Observational studyClinical research in cardiology : official journal of the German Cardiac Society2017
Intravenous treprostinil infusion via a fully implantable pump for pulmonary arterial hypertension.
Observational study in Clinical research in cardiology : official journal of the German Cardiac Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01979822 (LPS), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
LPS (Lenus Pro Safety) - Study in Pulmonary Hypertension (PH)
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- Quality of life in patients with pulmonary arterial hypertension: A systematic review and meta-analysis.Health and quality of life outcomes · 2026Pooled it
- Evaluation of the Quality and Effect of 360° Safe Indwelling Infusion of Peripheral Venous Indwelling Needle in Pediatric Clinic.Journal of healthcare engineering · 2022Trial
- Periprocedural safety and outcome after pump implantation for intravenous treprostinil administration in patients with pulmonary arterial hypertension.BMC pulmonary medicine · 2021Observational
- Effect of Treprostinil on the Early Postoperative Prognosis of Patients with Severe Left Heart Valvular Disease Combined with Severe Pulmonary Hypertension.Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia · 2021Article
- A challenging case of severe pulmonary bleeding in a patient with congenital ventricular septal defect (VSD) and Eisenmenger syndrome: extracorporeal membrane oxygenation (ECMO) support and weaning strategies.Clinical research in cardiology : official journal of the German Cardiac Society · 2020Article
- Unexpected Acceleration in Treprostinil Delivery Administered by a Lenus Pro® Implantable Pump in Two Patients Treated for Pulmonary Arterial Hypertension.Frontiers in medicine · 2020Article
- The 6MWT as a prognostic tool in pulmonary arterial hypertension: results from the COMPERA registry.Clinical research in cardiology : official journal of the German Cardiac Society · 2018Article
- Future Applications of the Selective Prostacyclin (IP) Receptor Agonist Selexipag in Pediatric Pulmonary Hypertension.Pediatric cardiology · 2017Article
- Flow rate variance of a fully implantable pump for the delivery of intravenous treprostinil in pulmonary arterial hypertension.Pulmonary circulationArticle
- Should we use the oral selective IP receptor agonist selexipag off-label in children with pulmonary arterial hypertension?Pulmonary circulationArticle
- Intravenous treprostinil via an implantable pump in pediatric pulmonary arterial hypertension.Pulmonary circulationArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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
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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.