Department of Internal Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany.
Department of Pneumology, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany.
Clin Res Cardiol. 2017 Oct;106(10):776-783. doi: 10.1007/s00392-017-1114-1. Epub 2017 Apr 20.
Parenteral prostanoids infused via external pumps are well-established pulmonary arterial hypertension (PAH) treatments. However, local side-effects and systemic infections restrict their use. The purpose of this study was to investigate the safety of a fully implantable treprostinil infusion pump (LENUS Pro) in patients with PAH.
Thirty patients with PAH undergoing pump implantation (with stable PAH therapy for ≥3 weeks pre-implantation) were included in this prospective, multicenter, observational study (NCT01979822). Primary endpoints were predefined adverse events (AEs) during implantation, in-hospital and/or during 6-month follow-up. Refill-related AEs were a secondary endpoint.
Twenty-nine patients completed 6-month follow-up (one underwent lung transplantation). During implantation, one pneumothorax (not requiring drainage) occurred. Four patients had an in-hospital AE (including one catheter revision). During 6-month follow-up, AEs were most frequent at the first refill (10); the most common AE was seroma around the pump. No infections occurred. One pump required replacement because of a defective septum caused by use of a non-approved refill needle (associated with extravasation). Apart from the extravasation, no refill-related AEs were recorded. Post hoc efficacy analyses showed significant improvements in functional class [number in functional class I/II/III/IV: 0/5/21/2 (baseline) versus 3/8/17/0 (6 months); p = 0.012] and 6-min walk distance (mean ± standard deviation: 407 ± 122 m versus 445 ± 127 m; n = 17; p = 0.014).
This study supports use of a fully implantable treprostinil infusion pump in patients with PAH requiring parenteral prostanoids. Refills should be performed by specialized healthcare professionals at patients' homes or at experienced centers using approved equipment.
通过外部泵输注的肠外前列腺素已被广泛用于治疗肺动脉高压（PAH）。然而，局部副作用和全身感染限制了它们的使用。本研究旨在研究完全可植入的前列环素输注泵（LENUS Pro）在 PAH 患者中的安全性。
这项前瞻性、多中心、观察性研究（NCT01979822）纳入了 30 名正在接受泵植入的 PAH 患者（在植入前至少稳定接受 3 周的 PAH 治疗）。主要终点为植入过程中、住院期间和/或 6 个月随访期间的预先定义的不良事件（AE）。与再填充相关的 AE 为次要终点。
29 名患者完成了 6 个月的随访（1 名患者接受了肺移植）。植入过程中，发生 1 例气胸（无需引流）。4 名患者出现住院期间的 AE（包括 1 例导管修订）。在 6 个月的随访期间，第一次再填充时 AE 最常见（10 例）；最常见的 AE 是泵周围的血清肿。无感染发生。由于使用未经批准的再填充针导致隔膜缺陷（伴外渗），1 个泵需要更换。除了外渗，没有记录到与再填充相关的 AE。事后疗效分析显示，功能分级显著改善[功能分级 I/II/III/IV 的人数：0/5/21/2（基线）与 3/8/17/0（6 个月）；p=0.012]和 6 分钟步行距离（平均值±标准差：407±122 m 与 445±127 m；n=17；p=0.014）。
本研究支持在需要肠外前列腺素的 PAH 患者中使用完全可植入的前列环素输注泵。再填充应由专门的医疗保健专业人员在患者家中或在使用经批准设备的有经验的中心进行。
