{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T20:55:24Z","timestamp":1792184124015,"version":"4.4.0"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2021,3,5]],"date-time":"2021-03-05T00:00:00Z","timestamp":1614902400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European J of Heart Fail"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Attenuating exercise\u2010induced elevated left atrial pressure with an atrial shunt device is under clinical investigation for treatment of symptomatic heart failure (HF).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>\n                      PRELIEVE was a prospective, non\u2010randomised, multicentre, first\u2010in\u2010man study in symptomatic HF patients with reduced (HFrEF) or preserved (HFpEF) ejection fraction and pulmonary capillary wedge pressure (PCWP) \u226515\u2009mmHg at rest or \u226525\u2009mmHg during exercise. Here, we provide follow\u2010up data up to 1 year after implantation of the Atrial Flow Regulator (AFR) device. The AFR was successfully implanted in 53 patients (HFrEF\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a024 and HFpEF\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a029). Two patients were not enrolled due to an unsuccessful transseptal puncture. There was one device embolisation into the left atrium, which required surgical removal. One patient experienced a serious procedure\u2010related adverse event (post\u2010procedural bleeding and syncope). All patients with sufficient echocardiography readout confirmed device patency with left\u2013right shunt both at 3 (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a047\/51, 92%) and 12 (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a045\/49, 92%) months. At 3 months, rest PCWP decreased by 5 (\u221212, 0) mmHg (\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a00.0003, median Q1, Q3). No patient developed a stroke, worsening of right heart function or significant increase of pulmonary artery pressure. Six (6\/53, 11%) patients were hospitalised for worsening of HF and three (3\/53, 6%) patients died. We observed improvements in New York Heart Association functional class, 6\u2010min walking distance and quality of life (Kansas City Cardiomyopathy Questionnaire) in certain patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Implantation of the AFR device in HF patients was feasible. No shunt occlusion, stroke or new right HF was observed during the 1\u2010year follow\u2010up, with clinical improvements in certain patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ejhf.2119","type":"journal-article","created":{"date-parts":[[2021,2,8]],"date-time":"2021-02-08T23:16:22Z","timestamp":1612826182000},"page":"800-810","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":74,"title":["One\u2010year results of the first\u2010in\u2010man study investigating the\n                    <scp>Atrial Flow Regulator<\/scp>\n                    for left atrial shunting in symptomatic heart failure patients: the\n                    <scp>PRELIEVE<\/scp>\n                    study"],"prefix":"10.1093","volume":"23","author":[{"given":"Christina","family":"Paitazoglou","sequence":"first","affiliation":[{"name":"Interventional Cardiology Cardiologicum Hamburg  Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin W.","family":"Bergmann","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Cardiologicum Hamburg  Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramazan","family":"\u00d6zdemir","sequence":"additional","affiliation":[{"name":"Department of Cardiology Bezmi\u00e2lem Vak\u0131f University  Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman","family":"Pfister","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Pulmonology, Angiology and Intensive Care Medicine Heart Center University Clinic K\u00f6ln  K\u00f6ln Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jozef","family":"Bartunek","sequence":"additional","affiliation":[{"name":"Cardiovascular Center Onze\u2010Lieve\u2010Vrouw Hospital  Aalst Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teoman","family":"Kilic","sequence":"additional","affiliation":[{"name":"Department of Cardiology Kocaeli University Medical Faculty  Kocaeli Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Lauten","sequence":"additional","affiliation":[{"name":"Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Schmeisser","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Angiology |University clinic Magdeburg A.\u00f6.R  Magdeburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehdi","family":"Zoghi","sequence":"additional","affiliation":[{"name":"Department of Cardiology Ege University Medical Faculty  Bornova\/Izmir Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan D.","family":"Anker","sequence":"additional","affiliation":[{"name":"Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Horst","family":"Sievert","sequence":"additional","affiliation":[{"name":"Cardiovascular Center Frankfurt  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Mahfoud","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Cardiology, Angiology and Intensive Care Medicine University Clinic Saarland  Homburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"AFR\u2010PRELIEVE Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,3,5]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu315"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehm037"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejhf.592"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehq426"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9149(58)90264-9"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cardfail.2014.01.005"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.032094"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/ehf2.12350"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejhf.111"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2015.03.198"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)00704-2"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)00585-7"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2018.07.001"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-19-00342"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.4244\/EIJY15M07_08"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11886-019-1118-8"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2018.2936"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.108.800490"}],"container-title":["European Journal of Heart Failure"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ejhf.2119","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ejhf.2119","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ejhf.2119","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T12:15:39Z","timestamp":1767701739000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ejhf.2119"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,5]]},"references-count":18,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2021,5]]}},"alternative-id":["10.1002\/ejhf.2119"],"URL":"https:\/\/doi.org\/10.1002\/ejhf.2119","archive":["Portico"],"relation":{},"ISSN":["1388-9842","1879-0844"],"issn-type":[{"value":"1388-9842","type":"print"},{"value":"1879-0844","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3,5]]},"assertion":[{"value":"2020-11-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-02-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-05","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}