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Procedural safety of a fully implantable intravenous prostanoid pump for pulmonary hypertension

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Abstract

Background

In patients with severe pulmonary arterial hypertension, subcutaneous or catheter-based 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 hypertension.

Methods

All 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. Intra-operative safety and in-hospital complications were analyzed for the two different implantation regimens.

Results

In total, 51 patients were included. No major intra-operative 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 patients.

Conclusions

Our 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 post-operative assessments. Future trials are required to provide further evidence for the long-term safety and efficacy of the pump using this approach.

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Author information

Authors and Affiliations

  1. Department of Pneumology, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany

    Manuel J. Richter & Hossein-Ardeschir Ghofrani

  2. Department of Internal Medicine, German Center for Lung Research (DZL), Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, 35385, Giessen, Germany

    Manuel J. Richter, Henning Gall, Friedrich Grimminger, Werner Seeger & Hossein-Ardeschir Ghofrani

  3. Department of Internal Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany

    Ralf Ewert & Christian Warnke

  4. Department of Vascular Surgery, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany

    Simon Classen

  5. Department of Thoracic Surgery, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany

    Eckhard Mayer

  6. Department of Medicine, Imperial College London, London, UK

    Hossein-Ardeschir Ghofrani

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  1. Manuel J. Richter
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Correspondence to Hossein-Ardeschir Ghofrani.

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Conflict of interest

Editorial 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. M.J.R. has received support from United Therapeutics and Bayer Pharma AG, and speaker fees from Actelion, Mundipharma, Roche, and OMT. R.E. has received research grants from Actelion and speaker fees from Bayer Pharma AG, GlaxoSmithKline, Pfizer, Encysive, and AstraZeneca. H.G. has received support and/or honoraria from Actelion, AstraZeneca, Bayer Pharma AG, GlaxoSmithKline, Janssen Cilag, Lilly, Pfizer, and United Therapeutics/OMT. W.S. has received speaker/consultancy fees from Pfizer and Bayer Pharma AG. F.G. 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). H.-A.G. 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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Richter, M.J., Ewert, R., Warnke, C. et al. Procedural safety of a fully implantable intravenous prostanoid pump for pulmonary hypertension. Clin Res Cardiol 106, 174–182 (2017). https://doi.org/10.1007/s00392-016-1037-2

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  • DOI: https://doi.org/10.1007/s00392-016-1037-2

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