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DOI: 10.1055/s-0039-3403348
Long-term safety and outcome of subcutaneous and intravenous treprostinil treatment in patients with severe chronic pulmonary hypertension
Publication History
Publication Date:
28 February 2020 (online)
Background: The objective of this study was to analyse safety, clinical effects and long-term outcomes of s. c. and/or i. v. treprostinil administered via Crono and implantable LENUS Pro pump in consecutive patients with severe PAH.
Methods: Thirty-seven PAH patients (20 females, mean age 51 ± 15 years, mean pulmonary arterial pressure at diagnosis 62.3 ± 14.4 mmHg, cardiac index 2.4 ± 0.7 L/min/m2, pulmonary vascular resistance 938 ± 351.7dyn×sec×cm−5, WHO functional class 6 II, 26 III, 5 IV) who were on triple PAH medication (ERA, PDE5 inhibitors and treprostinil s. c./i. v.) were clinically assessed every 3 months ([Fig. 1]). Survival rate was analysed using Kaplan Meier estimation.
Results: Patients showed a significant improvement of 6-minute walking distance after 3 (p = 0.021), 6 (p = 0.033) and 12 months (p = 0.042) of s. c. treprostinil treatment. Furthermore, tricuspid annular plane systolic excursion, right atrial and right ventricular area improved after 3 and 6 months s. c. treatment compared to baseline (all p < 0.05). After a mean therapy with treprostinil s. c. of 6 ± 0.9 months, in 24 patients a Lenus Pro pump was implanted for i. v. administration of treprostinil. Two pumps required surgical revision after 1.5 ± 1 months, four further pumps had to be explanted after 11 ± 12 months (due to infection n = 2, catheter occlusion n = 1, tear off of catheter n = 1). During a mean follow-up of 2.82 ± 1.95 years in all patients, 12 patients died, three patients received lung transplantation. Transplant-free survival after 1 year was 85.7%, after 2 years 69.2% and after 3 years 65.3%.
Conclusion: S. c. treprostinil as add-on to double combination treatment significantly improved right heart size and function in PAH. In most patients treprostinil could be continued via implanted Lenus Pro pump and showed in view of the severe disease a reasonable overall-survival.