{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T11:07:45Z","timestamp":1788520065508,"version":"build-2803163510"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T00:00:00Z","timestamp":1771372800000},"content-version":"vor","delay-in-days":137,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,10,4]],"date-time":"2025-10-04T00:00:00Z","timestamp":1759536000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"DeKe Medical"},{"name":"National Key R&D Program","award":["2023YFC2412800"],"award-info":[{"award-number":["2023YFC2412800"]}]},{"name":"National Key R&D Program","award":["2022YFC2402804"],"award-info":[{"award-number":["2022YFC2402804"]}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82570443"],"award-info":[{"award-number":["82570443"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82570443"],"award-info":[{"award-number":["82570443"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Despite the potential of alginate hydrogel intramyocardial injections in the treatment of heart failure (HF), minimally invasive implantation techniques remain scarce. This study evaluated the safety and feasibility of percutaneous transcatheter endocardial alginate hydrogel injection (TEAi), facilitated by novel implants and a dedicated catheter-based device, in patients with HF with reduced ejection fraction (HFrEF).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and Results<\/jats:title>\n                    <jats:p>This first-in-human study enrolled HFrEF patients [New York Heart Association (NYHA) Class III\u2013IV and left ventricular ejection fraction (LVEF) \u226435%]. The primary endpoint was the incidence of procedure- or device-related serious adverse events (SADEs) at 30 days. Secondary endpoints included the device success rate, HF hospitalization at 6 months, and change from baseline to 6 months post-procedure in the following parameters: LVEF as assessed by MRI; NYHA functional class; 6 min walk test distance (6MWT); the quality of life assessed by the Kansas City Cardiomyopathy Heart Failure Questionnaire (KCCQ); and serum N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) level. Pre- and post-procedural biomechanical analysis was also evaluated. Ten patients successfully underwent TEAi with no SADEs at 30 days. There was one death and two HF hospitalizations at 6 months. At 6 months, LVEF improved from 17.7% \u00b1 3.8% to 24.9% \u00b1 11.2% (P = 0.021), end-systolic volume decreased from 297.5 \u00b1 67.9 mL to 264.8 \u00b1 101.4 mL (P = 0.029), and KCCQ scores increased from 49.7 \u00b1 3.9 to 79.0 \u00b1 8.07 (P = 0.008). No statistically significant changes were observed in end-diastolic volume, NT-proBNP and 6MWT at six months compared with the baseline. Biomechanical analysis revealed a reduction in peak left ventricular end-diastolic wall stress (6.5 \u00b1 1.1 kPa vs. 5.9 \u00b1 1.3 kPa, P = 0.043).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>TEAi is feasible and safe for the treatment of HFrEF, warranting further randomized, efficacy clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ehf2.15417","type":"journal-article","created":{"date-parts":[[2025,10,4]],"date-time":"2025-10-04T13:28:33Z","timestamp":1759584513000},"page":"4266-4276","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Percutaneous Endocardial Alginate\u2013Hydrogel Injection in the Treatment of Heart Failure: First-in-Human Study"],"prefix":"10.1093","volume":"12","author":[{"given":"Bo","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Cardiology, Xijing Hospital, Fourth Military Medical University , Xi'an ,","place":["China"]},{"name":"Corrib Research Centre for Advanced Imaging and Core Laboratory, University of Galway , Galway ,","place":["Ireland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuo","family":"Wang","sequence":"additional","affiliation":[{"name":"Digital Medical Research Center, School of Basic Medical Sciences, Fudan University , Shanghai ,","place":["China"]},{"name":"Shanghai Key Laboratory of Medical Imaging Computing and Computer Assisted Intervention , Shanghai ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Xijing Hospital, Fourth Military Medical University , Xi'an ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. Scott","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Virginia , Charlottesville, Virginia ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rutao","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Xijing Hospital, Fourth Military Medical University , Xi'an ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Meng","sequence":"additional","affiliation":[{"name":"Department of Ultrasonography, Xijing Hospital, Fourth Military Medical University , Xi'an ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Radiology, Xijing Hospital, Fourth Military Medical University , Xi'an ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cun-jun","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Xijing Hospital, Fourth Military Medical University , Xi'an ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinobu","family":"Onuma","sequence":"additional","affiliation":[{"name":"Corrib Research Centre for Advanced Imaging and Core Laboratory, University of Galway , Galway ,","place":["Ireland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yunbing","family":"Wang","sequence":"additional","affiliation":[{"name":"National