Pulmonary Hypertension Clinical Trial
Official title:
LPS (Lenus Pro Safety) - Study in Pulmonary Hypertension (PH)
The clinical study aims to investigate the numbers of predefined complications in the first
six month after implantation of the implantable LENUS Pro® medications pump for intravenous
application of treprostinil sodium in patients with PAH.
The manufacturer is Tricumed GmbH, Germany; exclusive marketing rights: OMT GmbH & Co KG
78665 Frittlingen, Germany.
The previously used fully implantable pumps have been improved by development of additional
safety options (e.g. acoustic occlusion alarm) for use in patients with PH. In the meantime,
the pump (manufacturer: Tricumed GmbH, Germany, exclusively marketing rights: OMT GmbH & Co
KG, 78665 Frittlingen, Germany) is offered with an option that meets the requirements for
use in treating PH patients. It is based on a constant flow system that consists of gas
driven micro-infusion via a chip capillary. The medication is filled into a titanium
reservoir via a so-called filling septum (silicon membrane). The membrane is punctured
percutaneously with a special needle by specially trained personnel for filling under
aseptic conditions. Various safety options ensure a continuous flow rate of the medication
and signalize any malfunctions. If catheter occlusion is signalized, the catheter can be
rinsed through a second septum in the pump after a percutaneous puncture without emptying
the medication reservoir. The pump is available in two sizes (20 ml or 40 ml filling
volume). The flow rate set for the 20 ml pump is 1.0 ml/ 24 hours, so that refilling is
required every 19 to 20 days. The flow rate set for the 40 ml pump is 2.3 ml/ 24 hours, so
that refilling is required every 29 to 30 days. Initial experience with the use of this pump
has shown good results for up to 3 years of use (minor complications during implantation, no
pump defects in long-term usage, reliable filling under outpatient conditions).
R. Ewert; M. Halank, L. Bruch; H.A. Ghofrani. The implantable pump - a new option for
intravenous therapy in patients with severe pulmonary hypertension. Am J Respir Crit Care
2012;186:1196-98 Steringer-Mascherbauer R., Eder V., Ebner Ch. et al. First experience with
intravenous treprostinil delivered by an implantable pump (Lenus Pro®) with filling
intervals of 28 days in a patient with pulmonary arterial hypertension (PAH) - a case
report. ATS Poster Desole S, Velik-Salchner C, Fraedrich G et al. Subcutaneous implantation
of a new intravenous pump system for prostacyclin treatment in patients with pulmonary
arterial hypertension. Heart Lung 2012 Aug 21. [Epub ahead of print]
Such pumps have been implanted in more than 90 patients in various European countries during
the past 3 years. Experience shows that most of the patients selected for implantation have
FC II-IV under combination therapy (2-3 specific PH-medications). The previous medication
was either regarded as insufficient in respect to cardiopulmonary stabilization or the side
effects of the therapy were intolerable. The latter applied particularly to patients with
subcutaneous delivery of treprostinil in fairly large doses.
Given the previous application of the LENUS Pro® pump in the context of individualized
healing attempts, the initiators of the planned study consider that it is necessary to
ascertain the safety of this fully implantable pump system in a controlled prospective
study.
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Observational Model: Cohort, Time Perspective: Prospective
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