{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T01:29:34Z","timestamp":1785115774489,"version":"3.55.0"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T00:00:00Z","timestamp":1762905600000},"content-version":"vor","delay-in-days":883,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2023,6,13]],"date-time":"2023-06-13T00:00:00Z","timestamp":1686614400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Occlutech International AB"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>We aim to assess the theoretical impact of the atrial flow regulator (AFR) on survival in heart failure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>The prospective, multicentre, open-label, non-randomised PRELIEVE study (NCT 03030274) assessed the safety and efficacy of the Occlutech AFR device in patients with symptomatic heart failure with reduced ejection fraction (HFrEF) (left ventricular ejection fraction (LVEF) \u2265 15% and &amp;lt;40%) or heart failure with preserved ejection fraction (HFpEF) (LVEF \u226540% and &amp;lt;70%) and elevated PCWP (\u226515 mmHg at rest or \u226525 mmHg during exercise). In this analysis, after the first 60 patients completed 12 months of follow-up, the theoretical impact of AFR implantation on survival was assessed by comparing the observed mortality rate with the median predicted probability for one-year mortality. Each subject's risk of mortality was predicted from individual baseline data using the Meta-Analysis Global Group in Chronic HF (MAGGIC) prognostic model. A total of 87 patients (46% female, median age 69 years [IQR 62\u201374]) had undergone successful device implantation for the treatment of HFrEF (53%) and HFpEF (47%). Sixty patients had a complete 12 month follow-up. The median follow-up was 351 days (interquartile range [IQR] 202\u2013370). Six (7%) patients died during follow-up (8.6 deaths per 100 patient-years; 95% confidence interval [CI] 2.7 to 15.5), all of which had HFrEF. The median predicted mortality rate for the overall study population was 12.2 deaths per 100 patient-years (95% CI 10.2 to 14.7). While the observed mortality rate (0 deaths per 100 patient-years) was significantly lower than the median predicted mortality rate (9.3 deaths per 100 patient-years; 95% CI 8.4 to 11.1) in patients with HFpEF (\u22129.3 deaths per 100 patient-years; 95% CI \u221211.1 to \u22128.4), there was no difference in patients with HFrEF (\u22123.6 deaths per 100 patient-years; 95% CI \u22129.5 to 3.0). Four deaths were HF-related deaths (5.7 HF-related deaths per 100 patient-years; 95% CI 1.4 to 11.9; 10.8 HF-related deaths per 100 patient-years; 95% CI 2.5 to 23.1 in the HFrEF subgroup).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In patients with HFpEF, the mortality rate following AFR implantation was lower than the predicted mortality rate. Dedicated randomised, controlled trials are needed \u2013 and currently ongoing \u2013 to investigate whether the AFR improves mortality.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ehf2.14384","type":"journal-article","created":{"date-parts":[[2023,6,14]],"date-time":"2023-06-14T00:47:53Z","timestamp":1686703673000},"page":"2559-2566","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Predicted Impact of Atrial Flow Regulator on Survival in Heart Failure with Reduced and Preserved Ejection Fraction"],"prefix":"10.1093","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1434-9556","authenticated-orcid":false,"given":"Lucas","family":"Lauder","sequence":"first","affiliation":[{"name":"Klinik f\u00fcr Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universit\u00e4tsklinikum des Saarlandes and Saarland University , Homburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin W.","family":"Bergmann","sequence":"additional","affiliation":[{"name":"Department of Interventional Cardiology, Cardiologicum Hamburg , Hamburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Paitazoglou","sequence":"additional","affiliation":[{"name":"University Heart Center L\u00fcbeck, Medical Clinic II, Cardiology, Angiology, Intensive Care Medicine, UKSH University Hospital Schleswig Holstein , L\u00fcbeck ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramazan","family":"\u00d6zdemir","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Bezmi\u00e2lem Vak\u0131f University , Istanbul ,","place":["Turkey"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christos","family":"Iliadis","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Pulmonology, Angiology and Intensive Care Medicine, Heart Center University Clinic K\u00f6ln , K\u00f6ln ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jozef","family":"Bartunek","sequence":"additional","affiliation":[{"name":"Cardiovascular Center, Onze-Lieve-Vrouw Hospital , Aalst ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Lauten","sequence":"additional","affiliation":[{"name":"Department of General and Interventional Cardiology, Helios Klinikum Erfurt , Erfurt ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Keller","sequence":"additional","affiliation":[{"name":"ACOMED Statistik , Leipzig ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Weber","sequence":"additional","affiliation":[{"name":"ACOMED Statistik , Leipzig ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Horst","family":"Sievert","sequence":"additional","affiliation":[{"name":"Cardiovascular Center Frankfurt , Frankfurt ,","place":["Germany"]}],"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 ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4425-549X","authenticated-orcid":false,"given":"Felix","family":"Mahfoud","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universit\u00e4tsklinikum des Saarlandes and Saarland University , Homburg ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,6,13]]},"reference":[{"key":"2026012114090976000_ehf214384-bib-0001","doi-asserted-by":"crossref","first-page":"3721","DOI":"10.1093\/eurheartj\/ehz713","article-title":"The haemodynamic basis of lung congestion during exercise in heart failure with preserved ejection fraction","volume":"40","author":"Reddy","year":"2019","journal-title":"Eur Heart J"},{"key":"2026012114090976000_ehf214384-bib-0002","doi-asserted-by":"crossref","first-page":"669","DOI":"10.1161\/CIRCHEARTFAILURE.111.961789","article-title":"Sympathetically mediated changes in capacitance","volume":"4","author":"Fallick","year":"2011","journal-title":"Circ Heart Fail"},{"key":"2026012114090976000_ehf214384-bib-0003","doi-asserted-by":"crossref","first-page":"1960","DOI":"10.1002\/ejhf.2360","article-title":"Feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure: a systematic review and meta-analysis","volume":"23","author":"Lauder","year":"2021","journal-title":"Eur J Heart Fail"},{"key":"2026012114090976000_ehf214384-bib-0004","doi-asserted-by":"crossref","first-page":"1130","DOI":"10.1016\/S0140-6736(22)00016-2","article-title":"Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial","volume":"399","author":"Shah","year":"2022","journal-title":"Lancet"},{"key":"2026012114090976000_ehf214384-bib-0005","doi-asserted-by":"crossref","first-page":"403","DOI":"10.4244\/EIJ-D-19-00342","article-title":"The AFR-PRELIEVE trial: a prospective, non-randomised, pilot study to assess the atrial flow regulator (AFR) in heart failure patients with either preserved or reduced ejection fraction","volume":"15","author":"Paitazoglou","year":"2019","journal-title":"EuroIntervention"},{"key":"2026012114090976000_ehf214384-bib-0006","doi-asserted-by":"crossref","first-page":"800","DOI":"10.1002\/ejhf.2119","article-title":"One-year results of the first-in-man study investigating the atrial flow regulator for left atrial shunting in symptomatic heart failure patients: the PRELIEVE study","volume":"23","author":"Paitazoglou","year":"2021","journal-title":"Eur J Heart Fail"},{"key":"2026012114090976000_ehf214384-bib-0007","doi-asserted-by":"crossref","first-page":"2129","DOI":"10.1093\/eurheartj\/ehw128","article-title":"2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure","volume":"37","author":"Ponikowski","year":"2016","journal-title":"Eur Heart J"},{"key":"2026012114090976000_ehf214384-bib-0008","doi-asserted-by":"crossref","first-page":"1750","DOI":"10.1093\/eurheartj\/ehr254","article-title":"The survival of patients with heart failure with preserved or reduced left ventricular ejection fraction: an individual patient data meta-analysis","volume":"33","author":"Meta-analysis Global Group in Chronic Heart Failure (MAGGIC)","year":"2012","journal-title":"Eur Heart J"},{"key":"2026012114090976000_ehf214384-bib-0009","doi-asserted-by":"crossref","first-page":"1404","DOI":"10.1093\/eurheartj\/ehs337","article-title":"Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies","volume":"34","author":"Pocock","year":"2013","journal-title":"Eur Heart J"},{"key":"2026012114090976000_ehf214384-bib-0010","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1111\/ejhf.32","article-title":"Predicting survival in heart failure: validation of the MAGGIC heart failure risk score in 51 043 patients from the Swedish heart failure registry","volume":"16","author":"Sartipy","year":"2014","journal-title":"Eur J Heart Fail"},{"key":"2026012114090976000_ehf214384-bib-0011","doi-asserted-by":"crossref","first-page":"3599","DOI":"10.1093\/eurheartj\/ehab368","article-title":"2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure","volume":"42","author":"McDonagh","year":"2021","journal-title":"Eur Heart