{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2022,4,4]],"date-time":"2022-04-04T22:16:58Z","timestamp":1649110618562},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,5,15]],"date-time":"2021-05-15T00:00:00Z","timestamp":1621036800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,5,15]],"date-time":"2021-05-15T00:00:00Z","timestamp":1621036800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"German Centre of Lung Research"},{"name":"Medizinische Hochschule Hannover (MHH)"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Pulm Med"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this retrospective observational study, we analyzed all patients with pulmonary arterial hypertension undergoing LenusPro\u00ae pump implantation between November 2013 and October 2019 at our center. Periprocedural safety was assessed by describing all complications that occurred within 28 days after surgery; complications that occurred later were described to assess long-term safety. Clinical outcomes were measured by comparison of clinical parameters and echocardiographic measurements of right ventricular function from baseline to 6-months-follow-up.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Fifty-four patients underwent LenusPro\u00ae pump implantation for intravenous treprostinil treatment during the investigation period. Periprocedural complications occurred in 5 patients; the only anesthesia-related complication (right heart failure with recovery after prolonged intensive care and death in the further course) occurred in the only patient who underwent general anesthesia. All other patients underwent local anesthesia with or without short-acting (analgo-) sedation. Eighteen long-term complications occurred in 15 patients, most notably pump pocket or catheter related problems. Transplant-free survival rates at 1, 2, and 3 years were 77\u2009%, 56\u2009%, and 48\u2009%, respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Subcutaneous pump implantation under local anesthesia and conscious analgosedation while avoiding intubation and mechanical ventilation is feasible in patients with advanced PAH. Controlled studies are needed to determine the safest anesthetic approach for this procedure.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Background\/Objectives<\/jats:title>\n                <jats:p>Intravenous treprostinil treatment via a fully implantable pump is a treatment option for patients with advanced pulmonary arterial hypertension. However, there is no consensus on the preferred anesthetic approach for the implantation procedure. Primary objective was to assess periprocedural safety with particular attention to feasibility of local anesthesia and conscious analgosedation instead of general anesthesia. Long-term safety and clinical outcomes were secondary endpoints.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12890-021-01541-3","type":"journal-article","created":{"date-parts":[[2021,5,15]],"date-time":"2021-05-15T16:02:54Z","timestamp":1621094574000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Periprocedural safety and outcome after pump implantation for intravenous treprostinil administration in patients with pulmonary arterial hypertension"],"prefix":"10.1186","volume":"21","author":[{"given":"Jan C.","family":"Kamp","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Fuge","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan F.","family":"Karsten","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"R\u00fcmke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marius M.","family":"Hoeper","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Da-Hee","family":"Park","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"K\u00fchn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen M.","family":"Olsson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,5,15]]},"reference":[{"key":"1541_CR1","doi-asserted-by":"publisher","first-page":"306","DOI":"10.1016\/S2213-2600(15)00543-3","volume":"4","author":"MM Hoeper","year":"2016","unstructured":"Hoeper MM, Humbert M, Souza R, Idrees M, Kawut SM, et al. A global view of pulmonary hypertension. Lancet