Ralf Ewert1, Manuel J Richter2,3, Regina Steringer-Mascherbauer4,5, Ekkehard Grünig6, Tobias J Lange7, Christian F Opitz8, Christian Warnke1, Hossein-Ardeschir Ghofrani9,10,11. 1. Department of Internal Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany. 2. Department of Pneumology, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany. 3. Department of Internal Medicine, Member of the German Center for Lung Research (DZL), Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, Klinikstrasse 33, 35392, Giessen, Germany. 4. Department of Cardiology and Angiology, Public Hospital Elisabethinen Linz, Linz, Austria. 5. Academic Teaching Center, Linz, Austria. 6. Centre for Pulmonary Hypertension, Thoraxklinik at the University Hospital Heidelberg, Heidelberg, Germany. 7. Division of Pneumology, Department of Internal Medicine II, University Medical Center Regensburg, Regensburg, Germany. 8. Department of Cardiology, DRK Kliniken Berlin, Berlin, Germany. 9. Department of Pneumology, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany. ardeschir.ghofrani@innere.med.uni-giessen.de. 10. Department of Internal Medicine, Member of the German Center for Lung Research (DZL), Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, Klinikstrasse 33, 35392, Giessen, Germany. ardeschir.ghofrani@innere.med.uni-giessen.de. 11. Department of Medicine, Imperial College London, London, UK. ardeschir.ghofrani@innere.med.uni-giessen.de.
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.
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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