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Title of Journal: Clin Res Cardiol

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Abbravation: Clinical Research in Cardiology

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Springer Berlin Heidelberg

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DOI

10.1007/bf00299322

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1861-0692

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Procedural safety of a fully implantable intraveno

Authors: Manuel J Richter Ralf Ewert Christian Warnke Henning Gall Simon Classen Friedrich Grimminger Eckhard Mayer Werner Seeger HosseinArdeschir Ghofrani
Publish Date: 2016/09/26
Volume: 106, Issue: 3, Pages: 174-182
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Abstract

In patients with severe pulmonary arterial hypertension subcutaneous or catheterbased intravenous application of prostanoids carries a risk of local side effects or systemic infections which limits their use and acceptance Recently a fully implantable pump for continuous application of intravenous treprostinil was approved in Germany However surgery is a major risk for patients with severe pulmonary arterial hypertension The purpose of this study was to investigate the safety of a fully implantable pump inserted under local or general anesthesia in patients with severe pulmonary hypertensionAll patients with pulmonary hypertension undergoing pump implantation for the continuous application of intravenous treprostinil were included from two German centers Surgery was performed under local or general anesthesia according to the protocol of the recruiting center Intraoperative safety and inhospital complications were analyzed for the two different implantation regimensIn total 51 patients were included No major intraoperative complications were recorded During the observation period two patients died of progressive right heart failure and two patients required treatment in the intensive care unit for acute right heart decompensation and respiratory failure In total major complications occurred in 8 out of 51 patientsOur observational study provides preliminary evidence supporting the procedural safety of a fully implantable pump inserted under local or general anesthesia for patients with severe pulmonary hypertension The observation of major complications in a subset of patients requires extensive pre and postoperative assessments Future trials are required to provide further evidence for the longterm safety and efficacy of the pump using this approachEditorial assistance was provided by Adelphi Communications Ltd Bollington UK at the request of the authors This study was supported by a publication grant from United Therapeutics MJR has received support from United Therapeutics and Bayer Pharma AG and speaker fees from Actelion Mundipharma Roche and OMT RE has received research grants from Actelion and speaker fees from Bayer Pharma AG GlaxoSmithKline Pfizer Encysive and AstraZeneca HG has received support and/or honoraria from Actelion AstraZeneca Bayer Pharma AG GlaxoSmithKline Janssen Cilag Lilly Pfizer and United Therapeutics/OMT WS has received speaker/consultancy fees from Pfizer and Bayer Pharma AG FG has received research grants from Bayer Pharma AG Pfizer Ergonex and Encysive honoraria from Bayer Pharma AG Pfizer Actelion Encysive and Novartis and has been a paid consultant for Nycomed Altana Pharma HAG has received fees from Actelion Bayer Pharma AG Gilead GSK Lilly Lung Rx Merck Novartis and Pfizer The other authors have no relevant relationships to disclose

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