{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:57:29Z","timestamp":1789693049064,"version":"4.0.1"},"reference-count":11,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2018,10,11]],"date-time":"2018-10-11T00:00:00Z","timestamp":1539216000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Procyrion, Inc"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2019,2,15]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>There are limited options for percutaneous mechanical circulatory support (pMCS) in patients requiring high\u2010risk percutaneous coronary intervention.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>This first\u2010in\u2010human, single\u2010center study aimed to evaluate the safety and feasibility of a novel pMCS device in high\u2010risk percutaneous coronary intervention patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Aortix (Procyrion, Houston, Texas) is a pMCS device deployed in the descending aorta via the femoral artery that uses axial flow to provide cardiac unloading and augment renal and systemic perfusion. We assessed the use and effect of the Aortix device in six patients undergoing high\u2010risk PCI. All patients had impaired left ventricular function, complex coronary disease, renal dysfunction, and suitable iliofemoral anatomy for Aortix placement via transfemoral approach. We recorded periprocedural events including hemodynamic effects of the device on cardiac output and urine output. We then followed patients up to 30\u2009days following the PCI procedure for adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Aortix delivery (18\u2009Fr sheath) took 4\u20139 min, mean support time was 70 (range 47\u201395) min, and mean flow rate through the device was 3.5 L\/min. During support, mean rate of urine output increased 10\u2010fold (range 2.5\u201325.0x). Estimated GFR improved at discharge compared with baseline (mean increase 6.95\u2009\u00b1\u20098.09\u2009mL\/min). There were no device failures and PCI was successful in all patients. Aortix was removed and hemostasis was achieved with a vascular closure device and manual pressure. No patients experienced adverse events or hemodynamic compromise. No clinically significant hemolysis occurred (mean LDH 239.2\u2009\u00b1\u200973.6 mU\/mL at baseline and 206.4\u2009\u00b1\u200982.2 mU\/mL at discharge). No vascular access complications were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Aortix, a novel pMCS device, was successfully deployed and retrieved in all initial patients undergoing high\u2010risk PCI. We noted no significant hemolysis with temporary use of this axial flow device. Improvement in eGFR suggests a potential renal protective effect and is an important area for future investigation in patients with impaired left ventricular function and renal dysfunction.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.27857","type":"journal-article","created":{"date-parts":[[2018,10,12]],"date-time":"2018-10-12T00:39:53Z","timestamp":1539304793000},"page":"428-433","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["First\u2010in\u2010human experience with Aortix intraaortic pump"],"prefix":"10.1002","volume":"93","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1269-9114","authenticated-orcid":false,"given":"Amit N.","family":"Vora","sequence":"first","affiliation":[{"name":"Duke Clinical Research Institute Duke University Medical Center  Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Schuyler Jones","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Duke University Medical Center  Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam D.","family":"DeVore","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Duke University Medical Center  Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian","family":"Ebner","sequence":"additional","affiliation":[{"name":"Sanitorio Italiano  Asuncion Paraguay"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Clifton","sequence":"additional","affiliation":[{"name":"Procyrion, Inc.  Houston Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manesh R.","family":"Patel","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Duke University Medical Center  Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,10,11]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.08.007"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2015.03.036"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAT.0b013e31828a6e74"},{"key":"e_1_2_7_5_1","first-page":"175","article-title":"Intra\u2010aortic balloon counterpulsation support for elective coronary angioplasty in the setting of poor left ventricular function: A two center experience","volume":"2","author":"Anwar A","year":"1990","journal-title":"J Invas Cardiol"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/0735-1097(90)90257-P"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2010.1190"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2009.09.018"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.112.098194"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(14)60813-5"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(15)60800-2"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1210357"}],"container-title":["Catheterization and Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fccd.27857","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ccd.27857","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T05:53:07Z","timestamp":1694670787000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ccd.27857"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,10,11]]},"references-count":11,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2019,2,15]]}},"alternative-id":["10.1002\/ccd.27857"],"URL":"https:\/\/doi.org\/10.1002\/ccd.27857","archive":["Portico"],"relation":{},"ISSN":["1522-1946","1522-726X"],"issn-type":[{"value":"1522-1946","type":"print"},{"value":"1522-726X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,10,11]]},"assertion":[{"value":"2018-05-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-11","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}