Respir Med 2016; 4: 306\u2013322. https:\/\/doi.org\/10.1016\/S2213-2600(15)00543-3.","journal-title":"Lancet Respir Med"},{"key":"1541_CR2","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1093\/eurheartj\/ehv317","volume":"37","author":"N Gali\u00e8","year":"2016","unstructured":"Gali\u00e8 N, Humbert M, Vachiery JL, Gibbs S, Lang I, et al. 2015 ESC\/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016;37:67\u2013119. https:\/\/doi.org\/10.1093\/eurheartj\/ehv317.","journal-title":"Eur Heart J"},{"key":"1541_CR3","doi-asserted-by":"publisher","unstructured":"Gali\u00e8 N, McLaughlin VV, Rubin LJ, Simonneau G. An overview of the 6th world symposium on pulmonary hypertension. Eur Respir J. 2019;53(1):1802148. https:\/\/doi.org\/10.1183\/13993003.02148-2018.\u00a0","DOI":"10.1183\/13993003.02148-2018"},{"key":"1541_CR4","doi-asserted-by":"publisher","unstructured":"Hoeper MM, Opitz C, Gr\u00fcnig E, Halank M, Ewert R, et al. Targeted therapy of pulmonary arterial hypertension: updated recommendations from the Cologne Consensus Conference 2018. Int J Cardiol 2018;;272S:37\u201345. https:\/\/doi.org\/10.1016\/j.ijcard.2018.08.082.","DOI":"10.1016\/j.ijcard.2018.08.082"},{"key":"1541_CR5","doi-asserted-by":"publisher","unstructured":"Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1996;334(5):296\u2013301. https:\/\/doi.org\/10.1056\/NEJM199602013340504.","DOI":"10.1056\/NEJM199602013340504"},{"key":"1541_CR6","doi-asserted-by":"publisher","unstructured":"Lindegaard Pedersen M, Kr\u00fcger M, Grimm D, Infanger M, Wehland M. The prostacyclin analogue treprostinil in the treatment of pulmonary arterial hypertension. Basic Clin Pharmacol Toxicol. 2019. https:\/\/doi.org\/10.1111\/bcpt.13305.","DOI":"10.1111\/bcpt.13305"},{"issue":"7","key":"1541_CR7","doi-asserted-by":"publisher","first-page":"748","DOI":"10.1016\/j.healun.2019.05.002","volume":"38","author":"KM Olsson","year":"2019","unstructured":"Olsson KM, Richter MJ, Kamp JC, Gall H, Heine A, et al. Intravenous treprostinil as an add-on therapy in patients with pulmonary arterial hypertension. J Heart Lung Transplant. 2019;38(7):748\u201356. https:\/\/doi.org\/10.1016\/j.healun.2019.05.002.","journal-title":"J Heart Lung Transplant"},{"key":"1541_CR8","doi-asserted-by":"publisher","unstructured":"Kurzyna M, Ma\u0142aczy\u0144ska-Rajpold K, Koteja A, Pawlak A, Chrzanowski \u0141, et al. An implantable pump Lenus pro\u00ae in the treatment of pulmonary arterial hypertension with intravenous treprostinil. BMC Pulm Med. 2017;17(1):162. https:\/\/doi.org\/10.1186\/s12890-017-0474-7.","DOI":"10.1186\/s12890-017-0474-7"},{"key":"1541_CR9","doi-asserted-by":"publisher","unstructured":"Richter MJ, Harutyunova S, Bollmann T, Classen S, Fuge J, et al. Flow rate variance of a fully implantable pump for the delivery of intravenous treprostinil in pulmonary arterial hypertension. Pulm Circ. 2020;10(1):2045894020910136. https:\/\/doi.org\/10.1177\/2045894020910136.","DOI":"10.1177\/2045894020910136"},{"issue":"6","key":"1541_CR10","doi-asserted-by":"publisher","first-page":"1302","DOI":"10.1183\/09031936.00089212","volume":"41","author":"S Meyer","year":"2013","unstructured":"Meyer S, McLaughlin V, Seyfarth HJ, Bull TM. Vizza CD, et al. Outcomes of noncardiac, nonobstetric surgery in patients with PAH: an international prospective survey. Eur Respir J. 2013;41(6):1302\u20137. https:\/\/doi.org\/10.1183\/09031936.00089212.","journal-title":"Eur Respir J"},{"key":"1541_CR11","doi-asserted-by":"publisher","unstructured":"Olsson KM, Halank M, Egenlauf B, Fistera D, Gall, H, et al. Decompensated right heart failure, intensive care and perioperative management in patients with pulmonary hypertension: updated recommendations from the Cologne Consensus Conference 2018. Int J Cardiol. 2018;272S:46\u201352. https:\/\/doi.org\/10.1016\/j.ijcard.2018.08.081.","DOI":"10.1016\/j.ijcard.2018.08.081"},{"key":"1541_CR12","doi-asserted-by":"publisher","first-page":"1691","DOI":"10.1016\/j.jacc.2005.02.055","volume":"45","author":"G Ramakrishna","year":"2005","unstructured":"Ramakrishna G, Sprung J, Ravi BS, Chandrasekaran K, McGoon MD. Impact of pulmonary hypertension on the outcomes of noncardiac surgery: predictors of perioperative morbidity and mortality. J Am Coll Cardiol. 