末期容积指数 176.7±14.3 mL/m；范围 158.9-205.9 mL/m）。PPVI 的中位年龄为 21.7±6.5 岁（范围 13-36 岁）。5 例患者成功植入 28mm 瓣膜，另 5 例患者植入 26mm 瓣膜，均装载在 18F 输送导丝上。在任何患者中均未观察到显著的围手术期并发症。在 6 个月的随访中，右心室舒张末期容积指数显著降低至 126.3±20.3 mL/m（范围 99-164.2 mL/m），右心室与肺动脉之间的峰值瞬时压力梯度的平均值从 PPVI 前的 6.8±3.5 mm Hg（范围 2-12 mm Hg）降至 5.7±6.7 mm Hg（范围 2-12 mm Hg），且无明显的肺动脉瓣反流。瓣膜无不良事件发生。
结论
成功完成了用于治疗先天性右心室流出道病变的 Pulsta 瓣膜的可行性研究，计划进行 Pulsta 瓣膜植入术，且短期疗效良好，无严重不良事件发生。
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