Key result
The use of the Lenus Pro implantable pump for intravenous treprostinil significantly improved the Physical Component Score of the SF-36 from 28 to 38 points (p<0.001) compared to baseline subcutaneous infusion.
Why the study?
Does intravenous treprostinil via the Lenus Pro implantable pump improve health-related quality of life in PAH patients intolerant to subcutaneous treprostinil?
Observational (n=12)
Yes
Does intravenous treprostinil via the Lenus Pro implantable pump improve health-related quality of life in PAH patients intolerant to subcutaneous treprostinil?
Absolute Event Rate: 38% vs 28%
p-value: p=<0.001
Switching from subcutaneous to intravenous treprostinil via an implantable pump significantly improves physical quality of life and vitality in PAH patients who cannot tolerate subcutaneous infusion pain.
BACKGROUND: Subcutaneous treprostinil is a prostacyclin analogue used to treat pulmonary arterial hypertension (PAH). Due to local pain it can cause a deterioration of heart related quality of life (HRQoL) or even abandonment of treatment. The aim of this paper was to assess the feasibility of treatment with intravenous treprostinil administered by means of the Lenus Pro® implantable pump. METHODS: This was a retrospective, multi-center study involving 12 patients (8 females) with PAH treated with a subcutaneous infusion of treprostinil with intolerable pain at the infusion site. Clinical evaluation, including HRQoL assessment with SF-36 questionnaire was performed, before pump implantation and 2-9 months after. The median time of follow-up time was 14 months (4-29 months). RESULTS: After implantation of the Lenus Pro® pump, no statistically significant changes were observed in the 6-min walking distance and NT-proBNP. After implantation 50% of patients were in II WHO functional class (33% before, p = 0,59). There was a significant improvement in HRQoL within the Physical Component Score (28 ± 7 vs 38 ± 8 pts., p < 0,001) and in specific domains of SF-36 form: physical role (31 ± 7 pts. vs. 41 ± 12 pts., p = 0,03), bodily pain (31 ± 12 vs. 50 ± 14 pts., p = 0,02), and vitality (37 ± 8 pts. vs. 50 ± 14 pts., p = 0,03). During the periprocedural period, one patient developed a recurrent haematoma at the implantation site. During follow-up in one patient, the drug delivering cannula slipped out of the subclavian vein, what required repositioning repeated twice, and in another patient an unexpected increase in the drug administration rate was observed. CONCLUSIONS: In patients with PAH who do not tolerate subcutaneous infusion of treprostinil, the use of the Lenus Pro® implantable pump results in significant subjective improvement of vitality and physical aspect of the HRQoL with acceptable safety profile.
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Kurzyna et al. (2017) conducted an observational in Pulmonary arterial hypertension (n=12). Lenus Pro implantable pump for intravenous treprostinil vs. Subcutaneous treprostinil (baseline) was evaluated on Physical Component Score (SF-36) (p=<0.001). The use of the Lenus Pro implantable pump for intravenous treprostinil significantly improved the Physical Component Score of the SF-36 from 28 to 38 points (p<0.001) compared to baseline subcutaneous infusion.
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