Richter, Manuel J., Harutyunova, Satenik, Bollmann, Tom, Classen, Simon, Gall, Henning, Gerhardt, Felix, Grimminger, Friedrich, Grimminger, Jan, Gruenig, Ekkehard, Guth, Stefan, Halank, Michael, Heine, Alexander, Hoeper, Marius M., Klose, Hans, Lange, Tobias J., Meyer, Katrin, Neurohr, Claus, Nickolaus, Kai, Olsson, Karen M., Opitz, Christian F., Rosenkranz, Stephan, Seyfarth, Hans-Juergen, Warnke, Christian, Wiedenroth, Christoph, Ghofrani, Hossein A. and Ewert, Ralf (2018). Long-term safety and outcome of intravenous treprostinil via an implanted pump in pulmonary hypertension. J. Heart Lung Transplant., 37 (10). S. 1235 - 1245. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1557-3117

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Abstract

BACKGROUND: We examined safety and long-term outcomes of intravenous treprostinil administered via the implantable LENUS Pro pump in patients with severe pulmonary hypertension (PH). METHODS: Patients with PH undergoing pump implantation between December 2009 and October 2016 in German referral centers were retrospectively analyzed (end of follow-up: May 2017). The primary objective was to determine long-term safety of the implantable pump. Secondary end points were 3-year survival and prognostic relevance of pre-implantation hemodynamics. RESULTS: We monitored 129 patients (120 with pulmonary arterial hypertension, 1 with PH due to lung diseases, and 8 with inoperable chronic thromboembolic PH) for 260 patient-years (median follow-up, 19 months; interquartile range, 11-34 months). There were 82 complications/peri-procedural events in 60 patients; of these, 57 were serious adverse events (0.60 per 1,000 treatment-days), including 2 peri-procedural deaths due to right heart failure. The incidence of complications related to the pump, catheter, infection, and pump pocket per 1,000 treatment-days was 0.074, 0.264, 0.032 (3 local infections; no bloodstream infections), and 0.380, respectively. Three-year overall and transplant-free survival were 66.5% and 55.7%, respectively (39 patients died; 16 underwent lung transplantation). Baseline cardiac index independently predicted transplant-free survival (multivariate hazard ratio, 1.90; 95% confidence interval, 1.11-3.28; p = 0.019; n=95). CONCLUSIONS: Our data suggest that intravenous treprostinil via the LENUS Pro pump in advanced PH is associated with a very low risk of bloodstream infections, but other serious adverse events may occur. Therefore, this therapy needs standardization and should be offered in specialized PH centers only. Further technical advances of the pump system and prospective studies are needed. (C) 2018 International Society for Heart and Lung Transplantation. All rights reserved.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Richter, Manuel J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Harutyunova, SatenikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bollmann, TomUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Classen, SimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gall, HenningUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gerhardt, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grimminger, FriedrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grimminger, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gruenig, EkkehardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guth, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Halank, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heine, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoeper, Marius M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klose, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lange, Tobias J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meyer, KatrinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Neurohr, ClausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nickolaus, KaiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Olsson, Karen M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Opitz, Christian F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rosenkranz, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seyfarth, Hans-JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Warnke, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wiedenroth, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghofrani, Hossein A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ewert, RalfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-170361
DOI: 10.1016/j.healun.2018.06.006
Journal or Publication Title: J. Heart Lung Transplant.
Volume: 37
Number: 10
Page Range: S. 1235 - 1245
Date: 2018
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1557-3117
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
BLOOD-STREAM INFECTIONS; SURVIVAL; THERAPY; PROSTACYCLIN; GUIDELINES; SYSTEMMultiple languages
Cardiac & Cardiovascular Systems; Respiratory System; Surgery; TransplantationMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/17036

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