{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T23:49:54Z","timestamp":1792194594180,"version":"4.4.0"},"reference-count":11,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Heart Failure"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25\u201387) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Registration:<\/jats:title>\n            <jats:p>\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">http:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              . Unique identifier: NCT02645539.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circheartfailure.119.006666","type":"journal-article","created":{"date-parts":[[2020,4,8]],"date-time":"2020-04-08T09:00:23Z","timestamp":1586336423000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":20,"title":["Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients"],"prefix":"10.1161","volume":"13","author":[{"given":"Nir","family":"Uriel","sequence":"first","affiliation":[{"name":"Division of Cardiology, Columbia University Medical Center, New York, NY (N.U., G.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valluvan","family":"Jeevanandam","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teruhiko","family":"Imamura","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.)."},{"name":"Second Department of Medicine, University of Toyama, Japan (T.I.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Onsager","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tae","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeyoshi","family":"Ota","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen","family":"Juricek","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Combs","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Lammy","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Chicago Medical Center, IL (V.J., T.I., D.O., T.S., T.O., C.J., P.C., T.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonna","family":"Patel-Raman","sequence":"additional","affiliation":[{"name":"NuPulseCV, Raleigh, NC (S.P.-R., J.R.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua R.","family":"Woolley","sequence":"additional","affiliation":[{"name":"NuPulseCV, Raleigh, NC (S.P.-R., J.R.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel","family":"Sayer","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Columbia University Medical Center, New York, NY (N.U., G.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmelo","family":"Milano","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Duke University, Durham, NC (C.M., J.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob","family":"Schroder","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Duke University, Durham, NC (C.M., J.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ezequiel","family":"Molina","sequence":"additional","affiliation":[{"name":"Department of Surgery, MedStar Washington Hospital Center, DC. (E.M.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Grinstein","sequence":"additional","affiliation":[{"name":"Department of Cardiology, MedStar Washington Hospital Center, DC. (J.G.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erik","family":"Suarez","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Houston Methodist Research Institute, Houston, TX (E.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry D.","family":"Estep","sequence":"additional","affiliation":[{"name":"Kaufman Center for Heart Failure Treatment and Recovery, Cleveland Clinic Foundation, OH (J.D.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjeev","family":"Aggarwal","sequence":"additional","affiliation":[{"name":"Mid America Heart &amp; Lung Surgeons, Saint Luke\u2019s Mid-America Heart Institute, Kansas City, MO (S.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Silvestry","sequence":"additional","affiliation":[{"name":"Department of Heart Failure and Transplant, AdventHealth Cardiovascular Institute, Orlando, FL (S.S., N.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nirav","family":"Raval","sequence":"additional","affiliation":[{"name":"Department of Heart Failure and Transplant, AdventHealth Cardiovascular Institute, Orlando, FL (S.S., N.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"On behalf of the iVAS Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000152"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.healun.2018.11.013"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.healun.2016.09.002"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchf.2017.02.016"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.healun.2017.10.011"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1177\/2047487315625235"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jchf.2013.06.002"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2015.05.087"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cardfail.2018.11.001"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2015.05.014"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.healun.2017.07.005"}],"container-title":["Circulation: Heart Failure"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCHEARTFAILURE.119.006666","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T01:38:00Z","timestamp":1715564280000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCHEARTFAILURE.119.006666"}},"subtitle":["Results of the Multicenter Feasibility Trial"],"short-title":[],"issued":{"date-parts":[[2020,4]]},"references-count":11,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2020,4]]}},"alternative-id":["10.1161\/CIRCHEARTFAILURE.119.006666"],"URL":"https:\/\/doi.org\/10.1161\/circheartfailure.119.006666","relation":{},"ISSN":["1941-3289","1941-3297"],"issn-type":[{"value":"1941-3289","type":"print"},{"value":"1941-3297","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,4]]},"assertion":[{"value":"2019-10-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-02-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-04-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e006666"}}