2005; 45:1691\u20139.","journal-title":"J Am Coll Cardiol"},{"key":"1541_CR13","first-page":"239","volume":"70","author":"OA Minai","year":"2006","unstructured":"Minai OA, Venkateshiah SB, Arroliga AC. Surgical intervention in patients with moderate to severe pulmonary arterial hypertension. Conn Med. 2006;70:239\u201343.","journal-title":"Conn Med"},{"key":"1541_CR14","doi-asserted-by":"publisher","first-page":"1294","DOI":"10.1183\/09031936.00113009","volume":"35","author":"LC Price","year":"2010","unstructured":"Price LC, Montani D, Jais X, Dick JR, Simmoneau G, et al. Noncardiothoracic nonobstetric surgery in mild-to-moderate pulmonary hypertension. Eur Respir J. 2010;35:1294\u2013302.","journal-title":"Eur Respir J"},{"issue":"6","key":"1541_CR15","doi-asserted-by":"publisher","first-page":"1603","DOI":"10.1213\/01.ane.0000062523.67426.0b","volume":"96","author":"LG Fischer","year":"2003","unstructured":"Fischer LG, Van Aken H, B\u00fcrkle H. Management of pulmonary hypertension: physiological and pharmacological considerations for anesthesiologists. Anesth Analg. 2003;96(6):1603\u201316. https:\/\/doi.org\/10.1213\/01.ane.0000062523.67426.0b.","journal-title":"Anesth Analg."},{"key":"1541_CR16","doi-asserted-by":"publisher","unstructured":"Hoeper MM, Kramer T, Pan Z, Eichstaedt CA, Spiesshoefer J, et al. Mortality in pulmonary arterial hypertension: prediction by the 2015 European Pulmonary Hypertension Guidelines Risk Stratification Model. Eur Respir J. 2017;50(2):1700740. https:\/\/doi.org\/10.1183\/13993003.00740-2017.","DOI":"10.1183\/13993003.00740-2017"},{"key":"1541_CR17","doi-asserted-by":"publisher","first-page":"349","DOI":"10.19224\/ai2017.349","volume":"58","author":"G Geldner","year":"2017","unstructured":"Geldner G, Karst J, Wappler F, Zwissler B, Kalbe B, et al. Pr\u00e4operative Evaluation erwachsener Patienten vor elektiven, nicht herz-thoraxchirurgischen Eingriffen. Gemeinsame Empfehlung der DGAI, DGCH und DGIM. An\u00e4sth Intensivmed. 2017;58:349\u201364. https:\/\/doi.org\/10.19224\/ai2017.349.","journal-title":"An\u00e4sth Intensivmed"},{"key":"1541_CR18","doi-asserted-by":"publisher","unstructured":"Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, et al. 2014 ACC\/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology\/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014;64(22):e77-137. https:\/\/doi.org\/10.1016\/j.jacc.2014.07.944.","DOI":"10.1016\/j.jacc.2014.07.944"},{"key":"1541_CR19","doi-asserted-by":"publisher","first-page":"356982","DOI":"10.1155\/2012\/356982","volume":"2012","author":"J Gille","year":"2012","unstructured":"Gille J, Seyfarth HJ, Gerlach S, Malcharek M, Czeslick E, et al. Perioperative anesthesiological management of patients with pulmonary hypertension. Anesthesiol Res Pract. 2012;2012:356982. https:\/\/doi.org\/10.1155\/2012\/356982.","journal-title":"Anesthesiol Res Pract"},{"issue":"2","key":"1541_CR20","doi-asserted-by":"publisher","first-page":"117","DOI":"10.1055\/s-0041-110294","volume":"70","author":"HJ Seyfarth","year":"2016","unstructured":"Seyfarth HJ, Wirtz H, Gille J, Gerlach S, Grachtrup S, et al. Management and outcome of surgery in patients with severe pulmonary hypertension: a single-center experience. Pneumologie. 2016;70(2):117\u201322. https:\/\/doi.org\/10.1055\/s-0041-110294.","journal-title":"Pneumologie."},{"issue":"4","key":"1541_CR21","doi-asserted-by":"publisher","first-page":"395","DOI":"10.4103\/1658-354X.87270","volume":"5","author":"JD Tobias","year":"2011","unstructured":"Tobias JD, Leder M. Procedural sedation: a review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011;5(4):395\u2013410. https:\/\/doi.org\/10.4103\/1658-354X.87270.","journal-title":"Saudi J Anaesth."},{"issue":"3","key":"1541_CR22","doi-asserted-by":"publisher","first-page":"174","DOI":"10.1007\/s00392-016-1037-2","volume":"106","author":"MJ Richter","year":"2017","unstructured":"Richter MJ, Ewert R, Warnke C, Gall H, Classen S, et al. Procedural safety of a fully implantable intravenous prostanoid pump for pulmonary hypertension. Clin Res Cardiol. 