PURPOSE: Subcutaneous (s.c.) Treprostinil (Remodulin®) is an established treatment for PAH. Infusion site pain leads to discontinuation of treatment in about 15%. Intravenous (i.v.) administration of prostanoids using external pumps is problematic with regard to infections.
METHODS: The Lenus Pro® implantable pump was specifically developed for i.v. administration of Treprostinil. We report first experience using the 40 ml Lenus Pro® pump with a constant flow rate of 1.3 ml/day, allowing a 28-day-filling-interval.
RESULTS: For example Patient 1 - functional class (NYHA) IV with recurrent syncopes during exercise. Right heart catheterization confirmed PAH with mean pulmonary arterial pressure (mPAP) of 62 mm Hg. Cardiac index at baseline 1.38 l/min/m2, NT-proBNP 1561 ng/l, a six minute walk test (6MWD) could not be performed. Bosentan treatment was started. Additional s.c. Treprostinil led to a substantial improvement. The patient experienced site pain and an infection of the infusion site requiring hospitalization. In August 2010 mPAP was 29 mm Hg, cardiac index 2.41 l/min/m2. MR testing showed an improvement of right ventricular function (RVEF increasing from 42% up to 59%). 40 ml Lenus Pro® pump was implanted September 2010 in general anesthesia. Subsequently we successfully implanted another 4 Lenus Pro® pumps. All these patients had shown significant clinical response to s.c. Treprostinil but reported site pain.- In summary Treprostinil led to an improvment in all patients, represented in an increase of 6MWD from 260,6 m to 352,8 m and a decrease of NTpBNP from 6977 ng/l to 1466 ng/l. Postoperatively two patients developed mild seroma; no other complications were observed.
CONCLUSIONS: All patients improved under Trepostinil s.c. but suffered of infusion site pain or infection.
CLINICAL IMPLICATIONS: Administration of i.v. Treprostinil with the implantable Lenus Pro® pump offers an exciting option to minimise the risk of infections. Treprostinil therapy with a filling interval of 28 days in an outpatient setting ensures optimal patient management, compliance and an increase in quality of life.
DISCLOSURE: The following authors have nothing to disclose: Regina Steringer-Mascherbuaer, Veronika Eder, Christian Ebner, Johannes Niel, Reinhold Fuegger, Susanne Wittrich, Charlotte Huber, Hans Jochen Nesser
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