Department of Pediatrics, Seoul National University Children's Hospital, Seoul National University School of Medicine, Seoul, South Korea.
Department of Pediatrics, Sejong General Hospital, Bucheon, South Korea.
Catheter Cardiovasc Interv. 2021 Nov 1;98(5):E724-E732. doi: 10.1002/ccd.29865. Epub 2021 Jul 6.
The aim of this study is to present the mid-term outcomes of Pulsta valve.
The Pulsta valve is a Self-expandable knitted nitinol-wire stent mounted with a treated tri-leaflet α-Gal-free porcine pericardial valve for percutaneous pulmonary valve implantation (PPVI) in patients with native right ventricular outflow tract (RVOT) lesions.
A multi-center clinical trial using Pulsta valve® was designed for patients with severe pulmonary regurgitation (PR) in the native RVOT in multiple centers in South Korea and 25 patients were enrolled. Before PPVI, severe PR (mean PR fraction: 45.5 ± 6.9%) and enlarged RV volume (mean indexed RV end-diastolic volume; 169.7 ± 13.0 ml/m ) was present. The mean age was 21.6 ± 6.6 years old.
All patients were successfully implanted with 26, 28, or 32 mm diameter of Pulsta valve loaded on the 18 or 20 French delivery catheters. At 6 months follow up, indexed RV end-diastolic volume was decreased to 126.9 ± 16.9 ml/m . At mean 33.1 ± 14.3 months follow-up, the mean value of mean pressure gradient in Pulsta valve was 6.5 ± 3.0 mmhg without significant PR. There was no serious device-related adverse event.
A multi-center clinical trial was completed successfully with planned Pulsta valve implantation and demonstrated good mid-term effectiveness without device-related serious adverse events.
本研究旨在介绍 Pulsta 瓣膜的中期结果。
Pulsta 瓣膜是一种自扩张编织镍钛诺丝支架，带有经过处理的三叶式无α-Gal 猪心包瓣，用于经皮肺动脉瓣植入术（PPVI）治疗先天性右心室流出道（RVOT）病变患者。
在韩国的多个中心进行了一项多中心临床试验，使用 Pulsta valve®治疗 25 名患有先天性 RVOT 重度肺动脉瓣反流（PR）的患者。在 PPVI 之前，存在严重的 PR（平均 PR 分数：45.5±6.9%）和 RV 体积增大（平均指数化 RV 舒张末期容积；169.7±13.0ml/m ）。平均年龄为 21.6±6.6 岁。
所有患者均成功植入 26、28 或 32mm 直径的 Pulsta 瓣膜，装载在 18 或 20 法国输送导管上。6 个月随访时，指数化 RV 舒张末期容积降至 126.9±16.9ml/m 。平均 33.1±14.3 个月随访时，Pulsta 瓣膜平均压力梯度为 6.5±3.0mmHg，无明显 PR。无严重与器械相关的不良事件。
成功完成了多中心临床试验，计划进行 Pulsta 瓣膜植入术，并显示出良好的中期效果，无与器械相关的严重不良事件。
