Manuel J Richter1, Satenik Harutyunova2, Tom Bollmann3, Simon Classen4, Henning Gall5, Felix Gerhardt Md6, Friedrich Grimminger5, Jan Grimminger7, Ekkehard Grünig2, Stefan Guth8, Michael Halank9, Alexander Heine3, Marius M Hoeper10, Hans Klose11, Tobias J Lange12, Katrin Meyer10, Claus Neurohr13, Kai Nickolaus14, Karen M Olsson10, Christian F Opitz15, Stephan Rosenkranz6, Hans-Jürgen Seyfarth16, Christian Warnke3, Christoph Wiedenroth8, Hossein A Ghofrani17, Ralf Ewert18. 1. Department of Pneumology, Kerckhoff Heart, Rheuma and Thoracic Center, Bad Nauheim, Germany; Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC),Giessen, Germany; German Center for Lung Research (DZL), Giessen, Germany. 2. Center for Pulmonary Hypertension, Thorax Clinic at the University Hospital Heidelberg, Heidelberg, Germany. 3. Department of Internal Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany. 4. Department of Vascular Surgery, Kerckhoff Heart, Rheuma and Thoracic Center, Bad Nauheim, Germany. 5. Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC),Giessen, Germany; German Center for Lung Research (DZL), Giessen, Germany. 6. Department III of Internal Medicine and Cologne Cardiovascular Research Center (CCRC), Cologne University Heart Center, Cologne, Germany. 7. Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC),Giessen, Germany; German Center for Lung Research (DZL), Giessen, Germany; Department of Pneumology, University of Hamburg, Hamburg, Germany. 8. Department of Thoracic Surgery, Kerckhoff Heart, Rheuma and Thoracic Center, Bad Nauheim, Germany. 9. Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany. 10. German Center for Lung Research (DZL), Giessen, Germany; Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany. 11. Department of Pneumology, University of Hamburg, Hamburg, Germany. 12. Department of Internal Medicine II, Division of Pneumology, University Medical Center Regensburg, Regensburg, Germany. 13. Division of Pulmonary Diseases, Ludwig Maximilians University, Munich, Germany. 14. Department of Pneumology, Kerckhoff Heart, Rheuma and Thoracic Center, Bad Nauheim, Germany. 15. Department of Cardiology, DRK Kliniken Berlin, Berlin, Germany. 16. Department of Pneumology, University of Leipzig, Leipzig, Germany. 17. Department of Pneumology, Kerckhoff Heart, Rheuma and Thoracic Center, Bad Nauheim, Germany; Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC),Giessen, Germany; German Center for Lung Research (DZL), Giessen, Germany; Department of Medicine, Imperial College London, London, United Kingdom. 18. Department of Internal Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany. Electronic address: ewert@uni-greifswald.de.
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 periprocedural 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.
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 periprocedural 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 patientsdied; 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.
Authors: Jan C Kamp; Jan Fuge; Jan F Karsten; Stefan Rümke; Marius M Hoeper; Da-Hee Park; Christian Kühn; Karen M Olsson Journal: BMC Pulm Med Date: 2021-05-15 Impact factor: 3.317
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Authors: Manuel J Richter; Satenik Harutyunova; Tom Bollmann; Simon Classen; Jan Fuge; Henning Gall; Felix Gerhardt; Hossein A Ghofrani; Hartmut Gunkel; Ekkehard Grünig; Michael Halank; Alexander Heine; Hans Klose; Tobias J Lange; Claus Neurohr; Kai Nickolaus; Christian F Opitz; Stephan Rosenkranz; Hans-Jürgen Seyfarth; Khodr Tello; Ralf Ewert; Karen M Olsson Journal: Pulm Circ Date: 2020-03-13 Impact factor: 3.017