Intravenous treprostinil infusion via a fully implantable pump for pulmonary arterial hypertension
ObjectivesParenteral 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 infus...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
20 April 2017
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| In: |
Clinical research in cardiology
Year: 2017, Volume: 106, Issue: 10, Pages: 776-783 |
| ISSN: | 1861-0692 |
| DOI: | 10.1007/s00392-017-1114-1 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1007/s00392-017-1114-1 Verlag, Volltext: https://doi.org/10.1007/s00392-017-1114-1 
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| Author Notes: | Ralf Ewert, Manuel J. Richter, Regina Steringer-Mascherbauer, Ekkehard Grünig, Tobias J. Lange, Christian F. Opitz, Christian Warnke, Hossein-Ardeschir Ghofrani |
| Summary: | ObjectivesParenteral 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.MethodsThirty 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.ResultsTwenty-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).ConclusionsThis 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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| Item Description: | Gesehen am 09.11.2018 |
| Physical Description: | Online Resource |
| ISSN: | 1861-0692 |
| DOI: | 10.1007/s00392-017-1114-1 |