2017;106(3):174\u201382.","journal-title":"Clin Res Cardiol"},{"issue":"10","key":"1541_CR23","doi-asserted-by":"publisher","first-page":"776","DOI":"10.1007\/s00392-017-1114-1","volume":"106","author":"R Ewert","year":"2017","unstructured":"Ewert R, Richter MJ, Steringer-Mascherbauer R, Gr\u00fcnig E, Lange TJ, et al. Intravenous treprostinil infusion via a fully implantable pump for pulmonary arterial hypertension. Clin Res Cardiol. 2017;106(10):776\u201383. https:\/\/doi.org\/10.1007\/s00392-017-1114-1.","journal-title":"Clin Res Cardiol"},{"issue":"10","key":"1541_CR24","doi-asserted-by":"publisher","first-page":"1235","DOI":"10.1016\/j.healun.2018.06.006","volume":"37","author":"MJ Richter","year":"2018","unstructured":"Richter MJ, Harutyunova S, Bollmann T, Classen S, Gall H, et al. Long-term safety and outcome of intravenous treprostinil via an implanted pump in pulmonary hypertension. J Heart Lung Transplant. 2018;37(10):1235\u201344. https:\/\/doi.org\/10.1016\/j.healun.2018.06.006.","journal-title":"J Heart Lung Transplant"},{"issue":"6","key":"1541_CR25","doi-asserted-by":"publisher","first-page":"1128","DOI":"10.1016\/j.chest.2017.04.188","volume":"152","author":"AB Waxman","year":"2017","unstructured":"Waxman AB, McElderry HT, Gomberg-Maitland M, Burke MC, Ross EL, et al. Totally implantable IV treprostinil therapy in pulmonary hypertension assessment of the implantation procedure. Chest. 2017;152(6):1128\u201334. https:\/\/doi.org\/10.1016\/j.chest.2017.04.188.","journal-title":"Chest."},{"issue":"9","key":"1541_CR26","doi-asserted-by":"publisher","first-page":"2173","DOI":"10.1111\/j.1600-6143.2010.03192.x","volume":"10","author":"KM Olsson","year":"2010","unstructured":"Olsson KM, Simon A, Strueber M, Hadem J, Wiesner O, et al. Extracorporeal membrane oxygenation in nonintubated patients as bridge to lung transplantation. Am J Transplant. 2010;10(9):2173\u20138. https:\/\/doi.org\/10.1111\/j.1600-6143.2010.03192.x.","journal-title":"Am J Transplant"}],"container-title":["BMC Pulmonary Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12890-021-01541-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12890-021-01541-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12890-021-01541-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,5,15]],"date-time":"2021-05-15T16:03:35Z","timestamp":1621094615000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcpulmmed.biomedcentral.com\/articles\/10.1186\/s12890-021-01541-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,15]]},"references-count":26,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["1541"],"URL":"https:\/\/doi.org\/10.1186\/s12890-021-01541-3","relation":{},"ISSN":["1471-2466"],"issn-type":[{"value":"1471-2466","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,5,15]]},"assertion":[{"value":"27 October 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 May 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 May 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"According to the recommendations of the local ethical committee at Hannover Medical School asking for ethical advice is not mandatory in the case of a strictly retrospective data analysis of anonymized data or biomaterials (ExternalRef removed). Treatment with treprostinil and pump implantation were not performed in an experimental design but as standard treatment in clinical routine. However, all patients gave written informed consent for the use of their data (Hannover Medical School Institutional Review Board Nr. 2923\u22122015).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"JCK, JF, JFK, SR, DP and CK declare that they have no financial and personal relationships with other people or organizations that could inappropriately influence their work; MMH reports personal fees for lectures and\/or consultations from Acceleron, Actelion, Bayer, GSK, Janssen, MSD, and Pfizer, all outside the submitted work; KMO reports personal fees from GSK, United Therapeutics, Pfizer, Bayer, MSD, Actelion\/Janssen, and grants from Actelion, all outside the submitted work.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"164"}}