Engineering Research Center for Biomaterials, Sichuan University , Chengdu ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick W.J.C.","family":"Serruys","sequence":"additional","affiliation":[{"name":"Corrib Research Centre for Advanced Imaging and Core Laboratory, University of Galway , Galway ,","place":["Ireland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Runlin","family":"Gao","sequence":"additional","affiliation":[{"name":"Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Randall J.","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of California\u2013San Francisco , San Francisco, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Tao","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Xijing Hospital, Fourth Military Medical University , Xi'an ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,10,4]]},"reference":[{"key":"2026021804222569300_ehf215417-bib-0001","doi-asserted-by":"publisher","DOI":"10.3390\/ijms23073482","article-title":"Progress in bioengineering strategies for heart regenerative medicine","volume":"23","author":"H\u00e4neke","year":"2022","journal-title":"Int J Mol Sci"},{"key":"2026021804222569300_ehf215417-bib-0002","doi-asserted-by":"publisher","first-page":"170","DOI":"10.1016\/j.actbio.2020.04.033","article-title":"Intra-myocardial alginate hydrogel injection acts as a left ventricular mid-wall constraint in swine","volume":"111","author":"Sack","year":"2020","journal-title":"Acta Biomater"},{"key":"2026021804222569300_ehf215417-bib-0003","doi-asserted-by":"publisher","first-page":"714","DOI":"10.1016\/j.jacc.2005.04.056","article-title":"Thickening of the infarcted wall by collagen injection improves left ventricular function in rats: a novel approach to preserve cardiac function after myocardial infarction","volume":"46","author":"Dai","year":"2005","journal-title":"J Am Coll Cardiol"},{"key":"2026021804222569300_ehf215417-bib-0004","doi-asserted-by":"publisher","first-page":"1388","DOI":"10.1161\/CIRCULATIONAHA.107.727420","article-title":"Effect of injectable alginate implant on cardiac remodeling and function after recent and old infarcts in rat","volume":"117","author":"Landa","year":"2008","journal-title":"Circulation"},{"key":"2026021804222569300_ehf215417-bib-0005","doi-asserted-by":"publisher","first-page":"11507","DOI":"10.1073\/pnas.1004097107","article-title":"Injectable hydrogel properties influence infarct expansion and extent of postinfarction left ventricular remodeling in an ovine model","volume":"107","author":"Ifkovits","year":"2010","journal-title":"Proc Natl Acad Sci U S A"},{"key":"2026021804222569300_ehf215417-bib-0006","doi-asserted-by":"publisher","first-page":"751","DOI":"10.1016\/j.jacc.2011.10.888","article-title":"Catheter-deliverable hydrogel derived from Decellularized ventricular extracellular matrix increases endogenous cardiomyocytes and preserves cardiac function post-myocardial infarction","volume":"59","author":"Singelyn","year":"2012","journal-title":"J Am Coll Cardiol"},{"key":"2026021804222569300_ehf215417-bib-0007","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1016\/j.ijcard.2015.06.111","article-title":"The feasibility and safety of Algisyl-LVR\u2122 as a method of left ventricular augmentation in patients with dilated cardiomyopathy: initial first in man clinical results","volume":"199","author":"Lee","year":"2015","journal-title":"Int J Cardiol"},{"key":"2026021804222569300_ehf215417-bib-0008","doi-asserted-by":"publisher","first-page":"2022","DOI":"10.1016\/j.ijcard.2013.01.003","article-title":"Algisyl-LVR\u2122 with coronary artery bypass grafting reduces left ventricular wall stress and improves function in the failing human heart","volume":"168","author":"Lee","year":"2013","journal-title":"Int J Cardiol"},{"key":"2026021804222569300_ehf215417-bib-0009","doi-asserted-by":"publisher","first-page":"1014","DOI":"10.1016\/j.jacc.2009.06.010","article-title":"Intracoronary injection of in situ forming alginate hydrogel reverses left ventricular remodeling after myocardial infarction in swine","volume":"54","author":"Leor","year":"2009","journal-title":"J Am Coll Cardiol"},{"key":"2026021804222569300_ehf215417-bib-0010","doi-asserted-by":"publisher","first-page":"252","DOI":"10.1016\/j.jchf.2013.02.006","article-title":"Augmentation of left ventricular wall thickness with alginate hydrogel implants improves left ventricular function and prevents progressive remodeling in dogs with chronic heart failure","volume":"1","author":"Sabbah","year":"2013","journal-title":"JACC: Heart Fail"},{"key":"2026021804222569300_ehf215417-bib-0011","doi-asserted-by":"publisher","first-page":"314","DOI":"10.1002\/ejhf.449","article-title":"One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure: one-year follow-up results from AUGMENT-HF","volume":"18","author":"Mann","year":"2016","journal-title":"Eur J Heart Fail"},{"key":"2026021804222569300_ehf215417-bib-0012","doi-asserted-by":"publisher","first-page":"403","DOI":"10.1089\/107632704323061762","article-title":"Fibrin glue alone and skeletal myoblasts in a fibrin scaffold preserve cardiac function after myocardial infarction","volume":"10","author":"Christman","year":"2004","journal-title":"Tissue Eng"},{"key":"2026021804222569300_ehf215417-bib-0013","doi-asserted-by":"publisher","first-page":"414","DOI":"10.3389\/fbioe.2020.00414","article-title":"Alginate