Procedural safety of a fully implantable intravenous prostanoid pump for pulmonary hypertension.
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.
Department of Pneumology, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany.|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
MJ
Richter
Department of Internal Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany.
Ralf
R
Ewert
Department of Internal Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany.
Christian
C
Warnke
Department of Internal Medicine, German Center for Lung Research (DZL), Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, 35385, Giessen, Germany.
Henning
H
Gall
Department of Vascular Surgery, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany.
Simon
S
Classen
Department of Internal Medicine, German Center for Lung Research (DZL), Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, 35385, Giessen, Germany.
Friedrich
F
Grimminger
Department of Thoracic Surgery, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany.
Eckhard
E
Mayer
Department of Internal Medicine, German Center for Lung Research (DZL), Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, 35385, Giessen, Germany.
Werner
W
Seeger
Department of Pneumology, Kerckhoff Heart and Thoracic Center, Bad Nauheim, Germany. ardeschir.ghofrani@innere.med.uni-giessen.de.|Department of Internal Medicine, German Center for Lung Research (DZL), Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center, 35385, Giessen, Germany. ardeschir.ghofrani@innere.med.uni-giessen.de.|Department of Medicine, Imperial College London, London, UK. ardeschir.ghofrani@innere.med.uni-giessen.de.
Hossein-Ardeschir
HA
Ghofrani
D000328:Adult; D000959:Antihypertensive Agents / Q000008:administration & dosage; D011464:Epoprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000503:physiopathology; D015918:Infusion Pumps, Implantable; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011453:Prostaglandins / Q000008:administration & dosage; D011669:Pulmonary Wedge Pressure / Q000502:physiology*; D012189:Retrospective Studies; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D011453:Prostaglandins; D011464:Epoprostenol; C427248:treprostinil
Implantable pump; Intravenous prostanoid; Pulmonary arterial hypertension
Aesthet Surg J. 2009 Mar-Apr;29(2):122-8
19371843
Semin Cardiothorac Vasc Anesth. 2014 Dec;18(4):310-8
24828282
Heart Lung. 2012 Nov-Dec;41(6):599-605
22920608
J Bone Joint Surg Am. 2006 May;88(5):959-63
16651569
Chest. 2015 Feb;147(2):484-494
25320967
Respiration. 2013;86(5):402-6
23817035
Anesthesiology. 2003 Dec;99(6):1415-32
14639158
Eur Respir J. 2013 Jun;41(6):1302-7
23143546
Chest. 2004 Jul;126(1):90-4
15249447
Eur J Radiol. 2011 Sep;79(3):338-42
20227211
Eur Respir Rev. 2014 Dec;23(134):408-9
25445938
J Cardiovasc Pharmacol. 2003 Feb;41(2):293-9
12548091
World J Surg. 2015 Feb;39(2):328-34
25245435
Eur Respir J. 2009 Jul;34(1):132-7
19251782
Chest. 2016 Jul;150(1):27-34
27396777
Eur Respir Rev. 2014 Dec;23(134):469-75
25445945
Expert Opin Drug Metab Toxicol. 2010 Nov;6(11):1313-32
20738226
Anaesthesia. 1996 Oct;51(10):981-5
8984879
Eur Respir J. 2014 Jun;43(6):1691-7
24627535
Eur Respir J. 2009 Dec;34(6):1219-63
19749199
Anesth Analg. 2003 Jun;96(6):1603-16
12760982
Eur Heart J. 2016 Jan 1;37(1):67-119
26320113
J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D60-72
24355643
Mayo Clin Proc. 2012 Sep;87(9):825-34
22883740
Bone Marrow Transplant. 1998 Jun;21(11):1149-52
9645579
Am J Phys Med Rehabil. 2000 Nov-Dec;79(6):536-41
11083304
J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D34-41
24355639
Int J Clin Pract Suppl. 2008 Jul;(160):5-9
18638170
N Engl J Med. 1996 Feb 1;334(5):296-301
8532025
Eur J Clin Microbiol Infect Dis. 2013 Jul;32(7):883-9
23388830
J Heart Lung Transplant. 2010 Aug;29(8):841-6
20430649
Chest. 2012 Jan;141(1):36-42
21659437
J Bone Joint Surg Am. 2006 Feb;88(2):282-9
16452738
Am J Respir Crit Care Med. 2012 Dec 1;186(11):1196-8
23204382
Am J Respir Crit Care Med. 2002 Mar 15;165(6):800-4
11897647