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01-10-2017 | Original Paper

Intravenous treprostinil infusion via a fully implantable pump for pulmonary arterial hypertension

Authors: Ralf Ewert, Manuel J. Richter, Regina Steringer-Mascherbauer, Ekkehard Grünig, Tobias J. Lange, Christian F. Opitz, Christian Warnke, Hossein-Ardeschir Ghofrani

Published in: Clinical Research in Cardiology | Issue 10/2017

Abstract

Objectives

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.

Methods

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.

Results

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).

Conclusions

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.

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Title: Intravenous treprostinil infusion via a fully implantable pump for pulmonary arterial hypertension
Authors: Ralf Ewert
Manuel J. Richter
Regina Steringer-Mascherbauer
Ekkehard Grünig
Tobias J. Lange
Christian F. Opitz
Christian Warnke
Hossein-Ardeschir Ghofrani
Publication date: 01-10-2017
Publisher: Springer Berlin Heidelberg
Published in: Clinical Research in Cardiology / Issue 10/2017
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-017-1114-1

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