formulations: current developments in the race for hydrogel-based cardiac regeneration","volume":"8","author":"Cattelan","year":"2020","journal-title":"Front Bioeng Biotechnol"},{"key":"2026021804222569300_ehf215417-bib-0014","doi-asserted-by":"publisher","first-page":"H1708","DOI":"10.1152\/ajpheart.00911.2004","article-title":"Alginate plasma expander maintains perfusion and plasma viscosity during extreme hemodilution","volume":"288","author":"Cabrales","year":"2005","journal-title":"Am J Physiol Heart Circ Physiol"},{"key":"2026021804222569300_ehf215417-bib-0015","doi-asserted-by":"publisher","first-page":"715","DOI":"10.1016\/j.jacc.2016.05.053","article-title":"Bioabsorbable intracoronary matrix for prevention of ventricular remodeling after myocardial infarction","volume":"68","author":"Rao","year":"2016","journal-title":"J Am Coll Cardiol"},{"key":"2026021804222569300_ehf215417-bib-0016","doi-asserted-by":"publisher","first-page":"2297","DOI":"10.1093\/eurheartj\/ehv259","article-title":"A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial)","volume":"36","author":"Anker","year":"2015","journal-title":"Eur Heart J"},{"key":"2026021804222569300_ehf215417-bib-0017","doi-asserted-by":"publisher","first-page":"842","DOI":"10.1007\/s12265-024-10497-8","article-title":"Percutaneous alginate hydrogel endomyocardial injection with a novel dedicated catheter delivery system: an animal feasibility study","volume":"17","author":"Wang","year":"2024","journal-title":"J Cardiovasc Transl Res"},{"key":"2026021804222569300_ehf215417-bib-0018","doi-asserted-by":"publisher","first-page":"326","DOI":"10.1093\/eurheartj\/ehac671","article-title":"First-in-human transcatheter endocardial alginate-hydrogel implantation for the treatment of heart failure","volume":"44","author":"Wang","year":"2023","journal-title":"Eur Heart J"},{"key":"2026021804222569300_ehf215417-bib-0019","doi-asserted-by":"publisher","first-page":"961","DOI":"10.1016\/j.jchf.2020.10.002","article-title":"Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium","volume":"8","author":"Abraham","year":"2020","journal-title":"JACC Heart Fail"},{"key":"2026021804222569300_ehf215417-bib-0020","doi-asserted-by":"publisher","first-page":"935","DOI":"10.1016\/j.athoracsur.2011.04.089","article-title":"A novel method for quantifying the in-vivo mechanical effect of material injected into a myocardial infarction","volume":"92","author":"Wenk","year":"2011","journal-title":"Ann Thorac Surg"},{"key":"2026021804222569300_ehf215417-bib-0021","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0021571","article-title":"Increased infarct wall thickness by a bio-inert material is insufficient to prevent negative left ventricular remodeling after myocardial infarction","volume":"6","author":"Rane","year":"2011","journal-title":"PLoS ONE"},{"key":"2026021804222569300_ehf215417-bib-0022","doi-asserted-by":"publisher","first-page":"659","DOI":"10.1016\/j.jacbts.2019.07.012","article-title":"First-in-man study of a cardiac extracellular matrix hydrogel in early and late myocardial infarction patients","volume":"4","author":"Traverse","year":"2019","journal-title":"JACC: Basic Transl Sci"},{"key":"2026021804222569300_ehf215417-bib-0023","doi-asserted-by":"publisher","first-page":"681","DOI":"10.1177\/0885328218805878","article-title":"Advanced material catheter (AMCath), a minimally invasive endocardial catheter for the delivery of fast-gelling covalently cross-linked hyaluronic acid hydrogels","volume":"33","author":"Dolan","year":"2018","journal-title":"J Biomater Appl"},{"key":"2026021804222569300_ehf215417-bib-0024","doi-asserted-by":"publisher","first-page":"2627","DOI":"10.1161\/CIRCULATIONAHA.106.657270","article-title":"Theoretical impact of the injection of material into the myocardium: a finite element model simulation","volume":"114","author":"Wall","year":"2006","journal-title":"Circulation"},{"key":"2026021804222569300_ehf215417-bib-0025","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.116.004058","article-title":"Injectable shear-thinning hydrogels for minimally invasive delivery to infarcted myocardium to limit left ventricular remodeling","volume":"9","author":"Rodell","year":"2016","journal-title":"Circ Cardiovasc Interv"}],"container-title":["ESC Heart Failure"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/eschf\/article-pdf\/12\/6\/4266\/66967864\/eschf_12_6_4266.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/eschf\/article-pdf\/12\/6\/4266\/66967864\/eschf_12_6_4266.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,18]],"date-time":"2026-02-18T09:22:35Z","timestamp":1771406555000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/eschf\/article\/12\/6\/4266\/8488215"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,4]]},"references-count":25,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2025,10,4]]},"published-print":{"date-parts":[[2025,12,1]]}},"URL":"https:\/\/doi.org\/10.1002\/ehf2.15417","relation":{},"ISSN":["2055-5822"],"issn-type":[{"value":"2055-5822","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2025,12]]},"published":{"date-parts":[[2025,10,4]]},"assertion":[{"value":"2025-02-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-19","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-04","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}