J"},{"key":"2026012114090976000_ehf214384-bib-0012","doi-asserted-by":"crossref","first-page":"1451","DOI":"10.1056\/NEJMoa2107038","article-title":"Empagliflozin in heart failure with a preserved ejection fraction","volume":"385","author":"Anker","year":"2021","journal-title":"N Engl J Med"},{"key":"2026012114090976000_ehf214384-bib-0013","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1016\/j.ahj.2019.10.015","article-title":"Transcatheter InterAtrial shunt device for the treatment of heart failure: rationale and design of the pivotal randomized trial to REDUCE elevated left atrial pressure in patients with heart failure II (REDUCE LAP-HF II)","volume":"226","author":"Berry","year":"2020","journal-title":"Am Heart J"},{"key":"2026012114090976000_ehf214384-bib-0014","doi-asserted-by":"crossref","first-page":"1383","DOI":"10.1056\/NEJMoa1313731","article-title":"Spironolactone for heart failure with preserved ejection fraction","volume":"370","author":"Pitt","year":"2014","journal-title":"N Engl J Med"},{"key":"2026012114090976000_ehf214384-bib-0015","doi-asserted-by":"crossref","first-page":"1609","DOI":"10.1056\/NEJMoa1908655","article-title":"Angiotensin\u2013neprilysin inhibition in heart failure with preserved ejection fraction","volume":"381","author":"Solomon","year":"2019","journal-title":"N Engl J Med"},{"key":"2026012114090976000_ehf214384-bib-0016","doi-asserted-by":"crossref","first-page":"212","DOI":"10.1016\/j.cardfail.2014.01.005","article-title":"Effects of an interatrial shunt on rest and exercise hemodynamics: results of a computer simulation in heart failure","volume":"20","author":"Kaye","year":"2014","journal-title":"J Card Fail"},{"key":"2026012114090976000_ehf214384-bib-0017","doi-asserted-by":"crossref","first-page":"364","DOI":"10.1161\/CIRCULATIONAHA.117.032094","article-title":"Transcatheter interatrial shunt device for the treatment of heart failure with preserved ejection fraction (REDUCE LAP-HF I [Reduce elevated left atrial pressure in patients with heart failure])","volume":"137","author":"Feldman","year":"2018","journal-title":"Circulation"},{"key":"2026012114090976000_ehf214384-bib-0018","doi-asserted-by":"crossref","first-page":"588","DOI":"10.1161\/CIRCHEARTFAILURE.109.930701","article-title":"Exercise hemodynamics enhance diagnosis of early heart failure with preserved ejection fraction","volume":"3","author":"Borlaug","year":"2010","journal-title":"Circ Heart Fail"},{"key":"2026012114090976000_ehf214384-bib-0019","doi-asserted-by":"crossref","first-page":"3103","DOI":"10.1093\/eurheartj\/ehu315","article-title":"Pulmonary capillary wedge pressure during exercise and long-term mortality in patients with suspected heart failure with preserved ejection fraction","volume":"35","author":"Dorfs","year":"2014","journal-title":"Eur Heart J"},{"key":"2026012114090976000_ehf214384-bib-0020","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1016\/S0735-1097(97)00525-1","article-title":"Differential effect of acute baroreceptor unloading on cardiac and systemic sympathetic tone in congestive heart failure","volume":"31","author":"Kaye","year":"1998","journal-title":"J Am Coll Cardiol"},{"key":"2026012114090976000_ehf214384-bib-0021","doi-asserted-by":"crossref","first-page":"2556","DOI":"10.1093\/eurheartj\/ehaa495","article-title":"Randomized trials of invasive cardiovascular interventions that include a placebo control: a systematic review and meta-analysis","volume":"41","author":"Lauder","year":"2020","journal-title":"Eur Heart J"},{"key":"2026012114090976000_ehf214384-bib-0022","first-page":"776","article-title":"Linear regression analysis: part 14 of a series on evaluation of scientific publications","volume":"107","author":"Schneider","year":"2010","journal-title":"Dtsch Arztebl Int"}],"container-title":["ESC Heart Failure"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/eschf\/article-pdf\/10\/4\/2559\/64704893\/eschf_10_4_2559.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/eschf\/article-pdf\/10\/4\/2559\/64704893\/eschf_10_4_2559.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T19:09:41Z","timestamp":1769022581000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/eschf\/article\/10\/4\/2559\/8285318"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,13]]},"references-count":22,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2023,6,13]]},"published-print":{"date-parts":[[2023,8,1]]}},"URL":"https:\/\/doi.org\/10.1002\/ehf2.14384","relation":{},"ISSN":["2055-5822"],"issn-type":[{"value":"2055-5822","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,8]]},"published":{"date-parts":[[2023,6,13]]},"assertion":[{"value":"2022-06-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-04-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-06-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}